Asistencia Villa Rehabilitation and Care Center, DAB CR6366 (2023)

DECISION

Petitioner, Asistencia Villa Rehabilitation and Care Center, is a skilled nursing facility (SNF) located in Redlands, California, certified by and participating in the Medicare and Medicaid programs.  Based on a survey completed on August 12, 2019, Respondent, the Centers for Medicare & Medicaid Services (CMS), determined Petitioner was not in substantial compliance with Medicare participation requirements.  As a result of its determination, CMS imposed a $15,310 per-instance civil money penalty (CMP) against Petitioner.  As explained herein, I grant CMS’s motion for summary judgment, affirm CMS’s imposition of penalties, and find the CMP selected by CMS reasonable.

I.    Background

The California Department of Public Health (CDPH or state survey agency) conducted a recertification survey at Petitioner’s facility from August 5 to August 12, 2019.  The results of that survey led CMS to find Petitioner substantially noncompliant with Tag F812¹  (42 C.F.R. § 483.60 – food safety requirements) at the “K” scope/severity level.

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CMS Ex. 1 at 82-90.²  CDPH found the immediate jeopardy condition cited under Tag F812 began on August 3, 2019 and abated on August 7, 2019.  CMS Ex. 1 at 84; CMS Ex. 2 at 1.

On January 7, 2020, CMS imposed a per-instance penalty of $15,310 against Petitioner for the noncompliance identified under Tag F812 at the August 2019 survey.  CMS Ex. 2 at 1-2.  CMS adopted CDPH’s finding that immediate jeopardy abated on August 7, 2019.  Id. at 1.  In addition to the $15,310 penalty, CMS warned Petitioner of other remedies it could impose, including denial of payment for new admissions starting November 8, 2019, withdrawal of its approval for Petitioner’s nurse aide training and competency evaluation program (NATCEP), and termination of Petitioner’s provider agreement by February 8, 2020.  Id. at 1-5.  After a follow-up survey, CDPH determined Petitioner returned to substantial compliance as of October 3, 2019.  CMS notified Petitioner it would no longer impose a denial of payment for new admissions or terminate its provider agreement.  Id. at 2.

On March 6, 2020, Petitioner timely challenged CMS’s action by filing a request for hearing before an Administrative Law Judge in the Civil Remedies Division.  I was designated to hear and decide this case.  On March 9, 2020, I issued an Acknowledgment and Pre-hearing Order (APHO) that set forth deadlines for the parties to file pre-hearing submissions, including briefs, exhibits, witnesses, and direct testimony for any proposed witnesses.  APHO at ¶¶ 5-10.

On April 22, 2020, CMS filed a partial motion to dismiss.  On April 23, 2020, the parties jointly sought to stay the filing deadlines pending a ruling on CMS’s partial motion to dismiss, which I granted.  On May 22, 2020, Petitioner filed a response opposing CMS’s partial motion to dismiss.  On February 3, 2021, I granted CMS’s partial motion to dismiss and issued a new Standing Pre-hearing Order that set forth deadlines for the parties to file pre-hearing submissions including briefs, exhibits, witnesses, and the direct testimony of any proposed witnesses.  Standing Pre-hearing Order at ¶¶ 5-12.

On April 5, 2021, CMS filed a combined pre-hearing brief and motion for summary judgment (CMS Br.).  On June 3, 2021, Petitioner filed a combined pre-hearing brief and

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response in opposition to CMS’s motion for summary judgment (P. Br.).  On June 17, 2021, CMS filed objections to Petitioner’s proposed exhibits.

II.    Admission of Exhibits

CMS filed 13 proposed exhibits (CMS Exs. 1-13) with its combined pre-hearing brief and motion for summary judgment.  Absent objection from Petitioner, I admit CMS Exhibits 1 through 13 into the record.

Petitioner filed two proposed exhibits (P. Exs. 1-2) with its combined pre-hearing brief and response to CMS’s summary judgment motion.  CMS objected to Petitioner’s Exhibit 1, the declaration of Petitioner’s proposed expert witness, asserting it misstated facts in the record, relied on unidentified and undisclosed sources, cited to outdated and irrelevant standards, set forth facts of which the witness had no direct knowledge, and assumed facts not in evidence.  CMS also objected to Petitioner’s Exhibit 2, a “Refrigerator/Freezer Temperature Log” from August 2019, as irrelevant because it pertains to a different period of time than that at issue here.  Because CMS’s objections go to the weight I should accord these exhibits and not their admissibility, I overrule CMS’s objections and admit Petitioner’s Exhibits 1 and 2 into the record.

III.    Issues

A.    Whether summary judgment is appropriate;

B.    Whether Petitioner was in substantial compliance with Medicare participation requirements at 42 C.F.R. § 483.60 (Tag F812) at the time of the August 2019 survey;

C.    If Petitioner was not in substantial compliance, whether CMS’s immediate jeopardy determination was clearly erroneous; and

D.    If Petitioner was not in substantial compliance, whether the CMP imposed by CMS is reasonable.

IV.    Jurisdiction

I have jurisdiction to hear and decide this case.  Social Security Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

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V.    Discussion

A.    Applicable Legal Authority

1.    Evidentiary standards for deficiencies

The Act sets requirements for SNFs like Petitioner to participate in the Medicare program.  The Secretary of the U.S. Department of Health and Human Services (Secretary) is authorized to promulgate regulations implementing those statutory provisions.  Act § 1819 (42 U.S.C. § 1395i-3).  These regulations are found at 42 C.F.R. pts. 483 and 488.

A SNF must maintain substantial compliance with program requirements to participate as a provider in the program.  To be in substantial compliance, a facility’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements.  Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. § 488.10.  The Act also authorizes the Secretary to impose enforcement remedies against SNFs that do not comply with the participation requirements.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)).  The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance.  42 C.F.R. § 488.406.  Among other enforcement remedies, CMS may impose a per-day CMP for the number of days a facility is out of substantial compliance or a per-instance CMP for each instance of noncompliance.  42 C.F.R. § 488.430(a).

Relevant here, a per-instance CMP initially ranged from $1,000 to $10,000.  42 C.F.R. § 488.438(a)(2).  However, CMS increased CMP amounts to account for inflation beginning August 1, 2016.  Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Pub. L. No. 114-74, 129 Stat. 584, 599; see also 42 C.F.R. § 102.3.  The adjusted CMP amounts apply to deficiencies cited after November 2, 2015, thus subjecting Petitioner’s alleged deficiencies to the increased CMP amounts.  81 Fed. Reg. 61,538 (Sep. 6, 2016).  In 2020, when CMS imposed the CMP at issue here, a per-instance CMP could range from $2,233 to $22,320.  86 Fed. Reg. 62,938 (Nov. 15, 2021).

If CMS imposes a CMP against a facility based on a noncompliance determination, the facility may request a hearing before an ALJ to determine whether there was a basis for the deficiency findings that led to the imposition of the remedy and whether the CMP imposed was reasonable.  Act §§ 1128A(c)(2) (42 C.F.R. § 1320a-7a(c)(2)), 1819(h)(2)(B)(ii) (42 C.F.R. § 1395i(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g),

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488.434(a)(2)(viii), 498.3(b)(13).  However, CMS’s choice of remedies and the factors it considered when deciding upon remedies are not subject to review.  42 C.F.R. § 488.408(g)(2).

2.    Burdens of proof and persuasion

Neither the Act nor its implementing regulations allocate the burden of proof or the quantum of evidence necessary to meet that burden.  In the context of a regulatory enforcement action, it would be reasonable to require the enforcing agency to establish by proof and persuasion that it was justified to impose penalties under the Act and its regulations.  Nevertheless, the Departmental Appeals Board has imposed a burden-shifting regime in cases involving the imposition of enforcement penalties against providers whose appeals are adjudicated under 42 C.F.R. Part 498.  Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); VITAS Healthcare Corp. of Calif., DAB No. 1782 at 4 (2001); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

Under that regime, CMS has the burden to come forward with evidence sufficient to make a prima facie showing³ it had a basis for the imposition of a penalty.  In Hillman, the Board identified the elements it believed necessary for CMS to make such a showing:

[CMS] must identify the legal criteria to which it seeks to hold a provider.  Moreover, to the extent that a provider challenges [CMS’s] findings, [CMS] must come forward with evidence of the basis for its determination, including the factual findings on which [CMS] is relying and, if [CMS] has determined that a condition of participation was not met, [CMS’s] evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

DAB No. 1611 at 8.

Once CMS makes a prima facie showing of noncompliance, Petitioner bears the burden of persuasion and must prove by a preponderance of the evidence of record that it

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substantially complied with statutory and regulatory requirements.  See Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

To date, federal district and circuit courts have declined to disturb this burden-shifting regime on due process or other grounds.  See, e.g., Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff’d, Fairfax Nursing Home v. Dep't of Health & Human Servs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

The U.S. Supreme Court recently examined the scope of the Secretary’s rulemaking authority in the context of Medicare reimbursement and held that under section 1871 of the Act, the Secretary must comply with notice-and-comment rulemaking under the Administrative Procedure Act to impose any requirements upon regulated entities which constituted a change in a substantive legal standard.  Azar v. Allina Health Servs., 588 U.S. __, 139 S. Ct. 1804 (2019) at 1809-14.  It remains to be seen whether federal courts applying the Allina standard in reviewing the Board’s burden-shifting regime will find it constitutes a “change in a substantive legal standard” under the Allina holding or consider it a procedural mechanism within the Board’s delegated authority to impose as a reviewing body of ALJ decisions pertaining to CMS’s regulatory enforcement actions.  Until such judicial scrutiny demands otherwise, and absent modification of the Act or CMS’s implementing regulations, I apply the Board’s burden-shifting regime.

3.    Standard for summary judgment

Summary judgment is appropriate in cases where 42 C.F.R. Part 498 applies if there is no genuine dispute of any material fact and the moving party is entitled to judgment as a matter of law.  Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 750 (6th Cir. 2004); CRDP § 19(a).  A “genuine” dispute exists if “the evidence is such that a reasonable [trier of fact] could return a verdict for the nonmoving party,” (Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)), and a “material” fact is one “that, if proven, would affect the outcome of the case under governing law.”  Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 3 (2010).

To obtain summary judgment, the moving party must show that there is no genuine dispute of material fact requiring an evidentiary hearing and that it is entitled to judgment as a matter of law.  Mission Hosp. Reg’l Med. Ctr., DAB No. 2459 at 5 (2012).  If the moving party meets this initial burden, the non-moving party must “come forward with ‘specific facts showing that there is a genuine issue for trial.’”  Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986).  “To defeat an adequately

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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., DAB No. 2300 at 3.

In evaluating a motion for summary judgment, an ALJ does not address credibility or evaluate the weight of conflicting evidence.  Holy Cross Village at Notre Dame, Inc., DAB No. 2291 at 5 (2009).  Rather, in examining the evidence to determine the appropriateness of summary judgment, an ALJ must draw all reasonable inferences in the light most favorable to the non-moving party.  See Brightview Care Ctr., DAB No. 2132 at 10 (2007) (upholding summary judgment where inferences and views of non-moving party are not reasonable).  “[A]t the summary judgment stage the judge’s function is not . . . to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial.”  Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the nonmoving party’s legal conclusions.  Cedar Lake Nursing Home, DAB No. 2344 at 7 (2010).

B.    Undisputed Facts

The deficiencies cited by CMS stem from observations taken and records reviewed by CDPH during a survey conducted from August 5 through 12, 2019.  Petitioner used a walk-in refrigerator to store perishable and temperature-controlled food items intended for service to residents.  Petitioner’s kitchen staff were required to:  record the temperatures of the refrigerator and freezer upon arrival and before beginning food preparation, and again at the end of the working day; initial the record; and record any action taken if the temperatures were not at the required temperature or within the required temperature range.  CMS Ex. 6 at 1; CMS Ex. 3 at 1-2.  In the event of a refrigerator or a freezer outage, staff members were required to transfer foods to a working unit within four hours of identifying the outage.  CMS Ex. 6 at 2.

CDPH surveyor Lil Antonette Javier, R.N., accompanied by Petitioner’s dietary supervisor, inspected Petitioner’s kitchen on August 5, 2019.  CMS Ex. 11 ¶¶ 3-6; CMS Ex. 9 at 2.  Surveyor Javier observed the walk-in refrigerator thermometer displayed a temperature above 41 degrees Fahrenheit.⁴  CMS Ex. 11 at ¶ 6; CMS Ex. 9 at 2.  The surveyor asked to review Petitioner’s refrigerator temperature log, which confirmed display temperatures for the walk-in refrigerator exceeding 41 degrees the previous two days and in one instance reflected a reading of 50 degrees.  CMS Ex. 11 at ¶ 6; CMS Ex. 3 at 1.  Surveyor Javier declared facility staff informed her the facility’s maintenance

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supervisor and Administrator were made aware the refrigerator was not cooling properly but that it had not yet been repaired. CMS Ex. 11 at ¶ 6;  CMS Ex. 9 at 3.

Surveyor Javier interviewed Petitioner’s cook, who indicated she removed some of the food items stored in the refrigerator based on her belief the refrigerator was malfunctioning.  CMS Ex. 11 at ¶ 7; CMS Ex. 9 at 3.  However, the cook had not checked or removed eggs or milk since becoming aware the refrigerator stopped cooling properly.  Id.  Surveyor Javier measured the temperature of several food items in the refrigerator, which ranged from 44 to 52.6 degrees.  CMS Ex. 11 at ¶ 7; CMS Ex. 9 at 3-4.

Surveyor Javier interviewed other staff members who claimed they had unsuccessfully tried to lower the refrigerator’s temperature by opening the door of the adjoining walk-in freezer.  CMS Ex. 11 at ¶ 8; CMS Ex. 9 at 3.  The surveyor also noted that by the time the survey began, Petitioner had already served breakfast to its residents.  CMS Ex. 11 at ¶ 9.  Surveyor Javier did not observe residents consuming or being served perishable or temperature-controlled food items that came from the walk-in refrigerator but noted the breakfast menu that day offered milk with cereal or as a beverage selection.  CMS Ex. 11 at ¶ 9; CMS Ex. 5.

Petitioner does not dispute the accuracy of its own temperature log.  It otherwise concedes the following facts:

• Petitioner’s maintenance supervisor and Administrator were notified on August 3, 2019 that the walk-in refrigerator was not maintaining a temperature at or below 41 degrees.  P. Ex. 1 at ¶ 10; P. Br. at 4; CMS Ex. 3 at 1.
• A member of Petitioner’s kitchen staff notified a repair technician of the issue on August 3, 2019; the technician did not inspect the refrigerator until August 5, 2019.  P. Ex. 1 at ¶¶ 10-11; P. Br. at 5.
• A member of Petitioner’s kitchen staff opened the freezer door to cool the refrigerator and discarded perishable foods on August 4, 2019, based on the belief that the refrigerator was malfunctioning.  P. Ex. 1 at ¶ 11; P. Br. at 13, 14.
• The facility’s temperature log reflected refrigerator air temperature readings of 45, 46, and 48 degrees, respectively, for August 3 through 5, 2019.  P. Ex. 1 at ¶ 11; CMS Ex. 3 at 1.
• Petitioner’s refrigerator operated out of specification for up to three days.  P. Ex. 1 at ¶ 13; CMS Ex. 3 at 1.

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• There was a risk for a harmful bacterium growth at the refrigerator temperatures at issue here.  P. Ex. 1 at ¶¶ 12, 14; P. Br. at 17.
• Storing shelled eggs above 46 degrees risks a slow growth of salmonella.  P. Ex. 1 at ¶ 14.
• Milk and liquid eggs stored at unsafe temperatures may spoil if unopened in the original packaging.  P. Ex. 1 at ¶ 14.
• Storing egg salad at unsafe temperatures risks the slow growth of listeria.  P. Ex. 1 at ¶ 14.
• Petitioner’s menu for the week of the refrigerator malfunction contained hard boiled eggs, eggs of choice, egg salad, unspecified milk, and milk in cartons.  CMS Ex. 5 at 1-2, 9-11, 16, 19, 20.

C.    Discussion⁵

The applicable regulations in effect at the time of the survey establish the requirements for the procurement, storage, preparation, and service of food provided to facility residents:

(i)  Food safety requirements. The facility must—

(1)  Procure food from sources approved or considered satisfactory by federal, state, or local authorities;

* * * *

(2) Store, prepare, distribute, and serve food in accordance with professional standards for food service safety.

42 C.F.R. § 483.60.

Consistent with this regulation, CMS’s State Operations Manual requires facilities like Petitioner to meet professional standards for food handling practices to prevent the outbreak of foodborne illness, including keeping time and temperature-controlled foods at or within safe temperature ranges.  See CMS SOM, App. PP at 647-48, 652-55, 657, 659.  CMS recognizes both the U.S. Food and Drug Administration’s Food Code and the

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Centers for Disease Control and Prevention’s food safety guidance as national standards for food handling practices.  SOM, App. PP at 648.  The FDA’s Food Code specifies food requiring refrigeration must be kept at 41 degrees or less while unpasteurized eggs can be held up to 45 degrees.  CMS Ex. 13 at 125.  Consistent with these authorities and their obligation to reduce, eliminate, or prevent the possibility of food safety hazards and outbreaks of foodborne illness, regulated facilities must keep refrigerators in good working condition to keep foods at or below 41 degrees.  Id. at 659, 666.

1.    Petitioner failed to substantially comply with 42 C.F.R. § 483.60(i) (Tag F812) by storing food intended for its residents’ consumption in a malfunctioning walk-in refrigerator.

CMS contends Petitioner did not substantially comply with 42 C.F.R. § 483.60(i) by storing food in a malfunctioning walk-in refrigerator and failing to discard all at-risk or affected food items.  CMS Br. at 9-13; CMS Ex. 1 at 82-90.  Petitioner argues summary judgment is inappropriate because CMS misapplied food safety standards and relied on improper hearsay statements and unqualified surveyor testimony.  P. Br. at 9-13.  Petitioner also asserts CMS has not established as an undisputed fact that the facility actually served perishable food stored at unsafe temperatures to its residents.  Id. at 13-16.  Petitioner further claims the testimony of its own expert witness creates a triable issue of fact.  Id. at 16-17.  Finally, Petitioner contends the reasonableness of the penalty imposed by CMS is a triable issue of fact precluding summary judgment.  Id. at 17-18.  As explained below, I reject Petitioner’s arguments and conclude Petitioner did not substantially comply with its regulatory obligation to meet professional food safety standards for the storage, preparation, distribution, and service of food to its residents.

In the first place, summary judgment is appropriate here as there is no genuine dispute between the parties as to the factual basis for the cited deficiency.  42 C.F.R. § 483.60(i)(2) requires Petitioner to meet professional standards for food handling practices.  Both CMS’s guidance and the FDA’s 2017 Food Code specify perishable foods must be kept below 41 degrees.  SOM, App. PP at 648; CMS Ex. 13 at 125.

There is no dispute Petitioner’s walk-in refrigerator did not maintain the necessary temperature for at least three days.  Petitioner’s own staff measured and recorded temperatures in the facility’s log confirming the refrigerator’s temperature measured 45 degrees the morning and evening of August 3, 2019, 46 degrees the morning of August 4, 2019, 50 degrees the evening of August 4, 2019, and 48 degrees the morning of August 5, 2019.  CMS Ex. 3 at 1; P. Ex. 1 at ¶ 11.

Equally, there is no dispute that perishable food contained within the refrigerator and intended for facility residents was not kept at safe temperatures.  Surveyor Javier directly measured several perishable food items contained inside Petitioner’s refrigerator intended for residents’ consumption which ranged from 44 to 52.6 degrees, well within the

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“danger zone” for foodborne illness recognized by the FDA.  CMS Ex. 11 at ¶ 7; CMS Ex. 9 at 3-4 (recording the internal temperatures of a tuna sandwich, lactose-free milk, and milk in a small four-ounce carton); see also CMS Ex. 13 at 125 (describing the time and temperature control requirements for food safety and hot and cold holding, i.e., the “danger zone”).

This undisputed evidence is sufficient for me to conclude Petitioner’s refrigerator was not operating at a temperature sufficient to keep foods cold enough to prevent foodborne illness, as required by CMS and FDA guidance concerning professional food handling standards and thus placing the facility’s residents at risk of foodborne illness.  CMS Ex. 11 at ¶¶ 6-10; CMS Ex. 1 at 83.

Petitioner’s various arguments to forestall summary judgment are without merit.  Petitioner first claims CMS applied the wrong FDA guidance to determine a deficiency.  P. Br. at 9-10 (citing section 3-501.12 of the 2017 FDA Food Code).  Petitioner claims this section, governing “slacking” (gradual thawing) of frozen food, has no bearing on the appropriate temperature for perishable foods contained in its walk-in refrigerator.  Id. at 10.  Petitioner is correct in that regard but makes no effort to explain why it believes CMS premised its deficiency finding on that provision.  In its brief, CMS fails to cite the actual provision of the FDA Food Code upon which it relies but the proposition it pincites in the Food Code can only refer to section 3-501.16, not section 3-501.12, which is found three pages earlier.  CMS Br. at 4; CMS Ex. 13 at 122, 125.  Similarly, in describing the basis for the deficiency finding, the SOD directly quotes from section 3-501.16, “Time/Temperature Control for Safety Food, Hot and Cold Holding.”  Compare, CMS Ex. 1 at 88 (“‘TIME/TEMPERATURE CONTROL FOR SAFETY FOOD . . . shall be held . . . Under refrigeration that maintains the FOOD temperature at [41 degrees] or less . . .’”) with CMS Ex. 13 at 125.⁶  There is simply no reason to conclude, as Petitioner has, that either CDPH or CMS relied on the provision of the FDA Food Code pertaining to slacking of frozen foods here.

Petitioner next claims summary judgment to be inappropriate because it disputes statements from its employees recorded by CDPH during the survey, which it claims to be unreliable hearsay unsupported by underlying documentary evidence.  P. Br. at 11.  First, as I have already discussed, the undisputed documentary evidence, namely Petitioner’s refrigerator temperature log, is sufficient to establish the facts necessary to affirm CMS’s deficiency finding.  CMS Ex. 3.  Food required to be held at 41 degrees or less was not held to such temperatures over a three-day day period between August 3 and August 5, 2019.  Id.  This evidence aside, the examples cited by Petitioner of inconsistent statements recorded by state agency surveyors do not appear inconsistent with the

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temperature log, as Petitioner claims.  P. Br. at 11 (characterizing as inconsistent the surveyor’s observation that Cook 1 did not know how long the refrigerator temperature exceeded 41 degrees before 5:00 a.m. with the fact that Cook 1 checked the refrigerator at 5:00 a.m.).  Petitioner also confusingly claims the surveyor’s observation to be inconsistent with the fact that it properly documented its temperature logs daily.  Id.  Neither of these facts are inconsistent with the statement recorded by the surveyor and allegedly made by Cook 1.  Nor do they undermine the factual basis for the deficiency finding by CMS memorialized in the facility’s temperature log.  Finally, Petitioner does not dispute that its staff acted on the belief that the refrigerator was not cooling properly by opening the freezer door, calling a repair technician, and discarding some perishable food items.  Petitioner’s claim of supposed inconsistencies between statements recorded by the survey team and the documentary evidence of record is without merit.

Petitioner also attacks unidentified opinions and conclusions made by Surveyor Javier, claiming they do not meet the standard for competent expert testimony under the Federal Rules of Evidence and by the U.S. Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).  P. Br. at 12-13.  Whatever the merits of this argument, it is irrelevant.  I have not relied on any opinion or conclusion made by Surveyor Javier to conclude summary judgment is proper here.

Petitioner goes on to assert that a material dispute exists as to whether its walk-in refrigerator reached a temperature of 50 degrees, as it believes CMS contends, or 48 degrees.  P. Br. at 13.  Even if Petitioner fairly characterized CMS’s argument, this is not a material dispute.  Whether it measured 48 or 50 degrees, Petitioner’s refrigerator stored perishable food intended for its residents at unsafe levels that did not meet professional food handling standards.

Petitioner also claims CMS has not established its residents actually received food from the malfunctioning refrigerator.⁷  Id. at 14. This argument is irrelevant.  A deficiency under 42 C.F.R. § 483.60(i)(2) does not arise when incorrectly stored food is served to residents or when residents thereby suffer harm.  CMS need only show a facility did not meet professional standards for food handling practices.  It has done so.

Petitioner next contends summary judgment is precluded by the testimony of its expert witness, Arthur Miller Ph.D., a food safety expert who testified Petitioner’s food service

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was not a direct or immediate threat to its residents.  P. Br. at 16-17, citing P. Ex. 1.  But Dr. Miller does not refute or dispute the temperature measurements of the perishable food items contained in Petitioner’s refrigerator by Surveyor Javier.  Nor does Dr. Miller contest the accuracy of the refrigerator temperature log reflecting measured temperatures above 41 degrees for three days.  P. Ex. 1 at ¶ 11; CMS Ex. 3 at 1.  His opinion does not create a “triable issu[e] of fact” as to the recorded temperatures of the walk-in refrigerator or of the food within it directly measured by Surveyor Javier.

Petitioner otherwise seeks to rely on Dr. Miller’s assertion that its food service did not pose a “present or immediate threat” to its residents as a basis to deny summary judgment.  P. Br. at 16-17.  Dr. Miller opined the temperatures measured here would result in only a minimal risk of harmful bacterium growth and observed CMS did not document actual food spoilage or resulting food-based sickness among facility residents.  Id. 

Petitioner’s reliance on Dr. Miller’s opinion is unavailing.  Even taken to be true, his opinion as to whether the temperatures measured during the period at issue posed a food-based risk to resident health and safety is immaterial.  There is no dispute Petitioner’s walk-in refrigerator did not keep such food intended for service to its residents below 41 degrees.  42 C.F.R. § 483.60(i)(2) required Petitioner to meet professional food handling standards.  CMS identified these standards in its own sub-regulatory guidance and by reference to the FDA Food Code, both of which require certain perishable foods to be kept below 41 degrees.  SOM, App. PP at 648; CMS Ex. 13 at 125.  As such, Dr. Miller’s opinion as to whether it was in fact safe to keep perishable food at higher temperatures than 41 degrees for three days is irrelevant.  Whatever his qualifications, they are inadequate to serve as a basis upon which I could rely to disregard prevailing professional food handling standards.

Petitioner’s assertions that CMS did not demonstrate improperly stored food was actually served to residents and that there was no evidence of actual resident harm are equally irrelevant – a deficiency under 42 C.F.R. § 483.60(i)(2) does not arise when incorrectly stored food is served to residents or when residents suffer harm from it.  CMS need only show a facility did not meet professional standards for food handling practices.  It has done so.  Even accepted as true, Dr. Miller’s opinion has no bearing on the outcome here.

Petitioner has failed to prove a genuine dispute of material fact exists with respect to its regulatory obligation to consistently store perishable foods intended for residents’ consumption at temperatures deemed safe under professional food handling standards.  Its own temperature log confirmed it did not do so.  As a result, I find Petitioner failed to substantially comply with the requirements of 42 C.F.R. § 483.60(i), Tag F812.

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2.    Petitioner was not in substantial compliance because its failure to store, prepare, distribute, and serve food in accordance with professional standards for food service safety posed a risk of more than minimal harm to resident health and safety.

There is no material dispute Petitioner did not substantially comply with its obligation to meet professional food service safety standards during the relevant period.  Nor is there any doubt this noncompliance posed a risk of more than minimal harm to the facility’s residents.  Petitioner stored food in a malfunctioning refrigerator for three days, evidenced by temperature measurements of the refrigerator and the perishable foods stored in that refrigerator.  CMS Ex. 3 at 1.  Regardless of whether Petitioner formally described it as an “outage,” its staff and management knew the refrigerator was not cooling properly based on these measurements and took actions evincing that knowledge, including an attempt to reduce the refrigerator’s temperature by opening the door of the adjoining walk-in freezer, reporting the issue to management, and requesting repair services.  CMS Ex. 3 at 1; CMS Ex. 11 at ¶ 8; CMS Ex. 9 at 3.

Despite the facility’s self-imposed obligation to transfer perishable food to a working refrigerator within four hours, there is no evidence any such transfer took place.  CMS Ex. 6 at 2.  Only some of the perishable food items stored in the malfunctioning refrigerator were discarded.  CMS Ex. 11 at ¶ 7; CMS Ex. 9 at 3.  Several food items remaining in the refrigerator on the first day of the survey measured well over 41 degrees.  CMS Ex. 11 at ¶ 7; CMS Ex. 9 at 3-4.  Finally, Petitioner’s aged and infirm residents collectively faced a heightened risk of contracting foodborne illness and suffering serious complications from such illness.  The conditions and practices described above placed Petitioner’s vulnerable residents at substantial risk of foodborne illness and violated 42 C.F.R. § 483.60(i) (Tag F812).  Petitioner’s failure to store, prepare, distribute, and serve food in accordance with professional standards for food service safety posed a risk of more than minimal harm to resident health and safety.

3.    CMS’s immediate jeopardy determination is not reviewable.

Petitioner argues any potential harm from the deficient practices cited here does not meet the definition of “immediate jeopardy.”  P. Br. at 3, 5, 16.  However, I cannot overturn CMS’s determination of immediate jeopardy unless doing so would change the range of civil money penalties assessed.  NMS Healthcare of Hagerstown, DAB No. 2603 at 6-7 (2014) (“The level of noncompliance may be appealed, and reviewed, only if a successful challenge would affect the range of the CMP amounts that CMS could collect or affect a finding of substandard quality of care that resulted in the loss of a nurse aide training program.”) (citing 42 C.F.R. § 498.3(b)(14), (d)(10)(i)-(ii)).  In this case, CMS imposed a per-instance CMP.  The regulations provide only one range for per-instance CMPs.  42 C.F.R. § 488.845(b)(6).  Overturning the immediate jeopardy finding would therefore

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have no effect on the range of the CMP issued.  CMS’s determination of immediate jeopardy is not reviewable.

4.    CMS’s immediate jeopardy determination is not clearly erroneous.

Both parties have argued the merits of CMS’s immediate jeopardy finding.  CMS Br. at 8-12; P. Br. at 3, 8-9, 16-18.  As I have explained, the finding of immediate jeopardy is not reviewable for purposes of establishing a penalty range.  But that finding does bear upon the seriousness of the deficiency in determining the overall reasonableness of the penalty.  NMS Healthcare, DAB No. 2603 at 1 n.1 (“Thus, an immediate jeopardy citation is relevant to the seriousness of deficiencies and is a factor to be considered by an ALJ when determining whether the amount of a CMP is reasonable even where, as here, the immediate jeopardy determination itself is not subject to review because CMS imposed a per-instance CMP.”).  I therefore evaluate CMS’s immediate jeopardy determination in this context.

CMS determined Petitioner’s deficiencies related to food safety posed widespread immediate jeopardy to its residents.  CMS Ex. 2 at 1.  Based on undisputed facts in the record before me, I cannot say CMS’s determination was clearly erroneous.  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.  The regulation does not require a resident to sustain actual harm or a surveyor to observe or identify a particular resident harmed or threatened with harm.  Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012).  I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c)(2).

The “clearly erroneous” standard imposes on facilities a heavy burden to show no immediate jeopardy, and the DAB has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (citing Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)), aff’d, Barbourville Nursing Home v. United States Dep’t of Health & Human Servs., 174 F. Appx. 932 (6th Cir. 2006); see also, e.g., Easley v. Cromartie, 532 U.S. 234, 242 (2001) (“In applying [the clearly erroneous] standard, . . . a reviewing court must ask whether, ‘on the entire evidence,’ it is ‘left with the definite and firm conviction that a mistake has been committed.’”).

Petitioner demonstrated multiple serious shortcomings in its food storage, preparation, and service practices.  It failed to keep temperature-controlled foods at or below the temperature required by prevailing professional food service safety standards by using a walk-in refrigerator its staff knew was not cooling properly for three days.  It failed to monitor perishable, temperature-controlled foods to ensure the items remained at or

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below safe temperatures.  It failed to ensure the affected foods were transferred to a working unit or promptly discarded.  It failed to replace the affected foods.  In sum, Petitioner failed to store, prepare, distribute, or serve food in accordance with professional standards for food service safety.

These failures increased the risk of foodborne gastrointestinal illnesses for Petitioner’s 64 residents who received oral diets.  CMS Ex. 1 at 83.  Petitioner’s dietary supervisor may have directed staff to open the walk-in freezer door to cool down the refrigerator until the refrigerator side could be repaired, but there is no way to confirm whether the affected food items had been at or below a safe temperature overnight prior to the first recorded unsafe refrigerator temperature.  Id. at 85.  Further, there is no evidence Petitioner monitored the refrigerated foods to ensure they remained at or below safe temperatures.  Id. at 86.  Petitioner discarded the affected foods from the malfunctioning refrigerator only after CDPH began its survey and the surveyors declared immediate jeopardy.  Id. at 89-90.

Petitioner cannot reasonably assert a facility’s correction of a deficiency after its identification by a surveyor demonstrates substantial compliance with a participation requirement.  Quite the opposite is true.  Indeed, Surveyor Javier discovered food items in the malfunctioning refrigerator dated from before the first excessive temperature measurement on August 3, 2019.  CMS Ex. 1 at 84.  She also recorded temperatures of food items in the refrigerator ranging from three to twelve degrees above the maximum safe temperature level.  CMS Ex. 1 at 87-88; CMS Ex. 11 at ¶ 7; CMS Ex. 9 at 3-4.  Petitioner’s meal records revealed menu options offered to residents at the time of the malfunction included the affected food items in a meal or as a beverage selection.  CMS Ex. 11 at ¶ 9; CMS Ex. 5.  Petitioner’s lack of compliance with professional food safety standards plainly put its residents at risk of foodborne illness.

In response, Petitioner argues that no residents were harmed, there was no evidence it served perishable food stored at unsafe temperatures, and that the deficiencies cited arose from “uncorroborated and unreliable hearsay, along with a deficient investigation wherein the surveyors ignored important evidence and misstated percipient witnesses.”  P. Br. at 8-9, 11, 13.  But as I have discussed, the applicable regulation does not require evidence of actual service of improperly stored food or subsequent illness to facility residents.  The fact that none of Petitioner’s residents appear to have been harmed by the facility’s deficient food storage, preparation, service, and sanitation practices simply reflects good fortune.  It does not lead me to conclude CMS’s finding of immediate jeopardy was clearly erroneous.  See Lakeport, DAB No. 2435 at 7 (“[I]mmediate jeopardy exists if a facility’s noncompliance is likely to cause serious injury, harm, impairment, or death if not corrected, even if the surveyors did not observe or identify a particular resident who was actually threatened with harm during the survey.”) (citations omitted).

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5.    The $15,310 per-instance CMP imposed by CMS is reasonable.

Petitioner contends the reasonableness of the penalty imposed by CMS is a triable issue of fact precluding summary judgment.  Id. at 17-18.  This is incorrect.  The reasonableness of a CMP is a legal issue, not a factual one.⁸  Crawford Healthcare & Rehab., DAB No. 2738 at 18-19 (2016) (citing Cedar Lake Nursing Home, DAB No. 2344 at 12 (2010)).

Here, CMS imposed a per-instance CMP of $15,310.  In 2020, a per-instance CMP could range from $2,233 to $22,320.  86 Fed. Reg. 62,938.  In determining the reasonableness of the penalty amount imposed by CMS, I look to the factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  These factors include the seriousness of the deficiency and the facility’s compliance history, financial condition, and degree of culpability.  Id.

My analysis at Sections V.B and V.C(1)-(2) supra highlights the seriousness of Petitioner’s noncompliance.  Petitioner does not dispute the temperatures recorded by its staff on its Refrigerator/Freezer Temperature Log.  CMS Ex. 3.  Petitioner similarly does not dispute the fact its elderly and infirm residents were at a heightened risk of contracting foodborne illness and suffering serious complications from such illness.  CMS Ex. 11 at ¶ 10.  Despite having policies in place to assure proper storage, preparation, distribution, and service of food in accordance with professional standards for food service safety, Petitioner failed to ensure its staff adhered to those policies and thus professional food handling standards.  Petitioner thereby subjected its elderly residents to an unnecessary and potentially dangerous risk of exposure to foodborne illness.  The seriousness of its noncompliance amply supports the mid-range per-instance CMP amount selected by CMS.

CMS also points to Petitioner’s compliance history to justify the CMP imposed, noting the facility has a history of noncompliance with citations at a scope and severity of at least a “D” level in each of the preceding three surveys.  CMS Br. at 15; CMS Ex. 12 at 1-2.  Petitioner does not dispute CMS’s allegations.  Petitioner’s history of noncompliance with health safety requirements from 2016 through 2018 supports the CMP imposed by CMS in this case.

CMS characterizes Petitioner’s culpability as high owing to its failure to correct a known substandard practice that placed its residents at risk for foodborne illness.  CMS Br. at 15.  CMS also points out Petitioner presented no evidence of inability to pay.  CMS Br. at 15; see also P. Req. for Hearing at 6.  Petitioner asserts its culpability was low, as reflected

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by staff attempts to address the malfunctioning refrigerator by opening the freezer door to cool it down.  P. Br. at 5.  It also points out its noncompliance did not cause or was not likely to cause serious harm or imminent injury to residents.  Id. at 17-18.

I do not believe Petitioner intended to neglect or disregard its residents.  Nevertheless, a significant level of culpability is apparent here from the facility’s indifference to the variety of food safety issues discovered by the state surveyor.  As CMS observed, Petitioner knew its walk-in refrigerator was not operating at safe temperatures and undertook to repair it, but nevertheless failed to discard the affected food.  CMS Br. at 15; see also CMS Ex. 11 at ¶ 7; CMS Ex. 9 at 3-4 (internal temperatures measured on the day of the survey showing several perishable food items inside Petitioner’s refrigerator ranged from 44 to 52.6 degrees).  The likelihood of harm to elderly residents that could stem from poor food storage and preparation and inadequate training of staff concerning food safety should have been apparent to Petitioner and its staff.

In sum, given the seriousness of the deficiency, Petitioner’s history of noncompliance, its culpability, and the absence of evidence suggesting an inability to pay, the $15,310 mid-range per-instance CMP selected by CMS for immediate jeopardy noncompliance is reasonable.  38-40 Freneau Avenue Operating Company LLC, d/b/a Atrium Post Acute Care of Matawan, DAB No. 3008 at 13 (2020) (absent factors warranting a reduction, a mid-range per-instance CMP for immediate-jeopardy-level noncompliance is manifestly reasonable); Southpark Meadows Nursing & Rehab. Ctr., DAB No. 2703 at 12-15 (2016) (holding a per-instance CMP “slightly less than the mid-point of the applicable penalty range” was “manifestly reasonable given the level of severity and scope” of the deficiency).

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VII.    Conclusion

Petitioner did not substantially comply with the regulatory obligation to meet professional food safety standards for the storage, preparation, distribution, and service of food to its residents, and was therefore not in substantial compliance with 42 C.F.R. § 483.60(i).  There is no genuine dispute of material fact concerning the bases for the cited deficiency.  Petitioner failed to keep temperature-controlled foods at or below safe temperatures and failed to timely discard affected foods.  CMS’s immediate jeopardy determination is not reviewable and the $15,310 per-instance CMP it selected is a reasonable enforcement remedy.  For these reasons, I grant summary judgment in favor of CMS.

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Endnotes

¹  Tag F812 concerning food safety is discussed in the CMS State Operations Manual (SOM) Appendix PP, beginning at PDF counter 646, available at https://www.cms.gov/Medicare/Provider-Enrollment-and-certification/GuidanceforLawsAndRegulations/Downloads/Appendix-PP-State-Operations-Manual.pdf (last rev. Feb. 3, 2023).

²  CMS initially cited Petitioner with 20 other instances of noncompliance under Tags F552, F578, F580, F623, F657, F677, F679, F684, F688, F692, F693, F695, F725, F755, F758, F759, F803, F805, F838, and F880.  CMS Ex. 1 at 1, 4, 9, 12, 17, 19, 26, 28, 37, 40, 42, 45, 51, 58, 62, 66, 74, 81, 90, 93.  As explained in my February 3, 2021 Order Granting CMS’s Partial Motion to Dismiss, I conclude the holding of Plott Nursing Home v. Burwell, 779 F.3d 975 (9th Cir. 2015) does not require review of deficiencies CMS did not rely on in imposing a penalty.  I therefore confine my review to the deficiency cited under Tag F812.

³  The Board has not specified the quantum of evidence necessary for CMS to show it met its prima facie burden but has observed CMS must produce “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.”  Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007); see also Black’s Law Dict. (8th ed. 2004) at 1228 (“Prima facie” means generally that the evidence is ‘[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted’”).

⁴  Temperatures are referenced in this decision using the Fahrenheit scale.

⁵  My findings of fact and conclusions of law appear as numbered headings in bold italic type.

⁶  The surveyor’s quotation does include the word ‘frozen’ at the outset, but it is clear the remainder comes entirely from section 3-501.16, not 3-501.12.  CMS Ex. 1 at 88.  Petitioner cannot evade summary judgment by means of a typographical error.

⁷  Petitioner also claims a genuine dispute exists as to whether its refrigerator actually malfunctioned and whether perishable foods were actually stored at unsafe temperatures from August 3 to August 5, 2019.  P. Br. at 15.  This argument makes little sense on its face, since Petitioner’s own temperature log recorded measurements exceeding 41 degrees at various points over three days, and the record itself documents efforts by Petitioner’s staff to alert management and seek out repair services.  CMS Ex. 3 at 1 (notating “called my boss” and “maintenance was repairing 8/4/19” next to the rows for August 3 and 4, 2019, when temperatures of 45 to 50 degrees were recorded in the morning and evening).

⁸¹  It is possible to defeat summary judgment as to reasonableness of the penalty if there is a genuine dispute concerning facts that affect the assessment of the relevant regulatory factors.  Crawford, DAB No. 2738 at 19.  No such dispute exists here.