The Grand Rehabilitation and Nursing at Utica, DAB CR6663 (2025)

DECISION

The Grand Rehabilitation and Nursing at Utica (Petitioner or “the facility”) challenges the determinations by the Centers for Medicare & Medicaid Services (CMS) that it was out of compliance with the Medicare program participation requirement regarding food safety (42 C.F.R. § 483.60(i)(1), (2)) (cited as Tag F812) and that its noncompliance amounted to immediate jeopardy to resident health and safety.  Petitioner also challenges the remedies imposed, specifically, a per-day civil monetary penalty (CMP) of $16,304 for one day of immediate jeopardy noncompliance on December 14, 2021, and a per-day CMP of $435 for non-immediate jeopardy noncompliance from December 15, 2021 through January 31, 2022.  For the reasons discussed below, I conclude that Petitioner was not in substantial compliance with Medicare program requirements.  CMS’s immediate jeopardy determination was not clearly erroneous, and the remedies imposed are reasonable.

I.    Background

The Social Security Act (Act) establishes requirements for skilled nursing facility (SNF) participation in the Medicare program and authorizes the Secretary of Health and Human Services (“the Secretary”) to promulgate regulations implementing those statutory provisions.  See 42 U.S.C. § 1395i-3; 42 C.F.R. pts. 483 and 488.  To participate in the

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Medicare program, SNFs must maintain substantial compliance with program participation requirements.  In order to be in substantial compliance, any deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10, 488.20.  The Act and its implementing regulations require that facilities be surveyed on average every 12 months, and more often if necessary, to ensure that identified deficiencies are corrected.  42 U.S.C. § 1395i‑3(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.

CMS may impose a per-day CMP for the number of days a facility is not in substantial compliance or a per-instance CMP for each instance of the SNF’s noncompliance.  42 U.S.C. § 1395i-3(h)(2)(B)(ii); 42 C.F.R. § 488.430(a).1  If CMS imposes a remedy based on a noncompliance determination, then the facility may request a hearing before an administrative law judge (ALJ) to challenge the noncompliance finding and enforcement remedy.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

The New York Department of Health (state agency) completed a recertification and complaint investigation survey of the facility on December 21, 2021, at which time it determined that the facility was not in substantial compliance with Medicare program participation requirements.  CMS Ex. 1.  The state agency cited, inter alia, immediate jeopardy noncompliance2 with 42 C.F.R. § 483.60(i)(1), (2) (Tag F812), with a scope and severity level (s/s) of “L.”3  CMS Ex. 1 at 1, 39-56.  The statement of deficiencies (SOD)

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reported that the state agency identified immediate jeopardy on December 14, 2021, and that Petitioner abated immediate jeopardy as of December 15, 2021.  CMS Ex. 1 at 1-2.

In a letter dated January 24, 2022, CMS informed Petitioner that the “survey revealed that your facility is not in compliance with the Federal requirements . . . During the course of the survey, the facility alleged and the State Survey Agency verified that the IJ [immediate jeopardy] was removed as of December 15, 2021, however, noncompliance continued to exist.”  CMS Ex. 3 at 1.  CMS informed Petitioner that the immediate jeopardy was for one day, December 14, 2021.  CMS imposed a per-day CMP of $16,304 for the single day of immediate jeopardy noncompliance, and a per-day CMP of $435, effective December 15, 2021, with the CMP continuing to accrue, based on the continuing noncompliance under Tag F812 and the remaining tags cited in the SOD.  CMS Ex. 3 at 1.  CMS also informed Petitioner that continued noncompliance would result in a denial of payment for new admissions (DPNA), effective March 21, 2022, and termination of its Medicare provider agreement, effective June 21, 2022.  CMS Ex. 3 at 1.

On March 11, 2022, CMS informed Petitioner that based on a revisit survey conducted on February 15, 2022, it determined that the facility returned to substantial compliance effective March 7, 2022.  CMS Ex. 46 at 1.  CMS notified Petitioner that the proposed DPNA and termination had been rescinded, and that it had lost approval to conduct a Nurse Aide Training and Competency Evaluation Program.  CMS Ex. 46 at 1.  CMS imposed the following CMPs:  a per-day CMP of $16,304 effective December 14, 2021, for one day of immediate jeopardy noncompliance, and a per-day CMP of $435 effective December 15, 2021 through March 6, 2022, for continuing noncompliance.4  CMS Ex. 46 at 1.

Petitioner timely requested a hearing on March 25, 2022.  CMS filed a pre-hearing brief (CMS Pre-hrg. Br.), along with 50 proposed exhibits (CMS Exs. 1-50), and Petitioner filed a pre-hearing brief and seven proposed exhibits (P. Exs. 1‑7).  At the time of the January 24, 2023 pre-hearing conference, I admitted all of the proposed exhibits, with CMS Exhibits 26, 27, 29, 30, 32, and 33 provisionally admitted pending the appearance of the witnesses for cross-examination.  See January 24, 2023 Order Summarizing Pre-Hearing Conference.

CMS submitted the written direct testimony of the following six surveyors:  E. Quinones (CMS Ex. 26), W. Brunnett (CMS Ex. 29), J. Stadler (CMS Ex. 32), R. Tringale (CMS Ex. 35), A. Tuttel (CMS Ex. 37), and K. Wilber (CMS Ex. 39).  Petitioner requested an opportunity to cross-examine Surveyors Quinones, Brunnett, and Stadler, and these

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witnesses were cross-examined at the video teleconference hearing on March 13, 2023.  I therefore admit CMS Exhibits 26, 27, 29, 30, 32, and 33 in addition to the previously admitted evidentiary exhibits.

Petitioner submitted the testimony of three witnesses:  the facility’s Administrator, F. Deck, LNHA (P. Ex. 1); Regional Clinical Director “CNY” for The Grand Healthcare System, S. Maxwell, RN (P. Ex. 3); and the facility’s medical director, J. Amidon, DO (P. Ex. 6).  CMS did not request an opportunity to cross-examine these witnesses.

Following the hearing, a transcript (Tr.) of the hearing was made available to the parties.  Thereafter, the parties filed post-hearing briefs (CMS Post-hrg. Br.; P. Post-hrg. Br.) and post-hearing reply briefs (CMS Post-hrg. Reply; P. Post-hrg. Reply).  The record is closed and the case is ready for a decision.

II.   Issues

At the January 24, 2023 pre-hearing conference, the parties agreed that the following issues are presented for review:

Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.60(i)(1), (2) (cited as Tag F812);

If not, whether the deficiency posed immediate jeopardy to resident health and safety on December 14, 2021;

Whether a per-day CMP of $16,304 for immediate jeopardy noncompliance is reasonable;

Whether Petitioner remained out of substantial compliance with the aforementioned Medicare participation requirement until January 31, 2022;

If so, whether a per-day CMP of $435 beginning on December 15, 2021, and continuing until January 31, 2022, is reasonable.

See January 24, 2023 Order Summarizing Pre-Hearing Conference; Tr. 4.

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III.    Discussion5

1. Pursuant to 42 C.F.R. § 483.60(i)(1), (2), a facility is required to procure food from sources approved by federal, state, or local authorities, and to store, prepare, distribute, and serve food in accordance with professional standards for food service safety.
2. Petitioner had a policy to store cold foods at 40℉ or below.
3. The surveyors recorded a temperature of 59.5℉ for milk stored in a walk-in cooler.  At the time the surveyors notified Petitioner of the milk storage temperature on December 14, 2021, facility staff had already served lunch trays with milk from that cooler to five units.  Petitioner does not dispute that 57 residents received the milk, and several residents consumed the milk.
4. Surveyors recorded temperatures of refrigerated items that were 50℉ or above, to include:  cold cut turkey and ham; a tray of egg salad; a tray of ham salad; a tray of ground sausage; a container of tomato sauce; a box of cubed cheese; a hotel pan of hard-boiled eggs; and a hotel pan of rigatoni.  Several other items were stored above 41℉:  a large tray of stewed tomatoes (47℉); a case of shell eggs (47℉), and seven boxes of shredded cheddar and mozzarella cheese (44℉).
5. Although all of Petitioner’s units were supposed to be notified of the out-of-temperature milk, surveyors on two units observed that the milk had not been removed from the residents’ trays, and Petitioner’s staff removed the milk only after being asked to do so by the surveyors.
6. Petitioner did not know that the walk-in cooler that was holding the milk and the other out-of-temperature foods was malfunctioning.  Petitioner also did not know that the cooler’s thermometer was not working properly.
7. Petitioner failed to ensure that both a walk-in cooler and the thermometer used for that cooler were functioning properly, as required by professional standards for food service safety.
8. Petitioner failed to store milk and other food products at safe refrigerated temperatures, as required by professional standards for food service safety.
9. Petitioner had a policy to store hot foods at a holding temperature of at least 135℉.

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10. Surveyors determined that hot foods were held at the following temperatures:  meatballs – 123℉; mashed potatoes – 129℉, and red sauce – 128℉.
11. Petitioner failed to ensure that hot foods on the service line were held at a safe temperature range, as required by professional standards for food service safety.
12. Surveyors documented that corn beef wrapped in aluminum foil and two cases of ground sausage were wet and encased in the ice dripping from compressor lines, to the point that the foil/packaging was compromised.
13. Surveyors observed that the ice machine showed signs of dark spotty mold inside the unit, the top and outside of the machine were unclean with food spills and sticky, and the ice scoop was stored inside a holder that was unclean and soiled.
14. Surveyors observed that the walk-in freezer had frost puddling under the condenser fans unit, a sheet of ice on the floor, four boxes of food that were wet from dripping condensate, and two large sheet trays collecting condensate water that was frozen solid and spilling over the trays.
15. The surveyors’ observations relating to Petitioner’s kitchen cleanliness and equipment issues amount to a failure to comply with professional standards for food service safety.
16. Petitioner failed to adhere to its own policies addressing food preparation and service, food receiving and storage, and sanitization in accordance with professional standards for food safety, in contravention of the participation requirement at 42 C.F.R. § 483.60(i)(1), (2).
17. Petitioner’s multiple food safety failures placed its residents at risk of more than minimal harm, and thus, it was not in substantial compliance with 42 C.F.R. § 483.60(i)(1), (2).

Observations by the survey team

Surveyors inspected Petitioner’s kitchen and related areas during the December 13-14, 2021 survey.  Surveyors observed and documented the following: 

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Malfunctioning walk-in cooler # 2, with malfunctioning thermometer

• At 11:50 am on December 14, 2021, Surveyor Stadler recorded the internal ambient air temperature of Petitioner’s walk-in cooler # 2 to be 50℉. 6  The walk-in cooler had a hanging manual thermometer indicating a temperature between 38℉ and 40℉.  CMS Exs. 1 at 48; 31 at 1; 32 at 4.  The surveyors observed that the seal on the cooler’s door was ripped and torn, and the Food Service Director (FSD) reported that the door could not be sealed, but could be pushed closed.  CMS Ex. 1 at 40, 43.
• At 12:45 pm, Surveyor Quinones recorded the internal ambient air temperature of walk-in cooler # 2 to be 55℉.7  The temperature of the prepared milk in cups stored within the tray line holding refrigerators was between 55℉ and 60℉.  Walk-in cooler # 2’s hanging manual thermometer indicated the temperature of the cooler was 39℉.  CMS Exs. 1 at 48; 25 at 2; 26 at 6. 

Out-of-temperature food items that had been stored in walk-in cooler # 2

• Cold cut turkey and ham were recorded to be 55℉; the FSD discarded these items.
• A tray of egg salad was recorded to be 53℉; the FSD discarded this item.
• A 6-inch tray of ham salad was recorded to be 53℉; the FSD discarded this item.
• A tray of ground sausage was recorded to be 55℉ and was labeled and dated on December 13, 2021; the FSD discarded this item.
• A container of tomato sauce was recorded to be 52℉ and was dated December 13, 2021; the FSD discarded this item.
• A large tray of stewed tomatoes, labeled and dated December 11, 2021, was recorded to be 47℉; the FSD discarded this item.
• A box of cubed cheese was recorded to be 55℉; the FSD discarded this item.
• A 4-inch-deep hotel pan of hard-boiled eggs was recorded to be 52℉; the FSD discarded this item.
• A 4-inch-deep hotel pan of rigatoni was recorded to be 51℉; the FSD discarded this item.

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• A case of shell eggs was recorded to be 47℉; the FSD discarded this item.
• Seven boxes of shredded cheddar and mozzarella cheese were recorded to be 44℉; the FSD discarded these items.8

CMS Exs. 1 at 42-43;9 25 at 2; 26 at 4.

Out-of-temperature dairy items that had been stored in walk-in cooler # 2

• At approximately 12:43 pm on December 14, 2021, milk from walk-in cooler # 2 was recorded to be 59.5℉.  CMS Exs. 1 at 39, 42-43; 26 at 2; 32 at 5, 6; see CMS Ex. 34 at 25.  The surveyors informed the FSD of the milk temperature, and the FSD pulled the milk from meal service at 12:45 pm.  CMS Exs. 1 at 40; 26 at 2; 32 at 5; see CMS Ex. 34 at 26.  The milk had already been delivered on lunch trays to the residents in Units 2S, 2W, 4, 5, and 7, but Units 3 and 6 had not been served yet.  CMS Ex. 1 at 40, 43; see CMS Ex. 34 at 26.  The surveyors also advised Petitioner’s Administrator and Assistant Administrator, who stated they would call the units to ensure the milk was removed from service on Units 2S, 2W, 4, 5, and 7.  CMS Exs. 1 at 44; 26 at 5; 35 at 4.  Out of a census of at least 200 residents, 57 residents received the milk.  CMS Ex. 1 at 40.
• The surveyors recorded temperatures of 52℉ for cottage cheese and yogurt that had been stored in the walk-in cooler.  Petitioner removed these items from the lunch service.  CMS Exs. 1 at 1, 43; 34 at 26.
  
  Unit 3 and Unit 4 observations:  On Unit 4, at approximately 12:41 pm, Surveyor Brunnett recorded Resident # 71’s milk to be 64℉ and Resident # 105’s milk to be 65℉.  On Unit 3, at approximately 12:49 pm, Surveyor Brunnett observed that the residents had milk on their trays and that staff had not removed the milk.  CMS Exs. 29 at 3; 34 at 3.  He testified that “Unit 3 was called at 12:52 p.m. and the dairy products were not removed from the resident trays.”10  CMS Ex. 29 at 2.

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Surveyor Brunnett observed that Resident # 178 took two sips of milk; the milk temperature was 64 ℉.  CMS Ex. 29 at 3.  Although two dietary aides were briefly on Unit 3 at 12:50 pm. and 1:04 pm, neither took any action to remove the milk products.  CMS Ex. 34 at 3.  At 1:08 pm, Surveyor Brunnett observed that the meal trays were removed from the residents’ rooms.  He told staff to ensure that no milk or milk products were left in the residents’ rooms.  CMS Exs. 1 at 44; 29 at 3.  The LPN informed him that five residents had consumed all the milk on their lunch trays.  CMS Ex. 29 at 3.

Unit 2S observations:  On December 14, 2021, at 12:56 pm, Surveyor Wilber observed the lunch meal cart arrived on Unit 2S.  At 1:01 pm, she recorded the temperature of the milk on Resident # 168’s tray to be 73.1℉.  CMS Exs. 1 at 46; 39 at 1-2.  At that time, she asked the LPN Manager to remove all milk products from the residents’ trays.  In addition, at her direction, staff removed milk and milk products from the trays of an additional 14 residents who had not yet been served.  The LPN told the surveyor that she was not aware of any issues with the temperature of milk and milk products until she had been informed by the surveyor.  CMS Exs. 1 at 45; 39 at 2.

Hot-holding violations

On December 14, 2021, at 11:30 am, Surveyor Stadler observed and recorded the following hot foods on the service line that were not at an acceptable temperature: 

• Red sauce was recorded to be 128℉.
• Meatballs were recorded to be 123℉.
• Mashed potatoes were recorded to be 129℉.

After the surveyor brought these temperatures to the FSD’s attention, staff removed these items from service and reheated the items to 165℉.  CMS Exs. 1 at 50; 31 at 1; 32 at 3, 6.

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Adulterated food found in the walk-in cooler and freezer

At 11:40 am on December 14, 2021, Surveyor Stadler observed and documented adulterated food products: 

• A case containing lettuce, located on the top shelf of the rack in walk-in cooler # 1, appeared rotten and partially liquefied.  The bagged lettuce was stamped by the manufacturer with the date of 11/29/21.11  Staff discarded the entire box.
• The discarded box also contained unwrapped herbs that were wilted and rotting and pre-bagged salad mixes.
• In a freezer, corned beef in a foil pan wrapped in aluminum foil, labeled with a date of 11/9/21, was encased in ice.  The aluminum foil covering was partially ripped and ice from the freezer’s compressor lines/water was in contact with the corned beef.  The pan of corned beef was voluntarily discarded due to the ice encasing it.

CMS Exs. 1 at 40, 49, 55; 31 at 1-2; 32 at 4, 5-6, 7; 44.

Physical contamination and cleanliness issues

On December 13, 2021, the survey team documented the following issues in Petitioner’s kitchen: 

• The ice machine had a dark, spotty, mold-like substance on the inside.  The top and outside of the machine had food spills and was sticky.
• The plastic holder for the ice scoop and the wall to which it was attached were unclean and soiled.
• The walk-in freezer had the following problems:  frost puddling under the condenser fans unit; a 3’ x 3’ sheet of ice was on the floor under the storage racks and main aisle between the racks; four boxes of food product were wet from dripping condensate and there was ice buildup; two large sheet trays under the fans collected condensate water, and the water was frozen solid and spilling over the trays.
• The floors and walls in the food preparation areas and underneath and in front of the stoves and ovens were unclean and soiled with food debris.

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• The kitchen had several areas of black soiled flooring, and all the grout between the tiles was black.
• Improper air drying and storage were observed behind the 3-bay sink area.  Numerous sheet trays and deep trays were being improperly air-dried with water droplets on the outside and inside, as well as being stored tightly together.
• The floor in front of and under the dish machine was missing tiles and grout, and a 10’ x 10’ section contained standing water with food debris and spillage.
• The juice machine had juice spills on the lines.  The underside of the machine was sticky and juice was draining into a cut plastic bucket.
• Walk-in cooler # 2 had sliced cold cut turkey on the floor, racks, and shelves.  The floor had other food debris and was unclean.

CMS Exs. 1 at 51-53; 25 at 1; 26 at 8-10.

On December 14, 2021, the surveyors documented ongoing and additional problems in the kitchen: 

• The kitchen floors remained unclean and soiled with food debris and black grout, including under and behind major appliances on the cook lines.
• The stored dishware behind the 3-bay sink section, including the pans and trays, were stored wet and improperly air-dried, and stacked with water collecting inside and in between one another.
• The dishwashing area contained broken, missing floor tiles; grout had food debris; and there was milk spillage in the grout spaces and under the floor.
• The walk-in freezer had an approximately 8’ x 4’ sheet of ice on the floor under the storage racks.  The sheet pans were full of ice under the condenser fans.
• Inside the walk-in freezer, there were two 10-pound boxes of sausage, a 10-pound box of strudel, and a 14-pound box of pizza crusts covered in dripping, refrozen, and unclean condensate ice water.
• Inside the walk-in freezer, there was a foil pan of corned beef wrapped in aluminum foil, labeled with a date of 11/9/21, heavily encased in ice; the foil covering was partially ripped open, and the condensate ice/water was in contact with the corned beef.  Two cases of Italian sausage, meatballs, and similar product cases were also encased in ice.  The FSD discarded the corned beef.
• The handwashing sink did not have paper towels in the dispenser.
• The can opener had a black sticky substance.

CMS Exs. 1 at 54-55; 25 at 2; 26 at 10-11; 31 at 2; 32 at 5-6.

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Petitioner’s policies addressing food preparation and service, food receiving and storage, and sanitization

Petitioner has an undated “Food Preparation and Service” policy.  CMS Ex. 4.  The policy states:  “Food and nutrition services employees prepare and serve food in a manner that complies with safe food handling practices.”  CMS Ex. 4 at 1.  Under the subheading “Food Preparation, Cooking and Holding Time/Temperatures,” the policy states, in pertinent part: 

1. The “danger zone” for food temperatures is between 41°F and 135°F.  This temperature range promotes the rapid growth of pathogenic microorganisms that cause foodborne illness.
2. Potentially hazardous foods (PHF) include meats, poultry, seafood, cut melon, eggs, milk, yogurt and cottage cheese.
3. The longer foods remain in the “danger zone” the greater the risk for growth of harmful pathogens.  Therefore, [potentially hazardous foods] must be maintained below 41°F or above 135°F.
4. Potentially hazardous foods held in the danger zone for more than four hours (if being prepared from ingredients at room temperature) or six hours (if cooked and then cooled) may cause food-borne illness.
5. Food thermometers used to check food temperatures are clean, sanitized and calibrated for accuracy.

CMS Ex. 4 at 1-2.

Under the subheading “Food Service/Distribution,” Petitioner’s policy instructs, in pertinent part: 

1. Proper hot and cold temperatures are maintained during food service.  Foods that are held in the temperature “danger zone” are discarded after 4 hours.
2. The temperatures of foods held in steam tables are monitored throughout the meal by food and nutrition services staff.

CMS Ex. 4 at 3.

Petitioner’s undated “Food Receiving and Storage” policy states that “[f]oods shall be received and stored in a manner that complies with safe food handling practices.”  CMS Ex. 5 at 1.  This policy directs, in pertinent part:

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• Food Services, or other designated staff, will maintain clean food storage areas at all times.
• All foods stored in the refrigerator or freezer will be covered, labeled and dated (“use by” date).
• Refrigerated foods must be stored below 41°F unless otherwise specified by law.
• The freezer must keep frozen foods frozen-solid.  Wrappers of frozen foods must stay intact until thawing.
• Functioning of the refrigeration and food temperatures will be monitored at designated intervals throughout the day by the food and nutrition services manager or designee and documented according to state-specific requirements.

CMS Ex. 5 at 1.

Petitioner’s undated “Sanitization” policy states that “[t]he food service area shall be maintained in a clean and sanitary manner.”  CMS Ex. 16 at 1.  The policy requires, in pertinent part: 

• All kitchens, kitchen areas and dining areas shall be kept clean, free from litter and rubbish and protected from rodents, roaches, flies and other insects.
• All utensils, counters, shelves and equipment shall be kept clean, maintained in good repair and shall be free from breaks, corrosions, open seams, cracks and chipped areas that may affect their use or proper cleaning.  Seals, hinges and fasteners will be kept in good repair.
• Food preparation equipment and utensils that are manually washed will be allowed to air dry whenever practical, and positioned in a manner that allows for air flow between items until dry.
• Ice machines and ice storage containers will be drained, cleaned and sanitized per manufacturer’s instructions and facility policy.  Plasticware, china and glassware that cannot be sanitized or are hazardous because of chips, cracks or loss of glaze shall be discarded.  Damaged or broken equipment that cannot be repaired shall be discarded.
• Kitchen and dining room surfaces not in contact with food shall be cleaned on a regular schedule and frequently enough to prevent accumulation of grime.

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• The Food Services Manager will be responsible for scheduling staff for regular cleaning of kitchen and dining areas.  Food service staff will be trained to maintain cleanliness throughout their work areas during all tasks, and to clean after each task before proceeding to the next assignment.

CMS Ex. 16 at 1-2.

Analysis

Pursuant to 42 C.F.R. § 483.60(i)(1)-(2) (Tag F812), a facility must procure food from sources approved or considered satisfactory by federal, state, or local authorities, and store, prepare, distribute, and serve food in accordance with professional standards for food service safety.

The SOM provides guidance to state agency surveyors.  See CMS Ex. 41.  With respect to Tag F812, the SOM explains that the intent of the regulation is “[t]o ensure that the facility . . . [f]ollows proper sanitation and food handling practices to prevent the outbreak of foodborne illness.  Safe food handling for the prevention of foodborne illnesses begins when food is received from the vendor and continues throughout the facility’s food handling processes.”  CMS Ex. 41 at 1.  The SOM further explains: 

Nursing home residents risk serious complications from foodborne illness as a result of their compromised health status.  Unsafe food handling practices represent a potential source of pathogen exposure for residents.  Sanitary conditions must be present in health care food service settings to promote safe food handling.  CMS recognizes the U.S. Food and Drug Administration’s (FDA) Food Code and the Centers for Disease Control and Prevention’s (CDC) food safety guidance as national standards to procure, store, prepare, distribute and serve food in long term care facilities in a safe and sanitary manner.

. . . It is important to focus attention on the risks that are associated with foodborne illness by identifying critical control points (CCPs) in the food preparation processes that, if not controlled, might result in food safety hazards.  Some operational steps that are critical to control in facilities to prevent or eliminate food safety hazards are thawing, cooking, cooling, holding, reheating of foods, and employee hygienic practices.

CMS Ex. 41 at 1-2.

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The SOD stated that Petitioner was not in substantial compliance with 42 C.F.R. § 483.60(i)(1), (2) because, based on observation, interviews, and record review during the survey, “the facility failed to store, prepare, distribute, and serve food in accordance with professional standards for food service safety affecting the entire facility.”  CMS Ex. 1 at 39.  The SOD stated the following, in pertinent part: 

Specifically, the facility failed to maintain a walk-in cooler in operating condition and was found to have an ambient air temperature above 45 [℉].  Milk from that walk-in cooler was found to be at 59.5 [℉] and was to be served to residents (required temperature:  45 [℉] or less per New York State, NYS, code and 41 [℉] or less per Food and Drug Administration, FDA, food code).  Additional food product in a stand-up cooler that came from the improperly functioning walk-in cooler contained cottage cheese which was measured at 52 [℉]. . . .  Fifty-seven residents . . . received potentially hazardous foods.  The thermometer in the walk-in cooler was reading 39 [℉] and there was not a process in place to calibrate the thermometer in the walk-in cooler.  In addition, the seal to the cooler was ripped and torn.  Adulterated food was found in the functioning walk-in cooler which included bags of spoiled lettuce and moldy garnishes.  Hot food was not held at proper temperatures.  During lunch service, meatballs, mashed potatoes, and red sauce were held at 123-129 [℉].  (Required temperature: 140 [℉] or above per NYS code and 135 [℉] or above per FDA food code).  The facility was unaware and informed by the surveyor.  A leaking pipe from the compressor in the freezer was causing ice to build up and contaminate food products.  A pan of leftover corned beef (wrapped in foil) was adulterated when the ice came in contact with the food.  The facility's failure to properly maintain the kitchen puts 212 of the 216 residents at immediate risk for serious illness caused by consumption of potentially contaminated food and drink.  This resulted in Immediate Jeopardy to resident health and safety.

CMS Ex. 1 at 39-40.

Petitioner offered little in response to CMS’s evidence.  Petitioner concedes that surveyors found out-of-temperature and adulterated foods in the walk-in cooler (refrigerator) and freezer, but argues that noncompliance did not result because the items were voluntarily discarded and not served to any residents.  P. Br. at 5.  Petitioner does

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not deny that hot foods were held at improper temperatures, but claims that reheating was permitted and there was no risk of harm to any residents.  P. Br. at 6.  With respect to the milk found in the walk-in cooler to be well above 50℉, Petitioner argues that no residents fell ill from consuming the milk and that CMS relied upon the incorrect section of the FDA Food Code in citing a violation.  P. Post-hrg. Br. at 4-5.  Petitioner claims that none of the aforementioned deficiencies amounted to immediate jeopardy to resident health and safety.  P. Br. at 3.

I find that Petitioner had multiple failures with respect to food storage and safety, and thus failed to comply substantially with the requirements of 42 C.F.R. § 483.60(i)(1), (2).  Among the more egregious findings were the surveyors’ observations that the temperature of milk from Petitioner’s walk-in cooler was found to be at 59.5℉, with this same milk having been served at lunch to residents, and even consumed.  Petitioner’s deficiencies exposed its residents to more than a minimal risk of harm.

The SOD stated that Petitioner “failed to maintain a walk-in cooler in operating condition and was found to have an ambient air temperature above 45 [℉].  Milk from that walk-in cooler was found to be at 59.5 [℉] and was to be served to residents (required temperature: 45 F or less per New York State, NYS, code and 41 [℉] or less per Food and Drug Administration, FDA, food code).”  CMS Ex 1 at 39.  The SOD did not cite a specific section of the FDA Food Code.  CMS Ex. 1 at 39.  I note that Surveyor Quinones, in his declaration, cited section 3-202.11 of the FDA Food Code.  CMS Ex. 26 at 2.  Petitioner argues that this an inaccurate reference to the FDA Food Code and the “the relevant FDA standards for food distribution are in sections 3-501.18 and 3-501.19 of the [FDA] Food Code.”  P. Post-hrg. Br. at 6.

CMS submitted section 3-202.11 of the FDA Food Code as CMS Ex. 45 at 1-2.  As relevant to this discussion, that section states: 

Specifications for Receiving

3-202.11 Temperature.   
(A) Except as specified in ¶ (B) of this section, refrigerated, TIME/TEMPERATURE CONTROL FOR SAFETY [(TCS)] FOOD shall be at a temperature of [41oF] or below when received.[superscript omitted]

(B) If a temperature other than [41°F] for a TIME/TEMPERATURE CONTROL FOR SAFETY FOOD is specified in LAW governing its distribution, such as LAWS governing milk and MOLLUSCAN SHELLFISH, the FOOD may be received at the specified temperature.

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CMS Ex. 45 at 1.  Petitioner contends that this FDA Food Code section pertains to temperature requirements of food when it is received by a facility, not the resident, and is therefore inapplicable here.  Petitioner argues “[t]here is no evidence that the milk was above 41 [℉] when received by the Facility.”  P. Post-hrg. Br. at 6.

According to Petitioner, the relevant FDA standards are found in sections 3-501.18 and 3-501.19, rather than section 3-201.11, of the FDA Food Code.  I note that Petitioner did not offer sections 3-501.18 and 3-501.19 of the FDA Food Code as evidentiary exhibits.  Nor did Petitioner cite the text of these sections in its post-hearing brief.  Instead, in Petitioner’s words, “Section 3-501.18(A)(1) simply requires milk, and other refrigerated, ready-to-eat time/temperature control for safety food prepared and packaged by a food processing plant to be discarded within 24 hours after the container is opened.”  P. Post-hrg. Br. at 6.  As for Section 3-501.19(B), Petitioner claims that this section allows “‘time without temperature control’ to be ‘used as the public health control’ for ‘up to a maximum of 4 hours’ after removal from refrigerated storage.”  P. Post-hrg. Br. at 6.  Petitioner asserts that it complied with the requirements of both sections.  P. Post-hrg. Br. at 6.

Petitioner quotes an excerpt from the FDA Food Code, titled “Holding Cold Food Without Temperature Control,” which pertains to section 3-501.19.12  In this excerpt, the FDA discusses Listeria monocytogenes and how this bacteria is a “primary organism of concern” with foods once they begin to warm to room temperature after being removed from refrigeration.  Petitioner highlights the following sentence of the quoted passage: 

It is important to note that time/temperature control for safety foods held without cold holding temperature control for a period of 4 hours do not have any temperature control or monitoring.  These foods can reach any temperature when held at ambient air temperatures as long as they are discarded or consumed within the four hours.

P. Post-hrg. Br. at 7 (citing FDA Food Code, Annex 3, at 460).  According to Petitioner, based on the aforementioned FDA guidance, “milk ‘can reach any temperature when held at ambient air temperature’ for four hours without risk of this bacteria developing rapidly enough to present any health risk to Facility residents.”  P. Post-hrg. Br. at 8.

I reject Petitioner’s arguments.  Pursuant to 42 C.F.R. § 483.60(i)(2), Petitioner was required to “store, prepare, distribute and serve food in accordance with professional standards for food service safety.”  The SOM reports that CMS recognizes the FDA Food Code and the CDC’s food safety guidance “as national standards to procure, store,

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prepare, distribute and serve food in long term care facilities in a safe and sanitary manner.”  CMS Ex. 41 at 1.  As noted in the SOD, the FDA Food Code explicitly requires that the safe holding temperature for refrigeration is “41 [℉] or less.”  CMS Ex. 1 at 39; see CMS Ex. 41 at 8.

Petitioner offered no evidence challenging the survey team’s observation that milk from Petitioner’s walk-in cooler was found to be at 59.5℉.  Petitioner does not deny that this potentially hazardous milk was to be served, and in fact, was served, to its residents.  Nor does Petitioner deny that several residents actually consumed this milk.

Even if, as Petitioner claims, CMS imprecisely referenced the appropriate section of the FDA Food Code, I note that Surveyor Quinones, consistent with the SOD and his declaration, testified that the “federal level requirement for refrigeration is 41 [℉]” and confirmed that there were items in Petitioner’s walk-in cooler which “were above the FDA temperature of 41 [℉].”  Tr. 17; see CMS Ex. 41 at 8.

Petitioner does not deny that the FDA Food Code sets professional food safety standards pertaining to the safe refrigeration of foods, including milk.  Moreover, there is no dispute that the FDA Food Code requires that foods, including milk, be stored at 41℉ or less.  Regardless of the applicable FDA Food Code section, Petitioner has not rebutted the surveyors’ observation that milk from Petitioner’s walk-in cooler was found to be stored at a potentially hazardous 59.5 ℉.

Moreover, Petitioner’s claim that milk may be left out for 4 hours under FDA standards has no bearing on my analysis.  The evidence shows that, at the time the milk was taken out of Petitioner’s walk-in cooler, it was measured to be at the dangerously high temperature of 59.5℉.  Thus, even if the milk had only been left out only momentarily (which was not the case here), it was already potentially unsafe for consumption, having come out of a cooler warmer than 50℉.

By the time Petitioner’s FSD was made aware of the out-of-temperature milk and pulled it from the meal service at 12:45 pm, the milk had already been delivered to the residents on five units, some of whom had received their trays just before noon.  CMS Exs. 1 at 40, 43; 32 at 5, 6.  Although the units were supposed to have been alerted, apparently this information was not fully disseminated, as the surveyors on two units observed that staff did not remove the milk from the residents’ trays.  Petitioner has not disputed that 57 residents received the potentially hazardous milk.  CMS Ex. 1 at 40.  When staff did remove the milk, they did so only after being instructed to do so by the surveyors.  But for the surveyors’ intervention, Petitioner would have continued serving this milk, as well as other out-of-temperature dairy products (cottage cheese and yogurt) to its residents, putting them at risk of serious harm.

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Petitioner acknowledges that the milk and other dairy products from the cooler were “potentially consumed between 11:50 a.m. and 1:08 p.m.”  P. Post-hrg. Br. at 9.  According to Petitioner, this “is less than 2 hours of measured, documented, time out of temperature.”  P. Post-hrg. Br. at 9.  Petitioner relies on Dr. Amidon, its medical director, who opined that “[t]he dairy products were measured above 40 [℉], but were not at room temperature. . . .  Two hours is not sufficient time for bacterial growth to occur that could pose even a risk of serious injury, harm, or impairment to any Facility resident.”  P. Ex. 6 at 3.

I give little weight to Dr. Amidon’s opinion.  In acknowledging that the “dairy products were measured above 40 [℉],” he has not disputed the surveyors’ observations that the milk from Petitioner’s cooler was measured at 59.5℉.  However, Dr. Amidon fails to acknowledge or address that FDA standards required Petitioner to store milk at a refrigerated temperature of 41℉ or less.  Again, whether or not bacterial growth could have occurred in two hours is irrelevant since the milk could have already been unsafe for consumption at the time it had been removed from Petitioner’s walk-in cooler.

Petitioner also claims that “no resident showed any signs or symptoms of foodborne illness after consuming the milk.”  P. Post-hrg. Br. at 4.  I note that, in its request for hearing, Petitioner refers to FDA food safety guidance “For Older Adults and People with Cancer, Diabetes, HIV/AIDS, Organ Transplants, and Autoimmune Disease,” and claims this guidance “discusses the risk of foodborne illness increasing ‘[a]fter age 75.’” 13 Request for Hearing (RFH) at 5.  According to Petitioner, the average age of its residents during the relevant time was approximately 70.4 years, “well below this threshold.”  RFH at 5.  Petitioner’s witness, Mr. Maxwell, testified that “[a]s of December 31, 2021, i.e., the time of the relevant survey, the average age of the approximately 200 Facility residents was 70.09 years.”  P. Ex. 3 at 2.  However, Mr. Maxwell did not claim that residents’ ages somehow made them less likely to contract a foodborne illness.  Regardless of the “average age” of its residents, Petitioner cannot deny that it has many elderly residents who are at risk of contracting a foodborne illness from the consumption of potentially hazardous food products.  Moreover, as the SOM notes, nursing home residents who contract a foodborne illness “risk serious complications . . . as a result of their compromised health status.”  CMS Ex. 41 at 1.

Additionally, as previously discussed, Petitioner’s own policy on “Food Preparation and Service” recognizes that the “‘danger zone’ for food temperatures is between 41° F and 135° F.” and states “[t]his temperature range promotes the rapid growth of pathogenic microorganisms that cause foodborne illness. . . .  The longer foods remain in the ‘danger zone’ the greater the risk for growth of harmful pathogens.  Therefore, [potentially hazardous foods] must be maintained below 41° F or above 135° F.”  CMS Ex. 4 at 1-2.

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The Departmental Appeals Board (DAB) has explained that “[a] facility’s policies ‘may reflect [the] facility’s own judgment about how best to achieve compliance [with the participation requirements] and hence failure to comply with its own policies can support a finding that the facility did not achieve compliance with the regulatory standard.’”  Heritage House of Marshall Health & Rehab., DAB No. 3035 at 10-11 (2021) (quoting Bivins Mem’l Nursing Home, DAB No. 2771 at 9 (2017), appeal dismissed, No. 17-60292 (5th Cir. Aug. 15, 2017)).  The DAB has further explained that a facility’s failure to comply with its own policy can be a deficiency.  See Life Care Ctr. of Bardstown, DAB No. 2233 at 21-22 (2009).

Petitioner’s own policy explicitly recognizes the risk of foodborne illness to all of its residents when foods are not maintained in the safe temperature range required by professional food safety standards.  In requiring that potentially hazardous foods, which includes milk, be refrigerated below 41℉, Petitioner’s policy is more stringent than the FDA Food Code.14

It is fortunate that none of Petitioner’s residents became ill after consuming milk; however, residents need not suffer from foodborne illness in order for a deficiency to be cited under 42 C.F.R. § 483.60(i)(1), (2).  The record establishes that the milk from walk-in cooler # 2 was stored at 59.5℉, in contravention of both the FDA Food Code and Petitioner’s own policy.  Petitioner was not in substantial compliance with 42 C.F.R. § 483.60(i)(1), (2) as its noncompliance posed the risk for more than minimal harm to its residents.  Further, as I discuss further below, CMS’s determination that Petitioner’s overall noncompliance under 42 C.F.R. § 483.60(i)(1), (2) constituted immediate jeopardy is not clearly erroneous.

In addition to the milk, the surveyors recorded temperatures of numerous other food products in walk-in cooler # 2 that ranged from 44℉ to 55℉.  Petitioner has not disputed that these products were out of temperature (i.e., above 41℉), and in fact, its FSD discarded all of the items.  Given that the FSD admitted that he was unaware of how long the walk-in cooler was not working properly, it is evident that, but for the surveyors’ intervention, Petitioner would have continued to store the foods at unsafe temperatures in

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the malfunctioning walk-in cooler.  It is irrelevant that these potentially hazardous foods were thrown out before they could be consumed.  As with the milk, Petitioner failed to store foods at 41℉ or below, in contravention of professional standards for food safety and its own policy.  The noncompliance posed more than a minimal risk to resident health and safety, and therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.60(i)(1), (2).

The record shows that both Petitioner’s walk-in cooler and the hanging thermometer in the same walk-in cooler were malfunctioning.  The surveyors observed that the thermometer measured the temperature to be between 38℉ and 40℉, but that the ambient air temperature inside the walk-in cooler was actually 50℉.  Petitioner does not dispute that the walk-in cooler was malfunctioning.  However, it shirks responsibility for the inaccurate thermometer readings, claiming that the SOM lacks a calibration requirement, and its own policies and procedures required that it only monitor temperatures.  P. Post-hrg. Br. at 9-10.  Petitioner notes further that Surveyor Quinones acknowledged that the temperatures it logged were within an acceptable range.  P. Post-hrg. Br. at 8 (citing CMS Ex. 26 ¶ 12).

Petitioner’s claim that it properly relied on temperature readings it obtained with a faulty thermometer is patently absurd, particularly in light of the fact that its walk-in cooler was not operating properly.  Moreover, Petitioner has mischaracterized Surveyor Quinones’ opinion by selectively quoting his testimony.  Although Surveyor Quinones stated that “[a]ll facility recorded temperatures were within an acceptable range,” he added, “Unfortunately, they were not accurate.”  CMS Ex. 12 at 4.  Surveyor Quinones testified that Petitioner was “responsible for making sure that . . . recorded temperatures are accurate” and also “for maintaining all equipment including . . . thermometers, the door, the cooling process of the condenser in the unit.”  Tr. 33.  When asked about Petitioner’s hanging thermometer, Surveyor Quinones described it as “inexpensive,” “not calibratable,” and “commonly replaced,” and that it would have to be replaced if it were working improperly.  Tr. 35.

Petitioner’s regulatory obligation to ensure its equipment is in working order is clearly articulated in the SOM.  Under “Refrigerated Storage,” the SOM lists several practices to maintain safe refrigerated storage, including:  “[m]onitoring food temperatures and functioning of the refrigeration equipment daily and at routine intervals during all hours of operation.”  CMS Ex. 41 at 8.  Further, in addressing “Refrigeration,” the SOM provides that a facility’s “refrigerators and/or freezers must be in good working condition to keep foods at or below 41 [℉], and the freezer must keep frozen foods frozen solid.”  CMS Ex. 41 at 13.  The SOM goes on to list several methods to determine whether refrigerators and freezers are in working order, including:  “[d]ocument the temperature of external and internal refrigerator gauges as well as the temperature inside the refrigerator.  Measure whether the temperature of a PHF/TCS [potentially hazardous food/time/temperature control for safety] food is 41 [℉] or less.”  CMS Ex. 41 at 13.

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In addition, sections 4-203.11(B), 4-203.12, and 4-502.11(C) of the FDA Food Code require that temperature measuring devices must be maintained in good repair and be accurate in the intended range of use.  CMS Post-hrg. Reply at 3.

Furthermore, Petitioner’s own refrigerator temperature log sheet describes a protocol that is inconsistent with its claim that it was not required by any facility policy/procedure to ensure the accuracy of its thermometers.  Consistent with its “Food Receiving and Storage” policy (CMS Ex. 5 at 1), the pre-printed heading on its temperature log sheet requires Petitioner, among other things, to:  “[m]aintain refrigerator temperature at 40 [℉] . . . or below during stable times,” “[c]heck and record temperature once a day,” and “[c]omplete corrective action column if temperatures are not in proper ranges.”  CMS Ex. 12.  Further, the following directive appears in bold type:  “Check either an accurate internal probe (hanging or standing refrigerator thermometer) OR a built-in equipment thermometer.”  CMS Ex. 12; see Tr. 32.

To ensure that food was refrigerated at safe temperatures in accordance with professional food safety standards and its own policy, Petitioner was obligated to maintain both its walk-in cooler and the cooler’s thermometer in operating condition but failed to do so.  But for the survey, it appears Petitioner would have continued to store food products in a 50 [℉] walk-in cooler and rely on incorrect readings from a malfunctioning thermometer.  See CMS Ex. 32 at 4 (Petitioner’s FSD’s lack of awareness of how long the walk-in cooler was not operating properly).  Combined with the food temperature violations discussed above, Petitioner was unquestionably out of compliance with 42 C.F.R. § 483.60(i)(2).

Regarding the hot-holding violations, Petitioner has not disputed Surveyor Stadler’s observation that the temperatures of red sauce (128℉), meatballs (123℉), and mashed potatoes (129℉) on the service line were below the acceptable temperature for hot holding.  CMS Exs. 1 at 49-51; 31 at 1; 32 at 6; Tr. 58-59.  Citing surveyor testimony, Petitioner argues that the FDA Food Code permits food which is out of temperature for less than two hours to be reheated to above 165℉ and served.  P. Post-hrg. Br. at 5 (citing Tr. 63).  Petitioner claims that after its FSD became aware of these temperatures, it reheated the foods to at or above the FDA-required minimum temperature.  P. Post-hrg. Br. at 5; CMS Ex. 31 at 1.  Petitioner claims there was little risk of harm to its residents, much less a risk of serious harm.  P. Post-hrg. Br. at 5.

Surveyor Stadler testified that he “found that during lunch service, meatballs, mashed potatoes, and red sauce were held at 123-129 [℉], when the required temperature was 140 [℉] or above per NYS code and 135 [℉] or above per FDA food code.”  CMS Ex. 32 at 6.  Surveyor Stadler testified, on cross-examination, that the meatballs, red sauce, and mashed potatoes “were below 140 [℉].”  Tr. 58-59.  When interviewed by the surveyors, Petitioner’s FSD stated that hot foods should be at least 140℉.  CMS Exs. 1 at 50; 26 at 7; 31 at 3.  Surveyor Stadler’s testimony is consistent with the SOM

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provisions addressing food safety in food service and distribution.  Among other things, the SOM expressly instructs facilities to avoid “[h]olding foods in danger zone temperatures which are between 41 [℉] and 135 [℉].”  The SOM also states that, “the temperature of the foods should be periodically monitored throughout the meal service to ensure proper hot or cold holding temperatures are maintained.”  CMS Ex. 41 at 11.  Emphasizing the risk of unsafe holding temperatures, the SOM further states, “[t]he longer food remains in the danger zone, the greater the risks for growth of harmful pathogens.  Bacteria multiply rapidly in a moist environment in the danger zone . . . Rapid death of most bacteria occurs at 165 [℉].”  CMS Ex. 41 at 4.

Petitioner’s own “Food Preparation and Service” policy mirrors these provisions, stating, “the ‘danger zone’ for food temperatures is between 41°F and 135°F.  This temperature range promotes the rapid growth of pathogenic microorganisms that cause foodborne illness. . . . [t]he longer foods remain in the ‘danger zone’ the greater the risk for growth of harmful pathogens.  Therefore, PHF must be maintained below 41°F or above 135°F.”  CMS Ex. 4 at 1-2.

The record demonstrates that the temperatures of meatballs, mashed potatoes, and red sauce on Petitioner’s service line were in the “danger zone” of below 135 [℉], and but for the intervention of the surveyor, these potentially hazardous foods would have remained on the service line.  The fact that Petitioner removed and reheated these foods does not negate the deficient practice.  By failing to hold hot foods at safe temperatures, Petitioner disregarded its own policy and professional food safety standards, in violation of 42 C.F.R. § 483.60(i) (1), (2).

As for the adulterated food found in its walk-in cooler and freezer, Petitioner does not dispute the surveyors’ observations.  P. Post-hrg. Br. at 4; CMS Exs. 1 at 49, 55; 32 at 2, 4, 5-6, 7.  Nevertheless, Petitioner argues “[t]here are no adulterated food issues.”  P. Post-hrg. Br. at 4.  Petitioner claims that it “voluntarily discarded” all of the adulterated food in the walk-in cooler and that it was “not at that time” in the process of serving any of the adulterated food to residents.  P. Post-hrg. Br. at 4.  Petitioner argues that it acted consistent with its policy to periodically inspect the coolers “to make sure nothing was rotten and/or expired.”  P. Post-hrg. Br. at 4.

Petitioner’s arguments are not persuasive.  Whether Petitioner actually served adulterated food to residents is irrelevant to the question of whether Petitioner was noncompliant with 42 C.F.R. § 483.60(i)(1), (2).  Further, the SOM, under “Food Receiving and Storage,” states:

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When food, food products or beverages are delivered to the nursing home, facility staff must inspect these items for safe transport and quality upon receipt and ensure their proper storage, keeping track of when to discard perishable foods and covering, labeling, and dating all PHF/TCS foods stored in the refrigerator or freezer as indicated.

CMS Ex. 41 at 7.  Similarly, Petitioner’s “Food Receiving and Storage” policy requires that “[a]ll foods stored in the refrigerator or freezer will be covered, labeled and dated (“use by” date).  CMS Ex. 5 at 1.  Petitioner ignores the fact that adulterated foods were present and available for use and possible consumption by its residents, and that it did not “keep[ ] track of when to discard perishable foods.”  

By storing adulterated foods in its walk-in cooler and freezer, Petitioner failed to comply with professional food safety standards and its own policy relating to the safe storage of foods.  This deficient practice placed residents at more than a minimal risk of harm, and therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.60(i)(1), (2).  In the category of “Physical Contamination and Cleanliness,” the surveyors found a litany of problems in the kitchen.  CMS Exs. 1 at 51-55; 26 at 7-11.  Among the observations, the surveyors identified a dirty, moldy ice machine; a leaking freezer causing ice to build up and contaminate food products; a malfunctioning walk-in cooler; dirty floors and walls soiled with food debris; areas of black soiled flooring with black grout; and improper air drying and storage.

Petitioner has not disputed any of the surveyors’ observations.  Petitioner claims that it relied upon outside contractors for certain maintenance matters and that “the repairs occurred promptly” after it was made aware of the potential for temperature issues.  P. Post-hrg. Br. at 12 (citing P. Ex. 1 at 5).  Although the SOD documents that Petitioner took corrective actions regarding its freezer and walk-in cooler, such actions have no bearing on whether the deficient kitchen conditions constituted substantial noncompliance.  CMS Ex. 1 at 56.

By failing to maintain kitchen cleanliness and ensure that all equipment was working properly, Petitioner also contravened its own “Sanitization” policy, which required Petitioner to ensure that “[t]he food service area shall be maintained in a clean and sanitary manner.”  CMS Ex. 16 at 1.  Among other things, the policy required that all equipment “shall be kept clean, maintained in good repair . . .”; and that “[k]itchen and dining room surfaces not in contact with food shall be cleaned on a regular schedule and frequently enough to prevent accumulation of grime.”  CMS Ex. 16 at 1-2.

Petitioner’s deficient cleanliness practices bolster the finding of substantial noncompliance with 42 C.F.R. § 483.60(i)(1), (2).

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18. Petitioner has not demonstrated that CMS’s determination that the noncompliance with 42 C.F.R. § 483.60(i)(1), (2) on December 14, 2021, amounted to immediate jeopardy to resident health and safety is clearly erroneous.

CMS alleges that the noncompliance with 42 C.F.R. § 483.60(i)(1), (2) constituted widespread immediate jeopardy to resident health and safety (s/s “L”) for one day, December 14, 2021.  See CMS Post-hrg. Br. at 17-19.  Petitioner argues that the immediate jeopardy determination was clearly erroneous because no resident “was actually harmed by any foodborne illness” or exposed to a substantial likelihood of serious harm.  P. Post-hrg. Br. at 1-6, 9-10; P. Post-hrg. Reply at 1.

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.  I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The DAB directs that the “clearly erroneous” standard imposes on a facility a heavy burden to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (citing Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)).

The evidence supports that the finding of immediate jeopardy is not clearly erroneous.  As discussed above, the evidence establishes that Petitioner failed to store, prepare, distribute, and serve food in accordance with professional standards for food service safety, in violation of 42 C.F.R. § 483.60(i)(2).  Petitioner’s lapses in food service safety were egregious and spanned its entire food service operation:  a malfunctioning walk-in cooler stored numerous food products, to include milk, at unsafe temperatures; the thermometer in the same cooler was not working properly; a freezer was leaking; out-of-temperature milk was served to residents; adulterated foods were discovered in a walk-in cooler and the leaking freezer; hot foods on the service line were not properly heated; and numerous unsanitary conditions were observed in the kitchen area.

In arguing that none of this noncompliance posed a likelihood of serious harm, Petitioner contends that CMS did not follow revised SOM guidance in Appendix Q pertaining to the immediate jeopardy standard.  P. Post-hrg. Reply at 2-3.  Petitioner asserts that, under the guidance in Appendix Q, an immediate jeopardy finding depends on whether there was a likelihood of serious harm, and not just the potential for serious harm, and in its case, “[t]here was no evidence that would support a reasonable expectation of harm that rose to the level of serious harm.”  P. Post-hrg. Reply at 3.

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Petitioner’s argument regarding Appendix Q is unpersuasive.  As the DAB has explained, “Appendix Q’s purpose is to guide surveyors in applying a regulatory standard, not to define that standard.  The immediate jeopardy standard is defined by regulation in 42 C.F.R. § 488.301.”  Pinecrest Nursing & Rehab. Ctr., DAB No. 2446 at 19 (2012).  The DAB noted further that while Appendix Q is “instructive” on the issue of immediate jeopardy,” it “is not controlling authority.”  Id. at 19 (citing Agape Rehab. of Rock Hill, DAB No. 2411 at 19 (2011)).  I am bound by the regulatory definition in 42 C.F.R. § 488.301, and not by the SOM.  Miss. Care Ctr. of Greenville, DAB No. 2450 at 15-16 (2012).

The fact that no resident contracted a foodborne illness is frankly a stroke of good fortune.  I reiterate that, under the regulatory definition, a finding of immediate jeopardy does not require actual harm, only the likelihood of serious harm.  42 C.F.R. § 488.301.  See Liberty Commons Nursing & Rehab Ctr. - Johnston, DAB No. 2031 at 19 (2006) (“Immediate jeopardy exists if a SNF’s noncompliance is the type of noncompliance that would likely cause serious injury, harm, impairment, or death if not corrected, even if surveyors did not observe or identify a particular resident who was actually threatened with harm during the survey.”).

Of the food temperature deficiency findings, the most troubling involved milk that had been stored at 59.5℉ on December 14, 2021, and served to residents.  By the time Petitioner pulled the milk after being alerted by the surveyors, the milk had already been delivered on lunch trays to residents on several units, and, in several instances, already consumed.  It is evident that but for the surveyors’ intervention, the milk and other out-of-temperature dairy products would have remained on lunch trays and would have eventually been delivered to every resident.  I note the service of out-of-temperature milk was compounded by other failures that included the malfunctioning walk-in cooler and thermometer, which were made more egregious by the fact that Petitioner’s staff was unaware that the cooler was not holding foods at the proper temperature and that the thermometer was malfunctioning.  These failures, but for the intervention of the surveyors, posed a likelihood of a serious harm to Petitioner’s residents, and I find this situation alone supports a finding of immediate jeopardy.

As for the other deficient practices observed on December 14, 2021, to include additional out-of-temperature foods, adulterated foods, and hot-holding violations, the record shows that Petitioner’s staff acted only after being alerted by the surveyors.  Inasmuch as any of these food items could have been served to residents but for the intervention of the surveyors, Petitioner’s deficient food safety practices in these areas further exposed residents to a risk of serious harm.

I note that Petitioner contends that CMS only based its immediate jeopardy determination on “cold food, hot food, and adulterated food matters” and did not base it on “kitchen cleanliness or maintenance issues.”  P. Post-hrg. Reply at 6; see RFH.  As support,

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Petitioner cites the SOD and the declarations of Surveyors Tringale, Brunnett, and Stadler.  P. Post-hrg. Reply at 6.  However, the SOD, under Tag F812, includes the following statements: 

the facility failed to maintain a walk-in cooler in operating condition . . . the seal to the cooler was ripped and torn . . . a leaking pipe from the compressor in the freezer was causing ice to build up and contaminate food products . . . .  The facility’s failure to properly maintain the kitchen puts 212 of the 216 residents at immediate risk for serious illness caused by consumption of potentially contaminated food and drink.  This resulted in Immediate Jeopardy to resident health and safety.

CMS Ex. 1 at 39-40.  Further, each of the aforementioned declarations cited by Petitioner contains the following sentence taken from the SOD:  “[Petitioner’s] failure to properly maintain the kitchen put 212 of the 216 residents at immediate risk for serious illness caused by consumption of potentially contaminated food and drink.  This resulted in Immediate Jeopardy to resident health and safety.  CMS Ex. 1 at 39-40.”  CMS Ex. 29 at 2-3 (Declaration of Surveyor Brunnett); CMS Ex. 32 at 3 (Declaration of Surveyor Stadler); and CMS Ex. 35 at 3 (Declaration of Surveyor Tringale).  Contrary to Petitioner’s claims, the SOD’s explicit reference to Petitioner’s “failure to properly maintain the kitchen” encompasses all of Petitioner’s deficient kitchen practices (CMS Ex. 1 at 51-55), and there is nothing to suggest that those findings are not incorporated by the immediate jeopardy determination.  CMS Ex. 1 at 51-55.  Similarly, nothing in the SOD indicates that Petitioner’s maintenance issues were not considered in the immediate jeopardy determination.

Petitioner was unaware that its walk-in cooler and the thermometer for that cooler were malfunctioning, and the food items in that cooler were therefore stored at unsafe temperatures.  These critical maintenance failures, along with Petitioner’s dirty kitchen area, is further evidence of noncompliance that exposed residents to a risk of serious harm.

Petitioner’s systemic shortcomings with respect to food storage, preparation, distribution, and service of food were widespread, jeopardized the health and safety of its vulnerable residents, and likely would have continued but for the survey team’s intervention.  CMS’s immediate jeopardy determination for one day, December 14, 2021, is not clearly erroneous.

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19. Petitioner has not provided any basis to dispute CMS’s determination that, with respect to Tag F812, it returned to substantial compliance on January 31, 2022.

Once a facility is found to be out of substantial compliance, it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again.  Premier Living & Rehab Ctr., DAB No. 2146 at 23 (2008); Lake City Extended Care Ctr., DAB No. 1658 at 12-15 (1998).  The burden is on the facility to prove that it is compliant with program requirements and not on CMS to prove that deficiencies continued to exist after they were discovered.  Asbury Ctr. at Johnson City, DAB No. 1815 at 19-20 (2002); see also Grace Living Ctr. – Northwest OKC, DAB No. 2633 at 3 (2015) (citing Owensboro Place & Rehab. Ctr., DAB No. 2397 at 12 (2011)).  Noncompliance found during a survey is “presumed to continue until the facility demonstrates it has achieved substantial compliance.”  Taos Living Ctr., DAB No. 2293 at 20 (2009).

CMS determined that Petitioner’s noncompliance with 42 C.F.R. § 483.60(i)(1), (2), Tag F812, constituted widespread immediate jeopardy for one day, December 14, 2021.  As discussed above, I have upheld CMS’s immediate jeopardy determination.  Further, CMS found that, based on a re-visit survey, Petitioner returned to substantial compliance with respect to this tag on January 31, 2022.  CMS Ex. 2 at 30; see CMS Pre-hrg. Br. at 22; CMS Post-hrg. Br. at 19 n.3.  Petitioner has not challenged this determination regarding the January 31, 2022 date of return to compliance.  See P. Br. at 7 (arguing that it correct the cited deficiencies “by January 31, 2022”).  Accordingly, there is no basis to disturb this determination.15

20. A per-day CMP of $16,304 is a reasonable enforcement remedy for the one day of immediate jeopardy noncompliance on December 14, 2021.
21. A per-day CMP of $435 is a reasonable enforcement remedy for the substantial noncompliance that continued from December 15, 2021 until January 31, 2022. 

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, to include a CMP.  In determining whether the CMP imposed against Petitioner is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which

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includes neglect, indifference, or disregard for resident care, comfort or safety.  The absence of culpability is not a mitigating factor.  The factors listed in 42 C.F.R. § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, an ALJ must sustain the CMP.  Coquina Ctr., DAB No. 1860 at 32 (2002).

The DAB has explained that “it is settled law that ALJ review of the reasonableness of CMP amounts imposed by CMS is de novo.”  Fireside Lodge Retirement Ctr., Inc., DAB No. 2794 at 19 (2017).  I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the above factors. I am neither bound to defer to CMS’s factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  See, e.g., Barn Hill Care Ctr., DAB No. 1848 at 21 (2002).  The DAB has explained that “[t]he determination of whether a CMP amount is reasonable is a conclusion of law, not a finding of fact.”  Cedar Lake Nursing Home, DAB No. 2344 at 12 (2010), aff’d, 619 F.3d 453, 457 (5th Cir. 2010).

The regulations specify that a CMP that is imposed against a facility on a per-day basis will fall into one of two ranges.  42 C.F.R. §§ 488.408; 488.438.  The upper range of a CMP, $3,050 per day to $10,000 per day, as adjusted annually under 45 C.F.R. Part 102, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2).  The lower range of CMP, $50 to $3,000 per day, as adjusted annually under 45 C.F.R. Part 102, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii).  The inflation-adjusted per-day CMP ranges applicable to this case are $6,888 to $22,584 for immediate jeopardy-level deficiencies, and $113 to $6,774 for deficiencies that do not constitute immediate jeopardy.  45 C.F.R. § 102.3 (2021).  In assessing the reasonableness of a CMP amount, an ALJ looks at the per-day amount, rather than the total accrued CMP.  See Kenton Healthcare, LLC, DAB No. 2186 at 28 (2008).  Pursuant to 42 C.F.R. § 488.408(g)(2), a facility cannot appeal CMS’s choice of a remedy, and an appeal of a CMP is limited to review based on the regulatory factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404(a)-(c).  See, e.g., Senior Rehab., DAB No. 2300 at 19-20 (2010).

In this case, CMS imposed a per-day CMP of $16,304 for one day of immediate jeopardy noncompliance on December 14, 2021, under Tag F812, and a per-day CMP of $435 for the period December 15, 2021 until January 31, 2022, for the substantial noncompliance under Tag F812 that was not immediate jeopardy.

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Petitioner argues that the CMP amounts are unreasonable in light of the regulatory factors.  RFH at 6; P. Post-hrg. Br. at 11-12.  With respect to its history of noncompliance, Petitioner broadly contends that it does not have “repeated deficiencies for similar or otherwise relevant matters” and specifically, that it does not have a history of similar food temperature issues since a change in ownership in 2018.  RFH at 6; P. Post-hrg. Br. at 12 (citing P. Ex. 1).  Petitioner adds that its survey history is “unremarkable.”  RFH at 6; P. Post-hrg. Br. at 12 (citing P. Ex. 1).

Petitioner’s claim regarding its survey history is misleading and is contradicted by its Administrator’s testimony.  Mr. Deck, focusing on the period from around 2018 through the December 2021 survey, testified that Petitioner was “surveyed several times,” and “many surveys resulted in no findings for deficient practice at all, and there were only 15 surveys at which citations were issued by [the state agency].”  P. Ex. 1 at 3.  Mr. Deck listed 13 surveys that had been completed between August 6, 2018 and March 18, 2021, and the deficiencies cited at those surveys, which I summarize below:

• August 6, 2018 survey:  two deficiencies with a s/s as high as “E”
• November 7, 2018 survey:  one deficiency with s/s of “D”
• January 7, 2019 certification survey:  12 deficiencies related to health requirements with a s/s as high as “E,” as well as six life safety code (LSC) deficiencies cited.
• January 25, 2019 survey:  two deficiencies with s/s of “D”
• November 21, 2019 certification survey:  14 deficiencies relating to health requirements cited, to include a “J” level deficiency (42 C.F.R. § 483.25), as well as 14 LSC deficiencies cited.  Mr. Deck reported that two citations involved food service that were unrelated to the deficiencies at issue here.
• February 4, 2020 survey:  one deficiency with s/s “D”
• March 5, 2020 survey:  one deficiency with s/s “D”
• June 3, 2020 survey:  one deficiency with s/s “E”
• July 27, 2020 survey:  deficiencies with s/s “D”

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• October 9, 2020 survey:  deficiencies with s/s “D”
• January 6, 2021 survey:  deficiencies with s/s as high as “E”
• January 11, 2021 survey:  one deficiency (42 C.F.R. § 483.25) with s/s “G”
• March 18, 2021 survey:  one deficiency with s/s “D”

P. Ex. 1 at 4-5.  Based on Mr. Deck’s testimony, Petitioner has acknowledged an extensive history of noncompliance, with dozens of cited deficiencies involving health care requirements and another 20 deficiencies involving Life Safety Code requirements between August 2018 and March 2021.  The more than 50 cited deficiencies included actual harm and immediate jeopardy deficiencies cited at the G and J levels of scope and severity.  P. Ex. 1 at 3-5.  I note that Petitioner was also cited for two previous food service deficiencies, although Mr. Deck did not address the levels of scope and severity levels.  Petitioner’s conceded history of noncompliance supports the CMP amounts imposed.

With respect to the scope and severity of the present deficiencies, Petitioner argues that these factors do not support the CMP amounts.  Referring to the other, non-immediate jeopardy-level deficiencies that were cited during the December 2021 survey, Petitioner contends it was “in substantial compliance at all relevant times.”  P. Post-hrg. Br. at 12.  As for the relationship between deficiencies, Petitioner argues that each alleged violation is “isolated and unrelated.”  RFH at 6.

To the extent that Petitioner is suggesting that I must consider the other deficiencies which were cited during the December 2021 survey as part of my CMP discussion, Petitioner is mistaken.  The only deficiency before me is the citation under 42 C.F.R. § 483.60(i)(1), (2), Tag F812.  As such, my analysis of the CMP factors does not entail any review of the relationship between deficiencies.  Petitioner’s noncompliance with 42 C.F.R. § 483.60(i)(1), (2) resulted in widespread immediate jeopardy to resident health and safety for one day.  Thus, the scope and severity of the cited deficiency more than justifies the CMPs imposed.

Petitioner argues that it was not neglectful, indifferent, or acting in disregard for resident care, comfort, or safety.  RFH at 6; P. Post-hrg. Br. at 12.  Petitioner argues that its staff monitored the temperatures of the food service equipment and “responded immediately when issues were identified by the surveyors,” including making repairs.  P. Post-hrg. Br. at 12.  CMS argues that Petitioner’s culpability is high, asserting that Petitioner demonstrated a “complete systemic failure in the storage, preparation, distribution, and service of food.”  CMS Post-hrg. Reply at 6.  CMS contends further that “[e]very resident in the facility gets fed from [Petitioner’s] kitchen, and thus everyone in that facility was

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susceptible to potential foodborne illness from the gross negligence of the staff and management.”  CMS Post-hrg. Reply at 7.  I agree that Petitioner has considerable culpability.  As discussed above, Petitioner’s lapses with respect to storage, preparation, distribution, and food service were egregious and seemingly covered the entire spectrum of its food service operation.  Included in this serious deficiency, Petitioner had a malfunctioning cooler with a malfunctioning thermometer that stored foods at unsafe temperatures, and it served potentially hazardous milk, measured at 59.5℉, to 57 of its approximately 200-216 residents.  By the time the milk was pulled from the lunch service, several residents had already consumed it.  While Petitioner may have voluntarily thrown out numerous food items and made the necessary repairs, it is apparent that the presence of the survey team prompted these corrective actions.  Petitioner’s food safety failures created a widespread immediate jeopardy situation that affected all of its vulnerable residents, subjecting them to the likelihood of serious harm.  Finally, and with respect to its financial condition, Petitioner “does not claim financial hardship.”  RFH at 6 n.2.

Based on consideration of the relevant regulatory factors, I conclude that the per-day CMP of $16,304, in the middle of the allowable range for immediate jeopardy, is entirely reasonable, if not unreasonably low, and is more than justified by the egregious circumstances presented here.  Further, with respect to the per-day CMP of $435 for the non-immediate jeopardy noncompliance under Tag F812, this amount is at the very low end of the authorized CMP range.  In light of the relevant factors, I find that the per-day CMP of $435 from December 14, 2021 and continuing until January 31, 2022, is also reasonable for the non-immediate jeopardy noncompliance under Tag F812.

IV.    Conclusion

For the reasons discussed above, I conclude that Petitioner was not in substantial compliance with the Medicare participation requirement at 42 C.F.R. § 483.60(i)(1), (2).  A per-day CMP of $16,304 for one day of immediate jeopardy noncompliance on December 14, 2021, under Tag F812, and a per-day CMP of $435 beginning on December 15, 2021 until January 31, 2022, for non-immediate jeopardy noncompliance under Tag F812, are reasonable enforcement remedies.