Bartley Healthcare and Rehabilitation, DAB CR5274


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

Docket No. C-17-118
Decision No. CR5274

DECISION

Petitioner, Bartley Healthcare and Rehabilitation (“Petitioner” or “the facility”), challenges the determination by the Centers for Medicare & Medicaid Services (CMS) that it was not in substantial compliance with the Medicare program participation requirements that it develop a comprehensive care plan to meet a resident’s medical, nursing, mental, and psychosocial needs that are identified in the comprehensive assessment, as required by 42 C.F.R. §§ 483.20(d) and 483.20(k)(1), and that each resident receives adequate supervision and assistance devices to prevent accidents, as required by 42 C.F.R. § 483.25(h).  Petitioner also challenges the imposition of a civil money penalty (CMP) of $600 per day for the period October 21 through December 3, 2015, for a total CMP of $26,400.  For the reasons discussed below, I affirm CMS’s determination.

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

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provisions.  See 42 U.S.C. § 1395i-3; 42 C.F.R. parts 483 and 488.1  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 the 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).  The base penalty range, prior to any inflation adjustment, for a per-day CMP is $50 to $3,000 per day for less serious noncompliance, and from $3,050 to $10,000 per day for more serious noncompliance that poses immediate jeopardy2 to the health and safety of residents.3 42 C.F.R. § 488.438(a)(1).

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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(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

The New Jersey State Department of Health, Office of Long Term Care (state agency) conducted a survey of Petitioner’s facility in Jackson, New Jersey, from October 14 through 27, 2015.  See, e.g., CMS Exhibit (Ex.) 4.  The state agency cited two immediate jeopardy deficiencies at the “K” level of scope and severity4 on October 21, 2015, and immediate jeopardy was abated that same day.  See CMS Exs. 3 at 11, 27; 4 at 1; 23 at 1.  Additional deficiencies were cited during the October 2015 survey.  CMS Exs. 2, 3.  After the state agency completed a revisit survey on December 23, 2015, it informed Petitioner on December 30, 2015, that it had “corrected all deficiencies . . . as of December 4, 2015.”  CMS Ex. 5 at 1.

CMS, in a September 21, 2016 letter, informed Petitioner that it had imposed a $10,141 CMP based on the two immediate jeopardy deficiencies cited under 42 C.F.R. §§ 483.20(d) and 483.20(k)(1) (Tag F279) and 42 C.F.R. § 483.25(h) (Tag F323), and had imposed a $103 per day CMP thereafter.5  CMS Ex. 1.  Following the independent informal dispute resolution (IIDR) process (which occurred during the pendency of the instant request for hearing), CMS informed Petitioner on April 7, 2017, that it had reduced the scope and severity of the two immediate jeopardy deficiencies to

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the “G”6 level of scope and severity.  CMS Ex. 41.  CMS also revised the CMP to $26,400.  CMS Ex. 41 at 1.

Petitioner submitted its request for hearing on November 17, 2016, at which time it appealed the $52,268 CMP that was in effect at that time.7 Pursuant to my Acknowledgment and Pre-Hearing Order (Pre-Hearing Order), CMS filed a pre-hearing brief (CMS Br.) and motion for summary judgment, along with 43 proposed exhibits (CMS Exs. 1-43).  Petitioner filed a pre-hearing brief (P. Br.), a response to CMS’s motion for summary judgment, and 45 proposed exhibits (P. Exs. 1-45).

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In an Order dated July 10, 2017, I denied Petitioner’s June 5, 2017 request to amend its hearing request to add two other deficiencies cited under 42 C.F.R. § 483.25 (Tag F309) and 42 C.F.R. § 483.40(c)(1),(2) (Tag F387) to its current appeal.  I explained that because Petitioner did not timely include those deficiencies in its request for hearing, those deficiencies were administratively final.  42 C.F.R. §§ 488.440(b), 498.40(a), 498.70(c).  I further explained that “Petitioner has not pointed to any circumstance that amounts to good cause as to why, at the time it filed its request for hearing, it did not timely request a hearing regarding the deficiencies that are the subject of its motion seeking to amend its hearing request.”

Both parties submitted the written direct testimony of witnesses.  CMS Exs. 31-35; P. Exs. 2, 5, 8, 10.  Petitioner has not requested cross-examination of CMS’s witnesses, but CMS has objected to several witnesses and requested an opportunity to cross-examine various witnesses.

CMS objects to three of Petitioner’s proposed witnesses.  CMS argues that two of Petitioner’s witnesses, “M.W.”8 and Lauren Kessler, LNHA, did not submit sworn testimony.  In Section 8 of my Pre-Hearing Order, I directed that a party “must exchange as a proposed exhibit the complete, written direct testimony of any proposed witness” and that such testimony “must be submitted in the form of an affidavit made under oath or as a written declaration that the witness signs under penalty of perjury for false testimony.”  Petitioner did not submit any testimony for M.W., and the testimony it submitted for Ms. Kessler was not in the form of an affidavit or declaration as required (P. Ex. 11).  Further, Petitioner has not cited to the testimony of either of these witnesses in its brief, meaning that this testimony is not supportive of Petitioner’s arguments.  I therefore sustain CMS’s objections with respect to any testimony of M.W. and Ms. Kessler.

CMS also objects to the testimony of Janice Bengivenga, BSN, RN, based on irrelevance and that, pursuant to 42 C.F.R. § 488.318(b), “surveyor misconduct or inadequate survey performance are insufficient to rebut valid deficiency findings.”  In her testimony, Ms. Bengivenga complained that the October 2015 survey was “one of the most difficult surveys that I have ever worked on, and there seemed to be no way to satisfy the request of the team leader quickly enough.”  P. Ex. 10 at 4.  Ms. Bengivenga further complained that the surveyors were “rude” and “confrontational,” and that “the vast majority of the documents being requested by the surveyors each day were available . . . and that the surveyors had difficulty finding those records in the electronic medical records systems and further refused assistance to navigate these systems, causing confusion and misinformation in their conclusions.”  P. Ex. 10 at 2-4.  While I prefer that state agency employees and facility staff productively work together during surveys, it is not my role

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to assess the surveyors’ customer service skills.  And if Petitioner feels that the surveyors did not review all relevant records and that the remedies imposed are based on an inaccurate factual record, Petitioner has had the opportunity to submit any evidence and arguments for my consideration.  Ms. Bengivenga’s testimony does not provide any factual basis supporting that the remedy imposed is not reasonable.  While I will not exclude this testimony, I have determined that allowing CMS an opportunity to cross-examine this witness would serve no useful purpose.

CMS requests an opportunity to cross-examine three other witnesses:  Gail Rader, RN, MSN, NP; Deborah Gottlieb, RN, MSN, CALA, J.D.; and, Mark Weinstein, M.D.  Ms. Rader’s written direct testimony is of little probative value; while she opined that her “review of the record indicated that [Resident # 6’s] complex physical problems were properly care planned for,” her opinion lacks any support by reference to the actual care plan itself that was in effect at the time of the October 2015 survey.9  P. Ex. 2 at 16.10  Ms. Gottlieb proclaimed that “the entire survey report was issued in error” (P. Ex. 8 at 9), and Petitioner’s sole reference to Ms. Gottlieb’s testimony, with respect to the deficiencies at issue, is to her claim that the surveyors “missed” documents and did not adhere to the State Operations Manual.  P. Br. at 33.  Ms. Gottlieb argued that the deficiencies at issue constituted, at a maximum, “D” level deficiencies.  P. Ex. 8 at 2-3.  However, the scope of my review addresses the reasonableness of the CMP, and not the scope and severity of the deficiencies.  Dr. Weinstein opined that Resident # 6 did not have an allergy to chocolate and oranges because, in large part, her reported allergic reactions in the form of facial redness and flushing were due to other reasons such as hypertension and the effect of flavonoids that are found in chocolate and citrus fruits.  P. Ex. 5 at 5.  However, Dr. Weinstein’s opinion is of limited probative value because it fails to address the reported basis for Resident # 6’s reported allergic reaction, which was that she “breaks out into a rash” if she consumes chocolate and oranges.  CMS Ex. 10 at 35.  For the foregoing reasons, while I admit these exhibits into the record, I deny CMS an opportunity to cross-examine these witnesses because it would not be prejudicial to CMS.

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Because I will decide this matter on the merits, I need not rule on CMS’s motion for summary disposition.11

II.  Issues

The issues presented are:

Whether Petitioner was in substantial compliance with the Medicare program participation requirements at 42 C.F.R. §§ 483.20(d), 483.20(k)(1), and 483.25(h);

If Petitioner was not in substantial compliance, whether a per-day CMP of $600 from October 21, 2015 through December 3, 2015 is reasonable.

III.  Discussion12

  1. Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.20(d) and 483.20(k)(1) because it did not develop a comprehensive care plan to adequately address Resident # 6’s reported food allergies and behavioral problems.
  2. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h) because it did not provide adequate supervision and assistance devices to address Resident # 6’s behavioral problems that resulted in her ingesting foods to which she was presumed to be allergic.

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Factual Background

Resident # 6, a 61-year-old woman, was initially admitted to the facility on June 19, 2011.  CMS Ex. 10 at 88.  Her diagnoses included asthma, atelectasis, bipolar disorder, major depressive disorder, anxiety, dementia with behavioral disturbances, spastic diplegic cerebral palsy, intellectual disability, disorganized schizophrenia, and developmental disability.  CMS Ex. 10 at 5, 28, 31, 55, 70, 82, 88.

Reported allergies to chocolate and oranges

  • An August 9, 2014 Nutritional History13 for Resident # 6 provides the following information, in pertinent part:  “CHOCOLATE AND ORANGES CAUSE A RASH. NURSING AND KITCHEN AWARE.”  P. Ex. 24 at 1 (capitalization in original).  The source of this report is not documented on the form, and the form indicates that Resident # 6 was unable to comprehend her nutritional status and diet order.  P. Ex. 24 at 1.  That same day, Petitioner’s staff recorded in a progress note that a dietician “called this morning,” and “[s]tated that [Resident # 6] is allergic to chocolate and oranges and breaks out into a rash if consumed.”  CMS Ex. 10 at 35; P. Ex. 26 at 1.
  • A December 24, 2014 progress note documents that Resident # 6 “drank some of another resident’s coffee with hot chocolate in it” and reported “[c]hocolate allergy noted in resident chart.”  CMS Ex. 10 at 37, 42.  After Petitioner notified Dr. Alexander Kulczycki, Resident # 6’s physician, the physician issued an order for the generic form of Benadryl for “1 capsule (25 mg) by oral route every 6 hours as needed for allergic reactions.”  CMS Ex. 10 at 33.  The progress note documents that Dr. Kulczycki ordered Benadryl as needed every six hours for allergic reaction.  CMS Ex. 10 at 37.  A subsequent progress note reports that staff administered Benadryl.  CMS Ex. 10 at 38.
  • On February 3, 2015, Resident # 6 “was observed eating another resident’s chocolate cake” at dinner.14  CMS Ex. 10 at 47.  Resident # 6 was given Benadryl.  CMS Ex. 10 at 47.

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  • An April 7, 2015 progress note reports that Resident # 6 “may have consumed pieces of an orange from a fruit cup at dinner. . . .”  A “small rash and red patches of skin to her face, neck and arms” were observed; Resident # 6 was given Benadryl.  CMS Ex. 10 at 49.
  • On April 8, 2015, Petitioner documented that Resident # 6 had a food allergy to oranges of mild severity, with a cutaneous reaction.15  CMS Ex. 10 at 23.
  • On June 12, 2015, activity staff reported that Resident # 6 “ate oranges during dinner” and that her face was red but that she was not in respiratory distress.  CMS Ex. 10 at 55.  Petitioner administered Benadryl to Resident # 6.
  • On July 24, 2015, activity staff reported that Resident # 6 “had a cup of someone else’s orange juice.”  CMS Ex. 10 at 58.  A registered nurse documented that Resident # 6’s face was red.  CMS Ex. 10 at 58.  Petitioner administered Benadryl to Resident # 6.  CMS Ex. 10 at 58.
  • On September 3, 2015, Petitioner’s activity staff gave Resident # 6 a chocolate chip cookie.  CMS Ex. 10 at 60.  Resident # 6 took a bite out of the cookie before the nursing manager took away the cookie.  CMS Ex. 10 at 60.  Resident # 6 was given Benadryl.  CMS Ex. 10 at 60.
  • After completion of the survey, an outside laboratory performed an allergy blood test on November 12, 2015.  P. Ex. 27 at 1.  The laboratory’s November 27, 2015 report indicates that testing for antibodies to “Orange” and “Chocolate/Cacao” was negative.16  P. Ex. 27 at 1.

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  • On December 10, 2015, Dr. Kulczycki stated that Resident # 6 “originally came under my care with a history of allergies to chocolate and oranges.  She has since had testing which demonstrated she does NOT in fact have these allergies.”  CMS Ex. 26 at 150.  Dr. Kulczycki nonetheless maintained “an order of Benadryl as needed” as “a prn cautionary measure.”  CMS Ex. 26 at 150.

Resident # 6’s behavior

In addition to the incidents discussed above in which Resident # 6 took the food and drink of other residents, there are numerous instances17 when Resident # 6’s behavior impacted others:

  • A November 27, 2014 progress note reported that Resident # 6 “continues behaviors of yelling out until exhaustion.”  CMS Ex. 10 at 39.  Later that same day, Petitioner’s staff found Resident # 6 “removing her clothing” and that she had “removed her sneakers was attempting to stand to self[-]transfer to the other

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resident[’]s bed.”  Staff attempted redirections that included activities, food and beverages, change of environment, and crayon/drawing activity, and Petitioner reported that Resident # 6 would not engage in redirections or that redirections were unsuccessful.  CMS Ex. 10 at 39.  Petitioner reported that Resident # 6 continued to call out and would self-propel her wheelchair into other residents’ wheelchairs and staff.  CMS Ex. 10 at 39.

  • On December 12, 2014, staff discovered that Resident # 6 was resting with her eyes closed on top of another resident’s bed, and that her “clothes, abdominal binder and diaper were scattered throughout the floor” of the room.  Resident # 6 “was dressed in the other resident’s clothing.”  CMS Ex. 10 at 40.
  • A December 17, 2014 progress note reports that staff discovered Resident # 6 self-propelling around the unit, and that she was “removing her clothing in another resident[’]s bedroom and attempting to self[-]transfer herself on to the person[’]s bed at the same time.”  Staff noted that Resident # 6 was yelling out at staff, following staff and peers closely, and pretended to cry, and that she “continued [these] behaviors until exhaustion.”  CMS Ex. 10 at 41.
  • A December 24, 2014 progress note reports that, in the week prior, Resident # 6 had been administered Ativan four times “for behaviors for which redirections were unsuccessful.”  Staff documented that Resident # 6 “continues to call/yell out, follow staff and residents closely, and attempts to self[-]transfer without assistance.”  CMS Ex. 10 at 42.
  • On December 25, 2014, staff reported that Resident # 6 “was calling out, yelling at staff and residents,” and that she self-propelled into the quiet room, removed all her clothing, to include her adult brief, and “swatted at nurse with her hands” during redressing.  CMS Ex. 10 at 42.
  • A January 8, 2015 progress note reports that Resident # 6 “continues to call/yell out, follow staff and residents closely, and attempts to self[-]transfer without assistance.”  CMS Ex. 10 at 44.  Later that same day, staff reported that Resident # 6 was “calling out/yelling at staff,” “refused to go to bed,” and began to self-propel into other residents’ rooms, “attempting to touch [a] sleeping resident . . . .”  CMS Ex. 10 at 44.
  • On January 10, 2015, Petitioner administered Ativan to Resident # 6 because she was “yelling in the day room, and Petitioner reported that the Ativan had “positive effects.”  Resident # 6 had been self-propelling into other residents’ rooms and yelling.  Staff was unable to redirect or distract Resident # 6.  CMS Ex. 10 at 45.

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  • A January 17, 2015 progress note reported that Resident # 6 was “calling out,” self-propelling into furniture, and “removing her clothing in the dayroom and hallway.”  Although Resident # 6 was toileted and offered activities and a snack, she “continue[d] to call out and scream.”  Staff administered Ativan with a good result.  CMS Ex. 10 at 46.
  • A February 13, 2015 progress note documents that Resident # 6 was self-propelling around the unit and “derobing in other residents[’] rooms.”  CMS Ex. 10 at 48.
  • On June 9, 2015, Resident # 6 was self-propelling in the hallway, “yelling and shouting at staff and other residents.”  Art activity, a snack, television, and other recreational activities were not effective and she continued to yell out.  Staff administered Ativan “to help with anxiety.”  CMS Ex. 10 at 54.
  • On September 2, 2015, Resident # 6 was “found sitting on another resident[’]s bed with feces on the bed.”  After staff removed Resident # 6 from that room, Resident # 6 “later was found in another resident[’]s room with a broken picture frame in her hand.”  CMS Ex. 10 at 59.  A subsequent entry reports that Resident # 6 had been self-propelling around the unit that evening and “had removed her tab alarm and all of her clothing.”  CMS Ex. 10 at 59.
  • On September 9, 2015, staff reported that Resident # 6 continued “to wander into other residents[’] rooms and touch personal belongings, self[-] transfer onto other beds, and remove alarms.”  CMS Ex. 10 at 63; P. Ex. 38 at 3.
  • An October 13, 2015 progress note documents that Resident # 6 was making “hurtful comments to staff and peers, calling staff ugly monkey, yelling out NO! when staff made attempts to assist [her].”  CMS Ex. 10 at 68.

Resident # 6’s care plan

Resident # 6 had a care plan in effect at the time of the October 2015 survey.  CMS Ex. 10 at 24-32; P. Ex. 29 at 51-71.  The following focuses (i.e., problems) are addressed in the care plan:

Nutrition – history of weight loss
Falls/risk of falls
Range of motion of the right upper extremity
Pain

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Psychotropic drug use due to diagnoses of depressive disorder/anxiety/bipolar disorder with schizophrenia, pseudobulbar affect18
Risk for skin breakdown due to decreased mobility and incontinence
Congestive heart failure
Dysphagia

CMS Ex. 10 at 24-32; P. Ex. 29 at 51-71.  The care plan in effect at the time of the October 2015 survey lists “allergy to other foods” among the diagnoses on its final page.  CMS Ex. 10 at 31; P. Ex. 29 at 71.  The care plan obtained by the state agency at the time of the survey listed the following allergies on each page: “Penicillins, Chocolate, Oranges.”19  CMS Ex. 10 at 24-32.

Petitioner submitted an undated document that it identified in its list of exhibits as a “Kardex” record.  P. Ex. 31.  This document lists, under the “monitors” category heading, that staff “supervise [Resident # 6] during the meal and offer similar food items if she attempts to reach for food on other trays.”  P. Ex. 31 at 1.  The document also reports that if Resident # 6 “is found in another resident’s room it is most likely because she is looking for a bathroom – redirect and assist her with toileting.”20  P. Ex. 31 at 1.  While Petitioner claims on its exhibit list that this document is dated June 25, 2015, I observe

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that the only date on the document is a June 25, 2015 “admission date.”21  P. Ex. 31.  The aforementioned Kardex entries do not appear in Resident # 6’s care plan.

Petitioner submitted an IIDR request in May 2016.  CMS Exs. 7, 26.  In the cover letter accompanying the request, Petitioner acknowledged that Resident # 6’s care plan did not include interventions for reported food allergies, stating:

While it is true that the care plan did not contain a description of the interventions staff implemented for this resident, the lack of those statements on the care plan cannot possibly constitute immediate jeopardy since the staff was implementing interventions and the resident did not have actual allergies.  Bartley is aware that the interventions should have been written on the care plan.  However, at worst, the omission of the interventions from the care plan constitute a paperwork deficiency of no more than an A level.  The interventions were in place and being carried out.  There is no possible scenario in which a resident would be the likely victim of imminent harm if necessary care was being provided, although not written on one particular document in the medical records.

CMS Ex. 7 at 8.  In its IIDR request, Petitioner referred to Resident # 6’s reported allergies to oranges and chocolate as “presumed food allergies.”22 CMS Ex. 26 at 2.  Petitioner acknowledged that the statement of deficiencies “supports the fact staff knew of the food allergies and how to intervene regardless of what was or was not listed as an intervention in the care plan,” and that “staff always acted appropriately to intervene if there was a suspicion of ingestion of either of these two food items.”  CMS Ex. 26 at 3.  Petitioner further stated that “staff knew and properly addressed and responded to all resident behaviors regardless of whether each action taken was specifically identified in the written care plan.”  CMS Ex. 26 at 3; see CMS Ex. 7 at 1.

Relevant authority

With respect to care planning, 42 C.F.R. § 483.20(d) directs that a facility “must maintain all resident assessments completed within the previous 15 months in the resident’s active record and use the results of the assessments to develop, review, and revise the resident’s comprehensive plan of care.”  Pursuant to 42 C.F.R. § 483.20(k)(1), a facility “must

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develop a comprehensive care plan for each resident that includes measureable objectives and timetables to meet a resident’s medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment.”  Section 483.20(k)(1) further instructs that a care plan “must describe” the services “that are to be furnished to attain or maintain the resident’s highest practicable physical, mental, and psychosocial well-being as required under [42 C.F.R.] § 483.25 . . . .”  The DAB has explained that a comprehensive care plan “functions as a roadmap for all of the resident’s caregivers, including those unfamiliar with a resident or without professional training, to provide consistent care and services,” so that the care and services are “tailored to ‘attain or maintain the [resident’s’] highest practicable physical, mental, and psychosocial well-being.’”  Sheridan Health Care Ctr., DAB No. 2178 at 37 (2008), citing 42 C.F.R. § 483.20(k).  The DAB further explained that “the care plan must include sufficient guidance to ensure that the services provided promote the plan’s specified objectives.”  Id.  The DAB has also discussed that a care plan must “provide adequate guidance to staff to ensure that [a resident] receive[s] the requisite care.”  Deltona Health Care, DAB No. 2511 at 19 (2013).

Medicare program requirements further require that “[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.”  42 C.F.R. § 483.25.  Subsection 483.25(h) imposes specific obligations upon a facility related to accident hazards and accidents, as follows:

(h)  Accidents.  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.

The DAB has held that subsection 483.25(h)(1) 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)).  The provisions of section 483.25(h) “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, 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(h)(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

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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)).  Though a facility has the flexibility to choose the methods of supervision and assistance used to prevent accidents, it must also “provide supervision and assistance devices that reduce known or foreseeable accident risks to the highest practicable degree, consistent with accepted standards of nursing practice.”  Heritage Plaza Nursing Ctr., DAB No. 2829 at 6 (2017) (citing Century Care of Crystal Coast, DAB No. 2076 at 6-7 (2007), aff’d, Century Care of Crystal Coast v. Leavitt, 281 F. App’x 180 (4th Cir. 2008)).

Discussion

Petitioner correctly states “[t]here is little doubt that Resident No. 6 was a massively complicated, younger resident who exhibited behaviors that needed to be care planned for.”  P. Br. at 15.  Petitioner explained that “[i]t is impossible due to page limitation to refer to all undesirable behaviors that had to be care planned for,”23 and that “most specific to this dispute Resident No. 6 had sleep/wake cycle disturbance due to her diagnoses and wandered regularly into resident’s rooms.”  P. Br. at 21.  Petitioner accurately noted that Resident # 6 “displayed behaviors consistent with her mental health diagnoses of dementia, intellectual disability, depression, anxiety, schizophrenia, bipolar disorder, and pseudobulbar affect.”  P. Br. at 13.  Petitioner also acknowledged that Resident # 6 was “reported to have a food allergy” and “took food from others.”  P. Br. at 20.  A witness for Petitioner, Ms. Rader, testified that Resident # 6 “displayed undesirable behaviors which required care planning including pharmacological and non-pharmacological interventions, supervision, redirection, incentives and on occasion, one-to-one supervision.”  P. Ex. 2 at 14; see P. Br. at 21 (stating the same).

Despite Petitioner’s concession that Resident # 6’s significant undesirable behaviors required care planning, Resident # 6’s care plan failed to identify Resident # 6’s undesirable behaviors as a focus area, to particularly include her repeated taking of other residents’ food and drink to which she was presumed to be allergic.  Nor did the interventions in Resident # 6’s care plan address the aforementioned recurring problematic behaviors such as entering other residents’ rooms, disrobing, removing her diaper, removing her tab alarm, hitting, wandering, and taking other residents’ food and drink.  CMS Ex. 10 at 24-32; P. Ex. 29 at 51-71.  Petitioner, without citation to the care plan, argues that it took “intervening actions designed in controlling behaviors.”  P. Br. at 21.  Citing to “progress notes, orders, and assessments,” but not the care plan, Petitioner contends that it monitored Resident # 6’s behavior and attempted to divert her when she

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engaged in negative behaviors.24  P. Br. at 21.  And citing again to the same exhibits and not the care plan, Petitioner argues that the care plan and interdisciplinary conference notes from 2014 and February 2015 “indicate clear reference to planning for Resident No. 6’s wandering behaviors, practices of taking other resident[s’] foods and the need for staff supervision and intervention at meal times.”25  P. Br. at 21-22.

Although Petitioner repeatedly contends it care-planned for these behavioral problems, it fails to directly cite to the care plan in support of its arguments.  For example, Petitioner references care plan meeting reports, and not a care plan, to argue that the care plan directed that Resident # 6 “was fed by staff while [sic] meals in the day room, that she had to be qued [sic] and supervised during meal times and the detail that psychotropic drug use was implemented due to a history of yelling and screaming, hitting staff during care, episodes of anxiety and depression, [and a] history of sleep wake cycle disturbance.”  P. Br. at 22.

The care plan does not identify Resident # 6’s behaviors as a problem or focus area, nor does it identify Resident # 6’s presumed allergies to certain foods, along with her behavior of taking these types of foods from other residents, as problems that required care planning.  Rather, the care plan listed psychotropic drug use as a focus area, and listed several interventions under this focus area (which were significantly revised during the course of the survey).  CMS Ex. 10 at 26, 29-30.  None of the interventions specifically addressed the need for supervision, to include the one-on-one supervision Petitioner concedes was required.  P. Br. at 21 (stating that Resident # 6 “required care planning including pharmacological and non-pharmacological interventions, supervision, redirection, use of incentives, and on occasion, one-to-one supervision.”).  And with respect to the incentives, which Petitioner recognized Resident # 6’s care plan required, Petitioner points to no incentives in the care plan.  P. Br. at 21.  And although Petitioner acknowledged that it did not have enough pages to discuss all of Resident # 6’s undesirable behaviors, it fails to point to anything in the care plan that addresses Resident # 6’s repeatedly problematic behaviors, such as hitting, using her wheelchair to run into other residents, entering other residents’ rooms, disrobing, removing her diaper and tab alarm, going in other residents’ beds, touching other residents’ personal

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possessions, and taking other residents’ food and drink to which she was presumed allergic.

Petitioner argues there is “evidence of care planning for a resident reported to have a food allergy who took food from others,” yet once again it fails to point to any such evidence in the care plan.  P. Br. at 20.  Although Petitioner contends that “the resident resided and ate all meals on a highly supervised memory care unit and was assisted by staff at all meals with regard to meal consumption,”26 there is simply no evidence that placement in a memory care unit, alone, demonstrates adequate supervision during meals of a resident with presumed food allergies “who took food from others.”  P. Br. at 20.  And while Petitioner argues that Dr. Cheung incorrectly reported there were no care plan interventions related to her access to foods to which she was presumed allergic, it has not pointed to anything in the care plan that undermines Dr. Cheung’s assertion.   P. Br. at 20; see CMS Ex. 36 at 10.

Petitioner appears to misunderstand the purpose of a care plan, which is to be a resource that provides guidance to staff regarding the care of residents, and Petitioner ignores that staff members who are unfamiliar with Resident # 6 may be required to care for her at times.  It is utterly nonsensical to expect that nurses and other staff members would have to search through old nursing notes, progress notes, and care plan meeting notes in order to familiarize with Resident # 6’s problems, needs, and care strategies, when the purpose of a care plan is to provide a comprehensive resource so that staff can readily access the necessary guidance that, when followed, will ensure a resident receives adequate care.  See Deltona Health Care, DAB No. 2511 at 19.

Petitioner previously acknowledged that “it is true that the care plan did not contain a description of the interventions staff implemented for this resident  . . . .”  CMS Ex. 7 at 8.  Petitioner also conceded that it “is aware that the interventions should have been

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written on the care plan.”  CMS Ex. 7 at 8.  Although Petitioner argued that its “staff knew . . . how to intervene regardless of what was or was not listed as an intervention in the care plan,” such a claim is based on the precarious presumption that every staff member will be personally familiar with Resident # 6 such that a care plan is unnecessary.  CMS Ex. 26 at 3.  However, on at least one occasion Petitioner’s own staff gave her a cookie containing chocolate; on that occasion, Resident # 6 was stopped only because another staff member familiar with Resident # 6, a nursing supervisor, intervened.  If the nursing supervisor had been a new employee or had been working in a different unit than usual, she would not have learned of any necessary interventions by reviewing Resident # 6’s care plan.27  See CMS Ex. 10 at 60.

Resident # 6 had a reported history of allergies to chocolate and oranges, and regardless of whether she actually had these allergies, Petitioner presumed she had these allergies.  And on various occasions that she ingested chocolate and oranges, Petitioner documented observable physical reactions, to include a rash on at least one occasion, and administered Benadryl.  See CMS Ex. 10 at 49.  Even though Petitioner was under the impression that Resident # 6 had suffered a number of allergic reactions after she took other residents’ food, it still did not care plan for her known, predictable, and undesirable behaviors that were believed to result in allergic reactions.

Petitioner also knew that Resident # 6 “wandered regularly into resident[s’] rooms.”  P. Br. at 21.  This behavior was not just potentially unsafe for Resident # 6, but it could  adversely impact other residents; not only did Resident # 6 climb into other beds (even spreading feces on one occasion) and touch other residents’ personal items, but she also repeatedly yelled at other residents.  And in addition to her own risk of suffering from an allergic reaction when she took other residents’ food, Resident # 6’s taking of other residents’ food would naturally be bothersome to those residents.  By failing to address Resident # 6’s known undesirable behaviors, Petitioner failed to provide adequate guidance for staff to manage these behaviors.

By failing to adequately care plan for Resident # 6, Petitioner did not 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.”  Heritage Plaza Nursing Ctr., DAB No. 2829 at 6 (2017) (citing Briarwood Nursing Ctr., DAB No. 2115 at 5 (citing Woodstock Care Ctr. v. Thompson, 363 F.3d at 590).  Petitioner acknowledges the need for supervision of Resident # 6’s behaviors (P. Br. at 21), and its failure to provide guidance in Resident # 6’s care plan resulted in a failure to take “all reasonable steps” to ensure that Resident # 6 received adequate supervision to manage her behaviors and her access to foods to which she was presumed to be allergic.  42 C.F.R. § 483.25(h).

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  1. A per-day CMP of $600 for the period October 21 through December 3, 2015, is a reasonable enforcement remedy for Petitioner’s noncompliance.

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).  42 C.F.R. § 488.438(e)(3).  These factors include: 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.  42 C.F.R. § 488.438(f).  The absence of culpability is not a mitigating factor.  The factors 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.

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).

CMS imposed a per-day CMP of $600 for 44 days from October 21 through December 3, 2015, for a total CMP of $26,400.  Although Petitioner returned to compliance with respect to 42 C.F.R. § 483.25(h) on October 21, 2015 (see CMS Ex. 25 at 27), it remained out of compliance with 42 C.F.R. §§ 483.20(d) and 483.20(k)(1) through December 3, 2015.  See CMS Ex. 41 at 1.  Specifically, Petitioner asserted, in a plan of correction, that the date of completion was December 4, 2015, by which time it had, inter alia, reviewed and updated Resident # 6’s care plan and identified residents with new or recurring inappropriate behaviors “to determine if further assessment and/or care plan revision is needed.”  CMS Ex. 25 at 11-13.

Petitioner argues that it should not have been cited for any deficiencies pursuant to 42 C.F.R. §§ 483.20(d), 483.20(k)(1), and 483.25(h) based on the October 27 survey, and it broadly argues that a CMP is not justified.  P. Br. at 34.  However, Petitioner does not argue that a $600 per day CMP is unreasonable.28  Nonetheless, I will evaluate the factors set forth in section 488.438(f) and explain why the CMP is reasonable.

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The deficiency here is serious, and Petitioner is culpable.  Petitioner presumed that Resident # 6 was allergic to chocolate and oranges, and it repeatedly allowed her to ingest these substances.  And Petitioner concedes that Resident # 6 had frequent undesirable behaviors, to include wandering into other residents’ rooms and taking other residents’ food, yet did not address these behaviors in Resident # 6’s care plan.  In fact, Resident # 6’s care plan failed to address the supervision that was necessary to address these known behaviors, and it failed to provide guidance regarding management of her presumed food allergies and her repeated taking of other residents’ food.  The deficiency involving supervision is significant, and it directly resulted from the inadequate care plan that lacked guidance regarding the supervision and interventions necessary to address Resident # 6’s known behaviors and presumed food allergies.  Therefore, the care plan deficiency, alone, supports the 44-day CMP, which is at the low end of the penalty range.

Petitioner has not offered any evidence showing an inability to pay the per-day CMP.  Unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it.  Coquina Ctr., DAB No. 1860 (2002).

It is “well-settled” that “the period of noncompliance continues until the facility affirmatively demonstrates a return to substantial compliance.”  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, DAB No. 1658 at 12-15 (1998)).

Petitioner did not allege it returned to compliance with respect to care planning until December 4, 2015, and it has not asserted otherwise in its briefing.  CMS Ex. 25 at 13.  Therefore, a per-day CMP is appropriate from October 21, 2015, through December 3, 2015.  The per-day CMP of $600 is at the low end of the authorized penalty range ($50 to $3,000).  42 C.F.R. §§ 488.408(d)(1)(iii), 488.438(a)(1)(ii).  While Petitioner argues the per-day amount of the CMP is unreasonable, its arguments are not based on the regulatory factors.  P. Br. at 5-6.  Petitioner has not invoked any basis to reduce the CMP, and based on consideration of the relevant regulatory factors, the CMP is reasonable.29

IV.  Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.20(d), 483.20(k)(1), and 483.25(h).  Petitioner was not in substantial compliance with program participation requirements from October 21 through December 3, 2015, and a per-day CMP of $600 is a reasonable enforcement remedy.

  • 1. Federal nursing home regulations substantially changed beginning on November 28, 2016. 81 Fed. Reg. 68,688 (Oct. 4, 2016). Based on the date of the survey, which preceded the regulatory revisions, I refer to the regulations that were in effect at the time of the October 2015 survey.
  • 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.” See 42 C.F.R. § 488.301.
  • 3. The applicable CMP range increased to $103 to $6,188, beginning August 1, 2016, for deficiencies cited after November 2, 2015, to “reflect the statutorily mandated amounts and ranges as adjusted for inflation.” See 81 Fed. Reg. 61,538, 61,573-61,574 (Sept. 6, 2016); 45 C.F.R. § 102.3. 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, 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 (Sept. 8, 2016), https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-40.pdf, last visited February 19, 2019; 81 Fed. Reg. 61,538 (discussing that the law “provides a clear formula for adjustment of the civil monetary penalties, leaving agencies little room for discretion,” and that the increased penalties will apply to “penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015, the date of enactment of the 2015 Amendments.”). Although the noncompliance extended well after November 2, 2015, I apply the CMP range that pre-dated the cost of living adjustment because the deficiencies were cited at a survey completed on October 27, 2015.
  • 4. 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, § 7400.3.1 (Matrix for Scope and Severity), https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c07.pdf (last visited February 19, 2019); see 42 C.F.R. § 488.408. As relevant here, a scope and severity level of “K” indicates a pattern of immediate jeopardy to resident health or safety.
  • 5. The penalties imposed, when added correctly, do not total $52,268; CMS later adjusted the amount of the CMP. CMS Exs. 38, 39, and 41. I also point out that CMS imposed a prohibition against the provision of a nurse aide training and competency evaluation program (NATCEP) for a two-year period. CMS Ex. 1 at 3. CMS reported that Petitioner did not have an approved NATCEP (CMS Br. at 6, n. 6), and Petitioner does not appeal this issue.
  • 6. A scope and severity level of “G” corresponds to an isolated deficiency that involves actual harm that does not amount to immediate jeopardy.
  • 7. Petitioner challenged the then-immediate jeopardy deficiencies cited under 42 C.F.R. §§ 483.20(d) and 483.20(k)(1) (Tag F279) and 42 C.F.R. § 483.25(h) (Tag F323), along with five other deficiencies cited as having the potential for more than minimal harm without actual harm: 42 C.F.R. § 483.20(b)(1) (Tag F272); 42 C.F.R. § 483.35(e) (Tag F367); 42 C.F.R. § 483.60(c) (Tag F428); 42 C.F.R. § 483.60(b), (d), and (e) (Tag F431); and 42 C.F.R. § 483.75(l)(1) (Tag F514). Request for Hearing. In its April 7, 2017 letter, CMS explained that it had “imposed a $600 Per Day CMP based on the deficiencies at Federal Tag: F0279 – [scope and severity]: G – [42 C.F.R.] § 483.20(d), 483.20(k)(1) –Develop Comprehensive Care Plans and Federal Tag: F0323 – [scope and severity]: G – [42 C.F.R.] § 483.25(h) – Free of Accident Hazards/Supervision/Devices on October 21, 2015, and a $600 Per Day CMP for forty-three (43) days of continuing noncompliance from October 22, 2015 continuing through December 3, 2015.” CMS Ex. 41 at 1. CMS, in increasing the per-day CMP from $103 to $600 in April 2017, explained that the “$600 per-day CMP amount includes an additional amount added to the base amount for a “G” level deficiency, based on the culpability of the facility in failing to develop a comprehensive care plan to timely address the issues identified under F279, part B of the CMS-2567.” CMS Ex. 41 at 2. As such, the April 2017 letter indicates that the CMP was based on the deficiencies cited under Tags F279 and F323. See, e.g., Columbus Park Nursing & Rehab. Ctr., DAB No. 2316 at 7 (2010) (an SNF “has no right to an ALJ hearing to contest survey deficiency findings where CMS has not imposed any of the remedies specified at section 488.406 based on those findings, or where CMS imposed, but subsequently rescinded, any such remedies.”). Additionally, I have found that the two “G” level deficiencies support the $600 per day CMP; in fact, the care plan deficiency cited under Tag F279 which extended for the entire 44-day period of noncompliance, alone, warrants the $26,400 CMP. Because the “G” level deficiencies alone warrant the CMP imposed, I need not address the remaining deficiencies. Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 847 (6th Cir. 2010); Carrington Place of Muscatine, DAB No. 2321 at 20-21 (2010).
  • 8. CMS criticizes Petitioner for not providing the full name of M.W., who is the son of a resident. It appears that Petitioner redacted this name in order to protect the identity of the resident.
  • 9. Ms. Rader cites to P. Exs. 28, 29, 30, 31, 34, and 35, without any pinpoint citations in the more than 100 pages of evidence. P. Ex. 2 at 9. None of the records support that, at the time the survey was initiated, Resident # 6’s care plan adequately addressed reported food allergies and behavioral problems that enabled Resident # 6 to access those foods.
  • 10. Petitioner submitted another unsworn 28-page report by Ms. Rader, which included supporting exhibits. P. Ex. 1. For reasons unclear to me, Ms. Rader stated the following in her written direct testimony: "It is not feasible to provide the same level of detail in this written Declaration as it is in my written report." P. Ex. 2 at 3.
  • 11. Nonetheless, I agree with CMS that the two unappealed deficiencies cited at the “E” level of scope and severity under 42 C.F.R. § 483.25 (Tag F309) and 42 C.F.R. § 483.40(c)(1)-(2) (Tag F387), alone, would support a combined CMP of $600 per day. Because Petitioner did not timely appeal the surveyors’ findings that Petitioner failed to follow physician orders regarding the administration of Resident # 25’s blood pressure medication and failed to ensure that Resident # 25 and Resident # 32 were seen by their physician every 60 days, those deficiencies are administratively final. The two deficiencies, combined, would support a $600 CMP at the low end of the penalty range for 44 days of noncompliance. See CMS Ex. 25 at 23, 45. However, because the $600 per day CMP appears to be based on the deficiencies cited under tags F279 and F323, I will not grant summary disposition upholding the reasonableness of the CMP based only on the unappealed deficiencies.
  • 12. Findings of fact and conclusions of law are in bold and italics.
  • 13. With respect to feeding ability, this document reports that Resident # 6 had total dependence for eating. P. Ex. 24 at 3. I observe that Resident # 6’s care plan does not provide specific interventions addressing a need for total dependence for eating, but rather, instructs that staff should “[a]ssist with feedings as needed.” CMS Ex. 10 at 32. The Nutritional History documented a 25-pound weight loss in the previous four months since an April 2014 admission. P. Ex. 24 at 2.
  • 14. Several day later, in an apparent reference to this incident, Dr. Kulczycki reported the following in a progress note: “[P]er [nursing] [patient] is stealing other [patient’s] food (including chocolate)!” P. Ex. 35 (capitalization omitted). The physician’s report does not document any food allergies or reference treatment with Benadryl.
  • 15. Petitioner further reported “Reaction Sub Type: Stevens-Johnson syndrome.” CMS Ex. 10 at 23. However, Petitioner provided no supporting explanation for this apparent diagnosis, and there is no diagnosis by a physician that Petitioner had Stevens-Johnson syndrome, which can be manifested by a rash. See, e.g., https://rarediseases.info.nih.gov/diseases/7700/stevens-johnson-syndrometoxic-epidermal-necrolysis (last visited February 19, 2019).
  • 16. I do not accept this blood test result alone, as proof that Resident # 6 did not have allergic reactions to chocolate and oranges, and I note, even after receiving the results of the blood testing, Dr. Kulczycki maintained the order for Benadryl as needed as a precautionary measure. CMS Ex. 26 at 150. CMS’s witness, Dr. Cheung, contends that the allergy testing is “inadequate to rule out the resident’s allergies to chocolate or oranges . . .” and that, among other things, additional testing, “such as a skin test or oral food challenge, etc., should also have been conducted.” CMS Ex. 36 at 11. Dr. Cheung reported that Resident # 6’s “symptoms of redness in the face and skin rash” were an allergic reaction to chocolate, oranges, and orange juice. CMS Ex. 36 at 1, 10-12. Dr. Cheung further explained that the “rash and red face shortly after ingestion of these foods, which resolved after the resident was administered Benadryl, is consistent with an allergic reaction.” CMS Ex. 36 at 10. Dr. Weinstein, a witness for Petitioner, opined that Resident # 6’s “facial redness” and “flushing” after consumption of high-flavonoid foods, which cause dilation of blood vessels, was mistakenly reported as an allergy, and that Resident # 6’s other medical conditions, such as hypertension, “would also explain facial redness.” P. Ex. 5 at 5-6. Despite reports that Resident # 6 had rashes after exposure to chocolate and oranges, and Dr. Cheung’s opinion that the rashes were consistent with an allergic reaction, Dr. Weinstein failed to specifically address Resident # 6’s reported rashes after ingesting chocolate and oranges. Therefore, Dr. Weinstein failed to address a key symptom of suspected allergic reactions. And even if Resident # 6 did not have such allergies (which I do not find), Petitioner clearly believed at the time of the survey that Resident # 6 had such allergies (CMS Ex. 10 at 34) and administered Benadryl, which is known to cause a number of undesirable effects, because Resident # 6 ingested foods that she was presumed to be allergic to. See, e.g., https://medlineplus.gov/druginfo/meds/a682539.html (last visited February 19, 2019) (reporting side effects of dry mouth, nose, and throat; drowsiness; dizziness; nausea; vomiting; loss of appetite; constipation; increased chest congestion; headache; muscle weakness; excitement (especially in children), and nervousness).
  • 17. In addition to the episodes listed below that are documented in progress notes, I note that Petitioner’s weekly “Psych Review” reports document numerous episodes of problematic behavior. P. Ex. 38.
  • 18. The focus area listed as “[p]sychotropic drug use due to [diagnosis] of depressive disorder/Anxiety/bipolar disorder with Schizophrenia, Pseudo Bulbar Affect” included several interventions, to include: Escorting Resident # 6 from situations that cause increased agitation or frustration; allowing time to rest if Resident # 6 became agitated or frustrated; monitoring behaviors; and reviewing medication at least quarterly to address appropriateness, possible reduction, and behavioral changes. CMS Ex. 10 at 26-27, 29. On October 18, 2015, which was four days after the survey began, Petitioner revised Resident # 6’s care plan with respect to the following interventions: “Provide emotional and behavioral support as needed or requested or when yelling out becomes excessive,” and “Redirection with coloring as she likes her crayons and coloring book, prefers to do this in her room. Disney Channel is also effective.” CMS Ex. 10 at 26-27.
  • 19. The version of the care plan submitted by Petitioner, which it had continued to update well after the survey through January 2016, lists “Penicillins” as the only allergy. See P. Ex. 29 at 51-71.
  • 20. Interestingly, none of the incidents detailed above in which Resident # 6 entered other residents’ rooms appear to involve her looking for a bathroom, as evidenced by her changing into another resident’s clothes, getting into other residents’ beds, and handling their personal items.
  • 21. In Golden Living Center - Foley, the Departmental Appeals Board (DAB) stated, in relevant part: “We recognize that the facility’s ‘Kardex’ . . . is a system used by staff to summarize a resident’s plan of care for CNAs . . . .” DAB No. 2510 at 14 n.9 (2013). The DAB further explained, with respect to an entry in the Kardex, that the ALJ “could reasonably give little weight to this notation because it is undated and unsigned.” Id.
  • 22. I have adopted this terminology in this decision.
  • 23. I authorized the parties to each file a brief of up to 45 pages in length; Petitioner’s brief is 34 pages long.
  • 24. Petitioner cites to “P-EX-35-37” in support of these assertions. I note that I directed, in Section 4 of my Pre-Hearing Order, that each party “must cite the exhibit number and relevant page number.” P. Ex. 35 is a February 2015 progress note entered by Resident # 6’s physician, P. Ex. 36 is a radiology report of chest x-rays, and P. Ex. 37 is nine pages of nursing notes.
  • 25. I reiterate that Petitioner previously conceded that “the care plan did not contain a description of the interventions staff implemented for this resident” and that it was “aware that the interventions should have been written on the care plan.” CMS Ex. 7 at 8.
  • 26. Staff assistance with meals is not required by the care plan, and the nature of staff assistance during meals is not defined in the care plan. CMS Ex. 10 at 24-32; P. Ex. 29 at 51-71. The only care plan reference to staff assistance during meals is an intervention that was added to the care plan no earlier than June 25, 2015, that instructs staff to “[a]ssist with feedings as needed.” CMS Ex. 10 at 32. Any specific assistance can only be found in older care plan meeting reports that are not memorialized in the care plan that was in effect at the time of the survey. See P. Ex. 30. And although Petitioner’s Dementia Special Care Program and Dementia Unit policy indicates that room assignment for meals is based on whether a resident requires “maximal assist,” “minimal assist or supervision,” or is “verbally or behaviorally disruptive,” the care plan gave no indication of the level of assistance Resident # 6 required for meals. P. Ex. 33 at 5. The care plan did not direct that Resident # 6 should be “highly supervised” during meals, and her repeated consumption of other residents’ food and drink evidences a lack of supervision during meals. CMS Ex. 10 at 24-32.
  • 27. Further, Petitioner’s activity staff was clearly unaware of the presumed food allergy, in that a member of this staff provided the cookie to Resident # 6.
  • 28. Petitioner argues that the deficiencies cited at the “E” level of scope and severity would not support a $600 per day CMP. Petitioner’s Response to Motion for Summary Disposition at 6-8. However, I address only the “G” level deficiencies in this decision. Further, to the extent that Petitioner cites to an April 2005 Inspector General report to argue that a $600 per day CMP is excessive, I note that the data in the report consisted of CMPs collected in 2000 and 2001. See https://oig.hhs.gov/oei/reports/oei-06-02-00720.pdf (last visited February 19, 2019). CMS imposed the instant CMP in September 2016, and therefore, the CMP data in the report is at least 15 years out-of-date.
  • 29. Aside from the deficiencies that are the focus of this decision, I previously explained that the two unappealed deficiencies, cited under 42 C.F.R. §§ 483.25 and 483.40(c)(1)-(2), would support a combined CMP of $600 per day. Petitioner has not shown that any of the aforementioned regulatory factors would make a $600 per-day CMP unreasonable, and a $600 per-day CMP is at the low end of the penalty range, particularly for two deficiencies, one of which involved Petitioner’s administration of medication in contravention of a physician’s orders.