SUBJECT:

Berea Health Care Center,

Petitioner,

The Inspector General

I reverse the Center for Medicare and Medicaid Services's (CMS's) ⁽¹⁾ initial determination that Berea Health Care Center (Petitioner or Facility) failed to substantially comply with conditions of participation in the Medicare and Medicaid programs. CMS presented evidence that Petitioner did not, prima facie, substantially comply with F-323 (the requirement that the resident environment remain as free of accident hazards as possible). 42 C.F.R. § 483.25(h)(1). And, correspondingly, based on the same facts, CMS's evidence supports the conclusion that Petitioner failed, prima facie, to comply with F-490 (the requirement to administer the Facility adequately to maintain an environment as free of accident hazards as possible). 42 C.F.R. § 483.75. I conclude, however, that Petitioner has demonstrated, by a preponderance of the evidence, that the Facility substantially complied with these two requirements. CMS made additional determinations which Petitioner did not submit for my decision.

I. Background

This case came before me pursuant to a request for hearing Petitioner filed on May 11, 2001.

By letter dated March 14, 2001, CMS notified Petitioner that it was imposing several remedies pursuant to a survey conducted between February 12 and February 14, 2001, by the Kentucky Cabinet for Health Services (the Kentucky State survey agency). The remedy at issue in this case is a civil money penalty in the amount of $3,050 per day, for one day: February 12, 2001.

I scheduled a hearing to be held on April 8, 2003 in Lexington, Kentucky. On April 4, 2003, the parties, through counsel for Petitioner, moved to dispense with the hearing and agreed to a resolution of the issues present in this case based on documentary evidence and written briefs. By Order dated April 18, 2003, I approved the parties' proposed briefing schedule. ⁽²⁾ The parties filed stipulations of fact on April 30, 2003. ⁽³⁾ CMS filed a brief on May 19, 2003. Petitioner filed its response on June 18, 2003. The parties did not file reply briefs.

In anticipation of the hearing CMS filed 32 proposed exhibits (CMS Exs.), and Petitioner filed 17 proposed exhibits (P. Exs.). On May 1, 2002, I received CMS's objections to Petitioner's proposed exhibits 1, 2 and 12. Subsequently, I discussed these objections with the parties in a prehearing telephone conference. Because the parties' postures at the time of the prehearing conference were that the case would proceed to hearing, I reserved ruling on CMS's objections. The parties' joint stipulations of fact indicate that they stipulate to the admissibility of all the exhibits except for the three CMS objected to. CMS asserted in its written objection that the three exhibits, which are photographs, should be excluded because Petitioner has not provided sufficient foundation to authenticate them. I note that neither party addresses the exhibits in their briefs, either in reference to CMS's objections or to support a substantive point. Accordingly, I sustain CMS's objections to Petitioner's proposed exhibits 1, 2 and 12. CMS Exs. 1-32 and P. Exs. 3-11 and 13-17 are admitted as stipulated.

The basic facts giving rise to the matters at issue here are contained in the stipulations of fact agreed upon by the parties. To summarize, on January 17, 2001 Resident 4 was observed next to a housekeeping cart with an open bowl of Triad liquid cleaner in her hands. She appeared to be licking her lips, and thus, it was assumed that she had ingested some of the solution from the bowl that had been placed on top of the cart by a housekeeping employee. In response to that incident, the Facility conducted training of its housekeeping staff, and directed that open Triad liquid containers be placed in the lower compartment of the cleaning cart. No measures were taken concerning other cleaning materials that were carried on top of the cart.

During a standard survey conducted during the period February 12-14, 2001, by the Kentucky State survey agency, the surveyors raised their concerns that cleaning solutions presented a hazard to residents when kept on top of the housekeeping carts, or otherwise accessible to residents when the carts were parked in the hallway during housekeeping rounds.

CMS contends that based on observation, medical record review, and interview, the Facility failed to ensure that hazardous chemicals were kept out of reach of cognitively impaired residents. CMS claims that cleaning solvents and other chemicals were left unattended and accessible to residents. CMS adds that Petitioner's failure to maintain a resident environment as free of accident hazards as possible, amounts to immediate jeopardy inasmuch as the charged deficiency was likely to cause serious injury, harm, impairment, or death. CMS's brief at 2, 4.

Petitioner contends that it has complied with the requirement to maintain an environment as free as possible of accident hazards. Compliance with this requirement, suggests Petitioner, has to be tempered by the need to maintain and clean the Facility, including residents' rooms, in order to secure a healthy environment. Petitioner adds that although it is true that a resident did gain access to a cleaning solution (Triad) prior to the survey that gave rise to this action, the Facility took immediate steps to correct the exposure to hazards by requiring that open solutions be placed in a compartment on the housekeeping cart. Thus, concludes Petitioner, there is no evidence that any resident would be able to access the open container of the Triad cleaning solution inside the compartment, whether that compartment was locked or not. Petitioner's brief at 7,8.

II. Applicable Law and Regulations

Petitioner is a long-term care facility under the Social Security Act (Act) and regulations promulgated by the Secretary of Health and Human Services (Secretary). The statutory and regulatory 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 remedies including civil money penalties 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 the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. The applicable regulations at 42 C.F.R. Part 488 provide 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, and 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 Act and regulations make a hearing available before an administrative law judge to a long-term facility against whom CMS has determined to impose a civil money penalty. But the scope of such hearings is limited to whether an initial determination made by CMS is correct. Act, section 1128A(c)(2); 42 C.F.R. §§ 488.408(g), 498.3(b)(12) and (13). The hearing before an administrative law judge is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd 941 F2d. 678 (8^th Cir. 1991).

III. Issues and Discussion

A. Issue

Whether the Facility was complying substantially with federal participation requirements on the dates CMS determined to impose a civil money penalty.

B. Discussion

I decide that the Facility was in substantial compliance with F-323 and F-490 because the preponderance of the evidence is that hazardous chemicals were not unreasonably accessible to residents. The regulation requires that the Facility maintain an environment that is as free of accidents hazards as possible. As Petitioner argued in its brief the Departmental Appeals Board (Board) has addressed the level of a facility's responsibility under this standard. The Board has explained that the duty to ensure against accident hazards does not impose strict liability on a facility- there is an element of reasonableness in the requirement- yet a facility must do everything in its power to remove accident hazards. See Koester Pavilion, DAB No. 1750 (2000); and Wooodstock Care Center, DAB No. 1726 (2000). Applying the Board's interpretation of the standard to the facts in this case, I conclude that Petitioner did everything reasonably within its power to prevent access to hazardous cleaning solutions consistent with its duty to keep the Facility clean. By so concluding, I do not mean to say that no other possible options were available to Petitioner. But, rather, that the chosen course of action to eliminate that type of hazard here under consideration satisfied the standard of reasonableness required by the regulations.

The evidence presented by CMS, however, if un-refuted, does support a finding that cognitively impaired residents were exposed to unnecessary accident hazards. It is undisputed that Resident 4 was cognitively impaired and that, on an occasion prior to the survey, she possibly drank from a bowl with Triad cleaning solution that she found sitting on top of a housekeeping cart. ALJ Ex. 1. And, it is undisputed also that there were other cognitively impaired residents at the Facility. P. Ex. 16, at 33. The alleged hazard to these residents was observed by Bob Durham, consultant pharmacist on the inspection team and surveyor, Phyllis Monhollen. Mr. Durham testified ⁽⁴⁾ that he observed two housekeeping carts parked in the hallway outside of two different resident rooms. Mr. Durham testified that he observed the carts for approximately three minutes during which time the housekeepers were inside the residents' rooms. Mr. Durham observed also that there were spray bottles and other bottles on top of the carts, small buckets of cleaning solution inside compartments in the carts, and, Mr. Durham testified, that he saw "crooked-necked" bottles on each cart that appeared to be toilet cleaner. Mr. Durham testified that one of the crooked-neck bottles did not have a safety cap on it. P. Ex. 16, at 5-9. Mr. Durham testified also that the crook-necked bottle that did have a safety cap had a white safety cap. P. Ex. 16, at 12. In addition, CMS alleges, based on Mr. Durham's testimony, that one of the compartments on the housekeeping carts was partially open, and that the compartments on both carts were unlocked. CMS Ex. 3, at 20-21. After observing the carts in the hallway, Mr. Durham sought Ms. Monhollen and both of them went to view the carts together.

The carts had been returned to a locked storage room and that is where Mr. Durham and Ms. Monhollen made an inventory of the solutions on top of the carts. The chemicals allegedly on top of the carts included Crew Shower Tub and Tile Cleaner, Cleaner Degreaser, Glass Cleaner, End Bac II Disinfectant, Johnson Multi Furniture Cleaner, Triad Disinfectant, Chlorine Cleanser, Johnson Shine Up Furniture Polish, and Sno Bol Toilet Bowl cleaner.

CMS asserts that a review of the Material Safety Data Sheets reveals that the Chlorine Cleanser ⁽⁵⁾ observed on top of one cart contained a carcinogen, and the Crew Cleanser is classified as a corrosive that could be harmful if swallowed, while Sno-Bol Toilet Bowl Cleaner could cause grievous harm, including death, if swallowed. CMS Ex. 3, at 21-22. CMS adds that Triad cleaning solution is a germicidal cleaner that is corrosive and harmful if swallowed. CMS Ex. 3, at 21. At page 2 of its brief CMS mentions an additional carcinogen containing cleanser (Triple 3) that is not included in the statement of deficiencies. CMS Ex. 3, at 20-21.

If these allegations stood un-refuted they would support a determination that the Facility was not substantially compliant with F-323 or its corollary F-490. If hazardous chemicals were left where they could be easily accessed by cognitively impaired residents, that would present an accident hazard within the Facility's power to prevent. If the bottles with spray tops and other tops contained hazardous substances that could be sprayed or consumed by cognitively impaired residents that would seem also to be an avoidable accident hazard. And, if buckets containing hazardous solutions were left where they were easily accessible to cognitively impaired residents, that would appear to be a similarly avoidable accident hazard. Perhaps most troubling would be if a bottle of Sno Bol cleaner were left open on top of a cart because it is undisputed that the chemicals in Sno Bol can cause extremely serious harm or death. The weight of the evidence, however, supports the finding that these substances were not easily accessible, and the evidence supports the conclusion that the Facility took all the reasonable steps in its power to remove the accident hazards presented by the cleaning solutions.

Based on the January 17, 2001 incident when Resident 4 picked up a bowl with Triad cleaning solution in it, the Facility took measures to address open containers that could be picked up and drunk by cognitively impaired residents. The Facility conducted training of the housekeeping staff, and a decision was made to keep the Triad solution inside a compartment of the cart. Petitioner asserts that after the incident with Resident 4, open containers of Triad disinfectant were always placed in a lower compartment of the cart. It did not seem to the Facility staff that it was necessary to lock the compartment every time a portion of the solution was obtained from the open bowl during cleaning. P. Ex. 16, at 52. Petitioner introduced evidence from the State hearing that the Facility did not have a policy of locking the compartment on the cart where the Triad solution buckets were kept. Petitioner introduced evidence, also from the testimony at the State hearing, that the purpose of moving the buckets to the compartment was to keep them out of Resident 4's sight. This measure, even if the door to the compartment was partly open, would be sufficient to safeguard Resident 4 from accessing the buckets, because it placed the bucket inside the cart and outside of Resident 4's line of sight, thus removing the hazard that Resident 4 would be tempted to drink from the buckets. P. Ex. 16, at 65. This evidence contradicts CMS's assertion that the Facility failed to adhere to its own safety guidelines by not keeping the lower compartment of the housekeeping carts locked. CMS Brief. at 3-4. I conclude that by putting the buckets inside compartments with closing doors, the Facility took an effective and reasonable measure to remove an accident hazard. I conclude also that the possibility that some other cognitively impaired resident might rummage through the housekeeping cart and discover a bucket within the closed compartment is too speculative an eventuality to require the Facility to anticipate. ⁽⁶⁾ I reach this last conclusion based on the lack of any evidence introduced by CMS that there were cognitively impaired residents who could or were likely to investigate the lower compartments of the carts, and the Facility's need to consider also the efficient conduct of housekeeping operations. Inherent in the element of reasonableness for measuring the degree of compliance is the Facility's obligation to balance the accident hazard presented by exposure to cleaning chemicals with meeting its other responsibilities, i.e., keeping the Facility clean. In judging how to balance these obligations it was appropriate that the Facility consider the nature of the hazard posed by the cleaning solutions. It would not, for instance, be a reasonable decision to leave a potentially fatal cleaning solution in the closed compartment. But, Petitioner has demonstrated that it considered the nature of the hazard, while CMS appears to have made assumptions about the strength of the cleaners that the evidence does not support.

Petitioner disputes CMS's claim that exposure to the contents of several of the bottles that remained on top of the cart presented a hazard risk. For example, based on the Material Safety Data Sheets for these products, although the Triad disinfectant and the Crew Shower Room Cleaner may be harmful at full strength, they constitute only a slight health hazard when used in diluted fashion as was the Facility practice. P. Ex. 16, at 50, 68. Petitioner is correct in its assertion that CMS did not consider that the Triad solution and Crew Shower Room Cleaner were diluted products, and, thus, not the high risk hazards CMS assumed them to be. In one instance, a chemical claimed to be hazardous by CMS in its brief, was not even noted by the surveyors in the statement of deficiencies. ⁽⁷⁾ With respect to SSS Cleanser claimed to contain a human carcinogen, CMS failed to establish how that posed a danger to residents. In fact, the Material Safety Data Sheet states that, although the substance may cause respiratory tract irritation, silicosis is only possible with prolonged or repeated inhalation. Additionally, the Material Safety Data Sheet states that ingestion is not expected to cause any hazard in normal industrial use. CMS Ex. 20, at 3. Thus, the Facility's judgement to consider the slight health risk presented by the Triad solution, with the likelihood it would be discovered in its closed compartment was appropriate.

Concerning the other cleaners present on the top of the carts, Petitioner presented undisputed evidence that it had assessed whether residents could open or manipulate spray bottles, or open the other bottles and determined that they could not. P. Ex. 16, at 50-54, 61. Moreover, the spray bottles had on/off nozzles so there was an impediment to a resident spraying them. P. Ex. 16, at 40. Petitioner's point concerning the risk from these cleaners in their diluted form applies also to the bottles on the tops of the carts. The chemicals on the cart, with the exception of the Sno Bol cleaner, were diluted and so presented a low risk of harm to residents if capped or with a spray top. P. Ex. 16, at 50-51. Consequently, Petitioner argues, there was no likelihood of residents gaining access to harmful chemicals. P. Brief. at 7, 8. A State surveyor testified in the State proceedings that if children could remove safety lids from containers, cognitively impaired individuals lacking motor strength and dexterity could do likewise. P. Ex. 16, at 33. I am not persuaded that it is appropriate to compare the motor ability and mental ingenuity of children with that possessed by the feeble and cognitively impaired elderly.

The allegation that Sno Bol cleaner was left open on top of a cart presents a more troubling scenario. Unlike the other solutions, the evidence is that Sno Bol presents a serious hazard. Petitioner concedes that this product contains a dangerous chemical. Petitioner's brief at 8-9. However, the allegation that a bottle of Sno Bol was left open on one of the two carts observed by the surveyor is unreliable. As I discussed above, Mr. Durham testified that there was an open crook-necked bottle of cleaner (later identified as Sno Bol cleaner) on one of the carts. But Mr. Durham could not identify which of the two carts he saw the bottle on, he only identified it as a "crook-necked" bottle and he identified the color of the safety cap belonging to the bottles as white. Weighed against the evidence presented by the Facility, Mr. Durham's testimony is too imprecise to consider it reliable. At the State hearing Petitioner introduced the testimony of the Housekeeping Supervisor, Christine Taylor. Ms. Taylor was performing housekeeping duties using one of the two carts Mr. Durham observed at the survey. Ms. Taylor indicated that of the two carts, her's was the only one with a bottle of Sno Bol on it because the employee using the other cart was allergic to Sno Bol and had been excused from carrying it on her cart. P. Ex. 16, at 70. Ms. Taylor indicated that she always kept the safety cap on the bottle, removing it only when she removed the bottle from the cart to use it. She also testified that the safety caps on Sno Bol bottles are blue, not white. P. Ex. 16, at 70-71. Contrasted with Mr. Durham's testimony, Ms. Taylor's is specific while Mr. Durham's is vague. Mr. Durham could not say what the name of the product he observed was, he could not say which cart had the bottle that was missing its safety cap, and he was mistaken about the color of the safety cap on bottles of Sno Bol- a mistake that CMS offered no evidence to rectify. Accordingly, I find, by a preponderance of the evidence that there is no basis for finding that there was an open bottle of Sno Bol cleaner accessible to the residents.

In view of the foregoing, I conclude that CMS has failed to demonstrate that Petitioner did not take reasonable measures to remove accident hazards, and, I conclude, therefore, that Petitioner was substantially compliant with the requirements described by F-323 and its corollary F-490. All CMS has shown is that the Facility stored a diluted solution of Triad disinfectant in the lower compartment of a housekeeping cart during cleaning operations, and that other bottles of cleaners and polishes were placed on top of the carts. Petitioner presented undisputed evidence that pursuant to an assessment, the contents of those containers were inaccessible to Facility residents because, due to their lack of motor dexterity, they were unable to open them or manipulate their operating spray handles. Furthermore, Petitioner demonstrated that it assessed the risk from the different cleaning agents more accurately than CMS because Petitioner considered the risk associated with the products in the diluted form in which they were used. Moreover, in the instance of the Sno Bol cleaner which did present a hazard if accessible to residents, the weight of the evidence does not support a finding that Sno Bol was accessible to residents because the reliable evidence shows it was stored in a bottle with a safety cap.

Consequently, CMS did not establish a reasonable connection between the cleaning and maintenance items utilized by the Facility and the realistic likelihood of harm to residents. CMS's prima facie case has been overcome by Petitioner by a preponderance of the evidence.

IV. Conclusion

I conclude that Petitioner was in substantial compliance with the requirements cited by CMS under F-323 and F-490, during the period February 12 and 13, 2001. Accordingly, I reverse CMS's initial determination that Petitioner was not in substantial compliance with those requirements, and I conclude that CMS is not authorized to impose the civil money penalty in the amount of $3,050.

José A. Anglada

Administrative Law Judge

1. The Health Care Financing Administration (HCFA) was renamed the Centers for Medicaid and Medicare Services (CMS). Reference to either shall apply to both names.

2. The briefing deadlines allowed the parties to file joint stipulations by April 25, 2003. CMS was required to file a brief by May 16, 2003, and Petitioner's response was due on June 16, 2003. CMS's reply, if any, was due by July 16, 2003.

3. I have entered the parties' Stipulations into the record as ALJ Ex.1.

4. An administrative hearing was held on these issues in Kentucky on April 26, 2001. Petitioner's Exhibit 16 is a transcript of that proceeding and it contains testimony relevant to the instant case.

5. This appears to be the same cleaner referred to by CMS in its brief at page 2, n.1 as "SSS Cleaner."

6. The surveyors learned from interview that Resident 4 would wander into other resident's rooms and pick up and drink water or fluids from their over-bed tables. CMS over reaches when it concludes from this, that a danger existed that Residents 4 or other cognitively impaired residents would rummage through the compartment underneath the cleaning cart seeking fluids to drink. P. Ex. 16, at 32.

7. See CMS Ex. 3, at 20- 21; CMS's brief at 2, n.1.