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CASE | DECISION |JUDGE | FOOTNOTES

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
IN THE CASE OF  


SUBJECT:

Woodland Village Nursing Center,

Petitioner,

DATE: November 16, 2005
                                          
             - v -

 

Centers for Medicare & Medicaid Services.

 

Docket No.C-03-022
Decision No. CR1367
DECISION
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DECISION

Petitioner, Woodland Village Nursing Center, violated 42 C.F.R. � 483.25(j) (1) with respect to one resident as found by a survey of the facility completed on July 16, 2002. Petitioner did not violate 42 C.F.R. � 483.25(d)(2) as alleged by the Centers for Medicare & Medicaid Services (CMS). There is a basis for the imposition of a civil money penalty (CMP) and a CMP of $100 per day for the period July 16, 2002 through September 19, 2002, a total CMP of $6,500, is reasonable.

I. Background

Petitioner, which is located in Diamondhead, Mississippi, was subject to a complaint investigation by the Mississippi Department of Health (the state agency), which ended on July 16, 2002. The state agency determined that Petitioner was not in substantial compliance with Medicare and Medicaid participation requirements and recommended that CMS impose remedies. CMS advised Petitioner by letter dated August 5, 2002, that it concurred with the state agency findings and recommendations and that it intended to impose the following remedies: a CMP of $600 per day effective July 16, 2002 until Petitioner achieved substantial compliance; a denial of payment for new admissions (DPNA) effective September 24, 2002 until Petitioner achieved substantial compliance; and termination effective January 16, 2003, if substantial compliance was not achieved before that date.

The state agency conducted a revisit of Petitioner's facility on September 20, 2002, and it was determined that the facility was again in substantial compliance with participation requirements. CMS notified Petitioner by letter dated October 7, 2002, that because it had achieved compliance, the DPNA and termination remedies were not to be effectuated and were rescinded. However, CMS advised that the CMP of $600 per day for the period July 16 through September 19, 2002, would be imposed.

Petitioner requested a hearing before an administrative law judge (ALJ) on October 3, 2002. The case was assigned to me for hearing and decision on November 7, 2002. The case was set for hearing several times but on January 20, 2004, the parties jointly moved that the case be decided on the written record and Petitioner waived the right to have an oral hearing. The parties filed motions for a decision on the documentary record and opening and reply briefs. CMS submitted exhibits (CMS Exs.) 1 through 24 with its exhibit and witness lists on December 9, 2002. Petitioner submitted exhibits (P. Exs.) 1 through 19 with its exhibit and witness lists on December 23, 2002. Petitioner objected to the admissibility of CMS Ex. 18, pages 9 through 24, on grounds that the document was not properly authenticated and was hearsay. CMS withdrew pages 9 through 24 of CMS Ex. 18, and Petitioner's objection is moot. There were no other objections to the admissibility of any evidence. Accordingly, CMS exhibits 1 through 17, 18 (pages 1 through 8 only), and 19 through 24 and Petitioner's exhibits 1 through 19 are admitted.

II. Discussion

A. Findings of Fact

The following findings of fact are based upon the exhibits admitted. Citations to exhibits related to each finding of fact may be found in the analysis section of this decision if not indicated here.

1. Resident 6, the subject of the alleged violation of 42 C.F.R. � 483.25(d)(2), was not incontinent of bladder.

2. Petitioner did not follow its policy regarding hydration for Residents 5, 6, and 7.

3. The evidence does not show that Residents 5, 6, and 7 had insufficient fluid intake.

4. During the period May 24, 2002 through June 9, 2002, Resident 4 consumed less liquid than recommended by Petitioner's registered dietician.

5. On June 9, 2002, Resident 4 was admitted to the hospital from Petitioner's facility and she was suffering from a urinary tract infection (UTI) and dehydration.

6. Petitioner knew that Resident 4 was at risk for dehydration, Petitioner had care planned for the risk, and Petitioner's records reflect decreased consumption of liquids by Resident 4 prior to her hospitalization on June 9, 2002.

7. Resident 4 suffered actual harm by becoming dehydrated.

B. Conclusions of Law

Petitioner's request for hearing was timely and I have jurisdiction to review all alleged deficiencies that are alleged to be the basis for the imposition of an enforcement remedy.

1. Petitioner timely requested a hearing and I have jurisdiction.

2. Section 483.25(d)(2) of Title 42 C.F.R. does not apply in the case of a resident who is not incontinent of bladder.

3. CMS has failed to make a prima facie showing of a violation of 42 C.F.R. � 483.25(d)(2) (Tag F 316).

4. Section 483.25(j) of Title 42 C.F.R. requires that a facility provide residents with sufficient fluid intake to maintain proper hydration and health.

5. To make a prima facie showing of a violation of 42 C.F.R. � 483.25(j), CMS must show that a facility did not provide a resident proper hydration and such showing may be by evidence of signs and symptoms of insufficient fluid intake, abnormal laboratory values, or a diagnosis of dehydration.

6. CMS did not make a prima facie showing of a violation of 42 C.F.R. � 483.25(j) with respect to Residents 5, 6, and 7, because there is no evidence of insufficient fluid intake, abnormal laboratory values, or a diagnosis of dehydration.

7. Petitioner violated 42 C.F.R. � 483.25(j) (Tag F 327) with respect to Resident 4 but not with respect to Residents 5, 6, and 7.

8. The proposed CMP of $600 per day for the period July 16, 2002 through September 19, 2002 is not reasonable, but a CMP of $100 per day for that period is reasonable.

C. Issues

The issues in this case are:

Whether there is a basis for the imposition of an enforcement remedy; and,

Whether the remedy imposed is reasonable.

The CMS surveyors cited Petitioner with violations of 42 C.F.R. �� 483.20(b) (Tag F 272) (2); 483.20(g)-(h) (Tag F 278); 483.20(k) (Tag F 279); 483.25(d)(2) (Tag F 316), and 483.25(j) (Tag F 327) based upon the survey ended July 16, 2002. However, the alleged violations of Tags F 272, 278, and 279 were cited as being at a scope and severity level of C, a level that is not sufficient to be the basis for the imposition of an enforcement remedy, (3) and those alleged deficiencies are not at issue in this appeal pursuant to 42 C.F.R. � 498.3(b)(13).

D. Applicable Law

Petitioner is a long-term care facility participating in the federal Medicare program as a skilled nursing facility (SNF) and in the state Medicaid program as a nursing facility (NF). The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Social Security Act (Act) and at 42 C.F.R. Part 483. Sections 1819 and 1919 of the Act vest the Secretary of Health and Human Services (Secretary) with authority to impose CMPs against a long-term care facility for failure to comply substantially with federal participation requirements.

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. Facilities that participate in Medicare may be surveyed on behalf of CMS by state survey agencies in order to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. �� 488.10-488.28, 488.300-488.335. Pursuant to 42 C.F.R. Part 488, CMS may impose a per instance or per day CMP against a long-term care facility when a state survey agency concludes that the facility is not complying substantially with federal participation requirements. 42 C.F.R. �� 488.406; 488.408; 488.430. The regulations in 42 C.F.R. Part 488 also give CMS a number of other remedies that can be imposed if a facility is not in compliance with Medicare requirements.

The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties. 42 C.F.R. �� 488.408, 488.438. The upper range of CMP, of from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a facility's residents, and in some circumstances, for repeated deficiencies. 42 C.F.R. �� 488.438(a)(1)(i), (d)(2). The lower range of CMP, of from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy but either cause actual harm to residents, or cause no actual harm, but have the potential for causing more than minimal harm. 42 C.F.R. � 488.438(a)(1)(ii).

The Act and regulations make a hearing before an ALJ available to a long-term care facility against which CMS has determined to impose a CMP. Act, section 1128A(c)(2); 42 C.F.R. �� 488.408(g), 498.3(b)(13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F.2d 678 (8th Cir. 1991). A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. � 488.408(g)(1); see also 42 C.F.R. �� 488.330(e) and 498.3. However, the choice of remedies by CMS or the factors CMS considered when choosing remedies are not subject to review. 42 C.F.R. � 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the CMP that could be collected by CMS or impact upon the facility's nurse aide training program. 42 C.F.R. �� 498.3(b)(14), (d)(10)(i). CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. � 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6th Cir. 2003). The Departmental Appeals Board (the Board) has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Koester Pavilion, DAB No. 1750, at 8 (2000). Review of a CMP by an ALJ is governed by 42 C.F.R. � 488.438(e).

When a penalty is proposed and appealed, CMS must make a prima facie case that the facility has failed to comply substantially with federal participation requirements. "Prima facie" means that the evidence is "[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted." Black's Law Dictionary 1228 (8th ed. 2004). See also, Hillman Rehabilitation Center, DAB No. 1611, at 8 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999). To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. 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); Hillman Rehabilitation Center, DAB No. 1611.

E. Analysis

There are two alleged deficiencies at issue, the alleged violation of 42 C.F.R. � 483.25(d)(2) involving Resident 6 and the alleged violation of 42 C.F.R. � 483.25(j) involving Residents 4, 5, 6, and 7. The general quality of care requirement for long-term care facilities is established by 42 C.F.R. � 483.25, which provides that "[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care." The regulation also establishes specific quality of care requirements, which Petitioner allegedly violated in this case.

1. CMS has failed to make a prima facie showing of a violation of 42 C.F.R. � 483.25(d)(2) (Tag F 316).

The specific quality of care requirement allegedly violated provides:

(d) Urinary Incontinence. Based on the resident's comprehensive assessment, the facility must ensure that -

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(2) A resident who is incontinent of bladder receives appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible.

42 C.F.R. � 483.25(d)(2). The SOM, Guidance to Surveyors for Tag F 316, at PP-97, indicates that the focus of the provision is upon those residents who have been or should have been identified as being incontinent.

The state agency completed a survey at Petitioner's facility on July 16, 2002. The findings of that survey are recorded in the SOD with that date. CMS Ex. 2. The surveyor alleges generally that Petitioner violated the regulation because it failed to "follow-up on a positive urine culture for Resident #6 who had been treated for a urinary tract infection." Id. at 6-7. More specifically, the surveyor alleges that, according to Resident 6's records, the attending physician ordered Cipro on March 24, 2002, for signs and symptoms of a UTI. Id. at 7. On April 3, 2002, the physician ordered Macrobid, also for a UTI. A new order for Macrobid was made on April 16, 2002, for 10 days, to be followed by a urine culture and sensitivity test after 14 days. Id. Resident 6's records show that a urine sample was collected for testing on April 30, 2002 (P. Ex. 11, at 187), but no laboratory report could be located. Facility staff obtained a copy of the report from the laboratory on July 16, 2002, when the surveyor brought the matter to their attention. The surveyor alleges that there is no evidence that the laboratory report dated May 2, 2002, was obtained by the facility and reported to the treating physician before the survey. CMS Ex. 2, at 7.

During the survey, the surveyor obtained copies of select parts of Petitioner's treatment record for Resident 6 which were admitted as part of CMS Ex. 16. The records the surveyor obtained do not indicate that Resident 6 was assessed as being incontinent of bladder. Petitioner offered additional documents from the resident's treatment record that were admitted as P. Ex. 11. The resident's Admission Nursing Assessment dated March 22, 2002, shows that she was assessed as being continent of bladder. P. Ex. 11, at 42. A risk assessment shows that the resident was repeatedly assessed as continent on admission and again on August 3, 2002, November 25, 2002, and December 12, 2002. Id. at 50. Nurse's Notes from March 22 through 31, 2002, April 1 through 15, 2002, and April 27, 2002, show the resident was continent of bowel and bladder. Id. at 184-85, 190-93. A Doctor's Progress Note from May 6, 2002 shows that Resident 6 experienced nocturia (a need to get up to use the toilet at night), and then on May 27, 2002, she had urge and stress incontinence. Id. at 55. Both the incidence of nocturia and incontinence were after the period at issue in the alleged deficiency. Nurses Daily and Weekly Charting forms from July 2002 show the resident consistently continent of bowel and bladder. Id. at 93-108, 128-30.

Petitioner argues in its brief in support of its motion that CMS has not shown a deficiency because it has not shown that Resident 6 was incontinent of bladder. Petitioner's Brief in Support of its Motion for Judgment on the Record (P. Brief) at 8; Petitioner's Brief in Response (P. Response) at 6. CMS argues that Petitioner's records show that Resident 6 "experienced some period of incontinence," citing the progress note from May 27, 2004 at P. Ex. 11, at 55. CMS Reply Brief (CMS Reply) at 3.

When a remedy is imposed and appealed, CMS must make a prima facie showing that the facility has failed to comply substantially with federal participation requirements. 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); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999). CMS bears the initial burden of producing evidence sufficient to establish a prima facie case for each alleged violation of the regulations. The Board defined the requirements for a prima facie case in the Hillman decision:

HCFA (4) must identify the legal criteria to which it seeks to hold a provider. Moreover, to the extent that a provider challenges HCFA's findings, HCFA must come forward with evidence of the basis for its determination, including the factual findings on which HCFA is relying and, if HCFA has determined that a condition of participation was not met, HCFA's evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

DAB No. 1611, at 11. If a provider appeals an enforcement decision, CMS has the initial burden of showing that its decision to terminate is legally sufficient under the statute and regulations. To make a prima facie case that its decision was legally sufficient in this case, CMS must: (1) identify the statute, regulation or other legal criteria to which it seeks to hold the provider; (2) come forward with evidence upon which it relies for its factual conclusions that are disputed by Petitioner; and (3) show how the deficiencies it found amount to noncompliance that warrants an enforcement remedy. CMS has failed to show that 42 C.F.R. � 483.25(d)(2) was applicable to the case of Resident 6. Thus, CMS has failed to make a prima facie showing of a violation.

I conclude that CMS has failed to make a prima facie showing of a violation of 42 C.F.R. � 483.25(d)(2). In fact, other than one instance of incontinence that did not occur during the period at issue in the alleged deficiency, Resident 6 was always observed to be continent of bladder. Furthermore, the deficiency as written does not allege that Petitioner failed to give appropriate care and treatment to prevent a UTI but, rather, that Petitioner failed to obtain a laboratory report and inform the physician of the laboratory results related to an allegedly existing UTI. The plain language of the regulation clearly makes it applicable to residents who suffer from bladder incontinence. CMS has failed to show that the regulation is applicable to the facts alleged related to Resident 6 and has failed to establish an element of its prima facie case.

2. Petitioner violated 42 C.F.R. � 483.25(j) (Tag F 327).

The specific quality of care requirement allegedly violated provides:

Hydration. The facility must provide each resident with sufficient fluid intake to maintain proper hydration and health.

42 C.F.R. � 483.25(j). The SOM, Guidance to Surveyors for Tag F 327, at PP-109, gives the surveyor probes to use in assessing a facility's compliance with the regulation. The two probes question whether the sampled residents show clinical signs of insufficient fluid intake or abnormal laboratory values, or whether the facility provided residents with adequate fluid intake to maintain proper hydration and health.

The surveyor alleges in the SOD that for residents 4, 5, 6, and 7, Petitioner failed to complete a dehydration risk assessment as scheduled, failed to monitor fluid intake, failed to care plan for problems placing residents at risk for dehydration, and failed to notify physicians as required by facility policy when the residents' fluid intake was less than the facility's registered dietician's recommendations for a period of three consecutive days. CMS Ex. 2, at 7-8. Petitioner argues that none of the actions it allegedly failed to take under its hydration policy is required by the regulation, which only requires that the facility provide its residents with sufficient fluid intake to maintain proper hydration and health. P. Brief at 12-13. Petitioner further argues that CMS has failed to allege or show that Petitioner failed to ensure the residents received sufficient fluids. Id. Regarding Resident 4, CMS argues that she was admitted to the hospital with a diagnosis of dehydration, and that is sufficient evidence to establish that she was not provided with sufficient fluid intake. CMS Brief in Support of the Motion for Decision on the Record (CMS Brief) at 9. Regarding Residents 5, 6, and 7, CMS argues that the facility's failure to monitor and report to the physician that the residents were consuming less fluid than Petitioner's registered dietician had recommended placed them at increased risk for dehydration. CMS Brief at 9-12.

I have already discussed that, when a provider requests review of a CMS enforcement decision, CMS has the initial burden of showing that its decision to impose an enforcement remedy is legally sufficient under the statute and regulations. To make a prima facie case that its decision was legally sufficient in this case, CMS must: (1) identify the statute, regulation or other legal criteria to which it seeks to hold the provider; (2) come forward with evidence upon which it relies for its factual conclusions that are disputed by Petitioner; and (3) show how the deficiencies it found amount to noncompliance that warrants an enforcement remedy. CMS fails to make a prima facie showing that the examples of Residents 5, 6, and 7 violate 42 C.F.R. � 483.25(j), because CMS presented no evidence that Petitioner failed to provide those residents with sufficient fluid intake to maintain proper hydration and health. CMS only shows that Petitioner did not comply with its policies and the recommendations of its registered dietician. CMS wants me to infer that these residents were not properly hydrated and healthy from the facts that the registered dietician recommended a level of fluid intake for each of these residents and the residents failed to consume liquids at the recommended level. However, CMS points to no direct evidence that Residents 5, 6, and 7 were not properly hydrated and healthy during the period placed in issue by the surveyor, July 1 through 15, 2002. (5) The SOM directs surveyors to look for clinical signs such as dry skin and mucous membranes, cracked lips, poor skin turgor, thirst, fever, or abnormal laboratory values to determine that a resident is not properly hydrated. SOM, Guidance to Surveyors, at PP-109. CMS points to no evidence of the sort suggested by the SOM. Absent some evidence that Residents 5, 6, and 7 were not properly hydrated and healthy, I will not infer they were not based upon Petitioner's failure to strictly follow its policy, a policy not dictated or required by 42 C.F.R. � 483.25(j). Thus, I must conclude that CMS has failed to make a prima facie showing of a violation of 42 C.F.R. � 483.25(j) based on the examples of Residents 5, 6, and 7.

However, I do find that CMS made a prima facie showing of a violation of 42 C.F.R. � 483.25(j) based on the example of Resident 4 for the period May 24, 2002 through June 9, 2002. In the case of Resident 4, the surveyor alleges that the resident's fluid intake was less during the period May 24 through June 3, 2002, than what had been recommended by Petitioner's registered dietician in care planning for the resident. CMS Ex. 2, at 8-9. According to the surveyor, on June 9, 2002, Resident 4 was admitted to the hospital suffering from dehydration. Id. at 8. Petitioner does not dispute that Resident 4 consumed less liquid than its registered dietician had recommended. P. Brief at 15; P. Response at 12-13; CMS Ex. 14, at 8-9, 11; P. Ex. 9, at 85-86, 101. I am not persuaded that the fact that Resident 4 consumed less fluid than recommended is determinative. Rather, the question under the regulation is whether or not a resident was properly hydrated and, according to the SOM, proper hydration is primarily determined by looking for signs and symptoms of dehydration.

In the case of Resident 4, a discharge summary from Hancock Medical Center shows that Resident 4 was admitted there from Petitioner's facility on June 9, 2002. Upon admission, Resident 4 was diagnosed as being dehydrated and in acute renal failure with a BUN of 97 and creatinine of 2.3, and she was hypernatremic with a sodium level of 161. CMS Ex. 14, at 13, 67. I find evidence of a diagnosis of dehydration by treating physicians in a hospital setting to be highly credible and probative. The hospital physicians and staff actually observed and treated Resident 4 and were in the best position at the time to opine as to her status and the nature of her condition. Subject to rebuttal by Petitioner or proof of an affirmative defense, I find the evidence that Resident 4 was admitted to the hospital from Petitioner in a dehydrated state is a prima facie showing that Petitioner failed to ensure that the resident was properly hydrated, thereby violating the regulation. The hospital discharge summary also includes a report from the resident's daughter that Resident 4 ate and drank very little in the 24 to 48 hours leading to her hospital admission and that her condition improved significantly upon being properly re-hydrated, facts consistent with her being dehydrated upon admission. Id. at 13, 51-52 (Nurse's Notes from June 8 and 9, 2002, reflect decreased intake), 67; P. Ex. 9, at 71-75. CMS's allegations that Petitioner failed to follow its policy add nothing to the prima facie showing, except to bolster it by highlighting that Petitioner had recognized and care planned for a risk of dehydration for Resident 4 and then failed to follow through with its own protocol to prevent it. I note that Petitioner's records for Resident 4 show that a Resident Assessment Protocol (RAP) for dehydration/fluid maintenance was triggered for Resident 4 on June 6, 2002, three days before her admission to the hospital. CMS Ex. 14, at 14, 25-26; P. Ex. 9, at 28, 39-40.

Petitioner's records clearly reflect that Resident 4 had declining fluid intake in the period leading to her hospitalization on June 9, 2002, and this fact was recognized by Petitioner's staff. Nevertheless, Petitioner now argues that Resident 4 was not dehydrated, which is contrary to the diagnoses of treating physicians and observations contained in Petitioner's records and those from the hospital. However, Petitioner presents no competent medical evidence in support of its position. Thus, Petitioner fails to rebut CMS's prima facie case.

Petitioner argues that the "surveyor made no allegations or findings that R4's fluid intake was not sufficient to maintain proper hydration and health with regard to the specific factors affecting R4, nor did the survey show any harm that resulted from the amount of fluid intake provided R4." P. Brief at 14. While the allegations in the SOD might not be a model of drafting, the language regarding Resident 4 is certainly precise enough to give Petitioner notice of the deficiency alleged. For example, the SOD states that Resident 4 was admitted to the hospital from Petitioner's facility; according to physicians who examined her, Resident 4 was suffering from dehydration at the time she was admitted; and Petitioner's records show that Petitioner had not followed its care plan and policies to ensure Resident 4 received sufficient fluid intake to maintain proper hydration and health and not become dehydrated. CMS Ex. 2, at 8-9. Although the surveyor did not specifically allege that dehydration is actual harm, a fair reading of the allegations in the SOD is that Resident 4 suffered actual harm requiring hospitalization because she was dehydrated as well as suffering a UTI and acute renal failure. Thus, I find Petitioner's arguments about the sufficiency of the SOD to be without merit.

Petitioner also argues that the surveyor and CMS presented no "documented evidence" that Resident 4 did not receive sufficient fluids. P. Brief at 14-15. I find that the hospital records are credible evidence and that the diagnosis of dehydration contained therein is more than sufficient evidence to satisfy CMS's initial burden to show Resident 4 did not receive adequate fluids to maintain hydration. I do not accept Petitioner's assertion that "any reasonable person would certainly recognize that eighty-three percent (83%) of the registered dietician's recommended daily intake" would be sufficient for Resident 4 to maintain hydration and health. Id. at 15 (emphasis in original). Petitioner's asserted fact is not a matter of common knowledge and Petitioner has offered no evidence to support the assertion.

Petitioner further asserts that the hospital records for Resident 4 "clearly reveal that the patient was in fact not dehydrated upon admission." P. Brief at 16. Petitioner relies upon a laboratory report, arguing that it shows that Resident 4's urine specific gravity was in the normal range, indicating that Resident 4 was not dehydrated. Id. Petitioner points to Medicare hospital admissions standards for dehydration and asserts that they support the conclusion that the resident was properly hydrated upon her admission to the hospital. Id. Petitioner also argues that Resident 4 had enough urine output to allow for a urinalysis and she was recorded to have urine output while at the facility. Id. at 17. Petitioner offers arguments but no competent medical evidence or opinion to support those arguments. Furthermore, Petitioner's arguments are insufficient to overcome or rebut the credible evidence produced by CMS in the form of medical records that include the credible medical opinions of physicians who examined and treated Resident 4 and concluded that she was dehydrated when she was admitted from Petitioner's facility. The medical records also establish that Resident 4 suffered actual harm because she was not properly hydrated.

3. The proposed CMP of $600 per day for the period July 16, 2002 through September 19, 2002, is not reasonable, but a CMP of $100 per day for that period is reasonable.

I have concluded that Petitioner violated 42 C.F.R. � 483.25(j) in the case of Resident 4, the violation is a basis for the imposition of an enforcement remedy, including a CMP. CMS imposed a CMP of $600 per day for the period July 16, 2002, the day the survey ended, through September 19, 2002, the day prior to the date on which Petitioner was found to have returned to substantial compliance. CMS Exs. 9, 22. Petitioner denied any deficiencies existed and did not argue that substantial compliance was achieved at any date earlier than September 20, 2002. Thus, the duration of the enforcement remedy has not been placed in issue.

I must also consider whether the amount of the CMP imposed is reasonable, applying the factors listed in 42 C.F.R. � 488.438(f). Emerald Oaks, DAB No. 1800, at 10; CarePlex of Silver Spring, DAB No. 1683, at 16-17 (1999); Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629 (1997). In reaching a decision on the reasonableness of the CMP, I may not look into CMS's internal decision-making process. Instead, I consider whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved (financial condition, facility history, and culpability). I am neither bound to defer to CMS's factual assertions, nor free to make a wholly independent choice of remedies without regard to CMS's discretion. Community Nursing Home, DAB No. 1807, at 25 (2002); CarePlex, DAB No. 1683, at 11.

In determining a reasonable CMP, the following factors specified at 42 C.F.R. � 488.438(f) must be considered: (1) the facility's history of non-compliance, including repeated deficiencies; (2) the facility's financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. � 488.404; and (4) the facility's degree of culpability. In deciding what penalty amount is reasonable, I must examine the evidence that relates to the regulatory factors.

The CMP proposed by CMS was based upon the findings and recommendation of the state agency, including alleged violations of 42 C.F.R. �� 483.25(d)(2) and (j) with four examples cited under the latter. I have found that CMS failed to prove the alleged violation of 42 C.F.R. � 483.25(d)(2) and proved only one example of a violation of 42 C.F.R. � 483.25(j). Thus, it is apparent that some adjustment of the proposed CMP may be appropriate. I have been given no evidence of a history of noncompliance and there is no allegation that Petitioner does not have the means to pay a CMP. I consider that the one violation of 42 C.F.R. � 483.25(j) that CMS proved involved actual harm to Resident 4. The evidence does not support a finding that there was a pattern or widespread violation of 42 C.F.R. � 483.25(j), and I conclude that it was an isolated incident. I do find that Petitioner was culpable, for the following reasons: 1) Petitioner had assessed Resident 4 as at risk for dehydration and had care planned for that risk, yet Petitioner's staff did not implement the care plan; 2) Petitioner had a policy and protocol to ensure residents' hydration and health, yet Petitioner did not ensure that staff followed the protocol in caring for Resident 4; and 3) because Petitioner's staff failed to provide care to Resident 4 in accordance with her care plan and the facility's policy, Resident 4 did not receive adequate hydration and, in fact, became dehydrated.

I conclude that a CMP of $600 per day is not reasonable, but, given the foregoing factors, a CMP of $100 per day for the period July 16, 2002 through September 19, 2002 is reasonable. The total CMP of $6,500 is calculated by counting July 17, 2002 as the first full day with the last day counted being September 19, 2002, the day before surveyors verified compliance was achieved, a total of 65 days.

III. Conclusion

For the foregoing reasons, I conclude that Petitioner violated 42 C.F.R. � 483.25(j) with respect to Resident 4. No violation of 42 C.F.R. � 483.25(d)(2) has been proven. A CMP of $600 per day for the period July 16, 2002 through September 19, 2002, is not reasonable, but a CMP of $100 per day for that period is reasonable. The total CMP is $6,500.

JUDGE
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Keith W. Sickendick

Administrative Law Judge

FOOTNOTES
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1. All references are to the revision of the Code of Federal Regulations (C.F.R.) in effect at the time of the surveys, unless otherwise indicated.

2. State surveyors use "Tag" designations that refer to the part of the State Operations Manual (SOM), Appendix P, "Survey Protocol for Long Term Care Facilities," "Guidance to Surveyors" that pertains to the specific regulatory provision allegedly violated.

3. The cited deficiencies are set forth in a Statement of Deficiency, Form 2567L (SOD), prepared by the state surveyors. Each deficiency includes a scope and severity (SS) level such as "SS=D." See, e.g., CMS Ex. 2, at 1 (left column). Scope and severity levels are used by CMS and a state agency when selecting remedies. The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the SOM, section 7400E. A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm. Facilities with deficiencies of a level no greater than C remain in substantial compliance. 42 C.F.R. � 488.301. A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy. A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy. Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety. Letters A, D, G, and J indicate an isolated occurrence, letters B, E, H, and K indicate a pattern of occurrences, and letters C, F, I, and L indicate widespread occurrences. The matrix, which is based on 42 C.F.R. � 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency. See SOM, section 7400E.

4. The Health Care Financing Administration (HCFA) is the former name of CMS.

5. The surveyor collected documents from Petitioner's records for each of the residents during the survey. My review of those records reveals that Residents 5, 6, and 7 were at risk for dehydration. Petitioner recognized that risk, and care planned for the risk. There is no question that the residents did not consume as much fluid as recommended by Petitioner's registered dietician. However, the records do not show that there were signs and symptoms of dehydration during the period focused upon by the surveyor. CMS Exs. 15, 16, and 17.

CASE | DECISION | JUDGE | FOOTNOTES