SUBJECT:

Guardian Health Care Center,

Petitioner,

The Inspector General

DECISION

This case came before me pursuant to a request for hearing filed by Petitioner, Guardian Health Care Center, on March 10, 2003.

On December 12, 2002, January 10, 2003, and January 31, 2003, the Centers for Medicare and Medicaid Services (CMS) issued notices informing Petitioner that CMS was imposing the following remedy pursuant to a survey completed on November 7, 2002, by the Ohio Department of Health (ODH):

A Civil Money Penalty (CMP) in the amount of $500 per day for the period November 7, 2002 through December 4, 2002, and $50 for December 5, 2002. ⁽¹⁾

On August 13, 2003, CMS filed a motion for summary judgment accompanied by a brief and 11 exhibits. Petitioner submitted a brief in opposition to summary judgment on October 7, 2003, accompanied by two proposed exhibits. CMS filed a reply to Petitioner's brief in opposition on November 17, 2003. The exhibits have been admitted into the record as CMS Exhibits 1-11 (CMS Exs. 1-11) and Petitioner's Exhibits 1-2 (P. Exs. 1-2).

Based on the affidavits, other documentary evidence, the written arguments of the parties and the applicable law and regulations, I find that from November 7, 2002, through December 4, 2002, Petitioner was not in substantial compliance with Medicare/Medicaid participation requirements.

I. Applicable Law and Regulations

Petitioner is a long-term care facility subject to the Social Security Act (Act) and regulations promulgated by the Secretary of Health and Human Services (Secretary). The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Act, and at 42 C.F.R. Part 483.

Sections 1819 and 1919 of the Act invest the Secretary with authority to impose remedies including CMPs and denial of payment for new admissions (DPNA) against a long-term care facility for failure to comply substantially with participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the States the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. The applicable regulations, at 42 C.F.R. Part 488, provide that facilities which participate in Medicare may be surveyed on behalf of CMS by State survey agencies in order to ascertain whether the facilities are complying with participation requirements. 42 C.F.R. �� 488.10-488.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. �� 488.300-488.335. Under Part 488 of the Code of Federal Regulations, a State or CMS may impose a CMP against a long-term care facility where a State survey agency ascertains that the facility is not complying substantially with participation requirements. 42 C.F.R. �� 488.406, 488.408, and 488.430. The penalty may start accruing as early as the date that the facility was first out of compliance until the date substantial compliance is achieved, or the provider agreement is terminated. 42 C.F.R. � 488.440.

The regulations define the term "substantial compliance" to mean:

[A] level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.

42 C.F.R. � 488.301.

The Act and regulations make a hearing before an administrative law judge (ALJ) available to a long-term facility against which CMS has determined to impose a CMP. But the scope of such hearings is limited to whether an initial determination made by CMS is correct. Act, section 1128A(c)(2); 42 C.F.R. �� 488.408(g), 498.3(b)(12) and (13). The hearing before an administrative law judge is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F.2d 678 (8^th Cir. 1991).

II. Issues

1. Whether the facility was complying substantially with federal participation requirements from November 7, 2002 through December 7, 2002; and

2. Whether the amount of the penalty imposed is reasonable, if noncompliance is established.

III. Discussion

A. The Parties' Arguments

1. CMS's Contentions.

CMS contends that Petitioner failed to comply with the requirement at 42 C.F.R. � 483.25(h)(2) with respect to Quality of Care. According to CMS, the survey completed on November 7, 2002 revealed that Petitioner's facility did not ensure that each resident received adequate supervision and assistance devices to prevent accidents.

2. Petitioner's Contentions.

Petitioner contends that CMS has submitted an incomplete and improper Motion for Summary Affirmance. Specifically, Petitioner argues that CMS has failed to submit proper and relevant declarations. According to Petitioner, all that CMS has done is present a prima facie case, which it has overcome with real evidence. Petitioner's Brief (P. Br.) at 3. Petitioner also contends that CMS improperly relies on the holding in Hillman. ⁽²⁾ Lastly, Petitioner argues that the standard of care proposed by CMS runs against the grain of State and Federal court precedents (under the Federal Tort Claims Act) with respect to the standard of duty in personal injury claims for damages resulting from accidents. Id. at 7-10.

B. Findings of Fact and Conclusions of Law

I make the findings of fact and conclusions of law (Findings) set forth below to support my decision in this case.

1. CMS presented a prima facie case that, in caring for three residents, the facility failed to provide adequate supervision and assistance devices to prevent accidents.

CMS presented evidence from which I can conclude that from November 7, 2002 through December 4, 2002, Petitioner was not in substantial compliance with the federal participation requirements at 42 C.F.R. � 483.25(h)(2) at less than the immediate jeopardy level. The survey report listed an alleged deficiency at Tag F324 with regard to Petitioner's treatment of Resident Nos. 44, 37, and 19. CMS Ex. 1, 21-27.

The applicable regulation at 42 C.F.R. � 483.25(h)(2), entitled "Quality of Care" provides:

The facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents.

a. Resident No. 44

Resident No. 44 (R44) was admitted to the facility on April 16, 2002, with diagnoses that included: Parkinson's, Dementia, Status-post Cerebral Vascular Accident, Prostate Cancer, Depression and Hypothyroidism. CMS Ex. 1, at 21. Review of the facility's nurses' notes and fall investigation report indicated that on July 17, 2002, the resident was being given assistance in bathing by a licensed practical nurse (LPN). The resident was sitting on the side of the bed. In response to the resident's request for privacy while bathing the genital area, the LPN pulled the curtain, reminded the resident not to stand, and left him unsupervised. Less than 2 minutes later, the LPN heard the resident fall. When she opened the curtain, the resident was lying on the floor. An assessment revealed a laceration to the left facial area above the eyebrow, approximately 1.5 cm. long and .5 cm deep. He also complained of left hip pain. R 44 was transferred to the hospital and readmitted on July 22, 2002, after undergoing left hip fracture repair. Id. at 21-22.

Further review showed that R44 had experienced other falls, one of which resulted in injury. On April 16, 2002, he was found lying on the blue fall mat on the floor. At that time, interventions were put in place consisting of a low bed placed against the wall, floor mats, bed alarm, chair alarm, and a lap buddy. Id. at 22.

On May 22, 2002, R44 was found on the floor after tipping his chair over. In response, the facility added anti-tipping devices to the chair the following day. Id.

The nurses' notes revealed that, on June 29, 2002, the resident was found on the floor of the bathroom in front of his wheelchair. The record lacked documentation regarding the sounding of the wheelchair alarm. In fact, the investigation indicated that the resident had a seatbelt and a lap buddy secure, but no alarm was present on the resident or the chair. Assessment of the resident revealed a laceration over the left eye, with moderate bleeding. The facility continued with the same previous interventions and again placed an alarm on the wheelchair. Id. at 22-23.

The nurse's aide assignment card, dated April 2002, indicated that R44 was fully dependent on staff for all activities of daily living, including bathing. CMS Ex. 1, at 23; CMS Ex. 7, at 1. The fall risk assessments for April 17, 2002 and July 10, 2002 indicated that the resident had a fall risk score of 18, whereas the legend noted that a score greater than 10 would put the resident at risk for falls. CMS Ex. 1, at 23.

b. Resident No. 37

Resident No. 37 (R37) was admitted to the facility with diagnoses that included: Dementia with delusions, Alzheimer's Dementia, and Depression. On June 25, 2002, she was identified as being a high risk for falls. CMS Ex. 1, at 23.

The Minimum Data Set (MDS) indicated that the resident required the supervision of one staff person for toileting. Additionally, the interdisciplinary notes stated that the resident had fallen attempting to go the bathroom on the following occasions;

�On May 18, 2002, the resident got out of bed and fell on the way to the bathroom. She was placed on a "take in advance of need" program.

�On June 3, 2002, the resident was noted lying on the floor next to the bed. She suffered an open area injury to the right side of the head near the brow. The facility investigation lacked information to determine if the fall was related to incontinence.

�On August 4, 2002, the resident was found on the floor near the foot of the bed. She had urinated on the floor, slipped and fell. The facility placed a bed side commode in her room.

�On August 10, 2002, the resident fell while walking to the bathroom. She had voided a large amount of urine while walking. As a result of the fall, the resident sustained a fractured right hip that required open reduction and internal fixation surgery. There was no evidence that the facility implemented any effective interventions to prevent falls related to incontinence.

Id. at 23-24.

c. Resident No. 19

Resident No. 19 (R19) was admitted to the facility with diagnoses of that included: Aspiration Pneumonia, Congestive Heart Failure, Diabetes Mellitus, High Blood Pressure, Cerebral Vascular Accident, and Psychosis Disorder. He was assessed as requiring extensive assistance for transferring, dressing, hygiene, bathing, and required one-person physical assistance by staff for locomotion and two-person assistance for toileting. Thus, it was determined that the resident was at risk for falls. Id. at 24.

On October 20, 2002, the resident was found on the floor of the dining room lounge. At that time, he had been sitting in a straight back chair. Although three nursing assistants were assigned to the area where the incident occurred, no staff member was present when the resident fell. The resident received first aid treatment for an elbow injury. In the wake of the resident's fall/unpredictable behavior, the facility implemented the following interventions:

�Approach in a non-threatening manner;

�Keep activity department involved with one on one activities;

�Dietary consult;

�Place in geriatric chair.

Id. at 25-26.

During an interview with the facility's quality assurance nurse and social services director on November 6, 2002, the surveyors learned that on October 20, 2002 the resident had been brought into the dining room and was removed from his wheelchair and left unattended on a regular chair. Id. at 26.

On November 7, 2002, the surveyor observed R19 in the dining room seated in a regular straight back chair at a dining table. The surveyor observed the resident to be unattended and unsupervised for a period of five minutes, inasmuch as no staff was present in the dining room or in the nearby area. A restorative staff member entered the dining room a few minutes later, acknowledged that R19 should not have been left alone at the table, and placed him in a geriatric chair. CMS Ex. 1, at 26-27; CMS Ex. 9, at 18.

In view of the foregoing discussion, I find that CMS has established a prima facie case that Petitioner failed to provide R44, R37 and R19 with adequate supervision and assistance devices, and that such conduct resulted in actual harm. Petitioner has not come forward with persuasive evidence to establish that there is a material issue as to any material fact.

2. CMS is entitled to summary judgment.

CMS contends that there are no material issues of fact in controversy and that this case may be disposed of through summary judgment without the need for an in person hearing. It is Petitioner's position that, since CMS bears the burden of proof and has done nothing more than offer a prima facie case, I should rule in Petitioner's favor.

Unless the parties have raised a genuine issue of material fact, I may decide this case on summary judgment, without an evidentiary hearing. Livingston Care Center, DAB No. 1871 (2003); Crestview Parke Care Center, DAB No. 1836 (2002); Everett Rehabilitation and Medical Center, DAB No. 1628, at 3 (1997); Carmel Convalescent Hospital, DAB No. 1584, at 27 (1996); Fed. R. Civ. P. 56 (summary judgment is appropriate when there is no genuine issue as to any material fact and the proponent is entitled to judgment as a matter of law). An appellate panel of the Departmental Appeals Board (Board) recently reiterated in Livingston Care Center that:

CMS is entitled to summary judgment if it has (1) made a prima facie case showing that [the facility] was not in substantial compliance with one or more participation requirements, and (2) demonstrated that there is no dispute about any fact supporting its prima facie case and that it is otherwise entitled to judgment as a matter of law. CMS is not entitled to summary judgment if [the facility] has proffered evidence that would permit an ALJ to conclude that it was in substantial compliance with Medicare/Medicaid participation requirements during the relevant period.

DAB No. 1871, at 6.

In attempting to defeat a motion for summary judgment, a party may not rely on the denials of its pleadings, but is required to tender evidence of specific facts in the form of affidavits and/or other admissible documentary evidence, in support of its contention that a dispute exists. Crestview, DAB No. 1836, at 6 (citing Matsushita Elec. Ind. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n. 11 (1986)). Where a Petitioner raises a factual dispute, an ALJ determines whether the facts are material by resolving all factual disputes in favor of the non-moving party (here, Petitioner). If after the ALJ has resolved all the factual disputes in favor of Petitioner, and nevertheless finds that CMS has established lack of substantial compliance justifying the penalties imposed, the disputed facts are not material and CMS is entitled to summary judgment. ⁽³⁾

Petitioner has submitted a brief, devoted mostly to an analysis of the burden of proof in Hillman, supra, and the standard of care in personal injury and wrongful death cases. Neither of those issues are a concern in the case at hand. In fact, Petitioner fails to address the threshold issue of whether summary judgment is appropriate in this case. As stated earlier, the Board has held that CMS is entitled to summary judgment if it has made a prima facie showing that the facility was not in substantial compliance with one or more participation requirements, and demonstrated that there is no dispute as to any fact supporting its prima facie case, and that it is otherwise entitled to summary judgment as a matter of law. On the other hand, CMS is not entitled to summary judgment if the facility has proffered evidence that would permit an ALJ to conclude that it was in substantial compliance with Medicare participation requirements. See Livingston Care Center, supra.

Petitioner concedes that CMS has made a prima facie showing that its facility was not in substantial compliance. P. Br. at 3. Thus the only remaining issue is whether, notwithstanding CMS's prima facie case, there is any dispute as to any fact supporting its prima facie showing. In an attempt to defeat CMS's motion for summary judgment, Petitioner has merely relied on the denials contained in its request for hearing. See P Ex. 2, at 1-10. Petitioner has tendered no specific facts in the form of affidavits or other documentary evidence in support of its contention that CMS is not entitled to summary judgment as a matter of law. In its only affidavit, Petitioner makes conclusory claims, and fails to indicate with specificity what facts create the existence of a controversy regarding CMS's charge that Petitioner was not is substantial compliance with Quality of Care requirements at Tag F324, under 42 C.F.R. � 483.25(h)(2). P. Ex. 1.

Petitioner also asserts that CMS has submitted an incomplete "Motion for Summary Affirmance," yet fails to explain wherein lies the "incompleteness." Moreover, although Petitioner acknowledges that CMS has come forward with a prima facie case, and argues that all it needs to do is "meet the same level of proof to prevail," there is a dearth of proof in that which it has offered for my consideration. The closest that Petitioner comes in its attempt to address the issues before me is when it labels Barbara Stewart's affidavit as inadmissible, irrelevant, and contends that the affidavit of Douglas Wolfe merely identifies documents without offering to establish the truth of the contents of those documents. P. Br. at 5 ⁽⁴⁾; CMS Exs. 11, 12. However, it is obvious that the two affidavits submitted by CMS did not have the purpose of establishing facts through their contents. Both are properly admissible for their intended purpose. The affidavit of Barbara Stewart ⁽⁵⁾ attests to the official capacity of the three surveyors who conducted the survey in question, and identifies each one by name, and associates each surveyor's participation in establishing the deficiencies with respect to the three residents included in Tag F324. The affidavit of Douglas Wolfe ⁽⁶⁾ states that CMS Exhibits 2, 3,and 4 are official agency documents prepared by CMS Region V in the due course of business and concern Petitioner's facility. He also asserts that CMS Exhibits 1 and 6 are true and correct documents received from the facility. I find, therefore, that Petitioner's objections to CMS Exhibits 11 and 12 are misplaced.

3. A basis exists to impose remedies against Petitioner for deficiencies that are at the less than immediate jeopardy level of noncompliance.

In spite of all the precautions taken with respect to R44, he experienced several falls between April 16, 2002 ⁽⁷⁾ and July 17, 2002. Those falls not only placed the resident at risk for injury, but in fact resulted in actual harm when he fell on July 17, 2002. On that occasion, he suffered a fractured hip. The "Resident Care Kardex Record" reflected that R44 was totally dependent on staff for performance of all activities, and the Risk Fall Assessment indicated that he was at risk for falls. CMS Ex. 7, at 1; CMS Ex. 1, at 23. Although the record was clear that R44 was totally dependent for all care, on July 17, 2002, the LPN left the resident unattended and unsupervised while bathing. CMS Ex. 7, at 10. The LPN reported that she left the resident alone in order to give him privacy while he bathed his private parts. Nonetheless, I find that it was inappropriate to place herself where the resident was out of her sight, and she was unable to provide immediate assistance to prevent an accident. The resident also suffered a laceration in the left eye on June 22, 2002, when he fell on the bathroom floor apparently from his wheelchair. Planned interventions included placement of an alarm on the wheelchair, but the facility investigation concluded that no alarm was present at the time of that fall. Thus, given R44's risk for falls as well as his history of falls, the facility staff should have foreseen that, if left unattended and unsupervised or without proper fall interventions, he was at risk of harm.

In the case of R37, the surveyor found no evidence that the facility implemented any effective interventions to prevent falls related to incontinence. As a result of the failure to implement fall interventions related to incontinence, the resident experienced several falls and suffered actual harm. According to nursing documents, the resident's falls were associated with attempts to reach the bathroom unassisted. CMS Ex. 8, at 5. When the resident fell on May 5, 2002, she was placed on a "take in advance of need" program. However, the record is silent as to the actual implementation of that intervention. In fact, when R37 fell and fractured her hip on August 10, 2002, she was on her way to the bathroom unassisted, and had voided large amounts of urine when she slipped. Id.

Inasmuch as the facility had determined that R37 was at risk for falls and had diagnoses of Dementia and Alzheimer's, and was predisposed to walking to the bathroom on her own, it should have been anticipated that she may suffer harm if left unsupervised or without appropriate interventions. CMS Ex. 8, at 10; CMS Ex. 1, at 23.

The record reflects that R19 fell from a straight back chair on October 20, 2002, and suffered no subsequent falls. He was, however, exposed to the risk of suffering more than minimal harm, when he was left unattended and unsupervised in a straight back for approximately five minutes on November 7, 2002. On that occasion, the facility neglected to place the resident in a geriatric chair in keeping with the planned intervention implemented in the wake of his fall from a straight back chair on October 20, 2002. CMS Ex. 1, at 25-27.

In view of the foregoing, I conclude that CMS has satisfied the criteria for imposing remedies at the less than immediate jeopardy level. First CMS established a prima facie case, which Petitioner did not rebut, that as of November 7, 2002, it was not complying substantially with the participation requirements at 42 C.F.R. � 483.25(h)(2). Indeed, there is not only a prima facie case of noncompliance present here, but the preponderance of the evidence is that Petitioner was not complying substantially with this requirement. Second, Petitioner did not show it had eliminated the noncompliance on any date prior to December 4, 2002. Thus, I find that CMS may impose a CMP in the range of from $50 to $3,000 per day beginning November 7, 2002, and continuing through December 4, 2002.

4. The amount of the penalty imposed by CMS is reasonable.

CMS imposed a $500 per day CMP for the period beginning November 7, 2002, and continuing through December 4, 2002. I sustain the penalty imposed. A penalty of $500 per day falls within a reasonable range of penalties which may be imposed for deficiencies that are at the less than immediate jeopardy level of noncompliance. 42 C.F.R. � 488.438(a)(ii). The beginning date of the penalty is the date that CMS first determined Petitioner not to be complying substantially with participation requirements. 42 C.F.R. � 488.440(a).

CMS argues that the CMP imposed is reasonable in light of the following factors specified in 42 C.F.R. � 488.438(f) ⁽⁸⁾:

�The facility's history of noncompliance

During the prior standard survey, the facility was found out of compliance at the "G" (actual harm) level under the same regulatory grouping (Quality of Care) that is involved in the present case.

�The facility's financial condition supports the reasonableness of the CMP

Petitioner has not come forward with any evidence that, as a result of its financial condition, it would be unable to satisfy the CMP imposed. Furthermore, Petitioner has not disputed CMS's assertion that Petitioner owns eight other nursing homes, in addition to the one subject of these proceedings.

�The seriousness of the deficiency and the facility's culpability support the reasonableness of the CMP

R44 and R37 suffered serious injury (hip fractures and other injuries) due to the facility's neglect in providing them care and demonstrating disregard for the safety of its residents. The facility was aware of the residents' history of falls, their difficulty in maintaining balance, and total dependence on staff for toilet use and personal care. Nonetheless, the LPN providing bathing assistance to R44 left him unattended. R37 also suffered actual harm due to the facility's failure to provide adequate supervision and assistance devices with respect to incontinence.

Petitioner does not dispute the existence of the factors that support the CMP imposed in this case. Accordingly, I find that the amount of the CMP is reasonable.

IV. Conclusion

I conclude that CMS correctly determined that, beginning November 7, 2002 through December 4, 2002, Petitioner was not complying with federal requirements governing participation of long-term care facilities in Medicare and State Medicaid programs at the less than immediate jeopardy level. I further determine that the imposition of a CMP of $500.00 per day is reasonable.

José A. Anglada

Administrative Law Judge

1. At this time, CMS only seeks judgment as to the CMP of $14,000 for the period November 7, 2002 through December 4, 2002.

2. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. United States Department of Health & Human Services, Health Care Financing Administration, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999) .

3. In this regard, it is important to distinguish between facts and conclusions. Conclusions and legal arguments do not establish material facts in dispute.

4. Petitioner did not number the pages of its brief, thus it is necessary to count the pages in order to locate the reference here under discussion.

5. Barbara Stewart was employed by the ODH, Akron District Office, as District Office supervisor.

6. Douglas Wolfe was the Principal Program Representative in the Michigan/Ohio Long Term Care Branch of CMS Region V, Division of Survey and Certification.

7. The resident began to experience falls the same day he was admitted to the facility.

8. CMS Brief at 13-14.