Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Kingsville Nursing and Rehabilitation Center,
(CCN No. 675815),
Petitioner,
v.
Centers For Medicare & Medicaid Services.
Docket No. C-22-568
Decision No. CR6212
DECISION
I enter summary judgment sustaining the determination of The Centers for Medicare & Medicaid Services (CMS) to impose a per-instance civil money penalty of $19,460 against Petitioner, Kingsville Nursing and Rehabilitation Center, a skilled nursing facility.1
I. Background
CMS filed exhibits with its motion for summary judgment that it identified as CMS Ex. 1-CMS Ex. 11. Petitioner responded with exhibits that it identified as P. Ex. 1-P. Ex. 7. Petitioner objected to my receiving some of CMS’s exhibits.
I make no rulings on Petitioner’s objections, nor do I receive exhibits into evidence. In this decision I rely solely on material facts that are not in dispute. I cite to some exhibits but only to illustrate undisputed facts.
Page 2
II. Issues, Findings of Fact and Conclusions of Law
A. Issues
The issues are whether undisputed material facts establish that Petitioner failed to comply substantially with a Medicare participation requirement and whether CMS’s penalty determination is reasonable.
CMS raised an additional issue in its motion: whether Petitioner’s alleged noncompliance was so egregious as to put a resident or residents of Petitioner’s facility in a state of immediate jeopardy. CMS’s Prehearing Brief and Motion for Summary Judgment (CMS’s brief) at 1. Petitioner denies that any possible noncompliance rose to the level of immediate jeopardy. I do not address the issue of immediate jeopardy in this decision as it is unnecessary that I do so. The penalty that CMS determined to impose, a per-instance civil money penalty, is sustainable without regard to whether Petitioner’s noncompliance put a resident or residents in immediate jeopardy. 42 C.F.R. § 488.438(a)(2); 45 C.F.R. Part 102.
B. Findings of Fact and Conclusions of Law
In deciding to issue summary judgment I base my findings and conclusions entirely on material facts that are undisputed. I also draw from the facts any inferences that are favorable to the party opposing the motion.
- Noncompliance
CMS alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25. In relevant part this regulation requires that, based on a comprehensive assessment of residents’ conditions and needs, a skilled nursing facility must ensure that the residents receive care in accordance with professional standards of practice and the residents’ comprehensive plans of care. CMS asserts that Petitioner’s staff contravened this requirement by serving the wrong meal to a resident in violation of the resident’s physician’s order, Petitioner’s plan of care for that resident, and Petitioner’s unwritten policy for ensuring that residents receive appropriate meals. CMS contends that the consequence of these failures was that the resident developed aspiration pneumonia, necessitating his hospitalization.
The undisputed facts unequivocally establish Petitioner’s noncompliance.
This case centers on the care that Petitioner’s staff provided to an individual identified as R1. As of March 28, 2022, R1 was aged 81 and suffered from multiple impairments and illnesses. CMS Ex. 5 at 2, 16. These impairments included Alzheimer’s disease resulting
Page 3
in moderate cognitive loss. Id. at 6. The resident required assistance with daily activities including eating. Id. at 10.
The resident had no teeth and refused to wear dentures. P. Ex. 6 at 1; P. Ex. 7 at 1. That made it difficult for him to chew his food. Id. He was at risk for suffering from dysphagia (difficulty swallowing). CMS Ex. 6 at 40. Dysphagia can lead to choking or aspiration pneumonia, a form of pneumonia that may occur when food enters the lungs. Causes and Diagnoses of Aspiration Pneumonia,https://www.nm.org/conditions-and-care-areas/gastroenterology/aspiration-pneumonia/causes-and-diagnoses (last visited December 29, 2022).
The resident’s physician ordered that R1 receive pureed food with a regular liquids consistency. CMS Ex. 7 at 1. Petitioner’s staff prepared a care plan for the resident, based on the staff’s assessment of R1’s condition and on his physician’s orders. CMS Ex. 6. The care plan explicitly directed staff to provide R1 with pureed food. Id. at 40.
Petitioner did not have a written policy instructing its staff how to ensure that residents received prescribed diets. CMS Ex. 4 at 2. However, Petitioner’s kitchen staff and nurses were supposed to check residents’ food trays to ensure that the residents were served food that conformed to prescribed diets. Id.
On the evening of March 28, 2022, Petitioner’s staff served R1 with a meal consisting of food described as “regular” or “mechanical soft.” CMS Ex. 10 at 4-5. A “mechanical soft” diet consists of food that has been altered in texture to make it easier to swallow. Mechanical soft food may include pureed food, but it may also include chopped or ground food. Mechanical Soft Diet, https://patient.uwhealth.org/healthfacts/363 (last visited December 29, 2022). The resident consumed about 25% of this meal and began coughing, bringing up a moderate amount of phlegm. CMS Ex. 10 at 7; CMS Ex. 2 at 5.
About 90 minutes after this episode, R1 complained of shortness of breath. CMS Ex. 2 at 5. He registered abnormally low blood pressure. Id. The resident’s physician ordered that the resident be sent to an emergency room. Id. The resident was admitted to a hospital. Id. at 5-6.
Staff error was the reason for feeding R1 a mechanical soft meal instead of a pureed meal. On the evening of March 28, 2022, Petitioner’s kitchen staff was distracted by the presence of maintenance personnel, causing them to serve the incorrect meal. CMS Ex. 4 at 1, 3. That error was compounded by the failure of a licensed vocational nurse to check food trays on that evening. Id. Consequently, nursing assistants passed out food trays to residents without those trays being checked. Id.
Serving R1 mechanical soft food clearly violated a physician’s order and the resident’s plan of care. It also violated Petitioner’s unwritten policy that staff check residents’ food
Page 4
trays to ensure that they were receiving food according to their prescribed diets. CMS Ex. 4 at 2. There is no question that these multiple failures endangered R1. Individually and collectively, they constitute noncompliance with the requirements of 42 C.F.R. § 483.25. The Laurels at Forest Glenn, DAB No. 2182, at 18 (2008) (“the Board has decided, a facility's failure to follow or implement its own resident care policy may constitute a deficiency under section 483.25”).
To find noncompliance it is unnecessary that I find that feeding this resident mechanical soft food caused him to suffer from aspiration pneumonia. All that is necessary to find noncompliance is the potential for more than minimal harm resulting from Petitioner’s errors, and the undisputed facts certainly establish that potential. 42 C.F.R. § 488.301 (definition of substantial compliance). Both the resident’s physician and Petitioner’s staff had found R1 to be at risk for choking or pneumonia. CMS Ex. 7 at 1; CMS Ex. 6 at 40. Feeding the resident the wrong foods increased the risk that the resident would suffer severe adverse consequences.
I find Petitioner’s arguments and assertions to be without merit.
Broadly summarized, Petitioner asserts “no harm, no foul,” by contending that CMS has not offered facts to prove that its staff’s feeding R1 mechanical soft food caused the resident to experience actual harm. I find this argument to be unavailing because whether or not the resident was harmed on March 28, 2022, is not an outcome-determinative element of this case.
Petitioner argues, first, that CMS’s assertion that the resident had aspiration pneumonia is without any evidentiary support because CMS offered no clinical record establishing that R1 suffered from aspiration pneumonia. Petitioner’s Response to Motion for Summary Judgment and Prehearing Brief (Petitioner’s brief) at 9, 12-13. But, and as I have explained, it is not a necessary element of my finding of noncompliance that R1 developed aspiration pneumonia.
Petitioner is noncompliant not because its staff’s errors caused the resident to choke or to have aspiration pneumonia on March 28, 2022, but because those errors exposed R1 to the risk of choking or aspiration pneumonia.2 In fact, R1 faced such risks on any occasion that he consumed non-pureed food. The resident’s physician’s order for a pureed diet plainly addressed the eating and swallowing-associated risks that the resident faced. CMS Ex. 7 at 1. So did the resident’s plan of care. P. Ex. 6 at 1; P. Ex. 7 at 1.
Page 5
Petitioner makes a similar argument in asserting that there is no evidence that R1 choked on March 28. Petitioner’s brief at 13. For the reasons that I have explained, my findings of noncompliance do not depend in any respect on whether the resident choked. Petitioner asserts that a swallowing study completed on April 5, 2022, showed that the resident could safely consume a mechanical soft diet. Petitioner’s brief at 14; P. Ex. 2. Petitioner argues from this asserted finding that its staff’s error in feeding mechanical soft food to R1 on March 28, 2022, was harmless and cannot be a basis for a finding of noncompliance.
I disagree. The noncompliance in this case is blatant failure by Petitioner’s staff to comply with a physician’s order and the resident’s plan of care. That noncompliance was substantial even if in hindsight the order that the resident receive a pureed diet proved to be overly cautious.
But that order was not overly cautious. Indeed, it reflected an astute assessment of the resident’s condition. Petitioner’s assertions notwithstanding, the swallowing study relied on by Petitioner did not conclude that the resident could safely consume a mechanical soft diet. To the contrary, the study found R1 to be at high risk for choking or aspiration pneumonia, and provided substantial support, both for R1’s physician’s order and for Petitioner’s staff’s assessment of the resident and its plan of care.
As part of the study R1 was fed a very small quantity of mechanical soft food, which he swallowed without choking. P. Ex. 2 at 2. However, the study noted that the resident had obvious difficulty when swallowing. It found that the resident demonstrated: “poor bolus formation, poor mastication crush power with limited rotary jaw movement . . . .” Id. at 1. The study concluded that:
Although no penetration/aspiration/choking was visualized, this patient exhibits high risk due to reduced oral control, swallow delay, residuals, narrowed pharyngeal/pharyngoesophageal space.
Id. at 2.
Finally, Petitioner asserts that the resident occasionally ate unaltered meals that were brought to him by members of his family. Petitioner’s brief at 14. From this assertion it appears to argue that if the family could feed unaltered food to the resident, then there was no constraint on Petitioner’s staff doing so as well.
The possibility that members of R1’s family may have provided the resident with unaltered food is no defense. The results of the swallowing study make it evident that supplying unaltered food to the resident was dangerous. The fact that family members may have done so provided no excuse for members of Petitioner’s staff to do so as well, whether the food supplied to the resident was unaltered or mechanical soft.
Page 6
- Remedies
CMS imposed a per-instance civil money penalty of $19,460 against Petitioner. I find this penalty amount to be reasonable.
As I have discussed, noncompliance so severe as to pose immediate jeopardy for a resident or residents of a facility is not a necessary element of deciding whether a per-instance civil money penalty is reasonable. A per-instance penalty may fall within a range established at 42 C.F.R. § 488.438(a)(2), and 45 C.F.R. Part 102, which annually adjusts penalty amounts, without necessitating the presence or absence of immediate jeopardy.
Reasonableness of a per-instance penalty may be evaluated based on regulatory factors set forth at 42 C.F.R. §§ 488.438(f)(1)-(4) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)). These factors may include the seriousness of noncompliance, a facility’s culpability and its compliance history, and its financial condition. They do not require a finding of immediate jeopardy to sustain a per-instance penalty.
The per-instance penalty that CMS determined to impose is within the permissible range for a per-instance penalty albeit close to the top end of that range. CMS contends that the penalty amount is justified by the seriousness of Petitioner’s noncompliance and its culpability.
As to seriousness, CMS argues that R1 experienced pain and suffering as a consequence of the noncompliance and that he could have experienced serious adverse health issues, including death. CMS’s brief at 11. I make no findings as to whether the resident experienced pain and suffering. The noncompliance nonetheless was very serious. The undisputed facts amply establish the level of risk that Petitioner’s noncompliance caused. Objective and undisputed clinical evidence proves that R1 was at high risk for choking and aspiration. P. Ex. 2 at 2. Feeding mechanical soft food to R1 exposed the resident to potentially lethal consequences.
The undisputed facts also establish that Petitioner is culpable for the errors that its staff committed. On March 28, 2022, a licensed vocational nurse was assigned the responsibility for checking food trays to assure that residents received their prescribed diets. She admitted that she was too busy to check the trays. CMS Ex. 4 at 1. Another staff member should have been assigned to check the trays, but none was assigned. This lapse in care was dereliction of duty by Petitioner’s staff, dereliction that put not only R1 at risk but potentially, other residents as well, because the failure to check didn’t just apply to R1’s food tray, but to those of all of Petitioner’s residents.
Petitioner challenges the penalty amount first, by contending that the undisputed facts do not establish immediate jeopardy level noncompliance. Petitioner’s brief at 16. I need
Page 7
not rehash my reasons for finding it unnecessary to address the question of whether the noncompliance rose to the level of immediate jeopardy. Suffice it to say that the regulatory factors – the seriousness of Petitioner’s noncompliance and its culpability – are ample basis to sustain the penalty amount without regard to whether immediate jeopardy was present.
Petitioner also asserts that there is a fact issue whether the penalty amount should be reduced if immediate jeopardy is not present. Petitioner’s brief at 17. I disagree. The undisputed facts establish the seriousness of Petitioner’s noncompliance and its culpability and justify the entire penalty amount.
Petitioner makes no argument about its loss of authority to conduct NATCEP.
Endnotes:
1 Petitioner also loses the authority to conduct nurse aide training (NATCEP) for a period of two years as a consequence of the penalty amount that I sustain.
2 That said, the most likely reason for R1’s hospitalization on March 28, 2022, was that he inhaled food particles. A hospital clinical record submitted by Petitioner include imaging findings showed that the resident had a mild amount of patchy infiltrate in his left lower lung which appeared to be new and which should be “correlated with any clinical evidence of pneumonia.” P. Ex. 1 at 1.
Steven T. Kessel Administrative Law Judge