Fulton Gardens Post-Acute, LLC, DAB CR6219 (2023)

DECISION

Petitioner, Fulton Gardens Post-Acute, LLC, is a long-term care facility, located in Stockton, California, that participates in the Medicare program.  After one of its residents lost a substantial amount of weight in a short period of time, surveyors from the California Department of Public Health (state agency) investigated.  Based on the results of that complaint investigation/survey, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with 42 C.F.R. § 483.25(g), a section of the quality-of-care regulation that governs assisted nutrition and hydration.  CMS imposed a per-instance civil money penalty (CMP) of $10,605.

Petitioner appealed.  The parties agree that this matter may be decided based on the written record.

For the reasons set forth below, I find that the facility was not in substantial compliance with section 483.25(g) and that the penalty imposed is reasonable.

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Background

The Social Security Act (Act) sets forth requirements for nursing facilities participating 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.  The state agency must also investigate all complaints.  Act § 1819(g)(4).

Here, responding to a complaint, a surveyor from the state agency arrived at the facility on August 7, 2020, to investigate.  CMS Ex. 11 at 1.  The state agency subsequently expanded the investigation and completed an abbreviated survey on September 30, 2020.  Based on the survey findings, CMS determined that the facility was not in substantial compliance with 42 C.F.R. § 483.25(g)(1)-(3) (Tag F692) (quality of care – assisted nutrition), cited at scope and severity level G (isolated instance of substantial noncompliance that causes actual harm but does not pose immediate jeopardy to resident health and safety).  CMS Exs. 1, 18.

Following a revisit survey, completed November 10, 2020, CMS determined that the facility returned to substantial compliance on November 10.  CMS Ex. 18 at 2.

CMS has imposed a per-instance penalty of $10,605.  CMS Ex. 18.

Petitioner appeals, and the parties agree that this matter may be decided based on the written record.  Order Summarizing Pre-hearing Conference at 2 (Aug. 9, 2022).  The parties have submitted pre-hearing briefs (CMS Br.; P. Br.) and closing briefs (CMS Cl. Br.; P. Cl. Br.).  CMS replied to Petitioner’s closing brief (CMS Reply).

In the absence of any objections, I have admitted into evidence CMS Exs. 1-19 and P. Exs. 1-2.  Order Summarizing Pre-hearing Conference at 2.

Issues

The issues before me are: 

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• Was the facility in substantial compliance with 42 C.F.R. § 483.25(g)(1)-(3), and
• If the facility was not in substantial compliance, is the penalty imposed – $10,605 per instance – reasonable?

Petitioner complains that the deficiency should not have been cited at scope-and-severity level G.  See P. Br. at 3, 4; P. Cl. Br. at 2.  But I have no authority to review CMS’s scope-and-severity determination.  The regulations authorize such review if:  1) a successful challenge would affect the range of the CMP; or 2) CMS has made a finding of substandard quality of care that results in the loss of approval of the facility’s nurse aide training program.  42 C.F.R. § 498.3(b)(14), 498.3(d)(10).  Here, because the regulation provides only one range for per instance penalties, the CMP range would not change if I lowered the scope and severity.  42 C.F.R. § 488.438(a)(1).  CMS did not find substandard quality of care, so the facility’s nurse aide training program (if it has one) is not affected.  See CMS Ex. 18.

Discussion

1. The facility was not in substantial compliance with 42 C.F.R. § 483.25(g)(1)-(3) because, contrary to the regulation and the facility’s policies, its nutritional assessments did not accurately reflect the residents’ conditions, its care plans did not adequately address the residents’ nutritional needs, its staff did not consistently follow facility policies or implement the interventions called for in resident care plans, and its residents did not maintain acceptable parameters of nutritional status, such as stable body weight.¹

A.  Program Requirements.

Program requirement:  42 C.F.R. § 483.25(g)(1)-(3) (Tag F692).  The statute mandates that the facility ensure that each resident receive, and the facility provide, the necessary care and services to allow the resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident’s comprehensive assessment and plan of care.  Act § 1819(b)(2).  To this end, the “quality-of-care” regulation mandates, among other requirements, that the facility ensure that, based on a comprehensive assessment, a resident:  1) maintains acceptable parameters of nutritional status, such as usual body weight or desirable body weight range and electrolyte balance, unless the resident’s clinical condition demonstrates that this is not possible or resident preferences indicate otherwise; 2) is offered sufficient fluid

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intake to maintain proper hydration and health; and 3) is offered a therapeutic diet when there is a nutritional problem, and the health care provider orders a therapeutic diet. 

The clinical condition exception is a narrow one and applies only when the facility can demonstrate that it cannot provide nutrition adequate for the resident’s overall needs, so the weight loss was unavoidable.  Texan Nursing & Rehab. of Amarillo, LLC, DAB No. 2323 at 11 (2010); The Windsor House, DAB No. 1942 at 18 (2004).

The facility must “take reasonable and timely measures to minimize the risk that nutritional impairment will become manifest.”  The question is not whether a resident’s weight falls below a particular threshold; the question is whether the facility takes reasonable and timely steps to help ensure that the resident maintains acceptable parameters of nutritional status.  Carrington Place of Muscatine, DAB No. 2321 at 9-10 (2010).²

B.  Facility Policies.

As the Departmental Appeals Board has repeatedly explained, a facility’s policy for implementing a regulatory requirement reflects the facility’s own judgment about how best to achieve compliance.  Failing to comply with its own policies “can support a finding that the facility did not achieve compliance with the regulatory standard.”  Bivins Mem’l Nursing Home, DAB No. 2771 at 9 (2017); see Rockcastle Health & Rehab. Ctr., DAB No. 2891 at 19 (2018) (ruling that, absent contrary evidence, it is reasonable to presume that the facility’s policies reflect professional standards); Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013); Life Care Ctr. of Bardstown, DAB No. 2233 at 21-22 (2009) (finding that a facility’s failing to comply with its own policies can constitute a deficiency).

Facility policy:  assessment and management of resident weights.  The facility had in place a written policy for assessing and managing its residents’ weights.  Reflecting the language of the regulation, the policy’s stated purpose is to:  “ensure that each resident maintains acceptable parameters of weight and nutritional status, such as body weight and protein levels,” unless this is not possible because of the resident’s clinical condition,

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based on the resident’s comprehensive assessment; and to ensure that a resident with a nutritional problem receives a therapeutic diet.  CMS Ex. 8 at 1.

According to the policy, residents must be weighed upon admission and re-admission, then weekly for four weeks, and then monthly thereafter.  At the discretion of the licensed nurse or the interdisciplinary team, additional weights are obtained.  The facility must also obtain weights for all residents receiving dialysis.  The equipment used for weighing must be maintained and calibrated according to the manufacturer’s recommendations and the facility’s preventive maintenance plan.  Id.

A licensed nurse must weigh the resident.  Hospital weight does not serve as an admission or re-admission weight.  Staff should document whenever adaptive or assistive equipment is used to weigh a resident.  Id.

If the resident’s weight is less than or greater than 5% than the resident’s previous weight, the nurse must immediately re-weigh the resident, and a licensed nurse must verify its accuracy.  Weights are entered into the clinical record on the shift during which the weights are taken.  Id.

The policy includes specific instructions for managing weight change: 

• Significant weight changes are reviewed by the Director of Nursing (referred to as the DNS) or designee, who must be a licensed nurse.  Significant weight changes are:  5% in one month; 7.5% in three months; and 10% in six months.
• The Director of Nursing or designee:  reports the weight change on the resident’s medical record and on the 24-hour report; notifies the physician and dietician of significant weight changes; and documents, in the nurses’ notes, that these individuals have been notified.
• The registered dietician completes a nutritional assessment on all residents with significant weight changes and documents, in the medical record, the nutritional assessment and weight management recommendations.
• The licensed nurse notifies the physician of the dietician’s recommendations and notifies the family/health care decision-maker of the weight change.
• A physician who does not implement the dietician’s recommendations must document the rationale for not doing so.  The licensed nurse also documents the physician’s refusal and communicates this information to the Director of Nursing for follow-up on the 24-hour report.

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• Residents with significant weight changes are weighed at least weekly and the issues are discussed at the “Resident at Risk” or other clinical meeting to determine possible causes of the weight gain or loss, including goals for care.
• The interdisciplinary team care plan is updated to reflect individualized goals and approaches for managing the weight change.

CMS Ex. 8 at 1, 2.

Facility policy:  care planning.  Consistent with federal requirements (see 42 C.F.R. § 483.21), the facility had in place a policy to “ensure that a comprehensive, person-centered care plan” is developed for each resident based on the resident’s assessed needs. The policy directs the facility’s interdisciplinary team to develop a baseline and/or comprehensive care plan for each resident.  The care plan “serves as a course of action” where the resident (or representative), the attending physician, and the interdisciplinary team “work to help the resident move toward resident-specific goals that address the resident’s medical, nursing, mental, and psychosocial needs.”  CMS Ex. 8 at 3. 

A licensed nurse initiates the care plan, which is finalized in accordance with federally-mandated guidelines (OBRA and MDS) and is updated as indicated for a change in condition, the onset of new problems, the resolution of current problems, and “as deemed appropriate by clinical assessment and judgment on an as-needed [basis].”  Id. (emphasis added).

Facility policy:  dietary services.  The facility had in place a policy “[t]o ensure that residents are properly assessed for dietary needs.”  Pursuant to the policy, the facility’s dietician completes a nutritional assessment that was initiated by the dietary manager when the resident was admitted.  Nutritional assessments are also completed upon readmission, annually, and when there is a change in condition.  CMS Ex. 8 at 6.

The dietary manager initiates the assessment when the resident is admitted, using information from the resident’s medical record, including:  diagnosis; diet order; nutritional supplement; skin condition; ability to chew/swallow; feeding status; meal intake percentage; height, weight, and usual body weight; and birth date, admission date, room number, and resident name.  Id.

The dietician reviews the information provided by the dietary manager and revises or updates it as necessary.  The dietician is responsible for completing the following:  pertinent medication; laboratory data; ideal body weight; body mass index; and estimated nutritional needs.  The dietician provides a narrative of recommendations in the assessment section and identifies any weight loss or dehydration risk factors.  The dietician completes the assessment within 14 days of admission and signs and dates the

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assessment on the day it’s completed.  The process is repeated each time a nutritional assessment is completed.  Id.

Facility policy:  nutritional care planning.  The facility had a policy “[t]o ensure that residents’ nutritional needs are met through . . . individualized nutritional care plans.”  CMS Ex. 8 at 7.  Using the information from the resident’s nutritional assessment, the dietary manager, with the interdisciplinary team, develops a nutritional care plan.  Id.

The dietary manager attends the resident care conference and, providing information from the nutritional assessment, assists the team with developing a nutritional care plan that identifies the problems/risks, goals, and approaches for meeting the resident’s nutritional needs.  The care plan is reviewed no less than quarterly and more frequently to reassess problems/risks, goals, and approaches.  The dietician reviews and adds to the nutritional care plan, as appropriate.  Nutritional progress notes can be used between care plan reviews to document changes in nutritional status and recommendations.  The dietician and dietary manager may consider reviewing, monthly, the nutritional care plans for residents on tube feedings or who are identified to be at risk for weight loss or pressure ulcers.  Id.

C.  The Facility’s Failure to Meet Resident 1’s Nutritional Needs.

Resident 1 (R1).  R1 was an 80-year-old man, admitted to the facility on June 20, 2020, after an acute-care hospital stay and very brief return home.  He suffered from a long list of impairments, including type 2 diabetes, epilepsy, congestive heart failure, depressive disorder, artherosclerosis, deep vein thrombosis, gastro-esophageal reflux disease, gout, anorexia, dysphagia, oropharyngeal phase, and adult failure to thrive.  CMS Ex. 3 at 1-2.

A dietary profile, dated June 26, 2020, indicates that R1 was ordered a consistent carbohydrate diet (CCHO), which is a diet often ordered for diabetics.  The profile also indicates that the resident required partial assistance with eating.  CMS Ex. 3 at 24-27.

A skin assessment, dated June 20, 2020, indicates that R1 had a pressure ulcer on his coccyx, which was unstageable (full thickness tissue loss in which the base of the ulcer is covered by slough and/or eschar).  CMS Ex. 3 at 134.

Several of R1’s conditions put him at a heightened risk for weight loss.  Anorexia is an eating disorder that causes weight loss.  Adult failure to thrive is a condition, caused by one or more chronic illnesses, that can lead to poor appetite, weight loss, pressure sores, increased fatigue, and progressive functional decline.  Dysphagia oropharyngeal phase refers to swallowing problems that occur in the mouth and/or throat.  CMS Ex. 12 at 3 (Voss Decl. ¶ 5).

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Before he was admitted to the facility, R1’s hospital reported that, for weeks, his appetite had been poor.  He suffered significant bouts of nausea and multiple episodes of vomiting.  Over the prior month, he had lost a significant amount of weight.  CMS Ex. 3 at 7.  He required assistance with eating and other activities of daily living.  CMS Ex. 3 at 11.

Following his admission, R1 maintained his weight – 221 pounds – for about two weeks; however, between July 6 and July 12, his weight dropped to 206.3 pounds.  CMS Ex. 3 at 22.  In a progress note, dated July 17, 2020, the facility’s dietician noted this loss.  She also reported that, in the prior week, the resident ate about 38% of his meals with two refusals.  She recommended supplemental shakes and snacks three times a day, which were ordered.  She indicated that R1’s food preferences should be updated (he said that he was not used to the flavors of the food being provided).  She also noted a “diet discrepancy”:  the resident was not receiving fortified foods.  She recommended that R1 be weighed weekly.  CMS Ex. 3 at 35-36.

Staff did not follow the dietician’s recommendation to weigh the resident weekly.  Although they weighed him on July 19 – he weighed 207.9 pounds – they did not weigh him again for almost three weeks.  When staff finally weighed R1 on August 7, 2020 (the first day of the survey), they recorded that he had lost an additional 20 pounds, weighing 187.8.  Thus, according to the facility’s records, between July 6 and August 7, he lost about almost 34 pounds – more than 15% of his body weight.  CMS Ex. 3 at 22.

A nutritional progress note, dated August 13, 2020, cites R1’s weight loss (15.3%) and describes his diagnosis as “severe malnutrition” related to poor appetite.  CMS Ex. 3 at 78.

To demonstrate that it substantially complied with the regulation, the facility must prove that this weight loss was unavoidable by showing that it took “adequate and timely steps to ensure that the resident received adequate nutrition.”  These steps include:  assessing the resident for risks to nutritional status; implementing appropriate interventions based on the assessment’s findings; and monitoring the effectiveness of those interventions.  Carrington Place, DAB No. 2321 at 11-12.  The facility did not take these steps.  It failed to meet R1’s nutritional needs in four significant ways, putting it out of substantial compliance with section 483.25(g):  1) R1’s nutritional risk assessment inaccurately described his risk factors for weight loss; 2) R1’s care plan did not adequately address his needs; 3) facility staff did not follow the interventions listed in R1’s care plan; and 4) the facility did not revise R1’s care plan when its interventions proved ineffective in preventing the resident’s weight loss.

Inadequate and inaccurate nutritional assessment.  An assessment must accurately reflect (among other factors) the resident’s disease diagnoses and health conditions,

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dental and nutritional status, and skin condition.  See 42 C.F.R. § 483.20(b); CMS Ex. 8 at 6 (facility policy requiring proper nutritional assessment).

The facility’s registered dietician prepared a nutritional risk assessment for R1.  Dated June 26, 2020, it records R1’s height as six feet tall and his weight as 221.1 pounds (as of June 21, 2020).  His usual weight is recorded as 270 pounds, and his goal weight is listed at 200-220.  CMS Ex. 3 at 28.  The assessment reflects that the resident had lost 18.5% of his body weight in the preceding six months and that his food and fluid intake was less than 50%.  CMS Ex. 3 at 28-29; see CMS Ex. 8 at 1 (defining as “significant” a 10% weight loss in six months).

The assessment also indicates that R1 “sometimes” experiences nausea and vomiting.  CMS Ex. 3 at 30.  It says that he receives no therapeutic nutrition supplement and eats a cut-up/minced diet.  CMS Ex. 3 at 31.  The dietician recommended that R1’s diet be “liberalized” to regular, mechanical, soft with fortified foods.  He should be given snacks three times a day.  Staff should monitor his weight, oral intake, and skin, and do labs, as needed.  CMS Ex. 3 at 33.

The assessment inaccurately reports that R1 had no pressure sores and no problems with swallowing, when, in fact, he had both.  CMS Ex. 3 at 30, 31; see CMS Ex. 3 at 2, 134.  His treatment records confirm that he had a pressure sore.  Oropharyngeal dysphagia affects the ability to swallow, so he had a problem with swallowing.  CMS Ex. 3 at 30, 31; see CMS Ex. 3 at 2, 134.  The surveyors (who are registered dieticians) explain the importance of accurately documenting such risks:  doing so helps ensure that the resident receives an appropriate diet and nutrient composition.  It is important to document a pressure ulcer because a pressure ulcer indicates that the resident’s meals should be fortified with additional protein and calories to encourage wound healing.  Care planners must know that a resident has difficulty swallowing in order to determine the types of food the resident can safely consume to maximize nutrient intake and prevent choking.³  If a resident cannot consume food safely, he could lose weight.  Moreover, if the resident’s assessment is not accurate, facility staff (kitchen and nursing) may not know the resident’s limitations with respect to the foods he can consume safely, which could result in his being served unsafe or otherwise inappropriate foods.  CMS Ex. 12 at 4 (Voss Decl. ¶ 8); CMS Ex. 13 at 3-4 (Muller Decl. ¶ 7).

The surveyors interviewed the facility’s registered dietician, who admitted that, at the time of his admission, R1 had difficulty swallowing.  She was not aware of his pressure ulcer.  CMS Ex. 13 at 3-4 (Muller Decl. ¶ 7).  That the dietician made these statements is unrefuted.  See Beatrice State Developmental Ctr., DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could have but did not present employee testimony that

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refuted the statements the surveyors claimed they made); Omni Manor Nursing Home, DAB No. 1920 at 11 (2004) (holding that the statements facility employees made to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence).

Inadequate care plan.  The facility developed a care plan for R1.  In light of his significant risk for additional weight loss, R1’s care plan includes remarkably few interventions designed to address his specific nutritional issues.  The care plan identifies as its “focus” that R1 has “the following dietary orders:  general, mechanical soft, thin liquids.”  Its goal is for the resident to “adhere to diet as ordered.”  The listed interventions are:  monitor meal intake, provide diet as ordered, and provide food preferred, if not in conflict with the treatment plan.  CMS Ex. 3 at 178-79.  In a related “focus,” described as “weakness related to anorexia, failure to thrive, hypothyroidism,” the care plan sets as a goal that the resident be able to participate with activities within limits and tolerance, daily.  The list of interventions includes:  diet as ordered and monitor % of intake and appetite; monitor weight, and notify MD of significant weight changes.  CMS Ex. 3 at 176.

On July 9, 2020, the facility revised R1’s care plan, adding additional general interventions, ostensibly aimed at maintaining the resident’s skin integrity:  “encourage good nutrition and hydration in order to promote healthier skin”; and “nutritional approaches per [registered dietician] recommendations and ordered by physician.”  CMS Ex. 3 at 201 (emphasis added).

Neither version of R1’s care plan adequately addresses his significant nutritional needs.  The interventions generally direct staff to follow dietary orders and monitor his meal intake.  CMS Ex. 3 at 176, 178.  Surveyor Tammie Voss, MA, RD, points out that the plan includes no specific guidelines tailored to the resident’s risk for weight loss.  Missing are guidelines for identifying problems with the resident’s appetite, his meal intake, and weight loss.  As Surveyor Voss explains, “Including specific guidelines in the initial care plan would have assisted staff in tracking and identifying nutrition and weight loss issues as they arose.”  CMS Ex. 12 at 3 (Voss Decl. ¶ 6).

Surveyor Evelyn Muller, MS, RD, concurs.  In addition to containing guidelines and time parameters for identifying problems with the resident’s appetite, meal intake, and weight loss, the plan should instruct staff on when and how to intervene for suspected problems, including when to notify a physician about the resident’s weight loss (which staff failed to do here).  CMS Ex. 13 at 3 (Muller Decl. ¶ 5).

During her interview with the surveyors, the facility’s registered dietician conceded that R1’s care plan “did not address his nutritional risks.”  CMS Ex. 13 at 4 (Muller Decl. ¶ 9).  Again, that the dietician made this statement is unrefuted.  See Beatrice State , DAB No. 2311 at 17, 18; Omni Manor, DAB No. 1920 at 11.

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Where the resident’s care plan does not address the resident’s needs and provide appropriate interventions, the facility is not providing necessary care and services.  The care plan must include “sufficient guidance to ensure that the services provided promote the plan’s specified objectives.”  Sheridan Health Care Ctr., DAB No. 2178 at 37 (2008).  In Sheridan, the resident’s care plan identified as problems a resident’s low weight and refusals to eat but provided no direction or strategies for staff to follow in addressing the resident’s injurious fasting behaviors.  The plan’s broad instructions to “encourage oral intake” and “encourage H2O” did not provide staff with “meaningful guidance” to respond effectively and consistently.  Id.  The Departmental Appeals Board concluded that the inadequate care plan put the facility out of substantial compliance with the quality-of-care regulation.  Id. at 39.

Here, the instructions included in R1’s care plan and its amendment are no more specific or helpful than those described in Sheridan.  As Surveyor Voss explains, the plan should have been personalized to address R1’s specific needs.  Staff should have regularly evaluated how well the plan’s interventions were working, but, for them to do that, the plan had to have specific parameters and time frames.  If the goals were not met within the identified time frames, facility staff (including the dietary manager and the interdisciplinary team) should have intervened and modified the plan to assist the resident in meeting his goals.  CMS Ex. 12 at 3, 4 (Voss Decl. ¶¶ 7, 9); see CMS Ex. 8 at 7.

Staff failures to follow facility policies and to implement care plan interventions.
The record shows that staff were not consistently implementing R1’s care plan directives or following facility policies.  Failing to follow a resident’s care plan presents one of “the clearest cases of failure to meet” the quality-of-care regulation.  Spring Meadows Health Care Ctr., DAB No. 1966 at 17 (2005); see Kenton Healthcare, LLC, DAB No. 2186 (2008); St. Catherine’s Care Ctr. of Findlay, Inc., DAB No. 1964 at 13 n.9 (2005).  Failing to comply with its own policies supports the finding that the facility was not acting within the standard of care and was not in substantial compliance with the regulations.  Heritage House of Marshall Health & Rehab., DAB No. 3035 at 10-11 (2021); Emery Cnty. Care & Rehab. Ctr., DAB No. 3006 at 11 (2020) (explaining 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”); Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013); Life Care Ctr. of Bardstown, DAB No. 2233 at 21-22 (2009); The Laurels at Forest Glenn, DAB No. 2182 at 18 (2008).

Initially, staff more or less followed the facility’s general policy to weigh the resident upon admission and then weekly for four weeks (CMS Ex. 8 at 1).  However, they disregarded the registered dietician’s July 17 recommendation that he be weighed weekly (CMS Ex. 3 at 36), his care plan instruction requiring them to follow the dietician’s

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recommendations (CMS Ex. 3 at 201), and the facility’s more specific policy requiring staff to weigh “at least weekly” residents with significant weight changes.  CMS Ex. 8 at 2; see CMS Ex. 12 at 5 (Voss Decl. ¶ 11) (concurring with the requirement that residents at risk of weight loss, such as R1, should be weighed at least weekly until their weight stabilizes).⁴

R1’s care plan directed the facility to provide the resident with his preferred foods.  CMS Ex. 3 at 178.  Respecting a resident’s food preferences helps to prevent weight loss.  CMS Ex. 13 at 7 (Muller Decl. ¶ 21).  That R1 wasn’t eating the food offered suggests that he did not like it.  In fact, he did not.  He complained that he had never eaten these foods before.  He complained that “when he puts food in his mouth,” it does not taste like food.  He said that it “tasted like dead people.”  CMS Ex. 3 at 40; CMS Ex. 12 at 8 (Voss Decl. ¶ 21).  He also said that he was often too cold to eat the cold foods that were offered to him.  He repeatedly asked for pork and beans, pot pies, and real eggs.  CMS Ex. 3 at 35; CMS Ex. 12 at 8 (Voss Decl. ¶ 21); CMS Ex. 13 at 7 (Muller Decl. ¶ 21); see CMS Ex. 11 at 2.

R1’s food preferences were not exotic, expensive, or difficult to obtain.  The facility’s dietician explained that, although the kitchen did not usually stock the items, staff could special order them from the food vendor.  It did not do so, waiting to see if the resident would try the foods served (notwithstanding the well-documented fact that he had tried them and repeatedly refused to eat them).  The facility finally began to offer R1 his food preferences in August.  CMS Ex. 10 at 1.  By that time, he had lost more than 30 additional pounds.  CMS Ex. 3 at 22.

R1’s physician should have been notified of his poor oral intake and his significant weight loss, but the facility provided no documentation that it did so prior to August 7.  CMS Ex. 1 at 2; CMS Ex. 3 at 82-83.

Facility failure to amend R1’s care plan when it proved ineffective.  By July 12, 2020, it was apparent that the interventions listed in R1’s care plan (to the extent they were implemented), were not working.  The resident had lost 15.3 pounds, or 6.9% of his body weight in just one week.  CMS Ex. 3 at 22.  The registered dietician conceded that she “probably should have followed up” on R1 after his initial weight loss, but she did not.  CMS Ex. 13 at 4 (Muller Decl. ¶ 10).

The registered dietician also told the surveyors that R1’s food intake did not improve after his July 6-20 weight loss.  During that time, he often ate less than a quarter of his

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meals (“0-25%”).  He refused snacks and healthy shakes.  CMS Ex. 13 at 5 (Muller Decl. ¶ 11).

R1’s Interdisciplinary Team should have been meeting to update the resident’s care plan “to reflect individualized goals and approaches for managing [his] weight change” but it did not.  CMS Ex. 8 at 2; CMS Ex. 12 at 7 (Voss Decl. ¶ 20).

D.  The Facility’s Failure to Meet the Nutritional Needs of Four Other Residents.

Marilyn Hansen was the surveyor who initially went to the facility on August 7, 2020.  CMS Ex. 11 at 1.  She reported to her supervisor, Deborah Clifton, RN, BSN, MSN, PHN, her concerns about R1’s severe weight loss and the “lack of mitigation and appropriate care plans to intervene” as his weight plummeted.  Supervisor Clifton recommended expanding the survey sample to include additional residents, which Surveyor Hansen did, adding four additional residents, whose “weight loss . . . fell below the standard of care for ensuring adequate nutritional intake.”  CMS Ex. 14 at 3 (Clifton Decl. ¶ 6).

Supervisor Clifton also recommended that Surveyor Hansen seek assistance from registered dieticians “to assist with the unique nutrition issues presented from the survey findings.”  Registered dieticians Voss and Muller were added to the survey team.   CMS Ex. 14 at 3 (Clifton Decl. ¶ 7).

All four of the residents added to the survey sample had experienced rapid, unanticipated weight loss that the facility did not timely address: 

Resident 2 (R2).  R2 was an 85-year-old woman, initially admitted to the facility on February 25, 2015, and readmitted on March 23, 2018.  She suffered from congestive heart failure, hypertension, a bladder disorder, and type 2 diabetes.  She had had a cerebral infarction (stroke).  She had difficulty walking, suffered muscle weakness, and had repeated falls.  CMS Ex. 4 at 1-2.

On July 1, 2020, R2 weighed 157.5 pounds.  CMS Ex. 4 at 3, 18.  On August 7, 2020, she weighed 148.4 pounds.  CMS Ex. 4 at 3, 26.  She lost 9.1 pounds or 5.8% of her body weight in just over a month.  A dietary progress note shows that the resident had been losing weight since May 5, when she weighed 161.2 pounds.  By August 7, her weight was down 12.8 pounds, or 7.9% of her body weight.  The bulk of this loss – 9.1 pounds – occurred between July 1 and August 7.  A dietary/nutritional progress note characterizes her weight loss as “significant.”  CMS Ex. 4 at 4, 22; see CMS Ex. 8 at 1 (policy defining significant weight changes as 5% in one month, 7.5% in three months).

Until August 7, when the survey team arrived, the facility had done nothing to address R2’s weight loss.  In a September 9, 2020 interview with the surveyors, the dietician

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conceded, “It doesn’t look like we . . . updated the care plan for the recent weight loss.”  CMS Ex. 12 at 6 (Voss Decl. ¶ 15).

Review of the record confirms the dietician’s concession.  R2’s care plan was not updated to reflect her weight loss.  Indeed, her plan had not been changed for almost a year, which is especially significant because her earlier plan addressed her obesity.  An entry dated October 15, 2019, identifies potential nutritional problems related to her diabetes and heart failure, and sets as a goal that the resident would not develop complications related to obesity.  She then weighed between 156.8 and 159 pounds.  The interventions were to “explain and reinforce to the resident the importance of maintaining the diet ordered,” encourage the resident to comply, and to explain the consequences of refusal.  The plan notes that the resident chooses not to be on a weight-loss program.  “She stated that she understands the risks and benefits and is content that things remain as they are.”  CMS Ex. 4 at 12-13; see CMS Ex. 4 at 3.

Facility staff finally updated R2’s care plan on August 7 and 8, 2020, identifying a nutrition risk based on her weight loss.  It sets as goals that the resident have no signs or symptoms of dehydration and that she tolerate her diet without chewing difficulty, swallowing difficulty, or GI distress.  CMS Ex. 4 at 14.  The interventions include “monitor for [signs and symptoms] of dehydration; refer to the dietician; diet as ordered; encourage her eating more than 75% of each meal; “Snacks!”; encourage her participation in self-feeding, if appropriate; assist with meals, as needed; offer a substitute if the intake is at or below 75%; supplemental nourishment, as ordered; monitor labs, as available; notify the physician if her weight changes five pounds or more in a month; and encourage compliance with diet restriction.  CMS Ex. 4 at 14.

As with R1, the plan interventions fall short of what was required.  They provide no specific parameters for fluid intake and do not tell staff what to do if parameters are not met.  They include no directions for what to do if the resident does not consume 75% of her meal.  The care plan does not tell staff how long to monitor the resident’s intake before acting.  Interventions such as “Snacks!” and “supplements/nourishment as ordered” provide no details as to when snacks and supplements should be offered.  CMS Ex. 12 at 6 (Voss Decl. ¶¶ 14, 15); see Sheridan, DAB No. 2178 at 37.  It also seems that the facility’s dietician did not participate in developing the plan (hence the instruction to “refer to the dietician”).

Resident 3 (R3).  R3 was a 75-year-old man, admitted to the facility on December 11, 2018.  His diagnoses included arteriosclerotic heart disease, dementia, gastric ulcer, and gastro-esophageal reflux disease.  CMS Ex. 5 at 1-2.

A care plan, initiated on October 21, 2019, indicates that R3 had a general, regular diet with thin liquids.  Its interventions are minimal and include no specific instructions.  It

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generally directs staff to monitor meal intake and provide diet as ordered.  CMS Ex. 5 at 16.

Between July 4 and August 7, 2020, R3 lost 12.6 pounds, 5.7% of his body weight, dropping from 221 pounds to 208.4 pounds in a month.  CMS Ex. 5 at 3.  An August 14, 2020 dietary/nutritional progress note characterizes his weight loss as “significant.”  CMS Ex. 5 at 4, 22; see CMS Ex. 8 at 1 (policy defining significant weight changes as 5% in one month).

An assessment summary, dated August 7, erroneously indicates that R3’s weight loss began on August 7.  CMS Ex. 5 at 7.  In fact, by August 7, he had already lost a significant amount of weight.  A progress note, dated August 10, reflects a “WEIGHT WARNING” (CMS Ex. 5 at 6), but the assessment summary, dated August 8, does not list weight loss as a specific health concern.  CMS Ex. 5 at 7 (responding “Not applicable” when asked to list other health concerns).

Facility staff did not address the problem of R3’s weight loss until August 7 (again, the first day of the survey), when they modified the resident’s care plan.  As with the other residents’ care plans, the changes consisted of general (and inadequate) interventions:  refer to the dietician; diet as ordered; and encourage the resident to eat more than 75% of each meal.  CMS Ex. 5 at 17.

Another entry, also dated August 7, indicates that the resident is COVID positive.  However, its “focus” is confusing:  “Weight gain 9.1 lbs, 4.5% comparison weight 8/7/2020 208.4 lbs.”  CMS Ex. 5 at 18.  The “goal” is even more confusing:  “without:  chewing difficulty – swallowing difficulty – GI distress X 3 months.”  The interventions are similar to the very general instructions found in the other resident plans, and, for the same reasons, they were inadequate:  Snacks; encourage participation in self-feeding, if appropriate, assist with meals, as needed; supplements/nourishment as ordered; monitor labs, as available; notify MD of weight changes “+5#/month.”  CMS Ex. 5 at 18.

In her September 9 interview, the dietician told the surveyors that the nurses developed the August 7 care plan and that she had “missed that [care plan] again.”  She also agreed that there were “not enough interventions” in the care plan to address the resident’s weight loss.  CMS Ex. 13 at 6 (Muller Decl. ¶ 17).  The following day, she was apparently (finally) involved in amending the plan.  CMS Ex. 5 at 22-23.

Resident 4 (R4).  R4 was a 64-year-old man, originally admitted to the facility on July 13, 2018, and readmitted on November 13, 2019.  He had a long list of impairments, including epilepsy, bipolar disorder, muscle weakness, acute respiratory failure with hypoxia, and a generalized anxiety disorder.  He was developmentally disabled, with an abnormal gait.  He had dysphagia oropharyngeal phase, affecting his ability to swallow.   

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He had a gastrostomy, a surgical opening into the stomach from the abdominal wall (for a feeding tube).  CMS Ex. 6 at 1-2.

R4’s care plan, dated November 14, 2019, indicates that R4 then required tube feeding related to his dysphagia.  CMS Ex. 6 at 2, 14-15.  A separate entry, dated November 16, 2019, notes that the resident is “at nutrition risk secondary to risk for aspiration, behavior issues affecting intake, chewing deficit, decreased ability to eat independently, swallowing deficit.”  The plan calls for a “[g]eneral diet for trial feeding.”  CMS Ex. 6 at 16.  The plan’s goal is that the resident have no signs or symptoms of dehydration.  Most of the interventions are dated February 1, 2020, and they generally direct staff to follow orders (diet as ordered, supplements/nourishment as ordered, vitamins/minerals as ordered, protein supplement at med pass, as ordered).  The plan also directs staff to monitor labs, as available, and notify the physician of any weight change equal to or greater than five pounds.  Id.  An intervention, dated April 3, 2020, directs staff to hold the resident’s tube feeding if he consumes orally 50% or more of his meal.  CMS Ex. 6 at 16.

A confusing and undated entry lists as its “focus” R4’s dietary orders:  general diet, mechanical soft texture, nectar-thick consistency, “related to DYSPHAGIA, OROPHARYNGEAL PHASE . . .); GASTROSTOMY STATUS . . .[;] SUPERVISED meals; EQUIPMENT:  notched ‘nosy’ cup, divided plate, NO straws; assist [with] cutting food into bite-size pieces.”  CMS Ex. 6 at 17.  The plan lists two goals.  The first, dated November 20, 2019, says “adhere to diet, as ordered.”  The second goal was initiated and resolved on the same day, November 27, 2019; it says, “will receive nothing by mouth through dietary services.”  Similarly, one of the interventions – “currently working with [speech language pathologist]” – was also initiated and resolved on the same day, November 27. 2019.  A second intervention, initiated February 20, 2020, and resolved April 4, 2020, directs that the resident remain on NPO (nothing by mouth) status.  The remaining interventions are dated April 4, 2020:  monitor meal intake; provide diet as ordered; and provide preferred food if not in conflict with treatment plan.  Id.

Thus, it seems that, as of April 3 or 4, 2020, R4 was able to take his nourishment by mouth.  A care plan entry, dated April 10, 2020, indicates that the resident “requires RNA” (restorative nurse assistant) and a feeding program.⁵ The plan notes that R4 is at risk for aspiration, secondary to his oropharyngeal dysphagia and developmental disability, affecting his ability to follow safe swallowing strategies independently.  The plan’s goals, also dated April 10, are that he will be able to feed himself, with supervision, and that he will “improve in safe self-feeding.”  The interventions listed include:  allow and encourage the resident to feed himself with less assistance; assist the resident with meals, as needed; cue the resident for small bites and liquid sips; monitor

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for dietary intake; monitor for signs and symptoms of aspiration during feeding; monitor for tolerance with food consistency and call the physician if the resident is unable to tolerate diet consistency; review the resident’s feeding status with the RNA; RNA dining at meals to cue the resident for reduced “rate and small sips/bites”; assistance with upright positioning, cutting food into bite-sized pieces, and positioning of specialized cups and utensils; and RNA feeding program as ordered.  CMS Ex. 6 at 19.

In addition to his other issues, which the care plan mentioned, R4 had a history of significant weight gains and losses.  Between July 1 and August 7, 2020, he lost 16.7 pounds, 10% of his body weight; his weight dropped from 167.1 pounds to 150.4.  CMS Ex. 6 at 3, 7.  Yet, until the surveyor arrived at the facility on August 7, his care plan did not even identify him as a nutrition risk, much less develop interventions to address the problem.  See CMS Ex. 6 at 3, 14-22.  During her September 9 interview with the surveyors, the facility’s registered dietician confirmed that the facility should have had a care plan in place to address R4’s dramatically fluctuating weight.  CMS Ex. 13 at 6-7 (Muller Decl. ¶ 18).

On August 7, staff – not including the dietician – amended R4’s care plan to include “resident is at nutrition risk secondary to losses, 16.7 lbs in a month.”  The plan’s goals are listed as:  the resident will have no signs or symptoms of dehydration, and the resident will tolerate his diet without chewing difficulty, swallowing difficulty, or GI distress.  The interventions are similar to the non-specific (and inadequate) interventions listed in the other residents’ plans:  refer to the registered dietician; diet as ordered; encourage more than 75% intake at each meal; encourage participation in self-feeding, if appropriate; assist with meals, as needed; offer substitute if intake is less than or equal to 75%; supplements/nourishment, as ordered; monitor labs, as available; and notify physician if weight changes by over five pounds in a month.  CMS Ex. 6 at 20; see Sheridan, DAB No. 2178 at 37.

Resident 5 (R5).  R5 was an 86-year-old woman, admitted to the facility on November 25, 2013, suffering from cerebrovascular disease, post-polio syndrome, gastro-esophageal reflux disease, macular degeneration, and dementia.  CMS Ex. 7 at 1-2.  Between July 5 and August 7, 2020, she lost 12.4 pounds, or 8.6% of her body weight (from 144 to 131.6 pounds).  CMS Ex. 7 at 7, 30.  A change-of-condition report inaccurately states that the resident’s weight loss began on August 7, 2020.  CMS Ex. 7 at 9.

Again, the facility did not amend the resident’s care plan to address her weight loss until August 7, 2020.  CMS Ex. 7 at 28.  Again, the facility’s dietician did not participate in developing the plan.  In her September 9, 2020 interview, she conceded that she “could have added to the care plan.”  CMS Ex. 13 at 7 (Muller Decl. ¶ 19).

The plan’s focus and goals are virtually identical to those in R4’s care plan:  “resident is at  nutrition risk secondary to weight losses, 12.4 lbs. in a month” and the resident will

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have no signs or symptoms of dehydration; the resident will tolerate her diet without chewing difficulty, swallowing difficulty, or GI distress.  CMS Ex. 7 at 28.  The interventions are the same nonspecific (and inadequate) interventions added to the other residents’ care plans:  diet as ordered; encourage more than 75% intake at each meal; snacks; and supplements/nourishment as ordered.  CMS Ex. 7 at 28.  A nurse’s summary, dated August 9, reports that R5 ate 0-25% of her meals and had declared that she didn’t like the food.  CMS Ex. 7 at 18.  Her care plan was not amended to address that issue.  CMS Ex. 7 at 28.

Thus, the facility did not comply substantially with section 483.25(g).  Facility staff inadequately assessed its residents who had lost significant amounts of weight over short periods of time.  The facility’s registered dietician was not generally involved in or even aware of the nutritional care plans that were developed by nursing staff.  And those non-dieticians drafted similar generic – and inadequate – care plans that did not provide sufficient guidance to ensure that the services provided would promote the plan’s specified objectives.  Staff regularly did not follow the facility’s policies and care plan directions.  When it became apparent that the nutritional care plans were ineffective, facility staff did not follow up.

E.  Petitioner’s Responses.

As a threshold matter, I note that Petitioner makes a lot of assertions but, contrary to my explicit instructions, does not support those assertions with citations to the record.  In my standing order, I directed the parties to cite the exhibit number and page number of any exhibit upon which a party relies.  Standing Order at 3 (¶ 4(c)(1)) (April 7, 2021).  Petitioner has disregarded my instructions.  Except to mention, generally, which of CMS’s exhibits contains an individual resident’s medical records, Petitioner cites to no exhibits; it provides no page numbers.  Petitioner’s failure to comply with my order interferes with the speedy, orderly, fair conduct of these proceedings.  See id. at 7 (¶ 13).

In its closing brief, Petitioner responds to CMS’s complaint about the absence of “appropriate references to the evidence [it] relied on.”  Petitioner apologizes and claims that it “relies on the same evidence proffered by CMS.”  P. Cl. Br. at 1.  This is neither accurate nor helpful.  In fact, Petitioner made (unsupported) factual allegations that CMS not only did not raise, but actively disputes, asserting that those allegations are “unmoored to any of the residents’ treatment records.”  CMS Cl. Br. at 12.

In support of its otherwise unsupported arguments, Petitioner submits one exhibit, the written declaration of Michelle West, RN, who “provided [c]linical and [r]egulatory support” to the facility.  P. Ex. 1 at 2 (West Decl. ¶ 5).  The witness does not claim that she visited the facility, spoke to its residents, or that she interviewed any staff, including the facility’s registered dietician.  She does not claim specialized knowledge in nutrition.  I am not required to accept a witness’s unsupported speculation.  See W. Tex. LTC

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Partners, Inc., DAB No. 2652 at 15 (2015) (holding that unsupported speculation does not even create a “metaphysical doubt,” much less a genuine dispute of material fact).

The West declaration parrots Petitioner’s arguments, and, like Petitioner’s written arguments, is devoid of citations.  And the arguments presented by Petitioner and its witness lack merit.

Resident right to refuse medical treatment.  According to Petitioner, when R1 did not eat what the facility offered, he was exercising his choices and his right to refuse medical treatment.  P. Br. at 3; P. Ex. 1 at 3 (West Decl. ¶ 8).

Petitioner seems to conflate R1’s weight loss with his occasional disinclination to wear a face mask in response to the COVID outbreak.  P. Br. at 7.  According to a July 17, 2020 care plan entry, “every now and then” the resident takes off his face mask.  CMS Ex. 3 at 206.  Nothing suggests that his removing his mask is related to his nutritional issues.  See COVID discussion, below.  Moreover, by July 17, R1 had already lost a substantial amount of weight, and his need for nutritional interventions was well-documented.  CMS Ex. 3 at 35-36.

Nor does any other evidence show that R1 refused treatment related to his nutritional needs.  Even in his advance directive, dated June 22, he agrees to a trial period of artificial nutrition, including feeding tubes, if necessary.  See CMS Ex. 3 at 13.⁶  As the discussion above establishes, nothing in the record suggests that R1 was refusing to eat for any reason other than that he did not like the food that was served to him, an issue that the facility could easily have addressed.

No potential harm.  Petitioner asserts – again without support – that “[t]here was no potential for inadequate nutritional intake resulting in significant health problems or significant harm” to any of the residents who suffered significant weight loss.  “This potential neither existed nor did any harm occur.”  P. Br. at 3.  This is not a serious argument.  After all, following his significant weight loss, R1 was diagnosed with severe malnutrition, a condition that affects the function and recovery of every organ system, including muscle function, cardiorespiratory function, and gastrointestinal function.  CMS Ex. 3 at 78.  Malnutrition affects immunity and wound healing.  Malnourished patients, particularly the elderly, have a higher incidence of complications and mortality rates.  Further, unintentional weight loss, by itself, is associated with significant adverse health outcomes, including increased mortality, decline in activities of daily living or

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physical function, and poorer quality of life.  See John Saunders & Trevor Smith, Malnutrition:  Causes and Consequences, Clin. Med. (Lond), National Library of Medicine (Jan. 18, 2023).  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4951875/.

As Surveyor Voss explains, rapid weight loss can lead to serious complications.  It may indicate that the resident is having difficulty absorbing and digesting food.  Severe weight loss can lead to muscle wasting, the development or delayed healing of pressure ulcers, and a decline in the resident’s ability to perform activities of daily living.  Severe weight loss can affect mental status and cause fatigue.  Once severe weight loss has occurred, it can be difficult to gain the weight back, especially for the elderly.  CMS Ex. 12 at 7 (Voss Decl. ¶ 19).  Hence, the regulation requires that the facility ensure that each resident maintains acceptable parameters of nutritional status, such as usual body weight or desirable body weight range.

Given these very real dangers, a facility’s failing to address adequately a resident’s unexpected weight loss poses the potential for causing more than minimal harm, which puts the facility out of substantial compliance.  42 C.F.R. § 488.301.

The weights the facility recorded were inaccurate.  Petitioner claims that the weights facility staff recorded were not necessarily accurate because some of the scales they used had not been calibrated.  R1 and others were transferred to the facility’s COVID wing.  The scale company vendor could not enter that wing to calibrate the equipment.  P. Br. at 6-7; P. Ex. 1 at 3 (West Decl. ¶ 9).  Because R1 was weighed on an inaccurate scale, according to Petitioner, his weight loss was not as dramatic as his medical records suggest.  When, on August 14, he returned to the general population and was weighed on a properly-calibrated scale, he weighed 196.6 pounds, which shows that the weight recorded on August 7 (187.8 pounds) was not accurate.  CMS Ex. 3 at 22.

If, in fact, facility staff were weighing these vulnerable residents on what they knew were unreliable scales, it was incumbent upon them to find a way to ensure accurate weights for those residents at risk.  The facility’s policies require that equipment used for weighing residents be maintained and calibrated.  CMS Ex. 8 at 1.  A licensed nurse must weigh the resident, and, if the resident’s weight has changed by 5% or more, the nurse must re-weigh immediately.  The licensed nursed must verify the accuracy of the resident’s weight.  CMS Ex. 8 at 1.  But it seems that the nurses did not even note that the weights they recorded were questionable.  They simply wrote them down and pretended they were accurate (although, as we have seen, they did not then act on the dramatic results).

Putting aside Petitioner’s disturbing admission that facility staff willfully recorded untrustworthy weights into the resident records without informing the residents, their responsible parties, physicians, or the state agency, the undisputed evidence shows that R1 nevertheless lost a disturbing amount of weight in a short time.  Even accepting that

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August 7 weight (187.8 pounds) was inaccurate, R1’s weight dropped from 207.9 pounds to 196.6 pounds between July 19 and August 7; he lost 11.3 pounds or 5.4% of his body weight, in three weeks.  Moreover, on July 6, 2020, he weighed 221.6 pounds; less than two months later, his weight was down to 192.4 pounds, a loss of 29.2 pounds (13.2% of his body weight).  CMS Ex. 3 at 22.  Even accepting Petitioner’s claims that staff reported an inaccurate weight on August 7, R1 was still losing weight at an alarming rate – almost double what the facility’s policy considered significant.  CMS Ex. 8 at 1.

It’s all COVID’s fault.  Petitioner also blames the COVID pandemic for its failure to address its residents’ significant losses of weight: 

Here, the world was literally seized by the global COVID pandemic.  The federal government, state governments, state and local Health Departments, and County governments all rose to the challenge of responding to the shifting scientific knowledge about the virus.  This had the unintended consequence of creating a panoply of regulations, restrictions, guidance and directives for skilled nursing facilities to respond to in the moment, and adapt to as those regulations and directives evolved and changed.

P. Br. at 3.  This seems like an argument drafted for a different case.  COVID simply does not excuse every regulatory violation.  The quality-of-care regulation, including its nutritional status subpart, was not newly-created in response to the COVID epidemic.  The requirement that facilities ensure that residents maintain acceptable parameters of nutritional status is long-standing.

Moreover, Petitioner’s effort to blame COVID for its substantial noncompliance with the quality-of-care regulation fails for three reasons:  1) the facility’s deficiencies predated R1’s (and other residents’) contracting COVID; 2) R1’s medical record establishes that he experienced no loss of appetite or other gastro-intestinal symptoms related to COVID; and 3) that a resident was diagnosed with COVID does not excuse the facility from its obligation to ensure that the resident maintains acceptable parameters for nutritional status.  If anything, facilities should have been more vigilant in ensuring that residents suffering from COVID were properly nourished.

First, by the time R1 was diagnosed with COVID, he had already lost significant weight.  In six days, between July 6 and July 12, he lost more than 15 pounds.  CMS Ex. 3 at 22.  He was not diagnosed with COVID until two weeks later, on July 31, 2020.  CMS Ex. 3 at 86-87.⁷

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Second, no evidence suggests that R1’s loss of appetite or his weight loss was related to his COVID diagnosis.  In fact, staff reported that he experienced no signs or symptoms of COVID.  CMS Ex. 3 at 85-87.  According to R1’s medical records, his “severe malnutrition” was related to his poor appetite; his assessment does not suggest that his diagnosis was related to his contracting COVID.  CMS Ex. 3 at 78.

Third, as CMS points out, a COVID diagnosis does not excuse the facility from providing nutrition and hydration services and care.  Even assuming that other, non-nutritive factors affect a resident’s weight loss, that fact alone does not establish the facility’s substantial compliance.  A facility must “do more than posit a cause for significant unplanned weight loss in order to demonstrate substantial compliance” with the assisted nutrition regulation; it must “prove that the weight loss was unavoidable.”  Carrington, DAB No. 2321 at 11, citing The Windsor House, DAB No. 1942 at 17-19.  To do so, the facility must show that the weight loss occurred “despite adequate and timely steps to ensure that the resident received adequate nutrition.”  Carrington at 11, citing The Windsor House at 23.  These steps include “assessing the resident for risks to her nutritional status, implementing appropriate interventions based on the assessment’s findings, and monitoring the efficacy of those interventions.”  Carrington at 11-12, citing The Windsor House at 23-34.

The evidence establishes that the facility did not take “adequate and timely steps to ensure that the resident received adequate nutrition,” which put the facility out of substantial compliance with section 483.25(g).

2. The penalty imposed is reasonable.

Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case, April 1, 2021.  CMS Ex. 18; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).  CMS imposed a penalty of $10,605 per-instance, which is in the low-to-mid range for per-instance penalties ($2,233 to $22,320).  42 C.F.R. §§ 488.408(d), 488.438; 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2879 (Jan.17, 2020).  Considering what CMS might have imposed – a comparable per-day penalty for multiple days of substantial noncompliance – this penalty is modest.  See Plum City Care Ctr., DAB No. 2272 at 18-19 (2009) (observing that even the maximum per-instance CMP can be “a modest penalty when compared to what CMS might have imposed.”).⁸

To determine whether the CMP is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance, including repeat deficiencies; 2) the facility’s financial condition; 3) factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for

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resident care, comfort or safety.  The absence of culpability is not a mitigating factor.  The factors 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.

The burden is on the facility to demonstrate that a reduction is necessary to make the CMP amount reasonable.  Heritage Plaza Nursing Ctr., DAB No. 2829 at 22 (2017). Here, Petitioner has not met that burden.  Except to argue that it was in substantial compliance, so no penalty should be imposed, Petitioner has not challenged the amount of the penalty as unreasonable.

Conclusion

The facility was not in substantial compliance with 42 C.F.R. § 483.25(g)(1)-(3), and the penalty imposed – $10,605 per instance – is reasonable.

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Endnotes

¹ My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision.

² The regulations governing long-term care facilities were revised in October 2016, effective November 28, 2016. The quality-of-care regulation, 42 C.F.R. § 483.25, was reconfigured, and the subsection governing assisted nutrition was moved from section 483.25(i) (Tag F325) to 483.25(g) (Tag F692). 81 Fed. Reg. 68,688, 68,860-68,861 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (July 13, 2017). The changes do not alter the validity of decisions that predate the revision. Although the revised regulation is more comprehensive and detailed, the basic requirements for assisted nutrition remain the same.

³ Difficulty swallowing also increases the risk for aspiration pneumonia (a lung infection that develops after a resident aspirates food, liquid, or vomit into his lungs). CMS Ex. 12 at 4 (Voss Decl. ¶ 8).

⁴ “Assessment summaries,” dated July 25, August 1, and August 5, 2020, specifically call for the resident’s weight along with his vital signs. However, staff did not record his weight. CMS Ex. 3 at 84, 85, 89.

⁵ A restorative nurse assistant is a nurse aide who has been trained in specific therapeutic techniques, including feeding techniques.

⁶ In this regard, the resident’s plan is confusing and seemingly inconsistent. It includes a June 22, 2020 entry describing his advanced care directives. On the one hand, it says “no tube feeding at this time per resident choice”; but it also says “TRIAL PERIOD OF ARTIFICIAL NUTRITION, INCLUDING FEEDING TUBES.” CMS Ex. 3 at 189 (emphasis in original).

⁷ Of course, we do not know exactly how much weight R1 lost before he contracted COVID, because staff did not weigh him. 

⁸ The penalty could have been as high as $6,695 per day, starting about the time R1 was admitted to the facility, June 20, 2020. CMS Ex. 3 at 1; see 85 Fed. Reg. 2869, 2879.