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                              Generations at McKinkley Place, DAB CR5233 (2019)
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Generations at McKinkley Place, DAB CR5233 (2019)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





Generations at McKinley Place,
	(CCN: 146003),
	Petitioner
	v.
	Respondent.
Docket No. C-18-1123Decision No. CR5233January 18, 2019

        
              
    

      DECISION
I grant summary judgment in favor of the Centers for Medicare & Medicaid Services (CMS) sustaining its determination to impose a per-instance civil money penalty of $18,500 against Petitioner, Generations at McKinley Place, a skilled nursing facility in Illinois.
I. Background
CMS moved for summary judgment.  With its motion, CMS filed 16 proposed exhibits that it identified as CMS Ex. 1-CMS Ex. 16.  Petitioner opposed the motion and with its opposition filed a single exhibit that it identified as P. Ex. 1.
It is unnecessary that I rule on the admissibility into evidence of the parties’ proposed exhibits inasmuch as I decide this case based on undisputed material facts and the law.  I cite to some of the exhibits in this decision but only to illustrate undisputed facts or to address a party’s argument.
Page 2
II. Issues, Findings of Fact and Conclusions of Law
A. Issues
The issues in this case are whether Petitioner failed to comply substantially with a Medicare participation requirement and whether a per-instance civil money penalty of $18,500 is reasonable.
The parties have raised other issues, either in Petitioner’s hearing request or in their briefs, which are not relevant to my decision.  In its hearing request, Petitioner challenged numerous findings of noncompliance that CMS made based on a compliance survey that ended on February 13, 2018.  However, CMS made its remedy determination based on only one of these findings of noncompliance, Petitioner’s alleged failure to comply with 42 C.F.R. § 483.60(i)(2).  That is the only noncompliance finding that is relevant inasmuch as the remedy that CMS seeks to impose emanates from that finding alone.  42 C.F.R. § 488.408(g)(1).
Both parties address the surveyors’ finding that Petitioner’s alleged noncompliance was so egregious as to put residents at Petitioner’s facility in a state of immediate jeopardy.  I do not address CMS’s immediate jeopardy finding because it is unnecessary that I do so.  A finding of immediate jeopardy is not a necessary element of the remedy that CMS determined to impose.
There are circumstances where a finding of immediate jeopardy is necessary to a remedy determination.  For example, a finding of immediate jeopardy justifies a per diem civil money penalty (a penalty for each day of a skilled nursing facility’s noncompliance) in the upper range of per diem penalties.  42 C.F.R. § 488.438(a)(1)(i).  In the instance of an upper-range penalty, the presence of immediate jeopardy becomes a critical basis for the penalty because, without a finding of immediate jeopardy, such a penalty would not be justified.
However, where as in this case CMS determines to impose a per-instance civil money penalty, a finding of immediate jeopardy is not a necessary element of the remedy determination.  42 C.F.R. § 488.438(a)(2).  Whether the amount of a per-instance penalty is reasonable depends on evaluation of facts pertaining to regulatory factors set forth at 42 C.F.R. §§ 488.438(f)(1)-(4) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  Those factors govern the per-instance penalty amount.  The presence or absence of immediate jeopardy is not one of the listed factors.
To be sure, the presence of immediate jeopardy signals a very serious noncompliance event and seriousness of noncompliance is one of the regulatory factors that I must evaluate in order to decide whether a penalty is reasonable.  However, I may evaluate seriousness without determining whether noncompliance meets the specific criteria that
Page 3
define immediate jeopardy.  For that reason, it is unnecessary that I decide whether Petitioner’s noncompliance rises to the immediate jeopardy level.
B. Findings of Fact and Conclusions of Law
At the heart of this case are allegations by CMS that Petitioner’s staff failed to follow appropriate protocol for cooling cooked meat (roast beef).  CMS asserts that the staff not only violated widely accepted standards for cooling meat but that it violated its own policy, which duplicates accepted standards.
A skilled nursing facility must “store, prepare, distribute, and serve food in accordance with professional standards for food service safety.”  42 C.F.R. § 483.60(i)(2).  In implementing this regulation, CMS accepts the United States Food and Drug Administration’s Food Code as a national standard for food procurement, storage, and preparation, and it requires skilled nursing facilities to comply with this standard.  CMS State Operations Manual, App’x PP at 587 (SOM).
The SOM specifies what a facility must do when it cools a potentially hazardous food such as cooked meat.  It defines food temperatures above 41 degrees and below 135 degrees Fahrenheit as constituting a danger zone that allows the rapid growth of pathogenic microorganisms that may cause illness.  *Id.* at 588.  It warns that cooked food held at temperatures falling within the danger zone for more than six hours may cause a foodborne illness outbreak if consumed.  *Id.*  It directs that total cooling time for potentially hazardous cooked food, such as cooked meat, should not exceed six hours and that such food is best cooled rapidly within two hours, from 135 to 70 degrees Fahrenheit, and within four additional hours to approximately 41 degrees Fahrenheit.  *Id.* at 596.
Petitioner’s policy for cooling potentially hazardous cooked food is identical to that stated by the Food and Drug Administration and CMS.  CMS Ex. 11.  As is required by these authorities, Petitioner’s policy requires that cooked food be cooled from 135 to 70 degrees Fahrenheit within two hours and to 41 degrees Fahrenheit within six hours.  *Id.*  Petitioner’s policy requires its staff to record in a log measured temperatures and the times when those temperatures were measured.  *Id.*
The following facts are undisputed, and they establish failure by Petitioner’s staff to comply with Petitioner’s policy, recognized standards, and regulatory requirements.
On February 6, 2018, a surveyor employed by the Illinois Department of Public Health observed one of Petitioner’s cooks prepare roast beef to serve to Petitioner’s residents during that day’s noon meal.  CMS Ex. 4 at 28; CMS Ex. 6 at 1.  The surveyor saw pans of roast beef that had been sliced and covered with gravy.  These pans were sitting in a steam tray, ready for service to residents.  CMS Ex. 7 at 3.  The surveyor asked the cook
Page 4
when the meat had been cooked.  The cook replied that he had put six roasts in the oven the previous afternoon before leaving work.  CMS Ex. 8 at 1.  The cook averred that he had told the evening cook to take the meat out of the oven when cooked, drain the broth, and cool the meat.  CMS Ex. 4 at 28; CMS Ex. 7 at 3; CMS Ex. 8 at 1-2.  The cook told the surveyor that he hadn’t given his evening replacement any instructions as to how to cool the roast beef.  He could not confirm whether the meat’s cooling time and temperatures had been monitored or logged.  He admitted that he did not have any cooling log for the beef.  The cook also admitted that he had not taken the temperature of the roasts before preparing them for service on the morning of February 6.  *Id.*
At about 9:30 a.m. on February 6, the surveyor asked the cook to show him any roasts that had not been prepared for immediate service to residents.  CMS Ex. 4 at 30.  The cook showed the surveyor two roasts that were covered with foil in Petitioner’s walk-in refrigerator.  The roasts were sitting in an inch of oily fat and broth.  The surveyor asked the cook to take the temperature of the roasts using the facility’s thermometer and the surveyor’s thermometer.  Both thermometers recorded an internal temperature of 66 degrees Fahrenheit, about 15 hours after the roasts were removed from the oven.  *Id.*; CMS Ex. 7 at 3; CMS Ex. 8 at 2.
Petitioner’s corporate dietician happened to be at the facility during the survey.  After observing the roast beef, the dietician instructed the cook to throw it out and to prepare something else for the noon meal.  CMS Ex. 4 at 30; CMS Ex. 8 at 2.
The surveyor also interviewed Petitioner’s evening cook.  CMS Ex. 4 at 28; CMS Ex. 7 at 4.  The evening cook told the surveyor that she had removed the roasts from the oven at about 6:15 p.m. on the evening of February 5.  She averred that she had allowed the roasts to rest briefly at room temperature, then covered them tightly with foil, and placed them in Petitioner’s refrigerator.  *Id.*She admitted that she did not take any steps to rapidly cool the roasts.  Additionally, she admitted that she did not know that she needed to take special steps to rapidly cool the meat, and she stated that she did not recall receiving any training on rapid cooling procedures.  *Id.*
Based on these undisputed facts, Petitioner was manifestly deficient in several respects.
Petitioner’s staff was unaware of the need to follow prescribed procedures to rapidly cool cooked meat.  Furthermore, the staff was unaware of Petitioner’s own policy directing that potentially hazardous food, including cooked meat, be cooled rapidly.
	The staff did not follow recognized procedures and Petitioner’s policy for cooling cooked potentially hazardous substances, including cooked meat.Page 5
The staff failed to:  take any steps to cool cooked meat rapidly, monitor the internal temperature of cooked meat, and record those temperatures in a temperature log.
	Because the staff failed to follow prescribed procedures and the facility’s policy it had no way of knowing whether or not the roast beef was safe to serve to residents.Petitioner’s staff’s failure to follow prescribed procedures and the facility’s policy put residents at risk for serious harm or worse.  The standards on which Petitioner based its policy recognize that improperly cooked meat may serve as a medium for the growth of pathogens.  Ingesting infected meat may result in serious illness, at the least.  I take notice that the residents of Petitioner’s facility – frail, elderly, sick – are at much greater risk from the adverse effects of food borne pathogens than is the general population.
Petitioner makes several arguments in opposition to CMS’s motion.  I find these arguments to be without merit.  And, although Petitioner contends that there are disputed issues of material fact, it has not offered any facts that contradict or refute those that I recite above.
First, Petitioner contends that it had a system of checks and balances in place that would have prevented any of the roast beef from being served on February 6, 2018.  Petitioner’s response to CMS’s motion (“Response”) at 6-11.  Its sole support for this contention is the affidavit of its corporate dietary manager, Ms. Nenita Guzman.  P. Ex. 1.  Petitioner contends that Ms. Guzman, who was visiting Petitioner’s facility on February 6, would have noticed that the meat had not been properly cooled without the surveyor’s intervention and would have ordered that the meat be discarded before it was served to Petitioner’s residents.  *Id.* at 2.
For purposes of deciding CMS’s motion, I accept Ms. Guzman’s assertions.  I infer, if only for purposes of deciding the motion, that she would have interdicted the service of roast beef on February 6 even without the presence of CMS’s surveyor.  But, this serves as no defense to those facts adduced by CMS.  The undisputed facts show that Petitioner’s staff was unaware of both Petitioner’s policy and the rationale for that policy.  The deficiency in this case is not only that Petitioner’s cook was about to serve improperly cooled beef to the residents, but that Petitioner’s cooks (day and evening) did not understand the need to follow precise protocols for cooling cooked meat and did not follow the policies laid down by Petitioner’s management.
Ms. Guzman was only an intermittent visitor to Petitioner’s facility.  She was not there every shift on every day.  Her intervention on February 6 was fortuitous.  But, Petitioner offered nothing to show that Ms. Guzman or anyone else would have intervened similarly on any other date.  The undisputed facts lead inescapably to the conclusion that
Page 6
Petitioner’s cooks were preparing and serving potentially hazardous food without regard to established protocol and Petitioner’s policy and that these actions were occurring on days when Ms. Guzman was not present at the facility.
Petitioner goes on to argue that its kitchen’s checks and balances system would have prevented the improperly cooled meat from being served “well before the meal was actually served to resident[s].”  Response at 9.  However, Petitioner offers no facts to support this claim.  The only “checks and balances” that Petitioner can cite are Ms. Guzman’s fortuitous presence in the kitchen on February 6, 2018.  That is no system and no guarantee that the staff would not serve improperly cooled meat at any meal when Ms. Guzman was not present.
It is true that Petitioner had a policy that, if implemented, would protect its residents against the service of improperly cooled meat.  But, the undisputed facts show that the policy was not implemented.  Indeed, those facts establish that Petitioner’s cooks were unaware of the policy and were certainly not following it.  For example, the undisputed fact is that Petitioner’s cooks were not logging the temperatures of cooked meat as it cooled.
Petitioner recites at length the training and experience of its cooks, arguing that such training and experience would have protected Petitioner’s residents from harm.  Response at 9-10.  Additionally, it asserts that it regularly in-services its staff to assure that they follow proper food handling procedures and Petitioner’s policy.  *Id.* at 10-11.  However, whatever credentials Petitioner’s staff may have had and whatever training they may have received, it is evident that they were unaware of the proper techniques for cooling cooked meat and were not following Petitioner’s policy.  In this case, training and experience does not countervail the obviously deficient actions of the staff.
Next, Petitioner argues that the record contains nothing showing that the roast beef that was sliced and ready to be served to residents on February 6, 2018, was at an improperly high temperature before being served.  Response at 11-12.  It contends that there was no way of knowing whether the meat had cooled sufficiently and over the requisite time period because the surveyor did not take the temperature of that meat.  This argument misstates the issue but it also proves Petitioner’s noncompliance.
The issue is not whether the roast beef that was about to be served had cooled to 41 degrees Fahrenheit during the approximately 15 hours between the time it was removed from the oven and the time that the surveyor observed it.  Rather, the issue is whether Petitioner’s staff followed proper protocols and procedures in order to assure that the roast beef would be cooled to an acceptable temperature within the requisite period of time, that being two hours to reduce the internal temperature of the meat to 70 degrees and six hours total to reduce the meat’s temperature to 41 degrees.  In that respect, the staff was completely deficient.
Page 7
Indeed, and as Petitioner concedes, there is no way of knowing whether the meat had cooled to a safe temperature within the requisite time period because no one monitored it.  No one took the roast beef’s temperature.  No one recorded temperatures in a log.  On the morning of February 6, whether the roast beef was safe to serve was at best a matter of random chance.  That is a manifest failure to comply, not only with Petitioner’s policy, but also with regulatory requirements.
Petitioner argues also that I cannot infer reasonably that the roast beef that its staff had prepared for service to residents was improperly cooled from the fact that other roasts had not been properly cooled.  Response at 12.  Petitioner’s premise is that the surveyor took temperature readings from roasts that its staff had not prepared for service to Petitioner’s residents.  Petitioner suggests that the roasts from which the surveyor took temperature readings were designated for residents of another facility.
Petitioner offered nothing to corroborate this assertion.  Nevertheless, I will accept it as true if only for purposes of deciding CMS’s motion for summary judgment.  Petitioner obtains no benefit from the assertion.  As I have stated, there was a wholesale failure by Petitioner’s staff to cool cooked meat properly.  It doesn’t matter whether some of the roasts that the staff cooled improperly had a destination other than Petitioner’s dining room.  The irrefutable fact is that *none* of the roasts prepared by Petitioner’s staff were cooled pursuant to protocol and Petitioner’s policy.
Petitioner argues that no harm could have resulted from improper cooling of the cooked meat inasmuch as the meat was discarded prior to being served.  Response at 13-15.  Although Petitioner couches this argument as an attack on CMS’s immediate jeopardy finding it also addresses the more basic question of whether Petitioner’s noncompliance put residents at risk for harm, and so, I will address it in that context.
The gravamen of Petitioner’s argument is a kind of “no harm, no foul” assertion.  Essentially, it contends that there can be no deficiency, or at least not a serious deficiency, if noncompliant conduct fails to harm a resident.
Certainly, no resident suffered food-borne illness resulting from consuming the roasts that were prepared for service on February 6, 2018.  Petitioner’s staff discarded those roasts after being confronted by a surveyor on that date at the direction of its dietary consultant.  But, that fact raises the question of whether there existed a substantial possibility and even a likelihood of harm at Petitioner’s facility.  The possibility of harm was a constant presence at the facility because Petitioner’s staff did not comprehend the need to cool cooked meat properly and was not following Petitioner’s policy for cooling cooked meat.  There is no way of knowing whether other meals on other dates included improperly cooled meat because Petitioner’s staff was not following Petitioner’s protocol nor was it keeping a temperature log of cooling meat.  The failure to do so caused an ongoing possibility of harm to Petitioner’s residents.  That is the only reasonable
Page 8
inference that I can draw from the fact that neither of the cooks interviewed by surveyors understood the need to follow precisely the cooling protocol and to maintain a temperature log.  I note that Petitioner had the opportunity to offer temperature logs, if they existed, in order to refute the evidence of noncompliance.  It did not.
The remaining question is whether a per-instance civil money penalty of $18,500 is reasonable.1
  I find that the undisputed material facts establish that it is.
I note, preliminarily, that the parties have put before me all of the facts that they have to offer about the reasonableness of the penalty.  I afforded CMS and Petitioner the opportunity to present evidence on all issues, and the deadline for presenting evidence expired.  There is nothing left for the parties to offer, or for me to consider, on the issue of reasonableness of the penalty.
The penalty of $18,500 is within the range of penalty amounts that CMS may impose on a per-instance basis for noncompliance with regulatory requirements.  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3.  As I have stated, the reasonableness of a per-instance penalty must be decided based on regulatory factors stated at 42 C.F.R. §§ 488.483(f)(1)-(4) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).
The factor that is most pertinent here is the seriousness of Petitioner’s noncompliance.  I find that the undisputed material facts establish that the seriousness of Petitioner’s noncompliance, standing alone, is sufficient to justify the $18,500 penalty amount.  The failure by Petitioner’s staff to follow required protocol for cooling cooked meat and their failure to comply with and even ignorance of Petitioner’s own policy put residents of the facility at risk for serious harm resulting from consumption of food borne pathogens.
Petitioner has not challenged the guidelines for cooling cooked meat.  Its own policy recognizes the dangers inherent in improper cooling.  When cooked meat is improperly cooled, there is a serious risk that pathogens will grow within the meat.  If those pathogens are consumed, they may cause serious and even life-threatening illness.  The risk is especially acute with consumers who are elderly, frail, and infirm.
Petitioner’s staff put residents at risk because they ignored established protocol and Petitioner’s policies.  As I have said, it was fortuitous that a surveyor and Petitioner’s dietary consultant were present at the facility on February 6, 2018, and intervened to prevent possibly contaminated meat from being served to residents on that date.  That said, there is nothing to show that such intervention occurred or would have occurred on
Page 9
other dates when the consultant or a surveyor wasn’t present.  The ignorance of protocol and policy manifested by Petitioner’s cooks makes it obvious that the risk of serving contaminated food products to Petitioner’s residents was an ongoing issue.  Given this, $18,500 is not only a reasonable penalty but also a modest one.  The penalties could have added up to a much larger sum had CMS exercised its discretion to impose daily civil money penalties to remedy the ongoing noncompliance.  *See*42 C.F.R. § 488.438(a)(1)(i), (ii).
CMS cites Petitioner’s compliance history as a second justification for imposing the $18,500 penalty.  As CMS notes, Petitioner has a relatively long history of regulatory noncompliance that includes a failure to comply with the regulation in effect in January 2017 governing food preparation and service.  CMS Ex. 3 at 4-7.  This compliance history is an added basis for supporting the penalty amount, although, and as I hold, the seriousness of Petitioner’s noncompliance is, in and of itself, sufficient to support the penalty.
Petitioner asserts that its facility had recently undergone a change of ownership and it contends that it should not be judged on its previous owner’s transgressions.  It makes generalized assertions about how the facility’s new management endeavored to improve conditions at the facility.  Response at 16.  However, these assertions do not address the specific issues raised in this case.  Although Petitioner asserts that it implemented “new systems” designed to provide better care to its residents, it failed to provide any facts showing how it improved its staff’s food preparation.  Moreover, the assertion of imposition of “new systems” is belied by the ignorance of any systems manifested by Petitioner’s staff on February 6, 2018.
Finally, the imposition of an $18,500 civil money penalty against Petitioner causes it to lose authority to conduct a nurse aide training and competency evaluation program (NATCEP) for a period of two years.  Petitioner challenged this remedy in its hearing request.  However, it does not dispute that the loss of authority to conduct NATCEP follows the imposition of the penalty as a matter of law.


          /s/
        Steven T. Kessel

                      Administrative Law Judge
      1. In its combined pre-hearing brief and motion for summary judgment (“Brief”), CMS refers to a civil money penalty of $113,382.  Brief at 20.  I assume that this is an error inasmuch as the civil money penalty that CMS determined to impose in this case is limited to a per-instance penalty of $18,500. back to note 1 Back to top
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