SUBJECT:

Coquina Center,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

I sustain the determination of the Centers for Medicare and Medicaid Services (CMS) ⁽¹⁾ to impose a Civil Money Penalty (CMP) against Petitioner, Coquina Center, for failure to comply substantially with federal requirements governing participation of long term care facilities in Medicare and State Medicaid programs. The CMP of $10,000.00 per day, from April 13, 1999 through April 21,1999, is based on a finding of immediate jeopardy.

I. Background

This case came before me pursuant to a request for hearing filed by Petitioner, Coquina Center, on June 18, 1999, in accordance with section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R. §§ 488.408(g), 498.40.

On April 20, 1999, CMS informed Petitioner that, based on a survey, conducted on April 14,1999, it was imposing selected remedies due to Petitioner's failure to be in substantial compliance with the applicable federal participation requirements for long term care facilities.

CMS concurred with the State recommendation and imposed the following remedies:

•Termination of the provider agreement effective May 7, 1999. ⁽²⁾

•A civil money penalty in the amount of $10,000.00 per day effective April 14, 1999.

CMS Ex.1.

At the hearing, CMS offered 55 exhibits identified as CMS Exs. 1 - 55. Petitioner offered 64 exhibits identified as P. Exs. 1 - 64. The parties' exhibits were admitted into evidence without any objection.

Subsequent to the hearing, the parties submitted simultaneous post hearing briefs (CMS Br. and P. Br.), as well as response briefs (CMS Response and P. Response).

Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that from April 14, 1999 through April 21,1999, Petitioner was not in substantial compliance at the immediate jeopardy level. I further find that CMS was authorized to impose a CMP against Petitioner at the rate of $10,000.00 per day from April 14, 1999 through April 21, 1999.

II. Applicable Law and Regulations

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

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

Pursuant to the Act, the Secretary has delegated to CMS and the States the authority to impose remedies against a long term care facility that is not complying substantially with federal participation requirements. 42 C.F.R. Part 483 provides that facilities which participate in Medicare may be surveyed on behalf of CMS by State survey agencies in order to ascertain whether the facilities are complying with participation requirements. 42 C.F.R §§ 488.10 - 488.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. §§ 488.300 - 488.335. Under Part 488, a State or CMS may impose a CMP against a long term care facility where a State survey agency ascertains that the facility is not complying substantially with participation requirements. 42 C.F.R. §§ 488.406, 488.408, 488.430. The penalty may start accruing as early as the date that the facility was first out of compliance until the date substantial compliance is achieved or the provider agreement is terminated.

The regulations specify that a CMP that is imposed against a facility will fall into one of two broad ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of civil money penalties, of from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a facility's residents, and in some circumstances, for repeated deficiencies. 42 C.F.R. § 488.438(a)(1) and (d)(2). The lower range of civil money penalties, of from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents or cause no actual harm, but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(2).

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

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

42 C.F.R. § 488.301.

"Immediate jeopardy" is defined to mean:

[A] situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident. ⁽³⁾

Id.

In determining the amount of the CMP, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:

1. The facility's history of noncompliance, including repeated deficiencies.

2. The facility's financial condition.

3. The seriousness of the deficiencies as set forth at 42 C. F. R. § 488.404.

4. The facility's degree of culpability.

In a CMP case, CMS must make a prima facie case that the facility has failed to comply substantially with participation requirements. To prevail, a long term care facility must overcome CMS's showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997).

The Act and regulations make a hearing before an Administrative Law Judge available to a long term facility against whom CMS has determined to impose a CMP. Act, section 1128A(c)(2); 42 C.F.R. §§ 488.408(g), 498.3(b)(12), (13). The hearing before an Administrative Law Judge is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd 941 F.2d 678 (8^th Cir. 1991).

III. Issues

A. Whether the facility was complying substantially with federal participation requirements on the dates CMS determined to impose a CMP.

B. Whether CMS' determination of immediate jeopardy is clearly erroneous.

C. Whether the amount of the penalty imposed by CMS is reasonable, if noncompliance is established.

IV. Findings and Discussion

The findings of fact and conclusions of law noted below in italics are followed by a discussion of each finding.

1. The facility was not in substantial compliance with federal participation requirements from April 14, 1999 through April 21, 1999.

2. The facility failed to provide Resident 1 adequate supervision and assistance devices to prevent accidents. Petitioner's lack of intervention allowed the resident to suffer strangulation when the cord from the alarm device attached to his gown did not disengage when he slid from his wheelchair.

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

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

Surveyors findings for 42 C.F.R. § 483.25(h)(2) Quality of Care, as reflected at Tag F324 of the Statement of Deficiencies.

With regard to Tag F324, the surveyors set forth their findings in a Statement of Deficiencies. CMS Ex. 2. I repeat those findings immediately below.

A review of facility's clinical records revealed that on April 13, 1999, at approximately 4:20 p.m., Resident 1 was found in room 228 with his buttocks off the seat of his chair with the body alarm in place and pulling at the neck of the gown. The paramedics were called and he was determined to have expired. An interview with the charge nurse revealed that the alarm device was held to the resident's chair by pinning it to a blanket that was tied around the back of the chair. The cord from the alarm was tied to the upper part of the resident's gown. The alarm cord created a resistance that prevented the resident from sliding to the floor. The alarm never sounded as it was expected to do.

The initial care plan for the resident included the following approaches in response to his having fallen twice since admission:

•call light within reach in bed at all times;

•low bed; and

•keep within view when out of bed with body alarm.

The surveyors concluded that the facility was using an inappropriate alarm device in an attempt to prevent falls. They found the alarm to be an inexpensive security alarm for use by the general public to be manually activated in time of danger.

The surveyors also found that the facility had no instructions, policy or procedures for the application, use, or maintenance of the alarm device.

It was further noted that Resident 1 had been found on the floor of his room on April 12, 1999, and the body alarm had not sounded.

Discussion

A facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents. A facility's duty of care pursuant to 42 C.F.R. § 483.25(h)(2) is not absolute. The measures undertaken by a facility for the protection of its residents, however, must be adequate. Regulatory agencies entrusted by law with the task of ensuring that long term care facilities comply with federal participation requirements do not impose specific measures for the protection of residents. For example, as Petitioner correctly points out, there is no regulation or standard of practice requiring the use of alarms to protect residents from accidents. P. Br. at 25, 26. The method of protection is a choice the facility must make. However, once a facility decides to deploy a certain device to protect and supervise residents, it is under an obligation to establish procedures for its proper maintenance and use. This, of course, encompasses the facility's duty to ascertain that any deployed device is in place and operational, that established policies and procedures are appropriately communicated to staff, and that personnel are effectively trained in the application of selected protective measures and devices. Consistent with this reasoning, I find no merit in Petitioner's argument that its facility was not on notice that the device it used to supervise its residents posed a risk. CMS does not have to inform a facility a priori whether a given intervention is appropriate. The facility must consider the benefits and risks associated with any intervention it decides to implement for the protection of its residents. See P. Br. at 3.

In the case at hand, the facility decided to employ a body alarm to assist in the supervision of Resident 1. The interdisciplinary care plan team had determined that the best way to care for this resident was to make a call light available and within reach at all times while Resident 1 was in bed, provide assistance with transfers from bed to wheelchair, maintain his room free of debris, provide him with a low bed, and keep him within view when out bed with the body alarm on. Tr. at 35; CMS Ex. 48 at 62. Pertinent to this is a risk assessment of April 6, 1999, wherein it was noted that Resident 1 would frequently slide down in bed or chair. CMS Ex. 47 at 2.

In order to protect Resident 1 from accidents, Petitioner made use of an alarm device that was described at the hearing as a "Pull Tab" personal alarm sold under the trade name of Quorum. The alarm was held to the chair the resident was sitting in by being pinned to a blanket tied around the back of the chair. The cord from the alarm device was then attached to the front part of the resident's gown. Tr. at 30. It was intended that if the resident rose from his chair, he would pull on the cord connected to the alarm box until its plug pulled out of the alarm jack, thus triggering a loud noise that would alert staff. See P. Ex. 39 at 5.

Ms. Nancy Jo Smith, a State surveyor, testified that the alarm that was provided to Resident 1 was a Radio Shack ⁽⁴⁾ product designed for personal protection by individuals such as joggers in case they were attacked. The device would be clipped to the jogger's belt while running outdoors. If the jogger felt threatened, he or she would pull on the cord and set off the alarm. Tr. at 33. The piercing sound was designed to startle or deter thieves or attackers. P. Ex. 39. The manufacturer warned not to activate the device within 12 inches of an individual's ear since inner ear damage may result. P. Ex. 39 at 3.

A demonstration during the hearing revealed that in order for the cord to disconnect from the alarm, the pulling action had to be directly away from the top of the box. Thus, if the box were held in the upright position, the pulling action had to be vertical. If the pulling force was exerted on an angle or horizontally, the difficulty in triggering the alarm would range from difficult to impossible. Tr. at 258, 259.

Given the design and purpose of this personal attack alarm, it was unlikely that the resident would be able to set it off by a forward sliding action. Since the device was intended for intentional triggering by its user, it was inappropriate to expect a facility resident to set off the alarm automatically by exiting from his chair. The triggering mechanism would be set in motion only if the resident were to stand at just the right angle. Moreover, it would be even more difficult for the resident to trigger the alarm if he slid from the chair as opposed to standing up. ⁽⁵⁾ I find, therefore, that the Quorum personal attack alarm was inappropriately used in a long term care facility setting. Petitioner disingenuously claims that the Quorum alarm employed by its facility could also be used for personal protection by joggers, when in fact it is the other way around. The facility was employing a crime prevention alarm as a device with which it could supervise its residents. P. Br. at 21.

An added gravamen to Petitioner's use of an inappropriate device, is its failure to provide staff with policies and procedures regarding the proper use of such device. Tr. at 29. That is, no instructions were made available to staff that would indicate the proper placement of the device in a manner that would allow its tab to be disengaged when the resident attempted to exit from his chair. Furthermore, the staff was not informed as to how to attach the alarm to the resident without creating a strangulation hazard.

Ms. Karen Barker Robbins, Vice President of Clinical Services of Petitioner's parent company, testified that the facility chose the personal attack alarm for the following reasons:

•Ease of application by entry level employees.

•It had no on/off switch, and, therefore, a resident could not defeat its purpose.

•To prevent the use of a restraint.

Tr. at 208, 209, 212.

The reasons advanced by Ms. Robbins have no foundation. I see no ease in the application of a crime prevention device that had to be attached to the rear of a resident's chair and then pinned to his or her clothing at just the precise angle so that the tab would disengage from the alarm if the resident attempted to get up or were to fall from the chair. In this case, the difficulty was magnified due to the absence of instructions on how to apply the device.

The fact that the alarm had no on/off switch is unconvincing, because the resident would just as easily be able to defeat its purpose by removing the safety pin that attached the pull strap to the chest area of the resident's clothing.

Additionally, the facility's goal of employing a fall prevention measure that would allow freedom of movement was defeated by the personal attack alarm. This is evident from Ms. Robbins' recognition that the pull strap was so short that it forced the resident to remain in a rigid, upright position. During the course of Ms. Robbins' testimony, I brought to her attention that it appeared to me that a person would have to sit in an extremely rigid position not to pull that pin out. To that observation, she responded that: "...they activated them quite easily because there was just a small room for error because we really did want to try prevent people from getting up. Tr. at 211. In that sense, contrary to the facility's contention that the personal attack alarm provided freedom of movement, it was, to a certain extent, employed as a restraint.

Ms. Robbins did not mention that the alarm chosen by the facility for the protection of its residents was an inexpensive device intended for use by the general population for personal protection. ⁽⁶⁾ CMS Ex. 2 at 2. Yet Petitioner submitted into evidence examples of protective alarms suited for a nursing home setting, which seems to indicate that they knew of the existence of appropriate alarm devices that they could have employed. P. Exs. 40, 41. It is a sad commentary if they opted for the crime prevention type of alarm instead of the one depicted at P. Exs. 40 and 41 solely because they were inexpensive. Moreover, if as Ms. Robbins stated, the alarms were going off frequently, it appears that no consideration was given to the exposure of residents to inner ear damage from the piercing noise. P. Ex. 39 at 3.

Petitioner knew of the inadequacy of the Quorum personal attack alarm when the resident was found on the floor of his room on April 12, 1999. On that occasion, the alarm was found disconnected from the resident's gown, the safety pin used to attach the cord to the gown was open, bent, and no longer attached to the gown. Furthermore, the alarm had not activated. CMS Ex. 14 at 10; Tr. at 40. It was also known to the facility that Resident 1 had a tendency to slide down from his bed and chair. The facility had concluded that, as a result, the resident required frequent repositioning with maximum assistance. CMS Ex. 47 at 2. The care plan called for keeping the resident within view when out of bed with his body alarm. Nonetheless, the facility record does not indicate that he was observed when he fell to the floor on April 12, 1999, or when he slid from his chair and hanged himself on April 13. Petitioner claims that the standard for observing residents that are at risk for falls is every two hours. P. Br. at 20; Tr. at 231. However, the facility had concluded that observation every two hours was inadequate when the resident was out of bed with a body alarm, and that he required frequent repositioning. Consequently, the facility care plan called for keeping the resident within view. Thus, every two-hour observation was grossly inadequate for Resident 1. Petitioner misunderstands Ms. Robbins' testimony to the effect that: "just because a person is in isolation [because of his contagious infection] doesn't mean that they require any more observations." See P. Br. at 19. Although that may be true, it was not the fact of the resident's isolation that warranted ongoing supervision, but, rather, his very compromised physical and mental condition and the fact that he had a tendency to slide off the bed and chair and needed frequent repositioning. These needs could not be met with two hour observations. Petitioner fell woefully short of providing the level of supervision it had determined that Resident 1 required, and did not satisfy that requirement by placing him close to the nurses station in the hope that staff would stop and observe him as they passed by. Such a hit or miss approach to nursing care is unacceptable. P. Br. at 19. On a final note here, I must point out Petitioner's attempt at making an issue of the fact that no one really knows the details of exactly what happened on April 12 and April 13, 1999 is misplaced. I find that I am able to draw inferences and conclusions based on the facts available to me regarding those incidents, and also find that the facility's inability to explain what happened to the resident on April 12 or 13, 1999 is further indication of its failure to provide adequate supervision.

Petitioner puts much stock in the argument that the tragic incident resulting in the demise of Resident 1 was unforeseeable. Although the fact that an accident occurred does not by itself establish absence of adequate supervision, non-compliance may be found where the accident was preventable. CMS has established a prima facie case by coming forward with evidence that reveals that the facility did not provide adequate supervision and assistance devices to prevent accidents. Additionally, it has been shown that such a deficiency caused or was likely to cause serious injury, harm, impairment or death to a resident. The applicable regulations do not require that CMS show that Petitioner foresaw the precise way in which harm would be visited upon residents as a result of its facility's failure to comply with participation requirements. CMS has met its burden by showing that the facility not only used a crime prevention alarm in a manner unintended by its maker, but also applied it in a way that was clearly hazardous and where risks of injury were clearly foreseeable. ⁽⁷⁾ Such risks were foreseeable in light of Petitioner's knowledge that the alarm system had not functioned the previous day. At that time, the resident pulled so hard on the alarm cord, without setting it off, that the safety pin attached to the gown bent and became open. CMS Ex. 14 at 10. Furthermore, Petitioner knew of the resident's tendency to slide off the bed and chair, and, even knowing that, it did not provide staff with policies and procedures for use of the attack alarm in a way that did not pose a risk to residents. In the particular case of Resident 1, he was physically and mentally so compromised that he would be unable to extricate himself from a life threatening situation. That is precisely what happened on April 13, 1999, when he was unable to free himself from the strangle-hold of his night gown.

3. CMS' finding of immediate jeopardy from April 14, 1999 through April 21, 1999 was not clearly erroneous.

In view of the foregoing discussion, it is my finding that CMS has established a prima facie case that Petitioner was not in substantial compliance with federal requirements for long term care facilities participating in the Medicare and Medicaid programs from April 14, 1999 through April 21, 1999. Petitioner, on the other hand, has not overcome CMS's showing by a preponderance of the evidence. Furthermore, I sustain CMS's finding that Petitioner's level of noncompliance constitutes immediate jeopardy. It was reasonable for CMS to conclude that other residents, in a situation similar to Resident 1, were also likely to suffer serious injury, harm, impairment, or death.

Petitioner contends that the use of the personal attack alarm for the supervision of Resident 1, as well as the manner in which it was applied, was appropriate. However, before the State surveyors came on the scene, the facility removed all personal attack alarms and was unable to produce any of the devices for inspection. Tr. at 28. This is not a situation where the facility is being penalized for correcting a deficiency. If I am to accept that the facility truly believed that it was employing appropriate devices in an appropriate manner, I would also have to find that it proceeded to remove those devices prior to the arrival of the surveyors without a suspicion that they had any connection whatsoever with the death of Resident 1.

It is also Petitioner's position that since CMS found immediate jeopardy beginning the day following the accident resulting in the death of Resident 1, that somehow that detracts from a finding of non-compliance. Although it may have been appropriate for CMS to determine that immediate jeopardy began on April 13, 1999, nothing prevents it from starting the period of non-compliance the next day. CMS based its conclusion of immediate jeopardy on the facility's failure to provide adequate supervision and assistance devices to protect its residents. This state of affairs became evident when Resident 1 died of asphyxiation after he strangled himself with the neck of his gown due to the employment by the facility of a personal attack alarm as a fall prevention measure. Thereafter, Petitioner did not have in place adequate measures to protect its residents from accidents until April 22, 1999.

Ms. Nancy Jo Smith stated that she visited the facility on April 14, 18, and 19, 1999. The visits subsequent to the 14th of April were for the purpose of making observations as to how the residents were being supervised. Since the crime prevention devices had been removed, she was interested in seeing what the facility was using for alarms, whether any in-servicing was being conducted, and what protective measures for the residents were in place. She found that on the 18th of April there were no alarms in use. However, as an interim measure, the facility placed a group of residents in the day room and assigned a CNA to be with them for protection from falls and other hazards. The group was comprised of the residents from whom alarms had been removed. Tr. at 54, 55. Ms. Smith added that when she returned on the 19th, the alarms were in place, but policies and procedures for supervision had not been established, nor had in-servicing been completed. Tr. at, 58. Ms. Smith also noted that on the 18th of April, the CNA in charge of the residents from whom the alarms were removed, and who had been grouped in the day room, went away and left the residents alone. During her absence, one of the residents fell. Ms. Smith brought the incident to the attention of the facility to let them know that the interim measure in lieu of alarms was not working, because the person in charge of the residents that had been placed in the day room had left them alone. As a result, the facility put the new alarms in use the following day, although in-servicing had not been completed. Tr. at 59.

Surveyor Kimberly Smoak visited Petitioner's facility on April 15th to conduct a partial extended survey, and returned on the 22nd for a follow up visit. Her goal was mainly to examine the facility's policies and procedures. Tr. at 97, 98. As of the 15th of April, no alarms were in use by residents, and 22 had been identified as having had alarms removed from them. Tr. at 101.

Surveyor Eleanor McKinnon visited Coquina Center on April 16, 17, and 21, 1999. Her goal was to determine the adequacy of staffing and observe resident supervision. Tr. at 148. On the 16th, staffing appeared to be adequate, but the new alarms that had been ordered were not in place yet. The alternate safety monitoring system for the residents arrived and was unpacked at 11:30 a.m. on April 17. Ms. McKinnon noted that nurse consultants were present in the facility in the process of drafting policies and procedures. Fourteen residents were in the day room with a staff person. Although Ms. McKinnon was unable to identify those residents, I infer that they were the ones testified to by Ms. Smith as residents from whom alarms had been removed. Tr. at 151. On her last visit to the facility, Ms. McKinnon observed 11 residents in the day room under the care of one staff person. She noted that two chair alarms were in use. Ms. McKinnon asserted that the facility was not in compliance with Tag 324 on April 15, 1999, because they were still in the process of ordering alarms and in-servicing staff in order to implement the mode of supervision they had chosen. Tr. at 107.

Petitioner argues that based on an internal State survey agency report dated April 16, 1999, from Ms. Nancy Jo Smith to supervisor Karen Swann, its facility was appropriately supervising its residents at the time of the April 15 monitoring visit. CMS Ex. 1, at 6; P. Br. at 26, 29. At page 6 of that report, Ms. Smoak purportedly informed Ms. Smith that:

1. The Ombudsman representative was on site.

2. All inappropriate alarms were removed. 27 new alarm "Patient protectors" had arrived and after re-evaluation of the residents, 15 residents were provided with these new alarms.

3. Every two hours monitoring was in effect and was being documented.

4. Inservice presented on 4/14 and 4/15 included:

a. patient monitoring.

b. proper use of patient protector-new resident safety system.

5. Plans were made for in servicing all agency staff as they were scheduled.

As Petitioner points out, Ms. Smoak testified that she did not report any of her findings to Ms. Smith. She reported her documented observations directly to the field office manager, Ms. Karen Swann. Tr. at 124, 125; P. Br. at 26, 27. In order to clarify the apparent inconsistency, I recalled Ms. Smith to the stand motu proprio. On recall, Ms. Smith testified that she added to her own report the portion purportedly containing the findings of Ms. Smoak. ⁽⁸⁾ Those findings were supplied by her supervisor, Ms. Nancy Marsh. Tr. at 136. Ms. Marsh presumably summarized her understanding of Ms. Smoak's report as reflected at CMS Ex. 18, and provided that summary to Ms. Smith. Ms. Smith added that State survey agency supervisors have discretion to make modifications to survey reports. Tr. at 139, 140.

From the above circumstances, Petitioner argues that I should disregard the testimony that contradicts the purported summary of Ms. Smoak's report found at CMS Ex. 1, at 6. However, the overwhelming evidence in this case is that on April 15, 1999 there were no residents provided with any type of alarm to protect them from falls or other accidents. That was the unequivocal testimony of the three surveyors that testified. That fact was not contradicted by any of Petitioner's witnesses. The confusion appears to stem from the fact that on April 13, 1999, Petitioner immediately removed the inappropriate crime prevention alarms it had been using and ordered another type of alarm. Tr. at 157. However, as mentioned earlier, the new alarms were returned because the facility found them to be inadequate. Somehow the impression was incorrectly conveyed that the first delivery of alarms abated the existing deficiency. It is evident from the visits that the surveyors made to the facility after April 15, 1999, that no alarms were in place prior to April 19. Ms. McKinnon testified that the second delivery of alarms arrived on April 17, 1999. They were unpacked at 11:30 a.m. that same day. Ms. Smith noted that when she visited the facility on April 18, the residents from whom the alarms had been removed were left unattended and one of them fell. Therefore, she urged the facility to do something to protect the residents because the temporary measure in lieu of alarms was not working. As a result, deployment of the alarms began on April 19. At that time, in-servicing had not been completed. Additionally, the facility was still in the process of drafting policies and procedures for the supervision of its residents. All of these events to which the three surveyors testified, and which remain uncontradicted, occurred after April 15, 1999. Thus, based on a misunderstanding of what transpired on April 15, 1999, I cannot ignore events that took place subsequent to that date and which are not addressed at CMS Ex. 1, at 6. In view of the foregoing, I deny Petitioner's request to disregard the testimony of the surveyors regarding the existence of the deficiency subsequent to the untimely death of Resident 1 on April 13, 1999. I further find that the deficiency existed at the immediate jeopardy level through April 21, 1999. Tr. at 182. Petitioner has advanced no persuasive evidence to show that CMS's finding in this regard is clearly erroneous.

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

CMS imposed a $10,000.00 per day CMP for the period beginning April 14, 1999 and ending April 22, 1999. Petitioner claims that CMS offered no witness or documentary evidence at the hearing in support of the $10,000.00 CMP imposed. Consequently, argues Petitioner, CMS did not afford it an opportunity to inquire into the basis for the CMP, or to rebut the rationale for imposing the highest CMP allowed by law. In support of its contention, Petitioner relies mainly on the holding in Emerald Oaks, DAB No. 1800 (2001). ⁽⁹⁾ However, a correct reading of the decision in Emerald Oaks does not lead to the conclusion that CMS has to present documentary or testimonial evidence at the hearing to substantiate its claim that it considered the factors identified at 42 C.F.R. § 488.438(f) in determining the amount of the CMP imposed.

In the case at hand, CMS informed Petitioner that it had considered the factors listed in the regulation cited above in arriving at the amount of the CMP. CMS Ex. 6, at 3. If Petitioner disagreed with that assertion it should have presented evidence to contest the reasonableness of the amount of the CMP in the de novo hearing before me. Emerald Oaks, at 12. In order for Petitioner to put before me such matters as its compliance history, financial condition, or degree of culpability, it did not need to inquire into the basis for the CMP. Nothing prevented Petitioner from presenting evidence to rebut CMS's assertion that the factors set forth in the regulations justified the CMP imposed. Had Petitioner availed itself of that opportunity at the hearing, I would have considered the evidence presented in that regard along with any evidence presented by CMS in determining the reasonableness of the CMP. Emerald Oaks, at 12, 13. Rather than challenge CMS's assertion with evidence of its own, Petitioner elected to attempt to persuade me to look into the internal decision-making process of CMS officials, contrary to the Board's express holding in CarePlex of Silver Spring, DAB No. 1683, at 11 (1999).

In a more recent decision, the Board set forth with clarity the proper application of the regulation in determining the reasonableness of the CMP. Community Nursing Home, DAB No. 1807 (2002). The Board stated the following:

[W]hile the ALJ must consider evidence which is properly presented to him concerning any of the factors listed in 42 C.F.R. § 488.438(f), including financial condition, in evaluating whether the CMP is within a reasonable range, CMS does not automatically have to offer such evidence as part of its prima facie case. Rather, if a facility contends that its financial condition or some other factor makes a CMP unreasonable, then the facility must raise that contention on a timely basis before any question would arise as to CMS' responsibility for producing evidence as to that factor.

Community Nursing Home, at 22.

Petitioner's argument here is not different than that posed by the facility in the above cited case. The response in both cases is identical: The CMP may be sustained even in the absence of the presentation of any evidence by CMS on its consideration of the regulatory factors. Community Nursing Home, at 24.

In conclusion, inasmuch as Petitioner did not challenge any of the factors considered by CMS in arriving at the CMP, the findings by CMS as to that issue remain uncontested. I therefore have the authority to determine the reasonableness of the amount of the penalty even in the absence of such evidence in CMS's presentation of its prima facie case. In this case, the penalty arose from Petitioner's non-compliance concerning appropriate supervision and assistance devices to prevent accidents. The level of non-compliance constituted immediate jeopardy to health and safety. This stemmed from the improper use of a crime prevention device as a means of addressing resident supervision, which resulted in the death of Resident 1. Petitioner's actions placed other residents in similar jeopardy. In the face of such a severe deficiency, it was reasonable to impose a $10,000.00 per day penalty for the period commencing April 14, 1999 through April 21, 1999. Such a penalty is appropriate and within a reasonable range, given the circumstances of this case. I further find that it served the purpose of driving the facility back into compliance. Petitioner's argument that the CMP could not have been higher if its facility had done nothing at all is without merit. Had the facility taken no action all, the per day penalty would have continued for greater number of days, resulting in a higher dollar amount.

V. Conclusion

I conclude that CMS correctly determined that, beginning April 14, 1999 through April 21, 1999, Petitioner was not complying with federal participation requirements in the Medicare program at the immediate jeopardy level, and that the imposition of a CMP of $10,000.00 per day is reasonable.

José A. Anglada

Administrative Law Judge

1. The Health Care Financing Administration has been renamed the Centers for Medicare & Medicaid Services (CMS). Reference to either name shall apply to both names.

2. Petitioner came into substantial compliance prior to the effective date of the termination of the provider agreement. Thus, the CMP based on immediate jeopardy remained as the sole issue in the case.

3. See also Beverly Health & Rehabilitation-Springhill, DAB CR553 (1998).

4. Although the personal attack alarm employed by the facility was similar to one distributed by Radio Shack, described at CMS Ex. 54, it was in fact a product of Quorum International and is described at P. Ex. 39.

5. It is worthy of note that Petitioner acknowledged in its opening statement that the way the resident slid out of his chair would be the only way that the cord could not pull out.

6.

7. Petitioner should have also foreseen that if the alarm were to be activated, it may have caused ear damage to a resident.

8. Ms. Smith at one point even doubted whether she had typed the findings attributed to Ms. Smoak found at CMS Ex. 1, at 6; Tr. at 137.

9. Although Petitioner seems to rely on the holding of this case, it nevertheless describes the Board's language as "murky" (P. Br. at 31).