Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Fresh River Healthcare,
Centers for Medicare & Medicaid Services.
Docket No. C-19-31
Decision No. CR5352
June 19, 2019
I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a per-instance civil money penalty of $10,000 against Petitioner, Fresh River Healthcare, a skilled nursing facility.
The parties agreed that I could decide this case without an in-person hearing. CMS filed 17 proposed exhibits that it identified as CMS Ex. 1-CMS Ex. 17. Petitioner filed five proposed exhibits that it identified as P. Ex. 1-P. Ex. 5. CMS filed a pre-hearing brief (CMS’s brief) and a reply brief (CMS’s reply brief). Petitioner filed a brief (Petitioner’s brief) and a sur-reply brief (Petitioner’s sur-reply brief).
I receive the parties’ exhibits into evidence.
II. Issues, Findings of Fact and Conclusions of Law
The issues are whether Petitioner failed to comply substantially with a Medicare participation requirement and whether a per-instance civil money penalty of $10,000 is a reasonable remedy.
B. Findings of Fact and Conclusions of Law
CMS alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(d)(1), and (2). This regulation requires a skilled nursing facility to ensure that it provides its residents with an environment that is as free of accident hazards as is possible and that it provide its residents with adequate supervision and assistance devices to protect them against sustaining accidents.
This regulation, and its predecessor, have been interpreted on countless occasions to require a skilled nursing facility to protect its residents against all reasonably foreseeable accidents. Although the regulation does not impose a strict liability standard on a skilled nursing facility, it does require the facility to assess each of its residents for the risk of sustaining accidents, to plan that resident’s care accordingly, and to implement that plan of care so that each resident receives adequate protection against the possibility of sustaining accidents consistent with that resident’s physical and mental condition and his or her unique needs. In doing so, a facility must take into consideration and account for any potential hazards that might exist on its premises and it must make all reasonable efforts to protect each resident. Circumstances that might not be hazardous for individuals who are unimpaired may be fraught with danger for individuals with certain physical and/or mental conditions and a facility must recognize and address those circumstances for each of its residents.
This case involves a mentally ill resident (Resident 2) who obtained access to, and ingested, hand sanitizer, a commercial product containing ethanol, a potentially lethal substance when consumed in sufficient quantity. The resident sustained acute alcohol poisoning and had to be hospitalized for treatment. CMS argues that it was foreseeable that the resident might consume hand sanitizer if she obtained access to it. It asserts that Petitioner failed to protect Resident 2 and other residents against the hazards presented by that substance, failed to plan the resident’s care to account for the possibility that she might injure herself if she came into possession of a hazardous substance, and failed adequately to supervise Resident 2.
Petitioner counters CMS’s assertions by contending that the resident’s obtaining and consuming hand sanitizer was unforeseeable. It argues that nothing in Resident 2’s
background or in the most current assessments of her condition suggested that she would consume a hazardous substance such as hand sanitizer. It contends that the source of the hand sanitizer that the resident consumed is unknown. Finally, it contends that it adequately planned Resident 2’s care and protected the resident against all foreseeable accidents.
The facts of this case – which are largely undisputed – strongly support CMS’s contentions. I find that Petitioner failed to comply with its responsibility to protect Resident 2 in allowing her to obtain and consume hand sanitizer. Petitioner’s failure was both a failure to plan for the possibility that the resident might obtain and consume a hazardous substance, such as hand sanitizer, and a failure to supervise the resident adequately. These failures are substantial noncompliance with 42 C.F.R § 483.25(d)(1) and (2). The seriousness of Petitioner’s noncompliance and its culpability for that noncompliance merits a civil money penalty of $10,000.
Resident 2 had a long history of mental illness predating her admission to Petitioner’s facility on April 26, 2017. Her diagnoses included schizoaffective disorder. CMS Ex. 4 at 1-2. She had a history of self-injurious behavior. Petitioner’s amended request for hearing at 5. Upon her admission to Petitioner’s facility, Resident 2 was housed in a secured unit. CMS Ex. 5 at 1. The form authorizing that placement describes a secured unit as a residence that is:
designed for the safety and security of some residents who, because of a medical or psychiatric condition or cognitive impairment, require a secured setting to ensure their safety.
P. Ex. 3.
Petitioner’s staff assessed the resident and determined that she manifested signs of mental illness that included auditory hallucinations. CMS Ex. 5 at 3. On December 27, 2017, staff evaluated the resident’s mental state and concluded that the resident had schizophrenia and was at risk for her condition worsening. CMS Ex. 6 at 9.
The resident’s behavior while she lived in Petitioner’s facility clearly was irrational and at times, bizarre. She at times refused treatment. CMS Ex. 5 at 13. She wore the call light cord in her room and other cords as jewelry. Id. She would wear multiple layers of clothing. Resident 2 regularly paced the corridor of her unit and went into and out of other residents’ rooms. CMS Ex. 13 at 3.
Occasionally, Resident 2 engaged in destructive behavior. Petitioner’s staff believed that, on December 25, 2017, the resident tampered with a sprinkler head in her room, causing it to activate and resulting in a flood. CMS Ex. 5 at 15.
On multiple occasions, the staff noted that the resident’s behavior included hoarding items. The resident had a tendency to appropriate items from Petitioner’s facility and to cache them in her room. On December 30, 2017, for example, Petitioner’s staff discovered that Resident 2 had brought Christmas decorations into her room. CMS Ex. 7 at 3. On January 8, 2018, staff searched the resident’s room and discovered cached items that included cups, plastic spoons, napkins, towels, and blankets. CMS Ex. 8 at 1. When staff removed these objects, the resident became very agitated and threw a plate across her room. CMS Ex. 7 at 1. After this incident, Petitioner’s staff again assessed the resident’s condition and concluded that she had abnormal thought processes, associations, judgment, and insight. Once again, the assessment indicated that the resident manifested auditory hallucinations. CMS Ex. 6 at 7.
The staff assessed the resident again on January 15, 2018. CMS Ex. 6 at 6. Staff determined that the resident was severely disabled by her mental illness and that continued placement in a secured unit remained appropriate. The resident was assessed again in February 2018 with essentially identical findings.
Petitioner’s staff implemented interventions to deal with Resident 2’s behavior. The staff decided to randomly search the resident’s room for hoarded items. CMS Ex. 8 at 1. The staff updated the resident’s care plan with an instruction that the resident be observed for changes in her behavior. CMS Ex. 5 at 15. In response to the December 30, 2017 discovery that the resident had hoarded Christmas decorations, the staff checked on the resident at 15-minute intervals. CMS Ex. 7 at 3. However, staff ended these checks on January 3, 2018, because the staff determined that the resident was not manifesting significant behavioral problems as of that date.
However, even if the resident’s problems had abated somewhat, the potential remained for her to regress. On February 2, 2018, a physician assessed the resident’s mental status. Although the physician found the resident to be calm and friendly on that date, he also noted that the resident had delusions, was confused, and had been observed taking items into her room and hiding them. CMS Ex. 6 at 4.
The staff continued to assess Resident 2 as stable and doing relatively well. However, on the morning of February 14, 2018, the staff observed the resident lying on the floor, nonresponsive, with vomit in her hair, and exhibiting distressed breathing. CMS Ex. 11 at 1. Immediately after the staff discovered the resident, a nursing assistant reported that she had observed an empty bottle of hand sanitizer under the resident’s bed. Id. at 3. The nursing assistant reported that she threw the bottle away after emergency service technicians arrived at Petitioner’s facility to attend to Resident 2. Id.
The emergency service technicians transported the resident to a local hospital. At the hospital, the resident said that she had ingested hand sanitizer. CMS Ex. 12 at 2. The attending hospital staff found that the resident had an elevated blood alcohol level. The
hospital staff diagnosed the resident to be suffering from respiratory failure, severe sepsis, and acute encephalopathy, attributable to ingesting hand sanitizer. Id. The hospital treated and, eventually, released the resident after she recovered.
These facts plainly evidence a failure by Petitioner and its staff to fulfill their obligations to protect Resident 2. They depict Resident 2 as an individual with bizarre thought patterns whose actions often were highly irrational and potentially dangerous. Petitioner’s staff should have been acutely aware of the risk of self-injury posed by Resident 2’s behavior and should have been vigilant to assure that the resident did not injure herself. Despite staff’s knowledge of the resident’s proclivities, Petitioner did not provide the resident with sufficient supervision and protection to prevent the resident from ingesting hand sanitizer.
I find that the risk that the resident might ingest a dangerous substance was entirely foreseeable given her frequently bizarre behavior. Indeed, Petitioner describes Resident 2 as having a history of self-injurious behavior including a possible suicide attempt in the past by ingesting bleach. Petitioner’s hearing request at 2. That history, and more importantly, the bizarre behaviors manifested by the resident right up until the day that she ingested hand sanitizer, constituted ample warning to Petitioner and its staff that the resident was capable of harming herself. Petitioner’s staff should have been extremely vigilant in assuring that potentially dangerous items, such as hand sanitizer, were out of Resident 2’s reach. The staff failed to provide such protection.
I find that the source of the hand sanitizer was an unattended medication cart. Nurses using the cart employed hand sanitizer to clean their hands after treating residents and/or administering medication. Petitioner’s secured unit did not contain bottles of hand sanitizer as a matter of routine. CMS Ex. 13 at 6-9. Nurses passing medication either carried hand sanitizer in their pockets or placed it on the medication cart that would be brought into the secured unit when the staff administered medications. Id. Nurses kept hand sanitizer on the medication cart and would leave the cart by the nursing station in the secured facility while they attended to residents. Id. at 3.
An unattended medication cart with hand sanitizer presented an obvious risk in light of Resident 2’s proclivities for wandering the corridor in her unit and for appropriating and caching items. Petitioner’s staff should have been aware of that risk and should have taken the necessary precautions to avoid it.
Petitioner, noting that the nurse on duty on February 14, 2018, denied putting hand sanitizer on the cart, argues that the medication cart could not possibly have been the source of the hand sanitizer appropriated and consumed by Resident 2. Petitioner’s brief at 10; CMS Ex. 13 at 7. However, assuming that the nurse’s recollection is correct, that does not gainsay the possibility that the resident may have appropriated hand sanitizer on a date prior to February 14.
Furthermore, Petitioner should have protected Resident 2 from appropriating and consuming hand sanitizer even if the medication cart was not the source of the sanitizer that the resident obtained. A primary purpose of a secured unit is to be able to monitor the flow of traffic, including potentially injurious items, into the unit. Given that hand sanitizer is not routinely kept in Petitioner’s secured unit, the sanitizer appropriated and consumed by Resident 2 must have come from somewhere outside the unit, either on the medication cart or by some other unknown source. Petitioner’s duty to protect the resident included protecting the resident from potentially dangerous items like hand sanitizer without regard to the source of those items.
In the final analysis, the source of the hand sanitizer appropriated and consumed by Resident 2 is irrelevant. What matters is that it should not have been within the resident’s reach, however it made its way into the secured unit.
How could Petitioner’s staff have provided Resident 2 with more effective protection than it provided to her? The resident’s obvious propensity for hoarding items coupled with her tendency to pace and to enter off-limits areas such as other residents’ rooms, meant that the staff should have observed her far more closely than it did. Furthermore, it should have searched the resident’s room for contraband more than randomly. The resident’s consumption of hand sanitizer might well have been prevented had the staff been more diligent in observing her and in searching for contraband.
Also, the staff should have realized that leaving an item such as a bottle of hand sanitizer on an unattended medication cart – even one left at the nurse’s station – created an obvious hazard. The incident of February 14 would not have occurred had Petitioner’s staff followed simple precautions of never leaving the medication cart unattended or never leaving hand sanitizer unsecured.
As I have stated, the standard for compliance under 42 C.F.R. § 483.25(d)(1) and (2) is not one of strict liability. A facility is not liable for unforeseeable accidents. But, here, the resident’s appropriation and consumption of hand sanitizer were entirely foreseeable. The resident’s bizarre behaviors, her tendency to pace and to enter off-limits areas, her habit of misappropriating and caching contraband items, and her history of self‑destructive behavior, all comprised a stark warning to staff that this resident needed to be watched closely and that potentially hazardous items needed to be kept out of her reach. Furthermore, and as I have discussed, simple measures could have protected the resident.
Petitioner asserts that its staff had no reason to believe that Resident 2 might misappropriate and consume hand sanitizer, because Petitioner had never done so in the past and because staff had never seen the resident near the medication cart. Petitioner’s brief at 13. Assuming that to be so, that provided no basis for the staff to assume that the
resident would not misappropriate and consume hand sanitizer. The long list of Resident 2’s bizarre behaviors – especially including the resident’s proclivities for pacing the unit and misappropriating items – gave Petitioner’s staff ample warning not to leave unattended anything that might be hazardous.
Indeed, Petitioner’s current policy recognizes the risks of hand sanitizer to any resident suffering from cognitive impairments. That policy not only prohibits dispensers of hand sanitizer from being placed in the secured unit, it instructs nurses either to carry it in their pockets or to place it on a medication cart only while the cart is attended by a nurse. CMS Ex. 13 at 9.
Petitioner argues that it instituted its hand sanitizer policy only after the incident involving Resident 2 and that this policy, therefore, says nothing about the risks that Petitioner should have recognized prior to the occurrence of that incident. Petitioner’s sur-reply at 3‑4. I disagree. The policy reflects a sensible assessment of the risks attendant to the use of hand sanitizer in the secured unit. The mandates in that policy would have been as reasonable prior to February 14, 2018, as they are now. The failure by Petitioner to have this policy or something very similar in effect prior to February 14 evidences its failure to recognize and to address an obvious hazard.
Petitioner places great weight on a decision by another administrative law judge, which it asserts is very similar to the instant case. Berea Health Care Ctr., DAB CR1137 (2004). In that case, an administrative law judge held that a skilled nursing facility was not liable for leaving cleaning products unattended. Administrative law judge decisions are not binding precedent and I am under no obligation to follow the decision in Berea. I choose not to follow it even assuming that it might address facts that are similar to those that I find here. Furthermore, Berea is distinguishable because, in that case, CMS sought to impose per-diem penalties for a period of noncompliance. The administrative law judge in Berea found that the skilled nursing facility had rectified its noncompliance prior to the inception date of the proposed penalties. That is not the case here, where CMS advocates for a per-instance penalty.
Petitioner argues that CMS effectively demands that its staff never use hand sanitizer. It contends that CMS fails to see that the benefits of a compound such as hand sanitizer – averting the spread of pathogens – outweigh the risks resulting from bringing hand sanitizer into a secured unit. Petitioner’s brief at 16.
This argument is a red herring. CMS does not demand that Petitioner’s staff cease using hand sanitizer. Its case is based on the staff’s use of hand sanitizer without taking reasonable precautions to protect its residents.
I find reasonable the $10,000 per-instance civil money penalty that CMS determined to impose. The seriousness of Petitioner’s noncompliance and its culpability are ample justification for that penalty amount.
Permissible per-instance civil money penalties fall within a range of from $2,097 to $20,965. 42 C.F.R. § 488.438(a)(2), 45 C.F.R. § 102. The penalty that CMS determined to impose thus is roughly at the midpoint of the permissible per-instance penalty range.
In deciding whether a penalty amount is reasonable I may consider factors including the seriousness of a facility’s noncompliance and its culpability. 42 C.F.R. §§ 488.438(f)(1)‑(4); 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)). In this case, I find Petitioner’s noncompliance to be quite serious. Its failure to protect Resident 2 caused the resident to suffer actual harm from her ingestion of hand sanitizer, a physical reaction so severe that the resident needed hospital care to treat it. Moreover, Petitioner manifests considerable culpability for its noncompliance. As I have explained, Resident 2’s bizarre behaviors, coupled with Petitioner’s staff’s recognition that the resident continued to suffer from severe mental illness, put the staff on notice that the resident was at great risk for self-injury. Despite that, the staff failed to implement simple measures that might have protected the resident.
Steven T. KesselAdministrative Law Judge