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CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Appellate Division
IN THE CASE OF  


SUBJECT: Maine Veterans' Home - Scarborough,

Petitioner,

DATE: April 29, 2005

             - v -

 

Centers for Medicare & Medicaid Services

 

Docket No. A-04-110
Civil Remedies CR1157
Decision No. 1975
DECISION
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FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE D
ECISION

The Maine Veterans' Home - Scarborough (MVHS)appealed the March 22, 2004 decision of Administrative Law Judge (ALJ) Jose A. Anglada sustaining the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a civil money penalty (CMP) for failure to comply substantially with federal requirements for the participation of long-term care facilities in the Medicare and Medicaid programs. Maine Veterans' Home - Scarborough, DAB CR1157 (2004) (ALJ Decision). The Maine Department of Human Services, the State survey agency (SA), identified the deficiencies at issue in a February 3, 2003 complaint survey conducted after a resident died by asphyxia, caused by compression of his neck after becoming entrapped in a space between a quarter-length bed side rail and an air mattress. Based on the SA's findings regarding this resident and the use of air mattresses and bed rails for other residents, CMS imposed a CMP of $700 per day from February 3, 2003 through March 19, 2003.

We conclude that MVHS has shown no error of law in the ALJ Decision and that the ALJ's findings of fact are supported by substantial evidence in the record as a whole. As explained below, we modify one FFCL to better reflect the ALJ's analysis of that issue.

Applicable Law

The regulatory requirements for long-term care facilities that participate in Medicare or Medicaid are set forth at 42 C.F.R. Part 483. Compliance with the participation requirements is determined through surveys performed by state agencies under contract with CMS. Survey results are reported in a Statement of Deficiencies (SOD) that describes each failure to meet a participation requirement (deficiency) under a separate "tag" number. 42 C.F.R. § 488.325(a).

The participation requirements at issue here address (1) the quality of care provided to residents in the prevention of accident hazards (42 C.F.R. § 483.25(h)(1)), and (2) the comprehensive assessment of a resident's needs (42 C.F.R. § 483.20(b)).

Remedies may be imposed against a facility that is not in "substantial compliance" with one or more participation requirements. 42 C.F.R. § 488.408(d). A facility is not in "substantial compliance" with a participation requirement if it is found to have a deficiency that results in actual harm to a resident or poses a risk of more than minimal harm to resident health and safety. 42 C.F.R. § 488.301. "Noncompliance" is defined as "any deficiency that causes a facility to not be in substantial compliance." Id.

A CMP is one of the remedies that may be imposed against a facility that is not in substantial compliance. 42 C.F.R. § 488.408(d). A CMP in the range of $50-$3,000 per day may be imposed for one or more deficiencies that do not constitute "immediate jeopardy" but that either cause actual harm or create the potential for more than minimal harm. 42 C.F.R. § 488.438(a). The regulations provide a number of factors to be considered by CMS in determining an appropriate CMP amount within the applicable range. 42 C.F.R. § 488.438(f)(3), incorporating by reference 42 C.F.R. § 488.404.

If a facility timely appeals a finding of noncompliance resulting in a CMP, it has a right to a hearing before an ALJ. Before the ALJ, CMS must make a prima facie case that the facility was not in substantial compliance with one or more participation requirements; if CMS does so, then the facility will prevail only if it proves substantial compliance by a preponderance of the evidence. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); cf. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789(GEB), (D.N.J., May 13, 1999).

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; see, e.g., Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff'd, Fairfax Nursing Home v. Dep't of Health & Human Srvcs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003).

Record

Before the ALJ, the parties waived their right to an in-person hearing and requested a decision based on the documentary evidence and written memoranda. ALJ Decision at 2. The ALJ admitted CMS Exhibits 1 to 19 (CMS Exs.), Petitioner Exhibits 1 to 19 (P. Exs.), and ALJ Exhibit 1.

On appeal before the Board, MVHS submitted a chapter from a book titled Medical-Legal Aspects of Long-Term Care, and CMS submitted a document titled "Draft Guidance for Industry and FDA Staff Hospital Bed System Dimensional Guidance to Reduce Entrapment." There were no objections to either of these documents, and they are marked and admitted as Petitioner Exhibit 20 and CMS Exhibit 20 respectively. 42 C.F.R. § 498.86. The record also includes appellate briefs and a transcript of the September 8, 2004 oral argument requested by MVHS.

ANALYSIS
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1. We sustain the ALJ's conclusion that MVHS failed to substantially comply with 42 C.F.R. § 483.25(h)(1), which requires that facilities ensure the resident environment remains as free of accident hazards as is possible (Tag F323).

Facilities participating in the Medicare program must meet standards for quality of care in preventing accidents that provide as follows:

Each 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.

* * *

(h) Accidents. The facility must ensure that -

(1)The resident environment remains as free of accident hazards as is possible, and

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

42 C.F.R. § 483.25(h).

The SA cited MVHS for noncompliance with section 483.25(h)(1) after Resident #1 died while trapped between a raised bed rail and a pressure relieving air mattress. The alleged accident hazard at issue involved MVHS's use of Orthoderm air mattresses in conjunction with raised bed rails for Resident # 1 and six other residents.

On the afternoon of January 24, 2003, a Certified Nursing Assistant (CNA) found Resident # 1 seated on the floor with his head and chin stuck between the raised quarter rail and the air mattress. (1) ALJ Decision at 10, citing CMS Ex. 4, at 3. The CNA stated that she "kept trying to get him free. Finally I wrenched on the side rail. That's when he released. He was stuck in there pretty tight." Id. Resident # 1 appeared dead to the CNA when she entered the room. CMS Ex. 4, at 3. The Maine Medical Examiner subsequently concluded that the causes of death were asphyxia and compression of the neck. CMS Ex. 12, at 5.

Resident #1 was an extremely debilitated 83-year-old male. (2) ALJ Decision at 13, citing P. Ex. 1, at 2. He was assessed as being at high risk for falls; his risk factors included decreased mobility, poor judgment, and frequent falls. ALJ Decision at 13, citing P. Ex. 1, at 2. His care plan included multiple interventions to address this risk. CMS Ex. 11, at 71, 84, 88. Additionally, staff were directed to use quarter rails for his bed mobility. CMS Ex. 1, at 5. A few days before the incident, MVHS had provided Resident # 1 with an air mattress because he had a stage II pressure sore. ALJ Decision at 5, 10, citing CMS Ex. 4, at 4.

During the complaint survey on January 24, 2003, the surveyors observed six other residents using air mattresses; four of these residents had quarter rails in place and two had full rails. ALJ Decision at 6. During a revisit on February 3, 2003, the surveyors observed three residents on air mattresses with raised quarter rails and one with raised full rails. Id.

The ALJ made the following factual findings. The MVHS Nurse Manager informed the surveyors that it was facility practice to raise quarter rails on all residents' beds at the time of admission. ALJ Decision at 6, citing CMS Ex. 4, at 4. As to entrapment risks, the MVHS Administrator stated that in October 2001, in response to a Veterans Administration Patient Safety Alert (VA Alert), all 120 beds in the facility had been checked for gaps between its standard mattresses and bed rails and found to be in compliance with the gap allowance established by the VA. Id., citing CMS Ex. 4, at 5. The MVHS Administrator and Nurse Manager indicated that its air mattresses tended to be wider than standard mattresses, and therefore, the air mattresses had not been checked prior to Resident # 1's death for potential entrapment risks. Id. The Nurse Manager stated that bed rails were only evaluated for safety when they were used as restraints. Id.

The ALJ relied on the CMS State Operations Manual (SOM), which defines "accident hazard" as "a physical feature in the [nursing facility's] environment that can endanger a resident's safety." ALJ Decision at 12, citing CMS Ex. 10, at 9. As an example of an accident hazard, the SOM describes "spaces . . . between rails and the mattress . . . that can entrap limbs, neck, or thorax, and can cause injury or death. ALJ Decision at 12, citing CMS Ex. 10, at 9 (SOM App. PP-105). The ALJ concluded that the combination of raised bed rails and the air mattress constituted an accident hazard in violation of 42 C.F.R. § 483.25(h)(1). FFCL IV.C, ALJ Decision at 10.

MVHS challenges this FFCL on the grounds that the ALJ used the incorrect legal standard for accident hazard prevention. P. Br. at 11. MVHS asserts the ALJ failed to use a reasonableness standard and, instead, required MVHS to show that it did "everything in its power" to prevent bed rail entrapment. Id. MVHS argues that this language came from a case involving a violation of section 483.25(h)(2) (Coquina Center, DAB No. 1860 (2002)) and was not applicable to deficiencies cited pursuant to section 483.25(h)(1).

MVHS is correct that the ALJ's reference is from a case under (h)(2). (3) However, as explained below, we disagree with MVHS that the ALJ, in his discussion of the facts of the case, applied an incorrect legal standard.

The standard in section 483.25(h)(1) itself - that a facility "ensure that the environment is as free of accident hazards as possible" in order to meet the quality of care goal in section 483.25 -- places a continuum of affirmative duties on a facility. A facility must determine whether any condition exists in the environment that could endanger a resident's safety. If so, the facility must remove that condition if possible, and, when not possible, it must take action to protect residents from the danger posed by that condition. (4) If a facility has identified and planned for a hazard and then failed to follow its own plan, that may be sufficient to show a lack of compliance with regulatory requirement. In other cases, an ALJ may need to consider the actions the facility took to identify, remove, or protect residents from the hazard. Where a facility alleges (or shows) that it did not know that a hazard existed, the facility cannot prevail if it could have reasonably foreseen that an endangering condition existed either generally or for a particular resident or residents.

Here, CMS is not relying on evidence that a facility had actual knowledge that a condition that existed at the facility endangered resident safety, but on evidence that the facility had notice that particular environmental conditions, if they existed, would pose a risk of serious harm to certain residents that was avoidable. MVHS does not deny that it had notice of the risk posed by potential gaps between bed rails and mattresses, nor that the condition should and could have been removed if identified, but alleges that what it did was sufficient to meet its obligation under the regulation to determine whether the endangering condition existed at its facility. The ALJ properly addressed this issue by considering what notice the facility had, the nature of the potential harm, and whether what the facility did to evaluate whether the condition existed with respect to any of its residents could reasonably be considered sufficient to meet the regulatory standard.

The ALJ's discussion properly considered the actions taken by MVHS to address entrapment risks, including (1) its knowledge that potential gaps between bed rails and mattresses can pose entrapment risks, (2) MVHS's failure to identify whether there was an entrapment risk created by the combination of the air mattress and bed rails, (3) its failure to evaluate the risk to Resident # 1 and other similarly situated residents, and (4) its failure to take actions to prevent the risk of entrapment in a gap.

  • The ALJ found that MVHS had actual notice that a gap between mattresses and bed rails creates a risk of entrapment for some residents and is therefore a safety hazard. ALJ Decision at 13, citing CMS Ex. 8 (1995 Food and Drug Administration (FDA) Safety Alert to long term care facilities on dangers posed by gaps associated with bed rails, particularly to frail and confused residents) and CMS Exhibit 7 (July 2001 VA Alert as to dangers posed by bed rail entrapment and directing VA facilities to measure gaps between bed rails and mattresses.)


  • The ALJ found that, in accordance with the directive in the VA Alert, MVHS inspected the relationship between its standard mattresses and bed rails but not between its air mattresses and bed rails. ALJ Decision at 12, citing CMS Ex. 4, at 5.


  • The ALJ found that MVHS's failure to evaluate whether a gap existed and the fact that a gap did exist, at least on Resident # 1's bed, posed a particular risk to Resident # 1 who suffered from decreased mobility, poor judgment, and frequent falls. ALJ Decision at 13, citing P. Ex. 1, at 2. As the ALJ pointed out, Resident # 1 was the type of resident who is most vulnerable to entrapment because he may move without regard to his own safety and was more likely to become entrapped, and because he was weak and confused and would be less able to extricate himself from a gap. ALJ Decision at 13, citing VA and FDA Alerts.


  • Finally, the ALJ found that MVHS air mattresses were slippery and that this quality caused residents to slide in unintended directions. ALJ Decision at 13, citing CMS Ex. 4, at 3. The ALJ specifically noted that, in July 2002, one resident slid completely out of bed. Id. citing CMS Ex. 4, at 5. (5) The ALJ found that this quality increased the hazard posed by gaps, particularly to compromised residents like Resident # 1. Id.

Thus, the ALJ properly discussed factors related to the nature of the hazard and MVHS's lack of action in response to that hazard. This was the appropriate analysis for determining a violation of section 483.25(h)(1).

In oral argument before the Board, counsel for MVHS stated that, in response to the VA Alert, MVHS "measured every single bed rail and mattress in use in their facility, including the low air loss mattresses that were in use at the time." Tr. at 26-27. We treat counsel's statement as a challenge to the ALJ's finding that the Orthoderm air mattresses at issue in this case had not been inspected for risk of entrapment prior to Resident # 1's death.

We conclude that substantial evidence in the record as a whole supports the ALJ's finding for the following reasons.

  • The surveyors found that, before Resident # 1's death, these air mattress "were not assessed for the potential of entrapment by a resident." CMS Ex. 1, at 4.


  • MVHS did not specifically assert, or cite any evidence before the ALJ showing, that it had evaluated the risk of entrapment posed by these air mattresses in response to the VA Alert or at any time prior to Resident # 1's death.


  • The record does contain an affidavit from the MVHS Administrator that, in response to the VA Alert, "MVHS surveyed all of its beds and mattresses by October 10, 2001 and determined that all of its beds and mattresses were in compliance with the specific recommendations . . . ." P. Ex. 2, at 3. However, the Administrator did not say that this type of air mattress was in use and therefore inspected in 2001. It is reasonable to assume that, if MVHS had actually inspected these mattresses for entrapment risks prior to Resident # 1's death, the Administrator would have expressly stated that fact in his affidavit.


  • The surveyor's notes indicate that MVHS personnel stated that the air mattresses tended to be wider than the standard mattresses, "coming right to the rails." However, MVHS could not reasonably rely solely on this visual information in evaluating potential entrapment risks because mattresses are compressible and different types of mattresses present different degrees of compressibility. As the FDA Alert advised facilities: "Be aware that gaps can be created by . . . compression of the mattress which may be caused by patient weight, patient movement, or bed position." CMS Ex. 8, at 2.

MVHS asserts that the ALJ erred by failing to identify any professional standard of care it violated, i.e., any standard of care that would require it to ascertain whether there was a hazardous gap between the air mattress and the bed rail (P. Br. at 12) or any standard of care that would have required it to evaluate whether using this combination for Resident # 1 specifically posed a hazard (P. Br. at 14).

We reject this argument. First, the ALJ relied on a specific standard of care as to entrapment risks in citing the VA Alert, which instructed VA facilities to inspect their beds for entrapment risks. ALJ Decision at 12, 15. Second, section 483.25(h)(1) sets forth a standard of care by requiring that a facility ensure that the resident environment remains as free of accident hazards as is possible. As explained above, determining whether a facility has complied with this requirement may necessitate evaluating whether the facility has addressed foreseeable risks by identifying and removing hazards, where possible, or, where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible. (6) Standards of care as to specific types of accident hazards may be relevant to evaluating the foreseeability or the preventability of the risk, but they are not a necessary element of CMS's prima facie case.

MVHS argued that the ALJ erred in not considering testimony of its expert, Dr. Jeffrey M. Levine, that it met the standard of care for safety in the use of bed rails and air mattresses. Transcript (Tr.) at 17, relying on MVHS Ex. 11, at 3. The ALJ considered this testimony and found it unpersuasive because it was based on an erroneous factual assumption. Dr. Levine stated, "Prior to [Resident # 1's] death, the Veterans Home Staff assessed all beds for bedrail safety." P. Ex. 11, at 3. Implicit in Dr. Levine's assertion is the assumption that MVHS had evaluated the Orthoderm air mattresses for entrapment risks. However, as the ALJ found, Dr. Levine's statement "overlooks the fact that such assessment was conducted for the standard mattress and not for the air mattress." ALJ Decision at 13.

MVHS asserts that the ALJ erred in concluding it should have determined whether the air mattress/quarter rail combination posed a risk because "the hypothesis that an assessment would have prevented the accident in this case is speculative, being unsupported by any evidence anywhere in the record." MVHS Br. at 12. We find no error. While a mere evaluation might not have prevented the accident, it was a necessary prerequisite to identifying that the hazard existed. A facility can hardly keep "free of" accident hazards without paying ongoing attention to whether such hazards exist, nor can it reasonably rely on a previous evaluation if circumstances have changed. CMS Ex.7, at 4. (7)

In addition, MVHS objects to the ALJ's reliance on an academic paper that states that air mattresses may pose entrapment hazards to some residents due to gaps created by such mattresses' compressibility. P. Br. at 14, citing ALJ Decision at 14. MVHS states that the ALJ did not address "Petitioner's unrebutted evidence that the Orthoderm low air loss mattress used at the facility contains internal baffles designed precisely to counteract such compressibility." P. Br. at 14. For this proposition, MVHS cites the mattress operating manual at Petitioner Exhibit 13, at page 3.

We find the ALJ Decision to be supported by substantial evidence. In addition to the academic article, the ALJ relied on the VA Alert, which specifically cautioned facilities that mattress compressibility must be considered in evaluating whether mattress/bed rail combinations present entrapment gaps. CMS Ex. 8, at 2. Further, the ALJ did not disregard relevant portions of the operating manual. The manual contains no discussion of compressibility and baffles and does not indicate how its design is related to mattress/side rail entrapment. (8) It does, however, indicate that the mattress is designed to be inflated to different degrees of firmness, which could have affected a mattress' compressibility. The manual provides guidance as to the degree of inflation that should be used in different situations. For example, it states that -

the mattress should be adjusted to its most firm setting when placing a patient on the bed, performing nursing care, or changing dressings. The mattress should be adjusted firmer than normal when a patient is fowlered or side lying.

P. Ex. 13, at 4. (9)

The autopsy report stated that Resident # 1's bed was in a "semi-fowlered" position immediately prior to the accident. CMS Ex. 12, at 7. There is no evidence in the record as to the inflation level of Resident # 1's mattress at the time of the accident. Indeed, in extricating Resident # 1 from the gap, the nurses deflated his mattress. CMS Ex. 4, at 2.

MVHS refers to "unrebutted evidence that all low air loss mattresses used in the facility were in compliance with the recommended gap measurements." P. Br. at 14. MVHS cites Petitioner Exhibit 1, at 4, an affidavit of the MVHS Corporate Compliance Officer, stating that "[a]s of the time of the death of Resident No. 1, all gaps between bed rails and low air loss mattresses in use at MVHS were less than one inch." But MVHS offered no evidence that would explain how this statement is consistent with the evidence that the gap between the bed rail and air mattress was large enough to fit Resident #1's head and neck.

MVHS also argues that a "rehearsal event" is required before a facility should be considered to be on notice that an entrapment hazard is present. Tr. at 21. MVHS provided an article, discussing a "rehearsal event" as an incident in which a person is entrapped, found alive, and released. P. Ex. 20, at 265. We disagree. While a rehearsal event may provide notice of a risk that was previously unidentified, MVHS had actual notice that a potential gap between a mattress and a bed rail is a safety hazard but had not evaluated these particular mattresses to determine whether they presented an entrapment risk. Knowing the nature of this hazard, a facility could not reasonably rely on a one-time inspection of different mattresses to ensure that the facility was as "free of" this hazard as possible, nor reasonably wait until a resident got caught in a gap to take action.

For the preceding reasons, we conclude that the ALJ's determination that MVHS failed to comply substantially with 42 C.F.R. § 483.25(h)(1) (Tag F323) was free from legal error and supported by substantial evidence on the record as a whole.

2. We sustain the ALJ's conclusion that MVHS failed to substantially comply with 42 C.F.R. § 483.20(b), which requires comprehensive assessments of a resident's needs. (Tag F 272).

CMS cited MVHS for noncompliance with 42 C.F.R. § 483.20(b). Section 483.20 sets forth a facility's responsibilities for assessing its residents and developing comprehensive care plans based on those assessments. CMS relied on subpart (b)(1), which is titled "Comprehensive assessments" and provides:

(1) Resident assessment instrument. A facility must make a comprehensive assessment of a resident's needs, using the Resident Assessment Instrument (RAI) specified by the State. The assessment must include at least the following:

* * *

(xv) Special treatments and procedures.

"Special treatments and procedures" are defined by the SOM as "treatments and procedures that are not part of the basic services provided. For example, treatment for pressure sores . . . or devices and restraints." ALJ Decision at 7, citing CMS Ex. 10, at 5, 8.

The Resident Assessment Instrument (RAI) consists of three basic components: the Minimum Data Set Version 2.0 (MDS), the Resident Assessment Protocols (RAPs), and the RAI Version 2.0 Manual (RAI Manual). (10) RAI Manual at 1-3 - 1-4. The MDS is a "core set of screening, clinical and functional status elements, including common definitions and coding categories, which forms the foundation of the comprehensive assessment . . . ." Id. at 1-4. The RAPs are "structured, problem oriented frameworks for organizing MDS information, and examining additional clinically relevant information about an individual." (11) Id. The RAI Manual instructs facilities on the use of the RAI and RAPs.

CMS based its deficiency citation on the following two fact patterns.

Based on record reviews, observations and interviews[,] the facility failed to assess all residents at the time of admission for the use of quarter rails. In addition, the facility failed to assess 7 of 7 residents (#1, 2, 3, 4, 5, 6 and 7) identified as having an air mattress with bed rails for the potential risk of entrapment.

CMS Ex. 1, at 2.

In response to this deficiency citation, the ALJ made the following FFCL: "IV.B. The facility failed to assess all residents at the time of admission for the use of quarter rails. (Tag F 272)." While the FFCL is directed at the failure described by the first fact pattern, the ALJ's discussion of this deficiency focused primarily on the second fact pattern -- MVHS's failure to assess the risk of entrapment to some residents posed by the combination of the air mattress and bed rails.

We conclude that the record supports the ALJ's finding that MVHS failed to substantially comply with section 483.20(b) because it did not assess whether the use of this type of air mattress with quarter rails posed a safety hazard. (12) Section 483.25(h)(1) clearly informs facilities that they must ensure that the resident environment remains as free of accident hazards as possible. Section 483.20(b) requires facilities to engage in a comprehensive assessment of a resident's needs. Such an assessment necessarily includes evaluating the benefits and risks of a particular service initiated by a facility. In fact, the expert opinion of MVHS's expert, Dr. Levine, assumed that the proper use of bed rails requires assessment for bed rail safety. P. Ex. 11, at 3. Here, MVHS provided Resident # 1 and other residents with an air flow mattress to address skin breakdowns without assessing whether the combination of the air mattress and raised bed rails created an entrapment risk. (13)

MVHS argues that it did not have notice that it was required to assess the safety of air mattresses used with bed rails. P. Br. at 6. "Nowhere in the SOM . . . is there any support for the conclusion that a specific assessment is required for the combination of low air loss mattresses and bed rails." Id. MVHS complains about the ALJ's reliance on portions of the SOM and RAI Manual having to do with assessing bed rails as restraints, arguing that the restraint assessment language does not require safety assessments for bed rails used as mobility devices. Id. at 10; P. Reply at 2.

The fact that CMS identified no specific direction to facilities in the MDS, RAPs, RAI Manual or SOM to evaluate the safety of bed rails used as mobility aids and an air mattress does not mean that MVHS did not have a responsibility to do so. Resident safety is a basic facility responsibility. 42 C.F.R. § 483.25(h). As we discussed in the previous section, gaps that exist or could be created between bed rails and mattresses are well recognized as potential sources of entrapment, which could be lethal. Consequently, in the assessment or care planning for these residents, MVHS should have determined whether the combination of any bed rail and the air mattresses created an entrapment hazard. (14)

Survey instruments, such as the RAI, cannot incorporate every possible factor a facility should consider in a resident assessment. Thus the heading for section 4.9 of the RAI Manual asks "When is the Resident Assessment Instrument Not Enough?". It states that "completion of the MDS/RAPs does not necessarily fulfill a facility's obligation to perform a comprehensive assessment. Facilities are responsible for assessing areas that are relevant to individual residents regardless of whether or not the appropriate areas are included in the RAI." RAI Manual, at 4-18. Additionally, as cited by the ALJ, the SOM states: "The facility is responsible for addressing all needs and strengths of the resident regardless of whether the issue is included in the MDS or RAPs. The scope of the RAI does not limit the facility's responsibility to assess and address all care needed by the resident." (15) ALJ Decision at 7, citing CMS Ex. 10, at 5.

MVHS further objects to the ALJ's reliance on the SOM, stating that the SOM "cannot add new substantive requirements to the rule, nor amend its meaning in a substantive way." P. Br. at 8. However, the SOM here does not add a substantive requirement to section 483.20(b). Rather the SOM and the RAI Manual give notice to facilities of CMS's construction of section 483.20(b), i.e., that while the section directs facilities to conduct a comprehensive assessment using a specified assessment instrument, the specific instrument does not "limit the facility's responsibility to assess and address all care needed by the resident." This interpretation is reasonable because (1) the wording of section 483.20(b)(1) is that an assessment "must include at least" certain specified elements, and more generally refers to a "comprehensive" assessment of a resident's needs; (2) designing and using an instrument that describes every conceivable permutation of care needed by the nursing home population is impracticable if not impossible, and (3) limiting comprehensive assessments to a specific instrument would subject residents to the risk of having care needs not assessed because they were not on the instrument.

Further, MVHS's assertion that it did not have notice that it should assess the safety of the combination of the air mattress and the bed rail is contrary to repeated statements in the SOM and the RAI manual concerning a facility's obligation to assess the safety of interventions, particularly devices such as bed rails.

  • The RAI manual discusses bed rails as mobility aids in section G and as restraints in section P. RAI Manual at 3-112; 3-198-3-202. Section P instructs facilities how to determine whether a bed rail should be coded as a restraint, as a mobility device, or as both. Section P specifically warns facilities that "[w]hile the bed rails may not constitute a restraint, they may affect the resident's quality of life and create an accident hazard." CMS Ex. 9, at 6 citing RAI Version 2.0 Manual at 3-202 (emphasis added). This caution is underscored by other cautions in Section P concerning the hazard potential of restraints. Id. at 3-199, 3-201.


  • Resident # 1 had a history of falls and a care plan for falls. CMS Ex. 11, at 71, 84, 88. The RAP for assessing a resident at risk for falls instructs facilities to evaluate risk factors associated with the use of "appliances and devices," stating: "observe his/her use of the appliance for possible problems." RAI Version 2.0 Manual, App. C. at C-60. It also instructs facilities to evaluate "environmental/situational hazards." Id.


  • The SOM discussion of section 483.25(h)(1) (accident hazards) directs the reader to the discussion of section 483.13(a)(restraints) "for guidance concerning the use of bedrails." CMS Ex. 10, at 10. In the restraint section under the heading "Assessment and Care Planning for Restraint Use," the SOM discusses entrapment risks and specifically addresses bed rails when used as mobility/transfer devices. It provides:

    Before using a device for mobility or transfer, assessment should include a review of the resident's:

* * *

Ability to transfer between positions, to and from bed or chair, to stand and toilet (e.g., does the raised side rail add risk to the resident's ability to transfer?).

CMS Ex. 10, at 3 (emphasis added).

  • In the discussion of accident hazards, the SOM states that section 483.25(h)(1) corresponds to MDS version 2.0 section J (section 4 of which concerns accidents). CMS Ex. 10, at 9. It defines "accident hazards" as "physical features in the NF [nursing facility] environment that can endanger a resident's safety, including but limited to . . . spaces . . . between [side] rails and mattress, [and] between side rails and the bed frame . . . that can entrap limbs, neck or thorax, and can cause injury or death." CMS Ex. 10, at 10.

MVHS argues that, if it was required to assess the safety of the air mattress/side rail combination, Resident # 1 died within the 14 days allowed by section 483.20(b) to conduct an assessment. MVHS Br. at 6, n.1. Even if there was no deficiency as to Resident # 1 under this regulation, however, the records of other residents show that MVHS did not perform such safety assessments at any time after providing air mattresses in beds with raised bed rails. See CMS Exs. 14-17.

Thus, the ALJ properly concluded that MVHS was not in substantial compliance with section 483.20(b). We modify FFCL IV.B as follows to make it more consistent with the ALJ's analysis:

The facility failed to substantially comply with 42 C.F.R. § 483.20(b), which requires that facilities conduct comprehensive assessments of residents' needs. (Tag F272).

3. We sustain the ALJ's conclusions that a basis exists to impose remedies against MVHS based on its non-immediate jeopardy level deficiencies and that the amount of the penalty imposed by CMS is reasonable.

CMS imposed a CMP of $700 per day from February 3, 2003 through March 19, 2003. The ALJ concluded that a basis existed to impose remedies against MVHS and that the amount of the penalty was reasonable. ALJ Decision at FFCLs IV, D and C. Petitioner challenges both of these FFCLs.

CMS concluded that these deficiencies were at the "I" scope and severity level, involving widespread actual harm that is not immediate jeopardy. A CMP in the range of $50-$3,000 per day may be imposed for one or more deficiencies that do not constitute immediate jeopardy but that either cause actual harm or create the potential for more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii). Since we conclude the ALJ correctly determined that MVHS was in not in substantial compliance, a basis exists to impose a CMP in the range of $50-$3,000.

MVHS argues that the daily amount of the CMP ($700) is unreasonable. Within the applicable range, the regulations provide a number of factors to be considered by CMS in determining an appropriate CMP amount. These factors 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. Culpability for purposes of this paragraph includes, but is not limited to, neglect, indifference or disregard for resident care, comfort or safety. The absence of culpability is not a mitigating circumstance in reducing the amount of the penalty.

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

Before the ALJ, CMS relied on MVHS's history of noncompliance, its financial condition, the seriousness of the deficiencies, and MVHS's degree of culpability. ALJ Decision at 17. The ALJ agreed with CMS that these factors supported a CMP of $700 a day. Id.

On appeal, MVHS argues that its history of noncompliance should not have been a factor in determining the amount of the CMP because its prior noncompliance had no specific connection with the incidents in this case. P. Br. at 18.

We disagree. Section 488.438(f)(1) does not require the prior deficiencies to be connected to the incidents underlying the present deficiencies. "[A]n ALJ is not required as a part of assessing a facility's history of noncompliance under section 488.438(f)(1) to determine whether a CMP was previously imposed for the same deficiency." The Windsor House, DAB No. 1942, at 65-66 (2004).

MVHS also argued that the amount was unreasonable because, in a December 2002 survey, the SA did not cite MVHS's failure to assess the safety of the air mattress/side rail combination even though the survey involved Resident # 6, bed rails, and an air mattress. (In the prior survey, MVHS remedied the problem posed by Resident 6's slide out of bed off the slippery air mattress by instituting full side rails for Resident # 6.)

This argument does not justify modifying the per day amount of the CMP. The SA's previous failure to detect a deficiency does not invalidate an adequately documented deficiency. While the failure could arguably be relevant to MVHS's culpability, CMS obviously did not consider MVHS to be highly culpable since it imposed a CMP in the lower third of the relevant CMP range.

Citing CarePlex of Silver Spring, DAB No. 1683 (1999), MVHS also argues that the ALJ failed to address its argument below that "'evidence of due diligence in correcting deficiencies . . . is properly considered' with regard to the level of CMPs because, among other things, it relates to the factor of 'the facility's history of noncompliance.'" P. Reply at 7 (emphasis in original).

In CarePlex, CMS relied on the facility's very poor compliance history in setting the amount of the CMP even though the facility had a new owner who had acted with "due diligence in correcting deficiencies" before the survey at issue. The Board concluded that the record supported the ALJ's finding that the prior owner's compliance history was no longer predictive of likely future compliance and did not justify the amount of the CMP. CarePlex does not stand directly or inferentially for the proposition that a facility's due diligence in correcting a current deficiency makes its compliance history irrelevant to the determination of the amount of the CMP.

We therefore conclude that the ALJ's determination that the per day amount of the CMP was reasonable was free from legal error and supported by substantial evidence on the record as a whole.

As to the duration of the CMP, MVHS argues that the ALJ erred because he did not take into consideration its evidence that "it had taken substantial remedial measures to remove the alleged noncompliance even prior to the time period for which the CMPs were imposed." P. Br. at 17. MVHS points to the fact that it assessed each of the remaining residents using air mattresses and bed rails on the day of the accident. P. Br. 17, citing P. Ex. 1, at 4. It represents that the assessment was given to the surveyors who "commented that it was 'excellent.'" Id. citing P. Ex. 2, at 2. MVHS concluded: "Thus, as the Plan of Correction made clear, although the date certain for compliance was March 19, 2003, Petitioner had eliminated the alleged noncompliance even prior to the CMP period beginning February 3, 2003, and ending March 19, 2003." Id. citing P. Ex. 4, at 8-11.

The duration of a CMP is governed by 42 C.F.R. § 488.440, which provides that a per day CMP accrues until the facility achieves substantial compliance or the provider agreement is terminated. MVHS's POC detailed the steps that MVHS submitted as necessary to remedy the deficiency (including the need to ensure that the deficiency does not recur in some other fact pattern). The POC had a completion date of March 19. For example, March 19, 2003 was the completion date for implementing a bed rail risk protocol and for educating staff on the protocol. P. Ex. 4, at 10. While the POC dates are not determinative as to the dates these steps were taken, MVHS identified no evidence that would tend to show that it had completed the steps necessary for compliance prior to March 19. Since "[a] facility's noncompliance is deemed to be corrected . . . only when the incidents of noncompliance have ceased and the facility has implemented appropriate measures to ensure that similar incidents will not recur" (Florence Park Care Center, DAB No. 1931, at 30 (2004)), the evidence does not support a finding that MVHS returned to full compliance prior to March 19, 2003.

Conclusion

For the reasons explained above, we affirm all of the FFCLs in the ALJ Decision except for FFCL IV.B, which we modify to read:

The facility failed to substantially comply with 42 C.F.R. § 483.20(b), which requires that facilities conduct comprehensive assessments of residents' needs. (Tag F272).

JUDGE
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Daniel Aibel

Judith A. Ballard

Donald F. Garrett
Presiding Board Member

FOOTNOTES
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1. The following summary of facts is drawn from the ALJ Decision and the record before the ALJ. It is intended to provide a general framework for understanding the ALJ Decision and is not a substitute for the ALJ's findings.

2. While Resident # 1 was debilitated, he was not small. On January 12, 2003, facility records indicated he was five feet eight inches tall and weighed 204 pounds. CMS Ex. 11, at 65.

3. In earlier cases the Board used language such as "whether the facility had done all it could to prevent foreseeable accidents" or whether the facility did "everything in its power to prevent accidents." Coquina Center, DAB No. 1860 (2002); 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). Subsequently, we have stopped using these expressions because, when taken out of context, they may be misleading (Clermont Nursing and Convalescent Center, DAB No. 1923, at 21, n.20 (2004); The Windsor House, DAB No. 1942 (2004); Ivy Woods Health Care and Rehabilitation Center, DAB No. 1933 (2004); Windsor Health Care Center, DAB No. 1902 (2003)), and we have referred to Woodstock Care Center, DAB No. 1726, at 25-30, aff'd, Woodstock Care Ctr. V. Thompson, 363 F.3d 583 (6th Cir. 2003), in which we analyzed the wording, context, and history of section 483.25(h)(2). Cases under section 483.25(h)(1) and (2) may require different analyses of the effect of the regulatory language based on the specific issues and facts presented.

4. In determining what is "possible," the ALJ may need to consider factors such as applicable standards of care, other needs of residents, and practicable alternatives to mitigate an unavoidable hazard.

5. On appeal, MVHS objects to the ALJ's reliance on Resident # 6's sliding out of bed off the air mattress for two reasons. First, MVHS relies on the factual differences between Resident # 1 and Resident # 6, noting that Resident # 6 was a bilateral amputee who fell out of bed while trying to ambulate. MVHS Br. at 13. We reject this argument. The factual distinctions cited by MVHS are irrelevant to the ALJ's use of the incident. The ALJ cited this incident as support for his finding that the air mattresses were slippery (which MVHS admits at Petitioner Brief at note 2) and this quality increased the risk that a judgment-impaired weak resident might become trapped in the gap. Second, MVHS objects to the ALJ's omission of the fact that the SA "reviewed [Resident # 6's] records in the December 2002 annual survey, conducted only six weeks earlier, and had not noted any concerns about the incident or resulting plan of care." Id. This is not error on the ALJ's part. The SA's failure to cite based on what may have been the first incident of a fall due to a slippery mattress is not inconsistent with using that incident as evidence that the facility knew the mattresses were slippery.

6. MVHS mistakenly relies on Lake City Extended Care Center, DAB No. 1658 (1998), for the proposition that CMS was required to make a prima facie case as to a standard of care independent from the terms of section 483.25(h). In Lake City, CMS cited the facility for violating the requirement in 45 C.F.R. § 483.25 that a facility provide "the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being" because it failed to notify physicians when residents' temperatures exceeded 101 degrees. The Board agreed with the ALJ that "[t]he broad requirements of 483.25 implicitly include a requirement that a facility adhere to professionally recognized standards of care in providing care and treatment to its residents." DAB No. 1658, at 5, citing DAB CR494 (1997) at 16. Because CMS based the deficiency on the failure to comply with a professionally recognized standard of care involving notification of temperature change, it was required to make a prima facie case as to such a standard. In contrast, section 483.25(h)(1) establishes a standard of care - a facility must ensure that the resident environment remains as free of accident hazards as possible. Under section 483.25(h)(1), CMS must make a prima facie case as to the presence of a hazard. A facility may then attempt to prove substantial compliance by showing that it followed professionally recognized standards of care in identifying, removing or managing the hazard. MVHS tried to prove this with the letter from Dr. Levine, which, as described below, was not persuasive because it was based on an erroneous factual assumption.

7. For example, had MVHS known of the gap, it might have chosen to lower the quarter rail while the air mattress was in use for Resident # 1. The quarter rails were raised to increase Resident # 1's bed mobility. CMS Ex. 4, at 6. However, MVHS's January 12, 2003 assessment indicated that, in the last seven days, Resident # 1 was not using the quarter rails for bed mobility. CMS Ex. 11, at 64. If the quarter rails were not serving a purpose at the January 12 assessment, the risk they posed would seem to outweigh any benefit they provided.

8. The manual does refer to "individual air cushions," with "five separate sections." P. Ex. 13, at 3. We assume such sections would prevent air flow throughout the mattress and tend to reduce compressibility. However, since MVHS failed to evaluate the mattress for entrapment risks, there is no indication that MVHS relied on this feature to determine whether a gap could be created by compression.

9. In Fowler's position, the head of a patient's bed is raised 18 to 20 inches and the knees are also elevated. In a semi-Fowler's position, the head is less elevated. http://www.mercksource.com.

10. The MDS, RAPs, and Manual are found at http://www.cms.hhs.gov/MinimumDataSets20/.

11. The RAI Manual sets forth RAP "triggers" - i.e., "specific responses for MDS elements that identify residents who have or are at risk for developing specific functional problems and require further evaluation." Id. For example, the MDS element for restraints triggers the pressure sore RAP and the restraint RAP.

12. Some confusion on appeal stems from the use of the word "assess." The ALJ found that MVHS did not assess residents for use of quarter rails. He relied on surveyors' reports that MVHS personnel stated that "assessments were not done for quarter rails, as they were not considered restraints." ALJ Decision at 5, citing CMS Ex. 4, at 4. On appeal, MVHS points out that the sections of the MDS form dealing with bed rails as mobility enhancers were completed and asserts this is sufficient to establish it did assess the use of quarter rails for these residents. MVHS Br. at 5, citing CMS Ex. 11, at 40, 52, and 64; CMS Ex. 16, at 6, 10; CMS Ex. 14, at 33, 37; CMS Ex. 15, at 10, 14; CMS Ex. 17, at 12, 16, 22. We agree that MVHS's MDS forms support a finding that MVHS assessed whether these residents needed quarter rails as mobility enhancers. However, since MVHS personnel admitted to surveyors that no safety evaluation had ever been conducted for the combination of its bed rails and these air mattresses and the MDS form contains nothing related to such an assessment, this MDS form does not preclude a finding that MVHS failed to assess whether there were entrapment risks posed by the combination of the bed rails and air mattresses.

13. Because CMS limited its discussion of safety assessments to entrapment risks, we do not consider whether MVHS was also required to assess quarter bed rails for other types of safety hazards.

14. CMS cited MVHS under section 483.20(b), and we uphold the deficiency under that tag because MVHS could not show that it had conducted a safety analysis at any time for the combination of the air mattress and bed rail for its residents. A safety evaluation should have occurred when MVHS began using this type of air mattress with its existing beds, or, lacking a dependable finding that a gap could never occur between the particular side rails and the particular mattresses, as part of the assessment (section 483.20(b)) and care planning (section 483.20(k)) process. It is MVHS's failure to do any safety analysis on any of these occasions that provides the grounds for upholding this deficiency citation.

15. This ruling does not, as MVHS argues, create an "open ended discretion [for CMS] to impose arbitrary assessment requirements." MVHS Br. at 9. CMS will continue to have to show, as it did here, that it has reasonably interpreted the assessment and care planning requirements.

CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES