Creekside Healthcare Center, DAB CR6277 (2023)

DECISION

Respondent, the Centers for Medicare & Medicaid Services (CMS), found Petitioner, Creekside Healthcare Center (Creekside), out of substantial compliance with Medicare participation requirements.  CMS imposed a per-instance civil money penalty (CMP) of $17,500 against Creekside.  As explained here, I affirm CMS’s determination of noncompliance and sustain the imposed penalty.

I.     Background

Creekside is a skilled nursing facility doing business in San Pablo, California, certified by and participating in the Medicare and Medicaid programs.  The California Department of Public Health (CDPH or state agency) conducted a recertification survey from September 10 to September 13, 2018.  The results of that survey led CMS to find Creekside substantially noncompliant with Tag F812¹ (42 C.F.R. § 483.60(i) – food safety

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requirements) at the “L” scope/severity level.  CMS Ex. 1 at 20.²  CDPH found that the immediate jeopardy condition cited under Tag F812 abated on September 13, 2018.  CMS Ex. 2 at 1. 

On October 4, 2018, CMS imposed a per-instance penalty of $17,500 against Creekside for the noncompliance identified under Tag F812 at the September 2018 survey.  CMS Ex. 2 at 1-2.  CMS adopted CDPH’s finding that immediate jeopardy abated on September 13, 2018, but found Creekside remained out of substantial compliance with other program requirements set forth in the Statement of Deficiencies (SOD) issued by CDPH.  Id. at 2.  In addition to the $17,500 penalty, CMS warned Creekside of other remedies it would impose, including denial of payment for new admissions starting December 13, 2018, withdrawal of its approval for Creekside’s nurse aide training and competency evaluation program, and termination of Creekside’s provider agreement by March 13, 2019.  Id. at 2-3.  After a follow-up survey, CDPH determined Creekside returned to substantial compliance on December 10, 2018; CMS notified Creekside it would no longer impose a denial of payment for new admissions or terminate its provider agreement.  CMS Ex. 3 at 1‑2. 

On December 3, 2018, Creekside timely challenged CMS’ imposition of penalties by filing a request for hearing before an Administrative Law Judge in the Civil Remedies Division.  Upon my designation to hear and decide this case, I issued an Acknowledgment and Pre-hearing Order (APHO) that set forth deadlines for the parties to file pre‑hearing submissions including briefs, exhibits, witnesses, and the direct testimony of any proposed witnesses.  APHO at 3-4. 

Both parties filed pre-hearing submissions and pre-hearing briefs (CMS Br. and P. Br.).  Neither party objected to the opposing party’s proposed exhibits.  Each party requested cross-examination of the opposing party’s witnesses.  I issued an Order Setting Hearing Date on May 20, 2019 setting this matter for hearing to proceed by videoconference from February 10 to February 13, 2020.  Transcripts of that hearing became available to the parties on March 2 and 3, 2020. 

During the hearing, the parties continued to contest the impact of the Ninth Circuit Court of Appeal’s Plott decision on the scope of my review.  On February 12, 2020, I directed CMS to advise me whether it would dismiss any of the noncompliance citations aside

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from Tag F812.  On February 19, 2020, CMS indicated it would not dismiss the remaining seven deficiency tags and requested a supplemental hearing and briefing on those deficiencies in the event I determined Plott required me to adjudicate them. 

At my direction, the parties filed supplemental briefs to address whether the Plott decision required my consideration of the seven lesser deficiencies.  On June 29, 2021, I issued an order advising the parties I concluded Plott did not require me to review any deficiencies other than that arising under Tag F812.  The parties subsequently filed post-hearing briefs (CMS and P. Post-hearing Brs.).  The record in this case is closed and ready for decision.  APHO at 8. 

II.     Hearing and Admission of Exhibits

From February 10 through February 12, 2020, I held a videoconference hearing to allow Creekside to cross-examine CDPH surveyors Shola Ayodele, Supriya Ghai, and Sara Barriere and to allow CMS to cross-examine Creekside employees Suzanne Ousey (consulting dietitian), Thomas Durr (management patient advocate), Harpinder Kaur (dietary manager), Cami Mandell Gordon (dietitian), Neeru Neeru (cook), and Survinder Shergill (cook).  Hearing Transcript (Tr.) at 3, 160, 201.  At the outset of the hearing, I entered CMS Exhibits (CMS Exs.) 1 through 12 and 14 through 26³ and Creekside Exhibits (P. Exs.) 1 through 12 into the record.  Id. at 3, 17-19. 

III.     Statement of Issues

The issues presented are: 

1. Whether Creekside was in substantial compliance with 42 C.F.R. § 483.60(i) (Tag F812) at the time of the survey completed on September 13, 2018;
2. If Creekside was not in substantial compliance, whether CMS’ immediate jeopardy determination was clearly erroneous; and
3. If Creekside was not in substantial compliance, whether the civil money penalty imposed by CMS is reasonable. 

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IV.     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 Social Security 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 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-instance civil money penalty “for each instance that a facility is not in substantial compliance, regardless of whether or not the deficiencies constitute immediate jeopardy.”  42 C.F.R. § 488.430(a).  A per‑instance civil money penalty may range from $50 to $3,000 per day (adjusted annually for inflation) for less serious noncompliance, or $3,050 to $10,000 per day (also adjusted annually for inflation) for more serious noncompliance that poses immediate jeopardy to the health and safety of residents.  42 C.F.R. § 488.438(a)(1).⁴  “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 Creekside failed to substantially comply with 42 C.F.R. § 483.60(i), Tag F812.  

CMS contends Creekside violated Tag F812 by:  storing food in a malfunctioning freezer; failing to achieve and maintain a safe final cooking temperature of chicken; failing to ensure the correct calibration of facility food thermometers; posting inaccurate food cool-down instructions; and failing to properly sanitize kitchen equipment (evidenced by dirty dishes and improper use of quat sanitizer).  CMS Br. at 6-17; CMS Ex. 1 at 20-32.

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The relevant regulation establishes the requirements for the procurement, storage, preparation, and service of food provided to facility residents: 

(i)  Food safety requirements.  The facility must—

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

* * * * *

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

42 C.F.R. § 483.60(i).  CMS alleges Creekside did not substantially comply with the latter regulatory requirement.  CMS Br. at 6‑17.  As explained below, I concur and find Creekside did not substantially comply with the regulatory obligation to meet professional food safety standards for the storage, preparation, distribution, and service of food to its residents.

1. Creekside failed to meet professional food safety standards by storing food intended for residents in a malfunctioning freezer.

During the three-day survey period that began September 10, 2018, CDPH surveyor Shola Ayodele, accompanied by trainee surveyors Sara Barriere and Supriya Ghai, inspected Creekside’s kitchen, food storage, and food service areas.  CMS Exs. 4, 6, 14.⁵  Based on her observations the first morning of the survey, Surveyor Ayodele concluded the reach-in freezer Creekside used to store food (Freezer 1) did not properly function.  CMS Ex. 4 at 5 ¶ 11; see also CMS Ex. 1 at 20-27; Tr. at 30-52, 69-75.  The record before me supports the surveyor’s conclusion. 

First, Surveyor Ayodele noted Freezer 1’s interior thermometer⁶ reflected a temperature of 34° Fahrenheit (F), at least 24 degrees higher than the temperature recommended by the manufacturer to keep food frozen.  CMS Ex. 4 at 5 ¶ 11; CMS Ex. 1 at 7; CMS Ex. 12 at 1-3 (Freezer 1’s interior temperature 34° at 9:11 a.m., 32° at 11:11 a.m., and 24° at 3:45 p.m.).  She also observed “a significant amount of frost on the exterior of sherbet and other food items including chicken (both cooked and raw) along with frozen vegetables.”  CMS Ex. 4 at 5 ¶ 11.  The surveyor finally observed the chicken and

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vegetables both “showed evidence of some thawing.”  Id.  Based on these observations, Surveyor Ayodele opined Freezer 1 was not operating at a temperature sufficient to keep food frozen solid, as required by manufacturer instructions and the SOM, thus placing the facility’s residents at risk of foodborne illness.  CMS Ex. 4 at 5-6 ¶ 12; CMS Ex. 21 at 13. 

Creekside produced witnesses to dispute or explain away Surveyor Ayodele’s observations.  Dietitian Cami Mandell Gordon stated that on September 11, 2018, she “personally observed the freezers and their contents and [at] no point [believed] the temperature inside the freezer had reached a level that rendered the food unsafe for consumption.”  P. Ex. 1 at 3 ¶ 11-13.  Tom Durr, a patient advocate from Creekside’s management company, declared that during his visit on September 11, 2018, he personally observed food stored in the freezer “remained frozen solid at all times” until Creekside disposed of it in response to the surveyors’ concerns.  P. Ex. 5 at 1-2.  Consulting dietitian Suzanne Ousey asserted the actual temperature of the food stored in a freezer was more critical than the internal temperature of the freezer itself, opining “[i]f food stored inside the freezer maintains a temperature of 41° Fahrenheit, that food is safe for consumption.”  P. Ex. 4 at 2 ¶ 4.  Cook Neeru claimed that on September 10, 2018, she removed food from Freezer 1 for thirty minutes to clean it and observed both that Freezer 1’s temperature did not increase significantly during that time and that the freezer’s contents “stayed frozen.”  P. Ex. 2 at 2 ¶ 9.  Cook Shergill similarly declared that based on her observations on September 11, 2018, “food stored in the freezer remained frozen.”  P. Ex. 3 at 2 ¶ 9.⁷

Significantly, none of Creekside’s witnesses contradict recorded findings by the survey team showing Freezer 1’s internal temperature on September 10, 2018 were 34° F at 9:11 a.m., 32° F at 11:11 a.m., and 24° F at 3:45 p.m.  CMS Ex. 4 at 5 ¶ 11; CMS Ex. 12 at 1-3.  Ms. Mandell, Mr. Durr, and Cook Shergill made their observations the next day.  They also rely in part on subjective assessments of whether a given item looked frozen.  Mr. Durr’s statement is internally inconsistent as he claimed both that food in Freezer 1 “remained frozen solid at all times” but conceded ice cream and sherbet “showed some signs of thawing.”  P. Ex. 5 at 2.  I accord greater weight to the surveyors’ contemporaneous observations and objective measurements of freezer temperature on September 10, 2018.⁸

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Ms. Ousey’s claim that food in a freezer kept at or below 41 degrees is safe for human consumption is plainly incorrect.  Creekside’s own “Cold Storage Temperature Logging” policy states: “Freezer temperature standards are 0° F or below.”⁹  Compare P. Ex. 4 at 2 ¶ 4, with CMS Ex. 8 at 1.  The SOM provides “freezers must be in good working condition [and] the freezer must keep frozen foods frozen solid.”  CMS Ex. 21 at 13.  It also describes foods being safe at 41° F or below when in a refrigerator.  CMS Ex. 21 at 2, 13.  I accord no weight to Ms. Ousey’s opinion. 

Pursuant to the governing regulations, the SOM requires facilities like Creekside to inspect food and “ensure [its] proper storage . . . in the refrigerator or freezer as indicated.”  CMS Ex. 21 at 7.  It requires facilities to ensure that freezers be kept in good working condition, meaning they “keep frozen foods frozen solid.”  Id. at 13.  Based on the state agency surveyors’ observations of insufficient internal temperatures and signs of thawing in some foods contained in Freezer 1, I find it more likely than not that Creekside did not meet its regulatory obligation to ensure its freezers consistently maintained safe food temperatures.  

2. Creekside failed to realize and maintain final cooking temperature of chicken. 

CMS contends Creekside failed to meet its regulatory obligation to store, prepare, distribute, and serve food using professional standards for food safety by failing to achieve and maintain a safe cooking temperature for chicken¹⁰ served to its residents.  CMS Br. at 10-12.  The evidence of record supports CMS’s claim.  On the first day of the survey, Surveyor Ayodele observed Cook Shergill take “a stainless[-]steel container with several pieces of chicken breast out of the oven and place[] them on the tray line for lunch meal service.”  CMS Ex. 4 at 9 ¶ 20; see also CMS Ex. 1 at 27-28.  Using a

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calibrated food thermometer,¹¹ Surveyor Ayodele recorded the temperature of 150.6° F for a chicken breast taken from the oven (less than the safe internal cooking temperature of 165° F for baked chicken),¹² while temperatures taken by facility staff were significantly higher due to improperly calibrated food thermometers.  CMS Ex. 4 at 9 ¶ 21; CMS Ex. 6 at 5 ¶ 15; CMS Ex. 12 at 2.  Facility staff at that time returned the chicken breasts to the oven and, at the end of the tray line service, Surveyor Ayodele measured the cooking temperature of the same chicken as 156.7° F, still below the 165° F required for food safety.  CMS Ex. 4 at 9-10 ¶¶ 21-22; CMS Ex. 6 at 5 ¶ 15; CMS Ex. 12 at 2. 

Creekside cooks also were unable to properly calibrate their food thermometers using a 50/50 ice/water method.  CMS Ex. 4 at 11 ¶ 27; CMS Ex. 6 at 6 ¶ 17; CMS Ex. 12 at 3 (facility cooks demonstrated improper calibration by moving dial too soon).  When asked the safe temperature for cooking chicken, Cook Neeru stated that 140° F was “fine” and later stated that she boiled chicken breast to 140° F when preparing chicken salad.  CMS Ex. 4 at 10 ¶¶ 23-24; CMS Ex. 6 at 7 ¶ 19; CMS Ex. 14 at 4-5 ¶ 12; CMS Ex. 12 at 2-3.  Based on surveyor observations of chicken temperature when taken from the oven during tray line service, improper calibration of food thermometers by facility cooks, and incorrect answers concerning safe cooking temperature of chicken, the surveyors concluded that the facility placed residents at risk for foodborne illness by serving undercooked chicken.  CMS Ex. 4 at 9-11 ¶¶ 20-27; CMS Ex. 6 at 7 ¶ 19. 

Creekside does not challenge these observations.  It instead explains that Surveyor Ayodele recorded temperatures after chicken was cooked to a safe temperature and then temporarily stored in kitchen ovens for tray line service.  P. Br. at 8-10; P. Ex. 1 at 1-3 ¶¶ 3, 6‑9; P. Ex. 2 at 2 ¶¶ 5-6; P. Ex. 3 at 2 ¶¶ 5-6.  Cooks Neeru and Shergill testified they knew chicken needed to be cooked to 165° F and then held at temperatures above 140° F for safe service.  P. Ex. 2 at ¶¶ 5-6; P. Ex. 3 at 2 ¶¶ 5-6.  Creekside explains any confusion by its cooks in articulating proper cooking and maintenance temperatures for chicken resulted from Surveyor Ayodele’s “intimidating” style of questioning, causing them to be nervous and scared.  P. Ex. 1 at 2-3 ¶ 8; P. Ex. 2 at 1 ¶ 4; P. Ex. 3 at 1-2 ¶ 4; P. Ex. 4 at 3 ¶ 7.  More broadly, Creekside accuses Surveyor Ayodele of being unprofessional and prone to overstate deficiency findings based on other surveys she performed outside the record before me.  Id. 

Creekside’s contentions are unpersuasive.  First, there is no evidence in the record of measurements for temperatures of chicken taken from the oven during tray service on

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September 10, 2018 that corroborates the cooks’ assertions.  Creekside did submit such records for July and August 2018 to support its claim that its kitchen staff were aware of safe cooking temperatures and regularly applied them.  P. Ex. 7.  But it did not submit such records for the month of September 2018. 

Second, Creekside has submitted no records to document proper calibration by its staff of thermometers used to measure food temperatures during or at any time before the survey.  See, e.g., CMS Ex. 4 at 10-11 ¶¶ 26-27; CMS Ex. 6 at 6 ¶ 17 (recording a 30° F discrepancy between thermometers used by the surveyor team and the facility’s cooks).  Lacking evidence of proper calibration, it is difficult to give much weight to the temperature logs Creekside did generate or to Creekside’s claim that it took the task of achieving correct temperatures and documenting them seriously. 

Finally, Creekside’s “Cool Down Log” for cold foods also reflect initial cooking temperatures of 68°, 70°, and 140° for chicken used in chicken salad during July and August 2018, all of which fall short of the 165° safe cooking temperature for chicken.  P. Ex. 11.¹³  Cook Neeru’s mistaken assertions concerning the safe cooking temperature for chicken in conjunction with the lack of documentation for food temperatures taken in September 2018 and evidence that the facility did not properly calibrate its thermometers all lead me to conclude Creekside has not established chicken prepared and served during tray service on September 10, 2018 reached the safe temperature of 165° F before being made available to nursing home residents. 

Creekside’s challenges to Surveyor Ayodele’s conduct and demeanor during the survey are without merit.  P. Post-hearing Br. at 8-9.  In the first place, as the Department Appeals Board (DAB) has made clear, “allegations of inadequate survey performance are irrelevant to ALJ or Board review of CMS's noncompliance and remedy determinations,” if the evidence otherwise supports the cited deficiencies.  Avon Nursing Home, DAB 2830 at 11-12 (2017). 

I am otherwise unpersuaded by Creekside’s unsupported assertions that Surveyor Ayodele cited “immediate jeopardy” deficiencies at a higher rate than the “national average” for the same reasons I gave during the hearing.  P. Post‑hearing Br. at 9.  Creekside has presented no statistical data to provide foundation for such a claim and no evidence concerning the number of surveys conducted or deficiencies cited in California during the relevant period, much less deficiencies cited at the immediate jeopardy level of scope and severity.  Tr. at 164.  Even if Creekside successfully established this claim, I

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would still be bound by law and regulation to consider the evidentiary record before me to determine whether CMS had a basis to impose a remedy in this case. 

3. Creekside posted inaccurate food cool-down instructions. 

CMS contends Creekside’s staff did not know how to properly cool food, evidenced by a poster Creekside placed in its kitchen that CMS believes was inaccurate.  CMS Br. at 13-15.  With respect to reheating previously cooked food, the SOM states: 

Reheated cooked foods present a risk because they have passed through the danger zone multiple times during cooking, cooling, and reheating.  The PHF/TCS food that is cooked and cooled must be reheated so that all parts of the food reach an internal temperature of 165 degrees F for at least 15 seconds before holding for hot service. . . . Although proper reheating will kill most organisms of concern, some toxins, such as that produced by Staphylococcus aureus, cannot be inactivated by reheating food.

NOTE:  Using a steam table to reheat food is unacceptable since it does not bring the food to the proper temperature within acceptable timeframes. 

Id. at 9-10. “Cooked potentially hazardous foods that are subject to time and temperature control for safety are best cooled rapidly within 2 hours, from 135 to 70 degrees F, and within 4 more hours to the temperature of approximately 41 degrees F.” Id. at 10. “The total time for cooling from 135 to 41 degrees F should not exceed 6 hours.” Id. 

Surveyor Ayodele testified that Creekside posted “a confusing set of food cool down instructions” for its kitchen staff that “posed a risk of spreading food borne illnesses.”  CMS Ex. 4 at 4, 11 ¶¶ 9, 28.  Cook Neeru stated that she followed these instructions.  Id. at 11 ¶ 28 (citing CMS Ex. 1 at 29-30).  According to the surveyors, the posted food cool-down instructions stated “that if food does not cool down from 135 degrees Fahrenheit to 41 degrees Fahrenheit in 6 hours, then the item should be reheated to 165 degrees Fahrenheit for 15 seconds.” Id. (citingCMS Ex. 1 at 30); see also CMS Ex. 11 (facility “Cool Down” policy). 

Surveyor Ayodele explained this policy was inadequate because the Food and Drug Administration (FDA) Food Code requires “cooling from 135 degrees Fahrenheit to 70 degrees Fahrenheit in the first 2 hours.” Id. at 12 ¶ 29 (citing CMS Ex. 16). “The Food Code also indicates that the initial 2-hour cooling period is a critical element of this cooling process and that cooked hot food should be discarded immediately if the food is

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above 70 degrees Fahrenheit at two hours into the cooling process; or above 41 degrees Fahrenheit at six hours into the cooling process.” Id. (emphasis added).  

In short, Creekside’s policy permitted reheating of any cooled food by heating to 165 degrees for 15 seconds even if it had been improperly cooled, meaning its temperature exceeded 70 degrees Fahrenheit at two hours or 41 degrees at six hours.  Id. ¶ 30; see also CMS Ex. 6 at 6 ¶ 18; CMS Ex. 12 at 5.  CMS argues this policy is inconsistent with prevailing professional food standards.  

Creekside responds that the cool-down poster in fact stated “food must be cooled 70° within two hours . . . .” P. Br. at 11-12 (citingCMS Ex. 11).  Creekside argues that both the SOM and industry practice allow for reheating improperly cooled food to 165° F for at least 15 seconds, consistent with those posted instructions.  Id. at 12.  Cooks Neeru and Shergill and Dietitian Ousey declared the facility’s cool-down process required properly cooked food be cooled to 70° F within the first two hours and to 41° F “within another four hours.” P. Ex. 2 at 2 ¶ 7; P. Ex. 3 at 2 ¶ 7; P. Ex. 4 ¶ 3. 

Critically, however, Ms. Ousey admitted the facility policy allowed for reheating improperly cooled food to 165° Fahrenheit, though such reheating could be done only “once and is not advised in our policy and procedure.”  P. Ex. 4 at 2 ¶ 3.  As CMS has pointed out, professional food standards set forth both in the SOM and the FDA Food Code require improperly cooled down PHF like chicken to be discarded, not reheated.  Creekside improperly applied the reheating protocol set forth in the SOM to food that required discarding under the FDA Food Code.¹⁴  Creekside has not met its regulatory obligation to serve food to its residents in a manner consistent with professional food standards.  

4. Creekside did not properly sanitize kitchen equipment, as evidenced by dirty dishes and improper use of quat sanitizer.

The SOM contains guidelines for cleaning and sanitizing kitchen equipment and utensils.  CMS Ex. 21 at 14-15.  It recognizes “improper cleaning (washing and sanitizing) of equipment and [failing to protect] equipment from contamination via splash, dust, grease, etc.” are a potential source of foodborne illness.  Id. at 14.

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A facility may use “[a] 3-step process [to] manually wash, rinse, and sanitize dishware correctly.  The first step is thorough washing using hot water and detergent after food particles have been scraped off.”  CMS Ex. 21 at 14 (emphasis added).  After “washing and rinsing, dishes and utensils are [then] sanitized by immersion” in either hot water or “[a] chemical sanitizing solution used according to manufacturer’s instructions.  Chemical sanitization requires greater controls than hot water sanitization.  Manufacturer’s instructions must always be followed.”  Id. (emphasis in original). 

The SOM highlights the risks presented by sanitization solutions, as “[a] high concentration of sanitization solutions may be potentially hazardous (see manufacturer’s instructions) and may be a chemical contaminant of food.”  Id. at 15.  With respect to cleaning kitchen equipment, the SOM states: 

When cleaning fixed equipment (e.g., mixers, slicers, and other equipment that cannot readily be immersed in water), the removable parts must be washed and sanitized and non‑removable parts cleaned with detergent and hot water, rinsed, air-dried, and sprayed with a sanitizing solution (at the effective concentration).  Finally, the equipment is reassembled and any food contact surfaces that may have been contaminated during the process are re-sanitized (according to the manufacturer’s instructions).  Service area wiping cloths are cleaned and dried or placed in a chemical sanitizing solution of appropriate concentration. 

Id. (emphasis added). 

Surveyor Ayodele observed unsanitary conditions in the facility, stating as follows:  “I found a brown colored oily residue in the food mixer bowl stored away as clean.  I also found two scoops stored away as clean that were visibly soiled.”  CMS Ex. 4 at 13 ¶ 32 (citingCMS Ex. 1 at 30); see also CMS Ex. 12 at 1-2.  Creekside does not dispute these observations but argues instead that its staff would not have used these admittedly dirty utensils for food service.  P. Post-hearing Br. at 8.  Creekside’s argument concedes the existence of the deficiency and its arguments concerning harm (scope and severity) are irrelevant to the deficiency finding. 

During the survey, a facility dietary aide also demonstrated “testing of the quaternary sanitizer [Quat] used to clean food contact surfaces.” CMS Ex. 4 at 13 ¶ 33.  The concentration of the Quat sanitizer tested was between 400 and 500 parts per million (ppm); the dietary aide explained that the “facility practice was to add hot water if the reading was too high.”  Id.  Surveyor Ayodele reviewed manufacturer instructions which indicated “concentration of the sanitizing solution needed to be 150-400 ppm with an immersion of the testing strips for 10 seconds in the solution.  Id. at 14 ¶ 34 (citing CMS

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Ex. 31).  Surveyor Ayodele opined that the facility’s use of an “overly concentrated sanitizer posed a danger to residents.”  Id. at ¶ 35; see also CMS Ex. 6 at 7 ¶ 20 (improperly diluted quaternary sanitizer “used to clean food contact surfaces”).  

Creekside admits to use of overly concentrated Quat sanitizer by it staff during the survey but argues it “was not used on food preparation surfaces” and thus could not give rise to the harm described.  Id.  But Creekside’s consulting dietitian Ms. Ousey testified flatly to the contrary: “Q:  And is it your understanding the Quat sanitizer was used on food prep surfaces?  A:  Yes.” Tr. at 177.  Ms. Ousey later testified that while Quat sanitizer “would not come into direct contact with food that is being prepared,” she conceded that “sometimes Quat sanitizer does come into contact with food contact surfaces.”  Id. at 179.  The evidence of record supports CMS’s claim that Creekside improperly sanitized its kitchen equipment, as evidenced by dirty utensils and equipment and the improper use of overly concentrated quat sanitizer on food preparation surfaces. 

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

Creekside was required to “[s]tore, prepare, distribute, and serve food in accordance with professional standards for food service safety.”  42 C.F.R. § 483.60(i)(2).  Creekside argues its “technical noncompliance” with participation requirements did not constitute a failure to substantially comply with them.  P. Post‑hearing Br. at 2, 12; see also 42 C.F.R. § 488.301.  But as shown above, Creekside failed to meet this regulatory standard in a variety of ways that in conjunction posed a risk of more than minimal harm to its residents’ health and safety.  The facility stored food in a long-malfunctioning reach-in freezer in which food contents were not frozen solid, evidenced by internal freezer temperature measurements and the presence of thawed food.  More than once a facility cook wrongly stated the “safe” cooking temperature for chicken was 140° F, well below the correct temperature of 165° F.  Facility cooks could not correctly demonstrate food thermometer calibration to the CDPH survey team, rendering their food temperature readings taken during lunch service and previous food temperature logs unreliable.  Dirty utensils and equipment suggested unsanitary conditions in the facility’s kitchen while the use of excessively concentrated Quat sanitizer on food preparation surfaces increased the likelihood of residents’ exposure to toxic cleaners.  Finally, by virtue of their presence at a skilled nursing facility, Creekside’s aged and infirm residents collectively faced a heightened risk of contracting foodborne illness and suffering serious complications from such illness.  The conditions and practices described above placed Creekside’s vulnerable residents at substantial risk of foodborne illness and violated 42 C.F.R. § 483.60(i)(Tag F812). 

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B.       CMS’ immediate jeopardy determination is not reviewable.  

Creekside argues that any potential harm from the deficient practices cited here does not meet the definition of “immediate jeopardy.”  Id. at 12.  But I cannot overturn CMS’s determination of immediate jeopardy unless to do so would change the range of civil money penalties assessed.  NMS Healthcare of Hagerstown, DAB No. 2603 at 6-7 (2014) (“ The level of noncompliance may be appealed, and reviewed, only if a successful challenge would affect the range of the CMP amounts that CMS could collect or affect a finding of substandard quality of care that resulted in the loss of a nurse aide training program.”) (citing 42 C.F.R. § 498.3(b)(14)(i), (d)(10)(i)-(ii)).  The regulations provide for a single range of CMP amounts that may be imposed on a per-instance basis. 42 C.F.R. § 488.845(b)(6).  As the civil money penalty in this case is a per-instance civil money penalty, overturning the immediate jeopardy finding would not affect the range of civil money penalty issued.  CMS’s determination of immediate jeopardy is therefore not reviewable. 

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

Both parties have argued the merits of CMS’s immediate jeopardy finding. CMS Br. at 17-19; P. Br. at 16-17.  And while the finding of immediate jeopardy is not reviewable for purposes of establishing a penalty range, it does bear upon the seriousness of the deficiency in determining the overall reasonableness of the penalty.  NMS Healthcare, DAB No. 2603 at 1 n.1 (“Thus, an immediate jeopardy citation is relevant to the seriousness of deficiencies and is a factor to be considered by an ALJ when determining whether the amount of a CMP is reasonable even where, as here, the immediate jeopardy determination itself is not subject to review because CMS imposed a per-instance CMP.”).  I therefore evaluate CMS’s immediate jeopardy determination in this context. 

CMS determined Creekside’s deficiencies related to food safety posed widespread immediate jeopardy to its residents.  CMS Ex. 1 at 1.  On this record, I cannot say CMS’ determination was clearly erroneous.  Immediate jeopardy exists if a facility’s noncompliance “has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.  The regulation does not require that a resident actuallybe 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)(2). 

The “clearly erroneous” standard imposes on facilities a heavy burden to show no immediate jeopardy.  The DAB has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (citing Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)), aff’d, Barbourville

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

Creekside demonstrated multiple shortcomings in its food storage, preparation, and service practices, as well as kitchen sanitation.  It failed to keep foods frozen solid in a malfunctioning reach-in freezer with a known history of problems that required ongoing servicing.  It failed to ensure that its kitchen cooks knew the correct temperature for cooking chicken, either as a hot lunch entrée or for cold chicken salad, or that the cooks correctly calibrated food thermometers used to check and record food temperatures.  It failed to post accurate food “cool down” instructions to ensure that food not properly cooled to 70° F within the first two hours from cooking was not subsequently reheated and served to residents.  It failed to clean and sanitize utensils and equipment and food contact surfaces used to prepare and serve food for residents, and it failed to ensure that its staff was trained on how to clean and sanitize such items properly.  In sum, Creekside failed to store, prepare, distribute, and serve food in accordance with professional standards for food service safety. 

These failures increased the risk of inflicting foodborne illness to Creekside’s vulnerable residents, who already “risk[ed] serious complications from foodborne illnesses as a result of their compromised health status.” CMS Ex. 21 at 1.  Creekside’s management representative Mr. Durr may have directed that food from the malfunctioning freezer be discarded the day after the survey began, but he only did so after he learned that surveyors had raised questions concerning improperly frozen foods and food safety.  P. Ex. 5 at 1-2 ¶¶ 3-5.  Similarly, when Surveyor Ayodele questioned the cooking temperature of chicken during tray service on September 30, instead of explaining that the chicken had been initially cooked to the correct temperature of 165° F, the cooks simply returned the food to the oven, after which it still did not reach the required safe temperature.  CMS Ex. 4 at 9-10 ¶¶ 21-22.  Further, surveyor observations concerning unsanitary conditions – engine oil in the bottom of a malfunctioning mixer bowl, two dirty ice cream scoops, and improper concentration of Quat sanitizer used on food contact surfaces – suggest an ongoing neglect of sanitary requirements.  CMS Ex. 12 at 1-2, 6-7.  The overall lack of compliance with food safety standards indicates residents were at regular risk of foodborne illness as the result of Creekside’s failure to store, prepare, distribute, and serve food in accordance with professional standards. 

In response, Creekside argues principally that the deficiencies cited arose from “a series of misunderstandings between the surveyors and Creekside’s kitchen staff, as well as conclusions drawn by the surveyor that exaggerate or misrepresent the particular circumstances.”  P. Br. at 5.  Creekside’s arguments are unpersuasive for the reasons previously discussed.  The fact that none of the residents appear to have been harmed by

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Creekside’s deficient and unsanitary food storage, preparation, service, and sanitation 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 7 (“[I]mmediate jeopardy exists if a facility’s noncompliance is likely to cause serious injury, harm, impairment, or death if not corrected, even if the surveyors did not observe or identify a particular resident who was actually threatened with harm during the survey.”) (citations omitted). 

III.     The $17,500 per-instance civil money penalty imposed by CMS is 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. 

My analysisat Section II.C supra highlights the seriousness of Creekside’s noncompliance.  Creekside does not dispute its residents consumed food Creekside prepared and served during the relevant period.  Creekside similarly does not dispute its 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. 21 at 1.  But despite having policies in place to assure proper storage, preparation, distribution, and service of food in accordance with professional standards for food service safety, Creekside failed to ensure that its staff adhered to those policies and guidance.  Thus, Creekside subjected its elderly residents to an unnecessary and potentially dangerous risk of exposure to foodborne illness and toxic chemical exposure. 

With respect to past compliance history, Creekside argues it has a strong history of compliance, claiming CDPH’s public database shows no enforcement actions going back to 2016.  P. Pre-hearing Brief at 15-16 n.3 (citing https://www.cdph.ca.gov/Programs/CHCQ/LCP/CalHealthFind/Pages/Home.aspx (last visited Apr. 24, 2023).  But that website shows 32 complaints/reported incidents, 23 deficiencies, and 1 enforcement action in 2018 and 36 complaints/reported incidents and 14 deficiencies in 2019.  There are no prior years available for review.  Creekside’s compliance history in 2018 and 2019 supports the civil money penalty imposed by CMS in this case. 

As to culpability, CMS argues it is high because of Creekside’s failure to correct multiple substandard practices that placed its residents at risk for foodborne illness and toxic chemical exposure; CMS also points out Creekside presented no evidence of inability to pay.  CMS Br. at 20-21; CMS Post-hearing Br. at 22-24.  Creekside asserts
its culpability was low, reflected by staff attempts to comply with requirements (including disposing of freezer food), and because any noncompliance did not cause or

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was not likely to cause serious harm or imminent injury to residents.  P. Br. at 15-17; P. Post-hearing Br. at 11-12.

I do not believe Creekside intended to neglect or disregard its residents.  Nevertheless, a significant level of culpability is apparent here from the facility’s indifference to the variety of food safety issues discovered by the state surveyors.  The likelihood of harm to elderly residents that could stem from poor food storage and preparation and inadequate training of staff concerning food safety should have been clear to health care professionals operating a skilled nursing facility.

For these reasons, I find CMS’ imposition of a $17,500 per-instance civil money penalty for immediate jeopardy noncompliance to be reasonable.

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Endnotes

¹ Tag F812 concerning food safety is discussed in the CMS State Operations Manual (SOM) Appendix PP, beginning at PDF counter 552, available at https://www.cms.gov/Medicare/Provider-Enrollment-and-certification/GuidanceforLawsAndRegulations/Downloads/Appendix-PP-State-Operations-Manual.pdf (last rev. Nov. 22, 2017).

² CMS initially cited Creekside with seven other instances of noncompliance under Tags F578, F759, F801, F802, F804, F838, and F908.  CMS Ex. 1 at 1, 3, 5, 11, 17, 33, 38.  CMS argues my review in this case is limited to the deficiency for which CMS imposed a remedy (Tag F812).  CMS Br. at 4-6.  Creekside contends Plott Nursing Home v. Burwell, 779 F.3d 975 (9th Cir. 2015) requires me to review all eight deficiencies cited by CMS.  P. Post-hearing Br. at 2-3, 10.  As explained in my June 29, 2021 Order to Submit Post‑Hearing Briefing, I conclude the Plott holding does not require review of deficiencies CMS did not rely upon to impose a penalty.  I confine my review to the deficiency cited under Tag F812.

³ At the hearing, CMS counsel clarified CMS intentionally omitted filing a proposed Exhibit 13, ostensibly to create a “placeholder” for a potential future filing.  Tr. at 17-18.  I provisionally admitted CMS Exhibits 6 and 14 pending submission of amended exhibits by CMS, which it did on February 14, 2020.  Tr. at 18-19.  I therefore admit the amended versions of CMS Ex.6 and Ex. 14 into the record. 

⁴ The per-instance penalty range in effect during the survey was $2,140 to $21,393.  45 C.F.R. § 102.3 (Oct. 1, 2019); 83 Fed. Reg. 51,369, 51,370 (Oct. 11, 2018).

⁵ Surveyor Ghai served as the survey team’s scribe and generated the notes found at CMS Ex. 12.  CMS Ex. 4 at 4 ¶ 8.

⁶ There is no dispute that Freezer 1’s external temperature readout was faulty or that Creekside was aware of the defect, which is why its staff relied on analog internal thermometers placed inside.  CMS Ex. 1 at 24; P. Ex. 1 at 3 ¶ 11-12; P. Ex. 5 at 1-2 ¶ 3.

⁷ As of the hearing, Creekside employed neither cook.  Tr. at 248.

⁸ Creekside’s own temperature logs for Freezer 1 for the morning and afternoon of September 10, 2018 and the morning of September 11, 2018 fail to undermine the surveyors’ observations.   They reflect documented temperatures of “4.5” and “2.1” degrees for the morning and afternoon of September 10 and “10.1” degrees for the morning of September 11.  CMS Ex. 9 at 2.  But as Creekside concedes, the digital external thermometer readout for Freezer 1 was faulty while the internal thermometer its staff relied on was analog, meaning it was not possible to obtain decimal points for temperature measurements.  Surveyor Ayodele noticed this discrepancy with respect to facility temperature logs pertaining to Freezer 2 and discovered a facility employee simply added a decimal point from the faulty external display to the temperature taken from the internal analog thermometer.  CMS Ex. 4 at 8 ¶ 17.  This cavalier approach suggests facility staff did not take sufficient care to accurately maintain temperature logs for its freezers and refrigerators.

⁹ Creekside’s own food safety policy contradicts Ms. Ousey’s claim that the surveyors should have measured the temperature of the food in Freezer 1 and not relied on the freezer’s interior temperature.

¹⁰ The SOM defines the “danger zone” for Potentially Hazardous Foods (PHF) and Temperature Control for Safety (TCS) foods as temperatures between 41° F and 135° F “that allow the rapid growth of pathogenic microorganisms that can cause foodborne illness.”  CMS Ex. 21 at 2.  Chicken is a PHF.  Id.  at 5.  PHF and TCS foods “held in the danger zone for more than 4 hours (if being prepared from ingredients at ambient temperature) or 6 hours (if cooked and cooled) may cause a foodborne illness outbreak if consumed.”  Id. at 2. As the SOM explains, “[t]he longer food remains in the danger zone, the greater the risks” for resulting foodborne illness, as “[b]acteria multiple rapidly in a moist environment in the danger zone. . . . Rapid death of most bacteria occurs at 165 degrees F or above.”  Id. at 4.

¹¹ The surveyors calibrated their thermometers at 9:04 a.m. on the first day of the survey.  CMS Ex. 12 at 1.  Surveyor Ayodele also testified that it was her practice to calibrate her thermometer for every facility survey and confirmed she did so in this case.  Tr. at 75-77, 107.

¹² The SOM states that temperatures are crucial in preventing foodborne illnesses and that chicken should be cooked to 165° F as a safe cooking temperature.  CMS Ex. 21 at 9.

¹³ Creekside’s “Cool Down Log” could be understood to record food temperatures beginning after chicken first reached 165° F and then proceeded through the cool-down period.  But like the series of temperature readings for chicken taken from the oven during lunch service on September 10, 2018, these records do not document that the chicken ever first reached the initial safe temperature of 165° F before it began to cool down.

¹⁴ It is true that neither the regulations nor the SOM in effect at the time of the survey at issue here incorporate or refer to the FDA Food Code.  But the regulations do require facilities like Creekside to meet “professional standards for food service safety” in the storage, preparation, distribution, and service of food.  42 C.F.R. § 483.60(i)(2).  The FDA’s Food Code has existed for 30 years and provides a “model for best practices to ensure the safe handling of food in a retail setting” – in other words, it sets forth widely accepted professional standards for food service.  U.S. Food and Drug Admin., 2022 Food Code, available at https://www.fda.gov/food/retail-food-protection/fda-food-code (last rev. Feb. 9, 2023).  It is not unreasonable to expect Creekside to be aware of and meet prevailing professional food safety standards.