CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES

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


SUBJECT: Community Skilled Nursing Centre,

Petitioner,

DATE: July 27, 2005

             - v -

 

Centers for Medicare & Medicaid Services

 

Docket No. A-05-26
Civil Remedies CR1221
Decision No. 1987
DECISION
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FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE D
ECISION

Community Skilled Nursing Centre (Community or Petitioner), a nursing facility participating in the Medicare and Medicaid programs, appealed the September 28, 2004 decision of Administrative Law Judge (ALJ) Steven T. Kessel sustaining the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a $650 per day civil money penalty (CMP) for each day of the period February 27, 2003 and through March 13, 2003. Community Skilled Nursing Centre, CR1221 (2004) (ALJ Decision).

For the reasons discussed below, we affirm the ALJ Decision.

Legal Background

The regulatory requirements for long-term care facilities that participate in Medicare or Medicaid are set forth at 42 C.F.R. Part 483. The requirements at issue here are section 483.25(h)(2), which requires that facilities ensure that each resident receives adequate supervision and assistance devices to prevent accidents, and section 483.25(j), which requires that facilities provide each resident with sufficient fluid intake to maintain proper hydration and health.

Compliance with the participation requirements is determined through surveys performed by state agencies under contract with CMS. Based on survey findings, surveyors prepare a Statement of Deficiencies, which identifies and describes each failure to meet a participation requirement. 42 C.F.R. § 488.325(a). The state survey agency assesses the seriousness of deficiencies on a scale of "A" through "L" that denominates scope (whether the deficiency is isolated, pattern, or widespread) and severity (how great a harm, or potential for harm, is presented by the deficiency). 42 C.F.R. § 488.404.

A CMP is among the remedies which may be imposed against a facility that is not in "substantial compliance" with one or more participation requirements. 42 C.F.R. § 488.408(d). A facility is not in "substantial compliance" with a participation requirement if it is found to have a deficiency that results in actual harm to a resident or poses a risk of more than minimal harm to resident health and safety. 42 C.F.R. § 488.301. "Noncompliance" is defined as "any deficiency that causes a facility to not be in substantial compliance." 42 C.F.R. § 488.301.

If CMS decides to impose a CMP, it may impose the CMP for either the number of days the facility is not in substantial compliance (a per day CMP), or "for each instance that [the] facility is not in substantial compliance" (a per instance CMP). 42 C.F.R. § 488.430(a). A per day CMP must be in the range of $3,050-$10,000 per day for one or more deficiencies that constitute "immediate jeopardy" and $50-$3,000 for one or more non-immediate jeopardy deficiencies. 42 C.F.R. § 488.438(b).

The ALJ Decision

The ALJ made the following numbered findings of fact and conclusions of law (FFCLs):

1. As of February 27, 2003, Petitioner failed to comply with participation requirements to the extent that its noncompliance caused harm to residents of Petitioner's facility.

a. Petitioner failed to comply with the requirements of 42 C.F.R. § 483.25(h)(2).

b. Petitioner failed to comply with the requirements of 42 C.F.R. § 483.25(j).

2. Petitioner's failure to comply with the requirements of 42 C.F.R. §§ 483.25(h)(2) and 483.25(j) persisted through March 13, 2003.

3. Civil money penalties of $650 per day are reasonable to remedy Petitioner's noncompliance during the period that ran from February 27, 2003 through March 13, 2003.

Community stated that it was appealing all the FFCLs. Request for Review (RR) at 1.

Standard of Review

The standard for our review of an ALJ decision on a disputed issue of law is whether the ALJ decision is erroneous. Our standard of review on a disputed issue of fact is whether the ALJ decision as to that fact is supported by substantial evidence on the record as a whole. Guidelines - Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs (at http://www.hhs.gov/dab/guidelines/prov.html); South Valley Health Care Center, DAB No. 1691, at 2 (1999), aff'd, South Valley Health Care Center v. HCFA, 223 F.3d 1221 (10th Cir. 2000).

Substantial evidence is "more than a mere scintilla. It means such relevant evidence as a reasonable mind might accept as adequate to support a conclusion." Richardson v. Perales, 402 U.S. 389, 401 (1971), quoting Consolidated Edison Co. v. NLRB, 305 U.S. 197, 229 (1938). Under the substantial evidence standard, the reviewer must examine the record as a whole and take into account whatever in the record fairly detracts from the weight of the decision below. Universal Camera Corp. v. NLRB, 340 U.S. 474, 488 (1951). The reviewer does not, however, reweigh the evidence nor substitute his or her judgment for that of the initial decision-maker. Casias v. Secretary of Health & Human Services, 933 F.2d 799, 800 (10th Cir. 1991). Thus, the reviewer must not displace a "choice between two fairly conflicting views," even though a different choice could justifiably have been made if the matter had been before the reviewer de novo. Universal Camera, 340 U.S. at 488. The reviewer must, however, set aside the initial conclusions when he or she "cannot conscientiously find that the evidence supporting that decision is substantial, when viewed in the light that the record in its entirety furnishes, including the body of evidence opposed to the [initial decision-maker's] view." Id. In addition, the Board has held that an ALJ need not "cite to everything in the record which supports" the findings, but that the "evidence that the ALJ does cite must support the findings made." Reconsideration of Wesley Hal Livingston and Shoals Medical Equipment and Supply Co., Inc., DAB No. 1406, at 3 (1993).

ANALYSIS
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We first address Community's arguments that relate to both of the ALJ's findings of noncompliance. We then discuss the arguments that relate to the specific FFCLs.

The ALJ did not apply the wrong burden of proof.

Community asserts that the ALJ erroneously shifted the burden of proof to the provider in this case. Community argues that requiring a provider to prove compliance by the preponderance of the evidence conflicts with the Administrative Procedure Act (APA) and also that the "burden of proof standard" applied here "is a substantive rule" that was not promulgated pursuant to the notice and comment rulemaking procedures required by the APA. RR at 5-6.

We reject Community's arguments. As the Board has previously stated, the burden of proof that the Board applies is not a rule under the APA but instead is in the nature of an order setting forth a rationale, based on the statute and regulations, that establishes precedent for ALJ hearings in these cases. See, e.g., Batavia Nursing and Convalescent Center, DAB No. 1904 (2004), aff'd, Batavia Nursing and Convalescent Center v. Thompson, No. 04-3325 (6th Cir. April 15, 2005). Furthermore, while this rationale was originally set forth in Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. United States, No. 98-3789(GEB) (D.N.J. May 13, 1999), it has not been treated as a binding rule but has been reexamined as appropriate to different types of cases.

Additionally, how the ALJ allocates the burden of persuasion is relevant only when the evidence is in equipose. Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff'd, Fairfax Nursing Home v. Dep't of Health & Human Srvcs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003). The ALJ found that the weight of the evidence in this case "overwhelmingly supports CMS's contentions and arguments," and CMS would have prevailed even if he had allocated the burden of proof to CMS. ALJ Decision at 17. As described below, we agree with the ALJ that the evidence is not in equipose, and CMS would prevail in this case even if it were required to prove noncompliance by a preponderance of the evidence.

The ALJ's declining to address deficiencies below Level G does not result in Community's prevailing as to these lower level deficiencies.

CMS based its case before the ALJ on 12 deficiency citations, two at Level G (isolated actual harm that is not immediate jeopardy) and the remainder at lower scope and severity levels. ALJ Decision at 3. The ALJ Decision addressed only the two Level G deficiency citations. The ALJ concluded that the two Level G deficiencies provided a sufficient basis for upholding the $650 per day CMP. Id. Community argues that the "ALJ's failure to find that CMS made a prima facie showing on [the lower level deficiencies] means that Community Skilled must prevail on those findings." RR at 7.

We reject this argument. ALJs are not required to make findings of fact and conclusions of law on deficiencies that are not necessary to support the CMP imposed. Batavia, DAB No. 1904, at 21-22.

The ALJ's declining to address certain deficiencies is not tantamount to a finding that CMS failed to make a prima facie case or a finding in favor of Community on the unaddressed deficiencies. Nor does it mean that Community prevails as to those deficiencies. Rather, it reflects the ALJ's determination that the unaddressed deficiencies are not material, i.e., not necessary to support the remedy imposed. If we disagreed with the ALJ as to the materiality of the unaddressed deficiencies (which we do not), the appropriate result would be for us to remand the case to the ALJ to make additional findings (or, if appropriate, to make additional findings ourselves). (1)

Community's general objections do not provide a basis for reversing the ALJ Decision.

Community makes a number of general arguments concerning the ALJ's review of the record, the applicable standard of care, and the credibility of witnesses. First, Community argues that the ALJ "used selective portions of the facility's records to make its findings" when the records "must be reviewed in their totality." RR at 7.

As stated above, we uphold an ALJ decision when it is supported by substantial evidence in the record as a whole and free of legal error. Substantial evidence is "relevant evidence" which a reasonable person "might" accept to reach the conclusion drawn. The ALJ is not required to cite all evidence in the record supporting his or her findings, so long as substantial evidence in the record as a whole supports these findings. If a petitioner believes that an ALJ has failed to consider evidence in the record rebutting a finding, the petitioner should, on appeal, specifically identify that evidence and explain why it means that the finding is not supported by substantial evidence in the record as a whole. Here, Community makes the general allegation that the ALJ only "used selective portions of the record" but fails to identify specific evidence that the ALJ did not consider and fails to cite support for its own assertions of fact. (2) As explained in our discussion of the specific deficiencies, based on our review of the record, we conclude that the ALJ findings to which Community properly excepted are supported by substantial evidence on the whole record.

Community also contends that the ALJ held facility staff to a higher standard of care than required by the Social Security Act. RR at 7. Citing 42 U.S.C. § 1395i-3(b)(4)(A) (section 1819(b)(4)(A) of the Act), Community argues that "a facility is only required to be in substantial compliance with a requirement that the highest practicable care and services be delivered." Id. (emphasis in original). We reject Community's argument. Section 1819(b)(4)(A) of the Act uses the adjective "practicable" to modify the resident's condition, not the care and services the facility must provide. (3) Care and services must be provided in accordance with a resident's plan of care, which must be based on a comprehensive resident assessment. Additionally, a facility must comply with the remaining participation requirements established in the statute and regulations, including that services meet professionally recognized standards of care. Section 1810(b)(4) of the Act; 42 C.F.R. §§ 483.20(k)(3)(i) and 483.75(b). Under the regulations, a facility is not in "substantial compliance" with a participation requirement if it is found to have a deficiency that results in actual harm to a resident or poses a risk of more than minimal harm to resident health and safety. 42 C.F.R. § 488.301. The ALJ used these standards.

Community argues that the ALJ ignored the holding in Crestview Parke Care Center v. Thompson, 373 F.3d 743 (6th Cir. 2004) by "hold[ing] Community to a strict liability standard despite the Court's direction to the contrary." RR at 8. Community relies on the court's language, in discussing a deficiency cited under section 483.25, stating that "it is possible for a petitioner to show there was a justifiable reason for the violation . . . ." Crestview, 373 F.3d at 754. This holding in Crestview is consistent with the regulatory history of section 483.25, which acknowledges that negative outcomes may result from factors such as refusal of treatment and disease processes. 54 Fed. Reg. 5316, 5332 (Feb. 2, 1989). The preamble goes on to say that a facility could "direct surveyor attention to any evidence (the resident [sic] or the resident's clinical record) in order to show that a negative resident care outcome was unavoidable." Id.

The ALJ did not ignore this regulatory approach, nor the Crestview decision. Rather, the ALJ properly considered whether the care provided was consistent with the care the facility had determined was needed and was consistent with applicable professional standards of quality for preventing an undesirable outcome such as an accident or dehydration. For example, as to the deficiency citation under 42 C.F.R. § 483.25(h)(2) involving falls, the ALJ based his finding not on the fact that falls occurred but on the fact that Community failed to consistently provide the bed and chair alarms that it had determined were needed to help prevent falls.

Finally, Community argues that all of its witnesses are licensed professionals with extensive training, background, and experience in the nursing profession and had "deep, long term knowledge of each resident based upon routine and/or daily contact" that the state surveyors lacked. RR at 8. Presumably, Community is arguing that the ALJ should have given greater weight to the opinions of Community's witnesses than to CMS's witnesses.

Absent clear error, we defer to the findings of the ALJ on weight and credibility of testimony. Koester Pavilion, DAB No. 1750, at 15 (2000). Community has identified no error here. First, while Community's witnesses stated in their affidavits that they were "personally familiar" with the residents, their knowledge about care given to a resident was actually derived from record review and conversations with care-giving staff. ALJ Decision citing Tr. 121; 179-80. Second, the deficiency findings related to falls and hydration were based on resident records, so the relative credibility of witnesses as to these issues is irrelevant. Third, as discussed in the analysis, several of the statements of Community's witnesses are inconsistent with the facility's records or unsupported by those records. (4) Thus, here, as in Koester Pavilion, "[w]e find no compelling reason to reject the ALJ's determination about the relative credibility and persuasiveness of the testimony of these witnesses." (5) Id. at 22.

We sustain the ALJ's conclusion that, as of February 27, 2003, Petitioner failed to substantially comply with 42 C.F.R. § 483.25(h)(2), and its noncompliance caused harm to residents of Petitioner's facility. (FFCL 1.a.).

Section 483.25(h)(2) falls under the "quality of care" requirements, which share the same regulatory objective 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."

Section 483.24(h)(2) provides:

(h) The facility must ensure that -

* * *

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

In Woodstock Care Center, DAB No. 1726, at 25-30 (2000)(citing 54 Fed. Reg. 5316, 5332 (February 2, 1989)), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003), the Board analyzed the wording, context, and history of section 483.25(h)(2) and, based on that analysis, set out a framework for evaluating allegations of noncompliance with that requirement. The Board determined that although section 483.25(h)(2) does not hold a facility strictly liable for accidents that occur, it does require the facility to take reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his or her assessed needs and to mitigate foreseeable risks of harm from accidents. Id.; see also Odd Fellow and Rebekah Health Care Facility, DAB No. 1839 (2002). A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an "adequate" level of supervision and assistance devices under all the circumstances. See Woodstock Care Center at 28-35. What is "adequate" depends, of course, on the resident's ability to protect himself or herself from harm. Id.

Resident # 85

Resident # 85 was an 87 year-old woman who suffered from dementia, depression, impaired cognitive abilities, and physical impairments that included degenerative arthritis and glaucoma. ALJ Decision at 5, citing CMS Ex. 34, at 1. She was admitted to Community's facility on June 29, 2002. Id. at 5. As stated by Community's witnesses, Resident # 85 was at high risk for falls. P. Exs. 14, at 3; 15, at 2. In order to address this risk, Community's staff ordered that Resident # 85 be supplied with bed and chair alarms to alert the staff if she moved from the bed or chair. ALJ Decision at 5, citing CMS Ex. 34, at 3.

On July 29, 2002, a month after her admission, Resident # 85 was found on the floor of her room, near the door, complaining of pain in her left wrist. ALJ Decision at 6, citing CMS Ex. 34, at 5; P. Ex. 4, at 2. A few minutes prior to the discovery of the fall, Resident # 85 had been observed lying in her bed. Id., citing CMS Ex. 34, at 4, 6; P. Ex. 4, at 3. The resident's bed alarm did not sound when the resident left her bed. Id., citing CMS Ex. 34, at 6-8; P. Ex. 4, at 3-4. The alarm was found disconnected, folded, and placed at the bottom of the resident's bed. Id., citing CMS Ex. 34, at 6; CMS Ex. 16, at 23; P. Ex. 4, at 3. Subsequently, X-rays confirmed that she had fractured the distal portion of her left arm. Id., citing CMS Ex. 34, at 6-7; P. Ex. 4, at 3-4.

The ALJ concluded that Community's staff knew that Resident # 85 was at risk for falling; that they adopted measures to address this risk, which included chair and bed alarms; that immediately prior to her fall on July 29, Resident # 85 was in her bed but her bed alarm was disconnected, and, consequently, that Community failed to implement these protective measures effectively. ALJ Decision at 6. Because the bed alarm was found folded at the bottom of the bed, because Resident # 85 suffered from dementia and impaired cognitive abilities and would be unlikely to fold the alarm and place it on the bottom of the bed, and because Community disciplined a staff member for the condition of the alarm, the ALJ concluded that the inactive status of the bed alarm prior to Resident # 85's fall resulted from the actions of Community's staff and not Resident # 85. Id. Further, Community's "Fall Investigation Tool" report identified, as a contributing factor to the fall, the fact that "alarm not on bed correctly" and reflected that "staff error" was a factor in the accident. CMS Ex. 34, at 7.

On appeal, Community argues that the "evidence fails to establish that an alleged lack of supervision by the facility resulted in the deactivation of the alarm." RR at 9. We reject this argument. Section 483.25(h)(2) requires facilities to ensure that each resident receives adequate supervision and assistance devices to prevent accidents. Community determined to provide a bed alarm as an assistance device but, on July 29, did not do so. (6) These facts support the ALJ's finding that Community failed to ensure that Resident # 85 received adequate supervision and assistance devices to prevent accidents.

Community also argues that "[i]n the seven months between admission and the isolated incident on July 29, 2002, the facility successfully implemented measures to prevent falls during this time," and that "[t]he Record shows the preventive measures had been successful for this resident." RR at 9. Community cites no authority for its assertion that Resident # 85 was admitted seven months prior to this fall, and the assertion is contrary to the ALJ's findings that Resident # 85 was admitted in June 2002 and the accident at issue occurred on July 29, 2002. ALJ Decision at 5; see also CMS Ex. 34 at 4; CMS Ex. 1, at 17.

Community argues further that "[t]he facility routinely checks to ensure that the alarms are properly activated." and "[t]he record also shows that the facility routinely verified that the preventive measure was functioning properly." RR at 9. For this proposition, Community cites Petitioner Exhibit 4, at page 1, which is one page of nursing notes for the days July 24 and 25, 2002. As to alarms, these notes contain an entry for July 24 stating that "chair and bed alarm intact" and an entry on July 25 stating that Resident # 85 was "found walking in hall" and had "removed alarm by self." This evidence does not support Community's assertion of fact that the facility routinely checked and routinely verified the operation of alarms. Moreover, the ALJ could reasonably infer from Petitioner Exhibit 4 as a whole that the alarm had not been properly checked to ensure it was connected and functioning properly. See P. Ex. 4, at 4-5.

Finally, Community argues that "[a]ny more restrictive means to prevent falls would have been inappropriate under the circumstances" and cites pages 180 and 181 of the transcript. We reject this argument. The ALJ did not base the deficiency finding on the proposition that Community should have adopted more restrictive means to prevent Resident # 85 from falling. Further, the testimony on the cited transcript pages does not concern Resident # 85.

Resident # 93

Resident # 93 was 93 at the time of the survey and suffered from Alzheimer's Disease and depression. ALJ Decision at 7, citing CMS Ex. 35, at 1. Community's staff assessed the resident as being at a high risk for falls. Id., citing CMS Ex. 35, at 3. Community instituted multiple protective measures, including an electronic chair alarm and a seatbelt for her chair, which were to be in place when the resident was left alone in her room. Id.

On February 4, 2003, a nursing assistant put Resident # 93 in a chair in her room alone with the seatbelt attached but without a chair alarm. ALJ Decision at 7, citing CMS Ex. 35, at 5, 11. Resident # 93 unfastened her seatbelt, got up from her chair, and subsequently fell, sustaining lacerations to both sides of her head. Id., citing CMS Ex. 35 at 6, 8. Community's investigation determined that Resident # 93's accident involved staff error. Id., citing CMS Ex. 35 at 8; P. Ex. 5, at 1.

The ALJ concluded that staff's failure to ensure that the chair alarm was present and activated when Resident # 93 was left alone in her room constituted noncompliance with section 483.25(h)(2).

On appeal, Community asserts that this was an "isolated fall" and that the ALJ was holding Community to a "strict liability standard" because Resident # 93 fell "despite the best efforts of the facility to prevent falls." RR at 10. As a basis for this assertion, Community argues that, while the ALJ relied on the failure of the chair alarm, the chair alarm "would not prevent a fall, it would alert a care giver that a fall had occurred." Id. Community also argues that it took "numerous appropriate measures to prevent this resident from falling" and "the seatbelt was unsnapped and the alarm disabled by the resident himself/herself." Id.

Community fails to show that the ALJ erred. The ALJ did not hold Community to a strict liability standard; he held it to the undisputed standards it set for itself, which included providing a chair alarm for this resident when she was alone in her room. Further, the fact that a chair alarm may not prevent all falls is irrelevant in light of the fact that Community determined that a chair alarm should have been provided to this resident as part of ensuring that the resident received adequate supervision and assistance devices to prevent falls. (7) Finally, Community's report of the investigation conducted at the time of the fall states that Resident # 93 was placed in her room "with a quick release seat belt and no chair alarm." P. Ex. 35, at 9, 11 (emphasis added).

Resident # 124

Resident # 124 was 81 years old at the time of the survey and suffered from numerous impairments including mild mental retardation, anxiety, fluid in her lungs, a hiatal hernia, and Gastroesophageal Reflux Disease. ALJ Decision at 8, citing CMS Ex. 11, at 3; CMS Ex. 30, at 1. On or about April 17, 2002, a gastrostomy tube (G-tube) was inserted into the resident's stomach. Id., citing CMS Ex. 11, at 4. The G-tube was inserted from the exterior of the resident's skin into the resident's body cavity and eventually, into her stomach. It was held in place by an inflated balloon that was intended to prevent the G-tube from slipping out of the resident's stomach and body cavity. Id.

The nursing notes reflect that, on January 11, 2003, the G-tube was found out of Resident # 124's body three times: once at 6:30 a.m. with the balloon deflated; once at 2:15 p.m. with the balloon deflated, and once at 8 p.m. with the balloon inflated. CMS Ex. 30, at 10. For the 8 p.m. entry, the nurse wrote that the resident "pulled GT out with balloon inflated." Id. On January 12, 2003, the notes entered at 7:30 p.m. state the resident "pulled GT out with balloon inflated." Id. On January 13, the 1:30 p.m. entry states "G-Tube found out." Id. On January 14, the 4:30 p.m. entry states "G-Tube found out with balloon deflated." Id. On four of these occasions, the nurses observed some bleeding at the site. Id. at 10-11. Prior to January 14, the nurses had reinserted a G-tube, but the nurse was unable to do so on January 14. Id. On January 14, staff notified Resident # 124's doctor of the problem with the G-tube, and he ordered her sent to the hospital for reinsertion. Id. at 11. The hospital staff was unable to reinsert the G-tube and, instead, inserted a nasogastric tube through the resident's nose, down her esophagus, and into her stomach. ALJ Decision at 9, citing CMS Ex. 13, at 8; CMS Ex. 30, at 11; CMS Ex. 11, at 4.

The ALJ concluded that Community's staff knew or should have known, beginning January 11, 2003, that Resident # 124 had a propensity for pulling the G-tube from her body with serious consequences but failed to attempt any measures to prevent the resident from removing the tube. ALJ Decision at 9. As result, over a period of several days, the resident removed the tube repeatedly, causing bleeding at the site of the tube, and necessitating the resident's referral to an emergency room and insertion of a nasogastric tube as an alternative way of feeding her. Id. The ALJ concluded that "close supervision of this resident might have prevented this adverse consequence." Id. He also concluded that, by the time Community's staff notified the resident's physician of the resident's behavior on January 14, the resident had pulled the tube out at least six times. Id. He stated that, had the physician been notified sooner, the staff and the physician might have agreed on temporary or long-term measures to prevent the resident from engaging in self-destructive behavior.

On appeal, Community asserts that Resident # 124 did not have a history of removing her G-tube. It argues "CMS did not establish who or what caused the tube to be removed. Only twice was the tube removed by the resident." RR at 11, citing P. Ex. 14, at 3. (8)

We conclude that Community's arguments on appeal do not show that the ALJ erred. First, the nursing notes establish that the tube was removed at least twice by the resident. While they are silent as to the cause for the other four removals, they do not establish that the tube was not removed by the resident. Second, in concluding that a facility has failed to provide adequate supervision to prevent accidents, CMS is not required to establish the cause of each accident. As the ALJ stated, "The exact cause of the repeated removals of the G-tube is less important in the overall picture of things than is Community's failure to address the repeated removals. Community was under an obligation to protect the resident from removal whatever the cause." ALJ Decision at 10. Community cites no evidence in the record that would support a finding that Community sought to provide the type of supervision that would enable it to determine the causes of the removals or protect Resident # 124 from the removals. (9)

We sustain the ALJ's conclusion that, as of February 27, 2003, Petitioner failed to substantially comply with 42 C.F.R. § 483.25(j), and its noncompliance caused harm to a resident of Petitioner's facility. (FFCL 1.b.)

Section 483.25(j) also falls under the general quality of care requirements and provides:

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

This deficiency involved the care provided in November 2002 to Resident # 117, who became dehydrated in the course of the month. Resident # 117 was an elderly woman suffering from Alzheimer's type dementia. ALJ Decision at 11, citing CMS Ex. 25, at 1. Facility documentation indicated that Resident # 117 refused to eat the majority of her meals in November 2002. Id., citing CMS Ex. 1, at 22. On November 12, the nurses notes state the resident was lethargic. P. Ex. 6, at 46. On November 13, the resident was observed by her family to be lethargic, which can be a symptom of dehydration. ALJ Decision at 11, citing P. Ex. 6, at 47. On November 15 and 18-21, Resident # 117 had an elevated temperature, which can increase fluid needs. P. Ex. 6, at 50-55; CMS Ex. 3, at 21. On November 18, Resident # 117's son observed she was making gurgling noises, suggestive of a swallowing problem, when he tried to give her fluids. ALJ Decision at 11, citing P. Ex. 6, at 49-50. On November 20, laboratory tests indicated that Resident # 117 was dehydrated. Id., citing CMS Ex. 1, at 23 (elevated levels of sodium, chloride, blood urea nitrogen, and creatinine); P. Ex. 6, at 51. The tests were repeated on November 21, and they produced results that were even more suggestive of dehydration. Id. Additional tests performed on that day showed that the resident was likely aspirating (inadvertently inhaling) food and fluids. Id. On November 21, the resident's physician ordered that the resident be administered fluids intravenously. Id.

Community does not dispute that the laboratory tests showed that Resident # 117 was dehydrated. Rather, Community asserts that it properly cared for Resident # 117. RR at 12.

We reject Community's argument. Section 483.25(j) requires facilities to provide sufficient fluid intake to maintain proper hydration. Community failed to do this for Resident # 117. In order to demonstrate substantial compliance with this requirement, Community would have to show that Resident # 117 became dehydrated despite care that was consistent with professional standards of quality for preventing dehydration in someone of Resident # 117's condition.

In challenging the ALJ's determination that it did not provide proper care, Community argues, "The evidence clearly demonstrates that the facility closely monitored fluid intake for this resident throughout the month of November 2002." RR at 12. For this proposition, Community cites pages 45 through 52 of Petitioner Exhibit 6, which are nursing notes from November 9 to November 21. While these notes contain some entries about fluid intake, they neither constitute "closely monitor[ing]" nor reflect the type of monitoring that would constitute compliance with section 483.25(j) for the following reasons. First, even if Community could document Resident # 117's fluid intake during this period, that intake data would only be meaningful in relation to a baseline daily fluid need determination. However, Community identifies no records showing that it made any assessment of Resident # 117's baseline daily fluid needs pursuant to the standards set forth in the CMS State Operations Manual (SOM) or any other recognized hydration criterion. (10) Second, the nurses notes that Community cites do not systematically document Resident # 117's fluid intake because they do not purport to record all fluids she consumed, and they do not quantify all of the amounts of the fluids they do record. (11) ALJ Decision at 13. Thus, Community does not show that it attempted to determine, by some acceptable measure, the amount of fluid Resident # 117 required or that she was receiving that amount of fluid.

On appeal, Community also argues that the ALJ improperly relied on facts as indicative of dehydration which could be symptomatic of other conditions, for example, the fact that her son reported hearing gurgling sounds when he tried to give her juice. RR at 12. This reliance is not error. The ALJ noted these and other undisputed facts as risk factors for dehydration and indicators that should have alerted Community that it needed to engage in a more systematic process for determining whether Resident # 117's hydration needs were being met. These risk factors are noted in the SOM and, for Resident # 117, included "dementia in which resident forgets to drink," "refusal of fluids," "increased fluid needs (i.e., . . . fever)," and "functional impairments that make it difficult to drink, reach fluids, or communicate fluid needs." CMS Ex. 3, at 21.

We sustain the ALJ's conclusion that Community's failure to substantially comply with 42 C.F.R. §§ 483.25(h)(2) and (j) persisted through March 13, 2003. (FFCL 2).

The ALJ upheld CMS's determination that Community did not attain substantial compliance until March 14, 2003. ALJ Decision at 14. The ALJ based this determination on Community's allegation that it corrected its deficiencies effective March 14, 2003 and on a follow-up survey by the state survey agency conducted March 27, 2003. Id. We sustain the ALJ's determination because Community offers no arguments challenging the factual or legal basis of ALJ's finding on the duration of its noncompliance, and, therefore, has not raised any issue for our review.

We sustain the ALJ's conclusion that a CMP in the amount of $650 per day is reasonable to remedy Community's noncompliance. (FFCL 3).

The ALJ concluded that a $650 per day CMP was reasonable to remedy Community's noncompliance with the two G level deficiencies. ALJ Decision at 14. The ALJ discussed the criteria set forth at 42 C.F.R. § 488.438(f)(1)-(4) for setting penalty amounts and the evidence in the record that relates to those criteria.

Community offers no specific arguments or citations to the record addressing the ALJ's review of the CMP criteria and related evidence. For example, in response to the ALJ's discussion of the evidence concerning its history of noncompliance and repeat deficiencies, Community asserts, "Its history of noncompliance, including the presence, if any, of repeat deficiencies fails to warrant, in whole or in part, the CMP . . . ." RR at 13. Such conclusory and general assertions are insufficient to raise any issue for our review regarding whether the ALJ's findings are supported by substantial evidence and legally correct.

Conclusion

For the reasons discussed in our analysis, we affirm the ALJ Decision and affirm and adopt FFCL Nos. 1 through 3 set out therein.

JUDGE
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Cecilia Sparks Ford

Donald F. Garrett

Judith A. Ballard
Presiding Board Member

FOOTNOTES
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1. In examining whether the unaddressed deficiencies were material, we look at the issues decided by the ALJ. In cases involving a CMP imposed on a per day basis, there are three general issues: (1) Was there a basis for imposing any CMP (that is, did the provider in fact fail to comply substantially with program requirements)? (2) What was the duration of the period of noncompliance? (3) Was the amount of the CMP reasonable? As explained below, we conclude that the ALJ's determinations as to the each of these issues are supported by substantial evidence in the record as a whole and contain no error of law.

2. Board Guidelines for review of an ALJ decision direct parties to set forth "the basis for challenging each element of the ALJ decision" and to support each challenge by "precise citations to the record before the ALJ." See http://www.hhs.gov/dab/guidelines/prov.html. The ALJ here similarly informed the parties that they should cite any evidence they wished him to consider. Tr. at 6-7. Placing a duty on the parties in this type of case to assist in a potentially burdensome task is appropriate, particularly since resident records may be difficult to interpret. Use of such a procedural device does not, however, mean that evidence not specifically cited is excluded from the record. Nor does it relieve the ALJ of his responsibility to "study the record and make an independent analysis of the facts and contentions" (Manual for Administrative Law Judges, Administrative Conference of the United States (3rd ed. 1993)), or relieve us of our obligation to determine whether any ALJ findings to which a party has properly excepted that are material to our decision are supported by substantial evidence on the whole record. We do not infer from the ALJ's later statements indicating that he considered it inappropriate "to mine the record for evidence not brought to [his] attention" (ALJ Decision at 2) that he based his decision only on selective portions of the record, as Community alleges.

3. Section 1819(b)(4)(A) requires that a facility provide, among other things, nursing, rehabilitative, and medically-related social services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of the resident to the extent needed to fulfill all plans of care described in section 1819(b)(2) of the Act.

4. For example, two Community witnesses stated that Resident # 93 "disabled the chair alarm." P. Exs. 14, at 3 and 15 at 3. However, the report of the investigation Community conducted at the time of Resident # 93's fall stated that the resident was "placed in her room . . . with a quick release seatbelt and no chair alarm." CMS Ex. 35, at 9, 11.

5. As we have recognized in prior cases, if a qualified individual who cared for a specific resident over a long period of time testified about the resident and that testimony was consistent with documentary support that was complete, familiarity with a resident might be a reason to give more weight to the caretaker's testimony. Koester Pavilion, DAB No. 1750, at 15 (2000). Merely because some staff might generally be more familiar with residents, however, is not a reason to adopt a general rule requiring ALJs to give more weight to all testimony by staff members. Further, in evaluating testimony, an ALJ may reasonably take into account factors such as witness qualifications and experience, as well as self-interest. Id.

6. Generally, assistance devices are used to reduce the level of supervision that otherwise might be required. If a facility is aware that the assistance device might be removed by the resident, then it needs to increase supervision over whether the device is in place.

7. Contrary to Community's assertion, a chair alarm can prevent falls if staff reach a resident after the activation of an alarm and before a fall or if the alarm reminds a forgetful resident not to try to walk. In this case, Community's incident report indicates that Resident # 93 was found near the bathroom door and that there were newspapers on the floor, which were a "reason for the incident." P. Ex. 6, at 2; see also id. at 6 (nurses notes describing location of fall and presence of newspapers.) Had the alarm sounded, staff might have reached Resident # 93 before she reached the newspapers on the floor near the bathroom door.

8. Community did not establish the cause for the repeated removal of the G-tube. Its Director of Nursing (DON) stated that "when the balloon was found deflated it was not due to the resident pulling it out, but rather to defective G-tube balloons. On at least one occasion the tube 'popped out' while undressing. The g-tube balloon could have been defective." P. Ex. 14, at 2. However, on cross examination, he admitted that he had no knowledge that any balloon was defective in this case. Tr. at 95. Further, he testified that, prior to using a balloon, "you blow that balloon up, if it's defective discard it" and that, if the correct lubricant is used and the balloon is tested, it is rare to insert a defective balloon. Id. at 97. Finally, the DON testified that his knowledge of these events was based on record review. Tr. at 93-94. Community identifies no support in the resident's record for the DON's statement that the G-tube "popped out" while undressing and that the G-tube balloon was defective.

9. Citing page 69 of the transcript, Community also asserts that a surveyor admitted on cross-examination that the facility had acted properly in regards to Resident # 124. Community's assertion is completely baseless.

10. The SOM provides, "A general guideline for determining baseline daily fluids needs is to multiply the resident's body weight in kg times 30cc (2.2 lbs = 1 kg), except for residents with renal or cardiac distress. An excess of fluids can be detrimental for these residents." CMS Ex. 3, at 21 (SOM App. PP at PP-109).

11. For example, the entries related to fluid intake for November 11 state, "Ate 50% breakfast. Good fluid intake" and "refused dinner drank 125% supplement." P. Ex. 6, at 46. The entries for November 12 state, "Res lethargic. Gait unsteady. Up for meals. Refused to eat supper but taken 100% of supplement." Id. The entries for November 13 state, "refused all 6A medications and resource" and "'R' is lethargic and still not eating." Id. at 47.

A document in the record (CMS Exhibit 25, at page 26) indicates that Community recorded Resident # 117's food and fluid intake. This 'percent of intake' form records food and fluid intake at meals and at "10am", "3pm" and "HS." In the absence of an explanation of how to determine from this document the amount of fluid Resident # 117 received compared to her needs, however, the document has no probative value.

CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES