Lynwood Manor Healthcare Center, DAB CR5612 (2020)

DECISION

Petitioner, Lynwood Manor Healthcare Center, is a long-term care facility, located in Adrian, Michigan, that participates in the Medicare program.  Following a series of surveys, completed on February 27, 2017 (Life Safety Code), March 2, 2017 (complaint investigation/recertification survey), and May 3, 2017 (revisit survey), the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with multiple Medicare program requirements, and that one of its deficiencies posed immediate jeopardy to resident health and safety.  CMS has imposed civil money penalties (CMPs) of $7,004 per day for 13 days of immediate jeopardy and $1,015 per day for 22 days of substantial noncompliance that did not pose immediate jeopardy.

Petitioner has appealed, challenging some of the deficiencies found during the March 2 and May 3 surveys.  CMS moves for summary judgment, which Petitioner opposes.

For the reasons set forth below, I grant CMS’s motion.  The undisputed evidence establishes that the facility was not in substantial compliance with multiple program

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requirements, that one of its deficiencies posed immediate jeopardy to resident health and safety, and that the penalties imposed are reasonable.

Background

The Social Security Act (Act) sets forth requirements for nursing facilities participating 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, CMS imposed penalties based on findings from three surveys (CMS Ex. 1).

February 27, 2017 (Life Safety Code survey).1   A facility must meet the provisions of the Life Safety Code (LSC) of the National Fire Protection Association.  42 C.F.R. § 483.90(a)(1).  Following the facility’s annual LSC survey, completed February 27, 2017, CMS determined that the facility was not in substantial compliance with the following program requirements:

• LSC §§ 9.2.3, 18.3.2.5, and 19.3.2.5 (Tag K0324) (cooking facilities) cited at scope and severity level F (widespread substantial noncompliance that causes no actual harm with the potential for more than minimal harm);
• LSC §§ 9.7.5, 9.7.7, and 9.7.8 (Tag K0353) (sprinkler system – maintenance and testing) cited at scope and severity level E (pattern of substantial noncompliance that causes no actual harm with the potential for more than minimal harm);

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• LSC § 19.3.6.3 (Tag K0363) (corridor – doors) cited at scope and severity level E;
• LSC §§ 8.6.7.1 and 19.3.7.3 (Tag K0372) (smoke barrier construction) cited at scope and severity level E;
• LSC §§ 9.1.1, 9.1.2, 18.5.1.1, and 19.5.1.1 (Tag K0511) (utilities – gas and electric) cited at scope and severity level D (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimal harm);
• LSC §§ 6.4.4, 6.5.4, and 6.6.4 (Tag K0918) (electrical systems – essential maintenance and testing) cited at scope and severity level F;
• LSC §§ 10.2.3.6 and 10.2.4 (Tag K0920) (electrical equipment – power cords and extension cords) cited at scope and severity level E; and
• LSC §§ 11.3.1, 11.3.2, 11.3.3, 11.3.4, and 11.6.5 (Tag K0923) (gas equipment – cylinder and container storage) cited at scope and severity level E.

CMS Ex. 3 at 10; see CMS Ex. 1 at 1.

March 2, 2017 (complaint investigation and annual recertification survey).  Responding to a complaint that resident funds had been misappropriated (CMS Ex. 10), surveyors from the Michigan Department of Licensing and Regulatory Affairs (state agency) visited the facility to investigate and to conduct the facility’s annual recertification survey, which they completed on March 2, 2017.  They found that the facility again did not substantially comply with multiple program requirements:

• 42 C.F.R. §§ 483.10(c)(6), 483.10(c)(8), 483.10(g)(12), and 483.24(a)(3) (Tag F155) (resident rights – right to refuse treatment and right to basic life support based on an advanced directive) cited at scope and severity level E;
• 42 C.F.R. § 483.10(f)(10)(i)-(iv) (Tag F159) (resident rights – management of personal funds) cited at scope and severity level F;2
• 42 C.F.R. §§ 483.12(a)(3), 483.12(a)(4), and 483.12(c)(1)-(4) (Tag F225) (investigate and report allegations of abuse, neglect, and exploitation) cited at scope and severity level D;

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• 42 C.F.R. §§ 483.12(b)(1)-(3) and 483.95(c)(1)-(3) (Tag F226) (policies and training to prevent abuse, neglect, and exploitation) cited at scope and severity level E;
• 42 C.F.R. § 483.10(a)(1) (Tag F241) (resident rights – dignity and respect) cited at scope and severity level D;
• 42 C.F.R. § 483.20(b)(2)(ii) (Tag F274) (resident assessment following a significant change) cited at scope and severity level D;
• 42 C.F.R. §§ 483.20(d) and 483.21(b)(1) (Tag F279) (resident assessment – use and development of comprehensive care plans) cited at scope and severity level D;
• 42 C.F.R. § 483.25(e)(1)-(3) (Tag F315) (quality of care – incontinence) cited at scope and severity level D;
• 42 C.F.R. § 483.25(d) (Tag F323) (quality of care – accident prevention) cited at scope and severity level E;3
• 42 C.F.R. § 483.25(g)(1)-(3) (Tag F325) (quality of care – assisted nutrition) cited at scope and severity level D;
• 42 C.F.R. § 483.25(g)(2) (Tag F327) (quality of care – assisted hydration) cited at scope and severity level D;
• 42 C.F.R. § 483.35(a)(1)-(4) (Tag F353) (nursing services – staffing) cited at scope and severity level E;
• 42 C.F.R. § 483.60(d)(1)-(2) (Tag F364) (dietary services – food and drink) cited at scope and severity level E;
• 42 C.F.R. § 483.60(d)(4)-(6) (Tag F366) (dietary services – food and drink) cited at scope and severity level E;

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• 42 C.F.R. § 483.60(i)(1)-(3) (Tag F371) (dietary services – food safety) cited at scope and severity level F;
• 42 C.F.R. § 483.45(a) and (b) (Tag F425) (pharmacy services) cited at scope and severity level D;
• 42 C.F.R. §§ 483.80(a)(1)-(2), (4), 483.80(e), and 483.80(f) (Tag F441) (infection control – prevention, linens, and review) cited at scope and severity level D;
• 42 C.F.R. § 483.90(i)(5) (Tag F465) (physical environment – environmental conditions) cited at scope and severity level F; and
• 42 C.F.R. § 483.70(i)(1)-(5) (Tag F514) (administration – medical records) cited at scope and severity level D.

CMS Ex. 5.

May 3, 2017 (revisit survey).  The surveyors returned to the facility and completed a revisit survey on May 3, 2017.  Based on their findings, CMS determined that the facility had not returned to substantial compliance and, in fact, that one of its deficiencies posed immediate jeopardy to resident health and safety.  Specifically, the facility did not substantially comply with the following requirements:

• 42 C.F.R. § 483.10(g)(14) (Tag F157) (resident rights – information and communication; notification of changes) cited at scope and severity level D;
• 42 C.F.R. §§ 483.20(d) and 483.21(b)(1) (Tag F279) (resident assessment – use and development of comprehensive care plans) cited at scope and severity level E (repeat deficiency);
• 42 C.F.R. §§ 483.24 and 483.25(k)(1) (Tag F309) (quality of life; quality of care – pain management) cited at scope and severity level D;
• 42 C.F.R. § 483.25(b)(1) (Tag F314) (quality of care – skin integrity:  pressure ulcers) cited at scope and severity level D;
• 42 C.F.R. § 483.25(d) (Tag F323) (quality of care – accident prevention) cited at scope and severity level J (isolated instance of substantial noncompliance that poses immediate jeopardy to resident health and safety) (repeat deficiency);

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• 42 C.F.R. § 483.25(g)(1)-(3) (Tag F325) (quality of care – assisted nutrition) cited at scope and severity level D (repeat deficiency);
• 42 C.F.R. § 483.45(a) and (b) (Tag F425) (pharmacy services) cited at scope and severity level D (repeat deficiency); and
• 42 C.F.R. § 483.70(i)(1)-(5) (Tag F514) (administration – medical records) cited at scope and severity level D (repeat deficiency).

CMS Ex. 22.  Based on the survey findings, CMS determined that the facility was not in substantial compliance with Medicare program requirements and that its deficiencies under section 483.25(d) posed immediate jeopardy to resident health and safety.  CMS Ex. 1.

Following a June 8 complaint investigation and a revisit survey, completed June 21, 2017, CMS determined that the facility returned to substantial compliance on May 24, 2017.  CMS Ex. 1 at 2.

CMS has imposed civil money penalties of $7,004 per day for 13 days of immediate jeopardy (April 19 through May 1, 2017) and $1,015 per day for 22 days of substantial noncompliance that did not pose immediate jeopardy (May 2 through 23, 2017), for a total penalty of $113,382 ($91,052 + $22,330 = $113,382).  CMS Ex. 1 at 2.

Petitioner appeals, and CMS has moved for summary judgment.  CMS has submitted its motion and pre-hearing brief (CMS MSJ) with 37 exhibits (CMS Exs. 1-37).  Petitioner has submitted a brief in opposition to CMS’s motion for summary judgment (P. Opp.) and 21 exhibits (P. Exs. 1-21).

Issues

Based on the deficiencies that Petitioner does not challenge, I find that, from April 19 through May 23, 2017, the facility was not in substantial compliance with Medicare program requirements.

I next consider whether summary judgment is appropriate. 

On the merits, the sole issue presented is whether the facility was in substantial compliance with the following Medicare program requirements:  42 C.F.R. §§ 483.10(f)(10)(i)-(iv), 483.25(d), 483.60(i)(1)-(3), and 483.90(i)(5).

Immediate jeopardy.  In its hearing request, Petitioner challenged the immediate jeopardy determination.  However, in responding to CMS’s pre-hearing brief and motion for summary judgment, it abandoned that challenge, citing no evidence and making no

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argument that the immediate jeopardy determination was clearly erroneous.  See Acknowledgment and Pre-hearing Order at 4 (¶ 7) (November 16, 2017) (“A pre-hearing brief must contain any argument that a party intends to make.”).4

Penalty amounts.  Except to argue that it was in substantial compliance so no penalties should be imposed, Petitioner has not challenged the amounts of the civil money penalties:  $7,004 per day for each day of immediate jeopardy and $1,015 per day for each day of substantial noncompliance that did not pose immediate jeopardy.5   These amounts are at the low to very-low end of the penalty ranges ($6,394-$20,965 and $105-$6,289) and are modest considering the facility’s history of substantial noncompliance (CMS Ex. 3 at 4-9), the number and seriousness of the deficiencies cited during these surveys, and the number of deficiencies that were not corrected following the March survey.  42 C.F.R. §§ 488.404, 488.408(d)(1)(iii), 488.408(e)(1)(iii), 488.438(a)(1), 488.438(f).  Because I find that the facility was not in substantial compliance and that its deficiencies posed immediate jeopardy to resident health and safety, I sustain the penalty amounts.

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 & 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,

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173 (6th Cir. 2004) (quoting Celotex Corp. v. Catrett, 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. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986); Vandalia Park, DAB No. 1939 (2004); Lebanon Nursing & Rehab. Ctr., DAB No. 1918 (2004); Crestview Parke Care Ctr., DAB No. 1836 at 5 (2002). 

General denials do not satisfy a party’s burden to identify specific evidence demonstrating a material fact is in dispute.  Shah v. Azar, 920 F.3d 987, 995 (5th Cir. 2019); Forsyth v. Barr, 19 F.3d 1527, 1533 (5th Cir. 1994); Pearsall Nursing & Rehab. Ctr. - North, DAB No. 2692 at 7 (2016) (affirming summary judgment where Petitioner “refers broadly to ‘the evidence presented in [its] response’” but “identifies no specific evidence relevant to the material facts . . . .”); Ill. Knights Templar, DAB No. 2274 at 4 (finding that the non-moving party must furnish admissible evidence of a dispute concerning a material fact); 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.”  W. Tex. LTC Partners, Inc., DAB No. 2652 at 6 (2015), aff’d, W. Tex. 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. Industrial 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); see also 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.  W. Tex. LTC Partners,  DAB No. 2652 at 6-7, 14-15; cf. Guardian Health , 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.”); see Green Valley Health Care & Rehab. Ctr., DAB No. 2947 at 8 (2019) (quoting Johnson v. Perez, 823 F.3d 701, 705 (D.C. Cir. 2016) (noting that a genuine factual dispute does not exist “when a putatively disputed body of evidentiary material could not, even assuming a sympathetic factfinder, reasonably support a finding crucial to the nonmoving party’s legal position.”)).

Summary judgment applied to administrative review in Medicare cases.  It is well-established that an administrative law judge is empowered to decide a case on a motion for summary judgment, without an evidentiary hearing.  Shah, 920 F.3d at 996 (citing Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs., 619 F.3d 453, 457

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(5th Cir. 2010)); see Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445, 449 (7th Cir. 2010).6   Nevertheless, there seems to be some confusion about applying such well-founded principles of civil litigation to these proceedings, with some ill-informed advocates suggesting that, to do so, denies a party a fundamental right.  In one succinct observation, Judge Posner of the Seventh Circuit Court of Appeals gave lie to such misconceptions:  “All it means for a decision to be based on a grant of summary judgment is that there are no issues that would benefit from being resolved in an evidentiary hearing.”  Fal-Meridian, 604 F.3d at 449 (emphasis added).  

In Fal-Meridian, the Seventh Circuit considered specifically the appropriateness of granting CMS summary judgment in a nursing home case involving (then) section 483.25(h) (now section 483.25(d)).7   The court sustained the administrative law judge’s granting summary judgment in CMS’s favor because the petitioner/nursing home did not tender “evidence that, if believed, would show that it had done everything possible (within the meaning of the regulation) to minimize the risks of an accident.”  Id. at 451.

Here, as discussed below, the dispositive facts are not in dispute.  In opposing summary judgment, Petitioner relies on general denials, but does not identify specific evidence demonstrating a material fact in dispute.  Petitioner also points to the corrective measures the facility implemented after its deficient practices came to light – facts that are not seriously in dispute – but are not material.  And Petitioner relies on legal arguments and the opinions of its consulting nurse practitioner, who reviewed the record and concluded, generally, that the facility was substantially compliant.  But conclusory statements that are unsubstantiated by evidence of specific facts are insufficient to create a genuine

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factual dispute and do not preclude summary judgment.  See Guardian Health , DAB No. 1943 at 11 (characterizing as “conclusory in nature” claims that the facility provided “effective,” “appropriate,” or “aggressive” interventions.).

As the following discussion shows, no material facts are in dispute, and CMS is entitled to judgment as a matter of law.

1.  The undisputed evidence establishes that the facility was not in substantial compliance with 42 C.F.R. § 483.10(f)(10) because it did not monitor the activities of its business office manager, who mismanaged (and likely misappropriated) resident funds.8

Program requirement:  42 C.F.R. § 483.10(f)(10) (Tag F159).  A resident has the right to manage his or her financial affairs.  If the resident chooses to deposit personal funds with the facility, the facility must act as a fiduciary of the resident’s funds and hold, safeguard, manage, and account for those funds.  42 C.F.R. § 483.10(f)(10)(i).  Amounts over $100 must be deposited in interest-bearing accounts, separate from the facility’s operating accounts.  42 C.F.R. § 483.10(f)(10)(ii).  The facility must establish and maintain a system that “assures a full and complete and separate accounting, according to generally accepted accounting principles,” of each resident’s personal funds entrusted to the facility.  42 C.F.R. § 483.10(f)(10)(iii). 

Facility policy:  resident funds.  The facility had in place a written policy for the temporary safe-keeping of resident funds.  Among other provisions, it required the facility to “keep complete and accurate records of all funds.”  CMS Ex. 15 at 1.  The business office was required to deposit all funds into a bank; funds of more than $50 had to be deposited into an interest-bearing account.  The “controller” was required to reconcile the resident trust account monthly.  Id. 

The misappropriation.  On February 10, 2017, facility staff reported to the state agency that money was missing from the trust accounts of two of its residents.  CMS Ex. 10.  As part of the facility’s annual recertification survey, the surveyors investigated the report.  Surveyor David Donohue, R.N., questioned the facility’s administrator, its general counsel, and a corporate representative about the trust fund accounts.  These officials could not explain the facility’s system for keeping track of resident funds.  The administrator told Surveyor Donohue that a resident who wanted money would approach the business office manager; she then wrote a check payable to a facility staff member (nurse, housekeeper), who would cash the check and give her (the business office manager) the money.  The business office manager was supposed to give the money to

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the resident or make a purchase on the resident’s behalf.  The facility had no documentation for the suspect transactions and could not account for where the money actually went.  The facility’s administrator conceded that “we know our system is broke [sic].”  CMS Ex. 11 at 2-3 (Donohue Decl. ¶ 12); CMS Ex. 12 at 2, 4; see CMS Ex. 17 at 16-50.

Petitioner submits no evidence suggesting that it disputes any of these facts.  Indeed, no one disputes that the former business office manager mismanaged – and likely misappropriated – funds from the resident trust accounts.  See CMS Ex. 10 at 1 (naming the business office manager as the alleged perpetrator).  That one of its employees mismanaged resident funds puts the facility out of substantial compliance with section 483.10(f)(10).  It is well-settled that the facility is responsible for the misconduct of its employees.  Springhill Senior Residence, DAB No. 2513 at 14 (2013); Sunshine Haven Lordsburg, DAB No. 2456 at 16-17 (2012), aff’d in part sub nom. Sunshine Haven Nursing Operations, LLC v. U.S. Dep’t of Health & Human Servs., Ctrs. for Medicare & Medicaid Servs., 742 F.3d 1239 (10th Cir. 2015); Gateway Nursing Ctr., DAB No. 2283 at 8 (2009); Emerald Oaks, DAB No. 1800 at 7 n.3 (2001).

The undisputed evidence also establishes that the facility did not adequately monitor the business office manager’s activities.  Neither the (then) administrator nor any other facility employee denies that the facility failed to safeguard the residents’ accounts.  Nor does Petitioner claim that the (former) business office manager’s questionable check-writing “system” accorded with generally accepted accounting principles, which it obviously did not.  The undisputed evidence thus establishes that the facility did not oversee the (then) business office manager’s activities and, as a result, no one noticed that resident funds had disappeared.  This puts the facility out of substantial compliance with section 483.10(f)(10).

Petitioner’s response.  Petitioner, however, suggests, without support, that the facility discovered the financial discrepancies through its own internal audit, “demonstrating that the facility had a process, as part of its overall accounting framework, to review allegations of misappropriation.”  P. Opp. at 15.  In fact, the undisputed evidence shows that the facility did not regularly oversee management of the resident trust accounts.  It audited the accounts only after an outside source brought irregularities to the staff’s attention.  That, in the course of the audit, it discovered an additional misappropriation hardly exonerates the facility for its inattention.

According to the facility’s own investigative report:

• On January 19, 2017, the facility’s business office manager abruptly resigned, without giving notice.

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• Almost three weeks later, on February 6, 2017, a resident’s “POA” (individual who holds the resident’s power of attorney) contacted the interim business office manager to ask about an unauthorized withdrawal.  In reviewing the resident’s trust account statement, the POA noticed a $500 withdrawal, made on December 9, 2016.  She had not authorized the withdrawal and wanted to know why the money was withdrawn and how it was spent.  The interim business manager reported her concerns to the facility’s administrator.
• Facility staff reviewed the resident accounts and found that, before she resigned, the former business office manager made a second unauthorized, unexplained withdrawal, in the amount of $500, from a different resident’s account.
• The facility could not account for the missing funds.
• The facility then audited the resident trust accounts and, on February 8, 2017, it found that an additional $100 cash deposit, given to the former business office manager on behalf of a third resident, was not accounted for.

The facility returned the money to the residents and determined that a corporate employee, who was responsible for accounts receivable, would, in the future, audit the trust accounts monthly to avoid the problem recurring.  CMS Ex. 14.

CMS agrees that the facility eventually corrected this deficiency; at the time of the March survey it had drafted a plan of correction.  However, correcting a deficiency does not mean that the deficiency didn’t occur, and, because the facility was not in substantial compliance, CMS may impose a remedy.  Act § 1819(h); 42 C.F.R. §§ 488.400, 488.402.

Moreover, that the facility had a plan in place does not establish that it corrected the deficiency prior to the May survey.  Once (as here) a facility has been found to be out of substantial compliance, it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again.  Ridgecrest Healthcare Ctr., DAB No. 2493 at 2-3 (2013); Taos Living Ctr., DAB No. 2293 at 20 (2009); Premier Living & Rehab Ctr., DAB No. 2146 at 23 (2008); Lake City Extended Care, 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.  Owensboro Place & Rehab. Ctr., DAB No. 2397 at 12 (2011); 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) (quoting Life Care Ctr. of Elizabethton, DAB No. 2356 at 16 (2011)); accord, 42 C.F.R. § 488.454(a) and (e); Hermina Traeye Mem’l 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

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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, DAB No. 2493 at 2-3.

Here, the facility had seriously disregarded its oversight responsibilities.  After all, its written policy already required the “controller” to reconcile the resident trust account monthly; but that apparently had not been happening, or, if it had, it had not prevented the mismanagement of resident funds.9   Until the facility could show that its new requirement for monthly oversight would be effective, i.e., that it was properly implemented and that it resolved the problem, the facility did not meet its significant burden of demonstrating that it returned to substantial compliance.  Oceanside Nursing & Rehab. Ctr., DAB No. 2382 at 19 (2011); Premier Living & Rehab. Ctr., DAB CR1602 (2007), aff’d, DAB No. 2146 (2008).

2.  CMS is entitled to summary judgment because the undisputed evidence establishes that the facility’s kitchen staff did not store, prepare, distribute, and serve food in accordance with professional standards for food safety, putting the facility out of substantial compliance with 42 C.F.R. § 483.60(i).

Program requirement:  42 C.F.R. § 483.60(i) (Tag F371).  The facility must procure food from approved sources or sources considered satisfactory by federal, state, or local authorities.  It must store, prepare, distribute, and serve food in accordance with professional standards for food service safety.  The facility must also have a policy regarding the use and storage of foods brought to residents by family and other visitors to ensure its safe and sanitary storage, handling, and consumption.

The Departmental Appeals Board and the courts have consistently accepted surveyor observations to show unsanitary conditions.  In Crestview Park Care Center, the Sixth Circuit relied on surveyor observations to establish the facility’s substantial noncompliance.  Crestview Park Care Ctr. v. Thompson, 373 F.3d 743, 751 (6th Cir. 2004); see also Carrington Place of Muscatine, DAB No. 2321 (2010); Dialysis Ctr. of Moreno Valley, DAB No. 2193 (2008); Comty. Nursing Home, DAB No. 1807 (2002).  The Crestview court also rejected the facility’s related contention, similar to that made here, that the facility should not be held accountable for a dirty kitchen since a kitchen could appear unclean at any time because it is constantly in use.  Crestview, 343 F.3d at 751; see P. Opp. at 16.

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The facility’s kitchen conditions and practices.  Surveyor Kristen Nunham, R.N., toured the facility’s kitchen on February 27 and February 28.  She observed unsanitary and unsafe conditions and practices.  CMS Ex. 4 at 2 (Nunham Decl. ¶¶ 8, 9).  Among her observations:  the kitchen door did not close properly; and the handwashing sink did not have hot water.  CMS Ex. 5 at 99-101; CMS Ex. 13 at 9.

Handwashing.  The facility had in place a written handwashing policy.  The policy characterizes handwashing as “the single most important procedure for preventing nosocomial [hospital-acquired] infections.”  CMS Ex. 15 at 22.  The policy describes a detailed procedure for handwashing, which directs staff to dry hands with paper towels, turn the faucets off with a paper towel, and then discard the paper towels.  CMS Ex. 15 at 23. 

Notwithstanding these instructions, Surveyor Nunham observed a dietary aide enter the kitchen, wash his hands at the sink, then turn off the faucet by touching it with his clean hands.  In doing so, he contaminated his clean hands, which he then used to prepare food. CMS Ex. 4 at 3 (Nunham Decl. ¶ 11); CMS Ex. 13 at 9; see CMS Ex. 4 at 2 (Nunham Decl. ¶ 8).

Cleanliness.  Surveyor Nunham also observed food crumbs and debris at the bottoms of two utensil drawers.  In those drawers, she saw five utensils used in food preparation – a whisk, three spatulas, and a ladle – that were crusted with debris.  CMS Ex. 5 at 100; CMS Ex. 13 at 2; see CMS Ex. 4 at 2 (Nunham Decl. ¶ 8).

Leftover foods.  Most concerning, the facility had no procedures in place to ensure that leftover foods were cooled safely.  It did not maintain cooling logs; kitchen staff did not check food temperatures of foods that were cooling; and, when shifts changed, departing staff did not inform incoming staff where the food was in the cooling process.  CMS Ex. 4 at 2-3 (Nunham Decl. ¶ 10), CMS Ex. 5 at 100; CMS Ex. 13 at 2.

Petitioner’s response.  Petitioner does not dispute any of these specific facts but characterizes them generally as a “minor kitchen issues” that do “not demonstrate a lack of sanitary conditions in the facility or serve as an appropriate basis for this deficiency.”  P. Opp. at 16.  Without producing evidence or even identifying what the “factual issues” might be, Petitioner also argues that “factual issues remain regarding whether the temporary kitchen conditions identified by the surveyor constituted a deficient practice under the applicable regulation.”  P. Opp. at 17.  Whether the surveyor observations establish that the facility was not in substantial compliance with program requirements is a conclusion, not a fact.  As noted above, conclusions do not preclude summary judgment, and conclusory statements that are not substantiated by evidence of specific facts do not create a genuine factual dispute.  Guardian Health , DAB No. 1943 at 11.

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With respect to the surveyor’s specific observations, Petitioner argues that, for purposes of summary judgment, I must infer that the serving utensils were awaiting cleaning and would not have been used for meal service.  P. Opp. at 16.  This purely speculative claim does not create a fact in dispute, and I am not required to draw such an unreasonable inference.  These utensils were put away in utensil drawers, and they were dirty, as were the drawers themselves.  The only reasonable inference to be drawn from those undisputed facts is that the facility was not adequately cleaning its utensils before putting them away, which does not comport with basic sanitation standards.  Moreover, Petitioner has the burdens reversed.  CMS has shown that dirty utensils were stored away in dirty drawers.  If, in fact, Petitioner has evidence of a reasonable explanation for the facility’s storing dirty serving utensils in drawers (and I cannot imagine what that might be), it was required to produce it.  Shah, 920 F.3d at 995; Forsyth, 19 F.3d at 1533; Ill. Knights Templar, DAB No. 2274 at 4. 

The most serious of the food safety issues was the facility’s failure to adhere to accepted standards for cooling food.  CMS has come forward with evidence that improper cooling of foods leads to bacteria growth, which can cause foodborne illnesses.  CMS Ex. 4 at 2-3 (Nunham Decl. ¶ 10).  Petitioner produces no evidence suggesting a dispute as to the facility’s practices or the dangers they posed.  Indeed, although the facility’s registered dietician and its assistant dietary manager/cook both submitted written declarations, neither challenged the survey findings on this issue, and neither defended any of the facility’s cited practices.  P. Ex. 18 (Kittle Decl.); P. Ex. 19 (Flores Decl.).10

Thus, the undisputed evidence establishes that the facility’s kitchen staff did not follow safe handwashing practices nor meet professional standards for food safety; the facility was therefore not in substantial compliance with 42 C.F.R. § 483.60(i).

3.  The undisputed evidence establishes that the facility did not properly maintain its physical environment; as a result, the physical environment was not safe, functional, sanitary, and comfortable, which put the facility out of substantial compliance with 42 C.F.R. § 483.90(i).

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Program requirement:  42 C.F.R. § 483.90(i).  The facility must provide a safe, functional, sanitary, and comfortable environment.  Among other requirements, outside ventilation, by means of windows or mechanical ventilation, must be adequate. 

Surveyor observations.  Surveyor Donohue toured the facility on March 1, 2017, accompanied by the head of housekeeping and a member of the maintenance staff.  CMS Ex. 11 at 3 (Donohue Decl. ¶ 16).  The building was old and had not been well-maintained.  Because of its poor condition, particularly in the resident rooms and common areas, the atmosphere was neither comfortable nor home-like.  CMS Ex. 11 at 2 (Donohue Decl. ¶ 9).  Specifically:

• Many of the resident rooms were in disrepair, with holes in the walls, peeling paint, broken over-bed lights, broken furniture (dressers missing drawers), and corroded appliances.  CMS Ex. 11 at 3-4 (Donohue Decl. ¶ 16); CMS Ex. 12 at 10-12 (detailing specific observations by room number).
• A wall cabinet in the utility room, 200 hall, had a “severely corroded” shelf with a towel covered in rust and “a black substance,” which the maintenance staff member identified as “mold of some sort.”  CMS Ex. 11 at 4 (Donohue Decl. ¶ 16); CMS Ex. 12 at 11; see CMS Ex. 5 at 107-08.
• Surveyor Donohue found “particularly disturbing” the state of the shower room on the 100 hall.  It was also used as the facility’s “beauty salon” and contained eight folding chairs.  The salon’s sink was falling off the wall; the HVAC (heating, ventilating, air conditioning) units had peeling paint, and the vents were filled with dirt and dust; a portable commode sat in the middle of the room, and the head of housekeeping did not know when it had last been cleaned.  CMS Ex. 5 at 108; CMS Ex. 11 at 4 (Donohue Decl. ¶ 17); CMS Ex. 12 at 10.
• The shower room on the 200 hall was also in disrepair:  paint was peeling off the walls and the window had broken casings.  The entire room reeked of sewage.  Facility staff confirmed that the facility had “a drainage issue in here.”  CMS Ex. 5 at 107; CMS Ex. 11 at 4 (Donohue Decl. ¶ 18); CMS Ex. 12 at 11.

Petitioner’s response.  Petitioner identifies no specific evidence demonstrating any dispute over the surveyor’s observations.  Neither the staff who accompanied Surveyor Donohue on his tour nor any other facility employee offers testimony on the issue.  Nevertheless, without providing such evidence, Petitioner claims, generally, that “the evidence cited . . . in support of this deficiency remain[s] in dispute . . . .”  P. Opp. at 17.  Again, such general denials (and Petitioner’s contention barely even qualifies as such) do not satisfy Petitioner’s burden to identify specific evidence demonstrating a material fact in dispute.  Shah, 920 F.3d at 995; Forsyth, 19 F.3d at 1533; Pearsall Nursing , DAB No. 2692 at 7; Ill. Knights Templar, DAB No. 2274 at 4.

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Petitioner also characterizes the problems described as “superficial observations.”  P. Opp. at 17.  I find nothing “superficial” about a shower room reeking of sewage, peeling paint, broken furniture, corrosion, potential mold, a broken sink, or a filthy HVAC unit.  The undisputed evidence describes an environment that was unsafe, unsanitary, dysfunctional, and uncomfortable.  The facility was therefore not in substantial compliance with section 483.90(i), and CMS is entitled to summary judgment on that issue. 

4.  CMS is entitled to summary judgment because the facility did not tender evidence showing that it did everything possible (within the meaning of 42 C.F.R. § 483.25(d)) to minimize the risk of accidents.

Program requirement:  42 C.F.R. § 483.25(d) (Tag F323).  The statute mandates that the facility ensure that each resident receive, and the facility provide, the necessary care and services to allow the 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)(2).  To this end, the “quality of care” regulation mandates, among other requirements, that the facility “ensure” that each resident’s environment remain as free of accident hazards as possible and that each resident receive adequate supervision and assistive devices to prevent accidents.  42 C.F.R. § 483.25(d).  The facility must therefore eliminate or reduce a known or foreseeable risk of accidents “to the greatest degree practicable.”  Del Rosa Villa, DAB No. 2458 at 7 (2012); Clermont Nursing & Convalescent Ctr., DAB No. 1923 at 9-10 (2004), aff’d sub nom. Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 F. App’x 900 (6th Cir. 2005); accord Briarwood Nursing Ctr., DAB No. 2115 at 5 (2007) (holding that the facility must “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.”).  A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an “adequate” level of supervision under all the circumstances.  42 C.F.R. § 483.25(d)(2); Briarwood, DAB No. 2115 at 5; Windsor Health Care Ctr., DAB No. 1902 at 5 (2003), aff’d sub nom. Windsor Health Care Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005).

Repeat deficiencies:  shifting burdens.  Based on the March survey, CMS determined that the facility was not in substantial compliance with section 483.25(d).  Because Petitioner did not challenge that finding, it is final, and the facility was not then in substantial compliance with the regulation.  42 C.F.R. § 498.20(b).  Once a facility has been found to be out of substantial compliance, it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again.  Ridgecrest , DAB No. 2493 at 2-3; Taos Living Ctr., DAB No. 2293 at 20; Premier Living , DAB No. 2146 at 3; Lake City Extended Care, DAB No. 1658 at 12-15.  The burden is on the facility to prove that it is back in compliance, not on CMS to prove that deficiencies continued to

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exist.  Owensboro Place , DAB No. 2397 at 12; Asbury Care Ctr. , DAB No. 1815 at 19-20.

Facility policy:  burn prevention.  The facility had in place a written policy for preventing burns.  CMS Ex. 37.  To prevent burns from hot beverages, the policy requires that:  1) all residents be assessed for their ability to handle and consume containers of hot foods and beverages; 2) serving staff monitor hot foods and beverages as they are served to the residents; and 3) staff use appropriate assistive devices and provide appropriate supervision to residents who are at risk for burns and scalds.  CMS Ex. 37 at 2.

Elsewhere, the policy describes specific procedures for staff to follow, which include: 

• Upon admission, staff must evaluate the resident for safe consumption of hot beverages.
• If the resident does not “pass” the evaluation, a nurse must:  ensure that the “proper adaptive equipment is put into place”; initiate a care plan with specific interventions to minimize the risk for injury; and ensure that the “Kardex”11 includes appropriate interventions and adaptive equipment.
• Dietary staff must assess and document the temperatures of all food and beverages before serving.
• Staff must appropriately care plan and re-assess, quarterly, residents who have impairments that require adaptive equipment.

CMS Ex. 37 at 4.

The facility had a separate policy for coffee standards.  Among other requirements, the policy mandates that coffee brew temperatures “will be no higher than 160 degrees.”  All machines have to be turned down to brew at 160 degrees or lower.  Compliance for this is to be monitored “through weekly test trays,” with regional/company staff randomly auditing the tests.  CMS Ex. 37 at 5 (emphasis added).  The policy also requires supervision of those who require it and mandates that all departments, including activities, volunteers, and dietary, “need to be aware.”  Id.   

The facility had no written policies in place for responding to a hot liquid spill.  CMS Ex. 22 at 33.

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Resident 2 (R2).  R2 was a 70-year-old woman, admitted to the facility on July 18, 2014, suffering from a long list of impairments, including dementia, hypothyroidism, diabetes, hypokalemia (low potassium levels), epilepsy, atherosclerotic heart disease, chronic obstructive pulmonary disease, and dysphagia oropharyngeal phase (difficulty swallowing).  She experienced muscle weakness, muscle spasms, and had contractures of the upper and lower extremities.  CMS Ex. 16 at 1; CMS Ex. 32 at 1, 3; P. Ex. 1 at 2.

R2 required extensive assistance (one person) for eating.  CMS Ex. 32 at 15.  According to her hot beverage evaluations, she was not able to grasp a full mug and bring it to her mouth safely; she was not free of involuntary muscle movements or tremors; she was not alert and oriented (to person, place, and time); and her ability to swallow was impaired.  P. Ex. 2; P. Ex. 3 at 2; P. Ex. 4 at 2.

A dietary assessment, dated April 19, 2017, confirms that R2 required a sippy cup for all beverages, and her care plan directed the kitchen to provide a sippy cup “for all beverages.”  CMS Ex. 32 at 14; P. Ex. 4 at 1; P. Ex. 6 at 24; P. Ex. 7 at 14.  Though R2 apparently required a sippy cup as far back as October 2014, P. Ex. 15 at 6 (Rader Decl. ¶ 14), on April 11, 2017, R2’s physician again ordered that she have “sippy cups with meals,” an order Petitioner’s dietician confirmed.  CMS Ex. 32 at 7.

The incident:  April 19, 2017.  At about 5:15 a.m. on April 19, R2 was in the dining room.  She asked for coffee, and, without consulting the resident’s chart, the Kardex, or nursing staff, a dietary aide gave her some very hot coffee in a regular cup rather than a sippy cup.  The sippy cup instruction was on the resident’s meal ticket, and the dietary aide would have known about it when she checked the ticket, but she did not remember the resident and did not check the ticket.  CMS Ex. 4 at 3-4 (Nunham Decl. ¶ 16); CMS Ex. 27 at 5, 9-10; CMS Ex. 32 at 36, 37.

And the coffee was very hot, 190 degrees F – “way too hot,” according to the dietary aide and the facility policy.  Unable to hold the cup, R2 spilled the hot liquid over her chest and lap, sustaining a second degree burn12 on her chest and abdomen that measured 29 cm X 10.5 cm (approximately 11.4 inches X 4.1 inches).13  CMS Ex. 4 at 3-4 (Nunham

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Decl. ¶ 16); CMS Ex. 27 at 5, 9-10; CMS Ex. 32 at 36, 37.  According to the incident report, staff applied a cold wash cloth and ice to the wound.  CMS Ex. 32 at 36. 

Staff did not immediately report the incident to the resident’s physician.  CMS Ex. 4 at 5 (Nunham Decl. ¶ 22); CMS Ex. 22 at 39.  According to the incident report, they contacted him at 11:00 a.m.  CMS Ex. 32 at 36.  No evidence suggests that a physician ever assessed the wound.  See CMS Ex. 32. 

Petitioner’s response.  Petitioner concedes all of these facts.  It nevertheless maintains that it was in substantial compliance because it had appropriate policies in place; it properly assessed R2; and the resident’s care plan included an appropriate intervention.  P. Opp. at 5-6; P. Ex. 15 at 4 (Rader Decl. ¶ 12).  Petitioner dismisses the incident itself as the “misjudgment of a dietary aide.”  P. Opp. at 6.  I agree that the facility had in place policies and interventions that were designed to protect the resident from injuries.  I do not agree that the dietary aide’s “misjudgment” excuses the facility from culpability.  First, as discussed above, the facility is responsible for the actions of its employees.  Springhill , DAB No. 2513 at 14; Sunshine Haven Lordsburg, DAB No. 2456 at 16-17; Gateway Nursing , DAB No. 2283 at 8; Emerald Oaks, DAB No. 1800 at 7 n.3.

Second, and equally important, the facility’s deficiencies here show a more systemic problem than one isolated error in judgment.  Contrary to the requirements set forth in the facility’s policies, dietary staff had not been made aware of their responsibilities.  The dietary staff (not just one employee) did not assess and document coffee temperatures, as required, or, if they did, they simply disregarded the facility’s policy and served dangerously hot coffee.  Petitioner offered no evidence or explanation as to how the coffee could have been served at 190 degrees if the coffee machine was set to brew at 160 degrees as Petitioner’s policy required, or how its system of “weekly test trays” and periodic regional/company staff audits failed to prevent this.  And when the aide served the coffee at an unsafe temperature (according to Petitioner’s standard), neither she nor the nursing staff provided R2 with appropriate supervision and assistive devices to keep her safe.

Thus, the undisputed evidence establishes that the facility fell far short of doing all that was reasonably possible to minimize the risk of accidents from burns.14   Although it had

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appropriate policies in place, had assessed the resident, and, in her care plan, identified necessary interventions to keep her safe, staff disregarded the policies and the care plan instructions.  As the Board has repeatedly explained, a facility’s policy for implementing a regulatory requirement reflects the facility’s own judgment about how best to achieve compliance.  Failing to comply with its own policies “can support a finding that the facility did not achieve compliance with the regulatory standard.”  Bivins Mem’l Nursing, DAB No. 2771 at 9; see Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013); Life Care Ctr. at Bardstown, DAB No. 2233 at 21-22 (2009) (finding that a facility’s failing to comply with its own policies can constitute a deficiency).

These failures, by themselves, put the facility out of substantial compliance with section 483.25(d), without regard to its shortcomings in preventing falls (which, as the following discussion shows, were significant).

Facility policy:  fall prevention and risk assessment.  The facility had in place a written policy whose purpose was to provide a safe environment that “minimizes the potential for resident injury due to falls [and to] identify fall risk factors particular to the individual resident that may be reduced through care planning and implementation of individualized interventions.”  CMS Ex. 37 at 8.  The policy recognizes that falls are a common source of injury and death among the elderly.  Id.

The policy sets forth procedures that staff must follow: 

• All residents must be assessed for fall risk upon admission, then quarterly, and upon any significant change.
• Staff must use the results of the fall risk assessment to identify immediate measures that must be taken to prevent the resident from falling.
• The policy lists potential interventions, including providing a low bed, bed or chair alarms, body pillows, an adaptive call bell, a specific toileting schedule or bedside commode, teaching transfer techniques, and other measures, as appropriate.
• Risk factors and interventions are to be documented on the resident’s care plan and communicated to direct care staff for implementation.

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• After a fall, nursing staff will immediately assess the resident for potential injury and will treat as necessary.  The responsible nurse will document the circumstances and complete an incident report.  The nurse will take “any immediate measures necessary” to prevent a recurrence.
• The facility’s quality assurance committee must investigate the fall to identify contributing factors, the circumstances within or beyond the facility’s control in preventing the fall, and the measures the facility will take to minimize the risk of a recurrence.   
• The results of the committee’s investigation must be used to identify and care plan additional interventions as required to ensure the resident’s safety.

CMS Ex. 37 at 8-9.

Resident 7 (R7).  R7 was an 87-year-old woman, admitted to the facility on July 1, 2016.  CMS Ex. 33 at 24.  She suffered from hypertension, hyperlipidemia, atherosclerotic heart disease, chronic obstructive pulmonary disease, candidiasis (fungal infection of skin and nail), and cervicalgia (neck pain).  She had an anxiety disorder and cognitive deficits.  She had muscle weakness, tremors, and a history of repeated falls.  CMS Ex. 33 at 4, 5, 10.

R7’s gait was impaired, and she could not walk without assistance.  She was not aware of her limitations.  CMS Ex. 33 at 46.  To address her risk for falls, her care plan directed staff to “assist her with transfers,” be sure her call light is within reach, encourage her to engage in activities to promote exercise and improve strength and mobility, ensure she wears appropriate footwear, and “follow facility fall protocol.”  She was to have alarms to alert staff of her unassisted efforts to transfer herself.  CMS Ex. 33 at 13.  

R7’s falls.  R7 apparently experienced a fall on October 23, 2016, and, at that time, her care plan emphasized that she was supposed to have an alarm “at all times.”  The plan states “fallen star,” although what that means is not indicated in the facility records.  CMS Ex. 33 at 14, 22.  Nurse Consultant Gail Rader declares that “[f]allen star” is “a self-explanatory as the page used by staff to alert others that a resident has fallen.”  P. Ex. 15 at 12 (Rader Decl. ¶ 42); CMS Ex. 33 at 66.  In other words, it is not a program, doesn’t provide additional interventions, and makes no changes to the care plan.  It is a report.  See CMS Ex. 26 at 3 (Williams Decl. ¶ 12) (noting that “Fallen Star” “lacked any utility to actually prevent [the resident] from falling in the future.”).

At 1:00 p.m. on February 6, 2017, staff discovered R7 sitting on the floor in her room.  She had attempted to transfer from her bed to her wheelchair.  According to the incident report, no alarm had been ordered.  The report also says that R7 is independent with transfers, which she obviously was not.  To prevent additional falls, the report indicates

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that staff would begin “frequent checks,” although it includes no specific instructions as to how often or by whom the checks should be made, nor how they should be documented.  The report also indicates that staff should ask the resident to use her call light (which the undisputed evidence establishes she was not capable of remembering to do).  CMS Ex. 33 at 68-70; see CMS Ex. 33 at 14.

R7’s undated Kardex indicates that she had no alarms and did not use a wheelchair (which is obviously incorrect).  CMS Ex. 33 at 27.

At about 9:15 p.m. on March 7, 2017, staff responded to R7’s calls for help and found her on the floor, between her wheelchair and night stand.  She said that she had been trying to get from her bed to her wheelchair when she fell.  She was not injured.  CMS Ex. 33 at 36, 63-64.  To prevent further incidents, the facility installed an anti-rollback device on her wheelchair.  CMS Ex. 33 at 64.

According to the facility’s consultant, R7 had other falls, although the record does not include additional documentation of them.  Nurse Consultant Rader lists six falls, without providing dates or much detail.  P. Ex. 15 at 11 (Rader Decl. ¶ 36).  One occurred when R7 leaned forward in her wheelchair and fell.  For four of them (presumably including the February 6 and March 7 falls), she “was found” on the floor, apparently having attempted to transfer, unassisted, from bed to wheelchair.  For the final one, she slid out of bed and on to the floor.  Id.

Petitioner has not presented evidence establishing that the facility took all reasonable steps to protect R7 from accidents.  First, staff were not all aware of her limitations; some thought that she was independent with transfers.  CMS Ex. 26 at 3-4 (Williams Decl. ¶ 15); CMS Ex. 33 at 68.

Second, R7’s care plan requires that she have alarms in place.  CMS Ex. 33 at 13, 22 (“alarms at all times.”); CMS Ex. 33 at 24 (“[R7] has alarms to alert staff of unassisted attempts to transfer self.”).  Nothing in her care plan indicates that this intervention was cancelled, and certainly it should not have been cancelled without careful review by the facility’s Quality Assurance committee.  See CMS Ex. 37 at 9.  For her part, Nurse Consultant Rader virtually ignores the assessment/care plan directions calling for alarms to be in place; she does not even mention those instructions when she lists the interventions recorded in R7’s care plan and incident reports.  P. Ex. 15 at 12 (Rader Decl. ¶ 40).

Inconsistent with her care plan, R7’s undated Kardex indicates that she does not have alarms.  CMS Ex. 33 at 27.  Without providing specific evidence (such as an assessment, care plan intervention, physician order, or even staff testimony), Petitioner relies on the discrepancy between the care plan and the Kardex to declare that the alarms were

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discontinued, and, thus, to justify staff’s failing to follow the plan.  P. Ex. 15 at 12 (Rader Decl. ¶ 41).

This is not a reasonable inference.  A Kardex is not an assessment, a plan, or an order; it is supposed to reflect the instructions in the care plan.  An unexplained discrepancy between the Kardex and the care plan establishes that the facility was not in substantial compliance because it was not providing staff with accurate and consistent instructions, as required by its own policies.  See CMS Ex. 37 at 9 (“Risk factors and fall prevention measures will be documented on the resident’s comprehensive care plan and communicated to the direct care staff for implementation.”).  Moreover, even if I accepted, for purposes of summary judgment, Petitioner’s unsupported claim that orders for the chair and bed alarms had been cancelled, I would find that the facility was not in substantial compliance.  Based on her assessment and care plan, R7 required the alarms to keep her safe from accidents and injury.  No re-assessment, care plan, testimony, nor any other evidence in this record justifies the facility’s cancelling them.  By not applying the alarms, the facility failed to do everything it could to prevent accidents. 

Third, the care plan calls for “frequent checks.”  No one knows what that means, and nothing in this record suggests that staff were checking on R7 with any frequency.  Nurse Consultant Rader points to a chart for neurological checks and maintains that it defines “frequent checks.”  P. Ex. 15 at 13 (Rader Decl. ¶ 43), citing CMS Ex. 33 at 67.  The chart does not reflect any reasonable definition of “frequent checks.”  The chart represents the facility’s protocol for assessing a resident with a potential head injury (which seemed to happen with alarming frequency).  The potential time span is very limited.  Staff are to take vital signs every 15 minutes for just one hour; then every 30 minutes for the following hour; every hour for four hours, and, finally, every four hours for the next 24 hours.  CMS Ex. 33 at 67.  If, in fact, staff were following the chart’s guidance to implement the resident’s care plan, the so-called “frequent checks” would have been virtually meaningless.  The resident’s need for supervision – frequent checks – was not likely to end after just 30 hours.  Moreover, four-hour intervals could not be considered “frequent” by anyone’s definition; certainly, it would not be sufficient to protect a vulnerable resident from accidents. 

Resident 30 (R30).  R30 was an 87-year-old man, admitted to the facility on May 11, 2016.  Among other ailments, he suffered from atherosclerotic heart disease, chronic obstructive pulmonary disease, chronic kidney disease, hyperlipidemia, diabetes, and obesity.  He was demented and had a history of falling.  CMS Ex. 34 at 4.  He used a wheelchair for mobility.  CMS Ex. 34 at 5.  He required extensive assistance (two-person) for transfers, using a mechanical lift.  CMS Ex. 34 at 8-9. 

R30’s falls.  R30’s care plan lists 19 falls from June 22, 2016 through March 22, 2017, although that number does not include all of his falls, and, for most of the dates listed, the record here includes no investigative reports, witness interviews, or nurses’ notes

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describing the circumstances.15   CMS Ex. 34 at 16; see CMS Ex. 26 at 2 (Williams Decl. ¶ 11) (counting ten falls in five months).  The record includes some information regarding the following falls:

• November 24, 2016:  At 7:30 p.m. on November 24, R30 was found on the floor, apparently having fallen from his wheelchair; no one witnessed the fall.  Staff heard his alarm and found him, next to his wheelchair, on the floor of the sunroom.  CMS Ex. 34 at 133-34.  A neurological flow sheet indicates that staff took his vital signs every 15 minutes for one hour (7:30 p.m., 7:45 p.m., 8:00 p.m., 8:15 p.m., 8:30 p.m.) then hourly until 1:30 a.m. on November 25 (9:30 p.m., 10:30 p.m., 11:30 p.m., 12:30 a.m., 1:30 a.m.).  They then checked him every four hours until 5:30 p.m. on November 26 (5:30 a.m., 9:30 a.m., 1:30 p.m. and 5:30 p.m.).  CMS Ex. 34 at 137.
  
  A care plan entry, dated November 24, directs staff to “anticipate to meet resident needs.”  CMS Ex. 34 at 16.  This is not a useful intervention; it gives staff no directions as to what specifically they should do to prevent further accidents.

• December 25, 2016:  An incident report indicates that at 4:30 p.m. on December 25, R30 had been in his wheelchair moving up and down the hall.  His chair alarm was supposedly in place although it was not sounding when staff found him sitting on the floor, slumped over.  No one witnessed his fall, although staff surmised that he was trying to go outdoors.  According to the report, someone had seen him about 15 minutes earlier.  CMS Ex. 34 at 124-26.  He injured his head.  CMS Ex. 34 at 125. 
  
  A neurological flow sheet indicates that, following the fall, staff took the resident’s vital signs every 15 minutes for 45 minutes (from 4:30 p.m. until 5:15 p.m.), at 5:45 and 6:15 p.m., then hourly until 10:15 p.m.  They next took his vitals at 2:45 a.m., then every four hours until 2:45 p.m.  CMS Ex. 34 at 129.
  
  According to the report, the fall-prevention interventions in place at the time were the chair alarm, bed alarm, and mats on the floor.  CMS Ex. 34 at 126.  To prevent further incidents, the incident report says “resident to be walked when attempting

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to get up and walk” and “continue to monitor and follow care plan.”  CMS Ex. 34 at 125-26.  But these instructions would not have prevented R30’s fall (and did not prevent future falls).  To be implemented, staff would have to be present to observe the resident attempting to get up and walk.  “Monitor” provides staff no specific directions as to what they should do to prevent further accidents.

• December 29, 2016:  According to the facility’s incident report, at 6:00 p.m. on December 29, R30 had been sitting in his wheelchair before the front door.  He apparently stood and fell; again, there were no facility witnesses.16   The wheelchair was not locked.  The chair alarm was in place.  Although he had been “trying to get out of [his wheelchair] most of the afternoon” – extremely dangerous behavior for one as vulnerable as R30 – he was left alone and unsupervised.  Staff did not notify his physician or responsible party.  CMS Ex. 34 at 118.
  
  To prevent another fall, staff offered him snacks, moved him into the sunroom, and planned to give him more activities to keep him busy and to provide a high-back, reclining, low-seat chair.  CMS Ex. 34 at 119-20.
  
  This incident underscores staff’s failure to provide R30 with the supervision he required.  Staff had apparently checked on him frequently enough to identify his dangerous behaviors.  They were on notice that, given the opportunity, he would likely attempt to get out of his wheelchair.  Yet, they did not provide him the level of supervision they should have known he required to prevent a fall.

• December 30, 2016:  A “fallen star” report indicates that, at 9:00 a.m. on December 30, R30 was watching TV, and pushing his wheelchair toward the couch when he fell out of the chair.  A neurological flow sheet indicates that staff took his vital signs hourly for two hours, from 9:00 a.m. to 11:00 a.m.; then every four hours until 3:00 p.m. the following day.  CMS Ex. 34 at 121-22.
  
  To prevent future falls, staff indicated that they would provide a “dycem” (a non-slip strip or mat) and a wheelchair cushion with “crotch holder” (a pommel cushion).  CMS Ex. 34 at 121; see CMS Ex. 34 at 29 (indicating that a pommel cushion had been added to his care plan).  This is puzzling because his care plan indicates that these interventions were added much earlier, on May 23, 2016.  CMS Ex. 34 at 29.

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• February 9, 2017:  According to an incident report, at 9:30 a.m. on February 9, R30 was sitting in his wheelchair in the sunroom when he tried to stand and walk.  He fell to the floor.  There were no witnesses.  R30 had apparently been looking outside and, when found, pointed at an empty bird feeder.  CMS Ex. 34 at 106-10.  Bird-watching had been identified as one of his preferred activities; his care plan indicated that bird feeders were outside the window and directed staff to “ensure they are full of feed.”  CMS Ex. 34 at 7.  Assuming staff were aware of this directive (which they should have been), they did not follow it.
  
  R30’s wheelchair was not locked.  Although an alarm had been ordered, it was not in place.  He had no wedge cushions nor positioning pillows.  The report noted that he was noncompliant – “always trying to get up [and] walk.”  CMS Ex. 34 at 106.  Neither his physician nor his responsible party was notified.
  
  According to a neurological flow sheet, staff took his vital signs every 15 minutes from 9:30 a.m. until 10:15 a.m.; then every half hour for the next hour.  Notwithstanding an intervening fall and head injury (see below), they checked his vitals hourly until 3:15 p.m.; then every four hours until 7:15 p.m. on February 10.  CMS Ex. 34 at 114.
  
  To prevent further falls, the report indicates that the resident would be watched more closely and involved in activities.  CMS Ex. 34 at 107, 110.  Again, these instructions are not specific enough to be useful.
  
  Here, staff failed to follow R30’s care plan in multiple ways.  His alarms were not in place.  Staff did not assure that the bird feeders were kept full, as called for in his care plan, which likely contributed to his February 9 fall, when he attempted to get out to them.  CMS Ex. 34 at 7.  The required cushion was not in place.  He was left alone and unsupervised.

• February 9, 2017:  R30 fell again at 2:00 p.m. on February 9.  He had been showering when the shower chair broke.  Although he hit his head on the floor, the record shows that staff did not check his vital signs every 15 minutes or even every half hour.  They checked his vitals at 2:15 p.m., 3:15 p.m., and then every four hours until 7:15 p.m. on February 10.  CMS Ex. 34 at 112, 114.
  
  The report of this incident is inconsistent and inadequate.  On the one hand, it indicates R30 was last seen 15 minutes prior to the fall.  CMS Ex. 34 at 111.  On the other hand, it says that witnesses were bathing him at the time of the incident.  CMS Ex. 34 at 112.  Assuming, for the sake of summary judgment, that someone was with him, the facility has not explained or justified putting a vulnerable resident in an unreliable shower chair.

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• March 22, 2017:  At 6:51 a.m. on March 22, a nurse aide reported that R30 was on the floor of his room.  During morning care, he had been combative, swinging at the nurse aide; he punched her in the stomach.  According to the aide, when he leaned forward to punch her again, he slid off the edge of the bed, hitting his head on his roommate’s wheelchair (which was kept between the beds).  He had a large cut on his right forearm and scrapes on his chin and right hip.  He was assisted back into bed, using a floor lift.  His wounds were treated and vital signs taken.  CMS Ex. 34 at 61-62, 98, 102, 103.
  
  The investigative report indicates that his bed alarm was in place at the time and was sounding, although it also describes the resident as noncompliant, taking the alarm off.  It indicates that he was incontinent and was soiled; the nurse aides were attempting to clean him up at the time of the incident.  The interventions in place at the time were his low bed, mat, and bed alarm, although the mattress was not in the low position at the time.  It had been raised to assist with transfer.  CMS Ex. 34 at 98-101.
  
  From 6:45 a.m. until 7:45 a.m., staff checked his vital signs every 15 minutes.  From 7:45 until 8:45, they checked every 30 minutes.  And from 8:45 a.m. until 12:45 p.m., they checked hourly.  Thereafter, they checked him every four hours from 4:45 p.m. until 12:54 p.m. on March 23.  CMS Ex. 34 at 104.

• April 28 - 29, 2017:  An incident report indicates that at 11:30 p.m. (nurse’s note says 12:07 a.m.), staff found R30 on the floor of his room, with his legs out, leaning against his bed.  The interventions already in place are listed as “chair/bed alarm, fall mats.”  CMS Ex. 34 at 47, 86-87.
• April 29, 2017:  At 7:30 p.m., accompanied by his daughter, R30 was wheeling his wheelchair along the hall, using the handrail to pull himself along.  No positioning cushion or wedge was in place.  He leaned too far ahead to grasp the rail and fell out of his chair onto the floor.  He hit his head and had “open areas” per the incident report.  His physician ordered that he be sent to the emergency room for evaluation.  CMS Ex. 34 at 47, 90-92.  Staff did not witness the fall.  CMS Ex. 34 at 95-97.
  
  The incident report indicates that, to prevent additional falls, staff would check him every 15 minutes.  CMS Ex. 34 at 91, 92.  It appears that, when he returned from the hospital, they checked his vitals just once.  CMS Ex. 34 at 94.
  
  At 11:00 p.m. on April 29, the facility finally instituted and documented 15-minute checks.  The documentation stops at 11:00 p.m. on April 30 and begins again at 12:45 a.m. on May 1, ending at 10:45 p.m. on May 1.  CMS Ex. 34 at 140-41.

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Thus, after many months, many falls, and an emergency room visit, the facility finally instituted and documented a system for checking on R30.  But the documentation shows that the system was short-lived, lasting just two days.

On May 2, Surveyor Karen Williams, R.N., observed R30 up in his wheelchair.  He did not have a pommel cushion in place.  CMS Ex. 26 at 2 (Williams Decl. ¶ 11); CMS Ex. 28 at 7.  She later observed him, alone and unsupervised, in a common area.  He was grabbing on to tables, “trying to scooch himself” forward in his wheelchair to reach a puzzle that was about 15 feet away from him.  CMS Ex. 26 at 4 (Williams Decl. ¶ 19).  This was the type of behavior that had resulted in some of his falls.

Petitioner’s response.  According to Nurse Consultant Rader, Surveyor Williams did not see the pommel cushion because it had been discontinued by the time of the survey.  P. Ex. 15 at 13 (Rader Decl. ¶ 50).  Even if so (and no evidence supports the claim), this would not explain why the cushion was missing on February 9 or April 29.17

Nurse Consultant Rader cites no support for her claim except CMS Ex. 12, which consists of surveyor notes from the March survey and has nothing to do with R30 or the May survey findings.  On the other hand, P. Ex. 12 includes R30’s care plan, which talks about the pommel cushion, but it does not support Petitioner’s claim.  In fact, the plan calls for a pommel cushion in R30’s wheelchair, effective May 23, 2016.  That intervention was renewed on September 12, 2016, and May 17, 2017 (after the May survey).  P. Ex. 12 at 13; see CMS Ex. 34 at 29, 121.  Moreover, as with R7’s alarms, even if I accepted, for purposes of summary judgment, Petitioner’s unsupported claim that orders for the pommel cushion had been cancelled, I would find that the facility was not in substantial compliance.  Based on his care plan (which was presumably based on an assessment), R30 required the cushions to keep him safe from accidents and injury.  No re-assessment, care plan, testimony, nor any other evidence in this record justifies the facility’s cancelling that intervention.

Thus, as the above discussion shows, the undisputed evidence establishes that the facility did not do everything possible to minimize R30’s risks of an accident.

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Resident 34 (R34).  R34 was an 80-year-old man, admitted or readmitted (the record is not clear) to the facility on April 26, 2016.  CMS Ex. 35 at 28.  He had a long list of ailments, including chronic obstructive pulmonary disease, gastro-esophageal reflux disease, sleep apnea, overactive bladder, lumbago with sciatica, mononeuropathy of the right upper limb, polyosteoarthritis, obesity, restless leg syndrome, muscle wasting and atrophy, and abnormalities of gait and mobility.  He suffered from dementia, major depression, and anxiety.  CMS Ex. 35 at 7, 33.  He required extensive assistance (two- person) with transfers, using a mechanical lift as needed.  CMS Ex. 35 at 12.

R34’s falls.  R34’s care plan also includes a long list of falls – 14 falls from April 20, 2016, through April 17, 2017.  As with R30, that number does not include all of his falls, and, for most of the dates listed, this record includes no investigative reports, witness interviews, or nurses’ notes describing the circumstances.18   CMS Ex. 35 at 93.

On April 20, 2016, R34’s care plan called for a low bed with a mattress at his bedside.  CMS Ex. 35 at 92.19

On April 21, 2016, R34 fell and was sent to the emergency room with a fractured hip, although the record includes no details of that incident.  CMS Ex. 35 at 92, 93.  Thereafter, additional interventions were added to his care plan, which roughly correspond with the dates of his subsequent falls, although the record includes no additional information as to the falls themselves:

• May 6, 2016 – medication change due to fall;
• May 8, 2016 – bolsters to bed (May 6 and May 8, 2016 falls);
• May 12, 2016 – encourage asking for help (May 12, 2016 fall);
• June 4, 2016 – place in common area in view of staff when not in bed or recliner (June 4, 2016 fall);

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• August 16, 2016 – physical therapy for strength and mobility (August 16, 2016 fall);20
• August 22, 2016 – physical therapy assessment (August 22, 2016 fall);
• September 9, 2016 – resident to be in bed or recliner following meals (September 9, 2016 fall);
• September 21, 2016 – nurse aide “intervention on fall packet” (September 21, 2016 fall);
• October 22, 2016 – recliner chair remote to be out of resident’s reach (October 22, 2016 fall);

CMS Ex. 35 at 92-93.

The record includes some information regarding the following falls:

• November 21, 2016:  At 4:30 p.m. on November 21, staff “found” R34 on the floor in front of his reclining chair.  No one witnessed his fall.  He said that he was “going to get the TV.”  CMS Ex. 35 at 88-89.  According to the report, preventive measures were in place:  chair alarm, eye glasses, and call bell within reach.21   CMS Ex. 35 at 89.
  
  A neurological flow sheet indicates that staff took R34’s vital signs every 15 minutes for the first hour after his fall (4:30 p.m. until 5:30 p.m.); then every half hour from 5:30 p.m. to 7:00 p.m.; then hourly until 10:00 p.m.; then every four hours until 10:00 p.m. the following day.  CMS Ex. 35 at 91.
  
  The report identifies a new preventive measure:  to unplug the reclining chair while the resident is in it.  CMS Ex. 35 at 90, 92.

• December 30, 2016:  At 4:45 p.m. on December 30, 2016, a nurse aide responded to an alarm and again found R34 on the floor next to his recliner.  No one witnessed his fall.  He had been resting and could not recall what happened.  CMS Ex. 35 at 76-79.  The nurse aide assigned to care for him admitted she was on her break when it happened so would not comment.  CMS Ex. 35 at 79. 

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According to a neurological flow sheet, staff again took his vital signs every 15 minutes for the first hour after his fall (4:45 p.m. until 5:45 p.m.); then every half hour from 6:15 p.m. to 7:45 p.m.; then hourly until 11:45 p.m.; then every four hours until 7:45 a.m. the following morning.  CMS Ex. 35 at 80.

The intervention list adds “frequent checks while [the] resident [is] in [his] recliner chair.”  CMS Ex. 35 at 92.  But, again, the facility did not define “frequent” and did not document such checks. 

• April 17, 2017:  At 7:50 a.m. on April 17, R34 fell out of his wheelchair.  He slid out of his chair while eating breakfast in the dining room.  CMS Ex. 35 at 34, 71-74.  Although the incident report suggests that his wheelchair was not locked, the “fallen star” document claims that it was.  The incident report also indicates that the sling to R34’s Hoyer lift had been left in the wheelchair, and he was sitting on it.22   Staff did not consult his physician or notify his family.  CMS Ex. 35 at 71-73.
  
  From 8:00 a.m. until 8:45 a.m., staff checked R34’s vital signs every 15 minutes.  From 8:45 a.m. to 9:45 a.m., they checked his vital signs every half hour.  From 9:45 a.m. until 12:45 p.m., they checked hourly.  From 12:45 p.m. until 8:45 p.m. the following day (April 18), they checked every four hours.  CMS Ex. 35 at 75.
  
  R34 was assessed by an occupational therapist, who determined that he had positioning problems, but that skilled occupational therapy services were not medically indicated.  He was given a “more appropriate” wheelchair.  The report also notes that the resident’s family asked that foot rests be attached to his wheelchair.  CMS Ex. 35 at 34, 66, 92.23

• April 19, 2017:  At 9:31 a.m. on April 19, R34 “was observed” on the dining room floor.  No one witnessed his fall.  CMS Ex. 35 at 34.
• May 1, 2017:  At 4:35 p.m., on May 1, staff found R34 lying on the floor mat by the side of his bed.  He was not sure what happened.  No one witnessed his fall.  According to the incident report, bolsters, low bed with mats, and a sensor alarm were in place, although the report leaves unanswered the question as to whether the alarm was sounding and does not otherwise mention that it was.  The physician was not contacted.  CMS Ex. 35 at 33, 82-84.

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For the first hour, 4:45 p.m. to 5:45 p.m., staff checked R34’s vital signs every 15 minutes.  From 5:45 p.m. until 6:45 p.m., they checked each half hour.  From 6:45 p.m. until 10:45 p.m., they checked hourly.  They checked at 1:45 a.m. the following morning (May 2) and every four hours from 1:45 a.m. to 9:45 p.m.  CMS Ex. 35 at 87.

According to the report, to prevent future falls, staff would conduct 15-minute checks for three days.  CMS Ex. 35 at 83.

The following day, Surveyor Williams observed R34 in the hall, alone and unsupervised.  He told her that he was bored and had nothing to do.  CMS Ex. 26 at 5 (Williams Decl. ¶ 19).  She also observed that the resident was again sitting on the sling to his Hoyer lift, which staff had left in his wheelchair and may have contributed to his earlier falls.  CMS Ex. 26 at 4 (Williams Decl. ¶ 17).

As with R7 and R30, the facility’s records show that staff repeatedly failed to take necessary steps to prevent R34’s falls.  At the time of the survey, the care plan finally called for 15-minute checks; however, they were for three days only, and no evidence shows that they were implemented.

Petitioner suggests that, so long as it assessed a resident’s fall risks and added interventions to the resident care plan, it met the regulatory requirements.  By themselves, assessing the resident and drafting a care plan are not sufficient to satisfy the regulation.  The interventions must be meaningful, and staff must understand and implement them.

In a confusing assertion, Petitioner maintains that “frequent checks of residents are a common intervention and[,] though not specific in and of itself, cannot be assumed to be the cause of falls experienced by [R7, R30, and R34].  P. Opp. at 15; P. Ex. 15 at 14 (Rader Decl. ¶ 55).  I am not sure what this means.  If properly implemented, frequent checks are supposed to provide residents with a level of supervision sufficient to prevent accidents.  In any event, leaving vulnerable residents alone and unsupervised, without the assistive devices they need (as frequently happened here), can certainly result in falls.

I note, finally, that staff’s repeatedly failing to notify the residents’ physicians of their falls puts the facility out of substantial compliance with section 483.25(d) as well as section 483.10(g)(14).  The physician is part of the care-planning process, and he/she must be notified of a need to alter treatment.  42 C.F.R. §§ 483.21(b)(2)(ii)(A), 483.10(g)(14)(C).  Because staff did not consult physicians after the residents fell, the physicians could not participate in the care-planning, which undermines the facility’s ability to develop successful interventions.

As the Fal-Meridian court observed, the relevant questions are:  1) whether the facility’s “handling of [the resident’s] physical and mental infirmities was consistent with its duty

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to keep the [facility] free as possible from hazards that might cause an accident,” and 2) if not consistent, whether the facility’s dereliction of its duty was likely to cause serious injury, harm, impairment, or death to a resident.  Fal-Meridian, 604 F.3d at 447.  Here, CMS is entitled to summary judgment because Petitioner presents no admissible evidence of specific facts showing that it handled the residents’ infirmities “consistent with its duty” to keep the facility free from hazards that might cause an accident.  Drawing all reasonable inferences in Petitioner’s favor, the facility simply did not take adequate measures to prevent accidents for multiple residents.  This dereliction was likely to cause – and did cause – serious injury and harm to at least four of its residents (R2, R7, R30, and R34).

5.   The undisputed evidence establishes that CMS’s determination that the facility’s failure to do everything possible to minimize the risks of accidents 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)(2).  The Board has observed repeatedly that the “clearly 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.”  Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004) (citing Koester Pavilion, DAB No. 1750 (2000)); Daughters of Miriam Ctr., DAB No. 2067 at 7, 9 (2007).

Once CMS presents evidence supporting a finding of substantial noncompliance, it need not offer evidence to support its immediate jeopardy determination.  The burden is on the facility to show that CMS’s determination is clearly erroneous.  Grace Healthcare of Benton, DAB No. 2189 at 13 (2008) (citing Liberty Commons Nursing & Rehab Ctr. – Johnston, DAB No. 2031 at 17-18 (2006)) aff’d, Liberty Commons Nursing & Rehab Ctr. – Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007)).

The undisputed evidence here establishes that the facility’s noncompliance with section 483.25(d) caused serious injury and harm to its residents and was likely to cause additional injury and harm to others.

The burn.  Not only did R2 suffer a serious and painful injury, the facility’s practice of serving coffee at dangerously high temperatures and its failure to educate dietary staff as to their responsibilities in serving hot foods and beverages created the likelihood of inflicting additional serious harm on the residents.

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Petitioner’s response.  Citing the State Operations Manual, Petitioner concedes that a  second degree burn covering a large surface area would constitute serious injury or harm, but it then dismisses R2’s injury as relatively minor.  Hearing Request at 12-13.  Without commenting on the size of the burn, Petitioner notes that, hours after the incident, R2 had only two small fluid-filled blisters, and that, by late afternoon/early evening, she had stopped complaining of pain.  Hearing Request at 13.  In fact, undisputed evidence establishes that “by the next morning [R2’s chest] was all blisters.”  CMS Ex. 27 at 5.  And Petitioner concedes, based on the evidence presented, that the “burn initially was painful” and that R2 was administered pain medication for two days following the incident.  P. Opp. at 10.

Even if I agreed that R2’s situation did not equal the manual’s examples of  immediate jeopardy situations (which I do not), serving beverages at such high temperatures (which the facility was doing at the time) to frail and vulnerable nursing home residents is a dangerous practice, likely to cause serious injury and harm.24   The practice therefore poses immediate jeopardy to resident health and safety.

The falls.  R30 suffered multiple injuries as a result of his falls, including a head injury on December 25; a cut forearm, scraped chin and hip on March 22; and a head injury and “open areas,” requiring a trip to the emergency room on April 29.  He also hit his head when he fell in the shower room on February 9.  And although the record includes no details, R34 fractured a hip as the result of a fall on April 21.

Petitioner’s response.  Again, citing the State Operations Manual, Petitioner cites other examples of immediate jeopardy:  a fracture that might require surgery or a fall “that resulted in or had the potential to result in serious injury, impairment, harm, or death.”  Hearing Request at 12.  This seems to describe at least some of the falls that occurred here.  Given the frailty of the residents, any one of them had the potential for causing serious injury, impairment, harm, or death.

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Petitioner also argues that immediate jeopardy requires that the harm or potential harm “is likely to occur in the very near future to this individual or to others in the entity, if immediate action is not taken.”  Hearing Request at 13.  The Board has definitively rejected this position, finding that a facility’s deficiencies may pose immediate jeopardy even though the potential harm is not likely to occur in the near future.  Agape Rehab. , DAB No. 2411 at 19 (2011); Barbourville Nursing Home, DAB No. 1962 at 16-18 (2005) (finding that a facility’s failing to track information in accordance with its policies posed immediate jeopardy, even though no harm had resulted, and potential harm would not happen “in hours or days, but over weeks or months.”).

Because the facility’s deficiency under section 483.25(d) was likely to cause, and, in fact, did cause serious harm to vulnerable residents, CMS’s determination that the deficiency posed immediate jeopardy to resident health and safety was not clearly erroneous.

Conclusion

I find that the record is sufficiently developed, and the only reasonable conclusion that can be drawn from the undisputed facts is that the facility was not in substantial compliance with Medicare program requirements and that its deficiencies under section 483.25(d) posed immediate jeopardy to resident health and safety.  I therefore grant CMS’s motion for summary judgment.  The penalties imposed – $7,004 per day for each day of immediate jeopardy and $1,015 per day for each day of substantial noncompliance that did not pose immediate jeopardy – are reasonable.

1. Petitioner has contested only a few of the deficiencies cited.  It has not contested any of the Life Safety Code findings.  The uncontested deficiencies, for this and the other surveys, are nevertheless relevant.  They establish that the facility was not in substantial compliance, and they must be considered in determining whether the penalties imposed are reasonable.
• back to note 1
2. I highlight, in bold, the deficiencies that Petitioner has appealed.
• back to note 2
3. During the May 3 revisit survey, CMS cited section 483.25(d) as a repeat deficiency, finding then that it posed immediate jeopardy to resident health and safety.  CMS Ex. 22 at 31.  Petitioner challenged the May 3 citation.  However, as is plain from Petitioner’s hearing request, it did not challenge this citation from the March survey.  Because the May citation was for a repeat deficiency, the burden shifts to Petitioner to establish that the deficiency was corrected.  See discussion, below.
• back to note 3
4. Petitioner may have misunderstood my authority on this issue.  Referring to the immediate jeopardy determination, it asserts that “it is not within the discretion of the Departmental Appeals Board (‘DAB’) to determine whether said scope and severity was appropriate.”  P. Opp. at 1-2.  I find this statement puzzling.  I am authorized to review CMS’s immediate jeopardy determination here because Petitioner’s successful challenge would affect the penalty range.  42 C.F.R. § 498.3(b)(14).  I consider that Petitioner has waived the issue but, in an abundance of caution, I discuss below why CMS’s immediate jeopardy determination is not clearly erroneous.
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5. Penalty amounts have been inflation-adjusted and change annually.  45 C.F.R. § 102.3.  The amount is determined on the date the penalty is assessed, in this case, September 12, 2017.  CMS Ex. 1; 45 C.F.R. § 102.3; see 82 Fed. Reg. 9174, 9182 (Feb. 3, 2017).
• back to note 5
6. The courts that have considered applying principles of summary judgment to Medicare administrative proceedings have carefully avoided any suggestion that deciding a case on summary judgment means that it is decided without a hearing.  Throughout their decisions, they refer to deciding the case without an “oral hearing” or without an “evidentiary hearing.”  Although a case may be decided on summary judgment (or based on the written record), an administrative law judge, by considering the evidence and applying the law, has granted the petitioner a hearing, as required by sections 205(b) and 1866(h) of the Act.  See CNG Transmission Corp. v. FERC, 40 F.3d 1289, 1293 (D.C. Cir. 1994) (holding that a “paper hearing” satisfies statutory requirements for “notice and opportunity for hearing.”).
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7. The regulations governing long-term care facilities have been revised since the Seventh Circuit issued its decision in Fal-Meridian; the requirement that facilities minimize the risk of accidents is now found at section 483.25(d).  81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (July 13, 2017).  However, the substance of the “quality of care” requirements – which are also statutory – has not changed, so decisions that pre-date the regulatory changes remain valid.
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8. My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision.
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9. Failing to comply with its own policies supports the finding that the facility was not in compliance with regulatory requirements.  Bivins Mem’l Nursing Home, DAB No. 2771 at 9 (2017); Life Care Ctr. at Bardstown, DAB No. 2233 at 21-22 (2009).
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10. This is not surprising.  CMS, the Centers for Disease Control and Prevention, and the Food and Drug Administration have all warned that one of the most common causes of foodborne illness is improper cooling of cooked food.  See, e.g., CMS State Operations Manual, Appendix PP, Tag F371 at 416 (Rev. 168, eff. March 8, 2017), and references cited therein; FDA Food Code 3-501.14, 3-501.15 (2017), available at https://www.fda.gov/media/110822/download(last accessed May 6, 2020); see generally www.cdc.gov/nceh/ehs/ehsnet (last accessed May 6, 2020).
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11. A “Kardex” is a desktop file system that offers a brief overview of each resident.  Separate from the resident’s chart and kept in a central location, it gives staff quick access to resident information.  See, e.g., CMS Ex. 33 at 27.
• back to note 11
12. A second degree burn affects two layers of skin (dermis and epidermis), and is characterized by pain, redness, swelling, and blistering.
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13. Petitioner has not challenged Surveyor Nunham’s testimony regarding the size of the burn, which is based on reports from facility staff and the surveyor’s own examination.  One record entry, dated April 22, describes a much slighter injury on the left side of R2’s abdomen and chest, 4 cm X 7.5 cm (approximately 1.5 inches X 3 inches).  CMS Ex. 32 at 38.  Petitioner does not claim that this was the size of the resident’s burn, and all of the other evidence in the record describes a much larger area.  The document itself does not indicate what was measured.  However, on April 19, two fluid-filled blisters appeared, one of which opened on April 20, so this may have represented the open areas on the resident’s skin.  CMS Ex. 32 at 29, 30.  Neither party relies on the document, and the parties agree that it does not describe R2’s burn, so I draw no inferences from it.  In any event, inasmuch as serving such hot coffee to a vulnerable resident is likely to cause serious injury, the precise extent of R2’s injuries is not material.
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14. The parties dispute other aspects of the burn incident, most notably whether staff were properly trained in responding to burns and whether they responded appropriately to R2’s injury.  I need not decide these issues because the staff’s disregard of policies, assessments, and care plan instructions, by itself, puts the facility out of substantial compliance with the regulation.  I note that staff’s undisputed failure to consult immediately the resident’s physician when an accident results in injury puts the facility out of substantial compliance with 42 C.F.R. § 483.10(g)(14).  CMS cited a deficiency under that section, which the facility has not challenged.  CMS Ex. 22 at 1-3.
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15. The plan lists falls on the following dates:  June 22, 2016; July 1, 2016; July 10, 2016; July 29, 2016; August 20, 2016; September 8, 2016; September 11, 2016; September 16, 2016; October 3, 2016; November 3, 2016; November 24, 2016; December 15, 2016; December 25, 2016; December 29, 2016; January 16, 2017; January 25, 2017; February 9, 2017 (2 falls); and March 22, 2017.  The care plan does not list the fall that occurred on December 30, 2016, nor the falls that occurred on April 28-29, 2017.  See CMS Ex. 34 at 47, 86-92, 121.
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16. It is concerning that two days elapsed between the December 29 fall and the date the nurse signed the investigative report.  Compare CMS Ex. 34 at 118 with CMS Ex. 34 at 120.  During this delay, R30 fell again.
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17. The other fall reports are silent about the cushions, suggesting that they may not have been in place then, either.  This type of information is essential for future care planning and for the Quality Assurance committee.  How are the care planners to know if an intervention is effective if they don’t know whether it was implemented?  That the incident reports don’t mention whether the intervention was in place also shows that the facility wasn’t doing everything possible to prevent future accidents.
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18. The care plan lists falls on the following dates:  April 17, 2016; April 20, 2016; April 21, 2016 (with injuries); May 6, 2016; May 8, 2016; May 12, 2016; June 4, 2016; August 16, 2016; August 22, 2016; September 21, 2016; October 22, 2016; November 21, 2016; December 30, 2016; and April 17, 2017.  The care plan does not list the falls that occurred on April 19, 2017, and May 1, 2017.  See CMS Ex. 35 at 34, 82-84.
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19. On its face, the care plan is somewhat confusing in identifying the interventions in place to prevent falls.  However, the record includes a separate list of the interventions.  CMS Ex. 35 at 92.
• back to note 19
20. The record includes no evidence that physical therapy services were provided.
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21. The report erroneously indicates that R34 had not fallen within the previous six months; in fact, he had fallen the month before.  CMS Ex. 35 at 89.
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22. A Hoyer lift requires the use of a sling, which is placed beneath the resident before transfer.  The slings tend to be slippery.  CMS Ex. 26 at 4 (Williams Decl. ¶ 17).
• back to note 22
23. The absence of foot rests was one of the problems cited during the March 2 survey.  CMS Ex. 5 at 61-62.
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24. The  Board has discouraged this kind of reliance on the State Operations Manual; its provisions are “instructive,” but they are not binding.  We are bound by the regulatory definition in section 488.301.  Miss. Care Ctr. of Greenville, DAB No. 2450 at 15-16 (2012); Foxwood Springs Living Ctr., DAB No. 2294 at 9 (2009).  That definition “neither defines the term ‘likelihood’ nor sets any parameters as to the timing of potential harm.”  Miss. Care Ctr., DAB No. 2450 at 16 (quoting Agape Rehab. of Rock Hill, DAB No. 2411 at 19 (2011)).  Thus, the Board has concluded that a facility’s deficiencies may pose immediate jeopardy even though they do not create a “crisis situation.”  Miss. Care Ctr., DAB No. 2450 at 16.  This measured approach comports with the Supreme Court’s recent comments as to the value of sub-regulatory guidance.  See Azar v. Allina Health Servs., 139 S. Ct. 1804 (2019).
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