SUBJECT:

Brookridge Life Care and Rehabilitation,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

For the reasons discussed below, I affirm the Centers for Medicare & Medicaid Services' (CMS) determination to impose a civil money penalty (CMP) against Petitioner based on this noncompliance, but only for one day, beginning September 8, 2003 and ending September 9, 2003.

I. Procedural Background.

Petitioner, Brookridge Life Care & Rehabilitation Center, is a long-term care facility located in Morrilton, Arkansas. Petitioner is certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges CMS's determination that it was not in substantial compliance with program participation requirements. On September 12, 2003, the Arkansas State Survey Agency (state agency) completed a complaint and standard survey of Petitioner's facility. The survey resulted in findings of noncompliance at the immediate jeopardy level.

As a result, on October 28, 2003, CMS notified Petitioner, that among other things, the following remedies were being imposed: a "per day" civil monetary penalty (CMP) in the amount of $3,050 from September 5, 2003 through September 9, 2003; a CMP in the amount of $100 per day beginning September 10, 2003; a denial of payment for new admissions (DPNA) effective November 12, 2003; and termination of the facility's provider agreement effective December 12, 2003, should Petitioner not resume substantial compliance before those dates.

By letter dated December 22, 2003, Petitioner filed a hearing request electing to appeal only the immediate jeopardy level deficiencies. On January 6, 2004, the case was assigned to me for hearing and a decision. On March 23, 2004, CMS filed a motion for partial summary judgment with respect to the issues Petitioner did not challenge in its appeal. On March 24, 2004, CMS filed a motion for partial summary judgment. On March 31, 2004, Petitioner filed a reply to CMS's motion for partial summary judgment. On May 24, 2004, Petitioner filed a motion for summary judgment. On June 28, 2004, CMS filed a Response to Petitioner's motion and filed a cross-motion for summary judgment.

In a letter dated October 21, 2004, based in part, on the parties' motions, partial motions, and cross-motions for summary judgment I asked the parties to summarize their "global" positions. By letter dated October 27, 2004, Petitioner stated that "there is only one real issue before you, namely whether Petitioner was in violation of 42 C.F.R. � 483.25 (F309) (and subsidiary deficiencies at F490 and F521) . . . ." By letter dated November 4, 2004, CMS withdrew its motion for partial summary judgment. CMS agreed that the only issues to be decided are whether Petitioner was in substantial compliance with 42 C.F.R. � 483.25 (F309); 42 C.F.R. � 483.75 (F490), and 42 C.F.R. � 483.75(o)(2) and (3) (F521). Both parties, in their responses, also agreed that this matter could be disposed of without the need for an evidentiary hearing. Therefore, I make my decision in this case based on the written submissions as well as the evidence presented in the form of exhibits by the parties. CMS submitted exhibits labeled A-I. Petitioner submitted exhibits labeled A-P. The parties' exhibits are admitted without objection.

II. Issues

The issues to be decided in this case are:

1. Whether Petitioner was out of substantial compliance with participation requirements.

2. Whether the CMP imposed by CMS against Petitioner is reasonable.

III. Statutory and Regulatory Background

The Social Security Act (Act) sets forth requirements for long-term care facilities (Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities (NFs)) participating 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 long term care facilities participating in the Medicare program are found at 42 C.F.R. Parts 483, 488, 489, and 498.

To participate in the Medicare program, a long-term care 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.

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), 488.440.

In situations where deficiencies constitute immediate jeopardy, CMS may impose a CMP of between $3,050 and $10,000 per day. 42 C.F.R. � 488.438(a)(1)(I). In situations where 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 of $50 to $3,000 per day. 42 C.F.R. � 488.438(a)(1)(ii). An administrative law judge must uphold CMS's determination as to the level of noncompliance unless it is clearly erroneous. 42 C.F.R. � 498.60(c).

IV. Burden of Proof

As an evidentiary matter, CMS must set forth a prima facie case that a facility is not in substantial compliance. Petitioner then has the burden of coming forward with evidence sufficient to establish the elements of any affirmative argument or defense, and bears the ultimate burden of persuasion. To prevail, Petitioner must prove, by a preponderance of the evidence, that it was in substantial compliance with relevant statutory and regulatory provisions. Meadow Wood Nursing Home, DAB No. 1841 (2002); Cross Creek Health Care Center, DAB No. 1611 (1998), applying Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999); see Coquina Center, DAB No. 1860, n.4 (2002). I follow this precedent in making my decision here.

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

I make findings of fact and conclusions of law to support my decision in this case.

1. CMS has established a prima facie case that Petitioner was out of compliance with the participation requirements at 42 C.F.R. � 483.25 (F Tag 309)

CMS alleges that Petitioner failed to comply substantially with the general requirement of 42 C.F.R. � 483.25. ⁽¹⁾ CMS's allegations focus on two of Petitioner's residents who are identified as Resident #14 (R14) and Resident #15 (R15). Specifically, at the time of the September 9 survey, CMS alleges that Petitioner failed to ensure that the code status was documented in the clinical record and readily accessible to the nursing staff (F309 and F521); and failed to ensure that an effective system was in place to allow the nursing staff to access quickly a resident's code status in an emergency situation (F490).

R14 was a 92-year-old male admitted to Petitioner's facility on Friday, September 5, 2000, by his daughter and son. His admission assessment indicated that R14 suffered from, among other things, congestive heart failure, dementia, and dysphagia. On the morning of September 9, 2003, while in speech and occupational therapy R14 stopped breathing. There was no DNR form in R14's medical chart at the time he stopped breathing.

Petitioner argues that R14's daughter had durable power of attorney; that R14's daughter was there when he stopped breathing; and that R14 daughter's instructed the facility staff not to resuscitate based on a "do not resuscitate order" she had signed. Additionally, Petitioner argues that the Arkansas Rights of the Terminally Ill or Permanently Unconscious Act permits any patient and certain specified individuals on behalf of that patient to execute a declaration governing the withholding or withdrawal of life sustaining treatment.

Petitioner argues in its brief that it complied with R14's advance directive and with state law when Petitioner's staff withheld cardiopulmonary resuscitation (CPR) after R14 suffered cardiac and or respiratory arrest. Specifically, Petitioner argues that R14 executed, through his daughter, to whom he had given a durable power of attorney, a "no code" advance directive that was valid under Arkansas law; and that Petitioner's staff actually followed the instructions of the advance directive when R14 suddenly stopped breathing.

Petitioner goes to great lengths in explaining the Arkansas Right of the Terminally Ill or Permanently Unconscious Act, and whether R14's daughter held R14's durable power of attorney for health-care matters including end-of-life decisions in his case. I do not consider this question, as Petitioner frames it, to be the issue nearly as much as the far simpler question of whether R14's DNR forms were in his chart as prescribed by the facilities protocol and procedures.

With regard to facility documentation, what I am obliged to look into is whether, at the time of the survey, the surveyors and the facility staff were able to find the documents necessary to show compliance with the participation requirements. Their inability to find such documents is the gravamen of the citation at issue. The whereabouts of the documents or the date of their creation is beside the point when they are not in a resident's files when surveyors and facility staff are looking for them, either at the time of the survey or when a DNR decision needs urgently to be made.

It is this facility's protocol or procedure that the DNR form is to be signed by the resident's physician and placed in the resident's chart as soon as is practicable after the resident's admission. In this case, the resident was admitted to the facility on a Friday afternoon, September 5, 2003. Not including the weekend, the DNR form should have been received at the doctor's office on Monday, September 8, 2003, and, ideally, returned no later than that Monday evening or Tuesday morning, September 9, 2003. However, I cannot find in any of the briefs or in the evidentiary record an explanation as to why R14's clinical record did not contain his DNR form, or why R14's physician was not contacted until after he had expired, other than the fact that a state surveyor was on site and had requested the Resident's DNR form during the survey.

R15 was an 87-year-old female admitted to Petitioner's facility on July 2, 2003. R15's diagnoses included, among other things, Alzheimer's disease, hypertension, and depression. On September 9, 2003, the date of the survey, there was no documentation of the R15's code status in her clinical record. Surveyors cited this as an immediate jeopardy level deficiency.

What is being decided here is whether the DNR status of these two Residents was appropriately documented. I find that it was not. Thus, I find that CMS has established a prima facie case that Petitioner was out of compliance with the participation requirements at 42 C.F.R. � 483.25 (F Tag 309); and that immediate jeopardy existed beginning Monday, September 8, 2003, and was removed September 9, 2003, at 11:00 pm. CMS Ex. E, at 40.

2. CMS did not establish a prima facie case that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.75.

The regulation at 42 C.F.R. � 483.75, addresses standards of administration, and provides that a facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.

CMS alleged that this participation requirement was not met because the facility failed to ensure that an effective system was in place to allow nursing staff to quickly access a resident's code status in an emergency situation. In this case, to support its claim that the facility did not comply with the requirements governing administration, CMS relies on the same facts underlying its claim that the facility did not comply with the quality of care regulation. The administration deficiency is a derivative deficiency based on findings of other deficiencies. Cross Creek Health Care Center, DAB No. 1665, at 19 (1998).

Although I find that Petitioner was out of compliance with the quality of care requirement for one-day, I cannot sustain a finding of substantial noncompliance with the administration regulation, 42 C.F.R. � 483.75.

I find that Petitioner did have a system in place to allow nursing staff to quickly access resident's code status. The fact that the protocol was not followed or the fact that there was no documentation in the resident's clinical record does not mean that an effective system is not in place. The gravamen of this deficiency is a facility's failure to have a protocol or procedure in place, not merely the failure of the facility's staff to follow the protocol in a specific instance. It might very well be that proof of a series of staff lapses in following the protocol could prove ignorance of, or a systemic disregard of, the protocol, which in turn could be seen as an administrative failure to maintain the protocol in an effective and meaningful manner. That is not the case here, however, as the following discussion will make plain.

3. CMS did not establish a prima facie case that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.75(o)(2) and (3).

The regulations at 42 C.F.R. � 483.75(o)(2) and (3) require a facility to maintain a quality assessment and assurance committee. It also mandates that the committee meets at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary. It requires that the committee develop and implement appropriate plans of action to correct identified quality deficiencies.

CMS alleges that Petitioner failed to comply substantially with these requirements because Petitioner's administration and its quality assessment and assurance committee "failed to identify that there was a flaw in its system of documenting the resident's codes status and ensuring that the information was readily accessible to nursing staff in an emergency situation." CMS's Response to Petitioner's Motion for Summary Judgment at 7. Specifically, Petitioner's quality assurance and assessment committee failed to recognize that Petitioner was not timely documenting residents' code status. Id.

The guidance to surveyors contained in State Operations Manual, App. P. at PP 201 - PP 202, establishes a two-phased assessment process. The survey team is to review how the quality assurance committee functions and determine whether the committee has a formal method to identify issues which require quality assurance and assessment activities. If the survey team identifies quality issues, then the team determines whether the committee has a protocol for addressing specific quality problems.

Surveyors should not focus on if the quality assurance committee has identified and addressed deficiencies which the survey team identifies. Concentrate on verifying that the facility has a quality assurance committee which addresses quality concerns and that staff know how to access that process. Id.

The surveyors allege in the SOD that the regulatory requirements for a quality assessment and assurance committee were not met because:

the facility's Quality Assessment and Assurance (QA&A) committee failed to have a system in place to ensure the code status was documented and readily accessible to nursing staff in an emergency situation for 2 of 26 case mix residents (Residents #14 and #15).

P. Ex. A.

I find that these allegations fail to establish a prima facie case that Petitioner did not comply substantially with the participation requirements of 42 C.F.R. � 483.75(o)(2) and (3). CMS has offered no evidence to show that Petitioner failed to comply with the specific requirements of the regulation. In fact, Petitioner's Administrator at the time, Christy Smith, informed the surveyor that Petitioner had a Quality Assurance Committee, which consisted of Petitioner's department heads, and that the Committee meets once a month. See P. Ex. G.

There is no evidence in the record of this case from which I might infer that Petitioner failed to establish a quality assurance committee, that the committee did not meet, at least quarterly, or that it failed to identify issues with respect to which quality assessment and assurance activities were necessary. Nor has CMS offered any evidence to show that Petitioner's quality assurance committee failed to address the issues that were raised by the care that Petitioner's staff gave to R14 and R15.

Rather, it appears CMS has simply assumed that because the two Residents' files did not have the code documents, in their file, then Petitioner's quality assurance committee must have failed to discharge its obligations. I find that assumption to be inadequately supported by the record of this case.

Moreover, it is at least arguable that 42 C.F.R. � 483.75(o)(2) does not address the effectiveness of a facility's quality assurance committee. The regulation may be read as setting forth requirements addressing the formation and structure of such a committee, along with setting forth the ministerial duties of the committee. Whether the committee does a good or a bad job in assuring quality arguably is not addressed by the regulation, although it may be addressed elsewhere in the Part 483 regulations. CMS has failed to address this issue in its arguments. Rather, it has assumed that the regulation governs the effectiveness of a quality assurance committee without explaining how that is the case.

4. A Civil Money Penalty in the sum of $3,050 is reasonable.

CMS proposes a CMP of $3,050 per day, from September 5, 2003 through September 9, 2003, and a $100 per day CMP, from September 10 through October 11, 2003. The proven deficiency was one involving immediate jeopardy. Since the proposed $3,050 CMP is the minimum prescribed by law for immediate-jeopardy deficiencies, it is reasonable as a matter of law, but only for one day.

VI. Conclusion.

I affirm CMS's determination to impose a civil money penalty against Petitioner based on its noncompliance, but only for one day, and only in the amount of $3,050, which I find is reasonable in the circumstances.

Richard J. Smith

Administrative Law Judge

1. 42 C.F.R. � 483.25 directs nursing homes to provide its residents with the necessary care and services to attain or maintain the highest practicable physical, mental, and psychological well-being, in accordance with the comprehensive assessment and plan of care.