SUBJECT:

Crestview Manor,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I find that no basis exists for imposing remedies - in this case consisting of a per-instance civil money penalty of $4,500 - against Petitioner, Crestview Manor.

I. Background

Petitioner is a skilled nursing facility in Webster City, Iowa. It participates in the Medicare program. Its participation in that program is governed by sections 1819 and 1866 of the Social Security Act (Act) and by regulations at 42 C.F.R. Parts 483 and 488.

On January 16, 2004, Petitioner was surveyed by employees of the Iowa Department of Inspections and Appeals in order to determine whether Petitioner was complying with participation requirements (January survey). The surveyors concluded that Petitioner was not complying with several distinct participation requirements. Most prominently, the surveyors concluded that: Petitioner failed to ensure that its residents' environment was as free of accident hazards as is possible, thereby violating the requirements of 42 C.F.R. � 483.25(h)(1); and that Petitioner failed to ensure that each of its residents received adequate supervision and assistance devices to prevent accidents, thereby violating the requirements of 42 C.F.R. � 483.25(h)(2). The Centers for Medicare & Medicaid Services (CMS) concurred with these two findings and determined to impose a per-instance civil money penalty of $4,500 against Petitioner. ⁽¹⁾

Petitioner requested a hearing and the case was assigned to me for a hearing and a decision. I scheduled a hearing to be held in Des Moines, Iowa, on June 28, 2005. Shortly prior to the hearing the parties informed me that neither of them had in-person testimony to present. Therefore, I canceled the hearing and ordered that the case be tried based on the parties' written submissions.

The parties submitted proposed exhibits and pre-hearing briefs. After I canceled the hearing I afforded the parties the opportunity to file additional briefs and reply briefs. Each party filed a brief. Petitioner also filed a reply brief. CMS did not file a reply brief.

The proposed exhibits filed by CMS consist of CMS Ex. 1 - CMS Ex. 9. Petitioner objected to my receiving many of these proposed exhibits on two grounds. First, it contended that substantial portions of CMS's proposed exhibits pertained to findings of noncompliance made at the January survey other than the two findings that I cite above. Petitioner argues that these exhibits, or portions of them, are irrelevant to the case and should be excluded. Second, Petitioner contends that many of the exhibits, including the report of the January survey, contain hearsay and should be excluded for that reason. See, e.g., CMS Ex. 2.

I overrule Petitioner's objections and I receive all of CMS's proposed exhibits into evidence. As to Petitioner's relevancy objection, there is no harm to Petitioner in my receiving exhibits that do not relate strictly to the two alleged deficiencies that are at issue in this case. I simply disregard any exhibit or portion of an exhibit that is irrelevant in making my decision. In my decision I cite specifically to those exhibits submitted by each party on which I rely.

Petitioner's hearsay objections - particularly to statements made in the report of the January survey - are in part premised on the fact that CMS did not produce the sworn testimony of witnesses, including the surveyors who prepared the January survey report. ⁽²⁾ Petitioner argues that it will be prejudiced if I allow the surveyors' findings into evidence without Petitioner being given the opportunity to cross-examine the surveyors.

I find no prejudice to Petitioner here. The findings in the survey report are hearsay and, for reasons that I discuss below, are of little probative value absent the on the record testimony of the surveyors who made them. However, it is CMS, and not Petitioner, that pays the price for failing to produce the surveyors' sworn testimony.

Petitioner's proposed exhibits consist of P. Ex. 1 - P. Ex. 32. CMS did not object to my receiving these exhibits into evidence and, therefore, I receive them. ⁽³⁾

II. Issues, findings of fact and conclusions of law

A. Issue

The issue in this case is whether Petitioner failed to comply substantially with Medicare participation requirements, thereby justifying the imposition against it of a civil money penalty.

B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each Finding below as a separate heading. I discuss each Finding in detail.

1. The evidence does not support a conclusion that Petitioner failed to ensure that its residents' environment was as free from accident hazards as is possible.

CMS premises its assertion that Petitioner failed to comply with the requirements of 42 C.F.R. � 483.25(h)(1) on findings made by the surveyors at the January survey that water temperatures in Petitioner's facility were dangerously high. ⁽⁴⁾ According to the survey report, water temperatures that were recorded at Petitioner's facility on January 12, 2004 were as high as 143.4 degrees Fahrenheit. Several other temperatures recorded on that date exceeded 120 degrees. CMS Ex. 2, at 1 - 2. Temperatures recorded by the surveyors on subsequent dates did not exceed 120 degrees. Id. at 2 - 7.

CMS argues that water temperatures of 120 degrees or more are dangerous to residents. ⁽⁵⁾ Therefore, according to CMS, Petitioner failed to comply with the regulatory requirement by tolerating water temperatures at unsafe levels.

I find these allegations to be unpersuasive because CMS failed to lay any foundation to show that the surveyors' temperature readings are accurate. Furthermore, there is persuasive evidence which satisfies me that the surveyors' findings are not accurate.

CMS's standard instructions to surveyors state explicitly that water temperature readings are only meaningful insofar as the thermometers used to take such readings are properly calibrated and are accurate:

Calibration of thermometers are required to ensure accurate [water] temperature readings.

P. Ex. 32, at 2.

"Calibration" is a term of art. The manufacturer's instructions for the digital thermometer that the surveyors used contain rules for calibrating the instrument. These rules state that a thermometer may be calibrated by placing it in a well stirred liquid bath with a "standard" thermometer that is known to be accurate and comparing the readings of the two instruments. The bath should be heated and cooled and the thermometers should be checked at different temperatures. The instructions also contain a rule for assuring that a thermometer is accurate at 32 degrees Fahrenheit. P. Ex 32, at 5.

It would be unreasonable for me to presume that the temperature readings recorded by the surveyors are accurate absent any evidence to establish that they calibrated their thermometers in accordance with the manufacturer's rules, especially given CMS's instruction that calibration is an essential precondition to measuring water temperatures. But, CMS offered no evidence to show that the surveyors calibrated their thermometers in accordance with these rules. The January survey report is devoid of any evidence explaining whether or how the surveyors calibrated their thermometers. Nor does such an explanation exist in the surveyors' notes offered by CMS. See CMS Ex. 6. The failure of CMS to offer evidence to establish that the surveyors performed the essential preliminary act of calibrating the thermometers renders unpersuasive the temperature readings that are recited in the survey report.

Indeed, CMS does not even argue that the surveyors followed the manufacturer's instructions in calibrating the thermometers. CMS attempts to address its failure to show that thermometers were calibrated according to prescribed standards (or calibrated at all) by asserting, essentially, that such a failure is irrelevant. According to CMS: "Questions regarding calibration of thermometers could not reasonably be expected to account for a 23-degree departure from the standard." CMS's brief at 7. I disagree with this analysis. If the thermometers were not calibrated, it is not possible to say that any reading is accurate. There is no reason to conclude that a very high reading is inherently more accurate than is a reading at some other temperature absent evidence to show that the thermometer readings were reliable.

In fact, what evidence that exists concerning the issue of calibration supports the conclusion that the surveyors either calibrated the thermometers incorrectly or that they made disingenuous statements concerning calibration. Testimony given in a collateral State proceeding by the three surveyors who performed the January survey includes inconsistent and contradictory assertions as to how they allegedly calibrated the thermometers. It is not possible to reconcile these inconsistent and conflicting statements. The reasonable inference that I draw from them is that the surveyors failed to calibrate the thermometers at all. But, even assuming that the surveyors did something to check the thermometers' accuracy, none of their accounts of calibration comport with the manufacturer's calibration instructions.

The surveyor whose notes appear to be the basis for the temperature readings in the January survey report is James Berkley. CMS Ex. 2, at 1 -7; CMS Ex. 6, at 1 - 6. ⁽⁶⁾ As I discuss above, neither the survey report nor Mr. Berkley's notes provide any explanation of how the thermometers were calibrated. However in the State proceeding, Mr. Berkley testified how the surveyors might have tested the accuracy of their thermometers:

We will with the other team members gather our thermometers together. If we have a question about the accuracy of one thermometer versus another we will get a glass of ice water and then immerse all of the thermometers that we are trying to calibrate and question into the ice water and evaluate whether or not any of the thermometers measure grossly different from the other thermometers.

P. Ex. 11, at 3. I am not persuaded by Mr. Berkley's testimony that the surveyors actually "calibrated" their thermometers in this case according to the method he describes. As I have concluded, his testimony is not corroborated anywhere in the survey report nor in the surveyors' notes, and furthermore, it is inconsistent with the methodology that another surveyor contends the surveyors used. Also, Mr. Berkley's testimony couches the surveyors' actions in terms of what they typically did and is not an affirmation that the surveyors followed even this methodology in this case.

But, if the surveyors actually used this calibration method, it is clearly different from what the thermometers' manufacturer's protocol requires. Assuming that Mr. Berkley's rendition describes what the surveyors did here, the surveyors did not measure the accuracy of their thermometers against a standard, calibrated instrument. Moreover, they did not ascertain - indeed, they had no way of ascertaining - the true temperature of the water that they were using to calibrate their thermometers. In fact, Mr. Berkley's description of the ice water methodology that he used to calibrate thermometers differs in significant respects from the manufacturers' instructions for calibrating thermometers at 32 degrees Fahrenheit. P. Ex. 32, at 5.

My skepticism that the surveyors actually used Mr. Berkley's asserted calibration methodology - or any methodology for calibration - is reinforced by the testimony of the other two surveyors who performed the January survey. One of them, Ms. Stephanie Jones, testified that the surveyors used a totally different technique for calibrating the thermometers than the method which Mr. Berkley attested the surveyors typically used. Testifying in the same State proceeding as Mr. Berkley, Ms. Jones testified that the surveyors "calibrated" their thermometers in the following manner:

I'm pretty sure that when [Mr. Berkley] had concerns about the hot water temperatures I think we - all of us put our thermometers out on the table and tested the temperature of the room.

P. Ex. 12, at 8 - 9. The process described by Ms. Jones not only calls into question whether the surveyors followed the methodology for calibration described by Mr. Berkley, but it plainly departs from the manufacturer's instructions for calibrating thermometers.

The third surveyor who participated in the January survey testified to yet another version of what the surveyors did as respects calibration. Ms. Paula Del Carlo denied that the thermometers were calibrated at all:

Q. To the best of your knowledge do you know if the Department [Iowa Department of Inspections and Appeals] has a practice for the calibration of thermometers?

A. A practice, I don't know.

Q. Do you have a practice for the calibration of thermometers?

A. No.

Q. Do you have any recollection of calibrating your thermometer during the survey?

A. No.

P. Ex. 31, at 16.

CMS's failure to establish the reliability of the surveyors' temperature readings coupled with evidence showing that the surveyors calibrated the thermometers incorrectly, if they calibrated them at all, are sufficient reasons for me to find no basis for a violation by Petitioner of the requirements of 42 C.F.R. � 483.25(h)(1). There is additional reason for me to conclude that the temperature readings in the January survey report are not reliable. There are inexplicable discrepancies in water temperatures that were measured by the surveyors in rooms that are in close proximity to each other in Petitioner's facility. For example, at 4:15 p.m. on January 12, 2004, the surveyors contend that they measured the water temperature in room 407 of Petitioner's facility at 142.9 degrees Fahrenheit. But, at the same time on that date, water temperature in a nearby room, room 408, was measured at 116.9 degrees. That is a 26 degree difference in water temperature recorded in closely proximate rooms of Petitioner's facility at the same time. Yet, as Petitioner points out, the two rooms were fed water from a closed system and their outlets were approximately the same distance from Petitioner's boiler. Logically, the two rooms' water temperatures should have been identical, or at least very close, at the same time on the same date.

2. The evidence does not support a conclusion that Petitioner failed to provide its residents with adequate supervision and assistance devices to prevent accidents.

CMS's allegations that Petitioner failed to comply with the requirements of 42 C.F.R. � 483.25(h)(2) are based entirely on the circumstances pertaining to a resident who is identified as Resident # 9 in the January survey report. Resident # 9 eloped Petitioner's facility on November 23, 2003. CMS alleges that this elopement was the consequence of Petitioner's failure to provide her with adequate supervision.

Resident suffers from impairments that include Alzheimer's disease. On October 17, 2003 Petitioner's staff assessed the resident as having severely impaired decision making skills. The resident was found to be alert and oriented only to persons (meaning that she was not aware of her location or of date and time). CMS Ex. 2, at 8.

Resident # 9 was known to wander. CMS Ex. 2, at 9. She was admitted to Petitioner's facility on October 9, 2003 and began making elopement attempts almost immediately. She attempted to elope the facility on October 10 and 13, 2003. Id. Neither of these attempts succeeded. However, on November 23, 2003, Resident # 9 eloped from Petitioner's facility. Id. The resident eventually was found by a motorist, dropped off at the home of her spouse, and returned to Petitioner's facility. Id. at 10.

CMS contends that these facts establish that Petitioner failed to provide Resident # 9 with adequate supervision. CMS argues that Petitioner knew from the resident's history that the resident was a risk to elope yet failed to take adequate measures to ensure that she did not elope.

The duty of a facility to provide its residents with adequate supervision and assistance devices has been litigated many times in cases before administrative law judges and the Departmental Appeals Board. A facility has a duty to take all measures that are within its power to prevent accidents that are reasonably foreseeable. Madison Health Care, Inc., DAB CR1325 (2005). But, the duty of care owed by a facility to its residents is not one of strict liability. A facility is not per se liable for every accident that occurs on its premises.

Here, Petitioner plainly was under a duty to take measures to protect Resident # 9 from eloping. The resident - a demented individual who is unaware of her surroundings - is an obvious elopement risk. Petitioner knew that from its assessment of the resident and also from the resident's elopement attempts. Therefore, the question is whether Petitioner took reasonable measures to address the risk presented by the resident.

That question is not answered simply by the fact that the resident finally managed to elope Petitioner's facility. The circumstances that surround the resident's elopement are certainly relevant. But the elopement is in and of itself not a basis for finding Petitioner deficient given that the regulation does not impose a strict liability standard on a facility.

I find that, in fact, Petitioner took reasonable measures to protect Resident # 9 from elopement. The fact that the resident eloped despite these measures is not a basis to find Petitioner deficient. Viewed from the perspective of hindsight the measures that Petitioner implemented were not airtight. But, they were reasonable and appropriately addressed the problem at the time that they were implemented.

A primary safeguard that Petitioner's staff instituted to guard against the resident's elopement was to check and verify the resident's whereabouts in the facility at 15-minute intervals on an around-the-clock basis. CMS Ex. 3, at 17 - 25; P. Ex. 14, at 1 - 3. These checks were instituted by Petitioner's staff on October 10, 2003, the day after the date of the resident's admission, and the date of the resident's first, unsuccessful elopement attempt. P. Ex. 12, at 29. CMS does not contend that Petitioner's staff failed to conduct these checks as was required by this schedule.

As an additional intervention, Petitioner's staff redirected the resident when she wandered or appeared interested in eloping. CMS Ex. 10, at 3. The resident was noted to be cooperative and easy to redirect. Id. Petitioner's staff also involved the resident in activities as a diversion. P. Ex. 12, at 35. Petitioner's staff also consulted with the resident's family and physician about the resident's mood and, as a consequence, the resident was prescribed anti-anxiety medications. CMS Ex. 3, at 9. These were adjusted from time to time based on consultation with the resident's physician. Id.

Petitioner also undertook a measure to protect all of its residents - not just Resident # 9 - from eloping. All of the facility's exits had alarms. See CMS Ex. 8, at 39. ⁽⁷⁾ Petitioner's staff checked these alarms routinely. Id. CMS does not contend that any of these alarms were not checked or that they malfunctioned on November 23, 2003, the date of the resident's elopement.

Resident # 9's November 23, 2003 elopement occurred in spite of these interventions and measures. On that morning the resident had been seated at a table and was folding towels as a diversionary measure. But at 11:35 a.m., a nurse performing the 15-minute check of the resident could not locate her. CMS Ex. 2, at 9. The nurse immediately notified the facility's staff and the staff began to search for the resident. At 12:15 p.m. on that date, the staff called the resident's home and learned that a motorist had brought the resident there. Id. at 10.

It is unclear how the resident managed to escape the premises. The fact that the facility's alarms were functioning on the date of the elopement leads to the inference that someone, perhaps a visitor to the facility, allowed the resident to exit. But, in fact, all that is definitively known is that the resident was able to evade both the 15-minute checks and the facility's alarm system.

CMS argues that the resident's elopement is proof in and of itself that Petitioner should have done more to protect Resident # 9, arguing that, perhaps, Petitioner's staff should have posted photographs of its elopement-prone residents at exits. It also argues that other measures taken by Petitioner subsequent to the resident's November 23, 2003 elopement - consisting of having the resident wear an identification bracelet and a name tag, attempting to keep the resident out of the front living room area of the facility, and providing one-to-one supervision during periods of agitation - should have been implemented earlier.

Certainly, these measures may have provided an additional layer of security for Resident # 9. ⁽⁸⁾ But I do not conclude that Petitioner either knew or should have known that what it was doing for the resident prior to her elopement was inadequate.

The plan implemented by Petitioner's staff after the resident's October elopement attempts was a reasonable plan that addressed the elopement risks that Petitioner's staff knew about at that time. It provided the resident with close supervision, redirection, diversion, and medication to control her anxiety. The resident was further protected by Petitioner's alarm system. The measures undertaken by the staff were logical and, on their face, entirely rational. Moreover, these measures were effective in preventing the resident from eloping until November 23, 2003. The staff therefore had every reason to believe that these measures would be effective. There was nothing to suggest to the staff that a combination of close supervision, redirection, medication, and alarmed doors would not suffice to protect Resident # 9 from eloping.

3. No basis exists for CMS to impose remedies against Petitioner.

There is no basis for CMS to impose remedies against Petitioner. The evidence in this case does not support a conclusion that Petitioner was deficient in complying with those regulations that are the basis for CMS's remedy determination.

Steven T. Kessel

Administrative Law Judge

1. CMS does not contend that other findings of non-compliance that were made at the January survey are or should be the basis for its remedy determination. See CMS's brief at 1 - 10.

2. My initial pre-hearing order in this case directed the parties to produce as exhibits the sworn written direct testimony of all proposed witnesses. CMS failed to comply with this order and I ruled that the individuals whom CMS had listed as witnesses would not be permitted to testify in person.

3. Many of Petitioner's proposed exhibits also relate to deficiency findings that CMS does not rely on for its remedy determinations. Although I am receiving these exhibits into evidence, I am not relying on them for my decision in this case.

4. The January survey report also asserts that a surveyor discovered, in an unlocked shower stall in Petitioner's facility, a can of paint with a knife on its lid. CMS Ex. 2, at 7. CMS offered no discussion of this allegation in either its pre-hearing brief or in its brief, and has not identified any evidence that supports it. I conclude that CMS abandoned the allegation.

5. CMS offered no foundation for this assertion. Petitioner did not dispute it, however, and I therefore accept CMS's assertion only for purposes of deciding this case.

6. Mr. Berkley's name does not appear on his notes, but the initials "J.B." do, and I infer that these initials are his. See CMS Ex. 6, at 1.

7. The report of the January survey states that only seven of the eight exits had alarms. CMS Ex. 2, at 12. Petitioner denies this assertion, contending that all eight exit doors had alarms. Petitioner's reply brief at 43. Petitioner argues that proof that all eight doors had alarms may be found in a page, taken from a notebook, which contains handwritten records of what appear to be safety checks of eight doors. CMS Ex. 8, at 39. The document does not explicitly state that all eight doors had alarms and, arguably, it is ambiguous as to whether the doors were all alarmed. However, CMS did not file a reply brief, and so does not dispute Petitioner's contention that all eight doors had alarms. I accept Petitioner's contention that the exhibit proves that all eight doors had alarms because it is not disputed by CMS.

8. Petitioner contends that posting the resident's photograph would have violated her privacy rights. I find it unnecessary to decide this argument.