SUBJECT: Coquina Center,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

Coquina Center (Coquina) appealed the May 10, 2002 decision of Administrative Law Judge Jose A. Anglada (ALJ) sustaining the determination of the Centers for Medicare & Medicaid Services (CMS) imposing a civil money penalty (CMP) of $10,000 per day for the period April 14 through April 21, 1999. ⁽¹⁾ Coquina Center, DAB CR899 (ALJ Decision). CMS had imposed the CMP based on a complaint survey conducted by the Florida state survey agency, which found Coquina not in substantial compliance with a quality of care provision of the Medicare participation requirements and further found that the deficiency posed immediate jeopardy to resident health or safety. As discussed in detail below, we sustain the ALJ Decision.

Coquina argued generally that this case involved a tragic accident which was unforeseeable and for which Coquina should therefore not be held responsible. We agree with the ALJ that Coquina should have foreseen that its reliance on an alarm device to prevent residents from falling could result in serious injury to residents where the device was not marketed for use in nursing facilities, Coquina had not developed any instructions for use of the device, and Coquina did not provide adequate supervision of residents wearing the device. We further agree with the ALJ's finding that this constituted a deficiency under 42 C.F.R. § 483.25(h)(2) which posed immediate jeopardy, that the immediate jeopardy was not abated notwithstanding the removal of this alarm device, and that a $10,000 per day CMP was reasonable. Accordingly, CMS properly imposed this CMP beginning on the date of the survey until the date it resurveyed the facility and determined that Coquina was in substantial compliance. ⁽²⁾

The record for this case consists of the record before the ALJ, the parties' briefs on appeal, and an exhibit submitted by Coquina on appeal which the Board ruled on August 12, 2002 to add to the record as Appellate Exhibit A.

Legal Background ⁽³⁾

The regulatory requirements for long-term care facilities are set forth at 42 C.F.R. Part 483. The general "quality of care" requirement at section 483.25 provides that "[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care." The specific requirement at issue here, section 483.25(h)(2), requires that "[t]he facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents."

Compliance with the participation requirements is determined through the survey and certification process, set out at 42 C.F.R. Part 488, Subpart E. Surveys are generally conducted by a state survey agency under an agreement with CMS. Based on a survey's findings, surveyors prepare a Statement of Deficiencies, which identifies and describes each failure to meet a participation requirement. See CMS's State Operations Manual (SOM) § 7316. If a survey reveals that a facility is not in "substantial compliance" with federal participation requirements, the facility must submit a plan of correction for approval by the survey agency. 42 C.F.R. §§ 488.402(d), 488.408(f). Even if the plan of correction is accepted, the facility may not be regarded as in substantial compliance until the survey agency determines, following an onsite revisit or other means of verification, that the deficiency no longer exists. See 42 C.F.R. § 488.440(h); SOM § 7316.

Subpart F of Part 488 specifies the remedies that may be imposed by CMS based on a determination that a facility is not in substantial compliance with the requirements. One of the available remedies is a CMP. Section 488.430(a) provides in relevant part that-

HCFA or the State may impose a civil money penalty for . . . the number of days a facility is not in substantial compliance with one or more participation requirements . . . .

For deficiencies that constitute immediate jeopardy, a CMP in the range of $3,050 - $10,000 per day of noncompliance may be imposed. 42 C.F.R. § 488.438(a)(1)(i). For deficiencies that do not constitute immediate jeopardy, but either caused actual harm or caused no actual harm but have the potential for more than minimal harm, a CMP in the range of $50 - $3,000 per day may be imposed. 42 C.F.R. § 488.438(a)(1)(ii). A CMP continues until either "(1) The facility has achieved substantial compliance, as determined by HCFA or the State based upon a revisit or after an examination of credible written evidence that it can verify without an on-site visit" or "(2)HCFA or the State terminates the provider agreement." 42 C.F.R. § 488.454(a).

"Immediate jeopardy" is defined as -

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.

42 C.F.R. § 488.301.

The factors to be taken into account in setting the amount of a CMP are:

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

(2) The facility's financial condition.

(3) The factors specified in § 488.404 [relating to the seriousness of the deficiencies].

(4) The facility's degree of culpability. . . .

42 C.F.R. § 488.438(f) (italics in original).

A facility may appeal a certification of noncompliance leading to an enforcement remedy but may not appeal the choice of remedy. 42 C.F.R. § 488.408(g). A determination with respect to the level of noncompliance may be appealed only if a successful challenge on this issue would affect the range of CMP amounts that CMS could collect. 42 C.F.R. §§ 498.3(b)(13)(i) and 498.3(d)(10)(i). CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. § 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000).

Standard of review

The standard of review on a disputed issue of law is whether the ALJ decision is erroneous. The standard of review on a disputed factual issue is whether the ALJ decision is supported by substantial evidence in the record as a whole. Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs (at http://www.hhs.gov/dab/guidelines/); see also South Valley Health Care Center, DAB No. 1691 (1999), aff'd South Valley Health Care Center v. HCFA, 223 F.3d 1221 (10^th Cir. 2000); Lake Cook Terrace Center, DAB No. 1745, at 6 (2000).

The applicable burden of proof requires CMS to come forward with sufficient evidence to establish a prima facie case that the facility is not complying with one or more participation requirements. The facility may rebut a prima facie case of noncompliance by showing, by a preponderance of the evidence, that it is in substantial compliance with participation requirements. Hillman Rehabilitation Center, DAB Nos. 1611 (1997), and 1663 (1998); aff'd, Hillman Rehabilitation Center v. United States, No. 98-3789(GEB) (D.N.J. May 13, 1999); see also Cross Creek Health Care Center, DAB No. 1665 (1998) (same framework applies in long-term care facility cases involving CMPs). ⁽⁴⁾ Once CMS has established a prima facie case, the provider may then offer evidence in rebuttal, both by attacking the factual underpinnings on which CMS relied and by offering evidence in support of its own affirmative arguments. An effective rebuttal of CMS's prima facie case would mean that at the close of the evidence the provider had shown that the facts on which its case depended (that is, for which it had the burden of proof) were supported by a preponderance of the evidence. Id.

Federal courts have long recognized that substantial evidence is "more than a mere scintilla. It means such relevant evidence as a reasonable mind might accept as adequate to support a conclusion." Richardson v. Perales, 402 U.S. 389, 401 (1971) (quoting Consolidated Edison Co. v. NLRB, 305 U.S. 197, 229 (1938)). Under the substantial evidence standard, the reviewer must examine the record as a whole and take into account whatever in the record fairly detracts from the weight of the decision below. Universal Camera Corp. v. NLRB, 340 U.S. 474, 488 (1951). The reviewer does not, however, reweigh the evidence nor substitute his or her judgment for that of the initial decision-maker. Casias v. Secretary of Health & Human Services, 933 F.2d 799, 800 (10th Cir. 1991). Thus, the reviewer must not displace a "choice between two fairly conflicting views," even though a different choice could justifiably have been made if the matter had been before the reviewer de novo. Universal Camera, 340 U.S. at 488. The reviewer must, however, set aside the initial conclusions when he or she "cannot conscientiously find that the evidence supporting that decision is substantial, when viewed in the light that the record in its entirety furnishes, including the body of evidence opposed to the [initial decision-maker's] view." Id. In addition, the Board has held that an ALJ need not "cite to everything in the record which supports" the findings, but that the "evidence that the ALJ does cite must support the findings made." Reconsideration of Wesley Hal Livingston and Shoals Medical Equipment and Supply Co., Inc., DAB No. 1406, at 3 (1993).

Factual Background

The following summary of the undisputed facts is drawn from the ALJ Decision and the record below and is not intended to substitute for any of the ALJ's findings and conclusions.

Coquina is a long-term care facility located in Florida. Resident 1 was admitted to the facility on March 30, 1999 and was assessed as at risk for falls because of his physical and mental status. ALJ Decision at 2; CMS Ex. 46, at 1; CMS Ex. 48, at 4. On April 13, 1999, at approximately 4:20 p.m., Coquina's respiratory therapist found Resident 1 unresponsive in the private room in which he had been placed because he had a communicable infection that required isolation. CMS Ex. 2, at 1; CMS Ex. 11; ALJ Decision at 10; Tr. at 82. He had been seated in a chair wearing a hospital gown. ⁽⁵⁾

ALJ Decision at 5, 7; Tr. at 221. The cord from a pull-tab alarm device sold under the trade name of "Quorum" was attached to the upper part of his gown. ALJ Decision at 5, 7. The alarm itself was pinned to a blanket that was tied around the back of the chair in which he had been sitting. Id. Resident 1's buttocks were off the seat of his chair, but he had not slid to the floor. Id. at 5. He was strangled with the neck of his gown. Id. at 12. The alarm never sounded. Id. at 5.

Coquina reported the death to the Florida Agency for Health Care Administration, the state survey agency, which conducted a complaint investigation on April 14. CMS Ex. 10; ALJ Decision at 2. The Statement of Deficiencies (SOD) prepared by the surveyor, Surveyor Smith, stated that an interview with the charge nurse to clarify her notes about the incident revealed that the cord from the alarm device "caused the resistance" which prevented the resident from sliding to the floor. The SOD also stated that according to documentation and staff interviews, Resident 1 was last seen alive at approximately 2:30 p.m. The SOD noted that Resident 1 had been found on the floor in his room the previous day, and that the alarm had not sounded on that occasion either. The SOD further noted that Resident 1's care plan required that he be kept "within view when out of bed with body alarm." CMS Ex. 2.

The SOD concluded that Coquina was out of compliance with the quality of care requirement at section 483.25(h)(2)--

since it did not ensure that each resident receives adequate supervision and assistance devices to prevent accidents. The use of inappropriate alarm devices and the lack of supervision posed an immediate and serious threat to residents health, safety and well-being.

CMS Ex. 2, at 1. The SOD further stated:

The facility was using inappropriate alarm devices in an attempt to prevent falls. The devices in use were inexpensive security alarms for use by the general public to be manually activated in time of danger. . . . The facility had no instructions, policy or procedure for the application, use, or maintenance of the devices, nor was there a policy or procedure related to the frequency of checking and caring for the residents who were using these devices.

Id. at 2.

The SOD identified the deficiency under section 483.25(h)(2) as a "level J" deficiency, i.e., isolated in scope but posing immediate jeopardy to resident health or safety. Id. at 1; SOM § 7400.

Coquina submitted a plan of correction dated April 19, 1999 that detailed steps it would take to correct the alleged deficiencies. Coquina asserted in the plan that it "uses appropriate alarm devices in an attempt to prevent falls" (Coquina designated a completion date of "4/14"); that it "has a policy and procedure in place for the application, use and [maintenance] of alarm devices," that it "has a policy in place regarding the checking of customers utilizing alarm devices," that "[c]urrent alarm devices alarm appropriately," that "[a]ll customers using alarm devices have been assessed by nursing and screened by Rehab therapies for appropriate restraint alternatives" (designated completion date "4/19"); and that "[s]taff has been inserviced on the procedure for the application, use and [maintenance] of the new alarm device being used in the center" (designated completion date "4/18"). CMS Ex. 3, at 1-2.

Coquina removed all pull-tab alarm devices from the facility before the complaint survey commenced. Coquina put a different type of alarm device in place on April 19 and completed in-service training on use of this device on April 22. A resurvey of the facility on April 22 determined that Coquina was in substantial compliance with Medicare participation requirements as of that date. ALJ Decision at 14; Tr. at 61; Coquina Ex. 34.

ALJ Decision

The ALJ made four numbered findings of fact and conclusions of law, all of which Coquina appealed:

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.

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

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

ALJ Decision at 5, 11 and 15.

There is substantial evidence to support the ALJ's finding that use of the alarm device caused Resident 1's death.

In support of FFCL 2, the ALJ found that "[t]he alarm cord created a resistance that prevented the resident from sliding to the floor." See ALJ Decision at 5. In effect, the ALJ found that use of the alarm device caused Resident 1's strangulation death when the cord on the device held up Resident 1's gown and the gown tightened around his neck as he slid down in his chair. On appeal, Coquina argued that not enough was known about what happened to Resident 1 on April 13 to support this finding. Although Coquina acknowledged that it was possible that the alarm cord created resistance, Coquina stated that another possibility was that Resident 1 "caught the open backs of the sleeves of his gown over the arms of the heavy armchair as he slipped down, and that the sleeves, not the cord of the alarm, were drawn taut and caused the neck of the gown to ride up and compress the Resident's airway." Coquina Br. at 8-9, citing CMS Ex. 21 and Tr. at 222-223.

In response to a similar argument made before him, however, the ALJ maintained that there were sufficient facts available to him regarding this incident to support his inferences and conclusions. See ALJ Decision at 10. We agree. One of the documents on which the surveyor relied stated that Resident 1 was found "[w]ith buttocks off the seat of chair [with] body alarm in place pulling @ neck of gown." CMS Ex. 14, at 9 ("Incident Summary" dated 4/14/02," attached to surveyor's worksheet). The surveyor reported in the SOD that when she sought clarification of this note from the charge nurse, she was told that the cord from the alarm "caused the resistance which prevented the nurse and Respiratory Therapist from sliding the resident to the floor." CMS Ex. 2, at 1. The ALJ could reasonably infer from this report that the cord on the alarm device caused the gown to tighten around Resident 1's neck, leading to his strangulation death. ⁽⁶⁾

The evidence cited by Coquina is not necessarily inconsistent with this report. The contemporaneous notes of a nurse making rounds who was called into Resident 1's room by the respiratory therapist who had found Resident 1 unresponsive state that "the gown around his neck was holding [Resident 1] to the chair" and that the respiratory therapist "lifted the gown up and unhooked it from the chair." CMS Ex. 21, at 1. This description could encompass a situation where the gown was held to the chair by the alarm device rather than caught on the arms of the chair. Moreover, in the cited testimony, Coquina's witness Nurse Robbins merely stated that nothing "definitive" could be said about the cause of Resident 1's death since "the gown itself could have caught on the chair" instead of being held up by the alarm device. Tr. at 222. In any event, even if the alarm device was not directly implicated in Resident 1's strangulation, the failure of the alarm to sound when he slid out of his chair clearly prevented Coquina from providing a timely response to an emergency. If the alarm had sounded, Coquina's staff would have been alerted to Resident 1's fall and might have been able to take appropriate measures to prevent his strangulation and save his life. Accordingly, the ALJ could reasonably determine that the evidence cited by Coquina was not sufficient to rebut CMS's prima facie case that use of the alarm device led to Resident 1's death.

Furthermore, CMS may impose a CMP in the $3,050 to $10,000 range based on a deficiency that poses "immediate jeopardy," which is defined in 42 C.F.R. § 488.301 as noncompliance that causes, or is likely to cause, serious injury, harm, impairment, or death to a resident. Thus, the ALJ could have imposed a CMP in this range on the ground that use of the device was likely to cause serious injury by not sounding when a resident fell without finding that use of the alarm device led to Resident 1's death.

There is substantial evidence to support the ALJ's finding that the risk of injury from use of the Quorum alarm device was foreseeable.

In support of FFCL 2, the ALJ concluded that the risk of injury from Coquina's use of the Quorum alarm device to prevent patient falls was foreseeable. See ALJ Decision at 10-11. This conclusion was critical to the outcome of the case since, in order to evaluate a facility's compliance with section 483.25(h), the ALJ must engage in "an examination of whether the facility had done all it could to prevent foreseeable accidents" or whether the facility did "everything in its power to prevent accidents." Odd Fellow and Rebekah Health Care Facility, DAB No. 1839, at 6-7 (2002), quoting Asbury Care Center at Johnson City, DAB No. 1815, at 12 (2002) and Koester Pavilion, DAB No. 1750, at 25-26 (2000).

The ALJ reached the conclusion that the risk of serious injury from Coquina's use of the Quorum alarm device was foreseeable because this alarm device was not designed for use in a long-term care facility setting and Coquina did not provide staff with any instructions for use of the device. ⁽⁷⁾ The ALJ also concluded specifically that the risk of serious injury to Resident 1 from Coquina's use of this device was foreseeable based on the following: the alarm was not designed to sound unless the cord was pulled up vertically as opposed to pulled horizontally or at an angle, Coquina had assessed Resident 1 as having a tendency to slide down from his chair, and Resident 1 had fallen without the alarm sounding the day before the accident that resulted in his death. ALJ Decision at 7-11.

Coquina took exception to the ALJ's finding that the Quorum alarm device was not designed for use in a nursing facility setting. Coquina argued that Surveyor Smith mistakenly relied on manufacturer's instructions for a device other than the Quorum alarm. The ALJ himself noted that the manufacturer's instructions to which the surveyor referred in her testimony, at CMS Exhibit 54, are for an alarm device distributed by Radio Shack whereas the alarm device employed by Coquina was produced by Quorum International and is described in Coquina Exhibit 39. ALJ Decision at 7, n. 4. ⁽⁸⁾ Nevertheless, we conclude that the ALJ did not err in relying on this testimony in determining that the Quorum alarm device was inappropriate for use by a facility such as Coquina. Both the "RadioShack Personal Alarm" and the "Quorum Personal Attack Alarm" are pull-tab alarms promoted for use by individuals to ward off attackers. While the literature for the Quorum alarm device also describes two alternate uses (attaching the alarm to a purse or bag to deter thieves, and modifying the device to use a "door contact switch pin" instead of a "standard pin" and positioning it to sound when a door is opened), neither of these makes the Quorum alarm device any better suited to nursing facility use than the alarm device distributed by Radio Shack. ⁽⁹⁾

Coquina also argued that, in finding that the Quorum alarm device was inappropriate for use in a nursing facility, the ALJ ignored the testimony of Nurse Sodergren, who was offered by Coquina and accepted as an expert in nursing services in long-term care facilities. Coquina asserted that "Nurse Sodergren clearly testified that the device at issue here commonly was - and continues to be - used in nursing facilities as a 'body alarm,' that it can be positioned to sound if a resident stands or tries to get out of bed, and that there was nothing inappropriate about such use in this case." Coquina Br. at 31. ⁽¹⁰⁾ We do not read Nurse Sodergren's testimony as relating specifically to the Quorum alarm device at issue here, however. Her testimony was elicited by Coquina's counsel, who first directed her attention to "the alarm sitting on the bench in front of you," i.e., the Quorum alarm device, but then asked a series of questions referring to "that type of alarm," "that sort of alarm," "an alarm such as the one in front of you," and "this sort of an alarm." Tr. at 251-253. Thus, when she responded to counsel's request for her opinion "as to the appropriateness of the use of this alarm with respect to" Resident 1 (id. at 253), her opinion was based on testimony that related generally to pull-tab alarms she had seen used in nursing facilities. Evidence submitted by Coquina shows that there are several types of pull-tab alarm devices marketed specifically for use in nursing facilities (see Coquina Exhibits 40 and 41; Appellate Exhibit 67), so it is unclear whether Nurse Sodergren had ever seen a Quorum alarm device in use. Indeed, Nurse Sodergren stated that use of the Quorum alarm device had been demonstrated to her only the day before the hearing. Tr. at 257.

We conclude that the fact that Nurse Sodergren's testimony did not refer specifically to the Quorum alarm device makes it of little probative value. Even if other types of pull-tab alarm devices were appropriately used in nursing facilities, the record suggests that there are any number of features (e.g., the design and length of the cord, the type of trigger, the manner of attaching the device) that might have made the Quorum alarm device inappropriate for nursing facility use. In the case of an alarm device manufactured for nursing facility use, the manufacturer would presumably have tested the effectiveness of the device for nursing facility use. In the case of the Quorum alarm device, however, there is no evidence that the manufacturer had done any such testing or stood behind the product for nursing facility use. Coquina stated that the Quorum alarm device and other pull-tab alarm devices--presumably including those manufactured for nursing facility use--are "essentially similar, and differ only as to shape, features, etc.," not "some design or operational feature." Coquina Reply Br. at 5, n.4. However, Coquina provided no evidence that the different "shape, features, etc." did not affect how the devices operated. Coquina also observed that "[t]here is nothing unusual about a product used in nursing facilities also being sold to the public for a different use," citing as examples nutritional supplements originally created for tube-feeding of nutritionally compromised patients and adult incontinence briefs. Coquina Reply Br. at 5, n.3. This is not analogous to the situation here, however, where a product designed for use by the general public was used by a nursing facility for a specialized purpose.

Coquina also challenged the ALJ's reliance on its failure to provide staff with any instructions regarding the use of the Quorum alarm device as one basis for finding that the risk of harm from use of this device was foreseeable. Coquina cited the testimony of Nurse Robbins that it is easy to provide on-the-job training on the use of pull-tab alarm devices to entry level employees involved in care delivery. Coquina Br. at 33, citing Tr. at 208; see also Tr. at 207. On-the-job training does not necessarily obviate the need for a facility to develop written instructions for using equipment, however, particularly where, as here, the manufacturer did not provide any instructions for use of the Quorum alarm device for nursing facility residents. Without developing its own written instructions, Coquina could not assure that any decision it made regarding the proper way to use the alarm device would be communicated to all employees who needed this information. In any event, as with the testimony of Nurse Sodergren, the probative value of Nurse Robbins' testimony is questionable since she was referring to pull-tab alarm devices generally and not specifically to the Quorum alarm device. ⁽¹¹⁾ Even if it was self-evident how to properly use a pull-tab alarm that was designed specifically for nursing facility use, the ALJ reasonably found that, in the case of the Quorum alarm device, some instruction was necessary to "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" (since the tab did not disengage when Resident 1 slipped out of his chair) and "as to how to attach the alarm to the resident without creating a strangulation hazard." ALJ Decision at 8. ⁽¹²⁾

Coquina argued in addition that the ALJ's finding that the risk of serious injury from use of the Quorum alarm device was foreseeable was contradicted by testimony "to the effect that the device had been in use at Coquina and elsewhere for many years without any problems; that surveyors had never expressed any concerns regarding such alarms; [and] that no regulatory or professional agency had ever warned against their use." CMS Br. at 26. This argument mischaracterizes the testimony. Surveyor McKinnon, who was sent to Coquina to perform a monitoring visit after April 14, testified that she saw alarm devices of a type similar to the Quorum alarm device--not necessarily the Quorum alarm device itself--in use at Coquina and elsewhere in prior years. Tr. 164-165, 174-175. In addition, Surveyor McKinnon stated that she had not been aware that any alarm device she saw during prior surveys was not designed for medical use and was being used without policies or procedures, and stated that there was therefore no basis for citing its use as a deficiency in the absence of an accident. Tr. at 170, 175-176. Nurse Robbins stated that "there had not been numerous problems with this type of alarm," (Tr. at 283), not that there had been no problems at all. Moreover, Coquina could not reasonably expect any government agency or professional organization to issue a warning against using the Quorum alarm device to prevent residents from falling when this device had never been designed or marketed for this purpose.

Coquina argued further that the risk of serious injury to Resident 1 from use of the alarm was not foreseeable since there was no basis for the ALJ's finding that Coquina had assessed Resident 1 as having a tendency to slide down from his chair. (Coquina did not dispute the ALJ's finding, based on his own observation at the hearing, that the alarm was not designed to sound unless the cord was pulled up vertically (which would not occur if a resident slid down from his chair).) The ALJ relied on CMS Exhibit 47, an assessment form that requires a nurse to assign skin breakdown risk scores in six functional areas, including "Friction and Shear." Resident 1 was assessed by Coquina as having a "Problem" in this area (as opposed to a "Potential problem" or "No apparent problem"). The assessment form lists the following risk factors under "Problem":

Requires moderate to maximum assistance in moving. Complete lifting without sliding against sheets is impossible. Frequently slides down in bed or chair, requiring frequent repositioning with maximum assistance. Spasticity, contractures, or agitation leads to almost constant friction.

CMS Ex. 47, at 2 (emphasis added). Coquina contended that the assessment that Resident 1 had a problem in this area was not a finding that he had all of the listed risk factors, asserting that Resident 1 did not have spasticity or contractures and thus might not have had other of the risk factors. Coquina Br. at 15.

We do not find Coquina's argument persuasive. Coquina's assertion that Resident 1 did not have spasticity or contractures proves nothing since the relevant risk factor is described on the assessment form as "spasticity, contractures, or agitation." (Emphasis added.) With that exception, the wording of the risk factors under this "Problem" contrasts with the wording elsewhere on the form, where risk factors are listed in the alternative, separated by a capitalized "OR." On its face, this indicates that all risk factors listed must be present to select the item in question here. On the other hand, the instructions for the assessment form state: "Within each category, determine which numbered description best fits the customer's situation." CMS Ex. 47, at 1 (emphasis added). In light of these instructions, the form is best read as indicating that all of the risk factors listed under "Problem" in the "Friction and Shear" area generally occur together, so that Coquina should have been aware that Resident 1 might have these risk factors even if he had not manifested them. Thus, the ALJ reasonably inferred that Resident 1 had been assessed as having a tendency to slide down from his chair.

Coquina also maintained that the ALJ erred in relying on the fact that Resident 1 was found on the floor of his room on the day prior to his death in determining that the risk of serious harm from use of the Quorum alarm device was foreseeable. According to Coquina, "there is no evidence that the incident illustrated some hitherto unknown risk related to the alarm device, or even had anything to do with the device." Coquina Br. at 19. Coquina pointed out that one entry in the nurse's notes regarding this incident stated that Resident 1 was found "lying on his back on the floor in his room" (CMS Ex. 46, at 25) without indicating whether he "fell from bed, a chair, or while standing, or even whether he just simply lay down . . . ." Coquina Br. at 19. Coquina also pointed out that another entry on the same document stated "body alarm was (open pin) disconnected and gown off when found on floor earlier" with no indication "whether the Resident had removed the gown or opened the pin on the alarm himself; whether the gown had torn off during the fall or had been removed earlier; etc." Id. We agree that these notes are not conclusive regarding what occurred. Nevertheless, together with the prior entry in the nurse's notes indicating that Resident 1 was in his chair (CMS Exhibit 46, at 26), they certainly permit the inference that Resident 1 fell from his chair when he was wearing the alarm device without the alarm sounding. The general testimony cited by Coquina "that alarm devices are not foolproof and that they can malfunction or be disabled by residents" (Coquina Br. at 35, citing Tr. at 158-159, 227) does not detract from the significance of this inference. Regardless of the reason the alarm did not sound, Coquina should have known that the alarm was not serving its purpose.

Coquina also took the position that the ALJ improperly relied on the fact that it immediately discontinued using the Quorum alarm device after Resident 1's death as "a recognition by Coquina that the devices were defective or inappropriate." Coquina Br. at 22. Coquina asserted that "it is a basic substantive premise of American law . . . that the removal of a device from service after an accident cannot support any inference that use of the devices in the first place was improper . . . ." Id. at 22-23 (emphasis in original). We are not persuaded that the ALJ violated this legal principle, however. The ALJ Decision states that "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." ALJ Decision at 11. We take the second sentence to mean that it was the fact that Coquina made the alarm devices unavailable for inspection by the surveyors rather than its decision to discontinue using the alarm devices that the ALJ found telling. The unavailability of even a single alarm device for inspection the day after Resident 1's death prevented the surveyors from examining the Quorum alarm device to determine more precisely what role it played in Resident 1's death. Accordingly, it was not error for the ALJ to conclude that this fact undercut Coquina's position that it had no reason to believe that the alarm device was inappropriate for use on its residents.

Finally, Coquina asserted that the ALJ applied a strict liability standard, in violation of Board precedent, in finding a deficiency under section 483.25(h)(2). According to Coquina, the ALJ in effect determined that "it is sufficient that the harm simply occurs," and "simply considered only the tragic result" in this case in upholding the deficiency finding. Coquina Br. at 25-26, 29. This characterization of the ALJ Decision is baseless. As we indicated above, the ALJ followed Board precedent calling for an examination of whether the facility had done all it could to prevent foreseeable accidents. The ALJ found, based on substantial evidence in the record, that Resident 1's death resulted from Coquina's use of an inappropriate alarm device to prevent residents from falling (as well as inadequate supervision of Resident 1, as discussed below). Since there was a foreseeable risk that the facility could have practicably prevented, the ALJ correctly stated that CMS need not 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" in order to support its deficiency finding. ALJ Decision at 10.

There is substantial evidence in the record to support the ALJ's finding that Coquina failed to provide Resident 1 with adequate supervision to prevent accidents.

The ALJ stated in support of his finding in FFCL 2 that Coquina did not provide Resident 1 with adequate supervision to prevent accidents that Resident 1's plan of care called for keeping him within view when he was out of bed with a body alarm based on Coquina's determination that he needed "frequent repositioning with maximum assistance" as a result of his "tendency to slide down from his bed and chair." ALJ Decision at 10. The ALJ viewed the care plan as requiring "ongoing supervision" and concluded that "every two-hour observation," which Coquina asserted was the standard for residents at risk for falls, "was grossly inadequate for Resident 1." Id. ⁽¹³⁾ The ALJ also rejected Coquina's contention that it provided adequate supervision by placing Resident 1 in a room close to the nursing station "in the hope that staff would stop and observe him as they passed by," characterizing this as "a hit or miss approach to nursing care . . . ." Id.

On appeal, Coquina asserted that the ALJ's conclusion that Coquina's supervision of Resident 1 on the day of the accident was inadequate was not supported by any professional standard of care. Coquina argued that the plan of care provision on which the ALJ relied must be read in the context of the undisputed fact that Resident 1 had to be isolated due to his contagious infection and thus could not be placed in a location where he could be observed continuously. Coquina maintained that the testimony from both sides established that, by placing Resident 1 in a room on a high traffic corridor near the nursing station, Coquina ensured the maximum level of supervision that was practicable under the circumstances. Coquina also took the position that Resident 1 required continuous supervision only when he was agitated, and that this level of supervision was not warranted on April 13, when he was noted to be quiet.

We do not find Coquina's arguments persuasive. This Board has previously upheld deficiency findings under 42 C.F.R. § 483.25 based on a facility's failure to follow its plan of care since "[a] care plan is based on a facility's assessment of a resident's needs and represents an interdisciplinary team's best judgment of the services required for the resident, including services required under section 483.25." See Cherrywood Nursing and Living Center, DAB No. 1845, at 8 (2002); see also Crestview Parke Care Center, DAB No. 1836 (2002); Asbury Center at Johnson City, DAB No. 1815 (2002). The plain meaning of the regulation, which expressly requires that the facility provide care and services "in accordance with the plan of care," demands no less. Thus, no showing that Coquina failed to follow a professional standard of care is required. Coquina did not deny that the plan of care on its face required continuous, or ongoing, supervision. The plan of care was never changed to reflect a determination by Coquina that a lower level of supervision was appropriate under any circumstances. Furthermore, the testimony does not establish that Coquina's supervision of Resident 1 complied with the plan of care. Nurse Robbins testified that one way to provide continuous supervision would be to bring the resident "out in a common area so that would be multiple sets of eyes on them," giving as examples of a common area "[n]ursing station, activity room, the main lobby. Any sort of area where it was highly trafficked by multiple people." Tr. at 215. This does not say that continuous supervision could be provided by locating the resident in a private room, even if it is near a nursing station or off of a busy corridor. Surveyor Smith testified only that such a location would provide adequate supervision "[i]f the door were open and if they looked in there each and every time." Tr. at 84. Even if this could be said to constitute the degree of supervision required under Resident 1's plan of care (and that is by no means clear), however, the record does not establish that such supervision was actually provided. A contemporaneous note from the respiratory therapist describing the incident on April 13 indicates that the door to Resident 1's room was closed when he fell (CMS Ex. 11 (stating "At 16:20 I opened the door to [Resident #1's] room")). Coquina did not cite any evidence that the door of this private room was always kept open when Resident 1 was out of bed.

The ALJ's finding that there was noncompliance at the immediate jeopardy level from April 14 through April 21, 1999, is supported by substantial evidence.

In support of FFCL 3, ⁽¹⁴⁾ the ALJ found that it was evident when Resident 1 died on April 13 that there was immediate jeopardy due to Coquina's failure to provide adequate supervision and assistance devices to protect its residents. The ALJ further found that the immediate jeopardy continued until April 22, 1999 because Coquina did not have adequate measures in place to protect its residents from accidents until that date. ALJ Decision at 11-12. The ALJ cited the testimony of Surveyor Smith that no alarms were in use when she visited the facility on April 18, that Coquina had placed a group of residents in a day room and assigned a CNA to be with them for protection from falls, that the CNA had left these residents alone in the day room, and that one of the residents had fallen in the CNA's absence. ALJ Decision at 12. The ALJ also cited Surveyor Smith's testimony that although Coquina put new alarm devices in use on April 19, in-servicing had not been completed. Id. The ALJ noted that Coquina had requested that he disregard this testimony (as well as corroborating testimony by Surveyors McKinnon and Smoak, who visited the facility on other dates between April 14 and April 22) on the ground that an internal state survey agency report dated April 16, 1999 from Surveyor Smith to her supervisor purporting to summarize the results of an April 15 monitoring visit by Surveyor Smoak indicated that Coquina was appropriately supervising its residents at that time. However, the ALJ denied this request, finding that the report was based on a misunderstanding that new alarm devices delivered on April 15 "abated the existing deficiency," when in fact Coquina returned these devices, and that he could not "ignore events that took place subsequent to that date." Id. at 13-15.

On appeal, Coquina argued that the ALJ Decision failed to identify any act or omission on April 14 or after that constituted noncompliance or immediate jeopardy. According to Coquina, Resident 1's death could not be the basis for any level CMP on those dates because Coquina was no longer using the alarm device that allegedly resulted in Resident 1's death and because Coquina closely supervised residents at risk for falls until new alarm devices were put into place.

Coquina's argument has no merit. This Board has consistently rejected the idea that CMS must provide affirmative evidence of continuing noncompliance for each day that a remedy is in place. We quote at length from the most recent Board decision to address this matter, Regency Gardens Nursing Center, DAB No. 1858 (2002):

[I]n a recent case, the Board quoted with approval from the ALJ Decision the following language:

[U]nder the regulatory scheme, any deficiency that has a potential for more than minimal harm is necessarily indicative of problems in the facility that need to be corrected. Lake City Extended Care Center, DAB No. 1658, at 14 (1998). Since I found that the incidents in question have the potential for more than minimal harm, I must also find that the facility was out of compliance "from the date of the completion of the survey in which this incident was cited until the date of the resurvey in which substantial compliance was established." Emphasis added; id. at 14 - 15. Substantial compliance means not only that the surveyors found no other incidents, but also that the facility has implemented a plan of correction designed to assure that no such incidents occur in the future. No findings that the facility violated the standard of care between these dates are required in order to find the facility out of substantial compliance, nor can evidence of other incidents in which the facility met the standard of care change the fact that it was out of substantial compliance.

Barn Hill Care Center, DAB No. 1848, at 12-13 (2002), quoting DAB CR902, at 21-22 (2002). This discussion correctly focuses on substantiation of the initial finding that the facility was not in substantial compliance and assessment of whether its correction efforts had resulted in reestablishing substantial compliance. On appeal, Barn Hill argued, as did Regency in this case, that "CMS must assert and prove that Barn Hill was noncompliant on the days for which it actually imposed the CMP." Barn Hill at 13. The Board rejected that argument relying on the regulatory scheme and citing the following analysis from a prior case:

That scheme does not require that CMS provide affirmative evidence of continuing noncompliance, nor does it require that the surveyors identify the underlying problems giving rise to a deficiency finding as well as its factual basis. Instead, under the regulatory scheme, where there is a deficiency involving a potential for more than minimal harm -

the facility must submit a plan of correction which describes "1. How corrective action will be accomplished for those residents found to have been affected by the deficient practice; 2. How the facility will identify other residents having the potential to be affected by the same deficient practice; 3. What measures will be put into place or systemic changes made to ensure that the deficient practice is being corrected and will not recur, i.e., what program will be put into place to monitor the continued effectiveness of the systemic changes."

State Operations Manual, section 7304; see also [42 C.F.R.] sections 488.401 (definition of "Plan of correction"), 488.402(d) and 488.408(f)(1). Even if the plan of correction is accepted, the facility is not regarded as in substantial compliance until HCFA determines, usually through a revisit survey, that the deficiency no longer exists. Section 488.440(b) and (h). [footnote omitted]

Barn Hill at 14, quoting Lake City at 12-13.

The Board in Lake City summarized the correct standard to evaluate when remedies must end, as follows: "No findings that Lake City violated the standard of care between these dates were required in order to find Lake City out of substantial compliance, nor can evidence of other incidents in which Lake City met the standard of care change the fact that it was out of substantial compliance." Lake City at 14-15. The Board rejected Lake City's argument that it was out of substantial compliance only on the date of the incident on which the finding of noncompliance was based, finding that this was-

contrary to the regulatory scheme, which assumes that any deficiency that has a potential for more than minimal harm is necessarily indicative of problems in the facility which need to be corrected. If this were not the assumption, there would be no basis for requiring a plan of correction in the case of such a deficiency. Moreover, a plan of correction is required regardless of the scope of the deficiency, as long as the deficiency has a potential for more than minimal harm or involves actual harm. Section 488.402(d)(2). Since the ALJ found that the incident in question had a potential for more than minimal harm, he was required to find that Lake City was out of substantial compliance from the date of completion of the survey in which this incident was cited until the date of the resurvey in which substantial compliance was established. (Substantial compliance here meant not only that surveyors found no other incidents like the one at issue after the November survey but also that Lake City had implemented a plan of correction designed to assure that no such incidents would occur in the future.)

Lake City at 14-15. Similarly, in Careplex of Silver Spring, DAB No. 1683 (1999), the Board concluded that nothing "in the regulations suggests that . . . [CMS] is obligated to independently assess the status of a facility's compliance for each intervening date," pointing out that it would be "impracticable to expect surveyors to return daily to monitor corrections before the facility even offers a credible allegation that it has achieved substantial compliance." Careplex at 6.

Regency Gardens at 7-9.

Under the regulatory scheme set forth above, it is irrelevant that the SOD did not identify a specific incident occurring after April 13 which involved a violation of the regulations with which Coquina was found out of compliance. ⁽¹⁵⁾ The regulations presume that the problems which gave rise to the events of April 13 continued until Coquina implemented a plan of correction designed to prevent their reoccurrence. Coquina's April 19 plan of correction identified actions to correct the deficiency that was cited in the SOD. The designated completion dates for the various corrective actions in the plan were April 14 through April 19. Moreover, Coquina did not dispute the ALJ's finding that one of the corrective actions identified in the plan--in-service training on use of new alarm devices--was not completed until April 22.

Coquina further argued, however, that the interim measures it employed to protect residents from accidents until it began using a new type of alarm device were sufficient to correct the deficiency or at least abate the immediate jeopardy. It is questionable whether a facility can be found to have come back into compliance by taking steps other than those detailed in its plan of correction, particularly if the facility did not notify the surveyors at the time that it believed itself in compliance on this basis. Furthermore, it is questionable whether a facility can be found to have come back into compliance if it fails to establish that the interim measures it has taken were fully consistent with the affected residents' plans of care. ⁽¹⁶⁾ We need not reach these issues, however, since, even considering the opposing evidence cited by Coquina on appeal, we conclude that there is substantial evidence in the record to support the ALJ's finding that the steps Coquina took after April 13 to supervise residents at risk of falls were inadequate to prevent accidents. ⁽¹⁷⁾

Coquina argued that the ALJ should have considered a statement in the internal survey agency report that "[t]here appeared to be adequate supervision at the time of the 4/15/99 visit." CMS Ex. 1, at 6. As the ALJ pointed out, however, the report was premised on use of new alarm devices (the "Patient Protector") when in fact Coquina returned these devices because it found them to be inadequate. ALJ Decision at 14. Thus, the report addresses the adequacy of supervision only for the limited time, if any, that these devices were in use. ⁽¹⁸⁾

Coquina also cited a letter from the state survey agency advising Coquina that "no deficiencies were noted" in the April 15 monitoring visit. In addition, Coquina cited the testimony of Surveyor Smoak "that she did not observe any conditions at Coquina . . . that she would classify as immediate jeopardy" at the time of her visit on April 15. Coquina Br. at 41, citing Tr. at 104. As with the internal survey agency report, the ALJ could reasonably have determined that this evidence was entitled to little weight since it related to only one day during the period in question. Moreover, Coquina ignored Surveyor Smoak's explanation that the purpose of her visit to Coquina on April 15 was to conduct a partial extended survey, which is required when a facility has been found to have a deficiency involving a substandard quality of care, including a deficiency under section 483.25. ⁽¹⁹⁾ Tr. at 97, 110. Thus, as Surveyor Smoak's testimony makes clear, she was not there to review the existing deficiency finding. Tr. at 104, 110.

Coquina also challenged the ALJ's reliance on Surveyor Smith's testimony that on April 18 residents in a day room were left unattended and one had fallen. According to Coquina, Surveyor Smith was unable to state whether the residents she had observed in the day room were at risk for falls. In fact, however, Surveyor Smith testified that the residents she observed in the day room were "residents that they had removed alarms for and therefore had no protective device on them, they had placed them in a room with somebody to watch them." Tr. at 56. Moreover, there is evidence in the record from which the ALJ could reasonably infer that at least some of these residents were at risk of falling. The notes from Surveyor Smith's April 18 visit indicate that upon her entrance into the facility, an administrator had informed her that "Residents at risk will have a CNA assigned to them - Dayroom = 1 CNA." CMS Ex. 32, at 1. In addition, Nurse Robbins testified that if residents identified as at risk for falling "could come out of their room, then they went to a common area." Tr. at 241. Also included with CMS Exhibit 32 is the incident report for the fall in the day room and a resident assessment indicating that resident who fell had had multiple falls before. CMS Ex. 32, at 3-4. Thus, Surveyor Smith's testimony constitutes substantial evidence that supervision was inadequate.

Coquina also cited the testimony of Nurse Robbins as showing that, following Resident 1's accident, Coquina "implemented close supervision over the 20 or so residents who needed such supervision." Coquina Br. at 39. Nurse Robbins testified that "[u]ntil we could get . . . another alarm device in the building, . . . we placed the identified customers on every two hours observations . . . and then we documented [it] on the . . . medication administration record." Tr. at 229-230. It appears that documented two-hour checks were intended for residents at risk of falls only when they were in bed, however. ⁽²⁰⁾ The testimony cited by Coquina thus has no bearing on the ALJ's finding that supervision of at-risk residents in the day room was inadequate. Moreover, Nurse Sodergren testified that "different residents may be observed at different timeframes." Tr. at 251. ⁽²¹⁾ Coquina did not show that there were no patients who required monitoring more frequently than every two hours. The adequacy of two-hour checks here is also questionable in light of Surveyor McKinnon's testimony that staff "had to be more alert to what was happening" in the absence of the alarms to which they had been accustomed since "[t]here was a lot of turmoil going on in the building." Tr. at 181. Accordingly, the ALJ properly relied on Surveyor Smith's testimony to conclude that supervision of residents was inadequate throughout the period for which the CMP was imposed.

Coquina nevertheless argued that it was not possible to prevent all falls no matter how closely residents were supervised. Even if this is true, however, it does not excuse a facility's failure to provide adequate supervision. Coquina also maintained that the supervision it provided was sufficient to comply with section 483.25(h)(2) since there was no regulatory requirement that a facility use alarm devices to prevent accidents. The absence of a regulatory requirement for alarm devices is irrelevant in light of the ALJ's finding that Coquina provided neither adequate supervision nor adequate assistance devices to prevent residents from falling.

The ALJ's finding that a $10,000 per day CMP was reasonable is supported by substantial evidence in the record.

In FFCL 4, the ALJ found that a $10,000 per day CMP, the maximum amount permissible under the regulations for a deficiency involving immediate jeopardy, was reasonable. In support of this FFCL, the ALJ noted Coquina's contention that "CMS offered no witness or documentary evidence at the hearing in support of the $10,000.00 CMP imposed" and thus did not afford Coquina "an opportunity to inquire into the basis for the CMP, or to rebut the rationale for imposing the highest CMP allowed by law." ALJ Decision at 15. The ALJ stated, however, that CMS need not "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." Id. at 15. The ALJ continued:

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, [DAB No. 1800 (2001)] 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).

Id.

The ALJ also quoted Community Nursing Home, DAB No. 1807 (2002), as setting forth "the proper application of the regulation in determining the reasonableness of the CMP," as follows:

[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.

ALJ Decision at 16, quoting Community Nursing Home at 22.

On appeal, Coquina argued that the ALJ had "abdicat[ed] his responsibility to review the amount of the CMP," asserting specifically that "the ALJ did not take into account at all Coquina's efforts to protect its residents during the days following the accident . . . ." Coquina Br. at 45-46. According to Coquina, its case is "strikingly similar" to CarePlex, DAB No.1683, where the Board sustained the ALJ's decision to reduce the CMP to the lowest amount permitted by regulation ($50 per day) because "even before the survey at issue occurred, the provider had begun to respond appropriately to circumstances that the [state survey agency] later cited as a deficiency." Coquina Br. at 46 (emphasis in original).

We conclude that the ALJ did not err in not considering whether the CMP should have been reduced based on corrective actions taken by Coquina following Resident 1's death. As discussed above, the deficiency continued until April 22. CMS determined that the immediate jeopardy continued during this entire period, and the ALJ concluded that this determination was not clearly erroneous. We find that his conclusion is supported by substantial evidence since, as discussed above, Coquina did not provide adequate supervision to residents to prevent falls, and in-servicing to assure that all staff understood how to properly use the alarm device that Coquina began using on April 19 was not completed until April 22.

Moreover, contrary to what Coquina argued, CarePlex does not constitute precedent requiring a reduction of the CMP amount as a facility takes steps to correct a deficiency. The Board there determined that corrective actions taken by the facility were appropriately considered because they related to the facility's history of noncompliance under a prior owner by rebutting the presumption that this history remained predictive of likely future compliance. Coquina did not allege that its corrective actions were related to any of the regulatory factors which may be considered in setting the amount of a CMP.

Coquina also reiterated its argument below that CMS had offered no evidence at the hearing in support of the CMP amount. The ALJ correctly stated the law on this matter, however. In effect, there is a presumption that CMS has considered the regulatory factors in setting the amount of the CMP and that those factors support the CMP amount imposed by CMS. Unless a facility contends that a particular regulatory factor does not support that CMP amount, the ALJ must sustain it. (In Hillman, the Board specifically required CMS to make a prima facie case only with respect to any disputed fact.) If a facility does make such a contention, however, CMS then has a responsibility to produce evidence as to that factor. The ALJ must then "make an independent determination of whether the amount set by HCFA is reasonable based on the evidence as fully developed in the hearing." Emerald Oaks at 13, quoting CarePlex at 17-18.

In this case, however, Coquina did not contend before the ALJ (or even on appeal) that any particular regulatory factor did not support the CMP amount. Thus, the ALJ did not err in finding that the $10,000 per day CMP imposed by CMS was reasonable even though CMS never produced any evidence specifically addressing the regulatory factors. ⁽²²⁾

Conclusion

For the reasons discussed above, we sustain the ALJ Decision. In doing so, we affirm and adopt all the FFCLs made by the ALJ, with the exception of FFCL 2. As explained in footnote 3 of this decision, we modify this FFCL to read as follows:

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 chair.

Judith A. Ballard

Donald F. Garrett

Cecilia Sparks Ford
Presiding Board Member

1. CMS was previously named the Health Care Financing Administration (HCFA). See 66 Fed. Reg. 35,437 (July 5, 2001). We use "CMS" in this decision unless we are quoting from documents that refer to HCFA.

2. Coquina asserted that the period for which this CMP was imposed was unclear from the ALJ Decision. Both Findings of Fact and Conclusions of Law (FFCLs) 1 and 3 specify that the period was "from April 14 through April 21." ALJ Decision at 5, 11. There are also two other references in the ALJ Decision to this period. Id. at 2, 16. The reference on page 1 of the ALJ Decision to a CMP "from April 13, 1999 through April 21, 1999" appears to be inadvertent. The total amount of the CMP for the eight-day period is $80,000. (Although CMS advised Coquina that it had determined that Coquina was in substantial compliance as of April 22 (CMS Exhibit 34), CMS apparently never issued a letter specifying the total amount of the CMP.)

3. Citations are to the 2000 edition of the Code of Federal Regulations (C.F.R.).

4. Although the application to long-term care facilities of the rule in Hillman regarding burden of proof has been challenged in an appeal of Fairfax Nursing Home, Inc., DAB No. 1798 (2001) (see Fairfax Nursing Home v. HHS, U.S., No. 02-767, petition filed 11/13/02), we continue to believe that this application was proper. In any event, Coquina did not raise the applicability of Hillman as an issue on appeal. Moreover, this issue does not affect the outcome in this case since the rule in Hillman applies only when the evidence is in equipoise, a situation which is not present here.

5. Coquina pointed out that, although FFCL 2 refers to a wheelchair, the evidence of record shows that Resident 1 slid off of an arm chair rather than a wheelchair during the incident on April 13. Coquina Br. at 8, n.6, citing Tr. 219-220, 256-257. In fact, all other references in the ALJ Decision are to a chair rather than to a wheelchair. Moreover, CMS did not dispute that a chair rather than a wheelchair was involved in this incident. Accordingly, we modify FFCL 2 by substituting the word "chair" for "wheelchair."

6. Coquina pointed out on appeal that Surveyor Smith admitted at the hearing that she had no knowledge of what occurred other than what was reported in the SOD. Coquina Reply Br. at 3, citing Tr. at 86-92. Coquina did not point to any evidence that the charge nurse did not state what was reported in the SOD, however, or produce the charge nurse as a witness.

7. The SOD stated that Coquina had no "instructions, policy or procedure" for use of the Quorum alarm device. CMS Ex. 2, at 2. Although Surveyor Smith's testimony referred to the lack of "policies and procedures" (Tr. at 29), the ALJ properly understood it to be the equivalent of "instructions." See ALJ Decision at 8.

8. Coquina noted that the ALJ Decision characterizes the Quorum alarm device as "inexpensive." Coquina stated that this appeared to be based solely on CMS's erroneous assertion that the alarm device was purchased at Radio Shack. The ALJ might have been relying instead on an internal survey agency report which stated that "[a]ccording to the Director of Nurses (DON) these alarm devices were purchased because they cost considerably less than the medically approved alarms normally used for nursing home resident safety." CMS Ex. 1, at 4. In any event, it is unclear that the ALJ relied on the cost of the Quorum alarm device as a basis for his decision. Indeed, Coquina itself stated that the reference in the ALJ Decision to the cost of the device was "gratuitous commentary." Coquina Br. at 30.

9. Coquina also argued that the reliance on Surveyor Smith's testimony was "troubling" because she "ultimately conceded that she did not know 'if this is a proper device or not.'" Coquina Reply Br. at 7, quoting Tr. at 75. Surveyor Smith was responding to counsel's question whether "there is no way to properly use this device" or "the facility could have used this device properly but didn't." Tr. at 75. Thus, Surveyor Smith was not conceding that Coquina's use of the Quorum alarm device was appropriate.

10. Coquina also noted that Nurse Robbins, the Vice President of Clinical Services for its parent company, who also qualified as an expert, had expressed a similar opinion. Coquina Br. at 37. However, Nurse Robbins stated that her opinion that the Quorum body alarm "was appropriate" was based on the company's historical experience with "this body alarm throughout the Florida and North Carolina region . . . ." Tr. at 218. As noted below, however, the alarm device used was not necessarily the Quorum alarm device.

11. The ALJ could reasonably discount the testimony of these witnesses not only because it was vague or too general, but also because, for the most part, it was not based on personal, contemporaneous observation. Also, the mere fact that Nurse Robbins and Nurse Sodergren qualified as experts does not mean that their testimony is entitled to more weight than that of experienced surveyors.

12. Coquina asserted that both Nurse Robbins and Nurse Sodergren testified that, based on a reconstruction of the accident, they had concluded that the Quorum alarm device "had been properly clipped to the shoulder area of the Resident's gown, and affixed to his chair behind his shoulders or head at the time of the accident." Coquina Br. at 37, citing Tr. at 209-212, 218-219, 256-257. We see nothing in Nurse Sodergren's testimony that can be read as characterizing the alarm device as properly clipped to Resident 1's gown or affixed to his chair. Nurse Robbins stated merely that "as best we could tell, the device was applied properly" (Tr. at 219). Moreover, this testimony was contradicted by the contemporaneous statement of the Director of Nursing, reported in CMS's internal review report, that the alarm device used on Resident 1 was "an inappropriate alarm and it was wrongly applied." CMS Ex. 1, at 5.

13. The question of whether observation every two hours was adequate is also raised in connection with the ALJ's finding, discussed later in this decision, that noncompliance continued at the immediate jeopardy level through April 21, 1999.

14. This finding necessarily encompasses FFCL 1.

15. Moreover, we agree with the ALJ that, "[a]lthough 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." ALJ Decision at 12. The applicable regulations permit CMS to impose a CMP for "the number of days a facility is not in substantial compliance with one or more participation requirements . . . ." 42 C.F.R. § 488.430(a). Thus, as the Board observed in Barn Hill, although CMS might have imposed a CMP beginning on the date of the incident based on which CMS found that the facility was noncompliant, the imposition of the CMP beginning on the date of the survey (which was equally permissible) does not mean that CMS regarded the noncompliance as beginning on the later date. Barn Hill at 13, n.13.

16. Coquina nowhere established that it modified the plan of care for each resident previously requiring an alarm device to provide for supervision alone for the eight-day period in question.

17. Moreover, the fact that as of April 14, 1999, no alarm devices were in place for residents who, like Resident 1, had been assessed as needing a combination of such devices and supervision to prevent falls could itself be viewed as continuing noncompliance with section 483.25(h)(2).

18. Nurse Robbins testified that these alarm devices were not used at all. Tr. at 244.

19. Section 488.301 states that an "extended survey" is a "survey that evaluates additional participation requirements subsequent to finding substandard quality of care during a standard survey."

20. Coquina stated in its briefing that the measures it took "to assure the safety of its residents at risk for falls during the few days it took to obtain and install a new alarm system" included "close supervision in a day room during the day, and frequent checks at night." Coquina Reply Br. at 10-11.

21. Nurse Sodergren also stated that observation every two hours is the typical standard of nursing practice. Tr. at 251. She did not specify that this is the standard for residents at risk for falls when they are in chairs, however.

22. In any event, while he was not required to do so, the ALJ did find that the $10,000 per day CMP was reasonable based on the seriousness of the deficiency. See ALJ Decision at 16.