CASE | DECISION | JUDGE

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


SUBJECT:

Hermina Traeye Memorial Nursing Home,

Petitioner,

DATE: March 29, 2001
                                          
             - v -

 

Health Care Financing Administration

 

Docket No.C-99-165
Decision No. CR756
DECISION
...TO TOP

I enter the following decisions in these two cases.

• In the case that is docketed as Hermina Traeye Memorial Nursing Home, Docket No. C-99-165, I find that a basis exists to impose civil money penalties against Petitioner. I impose civil money penalties against Petitioner in the amount of $250 per day for each day of the period which begins on June 4, 1998 and ends on August 20, 1998. The total amount of civil money penalties that I impose in this case is $19,500.

• In the case that is docketed as Hermina Traeye Memorial Nursing Home, Docket No. C-99-595, I find that a basis exists to impose civil money penalties against Petitioner. I find that, as of April 23, 1999, Petitioner manifested deficiencies that constituted immediate jeopardy to Petitioner's residents. I impose civil money penalties against Petitioner in the amount of $3,050 per day for each day of the period which begins on April 23, 1999 and ends on May 15, 1999. The total amount of civil money penalties that I impose in this case is $70,150. Additionally, I sustain termination of Petitioner's participation in the Medicare program, effective May 16, 1999.

I. Background

Petitioner, Hermina Traeye Memorial Nursing Home, is a long-term care facility that is located on Johns Island, South Carolina. Prior to its termination from participating in Medicare, Petitioner was owned and operated by the Sea Island Comprehensive Health Care Corporation (Sea Island). Petitioner participated in the Medicare program until May 16, 1999, when HCFA terminated its participation. These two cases involve remedy determinations made by the Health Care Financing Administration (HCFA) based on the outcomes of compliance surveys conducted of Petitioner by the South Carolina Department of Health and Environmental Control (South Carolina State survey agency). The remedies that are at issue include HCFA's determination to impose civil money penalties against Petitioner in both of the cases and to terminate Petitioner's participation in Medicare in Docket No. C-99-595.

In 1998, the South Carolina State survey agency conducted compliance surveys of Petitioner which were completed on June 4, 1998 (June 1998 survey), August 5, 1998 (August 1998 resurvey), and September 10, 1998 (September 1998 resurvey). Petitioner was found not to be complying substantially with federal participation requirements at both the June 1998 survey and the August 1998 resurvey. Petitioner was found to be in compliance with federal participation requirements at the September 1998 survey. Based on the findings of noncompliance, HCFA determined to impose civil money penalties against Petitioner in the amount of $450 per day for each day of a period that began on June 4, 1998 and which ran through September 17, 1998. The total amount of these civil money penalties is $47,700. Petitioner requested a hearing from this determination. The case was docketed as Docket No. C-99-165 and assigned to me for a hearing and a decision.

In 1999, the South Carolina State survey agency conducted a compliance survey of Petitioner which was completed on April 23, 1999 (April 1999 survey). Petitioner was found not to be complying substantially with federal participation requirements. In four instances, the South Carolina State survey agency concluded that Petitioner's noncompliance was so egregious as to constitute immediate jeopardy to Petitioner's residents. Based on these findings, HCFA determined to impose civil money penalties against Petitioner in the amount of $10,000 per day for each day of a period that began on April 23, 1999 and which ran through May 15, 1999. The total amount of these civil money penalties is $230,000. Additionally, HCFA determined to terminate Petitioner's participation in Medicare. Petitioner requested a hearing. The case was docketed as Docket No. C-99-595 and it was assigned to me for a hearing and a decision.

My normal practice is to consolidate two cases which involve remedy determinations pertaining to the same facility. I would have followed this approach here. However, the Office of General Counsel assigned different teams of attorneys to each of the cases. As a courtesy to HCFA's counsel, I agreed not to consolidate the cases. I held the hearings sequentially in Columbia, South Carolina, on August 21 - 23, 2000. I have elected to consolidate my decisions in the two cases into a single document because it is more efficient for me to do so than to issue two separate decisions.

In Docket No. C-99-165, I received into evidence from HCFA exhibits that are identified as HCFA Ex. 1 - HCFA Ex. 62. In Docket No. C-99-595, I received into evidence from HCFA exhibits that are identified as HCFA Ex. 1 - HCFA Ex. 10 and HCFA Ex. 12. HCFA offered an additional exhibit in this case, HCFA Ex. 11, but I declined to receive it into evidence. In order to avoid confusion, I refer in these decisions to any HCFA exhibit that is in evidence in Docket No. C-99-165 as "165 HCFA Ex. (exhibit number) at (page number)." I refer in these decisions to any HCFA exhibit that is in evidence in Docket No. C-99-595 as "595 HCFA Ex. (exhibit number) at (page number)."

I received into evidence some exhibits from Petitioner which it offered as exhibits only in Docket No. C-99-165. I also received some exhibits from Petitioner which it offered as exhibits only in Docket No. C-99-595. Finally, I received some exhibits from Petitioner which it offered as exhibits in both cases. I refer in these decisions to any of Petitioner's exhibits that is in evidence as an exhibit only in Docket No. C-99-165 as "165 P. Ex. (exhibit number) at (page number)." I refer in these decisions to any of Petitioner's exhibits that is in evidence as an exhibit only in Docket No. C-99-595 as "595 P. Ex. (exhibit number) at (page number)." I refer in these decisions to any of Petitioner's exhibits that is in evidence in both cases as "165-595 P. Ex. (exhibit number) at (page number)." I received into evidence the following exhibits from Petitioner: 165 P. Ex. 1; 165 P. Ex. 2; 595 P. Ex. 3; 595 P. Ex. 4; 165-595 P. Ex. 5; 165-595 P. Ex. 6; 595 P. Ex. 7; 165 P. Ex. 8; 595 P. Ex. 9; 595 P. Ex. 10; 595 P. Ex. 11; 595 P. Ex. 12; 595 P. Ex. 13; 595 P. Ex. 14; 165-595 P. Ex. 15; 165-595 P. Ex. 16; 165-595 P. Ex. 17; 165-595 P. Ex. 18; 165-595 P. Ex. 19; 165-595 P. Ex. 20; 595 P. Ex. 21; 165 P. Ex. 22; 595 P. Ex. 23; 165-595 P. Ex. 24; 165-595 P. Ex. 25; 165-595 P. Ex. 26; and, 165-595 P. Ex. 27.

II. Threshold legal issues, issues, findings of fact and conclusions of law

A. Threshold issues

Petitioner filed several motions prior to the in-person hearings in these cases which, in part, addressed issues of law that were common to both cases. On August 14, 2000, I issued rulings on these motions. I restate in relevant part those rulings here and incorporate them into my final decisions in these cases. My rulings are as follows:

• Petitioner moved to dismiss HCFA's remedy determinations in both cases on the ground that the survey protocol used by the South Carolina State survey agency to conduct all of the surveys at issue was not published lawfully pursuant to the requirements of the Administrative Procedure Act. I denied Petitioner's motion because I concluded that I lacked the authority to hear and decide it. Rulings on Petitioner's Motions, August 14, 2000, at 2.

• Petitioner moved to dismiss HCFA's remedy determinations in both cases because of HCFA's alleged failures to provide Petitioner with notices of remedy determinations which complied with the requirements of law. In both cases, Petitioner argued that the notices sent to Petitioner by HCFA failed to give Petitioner notice of HCFA's determinations which complied with the requirements of 42 C.F.R. § 488.434. Additionally, in Docket No. C-99-165, Petitioner asserted that HCFA failed to give Petitioner written notice of its determinations. I concluded that the notices which HCFA sent to Petitioner complied with the minimum requirements of 42 C.F.R. § 488.434, although I found that the notices failed to provide Petitioner with any meaningful information as to how HCFA made its civil money penalty determinations. I held also that Petitioner was not denied due process by HCFA's failure to communicate its rationales to Petitioner inasmuch as my authority was to conduct a de novo hearing about the factors which are the basis for imposing civil money penalties in these cases. Rulings on Petitioner's Motions at 3-4. In Docket No. C-99-165, I found that HCFA had produced a letter dated August 13, 1998 which appeared to satisfy the minimum notice requirements for that case. I concluded that I could not find, as of the date of my rulings, that HCFA had failed to provide Petitioner with this document in August 1998. Id. at 3. Petitioner has not renewed its motion in Docket No. C-99-165 concerning HCFA's alleged failure to mail required notices to it.

B. Issues

1. Issues in Docket No. C-99-165

The issues in this case are whether:

• A basis exists to impose civil money penalties against Petitioner; and,

• The amount and duration of the civil money penalties that HCFA determined to impose against Petitioner are reasonable.

2. Issues in Docket No. C-99-595

The issues in this case are whether:

• A basis exists to impose remedies, including civil money penalties, against Petitioner;

• HCFA's determination that some of the deficiencies manifested by Petitioner as of April 24, 1999 were so egregious as to constitute immediate jeopardy to Petitioner's residents is clearly erroneous;

• The amount and duration of the civil money penalties which HCFA determined to impose against Petitioner are reasonable; and,

• HCFA may terminate Petitioner's participation in Medicare.

C. Findings of fact and conclusions of law



I make findings of fact and conclusions of law (Findings) to support my decisions in these cases. I set forth each of my Findings below as a separately numbered heading. In each heading I identify which of the cases the Finding applies to. I discuss each Finding in detail.

1. In Docket No. C-99-165, there is a basis for imposing civil money penalties against Petitioner for each day of a period that begins on June 4, 1998.

A basis exists in law for HCFA to impose civil money penalties against a long-term care facility which participates in the Medicare program or a State Medicaid program if the facility fails to comply substantially with one or more federal requirements governing Medicare or Medicaid participation. Social Security Act (Act), sections 1819(h)(2)(B)(ii), 1919(h)(3)(C)(ii); 42 C.F.R. §§ 488.406(a)(3), 488.430. A facility fails to comply substantially with a participation requirement where that facility is deficient in meeting that requirement and the deficiency poses a potential for causing more than minimal harm to the health and safety of the facility's residents. 42 C.F.R. § 488.301.

In Docket No. C-99-165, the South Carolina State survey agency found that Petitioner was not complying substantially with federal participation requirements beginning on June 4, 1998. 165 HCFA Ex. 5. The report of the June 1998 survey alleges that Petitioner was deficient in complying with 24 separate participation requirements. Id. In one instance, reported at Tag 253 of the survey report, the scope and severity level of the deficiency found by the surveyors was not so high as to constitute an alleged failure by Petitioner to comply substantially with a participation requirement. Id. at 22 - 24. In another instance, reported at Tag 224 of the survey report, the surveyors found, and HCFA initially agreed, that Petitioner manifested a failure to comply substantially with a participation requirement. However, HCFA withdrew its determination as to this tag shortly prior to the hearing of this case.

Petitioner has challenged four of the remaining 22 alleged episodes of failure to comply substantially with participation requirements. Petitioner asserts that HCFA failed to establish a prima facie case of noncompliance with respect to allegations of deficiencies that are cited at Tags 157, 174, 248, and 324 of the report of the June 1998 survey. But, Petitioner has not challenged specifically the remaining 18 findings of deficiencies. See Petitioner's posthearing brief in Docket No. C-99-165. These 18 deficiencies are established in the absence of any specific challenge to them by Petitioner. Consequently, Petitioner was not complying substantially with participation requirements as of June 4, 1998, and a basis exists to impose civil money penalties against Petitioner for a period of days which begins on June 4, 1998.

2. In Docket No. C-99-165, civil money penalties in the amount of $450 per day are unreasonable. Civil money penalties in the amount of $250 per day are reasonable.

Generally, a civil money penalty may fall within an upper range of from $3,050 to $10,000 per day for each day of noncompliance where a facility fails to comply substantially with a participation requirement or requirements if its noncompliance puts its residents in a state of immediate jeopardy. 42 C.F.R. § 488.438(a)(1)(i). I discuss what constitutes an immediate jeopardy level deficiency below at Finding 5.a. A civil money penalty may fall within a lower range of from $50 to $3,000 per day for each day of noncompliance where a facility fails to comply substantially with a participation requirement or requirements but its noncompliance does not put its residents in a state of immediate jeopardy. 42 C.F.R. § 488.438(a)(1)(ii).

The regulations establish the criteria to be used for determining the appropriate amount of a civil money penalty to be imposed within the upper and lower ranges of civil money penalties. These criteria are stated at 42 C.F.R. §§ 488.438(f) and 488.404 (which is incorporated by reference into 42 C.F.R. § 488.438(f)(3)). The relevant criteria are as follows:

• The facility's history of noncompliance, including the presence, if any, of repeat deficiencies. 42 C.F.R. § 488.438(f)(1);

• The facility's financial condition. 42 C.F.R § 488.438(f)(2);

• The factors that are specified at 42 C.F.R. § 488.404. 42 C.F.R. § 488.438(f)(3). These include the seriousness of a facility's deficiencies, the relationship between deficiencies, and the facility's prior history of noncompliance; and,

• The facility's culpability for its deficiencies. 42 C.F.R. § 488.438(f)(4).

A long-term care facility against whom HCFA has determined to impose a civil money penalty is entitled to a hearing before an administrative law judge at which the facility may contest HCFA's determination. Act, section 1128A(c)(2); 42 C.F.R. §§ 488.408(g), 498.3(b)(12), (13); see 42 C.F.R. § 488.438(e). A hearing before an administrative law judge is not confined to a review of the propriety of HCFA's remedy determination. It is a de novo hearing in which the administrative law judge determines independently what is the appropriate amount of a civil money penalty. The regulations make it explicit that, where an administrative law judge finds that a basis for a civil money penalty exists, then the administrative law judge must consider and apply the factors which I have discussed above in deciding the amount of a civil money penalty. 42 C.F.R. § 488.438(e)(3).

In Docket No. C-99-165, HCFA determined to impose lower range civil money penalties of $450 per day against Petitioner based on HCFA's acceptance of the findings of noncompliance that the South Carolina State survey agency made at the June 1998 survey of Petitioner. I conclude that penalties in this amount are unreasonable and that penalties of $250 per day are reasonable based on the following considerations:

• As of the June 1998 survey, Petitioner manifested fewer deficiencies than was found by the South Carolina State survey agency and accepted by HCFA. Although HCFA asserts that Petitioner failed to comply substantially with 22 separate participation requirements, Petitioner in fact failed to comply substantially with 19 participation requirements;

• The deficiencies that Petitioner manifested as of the June 1998 survey were not as serious as HCFA contends them to be. HCFA asserts that in several instances Petitioner's failure to comply with participation requirements harmed residents of Petitioner. In fact, Petitioner's deficiencies did not harm its residents. Rather, they posed only the potential for harm; and,

• Civil money penalties of $250 per day are reasonable when the nature and seriousness of Petitioner's deficiencies are considered.

a. Petitioner manifested fewer deficiencies as of June 4, 1998 than were found by the South Carolina State survey agency and accepted by HCFA.

As I discuss above, the South Carolina State survey agency originally found that Petitioner manifested 24 deficiencies as of June 4, 1998. Of these 24 alleged deficiencies 23 of them allegedly constituted failures by Petitioner to comply substantially with participation requirements. HCFA accepted these findings and based its determination to impose civil money penalties of $450 per day in part on its conclusion that Petitioner manifested 23 distinct failures to comply substantially with federal participation requirements as of June 4, 1998.

In fact, Petitioner actually manifested fewer deficiencies than was found to be the case by the South Carolina State survey agency and accepted by HCFA. Petitioner failed to comply substantially with participation requirements in 19 instances rather than the 23 instances alleged by HCFA. HCFA withdrew its allegations concerning one of these 23 alleged deficiencies. In three other instances I conclude that there is no basis to conclude that Petitioner was not complying substantially with participation requirements.

On the eve of the hearing HCFA withdrew its determination that Petitioner was deficient under Tag 224 of the report of the June 1998 survey. Petitioner challenged four additional deficiency findings that were made in the report of the June 1998 survey. These findings are cited at Tags 157, 174, 248, and 324 in the survey report. I agree with Petitioner that HCFA failed to establish a prima facie case of failure by Petitioner to comply substantially with participation requirements with respect to allegations made under two of these deficiency tags, Tags 157 and 174. The weight of the evidence establishes that Petitioner was complying substantially with the participation requirement that is the basis for the allegations made under Tag 324. I find that HCFA did establish a prima facie case of noncompliance under Tag 248, which Petitioner did not rebut with the preponderance of the evidence.

i. HCFA failed to establish a prima facie case that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.10(b)(11) as of June 4, 1998.

The report of the June 1998 survey alleges at Tag 157 that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.10(b)(11). 165 HCFA Ex. 5 at 1 - 4. The regulation requires, in relevant part, that a facility must: immediately inform a resident; consult with the resident's physician; and, if known, notify the resident's legal representative or an interested family member when there is a significant change in the resident's physical, mental, or psychosocial status. The surveyors who conducted the June 1998 survey alleged that "on the days of the survey, based on a record review" Petitioner failed to immediately inform a resident's treating physician when there was a need to alter a resident's treatment significantly. Id. at 2.

The fact allegations that underpin this conclusion all relate to the care that Petitioner allegedly gave to a resident who is identified in the survey report as Resident # 2. The surveyors alleged, in effect, that Petitioner's staff failed to notify the resident's physician of a developing infection. This resident was being fed via a surgically implanted feeding tube (PEG tube). The survey report alleges that, on January 4, 1998, a nurse observed that the skin around the PEG tube was very irritated and that a brownish fluid was draining around the tube. 165 HCFA Ex. 5 at 3. According to the survey report, the nurse failed to notify the resident's physician of this alleged change in the resident's condition. However, on January 13, 1998, the nurse placed a call to the resident's physician to inform the physician that the resident was now draining "dark, thick, foul smelling fluid." Id. Subsequently, the resident was hospitalized for treatment of the infection around the tube.

These allegations do not establish a prima facie case that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.10(b)(11) as of June 4, 1998. Assuming the allegations to be true, they establish a single episode of a failure by Petitioner's staff to notify a resident's physician of a significant change in the resident's medical condition in January 1998, approximately six months prior to the June 1998 survey. I do not find that a single isolated episode of staff error in the remote past is persuasive evidence of an ongoing failure by Petitioner to comply with a participation requirement at a survey that takes place six months after the occurrence of the episode.

The episode documented by the surveyors is too remote in point of time to allow for meaningful inferences to be drawn from it concerning Petitioner's compliance with participation requirements in June 1998. Notwithstanding the surveyors' assertions that Petitioner was deficient on the days of the survey, HCFA produced no evidence that Petitioner's staff was failing to provide necessary notification to physicians of changes in residents' medical conditions as of the days of the June 1998 survey.

I find also that the preponderance of the evidence establishes communication between Petitioner's staff and Resident # 2's physician concerning the resident's medical condition, including the condition of the resident's PEG tube. The resident's treatment records do not describe a specific communication between Petitioner's staff and the resident's physician concerning the nurse's observations of the resident's PEG tube on January 4, 1998. But, that does not mean that there was no communication about possible complications arising from use of the tube and any significant changes in the resident's condition.

The regulation does not require that a nursing note be written to document each and every communication between a facility's staff and a resident's physician. It requires only that communications be made where circumstances warrant them. I do not infer from the absence of a specific entry in the nursing notes that records a contact between Petitioner's staff and Resident # 2's physician on or about January 4, 1998, that there was no communication between Petitioner's staff and the physician concerning the resident's condition on that date. The resident's records suggest that there was close communication between Petitioner's staff and the resident's physician in early January 1998 concerning the resident's condition and possible complications concerning the resident's PEG tube. On January 6, 1998 the resident's physician ordered that the tube be changed. 165 HCFA Ex. 56 at 11. I infer from this order - which was made only two days after the nurse's January 4, 1998 observations - that it must have reflected the physician's concerns about the resident's condition including his concern that an infection might be developing at the site of the tube.

ii. HCFA failed to establish a prima facie case that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.10(k) as of June 4, 1998.

The report of the June 1998 survey alleges at Tag 174 that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.10(k). 165 HCFA Ex. 5 at 7 - 8. The regulation provides that a resident of a facility has a right to have reasonable access to use of a telephone where the resident may make calls without being overheard. The surveyors who conducted the June 1998 survey alleged that Petitioner failed to provide its residents with reasonable access to a telephone where calls could be made in privacy.

Id. at 7.

The survey report cites that a resident who is identified as Resident # 5 averred that there was no place in Petitioner's facility where it was possible to talk privately on the telephone. 165 HCFA Ex. 5 at 7. The resident is alleged to have asserted that a telephone was available for use at Petitioner's nurses' station but that it was noisy at that location and, furthermore, on one occasion the resident had to discontinue a call because a physician needed to use the phone. Id. at 7 - 8. The survey report also avers that four residents complained at a group meeting that there was no place in the facility where they could use the telephone. Id. at 8. Finally, Petitioner's social services director was reported to acknowledge that there was "a problem of telephone availability" at Petitioner's facility. Id.

I am not persuaded by these allegations that HCFA made a prima facie showing that Petitioner failed substantially to comply with the requirements of 42 C.F.R. § 483.10(k). The allegations in the survey report rest exclusively on hearsay. The surveyors did not determine independently what sort of telephone access was available to residents of Petitioner's facility.

Most rules of evidence bar admission of hearsay as evidence because of its inherent unreliability. I admit hearsay at hearings involving HCFA because these hearings are not jury trials and I am not going to be influenced by unreliable evidence. In most cases it is more efficient to admit hearsay at the hearing and to rule on its probative value at a later time. But, the fact that I admit hearsay does not mean that I find it to be reliable. Generally, hearsay is unreliable absent some evidence which shows that, in the circumstances of the case, it may be relied on.

Here, HCFA has not offered any corroborative evidence that would substantiate the hearsay complaints that are the basis for the allegations in the survey report. I find these complaints not to be reliable proof of a deficiency in the absence of any corroboration.

Moreover, the surveyors' allegations were to some extent undercut by the testimony offered at the hearing by one of the surveyors, Helen Jenkins. Ms. Jenkins acknowledged during her cross examination that residents could make private telephone calls from offices in Petitioner's facility. Tr. at 441 - 442. She attempted to qualify this admission by asserting that the offices were locked at nights and on weekends. Id. However, she acknowledged also that residents could make calls from Petitioner's nurses' station on nights and weekends, when the facility was likely to be less busy than at other times, and when noise and traffic were less likely to intrude on residents' privacy.

Finally, I conclude that the surveyors' allegations, even assuming their truth, fail to establish that Petitioner created a potential for more than minimal harm to its residents. HCFA offered no proof to show that residents were actually denied use of telephones when they needed to use them. And, HCFA did not show that residents who demanded privacy when making telephone calls were denied such privacy.

iii. The preponderance of the evidence establishes that Petitioner complied substantially with the requirements of 42 C.F.R. § 483.25(h)(2) as of June 4, 1998.

The report of the June 1998 survey alleges at Tag 324 that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.25(h)(2). 165 HCFA Ex. 5 at 43 - 44. This regulation requires a facility to ensure that each of its residents receives adequate supervision and assistance devices to prevent accidents. The survey report alleges that Petitioner failed to provide adequate supervision to a resident who had a history of sustaining falls. Id.

The fact allegations that are the basis for this assertion all relate to a resident who is identified in the survey report as Resident # 21. The survey report recites that the resident had a history of eight documented falls within the nine month period which predated the June 1998 survey. 165 HCFA Ex. 5 at 43. The survey report alleges that the resident sustained two additional falls on June 1, 1998 and again on June 3, 1998. According to the survey report, the resident fell out of a wheelchair on June 1, 1998 and out of bed on June 3, 1998. The survey report alleges that there was no "documented evidence" that Petitioner had attempted to identify the causes of these falls, or that it had made any attempts to prevent the resident from falling. Id. at 44.

The preponderance of the evidence proves that Petitioner provided Resident # 21 adequate supervision. Consequently, Petitioner was complying with the requirements of 42 C.F.R. § 483.25(h)(2) as of the June 1998 survey.

A facility is not required by 42 C.F.R. § 483.25(h)(2) to assure that its residents never sustain accidents. The regulation does not impose a strict liability standard on a facility. Rather, the regulation requires that the facility provide "adequate" supervision and assistance devices to its residents as a safeguard against accidents. A facility satisfies the requirements of the regulation if it takes reasonable precautions to protect the health and safety of its residents against accidental injuries. A facility is not deficient if an accident occurs despite the fact that it has taken reasonable precautions.

Here, the weight of the evidence establishes that Petitioner took reasonable precautions to prevent Resident # 21 from sustaining falls. The falls that the resident sustained in June 1998 occurred despite those precautions and not in the absence of precautions.

As the survey report notes, Resident # 21 had a history of falls. However, the survey report omits to state that, beginning in March 1998, Petitioner gave training and advice to its staff that was designed to assure that residents did not sustain preventable falls. 165 HCFA Ex. 36 at 1, 3, 5. These efforts succeeded in the case of Resident # 21. The resident sustained no falls for a four month period prior to June 1998.

Resident # 21 suffered from Alzheimer's Disease and dementia, along with other medical problems. In the days prior to June 1, 1998, the resident exhibited combative behavior. 165 HCFA Ex. 48 at 8, 10. In late May 1998, Petitioner's staff consulted with the resident's treating physician concerning whether the resident should receive Haldol. This was a medication which would be administered to deal with the resident's combative behavior. Id. at 10 - 11. On June 1, 1998, the resident's physician ordered that Haldol be administered to the resident. Id. at 10. The resident sustained a fall later that afternoon, approximately two and one-half hours after being medicated with Haldol. The medication was discontinued for a day after the resident sustained her June 1, 1998 fall. However, it was restarted on June 2, 1998 at a reduced dose on the orders of the resident's physician. Id. at 9. On the following morning, the resident fell from her bed. Id. at 8.

Petitioner contends, and I agree, that the resident's two falls on June 1, 1998 and June 3, 1998 were most probably the consequence of administration of Haldol to the resident. The evidence shows that the resident was being monitored on both June 1 and June 3, 1998. On June 1, the resident was seated at Petitioner's nurses' station when she fell. 165 HCFA Ex. 48 at 10. On June 3, the resident had been checked by a nurse only 25 minutes prior to falling from her bed. Id. at 8.

There is nothing in the record of the care that was given by Petitioner to Resident # 21 to suggest that Petitioner failed to provide adequate supervision to the resident. The resident fell despite being supervised by Petitioner's staff. The circumstances of the resident's two June 1998 falls suggest that no degree of observation would have prevented the resident from falling. That is evident from the fact that the resident was seated at Petitioner's nurses' station on June 1, 1998 when she sustained her first fall. Possibly, the resident might not have fallen had she been physically restrained, but that course of care had not been ordered by the resident's physician.

iv. HCFA presented a prima facie case, which Petitioner did not rebut, showing that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.15(f)(1) as of June 4, 1998.

The report of the June 1998 survey alleges at Tag 248 that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.15(f)(1). 165 HCFA Ex. 5 at 11 - 16. The regulation requires a facility to provide an ongoing program of activities designed to meet, in accordance with each resident's comprehensive assessment, the interests and the physical, mental, and psychosocial well-being of that resident. The survey report alleges that Petitioner failed to provide such a program to several of its residents.

The assertion of noncompliance in the survey report is based in large measure on observations that the surveyors made of several of Petitioner's residents during the survey period. Essentially, the report asserts that these residents all were supposed to be participating in a variety of activities. However, these residents were observed to be largely confined to their beds or chairs during the survey without participating in any activities. The report contends that Petitioner failed to offer satisfactory explanations for these residents' status.

Petitioner's response focuses on the care that it provided to one of these residents who is identified in the survey report as Resident # 1. This response explains why Petitioner was not involving the resident in group activities at the time of the survey, and why Petitioner's staff were occupying the resident with one-on-one activities that were more suitable for the resident given the resident's limitations. The explanation is persuasive. However, Petitioner has not explained why it apparently failed to provide similar measures to other residents whose circumstances were cited in the survey report. For that reason, I conclude that Petitioner did not rebut the prima facie case of noncompliance that HCFA established under Tag 248. For example, the surveyors observed that, during the survey, Resident # 14 was in bed with the blinds drawn and the television and radio in the resident's room turned off. Yet, the resident's assessment provided that the resident should be participating in activities from 1/3 to 2/3 of the time. 165 HCFA Ex. 5 at 13. Petitioner offered no explanation for its failure to provide activities for Resident # 14 during the survey. Resident # 15 was also observed to be inactive during the course of the survey, notwithstanding entries in the resident's record indicating that the resident should be participating in activities from 1/3 to 2/3 of the time.

b. The deficiencies that Petitioner actually manifested as of June 4, 1998, establish a level of noncompliance by Petitioner that is not so serious as was alleged in the report of the June 1998 survey.

The surveyors who prepared the report of the June 1998 survey assigned scope and severity ratings to all of the deficiencies that they identified at the survey. HCFA accepted these ratings and based its civil money penalty determination on them.

The scope and severity rating for each deficiency is expressed as a letter of the alphabet in the left hand margin of the survey report next to each deficiency tag heading. The scope and severity ratings for the June 1998 survey range from a rating of "B" for the deficiency identified at Tag 253 of the survey report to ratings of "G" for the deficiencies that are identified at Tags 157, 224, and 324 of the survey report. I take notice that these letter ratings correspond to specific categories of scope and severity. See 595 HCFA Ex. 6. Ratings of "A," "B," and "C," are the lowest ratings and do not indicate a potential for more than minimal harm. A deficiency that is assigned one of these ratings, therefore, is not indicative of a failure by Petitioner to comply substantially with participation requirements. Ratings of "D," "E," and "F," indicate that no actual harm resulted from the facility's noncompliance with participation requirements, although a potential for more than minimal harm resulted from the noncompliance. Ratings of "G" or higher involve findings of actual harm.

The report of the June 1998 survey asserts that, as of June 4, 1998, Petitioner manifested three "G" level deficiencies which allegedly caused actual harm to Petitioner's residents. HCFA based its determination to impose civil money penalties of $450 per day against Petitioner on these assertions. In fact, however, Petitioner manifested no "G" level deficiencies as of June 4, 1998. HCFA withdrew its allegations concerning Tag 224, one of the "G" level tags. I find at subpart a.i. of this Finding that HCFA failed to establish a prima facie case of noncompliance under Tag 157, another of the "G" level tags. And, I also conclude at subpart a.iii. that the preponderance of the evidence proves that Petitioner complied substantially with the requirements that are the standards for compliance under Tag 324, the third "G" level tag.

Thus, Petitioner manifested no deficiencies as of June 4, 1998 which posed more than a potential for harm to Petitioner's residents. Although Petitioner failed to comply substantially with participation requirements as of that date, its noncompliance was not so egregious as is alleged by HCFA.

c. Civil money penalties of $250 per day are reasonable when the nature and seriousness of Petitioner's deficiencies are considered.

I find civil money penalties of $250 per day to be reasonable in Docket No. C-99-165 because none of the deficiencies manifested by Petitioner as of June 4, 1998 caused harm to any of Petitioner's residents. My penalty finding also takes into account that there were fewer deficiencies as of June 4, 1998 than HCFA asserted to be the case.

HCFA provided only a brief analysis of its rationale for imposing civil money penalties of $450 per day against Petitioner:

Three (3) of the twenty four (24) deficiencies found by surveyors during the June 4, 1998 survey constituted actual harm to residents: Tag 157, Tag 324, and Tag 224, which was subsequently deleted from the 2567. Per 42 C.F.R. § 488.408(d)(2)(ii), one of the Category 2 remedies had to be applied in the subject action, as . . . [Petitioner] had at least two, if not three deficiencies which constituted actual harm that was not immediate jeopardy. Accordingly, the $450 per day . . . [civil money penalties were] well within the . . . [civil money penalties] range of $50 - $3,000 per day, as required in 42 C.F.R. § 488.408(d)(1)(iii).

HCFA's posthearing brief in Docket No. C-99-165 at 38. Its arguments essentially are that Petitioner manifested deficiencies which are the basis for civil money penalties in the lower range, and that civil money penalties of $450 per day are justified because "at least two" of the deficiencies caused actual harm to residents of Petitioner.

HCFA's rationale for penalties in the amounts that it determined to impose evaporates if Petitioner manifested no deficiencies that cause its residents to experience actual harm. And that is the case here. As I discuss above, at subpart b. of this Finding, Petitioner's deficiencies only potentially were harmful to Petitioner's residents. There were fewer deficiencies than HCFA contended, and the deficiencies were less serious than HCFA asserted. Therefore, the civil money penalty amounts need not be so high as HCFA originally determined. 42 C.F.R. §§ 488.438(f)(3), 488.404.

In reaching this conclusion, I take into account the findings that were made at the August 1998 resurvey of Petitioner. HCFA now asserts that one of the deficiencies that Petitioner manifested at the August resurvey caused Petitioner's residents to experience actual harm. That deficiency is stated at Tag 241 of the report of the August 1998 survey. 165 HCFA Ex. 8 at 7 - 10. Originally, HCFA also asserted another "actual harm" deficiency at Tag 224 of the report of the August 1998 survey. However, it has dropped this assertion. Below, at Finding 3, I explain my reasons for concluding that Petitioner was in fact not deficient under Tag 241 as of August 1998. Therefore, no "actual harm" deficiencies persisted in Petitioner's facility at any time after June 4, 1998 up until the date when Petitioner corrected all of the deficiencies that were identified at the June 1998 survey.

In both Docket No. C-99-165 and Docket No. C-99-595, Petitioner asserted that it lacked the financial wherewithal to pay the civil money penalties that HCFA determined to impose. I address the parties' arguments as to Petitioner's financial status below at Finding 8. It is sufficient for me to say here that I find that Petitioner did not prove that it lacked the ability to pay the civil money penalties that I have decided to impose in the two cases.

3. In Docket No. C-99-165, Petitioner attained substantial compliance with participation requirements as of August 21, 1998. Petitioner is not liable for civil money penalties after August 20, 1998.

HCFA asserts that Petitioner did not attain substantial compliance with participation requirements until September 18, 1998. Petitioner argues that it attained substantial compliance prior to that date. I conclude that Petitioner attained substantial compliance by August 21, 1998. Civil money penalties did not accrue against Petitioner after August 20, 1998, the last date of Petitioner's failure to comply substantially with participation requirements in Docket No. C-99-165. I base these conclusions on the following considerations.

• HCFA's determination to impose civil money penalties was not, as HCFA now contends, based in part on Petitioner's failure as of June 3, 1998 to comply with provisions of the Life Safety Code. HCFA's determination was based solely on Petitioner's failure to comply substantially with Medicare participation requirements. Furthermore, HCFA never gave Petitioner notice of any intent by HCFA to base its determination to impose penalties on Petitioner's failure to comply with provisions of the Life Safety Code. Therefore, HCFA may not base the date when civil money penalties ceased to accrue on Petitioner's coming into compliance with all provisions of the Life Safety Code.

• Petitioner was not complying substantially with some Medicare participation requirements as of the August 1998 resurvey. Therefore, civil money penalties continue to accrue against Petitioner after August 5, 1998, the date of the August 1998 resurvey, and until Petitioner attained compliance with participation requirements.

• However, Petitioner manifested only two failures to comply substantially with participation requirements as of August 5, 1998. HCFA either failed to establish a prima facie case that Petitioner was deficient in other respects as of August 5 1998 or Petitioner proved by a preponderance of the evidence that it was not deficient in other respects as of August 5, 1998. Therefore, Petitioner came into substantial compliance with participation requirements when it rectified the two deficiencies that existed as of August 5, 1998.

• Petitioner provided persuasive evidence that it complied substantially with all requirements as of August 21, 1998. HCFA offered no evidence which showed that Petitioner failed to come into compliance until after August 21, 1998.

a. The duration of civil money penalties depends on the date Petitioner attained substantial compliance with the Medicare participation requirements that are at issue in the June 1998 and August 1998 surveys. The date when Petitioner attained compliance with Life Safety Code requirements is not relevant to deciding the duration of civil money penalties.

HCFA argues that its determination to impose civil money penalties against Petitioner was, in part, based on Petitioner's failures to comply with the Life Safety Code as of June 3, 1998. 165 HCFA Ex. 7. Therefore, according to HCFA, civil money penalties should accrue until September 18, 1998, the date when the South Carolina State survey agency determined that Petitioner had attained compliance with the Life Safety Code. Petitioner asserts that Life Safety Code violations were not an element of HCFA's original remedy determination. Petitioner argues also that HCFA never gave it notice that civil money penalties would accrue until Petitioner corrected Life Safety Code deficiencies. It asserts that to now base the duration of civil money penalties on the date Petitioner corrected these deficiencies denies Petitioner due process.

There is no evidence in this case which suggests that HCFA based its determination to impose civil money penalties against Petitioner on Life Safety Code violations along with Petitioner's failures to comply with Medicare participation requirements. I conclude that Petitioner's compliance with the Life Safety Code was not an element that HCFA considered in determining to impose civil money penalties against Petitioner. Moreover, if HCFA did consider Life Safety Code violations as part of its penalties determination, it failed to give Petitioner notice of its determination.

HCFA offered no exhibits which show that Petitioner's failure to comply with elements of the Life Safety Code was a part of HCFA's determination to impose civil money penalties. It produced no witness who testified that HCFA considered Life Safety Code violations as an element of its civil money penalty determination. And, it produced no notices to Petitioner which show that HCFA told Petitioner, prior to or at the time that HCFA made its determination to impose penalties, that Life Safety Code violations were an element of that determination.

Petitioner was not advised until August 12, 1998 that civil money penalties might be imposed against it. On that date the South Carolina State survey agency notified Petitioner that, based on findings of enumerated deficiencies made at the August 1998 resurvey, the State survey agency had determined that Petitioner remained out of compliance with participation requirements. 165 HCFA Ex. 6 at 20. But, although the letter identified the specific alleged failures by Petitioner to comply with Medicare participation requirements that were found at the August 1998 resurvey, it did not mention Life Safety Code violations as being among those deficiencies.

On August 13, 1998 HCFA notified Petitioner that it had determined to impose civil money penalties against Petitioner. 165 HCFA Ex. 6 at 17 - 19. As was the case with the August 12, 1998 letter from the South Carolina State survey agency, HCFA's August 13, 1998 notice to Petitioner contained nothing to suggest that civil money penalties would accrue against Petitioner until Petitioner corrected Life Safety Code deficiencies. The entire thrust of the August 13, 1998 notice to Petitioner was that civil money penalties would accrue until Petitioner attained compliance with the Medicare participation requirements that were identified in the reports of the June 1998 survey and the August 1998 resurvey.

There were other communications between either HCFA and Petitioner or the South Carolina State survey agency and Petitioner. Only one of these communications mentions Life Safety Code violations, that being a letter from the South Carolina State survey agency dated September 14, 1998. 165 P. Ex. 2 at 68. In that letter - which was sent to Petitioner weeks after HCFA had determined to impose civil money penalties against Petitioner - the South Carolina State survey agency mentions that "a life safety code follow up will be done to determine LSC compliance." Id. But the letter does not assert or suggest that civil money penalties would accrue against Petitioner pending correction of Life Safety Code violations.

It is plain from the notices that HCFA and the South Carolina State survey agency sent to Petitioner that the basis for the civil money penalties that HCFA determined to impose was Petitioner's noncompliance with participation requirements governing long-term care facilities. Life Safety Code violations were simply not part of HCFA's determination to impose civil money penalties and, therefore, the duration of those penalties may not depend on the date that Petitioner corrected its Life Safety Code violations.

Moreover, the failure to give notice to Petitioner that the duration of civil money penalties would depend on the date that Petitioner corrected Life Safety Code violations raises a serious due process issue. It is hard to understand how civil money penalties could be remedial if a facility is not made aware of the basis for those penalties.

b. Petitioner was not complying substantially with Medicare participation requirements as of the August 1998 resurvey of Petitioner.

On July 14, 1998, Petitioner advised the South Carolina State survey agency that it had corrected all of the deficiencies that were identified at the June 1998 survey. The South Carolina State survey agency responded to this assertion by conducting the August 1998 resurvey of Petitioner. The purpose of the August resurvey was to determine whether Petitioner had attained compliance with Medicare participation requirements.

Daily civil money penalties would cease to accrue against Petitioner no later than August 5, 1998, the date of the August 1998 resurvey, if Petitioner was complying substantially with Medicare participation requirements as of that date. If there is compliance then there no longer exists a basis to impose civil money penalties. However, penalties could continue to accrue past the date of the resurvey if Petitioner was not complying substantially with all Medicare participation requirements as of the date of the resurvey. Even one failure by Petitioner to comply substantially with participation requirements as of the date of the resurvey would be a basis for daily civil money penalties to continue to accrue until Petitioner corrected that failure to comply.

The surveyors who conducted the August 1998 resurvey found that Petitioner manifested seven failures to comply substantially with participation requirements as of the completion of the resurvey. 165 HCFA Ex. 8. HCFA initially accepted these findings. However, it subsequently rescinded its determination of noncompliance as to one of the alleged deficiencies, which is stated at Tag 224 of the report of the August 1998 resurvey. See Id. at 5 - 7. HCFA continues to assert that Petitioner manifested six failures to comply substantially with participation requirements as of the August 1998 resurvey. Petitioner contests these noncompliance determinations.

I have reviewed each of the determinations and the parties' evidence and arguments concerning them. I find that Petitioner was not complying substantially with two participation requirements as of the August 1998 resurvey. As a consequence of this noncompliance, daily civil money penalties against Petitioner continue to accrue beyond August 5, 1998.

i. HCFA established a prima facie case, which Petitioner did not rebut, that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.10(c)(4) as of August 5, 1998.

Petitioner did not comply substantially with the participation requirement that is the basis for findings made at Tag 159 of the survey report. The report of the August 1998 survey alleges at Tag 159 that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.10(c)(2) and (3). 165 HCFA Ex. 8 at 1 - 5. However, it is apparent from the text of the survey report that the surveyors actually found that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.10(c)(4). This section provides that a facility must establish and maintain a system that assures a full and complete and separate accounting, according to generally accepted accounting principles, of each resident's personal funds entrusted to the facility on the resident's behalf.

The survey report alleges that Petitioner failed on behalf of five of its residents to establish and maintain a system that assures full and complete accounting of the residents' personal funds according to generally accepted accounting principles. The report cites several specific examples of Petitioner's alleged failure to do so based on a review of the residents' funds ledger. These include the following.

• In the case of a resident who is identified as Resident A, there had been no documented deposit of funds into the resident's account since June 1998, even though the resident had received her July 1998 Social Security check.

• There were discrepancies noted in the records of deposit to the account of another resident, who is identified in the resurvey report as Resident B. This resident was supposed to be receiving payments of $34.00 per month, however, the January and February 1998 entries showed unexplained deposits of only $30.00 to the resident's account.

• A resident who is identified in the resurvey report as Resident C, expired in November 1996. However, a ledger was maintained until June 30, 1997 showing that the resident continued to have a balance in his account. Petitioner's office manager was unable to explain what had become of the money in the resident's account.

• Another resident, who is identified as Resident G, expired at the end of October 1997. However, no final accounting of the resident's account was available.

• On July 24, 1998, Petitioner made a conveyance from its accounts to the estate of a resident who is identified in the resurvey report as Resident I. There was an unexplained discrepancy between the amount of the check to the estate and the balance in the resident's account.

These discrepancies and omissions are, for the most part, relatively minor. But when they are viewed as a group they suggest an overall sloppiness by Petitioner in its maintenance of resident accounts. I find that this sloppiness is prima facie evidence that Petitioner failed to maintain its residents' accounts in accordance with generally accepted accounting principles. There is a potential for harm to residents in Petitioner's failure to keep accurate financial records. That failure creates a risk that residents will be deprived of access to funds that belong to them.

As I discuss above, the resurvey report refers to 42 C.F.R. § 483.10(c)(2) and (3) when, in fact, the allegations of deficiency actually are based on alleged noncompliance with the requirements of 42 C.F.R..§ 483.10(c)(4). Petitioner contends that this misstatement in the resurvey report deprived it of adequate notice of the report's allegations.

I am not persuaded that Petitioner was denied adequate notice of the allegations at Tag 159 in the resurvey report. I do not find that any reasonable facility would be misled or confused by the allegations at that tag. Any confusion caused by mis-citation of the relevant regulation is dispelled by the report's accurate citation to the text of 42 C.F.R. § 483.10(c)(4) as the basis for the deficiency finding. Moreover, the referenced text is not an obscure part of the regulations. In the regulations it is printed directly after the text of 42 C.F.R. § 483.10(c)(2) and (3).

Petitioner argues that HCFA presented no evidence to support the allegations in the resurvey report. It is true that HCFA did not present corroborating evidence of these allegations. But, the resurvey report is in evidence for the truth of its contents. I find that the allegations in the survey report in this instance - although hearsay - are reliable prima facie evidence of noncompliance by Petitioner with participation requirements. I find these allegations to be more reliable than statements attributed to residents and staff because they consist of the surveyors' personal observations based on their review of Petitioner's records. Petitioner offered no affirmative evidence to rebut the allegations that were made under Tag 159. For example, it did not offer copies of its records as evidence that the surveyors' observations were inaccurate.

ii. HCFA established a prima facie case, which Petitioner did not rebut, that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.40(b) as of August 5, 1998.

The report of the August 1998 resurvey alleges at Tag 386 that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.40(b). 165 HCFA Ex. 8 at 12 - 16. The regulation provides, in relevant part, that a resident's treating physician must sign and date all orders for a resident. 42 C.F.R. § 483.40(b)(3).

The resurvey report alleges that, in two instances, residents' treating physicians failed to issue orders for changes in residents' medication. Specifically, the report alleges that, in one instance, a physician signed and dated a pharmacist's recommendation to reduce administration of medication to a resident with the accompanying phrase "o.k. to reduce." 165 HCFA Ex. 8 at 14. In another instance, a physician allegedly countersigned a pharmacist's recommendation to change the dosage of a medication to be administered to a resident without dating the signature. Id.

In the first instance, which addresses the care that was given to a resident who is identified as Resident # 7 in the resurvey report, the physician plainly issued an order that complied with all of the regulation's requirements. The physician made a statement ("o.k. to reduce") which, when read in context with the pharmacist's recommendation, was easy to understand. The pharmacist recommended reducing the medication and the physician approved the recommendation. The physician signed and dated the order.

However, in the second instance, which addresses the care that was given to a resident who is identified as Resident # 14 in the resurvey report, there was a failure by Petitioner to assure compliance with the requirements of the regulation. In this instance, the undisputed facts are that a physician signed, without dating, a pharmacist's recommendation to reduce the dosage of a medication that was being given to the resident. That action clearly can be interpreted as a physician's order. But, the physician had also issued a separate written order which directed that a different dosage of the same medication be given to the resident. The pharmacist's order, with the undated physician's signature on it, was dated by the pharmacist as July 13, 1998. The physician's written order was dated August 1, 1998. Thus, there were arguably two orders from the resident's physician, one dated, and one undated, which gave conflicting directions concerning administration of medication to the resident.

Petitioner was remiss in not assuring that the resident's physician properly dated both of the orders. Had the physician done so, it would have become clear which order superseded the other. In the absence of proper dating it was not possible for Petitioner's staff to know which dosage of medication the physician actually wanted to administer to Resident # 14. I conclude that this oversight failure by Petitioner posed a potential for more than minimal harm to the resident.

I would be reluctant to find a failure by Petitioner to comply with the requirements of the regulation based on a single isolated error by Petitioner's staff to obtain a dated physician's order. As I have held on many occasions, deficiencies generally are not based on single errors or omissions, but on the underlying practices of facilities. Here, however, the evidence is that Petitioner's practice in obtaining physicians' orders may have contributed to the error that was identified by the surveyors. I find that mis-communication between Petitioner's director of nursing and its staff resulted in a poor understanding by the staff as to what their obligations and duties were. In this case, Petitioner's staff asserted to the surveyors that it was a staff practice to accept a physician's countersignature on a pharmacist's recommendation as an order by the physician. However, Petitioner's director of nursing asserted to the surveyors that this was not, in fact, Petitioner's policy.

c. In other respects Petitioner complied substantially with participation requirements as of the August 1998 resurvey.

I do not find Petitioner to be deficient in other respects as of the August 1998 resurvey. HCFA failed to establish a prima facie case as to some of the allegations of noncompliance that were made in the resurvey report. In other instances Petitioner established by the preponderance of the evidence that it was complying substantially with participation requirements. This means that Petitioner manifested only two substantial deficiencies as of the August 1998 resurvey, which I discuss above at subpart b. of this Finding. And, it means also that Petitioner came into compliance with participation requirements when it corrected those deficiencies.

i. The preponderance of the evidence establishes that Petitioner complied substantially with the requirements of 42 C.F.R. § 483.15(a) as of August 5, 1998.

The report of the August 1998 resurvey alleges at Tag 241 that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.15(a). HCFA Ex. 8 at 7 - 10. The regulation requires a facility to promote care for each resident in a manner that maintains or enhances that resident's dignity in full recognition of the resident's individuality. The report of the resurvey asserts that Petitioner failed to comply with this regulation in providing care to one of the 17 residents whose cases were examined by the surveyors.

The resident whose dignity allegedly was affronted is identified in the report of the resurvey as Resident # 12. The report asserts, essentially, that this resident was removed, against her will, from a location outside of an activity room where residents had just begun to sing hymns. The report alleges further that the resident was taken, against her will, to Petitioner's lunch room thereby depriving the resident of an opportunity to participate in a religious service. The resident then allegedly waited in the lunch room for 25 minutes before lunch was served to the resident.

I find no affront to the dignity of Resident # 12 in the way in which Petitioner's staff dealt with the resident on August 5, 1998. Resident # 12 was not arbitrarily removed from an ongoing activity. She was taken to lunch at the end of the activity. Nor was she made to wait unreasonably for lunch. The delay in serving lunch to the resident on August 5, 1998 was not the fault of Petitioner.

The assertions in the report of the August 1998 resurvey, if considered in a vacuum, might be construed as evidence of an affront to the dignity of Resident # 12. However, the account omits facts which change the picture considerably. First, and contrary to what the resurvey report alleges, the religious services in question had not just begun at the time that the resident was taken to the lunch room. Rather, they were ending. The incident which is recounted in the survey report occurred at about 11:20 a.m. on August 5, 1998. 165 HCFA Ex. 8 at 8. As explained in Petitioner's response to the surveyors' findings the incident occurred at the end and not at the beginning of the religious services as described in the survey report. Id. at 9. The resident had been present at the religious services for approximately 20 to 30 minutes before being taken to the lunch room. Id. at 8. Furthermore, the resident was not made to wait for lunch at Petitioner's behest. The delay in serving lunch on the date in question was occasioned by the surveyors who were checking the temperature of the meals that were being served to the residents. Id. at 9 - 10.

ii. The preponderance of the evidence establishes that Petitioner complied substantially with the requirements of 42 C.F.R. §483.25 as of August 5, 1998.

The report of the August 1998 resurvey alleges at Tag 309 that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.25. 165 HCFA Ex. 8 at 11 - 12. This regulation requires that a facility provide to each resident, and that each resident receives, the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well being, in accordance with the resident's assessment and plan of care.

The fact allegations that are made under Tag 309 all relate to the care that Petitioner gave to a resident who is identified in the report of the August 1998 resurvey as Resident # 11. This resident wore a pacemaker. However, according to the resurvey report, there was no physician's order in the resident's records for the care and monitoring of the pacemaker. Nor, according to the resurvey report, had Petitioner's staff written a care plan for the care and monitoring of the resident's pacemaker. 165 HCFA Ex. 8 at 11 - 12.

The resurvey report seems not to focus on the care and services that Resident # 11 received from Petitioner's staff - which is what is addressed by 42 C.F.R. § 483.25 - but, on whether care was adequately documented. Thus, the resurvey report cites as specific examples of Petitioner's alleged deficiencies the failure of Petitioner to receive from Resident # 11's physician a written order concerning the resident's use of a pacemaker and the failure of Petitioner's staff to write a care plan concerning the resident's use of a pacemaker.

These allegations - assuming their truth - do not describe failures by Petitioner to comply with 42 C.F.R. § 483.25. The issue under the regulation is not whether Petitioner's staff adequately documented or planned the care of the resident's pacemaker absent some prima facie showing that a failure of documentation or planning resulted in a failure adequately to monitor the resident's use of a pacemaker. Documentation and planning deficiencies are addressed elsewhere in the regulations which govern long-term care facilities. The question here is whether Petitioner gave Resident # 11 adequate care and services for his pacemaker. Put simply, did Petitioner's staff monitor the resident's pacemaker to ensure that the pacemaker operated effectively and safely?

Furthermore, a failure by a physician to write a treatment order for a resident is not, per se, a deficiency under the regulation. The regulation addresses the care that a facility is to provide to a resident and not the care that a resident's physician must provide.

It would be a violation of 42 C.F.R. § 483.25 for a facility to fail adequately to monitor a resident's use of a pacemaker. It became apparent at the hearing of this case that the alleged failure by Petitioner's staff to check Resident # 11's pacemaker was a concern that underlay the inartfully written allegations at Tag 309 of the August 1998 resurvey report. Tr. at 325 - 326.

But, the evidence in this case establishes that Petitioner provided services to its residents to ensure that their pacemakers functioned properly. Resident # 11 received adequate monitoring from Petitioner's staff of his pacemaker.

After the June 1998 survey Petitioner undertook remedial measures that were designed to ensure that those of its residents who wore pacemakers received adequate monitoring and care. It listed all of its residents who wore pacemakers on a single document and instructed its charge nurses to record pacemaker checks for each of these residents. 165 HCFA Ex. 5 at 37. Furthermore, the evidence shows that Petitioner's staff monitored the pacemaker that was being worn by Resident # 11. Petitioner's staff checked the resident's pacemaker on July 16, 1998, just three weeks prior to the August 1998 resurvey. 165 HCFA Ex. 8 at 12; Tr. at 323.

iii. The preponderance of the evidence establishes that Petitioner complied substantially with the requirements of 42 C.F.R. § 483.40(c) as of August 5, 1998.

The report of the August 1998 resurvey alleges at Tag 387 that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.40(c). 165 HCFA Ex. 8 at 16 - 17. The regulation provides that a resident must be seen by his or her treating physician at least once every 30 days for the first 90 days after admission and at least once every 60 days thereafter. The resurvey report alleges that Petitioner failed to comply with this requirement in several instances.

HCFA did not address Petitioner's alleged failure to comply under Tag 387 in its posthearing brief regarding the August 1998 resurvey. But, it appears that HCFA's position is that a facility is liable per se if a resident's physician fails to make the requisite visits. I do not find that this is a reasonable application of the regulation.

The regulation governs the duties of a facility and not that of the physicians who visit a facility's residents. The physicians are not employees of the facility and the facility is not in a position to force physicians to see residents on any schedule. All that a facility can do is to make every reasonable effort to ensure that residents' physicians comply with a patient visit schedule.

Here, Petitioner made such efforts. As the resurvey report notes, on July 11, 1998, Petitioner sent a letter to each of its residents' physicians urging those physicians to comply with the requirements of 42 C.F.R. § 483.40(c). 165 HCFA Ex. 8 at 17. HCFA has offered no explanation as to why these efforts were not reasonable, nor has HCFA suggested what else, under the circumstances, Petitioner could have done. Given that, I find that Petitioner complied substantially with the requirements of the regulation.

iv. HCFA failed to establish a prima facie case that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.75(j) as of August 5, 1998.

The report of the August 1998 resurvey alleges at Tag 502 that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.75(j). 165 HCFA Ex. 8 at 17 - 18. This regulation requires a facility to provide or obtain laboratory services to meet the needs of its residents. It makes the facility responsible for the quality and timeliness of laboratory services.

The surveyors examined the treatment records of 17 residents at Petitioner's facility. Their report alleges that in one instance Petitioner failed to comply substantially with the requirements of the regulation. According to the report, on June 26, 1998, a physician issued a telephone order that laboratory tests be made for a resident who is identified as Resident # 3. However, the resident's record was devoid of any evidence that the tests were conducted. According to the resurvey report, Petitioner's staff acknowledged that the tests must not have been done.

Petitioner notes that the identical tests were done on July 22, 1998. 165 HCFA Ex. 8 at 18. Petitioner argues that HCFA has failed to make even a prima facie showing that there was a potential for harm to the resident from its failure to ensure that the tests that were ordered on June 26, 1998 were performed.

I disagree with Petitioner that a failure to perform laboratory tests for a resident does not on its face cause a potential for harm to the resident. I infer from the fact that the resident's physician ordered the tests that the physician was concerned enough about the resident's medical condition to believe that the tests might show some underlying problems. Failure to produce the results of these tests timely could conceivably have concealed those problems. That is a potential for harm.

But, I do not find that Petitioner was deficient as of the August resurvey. HCFA has identified only a single error by Petitioner's staff which occurred weeks prior to the resurvey. It offered no evidence that this error was repeated subsequently. Nor did it offer any evidence that Petitioner was failing to ensure that residents received the laboratory services that had been ordered for them at the time of the survey. I do not infer that the single error identified by the surveyors describes an ongoing problem at Petitioner's facility in the absence of any evidence to show that the problem recurred or was current as of the August 1998 resurvey.

d. Petitioner provided persuasive evidence that it complied substantially with all requirements as of August 21, 1998. HCFA offered no evidence which showed that Petitioner failed to come into compliance until after August 21, 1998.

The only substantial deficiencies that Petitioner manifested as of the August resurvey were those that were identified at Tags 159 and 386 of the August resurvey report. See Finding 3.b.i., ii. Petitioner averred, credibly, that it corrected each of these two deficiencies by August 21, 1998. 165 HCFA Ex. 8 at 1 - 2, 12, 14. HCFA offered no evidence to show that Petitioner failed to correct these deficiencies by August 21, 1998. Consequently, I conclude that Petitioner attained compliance with participation requirements by August 21, 1998. Civil money penalties accrued through August 20, 1998, the last day on which Petitioner was not complying substantially with participation requirements.

Petitioner submitted a detailed plan of correction in response to the August 1998 resurvey in which it explained how it would address the deficiencies that were identified at the resurvey. 165 HCFA Ex. 8. The proposed corrections that Petitioner offered under Tags 159 and 386 appear on their face to be reasonable. The South Carolina State survey agency plainly found them to be reasonable or it would not have scheduled a second resurvey to ascertain whether Petitioner had attained substantial compliance with participation requirements. Petitioner averred credibly that it would correct the deficiencies at Tags 159 and 386 by August 21, 1998.

The September 1998 resurvey identified no deficiencies in Petitioner's operations. The surveyors did not provide any detailed explanation of what it was that they reviewed. The surveyors made no findings as to the precise date when Petitioner attained compliance with participation requirements. Their only finding was that Petitioner was in compliance as of the September 1998 resurvey. For example, there is no indication in the record whether they reviewed the records that Petitioner maintained of patients' funds between August 1998 and September 1998 to ascertain when these records were brought into compliance with participation requirements.

Thus, Petitioner's credible assertions that it came into compliance as of August 21, 1998 are not refuted by any evidence to show that they came into compliance as of a later date. I conclude that Petitioner did attain compliance by August 21, 1998 in the absence of any credible evidence to refute that assertion.

HCFA's only argument at this time in support of its assertion that daily civil money penalties should continue to accrue until September 18, 1998 is that Petitioner was not found to be complying with the Life Safety Code until that date. At subpart a. of this Finding, I explain why Petitioner's compliance with the Life Safety Code is not a relevant consideration in deciding when daily civil money penalties ceased to accrue. I note, moreover, that Petitioner submitted a plan of correction to address those Life Safety Code violations that had been identified on June 3, 1998. 165 HCFA Ex. 7. In that plan of correction Petitioner averred credibly that it would correct all Life Safety Code violations by no later than August 20, 1998. HCFA has offered no evidence to refute Petitioner's statement that it corrected its violations by that date. As was the case with the September resurvey for compliance with participation requirements, the Life Safety Code resurvey simply determined that Petitioner had come into compliance as of the date of the resurvey without determining when actual compliance was attained by Petitioner.

4. In Docket No. C-99-595, there is a basis for imposing remedies against Petitioner for each day of a period that begins on April 23, 1999.

At the April 1999 survey of Petitioner, the South Carolina State survey agency surveyors found that Petitioner was not complying with more than 50 Medicare participation requirements. 595 HCFA Ex. 2 at 1 - 116. The surveyors found that some of these deficiencies did not constitute failures by Petitioner to comply substantially with participation requirements. However, the surveyors concluded that the great majority of the deficiencies that were manifested by Petitioner as of the April 1999 survey were substantial. Id.

Subsequently, HCFA rescinded two of the deficiency findings that were made at Tags 223 and 224 of the April 1999 survey report. It concurred with the South Carolina State survey agency as to all of the other deficiency findings. Petitioner challenged five of these findings of substantial noncompliance. The challenged findings are at Tags 241, 248, 252, 314, 441, and 490 of the April 1999 survey report. But, Petitioner did not challenge the more than 40 additional findings of substantial noncompliance that HCFA accepted.

As I discuss above, at Finding 1, even one failure by Petitioner to comply substantially with a participation requirement gives HCFA a basis to impose remedies against it. Here, Petitioner has not refuted allegations that it failed to comply substantially with numerous participation requirements. A basis exists to impose remedies against Petitioner beginning with April 23, 1999, the completion date of the April 1999 survey, based on the more than 40 findings of substantial noncompliance that were made at the April 1999 survey which Petitioner did not challenge. These deficiency findings are established in the absence of any challenge to them by Petitioner. Moreover, and as I discuss in detail below, at Finding 5, in two instances Petitioner failed to show that HCFA's findings of immediate jeopardy level deficiencies were clearly erroneous.

a. The remedies that HCFA is authorized to impose include civil money penalties for each day of Petitioner's noncompliance beginning on April 23, 1999.

As I discuss above, at Finding 1, HCFA is authorized to impose civil money penalties for each day that a facility fails to comply substantially with federal participation requirements. HCFA is authorized to impose civil money penalties against Petitioner for a period of days which begins on April 23, 1999 inasmuch as it is established that Petitioner was not complying substantially with participation requirements beginning on that date.

b. The remedies that HCFA is authorized to impose include termination of Petitioner's participation in Medicare.

The remedies that HCFA may impose for failure by a facility to comply substantially with participation requirements include termination of that facility's participation in the Medicare program. Although termination is frequently imposed where a facility manifests immediate jeopardy level deficiencies, such deficiencies are not a precondition for imposition of the remedy. HCFA may terminate a facility's participation in Medicare based on any failure by a facility to comply substantially with participation requirements whether or not that failure rises to the immediate jeopardy level. 42 C.F.R. § 488.456(b)(1)(i).

Petitioner argues that the sole basis for HCFA's determination to terminate Petitioner's participation in Medicare was its conclusion that Petitioner manifested immediate jeopardy level deficiencies. Petitioner contends that there would be no basis for HCFA to impose termination as a remedy if I were to find that Petitioner did not manifest immediate jeopardy level deficiencies. However, as I discuss at Finding 5.a., Petitioner did manifest immediate jeopardy level deficiencies as of April 23, 1999. Consequently, HCFA was authorized to terminate Petitioner's participation in Medicare based either on the presence of immediate jeopardy level deficiencies or on the presence of other deficiencies which, while substantial, were not at the immediate jeopardy level of scope and severity.

Furthermore, I do not agree with Petitioner's assertion that the sole basis for HCFA's determination to terminate Petitioner's participation in Medicare was the presence of immediate jeopardy level deficiencies. In the notices that HCFA sent to Petitioner concerning the imposition of remedies, HCFA told Petitioner that the determination to terminate Petitioner's participation in Medicare was predicated on all of the deficiency findings that were made at the April 1999 survey and not just on immediate jeopardy level deficiency findings.

That is evident from the language of the notices. On April 29, 1999, HCFA sent a notice to Petitioner. On May 7, 1999, HCFA sent an amended version of its notice to Petitioner (the amended notice also is dated April 29, 1999). 595 HCFA Ex. 3; 595 P. Ex. 3 at 60 - 63, 84 - 88. Both of these notices contained identical relevant language:

[The April 1999] survey found your facility was not in substantial compliance with the participation requirements and that conditions in your facility constituted immediate jeopardy to resident health and safety. A statements of deficiencies found during the survey was furnished to you by the State Survey Agency in a letters dated April 26 and April 28, 1999.

595 HCFA Ex. 3 at 1; 595 P. Ex. 3 at 60.

Both notices told Petitioner that remedies, including "involuntary termination of your provider agreements" had been recommended by the South Carolina State survey agency "based on these survey findings." Ids. I find the phrase "based on these findings" to refer to all of the findings of deficiencies that are stated in the report of the April 1999 survey and not just the four findings of immediate jeopardy level deficiencies.

c. Petitioner did not prove that it attained compliance with participation requirements prior to May 16, 1999, the date on which Petitioner's participation in Medicare was terminated.

The notices that HCFA sent to Petitioner on April 29 and May 7, 1999 invited Petitioner to submit a plan of correction which addressed the findings of deficiencies that were identified at the April 1999 survey. 595 HCFA Ex. 3 at 2; 595 P. Ex. 3 at 61. The notices told Petitioner that:

Failure to submit an acceptable . . . [plan of correction] will result in the termination of your provider agreements.

Id. The clear implication of these notices is that if Petitioner submitted an "acceptable plan of correction," termination of participation would not be imposed. Petitioner submitted a plan of correction to the South Carolina State survey agency on May 10, 1999. 595 P. Ex. 13 at 1 - 268. On May 17, 1999, HCFA rejected Petitioner's plan of correction. 595 P. Ex. 3 at 141 - 142. HCFA told Petitioner that it had rejected the plan because:

Your latest "credible allegation of compliance" did not allege that corrective action had actually removed the immediate jeopardy situations, or that compliance had been achieved. While corrective measures were proposed, there was no allegation of actual compliance.

Id. at 141.

I do not have the authority to adjudicate the question of whether HCFA abused its discretion in deciding not to accept a plan of correction. The regulations reserve to HCFA the authority to accept or reject a plan of correction. See 42 C.F.R. § 488.456(b)(1)(ii).

However, I do have the authority to decide when a facility attains compliance with participation requirements. If Petitioner had attained compliance with all participation requirements prior to May 16, 1999, then HCFA would not have had the authority to terminate Petitioner's participation in Medicare as of that date. That is because there would exist no legal basis to terminate Petitioner's participation in Medicare if it was, in fact, complying with all participation requirements prior to the date on which HCFA elected to impose termination.

Petitioner did not prove that it attained compliance with all participation requirements by May 16, 1999. That is made evident by Petitioner's plan of correction. Although Petitioner alleged that it had corrected "all" deficiencies as of May 10, 1999, its plan of correction acknowledged that, in many instances, corrections were "ongoing" as of that date. Thus, the plan of correction itself avers that corrections were in progress and not complete as of the date that Petitioner submitted it. That is true with respect to many of the deficiency findings that Petitioner did not challenge. And it is also true with respect to both of the findings of immediate jeopardy level deficiencies that are at issue in this case and which I sustain below, at Finding 5.a. 595 P. Ex. 13 at 22 - 23, 24 - 25.

5. In Docket No. C-99-595 civil money penalties in the amount of $10,000 per day are unreasonable for the period which begins on April 23, 1999 and which runs through May 15, 1999. Civil money penalties in the amount of $3,050 per day are reasonable.

HCFA determined to impose civil money penalties of $10,000 for each day of the period which begins on April 23, 1999 and which runs through May 15, 1999. Penalties in the amount of $10,000 per day are the highest that are permitted by law and are reserved for the most egregious immediate jeopardy level deficiencies. HCFA based its determination to impose these penalties on its conclusion that, during the period in question, Petitioner manifested four immediate jeopardy level deficiencies, some of which caused serious harm to residents of Petitioner.

I conclude that penalties in the amount of $10,000 per day are unreasonable. I find that civil money penalties in the amount of $3,050 per day are reasonable. I so find because Petitioner's deficient conduct was substantially less egregious than HCFA determined it to be. I base this conclusion on the following analysis.

• Petitioner was deficient at the immediate jeopardy level in fewer respects than HCFA originally determined. Petitioner manifested two, and not four, immediate jeopardy level deficiencies. And, one of these two deficiencies is a restatement of the other deficiency under a different regulation. In reality, Petitioner's deficient conduct at the immediate jeopardy level was limited to just one aspect of Petitioner's operations, the manner in which it tracked infections among its residents.

• HCFA in part based its determination to impose $10,000 per day civil money penalties against Petitioner on its conclusion that residents of Petitioner were experiencing actual and severe harm as a consequence of Petitioner's immediate jeopardy level deficiencies. However, there is no evidence that any of Petitioner's residents experienced actual harm as a consequence of the immediate jeopardy level deficiencies that were established. The evidence establishes only the likelihood that residents would experience severe harm if deficiencies continued unabated.

a. Petitioner manifested two immediate jeopardy level deficiencies as of April 23, 1999. Therefore, a basis exists to impose upper range civil money penalties against Petitioner.

An immediate jeopardy level deficiency is:

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.

It is not necessary that a resident be harmed or die in order for there to be immediate jeopardy. A situation which poses a likelihood for causing serious injury, harm, impairment, or death to a resident is sufficient to constitute immediate jeopardy even if actual harm has not yet occurred. Id.

The regulations require that deference be paid to HCFA in determining when immediate jeopardy exists. If there is a failure by a facility to comply substantially with a participation requirement, and HCFA determines that the level of noncompliance is immediate jeopardy, then HCFA's determination as to the level of noncompliance must be sustained unless it is established to be clearly erroneous. 42 C.F.R. § 498.60(c)(2).

i. HCFA established a prima facie case, which Petitioner did not rebut, that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.65(a)(1) - (3) to the extent that residents of Petitioner were at immediate jeopardy as of April 23, 1999.

The report of the April 1999 survey alleges at Tag 441 that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.65(a)(1) - (3) to the extent that residents of Petitioner were at immediate jeopardy. 595 HCFA Ex. 2 at 92 - 97. The regulation requires that a facility must establish an infection control program under which it: investigates, controls, and prevents infections; decides what procedures, such as isolation should be applied to an individual resident; and, maintains a record of incidents and corrective actions related to infections. The report alleges that Petitioner was deficient in complying with this regulation at the immediate jeopardy level in the following respects.

• Petitioner allegedly failed to track residents with infections.

• A resident, who is identified as Resident # 4, was on contact isolation for a possible infection with Methicillin Resistant Staphylococcus Aureus (MRSA). A nurse who treated the resident allegedly breached contact isolation protocols by: failing to wear a mask in the resident's presence; taping a bag containing biohazardous material to a table that was located outside of the resident's room; and, leaving the resident's room and walking down a corridor in Petitioner's facility while wearing a gown that the nurse had worn to treat the resident.

• The physician that treated a resident, who is identified in the survey report as Resident # 21, prescribed the administration to the resident of an antibiotic known as Trovan. However, the resident's records did not contain any statement describing the underlying infection the resident might have had which would justify the administration of Trovan to the resident. Petitioner's staff made no effort to determine whether the resident had an infection and, if so, the nature of the resident's infectious agent.

I am not persuaded that the alleged breaches of contact isolation protocol in the care that Petitioner gave to Resident # 4 constitute persuasive prima facie evidence that Petitioner was not complying with the requirements of 42 C.F.R. § 483.65(a)(1) - (3). First, HCFA failed to show that some of the conduct of the nurse who was observed caring for the resident actually violated isolation protocol. For example, it is not clear that the nurse needed to wear a mask in the presence of the resident because HCFA did not offer prima facie evidence showing that the nurse came close enough to the resident so that the resident potentially could infect the nurse through respiratory discharges. Second, there is no persuasive prima facie evidence that the nurse disposed of biohazardous materials improperly. Third, although it is clear that the nurse breached infection protocol by failing to remove a gown prior to exiting the resident's room and wearing the gown in a corridor of Petitioner's facility, that breach constitutes, at most, an isolated error. HCFA failed to show any systemic breach of infection control protocol by establishing this single error.

However, HCFA offered additional prima facie evidence which shows that Petitioner was not implementing an effective infection control program. The failure of Petitioner's staff to make efforts to identify the source of infection of Resident # 21 meant that the resident may have had a potentially dangerous and contagious infection that had not been identified. Petitioner's staff had no way of knowing - without establishing whether the resident was infected or the possible infectious agent - whether the resident could spread infection and whether precautions such as isolation needed to be taken with respect to the resident. Petitioner's attempt to rebut this evidence consists mainly of arguing that Petitioner was not responsible for altering or questioning the care that was ordered by the resident's physician. I do not disagree with this assertion but it begs the question of what constituted Petitioners' responsibility. Petitioner had a duty to make reasonable efforts to find out the source of the resident's infection. There is no evidence to show that Petitioner made such efforts. For example, Petitioner has not offered any evidence to show that Petitioner's staff queried the resident's physician about the nature of the resident's infection.

Moreover, HCFA established a prima facie case of an overall failure by Petitioner to track adequately those residents who had infections, in violation of the requirements of 42 C.F.R. § 483.65(a)(1) - (3). HCFA's assertions are supported by evidence that the surveyors obtained at the April 1999 survey and the testimony that HCFA elicited from Timothy Holtz, M.D. Tr. at 46 - 191. In addition to being a licensed physician, Dr. Holtz is employed as an epidemic intelligence officer for the Centers for Disease Control. Id. at 47. I find Dr. Holtz to have been a highly persuasive and credible expert witness.

Residents of nursing facilities are vulnerable to a range of contagious and life threatening infections. Tr. at 65 - 66. These infections may be bacterial, viral, or parasitic in nature. Id. Some of them may be spread by facility staff. Id. at 66. Others may be spread by resident to resident contact. Id.

It is necessary to track infections effectively given the susceptibility of nursing facility residents to infections and given further the dangers that infections pose to nursing facility residents. Effective tracking of infections means identifying each resident who has or who is likely to have an infection, determining the cause of any infection, and establishing the date when the resident became infected. Tr. at 55; see Attachment to Petitioner's posthearing brief. The causes of infection in a facility must be identified in order to prevent infections from spreading. Id. at 57. Surveillance of residents in a nursing facility is necessary in order to establish the presence of possible clusters of infection. Id. Poor surveillance of infections by a facility is likely to facilitate the spread of infections among residents. See Id. at 70 - 71, 82.

The surveyors asked Petitioner to provide them with documentation of the way in which it tracked infections. In response, Petitioner's staff provided the surveyors with two documents consisting of lists of residents who were suffering from infections. 595 HCFA Ex. 2 at 93. However, these lists for the most part failed to identify the residents' infection causing agents and in several instances they failed to verify the status or severity of the infections from which the residents were suffering. Petitioner would not have been able to identify the sources of infections from these lists. Tr. at 59 - 60. Nor would Petitioner have been able to contain clusters of infection using just these lists as surveillance mechanisms. Id. As Dr. Holtz noted:

[If these lists are Petitioner's] representation of an infection control program, it's a very poor example of surveillance and control activities. And with this poor surveillance, that it would likely result in the spread of infectious organisms within the facility.

Id. at 70 - 71.

Not only did HCFA present a prima facie case that Petitioner was not complying substantially with the requirements of 42 C.F.R. § 483.65(a)(1) - (3) in that it failed to track infections, but HCFA presented prima facie evidence that Petitioner's failure to track infections put residents of Petitioner in a state of immediate jeopardy. As Dr. Holtz observed, a failure by Petitioner to track infections would likely result in the spread of infectious organisms within Petitioner's facility. Tr. at 70 - 71. Residents likely would contract serious or life-threatening infections as a consequence.

Petitioner has not offered persuasive affirmative evidence to challenge the proposition that residents' health and safety would be jeopardized if it failed to track infections. Instead, Petitioner asserts that it was tracking infections adequately. Petitioner offered two types of records as documentary proof of its alleged infection tracking efforts. 165 - 595 P. Ex. 27 at 167 - 175, 180 - 185. I have examined these records closely. I do not find that they rebut by the preponderance of the evidence HCFA's prima facie case of Petitioner's noncompliance with the requirements of 42 C.F.R. § 483.65(a)(1) - (3). Nor do they prove to be clearly erroneous HCFA's determination that Petitioner's noncompliance placed residents of Petitioner in immediate jeopardy.

One of the records that Petitioner offered to prove its infection tracking efforts is entitled the "1999 Infection Control Tracking Record" for Petitioner's Units A, B, and C. 165 - 595 P. Ex. 27 at 167 - 175. This document contains entries for the months of February, March, and April 1999. I infer from these entries that the document was being maintained by Petitioner throughout the early part of 1999 and was being updated monthly.

The 1999 Infection Control Tracking Record, although it is certainly a more detailed listing of residents' infection status than the documents that the surveyors obtained, is not in and of itself proof that Petitioner maintained an effective infection tracking system. The document does not contain enough information so as to allow a facility to perform adequate infection surveillance. This document contains a list of residents of Petitioner by resident name. 165 - 595 P. Ex. 27 at 167. Next to the list of names are columns of spaces arranged vertically by month and horizontally by resident. The document is organized so that, by reading across the page, one can ascertain whether a resident suffered from an infection in any given month. Id. The document also contains information concerning the types of infections that residents were suffering from. However, it does not, for the most part, identify the specific organisms that were causing infections. Nor does it describe the treatments that were being given to the residents to deal with their infections or the precautions that were being taken to prevent the spread of infections.

The other record that Petitioner offered as evidence that it was tracking infections adequately is a document that is entitled "Infection Surveillance Form." 165 - 595 HCFA Ex. 27 at 180 - 185. The Infection Surveillance Form contains much more detailed information than is contained in the Infection Control Tracking Record or in the lists of names that Petitioner's staff gave to surveyors during the April 1999 survey. It lists: the name of each resident; that resident's date of admission; the date of onset of the resident's infection; the pertinent diagnosis; the type of culture taken to confirm the diagnosis; the organism that caused the resident's infection; whether re-cultures were taken of the resident; the treatment or antibiotic that the resident is receiving for his or her infection; the type of isolation that is being utilized as part of the resident's care; whether the infection was acquired at Petitioner's facility; and the date of resolution of the infection or discharge of the resident along with pertinent comments. Id.

Unlike the other documents that are of record, the Infection Surveillance Form is an effective tool for tracking infections. Tr. at 161. I would find that Petitioner overcame HCFA's prima facie evidence of failure by Petitioner to implement an infection tracking system were I to conclude that the Infection Surveillance Form was evidence of the state of Petitioner's infection tracking system as of the April 1999 survey.

However, I do not conclude that the Infection Surveillance Form is proof that Petitioner was effectively tracking infections as of the April 1999 survey. Petitioner has not shown that it actually was utilizing this form in April 1999. I infer from the appearance and contents of the form that it was created after completion of the April 1999 survey and reflects post-survey efforts by Petitioner to demonstrate that it was tracking infections.

The form was completed at one sitting. The April 1999 form was prepared no earlier than early May 1999. The entries on the form were not made contemporaneously with events as they occurred. I base my conclusion that the form was prepared in one sitting on the facts that all of the entries in the form are in the same handwriting and appear to have been made with the same pen. 165 - 595 P. Ex. 27 at 180 - 185. I base my conclusion that the form could not have been prepared sooner than early May 1999 on the fact that several of the entries in the April form are dated at the end of April 1999 and, in one instance, May 2, 1999. Id. at 180 - 182.

There is additional evidence from which I infer that the Infection Surveillance Form was not being used by Petitioner as of the April 1999 survey. Petitioner's plan of correction for the April 1999 survey, which Petitioner did not submit until May 10, 1999, does not allege that this form had been implemented prior to the survey. See 595 P. Ex. 13 at 25. However, it alludes to development of "new forms to enable appropriate tracking of residents with infections." Id. I infer that the "new forms" that the plan of correction refers to as having been developed by Petitioner after completion of the April 1999 survey include the Infection Surveillance Form.

I might have concluded that Petitioner was effectively tracking infections as of the April 1999 survey had Petitioner offered an Infection Surveillance Form completed for the month of March 1999. A form that was completed at the end of March 1999 likely would have satisfied me that Petitioner's staff was tracking infections as part of its regular duties and summarizing its tracking activities in a form that was generated at the end of each month. I would then have concluded that the form for April 1999 - even though it was prepared after the end of April and after completion of the April 1999 survey - reflected the activities that were taking place at Petitioner as of the date of the survey. However, in the absence of a March 1999 form, I can conclude only that some one at Petitioner's facility decided after completion of the April 1999 survey, and after Petitioner had been told that it was not tracking infections, that it would be in Petitioner's interest to complete a form showing that it was tracking infections in the month of April 1999. That is not enough to satisfy me that Petitioner was indeed tracking infections satisfactorily as of the April 1999 survey.

ii. HCFA established a prima facie case, which Petitioner did not rebut, that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.75 to the extent that residents of Petitioner were at immediate jeopardy as of April 23, 1999.

The report of the April 1999 survey alleges at Tag 490 that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.75 to the extent that residents of Petitioner were at immediate jeopardy. 595 HCFA Ex. 2 at 103 - 104. The regulation requires that a facility 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.

It is apparent from the face of the tag that the surveyors based their conclusion that Petitioner manifested an immediate jeopardy level failure to comply with 42 C.F.R. § 483.75 entirely on their conclusion that Petitioner was not complying with other participation requirements that govern resident care and well-being. The examples of alleged failures to comply with 42 C.F.R. § 483.75 that are recited in the survey report say no more than to incorporate by reference allegations stated elsewhere in the report that Petitioner failed to comply with regulations dealing with resident abuse, infection control, and quality of care. 595 HCFA Ex. 2 at 104. And, the surveyors based their conclusion that Petitioner manifested an immediate jeopardy level deficiency at Tag 490 entirely on their reliance on other alleged immediate jeopardy level deficiencies.

Petitioner has challenged all of the deficiency findings that form the basis for the surveyors' conclusion that Petitioner failed to comply with 42 C.F.R. § 483.75. It is unnecessary for me to review each of Petitioner's arguments, however, or to look at all of the deficiency tags that are the basis for the surveyors' conclusions about Petitioner's compliance under Tag 490. A basis exists to find an immediate jeopardy level deficiency under Tag 490 in Petitioner's immediate jeopardy level deficiency under Tag 441, which I have discussed above, at subpart a.i. of this Finding. Furthermore, had I not found an immediate jeopardy level deficiency under Tag 441, then I would have had no basis to find an immediate jeopardy level deficiency under Tag 490.

Having said that, however, I conclude also that Petitioner's deficiency under Tag 490 does not suggest any greater degree of overall noncompliance with participation requirements by Petitioner than is established by Petitioner's failure to comply with the requirements that are the basis for the deficiency findings that are made under Tag 441. In this instance, Petitioner's failure to comply with the requirements of 42 C.F.R. § 483.75 represents double counting of Petitioner's failure to comply with other participation requirements. Thus, saying that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.75 on the basis of the allegations that are elsewhere in the report of the April 1999 survey says nothing about the overall extent of Petitioner's noncompliance with participation requirements.

b. Petitioner manifested fewer immediate jeopardy level deficiencies than was alleged by HCFA.

The report of the April 1999 survey alleged that Petitioner manifested four immediate jeopardy level deficiencies. HCFA based its determination to impose civil money penalties of $10,000 per day against Petitioner based on the alleged presence of four immediate jeopardy level deficiencies. In fact, and as I find above at subpart a. of this Finding, Petitioner manifested only two immediate jeopardy level deficiencies. Furthermore, one of those deficiencies - stated at Tag 490 of the survey report - merely repackages deficiencies found elsewhere in the report, including the immediate jeopardy level deficiency that is stated at Tag 441. Thus, there was in fact only one circumstance in this case in which acts or omissions by Petitioner or its staff placed residents of Petitioner at immediate jeopardy. That was the failure by Petitioner to track infections.

c. The immediate jeopardy level deficiencies that Petitioner actually manifested as of April 23, 1999, establish a level of noncompliance by Petitioner that is not so serious as was alleged in the report of the April 1999 survey.

Three of the four immediate jeopardy level deficiencies that were cited in the report of the April 1999 survey were given scope and severity ratings of "L" by the surveyors who conducted the survey. 595 HCFA Ex. 2 at 18, 20, 103; see 595 HCFA Ex. 6. These alleged deficiencies were cited at Tags 223, 224, and 490 of the report of the survey. The fourth immediate jeopardy level deficiency, cited at Tag 441, was given a lower scope and severity rating of "K" by the surveyors. 595 HCFA Ex. 2 at 92; see 595 HCFA Ex. 6. HCFA has withdrawn its allegations concerning two of the "L" level deficiencies (Tags 223 and 224). And, the actual scope and severity of the deficiency at Tag 490 cannot be higher than the scope and severity of the remaining immediate jeopardy level deficiency at Tag 441. Therefore, both remaining immediate jeopardy level deficiencies have scope and severity ratings of "K." The scope and severity ratings for the established immediate jeopardy level deficiencies are lower than what was originally alleged for the deficiencies that have been rescinded.

There is a meaningful difference between the seriousness of what was alleged and what was established. The April 1999 survey report alleges, at the now-rescinded Tags 223 and 224, that Petitioner tolerated conduct that directly harmed certain residents. However, the principal immediate jeopardy deficiency that Petitioner actually manifested, at Tag 441 of the April 1999 survey report, only caused a likelihood for very serious harm to residents of Petitioner. There is no persuasive evidence of record that residents of Petitioner were actually harmed by Petitioner's failure to track infections adequately.

That Petitioner's failure to track infections posed the likelihood for serious harm, but did not actually cause residents to experience harm was made explicit by Dr. Holtz. Dr. Holtz concluded that Petitioner's failure to track infections resulted in a likelihood of serious harm or even death to residents. Tr. at 70 - 71. However, he did not find the presence of actual harm resulting from Petitioner's failure to track infections. See Id. Dr. Holtz found that there was no evidence of an epidemic or a cluster infection problem at Petitioner notwithstanding Petitioner's failure to maintain adequate infection tracking. Id. at 106 - 107, 109.

d. Civil money penalties of $3,050 per day are reasonable when the nature and seriousness of Petitioner's immediate jeopardy level deficiencies are considered.

HCFA premised its determination to impose civil money penalties against Petitioner, beginning April 23, 1999, on its conclusion that, as of that date, Petitioner manifested four immediate jeopardy level deficiencies, three of which resulted in very serious actual harm to residents. In fact, Petitioner manifested only two immediate jeopardy level deficiencies as of April 23, 1999. One of these deficiencies, at Tag 490, is merely a restatement of the deficiency that Petitioner manifested at Tag 441. The immediate jeopardy level deficiency that Petitioner manifested at Tag 441 did not actually harm any residents but posed a likelihood of serious harm or death for residents.

The $10,000 per day civil money penalties that HCFA determined to impose against Petitioner for its noncompliance, beginning on April 23, 1999, are the highest civil money penalties that the law permits. Penalties in these amounts are reserved for the most egregious violators of Medicare participation requirements. However, the evidence in this case shows that Petitioner's noncompliance - while very serious - does not approach the level of seriousness that was found originally by HCFA. I am reducing the civil money penalties that were imposed, beginning on April 23, 1999, to $3,050 per day. That reflects the greatly diminished seriousness of Petitioner's actual immediate jeopardy level deficiencies.

6. In Docket No. C-99-595, it is not necessary that I decide whether Petitioner was deficient in other respects as of the April 1999 survey.

Petitioner explicitly challenged certain additional non-immediate jeopardy findings of deficiency that were made in the report of the April 1999 survey. These other findings are at Tags 241, 248, 252, and 314 of the survey report. For several reasons, I conclude that it is unnecessary for me to address the parties' arguments about these tags.

First, HCFA would have a basis to impose remedies against Petitioner, including termination of participation, whether or not Petitioner was deficient under the challenged tags. Deciding in Petitioner's favor as to the remaining challenged tags would in no respect invalidate HCFA's authority to impose termination as a remedy. That is because Petitioner was not complying substantially with more than 40 other participation requirements and because Petitioner manifested two immediate jeopardy level deficiencies.

Second, I have not based my decision to impose upper range civil money penalties of $3,050 per day against Petitioner on the presence or absence of lower range deficiencies. I could not reduce the civil money penalties imposed against Petitioner below $3,050 per day even if Petitioner successfully challenged some of the non-immediate jeopardy level deficiency findings. And, I would not increase the civil money penalties above $3,050 per day were I to conclude that the challenged non-immediate jeopardy level deficiency findings should be sustained.

I conclude that, as a matter of law, I may not base the amount of immediate jeopardy level deficiencies on the presence of additional non-immediate jeopardy level deficiencies. The regulation which governs upper level civil money penalties provides that:

Penalties in the range of $3,050-$10,000 per day are imposed for deficiencies constituting immediate jeopardy . . . .

42 C.F.R. § 488.438(a)(1)(i) (emphasis added). I read this language as saying that only immediate jeopardy level deficiencies may be considered in deciding the appropriate amounts of civil money penalties that are imposed within the upper range. The presence of additional lower level deficiencies is not relevant to deciding the appropriate amount of an upper range penalty.

HCFA now argues that Petitioner's compliance history coupled with the large number of non-immediate jeopardy level deficiencies that were present as of April 23, 1999, in addition to the immediate jeopardy level deficiencies, militates in favor of civil money penalties at the maximum level. I disagree with this analysis. The regulation does not suggest that upper range civil money penalties may be increased beyond what is merited for upper level deficiencies based on the presence of additional lower level deficiencies or a facility's poor compliance history. The regulation does contain an exception for repeat lower level deficiencies. In that instance, civil money penalties may be imposed in the upper range. 42 C.F.R. § 488.438(a)(1)(i) (incorporating 42 C.F.R. § 488.438(d)(2)). However, that circumstance is not applicable here inasmuch as HCFA did not determine to impose civil money penalties in the upper range against Petitioner based on its alleged history of compliance or on the alleged presence of repeated deficiencies. See 42 C.F.R. § 488.438(a)(1)(i). Until now, HCFA has never made such a contention. HCFA has always argued that it was imposing civil money penalties of $10,000 per day based on the alleged presence of several immediate jeopardy level deficiencies.

Third, my decision to impose civil money penalties of $3,050 per day takes into consideration the seriousness of the immediate jeopardy level deficiencies that Petitioner manifested. I do not find it reasonable to increase these penalties based on the presence of other, non-immediate jeopardy level deficiencies. These deficiencies are less serious by an order of magnitude than the immediate jeopardy level deficiencies that Petitioner manifested. No remedial purpose would be served by increasing civil money penalties beyond what I have decided is reasonable.

7. In Docket No. C-99-595, Petitioner is liable for civil money penalties in the amount of $3,050 per day for each day of a period that begins on April 23, 1999 and which runs through May 15, 1999.

I have found that civil money penalties in the amount of $3,050 per day are reasonable. Finding 5. I also have found that Petitioner did not prove that it attained compliance with participation requirements, including those requirements pursuant to which Petitioner was found to be deficient at the immediate jeopardy level of noncompliance, prior to May 16, 1999, the date on which Petitioner's participation in Medicare was terminated. Therefore, Petitioner is liable for civil money penalties in the amount of $3,050 per day for each day of the period that begins on April 23, 1999 and which runs through May 15, 1999.

8. Petitioner's financial condition is not a basis for reducing the civil money penalties in either Docket No. C-99-165 or in Docket No. C-99-595.

The civil money penalties that HCFA determined to impose in Docket No. C-99-165 total $47,700. In that case, I am sustaining civil money penalties which total $19,500. The civil money penalties that HCFA determined to impose in Docket No. C-99-595 total $230,000. In that case, I am sustaining civil money penalties which total $70,150. The sum total of the civil money penalties that I am sustaining in the two cases is $89,650, less than 1/3 of the $277,700 in total civil money penalties that HCFA determined to impose.

In both cases, Petitioner argued strenuously that HCFA failed to consider its financial situation in determining the amounts of civil money penalties to impose and that the civil money penalties that HCFA determined to impose are unreasonably high in light of Petitioner's actual financial condition. HCFA opposed these arguments.

Petitioner asserts that in neither Docket No. C-99-165 nor in Docket No. C-99-595 did HCFA take Petitioner's actual financial condition into consideration in determining the civil money penalty amounts to be imposed in those cases. Petitioner argues that the appropriate remedy for me to order in the absence of any evidence that HCFA actually took Petitioner's financial condition into account is to impose a minimum civil money penalty.

I do not agree with Petitioner that the consequence of a failure by HCFA to fully review Petitioner's financial condition prior to making a determination to impose civil money penalties is that I should impose a minimum civil money penalty amount in each of these cases. The possibility that evidence offered by Petitioner as to its financial condition was not fully reviewed by HCFA is not a relevant consideration in deciding the amounts of civil money penalties to be imposed if I give Petitioner the opportunity to present such evidence as part of its case before me. My authority to hear and decide these cases is de novo. My obligation is to review evidence independently from what HCFA may have done with that evidence and to make my own decision as to appropriate civil money penalty amounts. Here, each side was given the opportunity to present evidence for my de novo consideration.

Petitioner contends that I should consider reducing the civil money penalties in C-99-595 down to as low as $50 per day based on evidence concerning Petitioner's financial condition. It argues that I should not be bound by the $3,050 minimum civil money penalty amount for an immediate jeopardy level deficiency but should reduce the penalties in Docket No. C-99-595 below that amount based on Petitioner's ability to pay the penalties.

I do not have the authority to reduce a civil money penalty below the minimum upper range penalty of $3,050 per day in a case in which I find an immediate jeopardy level deficiency. The penalty amount of $3,050 per day, and the total civil money penalties of $70,150, are the lowest civil money penalty amounts that I may impose in Docket No. C-99-595 regardless of the conclusions I might reach about Petitioner's financial condition. Thus, in Docket No. C-99-595, I do not have authority to reduce the civil money penalties below the minimum upper range penalty amount of $3,050 in light of my conclusion that Petitioner manifested immediate jeopardy level deficiencies.

There is no provision in the regulations which permits a civil money penalty of less than $3,050 per day in an immediate jeopardy situation. The regulations provide only that a civil money penalty of between $3,050 and $10,000 per day may be imposed for each day in which a facility manifests one or more immediate jeopardy level deficiencies. 42 C.F.R. § 488.438(a)(1)(i). A penalty amount of $3,050 per day constitutes a floor beneath which I may not go if I sustain a finding of an immediate jeopardy level deficiency.

Petitioner does not deny that the regulations fail to contemplate civil money penalties of less than $3,050 per day in a case involving immediate jeopardy level deficiencies. Petitioner argues that "the statute trumps the regulations in the event of an inconsistency." Petitioner's posthearing brief in Docket No. C-99-595 at 94 - 95, n.57. Petitioner claims that HCFA's determination in this case is inconsistent with the requirements of the Act even if it arguably might be consistent with the regulations. Id. Petitioner asserts that the Act requires that a civil money penalty be reduced - arguably down to as low as $50 per day - even where an immediate jeopardy level deficiency is present, where a facility's financial condition precludes payment of higher penalty amounts.

I am not persuaded by this argument. The regulations constitute the Secretary's application of the Act and I must apply them as they are written. Here, the Secretary has concluded that the minimum civil money penalty in an immediate jeopardy situation is $3,050 per day. I am required to follow that application of the Act. Moreover, I find nothing in either section 1819 of the Act, which confers authority on the Secretary to impose civil money penalties in cases involving long-term care facilities, or in section 1128A of the Act, which contains general guidelines for the imposition of civil money penalties, which is inconsistent with applicable regulations governing civil money penalties in long-term care cases. There is nothing in either section 1819 or section 1128A which states that a civil money penalty may be reduced below the $3,050 minimum amount for an immediate jeopardy level deficiency where a facility's financial condition warrants further reduction of the penalty amount.

Petitioner argues that its financial condition is precarious and that it may very well be forced into bankruptcy if it is required to pay the full civil money penalty amounts that HCFA determined to impose. For reasons that I have just explained, I have no authority to consider these arguments in Docket No. C-99-595 inasmuch as I have imposed the minimum civil money penalty amounts in this case. I do not find Petitioner's arguments to be persuasive in Docket No. C-99-165. In that case I have substantially reduced the civil money penalty amounts from what HCFA determined to impose based on my findings that Petitioner's deficiencies were not so numerous or so egregious as HCFA contended them to be. The total penalties that I am imposing in Docket No. C-99-165 are only a small percentage of what HCFA determined to impose. The evidence that Petitioner offered concerning its financial condition does not warrant further reduction of the civil money penalties. Petitioner argued that its financial condition would preclude it from paying the entire amount of the civil money penalties that HCFA determined to impose. It did not attempt to show that it was unable to pay the fraction of that amount that I imposed in Docket No. C-99-165.

JUDGE
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Steven T. Kessel

Administrative Law Judge

 

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