SUBJECT:

Autumn Breeze Health and Rehabilitation Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Autumn Breeze Health and Rehabilitation Center (Petitioner or Facility), is a long term care facility certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare & Medicaid Services' (CMS's) determination that, from September 19, 2001 through October 10, 2001, it was not in substantial compliance with program participation requirements, and that its deficiencies posed immediate jeopardy to resident health and safety. For the reasons set forth below, I find that this case presents no genuine issue of material fact requiring an in-person hearing, that the facility was not in substantial compliance with program participation requirements during the period in question, and that its deficiencies posed immediate jeopardy to resident health and safety. I therefore sustain the $3,050 per day civil money penalty (CMP).

Petitioner has not appealed CMS's subsequent determination that facility noncompliance continued at a lower scope and severity from October 11, 2001 through October 24, 2001, resulting in a $100 per day CMP.

I. Background

Following a survey completed on September 19, 2001, surveyors from the Alabama Department of Public Health (State Agency) detailed the circumstances surrounding the death of a facility resident after she suffered a fall and internal bleeding. CMS Exhibit (Ex.) 1. Based on the surveyor findings, the State Agency concluded that the facility was not in substantial compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs. Specifically, it found that the facility did not meet federal requirements under 42 C.F.R. § 483.25 (Tag F-309 - Quality of Care) at a "J" level of scope and severity (immediate jeopardy to resident health and safety).

CMS agreed with the State Agency, and so advised the facility in a letter dated September 25, 2001. CMS Ex. 3. CMS imposed a CMP of $3,050 per day, effective September 19, 2001, along with other remedies: (1) denial of payment for new Medicare and Medicaid admissions; (2) eventual termination of Petitioner's participation agreement; and (3) directed in-service training of staff. Thereafter, the State Agency completed a follow-up survey on October 11, 2001, and determined that the facility's substantial noncompliance continued, but the deficiencies no longer posed immediate jeopardy to resident health and safety. CMS Exs. 4, 5. CMS agreed, and, by letter dated October 22, 2001, advised Petitioner that its per day CMP was reduced to $100 effective October 11, 2001, and would continue until the facility achieved substantial compliance. The other remedies continued, except the facility's termination date was revised, from October 12, 2001, to December 19, 2001. CMS Ex. 6.

CMS apparently determined that the facility later achieved substantial compliance, because the $100 per day CMP ended on October 24, 2001. The CMP therefore totals $68,400. ($3,050 X 22 days = $67,100; $100 X 13 days = $1,300). CMS Ex. 20.

Petitioner timely filed a hearing request, dated November 21, 2001, and the case was assigned to me. CMS Ex. 7. Sometime thereafter, on February 28, 2002, CMS submitted a motion to dismiss, arguing that Petitioner's hearing request did not comply with regulatory requirements set forth at 42 C.F.R. § 498.40(b). I denied CMS's motion in a ruling and order, dated April 7, 2003. In that ruling, I directed the parties to submit a list of all proposed exhibits, a copy of each proposed exhibit, a list of all proposed witnesses, prior written statements from proposed witnesses, and a pre-hearing brief. I ordered the parties to exchange, as proposed exhibits, "the complete written direct testimony of any proposed witness." My order cautioned that neither party is entitled to supplement its pre-hearing exchange, but allowed that "a party may move to amend its prehearing exchange," and that I would decide such a motion "based on considerations of good cause and absence of prejudice to the opposing party." (Emphasis added). My order required that any party moving to supplement its exchange file with its motion "its entire proposed supplement," including copies of all proposed exhibits.

Because I agreed that Petitioner's hearing request did not set forth the specific findings of fact and conclusions of law with which Petitioner disagreed, nor the basis for contending that the challenged findings were incorrect, I directed Petitioner to submit the initial prehearing exchange first, with CMS's submissions due approximately 30 days later.

On July 7, 2003, Petitioner filed its pre-hearing brief (received July 8, 2003), accompanied by exhibit and witness lists. Petitioner submitted no exhibits and no written direct testimony of the listed witnesses. The submission did not include any explanation for these omissions nor request additional time in which to submit them. Instead, Petitioner filed a Request for Subpoenas, asking me to subpoena the documents on its exhibit list. The request did not meet the regulatory requirement that it specify the pertinent facts Petitioner expected to establish by the documents, nor explain why those facts could not be established without use of a subpoena. 42 C.F.R. § 498.58.

Nearly a month later, on August 5, 2003 (cover letter dated August 1, 2003), this office received Petitioner's Motion to Supplement its Pre-hearing Exchange with the written direct testimony of George Sutton, M.D., whose declaration was attached to the motion. The motion was accompanied by Petitioner's attorney's declaration that referred to unspecified "obstacles in contacting and securing [Dr. Sutton's] participation."

On August 6, 2003 (received August 7, 2003), CMS timely filed its pre-hearing submissions: a motion for summary judgment with brief in support (CMS MSJ Brief), a list of proposed exhibits, and the proposed exhibits themselves (except for CMS Exs. 1 - 7, which were filed with its Motion to Dismiss), including the written direct testimony of its witnesses. CMS also filed its objections to the admission of evidence not timely filed. Among other arguments against the admission of Dr. Sutton's declaration, it countered Petitioner's claim of "obstacles" by pointing out that Dr. Sutton was the facility medical director at the time of the survey, and had earlier attended the facility's informal dispute resolution proceedings.

In a filing dated August 26, 2003, and received on September 2, 2003, Petitioner submitted a document labeled "Supplemental Exchange of Documents," listing additional exhibits that it "intends to offer" at the hearing. The documents listed were not the same as had been listed in Petitioner's July 7 exhibit list, although the two lists likely contained some of the same documents, but in differing configurations. ⁽¹⁾ In a filing dated September 18, 2003, and received on September 23, 2003, CMS objected to Petitioner's proposed exhibits, pointing out that the documents were due no later than July 7, 2003, that Petitioner had not requested an extension of time in which to submit its exhibits, and that they were not filed in accordance with my April 7, 2003 order. ⁽²⁾

On September 23, 2003, this office also received Petitioner's brief in opposition to summary judgment (P. Opp. Brief). Although the cover letter that accompanied Petitioner's brief is dated August 28, 2003, that date is obviously in error. On its final page, the document itself is dated September 19, 2003. I note that under the regulations governing these proceedings, Petitioner's response was due 20 days from the date of CMS's mailing, so this submission was almost one month late. 42 C.F.R. § 498.17(b). As with its other late filings, Petitioner did not ask leave to file out of time. Nor did Petitioner offer any explanation for the late filing.

In its opposition to summary judgment, Petitioner discloses its plan to offer the testimony of two additional witnesses (whose declarations it did not offer) in addition to that of Dr. Sutton. Petitioner attributes its failure to provide these declarations, as well as its failure to provide timely Dr. Sutton's declaration, to the facility's change of ownership, which, Petitioner asserts, caused it "great difficulties in obtaining necessary documents as well as cooperation from former employees." Petitioner provides no details as to the timing of the change of ownership or its efforts to secure declarations from its proposed witnesses. Although Petitioner refers to the potential testimony of its witnesses, it otherwise does not mention any of its "proposed exhibits" - neither those listed in its July 7 submission nor those listed in its August 26 submission - and does not seem to rely on any information that might be contained in those documents.

In a June 24, 2004 ruling and order, I granted Petitioner's August 1, 2003 Motion to Supplement and admitted Dr. Sutton's declaration. I gave CMS thirty days to respond to the contents of that declaration. I declined to admit any of Petitioner's proposed exhibits. With respect to the first four exhibits listed in Petitioner's August 1, 2003 Motion to Supplement, I noted that Petitioner failed to submit copies of the actual documents, in contravention of my April 7 pre-hearing order. I was not persuaded that Petitioner required a subpoena to obtain what should have been its own documents. I also noted that Petitioner's subpoena request did not satisfy the regulatory requirements set forth in 42 C.F.R. § 498.58(c)(3) for issuance of a subpoena. Nevertheless, I granted Petitioner 30 days to demonstrate why subpoenas were necessary. I also denied admission of the five additional exhibits listed in Petitioner's August 26, 2003 Supplemental Exchange, noting that Petitioner had yet to submit any actual documents, that my April 7 order allowed only one supplemental exchange ("A party must file its entire proposed supplement with any motion that it makes to supplement a pre-hearing exchange") and that, absent a showing of good cause, I would permit no further supplements.

Although I reserved ruling on CMS's Motion for Summary Judgment pending receipt of the submissions called for in my order, I found that Petitioner had not contested the $100 per day CMP imposed from October 11 through 24, 2001 ($1,300 total), and therefore sustained that determination, leaving at issue the $3,050 per day CMP from September 19 through October 10, 2001. ($67,100 total)

CMS responded to my order on July 23, 2004 (received July 26, 2004), by submitting a short brief (CMS Reply) and one additional exhibit, CMS Ex. 21. Petitioner responded in a short submission, dated July 23, 2004 (received July 28, 2004), explaining that since it "was able to secure the necessary nursing facility medical records," it no longer required the items for which it had requested a subpoena, with one exception: medical records from Mobile Infirmary Medical Center. According to Petitioner, those records "may shed light on alternate causes of [R1's] bleeding," and "additional information could be gained from a complete review of the hospital medical records." Petitioner further asserts that because of confidentiality laws, the hospital will not release the information without a subpoena. I declined to issue a subpoena. Petitioner has not articulated a pertinent "fact" that it expects to establish through subpoena of these documents. At most, Petitioner has expressed the possibility that it might learn something from these documents that might lead to a pertinent fact. That is insufficient to satisfy the regulation. 42 C.F.R. § 498.58. ("The request must . . . [s]pecify the pertinent facts the party expects to establish by the witnesses or documents . . . .") Moreover, as demonstrated by the analysis set forth below, the actual cause of R1's bleeding and/or her death is not material to my finding of substantial noncompliance at the immediate jeopardy level.

Petitioner did not comment further on its failure to submit any actual exhibits other than the Sutton declaration. Sometime thereafter, however, a set of documents appeared in the Civil Remedies Division record file, tabbed Exhibits 1 through 5, that corresponds to the documents listed in Petitioner's August 26, 2003 "Supplemental Exchange of Documents." No letter of explanation accompanied these documents which were not date stamped. Apparently, these documents did not accompany the August 26 submission because: 1) they were not in the file up through the time of my June 24, 2004 ruling; 2) had Petitioner submitted, or intended to submit them, with its August 26 submission, it would have brought that to my attention when it responded to my June 24, 2004 ruling, since I said in that ruling that Petitioner had not submitted the actual documents; and 3) as late as July 23, 2004, Petitioner was asserting that it could not obtain all of these documents without my issuing a subpoena. ⁽³⁾ In any event, Petitioner seems not to have relied on the contents of these purported exhibits in presenting its case.

For purposes of resolving this summary judgement motion, I therefore admit CMS Exs. 1-21, and the Sutton declaration, which I have marked P. Ex. 1.

II. Issues

I consider first whether summary judgment is appropriate. ⁽⁴⁾

On the merits, the case presents the following issues:

1. Whether, from September 19 through October 10, 2001, the facility was in substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.25.

2. If the facility was not in substantial compliance, did facility conditions pose immediate jeopardy to resident health and safety?

With respect to the penalty imposed, CMS has imposed the minimum per day CMP for deficiencies constituting immediate jeopardy so the reasonableness of the amount of the CMP is not before me. Moreover, I have no authority to review CMS's choice of remedy, in this case, a per day CMP. 42 C.F.R. § 488.408(g)(2); see also 42 C.F.R. § 488.438(e) (administrative law judge (ALJ) may not review CMS's exercise of its discretion to impose a CMP).

III. Statutory and Regulatory Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483.

To participate in the Medicare and Medicaid programs, facilities periodically undergo surveys to determine whether they comply with applicable statutory and regulatory requirements for Medicare Skilled Nursing Facilities (SNFs) and/or Medicaid Nursing Facilities (NFs). They must maintain substantial compliance with program requirements. To be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm." 42 C.F.R. § 488.301.

Under the statute and "quality of care" regulation, each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, section 1819(b); 42 C.F.R. § 483.25. Accordingly, the facility must conduct an initial and periodic resident assessment of functional capacity that is comprehensive, accurate, standardized, and reproducible. 42 C.F.R. §§ 483.20, 483.25. The facility is required to make a comprehensive assessment of a resident's needs promptly after a significant change in the resident's physical or mental condition. 42 C.F.R. § 483.20(b)(2)(ii). The facility must also ensure that each resident receives adequate supervision and assistance devices to prevent accidents. 42 C.F.R. § 483.25(h)(2). An "accident" is "an unexpected, unintended event that can cause a resident bodily injury," excluding "adverse outcomes associated as a direct consequence of treatment or care (e.g., drug side effects or reactions)." State Operations Manual (SOM) Appendix PP, Guidance to Surveyors, Part 2, SOP 483.25 Quality of Care (Rev. 274, June 1995) (SOM Guidance); see Woodstock Care Center, DAB No. 1726, at 4 (2000), aff'd, Woodstock Care Center v. Thompson, No. 01-3889 (6^th Cir. Nov. 17, 2003) (unpublished).

Immediate jeopardy exists if the facility's noncompliance has caused or is likely to cause "serious injury, harm, impairment, or death to a resident." 42 C.F.R. § 488.301. Immediate jeopardy exists regardless of the scope and severity of the deficiency, so long as the deficiency involves a potential for more than minimal harm. Lake City Extended Care Center, DAB No. 1658, at 17 (1998). CMS's determination as to the level of a facility's noncompliance - which includes its immediate jeopardy finding - must be upheld unless it is "clearly erroneous." 42 C.F.R. § 498.60(c).

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, which include imposing a CMP. See Act, section 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more program requirements or for each instance that a facility is not in substantial compliance. 42 C.F.R. § 488.430(a). In situations where the deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for more than minimal harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day. Penalties in the range of $3,050 to $10,000 per day are imposed for deficiencies constituting immediate jeopardy. 42 C.F.R. § 488.438.

IV. Discussion

A. Summary disposition is appropriate because this case presents no dispute over genuine issues of material fact. ⁽⁵⁾

By interpretive rule, this tribunal has established a summary judgment procedure "akin to the summary judgment standard contained in Federal Rule of Civil Procedure 56." Crestview Parke Care Center, 373 F.3d, 750 (6^th Cir. 2004). The summary judgment rule exists, in large part, "to isolate and dispose of factually unsupportable claims or defenses." Livingston Care Center v. Dep't of Health & Human Services, 388 F.3d 168, 172 (6^th Cir. 2004), quoting Celotex Corp. v. Catrett, 477 U.S. 317, 323-24 (1986). Summary judgment is appropriate if a case presents no genuine dispute as to any material fact, and one party is entitled to judgment as a matter of law. The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law, or by showing that the non-moving party has presented no evidence "sufficient to establish the existence of an element essential to its case, and on which it will bear the burden of proof at trial." Livingston Care Center at 173, citing Anderson, 477 U.S. at 252, and Celotex Corp., 477 U.S. at 322. To avoid summary judgment, the nonmoving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986). See also Vandalia Park, DAB No. 1939 (2004) and Lebanon Nursing and Rehabilitation Center, DAB No. 1918 (2004). Denials in pleadings or briefs are not sufficient to overcome a well-supported motion. Nor is a mere scintilla of supporting evidence sufficient. "If the evidence is merely colorable or is not significantly probative, summary judgment may be granted." Livingston, at 4, quoting Anderson, at 249-50.

In this case, CMS alleges as undisputed fact - and presents evidence to establish - that the facility identified one of its residents, R1, as at high risk for falls, yet did not develop for her an individualized care plan to prevent falls. CMS MSJ Brief at 4-6. ⁽⁶⁾ CMS also notes as undisputed fact - and presents evidence to establish - that the facility's failure to develop an individualized care plan to prevent falls was "particularly problematic" because R1 was prescribed and administered anticoagulant medications that left her susceptible to uncontrolled bleeding in the event of even minor falls or trauma. Id. CMS alleges as undisputed fact - and presents evidence to establish - that the facility did not promptly advise R1's physician of her "grossly abnormal lab values (indicative of inadequate blood clotting) and symptoms of uncontrolled bleeding." CMS MSJ Brief at 2, 6-8. CMS alleges as undisputed fact - and presents evidence to establish - that on August 18, 2001, R1 threw up a brownish emesis with coffee ground appearance, symptomatic of internal bleeding, which should have been reported immediately to her physician. Although staff attempted to contact him, when he did not respond, the facility made no further efforts to reach him and followed no backup plan for contacting another physician. CMS MSJ Brief at 9. CMS alleges as undisputed fact - and presents evidence to establish - that, prior to August 20, 2001, R1 suffered multiple bruises and broken ribs, which staff attributed to a fall. However, the facility had no report of a fall prior to August 20, 2001. CMS MSJ Brief at 9-10. CMS alleges as undisputed fact - and presents evidence to establish - that during the afternoon of August 20, 2001, while her husband was attempting to help her to the bathroom, R1 fell. Later, at approximately 11:00 p.m. that night, staff found her on the floor, with the neck of her gown caught on the siderail of her bed. She suffered diminished pulse, and stopped breathing. Her arms and legs were covered with deep, dark bruises. An autopsy showed an elevated International Normalized Ratio (INR), ⁽⁷⁾ high Coumadin level, and massive blood loss. The pathologist attributed her death to "exsanguination," and the coroner determined that the cause of death was "hemothorax" (massive bleeding into the chest cavity) due to an "accident." CMS MSJ Brief at 10.

CMS tendered a significant amount of evidence to support these allegations. To avoid summary judgment, Petitioner was charged with submitting evidence sufficient to establish a dispute of material fact. As the Livingston court observed, a denial or mere scintilla of evidence would not be adequate to overcome a well-supported motion. Here, Petitioner's only evidence purporting to show a material fact in dispute is the Sutton declaration, which addresses only a few of CMS's allegations. P. Ex. 1 (Sutton Decl.)

The Sutton declaration lacks specificity and is not supported by medical records or other documentation. Dr. Sutton asserts, for example, that the facility "timely informed me of all laboratory results from tests that I ordered," but does not say when the facility notified him, nor what he considers "timely." P. Ex. 1.(Sutton Decl. ¶ 5) ⁽⁸⁾ He asserts that R1's INR values were "within normal range prior to her death," even though the medical records show that she had INR levels of 5.24, 7.72, and 8.41, where an INR of greater than 4.0 provides no additional therapeutic benefit, but is associated with a higher risk of bleeding. P. Ex. 1 (Sutton Decl. ¶ 8); CMS Exs. 2, at 3; 8, at 2 (Martin Decl. ¶ 10; 21, at 19. In Livingston, the appellate court found that such a "conclusory" declaration, which made no reference to existing medical records or any other documentation to support its claims, did not raise a genuine issue of material fact. Livingston, at 175. On the other hand, an appellate panel of the Departmental Appeals Board recently suggested, without reference to the Livingston reasoning, that a conclusory declaration may nevertheless be sufficient to create material facts in dispute. Residence at Kensington Place, DAB No. 1963, at 11 (2004). But see Guardian Health Care Center, DAB No. 1943, at 11(2004) ("A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.")

I need not consider the circumstances under which a witness' conclusory allegations create disputes of material fact, however, because, as set forth in more detail below, Petitioner's "evidence" on the physician notification issue is ultimately not material to resolving this case. Aside from the Sutton declaration, Petitioner does not respond to CMS's allegations with even a scintilla of evidence. CMS presents significant evidence of deficiencies, which the Sutton declaration does not address and which Petitioner disregards, but which, standing alone, establish substantial noncompliance at the immediate jeopardy level. According to Petitioner:

CMS's entire case relies on the allegations that the facility failed to timely inform [R1's] physician, George Sutton, of certain INR and Protimes and that such failure caused or was likely to cause serious injury, harm, impairment, or death. The critical element of this allegation involves the question of whether the facility timely informed [R1's] physician.

P. Opp. Brief at 3-4.

Petitioner is incorrect in declaring this case limited to the issue of whether the facility timely informed R1's physician of critical lab results. ⁽⁹⁾ CMS raises at least two other issues, either of which could justify a finding of substantial noncompliance at the immediate jeopardy level: 1) CMS alleges that the facility failed to develop an individualized care plan to prevent R1 from falling; and 2) CMS alleges that the facility did not investigate or otherwise respond appropriately to R1's injuries (bruises and broken ribs).

Petitioner does not challenge CMS's assertion that R1 was at high risk for falls, and, in fact, presents evidence to confirm CMS's assertion that her risk of injury due to a fall was particularly acute because she was susceptible to uncontrolled bleeding. P. Ex. 1. Petitioner presents no evidence suggesting that it developed an individualized care plan aimed at preventing falls. Petitioner presents no evidence that it reported or investigated R1's falls or her broken ribs.

Because CMS has proffered evidence showing that the facility was not in substantial compliance at the immediate jeopardy level, and Petitioner proffers no set of facts that, if accepted, would establish its substantial compliance with 42 C.F.R. § 483.25, CMS is entitled to summary judgment. Livingston Care Center, DAB CR906, at 6, aff'd DAB No. 1871 (2003), and aff'd 388 F.3d 168.

B. From September 19 through October 10, 2001, the facility was not in substantial compliance with the program participation requirement set forth at 42 C.F.R. § 483.25.

1. Although it recognized that she was at high risk for falls, and high risk for sustaining serious injury as a result of a fall, the facility failed to develop for R1 an individualized care plan to prevent falls.

The quality of care regulation, 42 C.F.R. § 483.25, imposes on facilities an affirmative duty designed to achieve favorable outcomes "to the highest practicable degree." Windsor Health Care Center, DAB No. 1902, at 16 - 17 (2003); Woodstock, DAB No. 1726, at 25 - 30. Among other specific requirements, the facility is required to "take reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his or her assessed needs and to mitigate foreseeable risks of harm from accidents." 42 C.F.R. § 483.25(h)(2); Windsor Health Care Center, DAB No. 1902, at 5 (2003); Asbury Center at Johnson City, DAB No. 1815, at 12 (2002); Koester, DAB No. 1750, at 25 - 26; Woodstock, DAB No. 1726, at 25. The regulation requires the facility to anticipate what accidents might befall a resident and to take steps - increased supervision or the use of assistance devices - to prevent them. Guardian Health Care Center, at 18. In this case, the facility assessed the risk of accidents, but did not then develop and implement a plan to prevent them.

R1 was a 79-year old woman admitted to the facility on August 9, 2001, after a six-day hospital stay for what appears to have been stroke secondary to atrial fibrillation. CMS Exs. 1, at 1; 8, at 1 (Martin Decl. ¶ 3); 9. That R1 was at high risk for falls is undisputed. During her hospital stay, she had attempted to get out of bed unassisted, but a bed alarm alerted hospital staff who were able to intervene and prevent a potentially dangerous situation. The hospital discharge summary advised the facility that R1 required a bed alarm. CMS Exs. 1, at 2; 8, at 4 (Martin Decl. ¶ 4). After her admission to the facility, the staff completed its own risk assessment, and confirmed that she was at risk for falls. CMS Ex. 10. R1 had an unsteady gait, and required significant assistance with most activities of daily living. She required one to two person physical assist in order to walk, or transfer from bed to chair. She required partial physical support to maintain her balance. CMS Ex. 16, at 3 - 4.

Facility staff told Surveyor Martin and the police detective who investigated R1's death, that R1 attempted transfers unassisted, including trying to get out of bed, and had suffered falls as a result. CMS MSJ Brief at 5; CMS Ex. 1, at 7 - 9. The Director of Nursing (DON), for example, told Surveyor Martin, "Yes [R1] had a habit of getting out of bed unassisted. She would just get up. She could ambulate in the room. If she wasn't assisted by a person, they'd find her ambulating in the room." CMS Ex. 1, at 7. One of the Licensed Practical Nurses (LPNs) told Surveyor Martin that R1 "needed extensive assistance because her mind was kind of bad. She was forgetful and confused at times. She was ambulatory with assistance because her gait was unsteady and to prevent her from falling." Id. A nurse assistant characterized R1's gait as "sort of wobbly," and said that she "had a history of getting up unassisted." CMS Ex. 1, at 7 - 8. Another LPN said that R1 "would attempt to get out of bed unassisted." Id. at 9. According to the police investigation, "[s]everal staff members stated to Det. Miller that the victim was prone to get out of bed on her own, and would sometimes fall." CMS Ex. 18.

CMS offers other evidence of R1's falls: as discussed below, X-rays taken on August 20 showed that R1 suffered broken ribs, and staff conceded that she had previously fallen. Nursing notes report that just before 8:00 p.m. on August 20, she fell while her husband was assisting her to the bathroom. CMS Exs. 1, at 14; 13, at 4. And later that night she suffered her final fall, and was found on the floor next to her bed, with the neck of her gown caught on the siderail.

Even though it recognized the problem, the facility did not develop an individualized care plan designed to prevent R1 from falling. On the day of her admission, facility staff completed what CMS characterizes as a "generic, pre-printed care plan for falls." CMS Ex. 8, at 2 (Martin Decl. ¶ 9). Nothing in the record suggests that this document constitutes an adequate plan to prevent falls. Indeed, on its face, the plan was plainly never intended to be more than preliminary. The document is labeled "Immediate Plan of Care At Risk for Falls," and suggests some approaches toward developing an individualized plan. But the facility did not then follow up on these approaches. Among the interventions checked were "assist in transfer" and "specify type of assistance," but nothing in the record suggests that any specifics were subsequently provided. Also checked were "institute fall prevention program," and "evaluate need for bed alarm [and] chair alarm: " CMS Ex. 11. Petitioner offers no evidence that staff followed up on these instructions.

Notwithstanding the hospital directive, and its own assessment, the facility did not evaluate R1 for a bed alarm. According to CMS, when Surveyor Martin asked the nurse supervisor responsible for R1 whether the facility had assessed R1 for a personal alarm, she answered, "not in a formal, paper trail kind of way." She claimed that staff had not told her of any unsafe behaviors, such as R1's attempts to get out of bed unassisted. CMS Exs. 1, at 11; 8, at 1 - 2 (Martin Decl. ¶ 5). Petitioner has offers no evidence establishing a dispute over any of these facts. The Sutton declaration, which is the sole evidence submitted by Petitioner, makes no claims as to the adequacy of the facility's efforts to prevent falls.

The undisputed evidence thus establishes that the facility recognized R1's high risk for falls and uncontrolled bleeding, yet did not develop an individualized care plan to prevent falls. I do not consider this providing R1 the "necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being," as required by the regulation.

2. The facility did not appropriately respond to R1's complaints of pain, nor to evidence that R1 had fallen, nor to evidence of injury.

A few days before her discharge from the hospital, X-rays were taken of R1's chest, which showed no broken ribs. CMS Exs. 1, at 2; 8, at 3 (Martin Decl. ¶ 16); 17. About a week after her admission to the facility, on August 17, 2001, R1 complained of pain in her left side, under her rib cage. CMS Ex. 8, at 3. Her complaints apparently continued, and nursing notes for the afternoon of August 20, 2001 reflect ongoing left-sided pain, with her family telling the nurse that she had suffered a "fall in past." The nurse also noted "dark to light bruises along bilateral upper arms," which she attributed to R1's high INR and Coumadin levels. The nurse obtained an order for an x-ray. CMS Exs. 1, at 6; 8, at 3 - 4 (Martin Decl. ¶ 16); 13, at 3. An X-ray taken at 5:30 p.m. on August 20 showed that R1 had multiple broken ribs on her left side. CMS Exs. 1, at 6; 17, at 2.

As discussed above, R1 had previously fallen while in the facility. An employee identified as Certified Nurses Assistant (CNA) # 6 told Surveyor Martin that R1 had fallen more than once, while in her room with her husband. CNA # 7 said that R1 suffered a fall prior to August 20, but could not remember the date. A third employee, CNA # 5, said that she had heard of R1 having a previous fall. Yet, Surveyor Martin found no reports of a fall or trauma to explain the broken ribs. CMS Exs. 1, at 9; 8, at 4 (Martin Decl. ¶ 17). Nor could she find any documentation that the facility had discussed fall risks with R1's family, even that though such discussion was listed among the interventions on the only care plan for falls that the facility could show for this resident. CMS Exs. 1, at 3; 11.

Viewing the evidence in the light most favorable to the facility, I accept that the bruises were the result of the anticoagulant medication, requiring no further investigation. However, the uncontroverted evidence establishes that R1 experienced falls prior to falling during the evening of August 20, yet, the facility provides no evidence that it reported or investigated those incidents. Moreover, broken ribs constitute a serious injury which the facility should have investigated. ⁽¹⁰⁾ A facility that is providing its residents "necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being" would necessarily investigate falls and injuries and take steps to ensure that such incidents did not recur.

C. The facility conditions posed immediate jeopardy to resident health and safety.

I next consider whether CMS's immediate jeopardy finding was "clearly erroneous." 42 C.F.R. § 498.60(c)(2). The Board has observed repeatedly that the "clearly erroneous" standard imposes on facilities a "heavy burden" to show no immediate jeopardy, and has sustained determinations of immediate jeopardy where CMS presented evidence "from which '[o]ne could reasonably conclude' that immediate jeopardy exists." Barbourville Nursing Home, DAB No. 1962, at 11 (2005); Florence Park Care Center, DAB No. 1931, at 27 - 28 (2004), citing Koester Pavilion, DAB No. 1750 (2000).

Here, I need not find that R1's death, or even any specific injuries, were attributable to a fall at the facility. Immediate jeopardy exists if the facility's noncompliance has caused or is likely to cause "serious injury, harm, impairment or death to a resident." 42 C.F.R. § 488.301. Petitioner has simply presented no evidence to counter CMS's showing that R1 was at risk for serious injury from falls, yet the facility did not take necessary steps to protect her. Even when she fell, and, even when staff discovered injuries, the facility did not investigate or develop the requisite plan. This creates a situation likely to cause "serious injury, harm, impairment or death to a resident." I therefore conclude that CMS's immediate jeopardy determination is not clearly erroneous.

D. Because I have found facility noncompliance at the immediate jeopardy level, the CMP must be at least $3,050 per day for each day of noncompliance.

Since I have determined that the facility was out of compliance at the immediate jeopardy level, the regulations limit my authority to review the amount of the CMP. In situations such as this, where the deficiencies constitute immediate jeopardy, CMS may impose a CMP in the range of $3,050 to $10,000 per day. 42 C.F.R. § 488.438. Where a CMP of $3,050 per day is imposed, the daily amount must be sustained unless the long term care facility establishes that the determination of immediate jeopardy is clearly erroneous. Hermina Traeye Memorial Nursing Home, DAB No. 1810, at 16 (2002).

E. The duration of the penalty is consistent with statutory and regulatory requirements.

In its pre-hearing brief, Petitioner asserts that "to the extent that any such Immediate Jeopardy ever existed, it should have ended on the date the resident died." P. Pre-hearing Brief, at 4-5.

The Board has repeatedly explained that under the regulatory scheme, any deficiency that has a potential for more than minimal harm is necessarily indicative of problems in the facility that need to be corrected. Barn Hill, DAB No. 1848 (2002) at 12-18; Lake City, at 14. Since I found that the deficiencies cited have the potential for more than minimal harm, I must also find that the facility was out of compliance "from the date of the completion of the survey in which [these] deficiencies were cited until the date of the resurvey in which substantial compliance was established." Lake City at 14 - 15. Substantial compliance means not only that the specific cited instances of substandard care were corrected, and that no other instances have occurred, but also that the facility has implemented a plan of correction designed to assure that no such incidents occur in the future. No findings that the facility violated the standard of care between these dates are required in order to find the facility out of substantial compliance, nor can evidence of other incidents in which the facility met the standard of care change the fact that it was out of substantial compliance. Barn Hill, at 14; Lake City, at 15. See also Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002) (The burden is on the facility to prove that it has resumed complying with program requirements, not on CMS to prove that deficiencies continued to exist after they were discovered.); Asbury Center at Johnson City, DAB No. 1815, at 19 - 20 (2002) ("[A] facility's return to substantial compliance must usually be established through a resurvey, and in a situation involving inadequate supervision, requiring such a resurvey seems wise."); Cross Creek Care Center, DAB No. 1665 (1998).

V. Conclusion

For all of the reasons discussed above, I uphold CMS's determination that from September 19 through October 10, 2001, Petitioner was not in substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.25 (Quality of Care), and that its deficiencies posed immediate jeopardy to resident health and safety. I therefore sustain the $3,050 per day CMP.

Carolyn Cozad Hughes

Administrative Law Judge

1. On July 7, Petitioner listed: 1) its "medical record of R1 for the period August 9, 2001, through August 21, 2001. . ."; 2) Death certificate of R1; 3) Report of autopsy of R1; and 4) Medical record of R1 from Mobile Infirmary Medical Center during 2001. Its August 26 submission lists as "additional documents:" 1) Petitioner's Medical Records for R1; 2) Quality of Care Guidelines § 483.25; 3) Citation/Statement of Deficiencies and Provider's Plan of Correction; and 4) Incident Report, dated 8/20/01. Petitioner has not explained whether it intended the second list as a substitute for or as a supplement to the first list.

2. It seems that Petitioner may have sent CMS a copy of the documents themselves. ("CMS has now received a package, postmarked August 28, 2003, containing what Petitioner styles as 'additional exhibits' to be admitted at hearing.") On the other hand, Petitioner was still asking that at least some of these documents be subpoenaed, so perhaps they were not included in the packet to CMS.

3. I note also that the documents do not comport with Civil Remedies Division procedures or with my April 7, 2003 order. Only one set of the documents has been provided. The documents are not identified with the docket number of the case. No marking is placed on the proposed exhibit itself, and the tabs do not even identify them as Petitioner's exhibits. The pages are not numbered.

4. Responding to my April 7, 2003 pre-hearing order, the parties have submitted all of their evidence, including the testimony of witnesses. In moving for summary judgment, CMS essentially avers that it has no need to cross-examine Petitioner's witness in order to prove its case. For its part, Petitioner has asserted no facts that it intends to bring out through cross-examination of CMS's witnesses that would materially affect the outcome of the case. In effect, nothing is missing from this record that must be adduced at an in-person hearing. Thus, this case presents even less justification for holding an in-person hearing than one would find in many summary judgment situations.

5. I make Findings of Fact and Conclusions of Law (Findings) to support my decision in this case. I set forth each Finding, in italics and bold, as a separate heading.

6. As demonstrated by my citations to CMS's argument, I limit my consideration here to facts explicitly relied on by CMS, the moving party.

7. INR is a lab test that measures how long it takes for a patient's blood to clot. For most clinical conditions, an INR of 2.5 to 3.0 indicates the appropriate anticoagulant dosage. The American College of Chest Physicians recommends that an INR level of 2.0 to 3.0 be maintained in patients, such as R1, who suffer from atrial fibrillation. INR values above 5.0 are considered dangerous. INR values of 1.0 indicate no anticoagulant effect. CMS Exs. 2, at 3; 8, at 2; 14; 21, at 18.

8. In its initial pre-hearing brief, Petitioner asserted, without supporting evidence, that the facility had directed the lab "to notify Resident #1's physician at Mobile Infirmary Medical Center's Protime Clinic of all lab values by facsimile." P. Pre-hearing Brief at 2. Ultimately, Petitioner did not follow-up on this claim, has presented no evidence to support it, and has not explained why, even if accepted, that fact should affect the outcome of this case.

9. Although I need not reach this issue in order to resolve this case, the facility presents no evidence that explains or justifies its 4-5 day delay in responding to R1's elevated INR. Dr. Sutton does not dispute CMS's assertions that the August 10 test result, at 5.24, was well above therapeutic range, and, in fact, "dangerous, indicating risk of hemorrhage." CMS Ex. 8, at 2 (Martin Decl. ¶ 10) . Although he characterizes the facility's reporting to him as "timely," he does not dispute CMS's specific assertions that the lab reported those results to the facility on August 11, nor that the facility advised his office of those results on August 15, assertions supported by entries in the nursing notes and physician progress notes. CMS MSJ Brief, at 2; CMS Exs. 12, at 1; 13, at 1; see also P. Pre-hearing Brief, at 3. Nor does he dispute that, between August 10 and August 15, R1 continued to take the anticoagulant, Coumadin. CMS Exs. 12, at 1; 13, at 1; 15, at 2. When informed of the August 10 INR, Dr. Sutton's nurse practitioner put the Coumadin on hold "until R1's INR dropp[ed] below 3.0." CMS Exs. 12, at 1; 13, at 1. But by the time the facility stopped administering the Coumadin, R1's INR had risen to 8.41, which the lab described as "an unusually prolonged result," and which CMS characterizes as "a medical emergency." CMS MSJ Brief at 8; CMS Exs. 1, at 4; 8 at 3(Martin Decl. ¶ 13); 14, at 2.

Dr. Sutton opines that R1 "was Vitamin K deficient and therefore naturally anti-coagulated," an opinion which seems well-supported by the record, and which CMS does not challenge. He addressed the condition by ordering Vitamin K shots "that remedied her anti-coagulation issues," but he did not do so until August 16, after almost a full week of dangerous INR levels. P. Ex. 1; CMS Exs. 8, at 3; 12, at 3; 13, at 2. Thus, a ccepting Dr. Sutton's statements as true establishes that the facility's medical director, fully aware of R1's dangerously high INR levels, continued to order the anti-coagulant drugs Coumadin and Plavix, until R1's INR reached emergency levels.

10. In this regard, CMS might have cited a deficiency under 42 C.F.R. § 483.13(c)(2) and (3), which require that the facility "ensure that . . . all injuries of unknown source" be reported and thoroughly investigated.