SUBJECT:

Argentine Care Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I grant the Centers for Medicare & Medicaid Services' (CMS's) motion for summary judgment and, thereby, sustain CMS's determination of substantial noncompliance at the immediate jeopardy level and imposition of remedies against Argentine Care Center (Petitioner).

I. Background

Petitioner is a nursing facility located in Linden, Michigan. On November 15, 2002, an abbreviated standard and partial extended survey was completed at Petitioner's facility by the Michigan Department of Consumer and Industry Services (state agency). The state agency determined, as reported in the CMS Form 2567 (Statement of Deficiencies or SOD), that Petitioner on November 6, 2002, had not been in substantial compliance with federal Medicare participation requirements, and that the noncompliance resulted in immediate jeopardy to Petitioner's residents. The state agency also determined that, while immediate jeopardy had been abated in one day, other uncorrected deficiencies remained. CMS concurred with the state agency and, on December 11, 2002, CMS notified Petitioner that CMS was imposing a per instance civil money penalty (CMP) in the amount of $3,500 for the noncompliance described in the November 15, 2002 SOD at F Tag 367; a per instance CMP in the amount of $3,500 for the noncompliance described in the SOD at F Tag 309; and a denial of payment for new admissions (DPNA) effective February 15, 2003. On January 23, 2003, Petitioner timely submitted a request for hearing to challenge CMS's determination. Subsequently, CMS rescinded the F Tag 367 deficiency citation, which reduced the outstanding CMP to $3,500. Petitioner (P.) Exhibit (Ex.) B1. The proposed DPNA was also rescinded. Id.

Thereafter, both CMS and Petitioner advised of their respective intent to file motions for summary judgment in the case. A briefing schedule was established. On July 14, 2003, CMS filed its Motion for Summary Affirmance. On the same day, Petitioner filed Petitioner's Motion for Summary Judgment, and three attached exhibits marked A - C (P. Exs. A1 - C1). ⁽¹⁾ Also, on July 14, 2003, the parties filed a stipulated set of facts. On August 4, 2003, CMS filed its Response to the Petitioner's Motion for Summary Judgment and 12 proposed exhibits (CMS Exs. 1 - 12). With its exhibit list, Petitioner submitted 10 proposed exhibits (P. Exs. A - J). There being no objection, I have admitted all attached documents and proposed exhibits into the record.

II. Applicable law and regulations

Petitioner is considered a long-term care facility under the Social Security Act (Act) and regulations promulgated by the Secretary of Health and Human Services (Secretary). The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Act and at 42 C.F.R. Part 483.

Sections 1819 and 1919 of the Act invest the Secretary with authority to impose CMPs against a long-term care facility for failure to comply substantially with federal participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. Part 488 of 42 C.F.R. provides that facilities participating in Medicare may be surveyed on behalf of CMS by state survey agencies in order to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. �� 488.10 - 488.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. �� 488.300 - 488.335. The regulations at 42 C.F.R. Part 488 give CMS a number of different remedies that can be imposed if a facility is not in compliance with Medicare requirements. Under Part 488, a state or CMS may impose a per instance or per day CMP against a long-term care facility when a state survey agency concludes that the facility is not complying substantially with federal participation requirements. 42 C.F.R. �� 488.406, 488.408, 488.430.

The regulations specify that a CMP which is imposed against a facility can be either a per day CMP for each day the facility is not in substantial compliance, or a per instance CMP for each instance that a facility is not in substantial compliance. 42 C.F.R. � 488.430(a). When penalties are imposed for an instance of noncompliance, the penalties will be in the range of $1,000 - $10,000 per instance. 42 C.F.R. � 488.438(a)(2).

The regulations define the term "substantial compliance" to mean "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.

Substantial noncompliance that is 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.

The Act and regulations make a hearing before an administrative law judge (ALJ) available to a long-term health care facility against whom CMS has determined to impose a CMP. Act, section 1128A(c)(2); 42 C.F.R. �� 488.408(g), 498.3(b)(12), (13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al., DAB CR65 (1990), aff'd, 941 F.2d 678 (8^th Cir. 1991).

III. Issues

The issues in this case are:

�whether a decision on summary judgment is appropriate;

�whether CMS has shown a basis upon which to assess a penalty against Petitioner for substantial noncompliance of requirements for participation in Medicare and Medicaid; and if so,

�whether the noncompliance posed immediate jeopardy; and

�whether the amount of the assessed penalty is reasonable.

IV. The Parties' Arguments

As described below, the parties have agreed on the essential facts in this case; i.e., one of Petitioner's residents was given a food item by a nurse aide (or CNA) that was inconsistent with the resident's prescribed diet and which led to the resident's death. CMS does not dispute that prior to this incident, Petitioner had attempted to ensure that the CNA was properly trained and certified, performed an adequate and thorough background check of the CNA, properly in-serviced staff, and had sufficient and proper policies and procedures in place for feeding residents.

Petitioner argues that "CMS has failed to produce or submit any facts or evidence showing that Argentine did anything improperly, systemically or otherwise, other than the occurrence of the incident itself." P. Brief (Br.) at 1. Petitioner phrases the dispute as a question of whether the regulations impose a standard equivalent to strict liability, or one more akin to negligence. Id. Petitioner also argues that the isolated event that did occur does not support a designation of immediate jeopardy. P. Br. at 3. According to Petitioner, as long as it took reasonable precautions to provide a resident with proper dietary services, and did not otherwise commit either a deliberate or negligent act, the requirements at section 483.25 of the regulations are satisfied.

CMS contends the deficiency at F Tag 309 does not "amount to the imposition of strict liability." CMS Response at 2. CMS asserts that "Petitioner's failure to dispute the implication of its employee's actions in the demise of Resident 1 unquestionably establishes grounds for it to be held responsible for the legal consequences of those actions under the regulations." Id. According to CMS, a provider cannot avoid accountability on grounds of lack of foreseeability, diligence of training and supervision, or attention to quality assurance. CMS Br. at 8.

V. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each Finding below as a separate heading. I discuss each Finding in detail.

A. Summary judgment is appropriate in this case because neither party has demonstrated any dispute over genuine issues of material fact.

Unless the parties raise a genuine issue of material fact, an ALJ may decide a case on summary judgment without an evidentiary hearing. Livingston Care Center, DAB No. 1871 (2003); Everett Rehabilitation and Medical Center, DAB No. 1628, at 3 (1997); Carmel Convalescent Hospital, DAB No. 1584, at 27 (1996). The Board reiterated in Livingston Care Center, that

CMS is entitled to summary judgment if it has (1) made a prima facie showing that [the facility] was not in substantial compliance with one or more participation requirements, and (2) demonstrated that there is no dispute about any material fact supporting its prima facie case and that it is otherwise entitled to judgment as a matter of law. CMS is not entitled to summary judgment if [the facility] has proffered evidence that would permit an ALJ to conclude that it was in substantial compliance with Medicare participation requirements during the relevant time.

Livingston Care Center, DAB No. 1871, at 6.

The essential question presented by this case is whether the Petitioner provided one resident, referred to as Resident 1 to protect her privacy, with the necessary care and services to attain or maintain her highest practicable physical, mental and psychosocial well-being in accordance with her comprehensive assessment and plan of care. 42 C.F.R. � 483.25. In this case, no one disputes the stipulated facts, discussed below. The conclusions I have reached result from my application of the pertinent law and regulations to the stipulated facts.

I can think of no testimony from witnesses that could add to the material facts in this case. As stated in Big Bend Hospital Corp. d/b/a Big Bend Medical Center, DAB No. 1814 (2002), "[t]o convene an in-person hearing where no proffered evidence would have any affect [sic] on the outcome would be an empty formalism and a waste of administrative and litigant resources." Id. at 15. There is no need for an in-person hearing "where no testimony (including cross-examination, regardless of how credible it might be) could alter the relevant factual findings." Id. at 16. I conclude, therefore, that summary judgment is appropriate in this case.

B. The evidence supports a finding that Petitioner failed to comply substantially with participation requirements at 42 C.F.R. � 483.25 (F Tag 309).

The regulations for Medicare participation at 42 C.F.R. � 483.25 require that each resident must receive and the facility must provide the necessary care and services to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care. I find that Petitioner failed to provide necessary services to ensure the resident's highest practicable physical well-being. Resident 1, discussed below, incurred actual harm (i.e., death) as a result of Petitioner's deficiency.

1. The Parties' Stipulated Set of Facts.

I record below, verbatim, (with grammatical errors) the stipulation of facts entered into by the parties to allow the reader to understand more easily my findings.

1. On November 15, 2002, the Michigan Department of Consumer and Industry Services (hereafter "MDCIS") conducted a complaint investigation at Petitioner Argentine Care Center (hereafter "Argentine") as a result of a self-reported incident.

2. The subject Resident [hereafter 'Resident'] identified on the CMS-2567L for the November 15, 2002 complaint investigation as Resident #1 had been a resident at Argentine since November 24, 1982. She had been admitted with a diagnosis that included hypothyroidism, arteriosclerotic heart disease, congestive heart failure, hypertension, peripheral vascular disease, arthritis, Parkinson's disease, transient ischemic attack, manic depression, and schizophrenia.

3. On April 21, 2002, Resident was evaluated by a speech therapist, in part, concerning her diet. The therapist recommended that her diet at that time be continued, i.e., mechanical soft and pureed food, but with suggested cueing, supervision and that alternate food preparation (smaller bites, finger foods) be provided.

4. Resident was re-evaluated again on May 20, 2002, by an Argentine speech therapist concerning her diet. The therapist noted that over the previous weeks, nursing had indicated that Resident had been pocketing food during meals while on the mechanical soft diet. The therapist observed that Resident was able to follow simple commands (i.e., open her mouth). According to the speech therapist, due to Resident's decline and inability to prepare and transfer the bolus with mechanical soft consistency food, it was recommended that her diet be changed to one of pureed/thin food.

5. On or before June 3, 2002, a physician order changed Resident's diet to one of pureed consistency. Resident's care plan was revised to reflect the diet change and to address weight loss and potential for dehydration. The MDS and RAP were also changed to reflect the new diet on June 11^th and 12^th.

6. On August 6, 2002, milk, juice and gravy/fats were incorporated into diet plan to address Resident's weight loss. On August 26, 2002, a "care conference" was held which addressed Resident by the interdisciplinary team.

8. On November 3, 2002, at approximately 2:15 p.m., Resident was sitting at a table in the main dining room. The diet card on her tray was consistent with her diet order and indicated that she was to receive "pureed diet with no breads." Additionally, the acceptance sheets that are filled out by staff members after each meal stated on the bottom right corner that Resident was to receive "pureed-no bread." At this table was the subject Argentine CNA [hereafter 'CNA'], who was assisting with the feeding of the residents assigned to this table, Resident among them. Resident asked for a sandwich. CNA called to the kitchen and asked for three sandwiches, two meat sandwiches and a peanut butter sandwich with no jelly. The kitchen staff sent three sandwiches up to the dining room. CNA gave Resident the peanut butter sandwich. Shortly thereafter Resident began choking. CNA immediately notified the charge nurse. The staff attempted to do the Heimlich maneuver but were unsuccessful in opening Resident's airway. At the same time, staff called 911. Emergency personnel arrived within five minutes and took over from the staff. Emergency personnel were able to clear the airway. Resident left the facility and was transported to the hospital. She was pronounced dead thereafter and the death certificate listed the cause of death as due to anoxia as a result of choking on ingested food.

9. Argentine's employee screening policy prior to employment is that a person's references are checked and that the employee is either in training to be certified as a nurse's aide or is already certified. Argentine's CNA training program is very extensive and includes both a clinical and a laboratory component. The total class time required is 79.5 hours. Four and one-half hours are spent on the topic area of meeting nutritional and hydration needs, and four hours are spent on the topic area of safety procedures. Topics covered within the feeding area include how to read a dietary card, how to properly feed a patient, factors that affect eating and nutrition, special dietary needs and fluid balance. There is a discussion of the various types of special diets that may be used for residents and that each resident has an individually planned meal. CNA candidates are provided a copy of the Nursing Assistant Basic Study Guide, which specifically instructs an aide to check the diet card and compare it with the meal served to a resident to make sure it is the correct meal, and warning that serving the wrong meal can cause severe problems. Candidates are provided a copy of Mosby's Textbook which also instructs to make sure to compare the items on a resident's tray with their dietary card. Candidates are tested in all areas and additionally must write a paper on a particular disease. Candidates must complete all of the training and pass all of the test areas. Once the training is complete, the candidate has a 90-day probationary period during which her performance is evaluated and reviewed by management. Only after successfully completing this probationary period will a candidate be given a completion certificate and then allowed to register for testing for certification.

10. CNA had started training at Argentine on August 19, 2002. CNA had been instructed on how to read dietary cards and to make sure that the resident received the proper food items on her tray. She received written material on how to read dietary cards. CNA's references were contacted and gave positive feedback about her. CNA completed all of the required training classes, both of the tests and the required paper. She received satisfactory scores on all of the topic areas including feeding, mealtime and the Heimlich maneuver. She received a top score in the area of safety consciousness. CNA acknowledged receipt of Mosby's Long Term Care Assistant Textbook on August 19, 2002. She obtained satisfactory marks in both her nursing aide training lab skills review and nursing aide training clinical skills reviews. Both the lab and clinical skills evaluations included feeding testing. The CNA passed her nurse aide training final examination. It is significant that CNA's final exam included a question concerning proper identifying liquid foods.

11. Argentine was initially cited for two immediate jeopardy deficiencies F309 and F367, which are defined as situations in which immediate corrective action is necessary because the facility's non-compliance with one or more requirements of participation has caused or is likely to cause serious injury, harm, impairment, or death to a resident receiving care in a facility (SOM, Appendix Q). There were no findings that Argentine failed to follow a precautionary procedure or that there was any systemic breakdown in the facility's policies. The regulatory requirements for the tags are located in 42 CFR �483.25 and �483.35(e). As a result of these tags, CMS initially imposed two CMPs of $3,500.00 each or a total of $7,000.00. Pursuant to 42 USC � 1819(f)(2)(B)(iii)(l)(b), Argentine is prohibited from conducting its own nurse-aide training.

12. On July 9, 2003, CMS notified Argentine that it was rescinding the F367 tag. This thereby reduced the CMP to a total of $3,500.00. Argentine remains prohibited from conducting its own nurse-aide training.

2. Determinations which hold a facility to an affirmative duty of care for its residents are not equivalent to the implementation of a "strict liability" standard.

Petitioner argues that it had appropriate "precautionary and safety measures in place to reasonably guard against foreseeable harm." P. Br. at 6. Further, Petitioner argues that the facts show that the safety measures in place were "adequate, complete, and reasonable to prevent the subject incident" cited, and the incident in itself was an isolated occurrence. P. Br. at 6. However, Petitioner continues, in spite of all plausible measures being taken, the event in question (Resident 1's choking and ultimate death) did occur. The crux of Petitioner's argument rests on the premise that the incident was an unforeseeable event and there was nothing further that the facility could have done to prevent it. Id. at 3. Petitioner states that section 483.25 of the regulations requires either a deliberate or a negligent act, and as long it took "reasonable precautions to provide a resident with proper dietary services, and did not otherwise commit either a deliberate or negligent act, section 483.25 is satisfied." Id. at 5, 6 - 7. Petitioner contends that, since the facts do not support such a finding, Petitioner was in substantial compliance with section 483.25, and the F Tag 309 citation is without foundation. Id. at 6 - 7. Petitioner concludes that, to be held accountable for Resident 1's death, would be comparable to the imposition of a strict liability standard not supported by the regulations or Departmental Appeals Board (DAB) case law. Id. at 4.

The term "strict liability" does not coincide exactly with cases such as this because it is a term used in tort law. In tort analysis, strict liability is used for a situation when an alleged tortfeasor's negligence need not be proved. The accident proves the tort. In cases concerning a nursing home's compliance with 42 C.F.R. � 483.25, rather than looking at the presence or absence of negligence, the focus is on the language of the regulation; i.e., each resident must receive and the facility must provide the necessary care and services 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 (emphasis added). The facility's duty as stated in the regulation is an affirmative duty.

In explaining what the facility must do, the DAB has stated that "a facility is not required to do the impossible or be a guarantor against unforeseeable occurrences, but is required to do everything in its power to prevent accidents." Koester Pavilion, DAB No. 1750, at 24 (2000). Although CMS deemed Petitioner's noncompliance as a failure to provide necessary services (42 C.F.R. � 483.25), rather than a failure to prevent accidents (42 C.F.R. �� 483.25 (h)(1) and (2)), the facility's duty as described in Woodstock Care Center, DAB No. 1726 (2000) is instructive. In that case, an appellate panel of the Board found that a facility is obligated to take measures that are designed, to the extent that is practicable, to ensure that residents do not sustain accidents that are reasonably foreseeable. Based on the standards expressed in Koester Pavilion and Woodstock Care Center, my decision in this case is based on my questioning whether Resident 1 received the services (an appropriate diet) that Petitioner had already determined as necessary by its comprehensive assessment and care plan; i.e., to ensure that Resident 1 did not choke, given Petitioner's recognition that Resident 1 was at risk for choking on all but pureed and thin foods. I find that Petitioner, through its CNA, did not provide Resident 1 with necessary care.

The regulations do not require that a facility use any particular system to prevent lapses as occurred in this case. Using an outcome-oriented approach, facilities have the flexibility to use a variety of methods, but they are responsible for achieving the required results. Woodward Hills Nursing Center, DAB CR991 (2003). Had Petitioner's system been fully implemented, a system that contemplated the CNA carefully reviewing food given to residents, the resident would not have choked.

Petitioner seems to argue that I must find the facility itself to have either negligently or deliberately fed Resident 1 a peanut butter sandwich. The facility, however, can act only through its employees. Without an elaborate discussion of how negligence is defined in the applicable jurisdiction, it certainly appears that the CNA was negligent in feeding the peanut butter sandwich to Resident 1. Moreover, the feeding of the sandwich was a deliberate act. In the case before me, there is no imaginable way for Petitioner to ignore its responsibility for the CNA's actions. She was acting on Petitioner's behalf as a nurse's aide employed by the facility. She was not on a "frolic or detour" of her own. She was acting within her duties as an employee. Petitioner is asking this tribunal to subscribe to the principle that a facility is not responsible for the actions of its employees. I note that Petitioner's argument is even less persuasive given that the CNA was still in the probationary period of employment, at which time she was to remain under review and evaluation. See P. Ex. C, at 3 - 5. Nonetheless, I emphasize that, at the time Resident 1 was given the peanut butter sandwich, the CNA was functioning in her official capacity as an employee/agent of Petitioner's facility. I agree with CMS's assessment of settled case law in this area. Specifically, in Cherrywood Nursing and Living Center, DAB No. 1845 (2002), the Board made it clear that a petitioner:

simply cannot claim that it should not be held responsible for the incidents involving the resident because the nurse aides failed to follow the care plan. The Board has consistently held that a facility cannot disavow responsibility for the actions of its employees. In a case involving a facility where a nurse failed to respond to calls for assistance from the visiting spouse of a resident who was experiencing trouble breathing, the Board stated: [The nurse's] employer cannot disown the consequences of the inadequacy of care provided by the simple expedient of pointing a finger at her fault, since she was the agent of the employer empowered to make and carry out daily care decisions.

Cherrywood, DAB No. 1845, at 14, citing Emerald Oaks, DAB No. 1800, at 7, n.3 (2001); Ridge Terrace, DAB No. 1834 (2002).

In its motion, Petitioner relies heavily on the Civil Remedies Division decisions of Oakwood Manor Nursing Center, DAB CR818 (2001), and Lineville Nursing Facility, DAB CR947 (2002), aff'd in part, DAB No. 1868 (2003), to support its position. Neither of these cases is exactly on point. Oakwood dealt with deficiency citations under section 483.13(b). This particular section of the regulations delineates the rights of a patient to be free from abuse. The ALJ in Oakwood concluded that, in order to get a complete reading of the provision, section 483.13(b) must be read in conjunction with section 483.10, which establishes that a facility must protect and promote the rights of each resident. The ALJ also referred to an appellate panel's determination in Beverly Health and Rehabilitation Center - Williamsburg, DAB No. 1748 (2001), which established that a finding of noncompliance under section 483.13(b), when read in conjunction with section 483.10, implied a failure (deliberate or negligent) by a facility to protect a resident from abuse, and therefore that the standard to be applied was not one of strict liability. Oakwood, DAB CR818, at 5. Finally, the ALJ in Oakwood concluded that section 483.13(b) does not impose a strict liability standard without taking into consideration surrounding circumstances. Id.

In Lineville, the petitioner was found not to be in substantial compliance with participation requirements under, among others, section 483.25(h)(2). Specifically, a resident was assisted to the bathroom by two nurse's aides, and left alone for privacy, with the door partially opened (for observation purposes) until the resident was finished. However, before the aides could reach her, the resident fell off of the toilet, sustaining some injuries. Petitioner relies on my statement, as the ALJ in Lineville, that:

[t]he regulations do not impose strict liability on a long term care facility with regard to residents' accidents. A facility is not required to assure that its residents never sustain accidents. Rather, the regulations require that the facility provide 'adequate' supervision and assistance devices for its residents as a safeguard against accidents. A facility satisfies the requirements of the regulations if it takes reasonable precautions to protect the health and safety of its residents against accidental injuries.

Lineville, DAB CR947, at 15.

Without regard to the fact that Lineville involves a slightly different section of 42 C.F.R. � 483.25, Petitioner contends that to support the finding of a F Tag 309 citation, there must be a basis of something other than the incident itself. Petitioner thus concludes that, as long as all reasonable measures and precautions are taken, and there were no deliberate or negligent acts committed by the facility, there cannot be a finding of noncompliance pursuant to section 483.25. I find, however, that an analysis of a failure to provide a necessary service, while similar, must be slightly different than a failure to provide adequate supervision to prevent accidents. Moreover, as I stated above, it is not the incident itself that has led me to conclude Petitioner was noncompliant. The circumstances surrounding this incident include the fact that Resident 1 was assessed by Petitioner to have significant difficulties in eating bread and included in her care plan that it was necessary for her to be fed pureed, non-bread, items. If Resident 1's family member had fed her a sandwich outside the facility, the incident "itself" might not have been insufficient to find Petitioner noncompliant. In this case, a CNA who Petitioner specifically assigned to feed Resident 1 fed her a peanut butter sandwich in contravention of her care plan.

As CMS pointed out, neither Oakwood nor Lineville is particularly beneficial to Petitioner's argument, and Petitioner's reliance on the proposition "that a nursing facility cannot be held strictly liable for the occurrence of unforeseen (and unforeseeable) consequences of accidents that cause harm to its residents" is misplaced. CMS Response at 2. Resident 1's choking was not an accident; R1 choked as a result of the act of one of Petitioner's employees. I agree with CMS that the provisions of the Act, as well as DAB decisions, specifically state that principals are liable for the actions of agents acting within the scope of their agency, and such liability includes assessments, penalties and exclusions. Id. at 3, citing Act, section 1128A(1), Ridge Terrace, DAB No. 1834 (2002). Petitioner cannot escape its responsibility under 42 C.F.R. � 483.25 by claiming that its adherence, to numerous administrative standards of hiring and training, excuses the specific actions of its staff members acting in the course of their assigned duties. Petitioner must accept the responsibility of giving this CNA direct care responsibilities that obviously exceeded her capabilities. Barn Hill Care Center, DAB CR902 (2002), aff'd, DAB No. 1848 (2002).

The regulation at section 483.25 does not impose a strict liability standard. However, the regulation does impose an affirmative duty to "provide services which achieve a positive outcome." Cherrywood, DAB No. 1845, at 10, citing Woodstock, DAB No. 1726, at 25. It is apparent that Petitioner did not meet this benchmark. As a result of the CNA's (Petitioner's employee's) actions, which resulted in the death of Resident 1, Petitioner cannot ignore its responsibility to adhere to the requirements under 42 C.F.R. � 483.25. Simply put, a facility is responsible for making sure that requisite services are provided to meet the needs of its residents, whether they are provided by "professionals, nurse aides, or other employees." Id.

3. The outcome of Petitioner's actions, i.e., Resident 1's death, was a foreseeable event.

Petitioner argues that, since it took every precaution to ensure proper training, certification, and background investigation of its CNA, and implemented sufficient policies and procedures regarding the feeding of residents, the resident's death was unforeseeable and an isolated event. P. Br. at 3.

Clearly by June 2002, it was foreseeable that Resident 1 could have complications with food ingestion. At that time, Resident 1 was assessed as experiencing problems with chewing. CMS Ex. 12, at 2. Based on the nutritional assessment, the resident was put on a pureed diet with no breads. Id. at 1, 2; see also, CMS Ex. 1, at 3; CMS Ex. 4, at 1. It was also noted by the state surveyor that a skilled swallowing assessment was conducted by Resident 1's speech therapist on May 20, 2002. The therapist concluded that, based on the resident's decline since her last evaluation one month prior, her inability to orally process foods with "mechanical soft consistency," it was recommended that the resident be put on a pureed/thin diet. CMS Ex. 1, at 4. At this point, Petitioner is on notice of a potential for harm if the resident is given anything but pureed meals. Going one step further, a meal card was present on Resident 1's meal tray at every meal as a reminder that this particular resident was on a "pureed/no breads" diet. See CMS Ex. 2, at 2. The evidence, together with the Stipulated Set of Facts, undeniably supports a finding that, on November 3, 2002, Resident 1 died due to the ingestion of a peanut butter sandwich provided by the CNA, causing the resident to choke and stop breathing. CMS Ex. 7; Stipulated Set of Facts at 3. The CNA assigned to assist residents at a specifically-designated table with feeding, Resident 1 among them, should have been aware of the resident's pureed-designated diet. At the time in question, i.e., November 3, 2002, a diet card (indicating a pureed diet) was present on Resident 1's tray as a "reminder"to staff members of the resident's specific dietary needs. Id. at 3. The diet card was available and accessible to the CNA or, for that matter, anyone who took the time to look at the resident's tray. Id. Given the circumstances of this case, i.e., the resident required a special diet as a necessary service, Petitioner's system was unable to assure that Resident 1 received the necessary service. That she would choke and die without the service was foreseeable.

C. CMS's classification of immediate jeopardy for Petitioner's substantial noncompliance is not clearly erroneous.

In this case, CMS assigned a scope and severity level to the cited deficiency as isolated and posing a risk of immediate jeopardy to the residents. As noted above, CMS assessed a per instance CMP of $3,500.

Appeal rights attach to certain initial determinations made by CMS as set forth in the regulations. The level of noncompliance, in this case immediate jeopardy, can be appealed but only if the range of CMP that can be collected could change, or if the facility's nurse aide training program will be affected due to a finding of substandard quality of care. 42 C.F.R. �� 498.3(b)(14)(i) and (ii), 498.3(d)(10)(i) and (ii).

A per instance CMP can be from $1,000 to $10,000. There is no specifically defined range of per instance penalty for findings of immediate jeopardy. 42 C.F.R. � 488.438(a)(2). Thus, a finding of immediate jeopardy can have no effect on a range of penalties. Nonetheless, CMS's determination of immediate jeopardy in this case is an appealable initial determination pursuant to section 498.3(b)(14)(ii) because the deficiency cited was a finding of substandard quality of care affecting the facility's nurse aide training program.

Immediate jeopardy is defined in the regulations 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.

I find that CMS's determination that Petitioner's residents were in a state of immediate jeopardy, not to be clearly erroneous. In this case, there is no dispute that feeding a peanut butter sandwich to the resident instead of her mandated diet caused her death. If the CNA's actions represent noncompliance on the part of the Petitioner, which I have found affirmatively, then the incident represents immediate jeopardy. CMS's finding of immediate jeopardy is not clearly erroneous.

D. The amount of the per instance CMP assessed against Petitioner, $3,500, is reasonable.

As noted above, a per instance CMP can range from $1,000 to $10,000. In considering whether the amount of the $3,500 CMP imposed by CMS is reasonable, I applied the four factors listed in 42 C.F.R. � 488.438(f). The factors are: (1) the facility's history of noncompliance; (2) the facility's financial condition; (3) the factors specified in 42 C.F.R. � 488.404; and (4) the facility's degree of culpability which includes, but is not limited to, neglect, indifference, or disregard for resident care, comfort or safety. The factors to be considered under 42 C.F.R. � 488.404 include the scope and severity of the deficiency and the facility's prior history of noncompliance with reference to the cited deficiency.

The parties did not present any evidence which would indicate that Petitioner had a prior history of noncompliance with regard to the cited deficiency before me or, for that matter, any cited deficiencies. Moreover, a lesser penalty is usually appropriate in instances of isolated immediate jeopardy-level deficiencies. Florence Park Care Center, DAB No. 1931, at 36 (2004). The state agency determined that this incident was, in fact, an isolated occurrence. See CMS Ex. 1, at 1 ([t]he highest scope/severity level cited during the survey was a "J."); CMS Ex. 11, at 1 (the most serious deficiency cited was at the immediate jeopardy-level J cited at F Tag 309. . . .).

On the other hand, there is no record evidence that Petitioner's financial condition is such that it could not pay $3,500 as a penalty. And, although the deficiency was isolated, the deficiency was severe and at the immediate jeopardy level. The severity of the deficiency suggests that a CMP higher than the minimum of $1,000 is reasonable.

CMS made no argument concerning Petitioner's culpability and I conclude that Petitioner's degree of culpability is relatively low in this situation. Nonetheless, although culpability can be used to substantiate a higher CMP, the absence of culpability is not a mitigating circumstance in reducing the amount of the penalty. 42 C.F.R. � 488.438(f)(4).

Finally, Petitioner has not presented any evidence to contradict the reasonableness of the amount of the CMP. The CMP imposed is at the lower end of the range of per instance CMPs. Considering that the resident in this case died as a result of Petitioner's actions, albeit an isolated occurrence, it would be difficult to argue that the imposition of a $3,500 CMP is anything but reasonable.

Based on my de novo review of all of the applicable factors together, I find that CMS's assessment of a per instance CMP of $3,500 in this case is reasonable.

VI. Conclusion

I grant CMS's motion for summary judgment and sustain CMS's determination against Petitioner of substantial noncompliance at the immediate jeopardy level, and the imposition of a per instance CMP in the amount of $3,500.

Anne E. Blair

Administrative Law Judge

1. I have designated the documents marked A, B, and C that were attached to Petitioner's motion as P. Exs. A1, B1, and C1 to distinguish them from Petitioner's later proposed exhibits.