SUBJECT:

Tri-County Extended Care Center,

Petitioner,

Centers for Medicare & Medicaid

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) ⁽¹⁾ to impose a Civil Money Penalty (CMP) against Petitioner, Tri-County Extended Care Center, for failure to comply substantially with federal requirements governing participation of long-term care facilities in the Medicare and Medicaid programs. The findings justify a CMP in the amount of $3,050, effective April 15, 2000, for one day of immediate jeopardy, and continuing at the rate of $450 per day effective April 16, 2000 through May 15, 2000.

I. Background

This case is before me pursuant to a request for hearing filed by Petitioner on July 27, 2000, in accordance with section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R. �� 488.408(g), 498.40.

On June 16, 2000, CMS informed Petitioner that based on a survey completed on May 1, 2000, by the Ohio Department of Health (ODH), it was imposing selected remedies due to Petitioner's failure to be in substantial compliance with the applicable federal requirements for nursing homes participants. CMS Ex. 1.

CMS concurred with the State recommendation and imposed the following remedies:

�Denial of payment for new Medicare and Medicaid admissions (DPNA).

�CMP in the amount of $3,050 per day effective April 15, 2000, for one day of immediate jeopardy, and continuing at the rate of $450 per day effective April 15, 2000.

Id. CMS sent Petitioner another letter on August 23, 2000, stating that as a result of a revisit survey conducted on May 26, 2000, the facility was found to be in substantial compliance with participation requirements effective May 16, 2000. CMS Ex. 2. As a result of the resurvey findings, CMS rescinded the DPNA. The following remedies remained in effect:

�CMP in the amount of $3,050, effective April 15, 2000, for one day of immediate jeopardy; and

�CMP of $450 per day effective April 16, 2000 through May 15, 2000.

Id.

At the hearing I held in Cincinnati, Ohio, on May 28, 2003, CMS offered 33 exhibits (CMS Exs. 1 - 33), and Petitioner offered seven exhibits (P. Exs. 1 - 7). The parties' exhibits were admitted into evidence without objection. Subsequent to the hearing, the parties submitted simultaneous post hearing briefs (CMS Br. and P. Br.), as well as response briefs (CMS Response Br. and P. Response Br.).

Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that on April 15, 2000, Petitioner was not in substantial compliance at the immediate jeopardy level. I further find that CMS was authorized to impose a CMP against Petitioner in the amount of $3,050, effective April 15, 2000, and continuing at the rate of $450 per day effective April 16, 2000 through May 15, 2000.

II. Applicable Law and Regulations

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

Sections 1819 and 1919 of the Act invest the Secretary with authority to impose CMPs and a DPNA against a long-term care facility for failure to comply substantially with 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. The regulations at 42 C.F.R. Part 483 provide that facilities which participate in the Medicare program may be surveyed on behalf of CMS by State survey agencies in order to ascertain whether the facilities are complying with participation requirements. See also 42 C.F.R �� 488.10 - 488.26. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. �� 488.300 - 488.335. Under Part 488 of the regulations, CMS or a State may impose a CMP against a long-term care facility when a State survey agency ascertains that the facility is not complying substantially with participation requirements. 42 C.F.R. �� 488.406, 488.408, 488.430. The penalty may start accruing as early as the date that the facility was first out of compliance and continue until the date substantial compliance is achieved, or the provider agreement is terminated. 42 C.F.R. � 488.440.

The regulations specify that a CMP that is imposed against a facility will fall into one of two broad ranges of penalties. 42 C.F.R. �� 488.408, 488.438. The upper range of CMPs, 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 CMPs, of 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 regulations define the term "substantial compliance" to mean:

[A] level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.

42 C.F.R. � 488.301.

"Immediate jeopardy" is defined to mean:

[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. ⁽²⁾

42 C.F.R. � 488.301.

In determining the amount of the CMP, the following factors specified at 42 C.F.R. � 488.438(f) must be considered:

1. The facility's history of noncompliance, including repeated deficiencies.

2. The facility's financial condition.

3. The seriousness of the deficiencies as set forth at 42 C. F. R. � 488.404.

4. The facility's degree of culpability.

In a CMP case, CMS must make a prima facie case that the facility has failed to comply substantially with participation requirements. To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dep't of Health and Human Services, Health Care Financing Administration, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999).

Both the statute and regulations make a hearing before an administrative law judge (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)(12), (13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al., DAB CR65 (1990), aff'd, 941 F.2d. 678 (8^th Cir. 1991).

III. Issues

The issues in this case are whether:

A. The facility was complying substantially with federal participation requirements on the dates CMS determined to impose a CMP;

B. CMS's determination of immediate jeopardy is clearly erroneous; and

C. The amount of the penalty imposed by CMS is reasonable, if noncompliance is established.

IV. Findings and Discussion

The findings of fact and conclusions of law noted below in italics are followed by a discussion of each finding.

A. The facility was not in substantial compliance with federal participation requirements on the dates CMS determined to impose a CMP.

1. Quality of Care (Tag F324). The facility failed to ensure that Residents 116, 105, and 108 (R116, R105, R108) received adequate supervision and assistance devices to prevent accidents by exposing them to risk of entrapment. In the specific case of R116, Petitioner's lack of interventions allowed him to become entrapped in side-rails, putting him at risk for strangulation, chest compression, and death. This constituted immediate jeopardy.

The applicable regulation at 42 C.F.R � 483.25(h)(2), entitled "Quality of care," provides that the facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents.

a. Surveyor findings for Tag F324, as alleged in the Statement of Deficiencies (CMS Ex. 21, at 14 - 19).

Based on observation, record review and staff interview, the surveyor found that the facility failed to ensure that residents were provided with adequate supervision and assistance devices to prevent accidents. According to the State survey agency this affected three of eight residents sampled in a population of 192. Id. at 15.

R116 was admitted to the facility on February 25, 2000, with diagnoses that included syncope, dehydration, and anemia. Upon admission, a physician's order was written for the use of two top half side-rails for bed mobility and transfer. On March 6, 2000, the resident was assessed with frequent bladder incontinence and required physical assistance with all care. He was at risk for falls due to a recent history of falls, lower extremity weakness, tiring easily, and requiring assistance with transfers. The facility assessed the resident as not being at risk for entrapment. Id.

On March 19, 2000, the resident was hospitalized for pneumonia, congestive heart failure, sepsis, and hypocalcemia; he was readmitted to the facility on March 27, 2000. Upon readmission, no evaluation or additional interventions were implemented for falls or entrapment prevention. Id. at 16.

On April 8, 2000, at 4:45 a.m., facility staff heard a noise and, upon inquiry, the resident was found lying on the floor near the heater unit. The resident complained of left hip pain and had two skin tears on the left shoulder. He was again transferred to the hospital where he underwent surgical repair of the left hip. Upon readmission to the facility on April 12, 2000, the resident was noted to be dependent and confused, and had significant decline in functional and cognitive ability. The record was silent as to changes or interventions for supervision and prevention of side-rail entrapment. R116 continued with the use of the top two non-padded half side-rails. Id.

On April 15, 2000, at 1:30 a.m., the resident was in bed, confused, and attempts to reorient him were unsuccessful. At 2:10 a.m. he was found lying on the floor with his head wedged between the side-rail and the mattress. Vital signs were absent. An interview with the coroner's office revealed that the preliminary determination as to cause of death was asphyxiation/suffocation. Id. at 16 - 17.

R108 had diagnoses of Parkinson's disease, dementia, major depression, and urinary retention. On February 25, 2000, he was assessed with short and long-term memory impairment, poor decision making ability, repetitive physical movements, and insomnia. He required physical assistance with all care and exhibited frequent bladder incontinence. A fall summary assessment identified the resident as at risk for falls due to restlessness, attempts at self transfer, poor judgment, and decreased safety awareness. The side-rail safety assessment identified no safety risks with the use of half side-rails. Id. at 17.

On February 23, 2000, at 4:10 p.m., the resident was heard screaming and was found on the floor beside the bed. On March 10, 2000, at 4:30 p.m., the resident was found on the floor with a 1.5 inch laceration to the head that required sutures. The facility documentation stated that the resident rolled out of the bed. After the fall, the facility did not implement interventions to prevent further accidents and injuries. Id. at 17.

R105 had diagnoses which included subdural hematoma, skull fracture, anemia, diabetes, degenerative joint disease, and cachexia. ⁽³⁾ On April 5, 2000, the resident was found on the floor by the bed with abrasions and bruising on the right side and rib area. A fall assessment identified the resident as at risk for falls due to impaired judgment, unsteady gait, and psychoactive medications. The side-rail assessment of April 14, 2000, did not identify any safety issues for R105 with the use of side-rails. Id. at 18.

b. Discussion

A facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents. 42 C.F.R. �� 483.25(h)(2). Gaps between side-rails and mattresses pose a real risk of harm, injury, or even death to residents in nursing homes. These risks are unequivocally real, and not merely imagined. The ALJ in Wellington Specialty Care & Rehabilitation Center, DAB CR548 (1998), stated that:

[S]ide rails can be dangerous to residents of long-term care facilities. There exists a risk that some residents under certain circumstances may suffer injuries from side rails. . . . On occasion, individuals have become wedged in the gaps between side rails, resulting in injuries or death to those individuals. The dangers posed by side rails impose on long-term care facilities a duty to assess and address the risk of using side rails.

Id. at 21. In the same decision the ALJ went on to say that:

On August 21, 1995, the Food and Drug Administration (FDA) sent an "Alert" to hospitals and long-term care facilities which warned them of the dangers that side rails posed. . . . This alert stated that since January, 1990, the FDA had received 102 reports of incidents involving entrapment of individuals in hospital bed side rails. The FDA noted that it had received reports of 68 deaths, 22 injuries, and 12 entrapments without injuries occurring in hospitals, long-term care facilities, and private homes.

Id. In response to CMS's assertion that subsequent to R116's hospitalization and discharge in March, 2000, the facility failed to evaluate the resident or implement additional interventions for falls or entrapment prevention, Petitioner argues that R116 was on a physical therapy program that improved his ambulation skills significantly. Petitioner relies on the testimony of Patricia Berling (Tr. at 223), Director of Nursing (DON), and P. Ex. 4, at 49, 55. Neither the DON's testimony nor the cited references at Ex. 4 lend support to the claim that the resident's improved condition made it unnecessary to evaluate him for fall risks and entrapment prevention. Although Ms. Berling stated that the resident's ambulation skills had improved significantly, no documentary support was offered for the assertion. Additionally, the reference to P. Ex. 4, at 49 and 55, is misplaced. At page 49 of Ex. 4, there is indication that the resident's speech therapy was discontinued after improvement; however, there is no correlation between speech improvement and ambulation skills. Furthermore, the indication at page 55 of P. Ex. 4, that the resident had improved subsequent to hospitalization, refers to improvement related to a bucal abscess and his congestive heart failure. A reduction in the swelling due to an abscess in the mouth, and stabilization of his congestive heart failure, did not diminish the need for proper risk fall evaluation and implementation of entrapment prevention measures.

Petitioner also maintains that when R116 returned from the hospital on April 12, 2002, no changes were determined necessary based on the facility's finding that he was alert, oriented, and able to follow directions. According to Petitioner, the hospital records noted that the resident was full weight bearing and ambulating. P. Br. at 16. However, Petitioner has not made available for review the hospital records that show that this 93- year-old resident was full weight bearing two or three days after undergoing hip replacement. Of course, even if the resident was full weight bearing, that would not diminish the facility's duty to re-evaluate R116 for the risk of side-rail entrapment when he was readmitted on April 12, 2000. I disagree with the DON's opinion that there was no significant change in the resident's status which required a reassessment. In this regard, I find Ms. Truett's testimony more persuasive. Ms. Truett testified that on April 20, 2000, she discussed the resident's condition upon readmission to the facility with facility staff. From discussion with staff, Ms. Truett learned that:

�R116 did not get up by himself, prior to, or subsequent to the hip fracture (Anita Flyn, nurse assistant, who usually provided care to resident).

�There was a "tremendous" difference in R116's status upon readmission on April 12, 2000. He was confused and required total care (Chris, RN Supervisor).

CMS Ex. 22, at 6; Tr. at 29, 30.

Ms. Truett also testified that R116 had demonstrated a decreased safety awareness when he fractured his hip attempting to get out of bed by himself, although he required assistance for ambulation. Tr. at 31.

The facts and history associated with R116 indicate that he was at risk for side-rail entrapment and should have been assessed accordingly. On March 6, 2000, a "Side Rail Safety Assessment" was completed for R116 after it was determined that half side-rails were necessary for increased bed mobility. CMS Ex. 28, at 13. At that time, the DON noted that skin tears and abrasions were risks associated with the use of the side-rails. However, no consideration was given to the risk of entrapment and assistance devices to prevent entrapment. Id. The facility ignored the need to apply measures to prevent entrapment in spite of the obvious risks posed in the case of R116. This is evident from the multiple diagnoses that were relevant to the issue here under consideration. Upon initial admission on February 25, 2000, R116's clinical picture included pernicious anemia, dehydration, syncope, venous insufficiency, congestive heart failure, pneumonia, atrial fibrillation, and left hip fracture. P. Ex. 4, at 1. As result of the resident's compromised health, the facility determined that self-care deficits and generalized weakness required a one-person assist for bathing, dressing, grooming, mobility, and transfer. P. Ex. 4, at 3.

R116 experienced further deterioration of his health when he was hospitalized on March 19, 2000, for pneumonia, congestive heart failure, sepsis, and hypocalcemia. However, no evaluation or additional interventions were implemented for falls or entrapment prevention when he was readmitted to the facility on March 27, 2000. P. Ex. 4, at 5.

R116's lack of awareness of safety hazards and diminished judgment resulted in the fall he suffered on April 8, 2000, when he fractured his left hip again. Nonetheless, when the resident was discharged on April 12, 2000, after hip surgery, the facility missed another opportunity to implement much needed interventions in order to protect R116 from risk of entrapment. The facility appeared to be blinded by the simplicity of the obvious. It ignored the fact that R116 was a very frail 93-year-old individual who weighed only 109.9 lbs., and who was so severely limited by significant health problems that he was a fitting example of the type of resident that needs to be protected from the risk of side-rail entrapment. CMS Ex. 28, at 14, 17. Thus, it is evident that Petitioner did not provide adequate supervision and assistance devices for the protection of R116. However, the fact that an accident occurred does not suffice to establish noncompliance. It must also be demonstrated that the accident was preventable. Given the fact that the resident was physically and mentally so compromised that he would be unable to extricate himself from a life threatening situation, the facility was derelict in not taking measures that were adequate to prevent an accident. The possibility that R116 may be a victim of side-rail entrapment was real and should have been foreseen by Petitioner.

The DON's testimony that padding the side-rails to seal the gap between the mattress and the rail was not an option because it would reduce the resident's bed mobility is unconvincing. ⁽⁴⁾ Tr. at 223. I note that she voiced her opinion in that regard without offering a rationale. Ms. Truett, on the other hand, stated that:

You can still use it [padding] because the side-rail's still up. And the padding - - because of the way the padding is made, it can - - there's straps that go through a bar. . . . And the noodles or pillows or something that you put just directly between the gap, it doesn't cover the side-rail at all. So, the side-rail is still completely able to be used; but the gap is eliminated. ⁽⁵⁾

Tr. at 46. In view of the above, I find that CMS has established a prima facie case that Petitioner was not in substantial compliance with federal participation requirements for long-term care facilities. ⁽⁶⁾ I further find that Petitioner has not overcome that finding by a preponderance of the evidence.

2. Staff Treatment of Residents (Tag F225). The facility failed to investigate and report Resident 113's (R113) left hip fracture and dislocation that resulted from an unknown cause.

The pertinent regulation provides as follows:

�The facility must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property. 42 C.F.R. � 483.13(c).

�The facility must have evidence that all alleged violations are thoroughly investigated, and must prevent further potential abuse while the investigation is in progress. 42 C.F.R. � 483.13(c)(3).

�The results of all investigations must be reported to the administrator or his/her designated representative and to other officials in accordance with State law (including the State survey and certification agency) within 5 working days of the incident, and if the alleged violation is verified appropriate corrective action must be taken. 42 C.F.R. � 483.13(c)(4).

a. Surveyor findings for Tag F225, as alleged in the Statement of Deficiencies (CMS Ex. 21, at 1 - 4).

Based on observation, record review, and staff interview, the State agency concluded that the facility failed to ensure that an injury of an unknown cause was thoroughly investigated and reported.

R113 was diagnosed with dementia, dehydration, arthritis, degenerative joint disease, and a history of left hip fracture. The resident had a long history of falls, one of which resulted in a left hip fracture on January 12, 2000. Subsequently, R113 continued to experience falls, but x-rays taken on February 24, 2000, revealed no significant findings. On April 7, 2000, the resident was admitted to the hospital due to dehydration. Upon readmission to the nursing facility on April 13, 2000, at 1:05 p.m., a full nursing physical assessment disclosed no range of motion difficulty in the lower extremities. The following day, however, at 11:00 a.m. and 6:00 p.m., the nursing staff documented that the resident's left leg was rotated outward with complaints of severe pain when attempts were made to straighten the leg. This finding led to a hospitalization, at which time it was documented that the resident experienced a "fracture dislocation of the left femur." The resident stated that she had fallen out of the bed the previous day. The clinical record gave no indication of the reason for the injury. Id. at 3 - 4.

The State agency determined that the clinical record was silent as to an investigation surrounding the injury. The nursing staff responsible for the care of the resident did not follow the facility policy to report the injury to the administrative staff. Consequently, the facility failed to report the result of an investigation concerning the origin of the injury suffered by the resident sometime between April 13 and 14, 2000. ⁽⁷⁾ Id. at 4.

b. Discussion

Petitioner contends that the facility did not feel any investigation was warranted as to the cause of the injury suffered by R113 because it was a spontaneous fracture related to her diagnoses. Thus, says Petitioner, it was not an injury of unknown origin because the facility was aware of the resident's medical history of osteoporosis, past osteoporotic fractures of her spine, and no trauma to the area, and it is an appropriate inference that the fracture was spontaneous. P. Br. at 4.

CMS argues that Petitioner's contention that R113 suffered a spontaneous fracture related to her diagnoses, based on the testimony of Ms. Patricia Berling, DON, is misplaced. See Tr. at 189. CMS asserts that, on cross examination, the DON admitted that she did not know, but rather inferred, that R113's left hip fracture was spontaneous. CMS Br. at 38; Tr. at 231 - 232. In this regard, CMS posits that Ms. Berling is not a medical doctor, and therefore, her testimony was grounded on mere speculation. Furthermore, states CMS, there is no evidence in the record that anyone from the facility consulted with or even contacted a medical doctor regarding R113's left hip injury, at any time, to determine the cause of the injury. Additionally, the facility record is devoid of any mention of the belief that the resident's fracture was caused by a pre-existing medical condition.

I agree with CMS. What Petitioner speculates, three years removed from the event, is of little probative value. It would be more persuasive for Petitioner to produce facility records documenting its findings relative to causality at the time of the incident. Inasmuch as the record is totally silent as to any investigation contemporaneous with the fracture suffered by R113 in April, 2000, I find that the facility failed to comply with the requirement to report the injury to the administrators. Consequently, the administrators did not initiate an investigation as to the cause of the injury. As a result, no measures were taken by the facility to prevent further injury from occurring to the resident. This failure created the potential for more than minimal harm.

3. Resident Assessment (Tag F272). The facility failed to assess R105 and R108 for risk of entrapment with the use of half, unpadded, side-rails.

The regulations at 42 C.F.R. �� 483.20(b) provide that the facility must make a comprehensive assessment of a resident's needs, which is based on a uniform data set specified by the Secretary, that describes the resident's capability to perform daily life functions and significant impairments in functional capacity.

a. State surveyor findings for Tag F272, as alleged in the Statement of Deficiencies (CMS Ex. 21, at 4 - 7).

Based on observation, record review, and staff interview, the State survey agency determined that the facility failed to ensure that there were comprehensive assessments made which described the residents' risk factors and safety issues regarding the use of side-rails.

R108 had diagnoses of Parkinson's disease, dementia, major depression, and urinary retention. He required physical assistance with all care, and was identified as being at risk for falls due to restlessness and attempts at self transfer. The "Side-rails Safety Assessment" identified no entrapment risks associated with the use of half side-rails. The resident was found lying on the floor on February 23, 2000 and March 10, 2000. After rolling out of bed and experiencing these falls, the facility did not comprehensively reassess the resident. Id. at 6.

R105 had diagnoses of subdural hematoma, skull fracture, anemia, diabetes, degenerativejoint disease, and cachexia. On April 5, 2000 ⁽⁸⁾, the resident was found on the floor by the bed. On April 8, 2000, he was found attempting to get out of bed without assistance. The following day the resident was assessed as requiring assistance with all care, and was identified as being at risk for falls due to impaired judgment, unsteady gait, and psychoactive medications. He was not assessed for safety issues.

b. Discussion

Petitioner claims that the facility considered the use of swimming noodles for R105 to fill the gap between the side-rail and the mattress, but was prohibited from doing so because they are not flame retardant. P. Br. at 7. The documentary evidence provided by Petitioner, however, fails to mention the options considered by the facility in order to fill the gap between the side-rail and the mattress. Specifically, the record does not show that the facility was prevented from using swimming noodles because they are not flame retardant. Additionally, as stated earlier, the surveyor mentioned swimming noodles as one of the possible interventions that could be implemented by the facility. It is interesting to note that the facility opted for the type of intervention that it considered to be inappropriate because it was not flame retardant. It ignored the possibility of employing other interventions.

Petitioner also argues that a comprehensive assessment of R105 was timely completed on April 14, 2000; and a comprehensive reassessment of safety issues was completed after each of R108's falls. P. Br. at 5, 7. CMS, however, does not charge Petitioner with failure to develop a comprehensive assessment, generally. CMS's position is that Petitioner failed to assess R108 and R105 in the area of risk of side-rail entrapment. Petitioner has not advanced any evidence that demonstrates that it made an assessment regarding these two residents' risk of side-rail entrapment.

In view of the above, I find that CMS has established a prima facie case that Petitioner was in violation of 42 C.F.R. � 483.20(b). Petitioner has not overcome CMS's showing. I further find that Petitioner's failure created the potential for more than minimal harm.

4. Quality of Care (Tag F314). The facility allowed Resident 22 (R22) to develop an avoidable pressure sore, and failed to ensure that a resident with pressure sores received the necessary care and services to promote healing, prevent infections, and prevent new pressure sores from developing.

The regulations at 42 C.F.R. � 483.25(c), require that a facility must ensure that a resident who is admitted without pressure sores does not develop them, unless the individual's clinical condition demonstrates that they were unavoidable, and a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing.

a. Surveyor's findings for Tag F314, as alleged in the Statement of Deficiencies (CMS Ex. 21, at 7 - 10).

R22 was assessed as incontinent of bowel and bladder, and requiring extensive physical assistance with bed mobility, transfers, and personal hygiene. He was dependent on staff for toileting. The facility had also assessed the resident as at risk for skin breakdown due to fragile skin, anemia, reddened heels, incontinence, and poor appetite and fluid intake. Id. at 8.

On March 30, 2000, the resident's coccyx was noted to be light red, without open areas. However, on April 7, 2000, nursing documented that R22's coccyx was deep red with a one centimeter open moist area. Id.

The care plan and/or physician orders included a therapeutic pressure relief mattress, incontinence checks every two hours, and repositioning at least every two hours. Id.

On April 21, 2000, from 7:10 a.m. to 10:20 a.m., the resident was observed lying on her back in the bed without the physician ordered pressure relief mattress, without repositioning, and without timely incontinent care. Incontinence care was not timely provided, although repeatedly requested by the resident. When incontinence care was finally provided, at 10:20 a.m., and the nurse removed the urine and feces soiled incontinence brief, the pressure sore on the coccyx did not have the physician ordered occlusive adhesive dressing. The surveyor noted an open stage II pressure sore just to the right of the coccyx, and the heels exhibited a stage I reddened and soft pressure sore. Id. at 9 - 10.

b. Discussion

In defense of the deficiency cited at Tag F314, Petitioner argues that:

�Ms. Truett, the State surveyor, acknowledged in her testimony that the facility had interventions in place in order to protect the resident from pressure sores.

�The pressure sore on R22's coccyx developed in the hospital.

�R22 had impaired renal function, a cardiac condition, and pulmonary edema.

�All residents were checked for incontinence between 7:00 and 7:30 a.m., including all residents mentioned in the Statement of Deficiencies.

�R22 was toileted every four hours.

�R22 was repositioned when fed in bed in a seated position.

�On April 21, 2000, the resident was not asking to be toileted; rather, she was yelling out inappropriately as an attention seeking manifestation of her dementia.

�The resident acquired the urinary tract infection outside the facility.

�The fact that the resident's coccyx healed in May, 2000, is evidence that she was given appropriate care.

�The resident was provided with a pressure reduction mattress and was repositioned every two hours.

P. Br. at 8, 9.

A review of the evidence in this case reveals that none of Petitioner's claims have merit. I will discuss each separately.

Ms. Truett did not testify that the facility had implemented interventions to protect the residents from pressure sores. What Ms. Truett said was that interventions were in place in the care plan. Tr. at 124. She stated that those interventions were included in the care plan, yet, in some cases, the facility failed to follow through in their implementation. CMS Ex. 24, at 28, 29. For example, the care plan included an intervention to check the resident's incontinent brief every two hours, but the surveyor observed that on April 21, 2000, the resident was given incontinence care at an approximately three-hour intervals. The resident was not given incontinence care before the three-hour period, although the surveyor noted her brief to be wet and soiled. The surveyor also observed that repositioning did not take place at two-hour intervals, and, after inspecting the mattress in the presence of the DON, found that no pressure relief mattress was being used, rather, a standard hospital mattress was found.

Petitioner argues that the pressure sore on R22 developed in the hospital in spite of the entry in its own records that the sore occurred in house. CMS Ex. 24, at 6; Tr. at 235.

I fail to see the import of Petitioner's assertion that the resident had impaired renal function, a cardiac condition, and pulmonary edema. I surmise that the statement is directed at suggesting that the pressure sore was unavoidable. Assuming that is the case, no authoritative evidence was advanced to establish that theory. I find that, if anything, those debilitating conditions placed a greater onus on Petitioner to implement whatever measures were necessary to prevent skin breakdown.

Petitioner's claim that all residents were checked for incontinence between 7:00 a.m. and 7:30 a.m., including all residents mentioned in the Statement of Deficiencies, does nothing to explain why R22 was not checked again for a period of approximately three hours. Petitioner places reliance for that claim on purported testimony found at page 231 of the transcript. I could not find such testimony there. If such testimony does exist, however, it would not show that R22 was in fact checked for incontinence between 7:00 a.m. and 7:30 a.m. on April 21, 2000. A statement by a witness regarding general facility practice lacks probative value to demonstrate that such practice has been carried out without fail in every instance with respect to every resident. ⁽⁹⁾

Petitioner asserts that R22 was toileted every four hours under the facility's habit training program. That is contrary to the needs established by the facility in the care plan calling for incontinence checks every two hours. CMS Ex. 24, at 28. It is also contrary to the professionally recognized standard of care for attending to incontinent residents which requires checks frequently or at two hour intervals. Britthaven of Raleigh, DAB CR901 (2002).

Placing the resident in a seated position when feeding is not the repositioning prescribed as an intervention to help prevent skin breakdown. The care plan required repositioning every two hours, yet Petitioner has not shown that the resident was fed every two hours. CMS Ex. 24, at 28. Also, I agree with CMS that Ms. Truett's testimony is persuasive. She stated that sitting up during feeding is not the repositioning called for in the care plan, because that position actually increased the pressure on R22's coccyx. CMS Response Br. at 10.

It is disingenuous for Petitioner to allege that on April 21, 2000, the resident was not asking to be toileted, but rather she was yelling out inappropriately as an attention seeking manifestation of her dementia. Ms. Truett testified that she witnessed the resident plead to be toileted, but her pleas were ignored for approximately two hours. Tr. at 115 - 117. Ms. Truett observed first hand that R22's brief was saturated with urine while facility staff walked by her without providing needed assistance. The resident's call to the staff was borne out of a real need to seek comfort, and not borne out of a desire for attention seeking. In fact, the nurse provided care only when the surveyor asked that care be given. The surveyor requested care for the resident at 9:55 a.m., and it was not forthcoming until 10:20 a.m. At that time the resident's brief was urine soaked and heavily soiled with feces. Tr. at 117. The facility's failure to provide timely incontinence care placed the resident at risk for additional skin breakdown and urinary tract infection. Tr. at 118.

I agree with CMS that Petitioner's argument that the resident acquired the urinary tract infection outside the facility is not relevant to the issue of whether the facility provided R22 with the necessary care and services to promote the healing of her coccyx pressure sore. CMS Response Br. at 11.

Petitioner's argument, that the fact that the resident's coccyx healed in May, 2000 is evidence that she was given appropriate care, is misplaced. The healing of the resident's pressure sore after the facility returned to compliance subsequent to the deficiency citation is only evidence that the statutory purpose of bringing the facility into compliance was accomplished.

Finally, Petitioner claims that R22 was provided a therapeutic mattress, and that the resident was provided with a pressure reduction mattress and was repositioned every two hours. P. Br. at 9. That assertion is based on the testimony of Ms. Patricia Berling. Tr. 216, 217. However, Ms. Berling failed to state when the resident was provided with a therapeutic mattress. Ms. Truett, on the other hand, was unequivocal in her testimony that on the morning of April 21, 2000, the DON, Ms. Rhonda Keyes, verified that R22's bed did not have a pressure relief mattress; rather, it had a light green, standard hospital mattress. Tr. at 126 - 127. Additionally, Ms. Truett did not observe anyone reposition R22 for approximately three hours on April 21, 2000. Id. at 125. In fact, Petitioner has elsewhere admitted to repositioning the resident when she was placed in a seated position while being fed. It is interesting to note that Petitioner makes many claims, that, if true, may have been easily supported with the testimony of the nurses that were providing direct care to the resident on the day in question. Yet, at the hearing, those people were conspicuous by their absence.

I find that Petitioner's inconsequential arguments do not overcome, by a preponderance of the evidence, the prima facie case established by CMS. I further find that there was actual harm, in that the resident developed an open stage II pressure sore as a result of the facility's failure to provide adequate care and treatment.

5. Quality of Care (Tag F316). Petitioner was not in compliance with the quality of care requirements at Tag F316.

The regulations at 42 C.F.R. � 483.25(d)(2) require that a facility must ensure that a resident who is incontinent of bladder receives appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible.

a. Surveyor findings for Tag F316, as alleged in the Statement of Deficiencies (CMS Ex. 21, at 10 - 14).

Resident 21 (R21)

R21 had a history of urinary tract infections and was assessed as occasionally incontinent of bladder. She was on a diuretic and required assistance with toileting. Planned interventions for bladder continence included toileting every two hours and checking and providing incontinence care after each incontinence episode. Id. at 11.

On April 21, 2000, from 7:10 a.m. to 10:17 a.m., the resident was observed in her room without being offered or assisted with toileting, or incontinence care. At 8:23 a.m. when the nurse aide transferred R21 to her wheelchair for breakfast, the resident's brief was noted to be urine saturated, and giving off a pervasive, and strong, foul urine odor. The brief's incontinent indicator (as identified by the manufacturer) was turned dark and there was a visible clumping of the brief's contents. After the resident was transferred onto the wheelchair, the brief could be seen falling off the resident and hanging below the chair soaked with urine. She remained that way from 8:25 a.m. until 10:17 a.m. At 9:55 a.m. the surveyor requested to observe care to R21 when it was provided. Care was provided at 10:17 a.m. When the nurse aide removed the incontinence brief, it fell to the floor visibly soaked. The resident was not provided toileting in a manner that would allow normal bladder function or incontinence care to prevent urinary tract infections. Id. at 11 - 12.

Resident 22 (R22)

On April 9, 2000, R22 was assessed as incontinent of bladder and dependent upon staff for toileting. It was noted that the resident did not display or voice any awareness of toileting needs and had recurrent urinary tract infections. Care plan interventions and/or physician orders included checking for incontinence every two hours. Id. at 13.

On April 21, 2000, the surveyor observed the resident lying in bed from 7:10 a.m. until 10:20 a.m. ⁽¹⁰⁾ without toileting or incontinence care. This care was not provided in spite of the resident's repeated pleas for assistance. A nurse aide finally provided incontinence care at 10:20 a.m., after the surveyor had asked to observe care for the resident at 9:55 a.m.. At that time the nurse aide removed a urine and feces soiled incontinence brief and did not offer toileting. The facility staff did not provide the toileting, incontinence care, and assistance requested by the resident to prevent the development of urinary tract infections and restore as much normal bladder function as possible. Id. at 13 - 14.

b. Discussion

With respect to the deficiency at Tag F316, concerning R21, Petitioner contends that the surveyor was mistaken in her understanding of the resident's diagnoses. P. Br. at 9, 10. Petitioner also argues that the surveyor acknowledged that she left the Unit where R21 was on, and walked more than a 100 yards around the facility before returning to R21's room. Furthermore, says Petitioner, Ms. Berling vigorously disputed the surveyor's testimony to the effect that R21 had a very soiled and wet brief on the morning of April 21, 2000, when she was transferred to her wheelchair. P. Br. at 11.

Petitioner asserts that the surveyor was mistaken in her testimony that R21 had diagnoses of chronic renal failure, urosepsis, and dehydration. P. Br. at 11. I find Petitioner's assertions are without merit. The conditions mentioned by the surveyor are in fact included in the facility's Medical Diagnosis and Data sheet. ⁽¹¹⁾ P. Ex. at 1. It is true that dehydration had resolved, but, nonetheless, the oversight is inconsequential, and has no bearing on the issue of whether Petitioner failed to provide the required incontinence care to R21 on April 21, 2000, in a manner that would prevent urinary tract infections and restore as much bladder function as possible.

Petitioner attempts to place in doubt Ms. Truett's testimony that she consistently observed R21 and R22 for approximately three hours without receiving incontinence care to prevent urinary tract infections. For this, Petitioner relies on the surveyor's testimony that on the morning of April 21, 2000, she walked from Unit 200 to Unit 400 and back. Petitioner would have me infer that Ms. Truett's absence from Unit 200 while walking a distance calculated to be more than a 100 yards, prevented her from consistently observing R21 and R22. Petitioner overlooks that Ms. Truett did not spend the entire morning pacing the length of the facility. Her testimony was that she walked from Unit 200 to Unit 400 and back, just once. More importantly, however, she conducted that sweeping check of the facility early in the morning and concluded it at approximately 7:22 a.m. Tr. at 173, 174. Afterwards she placed herself in the area of Unit 200, where she was able to consistently observe R21 and R22. Tr. at 103, 182.

Finally, Petitioner's argument that Ms. Berling vigorously disputed the surveyor's testimony to the effect that R21 had a very soiled and wet brief on the morning of April 21, 2000, when she was transferred to her wheelchair, is baseless. I find no probative value in Ms. Berling's testimony regarding the condition of R21's brief on the morning of April 21, 2000, because she was not there. Petitioner's assertion is based on the following testimony by Ms. Berling:

There was a nurse aide and an LPN who assisted this resident up. And, at that time, the LPN was quite upset with the citation because she said that, in fact, the brief had been dry when they got her up. But it was loose on the resident and fell to the floor, but the resident's brief was dry.

Tr. at 219 - 220. I am unable to judge the alleged statement of the LPN in order to determine if it was borne out of genuine indignation or whether it was feigned indignation in order to salvage her standing with her employer. If Petitioner wanted to provide a vigorous rendering of the incident in question, the best evidence would have been the testimony of the LPN in charge of the resident. I find the testimony of the surveyor who testified, based on first hand observation, to be more persuasive. Ms. Truettt stated as follows:

For the majority of the time, I was on the unit, either outside of the resident's room, in the hallway, or else in her room when I was watching her care.

. . . .

The door was open to the room. And they did the transfer of the resident. And when they did transfer her, her incontinent brief was wet with urine. It was heavily wet, and was hanging down between her legs and kind of half-off the wheelchair . . . . They didn't check her for incontinence. They didn't change her. And they didn't intervene with this wet brief hanging down off of her after they got her in the wheelchair.

Tr. at 100, 103-104. In view of the foregoing, I find that Petitioner failed to ensure that residents who were incontinent of bladder received the necessary care and services to prevent urinary tract infection and to restore as much normal bladder function as possible. Petitioner was well aware of the clinical status of R21 and R22, and the fact that they were at risk for urinary tract infections. P. Br. at 10, 11. However, Petitioner has not shown that it did all that it could to protect its residents from acquiring urinary tract infections. The only testimony presented by Petitioner was from Ms. Patricia Berling, the Minimum Data Set (MDS) nurse. However, Ms. Berling only assumed that the facility complied with the residents' care plan. She admitted lack of first hand knowledge regarding the actual measures taken by the facility in providing incontinence care to its residents. Tr. at 235 - 239.

B. CMS's determination of immediate jeopardy was not clearly erroneous.

The facility failed to provide R116 with adequate supervision and assistance devices to prevent accidents. Petitioner's lack of intervention allowed the resident to become entrapped in side-rails, putting him at risk for strangulation, chest compression, and death. Furthermore, Petitioner failed to provide persuasive evidence to show that the gaps were not likely to cause serious injuries. This deficiency constituted immediate jeopardy. CMS's determination of immediate jeopardy must be upheld unless I conclude that CMS's determination is clearly erroneous. 42 C.F.R. � 498.60(c)(2).

Petitioner argues that in the case of R116 it was not necessary to assess him for side-rail entrapment. It is also Petitioner's assertion that CMS's claim that the lack of padding caused the entrapment is without basis. Instead, states Petitioner, it is more credible that the resident experienced a syncope (brief loss of consciousness), or heart failure. P. Br. at 32. Petitioner theorizes that the resident's heart failure and/or syncope produced dizziness and loss of balance, that he passed out (or died from a cardiac event), and fell into the position he was found (entrapped in the side-rail). That, says Petitioner, is more credible than being in bed and slipping between the side-rail gap of an "unknown size . . ." P. Br. at 32 (emphasis added).

Petitioner's explanation as to how the resident possibly became entrapped in the side-rail is precisely why he needed to be evaluated for the most appropriate way to protect him from side-rail entrapment. Prior to R116 becoming entrapped, it was known to the facility that he suffered from congestive heart failure, experienced attacks of syncope that, by their very nature, occur without warning, had experienced a recent fall while attempting to get out of bed without assistance resulting in a hip fracture for which he required surgical repair, and was confused. All of these red flags sent a clear message to the facility that side-rail entrapment was a foreseeable possibility for this resident, and that reasonable and practicable means should have been implemented to prevent an accident.

Thus, Petitioner's dissertation with respect to the nature of syncope and its pathological ramifications does more to indict its facility rather than absolve it. P. Br. at 32 - 33. Furthermore, Petitioner admits that it had not even bothered to determine the size of the side-rail gap, labeling it as "unknown." Id. at 32 (emphasis added). The facility did not learn soon enough that the side-rail was large enough to entrap R116.

Petitioner's argument that R116 may have died due to a cardiac event, and that he fell between the side-rail and the mattress, is speculative. While Petitioner's theory as to how the resident may have died is pure conjecture, CMS has advanced an explanation of greater probative value. The surveyor reported that she interviewed Dr. Richard Burkhardt, Coroner, on April 24, 2000. At that time she learned that the resident had no coronary artery disease or other heart problems associated with his death, nor was there any indication of seizure activity. The Coroner's preliminary finding as to the cause of death was suffocation/asphyxiation. Interestingly, the Coroner indicated that the facility never notified him of the resident's death. The facility did notify the resident's physician, but merely reported that he had passed away. Nothing was mentioned as to the circumstances surrounding the death. Thus, the physician ordered the release of the body to the funeral home without first involving the Coroner's office for purposes of conducting an autopsy. CMS Ex. 22, at 7; CMS Ex. 28, at 12. In view of the above, it is fair to conclude that the more rational explanation for the cause of R116's death is strangulation from side-rail entrapment. I must add, however, that it is not essential for CMS to establish a causal relationship between the resident's death and the entrapment. It suffices to show, as CMS has done here, that the deficiency poses a risk that rises to the level of a likelihood that serious injury, harm, impairment, or death may occur. Fairfax Nursing Home, Inc., DAB No. 1794 (2001), at 13, aff'd, 300 F.3d 835 (7th Cir. 2002), cert. denied,537 U.S.1111 (2003). See also Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002).

In conclusion, I find that Petitioner has failed to show that CMS's determination that the deficiency here under consideration constituted immediate jeopardy was clearly erroneous. It was not unreasonable for CMS to conclude that, in a facility where side- rails similar to ones that caused the entrapment of R116, others such as R105 and R108 were likely to suffer serious, injury, harm, impairment, or death. CMS established that both of these residents were also at risk for side-rail entrapment, yet Petitioner did not implement measures to protect them from that type of accident. CMS Ex. 21, at 17 - 19.

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

CMS imposed a $3,050 CMP effective April 15, 2000, for one day of immediate jeopardy. There is no issue as to the reasonableness of the daily amount of the penalty, inasmuch as $3,050 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).

I also uphold CMS's determination that Petitioner was deficient at a level less than immediate jeopardy that constituted actual harm. CMS also established other deficiencies that were not actual harm, but created the potential for more than minimal harm. ⁽¹²⁾ The CMP of $450 per day imposed by CMS effective April 16, 2000 through May 15, 2000, is reasonable.

On June 16, 2000, CMS notified Petitioner that the imposition of the CMP took into consideration the facility's history and financial condition as well as the factors enumerated at 42 C.F.R. � 488.404. ⁽¹³⁾ CMS Ex. 1.

I find that Petitioner disregarded its duty to provide incontinence care to it residents in an egregious manner. Particularly, its culpability was evident when it ignored the repeated pleas of a resident to be provided with incontinence care. Petitioner was also derelict in its duty to comply with residents' care plans and physicians' orders concerning prevention and treatment of pressure sores. Moreover, Petitioner presented no evidence regarding its financial condition, nor did it otherwise dispute the reasonableness of the CMP imposed.

I have addressed all of Petitioner's arguments. However, the fact that I have not discussed all of the matters raised by Petitioner at length does not mean that I have not considered them. Those matters not specifically addressed are not worthy of comment or are not within the purview of my adjudicatory authority. ⁽¹⁴⁾

V. Conclusion

I conclude that CMS correctly determined that, effective April 15, 2000, Petitioner was not complying with federal participation requirements in the Medicare program at the immediate jeopardy level, and the imposition of a CMP of $3,050 per day is reasonable.

I also conclude that CMS properly imposed a CMP of $450 per day for deficiencies at the less than immediate jeopardy level from April 16, 2000 through May 15, 2000.

José A. Anglada

Administrative Law Judge

1. Effective July 5, 2001, the Health Care Financing Administration was renamed the Centers for Medicare & Medicaid Services (CMS). 66 Fed. Reg. 35,437 (2001). Reference to either name shall apply to both names.

2. See also Beverly Health & Rehabilitation-Springhill, DAB CR553 (1998).

3. A generally weakened, emaciated condition of the body, especially as associated with a chronic illness. Webster's New World Dictionary (3d ed. 1988) .

4. Assuming that there is a grain of truth in the DON's assertion that side-rail padding defeated the purpose of providing bed mobility to the resident, the record is devoid of any deliberative process that showed that such mobility outweighed any risk posed by the absence of the padding. I do not find that in her testimony the DON raised a legitimate concern that arose contemporaneous with the implementation of the side-rails, but rather, her testimony appeared to be an after-the-fact attempt to legitimize the lack of adequate supervision and assistance devices to prevent accidents.

5. Petitioner argues that Ms. Truett could not indicate what the fire safety rating was of swimming noodles. The argument is baseless, inasmuch as Ms. Truett was merely giving examples of materials that could be easily obtained in order to fill side-rail gaps, such as swimming noodles or pillows. It is up to the facility to decide how it will fill the side-rail gaps, and the device it will deploy as an intervention. If the facility had opted for noodles as an intervention device, but harbored doubts as to possible fire risks, that was a matter for the facility to resolve. Tr. at 181.

6. It is unnecessary that I discuss in detail the additional allegations of noncompliance relative to R108 and R105, or Petitioner's defenses to these additional allegations, because I find that Petitioner's failure to ensure that R116 received adequate supervision and assistance devices to prevent accidents is sufficient to justify CMS's determination that Petitioner did not comply substantially with federal participation requirements as outlined at 42 C.F.R. � 483.25(h)(2). Additionally, my findings under Tag F272 at Paragraph 3, below, are equally applicable here.

7. I infer that the fracture occurred sometime after 1:05 p.m. on April 13, 2000 and before 11:00 a.m. on April 14, 2000.

8. The record reflects that the resident attempted to climb out of bed on April 8, 2000, at 3:00 a.m., and was found on the floor lying by the bed on April 8, 2000, at 9:10 p.m. P. Ex. 5, at 48. Petitioner is correct in pointing out that the Statement of Deficiencies errs when it asserts that the resident fell on April 5, 2000. See P. Br. at 7. However, Petitioner omitted that it was on April 8, 2000, that R105 was found on the floor. The discrepancy is not material.

9. This statement is made to show the flaw in Petitioner's argument, and not to propose that a facility has to satisfy a standard of perfection.

10. R21 and R22 were roommates which allowed Ms. Truett to observe these residents at the same time. CMS Br. at 43; Tr. at 113.

11. Ms. Truett did not testify that the resident was afflicted solely with these conditions. Pertinent to this is the Statement of Deficiencies where it is stated that the resident's diagnoses included chronic renal failure, urosepsis, and dehydration. CMS Ex. 21, at 11 (emphasis added ).

12. I make reference to deficiency findings noted as Tags F225, F272, and F316. See CMS Ex. 21, at 1 - 7, 10 - 14.

13. The regulatory factors to consider in determining the amount of the CMP include the facility's history of noncompliance, the scope of the severity of the deficiencies, the facility's culpability, the facility's financial condition, and the factors specified in 42 C.F.R. � 488.404.

14. For example, Petitioner asserts that the Hillman standard is a substantive rule which was never promulgated as a regulation under the Administrative Procedures Act (APA) in accordance with 5 U.S.C. 553(b) and (c). P. Br. at 23 - 25.; see also Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dep't of Health and Human Services, Health Care Financing Administration, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999). I characterize Petitioner's assertion as a constitutional claim. Petitioner may not use this administrative appeals process to obtain redress for its alleged constitutional claims. See Serban I. Cocioba, M.D., DAB CR654 (2000) (finding no jurisdiction to rule on constitutional claims); Morton Markoff, D.O., DAB CR538 (1998) (administrative law judges lack authority to decide constitutional claims).