Heritage House of Richmond, DAB CR5453 (2019)

DECISION

As explained herein, I find in favor of the Centers for Medicare & Medicaid Services (CMS) against Petitioner, Heritage House of Richmond (Heritage), and sustain the imposition of a $10,391 per day civil money penalty for three days of immediate jeopardy noncompliance and a $303 per day penalty for seven days of non-immediate jeopardy noncompliance, for a total penalty of $33,294.

I. Background

Heritage is a skilled nursing facility doing business in Richmond, Indiana, certified by and participating in the Medicare and Medicaid programs. The Indiana State Department of Health (ISDH) conducted a recertification survey from November 1 to November 9, 2016. As a result, CMS found Heritage to be substantially noncompliant with Tag F371 (42 C.F.R. § 483.35(i)1  – food safety requirements) at the “L”

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scope/severity level. CMS Ex. 1 at 1.2  After a December 8, 2016 revisit survey, ISDH found that Heritage had returned to substantial compliance as of November 11, 2016. Id. at 2.

By letter dated February 21, 2017, CMS imposed a per-day penalty of $10,391 for three days of immediate jeopardy noncompliance and $303 for seven days of non-immediate jeopardy noncompliance, a total penalty of $33,294. Id. CMS adopted ISDH’s finding that Heritage returned to substantial compliance on November 11, 2016, and notified Heritage that neither the denial of payment for new admissions previously imposed by ISDH effective February 9, 2017, nor the mandatory termination set to take effect May 9, 2017, would go into effect. Id. at 1-2.

On April 21, 2017, Heritage timely requested a hearing to challenge CMS’ imposition of the penalties indicated above. Administrative Law Judge Scott Anderson was originally designated to hear and decide this case. On April 25, 2017, he issued an Acknowledgment and Pre-hearing Order (APHO), which I fully adopt, that set forth deadlines by which the parties were required to file their pre-hearing exchanges, including briefs, exhibits, witnesses, and the direct testimony of any witnesses identified. APHO at 3. 

CMS timely filed its pre-hearing exchange as well as a combined pre-hearing brief and motion for summary judgment (CMS Br.), while Heritage subsequently filed its pre-hearing exchange accompanied by a combined pre-hearing brief and response to CMS’ summary judgment motion (P. Br.). Neither party objected to the opposing party’s witnesses or exhibits nor requested cross-examination of the opposing party’s witnesses.

On August 25, 2017, this matter was transferred to me to hear and decide.

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II. Admission of Exhibits

CMS filed 13 exhibits in its pre-hearing exchange, identifying them as CMS Exs. 1 – 13. Heritage filed nine exhibits in its pre-hearing exchange, identified as Heritage Exhibits (P. Exs.) 1 – 11. There being no objection from either party, all exhibits are entered into the record.

III. A Decision on the Record is Appropriate

Neither party requested to cross-examine the opposing party’s witnesses. Therefore, a hearing is unnecessary and I will decide the matter based on the written record. See APHO at 6; Civ. Remedies Div. Pro. § 19(d). CMS’ pending summary judgment motion is denied as moot.

IV. Statement of Issues

The issues presented are:

A. Whether Heritage was in substantial compliance with 42 C.F.R. § 483.35(i) (Tag F371) at the time of the survey completed in November 2016;

B. If Heritage was not in substantial compliance, whether CMS’ immediate jeopardy determination was clearly erroneous; and

C. If Heritage was not in substantial compliance, whether the civil money penalties imposed by CMS are reasonable.

V. Discussion

To participate in the Medicare program, a skilled nursing facility must maintain substantial compliance with program participation requirements. 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. A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act, 42 U.S.C. § 1395i-3(b), (c), and (d), or the regulations at 42 C.F.R. pt. 483, subpt. B. “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.” 42 C.F.R. § 488.301.

CMS may impose enforcement remedies against a facility that is not in substantial compliance with a participation requirement. 42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406. Among these remedies, CMS may impose a per-day civil money penalty for the number of days a facility is not in substantial compliance. 42 C.F.R. § 488.430(a). A per-day civil money penalty may range from $50 to $3,000 per day for less serious

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noncompliance, adjusted annually for inflation, or $3,050 to $10,000 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents (also adjusted annually for inflation). 42 C.F.R. § 488.438(a)(1).3  “Immediate jeopardy” exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.” 42 C.F.R. § 488.301.

A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.” 42 C.F.R. § 488.408(g)(1); see also 42 C.F.R. §§ 488.330(e), 498.3. However, CMS’ 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).

A. CMS has established by a preponderance of evidence that Heritage failed to substantially comply with 42 C.F.R. § 483.35(i), Tag F371.

CMS contends Heritage violated Tag F371 by failing to sanitize dishware properly or train its staff on proper dishware sanitation methods, failing to thaw raw meat properly or train its staff to thaw raw meat properly, and failing to provide a clean and sanitary kitchen and food preparation equipment, thereby putting residents at risk of suffering harm from food-borne illness. CMS Br. at 4-9; CMS Ex. 2 at 6-11. The regulation at issue establishes the requirements for the procurement, storage, preparation, and service of food provided to facility residents, and provides, in pertinent part, that:

(i) Sanitary conditions. 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 under sanitary conditions; and

(3) Dispose of garbage and refuse properly.

42 C.F.R. § 483.35(i). CMS’ State Operations Manual (SOM) explains the intent of this requirement is “to prevent the outbreak of foodborne illness,” which poses a special risk to nursing home residents who face potentially “serious complications from foodborne illness as a result of their compromised health status.” CMS Ex. 13 at 2, 3 (emphasis omitted). The SOM provides detailed requirements and guidance for how properly to store, prepare, distribute, and serve food to comply with the regulation and minimize the potential for such illness. CMS Ex. 13. CMS alleges Heritage did not substantially comply with the second regulatory requirement by failing to store, prepare, distribute, and serve food under sanitary conditions. CMS Br. at 3. As explained below, I concur and find Heritage did not substantially comply with this requirement.

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1. Heritage did not sanitize dishware properly or train its staff on proper dishware sanitation methods.

During the survey period that began November 1, 2016 and ended November 9, 2016, ISDH surveyor Leslie Parrett inspected the kitchen, food storage, and food service areas of the facility. She observed residents using non-disposable dishware, dessert bowls, coffee cups, carafes, and water pitchers. CMS Ex. 12 at 2 ¶ 8. Because the facility’s dishwasher had broken prior to the survey, Heritage staff used a three-compartment sink to wash dishes manually. Id. Surveyor Parrett observed the absence of piled-up dirty dishes and inferred that Heritage’s staff was cleaning dishware, pots, and pans manually in the sink. Id.

Heritage does not challenge her observations; indeed, facility dietary manager Kimberly Lewis confirmed Heritage was “manually washing coffee cups, carafes and some dessert plates.” P. Ex. 5 at 1. Ms. Lewis also claimed the facility was using disposable dinnerware for meals, but based on the surveyor’s uncontested observations, I find it more likely than not that Heritage was cooking food and serving residents food and beverages with pots, pans, dishware, and related items that had been cleaned in the sink.

The SOM observes that “[a] potential cause of foodborne outbreaks is improper cleaning (washing and sanitizing) of contaminated equipment. Protecting equipment from contamination via splash, dust, grease, etc. is indicated.” CMS Ex. 13 at 16. It instructs facilities to use a 3-step process “to manually wash, rinse, and sanitize dishware correctly.” Id. First, dishware should be “thorough[ly] wash[ed] using hot water and detergent after food particles have been scraped.” Id. Second, dishware should be “rins[ed] with hot water to remove all soap residues.” Id. at 16-17. Third, dishware should be “sanitiz[ed] with either hot water or a chemical solution maintained at the correct concentration . . . for the effective contact time according to manufacturer’s guidelines.” Id. at 17. 

Regarding chemical sanitizers, the SOM primarily instructs facilities to follow the manufacturer’s guidelines, but also includes recommendations for concentrations and contact time (i.e., duration of object immersion in sanitizer solution): for chlorine (50-100 parts per million (ppm) minimum, 10 second contact time); iodine (12.5 ppm minimum, 30 second contact time); and Quaternary sanitizer (150-200 ppm minimum, contact time per manufacturer’s instructions). Id.

Heritage’s sanitation policy addressed the use of sanitizing solution when manually washing dishes. CMS Ex. 6. According to the facility policy, Heritage could use two types of chemical sanitizer: chlorine bleach or “Quat” (referring to sanitizers containing quaternary ammonium compounds). Id. When “mixing the chemical with water to prepare the proper strength, the [] manufacturer’s instructions must be followed and a test strip must confirm the proper dilution.” Id. Heritage’s policy indicated the proper

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concentration of Quat sanitizer to be 200 ppm. Id. This concentration is consistent with the Quat manufacturer’s recommendation of a concentration in the range of 150-400 ppm and the SOM’s recommendation of 150-200 ppm. CMS Ex. 5, CMS Ex. 13 at 17. Heritage’s policy required contact time of 30 seconds. CMS Exs. 3, 6. By contrast, the Quat manufacturer recommended a contact time of “not less than one minute.” CMS Ex. 5.

Surveyor Parrett interviewed several members of Heritage’s dietary staff, including two dietary aides. CMS Ex. 12 at 2 ¶¶ 9-11. One aide was unsure what type of sanitizer was in use and incorrectly believed the correct concentration of sanitizer to be 100-175 ppm. Id. at 2 ¶ 9. A second aide tested the sanitized water and found it to be at 150 ppm concentration, but did not know whether a reading of 150 ppm was adequate. Id. at 2 ¶ 10. The second aide informed Surveyor Parrett she had only been working at the facility for a month and a half and was not familiar with the test reading. CMS Ex. 2 at 9. Surveyor Parrett also observed the second aide “quickly dunk[]” dishware in the sanitized water for less than five seconds. CMS Ex. 12 at 2 ¶ 10; CMS Ex. 2 at 9.

Heritage does not dispute that the two dietary aides the surveyor interviewed were unfamiliar with the appropriate concentration range for Quat sanitizer, that one of the aides improperly sanitized dishware, or that the sanitizer was at a concentration below the level called for in its own policy. P. Br. at 7, 9. Instead, Heritage points out Surveyor Parrett observed dietary aides washing dishes in both the morning and afternoon and only reported problems in the afternoon, suggesting there were no problems in the morning. P. Br. at 6. Heritage also claims it had previously provided training to its staff on its procedures for manual washing and sanitizing dishware, and did so again within fifteen minutes of Surveyor Parrett’s observation of improper sanitization. Id. at 6-7. Heritage notes that testing of the sanitizer solution observed in use by the surveyor actually revealed it to be at a concentration recommended by the manufacturer, 150 to 400 ppm (400 ppm in the morning and 150 ppm in the afternoon). Id. at 7. Finally, Heritage asserts that it reviewed its residents’ records and found no evidence of illness, essentially arguing no harm resulted from the alleged deficiencies. Id.

None of Heritage’s claims undermine the surveyor’s observations, which demonstrate Heritage failed to meet the requirements of its own sanitation policy. A concentration of 150 ppm may have met the low end of the manufacturer’s suggested concentration range, but was 25 percent lower than the minimum concentration called for in Heritage’s own policy, a fact unnoticed by the dietary aide who did the testing. CMS Ex. 6; CMS Ex. 12 at 2 ¶ 10.

Even assuming the concentration of sanitizer was adequate, Heritage’s sanitation policy failed to comport with the manufacturer’s instruction to submerge objects in the sanitized water for not less than one minute, as it instead required only 30 seconds of

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submersion. CMS Exs. 3, 5, 6; CMS Ex. 13 at 17. And even if Heritage’s sanitation policy was adequate, the facility employees’ conduct does not bear out Heritage’s claim that it adequately trained its employees regarding its sanitation policy. One dietary aide submerged dishware in sanitized water for only a few seconds, far less than the 30 seconds called for by Heritage’s policy. CMS Ex. 12 at 2 ¶ 10; CMS Ex. 2 at 9; CMS Ex. 6. Both dietary aides were altogether unfamiliar with the proper concentration of sanitizer, and one did not know which sanitizer was in use and believed the proper concentration range to be less than the minimum concentration called for by Heritage’s policy. CMS Ex. 12 at 2 ¶¶ 9-10. In sum, there is sufficient evidence in the record before me to conclude that Heritage did not follow its own sanitation policy and did not adequately train its dietary staff. 

2. Heritage did not thaw raw meat properly or train its staff on how to thaw raw meat properly.

The SOM notes that thawing is part of food preparation and that “[i]dentification of potential hazards in the food preparation process and adhering to critical control points can reduce the risk of food contamination and thereby prevent foodborne illness.” CMS Ex. 13 at 10, 11 (emphasis omitted). The SOM lists proper methods for thawing frozen food, one of which is to “[c]ompletely submerge[e] the item under cold water (at a temperature of 70 degrees F or below) that is running fast enough to agitate and float off loose ice particles.” CMS Ex. 13 at 11. The SOM forbids thawing food at room temperature “because the food is within the danger zone for rapid bacterial proliferation.” Id.

Like the SOM, Surveyor Parrett observed in her declaration that “[i]mproper thawing can cause harmful bacteria to grow in the meat that is not killed by cooking,” posing a risk of “serious illness or death in the people eating the meat.” CMS Ex. 12 at 3 ¶ 14. She further stated that nursing home residents, “because of their age and health, are especially susceptible to foodborne illnesses,” which can cause “severe sickness [or] death.” CMS Ex. 12 at 4 ¶ 21.

Heritage had a policy concerning the proper method to thaw food, requiring frozen food to be “[s]ubmerged under running potable water, at a temperature of 70 [degrees] F or lower” with “[w]ater flow . . . strong enough to wash loose food particles into the overflow drain.” CMS Ex. 7.

On the first day of the survey, facility co-dietary manager Jennifer Hill “was the lead cook” on duty. P. Ex. 3 at 1 ¶ 3. The menu for the day included cheeseburgers for dinner, and she was solely responsible for thawing meat. P. Ex. 3 at 1, 2 ¶¶ 4, 8. Ms. Hill stated that at approximately 2:00 p.m., she put frozen ground beef in a plastic container, which she then placed in the sink. P. Ex. 3 at 1 ¶ 4. She “turned the cold water on to run over the meat in the container” and then left the facility to purchase

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additional ingredients for the evening meal. P. Ex. 3 at 1 ¶¶ 4, 5. In her absence, an unknown individual turned off the water. P. Ex. 3 at 1 ¶ 6. Before Ms. Hill’s return, Surveyor Parrett asked a dietary aide about the meat. CMS Ex. 12 at 3 ¶ 13; P. Ex. 2 at 1 ¶ 4. On her return, Ms. Hill asked the aide why the water was not running. P. Ex. 3 at 1 ¶ 6. The aide did not know who turned off the water, but told Ms. Hill that a surveyor had poked the meat with her finger and asked how long it had been there. P. Ex. 2 at 1 ¶ 5; P. Ex. 3 at 1-2 ¶ 6. At that point, Ms. Hill thought “the only thing to do was throw the meat away.” P. Ex. 3 at 2 ¶ 6.     

Heritage disputes Surveyor Parrett’s testimony that a dietary aide informed her she had been using hot water from a coffee maker to thaw meat, testimony upon which CMS relies in part. P. Br. at 5-6; CMS Br. at 7. I need not address this factual dispute. The evidence discussed above is undisputed and confirmed by Heritage’s own documents and witnesses. Heritage concedes that the ground beef “was not being thawed properly.” P. Br. at 9. While Ms. Hill was the person responsible for thawing the meat that day, another individual turned off the water running over the meat in her absence. P. Ex. 3 at 1 ¶ 6. This uncontested sequence of events demonstrates Heritage’s staff acted contrary to the facility’s policy and the SOM. CMS Ex. 13 at 11; CMS Ex. 7. 

Heritage argues this should not amount to a deficiency at all, since Ms. Hill ultimately discarded the meat. P. Br. at 9. This assertion is without merit. It seems plain from Ms. Hill’s statement that she felt she had no choice but to discard the meat after discovering a surveyor had observed it being improperly thawed. P. Ex. 3 at 1 ¶ 6. I cannot say from the record before me that the ground beef would not have been served absent the surveyor’s intervention. But I need not speculate as to what Ms. Hill might have done, because it is undisputed that another member of Heritage’s staff acted without regard for the facility’s policy by simply turning the water off, leaving meat that was to be served to Heritage’s residents thawing in an unsafe manner. That individual was clearly not trained properly as to Heritage’s meat thawing policy or the dire consequences of allowing food to thaw at room temperature, where it was subject to “rapid bacterial proliferation.” CMS Ex. 13 at 11. Accordingly, the record amply supports the conclusion that the facility failed to follow safe thawing procedures and that it had not adequately trained its staff as to its own policy.

3. Heritage did not keep its kitchen, food storage area, and food preparation equipment in sanitary condition.

The SOM contains guidelines for sanitizing areas and equipment used for food storage and preparation. Regarding non-refrigerator storage, the SOM states, “The focus of protection for dry storage is to keep non-refrigerated foods, disposable dishware, and napkins in a clean, dry area, which is free from contaminants.” CMS Ex. 13 at 9. As improper cleaning of contaminated equipment may cause foodborne illness, the SOM instructs that “[w]hen cleaning fixed equipment (e.g., mixers, slicers, and other

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equipment that cannot readily be immersed in water), the removable parts are washed and sanitized and non-removable parts are cleaned . . . and any food contact surfaces that may have been contaminated . . . are re-sanitized . . . .” CMS Ex. 13 at 16, 17.

Heritage had a six-step process for manually washing pots and pans. CMS Ex. 4. The first two steps detail how to properly fill the three-compartment sink. Id. at 1. Step 3 instructs staff to pre-scrape pots and pans; soak them for 5-10 minutes, depending on soil level; scrub all surfaces; and allow excess to drain into the first sink compartment. Id. at 2. Step 4 gives instructions for rinsing, step 5 gives instructions for sanitizing, and step 6 gives instructions for air drying. Id. at 1-2. This process is consistent with the SOM’s guidance for manual washing of dishware, which I have already discussed. See CMS Ex. 13 at 16-17.

Surveyor Parrett observed multiple unsanitary conditions in the facility. She saw “dust hanging from a ceiling vent in a storage area . . . contain[ing] dry ingredients in bins” that “could be contaminated by dust falling onto or into the bins.” CMS Ex. 12 at 3 ¶ 16. She observed “a black substance on the floor around the walls . . . indicat[ing] that the floor was not being properly cleaned.” Id. at 3 ¶ 17. She “noticed dried food debris in the kitchen’s light covers, the meat slicer, the stand-up mixer, the vent hood, and on the kitchen clock,” which posed “a risk that the debris could fall into food or onto the surfaces where food was prepared” and “indicated that the staff was not cleaning these surfaces and equipment.” Id. at 3 ¶ 18. 

Surveyor Parrett opined that the vent hood food debris posed a special risk because it “was above the stove” and “[s]team from open pots rises into the vent[, which] could loosen the debris stuck to the hood and potentially dislodge it to fall into the food being cooked. Id.at 3 ¶ 19. Finally, the surveyor “observed that cooking pans had burnt pieces stuck to them,” which “indicated the pans were improperly cleaned and the burnt pieces could contaminate whatever food was cooked next in the pans.” Id. at 4 ¶ 20.

Heritage does not dispute any of the surveyor’s observations detailed above. See P. Br. at 5, 9. The facility instead asserts that it corrected the unsanitary conditions related to pans and surfaces observed by Surveyor Parrett before serving residents their next scheduled meal. P. Br. at 9; see also P. Ex. 5 at 1-2. But Heritage’s swift response to Surveyor Parrett’s concerns does not undermine the fact that Heritage’s kitchen, food storage area, and food preparation equipment were not in sanitary condition at the time of the survey. The surveyor’s observations support the inference that the unsanitary conditions were not a temporary condition that arose over a short period between meals that had no potential to affect resident food service. By contrast, no evidence supports an inference that, absent the surveyor’s intervention, Heritage would have addressed these unsanitary conditions before serving food to its residents.

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4. Heritage’s failure to maintain sanitary conditions and practices related to food storage, preparation, and distribution violated 42 C.F.R. § 483.35(i), Tag F371, and posed a risk of more than minimal harm to resident health and safety.

Heritage was required to “[s]tore, prepare, distribute, and serve food under sanitary conditions.” 42 C.F.R. § 483.35(i)(2). As shown above, Heritage did none of these things. Unsanitary conditions were ubiquitous throughout all stages of food service, from storage through delivery of food to the residents. Heritage does not dispute the existence of many of the unsanitary conditions and practices identified by the surveyor. The unsanitary conditions and practices described above violated 42 C.F.R. § 483.35(i), Tag F371.

At the time of the survey, 70 of Heritage’s 72 residents ate food Heritage prepared and served. CMS Ex. 2 at 6-7; CMS Ex. 12 at 4 ¶ 21. By virtue of their presence at a skilled nursing facility, these residents collectively faced a heightened risk of contracting foodborne illness and suffering serious complications from such illness. CMS Ex. 12 at 4 ¶ 21; CMS Ex. 13 at 3. Though it did not agree with CMS’ severity level assessment, Heritage did concede that its residents were placed at risk of harm from its violation of the regulation, opining “the undisputed findings . . . warrant a severity level of ‘F,’” which corresponds to a widespread potential for more than minimal harm. P. Br. at 11. Thus, I have no difficulty concluding Heritage’s failure to store, prepare, distribute, and serve its food under sanitary conditions posed the potential of widespread and more than minimal harm to all 70 of the residents who ate food Heritage prepared and served.

B. CMS’ immediate jeopardy determination is not 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 that a resident actually be harmed. Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012). I must uphold CMS’ 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). The “clearly erroneous” standard imposes on facilities a heavy burden to show no immediate jeopardy, and the Departmental Appeals Board (DAB) has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.” See, e.g., 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. App’x 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

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whether, ‘on the entire evidence,’ it is ‘left with the definite and firm conviction that a mistake has been committed.’”).

In this case, CMS determined Heritage’s deficiencies related to food safety posed widespread immediate jeopardy to its residents. CMS Ex. 1 at 1. On this record, I cannot say I am left with a firm conviction that CMS’ determination was clearly erroneous. Heritage had multiple shortcomings in its food storage, preparation, and service practices. It failed to thaw raw meat properly or train its dietary staff to thaw raw meat properly. It failed to clean and sanitize dishware and pots used to prepare and serve food for residents, and it failed to ensure its dietary staff were trained on how to clean and sanitize such items properly. It failed to maintain its kitchen, food storage area, and food preparation equipment in sanitary condition. 

All of these failures increased the risk of inflicting foodborne illness on Heritage’s vulnerable residents, who already were “especially susceptible to foodborne illnesses,” CMS Ex. 12 at 4 ¶ 21, and “risk[ed] serious complications from foodborne illnesses as a result of their compromised health status,” CMS Ex. 13 at 3 (emphasis omitted). Ms. Hill may have thrown improperly thawed the meat out, but she did so only after she learned the surveyor asked about the meat. P. Ex. 3 at 1-2. Similarly, Surveyor Parrett’s observations concerning chronic unsanitary conditions – a black substance on the floor around the walls, dried food debris on various surfaces including the vent hood and food equipment – suggest a persistent neglect of sanitary requirements. CMS Ex. 12 at 3. The overall lack of compliance with sanitary standards suggests to me residents were still otherwise in danger even on days ground meat was not served.

In response, Heritage argues principally that the facts “do not support . . . a declaration of immediate jeopardy” because its noncompliance “did not allow/cause/result in, nor [was it] likely to allow/cause/result in, serious harm to a resident.” P. Br. at 9, 10. Specifically, Heritage asserts that: (1) no evidence shows any resident suffered harm from its noncompliance; (2) the dietary aide’s failure to submerge dishware long enough was an isolated incident; (3) the dietary aides’ unfamiliarity with the appropriate concentration of sanitizer posed no immediate threat, as the sanitizer was at a level recommended by the manufacturer; (4) the improperly thawed raw meat “was never in danger of being served to the residents”; (5) before serving another meal to residents, staff cleaned all the unsanitary objects and surfaces pointed out by the surveyor and were in-serviced on proper cleaning and sanitizing policies and procedures; and (6) no improperly sanitized dishes were served to residents. Id.

Heritage also asserts that Tag F371 is rarely, if ever, cited above an “F” scope/severity level, citing past DAB cases and its review of statements of deficiencies from Indiana from the past two years. Id. at 8. Finally, Heritage contends that the facts of this case more closely resemble examples of non-immediate jeopardy noncompliance given in the SOM, rather than examples of immediate jeopardy noncompliance. Id. at 11.

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Heritage’s arguments are unpersuasive. The fact that none of the residents were harmed by Heritage’s deficient and unsanitary food storage, preparation, and service practices simply reflects the facility’s very good fortune. It does not lead me to conclude that CMS’ finding of immediate jeopardy was clearly erroneous. See Lakeport, DAB No. 2435 at 8 (“[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). 

And as I have already discussed, the nature of the deficiencies observed by the surveyor and the lack of basic awareness of the dietary aides concerning the facility’s sanitation policy clearly suggest more than an isolated one-time failure to comply. Instead, it appears the facility had not been properly cleaning its kitchen facility for some time. Such unfamiliarity by facility staff clearly posed a threat, contrary to Heritage’s claims, in that they had no idea what level of sanitation concentration was appropriate. Even if they had accidentally used an appropriate concentration of sanitizer, as the facility alleges, they were not aware of the proper duration of immersion in sanitizer. Despite the facility’s bald assertion to the contrary, nothing in the record suggests to me that the improperly thawed meat would not have been served to the residents. In addition, Heritage’s swift reaction to correct deficiencies observed by a surveyor does not absolve the facility for failing to follow its own procedures and avoid those deficiencies in the first place. The fact that improperly sanitized dishes were not provided to residents is, again, another instance of good fortune. It does not suggest a finding of immediate jeopardy was improper.

Heritage’s claim that a finding of immediate jeopardy under Tag F371 is improper simply because no other facility in Indiana has been found deficient under that tag at the level of immediate jeopardy is without merit and does not require further explanation to reject. The facility’s claim that examples in the SOM undermine a finding of immediate jeopardy is equally without merit. Indeed, one of the examples of immediate jeopardy contained in the SOM contemplates the danger of contamination from improperly thawed meat: “A roast (raw meat) thawing on a plate in the refrigerator has bloody juices overflowing and dripping onto uncovered salad greens on the shelf below. The contaminated salad greens were not discarded and were used to make salad for the noon meal.” P. Ex. 10 at 2. In this case, Heritage’s failure to thaw raw meat properly could have led to a similar form of exposure to residents, had it served the improperly thawed meat. I see no basis to conclude a finding of immediate jeopardy is inappropriate.

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C. The $10,391 and $303 per-day civil money penalties imposed by CMS are reasonable.

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.

Neither CMS nor Heritage argue compliance history or financial condition are factors affecting the penalty amount. Considering the remaining factors, I conclude, based on the record before me, that Heritage’s noncompliance was very serious. The evidence shows, and Heritage does not dispute, that nearly all of the residents consumed food Heritage prepared and served. CMS Ex. 2 at 6-7; CMS Ex. 12 at 4 ¶ 21. Heritage similarly does not dispute that the residents, due to their advanced age and fragile health, were at heightened risk of contracting foodborne illness and suffering serious complications from such illness. CMS Ex. 12 at 4 ¶ 21; CMS Ex. 13 at 3. But despite having policies in place to assure proper sanitization of food dishware, pots, and pans, Heritage failed to ensure its food storage, preparation, and service practices adhered to those policies and guidance. Thus, Heritage subjected its elderly residents to an unnecessary and potentially dangerous risk of exposure to foodborne illness. Its apparent good fortune that none of its residents actually fell ill because of its noncompliance does not belie the seriousness of these deficiencies.

I must also consider culpability. I do not believe Heritage intended neglect, indifference, or disregard for its residents. Nevertheless, some level of culpability is apparent here, given the persistence and ubiquity of unsanitary conditions in the food storage and preparation areas, as well as the lack of adequate training reflected by the dietary staff’s limited knowledge of proper sanitation methods. The likelihood of harm to elderly residents that could stem from poor food sanitation and inadequate training of staff concerning food safety should have been clear to health care professionals operating a skilled nursing facility.

For these reasons, I find CMS’ imposition of a $10,391 per day civil money penalty for three days of immediate jeopardy noncompliance and a $303 per day civil money penalty for seven days of non-immediate jeopardy noncompliance, a total penalty of $33,294, to be reasonable.

1. CMS subsequently re-housed this regulation at 42 C.F.R. § 483.60(i), with some revisions. 81 Fed. Reg. 68,688, 68,861, 68,865 (Nov. 28, 2016). CMS now associates failure to satisfy food safety requirements with Tag F812. State Operations Manual (SOM) Appendix PP at 587, available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Downloads/Appendix-PP-State-Operations-Manual.pdf (last rev. Nov. 22, 2017). These changes have no bearing on the facts of this case, and there is no substantive change in the guidance provided in the SOM. I will therefore continue to refer to Tag F371 and the regulation in effect at the time of the survey.
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2. CMS initially cited Heritage with three other instances of noncompliance under Tags F272, F314, and F323 but has presented no evidence or arguments to me concerning those citations. CMS Exhibit (Ex.) 1 at 1. I need not address them because I conclude Heritage’s noncompliance with Tag F371 supplied an adequate basis for the penalties imposed by CMS irrespective of Heritage’s compliance with Tags F272, F314, and F323. See Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 847 (6th Cir. 2010) (“It is neither arbitrary nor capricious for the agency to conclude that, in the interests of judicial economy, it will review only those deficiencies that have a material impact on the outcome of the dispute.”).
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3. The penalty ranges in effect during the survey were $103 to $6,188 for less serious noncompliance and $6,291 to $20,628 for immediate jeopardy noncompliance. 45 C.F.R. § 102.3.
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