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CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES

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


SUBJECT: Good Samaritan Center,

Petitioner,

DATE: September 4, 2002
             - v -  

Centers for Medicare & Medicaid Services

 

Docket No. A-02-81
Civil Remedies CR884
Decision No. 1844
DECISION
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FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

Good Samaritan Center (Petitioner) appealed the March 21, 2002 decision of Administrative Law Judge (ALJ) José A. Anglada. Good Samaritan Center, DAB CR884 (2002) (ALJ Decision). The ALJ Decision sustained the determination by the Centers for Medicare & Medicaid Services (CMS) (1), based on a survey conducted on September 14-21, 1998, that Petitioner was not in substantial compliance with federal participation requirements for Medicare and Medicaid and that Petitioner's noncompliance constituted immediate jeopardy to its residents. At issue was whether gaps between the mattresses and side rails in Petitioner's facility establish a failure to comply substantially with the requirement at 42 C.F.R. § 483.25(h)(1) that a "facility must ensure that . . . [t]he resident environment remains as free of accident hazards as is possible."

Petitioner appealed the ALJ Decision. Petitioner argued that the ALJ had made findings of facts which were not supported by substantial evidence in the record and conclusions of law which were erroneous.

As explained in detail below, we uphold the ALJ's determination that Petitioner was not in substantial compliance with section 483.25(h)(1). We also uphold the ALJ's determination that this noncompliance constituted immediate jeopardy to its residents and his determination to impose a civil money penalty in the amount of $3,050 per day.

Factual and procedural background

The ALJ Decision contains a full discussion of the undisputed background facts, which we summarize here. This summary is intended to provide a general framework for understanding the decision and is not intended to be a substitute for the ALJ's findings. Petitioner is a long-term care facility in Kentucky. On September 13, 1998, Petitioner's staff found Resident 1 dead in her room. According to Petitioner's nursing notes in Resident 1's chart, at the time she was found, Resident 1 was "sitting on the floor beside bed w/ legs extended forward and back against her bed, her head between the mattress and siderails." CMS Ex. 2A. The side rail at issue was a quarter-length side rail at the head of the bed. A coroner subsequently determined that Resident 1 died of pulmonary embolism and had not choked to death on the side rail.

On September 14, 1998, the state survey agency began a complaint survey of Petitioner's nursing facility to investigate the circumstances surrounding Resident 1's death. In the course of that investigation, the surveyors ascertained that, when the side rail on Resident 1's bed was in the "up" position, there was a 4.5 inch gap between the bottom of the side rail and the top of the mattress. The gap resulted from the fact that Petitioner had recently acquired new mattresses for its beds from a different manufacturer than the manufacturer of the beds. Additionally, the surveyors determined that, because the mattresses were very compressible, this gap could be expanded to approximately 6 to 7 inches by pressing on the edge of the mattress. The surveyors also ascertained that the facility was using 84 beds with the same construction and the same type of mattress, although not all of these beds had the side rails up.

During visits to the facility, surveyors and Petitioner's staff performed demonstrations on the beds/mattresses at issue and determined that when the side rail was in the "up" position, it was physically possible for a person to have their head lying on the mattress with their neck under the bottom rail of the side rails.

On September 18, 1998, Resident 2 called for help and was found with his neck in the gap between the mattress and the side rail. Resident 2's lower body was on the floor but he was gripping the side rail to hold himself. The responding nurse obtained help from a second nurse to remove Resident 2 from the gap. Petitioner reported this incident to the state survey agency.

On September 19, 1998, Petitioner lowered all of its one-fourth side rails to the down position.

On September 21, 1998, the state survey agency issued a citation in which it concluded that the gaps between the mattresses and side rails constituted an accident hazard in violation of 42 C.F.R. § 483.25(h)(1) which posed an immediate threat to the health and well-being of the residents in the facility.

On October 1, 1998, CMS informed Petitioner that, based on a state survey conducted on September 14 - 21, 1998, CMS was imposing selected remedies against Petitioner due to its failure to be in substantial compliance with the applicable federal requirements. CMS stated that it concurred with the state remedy recommendation and was imposing the following remedies:

  • A civil money penalty (CMP) in the amount of $3,050.00 per day effective September 13, 1998. CMS Ex. 1. (2)
  • Termination of Petitioner's provider agreement effective October 17, 1998. (3)

Petitioner requested a hearing before an ALJ.

Before the ALJ, the parties agreed that an in-person hearing was not necessary and that this case could be disposed of on the basis of the written record. (4) Summary of Results of Prehearing Conference dated October 1, 2002; Petitioner letter dated October 31, 2001. CMS proposed 12 exhibits (CMS Exs. 1A - 12A) which were admitted into the record without objection. Petitioner proffered 16 documentary exhibits (P. Exs. 1A - 16P) which were admitted into the record without objection. Petitioner also proffered a videotape exhibit (P. Video Ex. 1) which was admitted into the record without objection. A written transcript of the videotape appears in the record as P. Ex. 1A. Each party submitted written briefs and response briefs in support of its respective contentions.

Standard of review

Before an ALJ, a sanctioned facility must prove substantial compliance by the preponderance of the evidence, once CMS has established a prima facie case that the facility was not in substantial compliance with relevant statutory or regulatory provisions. See Cross Creek Health Care Center, DAB No. 1665 (1998), applying Hillman Rehabilitation Center, DAB No. 1611 (1997) (Hillman), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789(GEB), at 25 (D.N.J. May 13, 1999). (5)

A party dissatisfied with an ALJ decision or dismissal may file a written request for review by the Departmental Appeals Board. 42 C.F.R. § 498.82(a). The request must "specify the issues, the findings of fact or conclusions of law with which the party disagrees, and the basis for contending that the findings and conclusions are incorrect." 42 C.F.R. § 498.82(b). On review, the Board may remand to the ALJ, or may modify, affirm, or reverse the ALJ's decision. 42 C.F.R. § 498.88.

The standard of review on a disputed factual issue is whether the ALJ decision is supported by substantial evidence in the record. Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs; see also Hillman, DAB No. 1611, at 6; Fairview Nursing Plaza, Inc., DAB No. 1715, at 2 (2000); South Valley Health Care Center, DAB No. 1691 (1999), aff'd South Valley Health Care Center v. HCFA, 223 F.3d 1221 (10th Cir. 2000). The standard of review on a disputed issue of law is whether the ALJ decision is erroneous. Id. The bases for modifying, reversing or remanding an ALJ decision include the following: a finding of material fact necessary to the outcome of the decision is not supported by substantial evidence; a legal conclusion necessary to the outcome of the decision is erroneous; the decision is contrary to law or applicable regulations; or a prejudicial error of procedure (including an abuse of discretion under the law or applicable regulations) was committed.

Issues on appeal

Petitioner challenged all four of the ALJ's numbered findings of fact and conclusions of law (FFCLs). The FFCLs are as follows:

1. The facility was not in substantial compliance with federal participation requirements from September 13, 1998 through September 19, 1998.

2. The facility failed to provide Residents 1 and 2 with an environment free of accident hazards by exposing them to risk of entrapment. Petitioner's lack of intervention allowed the residents to become entrapped in side rails, putting them at risk for strangulation, chest compression, and death. This constituted immediate jeopardy.

3. CMS's finding of immediate jeopardy was not clearly erroneous.

4. The amount of the penalty imposed by CMS is reasonable.

In conjunction with its request for review, Petitioner also filed a Motion for Consideration of Additional Evidence. CMS opposed the admission of additional evidence.

ANALYSIS
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1. Whether the ALJ's FFCLs that the facility was not in substantial compliance with federal participation requirements from September 13, 1998 through September 19, 1998 and that it failed to provide Residents 1 and 2 with an environment free of accident hazards are supported by substantial evidence. (FFCLs 1 and 2)

A. The ALJ decision is supported by substantial evidence.

Petitioner challenged the ALJ's finding that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h)(1). That regulation provides that a "facility must ensure that . . . [t]he resident environment remains as free of accident hazards as is possible." In CMS's State Operations Manual, which contains guidelines for surveyors, an "accident hazard" is defined as "a physical feature in the nursing facility's environment that can endanger a resident's safety." State Operations Manual at PP-104, HCFA Transmittal No. 274 (June 1995), Appendix P. (6)

The role of appellate review is not to substitute our evaluation of the evidence for that of the ALJ, but to determine whether the factual findings made by the ALJ are supported by substantial evidence in the record as a whole. See Lake Cook Terrace Center, DAB No. 1785 (2000); Beverly Health and Rehabilitation - Spring Hill, DAB No. 1696, at 40 (1999). Substantial evidence in the record as a whole supports the ALJ's finding that the presence of 4.5 to 7 inch gaps between the bottoms of side rails in the "up" position and the tops of mattresses on the beds in Petitioner's facility into which a body, neck or head could fit constituted prima facie evidence of an accident hazard. The ALJ reasonably relied on three considerations in making this determination.

First, the ALJ relied on a 1995 Food and Drug Administration (FDA) "Alert" (CMS Ex. 11A), disseminated to hospitals and long term care facilities such as Petitioner, which warned them of dangers posed by side rails, and on an article from the American Journal of Public Health, which analyzed adverse events reports made to the FDA on hospital beds between January 1985 and August 1995 (P. Ex. 6F). Both documents reported that the FDA had received reports of incidents involving side rail entrapment of individuals which included deaths involving "the entrapment of the head, neck and thorax," and injuries, involving "fractures, cuts, and abrasions to the extremities." Alert, CMS Ex. 11A at 2. The Alert specifically identified the potential for such accidents to occur in gaps between the side rail and mattress, including quarter-length side rails. Id. The Journal article confirmed this phenomenon: "[In reports to the FDA,] [e]ntrapment occurred most often between the side-rail and mattress, and the head or neck was the most frequently entrapped body part." Journal, P. Ex. 6F, at 2.

The FDA Alert and American Journal of Public Health article support the ALJ's finding that the gaps between the mattresses and side rails in Petitioner's facility into which a patient's body, neck or head could fit were accident hazards, i.e., a physical feature in the facility environment that could endanger a resident's safety. Further, the documents support the ALJ's finding that this type of hazard can result in deaths and serious injuries such as fractured extremities.

Additionally, these articles document that the majority of the reported entrapments occurred in nursing homes and support the ALJ's finding that such gaps are particularly hazardous to certain types of patients such as people suffering from "confusion, restlessness, lack of muscle control, or a combination of these factors" for whom facilities should take "additional safety measures" (Alert, CMS Ex. 11A, at 3) or people of "advanced age, female sex, low body weight, and cognitive impairment." Journal, P. Ex. 6F, at 2. As the ALJ noted, some of these factors were present as to Resident 1 (advanced age, female sex, a history of seizures). ALJ Decision at 7. Additionally, Resident 2 lacked muscle control in that he had no strength and little feeling in his legs. P. Ex. 1A, at 11-12.

Second, the ALJ relied on the incidents involving Resident 1 and Resident 2 as proof that residents' body parts not only could fit within the gaps at issue but that residents would actually end up caught in these gaps and be unable to escape. These incidents illustrate that these gaps were capable of entrapping residents and were therefore the type of gap identified by the FDA as hazardous to patient safety.

Third, the ALJ relied on the common sense observation that the presence of gaps on beds, particularly in bedrooms in which patients spend time unattended, into which elderly, infirm, or confused people can fit is a hazard to their safety and could cause them significant harm. Petitioner made much of the fact that its personnel and the surveyors could both fit themselves into the gaps and extricate themselves from the gaps. Petitioner urged that this evidence shows that the nature of this particular gap was such that it would not entrap anyone, i.e., anyone safely could extricate himself or herself if he or she fell in this gap. However, the ALJ properly found that this evidence had no probative value in relation to the risks posed by the side rail gaps in Petitioner's facility since the demonstrations were by individuals who were able to avoid entrapment by measures such as scooting down or sliding through the gaps. He wrote:

The ability of vigorous, able bodied, healthy individuals to avoid entrapment is not to compare with the ability of frail, elderly individuals, whose health is, physically and mentally, severely compromised.

ALJ Decision at 10. (7)

Petitioner provided no evidence to establish that the residents placed in the beds with the gaps were ones with an ability to avoid entrapment.

Finally, the ALJ relied on the fact that Petitioner provided no evidence that it took steps to address the hazards between September 13 when Resident 1 was found in the gap and September 19 when Petitioner lowered all quarter side rails. The ALJ cited to the range of precautions recommended by the Journal article to decrease the possibility of adverse events due to side rail entrapment. ALJ Decision at 7. The ALJ reasonably concluded that Petitioner had thereby failed to develop and implement an effective system to ensure that the resident environment remained as free from accident hazards as possible. ALJ Decision at 7, 8.

Therefore, we conclude that substantial evidence in the record as a whole supports the ALJ's determination that Petitioner failed to ensure that the resident environment remained as free of accident hazards as is possible.

B. Petitioner's arguments about the ALJ's finding of a deficiency are not persuasive.

On appeal, Petitioner offered the following five arguments as to why the ALJ Decision was incorrect in finding an accident hazard deficiency: (1) CMS failed to establish a prima facie case; (2) the ALJ erroneously treated the FDA alert concerning the general hazards of side rails as conclusive evidence that this configuration is hazardous; (3) the ALJ's findings of fact concerning Resident 1 were not supported by substantial evidence and contradict stipulated facts agreed upon by the parties; (4) the ALJ erroneously accepted CMS's theory about the second incident although surveyors conducted no investigation and relied on a demonstrably false affidavit; and (5) the ALJ erroneously relied on a theory of danger not reflected in the statement of deficiencies or even in CMS's argument.

First, Petitioner argued that "the ALJ Decision violated applicable law because it did not first consider whether CMS had established a prima facie case [as to the existence of an accident hazard], which it did not do." P. Br. at 4. Specifically, Petitioner asserted that the ALJ failed to consider that CMS's own evidence conflicts with its theory of the case. Petitioner asserted that this evidence was (1) Resident 1 died of natural causes and the bed rail was not implicated in her death; (2) the mattress in question is soft and highly compressible and would not be able to exert sufficient pressure to produce entrapment and asphyxia; (3) the surveyors tested the bed rail-mattress combination and found they could "slide in and out the space easily;" and (4) the height from the bed to the floor was only 20.5 inches so any resident whose neck was between the bed rail and the mattress would likely have his or her lower body on the floor. P. Br. at 5-6.

CMS's burden in relation to establishing a prima facie case is to come forward with evidence, sufficient with undisputed facts, to establish a legally sufficient basis for its determination, i.e., here that Petitioner failed "to ensure that the resident environment is as free of accident hazards as is possible." For the following reasons, the facts cited by Petitioner do not conflict with CMS's theory of the case or invalidate its prima facie case.

  • First, the fact that the coroner determined that Resident 1 actually died of natural causes rather than strangulation in the side rail/mattress gap does not mean that the gap did not constitute an accident hazard. It only means that no causal relationship was established between her death and the entrapment. The relevance of the event with Resident 1 is not that the gap caused her death but that she was able to slide into the existing gap and become entrapped. ALJ Decision at 8.


  • Second, the fact that the mattresses were soft and highly compressible does not mean that these gaps did not constitute a hazard. As the ALJ noted, the compressibility of the mattress made the gap even larger, thereby increasing the potential for body parts to actually fit in the gap. ALJ Decision at 7.


  • Third, the evidence that the surveyors could slide their necks in and out of the gaps easily, and that the height of the bed was such that a resident caught with a head between the rail and the mattress would likely have his or her lower body on the floor does not mean that these gaps did not create a hazard. Even if the degree of hazard the gaps posed might be mitigated in some types of accidents by these facts, CMS established a prima facie case that these gaps still constituted a hazard in the context of a nursing home population. For example, the ALJ noted the evidence CMS presented showed that Resident 1 was a 90-year-old female with a history of seizures and coronary artery disease who was weak from a recent hospitalization. He also noted that her record indicated she was at risks for falls. ALJ Decision at 7. Such a weak person could fall into the gap, catching her torso, neck or head, but not have the weight or strength to depress the mattress or the strength to extricate herself as easily as the surveyors; such a seizure-prone person could fall in the gap as a result of a seizure and not have the presence of mind to extricate herself without injury; such a person with coronary artery disease could fall in the gap and suffer additional coronary damage brought on by exertion or fright.

Thus, the facts cited by Petitioner do not persuade us that CMS failed to establish a prima facie case.

Second, Petitioner argued that the ALJ erroneously treated the FDA Alert concerning the general hazards of side rails as conclusive evidence that Petitioner's particular configuration of mattress and side rail was hazardous. Petitioner noted that the FDA Alert instructs facilities to "use compatible side rails and mattresses to prevent gaps in which a patient could become entrapped." CMS Ex. 11A, at 2. Petitioner asserted that this advice does not answer the question of what makes a side rail and mattress compatible or what type of gap has the potential for entrapment. Petitioner argued that the FDA Alert did not establish that a 4.5 inch gap per se was hazardous. Finally, Petitioner pointed to the fact that the American Journal of Public Health article noted that there had been insufficient information gathered to "evaluate the potential role in side rail entrapment of decreased motor control, cloth restraints, medication use, type of side rail and poor mattress fit." P. Ex. 6F, at 2.

While Petitioner is correct that the FDA Alert does not specify exact dimensions for a hazardous gap, the Alert is expressly directed at gaps in which patients could become entrapped. The ALJ reasonably construed the warning to apply to a gap into which bodies, heads, or necks could fit. However, Petitioner's point seems to be that the FDA Alert does not apply here because these gaps were so big that they were not hazardous, i.e., that any person could easily extricate him or herself from the gaps and therefore not be "entrapped." The ALJ considered and rejected this contention, and we agree for a number of reasons.

  • First, Petitioner's argument that these gaps could not result in entrapment because they allowed for self-help escape is based on too narrow a reading of the concept of entrapment. "Entrapment" means "the condition of being entrapped." "Entrap" means "to catch in or as if in a trap, to capture and hold." Webster's Third New International Dictionary. The concept of entrapment does not mean that one must be caught forever unless rescued by a third person. Therefore, simply because one can extricate oneself from a gap does not mean that there is no entrapment prior to the escape from being caught or held.


  • Second, as Resident 2's experience demonstrated, simple and immediate self-help extrication from these gaps was not an option available to everyone. It is undisputed that Resident 2, who had very limited feeling in and use of his legs, slid into the gap. Rather than being easily able to extricate himself, he had to call for help in a manner which indicated, as evidenced by the nursing notes, a considerable degree of distress and fear for his safety. ALJ Decision 10. Therefore, these gaps were shown to be capable of entrapping a patient so that the patient needed assistance to escape from the gaps. (8)


  • Finally, even if some mentally or physically compromised patients could actually extricate themselves after falling into these gaps, they could also easily inflict injuries on themselves while doing so. For example, as documented by the FDA, accidents in gaps have resulted in a range of injuries from death to injury to skin, soft tissues, and fractures or sprains. P. Ex. 6F at 2. Nursing home patients often have fragile bones and skin which could be hurt while the patient is trying to remove him/herself from such a gap. Thus, the fact that an entrapment may be temporary or resolved through self-help does not mean that it will not result in serious injury.

Therefore, we conclude the ALJ reasonably found that these gaps were the type of hazardous gap addressed by the FDA Alert: a gap between a side rail and a mattress in which a resident could become entrapped. Further, as the ALJ concluded, the fact that the American Public Health Journal stated there was insufficient information to evaluate the role of side rail/mattress fit in relation to other risk factors in gap injuries does not negate the finding of the Alert as to the danger of physical injury posed by gaps in which patients can become entrapped. ALJ Decision at 7.

We also reject Petitioner's complaint that CMS failed to show that this particular mattress and side rail combination was not "compatible" as that term was used in the FDA Alert. This argument misplaces the relative burdens of proof in a deficiency case. As the ALJ noted, the Alert specifically directed facilities to take special precautions when combining equipment from different manufacturers. ALJ Decision 7. Specifically, the Alert provided:

Be alert to replacement mattresses and bed side rails with dimensions different than the original equipment supplied or specified by the bed frame manufacturer. Not all bed side rails, mattresses, and bed frames are interchangeable. Variations in bed side rail design and thickness and/or density of the mattress may affect the potential for entrapment. When bed side rails and mattresses are purchased separately from the bed frame, check with the manufacturer(s) to make sure the bed side rails, mattress, and bed frame are compatible.

CMS Ex. 11A, at 2 (emphasis added).

Petitioner admitted these were recently installed mattresses, that it had determined the initial mattresses it obtained for the beds were too hard for good skin care so it purchased softer mattresses from a different manufacturer, and that there was a gap into which critical body parts could fit. These undisputed facts, coupled with Petitioner's documentation showing that two residents were found in these gaps, one dead and one calling for help to get out of the gap, support the ALJ's conclusion that this side rail/mattress combination was not "compatible" as that word was used by the FDA. Given these facts, it was incumbent on Petitioner to prove the combination was compatible by resort to the type of evidence it faults CMS for not producing, such as a statement from the manufacturers as to the compatibility of this particular combination of equipment. Petitioner offered no such evidence.

Third, Petitioner argued that the ALJ's findings of fact concerning Resident 1 were not supported by substantial evidence and contradicted stipulated facts agreed upon by the parties. The Petitioner alleged that the ALJ erred by "consistently assum[ing] that the bed rails were involved in the resident's death," despite CMS's stipulation to the contrary, and by finding, at page 8 of the ALJ Decision, that "[b]ecause the facility failed to eliminate the gap between the side rail and the mattress, Resident 1 was able to slide through the existing gap and become entrapped." P. Br. at 7. Petitioner asserted that "there is no credible evidence that Resident 1 was actually entrapped." Id. (emphasis in original).

We reject this argument for the following reasons.

  • Contrary to Petitioner's assertion, the ALJ did not assume that the bed rail contributed to Resident 1's death. His discussion concerning the evidence about Resident 1 is directed at determining Resident 1's position in death, i.e., whether Resident 1's head was between the bed rail and mattress or merely to the side of the bed rails. The nursing notes described her position as "sitting on the floor beside bed w/ legs extended forward and back against her bed, her head between the mattress and siderails." CMS Ex. 2A. However, Mr. Franklin, a LPN supervisor who witnessed Resident 1's position, asserted in his deposition that Resident 1's neck was merely a half-inch into the space between the mattress and side rail. P. Ex. 1A, at 13. The ALJ's discussion of the evidence goes to why he finds the description in the nursing notes more credible than Mr. Franklin's later representations and why he determined Resident 1's neck was between the side rail and mattress and not merely against the side rail as Mr. Frankin testified.


  • There was credible evidence in the record that Resident 1 was entrapped in this gap. Based on the nursing notes contemporaneous with the incident, the ALJ reasonably rejected Petitioner's assertion that Resident 1's neck was not actually in the gap when she was found. The ALJ also reasonably concluded that she could not have died first and then gotten herself seated by the bed with her neck in the gap. ALJ Decision at 8-9. Therefore, since sitting on the floor while being lodged under a side rail with one's head backwards on a mattress is clearly not a position one would choose to maintain, the fact Resident 1 was found dead in the gap supports the ALJ's finding that she was unable to extricate herself before or as she died and was therefore entrapped. (9)


  • As the ALJ recognized, whether or not Resident 1's death was caused or hastened by the presence of her throat between the rail and the mattress is not dispositive of whether these gaps constituted an accident hazard. Further, whether Resident 1 died as she fell into the gap or fell into the gap and then died is also not dispositive of whether these gaps constituted accident hazards. Rather, the relevance of Resident 1's position in death is that it demonstrated to Petitioner, as of September 13, 1998, that residents could and would accidentally fit critical body parts, such as necks, into these gaps.

Fourth, Petitioner argued that the ALJ erroneously accepted CMS's theory about the incident with Resident 2 although, Petitioner alleged, the surveyors conducted no investigation and relied on a demonstrably false affidavit. Petitioner asserted there was not sufficient evidence to support the ALJ's conclusion that Resident 2 was at risk for asphyxiation or any other kind of actual harm from the gap.

In making his determination, the ALJ relied on Petitioner's nursing notes, which state:

Res's call light went off. Picked up intercom and asked "May I help you?" Res state, "yes, I need out of this position." Hung up intercom and immediately went to Res's room. Found Res hanging off the bed with his lower body on the floor. Res's neck was between the bed and the siderail. Res's hands were on the siderail holding up his head. Res stated, "Help." Asked Res if he could breathe okay. --- he stated, "yes, for now." Informed Res I need to go get another staff member to assist in moving him and asked Res if he would be able to continue holding his head up. Res state, "Yes." Aid was on dinner break. Went to phone and called C/D unit. Nurse picked up phone. Explained the situation and that I need help moving the Res. Nurse state he was on his way. Hung up phone and ran back to Res's room. Found Res in the same position still holding his head up with his hands. Asked Res if he could still breathe okay. Res state, "Yes, but I can't hold myself up much longer." Informed Res another nurse was on his way and that we would move him. At that time the nurse came in and we proceeded to move Res into a semi-sitting position.

P. Ex. 8H, at 1-2.

The notes reflect Resident 2 was examined for injuries and moved back into his bed. The notes then state: "Asked Res if at any time he was unable to breathe, Res stated, 'No'." Id. at 2.

Based on this description of the incident, the ALJ determined that Resident 2 was entrapped in the gap and that the nurse questioned whether he was at risk for having his ability to breathe compromised. (10) These are perfectly reasonably inferences from the content of these notes, rather than, as Petitioner alleges, "a distortion of the chart entry." P. Br. at 11. The fact that Resident 2 reported, when back in bed, that he was never unable to breathe does not negate the reasonableness of the ALJ's findings. Resident 2 was able to breathe while he was in the gap because, as the nursing notes reflect, he continued to hold up his head with his hands.

Petitioner complained that the surveyors simply relied on the nursing notes rather than engaging in additional investigation and that therefore their investigation was so deficient as to render their conclusions about this incident invalid. Petitioner asserted that "the possibilities that CMS did not investigate include that the resident perceived a risk to himself that did not, in fact, exist, or that the perceived risk was something other than strangulation." P. Br. at 11. These considerations do not invalidate the ALJ's findings for the following reasons:

  • There is substantial evidence in the record to support the ALJ's determination that Resident 2 was at risk of impaired breathing from his position in the gap. This included reasonable inferences from Resident 2's own statements while in the gap and the contemporaneous statements of the nursing staff as reflected in the nursing notes.


  • The nursing notes support a finding that Resident 2 was concerned that if he did not continue to hold himself up, his breathing would be impaired. If, in fact, Resident 2 was concerned about some different risk, the burden was on Petitioner to determine what this risk was or to submit evidence to show that Resident 2 was not in fact at risk of impaired breathing.


  • Other evidence in the record showed that entrapment gaps create risks of injury, so even if Resident 2 was not at risk of impaired breathing, this would not undercut the ALJ's finding that Resident 2 was entrapped or at risk of other injuries, nor undercut the ALJ's overall finding that Petitioner was not in substantial compliance with the requirement that it ensure that the resident environment remain as free of accident hazards as is possible.

Petitioner also asserted that information in the affidavit filed by Surveyor Demaree is false. Demaree visited the facility on September 21, 1998, to review the incident involving Resident 2. In her affidavit she represented that, pursuant to instructions from staff members who represented to her that they had observed Resident 2 in the gap, she placed herself in the position in which Resident 2 was found. A photograph was submitted of her in this position. P. Ex. 16P. Petitioner asserted that Demaree actually never talked to anyone with first-hand knowledge of the incident involving Resident 2 and that the photograph is not an accurate depiction of the incident. Petitioner submitted multiple affidavits stating that no one in the room when the photograph was taken was an eyewitness to the incident.

The circumstances of the Demaree picture are not material to the ALJ Decision in that there is no indication in the decision that the ALJ relied on the picture. Further, the only aspect of the photograph that Petitioner identified as inaccurate is that Demaree is holding herself up with her hands on the outside of the rails while Resident 2 was holding himself up with his hands on the inside of the rails. However, Petitioner did not explain why this distinction is important to the consideration of whether Resident 2 was at risk of injury, nor did Petitioner submit its own photographic re-enactment of Resident 2's position. If the picture was wrong in a material way, Petitioner was free to explain or to put in its own picture.

Petitioner complained that the surveyors stopped gathering information and did not talk with eyewitnesses of the Resident 2 incident. However, at the point the survey agency made the decision to stop fact finding, it had the following sufficient basis for determining that these gaps were an accident hazard posing immediate jeopardy: the facility's beds had recently created gaps into which head, necks, torsos, and other body parts could fit; the facility had no procedure for evaluating whether such gaps created a hazard for a given resident in light of that resident's mental and physical condition; the facility's documentation showed that two residents had been found in those gaps within a week; and the FDA had issued an Alert as to the dangers posed by such gaps, particularly to compromised residents typical of nursing homes. Further, the reason the regulations provide for a hearing is to ensure that all relevant information is considered in assessing noncompliance with federal participation requirements and in imposing remedies. If the state survey agency terminated its fact finding prematurely, Petitioner was free to produce evidence of all relevant facts before the ALJ. Petitioner did not produce any persuasive evidence to counter the survey agency's findings. Thus, the ALJ did not err in upholding the CMS conclusion based on the surveyor's findings.

Fifth, Petitioner argued that the ALJ erroneously relied on a theory of danger not reflected in the statement of deficiencies, or even in CMS's argument. The ALJ wrote that the hazard posed by the gaps exposed the residents "to risk of entrapment" and that "Petitioner's lack of intervention allowed the residents to become entrapped in side rails, putting them at risk for strangulation, chest compression, and death." ALJ Decision at 5. Petitioner asserted that the injury first suggested, though not clearly stated, in CMS's statement of deficiencies was that of strangulation; that before the ALJ, CMS suggested the risk was of an injury caused by a limb being caught in the gap; and that the ALJ relied on "another theory of a hazard - that residents were at risk of chest compression.' ALJ Decision at 5." P. Br. at 15. Petitioner asserted there was no evidence in the record to support a finding that these gaps posed a risk of strangulation, fracture, or chest compression.

We reject this argument. As the FDA documented in its Alert, gaps in which patients can be entrapped can result in a range of serious injuries including death, fractures, cuts, and abrasions. CMS Ex. 11A at 4. Petitioner did not deny that it had notice from the FDA Alert of the type of the range of injuries which can be caused by such gaps. These injuries include the risk of strangulation and chest compression. The material facts here are that the gaps created accident hazards which had been documented by the FDA as placing residents at risk for a range of serious injuries and that Petitioner was aware of the gaps, but took no steps to free the residents' environment from these hazards. The mere fact that different examples of the type of risk have been given by CMS at various times and by the ALJ in his decision does not undercut the ALJ's finding that the gaps constituted accident hazards. Indeed, given that Petitioner had 84 beds with this mattress/side rail configuration (including at least 12 with side rails actually in use at the time of the survey), it is likely that use of the side rails posed different risks to different residents, depending on their personal characteristics and physical and mental status.

2. Whether the ALJ's determination that the deficiency under 42 C.F.R. § 483.25(h)(1) constituted immediate jeopardy was clearly erroneous.

The ALJ upheld CMS's determination that the deficiency under 42 C.F.R. § 483.25(h)(1) constituted immediate jeopardy. The regulations define "immediate jeopardy" 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. CMS's finding of immediate jeopardy must be upheld unless Petitioner proves that the determination is "clearly erroneous." 42 C.F.R. § 498.60(c)(2). As the ALJ noted, a finding of immediate jeopardy does not require a finding of actual harm but encompasses a situation that is "likely to cause" harm. Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002); Southridge Nursing and Rehabilitation Center, DAB No. 1778 (2001).

We uphold the ALJ's finding of immediate jeopardy as to the deficiency under section 483.25(h)(1) for the following reasons.

As explained above, the ALJ reasonably determined that the gaps between the side rails and the mattresses constituted accident hazards in violation of section 483.25(h)(1). He also reasonably determined that the CMS finding that such a hazard was likely to cause serious injury, harm, impairment, or death to a resident was not clearly erroneous. The record as a whole supports this finding. The FDA Alert, cited by the ALJ in his decision, documents that gaps which can result in entrapment between side rails and mattresses have caused a range of injuries, including death. The FDA regarded the threat posed by such gaps as so serious that it advised facilities to take special precautions when caring for high risk patients. The FDA wrote:

Additional safely measures should be considered for patients identified as high risk for entrapment. . . . . Bed side rails protective barriers may be used to close off open spaces in which these patients might accidently become entrapped.

CMS Ex. 11A, at 3.

Further, Petitioner failed to provide any persuasive evidence to show that these gaps were not likely to cause serious injuries. For example, the FDA Alert specifically recommended consultation with manufacturers when mattresses and bed frames were purchased separately "to make sure the bed side rails, mattress, and bed frame are compatible." CMS Ex. 11A, at 2. Petitioner submitted the assembly and operation manual for the bed and noted that it did not contain warnings concerning compatibility of mattresses. P. Ex. 7G. However, since the manual contains no information concerning mattresses, it does not tend to show that the bed and mattress were compatible as that term was used in the FDA Alert. Further, as explained above, the ALJ properly rejected as immaterial the evidence that surveyors and Petitioner's employees could sit on the floor, slide their necks into the gaps, and slide themselves back out of the gaps without injury. These simulations are not probative of the threat posed by the gaps to physically and mentally compromised residents who could fall into the gaps from the bed (Resident 2) or from a standing position by the side of the bed (possibly Resident 1) catching their torsos, head, necks or other body parts.

Therefore, the ALJ properly determined that it was not clearly erroneous for CMS to conclude that, in a facility of 84 bed/mattress combinations with gaps like the ones at issue here when the side rails were in an "up" position, residents were likely to become entrapped and suffer serious injury, harm, impairment, or death.

3. Whether the amount of the penalty imposed by CMS is reasonable.

CMS imposed a $3,050.00 per day CMP for the period beginning September 13, 1998, and ending September 19, 1998. Petitioner did not offer any specific arguments as to why the amount was not reasonable.

We agree with the ALJ that there is no issue as to the reasonableness of the daily amount of the penalty, inasmuch as $3,050.00 is the minimum that may be imposed by CMS where it is established that the participating facility has incurred a deficiency that reaches the level of immediate jeopardy. 42 C.F.R. § 488.438(a)(i).

4. Petitioner's Motion for Consideration of Additional Evidence and CMS's Motion to Strike are denied.

Petitioner filed a Motion for Consideration of Additional Evidence.

As to additional evidence, the rules for Part 498 hearings before the Board provide:

The Departmental Appeals Board may admit evidence not in the record in addition to the evidence introduced at the ALJ hearing (or the documents considered by the ALJ if the hearing was waived), if the Board considers that the additional evidence is relevant and material to an issue before it.

45 C.F.R. § 498.86(a).

The Board has issued guidelines for Part 498 proceedings. As to additional evidence, those guidelines provide:

While the panel may admit evidence into the record (during oral proceedings or through written submission), the panel will only do so if it considers the additional evidence to be relevant and material to an issue before it and the proponent demonstrates good cause for not producing the evidence during proceedings before the ALJ. The panel, if it deems it appropriate, will require production of relevant evidence or information at any point in the process.

GUIDELINES -- APPELLATE REVIEW OF DECISIONS OF ADMINISTRATIVE LAW JUDGES AFFECTING A PROVIDER'S PARTICIPATION IN THE MEDICARE AND MEDICAID PROGRAMS, ¶ 3(f).

The additional evidence consisted of documents relating to the credibility of Surveyor Demaree. The documents are records from a 1988 criminal conviction of Demaree and employment applications filed by Demaree with the Commonwealth of Kentucky throughout the 1990s. (11)

We decline to admit the proffered evidence because we conclude that Petitioner failed to show good cause for not producing and relying on the evidence during the proceedings below. It is apparent that Petitioner knew about the criminal conviction prior to the issuance of the ALJ Decision because it supplied some documents from the criminal proceeding to CMS in a June 2000 prehearing document exchange. Later, the parties agreed to waive an in-person hearing. In a confirmation letter setting forth procedures in lieu of an in-person hearing, the ALJ's staff attorney specifically told the parties to identity exhibits by 1A, etc., to avoid confusion with previous exhibit submissions. Petitioner then filed a set of exhibits numbered 1A through 16P, and did not include any exhibits related to this criminal conviction.

In addition, it is evident that the issue of Demaree's credibility was squarely before the ALJ. In fact, Petitioner directly challenged Demaree's credibility by introducing several affidavits from its employees attacking the veracity of Demaree's statements in her affidavit about her investigation of the incident with Resident 2. However, Petitioner did not include documents related to Demaree's criminal conviction in its final set of exhibits, and before the ALJ never asserted that there had been a criminal conviction or that the conviction showed Demaree to be a less credible witness. Thus, it is clear that Petitioner identified Demaree's credibility as an issue before the ALJ and had an opportunity to submit the information that it now seeks to have admitted into the record.

Petitioner asserted on appeal that it did not proffer evidence relating to Demaree's criminal conviction before the ALJ
because -

given the very embarrassing nature of this evidence and the potential consequence to Ms. Demaree, [Petitioner] did not previously believe it was necessary to offer this evidence. However, [Petitioner] has now argued in three separate briefs that Ms. Demaree's affidavits contained false information, yet each time CMS has taken no action to withdraw or revise the disputed statements. Instead, CMS has continued to argue them in its recent Response. In light of this and the ALJ's reliance upon the affidavit of Ms. Demaree in this decision, [Petitioner] feels it has become absolutely necessary to expose the lack of integrity of the survey agency official who both found the facility to be out of compliance and submitted the affidavits in question.

This justification does not constitute good cause for failing to proffer this evidence before the ALJ. The ALJ hearing is a de novo proceeding in which any shortcomings of CMS's investigation or determination, and/or the credibility of any proffered witness testimony, should be presented to the ALJ. It is contrary to the purposes of having a de novo hearing, contrary to the Guidelines, and contrary to the interests of efficient adjudication to permit tardy and piecemeal introduction of evidence. We therefore reject Petitioner's proffer of evidence as untimely.

Since we have declined to admit Petitioner's additional evidence, we deny as moot CMS's Motion to Strike Petitioner's arguments as to this evidence.

Conclusion

For the reasons explained above, we affirm FFCLs 1 through 4.

JUDGE
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Judith A. Ballard

Cecilia Sparks Ford

M. Terry Johnson
Presiding Board Member

FOOTNOTES
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1. CMS was previously named the Health Care Financing Administration (HCFA). See 66 Fed. Reg. 35,437 (July 5, 2001).

2. The state survey agency determined that Petitioner had come into substantial compliance with federal requirements as of September 19, 1998 by eliminating the gaps between mattresses and the side rails. The duration of the CMP was from September 13 to September 19, 1998 for a total of $18,300.

3. Since Petitioner returned to substantial compliance prior to October 17, 1998, the termination was not effectuated.

4. In his Decision, the ALJ referred to the parties' agreement for disposition for "summary judgment without the need for an in-person hearing." ALJ Decision at 2. While the term "summary judgment" is used in the Federal Rules of Civil Procedure to refer strictly to cases in which there are no material facts in dispute, the parties evidently chose this term to refer to their agreement on how to proceed despite their disagreement about material facts. They have not argued on appeal that the ALJ misconstrued their agreement or otherwise erred in issuing a disposition on the written record. Thus, we review the ALJ Decision for whether his findings on the material issues of fact are based on substantial evidence in the record before him, rather than by reviewing whether he correctly determined that there were no issues of material fact (construing the evidence in favor of the non-moving party), as would be appropriate in a true summary judgment case.

5. Petitioner appealed the ALJ's determination that CMS established a prima facie case as to Petitioner's substantial noncompliance. However, Petitioner did not appeal the ALJ's ruling that Petitioner, in challenging the imposition of a civil money penalty (CMP), had the ultimate burden of persuasion.

6. CMS cited to the State Operations Manual in its brief. CMS Reply Br. at 7. Petitioner did not challenge the applicability of this provision or assert that it did not have notice of the provision.

7. Petitioner argued that this statement by the ALJ negated CMS's prima facie case because the surveyors' testing was CMS's only evidence as to the rails' potential for entrapment. P. Br. at 6. This argument misconstrues the ALJ's statement. Based on Petitioner's admissions, the surveyor's testing, and the incidents with Residents 1 and 2, the ALJ properly concluded that critical body parts could fit in this gap. What he rejected as having no probative value was the surveyors' ability to extricate themselves from the gap. He reasonably found that the physical and mental abilities of healthy able-bodied people to extricate themselves from this gap are not a reliable measure of the abilities of a nursing home population to do the same thing.

8. Petitioner asserted that Resident 2 was never actually in danger but simply perceived himself to be in danger because of the compromised feeling in his legs. P. Br. at 11, n. 4. However, this is just the point. The nursing home population generally has an assortment of physical and mental conditions which would interfere with both a resident's strength and judgment in dealing with extricating him/herself from such a gap. That was why the ALJ did not find persuasive Petitioner's assertions that its employees and the surveyors could remove themselves from the gap.

9. Petitioner pointed to the statement in the coroner's report that "after talking to everyone involved, it was determined that [Resident 1] did not have her head stuck in the rail." P. Ex. 2B, at 2. This statement does not necessarily undermine the ALJ's finding that Resident 1 was between the mattress and side rail and therefore entrapped. The coroner's investigation was precipitated, according to his notes, "by an anonymous phone call [to the state agency], saying [Resident 1] choked to death on bedrail, and body was released to funeral home without an investigation." P. Ex. 2b, at 2. Therefore, the coroner's primary concern was whether Resident 1 had actually been strangled by the rail, not whether she had her head between the mattress and side rail. To the extent the coroner's statement means she did not have her head stuck in a way that caused her death, it is irrelevant. To the extent the coroner's statement means Resident 1's neck was not even in the side rail and Resident 1 was not entrapped, the ALJ reasonably chose to rely on the contemporaneous nursing notes indicating that Resident 1's neck was between the mattress and the side rail rather than on notes of the coroner's conversation with unknown individuals.

10. Petitioner submitted an affidavit from the nurse stating:

Since the resident is a large man and routinely required two people to transfer, I checked to make sure he was not having trouble breathing, then sought someone to help me move him safely. If he had been unable to breathe, or his airway had been in danger, I would have moved him myself without seeking assistance.

P. Ex. 5E, at ¶ 4. While this statement sets forth the nurse's conclusion that his airway was not in immediate danger, it does not clarify whether she reached this conclusion because Resident 2 assured her he could hold himself up or because she saw no risk at all posed by this situation. The fact that she recorded herself as asking him several times in a short period about his breathing would indicate that her conclusion was related to his assurances.

11. CMS opposed Petitioner's Motion, and contended that in any event the conviction was for a misdemeanor, not a felony as alleged by Petitioner.

CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES