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CASE | DECISION | JUDGE

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
IN THE CASE OF  


SUBJECT:

Mediplex of Massachusetts, Inc., d/b/a
Randolph Crossings Nursing Center,


Petitioner,

DATE:March 19, 1999
                                          
             - v -

 

Health Care Financing Administration.

 

Docket No.C-99-026
Decision No. CR584
DECISION
...TO TOP

FINAL DECISION ON REVIEW OF

ADMINISTRATIVE LAW JUDGE DECISION

I decide that the Health Care Financing Administration (HCFA) is authorized to impose a civil money penalty against Petitioner, Mediplex of Massachusetts, Inc., d/b/a Randolph Crossings Nursing Center, in the amount of $7,000 per day for each day of the period which begins on April 1, 1998 and which runs through April 22, 1998. I decide further that HCFA is authorized to impose a civil money penalty against Petitioner in the amount of $3,000 per day for each day of the period which begins on April 23, 1998 and which runs through June 30, 1998. Additionally, I decide that HCFA is authorized to impose a civil money penalty of $1,500 per day for each day of the period which begins on July 26, 1998 and which runs through August 13, 1998. I decide that HCFA is not authorized to impose a civil money penalty against Petitioner for any date after August 13, 1998. I decide that HCFA is not authorized to terminate Petitioner's participation in the Medicare program.

I. BACKGROUND

The Social Security Act (Act) authorizes HCFA to impose against a long-term care facility that participates in the Medicare or Medicaid programs a civil money penalty of up to $10,000 for each day that the facility is found not to be complying substantially with federal Medicare and Medicaid participation requirements. Act, Sections 1819 and 1919. Additionally, the Act authorizes HCFA to terminate the participation in Medicare of a long-term care facility that is not complying substantially with federal participation requirements. Act, Section 1866(b)(2). This case is brought pursuant to sections 1819, 1919, and 1866(b)(2) of the Act and implementing regulations at 42 C.F.R. Parts 483, 488, 489, and 498. Relying on these authorities, HCFA has determined to impose civil money penalties against Petitioner and to terminate its participation in Medicare.

Petitioner is a long-term care facility located in Randolph, Massachusetts. It participates in Medicare and in the Massachusetts Medicaid program. Residents of Petitioner include individuals who are eligible to receive nursing care benefits from Medicare or who are eligible to receive State Medicaid benefits. In 1998, Petitioner was surveyed several times by employees of the Massachusetts Department of Health (Massachusetts State survey agency). The relevant surveys occurred on the following dates in 1998:

March 26 - April 3; April 14; April 23; June 2; July 1; and September 29. At each of these surveys, the Massachusetts State survey agency found that Petitioner was not complying substantially with one or more federal participation requirements. HCFA concurred with these findings. HCFA determined to impose the following remedies against Petitioner: a civil money penalty of $7,000 per day for each day of the period which begins on April 1, 1998 and which continues through April 22, 1998; a civil money penalty of $3,000 per day for each day of the period which begins on April 23, 1998 and which continues through September 30, 1998; and termination of Petitioner's participation in Medicare effective October 1, 1998.

HCFA based its imposition of the $7,000 per day civil money penalty for the April 1 - 22, 1998 period on its determination that, during this period, Petitioner's noncompliance was so egregious that residents of Petitioner were in a state of immediate jeopardy. Under applicable regulations, "immediate jeopardy" means a situation in which a facility's compliance with one or more participation requirements has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident. 42 C.F.R. § 488.301. HCFA is authorized to impose a civil money penalty in an amount ranging from $3,050 to $10,000 per day for each day that a facility's noncompliance poses immediate jeopardy to its residents. 42 C.F.R. § 488.438(a)(1).

HCFA based its imposition of the $3,000 per day civil money penalty for the April 23 - September 30, 1998 period on its determination that, during this period, Petitioner's noncompliance was more than minimal but not at the immediate jeopardy level. HCFA is authorized to impose a civil money penalty in an amount ranging from $50 to $3,000 per day for each day that a facility's noncompliance is more than minimal but not at the immediate jeopardy level. 42 C.F.R. § 488.438(a)(2).

HCFA based its determination to terminate Petitioner's participation in Medicare, effective October 1, 1998, on a section in the regulations which directs HCFA to terminate a long-term care facility's participation in Medicare when a facility has not attained substantial compliance within six months of the last date of a compliance survey at which the facility is found not to be complying substantially with participation requirements. 42 C.F.R. § 488.412(d). In this case, October 1, 1998 is six months from the date when Petitioner was found to be not complying to the extent that its residents were in immediate jeopardy. Alternatively, HCFA based its determination to terminate Petitioner's participation in Medicare on sections of the Act and regulations which authorize HCFA to terminate a long-term care facility's participation in Medicare for any instance of failure by the facility to comply substantially with federal participation requirements. Act, section 1866(b)(2); 42 C.F.R. § 488.456(b)(1)(i).

Petitioner requested a hearing and the case was assigned to me for a hearing and a decision. I agreed to conduct a hearing on an expedited basis due to the possible impact that termination of Petitioner's participation in Medicare might have on residents of Petitioner. I conducted a hearing in Boston, Massachusetts on January 4 - 5, 1999. At the hearing, I received into evidence exhibits from both HCFA and Petitioner, consisting of HCFA Exhibits (HCFA Exs.) 1 - 90 and Petitioner Exhibits (P. Exs.) 1 - 137. Hearing Transcript (Tr.) at 50; 67. The following witnesses, all of whom are employees of the Massachusetts State survey agency, testified on behalf of HCFA:

Jill Mazzola, R.N. (Tr. at 70 - 190). Ms. Mazzola participated in the March 26 - April 3, 1998 survey of Petitioner. Tr. at 74.

Virginia Zoppo, R.N. (Tr. at 191 - 274). Ms. Zoppo participated in the June 2, 1998 and the September 29, 1998 surveys of Petitioner. Tr. at 193; 224.

Clair Kelly, R.N. (Tr. at 277 - 323). Ms. Kelly participated in the June 2, 1998 survey of Petitioner. Tr. at 281.

Susan Marks (Tr. at 323 - 329). Ms. Marks is a licensed social worker. She participated in the March 26 - April 3, 1998 survey of Petitioner. Tr. at 324.

Patricia Ryan, R.N. (Tr. at 329 - 356). Ms. Ryan participated in the July 1, 1998 survey of Petitioner. Tr. at 332.

The following witnesses testified on behalf of Petitioner:

Robert McMahan, R.N. (Tr. at 388 - 502). Mr. McMahan was director of survey and certification for Petitioner's parent corporation during the period of time that is at issue in this case. Tr. at 389.

Lauren Schembari, R.N. (Tr. at 503 - 553). Ms. Schembari is an assistant director of nursing at Petitioner's facility. Tr. at 504.

Pamela Athanas, R.N. (Tr. at 566 - 642). Ms. Athanas is Vice President of Clinical Services of Petitioner's parent corporation. Tr. at 567.

Roger Schutt, D.O. (Tr. at 642 - 673). Dr. Schutt is Petitioner's medical director. Tr. at 643.

Joan Chamberlain, R.N. (Tr. at 673 - 718). Ms. Chamberlain has served as Petitioner's director of nursing services since July 13, 1998. Tr. at 675.

II. SUMMARY OF DECISION

At issue in this case is a six month period which begins on April 1, 1998 and which runs through September 30, 1998. HCFA asserts that, during this period, Petitioner continuously failed to comply substantially with federal participation requirements. HCFA alleges that Petitioner's noncompliance during the period from April 1 until

April 23, 1998 was so severe as to constitute immediate jeopardy to Petitioner's residents. Petitioner does not dispute that, as of April 1, 1998, it was failing to comply substantially with participation requirements. Petitioner concedes that its noncompliance was at the immediate jeopardy level through April 13, 1998. Tr. at 35 - 38. It does not deny that a $7,000 per day civil money penalty is reasonable for the period that its noncompliance caused residents to be in immediate jeopardy. Id. Petitioner asserts that it attained substantial compliance with participation requirements on April 14, 1998 and remained compliant thereafter.

I find that, from April 1, 1998 until April 23, 1998, Petitioner was not complying with participation requirements to the extent that its residents were in immediate jeopardy. I base my conclusion on evidence that, until April 23, 1998, there continued to exist extremely serious problems with the way in which Petitioner administered medications to its residents. I find that, from April 23, 1998 until July 1, 1998, Petitioner remained noncompliant with participation requirements, albeit at a level of severity that was less than the immediate jeopardy level of severity. Petitioner attained substantial compliance with participation requirements by July 1, 1998 and remained in substantial compliance with participation requirements until July 26, 1998. However, beginning with that date, Petitioner again experienced significant problems with the way in which it administered medications to its residents. Petitioner did not resolve those problems until August 13, 1998. The weight of the evidence is that Petitioner regained substantial compliance with participation requirements on August 14, 1998 and remained compliant thereafter.

It is reasonable to impose civil money penalties against Petitioner in the amounts of: $7,000 per day for the period which begins on April 1, 1998 and which runs through April 22, 1998; $3,000 per day for the period which begins on April 23, 1998 and which runs through June 30, 1998; and $1,500 per day for the period which begins on July 26, 1998 and which runs through August 13, 1998. I base these penalty amounts on the factors which are established by the Act and regulations to determine civil money penalties. There is no basis to terminate Petitioner's participation in Medicare. The evidence does not show Petitioner to have been noncompliant with participation requirements for six continuous months. Additionally, the evidence does not show that Petitioner was failing to comply substantially with participation requirements as of October 1, 1998, the date when HCFA determined to terminate Petitioner's participation in Medicare.

III. ISSUES, FINDINGS OF FACT AND CONCLUSIONS OF LAW

A. Issues

The issues in this case are as follows.

1. On what, if any, dates after April 13, 1998 was Petitioner not complying substantially with federal participation requirements?

2. What was the level of Petitioner's noncompliance on dates after April 13, 1998, assuming that it was not complying substantially on any of those dates?

3. What civil money penalties would be reasonable to remedy any failure by Petitioner to comply substantially with participation requirements?

4. May HCFA terminate Petitioner's participation in Medicare effective October 1, 1998 either because Petitioner was not complying substantially with participation requirements for six continuous months or because Petitioner was not complying substantially with participation requirements as of the September 29, 1998 resurvey of 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 of my Findings in detail.

1. Between April 1 and April 23, 1998, Petitioner failed to comply substantially with participation requirements to the extent that its residents were in immediate jeopardy.

a. As of April 1, 1998, Petitioner was not complying with participation requirements to the extent that its residents were in immediate jeopardy.

The Massachusetts State survey agency surveyors who conducted the March 26 - April 3, 1998 survey of Petitioner found that Petitioner had failed in numerous respects to comply substantially with federal participation requirements. HCFA Ex. 38. The surveyors found that, in two respects, Petitioner's failure was so egregious as to put residents of Petitioner in immediate jeopardy. Id.; HCFA Ex. 19. Petitioner has not disputed these findings. Petitioner's Posthearing Brief (Br.) at 22.

Among the most egregious of the deficiencies identified in Petitioner's operations as of April 1, 1998 were its systemic failures to: protect its residents against developing pressure sores; treat pressure sores appropriately; and assure that its residents received prescribed medications consistent with the orders that had been given by the residents' treating physicians. The two immediate jeopardy level deficiencies that the surveyors identified are failures by Petitioner to:

• Develop and implement written policies and procedures that prohibit mistreatment, neglect and abuse of residents. HCFA Ex. 19 at 1; HCFA Ex. 38 at 1; 42 C.F.R. § 483.13(c)(1)(i). The surveyors found that Petitioner had failed to provide necessary services to its residents thereby neglecting them. Specifically, the surveyors concluded that Petitioner failed to: administer medications accurately to its residents; prevent the development of pressure sores in some of its residents; provide appropriate pain management to its residents; prevent its residents from experiencing significant weight loss; and prevent or identify the occurrence of fractures in its residents. HCFA Ex. 19 at 2 - 16; HCFA Ex. 38 at 2 - 16.

• Assure that each of Petitioner's 148 residents received the necessary care and services to maintain his or her highest practicable physical, mental, and psychosocial well being. HCFA Ex. 19 at 16 - 17; HCFA
Ex. 38 at 28 - 29; 42 C.F.R. § 483.25. The surveyors found that Petitioner manifested a pattern of medication errors which placed its residents at serious risk of harm. Id.

There is ample evidence to support the surveyors' findings of immediate jeopardy level deficiencies. For example, at the March 26 - April 3, 1998 survey, the surveyors identified at least five residents who manifested pressure sores that had not been detected by Petitioner's staff. HCFA Ex. 19 at 2 - 6; HCFA Ex. 38 at 2 - 6; Tr. at 113. In one instance, a resident had developed a pressure sore that had progressed to Stage III without detection by Petitioner's staff. Tr. at 113. A "Stage III" pressure sore is one which has progressed to the extent that it extends through subcutaneous tissue down to muscle. Id. Petitioner does not dispute this evidence. Indeed, Petitioner admits that it had a system-wide problem in identifying, preventing, and treating pressure sores. Tr. at 433 - 434.

b. Petitioner did not correct its immediate jeopardy level deficiencies prior to April 23, 1998.

Petitioner asserts that it corrected all immediate jeopardy level deficiencies (and, as I shall discuss at Finding 3, all other deficiencies that were identified at the March 26 - April 3, 1998 survey) by no later than April 14, 1998. Petitioner argues, alternatively, that HCFA has failed to show persuasively that any deficiencies in Petitioner's operation that persisted after April 13, 1998 were of such scope and severity as to constitute immediate jeopardy. Petitioner Br. at 22.

I held in Wellington Specialty Care & Rehabilitation Center, DAB CR548 at 18 - 19 (1998), that a facility has the burden of proving by the preponderance of the evidence that it has rectified its noncompliance with a participation requirement if noncompliance is established and the facility avers that it has corrected that noncompliance as of a subsequent date. Where HCFA establishes that deficiencies put residents of a facility in immediate jeopardy, it is the facility's burden to show that the immediate jeopardy has been removed. Furthermore, where a facility disputes HCFA's determination as to the level of a deficiency, the burden is on the facility to prove that the determination is clearly erroneous. See 42 C.F.R. § 498.60(c)(2).

I find April 23, 1998 - the date when the Massachusetts State survey agency determined that Petitioner removed immediate jeopardy - to be the date when Petitioner no longer manifested immediate jeopardy level deficiencies. Petitioner did not prove that it removed immediate jeopardy at an earlier date. The evidence that Petitioner offered to show that it removed immediate jeopardy by April 14, 1998 is rebutted by other, more persuasive, evidence.

Petitioner proved that it engaged in intensive efforts prior to April 14, 1998 to correct the immediate jeopardy level deficiencies that were identified at the March 26 - April 3, 1998 survey of Petitioner. Some of these efforts included:

• Obtaining the services of consultants to assist it in identifying and caring for pressure sores. P. Exs. 118 and 123; Tr. at 417; 507.

• Assessing each resident for the risk of developing, or the presence of, pressure sores. P. Ex. 120; Tr. at 416 - 417; 506 - 507.

• Providing training to Petitioner's nursing staff to assure that the staff was prepared to prevent, identify, and treat pressure sores. P. Exs. 10 - 13; Tr. at 422 - 428.

• Strengthening the care plan of each resident who was determined to be at risk for developing pressure sores. P. Exs. 124 - 125; Tr. at 509 - 511.

• Obtaining the services of pharmacy consultants to aid Petitioner in its efforts to improve the way in which it delivered medications to residents. P. Exs 7 - 8; Tr. at 410 - 413.

• Reviewing and revising Petitioner's medication administration policies and procedures. P. Exs. 2 - 5.

• Providing training to Petitioner's nursing staff to assure that the staff was well-versed in all aspects of medication administration. P. Ex. 1.

However, as salutary as these efforts may have been, they did not eliminate immediate jeopardy by April 14, 1998. The surveyors' findings, made at a survey conducted on April 14, 1998, establish that Petitioner was still experiencing significant problems as of that date in the way in which medications were being administered to Petitioner's residents. HCFA Ex. 22. HCFA's determination that immediate jeopardy persisted at Petitioner's facility until April 23, 1998 is sustained by the weight of the evidence. And, even if the weight of the evidence would not sustain HCFA's determination, Petitioner did not prove that determination to be clearly erroneous.

The surveyors who conducted the April 14, 1998 survey found that Petitioner continued to manifest serious problems in the way in which it administered medications to its residents notwithstanding Petitioner's assertion that it had removed immediate jeopardy. Among the problems uncovered by the surveyors were: mis-administration of the pain reliever Vicodin to a resident on April 4, 1998; administration of an overdose of Ritalin to a resident on April 9, 1998; a failure by Petitioner between March 30, 1998 and April 12, 1998 to administer an antidepressant, Paxil, to a resident despite a physician's prescription for the medication; administration of overdoses of ascorbic acid to a resident between March 30, 1998 and April 13, 1998; and, administration of an overdose of Ativan to a resident on April 13, 1998. HCFA Ex. 22 at 5 - 6.

Petitioner does not deny the presence of these errors. It argues that none of them caused a resident to experience significant harm. It argues, furthermore, that the errors are not inconsistent with Petitioner's assertion that it corrected its immediate jeopardy-level deficiencies by April 14, 1998 inasmuch as all of the errors occurred before April 14, 1998.

I am not persuaded by Petitioner's arguments that the errors detected by the surveyors on April 14, 1998 fail to show a continuing immediate jeopardy level deficiency in the way in which Petitioner administered medications to its residents. The persistence of errors in administering medication demonstrates that, as of April 14, 1998, Petitioner still could not assure that its residents would receive medications timely and according to the orders that the residents' physicians had issued.

The evidence of continuing errors in administration of medications shows that, as of pril 14, 1998, Petitioner had not yet broken its pattern of mis-administration of medications to residents despite Petitioner's intensive efforts to correct its immediate jeopardy level deficiencies. The potential for serious harm to residents lies in that continuing pattern. The inference that I draw from the continued presence of the pattern is that the possibility still existed that a resident of Petitioner's facility might be mis-administered medication in a way that could cause the resident to suffer serious harm or death. The fact that no resident actually may have been harmed by the mis-administration of medications that the surveyors unearthed on April 14, 1998 misses the point. The potential for immediate jeopardy level harm lay in Petitioner's propensity to mis-administer medications to its residents.

Petitioner's assertion that it corrected its immediate jeopardy level deficiencies by April 14, 1998 is additionally undercut by an audit report which was issued by one of its pharmacy consultants on April 13, 1998. HCFA Ex. 21. That report shows that, as of April 13, 1998, Petitioner continued to manifest numerous errors in the way in which it administered medications to its residents.

The audit report concluded that, as of April 13, 1998, the vast majority of Petitioner's residents were receiving medications in a safe and accurate manner. HCFA Ex. 21 at 3. However, it also concluded that, as of April 13, 1998, there remained several areas of deficiency which needed "immediate attention." Id. Among other things, the audit report identified: failures by Petitioner to deliver medications to residents that had been ordered for those residents; a medication sheet which did not match a resident's physician's orders; medication label discrepancies; incorrect dosages of medication noted on patients' records; and illogical choices of medication doses and administration. Id. at 3 - 4.

2. It is reasonable to impose a civil money penalty of $7,000 per day against Petitioner for each day of the period which begins with April 1, 1998 and which runs through April 22, 1998.

Petitioner does not dispute that a $7,000 per day civil money penalty is reasonable for each day of the period which begins on April 1, 1998 and which runs through April 13, 1998. Petitioner has acknowledged that its residents were in immediate jeopardy during that period and that a $7,000 per day penalty is reasonable given the circumstances and the factors which govern the amounts of civil money penalties.

I sustain a civil money penalty of $7,000 per day for each day beginning with April 1, 1998 and running through April 22, 1998 based on my finding that Petitioner was not complying with participation requirements on each of those dates to the extent that its residents were in immediate jeopardy. I find that the penalty of $7,000 per day should continue from April 14, 1998 through April 22, 1998, because the nature of the jeopardy that Petitioner's residents were experiencing was essentially the same during this latter period as it was during the period from April 1, 1998 through April 13, 1998. Notwithstanding Petitioner's efforts at correction, residents of Petitioner remained at a high risk for injury or death from mis-administration of medications during the period from April 14, 1998 through April 22, 1998.

3. Non-immediate jeopardy level deficiencies persisted at Petitioner's facility through June 30, 1998. Petitioner corrected all of these deficiencies by no later than July 1, 1998.

In this Finding, I discuss the period that begins with April 23, 1998 and which runs through June 30, 1998. I conclude that Petitioner remained noncompliant at a less than immediate jeopardy level of deficiency through June 30, 1998. However, I conclude also that Petitioner was complying substantially with participation requirements as of July 1, 1998.

Deciding the questions of whether Petitioner was noncompliant during the period beginning on April 23, 1998 and ending on July 1, 1998 requires me to consider findings that the Massachusetts State survey agency made at three surveys of Petitioner. These surveys include the March 26 - April 3, 1998 survey which, to some extent, I discussed at Finding 1. They also include a survey that was conducted on June 2, 1998 and a survey that was conducted on July 1, 1998. One principal purpose of the June 2, 1998 survey was to investigate a complaint that Petitioner had neglected the care of a resident on April 30, 1998. HCFA Ex. 43. The purpose of the July 1, 1998 survey was to conduct a comprehensive review of Petitioner's compliance status in order to ascertain whether Petitioner had attained substantial compliance with all participation requirements as of that date. HCFA Ex. 64.

a. Petitioner corrected all of the deficiencies that were identified at the March 26 - April 3, 1998 survey of Petitioner by July 1, 1998.

The first question that I address in this Finding is: when, if at all, did Petitioner correct all of the deficiencies - including deficiencies that were of less than an immediate jeopardy level - that the surveyors identified at the March 26 - April 3, 1998 survey of Petitioner? HCFA Ex. 38. In some respects, that question is answered by comparing what the surveyors found at this first survey with what they found at the July 1, 1998 comprehensive resurvey of Petitioner. In the latter survey, the surveyors found that, with one exception, all of the deficiencies that they had identified at the March 26 - April 3, 1998 survey had been corrected by July 1, 1998. See HCFA Ex. 64. Therefore, it is apparent that, at a minimum, Petitioner had corrected all but one of the deficiencies that were identified in the March 26 - April 3, 1998 survey by no later than July 1, 1998.

The question of when Petitioner corrected the deficiencies that were identified on March 26 - April 3, 1998 also is answered by evidence which describes: (1) the deficiencies other than immediate jeopardy level deficiencies that were established at the March 26 - April 3, 1998 survey, and; (2) the timing and effectiveness of Petitioner's efforts to correct those deficiencies. The surveyors who conducted the March 26 - April 3, 1998 survey identified more than 20 deficiencies in Petitioner's operation, in addition to those of an immediate jeopardy level, that constituted substantial failures by Petitioner to comply with federal participation requirements. HCFA Ex. 38. The surveyors determined that several of these deficiencies established that Petitioner was not complying with participation requirements to the extent that residents were placed at a risk of harm falling just short of the immediate jeopardy level. These deficiencies included findings that Petitioner failed to assure that:

• Comprehensive assessments of residents were accurate and signed by a registered nurse. HCFA Ex. 38 at 21 - 22; 42 C.F.R. § 483.20(i)(1).

• Comprehensive care plans were developed and periodically revised for its residents to address all resident care needs. HCFA Ex. 38 at 25 - 26; 42 C.F.R. § 483.20(d).

• Residents received routine, emergency, and as-needed medications on a timely basis. HCFA Ex. 38 at 97; 42 C.F.R. § 483.60.

• All drugs and biologicals were accurately acquired, received, dispensed, and administered. HCFA Ex. 38 at 99 - 100; 42 C.F.R. § 483.60(a).

Additionally, the surveyors found that some of the non-immediate jeopardy level deficiencies demonstrated that Petitioner was providing care of a substandard quality to its residents. A "substandard quality of care" is defined to mean deficiencies related to the quality of residents' life or care which constitute either immediate jeopardy to residents; a pattern of or widespread actual harm to residents that is not immediate jeopardy; or a widespread potential for more than minimal harm to residents, but which is not immediate jeopardy and which does not constitute actual harm. 42 C.F.R. § 488.301. These substandard quality of care deficiencies included failures by Petitioner to assure that:

• Residents who were dependent on Petitioner's staff for eating received the services that were necessary to maintain good nutrition. HCFA Ex. 38 at 38; 42 C.F.R. § 483.25(a)(3).

• Residents did not develop sores where development of pressure sores was avoidable. HCFA Ex. 38 at 40 - 41; 42 C.F.R. § 483.25(c).

• Residents who experienced psychosocial adjustment difficulties were given appropriate care. HCFA Ex. 38 at 54; 42 C.F.R. § 483.25(f)(1).

• Residents maintained acceptable parameters of nutritional status. HCFA Ex. 38 at 61; 42 C.F.R. § 483.25(i)(1).

• Residents received sufficient fluids to maintain proper hydration and health. HCFA Ex. 38 at 79 - 80; 42 C.F.R. § 483.25(j).

• Petitioner maintained a medication error rate of no worse than five percent and that there were no significant errors in administering medications to residents. HCFA Ex. 38 at 86 - 87; 42 C.F.R. §§ 483.25(m)(1); (m)(2).

There is some considerable overlap between what was identified by the surveyors at the March 26 - April 3, 1998 survey of Petitioner as immediate jeopardy level deficiencies and non-immediate jeopardy level deficiencies. The surveyors' findings concerning Petitioner's mis-administration of medications to residents are the basis for both immediate jeopardy level and non-immediate jeopardy level deficiency citations. So also are the surveyors' findings concerning Petitioner's failure to prevent, identify, and treat pressure sores. Successful efforts by Petitioner to rectify problems concerning administration of medications or pressure sores would address deficiencies at both the immediate jeopardy and the non-immediate jeopardy level.

As I discuss above, at Finding 1, Petitioner offered extensive testimony and documentary evidence to describe the efforts it made to correct the problems which the surveyors identified as being a basis for findings of immediate jeopardy level deficiencies. Much of this evidence addressed the way in which Petitioner dealt with its medication administration and pressure sore problems. Tr. at 388 - 502; 503 - 553. I am persuaded by this evidence that, by late April 1998, Petitioner had addressed successfully many if not all of the problems that it was experiencing in these areas.

However, I am not persuaded that Petitioner offered a compelling case as to how it addressed and rectified the other problems that the surveyors identified at the March 26 - April 3, 1998 survey which were not related to medication administration and the prevention, identification, and treatment of pressure sores. As I discuss above, the surveyors identified serious problems in Petitioner's operations which included problems with the way in which Petitioner planned the care of and assessed its residents, problems in administration, and problems with the delivery of services other than medication to residents.

I conclude that Petitioner did not present persuasive affirmative evidence that it corrected all of the deficiencies that were identified at the March 26 - April 3, 1998 survey prior to July 1, 1998. The evidence which Petitioner presented, while an impressive recitation of what Petitioner did to rectify medication- and pressure sore-related deficiencies, does not address satisfactorily what Petitioner did to correct the many other categories of deficiencies that were identified by the surveyors at the March 26 - April 3, 1998 survey.

Furthermore, Petitioner's assertion that it corrected all of the deficiencies that were identified at the March 26 - April 3, 1998 survey of Petitioner by no later than April 13, 1998 is belied by its previous representations to the Massachusetts State survey agency and to HCFA that it would correct - and, in fact, did correct - these deficiencies by June 30, 1998. The inference I draw from these previous representations is that Petitioner did not actually rectify all outstanding deficiencies before July 1, 1998. These representations constitute Petitioner's assessment of what it would be doing and when it would be doing it at a time when it was not in Petitioner's self-interest to claim an earlier compliance date.

On April 27, 1998, the Massachusetts State survey agency requested Petitioner submit a plan of correction to it addressing the non-immediate jeopardy level deficiencies that were identified at the March 26 - April 3, 1998 survey. HCFA Ex. 28. Petitioner submitted its plan on or about May 3, 1998. HCFA Ex. 38. In that plan, Petitioner averred that it would correct outstanding deficiencies by June 30, 1998, and not April 13, 1998 as it presently contends. Id. Petitioner subsequently amended its plan of correction. HCFA Ex. 40. In an addendum to the amendment, Petitioner averred that it would correct some, but not all, of the outstanding deficiencies by June 2, 1998. HCFA Ex. 41. On June 29, 1998, Petitioner advised the Massachusetts State survey agency that it would attain substantial compliance with participation requirements on June 30, 1998. HCFA Ex. 63.

The one allegedly uncorrected deficiency that the surveyors identified in the July 1, 1998 survey is in the area of resident assessment. HCFA Ex. 64 at 1; 42 C.F.R. § 483.20(k)(3)(ii). In the report of the July 1, 1998 survey, the surveyors erroneously cited the governing regulation for their deficiency citation as 42 C.F.R. § "483.20(d)(3)(ii)." No such section exists. It is apparent that the surveyors meant to cite 42 C.F.R. § 483.20(k)(3)(ii). This section of the regulations requires a long-term care facility to provide services to each resident in accord with a comprehensive plan of care that has been developed for that resident.

HCFA has subsequently asserted that Petitioner was also deficient as of July 1, 1998 in that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.25. This section requires that each resident of a long-term care facility receive the necessary care and services to attain or maintain the highest practicable level of well-being, in accordance with the resident's comprehensive assessment and plan of care. This new allegation does not, in fact, constitute an assertion that Petitioner manifested additional problems at the July 1, 1998 survey from that which the surveyors identified in their report. Rather, it relies on the identical facts that the surveyors identified in their report.

HCFA now argues that, under 42 C.F.R. §§ 483.20(k)(3)(ii) and 483.25, Petitioner was deficient in providing care to a resident whom the surveyors identified as Resident #2. HCFA Ex. 64 at 2. This resident had received a laceration to her scalp which had been repaired surgically with stitches. Id. The resident's treating physician ordered that Petitioner's nursing staff "cover sutures with telfa every shift." Id. Telfa is a non-adhesive dressing. Id. The physician additionally ordered nurses to monitor the resident "for signs and symptoms of infection every shift." Id.

Petitioner's alleged failure to comply with the requirements of 42 C.F.R. §§ 483.20(k)(3)(ii) and 483.25 lay in the way in which a nurse employed by Petitioner was alleged to have treated Resident #2's wound. A surveyor observed the nurse treating the wound without wearing gloves. HCFA Ex. 64 at 2. The surveyor observed the nurse treating the wound with non-sterile 4 x 4 gauze squares, which the nurse allegedly first deposited on the non-sterile surface of a dresser, thereby contaminating the squares. Id. According to the surveyor, the nurse attempted to clean the resident's wound by pouring saline solution over it. Some of the solution was observed to flow down the resident's face and onto the resident's garment. Id. The nurse attempted to remove dried blood from the wound with the allegedly contaminated gauze squares. Id. at 3. When that effort failed, the nurse allegedly attempted to clean the wound with a wash cloth. Id. Finally, according to the surveyor, the nurse was interrupted by other personnel who completed the process of cleaning the resident's wound.

HCFA asserts that the technique employed by the nurse in providing care to Resident #2 manifested deficiencies in the following respects:

• The treating nurse allegedly failed to comply with professional standards of quality in treating Resident #2. HCFA Br. at 20. Professional standards of quality allegedly required the nurse to use sterile technique to clean the resident's wound. Tr. at 340. The nurse failed to use sterile technique in that the nurse failed to wear gloves while treating Resident #2, used non-sterile gauze squares and a washcloth to treat the wound, and contaminated the already non-sterile gauze squares by placing them on a non-sterile surface. Id. at 337, 341.

• The treating nurse allegedly failed to comply with professional nursing standards by allowing the saline solution that was used to clean the resident's wound to run down the resident's face. HCFA Br. at 20. The possibility allegedly existed that an infection could be transmitted to the resident by the saline solution. Tr. at 341 - 342.

Petitioner has not challenged the observations of the surveyor as to how the nurse treated Resident #2. However, the manner in which the nurse provided care to the resident does not establish Petitioner to have been deficient in the care that it delivered to the resident. The preponderance of the evidence establishes that the nurse's treatment of Resident #2, while clumsy, did not demonstrate a failure by Petitioner to comply substantially with participation requirements.

First, HCFA failed to establish even a prima facie case that the treatment that the nurse provided to the resident was inconsistent with the order given by the resident's treating physician. A failure by the nurse to use sterile technique in cleaning Resident #2's wound simply is not, on its face, a failure to comply with the treating physician's order to the nurse. That order did not specify that the resident's wound be cleaned using sterile technique. Indeed, it said nothing about how the nurse was to have cleaned the resident's wound.

Second, I am not persuaded that applicable nursing standards would have required a nurse to use sterile technique to perform the care that is at issue here. The preponderance of the evidence is that, in cleaning a closed wound (the resident's wound had been sutured), sterile technique is not necessary. Dr. Schutt, who has eleven years experience as a physician treating the geriatric population, testified credibly that sterile technique would not be necessary to clean a wound of the nature of the wound manifested by Resident #2. Tr. at 643; 652 - 654. The technique utilized by Petitioner's nurse was entirely consistent with the applicable standard of care. Id.

Finally, I am not persuaded that the potential for more than minimal harm existed in the way in which the nurse provided care to Resident #2. The weight of the evidence is that there was no meaningful risk of harm to the resident from the nurse's use of non-sterile technique to clean the resident's wound. Tr. at 652 - 654. To a degree, this conclusion is supported by the facts that the resident's wound remained uninfected and eventually healed. P. Ex. 40 at 2, 4, 6 - 9; P. Ex. 43 at 5 - 12. It was inappropriate to for the nurse to allow saline solution to run down the resident's face. But, to find that a treatment technique is inappropriate is not to say that utilization of the technique placed the resident at risk for sustaining more than minimal harm.

b. By July 1, 1998 Petitioner corrected the additional deficiencies that the surveyors identified at the June 2, 1998 complaint investigation survey of Petitioner. The preponderance of the evidence does not sustain other allegations of deficiencies that were made in the report of the June 2, 1998 complaint survey.

When the surveyors visited Petitioner's facility to conduct the June 2, 1998 complaint survey, they found deficiencies that were in addition to those which had been identified previously at the March 26 - April 3, 1998 comprehensive survey of Petitioner. HCFA Ex. 43. I note that the report of the July 1, 1998 comprehensive survey fails to mention any of the deficiencies that the surveyors identified on June 2, 1998. See HCFA Exs. 43; 64. I infer from the failure of the surveyors to re-cite the deficiencies that they identified on June 2, 1998 in their July 1, 1998 comprehensive survey report that the previously cited deficiencies had been corrected by July 1, 1998.

I have also evaluated the findings that the surveyors made at the June 2, 1998 survey in order to decide whether they establish the presence of any deficiencies that persisted as of July 1, 1998. I find from the affirmative proof that Petitioner introduced that any actual deficiencies that the surveyors identified on June 2, 1998 were corrected by Petitioner prior to the July 1, 1998 comprehensive survey. Furthermore, I conclude that some of the allegations of deficiencies that the surveyors made are effectively rebutted by the evidence that Petitioner offered.

The June 2, 1998 survey of Petitioner focused on Petitioner's treatment of two residents who were identified in the report of that survey as Resident #1 and Resident #2. HCFA Ex. 43. A principal purpose of the June 2, 1998 survey was to investigate an incident that involved Resident #1. On April 30, 1998 this resident wandered from her room and fell down a flight of stairs. Id. The surveyors also investigated the circumstances of Resident #2. Resident #2 had attempted to elope from Petitioner's facility on several occasions. Id.

The evidence that the surveyors developed concerning Resident #1 shows that Petitioner's staff had lost track of the resident for a considerable period of time on April 30, 1998 prior to the resident being discovered lying injured at the bottom of a staircase. HCFA Ex. 43 at 1- 4. The surveyors concluded that Petitioner was deficient in numerous respects in the way it provided care to the resident on April 30, 1998.

Petitioner avers that, however it may have been deficient in caring for this resident, it corrected any deficiency immediately. Petitioner offered evidence to prove that within 24 hours of the incident it undertook numerous corrective actions that precluded the possibility of a recurrence. These measures included:

• Immediately testing and replacing defective door alarms. P. Ex. 30; Tr. at 577 - 579.

• Instituting daily door alarm checks by Petitioner's nursing staff and weekly door alarm checks by Petitioner's maintenance staff. P. Ex. 23 at 2; P. Ex. 31; Tr. at 582 - 583.

• Limiting staff access to keys to the locked bars of exit doors of Petitioner's facility. Tr. at 579.

• Providing training to Petitioner's nursing staff concerning Petitioner's elopement policies and procedures. P. Exs. 32 - 33; Tr. at 588 - 589.

• Suspending and ultimately terminating from employment the nursing assistant who was responsible for keeping track of the resident on the day of the incident. P. Ex. 29; Tr. at 585 - 587.

• Requesting the agency who employed the nurse-supervisor who was on duty at the time of the incident not to return the nurse-supervisor to Petitioner's facility. P. Ex. 26; Tr. at 587.

Petitioner quickly corrected the deficiencies that were established by the incident involving Resident #1. The corrective measures that Petitioner instituted were all undertaken and completed weeks prior to the June 2, 1998 complaint survey. The Massachusetts State survey agency surveyors who conducted the June 2, 1998 survey did not identify any evidence to show that the problems it identified in the care that Petitioner had provided to Resident #1 continued to be extant as of June 2, 1998, or even that they persisted after April 30, 1998.

The Massachusetts State survey agency surveyors and HCFA allege that the evidence which relates to the care that Petitioner gave to Resident #2 demonstrates that Petitioner failed to provide adequate supervision of the resident to prevent the resident from experiencing accidents. Resident #2 was diagnosed as being demented. HCFA Ex. 43 at 13. This resident was identified by Petitioner's staff as being at risk for elopement from Petitioner's facility. Id. at 13 - 14. In order to prevent the resident from eloping, Petitioner directed its staff to check on the resident's whereabouts at 15-minute intervals. Id. Notwithstanding, on one occasion, in January, 1998, the resident managed to elope. On that occasion, Resident #2 was found in Petitioner's facility's parking lot by a relative of another resident. Id.

The surveyors found that on other occasions, on May 16 and 17, 1998, the resident again attempted to elope Petitioner's facility. HCFA Ex. 43 at 14 - 15. On each of these occasions, a member of Petitioner's staff found the resident before the resident could leave the facility. Id. On May 31, 1998, the resident again attempted to elope. On this occasion, Petitioner's receptionist observed the resident leaving the facility by the facility's front door. Id. The receptionist called Petitioner's nursing staff to intercept the resident.

HCFA has not made even a prima facie showing that a potential existed for more than minimal harm to the resident from the limited degree of movement within Petitioner's facility that the resident was able to engage in. Although the evidence shows that, on one occasion, in January 1998, the resident succeeded in eloping, the evidence shows also that on each subsequent occasion on which the resident attempted to elope Petitioner's staff succeeded in intercepting the resident before the resident could elope. Although the supervision that Petitioner's staff gave to Resident #2 after January 1998 did not prevent some degree of movement by the resident within Petitioner's facility, it was adequate to prevent the resident from eloping the facility.

4. It is reasonable to impose a civil money penalty of $3,000 per day against Petitioner for each day of the period which begins on April 23, 1998 and which runs through June 30, 1998.

HCFA established a basis for imposing a civil money penalty against Petitioner for each day of the period which begins with April 23, 1998 and which runs through June 30, 1998. Petitioner was not complying substantially with federal participation requirements, at a level of noncompliance that is less than the immediate jeopardy level, on each day of that period.

I conclude that a civil money penalty of $3,000 per day - the maximum amount which is permitted for non-immediate jeopardy level deficiencies - is a reasonable civil money penalty to remedy Petitioner's noncompliance during the period which begins with April 23, 1998 and which runs through June 30, 1998. I do so for three reasons. First, because the deficiencies that persisted throughout the period approached immediate jeopardy in their scope and severity. Second, because Petitioner has a poor compliance history. Third, because Petitioner manifests a high degree of culpability for its deficiencies. In reaching my decision as to the amount of the civil money penalty I have considered Petitioner's efforts to correct the deficiencies that were identified at the March 26 - April 3, 1998 survey. These efforts were impressive and show a sincere attempt by Petitioner to correct outstanding deficiencies. However, they were insufficient to eliminate serious risks of harm to residents of Petitioner prior to July 1, 1998.

I have held in other decisions that an administrative law judge is required to conduct a de novo review of the evidence to decide what is an appropriate civil money penalty in the case where a long-term care facility is not complying substantially with participation requirements. CarePlex of Silver Spring, DAB CR536 (1998). In deciding what is reasonable in any case, the administrative law judge must look at factors governing the amount of a civil money penalty that are stated in the Act and in applicable regulations. Id. at 9 - 12. I have looked closely here at the evidence which relates to relevant factors that are stated in the Act and regulations.

One of the relevant factors that must be considered in deciding the reasonable amount of a civil money penalty is the seriousness of a long-term care facility's noncompliance with participation requirements. 42 C.F.R. § 488.404(b). Here, the evidence establishes that the deficiencies which Petitioner continued to manifest beginning with April 23, 1998 were very serious. In several instances, which I have discussed above, at Finding 3, these deficiencies approached the immediate jeopardy level of severity.

Another relevant factor that must be considered in deciding the amount of a civil money penalty is a facility's compliance history. 42 C.F.R. §§ 488.404(c)(2); 488.438(f)(1). In this case, HCFA established that Petitioner has a poor compliance history. Petitioner was found to be deficient in surveys that were completed on: April 19, 1996; May 21, 1996; March 6, 1997; and January 21, 1998. HCFA Exs. 1 - 3; 8. Some of the deficiencies that were identified at these earlier surveys resemble or are similar to deficiencies that were identified in the March 26 - April 3, 1998 survey of Petitioner. For example, the report of the survey that was completed on May 21, 1996 cited Petitioner for failing to prevent the development of an avoidable pressure sore in one of its residents. HCFA Ex. 2 at 13 - 14. The report of the survey that was completed on January 21, 1998 found that Petitioner manifested a high error rate in the administration of medications to its residents. This same finding was central to the immediate jeopardy level deficiency findings that were made at the March 26 - April 3, 1998 survey. HCFA Ex. 8.

The evidence of Petitioner's compliance history points to a third factor consisting of Petitioner's culpability for the deficiencies. 42 C.F.R. § 488.438(f)(4). It is apparent from Petitioner's history of deficiencies that the findings that were made at the March 26 - April 3, 1998 survey were the culmination of a history of noncompliance that began months or years earlier. That history of noncompliance shows that Petitioner was aware of the problems that resulted in the deficiencies that were identified at the March 26 - April 3, 1998 survey long before the surveyors identified those deficiencies. That knowledge is evidence of at least some indifference by Petitioner, prior to April, 1998, to the problems that caused the deficiencies.

My conclusion that Petitioner was aware of serious problems at its facility prior to the March 26 - April 3, 1998 survey - and thus culpable for them - finds considerable support in the testimony of Dr. Schutt, Petitioner's medical director. Dr. Schutt testified that in the autumn of 1997 he had become concerned about the way in which Petitioner's staff was administering medications to residents. Tr. at 647 - 649. He expressed his concerns to Petitioner's corporate staff. However, it was not until beginning in April, 1998, that Dr. Schutt observed considerable improvement in the way in which medications were administered to residents. Id. at 651 - 652.

5. Petitioner complied substantially with participation requirements from July 1, 1998 until July 26, 1998.

In this Finding and in the next two Findings I discuss the period which began on July 1, 1998 and which runs until October 1, 1998. No surveys were conducted of Petitioner between July 1, 1998 and September 29, 1998. On September 29, 1998, surveyors from the Massachusetts State survey agency returned to Petitioner and conducted a comprehensive survey to ascertain Petitioner's compliance with participation requirements. HCFA Ex. 79. The surveyors concluded that Petitioner was not complying substantially with participation requirements. HCFA relies on these findings by the surveyors to argue that Petitioner was not complying substantially with participation requirements during the entire period which begins on July 1, 1998 and which runs through September 30, 1998.

The surveyors who conducted the September 29, 1998 survey of Petitioner found that Petitioner was not complying substantially with three separate participation requirements. Their allegations are that Petitioner was not complying substantially with the requirements of:

• 42 C.F.R. § 483.20(k)(3)(i) (cited erroneously in the report of the September 29, 1998 survey as 42 C.F.R. § "483.20(d)(3)(i)") in that services that Petitioner provided to its residents did not meet professional standards of quality. HCFA Ex. 79 at 1 - 8.

• 42 C.F.R. § 483.60(a) in that Petitioner failed to assure that all drugs were dispensed accurately to one of Petitioner's residents. HFCA Ex. 79 at 8 - 10.

• 42 C.F.R. § 483.60(d) in that Petitioner failed to assure that drugs used at its facility were labeled in accordance with currently accepted medical principles. HCFA Ex. 79 at 10 - 11.

The allegations arise from the surveyors' review of treatment records and their observations of the care that Petitioner's staff gave to five residents. These residents are described in the report of the September 29, 1998 survey as Residents #s 1, 2, 3, 4, and 5. HCFA Ex. 79 at 1. The surveyors' findings with respect to Residents #s 1 - 4 are based on observations that the surveyors made of the care that Petitioner's staff gave to these residents on September 29, 1998. HCFA Ex. 79. The surveyors' findings with respect to Resident #5 are based on their review of treatment records which cover the period which began on July 26, 1998 and which runs through August 13, 1998.

There is nothing in the report of the September 29, 1998 survey which supports an inference that Petitioner was not complying with participation requirements between July 1, 1998 and July 26, 1998. See HCFA Ex. 79. At Finding 3, I conclude that Petitioner had attained compliance with participation requirements by July 1, 1998. HCFA has not established even a prima facie case of noncompliance during the July 1 - July 26, 1998 period. The allegations which the surveyors made concerning Residents #s 1 - 4 all relate to the manner in which Petitioner's nursing staff gave care to the residents on September 29, 1998. None of that evidence addresses an earlier period. The allegations which the surveyors made concerning Resident #5 all relate to the manner in which Petitioner's nursing staff gave care to the resident during the period which began on July 26, 1998. None of that evidence addresses care which was given to the resident prior to July 26, 1998.

6. Petitioner did not comply substantially with participation requirements during the period which begins on July 26, 1998 and which runs through August 13, 1998.

The surveyors who conducted the September 29, 1998 survey developed credible evidence that, during the period which begins on July 26, 1998 and which runs through August 13, 1998, Petitioner was not complying substantially with all three of the participation requirements that are cited in the report of the September 29, 1998 survey. HCFA Ex. 79. Petitioner's noncompliance arises from the manner in which Petitioner's staff gave care to Resident #5.

The unrebutted evidence which the surveyors adduced concerning the care which Petitioner gave to Resident #5 is as follows. Resident #5 had been prescribed Valium by her physician to treat an emotional disorder. On July 26, 1998, Petitioner's nursing staff ordered a refill of the resident's prescription for Valium. HCFA Ex. 79 at 6. The prescription was refilled incorrectly by the pharmacy from which the medication was ordered with Klonopin, another medication, and not Valium.

Klonopin is chemically related to Valium. However, it is not an identical medication. It can produce side effects in an individual when not administered properly which include drowsiness, confusion, slurred speech, and respiratory depression. HCFA Ex. 79 at 6.

The package of medication which was given to Petitioner as a refill of Resident #5's Valium prescription, but which contained Klonopin, was not clearly labeled as containing either Klonopin or Valium. Rather, the package contained two labels, one of which stated that the medication consisted of Valium, and the other of which stated that the medication consisted of Klonopin. Petitioner's staff failed to note the labeling discrepancy when they signed the medication in at the facility. HCFA Ex. 79 at 7. As a consequence, the medication was placed into the facility's medication cart and was administered to Resident #5 beginning on July 26, 1998. Id. Resident #5 continued to receive Klonopin in lieu of Valium until August 13, 1998. On that date, an audit by Petitioner's pharmacy consultant uncovered the medication error. Petitioner's physician ordered that administration of Klonopin to the resident be tapered off. This was accomplished without lasting injury to the resident.

During the period between July 26, 1998 and August 13, 1998, Resident #5 manifested signs which included fatigue, lethargy, extreme drowsiness, and respiratory congestion. HCFA Ex. 79 at 7 - 8. During this period the resident developed pneumonia. The signs manifested by the resident were consistent with an adverse effect of administration of Klonopin to the resident and also with pneumonia. Thus, it is not possible to find definitively that the resident's signs were due to mis-administration of Klonopin to the resident. Tr. at 666 - 668. There is no proof that the resident actually was harmed by the mis-administration of Klonopin. Id. at 663. However, there existed a potential for more than minimal harm to the resident resulting from the mis-administration of Klonopin to the resident. Id. at 665 - 666.

Petitioner immediately took a number of steps to address the problems which were exposed by this episode. Petitioner implemented its corrective actions by August 14, 1998. It terminated the employment of the two members of the staff who incorrectly signed Resident #5's medication into the facility. HCFA Ex. 79 at 2. It conducted retraining of the eight nurses who had administered the medication to the resident. Id.

The evidence relating to the mis-administration of Klonopin to Resident #5 establishes that, during the period from July 26 - August 13, 1998, Petitioner manifested a recurrence of problems relating to administration of medication to its residents. Petitioner's staff was remiss, both in checking the medication when it arrived at Petitioner's facility to assure that the prescription had been filled accurately, and in administering the medication to Resident #5 without verifying that the resident was receiving the correct medication. These errors establish that Petitioner was not complying substantially with the requirements of 42 C.F.R. §§ 483.20(k)(3)(i), 483.60(a), and 483.60(d) during the period in question.

Petitioner argues that the errors which relate to the mis-administration of medication to Resident #5 do not establish deficiencies when considered in context. Petitioner asserts, first, that the errors originated with the pharmacy that filled the prescription and not with Petitioner's staff. Furthermore, according to Petitioner, the errors must be considered against the backdrop of the extensive efforts that Petitioner had made in April, 1998 to correct problems relating to administration of medication to its residents and the many weeks of error-free administration in thousands of individual cases during the period between April and July, 1998. Petitioner notes also that it had discovered the errors relating to Resident #5 on its own and had reported those errors to the Massachusetts State survey agency.

I agree with Petitioner that there had been considerable improvement in its medication administration practices. Nor is the mis-administration of medication to Resident #5 entirely attributable to Petitioner's staff. The pharmacy which filled the prescription bears substantial responsibility for what happened to the resident. Moreover, the episode pertaining to Resident #5 is an isolated event. There is no evidence in the July 26 - August 13, 1998 period, as there was in April, 1998, of wholesale medication administration errors by Petitioner. Notwithstanding, the evidence relating to the administration of medication to Resident #5 establishes that Petitioner was not complying substantially with participation requirements during the July 26 - August 13, 1998 period. What happened in the case of Resident #5 was more than a simple error. Rather, it constituted an error that was repeated often over a period of days by multiple employees. By Petitioner's own admission, ten of its employees were still not sufficiently trained so as to be able to avoid potentially serious errors in the administration of medication.

7. Petitioner complied substantially with participation requirements after August 13, 1998.

The evidence of the care that Petitioner provided to Residents #s 1, 2, 3, and 4 provides no basis for me to conclude that Petitioner failed to comply substantially with participation requirements after August 13, 1998. The care that Petitioner delivered to these residents either comported with professional standards of quality or did not deviate from those standards to the extent that shortcomings in providing care posed the potential for more than minimal harm to the residents.

a. Petitioner was not deficient in providing care to Residents #s 1 and #2.

The allegation which the surveyors made concerning Petitioner's care of Residents #s 1 and 2 is that, in delivering care to the residents, Petitioner failed to comply with professional standards of quality. HCFA Ex. 79 at 1 - 3; 42 C.F.R. §483.20(k)(3)(i). Specifically, the surveyors asserted that a nurse employed by Petitioner improperly flushed the residents' gastrostomy tubes using ice water. Id.

Each of the residents was being fed through a gastrostomy tube. The physician's orders for each resident were that the tube be flushed periodically with water. HCFA Ex. 79 at 2 - 3. A surveyor who participated in the September 29, 1998 survey observed a nurse flushing each resident's gastrostomy tube with ice water. Id. The surveyor concluded that this technique violated professional standards of quality in that the use of ice water posed a risk of harm for the residents.

The use of small quantities of ice water to flush the residents' gastrostomy tube did not pose the risk of more than minimal harm to the residents. There is no evidence that either resident experienced pain or discomfort from the flushing of their tube. The persuasive opinion of Dr. Schutt is that using ice water to flush a gastrostomy tube would not pose a risk of harm to an individual. Tr. at 658 - 659. Dr. Schutt's opinion is corroborated by other expert testimony. P. Exs. 78 - 79. That is not to say that using ice water to flush a gastrostomy tube is necessarily good nursing practice. But, an inappropriate action by a nurse may not be the basis for finding a failure by a facility to comply substantially with participation practices in the absence of the risk for more than minimal harm. 42 C.F.R. § 488.301.

b. Petitioner was not deficient in providing care to Resident #3.

The surveyors who performed the September 29, 1998 survey of Petitioner cite Petitioner's care of Resident #3 as additional evidence that Petitioner failed to provide care that complied with professional standards of quality. HCFA Ex. 79 at 3 - 5; 42 C.F.R. § 483.20(k)(3)(i). The surveyors made two specific allegations concerning the care that Petitioner gave to Resident #3: first, that a nurse administered a medication, potassium chloride, to the resident in a tablet form whereas the prescription called for the medication to be administered in a liquid form; and second, that a nurse employed by Petitioner improperly failed to take the resident's pulse before administering a medication, Lopressor, to the resident.

Petitioner was not deficient in the manner in which its nurse administered potassium chloride to Resident #3. The administration of a tablet form of potassium chloride to the resident, as opposed to the prescribed liquid form of the medication, did not pose a risk of more than minimal harm to the resident. There is no credible evidence of record to show that the administration of the tablet form of the medication in the circumstance where the liquid form of the medication had been prescribed is even potentially harmful. Moreover, Dr. Schutt testified credibly that a person would absorb and distribute the tablet and liquid form of potassium chloride identically. Tr. at 658 - 659; see P. Ex. 76.

Petitioner was not deficient in the manner in which its nurse administered Lopressor to Resident #3. The gravamen of the surveyors' assertion with respect to the administration of Lopressor is that a surveyor did not personally observe a nurse take the resident's pulse prior to administering Lopressor in a situation where the resident's physician had ordered that the medication not be administered if the resident's apical pulse was below 50 beats per minute. HCFA Ex. 79 at 4 - 5. However, the nurse told the surveyor that the nurse had taken the pulse earlier and that it was above 50 beats per minute. Id. There is nothing in the surveyors' findings to suggest that the nurse was being less than credible when she made that statement to the surveyor. Nor is there anything in the regulations to suggest that the nurse was obligated to take the resident's pulse in the presence of the surveyor. Moreover, I note that the resident's pulse consistently had been reported as being above 50 beats per minute during the period when the resident was being administered Lopressor. P. Ex. 87 at 11.

c. Petitioner was not deficient in providing care to Resident #4.

The surveyors cite the care that Petitioner gave to Resident #4 as further evidence that Petitioner was not providing care that met professional standards of quality. HCFA Ex. 79 at 5 - 6; 42 C.F.R. § 483.20(k)(3)(i). The specific allegation that the surveyors made with respect to the care that Petitioner gave to Resident #4 is that a nurse who was employed by Petitioner improperly failed to take the resident's blood pressure before administering an anti-hypertensive medication to the resident.

I find no failure here by Petitioner to comply with professional standards of quality. The nurse who was questioned by the surveyor averred that she had taken the resident's blood pressure previously and that it was within the parameters defined by the resident's physician as a prerequisite for administering anti-hypertensive medication to the resident. HCFA Ex. 79 at 5 - 6. There is nothing to suggest that the nurse was dishonest nor is there any requirement that the nurse take the resident's blood pressure in the presence of a surveyor.

8. It is reasonable to impose a civil money penalty of $1,500 per day against Petitioner for each day of the period which begins on July 26, 1998 and which runs through August 13, 1998.

HCFA established a basis to impose a civil money penalty against Petitioner for the period which begins on July 26, 1998 and which runs through August 13, 1998. During that period Petitioner was not complying with participation requirements at a less than immediate jeopardy level of severity.

I find a civil money penalty of $1,500 per day to be a reasonable penalty for each day of the July 26 - August 13, 1998 period. This penalty is one-half the amount of the penalty that I have imposed for the April 23 - June 30, 1998 period. Reducing the penalty to $1,500 per day is a reasonable response to the diminished seriousness of the medication administration problems at Petitioner's facility. The problems associated with medication administration during this latter period were not the facility-wide problems that had existed previously. The problems that persisted after July 26, 1998 may be characterized as remnants of the previous systemic medication administration problems. The diminished seriousness of the problem reflects the intensive and largely successful efforts that Petitioner had made to correct the problem.

9. No basis exists to terminate Petitioner's participation in Medicare.

There is no basis in this case for me to sustain HCFA's determination to terminate Petitioner's participation in Medicare. Petitioner did not fail to comply substantially with participation requirements for six continuous months. Petitioner was in substantial compliance with participation requirements as of the date of the most recent survey of Petitioner, September 29, 1998.

 

JUDGE
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Steven T. Kessel

Administrative Law Judge

 

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