Petitioner, Care Inn of Abilene (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) determination that, when its air conditioning system broke down on September 4-5, 2000, it was not in substantial compliance with program participation requirements, and its conditions posed immediate jeopardy to the health and safety of its residents. Petitioner also challenges the amount of the Civil Money Penalty (CMP) imposed - $10,000 per instance. For the reasons set forth below, I conclude that the facility was out of substantial compliance with program requirements, and that its deficiencies posed immediate jeopardy to resident health and safety. I also conclude that the amount of the CMP is reasonable.

I. Background

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 (SNFs) and/or Medicaid (NFs). The Secretary of Health and Human Services contracts with state survey agencies to conduct those surveys. Social Security Act (Act) � 1864(a); 42 C.F.R. � 488.20. The regulations require that each facility be surveyed at least once every 12 months, and more often, if necessary, to ensure that identified deficiencies are corrected. 42 C.F.R. � 488.20(a).

In these cases, on July 20 and 21, 2000, the Texas Department of Human Services (State Agency) completed a recertification survey/complaint investigation and concluded that the facility was not in substantial compliance with federal requirements for nursing home participation in the Medicare and Medicaid programs. Specifically, the State Agency found deficiencies under 42 C.F.R. � 483.15 (quality of life), 42 C.F.R. � 483.20 (resident assessment), 42 C.F.R. � 483.25 (quality of care), and 42 C.F.R. � 483.70(a) (physical environment - Life Safety Code). CMS Exhibit (CMS Ex.) 1. The State Agency recommended to CMS that certain remedies be imposed. CMS agreed. In a letter dated August 22, 2000, CMS advised Petitioner that, based on the facility's current and past noncompliance, CMS: 1) would terminate the facility's provider agreement effective October 18, 2000; 2) was imposing a CMP of $300 per day effective July 20, 2000, until the deficiencies were corrected or the facility's provider agreement terminated; and 3) would deny payment for new admissions (DPNA) effective September 6, 2000. CMS Ex. 45, at 9-10.

Shortly thereafter, on September 4-5, 2000, two of the facility's three air conditioning units broke down, and the State Agency sent a team of surveyors to the facility to investigate and to monitor conditions. The survey team completed its visit on September 8, 2000. The State Agency found deficiencies under 42 C.F.R. � 483.15 (quality of life), 42 C.F.R. � 483.25 (quality of care), and 42 C.F.R. � 483.30 (nursing services), and concluded that those deficiencies posed immediate jeopardy to resident health and safety. CMS Ex. 2. By letter dated September 13, 2000, CMS advised the facility that it agreed with the State Agency's conclusions. Based on the facility's noncompliance, CMS would terminate the facility's provider agreement on October 1, 2000, and impose a CMP of $300 per day from July 20 through September 3, and $3,050 per day commencing September 4, for the period of immediate jeopardy. The DPNA would continue, and CMS would also impose state monitoring. CMS Ex. 45, at 7-8.

The State Agency completed another inspection survey on September 15, 2000, and determined that the facility had not achieved substantial compliance, but that the immediate jeopardy situation had been removed. CMS concurred, and, in a letter dated September 21, 2000, advised the facility that its conditions no longer posed immediate jeopardy, but it was still out of compliance with 42 C.F.R. � 483.15 (quality of life), 42 C.F.R. � 483.25 (quality of care), and 42 C.F.R. � 483.30 (nursing services); and was also out of compliance with 42 C.F.R. � 483.75 (administration). The letter set a new termination date, November 1, 2000, and advised that the CMP would be $300 per day from July 20 through September 3, $3,050 per day from September 4 through September 8, and $500 per day beginning September 9. CMS Ex. 45, at 5-6.

The facility filed a timely appeal, challenging the findings of all three surveys, and the matter was assigned to me as Docket No. C-01-067.

In the meantime, on October 6, 2000, the State Agency conducted another inspection survey, and again concluded that the facility was not in substantial compliance with program requirements, specifically, 42 C.F.R. � 483.13 (resident behavior and facility practices), 42 C.F.R. � 483.15 (quality of life), 42 C.F.R. � 483.20 (resident assessment), 42 C.F.R. � 483.25 (quality of care), 42 C.F.R. � 483.30 (nursing services), 42 C.F.R. � 483.40 (physician services), and 42 C.F.R. � 483.75 (administration). The State Agency nevertheless recommended an extension on the termination date to give the facility a final opportunity to achieve substantial compliance. In a letter dated October 18, 2000, CMS advised the facility that its new termination date would be January 16, 2001, and that, commencing October 6, its CMP would be $1,000 per day, continuing to accrue until the facility achieved substantial compliance or its provider agreement was terminated. The remedies set forth in the September 21 letter (DPNA, CMPs, and state monitoring) continued in effect. CMS Ex. 45, at 3-4.

The State Agency subsequently advised CMS that the reported deficiencies were corrected, and that the facility had achieved substantial compliance. By letter dated December 5, 2000, CMS advised Petitioner that its termination was rescinded, that the DPNA remained in effect from September 6 through November 14, but payments resumed effective November 15, 2000, and that the CMP would be $1,000 per day from October 6 through November 14, 2000 ($40,000). Although hardly a model of clarity, the letter also apparently rescinded the earlier CMP (for the period July 20 through October 5) and replaced it with a $10,000 per instance CMP. CMS Ex. 45, at 1-2; See Docket No. C-01-262, Hearing Request at 2.

By letter dated December 14, 2000, Petitioner timely requested a hearing, asserting that the deficiencies cited were "factually or legally invalid," and that the facility was in substantial compliance at the pertinent times. This second appeal was assigned to me as Docket No. C-01-262.

Petitioner asked that the two cases be consolidated. CMS did not object, and, by order dated August 14, 2001, I consolidated the cases. The parties subsequently resolved all issues except those relating to the September 8 survey, which ultimately resulted in a $10,000 per instance CMP. See CMS Pre-hearing Brief and Motion for Summary Judgment at 3 n.1.

CMS has moved for summary judgment. Petitioner opposes, arguing that issues of fact remain in dispute. CMS has submitted 47 proposed exhibits (CMS Ex. 1 through CMS Ex. 47). Petitioner has submitted 37 exhibits (P. Ex. 1 through P. Ex. 37). In the absence of objection, and for the purpose of deciding this summary judgment motion, I have admitted all proffered exhibits.

II. Issues

I consider first whether summary judgment is appropriate.

On the merits, this case presents the following questions:

III. Statutory and Regulatory Background

The 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. See Act, �� 1819 and 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483. Facilities must maintain substantial compliance with program requirements, and, 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.

The "quality of life" regulation includes an environmental requirement that the facility "must provide . . . (6) comfortable and safe temperature levels. Facilities initially certified after October 1, 1990 must maintain a temperature range of 71-81F. . . ." 42 C.F.R. � 483.15(h).

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, � 1819(h). CMS may impose a CMP for the number of days that a 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(a)(1). When penalties are imposed for an instance of noncompliance (whether or not in an immediate jeopardy situation), the penalties will be in the range of $1,000 to $10,000 per instance. 42 C.F.R. � 488.438(a)(2).

In setting the amount of the CMP, CMS considers: 1) the facility's history of noncompliance; 2) the facility's financial condition; 3) factors specified in 42 C.F.R.� 488.404; and 4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. 42 C.F.R. � 488.438(f). The factors in � 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies.

IV. Burden of proof

Once CMS has established a prima facie case that the facility was not in substantial compliance, the facility must prove, by a preponderance of evidence, its substantial compliance with program participation requirements. Emerald Oaks, DAB No. 1800, at 4 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998), applying Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999); See Coquina Center, DAB No. 1860, at 5 n.4 (2002).

V. Discussion

These facts are not in dispute: Petitioner is a 101 bed facility, built in the early to mid-1960's, located in Abilene, Texas. Seventeen of its beds are in a "secure" Alzheimer unit, which has its own dining area, shower and bathing areas, and is completely separate from the rest of the facility. Morris Declaration (Morris Decl.) at 3. In September 2000, 90 residents lived at the facility - 77 in the main section and 13 in the Alzheimer unit. Brinegar Declaration (Brinegar Decl.) at 2, � 1. The facility's air conditioning system then consisted of three industrial units. A twin unit, made up of two 25-ton units operating together, and a single 30-ton unit, cooled the main part of the building. Morris Decl. at 4; Cisneros Declaration (Cisneros Decl.) at 2. The Alzheimer unit was cooled by a completely separate system. Morris Decl. at 4.

Outside temperatures in September 2000 were "some of the hottest on record," consistently running 105 to 110F. Morris Decl. at 4; Petitioner's Brief (P. Brief) at 5. On Labor Day, September 4, 2000, at approximately 5:30 p.m., the twin air conditioning unit broke down. Morris Decl. at 3. The following day, the single 30-ton unit also broke down. The State Agency sent a survey team to investigate and monitor conditions in the facility. The survey team arrived at about 1:45 p.m. on September 5 and began to record temperatures. According to the Statement of Deficiencies, at 2:00 p.m. temperatures ranged between 72 and 80F; between 4:00 and 6:00 p.m., they ranged from 80 to 92.1F; from 7:00 to 9:00 p.m., they ranged from 85.6 to 92.4F; and from 10:00 until midnight, they were 76 to 89.8F. CMS Ex. 2, at 4; Brinegar Decl. at 2, � 3.

Petitioner does not dispute these temperatures, but asserts that beginning at 4:45 p.m. on September 5, its administrator and Director of Nurses began to monitor room temperatures hourly. P. Brief at 4. By 10:45 p.m., temperatures were below 80 "in a good portion of the building" and by 4:00 p.m. on September 6, temperatures were 80 or below in the entire building, and thereafter remained in that range - assertions consistent with CMS's position. Id.

Livingston Care Center 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 admissible discovery material, in support of its contention that a dispute exists. Crestview at 6 (citing Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986)).

Where Petitioner raises some factual disputes, the judge determines whether those facts are material by resolving all legitimate factual disputes in favor of the non-moving party, in this case, Petitioner. If, after so resolving all factual disputes, CMS establishes substantial noncompliance that justifies the penalties imposed, the disputed facts are not material and CMS is entitled to summary judgment. In this regard, it is important to distinguish between facts and conclusions. Conclusions and legal arguments do not establish material facts in dispute.

In this case, no one disputes the "fact" that by the afternoon of September 5, the main facility had no functioning air conditioning system. Nor has Petitioner challenged the "facts" proffered by CMS as to the actual temperatures in the facility on September 5. Nevertheless, Petitioner alleges that CMS is not entitled to summary judgment because several "issues of fact" remain in dispute. First, Petitioner points to the parties' dispute about whether the facility was "initially certified" prior to October 1, 1990 (and thus not subject to the regulatory provision setting forth specific temperature ranges). P. Brief at 7. This, however, is a legal question and not a factual dispute. The facts necessary to resolve the legal question - the dates on which Petitioner was certified for Medicare and Medicaid participation - are not in dispute. ⁽²⁾

Petitioner also cites as issues in dispute that would preclude summary judgment "a fact issue as to whether [the facility] was in compliance with the two regulations at issue," and whether CMS's declaration of an immediate jeopardy situation and its imposition of a CMP were appropriate. P. Brief at 8-9. Again, these are legal questions, not factual disputes.

Finally, Petitioner cites the "fact issue as to the extent of" its efforts to move residents to cooler locations, and whether the residents suffered harm. P. Brief at 8-9. I see no significant disagreement as to the facility's particular efforts to move residents, and to the extent that the parties disagree as to any other specific facts, I find, for the reasons discussed below, that the facts in dispute are not material. This matter is therefore appropriately resolved on summary judgment.

The requirement that facilities provide "comfortable and safe temperatures" applies to all facilities. However, the provision as to specific temperature ranges (71 to 81F) does not apply to facilities "initially certified after October 1, 1990." Petitioner argues that, because it was initially certified as a Medicaid-only intermediate care facility (ICF) on August 1, 1962, the specific temperature portion of the regulation does not apply. P. Brief at 5.

Long term care facilities include both skilled nursing facilities (SNFs), intermediate care facilities (ICFs), and, as of October 1, 1990, nursing facilities (NFs) created by the Omnibus Budget Reconciliation Act of 1987 (OBRA '87). Following the enactment of OBRA '87, the Secretary published one set of regulations that replaced the separate ones for SNFs participating in Medicare, and SNFs/ICFs. 54 Fed. Reg. 5316 (Feb. 2, 1989). These new regulations established "consistent requirements for SNFs under Medicare and SNFs and ICFs under Medicaid." Id. The Secretary repeatedly emphasized the goal of creating a "single, uniform set of requirements applicable to all SNFs and ICFs." Id.; 52 Fed. Reg. 38582 (Oct. 16, 1987) ("These conditions would replace the existing separate conditions for SNFs participating in the Medicare program, and SNFs and ICFs participating in the Medicaid program."(emphasis added)) Indeed, the Regulatory Impact Statement reports "very little impact on SNFs" which were already required to meet the majority of requirements included in the final rule, but recognizes that freestanding ICFs, without a SNF component, would likely be affected adversely because of the imposition of additional requirements - particularly increased staffing - not previously in effect for ICFs. 54 Fed. Reg. 5355-5356 (Feb. 2, 1989).

Specifically with respect to the temperature ranges, the Secretary acknowledged that specifying temperature ranges did not take into account the mechanical ability of various existing systems, but noted that facilities initially certified prior to the regulation's effective date "would not be required to modify their heating and cooling systems to maintain the specific temperature ranges." 56 Fed. Reg. 48846 (Sept. 26, 1991).

Unquestionably, the drafters intended to grandfather in Medicaid-only ICFs, and had Petitioner remained an ICF, the fact that it was "initially certified" prior to October 1, 1990 would be undisputed. But what happens when a Medicaid-only ICF subsequently seeks (and obtains) Medicare SNF certification? Does it still fall within the exception or has it again been "initially certified?" To resolve this question, I would look at the certification process the facility went through to obtain its Medicare SNF certification to determine whether this process more closely resembles an initial or a re-certification. However, I need not resolve this question in order to resolve this case. The parties do not dispute that the facility was still subject to the requirement that it maintain "comfortable and safe temperature levels." See P. Brief (analyzing 42 C.F.R. � 483.15(h)(6)) at 4; Petitioner's Reply Brief (P. Reply Brief) at 8. As discussed below, I conclude that the facility temperatures were neither comfortable nor safe.

CMS argues that, notwithstanding the regulatory exception, "comfortable and safe temperatures" should nevertheless be defined as temperatures between 71 and 81F, with only limited exceptions. Petitioner, on the other hand, argues that, because it falls within the regulatory exception, no particular temperature violates the regulation, absent a showing of actual harm to residents.

Existing facilities were "grandfathered" in so that they "not be required to modify their heating and cooling systems to maintain the required temperature ranges," a potentially very expensive proposition. But the waiver was never intended to excuse a facility whose existing system could maintain that temperature range nor to allow facilities in most sections of the country to operate without heating or air-conditioning. A strong case could be made for the proposition that a facility whose system could generally maintain those temperature ranges should be required to maintain those temperatures. Again, however, I need not resolve this somewhat difficult issue because the temperatures in the facility following the breakdown of its air-conditioning system far exceeded any standard of comfort or safety.

"Comfortable and safe temperature levels" means that the ambient temperatures should be in a relatively narrow range that minimizes residents' susceptibility to loss of body heat and risk of hypothermia or susceptibility to respiratory ailments and colds. Although there are no explicit temperature standards for facilities certified on or before October 1, 1990, these facilities still must maintain safe and comfortable temperature levels.

State Operations Manual (SOM) at PP-66.

In drafting the regulations, the Secretary relied on standards recommended by the American Society of Heating, Refrigerating, and Air-Conditioning Engineers [ASHRAE Standard, Thermal Environmental Conditions for Human Occupancy, ANSI/ASHRAE 55-1981] "with a few degrees in variation in consideration of lower metabolism rate of the nursing facility population, who are mostly elderly and/or less active than individuals in other settings." 56 Fed. Reg. 48846 (Sept. 26, 1991). CMS characterizes the ANSI/ASHRAE Standard as the recognized authority for determining the acceptable thermal environment in buildings (CMS Second Prehearing Brief at 5) and Petitioner does not challenge that assertion, describing the ASHRAE standards as a "much more balanced and flexible basis for analyzing the phrase 'comfortable and safe temperature levels. . . .'" P. Reply Brief at 4. According to the ASHRAE standards, the summer operative temperature range for sedentary or near sedentary individuals with a typical amount of clothing is 73-79F. For sedentary individuals with little to no clothing the upper limit is 84F. ASHRAE cites no circumstances under which temperatures above 84F would be acceptable for any group. ANSI/ASHRAE 55-1981 (CMS Second Prehearing Brief, Attachment B at 2-4). I therefore conclude that temperatures in excess of 85F are neither comfortable nor safe. ⁽³⁾ As the evidence establishes, following its air-conditioning system's breakdown, facility temperatures ranged well above that limit.

Both the surveyors and facility staff recorded temperatures in the facility on September 5. I did not detect inconsistencies between the two sets of records. Petitioner admits that "it was undeniably warm in the facility at that time" and, as reflected in the following charts, the recorded temperatures confirm that admission. P. Brief at 6.

9/5/00 Temperatures for East Hall Rooms ⁽⁴⁾

Room Numbers - East Hall

Room Numbers - West Hall

In addition, at 7:48 p.m. the surveyors reported temperatures of 92.4F in Resident #6's room (room number not identified). And, at 9:00 p.m., the temperature in that room was still 92.4F. CMS Ex. 2, at 6. The temperature in Resident #22's room (again not identified) was 88F at 9:23 p.m. CMS Ex. 2, at 6. Both parties report that the temperature in the dining room at 5:10 p.m. was 89.1F. CMS Ex. 2, at 5; P. Ex. 9, at 1.

The bottom line is that the facility, which is located in a very hot region of the country, operated without central air conditioning during one of its hottest summers on record, when day-time temperatures consistently ran 105-110F. Morris Decl. at 4-5. Temperatures then well exceeded comfortable and safe limits. CMS has therefore met its initial burden of establishing a prima facie case of substantial noncompliance.

Although on its face the quality of life regulation seems to suggest absolute liability (the facility "must provide . . . (6) comfortable and safe temperature levels"), review of its evolution shows that the Secretary anticipated limited flexibility as to temperature levels, and provided guidance as to the what the limits of that flexibility might be. Initially, the proposed regulations made no specific reference to facility temperature, but, in broad language, required the facility to "ensure that residents receive care in a manner and in an environment that maintains or enhances their quality of life. . . . (B) Standard: Environment. The facility must provide - (1) A clean, safe, comfortable and homelike environment." 52 Fed. Reg. 38598 (Oct. 16, 1987). Commenters objected to the use of the word "ensure" in proposed regulations "because it implies guarantees and it creates an unrealistic burden on the facility." 54 Fed. Reg. 5328 (Feb. 2, 1989). The Secretary agreed that in certain contexts, use of the word "'ensure' could inappropriately be construed as "imposing on the facility an absolute responsibility to achieve a prescribed result, without allowing for factors that are clearly beyond its ability to control." The Secretary responded by agreeing to limit his use of the word "ensure" to "factors for which the facility appropriately can be held responsible (such as the conduct of its own employees) or by allowing for exceptions when warranted by external circumstances that the facility cannot reasonably be expected to control." Id.

Commenters also recommended specific requirements for room size, room temperatures, ventilation, lighting, and sound levels. Id. And the published rule incorporated these recommendations, including, in � 483.15(h)(6), adding a specific temperature range.

SOM PP-66.

I recognize that the suggestions of flexibility found in the Secretary's responses to comments and in the SOM all address a facility's one or two degree deviation from the strict temperature range, and arguably might not even apply to the "comfortable and safe" requirement. I am nevertheless not prepared to rule that failure to maintain safe and comfortable temperatures is per se a violation. At most, however, any deviation from the regulatory standard is limited, and allowable only under truly extraordinary or unforeseeable circumstances. Without deciding whether circumstances can ever justify a facility's failure to maintain comfortable and safe temperatures, I consider next whether Petitioner has demonstrated extraordinary and unforeseeable circumstances that might preclude a finding of substantial noncompliance. According to Petitioner those circumstances exist here because: 1) it could not have anticipated that its air conditioning units would break down; and 2) it "took immediate, decisive, and appropriate action" to remedy the situation. P. Brief at 2.

I reject the facility's claim that it could not have anticipated that its air conditioning units would break down. Air-conditioning is a mechanical system, and mechanical systems do not last forever. The breakdown of a mechanical system is neither an extraordinary nor unforeseeable circumstance. Indeed, a relatively routine breakdown, like the compressors failing, is inevitable, and far more likely when greater demands, like extraordinarily hot summer temperatures, are placed on the system. Although the record here is virtually silent as to the age and condition of its air conditioning system, Petitioner has not suggested that it was new. ⁽⁶⁾

In fact, a few weeks earlier that summer, on July 25, the unit had also broken down. It turned out that a blade had broken off the fan, which the facility replaced. Morris Decl. at 14; P. Ex. 2, at 1. Petitioner argues that the earlier breakdown was wholly unrelated to the September breakdown, and "there was no reason [at that time] to request further expenditures on the unit." P. Brief at 5. I accept for these purposes that the earlier problem was not specifically related to the cause of the September breakdown. However, even a temporary breakdown should have reminded facility management of the system's vulnerability so that, at a minimum, it could have planned for a more serious breakdown. I agree with CMS that the facility should have had a disaster plan in place in the event the air conditioning system failed and the temperature levels became unacceptably high. Bennet Affidavit at 2. As review of the events of September 4 and 5 show, the facility did no advance planning and, during a critical time, was forced to scramble for a solution.

Nor do I agree that the facility "took immediate, decisive, and appropriate action." As review of the events of September 4 and 5 also shows, its ad hoc plan relied on the durability of the remaining unit, even though staff had been warned that it could not handle the additional load. They unnecessarily delayed purchase and installation of an adequate number of window units; they delayed calling in additional staff; and they did not carefully monitor the rising temperatures in resident rooms and common areas.

The problem began on the afternoon of September 4. The facility's maintenance man, Louis Cisneros, states that the building started getting warm at about 5:30 p.m. that day. He investigated and discovered that the twin compressors were down. Cisneros Decl. at 2. He reported the problem to the facility administrator, Janet Morris, who went to K-Mart and purchased some box fans. Morris Decl. at 3. Receipts confirm the September 4, 6:56 p.m. purchase of eight box fans from K-Mart. P. Ex. 1, at 2. Later that night, Administrator Morris returned to K-Mart and purchased six more box fans, although the date and time of that purchase is obscured on the receipt. P. Ex. 3, at 3; Morris Decl. at 7.

In its effort to repair the twin unit on the night of September 4, the facility had to shut down the sole functioning unit for the main part of the building. The facility apparently did not record temperatures, and, although there are suggestions that the facility became uncomfortably warm (Cisneros Decl. at 2; Morris Decl. at 9 "Some people did comment on the building getting warm on the evening of the 4^th when the 30 ton unit had to be shut off to check out the twin unit."), the record is silent as to exactly how hot the facility became that evening. In any event, by about 10:30 or 11:00 p.m. that night, the 30-ton unit was "back up and running." Morris Decl. at 9. The repair people warned facility staff, however, that the still-functional unit would not be able to cool the entire building during the extreme temperatures of the summer. "He said that it just couldn't pull that load and keep us cool but that it was going to maintain until the heat of the day." Morris Decl. at 6. The repair people also advised Mr. Cisneros that the twin compressors could not be repaired and had to be replaced. He talked to Administrator Morris and they came up with a plan to install window units in some rooms and use box fans to circulate the cooled air through the otherwise un-air-conditioned space. Cisneros Decl. at 4.

Aside from purchasing box fans, however, the facility apparently took no further action until the following morning. I find this delay disturbing. One of their major air conditioning units had broken; they knew that the other could not handle the building load and would break down during the heat of the day. Still, they did not immediately line up additional staff, did not review resident care plans to identify the most vulnerable, did not purchase an adequate number of window units, and they delayed implementation of their plan to install any window units.

According to Administrator Morris, she arrived at the facility at 6:00 a.m. on the morning of September 5, and subsequently met with the department managers to develop an action plan. Morris Decl. at 6. The statement from April Merchant, the facility's marketing/admission coordinator, sets that meeting time at 9:00 a.m. P. Ex. 7, at 1. The department heads then advised staff of their plan, which involved assigning staff to halls, checking residents for adequate hydration, offering them water, closing some doors and leaving others open to control the flow of air. According to Administrator Morris, she checked on residents and then went out to purchase more air conditioning units and box fans. She eventually called in additional staff - although she appears to have done this late in the afternoon, after the 30-ton unit broke down - and two or three husbands of staff volunteered to help Mr. Cisneros install the window units. Morris Decl. at 6, 8, 11. They began installing the window units on the morning of September 5. Morris Decl. at 5.

At 11:00 a.m. on September 5, Administrator Morris purchased 15 5,000 BTU window units from Sam's Club. P. Ex. 1, at 2; Morris Decl. at 7.

At some point (or points) that day, Administrator Morris spoke to her corporate superiors, and Petitioner contracted to purchase a 50-ton compressor replacement. Egbert Declaration. They learned that it would take 4 to 5 days to install the replacement unit.

As late as the surveyors' arrival, at 1:40 p.m. September 5, Administrator Morris was still developing her plan of action, which, at the time, did not include monitoring the heat levels in the building's rooms. CMS Ex. 2, at 22. The facility asserts that it began monitoring room temperatures at 4:45 p.m. Morris Decl. at 13. CMS alleges that monitoring was not implemented until 10:00 p.m. that night, and that adequate preparation had not been made to monitor or lower the escalating room temperatures. CMS Ex. 2, at 22. For purposes of ruling on this summary judgment motion, I accept Petitioner's representation as to the 4:45 p.m. monitoring. However, I consider unacceptable this almost 24-hour delay from the time the twin units broke down until the facility began even monitoring some temperatures in resident rooms and common areas. Further, the facility is vague as to how often it monitored temperatures, and how comprehensive those efforts were. ⁽⁷⁾ Certainly, it provided me with only very sporadic readings. For example, for the West Hall, the facility submits temperatures taken between 4:45 and about 5:15 p.m. on September 5, but then offers no temperature readings until 10:45 p.m. P. Ex. 9, at 1-2. For the East Hall, the facility's temperature logs contain no readings earlier than 10:00 p.m.

As predicted, at 3:00 or 3:30 p.m. the afternoon of September 5, the 30-ton unit broke down. Morris Decl. at 5. At that point the facility called in additional staff. Morris Decl. at 8. And staff went out to purchase more window unit air-conditioners, fans, and accompanying paraphernalia. At about 4:30 p.m. someone purchased air conditioning cords and adapters from Lowes. P. Ex. 1, at 3. At 6:06 p.m., someone - probably April Merchant who said that she purchased the box fans at 5:00 p.m. (P. Ex. 7) - purchased six additional box fans from K-Mart. P. Ex. 1, at 2; Morris Decl. at 7. At about 7:00 p.m., Administrator Morris purchased from Lowe's 16 window units plus cords and adapters. Morris Decl. at 7; P. Ex. 1, at 3. A few minutes later, she bought a couple of thermometers, also from Lowe's. P. Ex. 1, at 3. Indeed, the facility was still out buying very early in the morning on September 6. At 5:21 a.m., she purchased four more air conditioners, plus cords and adapters from Wal-Mart. P. Ex. 1, at 3. In her declaration, Administrator Morris characterizes the time as "just after midnight," although the receipt reflects 5:21 a.m. Morris Decl. at 7.

According to Administrator Morris, the facility did not purchase the necessary number of window units right away because they had planned to put units in every other room, and let the air blow through the connected bathrooms. "That plan worked well until the 30 ton unit went down later that day." Morris Decl. at 7. Of course they had been given ample notice that the 30-ton unit would go down. Administrator Morris said that the facility had difficulty finding enough window units to install, but had to purchase what was available. Morris Decl. at 10.

Administrator Morris concedes that, as late as 10:45 p.m. on the night of the 5^th, some rooms had temperatures "much above" 80F. Morris Decl. at 13. She is a little vague as to when "most of the facility" had cooled back down to a normal temperature: "By about 10:45 or so that night." Morris Decl. at 14. Even then, rooms 16 and 25 had temperatures of 88F. At 11:00 p.m., both rooms were still at 88F. P. Ex. 9, at 8. At midnight, both rooms were still at 88F. P Ex. 9, at 8. Room 21 remained at 84F through midnight. P. Ex. 9, at 8. The logs do not reflect that these rooms returned to reasonable temperatures (78 - 80F) until about 3 a.m. the morning of Sept. 6. P. Ex. 9, at 8-10.

Air conditioning systems break down and facilities should plan for that. Here, the facility did no advance planning for what it would do in the event its air conditioning broke down. Even knowing on the 4^th that its entire system would be out by the following day, it waited until the following day to take any significant action. Facility staff long delayed monitoring the rising temperatures in the facility. Temperatures in the facility, including resident rooms and common areas, were uncomfortable and unsafe for an extended period of time. Thus, I am not convinced that the facility: 1) could not have anticipated that its air conditioning units would break down; and 2) "took immediate, decisive, and appropriate action" to remedy the situation. I therefore find that it was out of substantial compliance with the regulatory requirement that it maintain comfortable and safe temperatures. 42 C.F.R. � 483.15(h).

I next consider whether CMS's immediate jeopardy finding was "clearly erroneous." 42 C.F.R. � 498.60(c)(2). Because the penalty range is the same whether or not conditions pose immediate jeopardy, this finding is of limited significance. 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. As noted above, immediate jeopardy can exist 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).

Petitioner alleges (and CMS disputes) that, other than "mild discomfort," no resident was harmed by the increased temperatures. See Barrera Declaration. Arguably, experiencing the discomfort of temperatures in the high eighties and low nineties itself constitutes actual harm. But the regulation does not require any showing of actual harm, and the parties do not seriously dispute the proposition that high temperatures can put frail elderly, particularly those with heart-related conditions, at risk. Bennet Affidavit at 2-3; see also Brinegar Decl. at 2, � 4. Administrator Morris concedes that when the first unit went down she "considered it a most serious situation." Morris Decl. at 8. Nor is it safe to subject staff to excessively warm temperatures. See National Academy of Sciences, Institute of Medicine (IoM), "Improving the Quality of Care in Nursing Homes" (1986), CMS Second Prehearing Brief, Attachment A ("The comfort of staff also is important because it affects quality of care.") ⁽⁸⁾ I am therefore not able to find "clearly erroneous" CMS's determination of immediate jeopardy. 42 C.F.R. � 498.60(c)(2).

Having found a basis for imposing a CMP, I now consider whether the amount imposed is reasonable, applying the factors listed in 42 C.F.R. � 488.438(f). The parties misapprehend the nature of my review. In its hearing requests, Petitioner complains that the CMS notices "fail to set forth appropriate consideration of the regulatory factors set forth at 42 C.F.R. � 488.438," and that CMS "did not appropriately evaluate the regulatory factors necessary to support any civil monetary penalty. . . ." Similarly, CMS claims that it "considered the regulatory considerations prior to assessing the penalty. . . ."

It is well-settled that, in reaching a decision on the reasonableness of the CMP, I may not look into CMS's internal decision-making processes. Instead, I consider whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved (financial condition, facility history, and culpability). I am neither bound to defer to CMS's factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS's discretion. Barn Hill Care Center, DAB No. 1848, at 21 (2002); Community Nursing Home DAB No. 1807, at 22 (2002), et seq.; Emerald Oaks, DAB No. 1800, at 9 (2001); CarePlex of Silver Spring, DAB No. 1638, at 8 (1999).

If a facility contends that its financial condition or some other factor makes a CMP unreasonable, the facility must raise that contention on a timely basis before any question would arise as to CMS's responsibility for producing evidence as to that factor. Community Nursing Home at 22, et seq.; Emerald Oaks. Where either party fails to take advantage of its opportunity to submit evidence of a facility's financial condition, that opportunity is waived. Community Nursing Home at 15-16; see also, Order Establishing Additional Pre-Hearing Requirements (April 25, 2002) at 3 ("I may exclude an argument and evidence that relates to such argument if a party fails to address it in its pre-hearing brief."). ⁽⁹⁾

The record before me provides little information as to the facility's history of noncompliance, and no information as to the facility's financial condition. With respect to the � 488.404 factors, I note that the absence of air conditioning during the Texas summer was a serious deficiency, which directly affected every single person in that facility. Although the facility did not deliberately bring about this crisis, as discussed above, it bears some degree of culpability for its failure to anticipate and plan a course of action before the crisis arose. I note also that efforts to prevent this type of crisis can be expensive. Petitioner concedes that, after having been informed that its remaining unit would not survive, it attempted to get by with fewer window units than necessary to cool adequately the entire facility. To achieve a level "reasonably related to an effort to produce corrective action," the CMP should thus be stiff enough to encourage the facility to plan in advance and immediately to take necessary (albeit potentially expensive) action. I am therefore not able to find unreasonable the imposition of a $10,000 per instance CMP.

VI. Conclusion

For all of the reasons discussed above, I uphold CMS's determination that, when its air conditioning system broke down on September 4-5, 2000, the facility was not in substantial compliance with program participation requirements, specifically 42 C.F.R. � 483.15 (quality of life), and its deficiencies posed immediate jeopardy to resident health and safety. The amount of the CMP imposed, $10,000 per day, is reasonable.

1. I make findings of fact and conclusions of law to support my decision in this case. I set forth each finding, in italics and bold, as a separate hearing.

2. Moreover, as discussed below, inasmuch as I conclude that temperatures in excess of 85 -90F are not "comfortable and safe," I need not decide here the applicability of the specific temperature range provision.

3. I make no judgment as to the safety and comfort of temperatures between 81 and 85F.

4. The shaded entries are those temperatures recorded by the surveyors. CMS Ex. 2, at 5-7. The unshaded entries were recorded by facility staff. P. Ex. 9, at 8-10.

5. Again, the shaded entries are those temperatures recorded by the surveyors. CMS Ex. 2, at 5-7. The unshaded entries were recorded by facility staff. P. Ex. 9, at 1. I am not able to determine whether the temperatures recorded between 4:45 and 5:15 p.m. (which are in bold) were recorded initially by the surveyors or by facility staff. The temperatures appear in both parties' submissions. CMS Ex. 24, at 19; P. Ex. 9, at 1.

6. Facility service logs list services provided, but neither party has explained the significance of its entries. CMS Ex. 25, at 3.

7. Receipts indicate that facility staff p urchased thermometers at 7:30 p.m. September 5. P. Ex. 1, at 3.

8. CMS relied on these recommendations from the IoM in drafting its regulations. 52 Fed Reg. 38583 (Oct. 16, 1987).

9. While an ALJ may consider a facility's financial condition in determining whether the amount of a CMP is within a reasonable range, the facility must initially raise that issue as a basis for disputing the reasonableness of the amount of the CMP. Where Petitioner did not raise the issue in its request for hearing, its response to CMS's motion for summary disposition, or its initial brief, the Board reasoned that the evidence of its financial condition was not relevant to any timely-raised issue in dispute before the ALJ, and the ALJ properly exercised his discretion by excluding it. Community Nursing Home at 21, 26.