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


SUBJECT:

Alden Town Manor Rehabilitation & HCC,

Petitioner,

DATE: January 24, 2006
                                          
             - v -

 

Centers for Medicare & Medicaid Services.

 

Docket No.C-03-519
Decision No. CR1398
DECISION
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DECISION

Petitioner, Alden Town Manor Rehabilitation & HCC, did not violate 42 C.F.R. § 483.25 with respect to Resident 1, as alleged by the Centers for Medicare & Medicaid Services (CMS) based upon the survey completed on February 14, 2003. There is no basis for the imposition of an enforcement remedy.

I. BACKGROUND

Petitioner is a long-term care facility located in Cicero, Illinois, and authorized to participate in the federal Medicare program. On February 14, 2003, Petitioner was subject to a complaint survey by the Illinois Department of Public Health (the state agency) and was found to have violated 42 C.F.R. § 483.25(h)(2) (1) related to quality of care. The state agency conducted a revisit survey on March 31, 2003, and found the facility to be in substantial compliance as of that date. On May 9, 2003, CMS notified Petitioner that a civil money penalty (CMP) of $200 per day was being imposed for the 45-day period of noncompliance from February 14, 2003 through March 30, 2003, a total CMP of $9,000. Petitioner timely requested a hearing on June 24, 2003. The case was assigned to me for hearing and decision on July 1, 2003, and a Notice of Case Assignment and Prehearing Case Development Order was issued at my direction on that date.

The case was set for hearing. On February 3, 2004, Petitioner waived oral hearing and requested a decision on the written record. By Order dated February 4, 2004, I accepted Petitioner's waiver of oral hearing and issued a briefing schedule as requested by the parties. CMS filed its exhibit list and CMS exhibits (CMS Exs.) 1 through 45 on March 3, 2004. CMS filed its brief on April 2, 2004 (CMS Brief). Petitioner filed its exhibit list and Petitioner's exhibits (P. Exs.) 1 through 4 on March 4, 2004. Petitioner filed its brief on April 30, 2004 (P. Brief). CMS filed a reply brief on May 17, 2004. No objections have been filed as to any exhibits and all are admitted as evidence. The parties filed a joint stipulation of undisputed facts on September 15, 2003 (Jt. Stip.) which I also consider in deciding this case.

II. DISCUSSION

A. Findings of Fact

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

1. Resident 1 was a resident at Petitioner's facility from December 18, 2002 until December 23, 2002 and suffered from coronary artery disease, hypertension, Alzheimer's dementia, and degenerative joint disease, and he had a history of cerebral vascular accident and congestive heart failure. Jt. Stip.

2. On December 23, 2002 at about 10:05 a.m., Janine Cordero, Registered Nurse (R.N.), found Resident 1 sitting in the dining room, spraying disinfectant in and around his mouth with his mouth wide-open and disinfectant solution dripping down his chin. Jt. Stip.

3. When staff took the disinfectant bottle from Resident 1, he appeared confused but his vital signs were normal. Jt. Stip.

4. Resident 1 was given milk per the label directions for the disinfectant that he had been spraying, which the parties agreed was UNO Disinfectant-Cleaner-Sanitizer (UNO). CMS Ex. 13; Jt. Stip.

5. Resident 1 was transported to the emergency room on December 23, 2002, at the direction of his physician and, upon arrival, he was suctioned because he was gaging and spitting out thick mucus secretions. He was suctioned later the same day for the same reason. Jt. Stip.

6. On December 23, 2002, a chest x-ray showed possible right lower lobe pneumonia and Resident 1 was subsequently admitted to the hospital with diagnoses including congestive heart failure and possible pneumonia. Jt. Stip.

7. On December 28, 2002, Resident 1 was transferred to hospice care with a diagnosis of aspiration pneumonia with respiratory failure and he died on December 30, 2002. The official cause of death was cardiopulmonary arrest due to, or as a consequence of aspiration pneumonia which was due to, or as a consequence of his dementia, congestive heart failure, cerebral vascular accident, and coronary artery disease. Jt. Stip.; P. Ex. 1.

8. Use solutions of UNO do not present a hazard of acute or chronic health effects in exposed persons. CMS Ex. 13 at 3.

9. Resident 1 sprayed the UNO only a matter of seconds before Nurse Cordero took the spray bottle from him and, at the time, there were no signs of coughing, vomiting, or respiratory distress. CMS Ex. 25; P. Ex. 3.

10. Resident 1 did not develop skin or eye irritation even though he had solution dripping from his face. There was no evidence of any burning or irritation of his mouth, nose, or throat.

11. Resident 1 was a significantly compromised 83-year-old with coronary artery disease, a history of congestive heart failure, and difficulty swallowing with a history of aspiration and subject to developing congestive heart failure and pneumonia from many causes. CMS Exs. 14, 16, 17, 19, and 22.

12. Petitioner had assessed Resident 1 as requiring supervision and Petitioner had established a care plan for him that required staff to keep him in common areas for staff supervision, to distract him from wandering down the corridors or into other resident's rooms, to redirect him, and to engage him in activities that would deter him from wandering. CMS Ex. 19; P. Brief at 14.

13. On December 23, 2002, after breakfast and before the incident, Resident 1 was, in fact, in the common area under the observation of two nurses, one of whom had him under direct observation, or essentially one-on-one supervision. P. Exs. 3, 4.

B. Conclusions of Law

1. Petitioner's request for hearing was timely and I have jurisdiction.

2. The Secretary of Health and Human Services (Secretary) has not provided a definition in the regulations for the term "accident" as that term is used in 42 C.F.R. § 483.25(h)(2). However, in its interpretive guidance for surveyors, CMS defines "accident" to be "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 (App.) P, Guidance to Surveyors, at PP-105, F324, Quality of Care (Rev. 274, June 1995), Woodstock Care Center, DAB No. 1726, at 4 (2000).

3. In order for CMS to make a prima facie showing of a violation of 42 C.F.R. § 483.25(h)(2), CMS must show that either an accident occurred or that Petitioner failed to minimize the risk of an accident, i.e. "an unexpected, unintended event that can cause a resident bodily injury."

4. CMS has failed in this case to show that the UNO disinfectant in the spray bottle had any potential for causing the resident "bodily injury" as required by the definition of "accident" adopted by CMS, and CMS has thus failed to make a prima facie case of a violation of 42 C.F.R. § 483.25(h)(2).

5. CMS has also failed to show that UNO disinfectant in the spray bottle had any potential for causing the resident "bodily injury" or presented an accident hazard in the environment and CMS has thus failed to make a prima facie case of a violation of 42 C.F.R. § 482.25(h)(1).

6. Petitioner had adopted a reasonable intervention requiring the supervision through observation of Resident 1 in public spaces and that intervention was implemented and effective on December 23, 2002, and Petitioner had no reason to know that closer supervision and/or physical restraint by staff would be necessary.

7. Petitioner did not violate 42 C.F.R. § 483.25 (h)(1) or (h)(2), as alleged by CMS.

8. There is no basis for the imposition of an enforcement remedy and, therefore, such remedy is unreasonable.

C. Issues

The issues in this case are:

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

Whether the remedy imposed is reasonable.

D. Applicable Law

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

Pursuant to the Act, the Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. Facilities that participate in Medicare may be surveyed on behalf of CMS by state survey agencies in order to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. §§ 488.10-488.28, 488.300-488.335. Pursuant to 42 C.F.R. Part 488, CMS may impose a per instance or per day CMP against a long-term care facility when a state survey agency concludes that the facility is not complying substantially with federal participation requirements. 42 C.F.R. §§ 488.406, 488.408, 488.430. The regulations at 42 C.F.R. Part 488 also give CMS a number of other remedies that can be imposed if a facility is not in compliance with Medicare requirements. Id. Pursuant to 42 C.F.R. § 488.301, "(i)mmediate jeopardy means 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." (emphasis in original). Further, "(s)ubstantial 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." Id. (emphasis in original).

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

The Act and regulations make a hearing before an administrative law judge (ALJ) available to a long-term facility against whom CMS has proposed a CMP. Act, section 1128A(c)(2); 42 C.F.R. §§ 488.408(g), 498.3(b)(13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F.2d. 678 (8th Cir. 1991). A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. § 488.408(g)(1); see also, 42 C.F.R. §§ 488.330(e) and 498.3. However, the choice of remedies by CMS or the factors CMS considered when choosing remedies are not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the CMP that could be collected by CMS or impact upon the facility's nurse aide training program. 42 C.F.R. §§498.3(b)(14) and (d)(10)(i). CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. § 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6th Cir. 2003). The Departmental Appeals Board (the Board) has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). Review of a CMP by an ALJ is governed by 42 C.F.R. § 488.438(e).

When a penalty is proposed and appealed, CMS must make a prima facie case that the facility has failed to comply substantially with federal participation requirements. "Prima facie" means that the evidence is "(s)ufficient to establish a fact or raise a presumption unless disproved or rebutted. Black's Law Dictionary 1228 (8th ed. 2004); see also, Hillman Rehabilitation Center, DAB No. 1611, at 8 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999). To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman Rehabilitation Center, DAB No. 1611.

E. Analysis

1. Petitioner did not violate 42 C.F.R. § 483.25 as alleged by CMS.

Section 483.25 of Title 42 C.F.R. establishes quality of care requirements for long-term care facilities. One such requirement is that a facility must ensure "[e]ach resident receives adequate supervision and assistance devices to prevent accidents." 42 C.F.R. § 483.25(h)(2). The regulation requires that a facility provide both "assistance devices" and "adequate supervision" to prevent accidents. In Woodstock Care Center, the Board considered whether the facility knew or reasonably should have anticipated the risk of the kind of events that occurred and whether any reasonable means were available to prevent them without violating the residents' rights. Woodstock Care Center, DAB No. 1726, at 26-27 (2000). The Board in Woodstock noted that, while a facility is permitted the flexibility to choose the methods it uses to prevent accidents, the chosen methods must constitute an "adequate" level of supervision and use of assistance devices given all the circumstances. What is "adequate" takes into consideration the resident's ability to protect himself or herself from harm. See Woodstock Care Center at 28-35; see also, Windsor Health Care Center, DAB No. 1902, at 5 (2003), aff'd, Windsor Health Center v. Leavitt, 127 Fed. Appx. 843, No. 04-3018 slip op., 2005 WL 858069 (6th Cir. April 13, 2005 ) ("(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.").

There is a prima facie showing of a violation of 42 C.F.R. § 483.25(h)(2), when: (1) the evidence shows that an accident occurred, with or without harm to a resident; or (2) the evidence shows that the facility failed to do what it could to supervise residents or provide assistance devices to minimize risks that could lead to accidents. 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)." SOM, App. P, Guidance to Surveyors, at PP-105, F324, Quality of Care (Rev. 274, June 1995), Woodstock Care Center, DAB No. 1726, at 4 (2000).

The parties have stipulated to many of the facts in this case. Jt. Stip. According to the stipulation, Resident 1 was a resident at Petitioner's facility from December 18, 2002 until December 23, 2002. Resident 1 suffered from coronary artery disease, hypertension, Alzheimer's dementia, and degenerative joint disease, and he had a history of cerebral vascular accident and congestive heart failure. His treating physician was Dr. Fahmy. On December 23, 2002, at about 10:05 a.m., a nurse found Resident 1 sitting in the dining room spraying disinfectant in and around his mouth with his mouth wide-open and disinfectant solution dripping down his chin. Staff took the disinfectant bottle from Resident 1 who appeared confused but got up and walked away from the table where he had been sitting. Resident's vital signs were taken and appeared to be normal. Resident 1 was given milk per the label directions for the disinfectant that he had been spraying. The parties agreed that the disinfectant was UNO Disinfectant-Cleaner-Sanitizer. The parties agreed to the disinfectant ingredients and they referred to CMS Ex. 13 as the material safety data sheet for the product. Resident 1 was transported to the emergency room on December 23, 2002, at the direction of his physician. When he arrived at Mount Sinai Hospital, a nurse suctioned Resident 1 because he was gaging and spitting out thick mucus secretions and he had to be suctioned later the same day for the same reason. A chest x-ray showed possible right lower lobe pneumonia. Resident 1 was subsequently admitted to the hospital with diagnoses including congestive heart failure and possible pneumonia. On December 28, 2002, Resident 1 was transferred to hospice care with a diagnosis of aspiration pneumonia with respiratory failure. Although the parties did not stipulate, there is no question that Resident 1 subsequently died. Resident 1's death certificate indicates he died on December 30, 2002 and that the cause of death was cardiopulmonary arrest due to, or as a consequence of aspiration pneumonia which was due to, or as a consequence of his dementia, congestive heart failure, cerebral vascular accident, and coronary artery disease. P. Ex. 1.

The surveyor, Kelly Way (CMS Ex. 40), alleges in the Statement of Deficiencies (SOD), based upon a records review, that Petitioner violated 42 C.F.R. § 483.25(h)(2) with regard to Resident 1. It is alleged more specifically in the SOD that Petitioner failed to supervise Resident 1, who was identified as requiring constant supervision, and prevent him from ingesting a cleaning disinfectant, which resulted in an emergency room visit for the resident. The surveyor asserts that Petitioner's care plan for Resident 1 indicated that he needed to remain in common areas where his movements and actions could be supervised due to his lack of awareness to person, place, and time; his erratic behavior; dependence on staff for self-care; and poor safety awareness. CMS Ex. 1 at 1-2. Surveyor Kelly records in the SOD that she was told by Resident 1's treating physician that he felt Resident 1's death was not directly related to the ingestion of the disinfectant, but he could not rule out that ingestion precipitated Resident 1's chronic illness that caused his death. CMS Ex. 1 at 2. Based upon an interview with Petitioner's Administrator, the surveyor concluded that the bottle of disinfectant had been left on a table in the dining room by a new housekeeper. CMS Ex. 1 at 3.

In its brief, CMS argues that there is sufficient evidence to constitute a prima facie showing of a violation of 42 C.F.R. § 483.25(h)(2) (Tag F324) and, although not alleged by the surveyor, a violation of 42 C.F.R. § 483.25(h)(1) (Tag F323) based upon Petitioner's failure to keep the environment free of accident hazards. CMS Brief at 9-23. Petitioner objects to my consideration of the alleged violation of 42 C.F.R. § 483.25(h)(1) (Tag F323), arguing that it would be a violation of its due process rights to add that charge. P. Brief at 2-4. Given my disposition of this case, it is not necessary to determine the issue raised by Petitioner. I consider first whether CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.25(h)(2). I also consider whether Petitioner's supervision of Resident 1 was adequate.

Petitioner does not dispute that Resident 1 obtained a spray bottle of UNO Disinfectant which he was observed spraying in and around his mouth. For purposes of my ruling on summary judgment, I accepted without further examination CMS's characterization of the incident as an accident. January 6, 2004 Order Denying Respondent's Motion for Summary Judgment at 5. However, examination of whether or not the incident involved an accident within the meaning of 42 C.F.R. § 483.25(h)(2) is required for a decision on the merits. The Secretary has not provided a definition in the regulations for the term "accident" as that term is used in 42 C.F.R. § 483.25(h)(2). However, in its interpretive guidance for surveyors, CMS defines "accident" to be "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)." SOM, App. P, Guidance to Surveyors, at PP-105, F324, Quality of Care (Rev. 274, June 1995), Woodstock Care Center, DAB No. 1726, at 4 (2000). In order for CMS to make a prima facie showing of a violation of 42 C.F.R. § 483.25(h)(2), CMS must show that either an accident occurred or that Petitioner failed to minimize the risk of an accident. In this case, CMS fails to make the required showing because it does not show that, even if the UNO disinfectant in the spray bottle was ingested by Resident 1, it had any potential for causing the resident "bodily injury" as required by the definition of accident adopted by CMS.

The problem for CMS is that there is no evidence of the actual contents of the spray bottle. Certainly, I accept the parties' stipulation that the bottle contained "UNO Disinfectant-Cleaner-Sanitizer." Jt. Stip. at 3. However, there is no agreement between the parties as to the strength of the sanitizer solution in the bottle or that it could cause Resident 1 "bodily injury." The material safety data sheet for UNO disinfectant states:

Protection for use solutions: The use dilution solutions of disinfectant prepared according to the current label instructions are not considered hazardous according to criteria of 29 CFR 1910.1200. However safety protection is recommended for eyes and skin when handling product concentrates.

CMS Ex. 13 at 3. The cited regulation, promulgated by the Occupational Safety and Health Administration of the Department of Labor (OSHA), was "intended to address comprehensively the issue of evaluating the potential hazards of chemicals, and communicating information concerning hazards and appropriate protective measures to employees, and to preempt any legal requirements of a state, or political subdivision of a state, pertaining to this subject." 29 C.F.R. § 1910.1200(a)(2). The regulation established the requirement for manufacturers to include product descriptions such as that for UNO at CMS Ex. 13. Pertinent definitions are found at 29 C.F.R. § 1910.1200(c) (emphasis in original):

Hazardous chemical means any chemical which is a physical hazard or a health hazard.

Health hazard means a chemical for which there is statistically significant evidence based on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed employees. The term ''health hazard'' includes chemicals which are carcinogens, toxic or highly toxic agents, reproductive toxins, irritants, corrosives, sensitizers, hepatotoxins, nephrotoxins, neurotoxins, agents which act on the hematopoietic system, and agents which damage the lungs, skin, eyes, or mucous membranes. Appendix A provides further definitions and explanations of the scope of health hazards covered by this section, and Appendix B describes the criteria to be used to determine whether or not a chemical is to be considered hazardous for purposes of this standard.

Physical hazard means a chemical for which there is scientifically valid evidence that it is a combustible liquid, a compressed gas, explosive, flammable, an organic peroxide, an oxidizer, pyrophoric, unstable (reactive) or water-reactive.

Sam Gaines, M.D., a medical advisor from the state agency, notes in his declaration that the statement on the UNO material safety data sheet that "use dilution solutions of disinfectant prepared according to the current label instruction are not considered hazardous according to criteria of 29 C.F.R. 1910.1200 " means that "safety protection, such as safety glasses and gloves are not required when handling the diluted solution." CMS Ex. 45 at 4. I accept Dr. Gaines statement as correct, however, it is incomplete. The foregoing definitions from the cited regulation also show that the statement on the material safety data sheet for UNO means exposure to use dilution solutions of UNO present no statistically significant incident of acute or chronic health effects. Dr. Gaines' opinion, that even a dilute solution of UNO presented the potential for acute or chronic health effects, is contrary to the representation of the material safety data safety sheet. CMS Ex. 45 at 4. His opinion is also at odds with the resource material he relied upon at CMS Ex. 42, which note health effects for concentrations above a certain level. While I do not disagree with the doctor's statement at page 4 of CMS Ex. 45 that "(a)lmost any substance, even those considered relatively safe, such as mouthwash or Tylenol, can have potentially serious health consequences depending on the nature, quantity, and duration of the exposure," I note that his opinion regarding the hazardous nature of the UNO disinfectant that Resident 1 sprayed is rendered without the very information that he recognizes is important. He has no information about whether the UNO was diluted and to what concentration, he has no idea of the duration of exposure, and he is not clear about the nature of the product and the "health hazard" presented based either upon the material safety data sheet or the Poisindex materials he refers to at CMS Ex. 42.

The evidence shows that properly diluted UNO presents little, if any, health hazard. CMS has presented no evidence of what was in the spray bottle. I have no evidence that indicates Petitioner had not properly diluted the UNO disinfectant in accordance with label instructions or that Resident 1 was spraying undiluted solution in and around his mouth. CMS would have me infer that the UNO solution in the bottle was hazardous from the facts that, upon arrival at the emergency room thick mucus secretions were suctioned from Resident 11's mouth and that there was evidence of developing pneumonia upon his admission to the hospital. However, the evidence before me, the UNO product information sheet at CMS Ex. 13, indicates that UNO, when not diluted in accordance with label instructions, would cause both skin and eye irritation and I see no indication that Resident 1 developed such irritation even though he had solution dripping from his face. CMS Exs. 29-33. Further, there is no evidence of any burning or irritation of his mouth, nose, or throat. The objective evidence from the hospital is also inconsistent with drawing the inference CMS wants me to draw, i.e. that the UNO solution in the bottle was hazardous and caused health effects in Resident 1. There is no question that Resident 1 was found spraying the UNO at 10:05 a.m. on December 23, 2002. At 1:45 p.m. on December 23, 2002, less than four hours later, a chest x-ray reflected "infiltrate right lower suggestive of right lower lobe pneumonia." CMS Ex. 31 at 2. I have no credible evidence which indicates that such objective manifestations can or would occur in such a brief period. While Dr. Gaines suggests that might be the case, I do not find his opinion particularly weighty given the dearth of evidence upon which he formed his opinions. Further, Dr. Gaines relied upon a note in an incident report that indicates Resident 1 had a "cough from irritant" (CMS Ex. 45 at 5-6; CMS Ex. 23), which I conclude was in error as Nurse Cordero, who observed Resident 1 spray the UNO and responded, noted no cough. P. Ex. 3 at 1-2.

The evidence shows that this resident was a significantly compromised 83-year-old with coronary artery disease, a history of congestive heart failure, and difficulty swallowing with a history of aspiration. CMS Exs. 14, 16, 17, 19, and 22. Considering the resident's history and compromised state, and the objective medical evidence from the hospital upon his admission on December 23, 2002, the weight of the evidence is consistent with Resident 1 developing congestive heart failure and pneumonia before he ever sprayed the UNO. CMS provided some treatise materials for my consideration (CMS Exs. 38 and 39) which are consistent with my conclusion that there are many possible causes for aspiration pneumonia for someone in a compromised state such as Resident 1. My conclusion is also supported by the statement the surveyor received from Nurse Cordero on December 27, 2002. CMS Ex. 25. Nurse Cordero's statement, within four days of the incident, indicates that she was in and out of the dining room area after breakfast and she saw Resident 1 spraying the UNO "in and around his face" with some dripping down his chin. She believed it was only a matter of seconds before she took the spray bottle away from the resident. She observed his mouth was wide-open but she observed no swallowing. She told the surveyor that the resident did not cough, choke or vomit, and there were no signs of respiratory distress. Id. In her declaration dated March 2, 2004, Nurse Cordero states that:

At approximately 10:05 am, (she) observed (Resident 1) sitting in the dining room with a spray bottle. (She) observed him spray the bottle at his face, releasing a mist-like substance, which dripped down his chin. He did not appear to spray the substance into his mouth. (She) did not see him swallow, cough, choke or vomit.

P. Ex. 3 at 1-2. Nurse Cordero was the only nurse to witness the incident. CMS Ex. 23 at 2.

The evidence in this case simply does not demonstrate that the UNO Resident 1 sprayed was in the concentration necessary to cause the hazard or risk for bodily injury that CMS needs to show to make a prima facie case. Not only has CMS not shown that there was an "accident" or risk of an accident, but CMS has not shown that the UNO sprayed was the "accident hazard" necessary to support a finding of a violation of 42 C.F.R. § 483.25(h)(1).

Furthermore, the evidence in this case shows that Resident 1 was under reasonable supervision at the time of the incident on December 23, 2002. There is really no question that Resident 1 required supervision or that Petitioner had established a care plan for him that required staff to keep him in common areas for staff supervision, to distract him from wandering down the corridors or into other resident's rooms, to redirect him, and to engage him in activities that would deter him from wandering. CMS Ex. 19; P. Brief at 14. The evidence before me shows that, on December 23, 2002, after breakfast and before the incident, Resident 1 was, in fact, in the common area under the observation of two nurses. Nurse Veronica Jones states in her declaration dated March 2, 2004, that she observed Resident 1 going in and out of the dining and, while she could not see him in the dining room, Nurse Cordero was positioned outside the dining room where she had a clear view of the room. P. Ex. 4. Nurse Cordero states in her declaration that she also observed Resident 1 going in and out of the dining room and she was positioned outside the dining room with her medication cart but with a direct view into the dining room. P. Ex. 3. There is no dispute that she actually observed Resident 1 spray himself. These facts show that the resident was under direct observation and supervision, really one-on-one supervision at the time of the incident. In this instance, Nurse Cordero was apparently too far away from the resident to prevent him from picking up the bottle and spraying himself. The evidence in this case does not show that this resident had engaged in similar activity before or that there was a need for staff to be close enough to the resident to immediately physically restrain him to prevent injury to himself or others. My conclusion is that Petitioner had adopted a reasonable intervention requiring the supervision of Resident 1 in public spaces and that intervention was implemented and effective on December 23, 2002, as demonstrated by Nurse Cordero's observation of Resident 1 spraying himself and her prompt response. I further conclude, based upon the evidence before me, that Petitioner had no reason to know that closer supervision and/or physical restraint by staff would be necessary.

2. There is no basis for the imposition of an enforcement remedy.

I have found that Petitioner did not violate 42 C.F.R. § 483.25 as alleged by CMS. Accordingly, there is no basis for the imposition of an enforcement remedy and no such remedy is reasonable in this case.

III. CONCLUSION

For the foregoing reasons, I conclude that Petitioner did not violate 42 C.F.R. § 483.25 with respect to Resident 1 and there is no basis for the imposition of an enforcement remedy.

JUDGE
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Keith W. Sickendick

Administrative Law Judge

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

CASE | DECISION | JUDGE | FOOTNOTES