SUBJECT: Bergen Regional Medical Center,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF

ADMINISTRATIVE LAW JUDGE DECISION

Bergen Regional Medical Center (BRMC) appealed a January 3, 2002 decision by Administrative Law Judge (ALJ) Carolyn Cozad Hughes sustaining the determinations of the Centers for Medicare & Medicaid Services (CMS) in two consolidated cases to impose a civil money penalty (CMP) of $5,000 per day from March 1 through 13, 1999 and a per instance CMP of $10,000 for May 18, 2000.⁽¹⁾ CMS had imposed the CMPs based on surveys conducted by the New Jersey Department of Health and Senior Services, the State survey agency, which found BRMC not in substantial compliance with several Medicare participation requirements and further found that the deficiencies posed immediate jeopardy to resident health and safety. For the reasons discussed below, we sustain the imposition of these CMPs.

Standard of review

The standard of review on a disputed issue of law is whether the ALJ decision is erroneous. The standard of review on a disputed factual issue is whether the ALJ decision is supported by substantial evidence in the record. Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs; see also South Valley Health Care Center, DAB No. 1691 (1999), aff'd South Valley Health Care Center v. HCFA, 223 F.3d 1221 (10^th Cir. 2000); Lake Cook Terrace Center, DAB No. 1745, at 6 (2000) (". . . it is not our role to substitute our evaluation of the evidence for that of the ALJ, but only to determine whether his factual findings are supported by substantial evidence in the record as a whole").

The ALJ Decision

The ALJ Decision summarized the facts as follows:

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. [citation omitted] 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. [citation omitted] Responding to a complaint regarding Resident #2's death, the [State agency] conducted a complaint investigation survey of the facility on March 1, 1999. [citation omitted] 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). [citation omitted]

ALJ Decision at 2.

The ALJ Decision noted that, by letter dated April 1, 1999, CMS advised BRMC that, based on these deficiencies, which constituted immediate jeopardy to resident health and safety, it was imposing a $5,000 per day CMP. Id. BRMC's request for a hearing on CMS's determination to impose this CMP was docketed as No. C-99-581. The ALJ Decision continued:

While Docket No. C-99-581 was pending, a third ventilator-dependent resident, E.M., [footnote omitted] 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.

ALJ Decision at 3. BRMC's request for a hearing on CMS's determination to impose a $10,000 per instance CMP was docketed as No. C-00-737.

The ALJ proceeded to make several findings of fact and conclusions of law, quoted below.

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[3].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.

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

1b. 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.

1c. 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.

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.

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.

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

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

ALJ Decision at 8, 14, 19-22, 27.

BRMC's Exceptions

Although the only numbered FFCL identified by BRMC was FFCL 1, we infer from BRMC's arguments that it also intended to take exception to FFCLs 1.a., 1.b., 2, 4 and 5, to the extent they relate to BRMC's treatment of Resident #1 and its effect on the amounts of both CMPs. BRMC did not take exception to FFCLs 1.c. and 3, which relate to BRMC's treatment of Resident #2 and of the third resident.⁽²⁾ Accordingly, we affirm these two FFCLs without further discussion.

We discuss BRMC's exceptions below, generally following the order in which they were made in BRMC's request for review of the ALJ's decision.⁽³⁾

1. The ALJ's finding that Resident #1 deliberately removed her tracheostomy tube on December 15 and December 30, 1998 and on February 1, 1999, is supported by substantial evidence.

FFCL 1.a. refers to the ALJ's finding, in the text that follows this FFCL, that Resident #1 deliberately removed her tracheostomy tube on December 15 and December 30, 1998 and on February 1, 1999. BMRC argued that there was no evidence supporting this finding. BRMC observed that the attending nurse's treatment notes for December 15 stated that she "found trach cuff out." Request for Review at 2, citing P. Ex. 6, at 117. BRMC asserted that this did not indicate that Resident #1 deliberately removed her tracheostomy tube.⁽⁴⁾ BRMC also cited a "professional medical opinion" that "partial dislodgment of the tracheal cuff may be caused unintentionally by any number of events, including coughing, chest physical therapy, suctioning, or changing or the tracheostomy tapes, or vigorous movement." Id., citing P. Ex. 17, at 6 (Affidavit of Fred M. Feinsod, MD, CMD, dated 6/26/01). With respect to the incident on December 30, BRMC noted that the certified nurse aide (CNA) who was in Resident #1's room when her tracheostomy tube became disconnected later made written statements that she did not see Resident #1 pull out the tube. Request for Review at 3, citing P. Ex. 18, at 2 (Affidavit of Vicky Lopez, CNA, dated 6/25/01) and P. Ex. 25 (statement of Vicky Lopez dated 3/15/99). BRMC dismissed the statement in the treatment notes for December 30 that "Resident pulled out trach" as the unwarranted presumption of "someone not present during the incident." Request for Review at 4, citing P. Ex. 6, at 121. BRMC argued that it reasonably presumed that Resident #1 did not attempt to remove her tube on any of the three dates in question in light of the number of days since November 20, 1998 (when BRMC discontinued a mitten restraint on Resident #1's right hand) that there had been no such attempts. BRMC cited the affidavit of the day charge nurse at the time, which stated in relevant part that there was no documentation in Resident #1's medical record in the two weeks before or after the December 15 and December 30 incidents of "acute restlessness" or "attempts . . . to remove her tracheal apparatus" or any other "behavior that would have necessitated reinitiating the mitten restraint . . . ." Request for Review at 4, citing P. Ex. 16, at 2 (Affidavit of Florence Jennings RN, dated 6/26/01).⁽⁵⁾

We conclude that the ALJ's finding that Resident #1 deliberately removed her tracheostomy tube on the three dates in question is supported by substantial evidence. (We address in the next section the ALJ's finding that, even if Resident #1 did not deliberately remove her tube, BRMC's failure to prevent the tube from becoming disconnected constituted immediate jeopardy.) As the ALJ noted, the fact that a tracheostomy tube can be disconnected by means other than deliberate removal by the ventilator-dependent individual is not probative of what happened here since "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." ALJ Decision at 15. Indeed, the treatment notes for Resident #1 for December 30 specifically state that Resident #1 pulled the tube out herself. Although the nurse who made the entry was not present at the time, this constituted a contemporaneous record of what BRMC's staff believed had occurred, and the ALJ could reasonably rely on it. Moreover, although the treatment notes for December 15 and February 1 do not specify how the tracheostomy tube became disconnected, the ALJ could reasonably infer that this occurred in the same manner as on December 30 in the absence of any evidence to the contrary.

We agree with the ALJ, moreover, that none of the evidence relied on by BRMC is inconsistent with the inference that Resident #1 deliberately removed her tracheostomy tube. As the ALJ observed, while the charge nurse's affidavit notes the absence in the medical record of any documentation that Resident #1 attempted to remove her tube, the affidavit does not suggest any other explanation for how the tube was removed. Furthermore, the ALJ reasonably concluded that the statement of the CNA that she did not see Resident #1 remove her tube on either December 30 or February 1 was not inconsistent with the inference that Resident #1 deliberately removed her tube since the CNA did not offer any other explanation for how the tube was removed. Indeed, the CNA's statement, quoted in the ALJ Decision, that she told Resident #1 on numerous occasions, including on February 1, "not to touch anything" when Resident #1 complained about her tracheostomy tube being tight, reflects the CNA's concern that Resident #1 might deliberately remove her tube and thus supports the ALJ's conclusion that Resident #1 succeeded in doing so. ALJ Decision at 17, citing P. Ex. 18.⁽⁶⁾

Accordingly, we uphold FFCL 1.a.

2. The ALJ did not err in concluding that, even if Resident #1 did not deliberately remove her tracheostomy tube, BRMC's failure to prevent the tube from being disconnected through other means constituted immediate jeopardy.

FFCL 1.b refers to the ALJ's conclusion that even if she accepted BRMC's assertion that Resident #1 did not deliberately remove her tracheostomy tube on the three dates in question, she would still find that an immediate jeopardy situation existed at BMRC. The ALJ stated in relevant part:

If the ventilator, upon which [Resident #1] 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.

ALJ Decision at 19.

On appeal, BRMC argued that "[a]bsent any indication of resident #1's attempt to self-extubate on December 15, and December 30, 1998, BRMC would have violated both federal and state regulations regarding the restricted use of restraints and could have been found to be abusive by punishing resident #1 through excessive use of physical restraints. Thus, the Interdisciplinary Team properly refrained from re-initiating the use of physical restraints when there was no evidence of resident #1 attempting to self-extubate . . . ." Request for Review at 3.⁽⁷⁾

This argument is based on a misreading of the ALJ Decision. The ALJ Decision does not state that BRMC should have used restraints to prevent Resident #1's tracheostomy tube from becoming disconnected in this situation, but rather refers more generally to BRMC's "failure to act" to prevent the recurrent disconnection of Resident #1 from her ventilator. ALJ Decision at 19.⁽⁸⁾ Indeed, it would make little sense to use a restraint to prevent a tracheostomy tube from becoming disconnected where, as BRMC argued occurred here, it had previously become disconnected by some means other than the resident's attempt to remove it. BRMC did not argue that there were no other measures it could have taken to prevent the tube from becoming disconnected or dispute the ALJ's conclusion that immediate jeopardy existed on any other basis. Thus, the ALJ reasonably concluded that BRMC's inaction created an immediate jeopardy situation.⁽⁹⁾

Accordingly, we uphold FFCL 1.b.

3. The ALJ did not err in concluding that BRMC was not in substantial compliance with 42 C.F.R. § 483.20 (Resident Assessment).

As part of FFCL 1, the ALJ found that from March 1 through March 18, 1999, BRMC was not in substantial compliance with the program participation requirement at 42 C.F.R. § 483.20 (Resident Assessment). The ALJ's analysis stated in part:

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.

* * * *

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." [footnote omitted]

ALJ Decision at 13-14.

On appeal, BRMC argued that, even if Resident #1 had deliberately removed her tracheostomy tube on December 15 and 30, a reassessment was not required. In support of this argument, BRMC cited 42 C.F.R. § 483.20(b)(2)(ii), which provides that a facility must conduct a comprehensive assessment of a resident "[w]ithin 14 calendar days after the facility determines, or should have determined, that there has been a significant change in the resident's physical or mental condition." That regulation further provides that a "significant change" means "a major decline or improvement in the resident's status . . . that has an impact on more than one area of the resident's status . . . ."⁽¹⁰⁾ According to BRMC, Resident #1 experienced no significant change. BRMC argued in addition that, even if a reassessment was required in this case, there was no requirement in the regulations that BRMC change its care plan following the reassessment. Request for Review at 4-5.

We need not reach this argument, however, because CMS did not rely on the requirement for reassessments at section 483.20(b)(2)(ii) as the basis for finding that BRMC was not in substantial compliance with 42 C.F.R. § 483.20. Instead, the survey report, which CMS incorporated by reference in its notice imposing the CMP, cites former section 483.20(d)(3)(i) at Tag F 281. CMS Ex. 4 at 3 (Docket No. C-99-581). This section, which has been redesignated as section 483.20(k)(3)(i), states that "[t]he services provided or arranged by the facility must . . . meet professional standards of quality." Moreover, in its brief below, CMS cited Tag F 281 and made no reference to the reassessment requirement at section 483.20(b)(2)(ii). See e.g., CMS Br. dated 6/26/01, at 13 (Docket No. C-99-581).

We conclude that the facts found by the ALJ clearly support a finding that BRMC violated section 483.20(k)(3)(i). The services provided by BRMC to Resident #1 did not "meet professional standards of quality" within the meaning of that regulation since BRMC did nothing to address a potentially life-threatening situation--the repeated disconnection of her tracheostomy tube. Thus, we need not determine whether a formal reassessment of Resident #1 was mandated by section 483.20(b)(2)(ii) in order to find that BRMC failed to comply with section 483.20.

Accordingly, we uphold the ALJ's finding in FFCL 1 that BRMC was not in substantial compliance with 42 C.F.R. § 483.20.

4. The ALJ did not err in finding that BRMC was not in substantial compliance with the program participation requirement at 42 C.F.R. § 483.25 (Quality of Care).

As part of FFCL 1, the ALJ concluded that from March 1 through March 18, 1999, BRMC was not in substantial compliance with the program participation requirement at 42 C.F.R. § 483.25 (Quality of Care). Although the ALJ did not elaborate on this conclusion, the survey report cited BRMC's failure to ensure that Resident #1 received proper tracheostomy care, as required by section 483.25(k)(4). CMS Ex. 4, at 5-6 (Docket No. C-99-581).

On appeal, BRMC argued that the ALJ failed to make any factual findings in support of her conclusion that BRMC was not in substantial compliance with section 483.25, and contended that the facts supported a contrary conclusion. BRMC asserted that the facility followed Resident #1's plan of care, which, BRMC implied, need not have been changed since BRMC reasonably presumed that Resident #1 did not attempt to remove her tracheostomy tube on December 15 and 30. Request for Review at 6-7.

BRMC's argument is devoid of any merit. As discussed above with respect to section 483.20(k)(3)(i), the ALJ found that, regardless of how Resident #1's tracheostomy tube became disconnected on those dates, BRMC did nothing to address this potentially life-threatening situation. This finding also supports the conclusion that BRMC violated section 483.25(k) by not providing proper tracheostomy care to Resident #1.

In further support of its position, BRMC cited the description in the ALJ Decision of actions that BRMC took to address the needs of Resident #1 prior to November 20, 1998, when her physician discontinued the order for a mitten restraint. Request for Review at 5-6, citing ALJ Decision at 9-10. However, these actions do not pertain to the time period when the ALJ found BRMC not in substantial compliance with the quality of care requirements.

Accordingly, we uphold the ALJ's finding in FFCL 1 that BRMC was not in substantial compliance with 42 C.F.R. § 483.25.

5. The ALJ did not err in finding that BRMC was not in substantial compliance with 42 C.F.R. § 483.13.

As part of FFCL 1, the ALJ found that from March 1 through March 18, 1999, BRMC was not in substantial compliance with the program participation requirement at 42 C.F.R. § 483.13 (Staff Treatment of Residents). Under Tag F 225, the survey report quoted parts of section 483.13(c) of this regulation (captioned "Staff treatment of residents,") including the following:

(2) 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).

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

(4) 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 5 working days of the incident, and if the alleged violation is verified appropriate corrective action must be taken.

In her analysis, the ALJ, citing the survey report, found that BRMC-

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

ALJ Decision at 11. Later, the ALJ stated that BRMC-

violated regulations when it failed to investigate [Resident #1's] 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.

Id. at 14.

On appeal, BRMC argued that the ALJ failed "to cite to any statutory or regulatory requirement that the facility purportedly violated by not reporting the death of resident #1 to the State agency." Request for Review at 5. We find no merit in this argument. The ALJ found in FFCL 1 that BRMC was not in substantial compliance with the part of section 483.13 addressing staff treatment of residents. This part includes the requirements for reporting alleged violations and the results of their investigation to the facility administrator and the state agency.

BRMC also argued that it did not violate section 483.13 because it "conducted an internal investigation in which it concluded that the death was not a reportable event." Request for Review at 5. This argument appears to be predicated on BRMC's view, articulated in its briefing before the ALJ, that "[a] provider is under no duty to report and investigate an injury or death when the facts viewed in their proper contexts raise no reasonable suspicion of mistreatment, neglect, or abuse." BRMC Br. in Docket No. C-99-581, dated 6/26/01, at 17 (citing Life Care Center of Hendersonville, DAB CR542 (1998)). Even assuming that this is the proper construction of the regulation, we are not persuaded that BRMC applied it correctly here. The fact that BRMC had documented two incidents in which Resident #1's tracheostomy tube became disconnected less than two months before Resident #1 died with her tube disconnected should reasonably have raised a suspicion that BRMC had neglected its obligation to ensure the safety of Resident #1. Thus, there was, in effect, an alleged violation that should have been reported to the state agency "immediately" under section 483.13(c)(1). Moreover, under section 483.13(c)(4), the results of BRMC's investigation should have been reported to the State agency within five days of the incident regardless of whether the investigation verified the alleged violation.

Accordingly, we uphold the finding in FFCL 1 that BRMC was not in substantial compliance with 42 C.F.R. § 483.13.

6. The ALJ did not err in finding that the $5,000 CMP imposed for each day from March 1 through March 18, 1999 was reasonable in amount.

In support of her finding at FFCL 2 that the $5,000 per day CMP was reasonable, the ALJ stated as follows:

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.

ALJ Decision at 21-22.⁽¹¹⁾

On appeal, BRMC argued that the ALJ's reliance on BRMC's failure to conduct an investigation of the death of Resident #1 in determining the reasonableness of the CMP amount was unwarranted since BRMC in fact conducted such an investigation. Request for Review at 6. The circumstances under which the investigation was conducted hardly render BRMC less culpable, however. These circumstances are described in the affidavit of BRMC's Vice President of Medical Affairs, which states in pertinent part that "[t]here was a regrettable delay in internal reporting so that BRMC's administration only learned of Resident [#1's] death six days afterward and as a result of their investigation of another resident's death . . . ." P. Ex. 20, at 4 (Docket No. C-99-581). The ALJ could reasonably determine that the failure to initiate such an investigation until after a second resident died under circumstances similar to the circumstances of Resident #1's death was evidence of BRMC's culpability since it demonstrated disregard for resident safety.

BRMC also argued on appeal that the number of days for which the CMP was imposed should be reduced. Specifically, BRMC contended that no CMP should be imposed for the 11 days that "lapsed, due to no fault or control of the facility, between the survey date (when the facility was found not to be in compliance) and the date that the facility received the notice of proposed deficiencies." Request for Review at 6. The survey was conducted on March 1, 1999, and the state survey agency's letter advising BRMC of the deficiency findings was faxed to BRMC on March 12, 1999. P. Ex. 22 (Docket No. C-99-581).⁽¹²⁾

The duration of the CMP imposed here is consistent with the applicable regulations, however. Section 488.402(f)(3) of 42 C.F.R. states that, except in the case of CMPs and State monitoring, CMS or the State (as authorized by CMS) gives notice of the remedy at least two calendar days before the effective date of the enforcement action where, as here, there is immediate jeopardy. Section 488.402(f)(6) provides that "[f]or civil money penalties, the notices must be given in accordance with the provisions of §§ 488.434 and 488.440." Section 488.440(a)(1) states that [t]he per day civil money penalty may start accruing as early as the date that the facility was first out of compliance, as determined by HCFA or the State." Pursuant to these regulations, CMS was authorized to impose a per day CMP retroactive to February 1, 1999, the date Resident #1 died, and arguably even earlier, regardless of the date BRMC received notice of the imposition of the CMP. Thus, BRMC can hardly complain that a CMP was imposed effective March 1, 1999.

Accordingly, we uphold FFCL 2.

7. The ALJ did not err in finding that the $10,000 per instance CMP imposed for May 18, 2000 was reasonable in amount.

In support of her finding at FFCL 4 that the $10,000 per instance CMP was reasonable, the ALJ, applying the four factors listed in 42 C.F.R. § 488.438(f), stated in part:

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. [the resident involved]. 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, the 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.

ALJ Decision at 27.

BRMC argued on appeal that since the ALJ's determination that the $10,000 per instance CMP was reasonable relied in large part on BRMC's "history of noncompliance," the per instance penalty "should also be reduced accordingly" if the $5,000 per day penalty "is found to be unreasonable and either dismissed in its entirety or significantly reduced." Request for Review at 6-7. As discussed above, however, we uphold the imposition of the $5,000 per day penalty.

BMRC also argued that the $10,000 per instance CMP should be dismissed in its entirety or reduced to $1,000 since, in the informal dispute resolution (IDR) process, the state survey agency had recommended the reduction of the CMP to $1,000. Request for Review at 6. BRMC asserted that since it had successfully demonstrated during the IDR process "that deficiencies should not have been cited," CMS should have adjusted the proposed CMP accordingly. Request for Review at 7. BRMC cited 42 C.F.R. § 488.331(c), which requires the rescission of any enforcement actions imposed as a result of deficiencies that are removed from the statement of deficiencies pursuant to the IDR.⁽¹³⁾ This argument constitutes an exception not only to FFCL 4, but also to FFCL 5, in which the ALJ specifically found that the recommendation made in the State IDR proceeding was not binding on CMS.

We conclude that the ALJ did not err in determining that the $10,000 per instance CMP was reasonable notwithstanding the recommendation of the State agency to reduce it. Contrary to what BRMC asserted, the September 20, 2000 letter from the State agency recommending reduction of the CMP amount contains no indication that the State agency removed any of the cited deficiencies from the statement of deficiencies. Instead, the letter merely states that it is "revising the remedies recommended to HCFA for the deficiencies cited on the [original] complaint survey . . . ." P. Ex. 7 (Docket No. C-00-737). Thus, there was no basis for applying the requirement in 42 C.F.R. § 488.331(c).

Moreover, the Act clearly provides that a state's role in the enforcement process is merely to recommend the imposition of remedies including CMPs where the state survey agency finds that a skilled nursing facility does not meet the Medicare conditions of participation, and that the Secretary is the ultimate decision-maker. See sections 1819(h)(1) and (2) of the Act; see also, 42 C.F.R. § 488.11(a). Consistent with these authorities, the State survey agency stated only that it was "recommending to HCFA that a per instance civil money penalty be imposed in the amount of $1,000 . . ." which "replaces and supercedes the per instance civil money penalty of $10,000 recommended in our Determination of Compliance dated June 30, 2000." P. Ex. 7 (Docket No. C-00-737).

Accordingly, we uphold FFCLs 4 and 5.

Conclusion

For the foregoing reasons, we uphold and adopt each of the FFCLs in the ALJ Decision.

Marc R. Hillson

M. Terry Johnson

Donald F. Garrett
Presiding Board Member

1. CMS was previously named the Health Care Financing Administration (HCFA). See 66 Fed. Reg. 35,437 (July 5, 2001). We use "CMS" in this decision unless we are quoting from documents that refer to HCFA.

2. Since BRMC did not dispute the ALJ's findings regarding these two residents, there would still be a basis for the CMP in each of the two docketed cases regardless of our disposition of the remaining exceptions. However, it remains necessary to review the ALJ's deficiency findings concerning Resident #1 since those findings support in part the ALJ's conclusions regarding the reasonableness of the amounts of the CMPs imposed.

3. BRMC did not file a reply brief following receipt of CMS's response to the request for review.

4. BRMC also asserted that this meant that only the cuff was out and not the tube itself. We do not find this argument persuasive since BRMC did not cite any evidence that a distinction was commonly made between the tracheostomy tube and the "trach cuff."

5. BRMC also appeared to argue that it was "implausible" that the Interdisciplinary Team would not have been aware of Resident #1's situation and have provided for restraints if in fact she had been attempting to remove her tracheostomy tube. Request for Review at 3. However, this assumes that BRMC provided proper care and treatment of Resident #1--the very matter in dispute.

6. The CNA made a similar statement to the surveyor regarding what she told Resident #1 on February 1. CMS Ex. 11, at 4 (Docket No. C-99-581).

7. BRMC identified as the relevant federal regulations 42 C.F.R. § 483.13(a) ("The resident has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms) and 42 C.F.R. § 483.15(a) ("The facility must promote care for residents in a manner and in an environment that maintains or enhances each resident's dignity and respect in full recognition of his or her individuality").

BRMC also cited N.J.S.A. 26:2H-12.8 and N.J.A.C. 8:39-4.1, quoting the provision in the latter that each resident shall be entitled "To be free from chemical and physical restraints, unless they are authorized by a physician or advanced practice nurse for a limited period of time to protect the resident or others from injury." Request for Review at 2.

8. What preventive action was appropriate would depend on what the cause of the disconnection was determined to be. The ALJ could not specify the appropriate action since BRMC never determined the cause. Even if BRMC determined that there may have been more than one possible cause, BRMC was obliged to address each possible cause. BRMC was not justified in failing to take action simply because it may have concluded the precise cause was indeterminate.

9. As the ALJ noted, CMS's determination as to immediate jeopardy must be upheld unless clearly erroneous. ALJ Decision at 8, citing 42 C.F.R. § 498.60(c)(2).

10. BRMC also cited CMS's "Guidance to Surveyors - Long Term Care Facilities," at Aa4 and Aa5 (attached to BRMC's request for review), which states that "[a] significant change reassessment is generally indicated if decline or improvement is consistently noted in 2 or more areas of decline or 2 or more areas of improvement."

11. Section 488.438(f) provides that CMS takes the following factors into account in determining the amount of penalty:

(1) The facility's history of non-compliance, including repeated deficiencies.
(2) The facility's financial condition.
(3) The factors specified in § 488.404 [including the scope and severity of the deficiencies, the relationship of the deficiencies resulting in noncompliance, and the facility's prior history of non-compliance].
(4) The facility's degree of culpability. Culpability . . . includes, but is not limited to, neglect, indifference, or disregard for resident care, comfort of safety. . . .

12. Although BRMC did not raise this argument before the ALJ, we address it here since CMS is not prejudiced by our conclusion.

13. BRMC cited section 488.431, a non-existent section, but apparently intended to cite section 488.331.