Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Potomac Falls Health & Rehab Center
Centers for Medicare & Medicaid Services.
Docket No. C-17-967
Decision No. CR5812
Potomac Falls Health & Rehab Center (Petitioner or "the facility"), is a skilled nursing facility (SNF) in Sterling, Virginia that participates in the Medicare program. Following a standard survey in March 2017, the Centers for Medicare & Medicaid Services (CMS) determined that Petitioner was not in substantial compliance with Medicare participation requirements and that one of the cited deficiencies posed immediate jeopardy to resident health and safety. CMS imposed, inter alia, a per-day civil monetary penalty (CMP) of $6,550 for 272 days during the period of immediate jeopardy noncompliance. For the reasons discussed below, I find that Petitioner was not in substantial compliance with Medicare program requirements. CMS's immediate jeopardy determination was not clearly erroneous, and the remedy imposed is reasonable.
The Social Security Act (Act) establishes requirements for SNF participation in the Medicare program and authorizes the Secretary of Health and Human Services (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, SNFs must maintain substantial compliance with program participation
requirements. In order to be in substantial compliance, 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).
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 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).
The Virginia Department of Health's Office of Licensure and Certification (state agency) completed a standard survey on March 23, 2017, at which time it determined that the facility was not in substantial compliance with Medicare program participation requirements. CMS Ex. 1 at 1. The state agency determined that one deficiency, cited as 42 C.F.R. § 483.25(d)(1)-(2)(n)(1)-(3),1 Tag F3232 at the "K"3 level of scope and
severity, was an immediate jeopardy deficiency,4 and that another deficiency, cited as Tag F309 at the "G" level scope and severity, resulted in actual harm to a resident. CMS Ex. 1 at 10-68. The state agency also cited other deficiencies at a lower level of severity than the aforementioned deficiencies. CMS Ex. 1 at 1-10, 68-90.
In a letter dated May 31, 2017, CMS notified Petitioner that it had not been in substantial compliance with Medicare program participation requirements and that it returned to substantial compliance effective May 12, 2017, based on a May 30, 2017 revisit survey. CMS Ex. 2 at 2. CMS imposed a per-day CMP of $6,550 for 272 days beginning June 23, 2016, through March 21, 2017, and a per-day CMP of $503 from March 22, 2017, until Petitioner returned to substantial compliance on May 12, 2017.5 CMS Ex. 2 at 2. The total CMP imposed was $1,806,750. CMS Ex. 2 at 2. On July 20, 2017, after CMS "determined that the CMP might cause undue financial hardship that could have a significant impact on [Petitioner's] ability to operate," CMS reduced the CMP by 20 percent to $1,445,400 and approved a 12-month payment plan.6 CMS Ex. 55 at 1.
Petitioner, through counsel, timely requested a hearing on July 27, 2017, in which it challenged the immediate jeopardy deficiency cited under 42 C.F.R. § 483.25(d)(1), (2). CMS filed a pre-hearing brief (CMS Br.) and 73 proposed exhibits (CMS Exs. 1-73), and Petitioner filed a pre-hearing brief (P. Br.) and 61 proposed exhibits (P. Exs. 1-61).
I held the first of two pre-hearing conferences on May 21, 2019. In an order dated May 23, 2019, modified by an order dated May 31, 2019, I summarized the discussions that took place during the first pre-hearing conference, to include my rulings on pending objections. I held the second pre-hearing conference on October 23, 2019. In an order dated October 24, 2019, I addressed additional evidentiary matters. Prior to the hearing, I admitted CMS Exs. 1-58, 60-61, 64‑65, and 67-737 and P. Exs. 1B, 2-61 into the evidentiary record.8 See Transcript (Tr.) at 7-8.
The parties and their witnesses appeared for cross-examination at an in-person hearing in Washington, DC on November 12-13, 2019. Tr. at 3 (listing Day 1 witnesses Ms. Russell, Mr. Covington, Ms. Darnell, Ms. Meyer, and Ms. Dawson), 465 (listing Day 2 witnesses Ms. Hojnacki, Ms. Genest, Ms. Barcus, Ms. Kelly, and Ms. Rojas); see CMS Exs. 60-61, 64-65; P. Exs. 43-45, 47-49, 51-52.9 The parties filed post-hearing briefs (CMS Post-Hrg. Br.; P. Post-Hrg. Br.) and reply briefs (CMS Post-Hrg. Reply; P. Post‑Hrg. Reply). The record is closed and the case is ready for a decision on the merits.
The issues presented are:
Whether Petitioner failed to substantially comply with the Medicare participation requirement at 42 C.F.R. § 483.25(d)(1), (2) (cited as Tag F323);
Whether CMS's finding that Petitioner's substantial noncompliance posed immediate jeopardy to resident health and safety was clearly erroneous;
Whether CMS's determination regarding the duration of the period of immediate jeopardy and noncompliance was clearly erroneous; and
Whether the CMP imposed by CMS is reasonable.
Resident # 18, a man born in 1958, had been a resident of the facility since June 2005. CMS Ex. 4 at 1. Diagnoses listed in Resident # 18's admission record include generalized and intractable epilepsy, spastic hemiplegia affecting the right dominant side, dysphagia, intellectual disabilities, and major depressive disorder. CMS Ex. 4 at 1. Physician progress notes also document a primary diagnosis of traumatic brain injury (TBI), and report that Resident # 18 had musculoskeletal contractures and generalized weakness. CMS Ex. 7 at 2, 4, 6. Resident # 18's physician assessed that he had a "poor prognosis." CMS Ex. 7 at 2, 4, 6.
Petitioner administered a Braden scale assessment in June 2016 and determined that Resident # 18 was at "moderate risk" for pressure sores based on the following factors: slightly limited sensory perception, occasionally moist skin, a "chairfast" degree of physical activity, very limited mobility, probably inadequate nutrition, and problematic friction and shear owing to his need for moderate to maximum assistance in moving. CMS Ex. 9 at 1-2.
A June 3, 2016 Minimum Data Set (MDS) assessment, signed by the MDS Coordinator on June 14, 2016, reports that Resident # 18 had limitation in functional range of motion of both upper and both lower extremities that "interfered with daily functions or placed [him] at risk of injury." CMS Ex. 5 at 16, 61. The MDS reported that during the lookback period, Resident #18 had total dependence on staff for performance of several activities of daily living (ADLs), including locomotion, transfers, dressing, and personal hygiene. CMS Ex. 5 at 15. The MDS assessment reported that Resident # 18 required extensive assistance, including weight-bearing support, with other ADLs. CMS Ex. 5 at 15. The MDS reported that Resident # 18 had a mechanically altered diet during the lookback period, which "require[d] change in texture of food or liquids (e.g., pureed food, thickened liquids)." CMS Ex. 5 at 23.
Facility records document that Resident # 18 was served all three meals in his room on June 23, 2016.11 CMS Ex. 6. Standing orders reflect that Resident # 18 was given coffee thickened with honey with each meal. CMS Ex. 6. Resident # 18 was on a pureed diet,
although he was permitted to eat mechanical soft food when his private caregiver or family was present.12 CMS Ex. 6.
A progress note dated June 24, 2016, documents that "Victor," Resident # 18's private sitter, reported that Resident # 18 "spilled hot coffee on self and have burn at [5:30 pm]." CMS Ex. 10 at 1 see P. Ex. 43 at 2-3 (Ms. Darnell's testimony about Victor's relationship with Resident # 18). The evidentiary record does not contain a statement from Victor, but the lead surveyor, Ms. Russell, reported the following information based on an interview with Victor, which she attested that she had "accurately documented" in the Form 2567 Statement of Deficiencies:
On 3/27/17 . . . an interview was conducted with Resident # 18's Private Caregiver. The Caregiver was asked to explain what happened the night Resident # 18 was burned from a coffee spill. The Caregiver stated, "[Resident # 18] has seizures. That day he said he liked to drink some coffee, so I went to the kitchen and got the coffee from the machine and I put thickener in it. After that I gave it to him and he had a seizure. His hand went down and the coffee went all over his abdomen. I toweled him off and told the nurse he had a seizure and spilt his coffee. Everytime he has a seizure I tell the nurse. She came in and checked him; he had blisters all over his belly.
CMS Exs. 1 at 25; 65 at 4-5.
The nurse who took the report "assessed" Resident # 18 and observed "burn on bilateral lower quad." CMS Ex. 10 at 1. The nurse documented that "[o]n the left quad is [a] blister" and [o]n right quad is [a] scar."13 CMS Ex. 10 at 1. The nurse reported that an
unidentified person applied a cold compress and that Resident # 18 denied any pain. CMS Ex. 10 at 1. The nurse reported that Resident # 18's physician had been notified and ordered a wound consultation. CMS Ex. 10 at 1; see CMS Ex. 11.
On the morning of June 24, 2016, another nurse documented the following in a progress note: "Assessed skin on left upper thigh. Small area of discoloration of skin noted[,] no open areas or blister noted today[.] Resident denied any discomfort." CMS Ex. 10 at 1; see P. Ex. 43 at 4 (testimony addressing "initial confusion" by staff that the burns were located on Resident # 18's thighs rather than his abdomen).
A June 24, 2016 body audit reported that the skin integrity of Resident # 18's abdomen was not intact, with an "[o]pen area on bilateral lower quad (Burn)."14 CMS Ex. 14 at 2.
Four days later, a June 28, 2016 progress note reports "abrasions noted on [Resident # 18's] stomach . . . ." CMS Ex. 10 at 2.
The following day, on June 29, 2016, a nurse reported the following in a progress note, apparently unaware that Resident # 18 had been injured when he spilled coffee six days earlier:
Wound nurse asked to assess open areas on the abdomen. Two open areas noted on abdomen that appear to be open areas from a previous blister. [A]reas cleaned and [foam] dressing was applied. Call placed to resident's mother, updated on open areas and treatment. Mother voiced understanding. Talked with mother about the possibility of the seat belt of the wheelchair causing the blister. [Resident # 18's mother] told this nurse that the resident's clothing may be too tight and she would buy him new clothing. She thanked this nurse for calling.
CMS Ex. 10 at 2. A subsequent note, only minutes later at 12:44 pm on June 29, 2016, reported that a nurse practitioner was "made aware of open areas on abdomen and new treatment." CMS Ex. 10 at 2.
Treatment administration records document that, beginning at 9:00 am on June 30, 2016, Petitioner initiated the following treatment regimen:15 "Foam dressing to open blister areas on abdomen every 3 days to prevent infection."16 CMS Ex. 13 at 26-29. The treatment record indicates 13 separate dressing applications on June 30, July 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, and August 2 and 5. CMS Ex. 13 at 26-29. Petitioner discontinued this treatment on August 5, 2016. CMS Ex. 13 at 28.
Weekly body audits document a prolonged wound healing process, in that the wounds remained open for as long as six weeks. CMS Ex. 13 at 28 (treatment administration record reporting repeated application of a foam dressings to "open blister areas on abdomen" from June 30 through August 5, 2016). A July 1, 2016 report, approximately one week after the burn, reports skin integrity in the middle of the lower abdomen was not intact with an "opened area" and treatment in place. CMS Ex. 14 at 4. A week later, on July 8, 2016, the body audit revealed an "[o]pen area on abdomen, treatment in place." CMS Ex. 14 at 6. The July 15, 2016 report again reports an "opened area" of the abdomen with treatment in place. CMS Ex. 14 at 8. Although a nurse reported on July 23, 2016, that the "[o]pen area on abdomen [was] almost healed," a subsequent report a week later on July 30, 2016, reported that Resident # 18 continued to have an "[o]pen area" on his abdomen. CMS Ex. 14 at 10, 12. On August 6, 2016, after Petitioner had discontinued treatment on August 5, 2016, a nurse documented that Resident # 18 had "2 reddened areas on abd[omen]." CMS Ex. 14 at 14; see CMS Ex. 13 at 28. An August 13, 2016 body audit documented "[o]ld burn [scars]," and the August 20, 2016 report is the first documentation that Resident # 18's skin integrity was intact following the June 23, 2016 injury. CMS Ex. 14 at 16, 18.
Facility records do not document that Petitioner complied with the June 23, 2016 order for a wound consultation. Petitioner has not appealed the corresponding deficiency cited
pursuant to 42 C.F.R. §§ 483.24, 483.25(k)(1) (Tag F309). See CMS Exs. 1 at 10-31; 11; P. Br. at 1 n.1.
The lead surveyor, Ms. Russell, interviewed a number of individuals as part of her investigation and reported that she "accurately documented," inter alia, conversations with both Resident # 18's mother and his private caregiver on March 23, 2017. CMS Ex. 65 at 4-5 (citing CMS Ex. 1 at 53-54, 56); see Tr. at 22-328 (cross‑examination of Ms. Russell). With respect to her conversation with Resident # 18's mother, the surveyor reported the following:
On 3/23/17 at 9:20 a.m. a phone interview was conducted with Resident #18's mother. The surveyor asked her about her knowledge of a coffee spill in June 2016. Resident # 18's mother stated, "They told me he had a hot coffee spill on his stomach. When [Victor] brought him home to visit I saw his stomach and I was shocked because it was so bad of a burn. It took a long time to heal. His belly it was big, open and bleeding. It was awful for a long time. They said it happened and it was no ones fault. He is an epileptic, he has seizures. They are not supposed to leave him with hot things because his seizures can happen anytime, any place, and any day. Some days he has 2-3 seizures he should be with somebody. I don't like it what happened, but I'm elderly, that's why we have a caregiver for him since day one.
CMS Exs. 1 at 53-54; 65 at 4. The surveyor reported the following information regarding her discussion with Victor, the private sitter:
They never put anything on it. But the belly got worse bleeding and raw. It was 3-4 days later they came in and put a bandage on it, his skin had two open spots. It took more than a month to heal. It would bleed and when I took him to the shower he said I have pain and pointed to his belly. I have been with him for over 10 years, he is like a brother to me.
CMS Exs. 1 at 25; 65 at 5.
Nine months after the burn injury, on March 23, 2017, a facility wound care nurse reported "measured scarring to [Resident # 18's] lower abdominal area." CMS Ex. 10 at 3. The nurse documented that site # 1, the right lower quadrant of the abdomen, had a scar measuring 6.0 x 7.5 x 0 (without indicating the unit of measurement). CMS Ex. 10 at 3. The nurse reported that site # 2, beneath the umbilicus to the left lower quadrant,
had a scar measuring 3.3 x 3.0 x 0 (also without indicating the unit of measurement). CMS Ex. 10 at 3. Ms. Russell testified that she was present at the time of the measurements and that the unit of measurement was centimeters.17 Tr. at 293. Ms. Russell also testified that the wound nurse measured the scars that Resident # 18 stated "were the areas on his abdomen . . . where he spilled his coffee." Tr. at 294.
Resident # 18 had a care plan focus for the "potential for actual decline in skin [related to] integrity and fragile skin." CMS Ex. 15 at 3-6, 53 (capitalization omitted). Interventions pre-dating the June 2016 coffee spill included the use of barrier cream, elevating heels off the bed, turning and repositioning, peri care after each incontinent episode, and assisting with toileting as necessary. CMS Ex. 15 at 3-5.
Petitioner initiated a care plan on June 29, 2016, for "actual impairment to skin" due, in part, to "open blisters on abdomen from hot coffee."18 CMS Ex. 15 at 7-8. Petitioner initiated the following two interventions on June 29, 2016:
- Educate resident/family/caregivers of causative factors and measures to prevent skin injury.
- Follow facility protocols for treatment of injury.
CMS Ex. 15 at 7-8.
A review of Resident # 18's care planning indicates that, at the time of his injury, care planning did not address his safety with respect to hot liquids. Compare CMS Ex. 15 at 3-6 with CMS Ex. 15 at 7. On March 22, 2017, during the survey, Petitioner added a care plan focus relating to Resident # 18's "risk for burns related to decreased sensation, seizure disorder, thickened liquids when drinking hot liquids (enjoys coffee)." CMS Ex. 15 at 1, 47. New interventions included educating Resident # 18's family and caregivers and encouraging the use of an adaptive cup with a lid. CMS Ex. 15 at 1, 47; see CMS Ex. 10 at 3 (March 22, 2017 progress note documenting that a nurse and social worker spoke with Resident # 18 and his "full time caretaker" and contacted Resident # 18's parents and informed them of "precautions needed when consuming hot liquids," including that "[l]ids will be used so it cannot be as easily spilled and other precautions will be put in place.").
The MDS reported that Resident # 18 required as much as extensive assistance with eating during the lookback period, yet care planning in effect at the time of the June 23, 2016 burn does not reflect any specific interventions with respect to meals. CMS Ex. 5 at 15; CMS Ex. 15, passim. Although Resident # 18's private sitter often assisted during the lunch and dinner meals, the evidence does not indicate that Resident # 18's care plan included interventions for meal assistance, to include when Resident # 18 consumed his breakfast meal with coffee thickened with honey each day before his sitter's arrival. See CMS Ex. 6. Although a care plan focus dating back to September 2012 recognized that Resident # 18 "has been assessed as having no or limited potential for change in ADL performance and requires extensive to total assistance with ADLs [related to] TBI, Incontinence, Intellectual disability Hemiplegia, and Limited Mobility," the care plan lacked specific interventions with respect to meals. CMS Ex. 15 at 13, 51 ("Assist with/provide ADL care as needed.").
Dating back to March 29, 2012, Resident # 18 had a care plan goal of being free from injury from seizures. CMS Ex. 15 at 15-16. However, interventions do not address the potential of hot liquid spills related to seizures. CMS Ex. 15 at 15-16.
Dating back to March 29, 2012, Resident # 18 had a care plan focus addressing his hemiplegia. CMS Ex. 15 at 30-31. Although interventions included pain management as needed, range of motion with daily care, and repositioning every two hours, no interventions address Resident # 18's functional limitation with ADLs associated with his right dominant side hemiplegia. CMS Ex. 15 at 30-31.
Petitioner's coffee service
The record does not indicate that, at the time of Resident # 18's injury, Petitioner had a hot liquids service policy that set guidelines for coffee service and temperatures. In the absence of such a policy, Petitioner utilized pre-printed forms to document food and beverage temperatures, with the reference temperature range for coffee listed as 140‑150 degrees.19 See, e.g., P. Ex. 31 at 2.
Petitioner maintained a coffee machine in each of its four units (Allegheny, Piedmont, Shenandoah, Tidewater). See P. Exs. 31-39. Logs maintained by Petitioner between June 2016 and March 2017 report that Petitioner generally, but not always, recorded the
temperature of coffee served at only the breakfast meal. Compare P. Exs. 31-39 (daily unit food temperature logs for all three meals) with P. Ex. 30 (Petitioner's summary of "Coffee Temperatures"). Although the pre-printed unit food temperature logs listed a coffee temperature range of 140-150 degrees, Petitioner recorded that coffee served on the Shenandoah unit (where Resident # 18 resided) during the month of June 2016, on 21 of 28 occasions, was in excess of 150 degrees.20 P. Exs. 30 at 5; 31 at 2-31. This was not an aberration. For instance, in December 2016, the Shenandoah unit coffee temperature was 150 degrees or lower on only two of the 28 recorded occasions, and in March 2017, until Petitioner abated immediate jeopardy on March 22, 2017, the breakfast meal coffee temperature was recorded as being in excess of 150 degrees on more than half of those days. P. Exs. 30 at 5; 39 at 97-118. Coffee temperatures for the Shenandoah unit are recorded for many, but not all, days; no coffee temperatures are recorded during the month of January 2017. P. Ex. 30 at 5. Shenandoah coffee temperatures were most frequently recorded to range between 150 and 159 degrees, but coffee temperatures were recorded to be as high as 185 degrees (October 29 and November 4, 2016) and at 180 degrees on at least 13 other occasions (October 1, 2, 7, 15, 16, 21, 30; November 11, 12, 18, 26, 27; December 10). P. Ex. 30 at 5.
On March 22, 2017, Petitioner made changes to its coffee service, including limiting the service temperature of coffee to no higher than 150 degrees. CMS Ex. 34 at 1-2. Petitioner would also assess all residents with impaired upper extremity mobility "to ascertain need for therapy referral for adaptive equipment." CMS Ex. 34 at 2. Hot beverages would be served with lids. CMS Ex. 34 at 2. After Petitioner implemented corrective actions, CMS determined that Petitioner abated immediate jeopardy on March 22, 2017. CMS Ex. 2 at 1.
A. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2) because it did not maintain an environment as free of accident hazards as possible and provide adequate supervision and assistance devices to protect Resident # 18 from foreseeable risks of harm.
B. Resident # 18 sustained a serious coffee burn injury on June 23, 2016.
C. After Resident # 18 sustained the coffee burn injury, Petitioner did not implement corrective actions to mitigate the risks of harm from avoidable accidents from hot liquids for 272 days, until March 22, 2017.
D. Petitioner has not submitted evidence showing that CMS's determination of immediate jeopardy was clearly erroneous.
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." 42 C.F.R. § 483.25. 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)21 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 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, 590 (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 SOM, Appendix PP, provides guidance to state agency surveyors.22 See P. Ex. 17 (Petitioner's submission of Transmittal 48 of Appendix PP, effective June 12, 2009). 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." SOM, Appendix PP (Rev. 173, Nov. 22, 2017). The SOM discusses that these conditions include decreased agility (reduced reaction time), decreased cognition or dementia, decreased mobility, and decreased ability to communicate. Id.
Petitioner's noncompliance with 42 C.F.R. § 483.25(d)(1), (2) was at the immediate jeopardy level of severity.
Petitioner primarily argues Resident # 18's injury was not serious enough to sustain a determination of immediate jeopardy. See, e.g., P. Br. at 5, 9, 19; 42 C.F.R. § 488.301 (defining immediate jeopardy as a situation in which noncompliance "has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident"). Quite stunningly, Petitioner's arguments that Resident # 18's burns were not serious are largely premised on the lack of contemporaneous documentation regarding the wounds. However, such a lack of documentation results from Petitioner's failure to comply with an order for a wound consultation, failure to timely treat the wounds, and failure to document the wounds, to include reporting the size, depth, and appearance of the wounds. See Tr. at 377 (Petitioner's statement that "[w]e even stipulated that some of the documentation regarding a burn is lacking, which is why we conceded [the deficiency cited as Tag] F309 respectfully."). Having admitted its failure to meet the quality of care requirements with respect to the treatment of Resident # 18's wounds, Petitioner argues that the residual scarring and/or hypopigmentation many months later does not support third-degree burns. See P. Br. at 22 n.17; P. Post-Hrg. Reply at 3. However, Petitioner fails to address that the severity of wounds is not necessarily based on residual scarring, particularly in this case, where the wounds required prolonged treatment for "open blister areas" for six weeks. CMS Exs. 10 at 1-3; 13 at 26-28; 14 at 2-13. The fact that the wounds remained open for so many weeks is consistent with reports that the wounds were large, bleeding, and awful in appearance. See CMS Exs. 1 at 22, 53-54; 65 at 4-5. Petitioner has not demonstrated that the citation of immediate jeopardy was clearly erroneous. Petitioner must fail in its effort to use its own failure to provide adequate care
for Resident # 18's injury as a weapon to challenge the immediate jeopardy determination.23
There is no dispute that Resident # 18 sustained a burn injury when he spilled coffee on himself. Although Petitioner, after the hearing, challenged the credibility of the surveyor's testimony about Resident # 18's mother's and private sitter's descriptions of his wounds,24 Petitioner quizzically did not question the surveyor about the veracity of these statements. CMS Ex. 65 at 4-5 (citing CMS Ex. 1 at 53-54, 56); see P. Post-Hrg. Reply at 8-9. Resident # 18's mother informed the surveyor that she "was shocked because it was so bad of a burn." CMS Ex. 1 at 53. The resident's mother further reported that Resident # 18's burns on his "belly" were "big, open, and bleeding" and that "it was awful for a long time." CMS Ex. 1 at 53. Resident # 18's sitter, who was present
at the time of coffee spill, reported that "the coffee went all over his abdomen" and Resident # 18 "had blisters all over his belly." CMS Ex. 1 at 25. The sitter also reported that Resident # 18's "belly got worse bleeding and raw" and that by the time Petitioner first bandaged the wound days later, "his skin had two open spots."25 CMS Ex. 1 at 25.
The residual scarring, measured nine months later, totaled approximately 55 square centimeters in size. CMS Ex. 10 at 3. Owing to Petitioner's failure to timely treat or document the wounds, the original size of the wounds is unknown in that no evidence of record indicates whether the residual scarring accurately represents the size of the wound or, rather, whether the scarring represents only the portions of the burn area that were more severe and/or did not heal as cosmetically well. After all, not every skin wound necessarily results in a long-term visible scar. See P. Ex. 43 at 4 (Ms. Darnell's testimony that scarring is "unusual" with second-degree burns). Because Petitioner did not obtain wound measurements, it is impossible to definitively compare the original size of the wounds with the residual scarring many months later.26
During the hearing, Petitioner misrepresented the evidence of record, stating it was "fact" that Petitioner "documented contemporaneously" that Resident # 18 had a "dime-sized burn on his abdomen." Tr. at 207. Petitioner used Ms. Nwankwo's description of the wound as dime-sized in support of arguments that the wound was a second-degree burn. P. Post-Hrg. Reply at 8 n.18 (citing CMS Ex. 67 at 1). However, Ms. Nwankwo did not contemporaneously report a dime-sized blister; rather, she reported that she observed a "left quad . . . blister" of unspecified size approximately 90 minutes after the injury.27
CMS Ex. 10 at 1; CMS Ex. 67 at 1. Ms. Nwankwo did not report that the blister was "approximately the size of a dime" until more than nine months later, on April 6, 2017. CMS Ex. 67 at 1. Further, these records do not indicate that, at the time of her observations on June 23, 2016, Ms. Nwankwo conducted a complete examination of Resident # 18's body, as opposed to examining a single blister. CMS Exs. 10 at 1, 67 at 1.
Ms. Nwankwo's June 24, 2016 progress note also does not report whether she examined Resident # 18's abdomen, in that she did not list the abdomen as the location of the injury, but, rather, reported that the injury involved the "quads." CMS Ex. 10 at 1. This imprecision led another nurse to later assess only Resident # 18's left thigh, at which time she reported "no open areas or blister noted today." CMS Ex. 10 at 1; see CMS Ex. 65 at 4-5 (incorporating CMS Ex. 1 at 23 (statement of Ms. Oltmanns,28 a facility licensed practical nurse, that she "read the nurse's note from the previous night and it said burn on quad. I thought it was on the leg so I went to look and I didn't see anything on the leg so I didn't proceed."); P. Ex. 43 at 4 (Ms. Darnell's testimony on "initial confusion" over the location of the injury). I also note that Ms. Nwankwo notified Resident # 18's physician of his burn injury and received his order for a wound consultation, yet Petitioner did not carry out this order. CMS Exs. 10 at 1; 11. Additionally, Ms. Nwankwo submitted her statement on April 6, 2017, more than nine months after the injury (CMS Ex. 67), but Petitioner did not offer her sworn written testimony when it filed its pre-hearing exchange later that year on December 8, 2017.
Ms. Dolores Darnell, RN, NHA, MBA, testified that Resident # 18's wound was a second-degree burn, based on her observation of the wound scars nine months later in March 2017.29 P. Ex. 43 at 3-4. Ms. Darnell testified that the "healed burn injury presented . . . as having been a superficial partial thickness (2nd degree) burn when she visited [Resident # 18]" after the survey. P. Ex. 43 at 4. Although Ms. Darnell stated in support of her opinion that second-degree burns "generally heal within 7-21 days," she did not reconcile why Resident # 18 required dressing changes for six weeks and that body audits revealed that the wounds remained open for approximately six weeks. See CMS Ex. 14 at 2‑13.
Petitioner also submitted a letter from "A.F. Hemphill, M.D., CWSP," dated June 27, 2017.30 P. Ex. 29. Dr. Hemphill addressed his correspondence to "Ms. Harris."31 P. Ex. 29. Dr. Hemphill reported that he "saw" Resident # 18 and "briefly examine[d] his abdominal skin" and noted two separate "hypopigmented areas."32 P. Ex. 29. Dr. Hemphill stated that he "cannot speak with any certainty regarding the etiologies of these hypopigmented areas" and opined that in his "experience this is atypical of a significant burn injury." P. Ex. 29. Dr. Hemphill did not define what he meant by the term, "significant burn injury," nor did he indicate that he had obtained a history of the injury or reviewed Resident # 18's chart, which may have provided useful information regarding the etiology. Nor did Dr. Hemphill address the evidence that Resident # 18's wound remained open for up to six weeks. Dr. Hemphill's statement is of little probative value.
The evidence supports that Resident # 18 sustained a serious burn injury on June 23, 2016. First, the scarring (otherwise described as hypopigmentation) from the burns, observed nine months later, covered a surface area totaling approximately 55 square centimeters, which is a significant portion of Resident # 18's abdomen. CMS Ex. 10 at 3. The ordinary experience of most people would likely reveal that not every skin wound
results in a visible scar or change in pigmentation. However, Petitioner has not submitted evidence that the areas of scarring represent the full size of the burns, as opposed to being residuals from the most severely burned areas or areas where the burns did not optimally heal. CMS Ex. 10 at 3. Regardless of whether the wound was second-degree or third‑degree, which cannot definitively be established in the absence of timely physician evaluation, medical treatment, and contemporaneous documentation describing the wounds, compelling evidence shows that Resident # 18 had a prolonged recovery with open abdominal wounds for approximately six weeks. See Crawford Healthcare and Rehabilitation, DAB No. 2738 at 16 (2016) (discussing that the course of recovery is properly considered when assessing the severity of a wound). Petitioner's records document that Resident # 18 received treatment in the form of dressing changes for his open wounds for six weeks, and this is a significant length of time for an incontinent resident to have open abdominal skin wounds when he is already at risk for a decline in skin integrity. CMS Exs. 14 at 2-13; 15 at 3-5; see CMS Ex. 65 at 17 (Surveyor Russell's testimony that "[b]urns also carry the risk of infection."). Additionally, Resident # 18's wounds were described as "bleeding and raw," "awful," "big, open and bleeding," and "shock[ing]," all descriptions that support a serious burn injury. CMS Ex. 1 at 22, 25; see CMS Ex. 65 at 4-5. Resident # 18's burn injury was serious, as contemplated for the purpose of immediate jeopardy.
With respect to the coffee burn itself, Petitioner did not maintain an environment as free of hazards as possible and provide adequate supervision to protect Resident # 18 from foreseeable risks from harm. 42 C.F.R. § 483.25(d)(1), (2). The June 2016 MDS assessment reports that Resident # 18 had limitation in functional range of motion of both upper and lower extremities that "interfered with daily functions or placed [him] at risk of injury." CMS Ex. 5 at 16. Significantly, Resident # 18 had hemiplegia affecting his dominant upper extremity, in addition to "intractable" seizures. CMS Ex. 4 at 1. Yet, Petitioner had not conducted a hot liquids assessment to determine whether Resident # 18 could safely handle hot liquids, and if not, whether any supervision or assistance devices (i.e., use lidded or adaptive cups) would prevent or mitigate the risk of accidents.33 Petitioner recognized that Resident # 18 had "been assessed as having no or limited potential for change in ADL performance and requires extensive to total assistance with ADLs [related to] TBI, Incontinence, Intellectual disability, Hemiplegia, and Limited Mobility." CMS Ex. 15 at 13. Yet, his care plan provided no specific interventions with respect to meals, only proving the vague intervention that Petitioner would assist and provide ADL care "as needed." CMS Ex. 15 at 51. It should have come as no surprise that one day, an epileptic resident with upper extremity impairments could have a seizure
during a meal. Even though Resident # 18 had a sitter who usually assisted him with lunch and dinner, no care plan intervention at that time would have prevented or mitigated the risk of injury with such an event.
Petitioner acknowledges that hot coffee served at a "normal" or "acceptable" temperature is "capable of causing a skin burn." Request for Hearing at 3 (bold, underline, and capitalization omitted). Yet, Petitioner had never conducted a hot liquids safety assessment of Resident # 18, an epileptic resident with limited mobility and hemiplegia in his dominant upper extremity along with impairment of his other upper extremity. Petitioner served Resident # 18 his coffee in a lidless cup without any other assistance devices in place, and he apparently suffered a seizure, spilled the coffee on himself, and sustained a serious coffee burn. CMS Br. at 4-5; P. Br. at 11 (briefs recognizing that Resident # 18's coffee spill was apparently preceded by a seizure). Petitioner neither recognized a plainly apparent accident hazard, nor did it ensure that Resident # 18 received adequate supervision and assistance devices to prevent a hot liquid injury. See Crawford, DAB No. 2738 at 5 (discussing that a facility, in general, must take all reasonable steps to mitigate foreseeable harm).
Immediate jeopardy continued until March 22, 2017.
Substantial compliance means not only that a facility corrected 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 DAB "has held that a facility found to have placed residents in an immediate jeopardy situation is presumed to continue to present immediate jeopardy unless the facility shows that the determination of continued immediate jeopardy is clearly erroneous." The Bridge at Rockwood, DAB. No. 2954 at 29 (2019), citing Brian Ctr. Health & Rehab,/Goldsboro, DAB No. 2336 at 7-8 (2010). The burden is on the facility to prove that it is compliant with program requirements, 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").
The DAB "has held that, in order to comply with section 483.25(h)(2), a facility "must identify and assess foreseeable accident risks; determine what, if any, interventions are
necessary and appropriate to mitigate the assessed risks; and take timely and effective steps to implement the chosen interventions." Good Shepherd Home for the Aged, Inc. DAB No. 2858 at 12 (2018) (internal citations and footnote omitted). Aside from failing to render physician care to Resident # 18 for his injury, Petitioner failed to implement meaningful corrective actions immediately following the injury. Petitioner did little to update Resident # 18's care plan, and it did not examine its coffee service procedures and coffee temperature to assess whether the temperature or manner of service of the coffee was a factor in Resident # 18's injury. Nor did Petitioner assess whether staff training was necessary. Petitioner also did not assess whether Resident # 18 (and other residents) could safely handle and consume hot liquids, to include determining whether supervision or assistance devices could prevent or mitigate a foreseeable risk of harm from hot liquid burns.
Even though Resident # 18 had sustained an actual burn on June 23, 2016, as a result of a hot liquid spill, Petitioner essentially did nothing to prevent the risk for future accidents with respect to Resident # 18. Petitioner's care plan interventions were limited to the vague intervention of educating Resident # 18 and his family/caregivers "of causative factors and measures to prevent skin injury" and to "[f]ollow facility protocols for treatment of injury." CMS Ex. 15 at 7. Petitioner's care plan includes no meaningful interventions that would prevent or mitigate the same type of injury. CMS Ex. 15, passim.
Had Petitioner evaluated its coffee service program following Resident # 18's injury, it may have taken notice that it frequently recorded that its coffee temperatures exceeded the 140-150 degree service temperature range that it had provided on its pre-printed food temperature logs (when such temperatures were actually recorded).34 See P. Exs. 30 at 5; 31. Even limiting discussion to only the Shenandoah unit, the temperature of coffee served in June 2016 on 28 out of 28 recorded days was 150 degrees or above, with coffee temperatures recorded as being above 150 degrees on 21 of 28 of those days.35 P. Exs. 30 at 5; 31 at 2-31. Further, Petitioner only recorded the coffee temperature one time per day, at the breakfast meal, even though it served coffee at all three meals and throughout the day. P. Ex. 31 at 2-31; see CMS Ex. 6. Had Petitioner conducted a review of its
coffee service following Resident # 18's burn injury, it could have made necessary changes to ensure that it was serving coffee within its own suggested temperature range.
The SOM, Appendix PP, provides guidance to state agency surveyors. Although the State Operations Manual is not binding on these proceedings and does not provide a specific temperature at which coffee must be served by SNFs, it nonetheless addresses the fundamental concept that as the temperature of a hot liquid increases, it takes less time for someone to sustain a burn when exposed to the hot liquid. The SOM gives the example 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. SOM, Appendix PP (Rev. 173, Nov. 22, 2017) (Table 1. Time and Temperature Relationship to Serious Burns). Thus, when liquids are served at higher temperatures than is necessary, residents may be unnecessarily exposed to harm. For example, neither a caregiver nor a resident who spills a hot liquid on himself may be able to clean a hot liquid spill within a single second, but if given a few more seconds to react, the caregiver or resident may be able to wipe off a spilled hot liquid, possibly preventing or mitigating a potential burn. Petitioner has not presented any evidence refuting that it did not have a reasonable basis to set its own hot liquid service temperature range between 140 and 150 degrees, yet at the time Resident # 18 sustained a burn, it frequently recorded coffee temperatures well in excess of that temperature range.36 See P. Ex. 30 at 1, 3, 5, 7 (summarizing breakfast coffee temperatures for three of the units, but with no temperatures recorded for the Piedmont unit that month). Coffee temperatures were frequently recorded to exceed 150 degrees through March 22, 2017. See P. Exs. 30-39.
Further, even though Resident # 18 had sustained a serious burn on June 23, 2016, Petitioner did not evaluate whether Resident # 18 (or other residents) should be assessed for the ability to handle and consume hot liquids. Such assessments could yield important information that would not only identify whether care plan interventions were appropriate to ensure that the necessary supervision was provided to prevent or mitigate avoidable accidents, but could also identify whether assistance devices, such as lidded cups, adaptive mugs, or protective blankets, would be appropriate. For example, it is possible that the use of an adaptive mug may have prevented Resident # 18 from dropping his mug, while a lidded cup may have prevented Resident # 18 from spilling as much coffee as he did on himself.
Petitioner did not implement significant and broad interventions until March 22, 2017. See CMS Ex. 34. At that time, Petitioner implemented the following interventions:
- Reducing the brewing temperature;
- Checking the coffee and hot water automatic dispensers prior to meals and at night each day;
- Recommending Resident # 18 use a lidded cup;
- Installing a barrier device to prohibit access to automatic coffee machines;
- Auditing residents for hot liquids risk;
- Assessing residents with impaired upper extremity mobility on an ongoing basis;
- Serving coffee to the general resident population in cups with lids;
- Educating dietary staff and night shift supervisors to record coffee and hot water temperatures at each meal, and holding back hot beverages until they cool to lower than 150 degrees;
- Educate staff, private caregivers, and volunteers regarding hot liquid services changes and that hot liquids should be served with a lid and not exceed 150 degrees; and
- Administrator will audit temperature logs to ensure compliance and variances will be addressed through the QAPI committee.
CMS Ex. 34 at 1-2. The implementation of these policies prior to Resident # 18's burn injury could have entirely prevented his injury, or at least yielded a less severe injury. After Resident # 18 sustained a serious injury, Petitioner did not implement any of these interventions at that time, nor did it evaluate whether it needed to review its policies, assess individual residents, or make changes to its hot liquids service. Petitioner did not implement the meaningful interventions listed above for another 272 days, until March 22, 2017. CMS Ex. 34.
E. A per-day CMP of $6,550 is a reasonable enforcement remedy for Petitioner's noncompliance with 42 C.F.R. § 483.25(d)(1), (2).
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, including 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. pt. 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 488.40(b)-(c). See, e.g., Senior Rehabilitation and Skilled Nursing Ctr., DAB No. 2300 at 19-20 (2010).
CMS imposed a per-day CMP of $6,550 for the period of immediate jeopardy noncompliance from June 23, 2016 through March 22, 2017, for a total CMP of $1,781,600.37 CMS Ex. 2 at 1-2. The per-day CMP of $6,550 is very close to the minimum permissible amount, in that penalties at that time ranged from $6,394 to $20,965 for immediate jeopardy deficiencies.38 42 C.F.R. §§ 488.408 (e)(1)(iii), 488.438(a)(1)(i); 45 C.F.R. § 102.3 (2017); see 82 Fed. Reg. 9174, 9182 (2017). Even
considering the remedies imposed for deficiencies involving Resident # 18 alone, the per‑day CMP of $6,550 based on immediate jeopardy, with noncompliance resulting in actual harm, is reasonable. 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. However, Petitioner has not demonstrated that it returned to substantial compliance before March 22, 2017, when it implemented numerous corrective actions.
The per-day CMP of $6,550 is reasonable. First, I note that Petitioner has considerable culpability and the deficiency was very serious. The undisputed facts show that Resident # 18 sustained a serious burn that remained open for approximately six weeks. CMS Exs. 13 at 26; 14 at 2-13; see 42 C.F.R. § 488.438(f)(4). At that time, Petitioner had not provided adequate supervision and assistance devices to prevent or mitigate the risk of a hot liquid injury to an epileptic resident with dominant side hemiplegia and bilateral upper extremity impairments. Petitioner implemented no meaningful corrective actions or interventions that would avoid foreseeable risks of hot liquids injuries until March 22, 2017.39
I also note that Petitioner was also cited for a deficiency that resulted in actual harm to Resident # 18, in that Petitioner inexcusably failed to provide a wound consultation for the burn injury that had been ordered for Resident # 18 and utterly failed to treat the burn injury for six days.40 See P. Br. at 24 ("In a very literal sense, Potomac Falls paid the price for the CMP related to F309, which incidentally was ascribed a scope and severity of a G-level (i.e., an isolated instance of actual harm)."). The CMP range for a G-level deficiency at that time ranged from $105 to $6,289, and, thus, the G-level deficiency alone could sustain more than 95 percent of the daily CMP of $6,550 imposed. 45 C.F.R. § 102.3 (2017); see 82 Fed. Reg. at 9182. The deficiencies are egregious. Not only did Resident # 18 sustain a serious burn that could have been avoided or mitigated, but even after the accident, Petitioner failed to implement corrective actions or initiate meaningful
interventions until March 22, 2017.41 Additionally, Petitioner failed to ensure that Resident # 18 received timely treatment for his burns.
CMS has the discretion to select the remedy, and it selected a per-day CMP. The per-day CMP is reasonable, in that it is at the bottom of the penalty range. The CMP is reasonable for the immediate jeopardy deficiency involving Resident # 18 alone, even without consideration of the other lower level deficiencies. I conclude that a per-day CMP of $6,550 for the duration of Petitioner's immediate jeopardy is reasonable pursuant to 42 C.F.R. § 488.438(f).
For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with Medicare participation requirements at 42 C.F.R. §§ 483.25(d)(1), (2) and that the per-day CMP of $6,550 from June 23, 2016, through March 22, 2017, is a reasonable enforcement remedy.
Leslie C. Rogall Administrative Law Judge
1. Both the state agency and CMS 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 31-32; 2 at 1. Because subsection 483.25(n)(1)-(3) is irrelevant to the deficiencies at issue, I do not further address that provision.
- back to note 1 2. Federal nursing home regulations substantially changed beginning on November 28, 2016. 81 Fed. Reg. 68.688 (Oct. 4, 2016). Additionally, the F-Tags cited herein pre-date CMS's redesignation of its F-Tags as of November 28, 2017. See CMS's F-Tag Crosswalk, https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationEnforcement/Downloads/F-Tag-Crosswalk.xlsx (last visited Feb. 5, 2021).
- back to note 2 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), ch. 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, ch. 7, § 7400.3.1 (Matrix for Scope & Severity) (Rev. 185, effective Nov. 16, 2018) (current version)); see also 42 C.F.R. § 488.408. A scope and severity level of "K" indicates a pattern of immediate jeopardy to resident health or safety, and a scope and severity level of "G" indicates an isolated instance of actual harm that is not immediate jeopardy to resident health or safety. SOM, ch. 7, § 7400.5.1 (Rev. 63, effective Sept. 10, 2010).
- back to note 3 4. As relevant here, 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.
- back to note 4 5. Petitioner challenges only the deficiency cited at the immediate jeopardy deficiency level; therefore, the CMP for the period from March 22 through May 11, 2017, is administratively final. Request for Hearing, dated July 27, 2017, at 1; Dkt. No. 1 of Departmental Appeals Board Electronic Filing System (DAB E-File).
- back to note 5 6. The payment plan carried an interest rate of 10.125 percent; the total amount due, with interest, would be $1,595,892.02. CMS Ex. 55 at 1.
- back to note 6 7. CMS withdrew the testimony of two witnesses and, therefore, I do not admit the evidentiary exhibits pertaining to these witnesses. See Tr. at 3; CMS Exs. 59, 62, 63, 66.
- back to note 7 8. Prior to the hearing, I had provisionally admitted the testimony of witnesses who had submitted direct testimony.
- back to note 8 9. CMS did not cross-examine several witnesses, and I admit this written testimony. See P. Exs. 42, 46, 50.
- back to note 9 10. Findings of fact and conclusions of law are in bold and italics.
- back to note 10 11. Ms. Hojnacki testified that Resident # 18 ate breakfast in his room and that he would eat lunch in the dining room "[w]hen his private-duty person came and brought him out." Tr. at 481.
- back to note 11 12. Petitioner allowed "families or residents to contract with individuals to sit with residents." CMS Ex. 52 at 1 (private duty sitter policy); see P. Ex. 40 (Petitioner's duplicative submission of this policy). Petitioner allowed a private sitter to assist a resident during meals and with personal needs "without doing any lifting." CMS Ex. 52 at 1. Ms. Hojnacki testified that Resident # 18's sitter was typically present "from about 1:00 p.m. to maybe 6:00 or 7:00 [p.m.]." Tr. at 481.
- back to note 12 13. More than nine months later, on April 6, 2017, the same nurse reported in a statement prepared after the survey that she observed a "blister approximately the size of a dime on the left lower quadrant and scar on the right lower quadrant of the abdomen." CMS Ex. 67 at 1. The nurse also reported that the caregiver explained that he did not report the burn immediately because "he did not know that coffee [could] burn the skin." CMS Ex. 67 at 1.
- back to note 13 14. It appears that Petitioner performs weekly body audits; the record includes completed body audit forms dated June 17 and 24, July 1, 8, 15, 23, and 30, August 6, 13, 20, and 27, and September 3, 2016. CMS Ex. 14.
- back to note 14 15. The record lacks any orders for treatment of Resident # 18's wounds. Although treatment administration records indicate that Petitioner applied a foam dressing to open blister areas every three days, the source of such a treatment order is unknown. CMS Ex. 13 at 26-28.
- back to note 15 16. Petitioner did not comply with the physician order for a wound consultation, and the sole treatment provided by Petitioner was the repeated application of foam dressings over the course of six weeks, which is not documented in any order associated with the voluminous record. CMS Exs. 11; 13 at 26-28. The record also lacks any indication that Petitioner administered any other treatments, such as topical ointments or antibiotics, even though Resident # 18's wounds remained open for approximately six weeks. CMS Ex. 13 at 26. Further, Petitioner did not collect objective data that can be used for comparative purposes when monitoring the healing of a wound, such as the size and depth of the burn injury, and characteristics such as drainage, odor, and bleeding.
- back to note 16 17. 2.54 centimeters equals one inch.
- back to note 17 18. At that time, Petitioner also care planned for a bruise on the left chest related to "standing left" and a bruise on the left lower abdomen "related to lifting with a gate [sic] belt." CMS Ex. 15 at 7.
- back to note 18 19. With the exception of hot cereal, the pre-printed form does not contain fields to document the temperature of other hot liquids, such as tea, decaffeinated coffee, and soup. P. Exs. 31-39. During the March 2017 survey, Petitioner implemented the use of a "hot beverage temperature log" form that recorded daily temperatures of coffee, decaffeinated coffee, and hot water, and instructed that hot liquids "must" be served below 150 degrees. CMS Ex. 38 at 1-4.
- back to note 19 20. Coffee served at breakfast in the Allegheny unit on June 18, 2016, was recorded as 210 degrees. P. Exs. 30 at 1; 31 at 48. The boiling point of water is 212 degrees.
- back to note 20 21. 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, 68,825 (Table 1) (Oct. 4, 2016).
- back to note 21 22. Appendix PP of the SOM has been revised since the survey. The current version (Rev. 173, dated Nov. 22, 2017) can be found at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf.
- back to note 22 23. This very situation exemplifies the rationale underlying the requirement for a Petitioner to show that a finding of immediate jeopardy is clearly erroneous pursuant to 42 C.F.R § 498.60(c)(2); but for this regulatory burden, a facility would be able to prevail against a finding of immediate jeopardy by simply failing to furnish records documenting the full extent of an injury.
- back to note 23 24. In its post-hearing reply brief, Petitioner alleges for the first time that Ms. Russell lacked a credible basis for making these "hearsay" statements. P. Post-Hrg. Reply at 8-9. Ms. Russell presented sworn testimony that she "accurately documented" her interviews of Resident # 18's mother and private caregiver (CMS Ex. 65 at 4-5); Petitioner has not shown that Ms. Russell's statements should be excluded because they are unreliable. See 42 C.F.R. § 498.61 ("Evidence may be received at the hearing even though inadmissible under the rules of evidence application to court procedure. The ALJ rules on the admissibility of evidence."). Petitioner has not offered any factual basis to support its belated argument that Ms. Russell did not credibly testify regarding the interviews she conducted during the investigation, particularly when Petitioner did not challenge this testimony on cross-examination. Tr. at 22-328. In the absence of any probative evidence to the contrary, there is no basis to reject Ms. Russell's reports, which were subject to cross-examination, as unreliable. CMS Ex. 65 at 4-5; see 42 U.S.C. 556(d). Petitioner also had an opportunity to submit testimony and evidence challenging this testimony. For example, although Petitioner's staff changed Resident # 18's wound dressings every three days for approximately six weeks, it did not present the testimony of any witness who reported observations of Resident # 18's wounds. See CMS Ex. 13 at 26-28. Petitioner also could have submitted the testimony of Ms. Nwankwo, who reported nine months later that she had seen a single dime-sized blister only 90 minutes after the injury. CMS Ex. 67 at 1; see CMS Ex. 10 at 1. Finally, Petitioner had an opportunity to call Resident # 18's mother and private sitter as witnesses, and it chose not to do so. I repeatedly explained that the Federal Rules of Evidence do not strictly apply to these proceedings, and Petitioner has had a meaningful opportunity to challenge this evidence.
- back to note 24 25. I note that this statement is consistent with Petitioner's limited contemporaneous documentation of the burns. See CMS Ex. 14 at 13 (August 6, 2016 report of "2 reddened areas on abd[omen]").
- back to note 25 26. I reject the opinion of Ilene Warner-Maron, PhD, RN-BC, CWCN, NHA, FCPP, that the burn was "second degree." P. Ex. 42 at 4. One basis for this opinion is that the wound did not require "acute level care services (hospitalization), surgery, antibiotics or other significant interventions." P. Ex. 42 at 4. Petitioner has not appealed the cited deficiency involving its lack of adequate care for the burn injury, which includes not complying with an order for a wound consultation and not providing treatment for the first six days following the injury. See CMS Ex. 1 at 10-31. Therefore, it is unknown whether, with timely treatment, additional interventions would have been prescribed.
- back to note 26 27. Petitioner has not submitted evidence showing that the full extent of a burn injury and blistering is evident only 90 minutes after a burn injury. In fact, Ms. Darnell testified that the extent of burns may not be evident immediately, stating that "[s]econd degree burns generally form blisters within 24 hours between the dermis and epidermis" and that burns "may initially appear to be only epidermal in depth, but may be determined to be partial thickness 12-24 hours later." P. Ex. 43 at 4.
- back to note 27 28. The SOD redacts the names of staff members. A staff roster is found at CMS Ex. 42.
- back to note 28 29. On cross-examination, Ms. Darnell acknowledged that she had never previously categorized the severity of a burn by looking at a scar nine months later. Tr. at 382.
- back to note 29 30. In a filing dated December 21, 2017, in response to CMS's evidentiary objections, Petitioner identified Dr. Hemphill as a "wound physician" and argued that he "is qualified to describe the nature of a wound he would have observed." (Dkt. No. 87 of DAB E-File). Petitioner did not submit a curriculum vitae for Dr. Hemphill, and Dr. Hemphill's letter is not printed on letterhead. P. Ex. 29. In fact, the letter lacks Dr. Hemphill's full name, address, licensure status, or any other useful information, such as whether he holds a certification by the American Board for Medical Specialties. Rather, Dr. Hemphill lists a post-nominal, "CWSP," after his name. P. Ex. 29. According to a website page with the heading "WoundEducators.com," a physician with the requisite experience who completes a self-paced online curriculum and answers 116 of 180 questions correctly on the written examination ("with 30 questions being ungraded") can become a Certified Wound Specialist Physician (CWSP). https://woundeducators.com/the-cwsp-certification/ (last visited February 5, 2021).
- back to note 30 31. Dr. Hemphill does not list a full name or address for Ms. Harris. P. Ex. 29. The evidentiary record contains an undated statement on Petitioner's letterhead submitted by "Phyllis Harris, RN," who identified herself as the Director of Nursing. CMS Ex. 69.
- back to note 31 32. The circumstances of this consultation are unclear. Being that Dr. Hemphill addressed this letter to Ms. Harris, it appears that Petitioner obtained this examination for purposes of the instant case. I note that even though Resident # 18's physician had ordered a wound consultation on June 23, 2016, this examination, performed more than a year later, is the only physician wound evaluation of record.
- back to note 32 33. Petitioner's witnesses, Ms. Genest, Ms. Meyer, Ms. Alexis, and Ms. Rojas, all apparently believe that lids on coffee cups can present a danger to residents. P. Exs. 44 at 11; 45 at 9; 50 at 4; 52 at 2. However, none of these witnesses opined that the use of a lidded cup by Resident # 18, an epileptic resident with hemiplegia and bilateral upper extremity impairments, would be an inappropriate intervention.
- back to note 33 34. While I do not equate a pre-printed form to a policy, in the absence of any other facility policy directing the service temperature range for coffee, I consider the reference range of 140-150 degrees pre-printed on the form to represent Petitioner's determination that coffee in that temperature range would be palatable and served at the safest temperature possible. P. Exs. 31-39.
- back to note 34 35. As I previously noted, Petitioner recorded that coffee served with the breakfast meal on another unit was two degrees short of boiling only days before Resident # 18 sustained his burn injury. P. Ex. 31 at 48.
- back to note 35 36. The breakfast coffee temperature on June 23, 2016, was recorded as 150 degrees. P. Ex. 31 at 24. As Petitioner correctly points out, "CMS does not know and does not claim to know the temperature of the coffee" that burned Resident # 18 that day. Request for Hearing at 3. Neither does Petitioner, and that gap in information is not supportive of Petitioner's position.
- back to note 36 37. Petitioner generally refers to its hardship request at P. Ex. 20, but does not make any specific regulatory arguments. P. Post-Hrg. Br. at 29. Pursuant to a hardship request, CMS reduced the CMP by 20 percent to $1,445,400. CMS Ex. 55 at 1.
- back to note 37 38. CMS incorrectly identifies the applicable CMP range as $6,291 to $20,628. CMS Br. at 22.
- back to note 38 39. Although CMS cited a "K" level of scope and severity (pattern of noncompliance that was immediate jeopardy to resident health and safety) that also included the potential for harm to other residents, the CMP that CMS imposed, which was very close to the minimum allowable amount per day, is fully supported by the immediate jeopardy deficiency involving the actual harm to Resident # 18, alone.
- back to note 39 40. And to the extent a June 29, 2016 progress note addresses "open areas from a previous blister," the reported etiology was a friction abrasion and not a coffee burn. CMS Ex. 10 at 2.
- back to note 40 41. I add that, to the extent that Petitioner argues no other burns occurred during the 272 days before it returned to substantial compliance (P. Br. at 3), Petitioner lacks credibility in making such a claim. Being that Petitioner, six days after the burn, attributed the "open areas" observed on Resident # 18's abdomen to a seat belt, and not a coffee spill, it does not appear that Petitioner has always had a mechanism to track and monitor residents' burn injuries. See CMS Ex. 10 at 2. Further, even though Resident # 18 had open burn wounds for more than a month, Petitioner's system of records failed to yield a single contemporaneous document providing a description of his wounds, to include the precise locations, sizes, and depths of the wounds.
- back to note 41