Generations at McKinley Place, DAB No. 3211 (2025)

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

Generations at McKinley Place (Petitioner), an Illinois skilled nursing facility (SNF), appealed an Administrative Law Judge (ALJ) decision granting summary judgment to the Centers for Medicare & Medicaid Services (CMS) and upholding a civil money penalty (CMP) CMS imposed for noncompliance with a Medicare participation requirement.  Generations at McKinley Place, DAB CR5233 (2019) (ALJ Decision).  The ALJ concluded that undisputed facts established that Petitioner was not in substantial compliance with the requirement in the regulations for long-term care facilities to store, prepare, distribute, and serve food in accordance with professional standards for food service safety and that the $18,500 per-instance CMP was reasonable.

Based on our de novo review of the record, we find no error by the ALJ and affirm the ALJ’s grant of summary judgment in favor of CMS.

Legal Background

To participate in the Medicare program, a SNF must be in “substantial compliance” with the program’s participation requirements in 42 C.F.R. Part 483, subpart B (sections 483.1 - 483.95).  42 C.F.R. §§ 483.1, 488.400.1  Under agreements with the Secretary of Health and Human Services, state survey agencies conduct onsite surveys to verify compliance with the Medicare participation requirements.  Id. §§ 488.10(a), 488.11; see also Social Security Act (Act) §§ 1819(g)(1)(A), 1864(a).  A “deficiency” is any failure to comply with a Medicare participation requirement, and a SNF is not in “substantial compliance” when it has one or more deficiencies that have the potential for causing “more than minimal” harm to residents.  42 C.F.R. § 488.301 (also defining “noncompliance” as “any deficiency that causes a facility to not be in substantial compliance”).

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State survey agencies periodically inspect SNFs on behalf of CMS to verify their compliance with Medicare participation requirements.  Id. §§ 488.10(a), 488.11, 488.308.  The state survey agency reports its findings in a Statement of Deficiencies (SOD) that identifies each deficiency with an “F-tag” number that corresponds to the relevant regulatory requirement and CMS guidance on that requirement.  Id. §§ 488.325(f)(1), 488.331(a); see generally State Operations Manual (SOM), CMS Pub. 100-07, Ch. 7, Survey and Enforcement Process for Skilled Nursing Facilities and Nursing Facilities.2  Additionally, the SOD indicates the survey agency’s evaluation of the “seriousness” of any cited deficiency.  42 C.F.R. § 488.404(a).  “Seriousness” is a function of “severity” (i.e.,no actual harm, potential for more than minimal harm, actual harm, or immediate jeopardy) and “scope” (i.e., whether the noncompliance isisolated, a pattern, or widespread) of the noncompliance at issue, where the highest level of severity is one that puts one or more residents in “immediate jeopardy.”  Id. §§ 488.404(b), 488.438(a); see also SOM, Ch. 7, §§ 7400.3, 7410.2.  “Immediate jeopardy” means “a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.

The participation requirement at issue in this appeal is the food safety requirement at 42 C.F.R. § 483.60(i)(2):  “(i) Food safety requirements.  The facility must – . . . (2) Store, prepare, distribute, and serve food in accordance with professional standards for food service safety.”

CMS may impose enforcement “remedies” on a SNF for noncompliance with one or more participation requirements.  See 42 C.F.R. §§ 488.402(b)-(c), 488.406, 488.408(d)(1)(iii)-(iv), (e)(1)(iii)-(iv).  Those remedies may include a CMP “for each instance that a facility is not in substantial compliance, . . . regardless of whether or not the deficiencies constitute immediate jeopardy.”  Id. § 488.430(a).  When CMS imposes a CMP for an instance of noncompliance, the penalty must be within the range of $1,000‑$10,000, as adjusted annually under 45 C.F.R. Part 102.  Id. §§ 488.408(d)(1)(iv), (e)(1)(iv), 488.438(a)(2).At the time of the survey, the range for a per-instance CMP was $2,097 to $20,965.  See id. §§ 488.408(d)(1)(iv), (e)(1)(iv), 488.438(a)(2); 45 C.F.R. § 102.3 (2017); 82 Fed. Reg. 9,174, 9,182-83 (Feb. 3, 2017).

A SNF may challenge a determination of noncompliance that led to the imposition of a CMP (or other enforcement remedy) by requesting a hearing before an ALJ and appealing any unfavorable ALJ decision to the Departmental Appeals Board (Board).  42 C.F.R. §§ 488.408(g)(1), 498.3(b)(13), 498.5(a)-(c).  The scope of ALJ or Board review may include whether the amount of the CMP is reasonable.  See id. § 488.438(e)(3), (f); North Las Vegas Care Ctr., DAB No. 2946, at 2 (2019).  However, a SNF may not contest CMS’s finding about the “level of noncompliance” (e.g., a finding of immediate

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jeopardy) except in limited circumstances, such as when a successful challenge would affect the range of CMP amounts that CMS may impose.  42 C.F.R. § 498.3(b)(14).

Case Background3

On February 13, 2018, two surveyors from the Illinois Department of Public Health (survey agency) completed an annual compliance survey of Petitioner’s facility.  CMS Ex. 4 (SOD).  The survey identified 14 deficiencies, including the one at issue here, noncompliance with 42 C.F.R. § 483.60(i)(2) (Tag F812), which the survey assessed at the scope and severity level “L,” meaning immediate jeopardy that is “widespread” in scope.  Id. at 27-28; CMS Ex. 1, at 1; see also SOM, Ch. 7, § 7400.5.1 (Rev. 161, eff. Sept. 23, 2016) (scope and severity matrix).4

The survey determined, “[b]ased on observation, record review, and interview” with two cooks and Petitioner’s corporate dietician, that “the facility failed to rapidly cool potentially hazardous food to a safe internal temperature of 41 degrees Fahrenheit (F) or below within the maximum permitted six hours to prevent food borne illness,” as required by facility policy, “Cooling Cooked PHF/TCS Foods (Potentially Hazardous
Food/Time Temperature Control for Safety).”  CMS Ex. 4, at 27-29; CMS Ex. 11 (facility policy); see also CMS Exs. 7, 9 (decls. of surveyor and surveyor supervisor).  The SOD explains that facility policy requires that hot foods be cooled “from 135 degrees F to 70 degrees F within two (2) hours, within four (4) more hours the food is cooled to 41 degrees F” and that “[c]ooling time from 135 degrees F to 41 degrees F does not exceed a total of six (6) hours.”  CMS Ex. 4, at 29.

On the morning of February 6, 2018, in the facility kitchen, the surveyor’s thermometer and the facility’s thermometer measured, at 66 degrees Fahrenheit, the internal temperature of a beef roast that the day cook reported had been cooked and put in a refrigerator over 15 hours earlier.  CMS Ex. 4, at 28-30.  The roast was one of six 12-to-14-pound roasts that, according to the evening cook whom the surveyor later interviewed, had been cooked the day before to internal temperatures of 186 degrees to be served to residents at the noon meal on February 6.  Id.  Two intact roasts were to be pureed and four had been sliced and the slices were seen covered with gravy.  Id.  According to the SOD, the evening cook said no rapid cooling measures had been used, and the day cook said that meat temperatures had not been recorded at specified intervals during cooling, as facility policy required.  Id.; see ALJ Decision at 3-4; CMS Ex. 7 at ¶¶ 8-15.  Petitioner’s corporate dietician was present with the surveyor in the kitchen on the morning of February 6, and after the roast’s temperature was measured and the day cook

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interviewed, she instructed the day cook to discard all of the roast beef.  CMS Ex. 4, at 29-30; CMS Ex. 7 at ¶¶ 9-12.

Petitioner disputes none of the factual information in the SOD or the surveyor’s declaration about what the surveyor saw and was told by the cooks on February 6, 2018.  Petitioner instead concedes that “the Facility cannot show or present evidence that it followed the cool down procedure for roast beef” and “cannot opine as to why staff answered the surveyor’s questions as they did.”  Request for Review (RR) at 4; P. Reply at 5.

The SOD alleges that the failure to cool the cooked beef as required “resulted in the facility preparing to serve unsafe food without recognizing the potential for food borne illness to all 149 residents” and “resulted in an Immediate Jeopardy” from February 5 to February 6, when the facility implemented measures such as posting the food cooling procedures, and training and testing staff for competency in serving food.  CMS Ex. 4,at 27-28, 31‑32; CMS Ex. 9 at ¶ 11.

Revisit surveys completed April 4 and April 18, 2018 found Petitioner corrected the deficiencies identified in the February survey, which had continued at a level lower than immediate jeopardy, by April 10, 2018.  CMS Ex. 1, at 1-2; CMS Ex. 2, at 7.  CMS then notified Petitioner by letter of May 16, 2018, that it was imposing a per-instance CMP of $18,500 for the single immediate-jeopardy-level deficiency cited as Tag F812.  CMS Ex. 1, at 2.5  CMS also informed Petitioner that due to the amount of the CMP, it would be prohibited from offering or conducting a Nurse Aid Training and/or Competency Evaluation Program for a period of two years from the date of a final decision upholding the CMP.  Id. at 4-5.

ALJ Proceedings and Decision

Petitioner timely requested an ALJ hearing.6  CMS moved for summary judgment, arguing that undisputed facts show Petitioner’s noncompliance with 42 C.F.R. § 483.60(i)(2) (Tag F812), because it “does not dispute that its roasts were not properly cooled, that improper PHF [potentially hazardous food] cooling endangers health and safety, or that its employee failed to follow the facility’s cooling policy and procedure” which “put all residents who would have been served the dangerous roast beef at risk for possible foodborne illness.”  CMS’s Combined Pre‑Hearing Brief & Motion for

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Summary Disposition (CMS ALJ Br.) at 12-13.  CMS submitted 16 exhibits, including the declarations of the two state agency surveyors (one who visited the kitchen on February 6, 2018 and spoke with the cooks, and the supervisor surveyor).  CMS. Exs. 7, 9.  CMS also submitted Petitioner’s policy for cooling potentially hazardous cooked foods, the U.S. Food and Drug Administration (FDA) 2017 “Food Code” recommendations, and the Illinois Department of Public Health “Temperature Requirements for Potentially Hazardous Foods in Retail Food Establishments.”  CMS Exs. 11, 14, 15.

Petitioner responded with a brief and one exhibit, the declaration of Petitioner’s corporate dietician.  Petitioner argued essentially that the corporate dietician’s regular presence in the facility and its “checks and balances system” ensure that “the roast beef would have never been served in the facility,” so “[t]here was no potential for harm” to any resident.  P. Resp. to CMS ALJ Br. & Pre-Hearing Br. (P. ALJ Br.)at 6-7; see also id. at 11 (“Any error that occurred on the day in question was due to human error and would have been caught and corrected by the Facility’s checks and balances system.”).  Petitioner objected to the SOD (CMS Ex. 4), portions of the surveyor’s declaration (CMS Ex. 7) and the surveyor’s notes (CMS Ex. 8) as hearsay, and to a portion of the surveyor’s declaration as speculation.  Id. at 17.  Petitioner also argued that summary judgment was not appropriate in light of material, contested facts, and “reserve[d] the right” to cross-examine CMS’s two witnesses.  Id. at 2, 17.

The ALJ granted summary judgment to CMS, finding that “facts [that] are undisputed . . . establish failure by Petitioner’s staff to comply with Petitioner’s policy, recognized standards, and regulatory requirements.”  ALJ Decision at 3.  Those facts comprise the undisputed information from the SOD and the surveyors’ declarations about the temperature of the roasts, the surveyor’s observations, and the cooks’ statements to the surveyor about preparation of the roasts, and their training and awareness of the facility’s policy and procedures for cooling potentially hazardous cooked food.  Id. at 3-4 (citing CMS Exs. 4, 7, 9 and 8 (surveyor’s notes)).  “Based on these undisputed facts,” the ALJ found Petitioner “manifestly deficient in several respects,” including that “staff did not follow recognized procedures and Petitioner’s policy for cooling cooked potentially hazardous substances, including cooked meat” because “staff failed to:  take any steps to cool cooked meat rapidly, monitor the internal temperature of cooked meat, and record those temperatures in a temperature log.” ALJ Decision at 4-5; see also id. at 7 (“The irrefutable fact is that none of the roasts prepared by Petitioner’s staff were cooled pursuant to protocol and Petitioner’s policy.”).  The ALJ further found that “staff’s failure to follow prescribed procedures and the facility’s policy put residents at risk for serious harm” and “caused an ongoing possibility of harm to Petitioner's residents.”  Id. at 5, 7.

The ALJ further concluded that undisputed material facts establish that the per-instance CMP of $18,500 that CMS imposed was reasonable, holding that “the seriousness of

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Petitioner’s noncompliance, standing alone, is sufficient to justify” the penalty amount.  Id. at 8.  “The failure by Petitioner’s staff to follow required protocol for cooling cooked meat and their failure to comply with and even ignorance of Petitioner’s own policy,” the ALJ found, “put residents of the facility at risk for serious harm resulting from consumption of food borne pathogens.”  Id.

Petitioner timely requested Board review.

Standard of Review

The Board reviews whether summary judgment is appropriate de novo.  Southpark Meadows Nursing & Rehab. Ctr., DAB No. 2703, at 5 (2016).  Summary judgment is appropriate when there is no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law.  Pearsall Nursing & Rehab. Ctr. - North, DAB No. 2692, at 5 (2016).  The “substantive law will identify which facts are material” and “[o]nly disputes over facts that might affect the outcome of the [case] under the governing law will properly preclude the entry of summary judgment.”  Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).

“To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact – a fact that, if proven, would affect the outcome of the case under governing law.”  Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300, at 3 (2010), aff’d, 405 F. App’x 820 (5th Cir. 2010).  “A party must do more than show that there is some metaphysical doubt as to the material facts.  Where the record taken as a whole could not lead a rational trier of fact to find for the non[-]moving party, there is no genuine issue for trial.’”  The Harborage, DAB No. 2905, at 5 (2018) (internal quotation marks and ellipses omitted).

In evaluating a party’s motion for summary judgment, we view the record in the light most favorable to the non‑moving party (Petitioner) and give that party the benefit of all reasonable inferences.  Pearsall, DAB No. 2692, at 5; Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); United States v. Diebold, Inc., 369 U.S. 654, 655 (1962); see also Heritage House of Marshall Health & Rehab., DAB No. 3035, at 8 (2021) (“we view the evidence in the light most favorable to the non-moving party and draw all reasonable inferences in that party’s favor”).  However, we are not required to draw unreasonable inferences or accept the non-moving party’s legal conclusions.  Brightview Care Ctr., DAB No. 2132, at 10 (2007).  Inferences based on speculation are not reasonable.  Dumas Nursing & Rehab., L.P., DAB No. 2347, at 18 (2010).

The Board’s standard of review on a disputed conclusion of law is whether the ALJ’s decision is erroneous.  Guidelines -- Appellate Review of Decisions of Administrative

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Law Judges Affecting a Provider’s Participation in the Medicare and Medicaid Programs (Guidelines), “Completion of the Review Process,” ¶ (c).7

Analysis

Petitioner contends that its “facility was, at all relevant times, in substantial compliance with the cited regulations, that the citation at an immediate jeopardy level was clearly erroneous, and that the imposed CMP was not reasonable.”  RR at cover page.  For the reasons set forth below, we conclude that undisputed material facts establish that Petitioner was not in substantial compliance with 42 C.F.R. § 483.60(i)(2) and that the ALJ did not err in granting summary judgment for CMS.  We also conclude that the amount of the CMP imposed against Petitioner is reasonable.  We therefore affirm the ALJ Decision.

A.    Undisputed material facts establish that Petitioner was not in substantial compliance with 42 C.F.R. § 483.60(i)(2) (Tag F812).

Section 483.60(i)(2) requires that a nursing facility “[s]tore, prepare, distribute, and serve food in accordance with professional standards for food service safety” (emphasis added). Neither party disputes that the referenced professional standards are the identical instructions for cooling cooked food in the FDA Food Code, the CMS SOM, and Petitioner’s policy for cooling potentially hazardous cooked foods, which cites the FDA and CMS publications.  CMS Ex. 11, at 1 (facility policy); ALJ Decision at 3 (“Petitioner’s policy for cooling potentially hazardous cooked food is identical to that stated by the [FDA] and CMS.”).8  “As is required by these authorities,” the ALJ observed, “Petitioner’s policy requires that cooked food be cooled from 135 to 70 degrees Fahrenheit within two hours and to 41 degrees Fahrenheit within six hours,” i.e., four hours after the first measurement.  ALJ Decision at 3; CMS Ex. 11, at 1; CMS Ex. 14, at 24 (2017 FDA Food Code); SOM, App’x PP, § F812 (Rev. 173, eff. Nov. 28, 2017) at 562.  Petitioner’s policy additionally requires that the temperature of the cooling food be measured at specified intervals to verify compliance with the cooling procedure and that “[t]ime and temperature are recorded on labels affixed to the pan and/or on a Two-Step Cool-Down Temperature Monitoring Log.”  CMS Ex. 11, at 1; see ALJ Decision at 3 (“Petitioner’s policy requires its staff to record in a log measured temperatures and the times when those temperatures were measured.”).

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All three food cooling policies (facility, FDA, and CMS) include methods to cool cooked foods to permissible temperatures within the required time period, such as cutting food into smaller portions, and ice water baths.  CMS Ex. 11, at 1; CMS Ex. 14, at 24-25; see ALJ Decision at 6 (citing facility’s “protocols and procedures in order to assure that the roast beef would be cooled to an acceptable temperature within the requisite period of time.”)

The FDA Food Guide identifies “Improper holding temperatures” as of one of the “major risk factors related to employee behaviors and preparation practice” that “contribut[e] to foodborne illness,” and cautions that “[f]or some, especially preschool age children, older adults in health care facilities, and those with impaired immune systems, foodborne illness is more serious and may be life threatening.”  CMS Ex. 14, at 7-8 (emphasis added).  The SOM identifies a “Danger Zone” of “temperatures above 41 degrees Fahrenheit (F) and below 135 degrees F that allow the rapid growth of pathogenic microorganisms that can cause foodborne illness” and that “may cause a foodborne illness outbreak if consumed” after being “held in the danger zone for more than . . . 6 hours (if cooked and cooled).”  SOM App’x PP § F812 (Rev. 173, eff. Nov. 28, 2017) at 555.  The Illinois Department of Public Health similarly identifies a “temperature danger zone” of 41-135 degrees Fahrenheit through which foods must be cooled “rapidly.”  CMS Ex. 15, at 1.

Petitioner does not dispute that on the morning of February 6, 2018 “[b]oth thermometers [surveyor’s and facility’s] recorded an internal temperature of 66 degrees Fahrenheit” in the measured roast, “about 15 hours after the roasts were removed from the oven” and that facility staff thus “did not follow recognized procedures and Petitioner’s policy for cooling cooked potentially hazardous substances, including cooked meat,” as the ALJ found.  ALJ Decision at 4.  Petitioner also does not dispute the surveyor’s testimony that the evening cook reported using no rapid cooling measures to cool the roasts pursuant to Petitioner’s policy and that the day cook reported not having followed Petitioner’s procedures for recording the measured temperatures of the roasts, as stated in the SOD.9  Id.; see also at 8 (Petitioner “had the opportunity to offer temperature logs, if they existed, in order to refute the evidence of noncompliance.  It did not.”).  Petitioner also does not challenge the ALJ’s description of this information as “undisputed facts.”  ALJ Decision at 4.  Indeed, Petitioner as noted concedes it “cannot show or present evidence that it followed the cool down procedure for roast beef.”  P. Reply at 5; see RR at 4-5 (facility “cannot opine as to why staff answered the surveyor’s questions as they did” and “cannot control the actions and words of each and every staff member”).  Petitioner also does not dispute that all six roasts had been cooked and refrigerated together the day

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before the survey.10  Finally, Petitioner does not dispute that, as the ALJ observed, improperly cooked meat “may serve as a medium for the growth of pathogens” the consumption of which “may result in serious illness” and that “the residents of Petitioner's facility - frail, elderly, sick - are at much greater risk from the adverse effects of food borne pathogens than is the general population.”  ALJ Decision at 5.

A similar case involving a food preparation deficiency for staff failure to apply or understand the same requirements for cooling cooked meat (cooling to 41 degrees Fahrenheit in six hours or less) supports the noncompliance finding here.  In Blossom South Nursing and Rehabilitation Center, DAB No. 2578 (2014), the surveyor’s and the facility’s thermometers showed temperatures of two roasts in the “danger zone” of 41 to 135 degrees Fahrenheit some 21 hours after they had been cooked and placed in a refrigerator, contrary to the facility’s cooling procedures and guidelines.11  Blossom South at 23.  As here, the facility “had policies for cooling hot foods, and [it] did not follow those policies for two roasts cooked” during the survey and a cook the surveyor interviewed “did not understand the procedures for cooling hot foods set out in [the facility’s] policies.” Id. at 23-24 (quoting ALJ’s decision, internal quote marks removed).  Also as here, the facility “d[id] not dispute that the roast was not properly cooled” or “that food that is not properly cooled can cause foodborne illnesses” and “endangers resident health and safety,” which, the Board concluded, “posed a potential for more than minimal harm.” Id. at 24.

Here there is similarly no dispute that the facility did not follow its policy and procedure for cooling the potentially hazardous cooked food seen during the survey as required by the regulation, and that staff reported not being aware of or not applying facility policy and procedure, which posed a potential for more than minimal harm.  There was thus no error in the ALJ’s determination that undisputed facts “establish failure by Petitioner’s staff to comply with Petitioner’s policy, recognized standards, and regulatory requirements.”  ALJ Decision at 3.  Thus, as in Blossom South, “we uphold the ALJ’s conclusion that [Petitioner] was not in substantial compliance with” the food preparation safety regulation now at 42 C.F.R. § 483.60(i)(2).  Blossom South at 25.

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B.    Petitioner’s arguments provide no basis to reverse the ALJ Decision or conclude Petitioner was in substantial compliance with section 483.60(i)(2).  

Petitioner argues “it was and remains in substantial compliance with this regulation” – section 483.60(i)(2) – “at all times”; that the ALJ erred for having not “viewed [the record] in the light most favorable to the non-moving party”; and that “upon review of all facts in the record, construed in the light most favorable to the non moving party, it becomes obvious that the decision to grant [summary judgment] is clearly erroneous and cannot stand.”  P. Reply at 1-2; RR at cover page, 1-2.

Petitioner primarily maintains that “[e]ven if the surveyor had not been present, [the corporate dietician] would have prevented the beef from ever being served” and that Petitioner’s various systems and staff training would prevent service of improperly prepared food.  P. Reply at 4.  More specifically, Petitioner asserts 1) the corporate dietician ordered the meat discarded after observing the lack of the required cooling logs and questioning the cooks, and not because of the surveyor’s measurement of the roast’s temperature; 2) the corporate dietician’s presence in the kitchen during the survey was not “fortuitous” as the ALJ stated (ALJ Decision at 5) but was “carefully planned to ensure that kitchen staff followed procedure,” 3) the facility’s staff were trained and credentialed in the food safety procedures and 4) its “new ownership . . . had systems in place” and “consultation agreements with various experts and vendors  . . . designed to prevent human error” that “catch mistakes” and provide residents “with warm, nutritious and above all, safe meals, made to industry and facility standards.”  RR at 3-5; P. Reply at 4-7; P. Ex. 1 at ¶¶ 44-47 (corporate dietician’s testimony that her recommendation to discard the roast beef “was not based on the temperature reading conducted by the surveyor” but on staff’s inability to provide “documentation of the two step cool down procedure”).

Petitioner’s arguments identify no material facts the ALJ failed to view in its favor, misstate the basis for the ALJ’s noncompliance finding, and demand inferences that the record does not reasonably support and that the ALJ and the Board are not required to draw in considering CMS’s motion for summary judgment.

1. The ALJ viewed material facts in Petitioner’s favor.

The ALJ did view in Petitioner’s favor the evidence regarding the actions and vigilance of the corporate dietician.  The ALJ “accept[ed the dietician]’s assertions . . . that she would have noticed that the meat had not been properly cooled without the surveyor’s intervention and would have ordered that the meat be discarded before it was served to Petitioner’s residents” and did “infer, if only for purposes of deciding the motion, that she would have interdicted the service of roast beef on February 6 even without the presence of CMS’s surveyor.”  ALJ Decision at 5.  The ALJ found those inferences did not undermine the deficiency finding because the dietician “was only an intermittent visitor

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to Petitioner’s facility” who “was not there every shift on every day” and whose “intervention on February 6 was fortuitous,” and because the two cooks reported being either unaware of the facility’s policy and procedures for cooling potentially hazardous cooked food, or aware of their existence but not following them in preparing the roast seen in the kitchen during the survey.  Id., see RR at 4 (admission that “staff answered the surveyor’s questions as they did).”

The ALJ did not err.  While insisting that the corporate dietician’s intervention “was not
fortuitous,” Petitioner does not dispute the related finding that she was an intermittent visitor who was not there daily.  RR at 3 (internal quotation marks removed).  Petitioner alleges only that she “audited” staff “at regular intervals,” while the dietician testified that she “spent a significant amount of time at the Facility” without specifying the duration, frequency, or regularity of the visits.  P. Reply at 5; P. Ex. 1 at ¶ 14.  The ALJ thus had no basis to infer that the dietician would have been present, or had been present, when staff could have failed on other occasions to follow the facility’s policy and procedures for cooling potentially hazardous cooked food as during the survey.

The ALJ also did not resolve disputed material facts or draw impermissible inferences as to staff training and awareness of facility policy.  The ALJ noted Petitioner’s representations about training and staff credentials and did not find or infer that the facility did not train staff.  The ALJ instead found only that the evening cook did not recall being trained, as she told the surveyor, and that staff “was unaware of the need to follow prescribed procedures to rapidly cool cooked meat” or “of Petitioner’s own policy directing that potentially hazardous food, including cooked meat, be cooled rapidly.”  ALJ Decision at 4, 6.  The ALJ thus found that the “undisputed facts” about the dietician’s visits and staff’s failure to follow facility policy “lead inescapably to the conclusion that Petitioner’s cooks were preparing and serving potentially hazardous food without regard to established protocol and Petitioner’s policy and that these actions were occurring on days when [the corporate dietician] was not present at the facility.”  Id. at 5‑6.  As Petitioner has not challenged the accuracy of the SOD’s and the surveyor’s accounts of the interviews with the two cooks, the ALJ correctly described this information as undisputed.  Id. at 3, 4.  In any event, to infer as Petitioner demands that staff were trained in and aware of Petitioner’s policy and procedure for cooling potentially hazardous cooked food would provide no basis to overlook their negligent or willful failure to follow that policy, as would be required to find Petitioner in substantial compliance.  See ALJ Decision at 6 (“undisputed facts show that . . . Petitioner’s cooks . . . were certainly not following” Petitioner’s policy).

Further, Petitioner’s purported records of in-service training on cooling potentially hazardous cooked foods often appear to be from other facilities or concern other issues.  See CMS Ex. 13, at 22, 24-25, 28 (Symphony of Decatur facility), 23 (Aspen Ridge Care Centre facility), 26-27 (cleaning schedules, attire, and thickened liquids), and 36 (proper

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handwashing procedures, unknown location).12  To the extent the ALJ accepted Petitioner’s claims about staff training, he was not required to do so.  See, e.g., Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300, at 3 (2010), aff’d, 405 F. App’x 820 (5th Cir. 2010) (“[T]he nonmoving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact”), The Harborage, DAB No. 2905, at 5 (2018) (internal quotation marks and ellipses omitted) (“A party must do more than show that there is some metaphysical doubt as to the material facts.”).

Petitioner’s assertions that it “cannot control the actions and words of each and every staff member, but it can control its actions and its response to staff actions,” are unavailing.  RR at 5.  To the extent that Petitioner attempts to distance itself from responsibility for the acts or omissions of its staff who failed to follow the relevant food safety standards, the Board has generally rejected this type of argument.  See, e.g., Madison County Nursing Home, DAB No. 2895, at 8-9 (2018) (explaining that a SNF “acts through its staff and administrators” and cannot dissociate itself from the consequences of its employees’ actions); Kindred Transitional Care and Rehab - Greenfield, DAB No. 2792, at 14 (2017) (explaining that a SNF “is properly held responsible” for employee misfeasance “by virtue of the obligations it assumes as a condition for receiving federal healthcare program monies”); Morris View Healthcare Ctr., DAB No. 3149, at 12 (2024) (quoting Cherrywood Nursing & Living Ctr., DAB No. 1845, at 10 (2002) (“The Board has consistently held that a facility cannot disavow responsibility for the actions of its employees.”)).

It is also not material whether the meat in question was served to a resident.  P. Reply at 6 (arguing that “[t]here was no serious violation of the regulation”).  The ALJ rejected the “no harm, no foul” argument “that there can be no deficiency, or at least not a serious deficiency, if noncompliant conduct fails to harm a resident.”  ALJ Decision at 7; see also id. (Petitioner’s argument “addresses the more basic question of whether Petitioner’s noncompliance put residents at risk for harm”); 42 C.F.R. §§ 488.430 (authorizing CMPs when a facility is “not in substantial compliance” with one or more participation requirements”); 488.301 (defining “substantial compliance” as a level of compliance such that any identified deficiencies pose no greater risk to resident health or safety than “the potential for causing minimal harm”) .

Again, the ALJ did not err, as “[t]here is no way of knowing whether other meals on other dates included improperly cooled meat,” based on the presence during the survey of “improperly cooled meat” in the kitchen “prepared for service” and staff’s undisputed admissions that they “did not comprehend the need to cool cooked meat properly” (evening cook) and were “not following Petitioner’s policy for cooling cooked meat” (day cook) “nor . . . keeping a temperature log of cooling meat.”  ALJ Decision at 7-8.

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Compliance with section 483.60(i)(2) does not turn on whether the facility served the improperly prepared roast beef that was undeniably in the time-and-temperature “danger zone” that allows the rapid growth of pathogenic microorganisms that can cause foodborne illness if consumed (although serving the potentially tainted meat would also constitute noncompliance).  As we observed in Blossom South, “it is irrelevant that the roasts were not served or whether they would have been served absent the surveyor’s intervention,” as the possibility “that food might have been served without having been properly cooled . . . posed a potential for more than minimal harm since it is undisputed that food that is not properly cooled can cause foodborne illnesses.”  Blossom South at 24.

As to potential for causing more than minimal harm, Petitioner does not claim its systems, training, and corporate dietician’s intermittent presence foreclosed the possibility of past or future lapses in implementing facility policy and procedures for preparing potentially hazardous food.  In any case, the requirement on summary judgment to “view the evidence in the light most favorable to the non-moving party and draw all reasonable inferences in that party’s favor,” Heritage House at 8, does not oblige an ALJ, or the Board in its de novo review, to infer hypothetical, alternate versions of the events of February 6, 2018 or speculative predictions about future actions.  “In the summary judgment context, we are obligated to draw only ‘reasonable’ inferences from the record, and inferences based on speculation are not reasonable.”  Oak Ridge Ctr., DAB No. 2913, at 22 (2018); see also Dumas Nursing & Rehab., L.P., DAB No. 2347, at 18 (2010) (“Inferences based upon speculation are not reasonable.”); accord Sylvie Wamba, DAB No. 3068, at 6 (2022).  Here, the undisputed facts (the improper preparation of roast beef in violation of Petitioner’s policy and procedure, and staff’s failure to understand or apply the facility’s policy and procedure) raise a more than theoretical possibility that on other occasions “Petitioner’s cooks were preparing and serving potentially hazardous food without regard to established protocol,” and might do so again.  ALJ Decision at 6.

Finally, the ALJ’s opinion that the corporate dietician’s presence and intervention during the survey was “fortuitous” does not concern a factual dispute requiring resolution.  Given that one definition and synonym of “fortuitous” is “fortunate,” and that the corporate dietician was not present at the facility on a daily or other regular schedule, her intervention was indeed fortuitous for the facility’s residents who were spared the possible adverse effects of consuming potentially tainted meat.  Fortuitous, Merriam-Webster.com Dictionary (Merriam-Webster, n.d.), https://www.merriam-webster.com/dictionary/fortuitous (last visited Oct. 20, 2025).

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2. Petitioner’s arguments do not address the basis for the noncompliance determination.

Petitioner’s arguments also do not address, and sometimes misstate, the specific basis of CMS’s and the ALJ’s determinations that it was not in substantial compliance with the food preparation requirements of 42 C.F.R. § 483.60(i)(2).  Petitioner asserts it complied with that regulation when Petitioner “instituted a systematic approach to its food preparation to ensure that it eliminated as much potential risk for human error as possible” because “[t]he regulations require that facilities must have systems and procedures in place to minimize risk, helping to eliminate the human factor in providing care.”  P. Reply at 2 (emphases removed), 5.  That description of section 483.60(i)(2) is not correct, and Petitioner did not identify another regulation containing such requirements.  Paragraph (i)(2) of section 483.60, unlike some other provisions of that regulation, does not address training, staffing, or systems to ensure food safety.  Cf., e.g., § 483.60(a)(1), (2) (requiring a full-time “qualified dietician or other clinically qualified nutrition professional” or a part-time dietician or other clinically qualified nutrition professional and a “director of food and nutrition services”).

As relevant here, paragraph (i)(2) of the regulation requires only that the facility “prepare” food “in accordance with professional standards for food service safety.”  The presence in Petitioner’s kitchen of the roast that unquestionably was not prepared in accordance with Petitioner’s policy and procedures for cooling potentially hazardous cooked food (and five other roasts of the same provenance), along with the undisputed threat of serious illness posed by improperly prepared meat, establish Petitioner’s noncompliance with the regulation.  The factual inferences Petitioner seeks concerning the facility’s systems and staff training are not material to whether Petitioner complied with the regulation.  The ALJ thus correctly observed that Petitioner’s assertions “that its facility had recently undergone a change of ownership and . . . about how the facility’s new management endeavored to improve conditions at the facility . . . do not address the specific issues raised in this case.”  ALJ Decision at 9.  Moreover, as the ALJ further found, the relevance of the facility’s “‘new systems’ is belied by the ignorance of any systems manifested by Petitioner’s staff” – i.e., the evening cook – on February 6, 2018.  Id.

Petitioner also establishes no error by stating “the ALJ contends that staff were unaware of the proper cooling procedure, and thus, the Facility was deficient at this section,” i.e., 42 C.F.R. § 483.60(i)(2).  RR at 4.  The basis for the ALJ’s noncompliance conclusion was not simply a cook’s admitted unawareness of facility policy and procedures for cooling potentially hazardous food, but the failure by both cooks to apply those procedures in preparing the meat seen during the survey awaiting service to residents.  Petitioner also argues, “CMS . . . assumes that the staff never followed the procedure related to meat cooling” but “did not present any evidence to support that conclusion.”  P. Reply at 5.  However, CMS did not allege, nor did the ALJ find, that staff never followed

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the procedure for cooling cooked meat, only that they did not do so in preparing roast beef for lunch on February 6, 2018, as Petitioner does not dispute.  These arguments do not suggest error in the ALJ’s determination that undisputed facts establish Petitioner’s noncompliance with the regulation.

We thus conclude that a rational trier of fact, viewing the record in the light most favorable to Petitioner and drawing all reasonable inferences in its favor, could not find that Petitioner was in substantial compliance with section 483.60(i)(2).

C.    The amount of the CMP is reasonable.

“The determination of whether a CMP amount is reasonable is a conclusion of law, not a finding of fact, so also is subject to de novo review.”  Rehab at River’s Edge, DAB No. 3163, at 10 (2024) (quoting Cedar Lake Nursing Home, DAB No. 2344, at 12 (2010), quotation marks omitted).  In deciding whether a CMP is reasonable, ALJs and the Board may consider only the factors specified in section 488.438(f).  42 C.F.R. § 488.438(e)(3); North Las Vegas at 16.  Those factors are:  (1) the SNF’s history of noncompliance; (2) the SNF’s financial condition – that is, its ability to pay the CMP; (3) factors specified in 42 C.F.R. § 488.404 (chiefly the “seriousness” of the noncompliance); and (4) the SNF’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort or safety.  42 C.F.R. § 488.438(f).  Although the Board and the ALJ review the CMP amount de novo, the CMP amount CMS selects “is presumptively reasonable based on those regulatory factors.”  North Las Vegas at 16.  The burden is on the facility to show “through argument and the submission of evidence addressing the regulatory factors, that a reduction [in the penalty amount] is necessary to make the CMP amount reasonable.” Id.; Good Shepherd Home for the Aged, Inc., DAB No. 2858, at 23 (2018).

CMS imposed a per-instance CMP of $18,500, in the upper range of the available amounts ($2,097 to $20,965).  CMS Ex. 1, at 2; see 42 C.F.R. §§ 488.408(d)(1)(iv), (e)(1)(iv), 488.438(a)(2); 45 C.F.R. § 102.3 (2017); 82 Fed. Reg. 9,174, 9,182-183 (Feb. 3, 2017).  CMS argued that the CMP was reasonable based on Petitioner’s past general noncompliance, including “twenty-three deficiencies at a scope/severity level of D or above during standard surveys and complaint investigations since July 2015.”  CMS ALJ Br. at 18.  CMS argued as well that the penalty was reasonable because it would not cause hardship to Petitioner or put Petitioner out of business.  Id.  Additionally, CMS noted that the seriousness of the cited deficiency at the immediate-jeopardy level “resulted in the entire facility’s residents nearly being served potentially dangerous, toxic meat.”  Id. at 19.  CMS argued that these factors support a per‑instance CMP on the upper end of the penalty range for per-instance CMPs.  Id. at 20.

Petitioner argues that the CMP is not reasonable because it had “procedures in place to mitigate the risk of human error that worked,” and the violation of the regulation was not serious.  P. Reply at 6.  Petitioner also argues that its prior regulatory history should not

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“add to its culpability” because its ownership changed in the month prior to the citation.  Id.  Petitioner claims that as part of its new ownership review process, it provided “re‑education and re-training for staff.”  Id.

We disagree.  Even accepting for purposes of summary judgment that Petitioner had no recent relevant history of noncompliance, the seriousness of the noncompliance at issue here “alone justifies the imposition of the maximum penalty amount in the per-instance CMP range.”  Madison County at 19.  The regulatory violation here resulted in “the potential for food borne illness to all 149 residents” whose age and conditions put them “at much greater risk from the adverse effects of food borne pathogens than is the general population.”  ALJ Decision at 5; CMS Ex. 4, at 27 (SOD finding that facility was “preparing to serve unsafe food without recognizing the potential for food borne illness to all 149 residents”).  Petitioner also is culpable for creating that risk, despite Petitioner’s claims that its staff training and food safety policies made the facility’s admittedly improper preparation of potentially hazardous food unlikely to have occurred previously or be repeated. However effective the alleged training and policies might have been on other past and future occasions, they undisputedly failed to prevent the improper preparation of food and serious resulting risk to residents in this instance.

Petitioner has thus not identified a genuine dispute of material fact relating to any of the regulatory factors or demonstrated that a reduction of the $18,500 per-instance CMP is warranted.  Accordingly, we conclude that per-instance $18,500 penalty CMS imposed is reasonable.

Lastly, while Petitioner argued that citation of the deficiency at the immediate-jeopardy level was clearly erroneous, Petitioner did not allege any error in the ALJ’s correct observation that a finding of immediate jeopardy is not a necessary element of the determination of a per-instance CMP (vs. a per-day CMP).  See RR at cover page, 2; ALJ Decision at 2-3 (“I may evaluate seriousness without determining whether noncompliance meets the specific criteria that define immediate jeopardy.  For that reason, it is unnecessary that I decide whether Petitioner’s noncompliance rises to the immediate jeopardy level.”).  An ALJ may review CMS’s determination of the level of noncompliance “only if a successful challenge . . . would affect:  (1) the range of [CMP] amounts that [CMS] could collect . . . or (2) a finding of substandard quality of care that results in the loss of approval” of a facility’s nurse aide training program.  42 C.F.R. § 498.3(b)(14), (d)(10)(i)-(ii); accord Madison County at 16.  CMS imposed a per-instance CMP against Petitioner, and the regulations provide for a single range of CMP amounts when imposed on a per-instance basis (as opposed to a per-day CMP).  42 C.F.R. §§ 488.438(a)(2), 488.845(b)(6); accord Shiloh First Health Care, Inc., DAB No. 2974, at 8 (2019); White Sulphur Springs Center, DAB No. 2520, at 17 (2013).  Because review of the immediate-jeopardy level would not affect the applicable per-instance CMP range, Petitioner may not challenge, and the ALJ may not decide, whether CMS’s

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determination of immediate jeopardy is correct.  Shiloh at 8; see also White Sulphur Springs at 17-18. 

Conclusion

For the reasons set forth above, we affirm the ALJ Decision.