SUBJECT:

Daughter of miriam Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I find to be clearly erroneous the determination of the Centers for Medicare & Medicaid Services (CMS) that Petitioner, Daughters of Miriam Center, manifested an immediate jeopardy level failure to comply with Medicare participation requirements. I reduce the civil money penalty that CMS determined to impose against Petitioner from $3,100 to $1,000.

I. Background

Petitioner is a skilled nursing facility in Clifton, New Jersey. It participates in the Medicare program. Its participation in Medicare is governed by sections 1819 and 1866 of the Social Security Act and by regulations at 42 C.F.R. Parts 483 and 488. Additionally, the hearing in this case is conducted pursuant to regulations at 42 C.F.R. Part 498.

On February 24, 2004, Petitioner was surveyed for compliance with participation requirements by the New Jersey State Department of Health and Senior Services, acting on behalf of CMS. The surveyors concluded that Petitioner failed to comply with the requirements of 42 C.F.R. � 483.20(k)(3)(i). This is a section of the regulations that requires a facility to meet professional standards of quality in providing care to its residents.

The surveyors found further that Petitioner's noncompliance was so egregious as to constitute immediate jeopardy for residents of the facility. The surveyors found that the noncompliance was limited to a single day, February 11, 2004. CMS concurred with the surveyors' findings and determined to impose a remedy against Petitioner consisting of a civil money penalty for one day, in the amount of $3,100.

Petitioner requested a hearing from CMS's determination and the case was assigned to me for a hearing and a decision. CMS then moved for summary disposition. Petitioner opposed the motion. I issued a ruling granting partial summary disposition to CMS. Ruling Granting Partial Summary Disposition and Setting Hearing Date, December 28, 2004 (Ruling). In that Ruling I held that the undisputed material facts of this case showed that Petitioner had been derelict in complying with professional standards of quality. CMS was therefore authorized to impose a civil money penalty against Petitioner. I held also that there was a dispute as to whether Petitioner's noncompliance was at the immediate jeopardy level. Consequently, I could not decide summarily the issue of whether the amount of the civil money penalty, $3,100, is reasonable. I set a hearing in the case to address only the questions of the level of Petitioner's noncompliance and the penalty amount.

I held a hearing in Newark, New Jersey, on July 7, 2005. I received into evidence from CMS exhibits identified as CMS Ex. 1 - CMS Ex. 20. I received into evidence from Petitioner exhibits identified as of P. Ex. 1 - P. Ex. 19. One witness testified, Ms. Mary Ann Palmer, a surveyor who participated in the February 24, 2004 survey. Tr. at 9 - 33.

II. Issues, findings of fact and conclusions of law

A. Issues

As I discuss above, I decided in my Ruling the issue of whether Petitioner did not comply with a Medicare participation requirement. I incorporate that Ruling into my decision and I do not discuss it further.

The issues remaining to be decided are:

1. Was CMS's determination that Petitioner's noncompliance was at the immediate jeopardy level clearly erroneous?

2. What is the reasonable amount of the civil money penalty to be imposed against Petitioner?

B. 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 as a separate heading. I discuss each Finding in detail.

1. CMS's determination that Petitioner's noncompliance was at the immediate jeopardy level is clearly erroneous.

As a general rule a facility may not challenge CMS's determination as to the level of its noncompliance with a participation requirement. The exception is where CMS determines that the noncompliance is at the immediate jeopardy level and where that determination, in turn, affects CMS's determination as to the civil money penalty amount or amounts that it intends to impose. The exception is met here.

Regulations define an immediate jeopardy level deficiency to mean:

a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.

42 C.F.R. � 488.301. The regulation does not explicitly define what is meant by the word "serious." However, both the common and ordinary meaning of the word and its use within the context of the regulation explain its meaning. In ordinary parlance, "serious" means something that is dangerous, grave, grievous, or life-threatening. Word Reference.com English Dictionary. The regulation plainly uses the word in that sense. The regulation makes it clear that "serious" injury or harm are incidents that are outside the ordinary by linking these two terms directly to the terms "impairment" and "death." A "serious" injury or harm, then, is an injury or harm that is grave, that requires extraordinary care, or which has lasting consequences. An injury that requires, for example, hospitalization, or which produces long-term impairment, or which causes severe pain, is a "serious" injury. That distinguishes the injury or harm from a situation that is temporary, which is easily reversible with ordinary care, which does not cause a period of incapacitation, which heals without special medical intervention, or which does not cause severe pain. ⁽¹⁾

An immediate jeopardy deficiency is established where noncompliance causes serious injury, harm, impairment, or death to a resident. However, it is not necessary to show that serious injury or harm has actually occurred in order to establish an immediate jeopardy level deficiency. Immediate jeopardy also exists where serious injury or harm is the likely consequence of a deficiency. Innsbruck Health Care Center, DAB No. 1948 (2005).

In Innsbruck, an appellate panel of the Departmental Appeals Board explained that a likelihood of serious injury, harm, impairment, or death means more than a mere potential for harm or a possibility that harm may occur. The regulations provide that a deficiency that is substantial but not at the immediate jeopardy level may exist where there is a potential for more than minimal harm to a resident. Consequently, there must be a much higher potential for harm in order for there to be immediate jeopardy. In the context of the regulations, a "likelihood" of serious injury or harm means that serious injury or harm is the likely - and not just the potential - consequence of a deficiency. Id.

Neither the regulations nor the Board appellate panel in Innsbruck define "likelihood." However, the commonly understood meaning of the term "likely" is that something is more probable than not. Here, I employ the term "likelihood" to mean that it is more probable that a serious injury or harm will occur than not.

In any case where a finding of immediate jeopardy is at issue CMS has the burden of coming forward with sufficient evidence to establish prima facie proof that the regulatory definition of immediate jeopardy is satisfied. Here, that burden means that CMS is obligated to establish prima facie that one of two criteria were met on February 11, 2004. CMS establishes a prima facie case of an immediate jeopardy level deficiency if it produces prima facie evidence that one or more of Petitioner's residents was seriously injured, harmed, impaired, or died as a consequence of a deficiency. Alternatively, CMS meets its burden if it proves, prima facie, that there was a likelihood of serious injury, harm, impairment, or death on February 11, 2004 as a consequence of a deficiency.

If CMS meets its burden to establish a prima facie case the burden then shifts to Petitioner to prove that immediate jeopardy is not present. In a case of immediate jeopardy the burden on Petitioner is heavy, assuming that CMS establishes its prima facie case. Petitioner must prove that CMS's immediate jeopardy determination is clearly erroneous in order to prevail. 42 C.F.R. � 498.60.

I find that CMS did not establish a prima facie case that Petitioner's noncompliance put residents of Petitioner's facility at immediate jeopardy. CMS failed to prove prima facie that one or more of Petitioner's residents experienced serious injury, harm, impairment, or death as a consequence of a deficiency. Nor did CMS prove prima facie that such consequences were likely. The evidence offered by CMS establishes that one of Petitioner's residents suffered actual harm from Petitioner's noncompliance. But, the evidence fails to establish that the harm was serious, as that term is used in 42 C.F.R. � 488.301. The prima facie evidence also establishes a potential for serious harm resulting from Petitioner's noncompliance with participation requirements. But, the evidence fails to establish the requisite likelihood of harm.

The evidence offered by CMS relating to its allegations of an immediate jeopardy level deficiency is as follows. On February 11, 2004, a nurse employed by Petitioner's facility committed errors in administering medication to residents. The nurse improperly administered medication to more than one resident. Additionally, the same nurse attempted to administer a potentially highly dangerous medication to another resident for whom the medication had not been prescribed. CMS Ex. 2, at 2.

The improperly administered medications included Vancomycin, an antibiotic. A physician had prescribed that this medication be administered to a resident, identified as Resident # 3, orally, four times daily. CMS Ex. 2, at 2. However, the nurse erroneously injected the medication into the resident's thigh. Id.; CMS Ex. 10; CMS Ex. 12. Also, the nurse erroneously administered medications, including Dilantin and Norvasc, to another resident, Resident # 4.

On that same date, the nurse attempted to administer Insulin to Resident # 4. CMS Ex. 2, at 2. This attempt was thwarted only by the resident's refusal to accept the medication. Resident # 3 plainly was harmed by the mis-administration of Vancomycin to her. The manufacturer's precautions for administration of the medication state that injection of the medication will cause pain, tenderness and muscle necrosis. CMS Ex. 11, at 1 - 2. The resident suffered from bruises at or near the site of the injection which were evident two weeks after the incident and she complained of pain in her thigh when her thigh was palpated. Tr. at 13 - 14.

However, there is no prima facie proof that the bruising suffered by the resident constituted either serious injury or harm within the context of 42 C.F.R. � 488.301. There is no evidence that the injury suffered by Resident # 3 was irreversible, that it required special medical attention, that it left the resident incapacitated or even significantly limited in her mobility or her ability to use her leg, or that it caused the resident to suffer from severe pain. The evidence offered by CMS is that the resident's thigh, in the vicinity of the site of the injection, was painful when palpated but not painful when not palpated. Tr. at 17. This was the only adverse effect, along with bruising, that the resident experienced. Id. The relatively minor consequences of the improper injection are made evident by the fact that the resident refused pain medication for her bruises. P. Ex. 5, at 4.

CMS contends that the limited pain and bruising experienced by Resident # 3 was, in and of itself, "serious" and therefore a basis for finding immediate jeopardy. While I agree with CMS that the resident was harmed more than minimally by the mis-administration of the medication, I do not agree that the limited proof of pain and bruising present in this case without evidence of loss of mobility or capacity is justification for a finding of a serious injury or harm, and a finding of immediate jeopardy.

There is no prima facie evidence that the mis-administration of medications to Resident # 4 caused that resident to suffer from any harm or injury. CMS offered evidence to show that mis-administration of Dilantin and Norvasc had the potential for causing more than minimal harm. But, there is no proof that the resident suffered from any of the potentially adverse affects of these medications. Nor is there proof that there was any probability that the resident would suffer from long-term adverse effects. See Tr. at 12.

There is, as I have stated, ample proof that there was a potential for serious harm to both Residents #s 3 and 4 resulting from mis-administration of medications to these residents. It is apparent from the manufacturer's warning about mis-administration of Vancomycin that Resident # 3 could possibly have suffered much more serious injury than that which she experienced. But, there is nothing in the manufacturer's warning that says that such injury was likely, as opposed to being possible. It would have been helpful if, for example, CMS had offered some proof to show that there was a likelihood that a person who is mis-administered Vancomycin would suffer from some incapacity. But, CMS did not offer such evidence. ⁽²⁾

CMS argues that its most persuasive evidence of an immediate jeopardy level deficiency lies in the thwarted attempt by the nurse to administer insulin to Resident # 4. CMS observes that insulin is a potentially lethal drug when mis-administered. It argues that the consequences to the resident, had the drug been administered to her, could very well have been grave. Thus, according to CMS, the resident was placed at immediate jeopardy by the nurse's attempt to give her insulin.

I find this reasoning to be unpersuasive. I agree with CMS that insulin is potentially a very dangerous drug when mis-administered. But, the problem with CMS's analysis is that it has provided nothing to establish that there was a likelihood that this resident would be harmed. In this case, the nurse was stopped by the resident's refusal to accept the medication. Conduct that might have been injurious or lethal, had it occurred, did not occur. It would be speculative, to say the least, to infer a likelihood of injury from a situation where no injurious conduct actually occurred.

Indeed, CMS's reliance on the attempted injection of insulin to the wrong resident underscores what I conclude is its incorrect reliance on a potential for harm as opposed to a probability of harm as a basis for its immediate jeopardy determination. The fact that Petitioner employed a nurse who was as incompetent in performing his or her duties as this one so plainly was created a potential for very serious harm. The practice errors that this nurse committed on February 11, 2004 were so egregious that it supports the inference that a potential for very serious harm to residents existed so long as the nurse was employed there. But, CMS failed to offer prima facie proof that the potential for harm resulting from the nurse's conduct translated into a likelihood that any resident would be harmed. ⁽³⁾

The nurse who perpetrated the mis-administration and attempted mis-administration of medicines on February 11, 2004 was not a regular employee of Petitioner's facility but was, in fact, a temporary employee who had been assigned to work on that date by an outside agency. The misfeasances committed by the nurse became known to Petitioner very shortly after they were committed and Petitioner immediately terminated the nurse's service. The possibility that this nurse might have committed additional practice errors at Petitioner's facility ended immediately with the termination of her service. A continued presence of the nurse at Petitioner's facility after February 11 would have raised the issue of whether the possibility that the nurse might have perpetrated additional harm would have evolved into a likelihood of such happening. But, that issue is speculative here, because the nurse's service was terminated immediately by Petitioner's management.

2. A civil money penalty of $1,000 is reasonable as a remedy for Petitioner's noncompliance on February 11, 2004.

Regulations governing the imposition of civil money penalties by CMS provide that penalties of from $3,050 to $10,000 may be imposed for each day of immediate jeopardy level noncompliance by a facility. Penalties of from $50 to $3,000 may be imposed for each day that a facility manifests noncompliance that is substantial but which falls below the immediate jeopardy level of noncompliance. 42 C.F.R. � 488.438(a)(1)(i), (ii). ⁽⁴⁾

In this case Petitioner's noncompliance was substantial but not at the immediate jeopardy level. Consequently, a basis does not exist to sustain CMS's determination to impose an immediate jeopardy level civil money penalty of $3,100. On the other hand, my finding that Petitioner failed to comply with a participation requirement means that a penalty in the range of from $50 to $3,000 per day is authorized.

Regulations govern how civil money penalty amounts are to be determined. Factors for establishing penalty amounts are set forth at 42 C.F.R. � 488.438(f)(1) - (4) and 42 C.F.R. � 488.404 (incorporated by reference into 42 C.F.R. � 488.438(f)(3)). These factors include: the scope and severity of a facility's noncompliance; the interrelationship between deficiencies; a facility's compliance history; its culpability; and its financial condition.

The factors do not operate as a formula for deciding penalty amounts. The presence of a certain number of factors does not, for example, dictate civil money penalties in a given range or amounts. Rather, the factors operate very much as rules of evidence in the sense that they define what evidence is relevant to deciding the amount of a civil money penalty.

Here, the scope and severity of Petitioner's noncompliance was relatively significant. A resident was actually harmed by the mis-administration of medication. Another resident was spared from the possibility of very serious harm only by her refusal to accept an injection of insulin. The potential for additional harm occurring on February 11, 2004 was certainly significant. Given that, I find the level of Petitioner's noncompliance on February 11, 2004 to be high albeit not at the immediate jeopardy level.

In deciding the level of Petitioner's noncompliance I have considered that the nurse in question was not one of Petitioner's regular employees but was an individual who was assigned to work at Petitioner's facility by an outside agency. That does not excuse Petitioner from full responsibility for the nurse's conduct on February 11, 2004. A skilled nursing facility is responsible for assuring that all of its employees - permanent or temporary - deliver care at a professionally acceptable level. Petitioner obviously failed to perform that duty here.

I recognize that Petitioner acted appropriately as soon as it became apparent that the nurse was incompetently performing her duties. However, that timely action by Petitioner did not relieve it of responsibility of assuring that the nurse was competent before she began treating Petitioner's residents.

The parties did not offer evidence as to other factors cited in the regulations aside from evidence relating to the scope and severity of Petitioner's noncompliance. There is nothing in the record, for example, that relates to Petitioner's past compliance history nor is there any evidence that addresses its financial circumstances. Given that, I must base my penalty decision solely on evidence relating to the scope and severity of Petitioner's noncompliance.

I find that a one-day civil money penalty of $1,000 is reasonable here. It reflects the relative significance of the noncompliance, the harm sustained by Resident # 3, and the potential for additional harm resulting from the nurse's misfeasance. But, it also takes into consideration that the actual harm resulting from Petitioner's noncompliance was not "severe".

Steven T. Kessel

Administrative Law Judge

1. Regulations published by the United States Department of Labor implementing the Family and Medical Leave Act of 1993 define a "serious health condition" to be: an injury including a period of incapacity that requires inpatient care; or, an injury requiring continuing treatment by a health care provider involving a period of incapacity. 29 C.F.R. � 824.114(a). This definition is consistent with the use of the term "serious" in the context of 42 C.F.R. � 483.301.

2. CMS relies on the fact that the manufacturer's precautions for Vancomycin warn that injection of the medication will cause tissue necrosis. Obviously, tissue necrosis poses the potential for very serious harm. But, CMS has offered no evidence as to what probabilities govern the extent of necrosis that a person is likely to suffer from mis-administration of the medication.

3. In this case the State survey agency apparently used a potential for harm standard to make its immediate jeopardy determination rather than assessing the likelihood of harm. Tr. at 22.

4. Regulations also provide for the imposition of per instance civil money penalties in the range of from $1,000 to $10,000 for each instance of noncompliance by a facility. 42 C.F.R. � 488.438(a)(2). CMS had the option of imposing a per instance civil money penalty here but elected instead to impose a daily penalty for Petitioner's single day of noncompliance.