SUBJECT:

Richmond Health and Rehabilitation Complex-Kenwood,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Richmond Health and Rehabilitation Complex-Kenwood, was in substantial compliance with Medicare and Medicaid participation requirements on December 20, 2001, and therefore, no enforcement remedy may be imposed.

I. Background

Petitioner, located in Richmond, Kentucky, is certified to participate in the Medicare program as a skilled nursing facility (SNF) and in the state Medicaid program as a nursing facility (NF). In a survey completed on January 4, 2002, the Kentucky State Survey Agency (or state agency) determined that Petitioner was not in substantial compliance with the participation requirements that govern nursing homes, and that the conditions at Petitioner's facility constituted immediate jeopardy to the resident's health and safety.

In a letter dated January 11, 2002, the sate survey agency notified Petitioner that it would recommend CMS impose the following remedies:

A Civil Monetary Penalty (CMP) of 5,050 per day effective December 30, 2001;

Denial of payment for new admissions (DPNA); and

Termination effective January 27, 2002.

Based on recommendations by the state agency CMS imposed a CMP in the amount $5,050 per day effective December 30, 2001, continuing until the jeopardy was removed or until the facility was terminated. The facility returned to substantial compliance on January 4, 2002. Petitioner was found by CMS to have violated 42 C.F.R. 483.25(h)(1), failure to provide residents with an accident free environment (Tag F 323).

By letter dated March 8, 2002, Petitioner requested a hearing challenging the findings of the state agency and the enforcement remedy imposed by CMS. On March 18, 2002, the case was assigned to me for hearing and decision. A hearing was held before me on September 23-24, 2003, in Louisville, Kentucky, and concluded on December 11, 2003, in Washington, D.C. At the hearing surveyors Ed Bowling and Robert Durham testified for CMS; Debra Vaughn, Janet Justice, and Mark Bruely testified on behalf of Petitioner. CMS submitted Exhibits (CMS Exs.) 1 through 29 with no objection by Petitioner. Petitioner submitted Exhibits (P. Exs.) 1 through 43 with no objection by CMS. The exhibits of both parties were admitted and received into evidence. Transcript (Tr.) at 29, 31.

Based on the applicable law and regulations, the documentary evidence, and the testimony taken at hearing, the preponderance of the evidence shows that on December 30, 2001, Petitioner was in substantial compliance with federal participation requirements governing nursing homes and, therefore, no enforcement remedy may be imposed.

II. Issues

The general issues are:

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

Whether the remedy imposed is reasonable.

III. Applicable Law

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 vest the Secretary of Health and Human Services (Secretary) with authority to impose CMP's 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 in 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.

The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two broad 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). There is only a single range of $1,000 to $10,000 for a per instance CMP, which applies whether or not immediate jeopardy is present. 42 C.F.R. �� 488.408(d)(1)(iv); 488.438(a)(2).

The Act and regulations make a hearing before an ALJ available to a long-term 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)(13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F2d. 678 (8^th 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. U.S. Dept. of Health and Human Services, 363 F.3d 583 (6^th Cir.2003). The Departmental Appeals Board (the Board or DAB) 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 remedy is imposed and appealed, CMS must make a prima facie showing 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). 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 (1997), aff'd Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999). A preponderance of evidence is "superior evidentiary weight that, though not sufficient to free the mind wholly from all reasonable doubt, is still sufficient to incline a fair and impartial mind to one side of the issue rather than the other." Black's Law Dictionary (7th ed. 1999) (cited by the Board in Beechwood Sanitarium, DAB No. 1906, at 38 (2004)).

IV. Findings of Fact, Conclusions of Law, and Discussion

I make findings of fact and conclusions of law to support my decision in this case. I set forth each finding below, in italics, as a separate heading.

1. The preponderance of the evidence establishes that at all relevant times Petitioner was in substantial compliance with participation requirements at 42 C.F.R. � 483.25(h)(1), (Tag F323).

This case arises from the death of an elderly female resident (R1), found lying partially on, and partially out of, her bed. On December 30, 2001, nurses aide Christina Arps found Resident R1 with her head between the mattress and side matters rail with her body off the bed. CMS Ex. 10, at 1. The resident had no pulse or respiration. Id. The nurses attempted cardiopulmonary resuscitation and the resident was later transported to a nearby hospital emergency room where she was pronounced dead. Id.

On January 4, 2002, state surveyors Ed Bowling and Robert Durham conducted a complaint investigation survey. The surveyors interviewed the facility staff involved and their written statements. An interview with Janet Justice, the facility's administrator, revealed that 20 new beds had been ordered and as of January 4, 2002 eleven of the new beds were being utilized by the residents. The new beds were all equipped with one-half side rails. R1 had received one of the new beds. However, R1 did not receive a new mattress. CMS argues that the facility's use of "the new bed and older improperly fitted mattress" caused serious injury, and arguably, the death of R1. CMS Post Hearing Brief at 14-15. Petitioner argues that the bed system - bed, mattress and side rails - used by R1 was as free of accident hazards as was possible; that R1's head was not caught between her mattress and side rail; and that the survey team failed to perform a complete and accurate survey.

According to the testimony of Debra Vaughn, Charge-Nurse, at approximately 8:45 p.m. on December 30, 2001, she responded to a call from R1. While attending to R1 nurse Vaughn noticed that R1 had been tearing at her brief, trying to get it off. Ms. Vaughn then contacted nurses aides, Christiana Arps and Marsha Burgess and directed them to change R1's brief. Tr. at 288. Later that evening at approximately 10:20 p.m. Ms. Vaughn was summoned to R1's room by Christina Arps and Marsha Burgess. Tr. at 289. In a statement prepared by Christina Arps she stated that she entered R1's room and found R1 with her neck caught between the bed rail, with her body on the floor. CMS Ex. 4, at 3.

At hearing Mr. Bowling testified that his interview with Christina Arps was consistent with her prior written statements - that R1's head was caught between the bed and the bed rail. Tr. at 74. Ms. Vaughn testified that when she entered R1's room she saw R1 "her back and head resting on the middle rail." Tr. at 292. Ms. Vaughn immediately assessed R1. When asked if she thought R1's head was entrapped, Ms. Vaughn testified "I don't think it was, because I could put my hand in there and support her head when we log rolled her." Id. "I think if it was wedged - you know, I would have marks on my hand. I would have scraped my hand, you know, trying to get it in there, and I would have had to, you know, pull and tug, and I didn't." Id.

Dr. John Hunsaker, III, deputy medical examiner, performed an autopsy on R1's body on January 1, 2002. P. Ex. 29. The original report, dated January 29, 2002, concluded that R1's "cause of death" was "positional asphyxia" and that the proximate cause (marked "due to") was "wedging of the head and neck between bed rail and edge of mattress." Id. However, because the preliminary report did not include an on-site investigation of the bed, mattress and rails, nor Dr. Hunsaker's personal interviews of the persons who first found and moved R1's body, on May 9, 2002, Dr. Hunsaker traveled to Richmond, Kentucky and performed a day-long investigation and conducted a series of interviews with all of the critical witnesses, including Debra Vaughn and Christina Arps. Tr. at 396, 398. Dr. Hunsaker questioned both witnesses and asked them to demonstrate how they found the body, head, and neck of R1 on the bed system in question on December 30, 2001. Tr. at 398.

After Dr. Hunsaker's investigation and reconstruction of events, he determined that the evidence required the following change:

I have concluded that the terms "wedging of head and neck between bed rail and edge of mattress" is inappropriate, in view of the various descriptions by initial eyewitnesses observing the decedent's predicament.

P. Ex. 9.

Subsequently, in a letter to the Madison County Coroner dated July 24, 2002, Dr. Hunsaker rewrote the proximate cause section of the autopsy report to read:

Compression of chest and neck against surface of mattress in kneeling position, with knees on floor and top of right shoulder pressing against bed rail.

P. Ex. 9.

Dr. Hunsaker, however, did not change his opinion as to the ultimate cause of death: "positional asphyxia." He noted, significantly, that the "contributory causes" to R1's death were "ischemic heart disease; dementia; limited mobility of lower extremities." Id. In his January 29, 2002 autopsy report he described his findings of ischemic heart disease in more detail when he wrote that a contributory cause of death was "constrictive atherosclerotic coronary artery and hypertensive heart disease." P. Ex. 19

Dr. Douglas M. Ackermann, a pathologist to whom the state medical examiner often sends complex, heart-related death cases, reviewed the evidence related to R1's death, including slides of actual heart tissue sectioned by Dr. Hunsaker at autopsy. P. Exs. 10, 40. Dr. Ackermann agreed with Dr. Hunsaker that R1 had significant ischemic heart disease, but not with Dr. Hunsaker's ultimate opinion as to the cause of her death. Dr. Ackerman did not agree that R1 was incapacitated and deprived of oxygen resulting in positional asphyxiation. Dr. Ackermann theorized that R1 most likely died of ischemic heart disease and a cardiac event. In support of Dr. Ackermann's theory, he focused on the autopsy finding that three main descending arteries were found to be 80%, 55%, and 70% stenosed, or occluded, which caused a lack of oxygen supply to the heart and fatal arrhythmia or disruption of the normal electrical system of the heart. Id.

Mark Bruley, a biomedical engineer and a member of the Hospital Bed Safety Work Group (HBSW) ⁽¹⁾, examined, measured, photographed, and used HBSW-designed tools and guidelines to test R1's bed system. Using these tools and procedures Mr. Bruley determined that the gap identified by the survey team complied with the current FDA guidelines and procedures. In his opinion, R1's bed system satisfied FDA "dimensional guidelines," "was safe for and appropriate for clinical use" and did not contain an "accident hazard." Tr. at 480-481. Mr. Bruley testified that he had tested both the new Jamison mattress and the Sunrise Medical mattress on the Freestyle bed (R1's bed). Mr. Bruley concluded that the different mattress would not have made the rail-mattress spaces smaller and would not have made R1's bed system safer. Tr. at 481. Like Dr. Hunsaker and Dr. Ackermann, Mr. Bruley also concluded that R1's head was not entrapped, citing credible witness accounts that her head was not wedged, the fact that she had good upper body strength to push herself off the side of the bed, and the geometry of the side rail and the absence of corresponding marks on R1's head and neck, a condition borne out by the autopsy photographs.

CMS's assertion that Petitioner failed to protect its residents against accident hazards centers on the alleged failure of Petitioner to assure that the mattresses fit the new beds. At hearing and in the briefs a substantial amount of information was provided regarding the bed system and the mattress. Yet I cannot find anywhere in the record a causal connection between the age of the mattress and any effect; in essence, no causation of any of the events in this case can be linked to the age or appearance of the mattress. During the course of their survey, the surveyors interviewed facility staff members and reviewed documents related to the death of R1. The information gained through interviewing staff was consistent with staff's notes, the incident report, and the investigation report made contemporaneously to the incident of December 30, 2001. Tr. at 110. I cannot find the surveyors' testimony, or for that matter the survey results in general, very helpful in that they only recite what was given to them by the facility, without testing that information critically by independent observation. I believe that the surveyors assumed too much based on Ms. Arps' first note, which was the only item ever actually to describe R1 as "caught" or entrapped in the bed, rail, and mattress. They also relied too heavily on the preliminary death certificate, which incorporated Ms. Arps' observations. In both cases, I cannot read Ms. Arps' statements as establishing any real entrapment. The surveyors seem to have begun acting on the belief that they had an entrapment before them, and then began to focus on the bed, mattress, and rails as the obvious cause. They saw an "old" mattress in a new bed and believed that they had found the instrumentality of the accident.

The more credible evidence, which makes up the preponderance of the evidence in this case, is the testimonial evidence of Ms. Vaughn, Dr. Hunsaker, Dr. Ackermann, and Mr. Bruley, who either had first hand knowledge of the incident or performed an investigation of the scene of the incident.

I find Ms. Vaughn to be a knowledgeable and credible witness. Tr. at 275-348. By all accounts she was on the scene at once: she went all the way into the room, she was the first one to closely examine R1's position, and she was one of the first to experience and observe precisely how R1's head and body were engaged with the bed and rail. I accept as correct in all particulars her description of the scene when R1 was discovered.

I accept Dr. Hyunsaker's "revision" of the circumstances as to R1's cause of death (Tr. at 108-109), and, by extension, the change in the immediate cause from what would have amounted to a "choking" phenomenon to one much more likely: an asphyxia caused by compression of R1's chest cavity.

Based on his background, education, experience, and on my assessment of the skill and objectivity with which he reached and expressed his conclusions, I accept Mr. Bruley's testimony without reservation or discount. To prepare his opinion and demonstrations, Mr. Bruley studied a comprehensive list of relevant documents and depositions, performed research on the bed and mattress, and conducted interviews with critical witnesses - Ms. Vaughn, Ms. Arps, and Ms. Justice. Mr. Bruley's well-informed and fully-supported testimony made it extremely difficult to accept that any entrapment at all took place, and, if it did, it was utterly beyond the ability of the facility to predict or prevent.

The regulation at 42 C.F.R. � 483.25 (h)(1) requires the facility to ensure that the resident environment remains as free from accident hazards as is possible. The facility must address known hazards and must also address hazards that it should know about. The regulation obligates a facility to ensure that any steps it takes to protect a resident or residents are effective.

A facility's duty to protect its residents is not one of strict liability, however. The fact that an accident or injury occurs at a facility is insufficient in and of itself to find the facility deficient. The occurrence of an accident or an injury to a resident is not a necessary predicate to a finding of noncompliance with the regulation. The regulation addresses accident hazards. A hazard may be present at a facility even if no accident occurs. And conversely, an accident may not by itself be sufficient to prove a failure by a facility to address the cause of that accident if the cause is one that the facility did not anticipate or should have anticipated.

Based on the applicable law and regulations, and the testimony taken at hearing, the preponderance of the evidence shows, that on December 30, 2001, Petitioner was in substantial compliance with federal requirements governing participation of nursing home facilities in Medicare and Medicaid and, therefore, no enforcement remedy may be imposed.

2. A CMP of $5,050 per day is unreasonable based on the facts of this case as there is no violation and therefore no basis for the imposition of a CMP.

The remedy determinations made by CMS in this case are premised on the findings of noncompliance made at the survey. I have found that the preponderance of the evidence establishes that, in fact, Petitioner was complying with participation requirements. Consequently, there is no basis for CMS to impose remedies against Petitioner.

V. Conclusion

As I have found Petitioner to be in substantial compliance with 42 C.F.R. � 483.25 (h)(1), no enforcement remedy may be imposed.

Richard J. Smith

Administrative Law Judge

1. The Hospital Bed Safety Group (HBSW) is a group of private and public organizations and individuals organized by the Food and Drug Administration (FDA) to study hospital bed safety issues and propose guidelines and tools to evaluate potential safety hazards in hospitals beds.