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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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Rolling Hills Health Care, |
DATE: September 29, 2005 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Centers for Medicare & Medicaid Services.
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Docket No.C-02-627
Decision No. CR1354 |
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DECISION I decide that Rolling Hills Health Center (Petitioner or facility) was not in substantial compliance with Medicare participation requirements as of the March 21, 2002 survey. I sustain the Centers for Medicare & Medicaid Services' (CMS's) determination to impose a denial of payment for new admissions (DPNA) from April 22, 2002, through June 12, 2002, against Petitioner. I. Background Petitioner is a nursing facility located in Topeka, Kansas, certified to participate in the Medicare and Medicaid programs as a provider of services. On March 21, 2002, surveyors from the Kansas Department of Health and Environment (State survey agency) concluded a survey of Petitioner to determine if Petitioner was in compliance with federal participation requirements. The State surveyors alleged, based on the survey, that Petitioner was not in substantial compliance with one participation requirement. The State survey agency sent Petitioner a notice letter dated April 4, 2002. The State survey agency advised Petitioner that the most serious deficiencies found at the March 21, 2002 survey were isolated deficiencies that constituted actual harm that did not amount to immediate jeopardy. The State survey agency advised Petitioner that, based on the deficiencies cited at the survey and its history of noncompliance from a prior survey, it would not be given an opportunity to correct the deficiencies before remedies were imposed. The letter advised Petitioner that a DPNA would be imposed, effective April 22, 2002. It also stated that Petitioner's provider agreement would be terminated on September 21, 2002, if Petitioner did not attain substantial compliance by that time. The letter further advised Petitioner that, as a matter of law, it would be prohibited from conducting its own nurse aide training and competency evaluation program (NATCEP) for two years. By letter dated July 8, 2002, CMS advised Petitioner that, based on a revisit survey dated June 12, 2002, Petitioner was as of that date in substantial compliance. CMS advised Petitioner that it was removing the DPNA remedy as of June 12, 2002. CMS Exhibit (Ex.) 3. Petitioner timely requested a hearing by an administrative law judge (ALJ) by letter dated June 4, 2002. I convened a hearing in Kansas City, Missouri, on February 9, 2004, and I concluded the hearing on February 10, 2004. At the hearing, I admitted CMS Exs. 1-4 and Petitioner's exhibits (P. Exs.) 1-15 into the record. Hearing Transcript (Tr.) 11-13. Subsequent to the hearing, on May 11, 2004, I received CMS's post-hearing brief (CMS Br.). I received Petitioner's post-hearing brief (P. Br.) on May 12, 2004. On May 24, 2004, I received CMS's reply brief (CMS R. Br.). I received Petitioner's reply brief (P. R. Br.) on May 26, 2004. II. Findings of Fact and Conclusions of Law
III. Issues, Applicable Law, Burden of Proof, and Analysis
The issues in this case are:
Title XVIII (Medicare) and Title XIX (Medicaid) of the Social Security Act (Act) (42 U.S.C. §§ 301-1397jj) set forth requirements for long-term care facilities, both skilled nursing facilities and nursing facilities, participating in the Medicare and Medicaid programs, and authorize the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions. Act, sections 1819, 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Parts 483, 488, 489, and 498. To participate in the Medicare program, a long-term care 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. A facility's noncompliance constitutes immediate jeopardy if it has caused or is likely to cause "serious injury, harm, impairment, or death to a resident." Id. Pursuant to the Act, the Secretary has delegated to CMS and the States the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. The regulations at 42 C.F.R. Part 488 provide that facilities which participate in Medicare may be surveyed on behalf of CMS by State survey agencies in order to ascertain whether the facilities are complying substantially with participation requirements. 42 C.F.R. §§ 488.10-488.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. §§ 488.300-488.335. If a facility is not in substantial compliance with participation requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, which include imposing a DPNA or a civil money penalty. See Act, section 1819(h). In this case, it is unnecessary that I consider the level of seriousness of the deficiency that is at issue in this case beyond deciding whether the alleged deficiency is "substantial." Under applicable regulations, I generally do not have authority to question the level of a deficiency in a case where CMS does not determine to impose a civil money penalty against a facility. 42 C.F.R. § 498.3(b)(14). Consequently, I would find Petitioner not to be complying substantially with a participation requirement if it manifested any deficiency that posed the potential for causing more than minimal harm to residents. And, if more than one deficiency was alleged, I would find that the presence of even one substantial deficiency - without regard to the presence or absence of others and without regard to its actual level of severity - would be sufficient to justify the imposition of remedies against a petitioner, including a DPNA.
When a penalty is proposed and appealed, CMS bears the burden of coming forward with evidence sufficient to establish a prima facie case that the facility failed to comply substantially with federal participation requirements. Petitioner then has the burden of coming forward with evidence sufficient to establish the elements of any affirmative argument or defense, and bears the ultimate burden of persuasion. To prevail, Petitioner must prove, by a preponderance of the evidence, that it was in substantial compliance with the relevant statutory and regulatory provisions. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999); see Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998).
At Tag F325 of the Statement of Deficiencies (SOD) from the March 21, 2002 survey, the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(i)(1). CMS Ex. 1, at 19-25. This regulation, which is entitled "Nutrition," requires that:
42 C.F.R. § 483.25(i)(1). The surveyors set the scope and severity of this alleged deficiency citation at level "G," which meant that it was an isolated incident of actual harm that did not constitute immediate jeopardy to resident health and safety. CMS Ex. 1, at 19. The surveyors alleged that Petitioner failed to meet this requirement for three residents in particular. These residents are identified in the SOD as Residents 402, 563, and 564. Although the SOD also mentions two other residents, Residents 300 and 423, CMS does not rely on these two residents or the references to them in the SOD. See Tr. 39; CMS Br. at 2.
The principal allegations contained in the SOD with respect to Resident 402 are that Petitioner: (1) failed to assess this resident for nutritional risk; (2) failed to provide timely nutritional interventions; and (3) failed to follow the care plan for this resident's eating needs. CMS Ex. 1, at 24. As stated in the SOD, Resident 402 had the following diagnoses in March 2002: dementia, hypothyroidism, psychosis, arthritis, and hard of hearing. CMS Ex. 1, at 23; see CMS Ex. 4, at 138. According to a quarterly assessment dated December 19, 2001, Resident 402 required physical assistance with transfers, locomotion, and eating. Id. The SOD notes that Resident 402's care plan, which was updated March 18, 2002, included these interventions: pureed diet, provide nutritional supplement per orders, allow ample time for meal consumption, offer snack and supplements, assist with eating as needed, and weights per orders. CMS Ex. 1, at 23-24; see CMS Ex. 4, at 148. The SOD stated further that the resident's nutritional risk assessment, dated July 18, 2001, was incomplete and had no score. CMS Ex. 1, at 24; see CMS Ex. 4, at 149. Allegedly, there were no further dietary assessments or notes in the records. CMS Ex. 1, at 24. The review of the facility's snack list revealed that the resident was not on the list. Id. According to the SOD (CMS Ex. 1), the weight records showed the following weights for Resident 402:
CMS Ex. 1, at 24; P. Ex. 12; see CMS Ex. 4, at 139. The SOD alleges that these weights revealed that the resident sustained a significant weight loss of 12% from January 17, 2002 through March 15, 2002. CMS Ex. 1, at 24. The SOD further alleges that the clinical record lacked evidence that the resident's weight loss was reevaluated and additional interventions implemented. The final allegation stated in the SOD with respect to this resident focuses on an incident that the surveyor observed on March 20, 2002, in the restorative dining area. The surveyor observed that a staff person was fully feeding Resident 402 a pureed meal, which appeared to be minimally eaten. After ten minutes, another staff person entered the dining area and pulled the resident's wheelchair from the table without asking staff or the resident if the resident was finished eating. The resident had consumed approximately 5% of the meal and 4 ounces of pudding. CMS Ex. 1, at 24; see CMS Ex. 4, at 140, 149. I conclude that Petitioner was deficient under Tag F325 with respect to its care of Resident 402. CMS established a prima facie case of noncompliance with the requirements of 42 C.F.R. § 483.25(i)(1), which Petitioner did not rebut by a preponderance of the evidence. During the period between January 17, 2002 and March 15, 2002, Resident 402's weight declined from 99.1 to 86.7 pounds, for a net loss of 12.4 pounds (a 12% loss) over a period of approximately two months. CMS Ex. 1, at 24; see CMS Ex. 4, at 139; P. Ex. 12. I agree with CMS that this weight loss is highly indicative of Petitioner's noncompliance with the regulation. Petitioner argues that there is documentation in Resident 402's record that shows that the resident was receiving timely nutritional interventions and was being monitored by the facility staff. Petitioner asserts that the resident's medication record shows that the resident was receiving Novasource four times a day. P. Ex. 13. Petitioner points out that progress notes dated November 1, 2001, December 27, 2001, January 3, 2002, and January 10, 2002, state that the resident was receiving "super cereal," weekly monitoring of her weight, and a pureed diet, which was implemented on January 10, 2002. P. Ex. 14. Petitioner also relies on a resident assessment protocol (RAP) document dated July 11, 2001, which contains the following comments concerning Resident 402's nutritional status: "Res has decreased appetite/fluid intake. Orders for pallative [sic] feedings only. Res has declining wt loss that is unavoidable due to terminal condition." CMS Ex. 4, at 146. This document also notes that the resident "refuses food/fluids frequently" and that staff will offer her fluids. Id. My review of the record shows that, despite her alleged terminal condition, Resident 402 maintained her weight for several months after July 2001 and prior to January 17, 2002. On October 24, 2001, her recorded weight was 96.2 pounds. On November 7, 2001, the resident weighed 95 pounds. See CMS Ex. 4, at 139. Approximately one month later, on December 8, 2001, her recorded weight was 95.8 pounds. In a progress note dated December 27, 2001, a nurse indicated that the resident's weight was 98.9 pounds, and wrote "[w]ill cont. supercereal. Wt. stable & [increasing]. Will DC weekly wts & monitor Q month." P. Ex. 14. The record shows that Resident 402 lost weight and weighed 88.7 pounds on January 2, 2002. P. Ex. 12. According to a progress note dated January 3, 2002, Resident 402 weighed 94.1 pounds on that date. The nurse wrote the following: "[w]ill monitor wt Q week. Cont on supercereal. Will call Dr. Cardona to inform of wt loss." P. Ex. 14. (2) A progress note dated January 10, 2002, indicates that the resident weighed 90.6 pounds. P. Ex. 14. The nurse wrote that the resident had gained 2.2 pounds from her past weight of 88.4 pounds. Her entry also stated "Diet pureed, c supercereal." Id. Between January 17 and January 21, 2002, Resident 402 lost approximately eight pounds. As indicated above, Resident 402 continued to lose more weight, and by March 15, 2002, her weight had dropped to 86.7 pounds. Resident 402's weight loss during the period January 17, 2002 through March 15, 2002, should have triggered dietary evaluations and appropriate interventions by Petitioner's staff to ensure that she maintained acceptable parameters of nutritional status. However, there is nothing in the record to show that Petitioner's staff evaluated the resident during this two-month period and introduced any changes in her diet to address her weight loss. Petitioner has offered no evidence to show what interventions, if any, were implemented to address Resident 402's weight loss during the period January 17, 2002 through March 15, 2002. Nor has Petitioner asserted that any such evidence exists. Petitioner appears to rely primarily on the progress notes mentioned above, dated November 1, 2001, December 27, 2001, January 3, 2002, and January 10, 2002, to show that it was providing adequate interventions to the resident. P. Br. at 19. Petitioner contends further that CMS's witness, Ms. Guffey-Morgan, R.N., testified that the interventions were "indicative of some monitoring and it would be indicative of - that there is something in place at that time." Tr. 54. Ms. Guffey-Morgan also acknowledged that, for the time period between November 2001 and January 10, 2002, the super cereal, which contained extra calories, was an intervention for weight loss. Id. at 55. It is evident that Resident 402's medication record and the progress notes described above show that certain dietary interventions were in place as of early January 2002. Moreover, during the time period covered by the progress notes, her weight was being monitored weekly. This evidence does not, however, demonstrate that Petitioner paid adequate attention to Resident 402's needs during the two-month time period during which she lost 12.4 pounds. At the hearing, Petitioner's Administrator, Mr. Klausman, testified that the facility would have a dietician assess a resident either "annually or with significant change." Tr. 119. When asked how the facility addresses residents who exhibit weight loss, Mr. Klausman stated that staff would first attempt to identify whether the resident's weight loss was avoidable or unavoidable. Tr. 128. He said that staff would look at the resident's "intakes" to determine whether the resident was eating and still losing weight or whether the resident was just not eating. Id. Mr. Klausman also stated that the staff would be "in contact with the [resident's] family as to what interventions they would like." Id. He stated further that interventions would be discussed at skin weight meetings, which are generally held weekly. According to Mr. Klausman, an interdisciplinary team would be involved in determining what interventions to implement. Tr. 129-30. Based on the lack of evidence in the record concerning Resident 402's weight loss during the period January 17, 2002 through March 15, 2002, it is apparent that Petitioner did not carry out the approaches described above by its Administrator. As I have already discussed above, the record is void of any documentation - dietary assessments, skin weight meetings, or interventions agreed upon by an interdisciplinary team - pertaining to Resident 402's weight loss.
Moreover, there is no persuasive evidence that supports Petitioner's claim that Resident 402's weight loss was unavoidable due to a terminal condition. As stated above, Petitioner relies on the RAP document that states that Resident 402 was to have "palliative feedings only" and had "declining wt loss that [was] unavoidable due to terminal condition" (CMS Ex. 4, at 146). However, this assessment document was dated July 11, 2001. Another document, a nutritional risk assessment form dated July 18, 2001, listed the resident's weight at 94.1, but had not been completed and did not have a score. Tr. 28; see CMS Ex. 4, at 149. Petitioner does not dispute that the assessment form had no score, but contends that it was an internal document that was "irrelevant" given the July 11, 2001 orders for palliative feedings only. P. R. Br. at 4. In describing what diagnosis constituted the resident's terminal condition, both Mr. Klausman and Ms. Bagby, R.N., the nurse consultant for Petitioner, opined that it was the resident's dementia with weight loss, and that this was also her qualifying diagnosis for hospice services. Tr. 126, 141-42, 160. Contrary to their testimony, however, Surveyor Guffey-Morgan testified that she did not see anything among Resident 402's diagnoses that would suggest a terminal diagnosis and added that "[d]ementia could be but it's not as it's put, no." Tr. 64. I find that the exhibits in evidence shed no light on whether the resident's terminal diagnosis was based on her dementia. Further, the fact that the resident needed hospice care does not establish that the maintenance of her weight was not possible. It is unclear when exactly the resident was receiving hospice care. According to Mr. Klausman, Petitioner's Administrator, Resident 402 "had been on hospice for several months in 2001 . . . [a]nd then came off." Tr. 126. He also stated that the resident "went back onto hospice" after the survey. Id. Moreover, Ms. Bagby acknowledged that it is possible for residents who receive hospice care to rally and be taken off hospice care and given a "more active form of treatment." Tr. 169. In the case of Resident 402, the record shows that she maintained her weight around 95-96 pounds during October, November, and December 2001. On January 2, 2002, the resident weighed 88.7 pounds, and on January 17, 2002, she weighed 99.1 pounds. Thus, while Resident 402 did experience some weight fluctuation from October 2001 through January 17, 2002, she managed to keep her weight relatively stable for the latter part of 2001, and was even able to gain weight as well. Based on the evidence, I am not persuaded that the resident's weight loss was unavoidable. Finally, Petitioner contends that Resident 402's weight loss may not have been "real" because the scale on her floor was unreliable. Tr. 124-25. Mr. Klausman, Petitioner's Administrator, testified that the scale was giving "inaccurate weights," and "[t]here were some jumps from up and down with several residents." Id. at 125. Mr. Klausman stated that the facility had the scale checked, and was told that there was "a possible six pound up or down problem." He stated that the problem could not be fixed, and the facility had to replace the scale. Id. Mr. Klausman testified that the scale was not replaced during the five-month period between October 24, 2001 and March 15, 2002. Tr. 139. When asked why the facility had not had the suspect scale checked during the five months given the fluctuations, Mr. Klausman explained that there may not have been immediate communication that the scale had a problem, and additionally, there are a "lot of factors when you weigh somebody," such as whether the person was weighed in a wheelchair or was weighed clothed. Tr. 140. He stated that, during the time frame in question, staff tried to identify what was causing the fluctuations and a faulty scale was not the first thing that would have come to mind. Id. It is evident from Mr. Klausman's testimony that, despite being aware that the scale on Resident 402's floor was possibly inaccurate, the staff nevertheless continued to use this scale to weigh Resident 402, as well as other residents, between October 24, 2001 and March 15, 2002. I find that Mr. Klausman offered no persuasive explanation to justify Petitioner's failure to check the scale for five months. Petitioner has offered no exhibits that document when the scale on Resident 402's floor was checked or replaced. Moreover, it is unclear from Mr. Klausman's statements what exactly the facility's approach was to attempt to find out the cause of the weight variations for Resident 402. Petitioner had the duty to track Resident 402's weight with a scale that worked, and had the further duty to then act and undertake any necessary interventions to address her weight loss. There is no evidence that, during the five months that Resident 402 was weighed using the suspect scale, Petitioner's staff took any steps to be certain that an accurate weight was taken. Even assuming that the scale was not reliable, Petitioner was under the obligation to monitor Resident 402's weight loss, pay adequate attention to her nutrition needs, and address her weight loss through further assessments and interventions. The evidence establishes that Petitioner failed to assess Resident 402 during the two-month period when she lost 12.4 pounds, and also failed to implement dietary interventions during this time frame. Petitioner thus failed to ensure that Resident 402 maintained acceptable parameters of nutritional status, and, as a result, Resident 402 suffered actual harm. With respect to CMS's allegation that Petitioner failed to follow Resident 402's care plan with regard to her eating needs, I do not find that this allegation is supported by the preponderance of the evidence. The only evidence presented by CMS concerns an incident that occurred on March 20, 2002, when Resident 402 was eating in the dining area and was taken by a staff person - allegedly abruptly - from the area before she had apparently finished her meal. CMS Ex. 1, at 24; see CMS Ex. 4, at 140, 149; Tr. 31-33, 62-67. CMS alleges that Resident 402's care plan was not followed in that she was not "allow[ed] ample time for meal consumption," nor did she receive "assist[ance] with eating as needed." CMS Ex. 1, at 24. Petitioner contends that Ms. Guffey-Morgan gave inconsistent testimony, calling into question the validity of her observation of Resident 402. P. Br. at 15-16. Petitioner asserts further that Resident 402 may have been sleeping during the meal, and this was the reason she was taken from the dining area without being questioned whether she was finished eating. Id. at 16-17. The evidence Petitioner relies on to support its contention that Resident 402 was sleeping is P. Ex. 15. This document is a signed statement dated March 26, 2002, from the staff person who assisted Resident 402 with her meal on March 20, 2002. The staff person wrote that the resident would not wake up during lunch. She told the state surveyor, who was standing behind her, that she "could not get [Resident 402] to wake up to eat." The staff person wrote that the Director of Nursing (DON) "came over to the table & I stated to her also that [Resident 402] would not wake up to eat." P. Ex. 15. (3) Petitioner notes further that Resident 402's care plan instructed staff to "assure resident is alert and responsive before assisting with eating." Tr. 55. (4) Petitioner argues that, given this care plan directive, the decision to remove a resident from the dining area when he or she appears to be sleeping would be a judgment call within the nurse's discretion. P. Br. at 17-18. Based on the foregoing evidence, I am persuaded that Petitioner has provided a reasonable explanation as to why Resident 402 was removed from the dining area during lunch before she had finished eating. CMS's witness, Ms. Guffey-Morgan, did not deny that the resident's eyes were closed, stating, "Her eyes may have been closed but she was eating what was fed to her, spoon fed. A lot of times people will close their eyes." Tr. 64-65. I find that this testimony supports, rather than rebuts, Petitioner's contention that the resident was sleeping. Moreover, CMS did not challenge Petitioner's claim that the resident was to be alert and responsive before staff assisted with her meals. Therefore, I find that Resident 402 was, more likely than not, sleeping during her meal, and the staff, acting in accordance with the resident's care plan, made a reasonable judgment call to remove her from the dining area. Even if the resident had been capable of continuing to eat her meal, I am satisfied that this incident was clearly de minimis and did not result in actual harm. CMS did not prove a prima facie case as to its allegation that Petitioner failed to follow the resident's care plan for her eating needs.
With respect to Resident 564, the SOD alleges the following: (1) there was no evidence that Petitioner had assessed the resident until she had a 6.29% weight loss; (2) there was no evidence that the dietician re-evaluated the resident during the weight loss; (3) there was no evidence that Petitioner followed its policy and procedure for weight loss; and (4) Petitioner failed to follow the physician's orders for assistive devices with meal intake. CMS Ex. 1, at 21. As stated in the SOD, Resident 564 had the following diagnoses in March 2002: generalized seizures, dementia, and high blood pressure. CMS Ex. 1, at 20; see CMS Ex. 4, at 159. According to a quarterly assessment dated January 9, 2002, the resident had difficulties with short and long term memory and required supervision with eating. CMS Ex. 1, at 20. The surveyor noted that the resident's care plan, which was updated January 16, 2002, lacked evidence that the resident required thickened to honey consistency liquids and interventions for weight loss. Id. According to the SOD, the weight records showed the following weights for Resident 564:
CMS Ex. 1, at 20; see CMS Ex. 4, at 161. The SOD notes that the resident sustained a weight loss of 7.4 pounds, a 6.29% loss in five months. CMS Ex. 1, at 20. The SOD alleges that the clinical record lacked evidence that the dietician had assessed Resident 564 from May 9, 2001 to March 19, 2002, during the period of her weight loss. The SOD also alleges that there was no evidence that interventions were started until February 24, 2002, when an order was received from the physician for a change in consistency of the diet. Id. According to the SOD, there was a physician's order dated February 28, 2002, which ordered a protein supplement for the resident three times a day. Another physician's order dated March 11, 2002, contained an order for "nosey" cups, which are assistive devices for drinking. (5) Id. The SOD notes that the resident's diet card, when reviewed on March 20, 2002, showed that the resident was on a pureed, no-added-salt diet, with honey thick liquids, and use of "nosey" cups. Id. The SOD also notes several observations made by the surveyor on March 18, 19, and 20, 2002. CMS Ex. 1, at 21. On March 18, 2002, at 12:30 p.m., during the noon meal, the surveyor observed the resident to have one "nosey" cup with thickened water. The SOD notes that the resident had thickened juice and milk in regular glasses, and the resident attempted to drink from them. Id.; see CMS Ex. 4, at 165. On March 19, 2002, at 7:45 a.m., during the morning meal, the surveyor observed the resident to have one "nosey" cup with thickened juice in it. The resident had thickened water and milk in regular glasses, and attempted to drink from them with staff assistance. The SOD notes further that the resident drank the eight ounces of the thickened juice from the "nosey" cup, drank none of the milk from the regular glass, and approximately four ounces of the eight ounces of the thickened water from the regular glass. CMS Ex. 1, at 21; see CMS Ex. 4, at 163. On March 19, 2002, at 12:25 p.m., and on March 20, 2002, at 1:05 p.m., the surveyor observed that the resident had no "nosey" cups present during the meal and the resident attempted to drink from regular glasses. Id. I conclude that Petitioner was deficient under Tag F325 with respect to its care of Resident 564. CMS established a prima facie case of noncompliance with the requirements of 42 C.F.R. § 483.25(i)(1), which Petitioner did not rebut by a preponderance of the evidence. The evidence shows that during the period between September 2001 and February 3, 2002, Resident 564's weight declined from 117.6 to 110.2 pounds, for a net loss of 7.4 pounds (a 6.29% loss) over a period of five months. CMS Ex. 1, at 20; see CMS Ex. 4, at 161. Resident 564's weight loss during this period should have triggered dietary assessments and appropriate interventions by Petitioner's staff to ensure that she maintained acceptable parameters of nutritional status. However, there is no evidence that Petitioner's staff assessed the resident during her weight loss over this five-month period. Moreover, Petitioner did not begin any dietary interventions until February 24, 2002, after the resident had already lost 7.4 pounds. Petitioner asserts that Resident 564's weight loss does not meet the criteria contained in the Guidance to Surveyors or the Resident Assessment Instrument (RAI) User's Manual for significant weight loss. P. Br. at 2-4. Petitioner contends also that "there were many examples of this resident being assessed for weight loss." P. Br. at 4. Petitioner points to interdisciplinary progress notes (P. Ex. 3) in the resident's medical record for support that it addressed Resident 564's weight at safety meetings and at a skin/weight meeting. The evidence cited by Petitioner is unpersuasive. An examination of the interdisciplinary progress notes (P. Ex. 3), which are dated January 16, 2002, February 6, 2002, February 27, 2002, and March 7, 2002, reveals scant mention of Resident 564's weight. In the note dated January 16, 2002, Petitioner's staff states, in relevant part, "#10 nutrition - goal met. wt. stable." P. Ex. 3. Staff then notes the resident's percent change in weight as follows: "-2% 30 days, -1% 90 days, +3% 180 days." Id. The resident's current weight is not given. As CMS points out, however, the characterization of the resident's weight as "stable" is contradicted by the other parts of the record that show the resident had lost weight since October 1, 2001. Moreover, from October 1, 2001 to January 3, 2002, the resident lost 7.3 pounds in this 90-day time period, which amounts to a more than 1% change in weight loss, despite what the progress note indicates. The next two progress notes, dated February 6, 2002, and February 27, 2002, were written following safety meetings. P. Ex. 3. The February 6, 2002 progress note states "Re near fall. PA was on, not sounded, stretched taught [sic], blue mat was down. Will cont safety measures." Id. The February 27, 2002 note states "Re: falls of 2/10/02 - Noc shift will do toileting rounds - PA on, Blue mat [down]." Id. It is clear that Petitioner's staff, at these meetings, dealt with the resident's risk for falls, and her actual falls. Contrary to Petitioner's claim, there is nothing in these progress notes from which I can conclude that its staff addressed Resident 564's weight at these meetings. The last progress note, dated March 7, 2002, was written after a skin/weight meeting, and states, "Res shows 4 # wt loss. Current wt 101.4." P. Ex. 3. The entry states further that "[s]taff are in process of [changing] method of weighing. will cont to monitor for more accurate wt. [changes]. Res on pureed diet due to noted decline." Id. I note that this March 7 entry is the only other interdisciplinary progress note, besides the January 16, 2002 note, that makes any mention of Resident 564's weight loss. The foregoing interdisciplinary notes lead me to conclude that Petitioner's staff did not adequately address Resident 564's weight loss. The staff failed to undertake any assessments of the resident as she continued to lose weight in early 2002. By March 7, 2002, the resident weighed 101.4 pounds, a serious decline from her weight of 121.2 pounds on October 1, 2001. CMS's surveyor witness, Ms. Dannels, testified that the resident did not have a significant decline in weight, noting it was about "6.1" percent, but that the unintended weight loss should have triggered interventions. Tr. 74-75; CMS Br. at 4. Ms. Dannels testified that, according to the record, Petitioner's dietician evaluated the resident on May 9, 2001, which was prior to the resident losing weight. Tr. 78. Ms. Dannels stated that, after this entry, there were no further dietician's notes in the resident's chart until March 19, 2002, during the survey. Id. Petitioner does not deny that it failed to have the dietician re-evaluate Resident 564 during her weight loss. Rather, it argues that the regulation does not require such a re-evaluation, that CMS noted that the resident's weight loss was not significant, and that the resident's weight loss did not meet the parameters as defined by either the Guidance to Surveyors or the MDS process. P. Br. at 5-6. Petitioner's witness, Ms. Bagby, a nurse consultant who was working with Petitioner during the survey (Tr. 152, 154-56), testified that, based on the weights noted in the SOD, the dietician would not have been required to do another evaluation of the resident. Tr. 158. It is true that the regulation at 42 C.F.R. § 483.25(i)(1) does not require that a resident be re-evaluated by a dietician. However, what the regulation does require is that a facility ensure that a resident maintains acceptable parameters of nutritional status, unless the resident's clinical condition demonstrates that this is not possible. Here, I find that Petitioner failed to monitor the resident's weight, and failed to implement necessary interventions to address her weight loss and ensure that she maintained acceptable parameters of nutritional status. Petitioner also points to dietary interventions that were implemented in an attempt to show that staff paid adequate attention to the resident's nutrition needs. Petitioner claims that these interventions are evidence that the resident was assessed. According to the record, on February 24, 2002, the resident's physician changed her diet consistency from a mechanical soft diet to a pureed diet since the resident was able to eat the latter. P. Ex. 2; P. Ex. 4, at 2. (6) On February 28, 2002, the physician gave an order for the resident to receive a protein supplement three times a day. P. Ex. 4, at 2; see CMS Ex. 4, at 160. The dietary interventions cited by Petitioner were undertaken in late February 2002. Petitioner offered no evidence that it was providing adequate interventions to address her weight prior to this time. While Ms. Bagby testified that another dietary evaluation would not have been required, she also stated that if a resident's weight continued to decline, possible approaches would be re-weighing and "probably . . . looking at food intake and some other things also." Tr. 157. Therefore, Ms. Bagby's own statement suggests that it would be appropriate to examine a resident's food intake when a resident continues to lose weight. Here, it is evident that Petitioner was remiss in monitoring Resident 564's weight. There is nothing in the record to indicate that, between October 2001 and late February 2002, Resident 564's dietary needs were ever examined and/or adjusted. Furthermore, Petitioner asserts that Resident 564's treating physician, Dr. Mhatre, was aware of the resident's weight loss and had implemented interventions to address it. P. R. Br. at 5. As support for this contention, Petitioner points to a "To Whom It May Concern" letter dated November 6, 2002, written by Dr. Mhatre. P. Ex. 6. The physician wrote, among other things, that "although patient did have minimal weight loss, the weight loss was not significant." Id. He stated that the resident's food intake was "extremely variable" because she has dementia and that her family had "declined for invasive intervention such as tube feeding." Id. Dr. Mhatre further wrote that he had ordered nutritional supplements for the resident, but that sometimes, she did not take them due to her dementia. He stated that "the chart review indicates that the weight loss was not significant at all to warrant any specific intervention at that time." Id. Petitioner also relies on Dr. Mhatre's examination notes, dated December 6, 2001, in which he stated that Resident 564 "does not like to eat, does not like forced feeding. The family wants supportive care, does not want any tube feeding." P. Ex. 1. I am not persuaded by Dr. Mhatre's November 6, 2002 letter. I note that this letter was not written contemporaneously, during the period of Resident 564's weight loss, but was written months later, in November 2002. Dr. Mhatre is vague and fails to give any specific time periods in his letter; therefore, it is questionable whether Dr. Mhatre's discussion of the resident's "minimal weight loss" even refers to the period in question. Assuming that Dr. Mhatre is referring to the period in question, his opinion that Resident 564's weight loss was not significant and did not warrant specific interventions does not adequately address the fact that the resident lost 7.4 pounds over a period of five months. Furthermore, although Dr. Mhatre expresses the opinion that the resident's weight loss was related to her dementia, he does not state that her weight loss was unavoidable. If, as Dr. Mhatre contended, the resident sometimes did not take her nutritional supplements due to her dementia, then it would appear that further measures would have been warranted to address the resident's weight loss and ensure that her nutritional needs were met. There is nothing in his letter that indicates that her dementia was so advanced during the period in question that it was not possible for Petitioner to ensure that the resident maintained acceptable parameters of nutritional status. For the foregoing reasons, I give little weight to Dr. Mhatre's letter. With respect to the allegation concerning Petitioner's failure to use assistive devices, the record shows that Petitioner did not consistently provide Resident 564 with "nosey" cups as ordered by her physician. According to the SOD, Ms. Dannels observed several mealtimes where the facility failed to give liquids using only "nosey" cups to Resident 564. CMS Ex. 1, at 21; see supra p. 25. Ms. Dannels observed that Petitioner gave the resident liquids using a combination of "nosey" cups and regular glasses. On two occasions, on March 19, 2002, and March 20, 2002, she observed that no "nosey" cups were present during the resident's meals, and the resident attempted to drink from regular glasses. CMS Ex. 1, at 21. Ms. Dannels testified that the resident had a physician's order dated March 11, 2002, for the use of a "nosey" cup. Tr. 75, 180. This order also stated that the consistency of liquids should be changed "to honey consistency." CMS Ex. 4, at 160; see Tr. 75. Petitioner offered no evidence to rebut the observations made by Ms. Dannels. Rather, Petitioner argues that Resident 564's physician ordered the "nosey" cup to prevent aspiration, and not to address her weight loss, and thus should not be considered a nutritional intervention. (7) P. Br. at 8-9, P. R. Br. at 6. According to both Petitioner's Administrator, Mr. Klausman, and Ms. Bagby, the "nosey" cup was ordered to prevent Resident 564 from aspirating when drinking. Tr. 121, 159. Mr. Klausman testified that he believed that a "nosey" cup "helps with residents who are having trouble swallowing liquids so that they don't aspirate so the liquid does not go into the lungs, it goes into the esophagus." Tr. 121. He claimed that he spoke to speech therapists that work with the facility, and was told "it's not nutritional that they're -- that's not what they're for." Tr. 136-37. While it is possible that the "nosey" cups were ordered due to aspiration concerns, I find that, regardless of the reasoning behind the physician's order, the fact remains that Petitioner failed to carry out its duty to use "nosey" cups for the resident. Moreover, the "nosey" cup's characterization as a device that assists with swallowing liquids does not mean that it has no connection whatsoever to a resident's nutritional needs. See Tr. 175. There is no dispute that a source of Resident 564's nutrition came in the form of liquids. Thus, for this resident, the "nosey" cup was, as CMS states, "the necessary vessel to transfer certain of Resident 564's sources of nutrition and calories . . . to [her] stomach. CMS R. Br. at 2. Because of Petitioner's failure to use the physician-ordered "nosey" cups consistently, Resident 564 had to attempt to drink out of regular glasses, and thus was often unable to drink all of the liquids provided her at mealtimes. Under these circumstances, it is evident that she did not receive all the nutrition and calories she could have, had she been able to consume all her liquids. I conclude that the evidence establishes that Petitioner failed to ensure that Resident 564 maintained acceptable parameters of nutritional status, in violation of 42 C.F.R. § 483.25(i)(1). Petitioner's failures were substantial and resulted in actual harm to Resident 564.
With respect to Resident 563, the SOD alleges the following: (1) there was no evidence that Petitioner reevaluated the interventions or addressed the resident's weight loss from January 16, 2002 until February 7, 2002, at which time a 6.1% loss occurred; (2) there was no evidence Petitioner followed the facility's weight loss protocol of providing 8 oz. of whole milk at each meal, 4 tsps. of extra fat/day; and (3) Petitioner failed to follow the planned interventions for positioning during meal time. CMS Ex. 1, at 23. As stated in the SOD, Resident 563 had the following diagnoses as of March 2002: dementia, hip fracture, and osteoporosis. CMS Ex. 1, at 21; see CMS Ex. 4, at 21. According to the resident's assessment dated February 20, 2002, she had difficulty with short and long term memory, required extensive assistance with eating, and had a history of pressure ulcers. CMS Ex. 1, at 22. The SOD noted that an updated care plan dated February 27, 2002, listed the following interventions: assist with dining as needed, offer fluids frequently, check for pocketed food after meals. The care plan did not mention that the resident required thickened liquids. According to the weight record, Resident 563 weighed 88.1 pounds on January 16, 2002, and 82.7 pounds in February 2002. The SOD alleged that the resident lost 5.4 pounds in one month, which meant a 6.1% weight loss. Id. The resident's laboratory test results dated January 10, 2002, showed that she had albumin and protein levels that were below the normal range. Id. The SOD also alleges that interdisciplinary notes dated December 27, 2001, showed that the resident was placed on Level 2 of the facility's protocol for weight loss. CMS Ex. 1, at 22. Petitioner's Level 2 protocol called for the following interventions: super cereal at breakfast, power potatoes at lunch, four teaspoons of extra fat/day, eight ounces of whole milk per meal, (8) and a snack three times a day. The SOD noted that the dietary menu card on February 20, 2002, at 4:00 p.m. did not list the extra fat and type of milk required. According to the SOD, on February 7, 2002, the resident's physician ordered that the resident was to receive four ounces of a high protein supplement two times a day, for breakdown. On February 21, 2002, the physician ordered that the resident was to get 60 cc of Novasource four times a day. Id. The SOD alleges further that interdisciplinary notes dated March 7, 2002, contained the following interventions: the resident was to be transferred to a regular chair in the dining room and assessed for eating. The SOD noted that there was no evidence that the dietician reassessed the resident's weight loss until March 18, 2002. The SOD also notes several observations made by the surveyor on March 18, 19, and 20, 2002. CMS Ex. 1, at 22-23. On March 18, 2002, at 12:25 p.m., during the noon meal, the surveyor observed the resident sitting in the wheelchair with the lap buddy on at the dining room table with eight ounces of thickened water and six ounces of thickened milk provided. Id. On March 19, 2002, at 12:25 p.m., during the noon meal, the surveyor observed the resident sitting in her wheelchair with four ounces of thickened juice, four ounces of thickened water, and four ounces of thickened milk offered. On March 19, 2002, at 5:30 p.m., the surveyor observed the resident sitting at the dining room table in her wheelchair. On March 20, 2002, at 7:55 a.m., during breakfast, and at 12:20 p.m., during the noon meal, the surveyor observed the resident sitting at the dining room table in her wheelchair. Id. at 23. I conclude that Petitioner was deficient under Tag F325 with respect to its care of Resident 563. CMS established a prima facie case of noncompliance with the requirements of 42 C.F.R. § 483.25(i)(1), which Petitioner did not rebut by a preponderance of the evidence. According to the record, Petitioner placed Resident 563 on Level 2 of its protocol for weight loss on December 27, 2001. CMS Ex. 1, at 22; see CMS Ex. 4, at 24; see Tr. 86. Petitioner's Level 2 protocol, which states that it is for "heavy weight loss," called for the following interventions: super cereal at breakfast, power potatoes at lunch, four teaspoons of extra fat/day, eight ounces of whole milk per meal, and a snack three times a day. CMS Ex. 1, at 22; P. Ex. 9, at 1; CMS Ex. 4, at 277. Between January 16, 2002 and around February 7, 2002, Resident 563's weight declined from 88.1 pounds to 82.7 pounds, for a loss of 5.4 pounds (a 6.1% loss) over approximately three weeks. (9) CMS Ex. 1, at 20; see CMS Ex. 4, at 24. Resident 563's weight loss during this period should have caused Petitioner's staff to assess the resident and re-evaluate the interventions currently in place to ensure that she maintained acceptable parameters of nutritional status. However, according to the record, Petitioner's staff failed to implement any other nutritional interventions for the resident prior to February 7, 2002. On February 7, 2002, the resident's physician ordered that she receive four ounces of a high protein supplement twice a day, and a liquid multivitamin daily for skin breakdown. P. Ex. 8, at 1; see P. Ex. 7. On February 8, 2002, the physician ordered that the resident's diet be changed to a pureed diet because the resident was not keeping her dentures in. P. Ex. 8. Another order dated February 21, 2002, states that the resident may receive 60 cc's of Novasource four times a day "for nutritional support." The order states further that the resident "may have diet consistency mech soft or pureed as res tolerates." P. Ex. 8, at 2; see P. Ex. 7. Moreover, the record shows that Petitioner failed to consistently provide the resident with eight ounces of whole milk per meal, as required under Petitioner's own weight loss protocol. During the noon meals on March 18 and 19, 2002, the surveyor observed that the resident received less than eight ounces of whole milk. Tr. 83; see CMS Ex. 4, at 28, 30. Petitioner does not deny the surveyor's observations. Instead, Petitioner puts forth several arguments to explain its failure to meet the facility's protocol requirement. Petitioner contends that the resident never consumed the less than eight ounces provided. Petitioner asserts, citing Ms. Dannel's testimony, that the resident drank only two ounces of milk during one of the observed meals, and approximately four ounces at the other meal. P. Br. at 11; see P. R. Br. at 7; see Tr. 94-95. Petitioner also relies on the testimony of its Administrator, Mr. Klausman, who stated that residents are sometimes poured smaller servings of a beverage if "they don't think they can get it [eight ounces] all down" (Tr. 122), and then receive refills from staff. P. Br. at 11. (10) Petitioner contends that because the resident never drank more than four ounces of milk, she did not require refills to meet the eight ounces required by the protocol. Lastly, according to Mr. Klausman, the protocol was not "policy or procedure" but only "guidance" and is not followed "in every single instance." Tr. 123. Petitioner contends that it was "individualizing the protocol" for the resident. P. Br. at 11. I am not persuaded by Petitioner's explanations. Petitioner states that it "had identified a concern with [Resident 563's] weight" (P. Br. at 7) and had placed the resident on Level 2 of its own weight loss protocol to address this issue. I note that Level 2 establishes interventions (i.e., supplements) to be given to those with "heavy weight loss." P. Ex. 9. Providing Resident 563 with eight ounces of whole milk per meal was one of these Level 2 interventions. The fact that the resident did not drink more than four ounces of milk at a meal is beside the point. Because the protocol was intended to increase Resident 563's daily caloric intake, it was Petitioner's responsibility to ensure that all, not some, of the Level 2 interventions were implemented for her. Although Petitioner states that it was "individualizing the protocol" for the resident, it never explains in what way the protocol was "individualized" for her. Moreover, Petitioner does not refer to anything in the record that would indicate that Resident 563 was not to receive the Level 2 interventions as written in its own facility documentation. Petitioner's failure to consistently provide the resident with eight ounces of milk per meal meant that, at those meals, the resident received an inadequate amount of calories. The evidence demonstrates that Petitioner did not implement all planned interventions to address the resident's weight loss and, thus, failed to ensure that the resident maintained acceptable parameters of nutritional status. With respect to the allegation that Resident 563 was not transferred to a regular chair for meals, I find that the evidence establishes that Petitioner's staff failed to carry out this intervention. Interdisciplinary notes dated March 7, 2002, directed that the resident be transferred to a regular chair in the dining room and that she was to be assessed for eating. CMS Ex. 4, at 24. At five different mealtimes, the surveyor observed that the resident was sitting in her wheelchair at the dining room table. See CMS Ex. 1, at 22-23. The surveyor also observed that the resident had a lap buddy on during one of the meals. (11) Petitioner does not dispute that Resident 563 was not transferred to a regular chair at the observed mealtimes. However, Petitioner argues that the resident did not have a physician's order to be transferred, and contends that the intervention was instead a "suggested intervention." P. R. Br. at 4. According to Ms. Bagby, the intervention was a "nursing approach," and not something that would necessarily be implemented at every meal. P. Br. at 13; P. R. Br. at 8; See Tr. 162. Petitioner contends further that the resident was a "known safety risk" (P. R. Br. at 8) and was left in her wheelchair during meals, with a lap buddy on, due to safety concerns. I find Ms. Bagby's testimony unpersuasive. Ms. Bagby was essentially an outside consultant who worked with Petitioner's former DON during the survey. Tr. 154-55. She was not present when Petitioner's staff wrote the March 7, 2002 interdisciplinary note containing the intervention. There is no evidence that Ms. Bagby discussed this interdisciplinary note or the intervention itself with Petitioner's staff. In offering her testimony, which was self-serving and speculative, Ms. Bagby pointed to nothing in Resident 563's medical record to support her claim that the intervention was not meant to be implemented at every meal. Moreover, although there may have been concerns for the resident's safety, Petitioner offered no persuasive evidence to show that the safety issues were to take precedence over other interventions relating to her dietary regimen. While the surveyor, Ms. Dannels, acknowledged that the lap buddy was used for safety reasons for Resident 563 (Tr. 102), she also testified that the necessity for a lap buddy would not "outweigh the order to reposition her for meals in a regular chair." Tr. 110. Ms. Dannels stated that Petitioner should be attentive to carrying out both interventions. Id. It is undisputed that the intervention to transfer to a regular chair, as written in the March 7, 2002 interdisciplinary note, does not mention that its implementation would be limited or dependent on other factors, such as safety. Thus, it would appear that Petitioner's staff contemplated that the resident would be transferred from her wheelchair to a regular chair at every meal. Petitioner has offered no evidence that establishes to my satisfaction that the resident's safety would have been compromised by her sitting in a regular chair at mealtimes. Contrary to Petitioner's arguments, I find that the evidence establishes that Petitioner did not implement all planned interventions under Resident 563's dietary regimen. I conclude that Petitioner failed to ensure that the resident maintained acceptable parameters of nutritional status, in violation of 42 C.F.R. § 483.25(i)(1). Petitioner's failures resulted in actual harm to Resident 563.
Under 42 C.F.R. § 488.406, a DPNA is one of the enforcement remedies that is available to CMS in the event of a facility's failure to comply substantially with participation requirements. See Act, section 1819(h). I have found that Petitioner was not in substantial compliance with a Medicare participation requirement as of the March 21, 2002 survey and, thus, there is a basis for the imposition of remedies against Petitioner. Based on Petitioner's noncompliance, I find that CMS is authorized to impose the remedy of DPNA against Petitioner from April 22, 2002 through June 12, 2002. Finally, the loss of Petitioner's NATCEP was mandatory by operation of law, triggered by the imposition of the DPNA. By regulation, the State survey agency had no choice but to deny or withdraw approval for a period of two years after the March 21, 2002 survey. 42 C.F.R. § 483.151(b)(2) and (e)(1). IV. Conclusion In view of the foregoing, I uphold CMS's determination to impose a DPNA against Petitioner for failing to comply substantially with a Medicare participation requirement. |
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Richard J. Smith Administrative Law Judge |
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1. The SOD alleged that the resident lost 5.4 pounds in one month. CMS Ex. 1, at 22. However, the period between January 16, 2002 and February 7, 2002, covers 23 days. 2. I note that the resident's weight fluctuated between December 27, 2001 and January 3, 2002; however, neither Petitioner nor CMS explained this variability. Petitioner does contend that there may have been a problem with the scale on Resident 402's floor (see infra p. 21); however, it is unknown whether that scale was used for the weights listed in the progress notes. In any event, in looking at the overall picture of Resident 402's weights, I find that these weight fluctuations do not change the fact that her weight trended downward and declined significantly. 3. Petitioner's witness, Ms. Bagby, was out of the building on March 20, 2002. Ms. Bagby testified that she had a conversation with the DON regarding this incident. Ms. Bagby stated that the DON made the decision to remove Resident 402 from the dining room out of concern for the resident's dignity. Tr. 166-67. 4. Neither Petitioner nor CMS submitted Resident 402's March 18, 2002 care plan as an exhibit. 5. A "nosey" cup is a type of cup used to assist a resident with the intake of liquids. See Tr. 75, 158-59, 180. It has a slot cut out for a person's nose. Tr. 75. Ms. Dannels testified that the cup is sometimes used with residents who have a limited range of neck motion so that they do not have to tilt their heads back in order to drink. Id. Ms. Bagby testified that a "nosey" cup may be used if a resident had a problem with potential aspiration from swallowing. Tr. 159. 6. The nursing notes dated February 24, 2002, state that the resident was "still not eating. choked on mechanical soft diet. Tried pureed diet, able to eat this well." P. Ex. 2. 7. Neither party submitted the actual physician's order of March 11, 2002, into evidence. 8. I note that the SOD incorrectly stated that the protocol called for eight ounces of whole milk per day. The protocol, which is P. Ex. 9, lists "Whole milk - 8 oz./meal" as one of the interventions under Level 2. 9. The SOD alleged that the resident lost 5.4 pounds in one month. CMS Ex. 1, at 22. However, the period between January 16, 2002 and February 7, 2002, covers 23 days. 10. Mr. Klausman also testified that, at the time, staff were using four-ounce cups to meet any residents' eight-ounce beverage requirements because they had run out of eight-ounce cups. Tr. 121-22; P. Ex. 10. 11. The surveyor, Ms. Dannels, testified that a lap buddy is a safety device used to assist with positioning and is also used to help keep a resident in the wheelchair. Tr. 102, 110. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||