Villa Marin, DAB CR5851 (2021)

DECISION

Petitioner, Villa Marin, is a long-term care facility, located in San Rafael, California, that participates in the Medicare program.  Following a combined complaint investigation and recertification survey, completed on February 6, 2018, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with multiple Medicare requirements and that its food-service deficiencies posed immediate jeopardy to resident health and safety.  Based on three of the deficiencies, CMS imposed civil money penalties (CMPs) of $13,499 per day for one day of immediate jeopardy and $405 per day for 77 days of substantial noncompliance that did not pose immediate jeopardy ($44,684 total).

For the reasons set forth below, I find:  that the facility was not in substantial compliance with the regulation governing food and nutrition services (42 C.F.R. § 483.60(i)), as well as the regulation requiring that the facility maintain its equipment (42 C.F.R. § 483.90(d)(2)); that the facility's food preparation and storage deficiencies posed immediate jeopardy to resident health and safety; and that the penalties imposed ($13,499 and $405 per day) are reasonable.

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Background

The Social Security Act (Act) sets forth requirements for nursing facilities participating in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary's regulations are found at 42 C.F.R. Part 483.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm."  42 C.F.R. § 488.301.

The Secretary contracts with state survey agencies to survey skilled nursing facilities in order to determine whether they are in substantial compliance.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys, and must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a); 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4).

In this case, on February 6, 2018, surveyors from the California Department of Public Health (state agency) completed a complaint investigation combined with the facility's annual recertification survey.  Based on the survey findings, CMS determined that the facility did not comply substantially with the following program requirements:

• 42 C.F.R. § 483.10(g)(2) (Tag F573 – resident rights:  information and communication), cited at scope and severity level D (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimal harm);1
• 42 C.F.R. § 483.21(b)(1) (Tag F656 – comprehensive, person-centered care planning), cited at scope and severity level D;
• 42 C.F.R. § 483.21(b)(3) (Tag F658 – comprehensive, person-centered care planning:  professional standards of quality), cited at scope and severity level E (pattern of substantial noncompliance that causes no actual harm with the potential for more than minimal harm);
• 42 C.F.R. § 483.60(i)(1)-(2) (Tag F812 – food and nutrition services:  food safety), cited at scope and severity level L (widespread substantial

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noncompliance that poses immediate jeopardy to resident health and safety);2

• 42 C.F.R. § 483.60(i)(4) (Tag F814 – food and nutrition services:  garbage and refuse disposal) cited at scope and severity level L;
• 42 C.F.R. § 483.75(a) (Tag F865 – quality assurance and performance improvement program) cited at scope and severity level D;
• 42 C.F.R. § 483.75(g)(2) (Tag F867 – quality assurance and performance improvement program:  quality assessment and assurance) cited at scope and severity level D;
• 42 C.F.R. § 483.80(a)(1)(2)(4) (Tag F880 – infection control:  prevention and control) cited at scope and severity level E; and
• 42 C.F.R. § 483.90(d)(2) (Tag F908 – physical environment:  space and equipment) cited at scope and severity level F (widespread substantial noncompliance that causes no actual harm with the potential for more than minimal harm).

CMS Ex. 1; P. Ex. 2.

CMS also determined that, for one day, the deficiencies cited under section 483.60(i) posed immediate jeopardy to resident health and safety.  Following a revisit survey, completed April 20, 2018, CMS determined that the facility returned to substantial compliance on that day.  CMS Ex. 12 at 1.

CMS imposed civil money penalties of $13,499 per day for one day of immediate jeopardy (February 1, 2018) and $405 per day for 77 days of substantial noncompliance that was not immediate jeopardy (February 2 through April 19, 2018).  The total penalty is $44,684.  CMS Ex. 12 at 2.

Petitioner appealed.

Petitioner limits its appeal to the three deficiencies for which penalties were imposed.  P. Br. at 1; see P. Ex. 1 at 2-3.  In any event, because CMS imposed no penalties for six of the deficiencies cited, the regulations provide that those citations are not reviewable.  See 42 C.F.R. § 498.3(b)(13) (defining an initial determination – which is subject to

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review – as a finding of noncompliance "leading to the imposition of enforcement actions").

On November 20, 2020, I convened a telephone hearing from Washington D.C.  Ms. Sonia Burnett appeared from Atlanta, Georgia, representing CMS.  Transcript (Tr.) 1.  Ms. Jillian Somers Donovan appeared from Marin County, California, representing Petitioner.  Tr. 1.  The witness, Surveyor Christine Demello, appeared from Santa Rosa, California.  Tr. 2.

The parties filed pre-hearing briefs (CMS Br.; P.Br.).  CMS filed a post-hearing brief (CMS Post-hrg. Br.).  Petitioner declined to file a post-hearing brief, opting to reply to CMS's brief instead (P. Reply).  CMS then filed a sur-reply (CMS Sur-reply).

Exhibits.  With its pre-hearing brief, CMS submitted 12 exhibits.  (CMS Exs. 1-12).  With its pre-hearing brief, Petitioner submitted 19 exhibits.  (P. Exs. 1-19).  CMS did not object to Petitioner's exhibits.  Petitioner objected to four of CMS's exhibits, and, during a pre-hearing conference, I ruled on those objections:

• Petitioner objected to CMS Ex. 3, a document labeled "Facility Assessment Tool," which lists the number of skilled residents in the facility and their diagnoses.  Petitioner complained that the document is out of date and otherwise irrelevant.  I overruled Petitioner's objection, noting that Petitioner could have provided more recent data.  It could have explained how the document does not reflect the facility's population at the time of the survey and why any changes since then would matter.  Petitioner did none of these.  Moreover, the document appears to be the only evidence in the record describing the entire resident population.  It is relevant and material and should be admitted.  42 C.F.R. § 498.60(b).
• Petitioner objected to CMS Ex. 7, the surveyor notes, characterizing them as hearsay.  I overruled Petitioner's objection, explaining that the federal rules of evidence do not apply in this forum and that, in any event, the surveyor was available for cross-examination.  42 C.F.R. § 498.61.
• Petitioner objected to CMS Ex. 8, the facility's "allegations of compliance," citing the Federal Rules of Evidence regarding subsequent remedial measures.  I overruled the objection, noting again that the federal rules do not apply to these proceedings.  Petitioner did not object to my admitting its actual Plan of Correction, which includes similar evidence.  CMS Ex. 9.  I rely on neither document to establish the facility's substantial noncompliance.  However, having independently determined that the facility was not in substantial compliance, I look at these as evidence of the facility's own assessment as to when it would correct its deficiencies.

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• Petitioner objected to CMS Ex. 10, the written declaration of Surveyor Christine Demello, pointing out that it had not been submitted in the proper form.  CMS subsequently submitted an amended version in the proper form.

I therefore admitted CMS Exs. 1-12 and P. Exs. 1-19.  Order Summarizing Pre-Hearing Conference at 2-3 (Oct. 21, 2020); Tr. 2.

Issues

1. From February 1 through April 19, 2018, was the facility in substantial compliance with 42 C.F.R. §§ 483.60(i) and 483.90(d)(2);
2. If, on February 1, 2018, the facility was not in substantial compliance with program requirements, did its deficiencies then pose immediate jeopardy to resident health and safety;
3. If the facility was not in substantial compliance, are the penalties imposed, $13,499 per day for 1 day and $405 per day for 77 days (total:  $44,684), reasonable?

Discussion

1.  Because the facility did not prepare, distribute, and serve food in accordance with professional standards for food service safety, did not properly dispose of garbage and refuse, and did not maintain essential equipment in a safe operating condition, it was not in substantial compliance with 42 C.F.R. §§ 483.60(i) and 483.90(d).3

Program requirement:  42 C.F.R. § 483.60(i) (Tags F812 and F814).  Among other requirements for food safety, the facility must store, prepare, distribute, and serve food in accordance with professional standards for food service safety.  It must also properly dispose of garbage and refuse.

Program requirement:  42 C.F.R. § 483.90(d)(2) (Tag F908).  The facility must maintain all essential mechanical, electrical, and patient care equipment in safe operating condition.

Policies.  As the Departmental Appeals Board has repeatedly explained, a facility's policy for implementing a regulatory requirement reflects the facility's own judgment

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about how best to achieve and maintain substantial compliance.  Failing to comply with its own policies "can support a finding that the facility did not achieve compliance with the regulatory standard."  Heritage House of Marshall Health and Rehab., DAB No. 3035 at 10-11 (2021); Bivins Mem'l Nursing Home, DAB No. 2771 at 9 (2017); see Rockcastle Health and Rehab. Ctr., DAB No. 2891 at 19 (2018) (ruling that, absent contrary evidence, it is reasonable to presume that the facility's policies reflect professional standards); Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013); Life Care Ctr. at Bardstown, DAB No. 2233 at 21-22 (2009) (finding that a facility's failing to comply with its own policies can constitute a deficiency).  Here, the facility had policies in place to assure food safety but, as the following discussion shows, staff failed to implement many of those policies in critical respects, which put the facility out of substantial compliance with section 483.60(i).

a)  The facility's substantial noncompliance with food safety requirements.

Policies.  The facility's policies addressing food safety issues included:

• Hair restraints.  Facility policy required that everyone wear hair restraints while in the kitchen; this included department associates, associates from other departments, and guests, such as vendors.  CMS Ex. 4 at 2.
• Storage of pots, dishes, flatware, and utensils.  Facility policy required staff to store pots, dishes, and flatware "in such a way as to prevent contamination by splash, dust, pests, or other means."  CMS Ex. 4 at 20.  To achieve this, dish handlers and tray line area assistants were directed to:
  
  Air dry all food contact surfaces, including pots, dishes, flatware, and utensils, before storage.  Do not stack or store when wet.
  
  Store all pots, dishes, flatware, and utensils six inches above the floor.
  
  Store all pots, glasses, and cups in an inverted position on a clean storage surface.  Invert the top plate, bowl, or dish of any stacks of dishes.
  
  Remove the carbon build-up from pots on a[n undesignated] basis (per local regulatory agent).
  
  Store utensils vertically, in a bucket with handles pointing up, to reduce the opportunities for contamination.
  
  Cooling wands should be placed in a clean, covered pan or wrapped in sanitary plastic or food-grade bag before placing them in the freezer.

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Specific instructions for flatware included:  wash hands before touching clean flatware; ensure that handles are in the upright position extending toward the customer, ready for service; to bag or roll flatware, be sure it is dry and clean, touch handles only or wear disposable gloves.  CMS Ex. 4 at 20, 21.

• Ice handling.  Among other instructions, the policy demanded that ice be protected from splash, drip, and hand contamination during storage and service.  Exposed areas were to be cleaned daily, and staff were instructed to follow the manufacturer's recommended cleaning schedule for cleaning the ice maker and ice bin.  CMS Ex. 4 at 10, 19.
• Sanitation.  Facility policy called for a "basic sanitation inspection" at least monthly to ensure that procedures were being followed and sanitation standards maintained.  In addition, a quarterly food safety and sanitation audit would be conducted using the "Food Safety and Sanitation Audit form."  Both the inspection and the audit used checklists and forms that were to be followed.  Action plans were to be developed for all areas not meeting the standards; cleaning schedules and frequencies were to be revised based on inspection findings.  CMS Ex. 4 at 18.
  
  The facility plainly recognized the particular dangers posed by raw meat.  In its policy addressing cleaning surfaces that come into contact with food, the facility described "raw animal products" as "potentially hazardous foods," so the surfaces that come into contact with them require special cleaning and sanitizing.  CMS Ex. 4 at 15.
  
  Policies concerning the dish machine stated that hot water is used to wash, rinse, and sanitize dishes.  Staff were required to fill out, on the dish machine temperature record form, the wash and final rinse temperatures during each period of use.  Once a day, staff were required to run a test strip through the dish machine to verify the surface temperature of a dish.  They were then required to attach the used test strip to the temperature log.  "The test strip must verify that the surface temperature of the plate reached 160ºF."  Staff were required to bring to the attention of management any substandard temperatures.  The food service supervisor was required to confirm that staff documented the temperature and test strips at each meal period.  CMS Ex. 4 at 16, 25 (emphasis added).
  
  Each work area was to be equipped with sanitizing solution, and moist cloths were to be used to wipe food spills.  Those cloths were to be used for no other purpose and had to be cleaned and rinsed frequently in the sanitizing solution.  In-use wiping cloths were to be kept in sanitizing solution between uses.  The cloths used for wiping food spills at stations handling raw animal products could not be used for any other purpose.  CMS Ex. 4 at 16, 21, 25.

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Practices.  Notwithstanding the facility's written policies, Surveyor Demello observed and documented multiple practices that violated facility policies and professional standards, jeopardizing food safety and putting the facility out of substantial compliance with 42 C.F.R. § 483.60(i).  Specifically:

• Hair restraints.  Surveyor Demello observed that staff were not uniformly following the facility's policy requiring hair restraints.  On January 29, 2018, the facility's executive chef covered his hair with a baseball cap but did not cover his beard.  Two staff members wore hair nets that did not cover all of their hair.  CMS Ex. 10 at 3 (Demello Decl.); see CMS Ex. 7 at 18.
  
  Petitioner's response.  Petitioner offers no evidence or argument disputing the surveyor observation that kitchen staff were not following the facility's policies regarding hair restraints.  Its sole response is a conclusory statement from registered nurse, Justin Salter, who serves as the facility's "Infection Preventionist."  RN Salter opines – without offering any underlying support – that the absence of hair restraints, along with other cited deficiencies (discussed below), are not "systemic issues that presented unsanitary conditions or had the potential for cross-contamination in the kitchen."  He also gratuitously claims that no evidence shows that any of the deficiencies, including lack of hair restraints, "presented the potential for food borne illness that could cause serious illness or death."  P. Ex. 4 at 2-3 (Salter Decl. ¶ 6).  In RN Salter's view, it seems, the facility's policy requiring hair restraints is essentially superfluous because staff's failing to follow it causes little, if any, harm.
  
  I disagree.  Hair is a physical contaminant, and dietary staff "must wear hair restraints (e.g. hairnet, hat, and/or beard restraint) to prevent hair from contacting food."  CMS Ex. 11 at 9 (SOM:  Strategies for Control of Potential Foodborne Illness).  The facility's policy reflects this widely-accepted food safety standard.  See, e.g., FDA Food Code § 2-402.11 (2017).4
• Storage of pots, dishes, flatware, and utensils.  Surveyor Demello observed and documented facility practices for storing pots, dishes, flatware, and utensils that were not consistent with facility policies.  Specifically:
  
  Instead of storing clean cooking utensils and plastic mugs as the facility policies required (utensils in a bucket with handles pointing up and mugs inverted with dishes on top), which minimizes the danger of contamination "by splash, dust

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pests, or other means," the utensils and mugs were heaped above the rim of uncovered bins, directly next to the dishwasher.

Food service dishes were not thoroughly cleaned and were stored wet, which can promote the growth of bacteria.  The "clean" mugs that were stored next to the dishwasher had visible food particles on them; the bin itself (storing mugs and utensils) had particles of food on the inside surface; a candy wrapper was mixed in with the utensils.

Food steam table pans were stored – stacked together and wet – on shelving between the three-compartment sink and food prep tables.  Food service staff washed the steam table pans at the three-compartment sink and added the wet pans to the stack of pans on the storage shelf, instead of placing them on a surface where they could air dry.  CMS Ex. 10 at 2 (Demello Decl.).

Petitioner's response.  Petitioner maintains that the area where the wet pans were stacked together was not a storage area, but a drying rack.  P. Br. at 15.  "That shelving area is specifically to allow pans to air dry before being placed in a storage area."  P. Ex. 3 at 5 (Rongey Decl. ¶ 11).  Apparently, however, staff were not aware that the pans should air dry because they stacked them together in a way that prevented it, in contravention of facility policy and professional standards.  CMS Ex. 4 at 20; FDA Food Code § 4-901.11.

RN Salter concedes that stacking wet pans in this fashion can result in mold growth, but, he maintains, mold would not be a problem unless the pans were left for 24-hours or more, and "there is nothing to suggest these pans were stored in this area and left for that period of time."  P. Ex. 4 at 2 (Salter Decl. ¶ 4).  Even assuming that it is ever acceptable to stack wet pans for any period of time (and both the facility's policy and professional standards say it is not), it is the facility's burden to establish that its practices were safe.  To protect against the growth of bacteria, the facility determined that pots, pans, dishes and the like must never be stacked when wet.  If, as RN Salter suggests, stacking wet pans is allowable for short periods, I would expect to see policies and procedures directing staff to unstack them and allow them to air dry at some point.  I see none.

• Food preparation.  Surveyor Demello also witnessed some disturbing practices in food preparation:
  
  Staff placed used paper towels on food preparation surfaces, including cutting boards.  CMS Ex. 10 at 1 (Demello Decl.).
  
  The food preparation area had three plastic bins, containing red onions, white onions, and potatoes.  The lids on the onion bins were loose; the lid on the potato

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bin covered only half of the potatoes in the container.  Staff prepared raw meat on a cutting board over the onions and potatoes.  The meat preparation surface had no sides, and "raw meat juice was being released from the meat" with the onion and potato bins sitting beneath.  CMS Ex. 10 at 1 (Demello Decl.); see CMS Ex. 7 at 17, 23.

Petitioner's response.  Dietary Supervisor June Rongey concedes that the meat was on a cutting board with no sides and that vegetable bins were beneath.  She does not claim to have personally witnessed the practice, but asserts that the cutting board was inside a lipped tray, that no meat juices were running into the vegetables, and that, because the activity "was also identified [presumably by Surveyor Demello] prior to the vegetables under the table being used for any purpose," they were discarded immediately, and no harm was done.  P. Ex. 3 at 5 (Rongey Decl. ¶ 12).

Surveyor Demello personally witnessed the practice and Dietary Supervisor Rongey does not explain how she knew about it.  So, to the extent that their narratives conflict, I find the surveyor's testimony more credible.  In any event, while it is fortuitous that the surveyor identified a dangerous practice before it could cause harm, the staff's ignorance of or disregard for basic safety measures is deeply concerning and put the facility out of substantial compliance.

I note also that RN Salter does not claim that this was a safe practice.  See P. Ex. 4 (Salter Decl.).

• Cleanliness.  The kitchen was not cleaned adequately.  Specifically:
  
  The oven used to keep resident food hot had burnt-on residue inside the compartment; and the warming oven next to it had baked-on dirt and food on the bottom.  The two main ovens had burnt-on food residue on the bottom of the ovens and on the oven racks; the plate warmer had brown staining along the back of the compartment.  CMS Ex. 10 at 1 (Demello Decl.).
  
  The large stand-alone burner (used for huge pots and pans) had food residue on the rack above the burner; the top of the appliance had "fresh and burnt on food residue."  CMS Ex. 10 at 1-2 (Demello Decl.) (emphasis added).
  
  The grill section of the main range had an accumulation of food residue on the rack, with grease and black crumbs of food particles under the grill and on the supporting edges of the grill.  CMS Ex. 10 at 2 (Demello Decl.).
  
  Surveyor Demello observed "an unidentifiable brown substance" (presumed to be food residue) clinging to the glass racks.  The rack on the top of the range (to

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support pans) had food particles on it.  Under the rack was aluminum foil covered with grease and burnt-on food residue.

The outside of the ice bin was visibly dirty.  The bin was full of ice and near the top was an area of unidentified brown substance.  When the area was wiped with a dry white cloth, an unidentifiable gray substance appeared beneath the brown substance.  No cleaning log was located with the ice maker.  CMS Ex. 10 at 2 (Demello Decl.).

Surveyor Demello observed a staff member using a visibly soiled oven mitt to place warmed metal plate holders onto food trays and to move the food trays down the line.  Staff told the surveyor that mitts were not washed; when worn out, they were thrown away.  CMS Ex. 10 at 3 (Demello Decl.).

Petitioner's response:  survey quality.  Surveyor Demello documented, in her notes and on the statement of deficiencies, her observations of dirt and other contaminants in the kitchen.  She testified credibly, and, in fact, Petitioner has neither claimed nor established that her observations were erroneous.  Instead, it levels a more overarching charge:  that Surveyor Demello was "less than thorough."  According to Petitioner, the surveyor should have inquired "into the timing of cleaning after meal services, how meal preparation and cleaning periods interacted, or how serving three levels of care impacted food preparation and cleaning scheduling."  P. Reply at 2-3.

Petitioner's criticism as to the quality of the survey fails for several reasons.  As a threshold matter, observing the food service operation while meals are being prepared is always appropriate, and probably necessary.  How else to review how food is prepared?  Nor is it the surveyor's job to figure out why the operations appear to be sub-standard.  If facility staff want to explain the facility's less-than-adequate performance, they are free to do so.  But it is the facility's responsibility to establish that, despite its evident deficiencies, it maintains substantial compliance.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997); see Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff'd, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App'x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001).

Next, I see no evidence suggesting any problems with the quality of the survey.  Even if there were, the regulations are explicit:  inadequate survey performance does not relieve the facility of its obligations to meet all requirements for program participation or invalidate adequately documented deficiencies.  42 C.F.R. § 488.318(b); Avon Nursing Home, DAB No. 2830 at 11-15 (2017) and cases cited therein (noting that "the Board has consistently held that allegations of inadequate

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survey performance are irrelevant to ALJ or Board review of CMS's noncompliance and remedy determinations.").

Petitioner's response:  food residue.  Consistent with its attack on the timing of the survey, Petitioner argues that the food residue Surveyor Demello observed was inevitable, given the timing of the observations; breakfast was being served, and staff were about to start cleaning.  P. Br. at 9-10; P. Ex. 3 at 2-4 (Rongey Decl. ¶¶ 5-9).  Petitioner also asserts that the kitchen was especially busy at the time of the surveyor observations because "an extra, large lunch party [was] going on that day."  P. Br. at 10; P. Ex. 3 at 3 (Rongey Decl. ¶ 4).

If a facility's dietary services are so overtaxed that it cannot maintain professional standards at all times, it has systemic problems that put it out of substantial compliance.  In Crestview Parke Care Ctr., the Court of Appeals for the Sixth Circuit affirmed the Board's decision that the facility was not in substantial compliance with the dietary services regulation because the kitchen was not clean or sanitary.  In doing so, the court explicitly rejected the facility's argument (similar to Petitioner's argument here) that it should not be held accountable for its purportedly temporary lack of cleanliness because it was constantly in use.  Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 751 (6th Cir. 2004), affirming in part Crestview Parke Care Ctr., DAB No. 1836 (2002).  Moreover, while some of the conditions might be explained by the ongoing work, Surveyor Demello also describes conditions that were attributable to long-standing inattention.  She refers to both "fresh and burnt-on residue," as well as "baked-on dirt."  CMS Ex. 10 at 1-2 (Demello Decl.).

Even if I accepted that the purported cleaning problems were attributable to the timing of the observations (which I do not), I would still be compelled to find the facility out of substantial compliance based on other deficiency findings that are unrelated to the timing of meals and clean-up:  inadequate hair restraints; purportedly "clean" mugs with visible food particles on them in a bin with food particles inside; a candy wrapper among purportedly clean utensils; stacking wet pans together, rather than allowing them to air dry; dirty oven mitts (discussed below); and, perhaps most disturbing, preparing raw meat above bins of vegetables.

Petitioner's response:  oven mitt and ice bin.  Petitioner does not challenge the inference that, pursuant to some unwritten policy, facility staff continued to use unwashed oven mitts – no matter how dirty or contaminated – until they were worn out.  Instead, RN Salter dismisses the significance of the practice.  He points out that the dirty oven mitt Surveyor Demello observed did not touch a resident's food or dish, but only the metal trays, which are handled by the nurse aides, so, according to RN Salter, the practice "was not an infection control issue."  P. Ex. 4

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at 2 (Salter Decl. ¶ 5).5   But oven mitts are used by multiple staff members in a variety of situations.  I find it highly unlikely that these contaminated mitts would not eventually come into contact with food or dishes, and I consider the facility's practice unsafe.

The facility offers no evidence to refute Surveyor Demello's observation of foreign substance(s) near the top of the ice bin, but asserts that the bin is cleaned at regular intervals and had been cleaned a month before the survey.  P. Br. at 14-15; P. Ex. 9.  But cleaning schedules, even if followed, do not relieve the facility of its obligation to assure that its premises are actually clean.  See Crestview Parke, 373 F.3d at 751.  The facility's policy requires that ice be protected from splash, drip, and hand contamination.  CMS Ex. 4 at 10, 19.  These can contaminate ice between scheduled cleanings, and, when that happens, the bin must be cleaned immediately.

RN Salter also concludes that both the dirty mitts and the dirty ice bin, along with the facility's problems with hair restraints and lack of a garbage can, were not systemic issues that "presented unsanitary conditions or had potential for cross-contamination in the kitchen."  P. Ex. 4 at 2-3 (Salter Decl. ¶ 6).  Again, I reject his unsupported conclusions.  First, the after-the-fact rationalizations of a facility employee cannot substitute for properly-developed policies.  Moreover, as those policies recognize, hair and dirt are contaminants.  Contaminants can make people sick, particularly the elderly and infirm.  Moreover, extra precautions should be taken to ensure that the ice machine is properly cleaned and sanitized because contaminated ice is specifically associated with Norovirus, a highly contagious virus that can cause vomiting and diarrhea, which are especially dangerous conditions for the elderly and people with weakened immune systems.  CMS Ex. 11 at 9.

Petitioner's response:  schedules.  Petitioner also asserts that the facility had cleaning schedules and cleaning lists in place, suggesting that the schedules themselves satisfy regulatory requirements.  P. Ex. 3 at 2-4 (Rongey Decl. ¶¶ 3, 5-9); P. Exs. 6, 7.  But schedules and lists do not establish that any of the listed tasks have been performed.  Crestview Parke, 373 F.3d at 751 (rejecting the facility's claim that evidence of cleaning schedules, procedures, and duties established that the facility was clean, safe, and well-maintained and concluding instead that, based on the surveyors' observations, the evidence showed that the facility "failed in the execution of its procedures."); see Crestview Parke Care Ctr., DAB No. 1836 (finding that "having a full-time housekeeping staff as well as policies and

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procedures for cleaning and maintaining the facility does not satisfy the requirement that the facility actually be kept clean and orderly." (emphasis in original)).

• Sanitation.  The facility did not follow its policy to ensure that its dishes were properly sanitized.  As noted above, the policy required staff to use test strips to test the temperatures in the dish machine.  Staff confirmed that the dishwasher sanitized dishes with heat and that they checked water temperatures three times a day.  However, staff also advised Surveyor Demello that the temperature test strips had not been working for about a week.  Instead of relying on the test strips, staff recorded, on the daily temperature log, temperatures from the gauges attached to the dishwasher.  CMS Ex. 6 at 3; CMS Ex. 7 at 19; CMS Ex. 10 at 3 (Demello Decl.).

Surveyor Demello's own observations confirmed what the staff told her.  At 11:50 a.m. on February 1, 2018, the person washing dishes ran the temperature test strip through the dishwasher; the test strip failed to react to the heat.  He tried four test strips, and all failed to react.  The food service staff member told Surveyor Demello that he did not alert management that the test strips were not working because he thought someone else would do it.  CMS Ex. 10 at 3 (Demello Decl.).

Although required to do so by facility policy, the food service supervisor was not confirming (because she could not) that staff documented the temperature and test strips at each meal period.  See CMS Ex. 4 at 16, 25.

Petitioner's response.  Food Service Supervisor Rongey points out that the dish machine had a temperature gauge on the outside and maintains, without support, that it was accurate.  She also asserts "[t]here is no evidence that Villa Marin's dishwasher was ever under the required temperature."  P. Ex. 3 at 5 (Rongey Decl. ¶ 10).  But we can't know whether the dishwasher's internal temperatures were safe because the system the facility had in place for testing them did not function properly.

By suggesting that the absence of evidence exonerates the facility, Petitioner again confuses the relative burdens here.  The facility determined, through its policies, that it would comply with sanitation standards for dishwashing by running a test strip through the dish machine to verify that the surface temperature of a plate reaches 160ºF.  CMS Ex. 4 at 16, 25.  This is consistent with professional standards.  CMS Ex. 11 at 17.  The facility was not capable of complying, staff knew it couldn't comply, yet no one reported the problem.  This puts the facility out of substantial compliance with section 483.60(i).

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b)  The facility's substantial noncompliance with garbage and refuse disposal requirements.

Policies.  The facility had in place policies to address garbage and refuse disposal.  They included:

• Hand hygiene.  Those associated with food handling were required to wash their hands with soap and water, and the policy listed specific times when they were required to do so, including:  before handling food or clean utensils, dishes, or equipment; after handling garbage; after handling rags or mops; and "[a]fter any other activity that may contaminate the hands."  CMS Ex. 4 at 8.  The policy mandated that hands be washed in sinks designated for that purpose, which were stocked with soap, paper towels, a covered waste receptacle, and a hand wash sign.  The policy also listed specific procedures for hand washing and instructed staff to dry their hands with a single use disposable towel.  CMS Ex. 4 at 7, 8.
• Garbage disposal.  As noted above, each handwashing sink was to be equipped with a covered waste receptacle.  CMS Ex. 4 at 8.  Garbage containers were to be clean, lined, and covered at all times.  CMS Ex. 4 at 12.

Practices:  garbage disposal.  Surveyor Demello observed that the handwashing sink in the kitchen did not have an available garbage can into which staff could discard paper towels after washing their hands.  At 8:30 a.m. on January 31, 2018, she observed staff washing their hands at the handwashing sink and walking past the dishwasher area to a garbage can.  They pushed the dirty trash can lid open with clean hands in order to dispose of the used paper towels.

Staff told Surveyor Demello that, about a week earlier, the facility's registered dietician had requested a replacement trash can, but it had not been provided.  The facility had no written work orders; such requests were made verbally, in person or by telephone.  Staff would also leave notes for the food service's general manager, but management had not responded to staff's requests.  CMS Ex. 10 at 2 (Demello Decl.); see CMS Ex. 7 at 3 (reporting the registered dietician's complaint that she "figured that the surveyors would do something" about getting a new trash can and that "she was tired of asking."); CMS Ex. 7 at 18, 19.

Facility's response.  Again, Petitioner does not question the surveyor's observation, but RN Salter includes this deficiency among those he claims were not systemic issues that "presented unsanitary conditions or had the potential for cross-contamination in the kitchen."  P. Ex. 4 at 2-3 (Salter Decl. ¶ 6).  I do not agree.  As the facility's policies indicate, used paper towels should be disposed of immediately; they should not be left on food preparation surfaces (as occurred here).  Staff should not be carrying them past

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sanitary areas; they should not have to touch a trash lid in order to dispose of them.  Touching a trash can lid is a practice that could contaminate freshly-washed hands.

Finally, to the extent that any of RN Salter's opinions suggest that the facility's deficiencies did not put it out of substantial compliance with program requirements, I need not accept them.  Agape Rehab. of Rock Hill, DAB No. 2411 at 16 (2011) ("Whether a facility is in substantial compliance is a legal issue, and an ALJ is not required to accept expert testimony on legal issues.").

Substantial noncompliance with section 483.60(i).  The facility's policies governing food safety were purposeful and reflected prevailing standards, and I reject Petitioner's efforts to minimize their efficacy.  Moreover, the after-the-fact rationalizations of a facility employee cannot substitute for properly developed and implemented policies.  The sheer number of violations, not to mention how potentially deadly some of them could be, shows serious and systemic problems with the facility's dietary services, putting it out of substantial compliance with section 483.60(i).

c)  The facility's substantial noncompliance with requirements that its equipment be properly maintained.

Policies.  The facility policy made the maintenance department responsible for maintaining equipment.  The maintenance director was required to develop and maintain a schedule to assure that facility equipment was safe and operable.  The director was also responsible for maintaining records and reports, including work order requests and maintenance schedules.  CMS Ex. 5 at 9.

Practices.  CMS lists the equipment that the facility did not maintain in a safe operating condition:  one refrigerator was not working; a freezer thermometer (for freezer no. 8) was not functioning; ovens ran at uneven temperatures; and a food warmer's built-in thermometer was not working.  CMS Ex. 1 at 35; CMS Ex. 7 at 18, 19.

Surveyor Demello also determined that the facility did not follow the facility's policy for keeping maintenance records.  Most kitchen maintenance (except changing light bulbs, adding bulletin boards, and fixing clogged drains) was contracted out, as was maintaining the basement ice maker.  Requests for services were made by phone.  But, contrary to the policy, the facility's maintenance department did not keep a log of kitchen repairs.  CMS Ex. 10 at 3 (Demello Decl.).

Petitioner addresses two of the four pieces of equipment Surveyor Demello cited, leaving two unchallenged.

Petitioner's response:  freezer thermometer.  Petitioner cites to its Plan of Correction, which says that the temperature gauge on the outside of freezer no. 8 "never reads

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correctly," but that the freezer had two internal thermometers "one at the back and one at the front[,] which reads perfectly."  CMS Ex. 9 at 36.  Literally, assuming the grammar is correct, this means that one of three thermometers was functioning properly, the one at the front.  In its brief, however, Petitioner cites the Plan of Correction and asserts that both internal thermometers were functioning.  P. Br. at 18-19.  In any event, neither interpretation is supported by reliable evidence.

Food Service Supervisor Rongey does not claim that any of the thermometers were functioning properly.  Instead, she focuses on the reason ice cream in the freezer was "softer than normal," leading the surveyor to conclude that the freezer's thermometer was not functioning properly.  Food Service Supervisor Rongey maintains that freezer no. 8 is self-defrosting and was going through the defrost cycle, leaving the ice cream softer than normal.  P. Ex. 3 at 6 (Rongey Decl. ¶ 13).  But Surveyor Demello examined the thermometer and noted that it was not functioning properly.  She brought her concerns to the attention of the executive chef, who checked the temperature numbers.  The thermometer on the left side read 50 degrees.  The executive chef said that the thermometer was broken.  He noted that a second thermometer on the right side of the refrigerator read 20 degrees.  He also speculated that the ice cream may have been soft because the freezer was recently restocked or because it was going through a defrost cycle (although apparently he didn't really know why).  CMS Ex. 1 at 36, CMS Ex. 7 at 18.6

Food Service Supervisor Rongey also claims that, during lunch, staff remove the ice cream from the freezer and put it in "a different freezer area for the residents."  At 1:30 p.m., they return it to freezer no. 8, at which time it is not as frozen.  P. Ex. 3 at 6 (Rongey Decl. ¶ 13).  Inasmuch as Surveyor Demello observed the softness of the ice cream at 8:30 a.m., this does not explain why the ice cream was soft.

In any event, the underlying deficiency was that at least one of the freezer thermometers was not properly maintained, and, no one disputes that.

Petitioner's response:  oven temperatures.  Petitioner does not challenge Surveyor Demello's observation about oven temperatures, but maintains that the ovens in question are older and not used for cooking food, but as warming ovens, keeping food at 250 degrees before it goes to the tray line or buffet.  P. Br. at 19, P. Ex. 3 at 6 (Rongey Decl. ¶ 14).  I see no reason why a warming oven should not be expected to maintain an even temperature, and, if it is properly maintained (as required by the facility policy), it would.

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Finally, even if I accepted that the equipment failings described by Surveyor Demello did not put the facility out of substantial compliance (which I don't), the facility did not keep maintenance records or log kitchen repairs, as required by its policies.  Its haphazard approach to maintenance issues compromised its ability to maintain all essential equipment in safe operating condition, which puts it out of substantial compliance with section 483.90.

2. CMS's determination that the facility's substantial noncompliance with the regulations governing food services posed immediate jeopardy to resident health and safety is not clearly erroneous.

Immediate jeopardy.  Immediate jeopardy exists if a facility's noncompliance has caused or is likely to cause "serious injury, harm, impairment, or death to a resident."  42 C.F.R. § 488.301.  CMS's determination as to the level of a facility's noncompliance (which would include an immediate jeopardy finding) must be upheld unless it is "clearly erroneous."  42 C.F.R. § 498.60(c).  The Board has observed repeatedly that the "clearly erroneous" standard imposes on facilities a "heavy burden" to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence "from which '[o]ne could reasonably conclude' that immediate jeopardy exists."  Heritage House, DAB No. 3035 at 21; Barbourville Nursing Home, DAB No. 1931 at 27-28 (2004) (citing Koester Pavilion, DAB No. 1750 (2000)); Daughters of Miriam Ctr., DAB No. 2067 at 7, 9 (2007).

Petitioner argues that its food safety deficiencies did not pose immediate jeopardy to resident health and safety.  Citing a provision of the State Operations Manual, Petitioner argues that, to sustain a finding of immediate jeopardy, CMS "must show that serious injury, harm, impairment, or death was likely to occur in the very near future."  P. Br. at 17 (emphasis in original); P. Reply at 5.

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

Second, the Board has rejected Petitioner's definition of immediate jeopardy.  In doing so, it has explained that relying on the State Operations Manual is misplaced; the manual

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provisions are "instructive," but they are not binding.7   We are bound by the regulatory definition in section 488.301.  Mississippi Care Ctr. of Greenville, DAB No. 2450 at 15-16 (2012); Foxwood Springs Living Ctr., DAB No. 2294 at 9 (2009).  That definition "neither defines the term 'likelihood' nor sets any parameters as to the timing of potential harm."  Mississippi Care Ctr., DAB No. 2450 at 16 (quoting Agape Rehab. of Rock Hill, DAB No. 2411 at 19 (2011)).  Thus, the Board has concluded that a facility's deficiencies may pose immediate jeopardy even though they do not create a "crisis situation."  Mississippi Care Ctr., DAB No. 2450 at 16.  A facility's deficiencies may pose immediate jeopardy even though the potential harm is not likely to occur in the near future.  Agape Rehab. of Rock Hill, DAB No. 2411 at 19; Countryside Rehab. and Health Ctr., DAB No. 2853 at 25 (2018) ("[T]he imminence of resident harm is not an element of the regulatory definition of immediate jeopardy."); Barbourville Nursing Home, DAB No. 1962 at 16-18 (2005) (finding that a facility's failing to track information in accordance with its policies posed immediate jeopardy, even though no harm had resulted, and potential harm would not happen "in hours or days, but over weeks or months.").

Petitioner claims that no resident has suffered a foodborne illness and cites Crawford Healthcare & Rehab, DAB No. 2738 at 16 (2016), for the proposition that the existence of actual harm "is an important factor that weighs on the likelihood of serious harm."  P. Reply at 6.  To the extent Petitioner is suggesting that Crawford stands for the proposition that actual harm is necessarily implicated in a finding of immediate jeopardy, Petitioner has turned that ruling on its ear.  There, the Board discussed survey guidelines for evaluating the severity of noncompliance in the face of actual injuries.  The guidelines instructed surveyors not to rule out a finding of immediate jeopardy if they find examples of negative outcomes that, in CMS's view, indicate – on their face – serious harm.  "Absent those particular outcomes, surveyors may still find that circumstances warrant a finding of immediate jeopardy" or may consider lower severity levels.  Crawford Healthcare, DAB No. 2738 at 16 (emphasis added).  Nothing in that decision suggests that actual harm is a necessary prerequisite to a finding of immediate jeopardy.

Indeed, the regulations do not require actual harm, only the likelihood of serious harm.  Mississippi Care Ctr. of Greenville, DAB No. 2450 at 15 (2012); Kenton Healthcare, LLC, DAB No. 2186 at 23 (2008).

The facility's dietary deficiencies, individually, presented multiple opportunities for contamination.  Beyond that, staff's apparent ignorance of, or disregard for, facility policies and basic food safety measures – particularly the importance of keeping raw

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meat away from vegetables and other foods – shows that the facility had systemic problems in implementing its policies and procedures, likely to cause serious harm to vulnerable residents.  CMS's determination that the facility's dietary services deficiencies posed immediate jeopardy to resident health and safety is therefore not clearly erroneous and must be sustained.

3. The penalties imposed are reasonable.

To determine whether the CMPs are reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  1) the facility's history of noncompliance; 2) the facility's financial condition; 3) factors specified in 42 C.F.R. § 488.404; and 4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort or safety.  The absence of culpability is not a mitigating factor.  The factors in 42 C.F.R. § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies.

I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the above factors.  I am neither bound to defer to CMS's factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS's discretion.  Barn Hill Care Ctr., DAB No. 1848 at 21 (2002); Comty. Nursing Home, DAB No. 1807 at 22 et seq. (2002); Emerald Oaks, DAB No. 1800 at 9 (2001); CarePlex of Silver Spring, DAB No. 1638 at 8 (1999).

The burden is on the facility to demonstrate that a reduction is necessary to make the CMP amount reasonable.  Heritage Plaza Nursing Ctr., DAB No. 2017 at 22 (2017).

Here, CMS imposes penalties of:

• $13,499 per day for one day of immediate jeopardy, which is in the mid-range of penalties ($6,394 to $20,965); and
• $405 per day for 77 days of substantial noncompliance that did not pose immediate jeopardy, which is at the very low end of the applicable penalty range ($105 to $6,289).

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42 C.F.R. §§ 488.408(d); 488.438; 45 C.F.R. § 102.3 (2017); 82 Fed. Reg. 9174, 9182-83 (Feb. 3, 2017).8   Considering the relevant factors, including the level of dysfunction in the facility's dietary services, these penalties are reasonable.

Petitioner maintains that it has a "very good compliance history."  P. Br. at 21.  It submits its health inspection summary from Nursing Home Compare, found on CMS's website.  P. Ex. 19.  The information provided is not especially informative for purposes of assessing whether the penalty here is reasonable, although it appears that the facility has a less than perfect history.9   Notably, during its October 2015 survey, it was not in substantial compliance with requirements that it store, cook, and serve food in a safe and clean way.  P. Ex. 19.  On the other hand, although it denies ignoring the issue (CMS Sur-Reply at 5), CMS presents no evidence of the facility's history, and has not pressed the point.  I therefore consider whether the penalties are reasonable without finding that the facility has a poor compliance history.

Petitioner does not claim that its financial condition affects its ability to pay the penalties.

Applying the remaining factors, I have discussed above the multiple, ongoing, and serious dietary deficiencies.  Staff were not properly trained, or they simply disregarded their training and engaged in unsafe practices – stacking wet pans rather than allowing them to air-dry, not ensuring that the ice machine was clean, and preparing raw meat on a cutting board above partially covered bins of vegetables.  Management ignored staff's legitimate requests; it should not be that difficult to get a replacement trash can.  In one instance, staff – including the responsible supervisor – did not even bother to ask for functioning test strips required to assure that dishes were properly sanitized.  For these failings, the facility is culpable.

I therefore find that the moderate to modest penalties imposed are reasonable.

4. CMS's determination as to the duration of the facility's substantial noncompliance is consistent with statutory and regulatory requirements.

Citing its Plan of Correction, Petitioner maintains that the facility brought itself into substantial compliance prior to April 20, 2018.

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Once a facility has been found to be out of substantial compliance (as Petitioner was here), it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again.  Ridgecrest Healthcare Ctr., DAB No. 2493 at 2-3 (2013); Taos Living Ctr., DAB No. 2293 at 20 (2009); Premier Living & Rehab Ctr., DAB No. 2146 at 23 (2008); Lake City Extended Care, DAB No. 1658 at 12-15 (1998).  The burden is on the facility to prove that it is back in compliance, not on CMS to prove that deficiencies continued to exist.  Asbury Care Ctr. at Johnson City, DAB No. 1815 at 19-20 (2002).

The facility must show that the incidents of noncompliance have ceased and that it has implemented appropriate measures to ensure that similar incidents will not recur.  Libertywood Nursing Ctr., DAB No. 2433 at 15 (2011) (citing Life Care Ctr. of Elizabethton, DAB No. 2367 at 16 (2011)); accord 42 C.F.R. § 488.454(a) and (e); Hermina Traeye Mem'l Nursing Home, DAB No. 1810 at 12 (2002) (holding that, to be found in substantial compliance earlier than the date of the resurvey, the facility must supply documentation "acceptable to CMS" showing that it was in substantial compliance and was capable of remaining in substantial compliance on the earlier date); Cross Creek Care Ctr., DAB No. 1665 (1998).  A facility's return to substantial compliance usually must be established through a resurvey.  42 C.F.R. § 488.454(a); Ridgecrest, DAB No. 2493 at 2-3.

Here, the facility's deficiencies were not the type (like a leaky roof or a broken dishwasher) that lend themselves to a quick fix.  To achieve substantial compliance, the facility had to review its practices, identify the areas of breakdown, and make changes to ensure that the problems did not recur.  Staff had to be trained to follow established practices, and management had to ensure that the new practices were being followed and that they were effective.  Until the facility could show that its training and other interventions were effective, i.e., that staff capably followed the training, that management put effective monitoring tools in place, and that those interventions resolved the problems, the facility had not met its significant burden of demonstrating that it returned to substantial compliance.  Oceanside Nursing and Rehab. Ctr., DAB No. 2382 at 19 (2011); Premier Living and Rehab. Ctr., DAB CR1602 (2007), aff'd DAB No. 2146 (2008).

The facility has thus not met its burden of establishing that it returned to substantial compliance any earlier than the date it was resurveyed, April 20, 2018.

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Conclusion

From February 1 through April 19, 2018, the facility was not in substantial compliance with Medicare program requirements and, on February 1, its food preparation and storage deficiencies posed immediate jeopardy to resident health and safety.  The penalties imposed – $13,499 per day for one day of immediate jeopardy and $405 per day for 77 days of substantial compliance that did not pose immediate jeopardy– are reasonable.

• 1. It seems that CMS subsequently removed this deficiency.  P. Ex. 2; P. Br. at 2.
• 2. I highlight, in bold, the deficiencies that are the subjects of this appeal.
• 3. My findings of fact and conclusions of law are set forth, in bold and italics, as captions in the discussion section of this decision.
• 4. CMS recognizes the FDA Food Code and CDC Food Safety Guidance as authoritative sources, setting the national standards for food safety.  CMS Ex. 11 at 2 (SOM § 483.60(i)).
• 5. Petitioner does not explain why the nurse aides' hands would not have been contaminated.
• 6. Self-defrosting freezers are designed so that the interior temperature of the cabinet keeps food at freezing temperatures, which casts doubt on one of Petitioner's explanations.
• 7. The Board's measured approach to the State Operations Manual is particularly astute, in light of the Supreme Court's views on the value of sub-regulatory guidance.  See Azar v. Allina Health Servs., 139 S. Ct. 1804 (2019).
• 8. Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case on August 13, 2018.  See CMS Ex. 12 at 2; 82 Fed. Reg. at 9182-83.
• 9. Petitioner emphasizes that it has had fewer deficiencies than average for the State of California (although not necessarily fewer than the national average).  I find it more significant that the facility had previously been cited for dietary deficiencies.