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                              Heritage House of Marshall Health and Rehabilitation, DAB CR5179 (2018)
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Heritage House of Marshall Health and Rehabilitation, DAB CR5179 (2018)








  
  
    

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





Heritage House of Marshall Health and Rehabilitation,
	(CCN: 67-6187),
	Petitioner,
v.
Centers for Medicare & Medicaid Services
Docket No. C-16-667Decision No. CR5179September 5, 2018

        
              
    

      DECISION
In this case we again consider a long-term-care facility’s obligations to protect its most vulnerable residents from developing avoidable pressure sores and to treat properly any sores that develop.
Petitioner, Heritage House of Marshall Health and Rehabilitation, is a long-term-care facility located in Marshall, Texas, that participates in the Medicare program.  Based on a survey completed on April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with multiple Medicare requirements and that its deficiencies posed immediate jeopardy to resident health and safety.  CMS imposed civil money penalties of $6,050 per day for one day of substantial noncompliance that posed immediate jeopardy to resident health and safety and $1,200 per day for one day of substantial noncompliance that did not pose immediate jeopardy (total penalty of $7,250).
CMS has moved for summary judgment.
Page 2
I grant CMS’s motion.  As discussed below, the undisputed evidence establishes that the facility was not in substantial compliance with Medicare program requirements, that its deficiencies posed immediate jeopardy to resident health and safety, and that the penalties imposed are not unreasonably high.
Background
The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  Act §1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301.
The Secretary contracts with state survey agencies to survey skilled nursing facilities in order to determine whether they are in substantial compliance.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys, and must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4).
Here, responding to a report of an incident, surveyors from the Texas Department of Aging and Disability Services (state agency) visited the facility to investigate, completing a partial survey on April 4, 2016.  CMS Exs. 1, 4; CMS Ex. 59 at 2 (Bailey Decl. ¶¶ 4, 5).  Based on their findings, CMS determined that the facility was not in substantial compliance with **42 C.F.R. § 483.25(c)1**(Tag F314) (quality of care – prevention of pressure sores) and that this deficiency posed immediate jeopardy to resident health and safety (scope and severity level K:  a pattern of noncompliance that poses immediate jeopardy to resident health and safety).  CMS also determined that the facility had corrected the immediate jeopardy but remained out of substantial compliance.  CMS Ex. 1.
CMS subsequently determined that the facility returned to substantial compliance on April 6, 2016.  CMS Ex. 2.
The parties inaccurately represent the amount and duration of the penalties.  CMS recognizes, correctly, that it imposed remedies for just two days of substantial
Page 3
noncompliance, one of which was at the immediate jeopardy level.  CMS also claims, correctly, that the amount of the penalty for the day of immediate jeopardy is $6,050.  But CMS incorrectly states that the amount of the non-immediate jeopardy penalty is $750.  CMS Br. at 2.  The evidence conclusively establishes that the amount is $1,200.  CMS Exs. 2, 3.
Petitioner’s representations are even more dramatically incorrect.  According to Petitioner, CMS imposed a penalty of $6,050 per day for 27 days of immediate jeopardy (March 8 through April 4) and a $1,200 per day penalty starting April 5 and continuing.  P. Br. at 1.  While the initial notice letter, dated April 25, 2016, imposes this penalty, CMS subsequently revised that determination.  CMS Exs. 1, 2.  In a notice letter, dated June 17, 2016, CMS advised the facility that the penalty amounts “are **now revised** to $6,050.00 per day for one (1) day of April 4, 2016 for a total of $6,050.00 and $1,200.00 per day for one (1) day of April 5, 2016 for a total of $1,200.00.  **The combined total is now $7,250.00.**”  CMS Ex. 2 at 1 (emphasis in original).  In a second notice, dated July 12, CMS repeated, with emphasis, the total amount of the penalty:  “**$7,250**.”  CMS Ex. 3.2
  While I agree that the evidence would likely support penalties of longer duration, CMS simply did not impose them.
Thus, CMS has imposed civil money penalties of $6,050 per day for the one day of immediate jeopardy (April 4) and $1,200 per day for the one day of substantial noncompliance that was not immediate jeopardy (April 5).  CMS Exs. 2, 3.
Petitioner requested review.
CMS filed its prehearing brief (CMS Br.) with 59 exhibits (CMS Exs. 1-53 and 55-60; CMS Ex. 54 is omitted).3
Petitioner filed its prehearing brief (P. Br.) with 44 exhibits (P. Exs. 1-44).  In multiple ways, Petitioner disregarded my prehearing order:
First, my order emphasizes that I will not accept any brief in excess of 25 pages.  Acknowledgment and Initial Pre-hearing Order at 4 (¶ 7) (July 5, 2016).  Yet, without filing an accompanying motion to explain why it could not comply,Page 4
Petitioner submitted a 27-page brief.  I will therefore disregard the last two pages of Petitioner’s brief.4
Second, my order directs Petitioner “NOT to file as proposed exhibits any documents that CMS has already filed among its proposed exhibits.”  Pre-hearing Order at 3 (¶ 2).  Petitioner simply disregarded this explicit directive and submitted multiple duplicates, resulting in a more cumbersome record.  *See* CMS Objections to Petitioner’s Exhibits at 6-7 for a list of duplicative exhibits.
	Finally, and most significantly, my order states:  “If a party’s argument relies on a particular exhibit, the party *must cite* the exhibit number and *relevant page number*.”  Pre-hearing Order at 4 (¶ 7) (emphasis added).  While CMS did not fully comply with this directive (particularly when citing Petitioner’s exhibits), Petitioner disregarded it altogether.  Petitioner does not cite *one single page number* but instead string-cites multi-page exhibits, making it virtually impossible to determine which evidence it relies on.  It is not the judge’s job to sift through copious documents in order to ascertain the support (if any) for a party’s arguments.CMS filed a motion for summary judgment (CMS MSJ).
Issue
As a threshold matter, I consider whether summary judgment is appropriate.
On the merits, the issues are:
Was the facility in substantial compliance with 42 C.F.R. § 483.25(c);
	If the facility was not in substantial compliance, did its deficiencies pose immediate jeopardy to resident health and safety; and
	If the facility was not in substantial compliance, are the penalties imposed ($6,050 per day for one day of immediate jeopardy and $1,200 per day for one day of substantial noncompliance that did not pose immediate jeopardy) reasonable.Page 5
Discussion
**Summary judgment**.  Summary judgment is appropriate if a case presents no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law.  *Bartley Healthcare Nursing and Rehab.*, DAB No. 2539 at 3 (2013), citing*Celotex Corp. v. Catrett*, 477 U.S. 317, 322-25 (1986); *Ill. Knights Templar Home*, DAB No. 2274 at 3‐4 (2009), and cases cited therein.
The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law or by showing that the non‐moving party has presented no evidence “sufficient to establish the existence of an element essential to [that party’s] case, and on which [that party] will bear the burden of proof at trial.”  *Livingston Care Ctr. v. Dep’t of Health & Human Servs.,*388 F.3d 168, 173 (6th Cir. 2004), quoting *Celotex Corp.*, 477 U.S. at 322.  To avoid summary judgment, the non-moving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists.  *Matsushita Elec. Indus. Co., Ltd., v. Zenith Radio Corp.,*475 U.S. 574, 586 n.11 (1986); s*ee also Vandalia Park,*DAB No. 1939 (2004); *Lebanon Nursing and Rehab. Ctr.,*DAB No. 1918 (2004).  The non‐moving party may not simply rely on denials, but must furnish admissible evidence of a dispute concerning a material fact.  *Ill. Knights Templar*, DAB No. 2274 at 4; *Livingston Care Ctr*., DAB No. 1871 at 5 (2003).  In doing so, the non‐moving party must show more than “some metaphysical doubt as to the material facts.”  *West Texas LTC Partners, Inc.*, *d/b/a Cedar Manor*, DAB No. 2652 at 6 (2015), *aff’d., West Texas LTC Partners, Inc. v. U.S. Dep’t. of Health & Human Servs.*, 843 F. 3d 1043 (5th Cir., 2016); *1866ICPayday.com L.L.C.*, DAB No. 2289 at 3 (2009), quoting *Matsushita Elec. Indus. Co.*, 475 U.S. at 587.
In examining the evidence for purposes of determining the appropriateness of summary judgment, I must draw all reasonable inferences in the light most favorable to the non‐moving party.  *Brightview Care Ctr.*, DAB No. 2132 at 2, 9 (2007); *Livingston Care Ctr.*, 388 F.3d at 172; *Guardian Health Care Ctr.,*DAB No. 1943 at 8 (2004); *but see* *Brightview*, DAB No. 2132 at 10 (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non‐moving party’s legal conclusions.  *West Texas LTC Partners, Inc.*, DAB No. 2652 at 6-7, 14-15; *Cf. Guardian Health Care Ctr.*, DAB No. 1943 at 11 (“A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.”).
Here, CMS has come forward with evidence – primarily the facility’s own documents – establishing facts showing that the facility was not in substantial compliance with section 483.25(c).  For its part, Petitioner offers some unsupported and speculative assertions but
Page 6
presents no admissible evidence of specific facts showing that a dispute concerning a material fact exists.
***1. CMS is entitled to summary judgment because the undisputed evidence establishes that facility staff did not take necessary precautions to protect residents from developing preventable pressure sores; and, when residents developed pressure sores, staff did not take all necessary precautions to promote healing, prevent infection, and prevent new sores from developing.  These deficiencies put the facility out of substantial compliance with 42 C.F.R. § 483.25(c).5***
**Program requirement:  42 C.F.R. § 483.25(c) (Tag F314)**.  Under the statute and the quality-of-care regulation, each resident must receive, and the facility provide, the necessary care and services to allow a resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being in accordance with the resident’s comprehensive assessment and plan of care.  Act § 1819(b); 42 C.F.R. § 483.25.  To this end, the facility must (among other requirements) ensure that a resident who enters the facility without pressure sores does not develop them unless his/her clinical condition shows that they were unavoidable, based on the resident’s comprehensive assessment.  42 C.F.R. § 483.25(c)(1).  If the resident already has pressure sores, the facility must ensure that he/she receives the treatment and services necessary to promote healing, prevent infection, and prevent new sores from developing.  42 C.F.R. § 483.25(c)(2).
In assessing the facility’s compliance with this requirement, the relevant question is:  did the facility “take all necessary precautions” to promote healing, prevent infection, and prevent new sores from developing.  If it did so, and the resident develops sores anyway, I could find no deficiency.  But if the evidence establishes that the facility fell short of taking all necessary precautions, it has violated the regulation.  *Fireside Lodge Ret. Ctr.*, DAB No. 2794 at 12 (2017) (holding that the issue was not whether a pressure sore could be expected to heal, but rather whether the facility staff provided the care and services necessary to promote healing); *Senior Rehab. & Skilled Nursing Ctr.*, DAB No. 2300 at 13-14 (2010), *aff’d , Senior Rehab. & Skilled* *Nursing Ctr*.*v. Health & Human Servs.*, No. 10-60241 (5th Cir. Dec. 20, 2010); *Koester Pavilion*, DAB 1750 at 32 (2000).
**Pressure sores**.  Pressure sores (also referred to as pressure ulcers or decubitus ulcers) are classified into stages, based on the extent of the damage to skin and underlying tissues.  At stage I, the skin may appear reddened, like a bruise.  Although the integrity of the skin remains intact, the area is at high risk of further breakdown, so it is crucial that the area be identified promptly and treated properly.  At stage II, the skin breaks open, wears
Page 7
away, and forms an ulcer.  At stage III, the sore worsens and extends beneath the skin surface, forming a small crater, presenting a high risk of tissue death and infection.  By stage IV, deeper tissues (muscles, tendons, bones) suffer extensive damage, which can cause serious complications, such as osteomyelitis (infection of the bone) or sepsis (infection carried through the blood).  *Altercare of Mentor*, DAB CR2870 at 4, n. 2 (2013), citing Madhuri Reddy, MD, MSc et al., *Preventing Pressure Ulcers:  A Systematic Review,*296(8) JAMA 974, 1020 (2006).
**Facility policies**.  This record includes no written policy that specifically addresses preventing pressure sores.  However, the facility had in place a repositioning policy.  Among other goals, its articulated purpose was “to prevent skin breakdown, promote circulation, and provide pressure relief for residents.”  The policy describes repositioning as a “common, effective intervention for preventing skin breakdown, promoting circulation, and providing pressure relief.”  CMS Ex. 52 at 3.
According to the policy, evaluating the resident’s skin integrity after pressure has been reduced or redistributed “should guide the development and implementation of repositioning plans.”  Those plans should be part of a comprehensive care plan that is consistent with the resident’s needs and goals.  The policy emphasizes that repositioning is critical for a resident who is immobile or dependent on staff for repositioning; it warns that a resident at risk of friction or shearing during repositioning may require a lifting device for repositioning.  The policy also tells staff not to position a resident on an existing pressure sore because doing so puts additional pressure on the already‐compromised tissue and may impede healing.  CMS Ex. 52 at 3.
The policy instructs staff to **evaluate**, **intervene**, **document**, and **report**:
**Evaluate**:
For residents who can reposition independently, the policy directs staff to determine whether he/she needs:  a repositioning device; instructions about why turning is important; encouragement to reposition; or monitoring to assure that turning occurs.
	The policy also directs staff to determine whether the resident has an existing pressure ulcer, and, if so, to avoid positioning the resident on the sore.
	For residents *who sit or recline in a chair* (or bed) with the back elevated to or above a thirty degree angle, staff should determine whether the resident needs position changes; and, if so, determine *whether they should be more frequent than hourly*.Page 8
The policy directs staff to consider the following components in evaluating a resident “in a chair”:  does the resident need assistance to maintain postural alignment; is the resident’s weight distributed evenly; does the resident need devices to maintain sitting balance; and is the resident able to learn (if so, staff should teach the resident to shift his/her weight every 15 minutes while in the chair); does the resident have a stage 1 pressure ulcer; and what support surface is in use.CMS Ex. 52 at 3-4.
**Intervene**:
The policy defines a “program” as “a specific approach that is organized, planned, *documented*, monitored, and evaluated.”  CMS Ex. 52 at 4 (emphasis added).  A turning/repositioning program includes “a *continuous consistent* program for changing the resident’s position and realigning the body.”  *Id*. (emphasis added).
	To determine how frequently they should reposition a resident who is bed or chair-bound, staff should consider:  the type of support surface; the condition of the resident’s skin; the resident’s overall condition; the resident’s response to his/her repositioning schedule; and the resident’s overall treatment objectives.
	Residents in bed should be on a repositioning schedule of every two hours or less.
	For *residents with pressure ulcers at stage I or above, a two-hour repositioning schedule is inadequate*.
	A resident in a chair should be on an *hourly repositioning schedule*.
	If a schedule is ineffective, the turning/repositioning *frequency must be increased*.
	Staff must avoid placing a resident on his/her greater trochanter (femur near the hip joint).CMS Ex. 52 at 4.
**Document**:  The policy dictates that the following information be recorded *in the resident’s medical record*:
The position in which the resident was placed (may be on a flow sheet);
	Name and title of the care-giver;Page 9
Any change in the resident’s condition;
	Any problems or resident complaints related to the procedure;
	Whether the resident refused care and why;
	Observations of anything unusual; and
	The signature and title of the person recording the data.CMS Ex. 52 at 5.
**Report**:  The policy instructs staff to:
Notify the supervisor if a resident refuses the procedure;
	Evaluate the basis for a resident’s refusing care; identify and evaluate potential alternatives; and
	Report other information “in accordance with facility policy and professional standards of practice.”CMS Ex. 52 at 5.
**Resident 6 (R6)**.  R6 was admitted to the facility on August 20, 2015.  He was then 75‐years-old.  CMS Ex. 9 at 1; CMS Ex. 35 at 1.  He suffered from a long list of debilitating ailments, including Parkinson’s disease, Type II diabetes, spinal stenosis, Vitamin D deficiency, gastroesophageal reflux disease, osteoarthritis, hypothyroidism, and kidney disorders.  CMS Ex. 9 at 4; P. Ex. 11 at 3, 4, 6.  He was unable to walk and required extensive assistance for bed mobility, transfers, and activities of daily living.  CMS Ex. 9 at 3; CMS Ex. 10 at 1; P. Ex. 22 at 6.  His body alignment was poor and he could not reposition himself.  P. Ex. 22 at 9.  He was incontinent of bowel and bladder.  CMS Ex. 9 at 4.
According to facility documents, R6 was admitted to the facility with no pressure sores, although the registered nurse who acted as the wound care nurse identified an area of redness and “mild irritation,” measuring 7.0 cm. x 7.0 cm., on his coccyx.  CMS Ex. 9 at 4; CMS Ex. 18 at 1; P. Ex. 3 at 1, 2; P. Ex. 9 at 30.  Petitioner now asserts that the irritated area was, in fact, a stage I pressure sore, but argues that the wound care nurse’s failure to identify it as such is “irrelevant.”  P. Br. at 7; *see* P. Ex. 42 at 11 (Hall Deposition).  I agree that the reddened skin on R6’s coccyx should have been identified as a stage I pressure sore.  *See* CMS Ex. 16 at 1; CMS Ex. 18 at 12 (later describing a
Page 10
stage II pressure sore on the resident’s coccyx).  However, I disagree that the error is irrelevant.  As noted above, because a stage I pressure sore puts the area at high risk of further breakdown, it is crucial that the area *be identified promptly* and *treated properly*.  According to the facility policy, “proper treatment” means that staff should avoid positioning the resident on the sore.  CMS Ex. 52 at 3.  It also means that *a two-hour repositioning program is inadequate* for residents with pressure ulcers at stage 1 or above.  CMS Ex. 52 at 4.  It is undisputed that facility staff did not then (or ever) recognize that R6 needed to be repositioned more frequently than every two hours.
That the wound nurse misidentified a stage I pressure sore may not be material, however.  Because he spent so much time in a chair, R6 should have been repositioned at least hourly.  CMS Ex. 52 at 4.  As discussed below, the undisputed evidence establishes that the facility *never* implemented a repositioning program for R6 that complied with its policies and the resident’s needs, which, by itself, puts the facility out of substantial compliance with section 483.25(c).  *Columbus Nursing & Rehab. Ctr.*, DAB No. 2273 at 7 (2009) (holding that staff’s failure to follow the facility’s wound care protocols violated section 483.25(c)).  Thus, the facility’s other shortcomings put it out of substantial compliance without regard to whether the resident had a pressure sore at the time of admission.
In any event, whether or not he already had a pressure sore at the time of his admission, everyone agrees that R6’s risk for developing one was high, with risk factors that included:  limited sensory perception; occasionally moist skin; inability to walk or bear weight, requiring assistance to transfer to a chair or wheelchair; inability to make, independently, frequent or significant changes in body extremity position; need for frequent repositioning with maximum assistance; spasticity, contractures, or agitation leading to “almost constant friction” with bed linens; it was “impossible” to lift his body without sliding him against his bed linens; and “probably” inadequate nutrition.  CMS Ex. 10 at 1; P. Ex. 7 at 1; P. Ex. 22 at 6.
**R6’s care plan**.  An interim care plan, dated August 20, instructs staff to reposition R6 every two hours; to do so, the plan calls for two staff members using a gait belt.  CMS Ex. 11 at 22.
Although R6’s care plan, dated September 2, does not specifically list as a problem his risk for developing pressure sores, in addressing other problems, the plan sets forth interventions aimed (directly or indirectly) at protecting skin integrity:
In addressing his bowel and bladder incontinence, the plan’s goal is to keep him clean, dry, and free from odors.  To do so, staff are required to provide incontinence care “per episode,” to use a barrier cream after incontinence care, to monitor for skin problems, and to notify his physician and family of any changes.  CMS Ex. 11 at 2.Page 11
In addressing his deficits with activities of daily living, staff are required to provide incontinence care every two hours and as needed.  CMS Ex. 11 at 9.
	In addressing his diagnosis of lymphedema, staff are directed to encourage the resident to be out of bed and to exercise daily; they are to monitor his skin for any breakdown.  CMS Ex. 11 at 13.The September 2 care plan thus barely addresses R6’s risks for developing pressure sores.  Notwithstanding his high risk, and the facility policy’s recognition that repositioning is important, the plan calls for *no specific repositioning program*.  For reasons that Petitioner has not explained, the (albeit inadequate) repositioning instructions from the interim plan were not incorporated into the September 2 plan, and, contrary to Petitioner’s unsupported claims (discussed below), facility documents establish that staff did not implement any repositioning program until October 16, 2015.  P. Ex. 5 at 4.  By then, R6 had three stage II pressure sores.  CMS Ex. 8 at 2-3.  Finally, the care plan does not address R6’s problem with bed linen friction.
A comment in the summary of his care plan conference, dated September 3, 2015, mentions a pressure reduction mattress, although what the team members meant by this is far from clear.  R6’s care plan does not mention any specific mattress, and the facility gave R6 its standard mattress, which Petitioner characterizes as a “pressure reduction mattress,” although it plainly was not the ideal mattress for someone as vulnerable to skin breakdowns as R6.  CMS Ex. 11 at 23; P. Ex. 2 at 1.  R6’s physician later ordered the more-appropriate low air mattress, but did not do so until October 15; and the facility did not provide it until October 21.  Again, by then, the resident had developed *three* stage II pressure sores (see discussion below).  CMS Ex. 13 at 24; CMS Ex. 14 at 4; CMS Ex. 15 at 1-2; CMS Ex. 16 at 1; CMS Ex. 33; CMS Ex. 59 at 3 (Bailey Decl. ¶2); *see* P. Ex. 1 at 1; P. Ex. 41.
Nursing notes for August and September 2015 do not refer to any repositioning program.  P. Ex. 9 at 23-30.  Very occasionally, a nurse’s note mentions helping R6 to reposition, but generally in response to his complaints of pain and not as part of a continuous, consistent program.  P. Ex. 9 at 24, 27; *see* CMS Ex. 52 at 4.
**Staff’s inadequate response to R6’s pressure sores**.  On **September 26, 2015**, staff reported that R6 had a Stage II pressure sore on his right hip (pressure sore #1).  It measured .50 cm. x .50 cm. x 0 cm., with scant drainage, redness around the wound, with the wound edges intact.  CMS Ex. 13 at 1-2.
The facility amended R6’s care plan.  A September 26 entry calls for a *low air mattress*.  CMS Ex. 11 at 24; P. Ex. 2 at 3.  In other entries, the amended plan directs staff to:  treat the area in accordance with the primary care physician’s orders; observe and document any signs and symptoms of infection; re-evaluate the area at least every two weeks to
Page 12
determine “the appropriateness of treatment orders if no signs of healing [are] noted”; ensure adequate nutrition and hydration; administer vitamins and minerals as ordered by his primary care physician; *turn and reposition at least every two hours* to alleviate pressure; and use padding to prevent skin contact.  CMS Ex. 11 at 24.  The amended care plan plainly conflicts with facility policies, which repeatedly warn that a two-hour repositioning schedule is insufficient for residents, such as R6, who are bed and chair‐bound and for residents, such as R6, with pressure sores at stage I or above.  CMS Ex. 52 at 4.
Moreover, R6’s medication administration record indicates that staff did not even begin to implement this inadequate repositioning program until almost three weeks later (October 16).  P. Ex. 5 at 4.  An occasional nurse’s note refers to staff repositioning the resident every two hours, but this falls far short of the level of documentation required by the facility policy, which directs staff to document in the resident’s medical record, each position change, including the new position; the names and titles of the care-giver and the person recording the data; changes; problems; and observations.  *See, e.g.*, CMS Ex. 18 at 10; CMS Ex. 52 at 5.
In a note dated October 6, staff report that the resident “does not always stay in position even with pillow support.”  But staff did not amend R6’s care plan to address this problem.  According to the note, they continued to reposition him every two hours and to encourage him to get out of bed into his wheelchair daily.  CMS Ex. 13 at 5; CMS Ex. 18 at 10.
On **October 12, 2015**, staff reported a stage II pressure sore, measuring 0.50 cm. x 0.50 cm. x 0.50 cm., on R6’s upper right buttock (pressure sore #2).  CMS Ex. 11 at 8; CMS Ex. 14 at 1; CMS Ex. 18 at 11.  The facility did not alter his care plan; it did not increase the frequency for repositioning him.  *Compare* CMS Ex. 11 at 8 *with* CMS Ex. 11 at 24.
On October 15, R6’s physician finally ordered a low air loss mattress.  P. Ex. 1 at 1; P. Ex. 6 at 9.
A nurse’s note, dated **October 16, 2015**, reports that R6 had a 11⁄2 to 2 inch wound between his buttocks (pressure sore #3).  She indicates that she would report it to the wound care nurse.  CMS Ex. 18 at 12.  In her October 20 assessment, the wound care nurse describes a stage II pressure sore, measuring, 6.20 cm. x 2.10 cm. x 0.10 cm. with a small amount of serosanguineous drainage.  CMS Ex. 16 at 1.
On October 16, staff began, for the first time, documenting in R6’s medical record that they changed his position.  But their documentation presents significant problems.  First, the directions to staff (dated October 15) do not reflect the care plan directives.  They say to reposition “frequently,” but do not specify any time interval.  CMS Ex. 12 at 35.  Second, in documenting, the staff make just one check per shift (6:00 a.m., 2:00 p.m., and
Page 13
10:00 p.m.) to show that they repositioned the resident, which does not comply with facility policies (CMS Ex. 52 at 5) and does not establish that staff adhered to the two‐hour repositioning program, inadequate as that might have been.  CMS Ex. 12 at 35, 80‐81.
On the same date, R6 started his physical therapy.  Therapy notes indicate that his functional range of motion had declined, as had his skin health.  P. Ex. 22 at 28.  The therapist also notes that his mattress is not adequate and that he needs a low air loss mattress to reduce body pressure when in bed.  P. Ex. 22 at 29.
On**October 20, 2015**, the wound care nurse documented another new wound (pressure sore #4) – a stage II pressure sore on R6’s left hip.  It measured 2.70 cm. x 3.10 cm. x 0.05 cm.  CMS Ex. 15 at 1.  Again, in contravention of facility policies, staff did not increase the frequency with which they repositioned the resident nor make any other changes to his care plan.  According to the note, they still repositioned him every two hours.  CMS Ex. 15 at 2.
The following day, October 21, the facility finally provided R6 with the low air loss mattress.  CMS Ex. 15 at 3; CMS Ex. 33; P. Ex. 1 at 5.
On **October 26, 2015**, the wound care nurse assessed yet another new wound (pressure sore #5), a stage II pressure sore on R6’s “left lateral malleolus” (bony projection on the side of the ankle).  It measured 2.40 cm. x 0.30 cm. x 0.01 cm.  CMS Ex. 17 at 1.
**Deterioration of pressure sore #1**.  Although the wound assessment reports are hardly models of precision, they seem to indicate that two of the pressure sores (#3 and #5 – coccyx and ankle) eventually improved.  CMS Ex. 16 at 7-29; CMS Ex. 17 at 4-14.  But other sores, particularly R6’s right hip wound (pressure sore #1) did not improve.  *See*, *e.g.*, CMS Ex. 14 at 4-10; CMS Ex. 15 at 10 (indicating that, by November 17, sore #4 had deteriorated to stage III); CMS Ex. 15 at 15 (indicating that, on December 28, sore #4 was unstageable due to slough/eschear); CMS Ex. 15 at 21; P. Ex. 16 (CT scan of sore #4, showing soft tissue swelling).  Indeed, over time, the condition of R6’s right hip wound (pressure sore #1) deteriorated dramatically.  CMS Ex. 13.6
The December 8, 2015 wound assessment report describes symptoms of infection – increased and malodorous or purulent drainage.  The wound measures 3.00 cm.Page 14
x 3.10 cm. x 0.20 cm.  CMS Ex. 13 at 28.  Notes indicate that the wound was cultured and the results were pending.  CMS Ex. 13 at 28.
By December 15, pressure sore #1 was not stageable because of slough/eschear, but it had increased in size to 3.80 cm. x 3.30 cm. x 0.30 cm.; the infection continued, causing pain, erythema (reddened skin) and malodorous or purulent drainage.  CMS Ex. 13 at 31.  R6’s physician ordered an antibiotic (Levaquin).  CMS Ex. 20 at 8; P. Ex. 6 at 15; P. Ex. 9 at 10.
	On December 30, the wound was at *stage IV* and the amount of drainage increased.  CMS Ex. 13 at 35.  With the infection continuing, the facility ordered a wheelchair cushion.  CMS Ex. 13 at 36.
	The wound assessment report, dated January 13, 2016, describes the status as “deteriorated,” measuring 2.90 cm. x 3.20 cm. x 2.50 cm., with increased and malodorous or purulent drainage.  CMS Ex. 13 at 41.
	On January 18, R6’s physician discontinued the Levaquin, which had proven ineffective, and ordered a different antibiotic, Bactrim.  CMS Ex. 20 at 10.  R6 also underwent a CT scan.  P. Ex. 9 at 5.  The CT scan showed gangrene surrounding the greater trochanter of the right femur and osteomyelitis on the lateral side of R6’s right greater trochanter.  P. Ex. 16 at 1.The results of R6’s CT scan were obviously alarming and he was subsequently referred to a surgeon.  But more than a week elapsed before his appointment.  When the surgeon finally saw him – on January 26, 2016 – he ordered R6 to go to the emergency room.  R6 was admitted to the hospital for intravenous antibiotics and surgery for the wound infections to both hips and his lower back.  CMS Ex. 4 at 15; P. Ex. 9 at 1.  The record is silent as to R6’s ultimate fate.
**The facility’s substantial noncompliance**.  At a minimum, to comply with section 483.25(c), the facility must follow its own policies and protocols.  *West Texas LTC Partners, Inc.*, DAB No. 2652 at 14; *Columbus Nursing & Rehab.*, DAB No. 2273 at 7.  As the above discussion shows, from the time of R6’s admission, staff generally disregarded facility policies for preventing pressure sores.  The wound nurse did not promptly identify R6’s stage I pressure sore.  Between the date of his admission (August 20) and the date the wound nurse identified his first stage II pressure sore (September 26), the facility had no continuous, consistent repositioning program in place for him and had not provided, or even ordered, an appropriate mattress.
Without mentioning any specific onset dates, Petitioner nevertheless claims that R6 was placed on a turning and repositioning program known as “Think Pink,” so-called because the nurse aides documented on a pink card that they repositioned the resident.  According
Page 15
to Petitioner, someone reviewed the cards, but then the facility threw the cards away.  P. Br. at 7.  Petitioner produced not one policy alluding to this program, not one card showing that staff documented changing a resident’s position, much less any card or other reference to staff having repositioned R6 as part of a “Think Pink” program.  The facility’s administrator does not mention it.  P. Ex. 43.  No direct care staff nor anyone else testified that staff, in fact, repositioned the resident as part of such an organized program.  Instead, Petitioner offers the testimony of Regional Nurse Consultant Sandra K. Hall, who agreed that the facility had a turning/repositioning program referred to as “Think Pink,” that R6 should have met the criteria for the program, and, in an amazing display of the multiple negative, states:  “I have no reason not to believe that he was not provided turning and repositioning.”  P. Ex. 42 at 13.7
  She did not mention when he might have been placed in the program nor what that would have meant in terms of repositioning him.
I recognize that, for purposes of summary judgment, I must draw all reasonable inferences in the light most favorable to the non-moving party.  However, unsupported speculation, such as Petitioner offers here, does not create even “metaphysical doubt” as to the material facts, much less raise the genuine dispute of material fact required to preclude summary judgment.  *West Texas LTC Partners, Inc.,* DAB No. 2652 at 15, *citing 1866ICPayday.com*, DAB No. 2289 at 3.8
Moreover, even if I accepted that R6 was placed on an (undocumented) repositioning program from the date of his admission (which I do not), I would nevertheless find the facility out of substantial compliance with section 483.25(c) because the undisputed evidence establishes that he was never repositioned more frequently than every two hours.  The facility policies emphasized that a two-hour repositioning program is
Page 16
inadequate for any resident suffering even one of R6’s conditions – one who is bed/chair-bound or one who has a stage I or above pressure sore.
Thus, the undisputed evidence establishes that the facility did not take necessary precautions to prevent R6 from developing pressure sores and was therefore not in substantial compliance with section 483.25(c).
**Responsible staff unable to monitor, set, or adjust residents’ low air mattresses**.  CMS has also come forward with evidence that at least two residents, R5 and R8, had physician orders for low air loss mattresses and had been provided them.  But no staff member was able to ensure that those mattresses were, and remained, properly inflated.
R5 was an 87-year old woman who had a stage IV pressure sore.  Her physician ordered a low air loss mattress for her and directed that the charge nurse “ensure proper inflation [every] shift.”  CMS Ex. 38; P. Ex. 27 at 2.  R8 had a stage III pressure sore on her sacrum.  CMS Ex. 48 at 23, 29.  She also had a low air loss mattress.  CMS Ex. 4 at 19.
The responsible nurses admitted to Surveyor Youlonda Bailey, R.N., that they did not know how to set R5’s air mattress properly.  One nurse admitted that, although she had documented that she checked the settings for R8’s low air loss mattress, she did not know if those settings were accurate.  CMS Ex. 59 at 8 (Bailey Decl. ¶¶ 20, 22).  The facility’s director of nursing told Surveyor Bailey that the facility did not have a manual instructing staff on how to set or check the accuracy of low air loss mattress settings.  CMS Ex. 59 at 8 (Bailey Decl. ¶ 8).
Petitioner does not deny this but maintains that the mattress settings are initially calibrated by the manufacturer’s representative when the company installs the mattress.  P. Br. at 22; P. Ex. 29.  For purposes of summary judgment, I accept this as true.  But, as R5’s physician order demonstrates, the settings on one of these mattresses can deviate, and they must be checked regularly to insure that they remain at the appropriate setting, based on the resident’s weight, so that resident derives maximum protection.  CMS Ex. 38 at 1.  The undisputed evidence thus establishes that the designated nurses were not capable of fulfilling this responsibility, which also puts the facility out of substantial compliance with section 483.25(c).
***CMS’s determination that the facility’s substantial noncompliance posed immediate jeopardy to resident health and safety is not clearly erroneous.*****Immediate jeopardy**.  Immediate jeopardy exists if a facility’s noncompliance has caused or is likely to cause “serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.  CMS’s determination as to the level of a facility’s noncompliance (which would include an immediate jeopardy finding) must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The Board has observed repeatedly that the “clearly
Page 17
erroneous” standard imposes on facilities a “heavy burden” to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  *Barbourville Nursing Home*, DAB No. 1962 (2005), *citing Florence Park Care Ctr.,*DAB No. 1931 at 27-28 (2004); *Daughters of Miriam Ctr.*, DAB No. 2067 at 7, 9 (2007).
Even though R6 was at high risk for developing pressure sores, the facility failed to implement basic interventions for preventing them.  At the time of his admission, the wound nurse did not properly identify the stage I pressure sore on his coccyx, and the facility did not promptly implement an adequate repositioning program.  Thereafter, when the resident had three stage II pressure sores, the facility still delayed implementing the program.  Although staff recognized that the resident needed a low air loss mattress, it did not provide one until weeks later.
As this case illustrates, a facility’s failure to take all necessary precautions to promote healing, prevent infection, and prevent new sores from developing is likely to cause serious injury, harm, impairment, or death to a vulnerable resident, like R6.  CMS’s determination that the deficiencies posed immediate jeopardy to resident health and safety is therefore not clearly erroneous.
***The penalties imposed are reasonable.***To determine whether a civil money penalty 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) 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 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 section 488.438(f) 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.  *Barn Hill Care Ctr.*, DAB No. 1848 at 21 (2002); *Cmty. Nursing Home*, DAB No. 1807 at 22 *et seq*. (2002); *Emerald Oaks*, DAB No. 1800 at 9 (2001); *CarePlex of Silver Spring*, DAB No. 1638 at 8 (1999).
Here, CMS imposes a penalty of $6,050 per day for one day of immediate jeopardy, which is at the lower-middle end of the penalty range ($3,050-$10,000).  42 C.F.R.
Page 18
§§ 488.408(e)(1)(iii), 488.438(a)(1)(i).  For the one day of substantial compliance that was not immediate jeopardy, CMS imposes a penalty of $1,200 per day, which is also at the lower-middle end of the penalty range ($50 to $3,000).  42 C.F.R. §§ 488.408(d)(1)(iii), 488.438(a)(1)(ii).
With respect to the section 488.438(f) factors, I note first that the facility has a significant history of substantial noncompliance, including noncompliance with section 483.25(c).  Based on surveys completed on February 26, 2013, October 4, 2013, and July 10, 2014, CMS found the facility out of substantial compliance.  In July 2014, its deficiencies posed immediate jeopardy to resident health and safety.  CMS Ex. 60 at 4 (Volmer Decl. ¶ 7).  By itself, the facility’s history justifies a penalty well above the minimum.
Petitioner does not claim that its financial condition affects its ability to pay the penalty.
Applying the remaining factors, facility staff did not implement basic precautions to protect its vulnerable resident from developing pressure sores.  This shows a high degree of neglect, indifference, and disregard for resident care, comfort, or safety, for which it is culpable.
For these reasons, I find that the relatively modest penalties are reasonable.
***CMS’s determinations as to the duration of the facility’s substantial noncompliance and immediate jeopardy are consistent with statutory and regulatory requirements.***Finally, Petitioner complains about the dates (April 4 and 5) for which CMS imposed penalties, pointing out that, by then, R6 was no longer a resident, and, thus, not in any danger.  I agree that CMS certainly could have imposed penalties beginning as early as August 20, 2015, and continuing.  For reasons it has not explained, it has not done so.
However, it is well-settled that, once a facility has been found to be out of substantial compliance (as Petitioner was here), it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again.  *Ridgecrest Healthcare Ctr.*, DAB No. 2493 at 2-3 (2013); *Taos Living Ctr*., DAB No. 2293 at 20 (2009); *Premier Living & Rehab. Ctr.*, DAB No. 2146 at 3 (2008); *Lake City Extended Care Ctr.*, DAB No. 1658 at 12-15 (1998).  The burden is on the *facility* to prove that it is back in compliance, not on CMS to prove that deficiencies continued to exist.  *West Texas LTC Partners, Inc.*, 843 F. 3d. at 1049; *Asbury Care Ctr. at Johnson City*, DAB No. 1815 at 19-20 (2002).
The facility must show that the incidents of noncompliance have ceased *and* that it has implemented appropriate measures to insure that similar incidents will not recur.  *Libertywood Nursing Ctr.*, DAB No. 2433 at 15 (2011), *citing Life Care Ctr. of Elizabethton*, DAB No. 2367 at 16 (2011); *accord*, 42 C.F.R. § 488.454(a) and (e);
Page 19
*Hermina Traeye Memorial Nursing Home*, DAB No. 1810 at 12 (2002) (holding that, to be found in substantial compliance earlier than the date of the resurvey, the facility must supply documentation “acceptable to [CMS]” showing that it was in substantial compliance and *was capable of remaining in substantial compliance* on the earlier date); *Cross Creek Care Ctr.*, DAB No. 1665 (1998).  A facility’s return to substantial compliance usually must be established through a resurvey.  42 C.F.R. § 488.454(a); *Ridgecrest Healthcare Ctr.,*DAB No. 2493 at 2-3.
Similarly, CMS’s determination that a facility’s ongoing noncompliance remains at the level of immediate jeopardy during a given period “is subject to the clearly erroneous standard of review under [42 C.F.R. §] 498.60(c)(2).”  *Life Care of Elizabethton*, DAB No. 2367 at 16, *quoting Brian Ctr. Health & Rehab./Goldsboro*, DAB No. 2336 at 7-8 (2010).  Further, if CMS accepts a deficient facility’s plan of correction, the facility must then timely implement all of the steps that it identified in the plan as necessary to correct the cited problems.  *Cal Turner Extended Care Pavilion*, DAB No. 2030 at 19 (2006); s*ee also Meridian Nursing Ctr.*, DAB No. 2265 (2009); *Lake Mary Health Care*, DAB No. 2081 at 29 (2007).
Here, Petitioner’s problems were not limited to one bad employee or one exceptionally ill resident.  They reflect systemic problems with management, staffing, and staff training.  These are precisely the types of deficiencies that the regulators contemplated when they specified that a facility’s return to substantial compliance would usually be established through a resurvey.  42 C.F.R. § 488.454(a).  The facility has not met its burden of establishing that it alleviated the immediate jeopardy nor that it returned to substantial compliance any earlier than April 4 and 5.  In fact, the facility explicitly advised the state agency (and CMS) that it would complete correcting its deficiencies on *April 6, 2016*.  CMS Ex. 5 at 1.  Nothing in this record suggests that the facility corrected any earlier than that date.
Conclusion
The undisputed evidence establishes that the facility was not in substantial compliance with Medicare program requirements and its deficiencies posed immediate jeopardy to resident health and safety.  The penalties imposed – $6,050 per day for one day of immediate jeopardy and $1,200 per day for one day of substantial noncompliance that was not immediate jeopardy – are not unreasonably high.  I therefore grant CMS’s motion for summary judgment.


          /s/
        Carolyn Cozad Hughes

                      Administrative Law Judge
      1. I apply the regulations in effect at the time of the survey here. Since then, CMS has amended its regulations governing nursing facility participation in the Medicare program. 81 Fed. Reg. 68,688 (October 4, 2016). back to note 1
                      2. Considering that Petitioner’s submissions here were due almost five months after CMS lowered the penalty to $7,250, and a full month after CMS filed its prehearing submissions, Petitioner’s misstatements are baffling. back to note 2
                      3. CMS mismarked one of its exhibits. A three-page document, titled “Nurse’s Notes” (notes dated from October 1, 2015 through January 25, 2016), is incorrectly marked as CMS Ex. 27. It should be marked CMS Ex. 26. CMS Ex. 27 is a five-page nursing assessment, dated January 20, 2016. back to note 3
                      4. In any event, the last two pages are essentially irrelevant. In them, Petitioner offers just one substantive argument, which is based on the erroneous assumption that CMS imposed penalties approximating $150,000. back to note 4
                      5. My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision. back to note 5
                      6. Some of the wound care nurse’s assessments seem out-of-sync with her objective observations. For example, in a November 24, 2015 entry, the wound nurse describes the wound (pressure sore #1) as “improved.” It then measured 3.00 cm. x 2.50 cm. x 0.10 cm. and was at stage III. CMS Ex. 13 at 22. One week earlier it was at stage II, which seems to show that it deteriorated significantly. CMS Ex. 13 at 18. back to note 6
                      7. Read literally, the witness is saying that she had reason to believe that R6 was not turned and repositioned, but I doubt that Nurse Consultant Hall meant to say that. back to note 7
                      8. Although the rules of evidence do not strictly apply in these proceedings, I have the authority to determine the admissibility of evidence. 42 C.F.R. § 498.61. Under the federal rules of evidence, a witness may testify to a matter only if sufficient evidence is introduced to support a finding that the witness has personal knowledge of the matter. Fed. R. Evid. 602. Here, Nurse Consultant Hall did not claim any personal knowledge that, from the time of his admission, R6 was on a repositioning program. She states that he “probably” was “turned and repositioned every two hours throughout his stay” at the facility and that “he would have met the criteria. . . .” She alludes vaguely to unidentified staff members telling her he was in the program but does not specify when this repositioning began. P. Ex. 42 at 12-13. I would decline to admit testimony so lacking in foundation. To avoid summary judgment, the non-moving party must submit admissible evidence of a dispute concerning a material fact. Illinois Knights Templar, DAB No. 2274 at 4. back to note 8 Back to top
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