SUBJECT:

Bergen Regional Medical Center,

Petitioner,

Centers for Medicare & Medicaid Services

Docket No.C-99-581, C-00-731
Decision No. CR854

DECISION

Petitioner, Bergen Regional Medical Center (Petitioner or Facility) is a nursing facility certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare & Medicaid Services'(CMS) determinations that, from March 1 through March 18, 1999, it was not in substantial compliance with program participation requirements and that its conditions posed immediate jeopardy to resident health and safety (Docket No. C-99-581), and that on May 18, 2000, it was not in substantial compliance with participation requirements and that its deficiencies again posed immediate jeopardy to resident health and safety (Docket No. C-00-737).

BACKGROUND

Petitioner is a long-term care unit (691 beds), and is one of three divisions of a large county-owned medical center. The other two divisions, a medical-surgical service (173 beds) and a behavioral health division (321 beds), are not the subject of these actions. Petitioner's Evidentiary Submission and Hearing Brief in Docket No. C-99-581 at 1.

On February 1, 1999, Resident #1, a ventilator-dependent resident with a tracheostomy, was found unresponsive, with her removed tracheal tube on her chest. She died shortly thereafter. Petitioner's Exhibit (P. Ex.) 6 at 125.⁽²⁾ Petitioner did not investigate nor report this death. Five days later, Resident #2 was found unresponsive, with her removed tracheal tube at her side. She also died. P. Ex. 7 at 39. Responding to a complaint regarding Resident #2's death, the New Jersey Department of Health and Senior Services (State Agency) conducted a complaint investigation survey of the facility on March 1, 1999. CMS's Exhibits (CMS Ex.) 2, 11. Following the survey, the State Agency cited three areas of deficiency: Staff Treatment of Residents, 42 C.F.R. § 483.13 (Tag F225), Resident Assessment, 42 C.F.R. § 483.20 (Tag F281), and Quality of Care, 42 C.F.R. § 483.25 (Tag F328). CMS Ex. 2, P. Ex. 3.⁽³⁾

By letter dated April 1, 1999, CMS advised the facility that it was not in compliance with federal requirements for participation in the Medicare and Medicaid programs, and that its conditions constituted immediate jeopardy to resident health and safety. CMS imposed a civil money penalty (CMP) of $5,000 per day for 18 days, from March 1, 1999, through March 18, 1999 ($90,000 total CMP), and prohibited the facility from conducting its own Nurse Aide Training and Competency Evaluation program for two years.

The facility timely appealed, and the case was assigned to Administrative Law Judge Joseph K. Riotto. At Petitioner's request, and in the absence of objection, Judge Riotto stayed the matter to allow the parties to pursue settlement negotiations. Apparently, settlement efforts were protracted and eventually broke down. In Judge Riotto's absence, the case was assigned to me.

While Docket No. C-99-581 was pending, a third ventilator-dependent resident, E.M.,⁽⁴⁾ dislodged her tracheostomy apparatus, requiring transfer to the Intensive Care Unit. In response, the State Agency conducted a complaint investigation survey on May 18, 2000. The State Agency concluded that the facility was not in substantial compliance with program participation requirements, specifically Resident Assessment, 42 C.F.R. § 483.20 (Tag F281) and Quality of Care, 42 C.F.R. § 483.25 (Tags F309 and F328), and that the conditions constituted immediate jeopardy to resident health and safety, but that the situation was corrected on the day of the survey. The State Agency recommended a per instance CMP of $10,000. By letter dated June 1, 2000, CMS advised Petitioner of its agreement with those conclusions.

Petitioner timely requested hearings to challenge CMS's determinations. In the interests of administrative efficiency, I have consolidated these appeals, captioned Docket Nos. C-99-581 and C-00-737.

After fully briefing the cases, the parties agreed that these matters may be resolved on the written submissions, and Petitioner has waived its right to in-person hearings. For Docket No. C-99-581, Petitioner moves for the admission into evidence of Petitioner's Exhibits 3, 6, 7, and 16 - 25. CMS moves for admission into evidence of CMS Exhibits 1 - 11, and 12 - 14 (formerly P. Ex. 1; 5 at 1 - 3, 37 - 39, and 83 - 101; and 9 at 23 - 35.⁽⁵⁾ In the absence of objection those documents are admitted.

For Docket No. C-00-737, Petitioner moves to admit P. Ex. 1 - 10. CMS moves for admission of CMS Exhibits 1 - 16. In the absence of objection, these documents are admitted.

I note that in footnotes to its submissions, Petitioner objects, for the first time, to my April 27, 2001 order which required the parties to file simultaneous briefs. Docket No. C-99-581, P. Br. at 5, fn. 3; Docket No. C-00-737, P. Br. at 5, fn. 2. Having failed to object at the time, Petitioner has waived its right to object. 42 C.F.R. § 498.50(b)(2) ("Copies of the order are sent to all parties and the parties have 10 days to file objections to the order.")

That Petitioner did not then object is hardly surprising. In its notices and statements of deficiencies, CMS spelled out the alleged deficiencies and has not deviated from those allegations. Prior to any briefing, the parties engaged in lengthy settlement negotiations, attempted informal dispute resolution, and exchanged documents, many of which were subsequently submitted into evidence. That Petitioner well knew the factual underpinnings of CMS's case is evident from its submissions, which include a lengthy recitation of what it characterizes as "The Undisputed Facts." Although it appears that some of those facts are disputed (as evidenced by the competing affidavits), each party demonstrated in its initial brief a clear understanding of the other's position. Petitioner has simply not been obligated to offer a "shot-gun defense" without adequate notice of the case against it. Moreover, following the submission of briefs, Petitioner was offered the opportunity for an in-person hearing, and specifically declined the offer.

ISSUES

Docket No. 99-581

1. Whether, from March 1 through March 18, 1999, the facility was in substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.13 (Staff Treatment of Residents), 42 C.F.R. § 483.20 (Resident Assessment), and 42 C.F.R. § 483.25 (Quality of Care).

2. If not in substantial compliance from March 1 through March 18, 1999, did conditions in the facility pose immediate jeopardy to resident health and safety?

3. If the facility was not in substantial compliance, is the amount of the CMP imposed, $5,000 per day from March 1 through March 18, 1999 (for a total of $90,000), reasonable?⁽⁶⁾

1. Whether, on May 18, 2000, the facility was in substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.20 (Resident Assessment), and 42 C.F.R. § 483.25 (Quality of Care).

2. If not in substantial compliance on May 18, 2000, did conditions in the facility pose immediate jeopardy to resident health and safety?

3. If the facility was not in substantial compliance, is the amount of the CMP imposed, $10,000, reasonable?

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, sections 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 and safety than "the potential for causing minimal harm." 42 C.F.R. § 488.301. A facility's noncompliance constitutes immediate jeopardy if it has caused or is likely to cause "serious injury, harm, impairment, or death to a resident." Id. Immediate jeopardy can exist regardless of the scope and severity of the deficiency, so long as the deficiency involves a potential for more than minimal harm. Lake City Extended Care Center, DAB No. 1658, at 17 (1998).

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, section 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. The facility is required to make a comprehensive assessment of a resident's needs promptly (within 14 days) after a significant change in the resident's physical or mental condition. 42 C.F.R. §§ 483.20, 483.25. The regulations also specifically require that the facility ensure proper tracheostomy treatment and care. 42 C.F.R. § 483.25(k)(4).

With respect to staff treatment of residents, the facility must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property. Among other requirements, the facility must ensure that all alleged violations involving mistreatment, neglect, or abuse, including injuries of unknown source and misappropriation of resident property, are reported immediately to the administrator of the facility and to other officials in accordance with State law, through established procedures, including to the State survey and certification agency. The facility must have evidence that all alleged violations are thoroughly investigated, and must prevent further potential abuse while the investigation is in progress. The results of all investigations must be reported to the administrator or his designated representative, and to other officials in accordance with State law, including to the State survey and certification agency, within five 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).

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, section 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).

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. Penalties in the range of $3,050 to $10,000 per day are imposed for deficiencies constituting immediate jeopardy. When penalties are imposed for an instance of noncompliance, the penalties will be in the range of $1,000 to $10,000 per instance. CMS increases the per day penalty amount for any repeated deficiencies for which a lower level penalty amount was previously imposed. 42 C.F.R. § 488.438.

In setting the amount of the CMP, CMS considers: 1) the facility's history of noncompliance; 2) the facility's financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. 42 C.F.R. § 488.438(f). The section 488.404 factors include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies.

BURDEN OF PROOF

In Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999), the Board set forth in considerable detail the appropriate allocation of the burden of proof in these cases. Initially, CMS must set forth the basis for its determination with sufficient specificity for the provider to respond. The provider, in turn, must identify which of the findings material to the determination it disputes, and must also identify any additional facts that it is asserting.

At hearing, CMS has the initial burden of coming forward with sufficient evidence to establish a prima facie case that it had a legally sufficient basis for termination, and the Petitioner has the burden of coming forward with evidence sufficient to establish the elements of any affirmative arguments or defenses. Petitioner bears the ultimate burden of persuasion. To prevail, Petitioner must prove by a preponderance of the evidence on the record as a whole that it was in substantial compliance with the relevant statutory and regulatory provisions. Id. at 8.

In Cross Creek Health Care Center, DAB No. 1665 (1998), and South Valley Health Care Center, DAB No. 1691 (1999), the appellate panel confirmed that the Hillman standards apply to CMP determinations as well as to termination cases.

DISCUSSION

In reviewing CMS's determinations in both Docket Nos. C-99-581 and C-00-737, I must answer two questions:

1) Was the facility in substantial compliance with the cited regulatory provisions? CMS must present a prima facie case with evidence that, if credible and unrebutted, would constitute proof that the facility was not in substantial compliance. The facility then has the ultimate burden of showing, by a preponderance of the evidence, its substantial compliance with each cited provision. Koester Pavilion, DAB No. 1750 (2000).

2) If I conclude that the facility was not in substantial compliance, I next consider whether the level of non-compliance posed immediate jeopardy to resident health and safety. CMS's determination as to immediate jeopardy must be upheld unless clearly erroneous (42 C.F.R. § 498.60(c)(2)), and the level of noncompliance is subject to review only if a successful challenge would affect the range of the CMP amounts that CMS could impose.

FINDINGS OF FACT AND CONCLUSIONS OF LAW

I make Findings of Fact and Conclusions of Law (Findings) to support my decision in this case. I set forth each Finding below, under the docket number of each case (C-99-581 and C-00-737), in italics, sequentially for both cases, as a separately numbered heading. I explain each Finding in detail.

1. From March 1 through March 18, 1999, Petitioner was not in substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.13 (Staff Treatment of Residents), 42 C.F.R. § 48.20 (Resident Assessment), and 42 C.F.R. § 483.25 (Quality of Care), and the facility's level of noncompliance posed immediate jeopardy to resident health and safety.

Resident #1 was 75-years-old on February 1, 1999. P. Ex. 6 at 126. She had been admitted to the facility eleven years earlier, diagnosed with chronic paranoid schizophrenia. She had histories of alcohol abuse, congestive heart failure, aortic stenosis, cellulitis of the right leg, and varicosities of the left leg. Id. at 1 - 2.

On May 25, 1998, Resident #1 suffered an acute myocardial infarction. She was resuscitated, intubated, and transferred to the medical center's intensive care unit (ICU) for evaluation and treatment, which included a tracheotomy, gastrostomy tube placement, and ventilation. Id. at 24 - 25. She subsequently became dependent on the ventilator. Id.

She was readmitted to the facility from ICU on June 25, 1998. Id. at 25. Almost immediately, the facility identified serious problems maintaining her on the ventilator. Treatment notes document her repeated efforts to climb out of bed and disconnect her tracheal tube. Id. at 27. The facility initially responded by observing her closely and giving her Ativan, a minor tranquilizer prescribed for agitation. Id. at 27, 28, 31. These interventions, however, did not prevent her from disconnecting the ventilator. Id. at 31, 33, 36, 38 ("keeps disconnecting self from vent") ("ventilator disconnected" four times) ("restless, trying to pull trach tubing out") ("trach tubing disconnected [twice]") (Ativan given, but she "attempted to remove tubes and trach several times"). Informed of her behaviors, one of her physicians, Dr. Rizzo, ordered wrist restraints. Id. at 38 - 39.

Into early July, Resident #1 continued to display restless behavior, repeatedly disconnecting her ventilator. Treatment notes document daily incidents. In response, staff increased their time with her, medicated her with Ativan, and applied wrist restraints as necessary. Id. at 42, 46 - 56, 60 - 66. A July 8, 1998 RAP Assessment Summary reiterates that Resident #1 pulled at her tube, that explanations of the danger involved did not affect her behavior, and that she required physical restraints to prevent her from extubating herself. Id. at 57 - 59.

On the morning of July 13, Resident #1 went into respiratory distress and was transferred to the ICU with an acute episode of congestive heart failure. Id. at 66 - 68. She was readmitted to the facility on August 7. Her left hand was flaccid and edematous, but, using her right hand, she continued her efforts to pull out her trach tube. Id. at 68 - 71, 73, 74. Initially, staff responded with monitoring and encouragement, without success, and, on August 11, when she continued to pull at the trach, a mitten was applied to her right hand.⁽⁷⁾ Id. at 74 - 75.

Subsequent treatment notes show that Resident #1's problematic behavior continued for several days, compelling the staff to intervene, generally by applying the mitten when other strategies failed. Id. at 75 - 78. It appears that Resident #1 then began to have periods of relative tranquility. Between August 15 and August 20, the notes do not mention additional problems with her trach tube. However, at 5:00 P.M. on August 20, she is described as restless, trying to pull out her trach tube, so staff applied the hand mitten to her right hand. Id. at 79. Over the next week she is described as "confused" and "fearful," displaying more restless behavior, and attempting to dislodge the trach, with staff applying the mitten to prevent it. Id. at 80 - 83. At 3:30 in the morning on August 29, staff found the trach removed, lying on her bed. It was replaced with apparently no ill effects. Id. at 83.

There followed another, longer period of relative calm, which lasted until October 2, during which time there is no indication that Resident #1 attempted to remove the tube. Id. at 85 - 95. However, notes from that date indicate that she was restless, and staff observed her attempting to pull out the trach appliance. Staff applied the mitten to her right hand. Id. at 95.

When her interdisciplinary team met on October 9, it recognized that Resident #1 continued to disconnect herself from the ventilator and that she pulled at her G-tube. Team notes document the facility response: a mitten placed on her right hand as needed, which was removed every two hours and during care. CMS Ex. 7 at 2. According to the treatment notes, she made no more attempts to remove the tube, so on November 20, her physician discontinued the mitten order "as it has not been used lately." P. Ex. 6 at 114.⁽⁸⁾

Early in the morning on December 15, however, Resident #1 was again found with the trach cuff out. Again, the house physician was able to replace it with no reported ill effects. Id. at 117. There followed a two-week period with no reported incidents, but, on December 30, staff again found Resident #1's trach apparatus out, and assumed that she had pulled it out again. This time it was reinserted with some difficulty. Facility staff then responded by observing Resident #1 and telling her not to remove the trach. Id. at 121. However, the facility attempted no other interventions to prevent the behavior.

When the Interdisciplinary Team met on January 15, 1999, it noted that the mitten order had been discontinued "as she no longer disconnects herself from the ventilator," without mentioning the two December instances of staff finding her disconnected from the ventilator. CMS Ex. 7 at 4. The Team concluded that "goal has been met - no longer uses mittens." P. Ex. 6 at 129.

On February 1, 1999, at 4:30 P.M., Resident #1 was found "pale" and "unresponsive," with the trach out. The respiratory therapist and house physician attempted to resuscitate her, but she did not respond and was pronounced dead at 4:40 P.M. Id. at 125.

The facility did not investigate Resident #1's death, and did not report the death to the State Agency. CMS Ex. 4 at 3. The State Agency learned of it when it went to the facility to investigate a subsequent death.

Resident #2 was admitted to the facility on February 2, 1999. She was an 87-year-old Spanish-speaking woman, suffering from respiratory distress, coronary artery disease, dysphagia, with a history of hyperthyroidism with a large goiter, myocardial infarction, and Parkinson's disease. She was admitted for subacute tracheostomy care pending thyroid surgery. Notwithstanding her impairments, her physician considered her a good candidate to achieve her prior functioning levels. P. Ex. 7 at 27 - 28, 66.

She was admitted wearing bilateral wrist restraints to prevent her from removing her trach collar ("she continually tries to pull out trach"). Id. at 29. At the time of her admission, facility staff removed the restraints and "communicated to resident [the] importance of leaving trach in place." Id. Nursing notes reflect that she nevertheless "continues to pull O2 from trach collar apart." Id. at 30.

An LPN advised Resident #2's physician that "use of restraints [is] illegal," and received a telephone order discontinuing wrist and chest restraints. Id. The record contains a written order, dated February 3, for mitts to be worn as needed on both hands to prevent pulling the trach. Id. at 10. At 9:00 P.M. on February 3, a nurse reported that "resident has not had any restraints on since admission." Id. at 30. Resident #2 is later described as "constantly pulling at trach collar." Id. at 31. At 2:30 A.M. the following morning, the tube was found on the floor. Staff responded by encouraging Resident #2 to keep it on. Id. At 9:00 A.M. she is described as "constantly pulling at trach collar," is instructed to leave it alone, but is "noncompliant." Id. Staff then called the physician who ordered a psychiatric consultation. Id. at 31 - 32. The psychiatric consult described Resident #2 as "confused," particularly at night, "moderately demented" and noted that she "does not remember to keep the trach collar." Id. at 11.⁽⁹⁾

In a subsequent clarification, the psychiatrist explained that, in addition to interviewing Resident #2, he spoke to the nurse on duty who told him that Resident #2 removed her trach collar at night, and that nursing staff would find the collar on the floor, and would note the resident to be blue. CMS Ex. 6 at 2. Upon learning the results of the psychiatric consultation, the Assistant Director of Nursing suggested that mittens be applied if Resident #2's physician would order them. P. Ex. 7 at 32. However, the record does not establish that staff actually obtained or used the ordered mittens.

Resident #2's efforts to disconnect her oxygen tubing continued. Id. at 33. On February 4, she is described as constantly touching the tracheal tube and collar, and staff found the tracheal collar off. Id. at 35. Staff instructed her not to do it, but the behavior continued. Id. at 36, 37.

At 3:15 A.M. on February 6, 1999, Resident #2 was found unresponsive, without pulse or blood pressure. Her trach tube was out, found lying at her side. Efforts to re-intubate were unsuccessful, and she was pronounced dead. Id. at 39, 48.

A discharge summary apparently written by her physician is not wholly consistent with the treatment notes. According to her discharge summary, orders were written for soft wrist restraints and vest restraint to be renewed every 24 hours and reassessed. Id. at 66. It does not mention the February 2 nursing note indicating a telephone order discontinued those restraint orders, and does not mention the order for mitts. Id. at 30. The summary confirms that Resident #2's tracheostomy tube was found on her left side, and opines that the cause of death was most probably airway obstruction. Id. at 66.

On February 8, 1999, the facility reported Resident #2's death to the State Agency, triggering the complaint survey. CMS Ex. 8 at 6. While investigating, the surveyors also learned of Resident #1's death. See CMS Ex. 11 at 5; CMS Ex. 8 at 4.

CONCLUSION

For all of the reasons discussed above, I uphold CMS's determinations that from March 1 through March 18, 1999, the facility was out of compliance with the program participation requirements for Staff Treatment of Residents (42 C.F.R. § 483.13); Resident Assessment (42 C.F.R. § 483.20); and Quality of Care (42 C.F.R. § 483.25); and, on May 18, 2000, the facility was out of compliance with the program participation requirements for Resident Assessment (42 C.F.R. § 483.20) and Quality of Care (42 C.F.R. § 483.25). The facility's deficiencies posed immediate jeopardy to resident health and safety, and the amounts of the CMPs imposed - $5,000 per day from March 1 through 18, 1999 (C-99-581), and $10,000 per instance for May 18, 2000 (C-00-737) - are reasonable.

I find the case of Resident #1 overwhelmingly sad. In fact, the record shows that for months following her initial intubation in May 1998, staff were attentive, sensitive, and appropriate. They kept her safe and alive while protecting her right to be free from unnecessary restraint, obviously a delicate balance, but one they negotiated skillfully from June through mid-November. Then, for some reason, they let down their guard. The regulations do not allow facilities to let down their guard, and for good reason, particularly when caring for a frail, elderly resident whose condition is so compromised. See Emerald Oaks, DAB No. 1800, at 21 (2001) ("An instance of exemplary treatment would not cancel out or make insignificant an instance of gross neglect").

The facility made several fatal errors with respect to Resident #1 that compromised the quality of care it provided, and that jeopardized her health and safety. The regulations require a change in a resident's care plan to address any significant change in behavior. 42 C.F.R. § 483.20(b)(2); 483.20(k) . The facility should have reassessed Resident #1 immediately when, following a period of relative tranquility, she dislodged the tracheostomy apparatus. But, by December 1998, staff no longer made serious efforts to prevent Resident #1 from disconnecting her breathing apparatus. That, over time, Resident #1 became less persistent (and more ill) did not excuse the facility from continuing its effort to prevent her from dislodging this vital equipment. Yet, the record shows that by December 1998, staff interventions were essentially limited to telling her not to remove the tube. But, instructing Resident #1 not to disconnect the ventilator had never worked, and by December and January, she was barely even verbal, so the odds of that strategy succeeding were even more remote.

Having failed to address the problem immediately when the dislodgment incidents occurred, the facility still had a second opportunity to correct that lapse and establish an effective intervention when the interdisciplinary team met in January 1999. But the team did not even consider the two December incidents of Resident #1 disconnecting her ventilator. When the team met, it concluded that the "goal has been met - no longer uses mittens." The team's report does not mention its other goal, that Resident #1 be kept safe. P. Ex. 6 at 129. An assessment that did not take into account recent and repeated potentially life-threatening behavior cannot be considered "comprehensive and accurate."⁽¹⁰⁾

Finally, even if I were convinced that Resident #1's actions were unforeseeable and unavoidable (which I am not), the facility violated regulations when it failed to investigate her death. The record does not establish that the events surrounding Resident #1's death were even reported to the facility administrator, much less reported to the State Agency.

Petitioner justifies its repeated failures to act by claiming that, after November 20, 1998, nothing untoward occurred to justify taking action to protect Resident #1, nor conducting an investigation following Resident #1's death. It denies that after November 20, 1998, Resident #1 even attempted, much less succeeded, in disconnecting her tracheostomy apparatus, and denies that the apparatus was disconnected at the time of Resident #1's death. I reject Petitioner's contentions for two reasons: 1) factually, Petitioner's scenario is not consistent with the contemporaneous medical record, which I find more credible than documents generated years after the event; and 2) even accepting Petitioner's assertion that Resident #1 did not act deliberately in causing the dislodgements, on three occasions between December 15, 1998 and February 1, 1999, her tracheostomy tube apparatus became sufficiently dislodged to affect her ability to breathe - a potentially life-threatening event to an individual who is ventilator-dependent - yet the facility took no action to identify an alternative cause and took no steps to prevent its reoccurrence.

a. Petitioner's factual claims regarding Resident #1 are not consistent with the contemporaneous medical record.

Petitioner suggests that the two December dislodgments were not caused by Resident #1's deliberate acts, and that Resident #1's tracheostomy apparatus was not really dislodged on February 1. In making these claims, Petitioner presents what would be a credible alternative explanation of the events of December 1998 through February 1999, except that Petitioner's explanation is not supported by the medical record. To prevail on its theory, Petitioner must impeach its own treatment records, showing that the contemporaneous information is inaccurate, and that later explanations -- produced for the first time years after the events - are more accurate.⁽¹¹⁾

The contemporaneous documentation as to the events of December 15 and December 31 is admittedly scanty. A treatment note dated December 15, 1998, states simply "found trach cuff out." P. Ex. 6 at 117. A treatment note dated December 30, 1998, states:

Resident pulled out trach. Resp. therapist attended. Dr. Saddie, House Physician, called. Trach reinserted [with] some difficulty. No distress noted. Remained awake and responsive. Observed [and] spoken to not to remove trach.

Id. at 121.

In a statement dated March 15, 1999, already some months after the fact, CNA Lopez indicates that, on or about December 31, 1998,⁽¹²⁾ while caring for another resident, she responded to a beeping machine, found Resident #1 "gasping," and "found something wrong in her neck." She does not explain what was wrong, but denies seeing Resident #1 touch her neck or remove or pull anything. P. Ex. 25; see also P. Ex. 18 at 2, para 5.

Neither the Lopez statement nor any other evidence is inconsistent with the inference that Resident #1 deliberately removed the tube herself on both occasions. In his affidavit, Dr. Feinsod suggests that dislodgment or partial dislodgment of a tracheal cuff could be caused "unintentionally by any number of events, including coughing, chest physical therapy, suctioning, changing tracheostomy tapes, or vigorous movement." P. Ex. 17 at 6, para 19. But, nothing in Resident #1's medical record suggests that, in the entire time she was attached to the ventilator, her tracheal apparatus ever became dislodged by one of these other means. Every single time the cuff became dislodged, staff reasonably attributed it to Resident #1's deliberate act, either because they witnessed it or because it was the most reasonable explanation.

Review of the treatment notes suggest that, by December, staff were not observing Resident #1 as carefully as they had been, and it may well be that no staff member actually observed the dislodgment. However, on both occasions, the staff reasonably inferred that she dislodged the tracheal apparatus herself, and nothing in the medical record suggests a more likely explanation. Most important, no one acted as though there were any other explanation. See P. Ex. 6 at 121 ("spoken to not to remove trach.")

I note that Charge Nurse Florence Jennings' affidavit is not inconsistent with this reading of the records. In her affidavit, dated June 26, 2001, she asserts that prior to the December 15 and December 30 incidents, "there was no documentation in her medical record of acute restlessness or attempts . . . to remove her tracheal apparatus." P. Ex. 16 at 2, para 11.⁽¹³⁾ Neither Nurse Jennings nor any of Petitioner's other witnesses claim that the December dislodgments were brought about by anything other than Resident #1's deliberate acts. In the absence of any other explanation, I find it far more likely that Resident #1 deliberately dislodged her tracheal apparatus on these two occasions.

Contemporaneous documentation of Resident #1's death on February 1 is also sparse, consisting of a short note in the treatment record:

[Resident #1] was found [with] trach out. Found pale, unresponsive. Pulse was present [and] BP 146/78. Resp Therapist attended to [and] tried to intubate resident. Dr. Juco, House physician, attended [and] replaced trach, resident was bagged. O2 sat dropped. For 10 min. bagging continued. B/P [and] pulse dropped. Resident continued to be unresponsive. Subcutaneous emphysema presents to face [and] neck. No pulse and no B/P present. Resident pronounced dead by Dr. Juco. Dr. Sallizone notified.

P. Ex. 6 at 125. I note that the record before me contains no discharge summary.

According to CMS Surveyor Ellen Bennet, on March 1, 1999, CNA Lopez told her that she saw Resident #1 in her room at about 2:30 P.M. the afternoon of February 1, and that Resident #1 held her hand over her neck and tracheal tube and said "tight." CNA Lopez put Resident #1's hand on a pillow on her thigh, covered it with a sheet, and told her "don't touch or you'll die." According to Surveyor Bennett, CNA Lopez admitted that she had not reported the incident to the nurse. CMS Ex. 11 at 4, para 11.

In her March 15, 1999 statement (P. Ex. 25), CNA Lopez is curiously silent about the events of February 1 but, in her June 2001 affidavit, she says that she visited Resident #1 at around 2:30 P.M. on the afternoon of February 1.

When I went to her room, I saw her on the chair. [Resident #1] stated to me "tight" and "digna." I told her not to touch anything. I put her hand on her lap and fixed her cover. She was fine and so calm, I did not see her touching her neck or tracheostomy tube. When I went back to her after approximately 20 to 30 minutes before I went to [Unit] 6-2, she was fine and calm. I did not see her pull on her tracheostomy tube on February 1, 1999.

P. Ex. 18 at 2, para 6. Elsewhere CNA Lopez indicates that Resident #1 "always told me 'tight neck and Digna,'" so "the first time and many times" she reported that to the nurse, but, whenever the nurse checked, the tracheostomy was not too tight.

Each time Resident [#1] told me those words, I comforted her, talked to her and explained not to touch anything. After I spoke with Resident [#1] she would become calm and not pull on her trach.

Id. at 1, para 4.

I do not see any serious inconsistency between Surveyor Bennet's representation of CNA Lopez's March 1 remarks to her and CNA Lopez's subsequent written statement. From them, I conclude that Resident #1 so often complained about the tracheostomy apparatus that, by February 1, CNA Lopez had stopped reporting her complaints to a nurse. The accounts differ somewhat on the question of whether CNA Lopez actually observed Resident #1 touching the apparatus, but CNA Lopez's actions in moving the resident's hand and telling her not to touch show that she had reason to fear that Resident #1 would touch and pull on her trach tube.

I am troubled that the record contains nothing generated closely after Resident #1's death from the person who purportedly found her and began treatment. Instead, Petitioner provides an affidavit from Respiratory Therapist MaryKulty Njonginiyil, prepared years after the event, which is arguably not wholly consistent with the treatment notes. According to Therapist Njonginiyil,

I left the resident's room to attend to other residents. I came back into the room at 1630 hours to give respiratory treatment to Resident [#1]'s roommate. While treating the roommate, I observed Resident [#1] in her chair and she appeared blue. I assessed that she was conscious by asking her if she was alright. I observed that her tracheostomy tube was partially out and attempted unsuccessfully to reinsert it.

P. Ex. 19 at 2, para 6.

The parties make much of Therapist Njonginiyil's assertion that the tube was "partially out," as opposed to completely dislodged. I do not see that dispute as critical. Accepting the affidavit, the tube was sufficiently dislodged that the resident was turning blue, and that it required reinsertion, which the therapist was not able to accomplish. I note that Therapist Njonginiyil does not say that she removed the tube, but that she initially attempted to reinsert it, without success. Although Petitioner argues that Therapist Njonginiyil removed the tube in order to begin resuscitation efforts (P. Reply Br. at 6), the affidavit does not say that. According to the affidavit, the therapist's first response was an attempt to reinsert the tube. When she was not able to do that, she started to ventilate with an Ambubag and facial mask. P. Ex. 19 at 2 - 3, para 8. CMS legitimately points out that, unless the tube was out, there would have been no need to reinsert it. CMS Br. at 39.⁽¹⁴⁾

Petitioner also argues that no one can know the cause of Resident #1's death, and disputes that it was related to the removal of her trach tube, suggesting instead that she had a heart attack. Certainly, Resident #1's medical condition was fragile, and I agree that the immediate cause of her death is a question that is not answered in the record before me. However, as I discuss below, whether it immediately caused her death, or even contributed to it, dislodgment of her tracheostomy tube apparatus, by itself, put her in jeopardy.

b. On three occasions between December 15, 1998 and February 1, 1999, Resident #1's tracheostomy tube apparatus became dislodged, a potentially life-threatening event to an individual who is ventilator-dependent, yet the facility took no action to identify an alternative cause for the dislodgment and took no steps to prevent its recurrence.

Even if I accepted Petitioner's version of the facts relating to Resident #1, I would still have to find that an immediate jeopardy situation existed at the facility. A finding of immediate jeopardy is not contingent on a finding of actual harm. Immediate jeopardy encompasses situations where there is a likelihood of serious harm. Fairfax Nursing Home, Inc., DAB No. 1794, at 14 (2001). On three occasions - December 15, December 30, and February 1 - something unquestionably went awry with Resident #1's attachment to her ventilator. If the ventilator, upon which she was dependent, were becoming disconnected by some means other than Resident #1's intentional action, the facility was no less obligated to investigate and intervene. For someone who is ventilator-dependent, to be disconnected from the ventilator creates a likelihood of serious harm. Here, the facility's failure to act in preventing the recurrent disconnection of this ventilator-dependent patient from her ventilator in itself created an immediate jeopardy situation.

Similarly, whether, on February 1, the ventilator tube became fully or partially dislodged, the dislodgement was sufficient to impair Resident #1's supply of oxygen, causing her to turn blue. Whether that immediately caused her death, or even contributed to it, does not change the fact that even a partial dislodgment presented a dangerous situation for her. That situation was reasonably foreseeable, particularly after the December incidents. Yet, the facility did not do everything in its power to prevent it. Moreover, after the fact, the incident certainly merited investigation and facility efforts to prevent similar incidents.

c. Notwithstanding Resident #2's repeatedly removing her tracheostomy tube apparatus, a potentially life-threatening event to an individual who is ventilator-dependent, the facility failed to implement an effective strategy to protect her.

Whether Resident #2 might have benefitted from an investigation of the circumstances surrounding Resident #1's death is a question that will not be resolved in this forum. However, the facility's failure to do everything in its power to protect its ventilator-dependent residents from dislodgement of their breathing apparatus is even more pronounced with respect to Resident #2, whose short stay at the facility was characterized by her own aggressive efforts to dislodge her breathing apparatus, and the facility's inadequate efforts to protect her.

Petitioner apparently concedes that facility staff did not communicate appropriate information to Resident #2's attending physician, and that nursing staff did not implement a February 3 order for mitten restraints. Dr. Nevins offers no defense of the facility's actions with respect to Resident #2; he admits that her death "may . . . have been caused by decannulation of the tracheal tube," and notes her previous attempts to remove the tube. P. Ex. 20 at 6, para 21.

Petitioner also agrees that mitten restraints could not be located on February 3, 1999 (P. Ex. 7 at 33), but minimizes the significance of that fact by suggesting that staff had nevertheless deliberately declined to implement the restraint order. ("[T]here is no credible evidence that the inability to locate mitten restraints on February 3 caused Bergen's nursing staff to forego use of restraints on February 4, 5, or 6, 1999.") P. Reply Br. at 10. Citing Dr. Feinsod's affidavit, Petitioner characterizes as a "bona fide nursing judgment" the facility's failure to apply mitten restraints, and argues that restraints "would likely have caused increased (sic) Resident 2's agitation level, a possible negative outcome considering Resident 2's recent myocardial infarction," and that the nurses were closely monitoring Resident 2's behavior, employing non-restraint techniques (frequent observation, working closely with Resident #2's daughter as interpreter to educate Resident #2, speech therapy, "utilization of the passe muir value to enhance communication," redirection and verbal cuing). P. Br. at 22; P. Reply Br. at 10.

Nothing in the record suggests that the nursing staff considered and rejected using the mittens in this way. To the contrary, the record shows that nursing staff requested the mittens because none of the alternative interventions were effective, and, based on the psychiatric assessment, staff understood that the less restrictive approaches were not likely to prove effective. See P. Ex. 7 at 32. Resident #2 had bilateral restraints upon admission because of her persistent attempts to remove the tracheostomy tube. Staff regularly found the tube disconnected and the resident turning blue. Resident #2 spoke only Spanish. She was moderately demented, confused, and could not remember that she needed to keep the tube in place. The record suggests that staff came to understand these realities.

Moreover, in light of the obvious and immediate danger that Resident #2 would dislodge her breathing apparatus, the demonstrated ineffectiveness of other interventions, and in the absence of any other effective intervention, I do not consider the staff's motivation for not implementing the physician's order for mitten restraints a dispositive factor, although I suspect that their inability to locate the mitten restraints contributed in a significant way to their failure to use them.

Thus, with respect to Resident #2, the facility again failed to intervene in any credible way in a situation in which the resident attempted, repeatedly and successfully, to disconnect herself from life-sustaining equipment, creating an immediate jeopardy situation.

Based on this, I conclude that from March 1 through 18, 1999, the facility was not in substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.13 (staff treatment of residents), 483.20 (resident assessment) and 483.25 (quality of care) and its deficiencies posed immediate jeopardy to resident health and safety. I next consider whether the amount of the CMP, $5,000 per day, is reasonable.

2. The amount of the CMP imposed against Petitioner in Docket No. C-99-581, $5,000 per day from March 1 through March 18, 1999, is reasonable.

Having found a basis for imposing CMPs, I now consider whether the amounts imposed are reasonable, applying the four factors listed in 42 C.F.R. § 488.438(f). My "inquiry should be whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved." CarePlex of Silver Spring, DAB No. 1683, at 8 (1999).

CMS has imposed a penalty of $5,000, which is at the lower end of the mandatory range ($3,050 to $10,000) for immediate jeopardy situations. With respect to the section 488.438(f) factors, the record suggests that the facility had a fairly good compliance history, but is silent as to its financial condition. However, the deficiencies were serious and the facility culpable. I am, therefore, not able to find CMS's determination unreasonable, particularly in light of the facility's dereliction of its responsibility to investigate the circumstances surrounding Resident #1's death, and its almost inexplicable failure to protect adequately Resident #2.

Docket No. C-00-737

3. On May 18, 2000, Petitioner was not in substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.20 (Resident Assessment), and 42 C.F.R. § 483.25 (Quality of Care), and the facility's level of noncompliance posed immediate jeopardy to resident health and safety.

Following the March 1999 survey, Petitioner submitted to CMS an acceptable plan of correction, which included the provision that

All tracheostomy residents will have a comprehensive assessment and review of their IDCP [Interdisciplinary Care Plan] to ensure that all care needs are being addressed. Residents with a history or potential for removing or touching their respiratory equipment will have their specific behavior addressed on their IDCP and identified on the interdisciplinary kardex. The plan of care and resident outcomes will be reviewed on a weekly basis by the Interdisciplinary team and a report submitted to the Director of Nursing by the Nurse Manager.

(Emphasis added) P. Ex. 3 at 8.

Resident E.M. was 66-years-old and living in a nursing home in March 2000, when she developed breathing problems and was taken to the Monmouth Medical Center (Monmouth). She presented to the emergency room at Monmouth on March 13, 2000, with edema, shortness of breath, and low oxygen level. She had a history of mental retardation and a superior medistinal mass, subsequently identified as a possible substernal goiter. P. Ex. 1 at 101.⁽¹⁵⁾ She was admitted to the Intensive Care Unit, and, while there, her respiratory condition deteriorated, until she required a tracheostomy and was attached to a ventilator. Monmouth treatment records identify repeated problems with E.M. pulling out her trach tube.

Apparently, in April, Monmouth approached Petitioner about an appropriate post-hospitalization placement for E.M., and, on April 27, 2000, faxed the facility a request for placement there. Among other significant matters, Monmouth advised the facility that E.M. was dependent on a ventilator and trach ("attempts [at] weaning unsuccessful") but that to prevent her from pulling out the trach or her PEG (percutaneous endoscopic gastrostomy) tube, she "must be restrained and sedated [with] Versed." Id. at 8.

The facility agreed to accept E.M., and she was admitted on May 9, 2000. Id. at 3. Treatment notes from the day of her admission indicate that she was on a ventilator, and had a G-tube and a Foley catheter. Her verbalization skills were described as "minimal." She was obese and non-ambulatory, expressing mild anxiety. Id. at 27.

Treatment records show that an interdisciplinary team met on the day of E.M.'s admission, but considered only the problem of pressure ulcers on her coccyx. E.M.'s Care Plan does not mention her tracheostomy nor her history of pulling out the trach tube. CMS Ex. 16 at 1.

The respiratory therapist reports that at 1:55 A.M. on the morning of May 12, 2000, he heard E.M's ventilator alarm going off, and found E.M.'s trach tube out. E.M. was in respiratory distress. P. Ex. 1 at 22, 54 - 55. She was cyanotic and bleeding at the back of the trach site. The emergency room doctor was called, and E.M.'s condition improved after she was re-intubated. Her own physician was called, who, among other orders, ordered mitten restraints. E.M. was transferred to the Intensive Care Unit (ICU) in bilateral mitten restraints. Id. at 14, 32 - 33.

Staff subsequently asked her if she had tried to pull out the tube, and she indicated yes. When asked if it had been an accident, she indicated no. Asked if she intentionally tried to remove it, she indicated yes. Id. at 38.

On May 13, 2000, E.M. was readmitted to the facility from the ICU, accompanied by the hospital transporter, respiratory therapist, and ICU RN. Upon arrival, she wore bilateral hand mittens for safety. Id. at 16, 34. Per physician order, "trach ties not to be released until 5/17/00," and she was put on one-to-one supervision. Id. at 16, 36. The restraint order remained in place until May 17, and thereafter she continued on one-to-one supervision. Id. at 18, 37 - 38, 40, 43, 46, 47, 48, 49, 50, 52.

Monmouth unambiguously conveyed the message that E.M. had extraordinary needs. Receipt of this information should have set off red flags, causing the facility to consider very carefully, before accepting her, its capacity to provide her with adequate care, and, having decided to accept her, the means by which it would address, in the interdisciplinary care plan, her troubling behavior. Yet, the interdisciplinary care team did not consider this behavior, and the plan did not address her arguably most significant and immediate problems -- keeping her ventilator and feeding tubes attached. After a few days in the facility, E.M. pulled out her trach tube, and her condition immediately became seriously compromised, requiring transfer to ICU. I do not consider her action "suddenly and without warning," as Petitioner suggests. P. Br. at 13. In fact, the facility was alerted, well in advance of her admission, that E.M. would likely pull out her trach or PEG tube, affording it the opportunity to consider how they could address that potentially life-threatening behavior. Moreover, even after the incident of May 12, the interdisciplinary care team did not immediately address E.M.'s behaviors in her care plan.

Petitioner defends its disregard of the "brief note" describing E.M.'s self-extubating behavior by characterizing the message as "a hearsay summary of a portion of [E.M's] chart." P. Br. at 17. I do not see how this helps Petitioner's case. That the note - which described dangerous behavior and the hospital's extreme responsive measures - was brief, and was not buried in a long medical record, makes the facility's failure to take notice of it all the more insupportable. If the facility had doubts about the reliability of the information conveyed, it was incumbent upon the facility to inquire further, not to disregard the information conveyed.⁽¹⁷⁾

Besides its claim that it could not have foreseen E.M.'s actions, Petitioner also argues: 1) that application of restraints was not appropriate; 2) that, in fact, its staff conducted multiple assessments; and 3) that, in any event, it was not required to assess the new resident until 7 days after admission, and not required to develop a care plan until 14 days after the assessment.⁽¹⁸⁾

With respect to the appropriateness of restraints, Petitioner points out, accurately, that "the goal of minimizing or eliminating restraint use has become central to both clinical practice and federal law." Facilities must be able to show that restraints are not imposed for discipline or convenience, and are necessary to treat a medical symptom. P. Br. at 14, citing CMS's State Operations Manual (SOM), Ch. 10, App. R; Cross Creek Health Care Center, DAB No. 1665 (1998). But this argument erroneously assumes that the facility's only options were to restrain E.M., which the Feinsod affidavit suggests may have been cruel,⁽¹⁹⁾ or to take no preventive steps at all. Minimally, the facility needed to figure out whether it was able to meet E.M.'s needs, and to consider how it could address her potentially life-threatening behavior. Her interdisciplinary care team was required to consider the matter, and come up with a plan. Certainly, the facility should have advised all staff of the risks posed by her past behavior. That the facility accepted E.M. without addressing the critical problem of potential self-extubation is the deficiency - not the facility's understandable reluctance to employ restraints.

Next, Petitioner argues that E.M. was assessed 37 separate times, counting as an assessment virtually every nursing note and recorded interaction between E.M. and facility staff. But, in none of these interactions, did staff consider E.M.'s history of self-extubation or propose a plan to address that significant problem. The facility cannot be considered to have been providing E.M. with the necessary care and services to allow her to maintain her highest practicable physical well-being if she is in danger of harming herself and Petitioner takes no action to prevent that harm.

Finally, Petitioner argues that its duty to develop a comprehensive care plan had not been triggered because, under the regulations, it had 14 days from the time of E.M.'s admission in which to complete an assessment and then an additional seven days in which to develop a care plan. I note, first, that the surveyors specifically cited 42 C.F.R. § 483.20(d)(3)(i) (which is now section 483.20(k)(3)(i)), and 42 C.F.R. § 482.25(k). Section 483.20(k)(3)(i) requires the facility to provide, pursuant to a comprehensive care plan, services that meet professional standards of quality. Section 483.25(k) requires that each resident receive the proper treatment and care to allow that resident to maintain the highest practicable physical well-being, specifically here with regard to tracheostomy care. Under ordinary circumstances a facility has these time frames in which to assess a new resident and develop a care plan. But, standards of care do not allow a facility three weeks to develop a care plan when faced with a resident whose behavior threatens her life. That the facility addressed, immediately upon admission, her needs with respect to the problem of pressure ulcers on her coccyx, suggests that it well understood that some problems simply cannot be put off for up to three weeks, but require immediate attention. For some reason, the facility failed to include what was arguably her most immediate problem in its consideration. The facility's failure even to consider the behavior falls short of doing "everything in its power" to prevent this type of incident. See Koester Pavilion, DAB No. 1750, at 14 (2001).

4. The amount of the CMP imposed against Petitioner in Docket No. C-00-737, $10,000, is reasonable.

Having found a basis for imposing CMPs, I now consider whether the amount imposed is reasonable, again applying the four factors listed in 42 C.F.R. § 488.438(f). The CMP imposed against Petitioner, $10,000, is the maximum CMP for an instance of noncompliance.⁽²⁰⁾ I consider the primary justifications here for imposing the maximum CMP to be the facility's history of noncompliance, particularly with respect to these specific deficiencies, and the very serious consequences which could have ensued to E.M. One year earlier, the facility had been cited for the same kind of problem and a CMP at the lower end was imposed. Indeed, like E.M., Resident #2 also self-extubated within days of her admission. The facility had promised to remedy the situation through imposition of its plan of correction, which included addressing the problem behavior for all residents with a history or potential for removing their respiratory equipment. But, that lower amount did not produce long-term corrective action. The facility again failed to assess and address the problem in a resident who presented an identified risk of behavior that could have had fatal results.

Whether I would have imposed the maximum CMP in this case is irrelevant. In light of the facility's history and the seriousness of the deficiency, I am not able to find unreasonable a $10,000 per instance CMP.

5. CMS is not bound in this case by the recommendation of a State informal dispute resolution proceeding.

In a letter dated September 20, 2000, the State Agency indicated that, as a result of an informal dispute resolution meeting, it would recommend to CMS reducing the CMP from $10,000 to $1,000. P. Ex. 7. CMS apparently rejected that recommendation. Petitioner argues, based on the language of 42 C.F.R. § 488.431, that CMS is bound to accept the State recommendation. That regulation provides, in relevant part:

If a provider is subsequently successful, during the informal dispute resolution process, at demonstrating that deficiencies should not have been cited, the deficiencies are removed from the statement of deficiencies and any enforcement actions imposed solely as a result of those cited deficiencies are rescinded.

But Petitioner does not claim that the State Agency removed any of the cited deficiencies from the statement of deficiencies. In fact, based on the State Agency's recommending a revised CMP that is still within the range for findings of immediate jeopardy for per instance CMPs, I can reasonably infer that the State Agency affirmed the deficiency findings at the immediate jeopardy level. Nothing in the regulations, or in the State Agency's letter, suggests that CMS must accept the recommendation.⁽²¹⁾

Carolyn Cozad Hughes

Administrative Law Judge

1. When these cases were initially docketed, CMS was referred to as the Health Care Financing Administration or HCFA. HCFA has since been renamed the Centers for Medicare & Medicaid Services or CMS. When I refer to anything in the record previously submitted as the Health Care Financing Administration or HCFA, I refer to it as the Centers for Medicare & Medicaid Services or CMS.

2. I discuss the admission of the parties' exhibits infra.

3. In some instances, the Statements of Deficiencies cite the regulations former, rather than current, designation. However, the parties agree that the citations identified in their briefs are accurate for the regulations relevant to Docket No. C-99-581 (CMS Memorandum of Law in Docket No. C-99-581 (CMS Br.) at 2, fn.2; Petitioner's Hearing Brief in Docket No. C-99-581 (P. Br.) at 2, fn.1), and that the citations identified in their briefs are accurate for the regulations relevant to Docket No. C-00-737 (CMS Memorandum of Law in Docket No. C-00-737 (CMS Br.) at 2, fn. 2; Petitioner's Hearing Brief in Docket No. C-00-737 (P. Br.) at 1 - 2). I note that Petitioner submitted response briefs in both cases (P. Reply Br.) and CMS submitted a response brief in Docket No. C-00-737 (CMS Reply Br.). As I discuss each case separately below, the designations CMS Br., P. Br., CMS Reply Br., and P. Reply Br. are not specifically noted by case.

4. Although referred to in the survey documents as Resident #1, to avoid confusion with Resident #1 from the 1999 survey, I refer to this resident by her initials.

5. Although part of an exhibit exchange earlier in this proceeding, Petitioner declined to move into evidence documents it had marked as P. Ex. 1, 2, 4, 5, and 8 - 15 for identification. These documents are only part of this record to the extent that parts of P. Ex. 1, 5, and 9 were offered for admission by CMS.

6. The bar on Nurse Aide Training and Competency Evaluation is not reviewable here, although the regulation was subsequently amended to allow such review. 42 C.F.R. § 498.3.

7. A mitten restraint is a soft cloth cover for the hand that prevents the coordinated use of a resident's fingers. It is considered "the least restrictive restraint." P. Ex. 16 at para. 10 (Jennings Affidavit).

8. In her affidavit, Nurse Jennings incorrectly states that nursing staff did not apply the mitten restraint from approximately October 21, 1998 through November 20, 1998. P. Ex. 16 at 2, para. 10. In fact, the mitten was applied on November 4 to prevent Resident #1 from rubbing and injuring her eye, not because she was attempting to disconnect the ventilator. P. Ex. 6 at 112. Further, review of the Daily Patient Care & Accountability Charts suggests that the mitten restraint might have been applied during the 7 to 3 shift as late as mid-November. If a check indicates mitten use, and a slash indicates no use, the November 1998 chart seems to show that the mitten restraint was applied on November 2, daily from the 5^th through the 10^th, and on November 16 and 17. Id. at 18. (Use of side rails appears to have a different designation, "SR X2." See Id. at 23). However, the parties offered no testimony explaining the significance of these documents. Some explanation might have been useful.

Curiously, the Daily Patient Care & Accountability Chart dated December 1998, continues to list the mitten restraint among the orders. Id. at 23. Elsewhere, however, the record indicates that the order was discontinued on November 20, and there appears to be no dispute between the parties that the order was discontinued as of that date.

9. The psychiatrist's finding of "moderately demented" is incorrectly recorded in the nursing notes as "mildly demented." P. Ex. 7 at 32.

10. I recognize Petitioner's assertion that Resident #1 did not deliberately dislodge her breathing apparatus, and discuss below why I reject the contention, and why, even if true, that fact does not relieve Petitioner of its obligation to assess the incidents and develop an appropriate strategy for protecting the resident from a reoccurrence.

11. The record indicates that by February 12, 1999, Petitioner conducted staff interviews and completed its internal investigation of the incidents cited (P. Ex. 3 at 4), but Petitioner has not offered these documents as evidence in this matter. In his affidavit, Dr. Feinsod indicates that he reviewed the facility's Quality Assurance investigation documents pertaining to Residents #1 and #2, but those documents were not produced. P. Ex. 16.

12. CNA Lopez misstates the date, which was December 30, 1998.

13. In fact, the order for side rails was renewed on December 1, 1998 "due to restlessness." P. Ex. 6 at 19, 22.

14. Therapist Njonginiyil's affidavit is not consistent with Dr. Nivens' statement that Therapist Njonginiyil "glanced over and noted that Resident [#1] had slumped over and was unresponsive." P. Ex. 20 at 3, para 10. The affidavit is also inconsistent with Dr. Nevins' conjecture that "when [Resident #1] slumped forward, the tube may have become partially dislodged." Id. at 3, para 11. Therapist Njonginiyil's affidavit suggests instead that Resident #1 was sitting up, turning blue, but still conscious, with the tracheostomy tube partially out.

15. Although Monmouth physicians considered many possible explanations for the medistinal mass, the record does not establish a clear diagnosis.

16. By the time of the survey, the facility seems to have abandoned its kardex system, but replaced it with another system, which, when properly implemented, was acceptable to CMS.

17. I note that virtually all medical records are technical hearsay, but that does not mean that we disregard them.

18. I also note and am frankly perplexed by the emphasis Petitioner gives to Monmouth's efforts to withhold and withdraw life sustaining medical treatment while E.M. was acutely ill. P. Br. at 5 - 9. That staff at Monmouth did not want to attach the ventilator and feeding tubes is absolutely irrelevant to this case. When admitted to the facility, E.M. was ventilator-dependent, and no decision had been made to remove her from life-support, so the facility was bound to provide care and services necessary to maintain a ventilator-dependent resident. See Emerald Oaks, DAB No. 1800 at 23. Moreover, even though E.M. was quite ill during her stay at Monmouth, the objective evidence to refuse her life support seems pretty thin. The medical record does not establish that she had a terminal illness, and repeated references to her having no quality of life do not seem to be supported, particularly by the time of her admission to the facility. She is "comfortable" and "pleasant." P. Ex. 1 at 29. She is "very pleased" when given a TV. She is glad to have the priest visit, and to receive a stuffed animal. Id. at 45 - 46. She generally does not appear to be in any pain. She is alert and has interests. See Id. at 90.

19. Considering that mitten restraints were applied with no reported ill effects from the time she self-extubated on May 12 until May 17, Dr. Feinsod may have over-stated his case. He does not suggest that the facility acted inappropriately in applying the bilateral mittens for five days.

20. CMS might have been justified in imposing a per day penalty, requiring assurances over time that these repeat deficiencies would not be repeated. So, although CMS imposed the maximum per instance CMP, the result was not as harsh as it might have been. See Lake City Extended Care Center, DAB No. 1658, at 14 - 15 (1998).

21. CMS's decision to reject is hardly surprising. To impose the minimum per instance CMP in an immediate jeopardy situation, for a facility that has a history of this deficiency, appears to be unreasonable. But, nothing in this record explains the State Agency's reasoning in this regard.