SUBJECT:

Holly Nursing and Rehabilitation Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Holly Nursing and Rehabilitation Center (Petitioner or facility), is a long-term care facility certified to participate in the Medicare and Medicaid programs as a provider of services. Following a survey completed March 5, 2003, the Centers for Medicare & Medicaid Services (CMS) determined that, from March 5 through 23, 2003, ⁽¹⁾ the facility was not in substantial compliance with a number of program requirements, and imposed a $500 per day civil money penalty (CMP) for those 19 days of purported noncompliance ($9,500 total). Petitioner here challenges that determination.

The parties have agreed that this matter may be decided on the written record, without an in-person hearing.

For the reasons set forth below, I find that the facility was not in substantial compliance with program requirements for the period in question, and find the amount of the CMP reasonable.

I. Background

Following a complaint investigation/survey completed March 5, 2002, surveyors from the Idaho Department of Health and Welfare (State Agency) determined that the facility was not in substantial compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs. Specifically, the surveyors found that the facility did not meet federal requirements under 42 C.F.R. § 483.25 (Tags F-324 and F-309 - Quality of Care) and 42 C.F.R. § 483.10(b)(11) (Tag F-157 - Notification of Rights and Services).

CMS agreed with the State Agency, and so advised the facility in a letter dated March 24, 2003. CMS Exhibit (Ex.) 33. After a follow-up visit on April 16, 2003, CMS determined that the facility achieved substantial compliance on March 24, 2003, and imposed a CMP of $500 per day from March 5, 2003 until March 24, 2003 (total $9,500). CMS Exs. 34, 37.

Petitioner timely requested a hearing, and the matter was assigned to me.

After receiving the parties' initial briefs (P. Pre-hearing Br. and CMS Pre-hearing Br.) and submissions, I scheduled a hearing for October 6-7, 2005. At a September 6, 2005, prehearing conference, however, the parties agreed to waive the in-person hearing, and resolve the case based upon their written submissions, as provided in 42 C.F.R. § 498.66. In an order dated September 29, 2005, I cancelled the scheduled hearing. Petitioner submitted its written waiver, dated October 5, 2005, by which it waived its right to appear and present evidence at an in-person hearing. The parties subsequently submitted a proposed briefing schedule. In an order dated October 17, 2005, I adopted the parties' briefing schedule. However, in error, the October 17, 2005 order referred to the briefing schedule as "briefing schedule for the filing of a motion for summary judgment." I realized the error while reviewing the parties' briefs, which included discussions of the standards for summary judgment. In an order dated February 23, 2006, I advised the parties that, as reflected in my earlier September 29, 2005 order, and Petitioner's October 5, 2005 waiver, this case would be decided based on the written record, as provided for in 42 C.F.R. § 498.66, and NOT on motions for summary judgment. The order then provided the parties the opportunity to file objections. The parties filed no objections.

The parties have filed their final briefs (CMS Br.; P. Br.; CMS Reply Br.). CMS initially filed 38 exhibits (CMS Exs. 1-38) and Petitioner has filed 17 exhibits (P. Exs. 1-17). In the absence of any objections, I admit CMS Exs. 1- 38 and P. Exs. 1-17. With its closing brief, CMS, without comment or explanation, attached an additional exhibit, labeled CMS Ex. 39. CMS does not ask leave to amend its pre-hearing exchange to add this additional exhibit. On the other hand, Petitioner offered no objection to its inclusion in the record, so I also admit CMS Ex. 39.

II. Issues

The case presents the following questions:

1. From March 5 through 23, 2003, was the facility in substantial compliance with requirements for facilities participating in the Medicare and Medicaid programs, specifically 42 C.F.R. § 483.25, and 42 C.F.R. § 483.10(b)(11)?

2. If the facility was not in substantial compliance, is the amount of the CMP imposed, $500 per day for nineteen days (total $9,500), reasonable?

III. Statutory and Regulatory Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483. Facilities must maintain substantial compliance with program requirements, and, 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.

Under the statute and "quality of care" regulation, each resident must receive and the facility must provide the necessary care and services to attain or maintain for each resident the highest practicable physical, mental, and psychological well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, section 1819(b); 42 C.F.R. § 483.25. Accordingly, the facility must conduct an initial and periodic resident assessment of functional capacity that is comprehensive, accurate, standardized, and reproducible. 42 C.F.R. §§ 483.20, 483.25. The facility must also make a comprehensive assessment of a resident's needs promptly after a significant change in the resident's physical or mental condition. 42 C.F.R. § 483.20(b)(2)(ii).

The facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents. 42 C.F.R. § 483.25(h)(2). An "accident" is "an unexpected, unintended event that can cause a resident bodily injury," excluding "adverse outcomes associated as a direct consequence of treatment or care (e.g., drug side effects or reactions)." State Operations Manual (SOM) Appendix PP, Guidance to Surveyors, Part 2, SOP 483.25 Quality of Care (Rev. 274, June 1995); see Woodstock Care Center, DAB No. 1726, at 4 (2000), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6^th Cir. 2003).

The facility must also "immediately inform" the resident, consult with the resident's physician, and, if known, notify the resident's legal representative or an interested family member of a need to alter treatment significantly (i.e., a need to discontinue an existing form of treatment due to adverse consequences, or to commence a new form of treatment). 42 C.F.R. § 483.10(b)(11).

If a facility is not in substantial compliance with program 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 CMP. See Act, section 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more program requirements or for each instance that a facility is not in substantial compliance. 42 C.F.R. § 488.430(a). In situations where the deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for more than minimal harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day. 42 C.F.R. § 488.438.

IV. Discussion

A. From March 5 through 23, 2003, the facility was not in substantial compliance with the program participation requirement set forth at 42 C.F.R. § 483.25(h)(2), because the facility did not provide an adequate level of supervision to prevent accidents. ⁽²⁾

The quality of care regulation, 42 C.F.R. § 483.25, imposes on facilities an affirmative duty designed to achieve favorable outcomes "to the highest practicable degree." Windsor Health Care Center, DAB No. 1902, at 16-17 (2003); Woodstock, DAB No. 1726, at 25-30. Among other specific requirements, the facility is required 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." 42 C.F.R. § 483.25(h)(2); Windsor Health Care Center, DAB No. 1902, at 5; Asbury Center at Johnson City, DAB No. 1815, at 12 (2002); Koester Pavilion, DAB No. 1750, at 25-26 (2000); Woodstock, DAB No. 1726, at 25. Under the regulation the facility must anticipate potential accidents and take steps to prevent them (increased supervision or the use of assistance devices). Guardian Health Care Center, DAB No. 1943, at 18 (2004).

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 under all the circumstances.

Windsor Health Care Center, DAB No. 1902, at 5.

At the time of the survey, Resident 1 (R1) was 92 years old. She had been admitted to the facility in October 2002, with diagnoses of hypothyroidism, cardiac dysrhythmia, arthritis, osteoporosis, and dementia. P. Ex. 7, at 1, 8; CMS Ex. 3, at 1, 8; CMS Ex. 26, at 3-4 (Bouse Decl. ¶ 6). The facility identified her as at risk for wandering, and she had a significant history of falls, including a December 18, 2002 fall that resulted in a fractured hip. She was then hospitalized, and returned to the facility on December 24, 2002. P. Ex. 7, at 5, 11; P. Ex. 11; CMS Ex. 3, at 5, 11; CMS Ex. 4; CMS Ex. 5, at 2. By February 12, 2003, R1 was requiring total assistance with all of her care. She was in pain, confused, and her physician had ordered Haldol to treat her organic mental syndrome. P. Ex. 3; CMS Ex. 5, at 2; CMS Ex. 7, at 1.

CMS cites two instances in which the facility failed to provide R1 the necessary levels of supervision and/or assistance devices: on February 18, 2003, she was left alone and unattended in a busy hospital emergency room; and, on March 2, 2003, she suffered a fall when her bed alarm did not go off as it should have.

February 18, 2003. On February 18, 2003, R1 had been throwing up for two days. She was described by nurses as "extremely lethargic - difficult to arouse," and unable to express her needs. Facility staff called her physician's office, who ordered her sent to the hospital emergency room for evaluation. P. Ex. 13, at 69, 70; CMS Ex. 2, at 5; CMS Ex. 5, at 2; CMS Ex. 7, at 1-2; CMS Ex. 26, at 14-15 (Bouse Decl. ¶33). A facility nurse called and advised emergency room staff that R1 was coming. CMS Ex. 7, at 4; CMS Ex. 2, at 5. A facility van delivered her there. At 1:20 p.m., the van driver left her in a wheel chair in the "very busy" emergency room (ER) with her medical records on her lap. She waited, unattended, for about 25 minutes. When her name was called, she was not able to answer. CMS Ex. 2, at 8. A family member did not arrive until after she had been taken in for treatment.

Petitioner does not dispute any of CMS's allegations, but argues that its van driver acted appropriately because she told the ER admitting nurse that she was leaving the resident "in the hospital's care," and "there is no indication in the record that the admitting nurse advised Petitioner's employee that the hospital was unable or unwilling to properly supervise the resident entrusted to their care." P. Br. at 15. Petitioner submits no declaration from its van driver or other support explaining what transpired in the emergency room. On the other hand, according to Surveyor Lorna Bouse, Marilyn Hornbaker, the hospital's triage director, complained that the facility was "notorious for bringing residents and dropping them off in the ER without supervision." Hospital personnel told the surveyors that they do not sit with waiting patients. On the day R1 came in, they had 101 patients, and were "very busy." Triage Director Hornbaker noted that the ER staff "confronted" the van driver about leaving the resident unattended, but the van driver said that she had others to transport. CMS Ex. 1, at 11; CMS Ex. 2, at 5, 8; CMS Ex. 26, at 15 (Bouse Decl. ¶ 34).

Although the record is sparse as to what transpired in the emergency room, it seems more likely that emergency room staff objected to the facility's leaving the resident. In any event, there is no dispute that the facility's van driver left a confused and lethargic resident - who was unable to respond to her own name - unattended in a busy emergency room with her medical records on her lap. She was recovering from a broken hip, and had a history of falls and wandering. A busy emergency room is simply not set up to afford an individual in R1's condition the degree of supervision she required to remain safe. It appears that the driver had no alternative because she was responsible for delivering other residents, for which the facility must be faulted. Fortunately, no injury resulted, but I find that this situation presented the potential for more than minimal harm.

March 2, 2003. The facility recognized that R1 was at risk for falls. She had already sustained a broken hip as the result of a fall. Among the interventions the facility had in place to prevent R1 from falling were "alarms in bed and when up in [wheelchair]." P. Ex. 10, at 2. Nevertheless, on March 2, 2003, a nurse aide found R1 on the floor of her room. The bed alarm was fastened but it had not gone off. P. Ex. 13, at 84; CMS Ex. 15. Staff investigated and concluded that the accident could have been prevented if the alarm had sounded, but the alarm string was too long, and the alarm was not fastened properly. CMS Ex. 15, at 4; CMS Ex. 1, at 12.

The facility recognized that R1 needed a bed alarm, and provided her with one, but, because the device was not used correctly, staff were not alerted and she suffered a fall. The facility was thus not taking adequate steps to prevent an accident and, for this reason, was not in substantial compliance with 42 C.F.R. § 483.25(h)(2).

I also conclude that, by itself, the facility's noncompliance with 42 C.F.R. § 483.25(h)(2) provides CMS a sufficient basis for imposing a CMP. The ALJ need not "address all of the deficiencies in order to conclude that CMS had a basis for imposing a CMP." Batavia Nursing and Convalescent Center, DAB No. 1904, at 23 (2004); Beechwood Sanitarium, DAB No. 1824, at 19 (2002) (within the ALJ's discretion to limit his decision to findings necessary to support the remedies imposed). I therefore decline to reach the more aggressively contested questions as to the facility's efforts to control R1's pain, and its performance in informing R1's family of significant changes in her treatment.

B. I find reasonable the $500 per day CMP, which is at the low end of the CMP range for non-immediate jeopardy situations.

Aside from its claims regarding compliance, Petitioner offers no argument as to the reasonableness of the CMP amount, and has arguably waived the issue. In any event, the penalty is at the low end of the range, and is justified by the relevant criteria.

As noted above, if CMS determines that a facility is not in substantial compliance with program requirements, it may impose a CMP for each day of substantial noncompliance. Act, section 1819(h); 42 C.F.R. § 488.402; 42 C.F.R. § 488.408. Where the deficiencies do not pose immediate jeopardy to res

ident health and safety, but have either caused actual harm or have the potential for more than minimal harm, the penalty will be in the range of $50 to $3,000 per day. 42 C.F.R. §§ 488.408(d), 488.438(a). At $500 per day, the penalty here is at the low end of the range.

I determine whether the amount of a CMP is reasonable by applying the factors listed in 42 C.F.R. § 488.438(f): 1) the facility's history of noncompliance; 2) the facility's financial condition; 3) factors specified in 42 C.F.R. § 488.404; and 4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort or safety. The absence of culpability is not a mitigating factor. 42 C.F.R. § 488.438(f). The factors in 42 C.F.R. § 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; 3) the facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies.

With respect to facility history, CMS presents evidence, which Petitioner does not challenge, establishing the facility's history of noncompliance. In an earlier complaint investigation (January 2003), the facility was cited for quality of care deficiencies that caused actual harm in incidents involving the same resident. CMS Exs. 32, 39. So the facility's history justifies an increased CMP.

Petitioner has not claimed that its financial condition prevents it from paying this small penalty.

Applying the remaining factors, I note that the deficiencies cited were not trivial. The facility's actions threatened resident comfort, health and safety, for which the facility is culpable. This conclusion, along with the facility's substandard history, justifies the relatively small monetary penalty imposed.

V. Conclusion

For all of the reasons discussed above, I uphold CMS's determination that Petitioner was not in substantial compliance with program participation requirements from March 5-23, 2003, and find reasonable the amount of the CMP imposed, $500 per day for 19 days (total $9,500).

Carolyn Cozad Hughes

Administrative Law Judge

1. In its brief, CMS sets the period of noncompliance as from March 5 through 24, 2003. But, because CMS found the facility in substantial compliance as of March 24, 2003, the period of noncompliance ran from March 5 through 23, 2003 (or from March 5 until March 24, 2003).

2. I make Findings of Fact and Conclusions of Law (Findings) to support my decision in this case. I set forth each Finding, in italics and bold, as a separate heading.