CASE | DECISION |JUDGE | FOOTNOTES

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
IN THE CASE OF  


SUBJECT:

Green Arces Manor,

Petitioner,

DATE: October 31, 2003
                                          
             - v -

 

Centers for Medicare & Medicaid

 

Docket No.C-02-794
Decision No. CR1100
DECISION
...TO TOP

DECISION

I uphold CMS's determination to assign the immediate jeopardy level of severity to the failure of Green Acres Manor (Petitioner or Facility) to comply with 42 C.F.R. § 483.35(h)(2). Section 483.35(h)(2) requires that a facility store, prepare, distribute, and serve food under sanitary conditions. Petitioner has not proven that CMS's determination that the deficiency presented immediate jeopardy was clearly erroneous. The evidence supports CMS's determination that, absent the intervention of a State surveyor, residents at Green Acres Manor would have been served unsanitary, hazardous food and that this would likely have caused the residents serious injury, harm, impairment, or death. I conclude that the civil money penalty CMS seeks to impose, $5,000, is a not a reasonable amount, rather $3,050 is a reasonable amount.

1. Background

This matter is before me on Petitioner's request for a hearing filed August 9, 2002 pursuant to 42 C.F.R. § 498.40. Petitioner's request stems from CMS's notice dated August 1, 2002, that informed Petitioner of the imposition of a $5,000 civil money penalty for a deficiency at the immediate jeopardy level of severity. The parties requested that I establish a schedule for motions and briefs, which I did by order dated January 7, 2003. In accordance with my order, I received the parties' Joint Stipulations of Fact on March 12, 2003. On March 24, 2003 I received the parties' Supplemental Joint Stipulations of Fact, CMS's Memorandum of Law in Support of CMS's Motion for Judgment (CMS's Brief), and the Brief on Behalf of Petitioner Green Acres Manor (Petitioner's Brief). On April 14, 2003 I received Petitioner's letter brief in response to CMS's Motion for Judgment (Petitioner's Reply), and CMS's Reply to Petitioner's Brief (CMS's Reply).

Petitioner submitted 13 numbered and marked exhibits (P. Exs.), including, as marked exhibits, the written declarations of Petitioner's witnesses. CMS submitted 17 numbered and marked exhibits (CMS Exs.), including, also as marked exhibits, the declarations of CMS's witnesses. Neither party objected to the exhibits, including declarations, of the other. Without objection I admit P. Exs 1-13 and CMS Exs. 1-17.

Although the briefing was initiated by CMS's motion, the parties agreed that it is appropriate for me to decide this case on the record without an oral hearing. In a letter dated December 17, 2002, Petitioner wrote "at this time it is Petitioner's position that this matter may be resolved through a review of only the documentary evidence." Following that letter, the parties submitted the briefs and exhibits, including witness statements, for my consideration. I construe Petitioner's statement in the letter and subsequent filings to be a waiver of oral hearing pursuant to 42 C.F.R § 498.66.

There are two issues before me: (1) whether CMS's determination to assess the deficiency under section 483.35(h)(2) at the immediate jeopardy level of severity is clearly erroneous; and (2) whether the amount of the civil money penalty, $5,000, is reasonable. Petitioner does not contest the deficiency under section 483.35(h)(2) itself, nor does it contest any other deficiency cited in the June 4, 2002 survey. See Supplemental Joint Stipulations of Fact.

2. Law

CMS has the authority to enforce Medicare participation by surveying facilities, or delegating surveying duties to State survey agencies, and imposing remedies, including civil money penalties, for the failure of a facility to substantially comply with participation requirements. See 42 C.F.R. Part 488. Affected parties may appeal the imposition of civil money penalties. See 42 C.F.R. § 498.40.

In this case, CMS imposed a $5,000 civil money penalty for Petitioner's failure to substantially comply with section 483.35(h)(2) at the immediate jeopardy level. Section 483.35 sets forth the dietary services requirements. Section 483.35(h)(2) provides that a facility must "[s]tore, prepare, distribute, and serve food under sanitary conditions."

Immediate jeopardy is defined as a situation in which 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. Immediate jeopardy does not require actual harm but encompasses a situation that is "likely" to cause harm. Good Samaritan Center, DAB No. 1844 (2002); Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002); Southridge Nursing and Rehabilitation Center, DAB No. 1778 (2001); Westgate Healthcare Center, DAB No. 1821 (2002).

When an affected party appeals CMS's finding of a deficiency, CMS bears the burden of coming forward with evidence sufficient to establish a prima facie case, while the petitioner must come forward with evidence sufficient to establish the elements of any affirmative arguments or defenses. The preponderance of the evidence standard applies in that situation. Hillman Rehabilitation Center, DAB No. 1611 (1997); aff'd Hillman Rehabilitation Center v. United States, No. 98-3789(GEB) (D.N.J. May 13, 1999). But, as in the instant matter, where CMS's determination as to the level of noncompliance only is at issue, CMS's determination must be upheld unless it is clearly erroneous. 42 C.F.R. § 498.60(c)(2). The burden is on the petitioner to prove that the determination was clearly erroneous. Woodstock Care Center, DAB No. 1726, at 9 (2000).

Concerning the reasonableness of a civil money penalty, the range of civil money penalties that CMS may impose for an immediate jeopardy level deficiency is from $3,050 to $10,000 per day for each day that the deficiency persists. 42 C.F.R. § 488.438(a)(i). The amount of penalty assessed in a given case depends on factors which may include: a facility's history of noncompliance, its financial condition, its culpability, the seriousness of a deficiency or deficiencies, and, the relationship of one deficiency to another. 42 C.F.R. § 488.438(f); 42 C.F.R. § 488.404(b), (c) (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).

3. Findings and Discussion

A. CMS's determination to assess the deficiency under 42 C.F.R. § 483.35(h)(2) at the immediate jeopardy level is not clearly erroneous.

After reviewing the exhibits and considering the arguments of the parties, I conclude that it was not clear error for CMS to determine it likely that residents would be seriously harmed by unsanitary food. The facts are consistent with at least some of the food present at the facility becoming hazardous due to its being stored at temperatures conducive to the development of harmful bacteria. And, the facts also support CMS's determination that hazardous food likely was, or likely would have been, served to residents.

The deficiency in this case is not disputed: Petitioner failed to store food under sanitary conditions when it allowed its walk-in refrigerator, that was supposed to be kept at temperatures of approximately 40-45 degrees Fahrenheit, to warm up to approximately 65 degrees Fahrenheit. As I discuss in detail below, the potential for food to become hazardous due to this lapse is not disputed, nor is it disputed that the potential health consequences for nursing home residents are very serious if they are exposed to hazardous food. Thus, the issue is essentially which party is correct about whether hazardous or potentially hazardous food was likely to have been actually served to residents. CMS maintains that it is likely the facility would have served hazardous food if the surveyor from the New Jersey State Department of Health and Senior Services, Yvonne Dixon, had not discovered the refrigerator was switched off and prompted the facility to take the prophylactic measure of discarding the food that had been stored in it. Petitioner counters that it is not likely that residents would have been served hazardous food because its staff would have noticed the warm up in time, and its meal preparation schedule and procedures had taken any susceptible food out of harms way before warm temperatures could have affected it. It is not sufficient, however, for Petitioner to offer a mere plausible competing theory under its burden in this appeal. Below, I first discuss the significance of Petitioner's heightened burden to my analysis. Then I discuss the undisputed facts, starting with an explanation of the perishable food storage guidelines and hazards, followed by the undisputed background facts. Finally, I discuss the parties arguments, my resolution of the disputed facts, and why I am not persuaded that CMS committed clear error in deciding that it was likely residents would be placed in immediate jeopardy by the facility serving them hazardous food.

The clearly erroneous standard of proof requires Petitioner to show more than an alternative plausible theory of the case. When a deficiency presents the likelihood of serious injury, harm, impairment or death of a resident or residents it rises to the severity level of immediate jeopardy. The determination that a deficiency reaches the immediate jeopardy level is CMS's assessment. In the instant matter, the question before me is whether CMS's assessment is clear error, because the regulations provide that CMS's severity determination must be upheld unless it is clearly erroneous. 42 C.F.R. § 498.60(c)(2). This is a higher standard of proof than applies under 42 C.F.R. Part 498 to appeals where a party contests the underlying deficiency itself. The clearly erroneous or clear error standard is higher than the preponderance of the evidence standard that applies to a petitioner's appeal on the merits of deficiency determinations. When it is the assessment of immediate jeopardy scope and severity that is being reviewed, the underlying deficiencies are established already. Because in this case the deficiency is established and Petitioner challenges only the severity of the determination, Petitioner cannot prevail by presenting merely an alternative plausible theory of the case. Petitioner is required to prove that CMS was clearly wrong about the likelihood of the serious harm befalling the residents- this is a high standard.

Perishable food must be stored in cold temperatures or it becomes hazardous- this is not disputed. It is also not controversial that the hazards associated with spoiled food can have especially severe consequences for the infirm and the elderly. These facts are reflected in the Facility's own internal food sanitation literature, guidance published by the FDA, and in food sanitation regulations promulgated by the State of New Jersey.

The Facility's own food spoilage guide instructs its food service staff to keep all perishable foods refrigerated at 45 degrees Fahrenheit or less, and the guide provides that when assessing risk, staff should discard food if they have any doubt whether it has spoiled (this guideline is made memorable by the phrase when in doubt throw it out). P. Ex. 10, at 1-2. The Facility's guide instructs staff also that "any food that has not been refrigerated below 45 degrees may be considered slightly spoiled," and that "bacterial spoilage begins as soon as food becomes warm." P. Ex. 10, at 1-2. The Facility's sanitation literature acknowledges also that quick bacteria growth in the 40-140 degrees Fahrenheit range can "cause sickness and sometimes death." P. Ex. 10, at 8.

The FDA has developed code concerning food service sanitation which further illustrates the hazards and recognized precautions associated with food storage temperatures. The FDA calls for maintaining refrigerator temperatures at 41 degrees Fahrenheit or below. CMS Ex. 12 (2001 FDA Food Code §§ 3-501.11 - 501.12, 3-501.16). In separately published advisory materials, the FDA Center for Food Safety and Applied Nutrition warns that above the recommended temperature bacteria can double in food every 20 minutes. CMS Exs. 15;14. In the advisory materials, the FDA recommends a refrigeration temperature of no higher than 40 degrees and refrigeration of "perishables" within two hours. CMS Ex. 14, at 7. The FDA explains that severe symptoms can result from bacteria, and that foodborne illness often presents flu-like symptoms, such as nausea, vomiting, diarrhea, and fever, so people may not recognize that a foodborne pathogen is the source of the illness. CMS Ex. 15, at 2-4, 9.

As a New Jersey nursing home the Facility must obey the New Jersey sanitation laws. The hazards associated with bacteria growth in perishable foods are also evident in requirements set forth in the New Jersey Code. The New Jersey Code requires that certain foods be stored at 45 degrees Fahrenheit or below (except when being prepared). It also requires that potentially hazardous foods shall not be held above 45 degrees Fahrenheit for more than four hours, or they cannot be used or sold, and that potentially hazardous foods must be refrigerated after preparation and should be rapidly cooled to below 45 degrees. CMS Ex. 13 ( N.J. A.C. (Sanitary Code) 8:24-3.2). The New Jersey Code defines "potentially hazardous food" as any food in whole or part milk product, or eggs, meat, poultry, fish, and shell fish in a form capable of supporting rapid and progressive growth of infections or toxigenic microorganism or slower growth of C. botulinum. CMS Ex. 13 (N.J. Admin. code tit. 8, section 24-1.3).

The hazards from spoiled food present a special concern for seniors and other nursing home residents. CMS noted that the purpose of sanitation regulation is to prevent food borne illness because such illnesses can be fatal to nursing home residents. CMS's Brief at 14. CMS posits that nursing home residents may be members of a "highly susceptible population" as defined in ¶ 44 of the FDA food safety code. CMS Ex. 12, at 22. As described by the FDA, these are persons more likely then the general population to experience food borne disease.

The hazards of improper food storage and the heightened concern when the consumers are nursing home residents emphasizes that the question in this case is whether potentially hazardous food likely was served or would have been served. The seriousness of the harm or potential harm to residents once spoiled food has been served is not disputed.

The failure to store food at appropriate temperatures constitutes substantial noncompliance with 42 C.F.R. § 483.35(h)(2). The fact of the deficiency with this requirement and some other situational facts concerning the survey on May 28, 2002 are not disputed. The parties agree that at approximately at 9:15 a.m., the surveyor, Yvonne Dixon, discovered that the Facility's walk-in refrigerator had been switched off and that the temperature inside had risen to 64 degrees Fahrenheit. P. Ex. 2; Joint Stipulations at 3,4, ¶¶ 11-12. A sign posted above the power switch on the refrigerator reminded staff not to turn the refrigerator off. Joint Stipulations at 4, ¶ 13. Perishable food including liquid eggs, milk, cottage cheese, coleslaw, cold cuts, eggs, cheese, tuna fish, raw fish, mayonnaise, juices, salad dressings, and bags of defrosted ground meat were stored inside the refrigerator. Joint Stipulations at 4, ¶14. In the refrigerator was also a container of milk in a bowl of ice and water. Ms. Dixon took the temperature of the milk and discovered it was 58 degrees Fahrenheit. Joint Stipulations at 4, ¶ 15.

The Facility's food service director, Mr. Buluan, told Ms. Dixon that the Facility's cook recorded the refrigerator's temperature at 5:00 a.m. the morning of the survey as 40 degrees Fahrenheit. Joint Stipulations at 4, ¶16. Mr. Buluan told Ms. Dixon also that he did not know who turned the refrigerator off or how long it had been off. Joint Stipulations at 4, ¶16. The Facility kept a temperature log; the entry for May 28, 2002 was filled-in by the Facility's cook. The cook's entry indicates that at 5:00 a.m. both the walk-in refrigerator and the freezer were 40 degrees Fahrenheit. Joint Stipulations at 4, ¶ 17.

The Facility's Dietary assignment sheet indicates that breakfast is prepared between 6:30 a.m. and 7:15 a.m. and served at 7:30 a.m. P. Ex. 2; P. Ex. 13. The Dietary Assignment sheet indicates also that lunch items are gathered between 6:30 a.m. and 7:15 a.m., that lunch is prepared between 8:45 a.m. and 10:00 a.m., and that lunch is served at 11:30 a.m.; P. Ex. 13.

Petitioner does not dispute that the temperature of the foods stored in the refrigerator after it had warmed up had the potential to cause harm. See Petitioner's Brief at 7. By approximately 11:00 a.m., the refrigerator temperature had fallen to 56 degrees Fahrenheit. Mr. Buluan told Ms. Dixon that it would take two or two and one-half hours for the temperature to return to an acceptable level. Joint Stipulation at 5, ¶21. After Ms. Dixon discovered the deficiency the Facility presented a plan of correction. The plan was accepted at approximately 1:00 p.m. In accordance with the plan, Petitioner took the temperature of food stored in the refrigerator, threw away food above 42 degrees Fahrenheit, warned food service employees for the lapse, and inserviced the staff about the importance of not turning the refrigerator off. Joint Stipulations at 5-6, ¶ 22.

The disputed points concern (1) whether the temperature log was altered by the Facility to cover-up that the refrigerator had been off for longer than from some point after 5:00 a.m. until approximately 9:15 a.m.; and (2) the likelihood of hazardous food being served to residents. I discuss the parties' arguments concerning these points, I discuss the evidence, and I explain my findings. Concerning the question of the altered temperature log, I explain my finding that the temperature log was not altered. Concerning the second point, I explain my finding that CMS's determination that it was likely that hazardous food was served or would have been served is not clearly erroneous. The basis for this finding is that is appears likely that hazardous food would have been served to residents (and, in fact, some of the affected food may have been served) if the surveyor had not discovered the refrigerator was turned off. This is supported by evidence indicating that the Facility conducted breakfast and lunch preparation and service as usual despite the rising temperature in the refrigerator, and that the staff turned the refrigerator off deliberately for their comfort.

Concerning the temperature log book kept by the Facility for the walk-in refrigerator and freezer, CMS hypothesizes that the refrigerator and freezer were turned off for a longer period than the morning of May 28, 2002, perhaps overnight. CMS bases its theory on the entry in the log book for May 28, 2002, which shows that the temperature entry for the refrigerator, putatively recorded by the cook at 5:00 a.m., is written over another number. CMS infers that the Facility deliberately altered the original entry by writing "40" over the true higher temperature reading to falsely show that the refrigerator was at an appropriate temperature at 5:00 a.m. See CMS's Brief at 6; P. Ex. 3. Petitioner counters that the cook mistakenly entered the wrong number in the box for the refrigerator, but that it was an innocent recording mistake, not intended to falsify the log, and which, significantly, he corrected at the time the log entry was made - at 5:00 a.m. P. Ex. 14; Petitioner's Reply at 3.

Although the overwrite is a coincidence that understandably drew CMS's attention, I agree with Petitioner that the more likely scenario is mistake, not deception. Petitioner makes a convincing observation that supports this interpretation. Ms. Dixon noted that the log book entry had been altered to indicate 40 degrees at the time of the survey. CMS Ex. 1, at 3. It is not credible that the log would have been altered in anticipation of her finding a deficiency; especially because, if the cook or other staff member had discovered the refrigerator had been turned off and wished to cover up the fact, it is reasonable to assume he would have switched the refrigerator back on. Accordingly, I do not weigh in my decision CMS's contention that the Facility altered the temperature log book.

As I have explained above, the deficiency and the potential hazard presented to residents is undisputed. But, Petitioner advances arguments that the deficiency did not rise to immediate jeopardy. (1) Petitioner argues (1) the facts do not support, in comparison with a previous Departmental Appeals Board case Petitioner asserts dealt with more serious deficiencies, an immediate jeopardy determination; and there is no precedent for finding that food sanitation deficiencies can form the basis for an immediate jeopardy determination; and (2) that, in the instant case, no food posed a hazard to residents because all potentially hazardous food was either removed from the refrigerator for breakfast and lunch preparation and service before temperatures could affect it, or it was food which although remaining in the refrigerator while it warmed up would have been discovered by the staff and discarded. I conclude, however, that Petitioner's arguments do not demonstrate the immediate jeopardy determination was clear error. The cases Petitioner cites do not present any rule or principle that food sanitation deficiencies cannot support an immediate jeopardy determination, nor do they present analogous circumstances which merit a finding in this case that the immediate jeopardy determination was clear error. Moreover, the facts demonstrate support for CMS's determination that the service of hazardous food to residents was likely.

Petitioner's asserts first that in Rose Care, DAB CR553 (1998), the facts supporting an immediate jeopardy determination (improper care to a resident concerning an IV pump and the facility's failure to use proper equipment) were worse than in the instant case, and urges that I find clear error on this basis. Petitioner's Brief at 6-7. Accepting, arguendo, Petitioner's characterization of the facts in Rose Care, I do find that case is not applicable to the instant matter. The likelihood of serious harm can arise under many circumstances, and Petitioner has failed to demonstrate how an arguably egregious incident in one case proves serious harm was not likely in the instant matter.

Petitioner cites also the cases Crestview Park Care Center DAB CR862 (2002) and Meadow Wood, DAB CR862 (2002) for the proposition that "dietary violations" have not risen to the immediate jeopardy level in other cases. Petitioner's Brief at 8. In Crestview, the facility was cited for improper food storage but not at the immediate jeopardy level. In Meadow Wood, the facility was cited for deficiencies related to food service, including having unwrapped and undated meat in a freezer, but not cited at the immediate jeopardy level. Petitioner asserts that there are no Departmental Appeals Board decisions where "dietary violations" were found to constitute immediate jeopardy. Petitioner's Brief at 8. Other than demonstrating that these cases concerned the same general requirements for participation in Medicare as in the instant matter, Petitioner has explained no principle or made any persuasive comparisons between those cases and this one. It is a question of fact whether a particular set of circumstances will likely cause serious harm. The scope of my review in this case is whether it was clearly erroneous for CMS to have determined the facts in the instant case presented immediate jeopardy. Petitioner has shown no inference to be drawn from those decisions that would demonstrate CMS's determination was clearly erroneous in this case. If there is a variance in the scope and severity determinations CMS makes from survey to survey, or region to region (I do not say there are), these are policy issues. Because my authority is limited in scope to a review of the merits of this case only, other issues do not guide my analysis of the facts in this case.

The next argument, that no hazardous food was or would have been served to residents, follows two paths. First, Petitioner argues that food taken from the refrigerator for breakfast and lunch preparation and service was removed from the refrigerator before it could have been affected by the temperature increase. Second, Petitioner argues that the food that remained in the refrigerator long enough to be affected by the temperature increase would have been discarded by the facility when staff discovered the refrigerator had warmed up. On the whole, the facts suggest otherwise. Petitioner's attempt to account for the food removed for breakfast and lunch preparation and service is incomplete and does not support a finding that the food could not have been affected. And, because the kitchen staff did not notice the refrigerator had warmed up on the morning of the survey, coupled with evidence that the staff was prone to turning the refrigerator off, the facts do not convincingly support a finding that the Facility staff would have discarded the food remaining in the refrigerator.

The first path of argument is that the breakfast and lunch foods could not have caused harm to residents because they were not affected by the rising temperature in the refrigerator. The fact scenario Petitioner posits is that the refrigerator was switched off between 6:00 a.m. and 9:15 a.m. Petitioner's Brief at 3; P. Ex. 13. Petitioner claims that all of the food necessary to prepare and serve breakfast was removed by 9:15 a.m., and therefore the temperature increase could not have affected it. Petitioner's Brief at 7; P. Ex. 13. Petitioner explains that at 5:00 a.m. the temperature in the refrigerator was acceptably cool, breakfast was served at 7:03 a.m., so foods removed for breakfast between 5:00 a.m. and 7:00 a.m. "could not have been affected prior to their removal." Petitioner's Reply at 4. Petitioner claims also that all of the food necessary to prepare and serve lunch was removed before the temperature increase could have affected it. Petitioner's Brief at 7; P. Ex. 13.

Petitioner's accounting for these foods, however, is not persuasive. The facts are that at approximately 5:00 a.m. the refrigerator was approximately 40 degrees Fahrenheit. At some undetermined point after approximately 5:00 a.m. the refrigerator was switched off, and by approximately 9:15 a.m. the temperature inside the refrigerator rose to 64 degrees Fahrenheit. The Facility's food service director, Mr Buluan, told Ms. Dixon that he did not know who turned the refrigerator off or how long it had been off. Joint Stipulations at 4, ¶16. So, while Petitioner asserts that the refrigerator was switched off between 6:00 a.m. and 9:15 a.m., all that is actually known is that the refrigerator was turned off at some point long enough before 9:15 a.m. to allow the temperature to climb to 64 degrees, but we have no evidence about the rate of the temperature increase.

Concerning meal preparation, the Facility's Dietary Assignment sheet indicates that breakfast is served at 7:30 a.m. and is prepared between 6:30 a.m. and 7:15 a.m. P. Ex. 2; P. Ex. 13. The Dietary Assignment sheet indicates also that lunch is served at 11:30 a.m.; that lunch items are gathered between 6:30 a.m. and 7:15 a.m.; and that lunch is prepared between 8:45 a.m. and 10:00 a.m. P. Ex. 13. But there is no way to track precisely when the refrigerator was turned off and at what rate the temperature climbed to a hazardous level. Petitioner's burden in this case is to fill this gap with sufficient evidence to show that these food would not have been affected by lack of proper refrigeration. The evidence Petitioner has offered concerning where the breakfast and lunch foods were during the time the refrigerator warmed up, however, is not sufficient to surmount Petitioner's burden that CMS's determination was clear error. The evidence is at best ambiguous about what foods were affected and in at least one instance, concerning some milk that caught the attention of the surveyor, there is evidence suggesting it was affected. Petitioner attempts to bolster its case by claiming that an "important factor" showing that no affected foods were prepared or eaten is that there were no complaints nor evidence of sickness. Petitioner's Reply at 4-5.

While Petitioner's claim that breakfast foods could not have been affected is the most plausible, even that leaves room for concern. Even if we assume the refrigerator was switched off immediately after 5:00 a.m., it is certainly believable that foods gathered immediately for preparation and service over the next hour or so would perhaps not be affected. But, because we cannot track the rate the temperature rose, and because we have only a general idea of what foods were removed early, more troubling scenarios also seem possible. What if, for instance, the temperature rose very rapidly, perhaps because staff opened the door to the refrigerator frequently while they worked? If this had been the case, how are we to know whether food items that were the last to be removed, at perhaps 7:00 a.m., were not affected. Could not those items have sat at a hazardous temperature for one hour from 6:00 a.m. to 7:00 a.m., or longer?

The opportunity for exposure to hazardously warm temperatures is even greater for lunch foods. According to the facility's Dietary Assignment Sheet, lunch foods are gathered at between 6:30 a.m. and 7:15 a.m., prepared between 8:45 a.m. and 10:00 a.m., and served at 11:30 a.m. So there are several hours when food could have been either sitting in a warm refrigerator and/or a warm kitchen. But Petitioner has not indicated how it can know these food items were unaffected, other than to generally assert they were removed and prepared. Unexplained is what the temperature of the refrigerator was when the food was removed and what happened to the food after that. The evidence is ambiguous because it does neither clearly show that food was cold when removed and then, either kept in cold storage elsewhere, nor if or when it was cooked, and so forth. Instead, Petitioner has presented only a range of time when it's staff is supposed to remove and prepare items. This leaves unresolved whether foods used for lunch were exposed to hazardous temperatures, and if they were, for how long. Reviewing general food preparation schedules is not sufficiently instructive to reassure. The general statement that foods were removed and therefore not affected (see P. Ex. 13, at 2) is not persuasive that all perishable foods involved in breakfast and lunch were unaffected. The fact that there are daily instructions that instruct kitchen staff to "pull out" items for lunch like ground meat, vegetables and starch at 6:30 a.m. to 7:00 a.m., and cook ground meat and vegetables needed for purees for lunch (see P. Ex 2, at 1-2) is not persuasive that all these instructions were followed on the day of the survey. Nor do the instructions appear to encompass all the perishable food items that would usually be associated with meal preparation, so these general instruction allow us only to speculate about what may have actually occurred in the kitchen on May 28, 2002.

What Petitioner's argument does reveal, however, is that from the time after the initial morning temperature check, until Ms. Dixon discovered the refrigerator was 64 degrees Fahrenheit, Petitioner lost track of whether the food it was serving to residents had been exposed to hazardous temperatures during storage or preparation. Petitioner's burden is to prove that CMS's determination was clearly erroneous, so absent proof that leaves no ambiguity that food was not stored between 45 and 64 degrees Fahrenheit for a significant period of time, I find it reasonable for CMS to have concluded that it was, and that, therefore, serious harm to residents was likely.

Moreover, one specific instance suggesting that affected food was served to residents highlights the Facility's inability to track the status of the food it was serving. As I discussed previously, Ms. Dixon discovered in the refrigerator a container of milk in a bowl of ice and water. Ms. Dixon took the temperature of the milk and discovered it was 58 degrees Fahrenheit. Joint Stipulations at 4, ¶ 15. The inference CMS drew from this is that the milk had been removed from the refrigerator for meal service and then replaced. CMS Reply at 8. Petitioner asserts that the milk was not necessarily served warmed up because it could have been put back cold and the temperature then risen with the warming fridge. Petitioner's Reply at 4. Ms. Dixon reports that a staff member indicated that the milk had been outside for breakfast and returned to the refrigerator. CMS Ex. 4, at 4-5; CMS Ex. 8, at 2. Perhaps, as Petitioner suggests, the milk was removed for breakfast having been served at an acceptable temperature, arguendo 40 degrees Fahrenheit. Perhaps the milk was then returned to the refrigerator, having been maintained at an acceptable temperature the whole time it was out of the refrigerator. Perhaps then the temperature rose until Ms. Dixon discovered it was 58 degrees Fahrenheit. This version of events is not implausible, but neither is it sufficient to prove clear error - it leaves undiminished the equally reasonable inference that the milk was stored at an unsafe temperature and was likely then served or would likely have been served.

Furthermore, whether the milk was taken out of a warm refrigerator or not, the fact it was taken out and put back at all presents the next point. Apparently, as would be expected, staff was entering and exiting the refrigerator during the meal preparation and service and either not noticing that the refrigerator was turned off, or possibly allowing it to remain off deliberately.

The second path Petitioner's argument follows is that food that was admittedly affected would not have been served. Petitioner asserts that staff would have noticed the refrigerator was warm before taking out dinner foods either in the evening, at the scheduled temperature check, or throughout the day as they worked. Petitioner's Brief, at 7-8. Petitioner buttresses this assertion with examples of the Facility's food safety vigilance. Petitioner explains that it has a history of compliance and has in place safeguards such as safety checklists, education programs and information sheets. Petitioner's Brief at 7-8; P. Exs. 7-10. And, Petitioner notes that the Facility's Administrator and other supervisory personnel make daily, unannounced "rounds" to ensure compliance with temperature control policy. P. Ex. 12.

These measures do show an awareness of the importance of proper food storage temperatures, they do not erase the fact that staff apparently had not noticed the rising temperature. Petitioner states:

Lunch foods were also removed from the refrigerator and were in the process of being prepared long before any increase in temperature could have affected them. While some lunch foods, such as milk had not yet been removed, the act of walking into a warm refrigerator certainly would have alerted the kitchen staff to the increased refrigerator temperature

Petitioner's Reply at 4. It is common sense that the kitchen staff would have been alerted at some point, the record is plain that the staff did not notice over the course of preparing and two meals and serving one. Moreover, Petitioner's own logic, that staff would notice a warm, silent refrigerator raises the suspicion that perhaps staff did notice.

In fact, CMS concluded from interviews conducted by the surveyors that staff members were turning the refrigerator off deliberately. CMS Brief at 6; CMS Ex. 8, at 3. Ms. Dixon indicated that she learned kitchen personnel did not like the refrigerator fan blowing on them. CMS Ex. 8, at 3. Petitioner disputes that any staff member made these comments, but I find Ms. Dixon's contemporaneous notes credible. Her notes from the survey indicate that at 10:00 a.m. "two of the staff told the surveyor that the workers usually turn off the refrigerator because they do not like the fan blowing on them." CMS Ex. 8, at 2. Ms. Dixon noted also that the Facility's Director of Food Services, Mr. Buluan, stated that the staff "constantly" turn the refrigerator off. He noted to the surveyor also that there was a sign posted by the refrigerator switch warning staff not to turn the refrigerator off. Mr. Buluan also told Ms. Dixon that staff has been inserviced about the same issue before. CMS Ex. 8, at 3. In a subsequent statement, Mr. Buluan denied stating "staff constantly turns the refrigerator off." P. Ex. 13, at 3. Mr. Buluan also claimed there had not been problems related to increased temperatures before. He did not, however, disavow the sign or that he had mentioned the inservicing contemporaneously with his speaking to Ms. Dixon in reference to the refrigerator having been turned off. I find no reason to conclude that Ms. Dixon fabricated that she was informed by more than one source at the Facility that staff turned the refrigerator off because the fan was blowing on them. In light if this evidence, what emerges is a credible impression of a Food Services Director, exasperated with his staff because they forget the refrigerator is off, or perhaps leave it off deliberately until they are done with their work.

Overall the evidence supports CMS's conclusion that hazardous food would likely have been served, although, it does not convince me with certitude that it would have been. Nonetheless, the evidence presented by Petitioner is not sufficient for me to conclude that CMS did not have a reasonable basis for so finding. Before Ms. Dixon's inspection, staff in the Facility's kitchen failed to notice the warm refrigerator or willfully ignored it. This went on despite the warning sign above the switch. The statements in the record supported by the contemporaneous notes of Ms. Dixon support the conclusion that staff deliberately turned of refrigerator for their comfort. This presents the unsettling inference that staff is not vigilant about the storage temperature and this informs my conclusion that it is uncertain that a staff member would have noticed the refrigerator was off in time to prevent compromised food from being served.

Based on the inability of Petitioner to convincingly demonstrate that no food that was served was affected, and based on the failure of the staff to notice or react to the fact refrigerator was off all or most of the morning, I conclude it is not reasonable to characterize CMS's immediate jeopardy assessment as clear error.

B. A civil money penalty of $5,000 per day is not reasonable; $3,050 per day is reasonable.

I do not minimize the seriousness of the deficiency, but based on my review of the evidence regarding the facility's culpability, I conclude that $5,000 is not a reasonable civil money penalty. I find that $3,050, the minimum civil money penalty for immediate jeopardy deficiencies, is a reasonable amount to achieve the remedial purpose of bringing Petitioner into compliance with the regulation.

The range of civil money penalties that CMS may impose for an immediate jeopardy level deficiency is from $3,050 to $10,000 per day for each day that the deficiency persists. 42 C.F.R. § 488.438(a)(i). Where penalties fall within this range depends on factors which may include: a facility's history of noncompliance, its financial condition, its culpability, the seriousness of a deficiency or deficiencies, and, the relationship of one deficiency to another. 42 C.F.R. § 488.438(f); 42 C.F.R. § 488.404(b), (c) (incorporated by reference into 42 C.F.R. § 488.438(f)(3). CMS asserts that a penalty of $5,000 is reasonable. It bases this argument on the fact the deficiency reached the immediate jeopardy level of severity, and because the Facility was highly culpable for neglecting to discover that the refrigerator had been turned off. CMS Brief at 3.

Petitioner asserts that $5,000 is not a reasonable amount of civil money penalty and urges me to consider its history of compliance and factors mitigating its culpability. Petitioner asserts that the temperature of the refrigerator was never above the required range except for in this one lapse. Petitioner's Brief at 5. And Petitioner argues that this positive track record coupled with Petitioner's efforts to comply, as reflected by evidence of staff training and the sign over the switch reminding staff to leave the refrigerator on, demonstrate a lack of neglect, indifference or disregard for resident care, comfort, or safety. Petitioner's Brief at 11.

Petitioner has submitted evidence that it knew its responsibility to maintain proper storage temperatures and that it trained and managed the staff concerning this requirement specifically and concerning the importance of food sanitation generally. See P. Exs. 7-10. I am convinced that these efforts demonstrate a continuing effort by the Facility to properly train and sufficiently impress staff with the seriousness of maintaining appropriate food storage temperatures and I find these efforts mitigate the Facility's culpability to a degree. Given that, it is not reasonable to impose civil money penalties which exceed the minimum amount that is required for immediate jeopardy level deficiencies. I conclude, therefore, that the remedy ought to be sufficient to prompt the Facility to take stronger measures to make staff comply. $3,050 is a reasonable amount to prompt Petitioner to achieve the desired result. On this point, I note that Petitioner asserts that, subsequent to the survey, the Facility has installed a lock box on the refrigerator switch. Petitioner's Brief at 11-12.

4. Conclusion

CMS's determination to assign the immediate jeopardy level of severity to Petitioner's (Green Acres Manor) failure to comply with 42 C.F.R. § 483.35(h)(2) is not clearly erroneous. Furthermore, the civil money penalty of $5,000 is not reasonable; $3,050 is reasonable.

JUDGE
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Alfonso J. Montano

Administrative Law Judge

FOOTNOTES
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1. Petitioner contends that there was no actual harm to residents. Petitioner's Brief, Preliminary Statement, at 1. It is not clear that Petitioner intended to assert this as a separate argument that the deficiency did not reach immediate jeopardy. I make no finding whether there was actual harm to residents or not, but insofar as Petitioner's argument is that no actual harm occurred, I note that it is well settled that actual harm is not necessary to support an immediate jeopardy determination. See Good Samaritan Center, DAB No. 1844 (2002); Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002); Southridge Nursing and Rehabilitation Center, DAB No. 1778 (2001); Westgate Healthcare Center, DAB No. 1821 (2002).

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