SUBJECT:

Autumn Care of Norfolk,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

Autumn Care of Norfolk (Petitioner or Facility) is a nursing facility, located in Norfolk, Virginia, that is certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare and Medicaid Services' (CMS) determination that, from July 11, 2000, through August 9, 2000, it failed to provide adequate care and failed to prevent accidents to one of its residents (Resident #1), and, therefore, was not in substantial compliance with Medicare requirements. For the reasons set forth below, I sustain CMS's determination that, with respect to its treatment of Resident #1, the facility was out of compliance with program participation requirements.

BACKGROUND

In May 2000, Resident #1 suffered a series of falls, one or more of which likely caused or exacerbated an acute subdural hematoma (bleeding bruise on the brain), which led to his death. Responding to complaints lodged by Resident #1's family, the Virginia Department of Health (State Agency) conducted a complaint investigation and abbreviated survey from July 6-11, 2000. ⁽¹⁾ Joint Stipulation of Facts (Joint Stip.) #2; Transcript (Tr.) 24-25; CMS Ex. 8. Following the survey, the State Agency concluded that, among other deficiencies, the facility failed to provide adequate care and failed to prevent accidents to Resident #1, and, therefore, was not in substantial compliance with the regulation governing quality of care: 42 C.F.R. �� 483.25 (Tag F309), 483.25(h)(2) (Tag F324), and 483.25(e)(2) (Tag F318). Joint Stip. #2; CMS Exs. 4, 9.

CMS reviewed the state findings and, by letter dated July 28, 2000, advised the facility that, because of the survey findings, it was denying Medicare and Medicaid payment for all new admissions, effective August 14, 2000, and it was considering imposing a civil money penalty (CMP). CMS Ex. 5. By subsequent letter, dated August 25, 2000, CMS advised the facility that it was imposing a CMP in the amount of $500 per day, effective July 11, 2000, which would continue to accrue until the facility achieved substantial compliance or its provider agreement was terminated. Joint Stip. #3; CMS Ex. 6.

The facility submitted a plan of correction, and, following a revisit survey on September 27, 2000, the State Agency concluded that the facility had achieved substantial compliance as of August 10, 2000. Joint Stip. #4; CMS Ex. 7. CMS reviewed the state's findings, and, by letter dated October 27, 2000, advised the facility that because it had achieved substantial compliance, CMS was rescinding the denial of payment for new admissions. However, CMS was imposing the $500 per day CMP from July 11, 2000, through August 9, 2000, for a total of $15,000. CMS Ex. 7.

Petitioner timely requested a hearing.

Petitioner subsequently conceded that it was out of compliance with some program requirements and that CMS had a basis for imposing a CMP. Joint Stip. #5; Amended Order (May 22, 2002). It limited its appeal to the two July 11, 2002 citations relating to Resident #1: 42 C.F.R. � 483.25 (Tag F309) and 42 C.F.R. � 483.25(h)(2) (Tag F324). Joint Stip. #6. The parties agree that a CMP of $250 per day is appropriate for the deficiencies that Petitioner did not appeal, and, if Petitioner does not here prevail on the compliance question, it will not contest the reasonableness of the remaining $7500 CMP ($250 per day from July 11 through August 10, 2000). Joint Stip. #7; CMS Brief at 2; P. Brief at 1.

A hearing was held before me on July 15 and 16, 2002, in Norfolk, Virginia. Mr. Joseph L. Bianculli appeared on behalf of Petitioner, and Mr. Alan C. Horowitz appeared on behalf of CMS. Prior to and during the hearing, CMS Exhibits (CMS Exs.) 1 through 45 and Petitioner's Exhibits (P. Exs.) 1 through 38 were admitted into evidence. However, inasmuch as P. Exs. 19-37 refer to issues resolved by the parties prior to hearing, and are no longer relevant to the issues before me, with the acquiescence of the parties, I subsequently struck P. Exs. 19-37 from the record. For the same reasons, I strike CMS Exs. 14 through 17.

ISSUE

The sole issue before me is whether, from July 11, 2000, through August 9, 2000, the facility was in substantial compliance with program participation requirements, specifically 42 C.F.R. �� 483.25 and 483.25(h)(2) (Quality of Care). The reasonableness of the amount of the CMP is not in question.

STATUTORY AND REGULATORY BACKGROUND

The Social Security Act (Act) sets forth requirements for nursing facility participation in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services to promulgate regulations implementing the statutory provisions. Act, �� 1819 and 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483.

To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements. To be in substantial compliance, a facility's deficiencies may "pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. � 488.301.

Under the statute and the "quality of care" regulation, each resident must receive, and the facility must provide, the necessary care and services to allow a resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, � 1819(b); 42 C.F.R. � 483.25. Accordingly, the facility must conduct an initial and periodic resident assessment of functional capacity. The assessment must be comprehensive, accurate, standardized, and reproducible. 42 C.F.R. �� 483.20, 483.25. The facility is required to make a comprehensive assessment of a resident's needs promptly after a significant change in the resident's physical or mental condition. 42 C.F.R. � 483.20(b)(2)(ii). The facility must also ensure that each resident receives adequate supervision and assistance devices to prevent accidents. 42 C.F.R. � 483.25(h)(2).

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. � 488.406, which include imposing a CMP. See Act, � 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more program requirements or for each instance that a facility is not in substantial compliance. 42 C.F.R. �� 488.430(a), 488.440. In situations where the deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for causing more than minimal harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day. 42 C.F.R. � 488.483(a)(1)(ii).

BURDEN OF PROOF

As an evidentiary matter, CMS must set forth a prima facie case that the facility was not in substantial compliance. Petitioner then has the burden of coming forward with evidence sufficient to establish the elements of any affirmative argument or defense, and bears the ultimate burden of persuasion. To prevail, Petitioner must prove, by a preponderance of the evidence, that it was in substantial compliance with relevant statutory and regulatory provisions. Meadow Wood Nursing Home, DAB No. 1841 (2002); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. HHS, No. 98-3789 (D.N.J. May 13, 1999); Cross Creek Health Care Center, DAB No. 1665 (1998). ⁽²⁾

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.

A. From July 11, 2000, through August 9, 2000, Petitioner was not in substantial compliance with program participation requirements, specifically 42 C.F.R. � 483.25 (Quality of Care).

In 1999, Resident #1 was a 93-year-old man who had been living a fairly active and independent life until November 22, when he was admitted to the hospital with a multitude of diagnoses: atrial fibrillation, congestive heart failure, chronic renal insufficiency, electrolyte imbalance, blindness, gastric bleeding, circulatory problems in his legs and feet, and dementia. Joint Stip. #8; P. Exs. 3, 4. Hospital admission records describe him as "fairly independent. Walks with a cane. Goes daily to the senior citizens center but today was too weak to do this." P. Ex. 4, at 6. He spent a week in the hospital, where staff described him as "very pleasant," but noted that because he was blind and hard of hearing, he required frequent orientation and monitoring. P. Ex. 4, at 1, 3. On November 29, 1999, Resident #1 was discharged from the hospital and admitted to the facility for physical therapy "at least temporarily . . . because he normally walks to the bus stop and goes to the senior citizens daily and is very wobbly walking and is unable [to] at the current time." P. Ex. 4, at 2. ⁽³⁾

Resident #1's first months at the facility were relatively uneventful. He successfully completed physical therapy, and remained independent in bathing, dressing, toileting, and transfers. CMS Ex. 12, at 32-35, 70, 72. However, on December 17, 1999, he was found sitting on the floor, apparently having fallen. P. Ex. 11, at 8. On March 3, 2000, he was found lying on the floor, apparently having fallen again. He denied hitting his head, and no injuries were noted. P. Ex. 11, at 19; CMS Ex. 12, at 19-20.

No other incidents were reported until May 2000, when Resident #1 suffered a series of falls in rapid succession. He fell twice on May 4, sustaining a small laceration under his right eye. CMS Ex. 12, at 21-22. On May 7, 2000, he was found sitting on the floor at the foot of his bed, a small bleeding skin tear to the right buttocks. At about this time, his behavior seems to have deteriorated, and he began banging his cane on the walls and engaging in other disruptive behaviors. P. Ex. 11, at 23, 24, 25, 26, 28, 29; CMS Ex. 12, at 10, 11, 12, 13, 14, 15. On May 12, 2000, he was again found lying on the floor, with a small laceration over his eyebrow. P. Ex. 11, at 26; CMS Ex. 12, at 13, 26-27. On May 20, 2000, he was found lying on the floor, saying that his knees had buckled. P. Ex. 11, at 29; CMS Ex. 12, at 28-29. At 1:30 the afternoon of May 21, 2000, a visitor found him on the floor beside his bed. He had a laceration on his forehead, and a skin tear on his right hand. P. Ex. 11, at 29-30; CMS Ex. 12, at 15-16, 30-31. On May 22, he was described as "very agitated" and began experiencing tremors in his hands and legs. P. Ex. 11, at 31; CMS Ex. 12, at 17. Throughout the following day, May 23, he was again described as "agitated" and "yelling and banging on [the] wall with [his] cane." P. Ex. 11, at 31; CMS Ex. 12, at 17. By 8:00 P.M. that night his temperature was slightly elevated - 99.4 degrees. P. Ex. 11, at 31; CMS Ex. 12, at 17.

At 1:30 A.M. the following morning, staff described him as "lethargic." He would not open his eyes when asked. He had coarse rales and rhonchi. He was incontinent of bladder and bowels, and his temperature had climbed to 103.7 degrees. P. Ex. 11, at 32; CMS Ex. 12, at 18. At 3:15 A.M., his temperature was still 103.5 degrees. Staff described "mouth with jerky involuntary movements and bilateral hands and R leg." They called the rescue squad, which arrived at 3:30 A.M. Id. He was taken to the emergency room, where physicians diagnosed a subdural hematoma. CMS Ex. 13, at 15. He was not a candidate for craniotomy, and he died on May 26, 2000. CMS Ex. 12, at 87.

1. Petitioner failed to insure that Resident #1 received adequate supervision and assistance devices to prevent accidents, as required by 42 C.F.R. � 483.25(h)(2).

In order to meet the overall quality of care requirement that it provide what is necessary for each resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, the facility must ensure that its supervision is adequate to prevent accidents. This requirement does not amount to strict liability or require absolute success in an obviously difficult task. Using an outcome-oriented approach, facilities have flexibility to use a variety of methods and approaches, but they are responsible for achieving the required results. In ensuring adequate supervision, the facility is not required to do the impossible or be a guarantor against unforeseeable occurrence, but "is required to do everything in its power to prevent accidents." (Emphasis added.) 42 C.F.R. � 483.25; Koester Pavilion, DAB No. 1750, at 24 (2000); Woodstock Care Center, DAB No. 1726, at 25 (2000).

At the time of his admission, the facility appropriately performed a risk assessment, and determined that Resident #1's risk for falls was high; he scored 13 on a scale that reckoned any score above 10 as high risk. Tr. 35; CMS Ex. 12, at 9. Although he had not fallen at all during the preceding three months, many factors put him at risk, including his age, sensory problems (poor vision and hearing), unsteady gait, osteoarthritis, and medications. Tr. 71, 205-207. Among other medications, he took Ativan (Lorazepam), a benzodiazepine sedative that can cause dizziness and disorientation. He took diuretics to control blood pressure, which can also cause problems with orthostatic hypotension (falling blood pressure due to a sudden change of position (Tr. 71)). Moreover, as CMS's witness, Dr. Patricia Ruze, ⁽⁴⁾ explained, lower blood pressure in general may cause problems with balance, increasing his risk for falls. Tr. 206-207.

The facility conducted quarterly risk assessments, and, on March 7, 2000, conducted a second risk assessment for Resident #1. By then, he had suffered two falls (December 17, 1999 and March 3, 2000), his level of consciousness had deteriorated, and his risk level increased from 13 to 17. CMS Ex. 12, at 9; Tr. 35-36. The facility reviewed his care plan but decided not to make any changes. Tr. 37. A physical therapy (PT) reassessment dated April 25, 2000, acknowledges the falls and Resident #1's "balance issues." At the same time, the assessment describes him as independent in bathing, dressing, toileting, transfers, bed mobility, and self-feeding, not requiring assistance. He is "alert, responsive" (although hard of hearing) and "able to follow simple commands." The assessment concludes that he does not then need skilled therapy. CMS Ex. 12, at 35-36.

CMS does not fault the facility for Resident #1's having fallen in December and March. Nor does CMS maintain that the facility erred in not changing Resident #1's care plan at the time of the quarterly assessment in March. CMS does not challenge the April PT reassessment. However, in CMS's view, when Resident #1 began experiencing multiple falls in May 2000, the facility did not respond by providing him the supervision and assistance devices adequate to prevent these accidents. CMS characterizes the facility's limited efforts to prevent falls as "too little" and "too late." CMS Br. at 17.

a. In May 2000, Resident #1's condition dramatically deteriorated, and that deterioration included a marked escalation in his number of falls.

Petitioner claims that Resident #1's problems existed throughout his stay in the facility, and argues that only the "benefit of hindsight" suggests that alternative interventions might have been attempted to prevent falls. P. Brief at 3, et seq. I do not disagree that Resident #1's decline likely began well before May, and was not a steady decline, but progressed by fits and starts. In retrospect, the earlier falls and episodes of erratic behavior all suggest the beginning of what Dr. Ruze described as his "accelerating deterioration." Tr. 260. Indeed, if someone had really been paying close attention, he/she might have observed, as early as December, disturbing changes from the "fairly independent" and "very pleasant" man described just a few weeks earlier in his hospital records. But the early changes were subtle and might not have been so easily detectable. For that reason, CMS does not hold Petitioner accountable for not identifying the changes and responding earlier. See Tr. 210. In May, however, the decline accelerated dramatically, and evidence of that deterioration included a marked escalation in his number of falls. As the evidence establishes, he then moved from a state of high-risk-but-experiencing-no-falls to that of higher-risk-and-experiencing-repeated-falls. Certainly, by the second week in May - when he had fallen four times in a little more than a week - his falls were easily foreseeable.

I was not persuaded by Petitioner's efforts to establish that Resident #1 remained at the same low level of function - and thus vulnerability to falls - throughout his stay. Petitioner seems to have lost sight of how functional Resident #1 was when first admitted to the facility. His initial assessments describe no episodes of incontinence and none of the kinds of behaviors staff later complained about, such as hitting the wall with his cane. Nothing in his care plan even mentions those kinds of behaviors. Indeed, at the time of his admission, records suggest hope that he would be able to return to his earlier, more independent life. P. Ex. 4, at 2 (Admitted "for rehab[,] at least temporarily . . . because he normally walks to the bus stop and goes to the senior citizens daily and is very wobbly walking and is unable [to] at the current time."); P. Ex. 5, at 2 (per Dr. Planas, transferred to the facility "for short term rehab."). He had no history of falls. ⁽⁵⁾ He was continent. P. Ex. 11, at 3, 4, 6. He ate meals in the dining room. P. Ex. 11, at 4, 7. According to his PT records, Resident #1 made good progress and met all of his goals. When his therapy was discontinued on December 20, 1999, he was able to ambulate 500 feet with his cane with good gait stability. He was independent in bathing, dressing, toileting, and transfers. CMS Ex. 12, at 32-34; Tr. 77-78. Indeed, as late as the April 25 PT reassessment, he was still described as "independent" and not needing assistance in toileting, transfers, and bed mobility. CMS Ex. 12, at 35-36.

To establish that Resident #1's condition did not decline, Petitioner cites to three nursing notes of purported "behavior problems" in December 1999 (P. Brief at 8), and offered staff testimony that was confused, inconsistent, certainly inconsistent with the medical record, and, in some cases, simply incredible.

First, the nursing notes Petitioner cites do not establish any examples of extreme behavior prior to May. A 10:00 A.M. entry on December 15, 1999, describes Resident #1 as "confused [with] resistance to care." P. Ex. 11, at 7. At 11:30 P.M. on December 16, he is "alert and disoriented. Resisting care at times. Very afraid when approached [and] holds on to cane . . . In no acute distress." P. Ex. 11, at 8. ⁽⁶⁾ A note dated December 24 states "appear[s] to be combative at times. Refused to take PO fluids . . . resting quiet [with] no difficulty." P. Ex. 11, at 12.

Contrast these relatively benign entries with what happened in May. At 3:00 A.M. on the morning of May 8, staff describe him as "very restless," having not slept the entire shift, hitting his cane on the wall in the hallway, going into other residents' rooms, yelling and disturbing them. At 12:55 that afternoon, he is again described as "very agitated, hitting walls with cane." He had apparently spread feces on the wall of his bedroom. P. Ex. 11, at 24; CMS Ex. 12, at 11. At 10:15 P.M. he was back up in his wheelchair, banging on the hall walls with his cane and yelling loudly. Staff took him to his room but he refused to put on his night clothes. P. Ex. 11, at 25; CMS Ex. 12, at 12. At 2:30 on the morning of May 9, he is again described as "agitated." Id. On May 11 at 10:45 P.M., he is up in his wheelchair, "increasingly agitated," and swinging his cane. P. Ex 11, at 26: CMS Ex. 12, at 13. The following day, May 12, at 5:00 P.M., he is again described as "very agitated," up in his wheelchair, hitting his cane on the wall. Id. At 9:30 P.M., he is found lying on the floor with another head injury. P. Ex. 11, at 26; CMS Ex. 12, at 13, 26-27. A May 13, 4:00 A.M. note indicates that he has been "[i]n and out of bed all night." P. Ex 11, at 26; CMS Ex. 12, at 13. On May 16, at 9:30 P.M., Resident #1 - who had consistently been described as continent - was found sitting on the side of his bed, having urinated a "large amount of urine on floor." He refused to be changed and put to bed, and is described as having "increased agitation." P. Ex. 11, at 28; CMS Ex. 12, at 14; Tr. 270.

Nor were Petitioner's witnesses credible when they denied that Resident #1's condition declined in May. Roberta Wolf is a licensed practical nurse (LPN) who worked at the facility on the afternoon/evening shift (3:00 P.M. to 11:00 P.M.). Tr. 342, 346. Initially, she testified that Resident #1's problems persisted throughout his time at the facility. Tr. 358. But she also testified that he began to fall frequently "towards the very end" of his stay. Tr. 353. Under cross-examination, she conceded that the during the month of May he was extremely and unusually agitated compared to all the prior months. Tr. 370. When asked how that statement could be reconciled with her earlier testimony that his behavior had been consistent throughout his stay, she conceded, "I guess it wouldn't be." Tr. 370. At one point, she agreed that his behavior was consistent in November, December, January, February, March, and April, but declined in May. Tr. 371. Ultimately, LPN Wolf said that she was "not sure" whether Resident #1's behavior, appearance, and condition were about the same in May as during the preceding months. Tr. 395.

Petitioner attributes LPN Wolf's apparent change of heart to her poor performance as a witness. I agree that her testimony did not further Petitioner's position, but I think it more likely that she changed her testimony because, when confronted with the documentary evidence, she could not justify the answers she had given. She simply gave up her efforts to reconcile Petitioner's theory of the case with the written record, and said that she did not know.

Registered Nurse Tamara Webster, who worked the night shift (11:00 P.M. - 7:00 A.M.), testified that Resident #1's condition stayed the same throughout his stay "until the very end," and that he was consistently unsteady on his feet. Tr. 434, 435, 449. But, when asked under cross-examination if he had improved with physical therapy, she said that she really did not know. Tr. 450. The December PT records carefully document Resident #1's ability to walk with his cane "with good gait stability." CMS Ex. 12, at 32-34. That she "could not remember" this documented improvement casts considerable doubt on her ability to remember accurately his condition and abilities throughout his stay. Moreover, the testimony of Shirley Blount, an LPN who worked the day shift, further undermines Petitioner's claim. LPN Blount observed that in May Resident #1 "had become irritable," and she attributed his irritability to his increased number of falls. Tr. 408-409.

Other evidence undermines Petitioner's assertion. Following Resident #1's transfer to the hospital on May 24, 2000, a consulting physician, David Waters, MD, reports that Resident #1 had been "reasonably functional" upon his admission to the facility, but "over the last month or so," began to fall quite frequently. CMS Ex. 12, at 88; CMS Ex. 13, at 31.

With respect to Resident #1's incidents of incontinence on May 16 and the morning of May 24, Petitioner characterizes them as unremarkable, claiming that Resident #1 was often incontinent. LPN Wolf testified that he was frequently incontinent in bed, especially at night, and this was true throughout his stay. Tr. 348. His assessment and the nursing notes directly contradict Petitioner's claim and LPN Wolf's testimony. P. Ex. 11, at 1; P. Ex. 11, at 3 ("continent of urine and stools."); P. Ex. 11, at 4 ("continent of B & B") (per LPN Wolf: "Res. continent of B & B"); P. Ex. 11, at 6 ("continent of urine & stool"); P. Ex. 11, at 7 ("continent of B & B"); P. Ex. 11, at 23 ("Resident not incontinent and denies having to go to the bathroom"). On cross-examination, LPN Wolf admitted that nurses would chart instances of incontinence (Tr. 375); however, on redirect, she changed course yet again and said that she would not document every instance of incontinence, "sometimes because you were concentrating on documenting other things instead of their incontinence because that is usually what the AD record was for." She then explained that the nurse aides document every shift whether the resident was continent or incontinent. Tr. 393. Petitioner produced no such documentation indicating incontinence. LPN Blount testified that he was "mostly continent." Tr. 416. Even RN Webster conceded that his incontinence on the night of May 23-24 "was new for him." Tr. 474. The overwhelming evidence, including Petitioner's own assessment, establishes that Resident #1 was continent and even generally independent in toileting. As I discuss in greater detail below, his episodes of incontinence represented a significant change, and should have alerted his care givers that he was in potentially serious trouble.

b. The facility's Falls Committee was ill-informed and ineffective.

Of course, the most compelling evidence of Resident #1's May decline are the falls themselves. He fell six times during an 18-day period, sustaining two falls on May 4, 2000 alone. I agree with CMS and Dr. Ruze that by the third fall, on May 7, the facility was on notice that he would likely fall again, and was obligated to "do everything in its power" to prevent further accidents. But, as CMS alleges, the facility response did not meet this standard. Although the facility had in place a Restraint and Falls Committee, the record shows little connection and no coordination between the Committee and the staff directly responsible for Resident #1's care. When the Committee met on May 10, Resident #1 had already fallen a total of five times during his stay at the facility, three of them during the preceding week. He had sustained injuries in two of those falls (a laceration under his right eye on May 4, and a skin tear to the right buttocks on May 7). Yet, the committee understood that he had fallen only twice and had sustained no injury. It offered only one recommendation: that he be put back to bed after lunch. P. Ex. 12, at 2; CMS Ex. 12, at 110.

Not only did the Falls Committee base its recommendation on inaccurate or incomplete data, no witness or documentary evidence explained how the recommended approach - to put the resident to bed after lunch - would prevent additional falls. The first time Resident #1 fell (December 17) he was found sitting on the floor at 7:00 P.M.. The second time (March 3) he was found at 5:30 A.M. lying on his side, having fallen when he came out of the bathroom. The facility presents little information as to the time and circumstances of the May 4 falls, except that he said he "fell asleep and was dreaming." The Falls Committee was likely responding to the circumstances surrounding one of these falls since the incident report indicates the time as "1:05" and its recommendation is "offer periods of rest in bed [every] 4-5 [hours] and to bed [after] lunch." CMS Ex. 12, at 21-22. However, this fall does not seem especially typical. For the May 7 fall, he was found on the floor at 5:15 A.M.. None of Petitioner's witnesses suggested a connection between Resident #1's falls and his being out of bed after lunch. In fact, they testified that he already spent most of his day in bed, and attributed his falls to his efforts to take himself to the bathroom without assistance. See Tr. 346-348.

Not surprisingly, following the May 10 Falls Committee meeting, Resident #1 continued to fall. At 9:30 P.M. on the night of May 12, he was again found lying on the floor, having fallen, and sustained a laceration over his eyebrow. P. Ex. 11, at 26; CMS Ex. 12, 13, 26-27. An incident report notes that he "gets up and down frequently" from bed to wheelchair, and recommends that he be monitored hourly, and every 30 minutes when agitated. ⁽⁷⁾ In a different script, someone has added to the incident report "assess for needs." CMS Ex. 12, at 27. ⁽⁸⁾

On May 17, the Falls Committee met again, and noted that Resident #1 had been found on the floor again. The Committee again recommended that he be put back to bed after lunch, and, for the first time, recommended bed/wheel chair alarms. P. Ex. 12, at 4; CMS Ex. 12, at 112. But the facility did not immediately install the alarms, and on May 20, Resident #1 was again found on the floor, having sustained his fifth fall since May 4. P. Ex. 11, at 28-29; CMS Ex. 12, at 14-15. The incident report does not mention the time of the incident, but states that he was "attempting to get out of [his] chair when he was found on the floor." Recommendations include: possible chair alarm, frequent reminders to ask for assistance, and frequent observation. CMS Ex. 12, at 28-29.

Thus, Resident #1 fell five times in a short period (and seven times in all) before the facility even considered applying a bed and chair alarm. It delayed even longer in actually implementing that alarm. The record is not clear as to when the facility finally did so. At 1:30 P.M. on May 21, a visitor found Resident #1 on the floor of his room, beside his bed. Resident #1 told staff that during lunch he tried to get out of his wheelchair, but lost his balance. He suffered a laceration on his forehead and a skin tear on his hand. P. Ex. 11, at 29-30; CMS Ex. 12, at 15-16. The incident report states that the resident is becoming weaker and needs assistance in transferring and "questionable side rail x1." Recommendations are "start bed/chair alarm it was applied." Written in a different hand is the notation "frequent visual checks." CMS Ex. 12, at 31.

Deborah Spruill, Regional Quality Assurance Nurse for the facility's parent corporation, ⁽⁹⁾ was not at the facility during this time, but, based on her reading of the incident report, initially opined that the alarm was in place prior to the May 21^st fall. On cross-examination, however, she admitted that she did not know exactly what day the alarm was put on. "That's not clear in the record." Tr. 536. "I don't believe the record shows exactly what time it was placed." Tr. 537. Nor does any other evidence in the record establish that the facility had installed alarms until after the May 21 fall. The recommendation in the May 21 incident report to "start" the bed and chair alarms suggests that the facility had not initiated the intervention prior to the May 21^st fall. Tr. 66. That the incident report says "it was applied" just means that the alarm was applied before the report was written - which was obviously after the fall. The first references to the alarms being in place follow a 4:30 P.M. entry in the nursing notes: "Personal alarm intact with eggcrate mattress on the floor next to the bed." P. Ex. 11, at 30; CMS Ex. 12, at 16.

Moreover, even if the alarm had been in place prior to the May 21^st fall, it was ineffective, suggesting additional deficiencies. The record does not indicate that any alarm went off, nor that staff responded. A visitor found Resident #1 on the floor. If an alarm had been in place, I would expect to see evidence that the facility investigated the reasons for its ineffectiveness, and the record contains none.

RN Webster said that she did not know when the facility implemented Resident #1's bed/chair alarm. Tr. 454. When asked whether the bed and chair alarms were available at the beginning of May, she was "not sure." Tr. 455. On the other hand, according to LPN Blount, staff could obtain an alarm "within a couple of minutes" and would document on the nursing notes every time they applied the alarm: "wheelchair alarm in place." Tr. 412. LPN Wolf said that it would take "less than 24 hours" to get an alarm in place and staff trained on it. Tr. 365-366. But later she said that she could not remember when the bed and chair alarms were used, and thought they were not used in the facility at the time. Tr. 391. Linda Barnes (nee Hill), Resident #1's stepdaughter, credibly testified that she visited her father often, and first noticed the bed alarm on Tuesday, May 23. She remembered the day because she was taking him a suit to wear for a special event at the facility. Tr. 176. She had last visited him on Friday, May 19. Tr. 179. From all of this, I conclude that the alarms were most likely installed on May 21, after Resident #1 had suffered his sixth fall.

On May 24, the Falls Committee finally recommended Resident #1's referral to the PT Department for re-assessment, but by that time Resident #1 had been transferred to an acute care hospital with a subdural hematoma. P. Ex. 12, at 6; Tr. 80.

c. The facility had no other coherent approach to preventing falls.

For the reasons discussed above, I consider the Falls Committee ill-informed and ineffective. Moreover, the facility did not seem to have in place any other coherent approach to preventing falls. Staff seemed ill-prepared to explain what they had been instructed to do. LPN Wolf, for example, had difficulty responding to basic questions about planning:

Q: What other sorts of things would be done in terms of planning for the care of a resident that was at high risk for falls? We know there is a written care plan for example in the documentation. How would that be created?

A: Well, since - with this resident, we did not have his bed rails up because he was at risk for falls.

Tr. 405. Similarly, RN Webster offered little to explain how staff assisted Resident #1, who was afraid of falling, except to say "We assisted him. We took him to the bathroom." Tr. 465. When asked to explain how staff addressed his fear of falling, LPN Blount did not have much to offer: when he called out, someone would go to assist him. Tr. 424-425.

According to staff, their principal approach to preventing Resident #1 from falling involved "frequent monitoring." Some facilities actually develop a form to document the frequency of monitoring. Tr. 60. But the facility has not established that it implemented any systematic means by which to insure that Resident #1 was monitored, and the documentation does not specifically identify frequent observation. Nor did the witnesses even agree as to the required frequency of checks. The May 12 incident report indicates that he should be checked hourly, and every 30 minutes when agitated. CMS Ex. 12, at 27. No witness suggested that he was being checked as frequently as every 30 minutes, although they seemed to agree that he was frequently agitated. LPN Wolf said staff would just check on him every few hours or less. Tr. 373-374. RN Webster said that staff would check him every two hours. Tr. 440.

That the facility did not develop a workable plan to prevent Resident #1 from falling might be attributable to the absence of an up-to-date assessment reflecting his increasing vulnerability. Virtually all of the witnesses considered appropriate some type of re-assessment. Nurse Surveyor Ann MacCallum ⁽¹⁰⁾ explained that an assessment could include review of Resident #1's medications to determine if any drug or drug interactions were causing him to fall. Tr. 75. The facility might have referred him back to the rehabilitation department to evaluate his balance. They could have evaluated his nutritional status to see if the falls were related to that. Tr. 76-79.

And the nurses themselves should have screened for orthostatic hypotension, which can cause falls. By checking Resident #1's blood pressure in reclining, sitting, and standing positions, staff could have detected any changes suggestive of that problem. According to Surveyor MacCallum's convincing testimony, performing this relatively simple procedure represents the standard of care for an individual who is experiencing falls. Tr. 102-103. Yet the record offers no indication that anyone in the facility ever checked Resident #1 for orthostatic hypotension. Tr. 103. Quality Assurance (QA) Nurse Spruill admitted that checking blood pressure at two parameters - either supine and sitting or supine and standing - is a way to check for orthostatic hypotension, but argued that the check should be performed "if each fall was based on them rising and immediately falling, and we did not know if that was the case." Tr. 549. I was not impressed by this defense. We know from the record that at least some of the falls occurred when Resident #1 stood up. CMS Ex. 12, at 28-29. Staff also testified that he fell when he tried to stand. Frankly, I am at a loss to understand why staff would have to know with certainty the circumstances of each fall before performing something as basic as taking blood pressure.

Dr. Ruze opined that, by May 7, the facility should have assessed environmental factors and medications (including a discussion about discontinuing his Coumadin). A PT assessment would have been helpful. Tr. 210-211, 237.

RN Webster agreed that a PT re-evaluation would have been appropriate when Resident #1 sustained his falls, although she could not remember whether she herself had ever recommended one, nor if he had received any PT in April or May. Tr. 452- 453. LPN Blount did not know whether Resident #1 had been re-evaluated by PT in May when his number of falls escalated, but agreed that the PT Department should re-evaluate a resident who experiences four falls in rapid succession. Tr. 422-423. Only Nurse Spruill equivocated about the appropriateness of a PT assessment. When asked whether it would have been appropriate to refer Resident #1 back to PT, she offered this confusing response:

I think in this facility, the report from the falls committee, every resident who is assessed that is sent to therapy, and therapy, at that point, should have made the decision in their own determination whether or not they felt this person needed to be re-evaluated. I have no way of knowing if they had seen something had changed that they could help with.

Tr. 521. But the PT Department was not consulted after Resident #1 began to experience his multiple falls, and the department was not represented on the Falls Committee.

Dr. Roque Planas, the facility's then medical director (Tr. 326) and Resident #1's nominal treating physician, testified that "we would want to know about [the falls] so we [could] go by and reassess the patient." Tr. 317, 318.

If you get concerned . . . about falls, what you would do is you would do a urine test and send it for cultures to see if there is an infection. Sometimes you might do a chest x-ray if you are concerned that the patient is not swallowing properly. You may want to check electrolytes. Those are kind of the basics.

Tr. 320. But Dr. Planas could not say whether any assessments were performed in this case. Tr. 319. "I don't know. I have not reviewed those records." Id. In fact, even though he was nominally Resident #1's treating physician and the facility's medical director (Tr. 326), Dr. Planas suggested that he may not even have been aware of Resident #1's falls, claiming that he "wasn't rounding at that facility at that time." Tr. 317.

The record shows little, if any, physician involvement in assessing Resident #1. RN Webster testified that, at the time of the May 7 fall, she specifically decided that it was not necessary to notify Resident #1's physician, even though this was Resident #1's third fall in just a few days and even though he had sustained an injury. CMS Ex. 12, at 23; Tr. 457. ⁽¹¹⁾ No evidence establishes that a physician saw and re-evaluated him after any of his falls until his final transfer to the hospital. Tr. 77. Dr. Planas certainly distanced himself from any involvement in Resident #1's care. When asked if it were possible that he might not even have seen or treated Resident #1, Dr. Planas conceded "Not that much. Not that much. Only at the beginning." Tr. 326-327. He had no recollection of the resident nor his family. Tr. 327-328.

The evidence establishes that in May 2000, Resident #1 began to suffer from multiple falls in rapid succession. CMS has more than satisfied its burden to establish that the facility failed to "do everything in its power" to prevent those falls. Petitioner submitted medical records showing that it took few affirmative steps to address the problem. No evidence establishes that appropriate assessments were performed nor that rational preventive measures were implemented in a timely manner. Petitioner thus did not insure that Resident #1 received adequate supervision and assistance devices to prevent accidents. It was therefore not in compliance with the requirements of 42 C.F.R. � 483.25(h)(2).

2. Petitioner failed to provide necessary care and services to allow Resident #1 to attain or maintain his highest practicable physical, mental, and psychosocial well-being as required by 42 C.F.R. � 483.25.

I next consider whether, in addition to its deficiencies in preventing accidents, the facility failed in other respects to provide care and services necessary to allow Resident #1 to attain or maintain his highest practicable physical, mental, and psychosocial well-being.

a. The facility did not insure that Resident #1 obtained the type of physician services that he required to maintain his highest practicable physical, mental, and psychosocial well-being.

Unquestionably, Resident #1 required careful medical monitoring, particularly as his decline accelerated throughout May. But, based on the record before me, the facility did not keep his physician well-informed and did not insure that he obtained the type of physician services that he required.

Petitioner argues that it "communicated regularly" with Dr. Planas and his office, and cannot be held responsible for his (or their) decision not to intervene. P. Brief at 34. The first problem with this argument is that, although staff regularly reported the results of blood tests, and occasionally advised the physician's office of falls (P. Ex. 11, at 22; CMS Ex. 12, at 113), Petitioner has not shown that its staff consistently and timely communicated to the physician such critical information as falls, injuries, changes in behavior, and staff's increasing administration of Ativan. Second, the facility certainly can and should be held responsible for Dr. Planas' deficiencies. He was, after all, the facility's medical director, responsible for the coordination of medical care in the facility. 42 C.F.R. � 483.75(i)(2)(ii). CMS could also have cited deficiencies under 42 C.F.R. � 483.40 (physician services) and 42 C.F.R. � 483.75(i) (medical director). It did not; but the circumstances creating deficiencies under those regulations also can - and, in this case, do - constitute deficiencies under 42 C.F.R. � 483.25.

Whether any physician fully assumed responsibility for Resident #1's care is highly questionable. Dr. Planas was Resident #1's nominal physician, and the facility had plainly identified him as the one responsible for Resident #1's care. Yet, from the beginning, Dr. Planas' involvement in Resident #1's care seems careless and haphazard. The record contains a document dated November 30, 1999, captioned "comprehensive evaluation - Level 3." It bears the signature stamp of Dr. Planas and raises some significant questions as to the care with which Dr. Planas examined Resident #1. The evaluation says that Resident #1 had "no history of chest pain, shortness of breath, cough . . ." P. Ex. 5, at 1. But Resident #1's hospital records list as his chief complaint "short of breath and coughing up phlegm." P. Ex. 4, at 5. The Planas evaluation finds no visual complaints or hearing difficulties. P. Ex. 5, at 2. But Resident #1 was blind and very hard of hearing. P. Ex. 11, at 1.

Dr. Planas did not know if he or any of his associates saw Resident #1 at all in the month of May. Tr. 332. He could not say whether any assessments were performed. Tr. 319. ⁽¹²⁾

Dr. Planas finally examined Resident #1 after his transfer to the hospital on May 24. Again, his report contains obvious but unexplained errors. Hospital physicians describe Resident #1 as "frail" and "cachectic." ⁽¹³⁾ CMS Ex. 12, at 88. Yet, in his summary, Dr. Planas describes him as "well developed" and "well nourished." CMS Ex. 13, at 29. Under HEENT (head, eye, ears, nose and throat), Dr. Planas describes Resident #1's head as "normocephalic" with "no recent external evidence of trauma." CMS Ex. 12, at 95. But this directly contradicts the ER physician and nursing assessments, which note discoloration on the forehead and "ecchymotic [bruised] area over his left frontal area on the left side" (forehead ). CMS Ex. 13, at 3- 4, 10, 11; Tr. 225-226, 227-229. ⁽¹⁴⁾ In testimony, Dr. Planas did not remember whether Resident #1 was "well-nourished" and "well-developed" as he had written. Tr. 321. He offered no credible explanation as to how he missed the bruising and laceration to Resident #1's face. See Tr. 323-325.

That a physician was not carefully monitoring his condition was particularly problematic because Resident #1 was taking both Ativan and Coumadin, each requiring special consideration when administered to an individual who suffers falls and head injuries. Ativan is a sedating, hypnotic medication that can increase confusion and the risk of falls. Tr. 233. From the time of his admission, Resident #1 had an order for Ativan (Lorazepam): "0.5 mg tablet by mouth as needed at bedtime for insomnia or agitation."CMS Ex. 12, at 39; Tr. 231. According to Dr. Ruze, this prescription, while ambiguous, could only reasonably have been interpreted as authorizing staff to administer the drug at bedtime.

Q: Based on that order . . . could a nurse give that drug at that dose in the morning?

A: I don't think so, not without a change from the physician, and the reason that I say that is . . . there are several very important parts of a prescription. One is obviously the medication and the dose of the tablet. You need to specify the route that the medication is given, which is by mouth, and then you need to do the frequency of dosing, and, if you are going to interpret this as saying "as needed for agitation," you would need to specify how frequently to give it as needed for agitation.

If you are going to interpret it that it was just to be given as it was needed for agitation, you could interpret that as every five minutes with no maximum dose. So it just doesn't make any sense to me to say that was just as needed for agitation. I think it really needs to say [as] needed at bedtime, one time, for insomnia or agitation.

Tr. 231-232. And yet, in May, staff began administering Ativan with increasing frequency, and started to administer it in the mornings, even though the physician order did not authorize such administration. See, e.g., P. Ex. 11, at 24, 26, 28; CMS Ex. 12, at 11, 13, 14.

QA Nurse Spruill agreed that the order was poorly written and open to interpretation. Tr. 495. "I think, in retrospect, a nurse would look at that order and try to get some type of clarification." Tr. 544. Nurse Spruill ineffectively attempted to defend the nursing errors. She agreed that the order was poorly written and vague, but did not find the nurses at fault for not recognizing that fact. "I don't find them at fault. I think they need more education." Tr. 544-545. I agree that the nurses needed more education, but that fact hardly excuses the facility from mis-administering medication.

Dr. Ruze found more to criticize in the staff's administration of Ativan. Reviewing the facility's medication records, she observed a significant increase in the amount of Ativan given Resident #1 "for agitation." Staff gave Resident #1 Ativan for sleep during his first week at the facility (six bedtime doses from November 29 through December 5 (P. Ex. 11, at 2-3)), but then virtually none for the rest of December. ⁽¹⁵⁾ From December until May, he received only an occasional dose at bedtime. ⁽¹⁶⁾ In May, staff significantly increased the administration of Ativan and, for the first time, started to give it to him in the morning. Tr. 261-264; CMS Ex. 12, at 38 et seq. Dr. Ruze considered this increase a

signal that the nursing staff felt that there was certainly increased agitation, and it is when we also see the behavioral changes in the chart. So what I see is a period where he was relatively free of any need for the sedation and this changed in the beginning of May.

Tr. 264.

Surveyor MacCallum expressed similar concern as to whether Resident #1's agitation contributed to his falls, and whether this type of agitation should have been reevaluated rather than simply medicated. In her view, the increase in the administration of Ativan shows a change in his condition that should have been assessed. Tr. 92. I agree that Resident #1's increasing need for Ativan should have alerted the health professionals that something was going on requiring investigation. Tr. 233. This means that the physician should have been notified and should have evaluated why this individual was requiring more Ativan. Tr. 234. Dr. Planas testified that he would not have known how often Ativan was given unless the facility told him, nor would he necessarily follow up to see how often the facility administered the Ativan in response to his PRN orders. Tr. 329-331.

Dr. Ruze pointed out an additional problem with the facility's continuing to give Ativan to Resident #1, noting the practice risked masking the patient's symptoms, which could tell you that something is going on, which "in this case was . . . a subdural hematoma." Tr. 234. See discussion below.

Prior to his admission into the facility, Resident #1 was put on Coumadin to prevent emboli or strokes. Tr. 302. Coumadin must be monitored carefully. If levels are too high, the patient risks bleeding complications; if the levels are too low, he risks developing emboli. Dr. Ruze testified that for any frail elderly person to sustain six falls in 18 days is a cause for concern, but especially here because Resident #1 was on Coumadin.

The Coumadin really is a signal . . . to physicians and nursing staff that any, even slight fall, could result in a significant and possibly fatal intracranial bleed.

Tr. 205; See also Tr. 82.

In a rare moment of recollection, Dr. Planas testified that he initially considered the problem of bleeding complications, but opted to follow the recommendation of Resident #1's attending "before he got to us." Tr. 305. He ordered that blood levels be taken twice a week, and whoever was on call would adjust the dosage based on those results. Tr. 303-304. However, as Dr. Ruze pointed out, no evidence shows that Dr. Planas or his colleagues were ever aware of Resident #1's many different behavioral changes and falls. While I do not discount the possibility of physician callousness to the needs of his patient, this ignorance might also explain why, notwithstanding his apparent attention to blood levels, Dr. Planas continued the order for Coumadin without re-considering its wisdom in light of Resident #1's falls and head injuries. Tr. 257.

Dr. Ruze recognized the need to balance the benefit with the risk, but noted that many physicians would have discontinued the Coumadin based solely on Resident #1's fall assessment score of 13 at the time of his admission. When reassessed in March with a score of 17, many physicians would have discontinued at that point.

Certainly, when the patient started falling, I think that the decision to anticoagulate that the patient should have been looked at again, and I think at the point he had fallen three times, I would have discontinued the Coumadin at that point.

Tr. 236. Without question, multiple falls are a contraindication to using Coumadin, particularly where, as here, three of those falls were associated with head injuries. Tr. 236, 208. At a minimum, a thorough neurological evaluation should have been performed, and the use of Coumadin reassessed. Tr. 209. Claiming "we are all going to die of something," Petitioner argues that since Resident #1 was not a surgical candidate, the facility's failure to recognize and respond to symptoms of a subdural hematoma caused no real harm. P. Brief at 5. I, of course, reject the notion that our common mortality justifies a facility's failure to provide appropriate care and services. Moreover, had the facility discontinued Resident #1's Coumadin and started him on Vitamin K (as the hospital did after it was too late), the severe bleeding might have been averted. Certainly, it is inappropriate to continue giving Coumadin to a man who demonstrates symptoms of a bleeding brain. Yet, no evidence establishes that any physician even considered changing the medication. Such inaction, in the case of an elderly man who has sustained multiple falls with head injuries, does not demonstrate that the facility was providing the care and services necessary to allow Resident #1 to maintain his highest practicable physical, mental, and psychosocial well-being.

b. Facility staff did not recognize nor adequately respond to significant symptoms following Resident #1's head injuries.

Facility staff simply failed to recognize, or they ignored, symptoms of serious head injury. LPN Wolf stated with "assuredness" that she never observed signs or symptoms of serious head injuries in Resident #1 throughout the time she cared for him. Tr. 357. I find this assertion puzzling since LPN Wolf also claimed to have been trained to look for "anywhere (sic) from increased agitation to difference in mannerisms" in someone with a head injury (Tr. 356), and, as I have already discussed in considerable detail, Resident #1 exhibited significant behavioral changes. One obvious incident occurred on May 16, when Resident #1 was found sitting on the side of his bed, having urinated "a large amount of urine on floor." He refused to be changed and put to bed, and is described as having "increased agitation." Dr. Ruze explained that an episode of incontinence, by itself, might not have raised suspicion, but it followed his having been found on the floor with a head injury. The unusual behavior should therefore have prompted a thorough neurological examination by a nurse. A thorough neurological evaluation by a nurse would have picked up his significant behavioral changes and that he had become less continent of urine, which should have prompted physician notification and evaluation. Instead, staff continued to mask his symptoms by dosing him with Ativan. Tr. 211-212, 270; CMS Ex. 12, at 13.

Staff simply did not perform appropriate neurological assessments and did not track Resident #1's status over time. As Surveyor MacCallum explained, staff should perform a neurological assessment immediately following a head injury and then on a frequent basis.

[T]he usual standard is to do serial neuro checks in order to see the comparison from one time to the next, and these reviews are usually done on a form that gives them the opportunity to chart them side by side, in order to see any changes quickly.

Tr. 82. The facility had in place for staff use a reasonably comprehensive form for performing these assessments. CMS Ex. 12, at 37; Tr. 238. However, as Dr. Ruze pointed out, comparing assessments over time to see the progression of change "is really the value in this kind of a form." CMS Ex. 12, at 37; Tr. 240. The records do not reflect that neurological assessments were performed on a systematic basis and the results compared. The records occasionally mention checks of vital signs following a head injury, but staff should have been performing serial neurological checks on a frequent basis. Tr. 86-87.

When asked to explain the "normal protocol" at Autumn Care for when a resident falls, LPN Wolf said that for a "normal fall with no apparent injury," they chart every shift, every 8 hours for 72 hours. Tr. 354 (but the record does not seem to contain consistent evidence of such charting). Her answer as to whether they would perform neurological checks was confusing. She said they would perform them "[i]f you saw it. See there is a difference between whether you saw it or you found it," but she also acknowledged that they would perform a neurological check "[i]f you found somebody with a head injury." Id.

The facility's inadequacies with respect to recognizing and responding appropriately to symptoms of a serious head injury are again apparent when considering staff reactions during Resident #1's last days at the facility. On May 21, he fell for the sixth time. He was not seen by a physician. Tr. 64. Surveyor MacCallum testified, and I agree, that it would have been appropriate for him to see a physician inasmuch as this was his sixth fall in a short time, and the third one in which he had hit his head. Id. An undated document, most likely prepared May 21, since it has the exact same vital signs as reflected in the nurses' notes, is captioned "neurological assessment," but states that "pt has visual impairment, unable to assess pupil reaction to light." CMS Ex. 12, at 37; see CMS Ex. 12, at 15. This was simply erroneous. As both Dr. Ruze and Surveyor MacCallum testified, Resident #1's pupils reacted to light. Previous neurological checks and hospital documentation confirm that his pupils reacted to light. Tr. 86, 238, 239; see also P. Ex. 11, at 9 (pupils reacted to light). Staff thus again failed to perform an adequate assessment.

c. The facility did not provide Resident #1 the care and services that he required when he became acutely ill on May 22-24.

Very early in the morning - 1:00 A.M. - on May 22, Resident #1 was "quite restless." P. Ex. 11, at 30; CMS Ex. 12, at 16. By 10:15 A.M. he was exhibiting tremors of the hands and legs and was "very agitated." P. Ex. 11, at 31; CMS Ex. 12, at 17. The tremors represented a significant change in status, and should immediately have been reported to the physician. See Tr. 96. Nevertheless, although staff noted that the physician "will be called," no evidence shows that the physician was called that day, nor that the physician was told about the tremors, changes in behavior, or agitation. In fact, even though these were new and alarming symptoms, staff did not even take the resident's vital signs. They just gave him Ativan. P. Ex. 11, at 31; CMS Ex. 12, at 17.

At 3:00 A.M. the morning of May 23, RN Webster described Resident #1 as "yelling and screaming," very afraid of falling, with

[b]ruising, purplish in color, noted to midforehead [and above] bridge of nose. Steristrips remain intact to midforehead above bridge of nose.

P. Ex. 11, at 31; CMS Ex. 12, at 17. She testified that the bruising did not cause her any concern because "apparently, he had a fall, and when you have a fall, you're going to have bruising." Tr. 466. She knew that Coumadin causes bleeding, but was not concerned about it. Tr. 466-467. ⁽¹⁷⁾

Later that day, at 1:47 P.M., staff paged Dr. Planas' physician assistant, but not to report the tremors, behaviors, or agitation. They only reported Resident #1's significant Potassium levels (K+ level of 2.7). Tr. 94-96. At 2:40 P.M., Dr. Montejo from Dr. Planas' office conveyed new orders, apparently not aware of the new symptoms. By 4:30 P.M., Resident #1 was again agitated, yelling and banging his cane on the wall. He complained that he had not voided since early in the morning. At 6:00 P.M. staff gave him more Ativan for agitation. They called lab values in to Dr. Ripoll, who suggested they encourage the Resident to take food and fluids. P. Ex. 11, at 31; CMS Ex. 12, at 17.

Linda Barnes saw her stepfather at about 6:30 that evening. He was lying on his bed, "out of it." His arms and legs were jerking with involuntary movements.

I was scared to death when I walked in and saw him like that. He had some white stuff in his mouth, and I thought it was like a foam or something. I went over to check, and it was actually a piece of bread that was left in his mouth, I guess, from the last time he was fed, I don't know.

Tr. 178. By 8:00 P.M. his temperature was 99.4 degrees. Staff gave him Tylenol. P. Ex. 11, at 31; CMS Ex. 12, at 17

RN Tamara Webster came on duty at 11:00 P.M. the night of May 23. She testified that, as far as she knew, Resident #1 was not sick, and nothing unusual was going on with him. Tr. 443-444, 447-448. She claims that no one mentioned that he had been having tremors. "I don't know. At that time, he wasn't having them. That had happened on a prior shift before me." Tr. 482. At about 1:30 A.M. on the morning of May 24, he had a temperature and "was really out of it and not himself." Tr. 444. Treatment notes describe him as "lethargic with eyes closed." P. Ex. 11, at 32; CMS Ex. 12, at 18. He would not open his eyes. She attempted to give him honey-thickened liquids, which he did not tolerate, but let "run out of [his] mouth." He had coarse rales and rhonchi. His temperature was 103.7 degrees, and, understandably, his skin was hot to touch. His pulse was 100; his respirations 28. He was incontinent of bladder and bowels. RN Webster conceded that his condition alarmed her. Tr. 468. "I really didn't know what was going on with him." Tr. 446. And yet, she did not call his physician. She said that "we have a little care plan that you could go by" in place of calling the physician. Tr. 478. She gave him a Tylenol suppository and a tepid sponge bath and "just monitored him." P. Ex. 11, at 32; CMS Ex. 12, at 18; Tr. 444-446, 469.

His condition remained the same at 2:15 A.M.. Staff still did not contact the physician.

At 3:15 A.M., Resident #1's temperature was still 103.5 degrees. His pulse was 104, respiration 32. Treatment notes record jerky involuntary movements of the mouth, both hands, and his right leg. His oxygen saturation level was 73%, a dangerous level showing that he was not getting enough oxygen. He was started on oxygen. Staff notified Dr. Ripoll of his decreased oxygen saturation level, his increased temperature and lethargy. Dr. Ripoll ordered that he be sent to the hospital. P. Ex. 11, at 32; CMS Ex. 12, at 18; Tr. 447. At 3:25 A.M., staff called for transport, but learned that it was not available until 6:00 A.M., so they called 911. At 3:30 A.M., the rescue squad arrived. P. Ex. 11, at 32; CMS Ex. 12, at 18. Staff told the paramedics that Resident #1 had a "significant LOC (level of consciousness) change 2-3 days ago." CMS Ex. 13, at 11, 18. He was taken to the emergency room where the ER team noted the bruising, the "altered LOC in a male who fell, who is on Coumadin," and immediately suspected a subdural hematoma. P. Ex. 13; CMS Ex. 13, at 3-5. A subsequent CT scan confirmed the suspicion. P. Ex. 14. See CMS Ex. 13, at 15. Resident #1 died on May 26. His death certificate listed the immediate cause of death as a "subdural hematoma, acute" and "fall." CMS Ex. 12, at 87.

This scenario shows numerous errors by facility staff: they failed to report his tremors to his physician; they performed inadequate assessments; and, they continued to mask his symptoms by giving him Ativan. They did not advise RN Webster of his significant symptoms when she came to work on the evenings of the 22^nd and 23^rd. Neither she nor other staff members even recognized significant symptoms of serious brain injury. Finally, staff failed to get him the immediate treatment he required when he became acutely ill.

Both Surveyor MacCallum and Dr. Ruze explained that lethargy is a very significant finding for someone with a head injury. People will usually open their eyes spontaneously, and, if not spontaneously, they will open their eyes when their name is called. Tr. 31, 32, 97-99, 241. This lethargy was combined with rales and rhonchi, extremely high temperature, fast pulse, high respirations, and incontinence. Dr. Ruze opined, "To me, reading this description, I would say call 911." Tr. 241. Dr. Planas agreed. He testified that if he were told that the patient had such an altered mental status, "we would have sent him to [the] emergency room . . . ." Tr. 335. He also agreed that incontinence of bladder and bowels after having sustained falls with head injuries, poses a "red flag" to the physician. Tr. 335.

Dr. Ruze also questioned trying to put liquid into the mouth of someone who is unresponsive, characterizing the effort as "contraindicated." Tr. 241. RN Webster offered no rational explanation for her action. Tr. 471-472.

Even QA Nurse Spruill made little effort to defend RN Webster's actions. When asked if she had any problems with RN Webster's delay in calling the physician, she did not claim that the nurse's response had been appropriate. She equivocated:

I don't know what all was going on. I wasn't there to see what was going on with the resident. I can't tell you exactly how quickly I could have called because I would have to be in with the patient, seeing what's going on.

Tr. 534, see also Tr. 502. Yet, when asked if she would call a physician if the resident's temperature was 106 degrees, she responded "absolutely." At 105 degrees, she said "I would think so." At 104 degrees, she said "probably." But at 103.7degrees - just .3 degrees lower - she again equivocated:

Again, I don't know what all is going on with the resident. I would rather, and a physician would rather, when you call them, to be able to tell them everything that you think you see is going on.

Tr. 534-535. Frankly, I was not impressed with this answer, and consider more credible the opinions of Dr. Ruze, Surveyor MacCallum, and even Dr. Planas on this issue.

QA Nurse Spruill conceded that staff should have performed routine neurological checks and that "all components" of a neurological check were not performed, although "they were doing parts of it." Tr. 548. In the presence of an obvious head injury, performing only part of a neurological assessment does not meet any standard of care that I am aware of. With regard to staff's failure to recognize a subdural hematoma, QA Nurse Spruill agreed that a change in consciousness is an indicator that something is going on neurologically. Tr. 546. She also agreed that incontinence of bladder and bowels would be significant "if it was totally new" but challenged that it was totally new in this case, a claim I have already rejected. Id.

To attain or maintain his highest practicable physical, mental, and psychosocial well-being, Resident #1 required an attentive and knowledgeable staff who recognized serious symptoms, performed comprehensive assessments, reported their findings to his physician, and sought appropriate and timely emergency care. The facility did not provide him the care and services that he needed and was therefore out of compliance with the quality of care regulation, 42 C.F.R. � 483.25.

CONCLUSION

For the reasons discussed above, I uphold CMS's determination that from July 11, 2000, through August 9, 2000, the facility was not in substantial compliance with program participation requirements for Quality of Care, specifically with respect to its treatment of Resident #1.

Carolyn Cozad Hughes
Administrative Law Judge

1. During an earlier survey (April 24-27), which is not the subject of this proceeding, state surveyors found the facility out of substantial compliance with program requirements. The July survey was both a revisit survey, to determine whether the deficiencies cited during the April survey had been corrected, and a complaint investigation, to investigate Resident #1's family's complaints about Resident #1's care. CMS Exs. 1-3; Tr. 24-25.

2. A second line of cases addressing the relative burdens of proof is of some interest here. As noted above, an earlier survey (April 24-27) found the facility out of compliance with program requirements, including 42 C.F.R. � 483.25 (quality of care). Petitioner did not contest the April survey findings, and must therefore be regarded as not in substantial compliance until it demonstrates, usually through a resurvey, that it has achieved substantial compliance. The burden would therefore be on the facility to prove, by preponderance of evidence, that it resumed complying with program requirements. CMS is not required to prove that the deficiencies continued to exist. Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002); see also Regency Gardens Nursing Center, DAB No. 1858 (2002); Barn Hill Care Center, DAB No. 1848 (2002); Lake City Extended Care Center, DAB No. 1658 (1998). To my knowledge, no one has addressed how this line of cases relates to Meadow Woods Nursing Home, et al., cited above, nor have I any reason to do so here where CMS has so clearly satisfied its evidentiary burden under any rationale.

3. Although Resident #1's medical records suggest an anticipated short-term stay at the facility, his stepdaughter testified that she thought his placement would be long-term. Tr. 189.

4. Dr. Patricia Ruze is a graduate of Yale University and has a medical degree from Dartmouth. She is currently medical director of the Northern Virginia Juvenile Detention Home and staff physician at the Flora Casey Clinic of the Alexandria Public Health Department. CMS Ex. 41. At the Casey Clinic she cares for elderly indigent patients and is experienced in working with geriatric patients in hospitals and as outpatients. Tr. 202-203, 289.

5. Notwithstanding its own risk assessment, Petitioner disingenuously suggests that, because he had multiple bruises on his hands and body at the time of his admission, Resident #1 had a history of falls. Its sole support for this assertion is LPN Shirley Blount's misunderstanding that this and "other information" meant that he had a history of falls. P. Brief at 8. LPN Blount was simply mistaken, as Petitioner well knows. Resident #1's bruises were caused by blood being drawn, by his IVs, and by his being pulled up in bed when he slipped down. Consistent with his taking Coumadin, he bruised easily. Tr. 190. I note also that if I thought LPN Blount were correct, I would have to conclude that the facility had serious deficiencies in its assessments for failing to reflect such critical information.

6. Interestingly, this note immediately precedes Resident #1's December 17 fall.

7. As discussed below, none of Petitioner's witnesses mentioned checking on the resident this frequently, claiming instead that they checked him "every two hours" or "every few hours or less."

8. Unattributed additions to incident reports and other records occur with disturbing frequency throughout the record. CMS Ex. 12, at 23, 24, 27, 30-31.

9. Nurse Spruill is a registered nurse who is pursuing a bachelor of science degree in nursing. She has a certificate in gerontology from Christopher Newport College, and has held nursing positions, including director of nursing, at long term care facilities and hospitals. P. Ex. 38.

10. Surveyor MacCallum is a medical facilities inspector with the State Agency. She has both a bachelors and a masters degree in nursing, and has worked as a nurse, hospital administrator, and nursing school instructor. She has been a nurse for over 30 years and a certified long term care surveyor since 1994. She is a member of the Institutional Review Board at the Eastern Virginia Medical School and Chairman of the Council of District Presidents of the Virginia Nurses Association. CMS Ex. 36.

11. RN Webster could not explain certain notations in her report. Someone, who was not identified, wrote in "Dr. Planas" and "faxed to office 5/10/00 1315." CMS Ex. 12, at 23; Tr. 458. She agreed it is not appropriate for someone to make such unattributed entries. Tr. 459. Similarly, on the incident report, RN Webster circled "no" to the question "Physician Notified." Someone else circled "Yes" and wrote in "Faxed 5/10/00" but did not initial or date the entry. CMS Ex. 12, at 24; Tr. 460. RN Webster did not know who had done that. At best, the facility waited three days to notify the physician, although Dr. Planas had no memory of being notified, and no orders were given. Tr. 54.

12. QA Nurse Spruill was understandably chagrined by Dr. Planas' testimony, claiming that he earlier told her that he was "very involved with the resident's care . . . knew the resident inside and out. Why he decided to change his mind when he got here, I'm not sure." Tr. 503. She then claimed that Dr. Planas' partners and nurse practitioner were at the facility, although she stated "I do not know, because I don't have the progress notes in front of me, how often someone actually saw him and wrote a note." Tr. 503-504. She agreed that if a physician or PA saw him she would expect him/her to write a note. Tr. 504. Few such notes are in this record, and the facility nurses who testified did not make a similar claim.

13. Cachexea is a profound and marked state of constitutional disorder; general ill health and malnutrition. Dorland's Illustrated Medical Dictionary, 27^th Ed. (W.B. Saunders Company 1988) .

14. Dr. Planas demonstrates a similar carelessness when, in the death summary, he describes Resident #1 as an "African American" which he was not. CMS Ex. 13, at 30.

15. Although not mentioned on the medication sheets, nurses' notes indicate he was also given Ativan for increased agitation at 7:00 P.M. on December 17, after his fall. P. Ex. 11, at 8.

16. There might be one exception to this, although the record is not clear. Petitioner claims that the MAR (Medication Administration Record) shows that Resident #1 was given a dose on March 30 at 10:30 A.M. "for anxiety." P. Brief at 12; CMS Ex. 12, at 44-45. Frankly, the document is difficult to read, was never explained, and appears internally inconsistent. Page 44 indicates the medication was given once during the month of March on March 30. The time is not easy to decipher. An entry on the following page indicates that the medication was given once in March, although the date is impossible to decipher. However, the time is quite readable as 5:30 P.M.. The reason for administering the medication is "anxiety." I find this troubling inasmuch as the nurses' notes do not reflect that he was having any problems with anxiety on March 30. P. Ex. 11, at 21.

17. Incredibly, even though she had just described his bruising, she then testified that he did not have any injuries in May. Tr. 467.