SUBJECT:

Red Hills Healthcare Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Red Hills Healthcare Center, Petitioner, requested a hearing to challenge the determination made by the Centers for Medicare & Medicaid Services (CMS) to impose against it two per instance civil money penalties (CMPs) of $3,050 (for a total of $6,100), a two day denial of payment for new Medicare and Medicaid admissions (DPNA), and prohibition of Petitioner's approval to offer nurse aide training and competency evaluation programs (NATCEP), based on deficiencies cited following a survey completed on December 12, 2002. ⁽¹⁾ For the reasons set forth below, I decide that CMS had the authority to impose the CMPs, the DPNA, and the prohibition of NATCEP, because Petitioner was not in substantial compliance with the cited participation requirements.

I. BACKGROUND

Petitioner is a nursing facility located in Sumner, Illinois. CMS determined that Petitioner was not in substantial compliance with federal participation requirements for nursing homes participating in the Medicare and Medicaid programs based on a survey by the Illinois Department of Public Health (State survey agency) which was completed on December 12, 2002. The State survey agency found Petitioner out of substantial compliance with the following participation requirements: 42 C.F.R. � 483.25 (F Tag 309 on the statement of deficiencies); 42 C.F.R. � 483.25(h)(2) (F Tag 324 on the statement of deficiencies); 42 C.F.R. � 483.30(b)(1)-(3) (F Tag 354 on the statement of deficiencies); and 42 C.F.R. � 483.75(e)(8) (F Tag 497 on the statement of deficiencies). The State survey agency also found that the noncompliance identified at F Tags 309 and 324 constituted immediate jeopardy. CMS exhibit (Ex.) 1. By letter dated February 7, 2003, CMS informed Petitioner that it would be imposing remedies based on these deficiencies, which remedies would include the two per instance CMPs of $3,050, the DPNA for two days (in effect from January 6 through 7, 2003, as the State survey agency found Petitioner had attained substantial compliance on January 8, 2003), and the loss of Petitioner's authority to conduct NATCEP. CMS Ex. 3.

Petitioner requested a hearing and the case was assigned to me for hearing and decision. CMS submitted a motion for summary affirmance (which I consider to be a motion for summary judgment, and which I refer to hereafter as CMS Br.), accompanied by 23 exhibits. Petitioner submitted a response and a cross-motion for summary judgment (which I refer to hereafter as P. Br.), accompanied by six attachments, which it submitted as exhibits A-F. CMS submitted a reply (which I refer to hereafter as CMS Reply Br.). In the absence of objection, I am admitting CMS exhibits (CMS Ex.) 1-23 and Petitioner's exhibits (P. Ex.) A-F.

I am not addressing the noncompliance at F Tags 354 and 497. It is not necessary for me to address these tags (which were not found to be at a level of immediate jeopardy) because the immediate jeopardy level noncompliance found at F Tags 309 and 324 alone justifies the remedies imposed. See Batavia Nursing and Convalescent Inn, DAB No. 1911, at 22-24 (2004).

Petitioner also submitted a motion for sanctions based on CMS's having ex parte contact with the treating physician of the resident whose care is at issue in this case. The physician was also Petitioner's medical director. I am denying that motion. I find no basis under section 1128A(c)(4) of the Social Security Act (Act), 42 U.S.C. � 1320a-7a(c)(4), to impose sanctions. CMS's conduct does not appear to be intentional, there is no prejudice to Petitioner, and I am not relying on what the physician told CMS counsel in making my decision.

II. APPLICABLE LAW

Long term care providers, such as Petitioner, participate in the Medicare program by entering into provider agreements with the United States Department of Health and Human Services (HHS). Requirements of participation are imposed by statute and regulation. Act, sections 1819, 1919; 42 C.F.R. Parts 483, 488, and 489. In order to continue in the Medicare and Medicaid programs, providers must remain in substantial compliance with participation requirements.

The regulations define "substantial compliance" as follows: "Substantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. � 488.301.

The regulations specify that a CMP imposed against a provider will fall into one of two broad ranges of penalties. 42 C.F.R. �� 488.408; 488.438. The lower range of CMPs, 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 upper range of CMPs, from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a provider's residents, and, in some circumstances, for repeated deficiencies. 42 C.F.R. �� 488.438(a)(1)(i), (d)(2). When penalties are imposed for an instance of noncompliance, the penalties will be in the range of $1,000 to $10,000 per instance. 42 C.F.R. � 488.438(a)(2). An administrative law judge (ALJ) may not set a penalty at zero or reduce a penalty to zero if the ALJ finds a basis for imposing a CMP exists. 42 C.F.R. � 488.438(e).

The preponderance of the evidence standard is applied to resolve disputed issues of fact, except as provided by 42 C.F.R. � 498.60(c)(2), which states that, in CMP cases, CMS's determination as to the level of noncompliance must be upheld unless it is clearly erroneous. CMS bears the burden of coming forward with evidence sufficient to establish a prima facie case that a provider was not in substantial compliance with the participation requirements at issue. Once CMS has established a prima facie case, the provider has the ultimate burden of persuasion: to prevail, the provider must prove by a preponderance of the evidence that it was in substantial compliance with each participation requirement at issue. See Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); Batavia Nursing and Convalescent Inn, DAB No. 1911; 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); see South Valley Health Care Center, DAB No. 1691 (1999), aff'd, South Valley Health Care Center v. HCFA, 223 F.3d 1221 (10^th Cir. 2000). ⁽²⁾

III. SUMMARY JUDGMENT

I am deciding this case on CMS's motion for summary judgment. An ALJ may decide a case on summary judgment, without an evidentiary hearing, if the case presents no genuine issue of material fact. Crestview Parke Care Center v. Thompson, 373 F.3d 743, 750 (6^th Cir. 2004); Livingston Care Center v. Dep't. of Health & Human Services, No. 03-3489, 2004 WL 1922168, at 3 (6^th Cir. Aug. 24, 2004). By interpretive rule, this tribunal has established a summary judgment procedure "akin to the summary judgment standard contained in Federal Rule of Civil Procedure 56." Crestview Parke Care Center, 373 F.3d 743, 750. Under that rule, the moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law, or by showing that the non-moving party has presented no evidence "sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Livingston Care Center, No. 03-3489, 2004 WL 1922168, at 4, citing Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). The nonmoving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986). See also Vandalia Park, DAB No. 1939 (2004); Lebanon Nursing and Rehabilitation Center, DAB No. 1918 (2004). A mere scintilla of supporting evidence is not sufficient. "If the evidence is merely colorable or is not significantly probative summary judgment may be granted." Livingston Care Center, No. 03-3489, 2004 WL 1922168, at 4, quoting Anderson v. Liberty Lobby, 477 U.S. 242, at 249-250 (1986). In deciding a summary judgment motion an ALJ may not make credibility determinations or weigh conflicting evidence but must instead view the entire record in the light most favorable to the non-moving party, all reasonable inferences drawn from the evidence in that party's favor. Innsbruck HealthCare Center, DAB No. 1948 (2004); Madison Health Care, Inc., DAB No. 1927 (2004).

In evaluating the parties' submissions, I find that even if I construe the entire record in the light most favorable to Petitioner, as discussed below, I would find that Petitioner was out of substantial compliance in this instance and that the noncompliance constituted immediate jeopardy. Moreover, Petitioner has tendered no specific facts to support that a material fact is in dispute, and CMS has made a prima facie case that it is otherwise entitled to judgment as a matter of law. See Carrier Mills Nursing Home, DAB No. 1883, at 3-4 (2003).

IV. FINDINGS OF FACT AND CONCLUSIONS OF LAW

1. As of the survey ending on December 12, 2002, Petitioner was out of substantial compliance with participation requirements.

A. Petitioner was out of substantial compliance with the participation requirement at F Tag 309.

F Tag 309 reflects a deficiency at 42 C.F.R. � 483.25. This regulation provides that each resident must receive, and a facility must provide, the necessary care and services to allow a resident to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care.

The statement of deficiencies (also called a CMS 2567 or 2567) recites findings of the State survey agency that the facility failed to ensure that all staff were properly trained in emergency medical situations. Specifically, the statement of deficiencies alleged that facility staff failed to appropriately respond to a medical emergency requiring cardiopulmonary resuscitation (CPR), asserting that Resident 12 was found in her room, after having slipped down in her wheelchair, with her safety device (a seat belt) around her neck. The State agency surveyors state that CPR was initiated and discontinued after 16 minutes without authorization to discontinue from appropriate medical personnel. Further, they allege that facility staff failed to contact any emergency medical services after initiating CPR for Resident 12. The surveyors assert that this failure resulted in an immediate jeopardy for Resident 12. CMS Ex. 1.

Resident 12 was a severely compromised individual. As portrayed in Petitioner's brief, and as CMS does not dispute, Resident 12 suffered from Huntington's Chorea Disease (Huntington's), depressive disorder, neuralgia, hypertension, and chronic choreathetosis. P. Br. at 5; CMS Ex. 16. Petitioner notes that Huntington's is a genetic progressive neuro-muscular disorder characterized by the gradual development of involuntary muscle movements affecting an individual's hands, feet, face and trunk. Progressive deterioration of cognitive processes and memory is a common feature of Huntington's. Resident 12 often exhibited uncontrolled, irregular, rapid jerky movements. P. Br. at 5-6. Petitioner notes that Resident 12 was comprehensively assessed at least quarterly. A care plan was developed and revised based on her condition, which was progressively declining. Resident 12 was reassessed on September 26, 2002, and, according to Petitioner, its interdisciplinary team determined that a wheelchair with a self-releasing seat belt was appropriate to protect her from falls. Further, Petitioner's staff was also conducting 15-minute visual checks on her. Id. at 6. Her physician's orders reflect that Resident 12 was to have as safety devices blue dycem in her wheelchair at all times to decrease her sliding forward, a low bed, and a safety belt on while she was in her wheelchair to limit falls. CMS Ex. 16, at 2.

Resident 12 died on November 23, 2002. Petitioner's nurse's notes for that day, at P. Ex. 18, at 4-5, indicate that:

5:00 p.m. Ativan given as per orders. Assisted up in chair [and] seat belt tightened. [Resident] had her feet up on the hand rails [and] the seat belt around her breast area.

5:30 p.m. CNA went to room to get resident to come to [dining room] for evening meal. Refused [at] this time to come out. Sitting in [wheelchair] seat belt around waist.

Late 5:15 p.m. Resident out in hall screaming [and] pulling hair [with] her hands. Seat belt around breast area again. Assisted up in [wheelchair] seat belt retightened. Escorted to room door left open to be able to observe [Resident].

5:45 p.m. CNA went back to room. Told resident to come to [dining room] that her supper was waiting. Resident slouched down in [wheelchair]. Refused to go to [dining room].

6:00 p.m. CNA went back to [Resident's] room to get [Resident] for supper [Resident] found [with] seat belt around arm pits [and] throat. Released seat belt felt for pulse. No pulse. Called for nurse.

6:01 p.m. Nurse entered room. [Resident] sitting on floor. CNA stated not breathing. CPR initiated. [Resident] eased to lying position on floor.

6:02 p.m. Maintenance man appeared. Relieved CNA so she could go get chart. CPR listed on chart. CPR continued as per policy.

6:17 p.m. CPR stopped. No pulse no respirations for one full minute.

6:20 p.m. Administrator called. States on her way.

6:22 p.m. Attempted to call ADON message left [with] husband.

6:24 p.m. [RN] contacted. Stated on his way . . . situation explained.

6:30 p.m. Attempted to call OSG was give[n] a number to contact.

6:35 p.m. Attempted to contact [Petitioner's physician]. Was informed he is out of town for the weekend.

7:00 p.m. Contacted [another physician and] informed her of the passing of this resident.

7:30 p.m. County Coroner . . . here to investigate resident death.

8:00 p.m. Body removed per LCAS to County Morgue per orders of . . . Lawrence County Coroner.

8:30 p.m. Inquiry made of incidents leading up to [and] including events before [and] after resident death.

9:30 p.m. Coroner called here. Daughter . . . had been contacted.

10:45 p.m. Husband called here. Explained that resident had died and events of death. Explained about Coroner's inquest [and] disposal of body.

Regarding other facts, Petitioner does not dispute that the CPR performed on Resident 12 was four cycles, five compressions to one breath. Petitioner does not dispute that the CNA initially did mouth to mouth, then the nurse (an R.N.) took over and the maintenance supervisor did the chest compressions. ⁽³⁾ Petitioner does not dispute that the facility did not call 911. Petitioner does not dispute that Resident 12 was cleaned up, her clothing was removed, and a gown was put on prior to the coroner arriving. See CMS 11, at 6; P. Br. at 7-9.

An autopsy was performed. On December 16, 2002, the pathologist who performed the autopsy stated that in his opinion "[d]eath in this 68 year old woman is attributed to postural asphyxia secondary to partial suspension by the waist restraint, after having slid down in a wheelchair. This is seen as the result of advanced Huntington's disease and physical deterioration. The characteristic changes of advanced Huntington's disease are present." CMS Ex. 21, at 4. A coroner's jury verdict on January 27, 2003, found Resident 12's "manner of . . . death to be accidental but preventable." Id. at 2. On February 24, 2003, the County Coroner sent a letter to the Illinois Department of Public Health. The County Coroner stated that the Coroner's Inquest revealed some concerns about Resident 12's death. Specifically, the County Coroner stated that Resident 12 "was found November 23, 2002 in her room at the nursing home, suspended by a lap belt restraint device located on her wheel chair. When the nursing home staff found the patient in this position, they removed her from the chair and began CPR. The investigation revealed that the staff did not request an ambulance upon finding the patient. Further, the nursing staff began CPR and discontinued CPR without a physician's order." Id. at 1.

CMS asserts that Petitioner did not provide Resident 12 with the necessary care and services to maintain her highest practicable physical well-being in accordance with her plan of care. Resident 12's plan of care indicated that she was a full code. CMS argues that when Resident 12 was found unresponsive, staff did not follow the correct CPR procedure and immediately call for an ambulance. CMS cites an American Heart Association (AHA) guide ("Heartsaver CPR") which delineates what it has determined are the critical actions necessary to treat such a life-threatening emergency (termed the chain of survival) - 1) phone 911 or other emergency response number to activate the emergency medical services system; 2) begin CPR; 3) early defibrillation by trained rescuers or emergency personnel; and 4) advanced care by emergency personnel and hospital personnel. CMS Ex. 23, at 2. CMS alleges based on this that Petitioner's staff should have continued CPR until emergency personnel arrived or they were instructed by a physician to stop rather than stopping after 16 minutes. CMS cites the AHA guide where it states that "CPR is the critical link that buys time between the first link (phone 911) and the third link (early defibrillation)." CMS Ex. 23, at 4. The AHA guide reflects that CPR should be continued "until additional treatment (defibrillation) restores normal heart action or until EMS personnel arrive." CMS Ex. 23, at 8. CMS states that the AHA guide also recommends providing CPR as 15 compressions then two breaths, not five compressions to each breath as done by Petitioner's staff. CMS Ex. 23, at 13. CMS also asserts that Petitioner is responsible for the actions of its employees as a matter of law, as their actions were taken within the scope of their employment.

Petitioner argues that just because Resident 12 died does not automatically mean that Petitioner's staff must be at fault or that an immediate jeopardy situation occurred. Petitioner asserts it properly cared for Resident 12 and that this accident could not have been prevented. Petitioner asserts that the pathologist who conducted the autopsy concluded that Resident 12's death was accidental and not due to Petitioner's staff's fault. Petitioner refers to a letter in which the pathologist states that "[i]t is important that you tell the family death did not result form the waist restraint compressing her neck, but from her sliding down and being unable to breathe due to her feeble condition. If there was not a waist restraint, she would have fallen on the floor . . . Sadly, her time was at the end due to her advanced Huntington's Disease." P. Ex. C. Moreover, Petitioner asserts that it cannot be held strictly liable for the isolated actions of its employees. It asserts that it provided appropriate training regarding emergency services prior to November 23, 2002. Further it asserts that it should not be found to have created an immediate jeopardy situation due to the failure of one nurse to follow correct emergency resuscitation procedures. Petitioner asserts that CMS submitted no medical evidence that it failed to properly care for Resident 12. It asserts that CMS relied on objective treatises to show why CPR was not properly performed, but fails to link any causal connection between the efforts of Petitioner's staff and Resident 12's death.

CMS has proved a prima facie case that Petitioner has not rebutted. Specifically, CMS has put forward a prima facie case that Petitioner failed to respond appropriately to a medical emergency requiring CPR, in that Petitioner did not follow correct CPR procedure, immediately call for an ambulance, or continue CPR until either emergency personnel arrived or its staff were instructed by a physician to stop. Petitioner has provided no evidence to show that its staff followed correct CPR procedure in order to rebut CMS's prima facie case on this point. It is not enough for Petitioner to assert that it was CMS's duty to submit a physician's testimony on this point. Instead, it is Petitioner's duty to rebut the prima facie case brought forward by CMS and to provide some scintilla of evidence that its staff followed correct CPR procedure. Here, Petitioner did not even provide a copy of its procedures and instructions to staff on performing CPR.

Petitioner argues that the pathologist indicated that Resident 12's death was accidental and that she did not die as the result of the waist restraint pressing against her neck, but by sliding down and being unable to breathe due to her condition. CMS never argued anything inconsistent with the contents of the pathologist's letter. The pathologist says the death was accidental, the coroner's inquest found the death to be accidental, but preventable. The pathologist's finding that Resident 12's death was due to postural asphyxia secondary to "partial suspension by the waist restraint, after having slid down in a wheelchair" does not rule out the possibility that Resident 12 could not breathe due to the restraint compressing her chest, and neither the pathologist's finding nor the coroner's jury's finding is inconsistent with the arguments and evidence advanced by CMS regarding this F Tag.

The findings of the pathologist and the coroner's jury, moreover, do not address the crux of CMS's allegation of deficiency as noted above - the allegedly faulty method by which Petitioner administered CPR to Resident 12. The only argument raised by Petitioner on this issue is that Petitioner cannot be held strictly liable at law for one isolated act of a single employee, and that there must be more than one individual involved and a pattern of conduct. Petitioner argues that although the nurse on duty was not currently certified to perform CPR, that did not mean that her skills should be automatically discounted. While this may be true, Petitioner does not argue or provide any affidavits or other evidence that the nurse administered CPR consistent with the procedures cited by CMS or set forth in other medical literature or pursuant to other medical authority. While Petitioner asserts that this is a genuine issue of material fact, simply making the assertion without any evidence to support it does not make it a contested material fact for purposes of overturning a motion for summary judgement. Moreover, where a nurse is acting within the scope of her employment responsibilities, her employer cannot disown the consequences of the inadequacy of her care by the expedient of pointing the finger at her fault, since the nurse was the agent of the employer and empowered to make and carry out daily decisions. Emerald Oaks, DAB No. 1800, at 7, n. 3 (2001); Ridge Terrace, DAB No. 1834, at 8 (2002). Further, in this instance, more than one employee was involved in performing the CPR - the nurse, a CNA, and a maintenance employee. Moreover, no one in the facility called for an ambulance when Resident 12 was found, and no one continued CPR after the nurse stopped.

B. Petitioner was out of substantial compliance with the participation requirement at F Tag 324.

F Tag 324 reflects a deficiency at 42 C.F.R. � 483.25(h)(2). This section of the regulations provides that a facility must ensure that "[e]ach resident receives adequate supervision and assistance devices to prevent accidents." The statement of deficiencies recites findings of the State survey agency that the facility failed to ensure that Resident 12 was appropriately supervised to ensure her safety in a self-release wheelchair seat belt. Specifically, Resident 12 was found non-responsive after having slipped down in her wheelchair in her room with the safety device around her neck. CMS Ex. 1, at 4-7.

CMS argues that Petitioner failed to take adequate precautions to prevent Resident 12 from sliding down in her wheelchair and being asphyxiated by her wheelchair seat belt. CMS notes that Resident 12 put her feet up over the arm rails of her wheelchair to keep her legs from moving, which would apparently cause her to slide down in her wheelchair. CMS asserts that Resident 12's diagnosis of Huntington's put her at great risk of being asphyxiated by her restraint. Thus, CMS asserts that Resident 12 should not have been left alone when she was agitated and had been observed sliding down in her wheelchair, been raised up, and had her seat belt tightened. CMS notes that no corrective action was taken at 5:45 p.m., when Resident 12 was noted slouched down in her wheelchair. Moreover, CMS asserts that Resident 12 should have been evaluated for a more appropriate restraint in light of her tendency to put her legs up, causing her torso to slouch down, and that Resident 12's condition made it more difficult for her to undo the seat belt. Finally, while CMS agrees that Petitioner took some measures to protect Resident 12, CMS states they were not sufficient. While the facility checked on Resident 12 at 15-minute intervals, CMS referred to medical literature which indicates a death like Resident 12's can occur in as little as 10 minutes. CMS recognizes that the resident did not need to be continually observed and that her behavior and mental functioning fluctuated. CMS acknowledges that she was presumably in more danger at certain times. CMS asserts, however, that when the resident was mentally agitated and engaging in behaviors that put her at risk, she should not have been put in her room. Moreover, while it was reasonable to try dycem as an intervention, it should have been clear from the frequency with which Resident 12 was found with a seat belt around her chest that the dycem was not sufficient to prevent her sliding down.

Petitioner argues that Resident 12 received adequate supervision and assistance devices to prevent accidents at all times. Petitioner asserts that CMS has portrayed Huntington's as a simple disease to care for when, in fact, it is extremely debilitating and the cause of Resident 12's death. Petitioner asserts its adequate precautions included use of an interdisciplinary team, 15-minute visual checks for supervision, instituting a wheelchair with a self-release belt to prevent Resident 12 from falling, and instituting the use of dycem to prevent her from sliding in her chair. Petitioner asserts that these were medically appropriate interventions. Moreover, Petitioner asserts that the methods and assistance devices in place were the least restrictive and adequate methods and devices it could have used and that they were part of a comprehensive care plan for the resident. Restraining her further, or more than her physician ordered, could have constituted a violation of restraint usage. Petitioner noted that even Resident 12 was pleased with the restraint.

Petitioner asserts that Resident 12 was observed no less than seven times between 5:00 p.m. and being discovered unresponsive, and that such frequent observations were not inadequate. Further, on November 23, 2002, Petitioner was conducting 15-minute visual checks on Resident 12. Petitioner argues that CMS provided no specific examples of inadequate supervision constituting noncompliance, and asserts further that this was not an immediate jeopardy situation. Petitioner also argues that it followed Resident 12's care plan completely, and that it was updated regularly to address her deteriorating condition. It followed, Petitioner contends, all her physician's orders without exception.

The Departmental Appeals Board has articulated a facility's obligations under 42 C.F.R. � 483.25(h)(2) in a string of recent cases. See Guardian Health Care Center, DAB No. 1943, at 17-18 (2004) and cases cited therein. The Board stated that the regulation requires a facility to provide adequate supervision and assistance devices to prevent accidents and set out a framework for evaluating allegations of noncompliance with the requirement. Although a facility is not to be held strictly liable for accidents that occur, a facility is required to take reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet a resident's needs and to mitigate foreseeable risks of harm from accidents. While a facility is permitted to choose its own methods to prevent accidents, those methods must be adequate under the circumstances. Whether the supervision and assistance devices are adequate depends on the resident's ability to protect him or herself from harm.

Resident 12 was a severely compromised resident. Petitioner had a high obligation to ensure the adequacy of the measures taken to prevent an accident such as the one that occurred, and the accident that did occur was absolutely foreseeable given the position of the waist restraint or seat belt during the last hour of Resident 12's life and Resident 12's physical and mental condition. While Petitioner did care plan to prevent accidents, these measures were not adequate on November 23, 2002. The use of the dycem was not unreasonable - it just did not prevent Resident 12 from sliding down in her wheelchair. The use of the waist restraint or seat belt was not inadequate initially - but on November 23, 2002, when Resident 12 was continually slipping down and displacing the seat belt from her waist to her breast and throat, it was. The 15-minute checks, while perhaps initially reasonable, were not when the nurses came in to Resident 12's room and found her seat belt out of position and Resident 12 apparently unable to undo the belt. It is also inexplicable to me that, at 5:45, after Resident 12 had already been pulled up and the seat belt repositioned more than once, Resident 12 was not repositioned when she was found by the CNA "slouched down" in her wheelchair.

2. Petitioner was out of compliance with the participation requirements at F Tags 309 and 324 at a level of immediate jeopardy.

"Immediate jeopardy" is defined as "a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." 42 C.F.R. � 488.301. Given CMS's expertise in determining the scope and severity of a cited deficiency, I cannot change CMS's assignment of immediate jeopardy unless that assignment is clearly erroneous. As found at 42 C.F.R. � 498.60(c)(2), I must uphold "CMS's determination as to the level of noncompliance of an SNF or NF . . . unless it is clearly erroneous." See also 42 C.F.R. � 498.3(d)(10). It is not necessary to show that there is a causal relationship between a resident's death and the noncompliance. It is only necessary to show that the deficiency poses a risk that rises to the level of a likelihood that serious injury, harm, impairment or death may occur. See Good Samaritan Center, DAB No. 1844, at 20 (2002).

I do not believe that CMS was clearly erroneous in its conclusion that Petitioner's failure to prevent Resident 12 from sliding down in her wheelchair caused at least a likelihood of serious harm or death. I have found that Petitioner failed to respond appropriately to a medical emergency requiring CPR and that Petitioner failed to appropriately supervise Resident 12 while she was wearing a waist restraint - under either scenario a likelihood of serious injury, harm, impairment or death could occur. I do not need to find specifically that Resident 12's death was itself caused by Petitioner's noncompliance.

3. The remedies imposed are reasonable.

As noted above, CMS imposed two per instance CMPs totaling $6,100, a two day DPNA, and a two-year NATCEP prohibition. If a facility is found to be out of substantial compliance with participation requirements at an immediate jeopardy level, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. � 488.406, including the imposition of a DPNA and a CMP (either per instance or per day). Moreover, a petitioner must lose its NATCEP for two years when it is subject to a partial extended survey as a result of a finding of substandard quality of care. Act, sections 1819(f)(2)(B) and 1919(f)(2)(B), as here. I cannot review the choice of remedies by CMS (42 C.F.R. � 498.3(d)), but I can consider whether the amount of the CMP imposed against Petitioner is reasonable.

The reasonableness of the amount of a CMP is determined by applying the factors listed in 42 C.F.R. �� 488.438(f) and 488.404. Emerald Oaks, DAB No. 1800, at 10 (2001); CarePlex of Silver Spring, DAB No. 1683, at 16-17 (1997). These factors include a facility's history of noncompliance; a facility's financial condition; a facility's degree of culpability, and the factors specified in section 488.404 which are considered in the selection of any remedy. This regulation calls for an initial assessment by CMS of the seriousness of the deficiency, which includes the degree of risk of harm that the deficiencies present and whether the deficiencies are isolated, part of a pattern, or widespread. 42 C.F.R. � 488.404(b). CMS may also consider "other factors, which may include, but are not limited to," how the deficiencies relate to each other and the facility's prior history of "noncompliance in general and specifically with reference to the cited deficiencies." 42 C.F.R. � 488.404(c). In this case CMS imposed two per instance CMPs of $3,050, totaling $6,100, for the deficiencies found at F Tags 309 and 324. Penalties may range between $1,000 to $10,000 per instance. At a level of immediate jeopardy, penalties for a per day CMP range from between $3,050 to $10,000 for each day a petitioner is out of substantial compliance. 42 C.F.R. � 488.438.

Petitioner has not specifically contested the reasonableness of the CMP, stating instead, in its report of readiness for hearing, that an issue exists as to "whether the remedies, including but not limited to the civil money penalties . . . imposed by CMS are justified." I agree with CMS, however, that the CMP imposed is reasonable and justified. Petitioner had an immediate jeopardy deficiency in its previous survey cycle under F Tag 324 in which a $3,050 CMP was imposed. CMS Ex. 4. Here, there were two deficiencies. CMS set $3,050 per instance CMPs totaling $6,100, although it could have imposed a per instance CMP of up to $10,000 and a per day CMP of from $3,050 to $10,000. Thus, the CMP imposed is in the lower range of CMPs that could have been imposed. Moreover, the deficiency here is a serious one, as the likelihood of harm was very high. Although only one resident was directly involved, that Petitioner's staff were not prepared to follow correct emergency resuscitation procedures could have endangered other residents' lives as well.

V. CONCLUSION

I conclude that Petitioner was out of substantial compliance with federal participation requirements at a level of immediate jeopardy. Accordingly, CMS was authorized to impose remedies including a DPNA and a CMP, and must impose the NATCEP. Further, I find that the amount of the CMP imposed is reasonable.

Alfonso J. Montano

Administrative Law Judge

1. Petitioner submitted two hearing requests relating to this December 12, 2002 survey cycle, which were docketed as Docket Nos. C-03-283 and C-03-382. By motion dated July 15, 2003, the parties requested that I consolidate these two cases. By order dated July 16, 2003, I consolidated the two cases into the record of Docket No. C-03-283.

2. In its brief, Petitioner argues that it should not bear the burden of persuasion as it was allocated in the Hillman case. P. Br. at 2-5. I adopt the burden as set forth in Departmental Appeals Board (DAB) decisions in the Hillman case, and as stated and discussed in detail in the Batavia Nursing and Convalescent Center and Batavia Nursing and Convalescent Inn cases cited above. However, I note that Petitioner has preserved its arguments regarding the burden of proof or persuasion for appeal.

3. The parties agree that the nurse's CPR certification had expired, but I do not consider this fact material to my decision. CMS has not specifically cited Petitioner as out of compliance because the nurse performing CPR did not have a current CPR certification, and I agree with Petitioner that the nurse's lack of a current certification does not automatically mean that she lacked the skills to perform CPR.