Regency Grande Nursing & Rehabilitation Center, CR6400 (2023)

DECISION

Petitioner, Regency Grande Nursing & Rehabilitation Center (Regency or facility), is a long-term-care facility located in Dover, New Jersey, that participates in the Medicare program.  Based on a recertification survey completed on May 2, 2022, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)(2) and that its deficiency posed immediate jeopardy to resident health and safety.  CMS imposed per-day civil money penalties (CMP) based on Federal Tag F689; a $13,820.00 per‑day CMP for one day of immediate jeopardy and substandard quality of care on April 26, 2022, and a $360.00 per‑day CMP for 72 days of continued noncompliance that did not pose immediate jeopardy totaling $25,920.00, for a total accrued amount of $39,740.00.  CMS Exhibits (Exs.) 2 and 3.¹  CMS subsequently determined that the facility achieved substantial compliance on July 8, 2022.  CMS Ex. 3 at 1.  Petitioner filed a Request for Hearing (RH) on August 3, 2022. 

Page 2

On August 5, 2022, Judge Leslie A. Weyn issued a Standing Prehearing Order for Medicare Health, Safety, and Quality Standards Cases (Order), setting forth pre-hearing procedures.²  Pursuant to the Order, CMS filed The Centers for Medicare & Medicaid Services’ Prehearing Brief and Motion for Summary Judgment (CMS PH Br.) and 27 proposed exhibits.  Petitioner filed Petitioner, Regency Grande Nursing & Rehabilitation Center’s Pre-Hearing Brief and Opposition to CMS’s Motion for Summary Judgment (P. PH Br.) and 17 proposed exhibits.  Neither party filed an objection to the other party’s proposed exhibits.  As a result, CMS Exs. 1-27 and P. Exs. 1-17 are admitted into the record. 

After carefully considering this record, I grant CMS’s motion for summary judgment.  As discussed below, the undisputed evidence establishes that the facility was not in substantial compliance with Medicare program requirements, that its deficiencies posed immediate jeopardy to resident health and safety, and that the penalties imposed are reasonable.  

I. Background

The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301. 

The Secretary contracts with state survey agencies to survey skilled nursing facilities in order to determine whether they are in substantial compliance.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys, and must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308. 

Here, surveyors from the New Jersey State Department of Health conducted a recertification survey from April 19, 2022 through May 2, 2022 and found deficiencies that required correction in order for the facility to continue to participate in the Medicare and Medicaid program.  CMS Ex. 2 at 1.  Specifically, the facility was found to be out of compliance with the provisions of 42 C.F.R. § 483.25(d)(1)(2), Free of Accident Hazards/Supervision/Devices at the Immediate Jeopardy level on April 26, 2022, and 72

Page 3

days of continuing noncompliance that did not pose immediate jeopardy.  CMS Exs. 2 and 3. 

II. Issues

As a threshold matter, I consider whether summary judgment is appropriate. 

On the merits, the issues are: 

1. Whether the facility was in substantial compliance with 42 C.F.R. § 483.25(d)(1)(2);
2. If the facility was not in substantial compliance, did its deficiencies pose immediate jeopardy to resident health and safety; and
3. If the facility was not in substantial compliance, are the penalties imposed ($13,820.00 per day for one day of immediate jeopardy and $360.00 per day for 72 days of substantial noncompliance that did not pose immediate jeopardy) reasonable.

It is also necessary to identify the issues that are not before me.  In the RH, Petitioner indicated it was disputing the validity of deficiencies under Tags F689 Free of Accident Hazards/Supervision/Devices; F838 Facility Assessment; F578 Request/Refuse/Discontinue Treatment, Formulate Advanced Directives; F667 ADL Care Provided to Dependent Residents; and K252 Number of Exits-Corridors.  RH at 2-3.  However, in the Prehearing Brief, Petitioner indicates that it “contests the validity of the cited deficiency at F689, the scope and severity thereof, and the associated per diem Civil Money Penalties as not reasonable.”  P. PH Br. at 2.  In the Order issued by Judge Weyn on August 5, 2022, the parties were notified that a brief submitted as part of the Prehearing Exchange “must contain all arguments that a party intends to make.”  Order at 3, ¶ (4)(c)(i).  Because Petitioner made no argument regarding any deficiency other than Tag F689, Free of Accident Hazards/Supervision/Devices, the other cited deficiencies are not addressed in this decision. 

In the RH, Petitioner also argues that the “Mandatory Three-Month Denial of Payment for New Admissions and the Mandatory Six-Month Termination PENDING are no longer appropriate remedies” and requested an amended penalty letter.  RH at 5.  However, as noted above, these penalties were never imposed because the facility was determined to be in substantial compliance prior to their imposition.  As a result, there is no right to a hearing on this issue.  42 C.F.R. § 498.3(b)(13). 

Page 4

III. Discussion

Summary judgment is appropriate if a case presents no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law.  Bartley Healthcare Nursing and Rehab., DAB No. 2539 at 3 (2013), citing Celotex Corp. v. Catrett, 477 U.S. 317, 322-25 (1986); Ill. Knights Templar Home, DAB No. 2274 at 3‑4 (2009), and cases cited therein. 

The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law or by showing that the non‑moving party has presented no evidence “sufficient to establish the existence of an element essential to [that party’s] case, and on which [that party] will bear the burden of proof at trial.”  Livingston Care Ctr. v. U.S. Dep’t of Health & Human Servs., 388 F.3d 168, 173 (6th Cir. 2004), quoting Celotex Corp., 477 U.S. at 322.  To avoid summary judgment, the non-moving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists.  Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986); see also Vandalia Park, DAB No. 1939 (2004); Lebanon Nursing and Rehab. Ctr., DAB No. 1918 (2004).  The non‑moving party may not simply rely on denials, but must furnish admissible evidence of a dispute concerning a material fact.  Ill. Knights Templar, DAB No. 2274 at 4; Livingston Care Ctr., DAB No. 1871 at 5 (2003).  In doing so, the non‑moving party must show more than “some metaphysical doubt as to the material facts.”  West Texas LTC Partners, Inc., DAB No. 2652 at 6 (2015), aff’d, 843 F.3d 1043 (5th Cir. 2016); 1866ICPayday.com, L.L.C., DAB No. 2289 at 3 (2009), quoting Matsushita Elec. Indus. Co., 475 U.S. at 587.  

In examining the evidence for purposes of determining the appropriateness of summary judgment, I must draw all reasonable inferences in the light most favorable to the non‑moving party.  Brightview Care Ctr., DAB No. 2132 at 2, 9 (2007); Livingston Care Ctr., 388 F.3d at 172; Guardian Health Care Ctr., DAB No. 1943 at 8 (2004); but see Brightview, DAB No. 2132 at 10 (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non‑moving party’s legal conclusions.  West Texas LTC Partners, Inc., DAB No. 2652 at 6-7, 14-15; Cf. Guardian Health Care Ctr., DAB No. 1943 at 11 (“A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.”). 

Here, CMS has come forward with evidence – primarily the facility’s own documents – establishing facts showing that the facility was not in substantial compliance with section 483.25(d)(1)(2).  As discussed below, Petitioner does not dispute the material facts but, instead, offers facts and opinions, which while accepted at face value, do not establish that a dispute concerning a material fact exists. 

Page 5

1. A. CMS is entitled to summary judgment because the undisputed evidence establishes that the facility failed to ensure that the resident environment remained as free of accident hazards as possible, and that each resident received adequate supervision to prevent accidents. These deficiencies put the facility out of substantial compliance with 42 C.F.R. § 483.25(d)(1)(2).³

As noted above, Regency was charged with a violation of 42 C.F.R. § 483.25.  The opening provision of that section of the regulations, which implements sections 1819(b)(2) (Medicare) and 1919(b)(2) (Medicaid) of the Social Security Act, states:  

Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents.  Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices . . . .

42 C.F.R. § 483.25.  42 C.F.R. § 483.25(d)(1) and (2) require the facility to ensure that-

The material facts in this case are not in dispute.  Resident # 383 (R383) was admitted to Regency on April 14, 2022 following a hospitalization for pneumonia.  Admitting diagnoses also included generalized muscle weakness, dysphagia - oropharyngeal phase, Barrett’s esophagus with dysplasia, and past myocardial infarction.  CMS Ex. 5.  At the time of admission, she was on a “mechanically altered diet of mechanical soft solids and thin liquids.”  CMS Ex. 9 at 2. 

On April 19, 2022, R383 underwent a Clinical Bedside Assessment of Swallowing:  Neuromuscular/Anatomic Disorders.  CMS Ex. 9 at 3.  The Speech-Language Pathologist (SLP) doing the assessment indicated R383’s Swallowing Abilities were at 60% and skilled SLP services for dysphagia were warranted to assess and evaluate the least restrictive oral intake and to decrease the risks of aspiration and oral/pharyngeal dysphagia.  Diet recommendations were for puree consistency solids and nectar thick liquids.  Id. at 4.  Trials of mechanical soft solids and thin liquids were attempted.  Id. at

Page 6

6.  R383 was observed to cough three times post swallow after thin liquids with delayed initiation of swallow.  Suspected loss of liquids prior to initiation of swallow was also noted.  Delay in transit and initiation of swallow were observed in a trial of mechanical soft solids.  Continuation of puree and nectar thick liquids was advised. 

On April 20, 2022, Pinakin Pathak, M.D., R383’s treating physician, completed an assessment and plan, which included diagnoses of aspiration pneumonia, pneumonia, unspecified, and Barrett’s esophagus with dysplasia, unspecified.  CMS Ex. 6 at 1.  On the same date, Dr. Pathak entered an order for “Therapeutic Diet:  Regular, Diet Consistency: Puree: fluid consistency: Nectar Thi . . . .”⁴ Id. at 3.  

The Interdisciplinary Care Plan for R383, dated April 19, 2022, included a potential problem with nutritional status as evidenced by R383’s risk for weight loss, secondary to decreased intake and swallowing problems.  Interventions for this problem included a puree diet with nectar liquids.  CMS Ex. 8 at 5. 

On April 26, 2022, at 11:42 AM, the surveyor observed the Daytime Cook puree meatballs for the lunch meal without following a standard recipe or manufacturer instructions for puree consistency.  Upon interview, the Daytime Cook reported that she “eyeballed” what the puree consistency should be.  CMS Ex. 17 at 3.  Both the Daytime Cook and the Evening Cook stated they did not follow any standardized recipe or instructions for pureed foods.  Id. at 3, 5.  The Evening Cook indicated that when he pureed food, he placed it in the blender and “walked away” to allow the food to blend.  Id. at 5.  

The surveyor observed the Daytime Cook transfer the pureed meatballs from the blender into a 1/6 Cambro pan and onto a steam table.  The surveyor observed that there were large particles of food being transferred in that mixture.  The Daytime Cook was observed to plate the pureed meatballs with chunks of intact meat onto a plate for R383. CMS Ex. 17 at 3; CMS Ex. 1 at 14. 

The surveyor then interviewed the facility SLP and requested that they verify that the consistency of the meatballs was appropriate.  The SLP initially indicated that: 

[P]ureed foods should be the consistency of applesauce, meaning “no consistency, no grains, and no food particles because those would be a choking hazard for people on pureed” diets and who would be at risk of aspiration (accidental breathing in of fluid or food into the lungs).  

Page 7

CMS Ex. 17 at 4.  The SLP was then asked by the surveyor to verify that the food on R383’s meal tray was the appropriate consistency.  The SLP initially indicated the food looked appropriate but after spreading a sample of the pureed meatballs on a plate, she identified large particles of food in the pureed meatballs and pushed them to the side of the plate.  The SLP informed the Food Service Director (FSD) that the pureed meatballs contained “chunks” and the texture was that of a mechanical soft diet.  The Daytime Cook stated she should have pureed the food longer.  The FSD confirmed that the pureed meatballs were not the appropriate consistency and instructed that the pureed meatballs be taken off the food service line and be re-blended.  Id. at 4-5.  

According to the surveyor, the pureed meatballs were taken off the steam table and re‑blended; however, the pureed meatballs on the tray for Resident # 383 that had already been plated were not removed and re-blended; the tray remained on the dining cart to be transported to the resident’s nursing unit.  CMS Ex. 17 at 5.  At this time, the porter, in the presence of the surveyor, left the kitchen with the lunch meals and proceeded to the first-floor nursing unit.  Id. at 6.  Despite the SLP confirming the inappropriate texture of the puree diet in the kitchen, the dining cart that contained the pureed tray for R383 was delivered to the nursing floor.  Both the SLP and FSD acknowledged that R383’s meal tray should not have been delivered to the nursing floor after the SLP confirmed the texture was inappropriate.  Id. at 7.  R383 had left the facility earlier that day so she did not receive the food tray.  CMS Ex. 1 at 18-19.  

In a subsequent interview, CNA # 2 told the surveyor that there were two residents on a pureed texture diet on that nursing unit, and one of those residents was confused but fed themselves.  CMS Ex. 1 at 20.  The surveyor asked the FSD to provide copies of the meal cards for every resident who would have received the main meal of pureed meatballs on April 26, 2022, and obtained the meal cards of ten residents, including Resident # 383.  CMS Ex. 17 at 8; CMS Ex. 18 at 8.  

CNA # 1 subsequently indicated to the surveyor that she would see “chunks” in the puree “every once in a while, mostly at breakfast.”  CMS Ex. 1 at 20.  She stated that if this occurred, she would mash the puree with milk and syrup.  CNA # 3 told the surveyor that “sometimes” the pureed food was an inappropriate consistency, and she would then tell the nurse who would tell the kitchen.  Id. at 21.  LPN # 1 told the surveyor that, in the past, there had been “chunks” in the pureed food and she had called the kitchen and spoken directly with the FSD to let him know.  Id. at 21-22.  The FSD denied ever being informed of pureed food with inappropriate consistency but indicated that the food processor was broken so only the blender was being used on that day.  Id. at 21.  The Director of Nursing (DON) confirmed that food needed to be smooth in texture to prevent aspiration and large particles in pureed food was a choking hazard.  Id. at 22. 

On the basis of this uncontested evidence, CMS concluded that: 

Page 8

The facility’s failure to ensure the puree consistency diet was free of large food particles posed a serious and immediate threat for adverse effects, including choking and aspiration, which would likely result in serious harm, impairment, or even death. 

CMS Ex. 1 at 15.  Petitioner does not directly challenge the above material facts.  Instead, it argues that R383 “could tolerate bite sized pieces” so that she was “not in immediate jeopardy of choking or aspirating.”  P. PH Br. at 12.  In essence, it asserts that R383 did not need to be on a pureed diet so “no harm, no foul”.  As evidence for this position, it has provided the opinions of three experts. 

In her Declaration, Dayna Cirincione, MS, CCC/SLP, stated that the surveyors did not utilize the results of the Modified Barium Swallow Study (MBSS), which she characterized as the “gold standard medical documentation,” in reaching their conclusions.  She opined that after reviewing R383’s results on the MBSS, R383 “was not at risk of choking or aspiration with bite size pieces on the meal tray.  The MBSS dated April 13, 2022, revealed [R383] could safely tolerate bite size solids and thin liquids.”  P. Ex. 2 at 2.  She concluded with her opinion that R383 “was never at any risk of harm, and in fact, the record itself is evidence of [R383’s] ability to tolerate the diet as it was prepared before the surveyors at the time of survey.”  Id. at 5.  

Peter O’Dougherty, MS, CCC/SLP, stated in his Declaration that the Bedside Swallow Assessment conducted by the facility SLP “is not a good indication of patient performance” and while “it does lend valuable information to caring for the patient, the MBS report provided more factual evidence of the patient’s swallow.”  Mr. O’Dougherty then offered his opinion that R383 would have been able to manage “chunks” of the size that were visualized in the photograph on CMS Ex. 10 at 1 without being at serious risk of harm or injury.  P. Ex. 3 at 5. 

Consistent with the granting of summary judgment, the opinions provided by Ms. Cirincione and Mr. O’Dougherty are not weighed or evaluated.  Instead, it is concluded that they do not provide “material facts” which would make the granting of summary judgment inappropriate.  In essence, they disagree with the order entered by the treating physician. 

As noted above, on April 20, 2022, Dr. Pathak entered a therapeutic diet order for R383 for a puree diet.  CMS Ex. 6 at 3.  Whether or not Petitioner’s witnesses agree with that order or believe it was not medically necessary is not relevant.  The relevant “material” fact is that the treating physician entered an order for a puree diet.  The facility then appropriately modified the care plan to include a puree diet with nectar liquids.  CMS Ex. 8 at 1, 5.  The facility’s Policy/Procedure on Food and Nutrition Services dated February

Page 9

1, 2022, provides that “residents will receive and consume foods in the appropriate form and/or the appropriate nutritive content as prescribed the physician . . . .”  CMS Ex. 13 at 2 (emphasis added).  As a result, after reviewing the evidence in the light most favorable to Petitioner, the material facts remain that Regency did not provide R383 with a diet in the form prescribed by her physician and did not abide by its own policy on this issue. 

The Board has repeatedly held that CMS may reasonably rely on a facility’s protocols and treatment policies as evidencing the facility’s own judgment of the care and services that are necessary at a minimum to attain or maintain its residents’ highest practicable physical, mental, and psychosocial well-being.  E.g., The Laurels at Forest Glenn, DAB No. 2182 at 18 (2008) (“CMS may reasonably rely on a facility’s policy relating to the care and treatment of its residents as evidencing the facility’s understanding of what must be done to attain or maintain residents’ highest practicable physical, mental, and psychosocial well-being.”); Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013) (“[T]he Board has long held that a facility’s own policy may be sufficient evidence both of professional standards of quality and of what the facility has determined is needed to meet the quality of care requirements . . . .”). 

A facility’s obligations under section 483.25 includes furnishing the care and services set forth in its own resident care policies.  Logan Healthcare Leasing, LLC, DAB No. 3036 at 14 (2021); Life Care Ctr. of Bardstown, DAB No. 2479 at 22 (2012) (citing cases), aff’d, 535 F. App’x 468 (6th Cir. 2013); Life Care Ctr. of Tullahoma, DAB No. 2304 at 34 (2010) (the care and services required by section 483.25 include care and services called for by a facility’s resident care policy), aff’d, 453 F. App’x 610 (6th Cir. 2011); Good Shepherd Home for the Aged, Inc., DAB No. 2858 at 12 (2018) (section 483.25 obligates a skilled nursing facility to follow its own resident care policies).  Indeed, “[o]nce a facility adopts a policy that incorporates the measures that are appropriate to assure that residents receive adequate supervision and assistance devices to prevent accidents . . . the facility is held to follow through on them.”  Heritage Plaza Nursing Ctr., DAB No. 2829 at 20 (2017). 

Petitioner cites other material facts that it believes renders summary judgment inappropriate.  It asserts that, in addition to the ability to tolerate non-pureed food, the “dietary prescription of pureed food was not to avoid aspiration but to facilitate better food intake[,]” leaving the reason for the prescription for pureed food as a material fact in dispute.  P. PH Br. at 8.  It similarly cites as another relevant material fact in dispute the opinion from Mr. O’Dougherty that there was a lack of information as to the reason why the physician changed the diet order to pureed food and no indication that it was because of “any concerns about aspiration or choking.”⁵  P. PH Br. at 10.  Again, even

Page 10

considering these assertions in the light most favorable to Petitioner, they do not establish a material fact in dispute.  The material fact here is that the treating physician ordered a puree diet for R383, which was not provided to her by the facility.⁶ 

I am aware that, for the purposes of summary judgment, I must draw all reasonable inferences in the light most favorable to the non-moving party.  However, second guessing the treating physician’s orders does not create even “metaphysical doubt” as to the material facts, much less raise a genuine dispute of material fact necessary to preclude summary judgment.  West Texas LTC Partners, Inc., DAB No. 2652 at 15, citing 1866ICPayday.com, L.L.C., DAB No. 2289 at 3.  Thus, even though Petitioner’s witnesses disagree with the opinion of the treating physician and the care plan developed by the facility, the material facts establish that Regency failed to provide R383 with an environment that was free of accident hazards and failed to provide adequate supervision to prevent accidents when it prepared food for her that was not appropriately pureed. 

2. B. CMS’s determination that the facility’s substantial noncompliance posed immediate jeopardy to resident health and safety is not clearly erroneous.

Immediate jeopardy exists if a facility’s noncompliance has caused or is likely to cause “serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.  CMS’s determination as to the level of a facility’s noncompliance (which would include an immediate jeopardy finding) must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The Board has observed repeatedly that the “clearly erroneous” standard imposes on facilities 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.”  Barbourville Nursing Home, DAB No. 1962 (2005), citing Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004); Daughters of Miriam Ctr., DAB No. 2067 at 7, 9 (2007). 

In this case, CMS imposed a per-day CMP for one day (April 26, 2022), of immediate jeopardy and substandard quality of care based on Federal Tag F689, at scope and severity level K.  CMS Ex. 2 at 1.  It determined that: 

The facility’s failure to ensure the puree consistency diet was free of large food particles posed a serious and immediate threat for adverse effects, including choking and aspiration,

Page 11

which would likely result in serious harm, impairment, or even death. 

CMS Ex. 1 at 15.  CMS further asserts that: 

The systemic problems evidenced by the failure of Petitioner’s staff on April 26, 2022 to ensure that the meatballs on Resident # 383’s plate were actually pureed, despite the surveyors directly asking staff to check the consistency of the meatballs before her tray was taken to her unit, supports the CMS’ immediate jeopardy determination, even though the resident herself happened not to be at the facility at the time. 

CMS PH Br. at 16. 

Petitioner asserts that “the assignment of an IJ deficiency under F-689 with S/S = ‘K’ was not appropriate.  It should be reconsidered and deleted.”  P. PH Br. at 24.  As support for this argument, it cites the Declaration of Nelia S. Adaci, RN, BSN.  P. Ex. 1.  Ms. Adaci opined that based on her extensive knowledge of the regulations, her clinical experience, and the two SLP experts, R383 was never in danger and so an immediate jeopardy was not warranted.  P. Ex. 1 at 12-13.  In addition, Ms. Adaci stated that it was her opinion that there was “no documentation to support the assertion of an IJ Deficiency with a Scope of K (Pattern).”  P. Ex. 1 at 14.  She asserts that while the surveyors were given a list of ten additional residents with puree diets, there were no references to investigations performed on these residents in the statement of deficiencies.  Id. at 13-14. 

With respect to Petitioner’s first argument that there was no harm or even risk of harm to R383 to justify the immediate jeopardy rating, I have reviewed the evidence in the light most favorable to the non-moving party and agree that because R383 was not at the facility at the time the meal in question was served, she did not experience actual harm.  However, actual harm is not necessary for a finding of immediate jeopardy.  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.”). Moreover, it is Petitioner’s burden to demonstrate that CMS’s immediate jeopardy findings were clearly erroneous.  See 42 C.F.R. § 498.60(c)(2); Miss. Care Ctr. of Greenville, DAB No. 2450 at 15 (2012), aff’d, 517 F. App’x 209 (5th Cir. 2013). 

Petitioner has not met that burden here.  As discussed extensively above, a meal was prepared for R383 that was not pureed and which was not consistent with either her

Page 12

physician’s order or the plan of care.  CMS Ex. 6 at 3; CMS Ex. 8 at 5.  Such gross noncompliance would likely cause serious injury or harm to R383. 

Petitioner next argues that there was no evidence to support a finding of a pattern of noncompliance at this level.  Petitioner does not dispute that there were other residents in the facility on puree diets.  It acknowledges that a list of ten additional residents with puree diets was provided to the surveyors.  P. Ex. 1 at 13-14.  It did not challenge the statement of CNA # 2 to the surveyor that there were two residents on a pureed diet on a particular nursing unit and one of those residents, although confused, fed herself.  CMS Ex. 1 at 20.  It did not challenge the observations on April 26, 2022, that the meatball puree contained chunks of solid food.  CMS Ex. 1 at 17, 19.  It did not challenge the statements of CNA # 1 that she had observed chunks in the pureed food in the past.  CMS Ex. 1 at 21.  It did not challenge the statement of the facility SLP that food particles would be a choking hazard for people on pureed diets.  CMS Ex. 17 at 4.  It did not challenge the statement of the DON that “large particles in pureed food was a choking hazard.”  CMS Ex. 17 at 9.  It did not challenge the statements by the FSD and the Daytime and Evening Cooks that there were no standard recipes or instructions for puree texture food.  Id. at 6.  It did not challenge the statement from the facility’s dietician that a facility should have standardized recipes so that the food comes out the same all the time and there should be recipes on how to puree foods.  Id. at 7.  Rather it alleges, through the declaration of Ms. Adaci, that the rating was erroneous because the surveyor did not discuss the specifics of those other residents in the report. 

Again, consistent with the granting of summary judgment, the opinion provided by Ms. Adaci is not weighed or evaluated.  Instead, I conclude that it does not provide “material facts” which would make the granting of summary judgment inappropriate.  I do not find that it was necessary for CMS to have interviewed every resident in the facility who was on a puree diet.  It was enough to establish through uncontested facts that there were several residents in the facility on puree diets, including one who fed herself, for whom a meal had been prepared that was not pureed and contained chunks of meat.  It was also enough to establish, through uncontested facts, that there was a systemic failure to ensure that food was pureed properly.  The above uncontested material facts established that chunks in pureed food posed a choking hazard for individuals on pureed diets.  The risk of serious harm to a number of vulnerable people from this deficiency is readily apparent.  Thus, a pattern of noncompliance in this area is clearly established and the finding of immediate jeopardy was not clearly erroneous. 

3. C. The evidence establishes that the penalty imposed is reasonable.

As noted above, CMS imposed a $13,820.00 per‑day CMP for the one day of immediate jeopardy on April 26, 2022, and a $360.00 per‑day CMP for the 72 days of continued noncompliance, totaling $39,740.00.  CMS Ex. 3 at 1.  Other than to assert that the CMP was “inherently unreasonable” or “unreasonable”, Petitioner has not presented any

Page 13

specific argument addressing the factors cited in 42 C.F.R. § 488.438(f)(1)-(4) and/or 42 C.F.R. § 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)); the regulations for assessing the reasonableness of the CMP.  RH at 5; P. PH Br. at 2.  Petitioner failed to argue that any of the factors support a reduction of the CMP amount.  Because of the presumption that CMS has considered the regulatory factors in setting the amount of the CMP and that those factors support the CMP amount imposed by CMS, unless a facility contends that a particular regulatory factor does not support the civil money penalty amount, an ALJ must sustain it.  Coquina Ctr., DAB No. 1860 at 32 (2002).  On that basis, I conclude that the CMP amount is reasonable. 

IV. CONCLUSION

I find that the facility was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)(2).  The CMP imposed of $39,740.00 is reasonable. 

Endnotes

¹  Additional remedies of termination of provider agreement and mandatory denial of payment for new admissions were not imposed because the facility achieved substantial compliance on July 8, 2022, prior to the effective dates of those remedies. 

²  This case was originally assigned to Judge Weyn, but was reassigned to me on September 28, 2023. 

³  My findings of fact and conclusions of law are set forth in bold and italic text in the discussion captions of this decision. 

⁴  The remainder of this order is not visible but it is presumed to be “Nectar Thick Liquids” since that characterization is used on the facility’s SLP assessment at CMS Ex. 9 at 3.  

⁵  I note that Dr. Pathak, the treating physician, included as part of the Assessment and Plan for R383 the diagnosis of aspiration pneumonia, which would strongly support the assumption that he did have concerns about aspiration when prescribing the puree diet.  CMS Ex. 6 at 1. 

⁶  Petitioner points to no authority which would justify not following a physician’s order because the physician did not provide a reason or an explanation for that order.