CASE | DECISION | JUDGE | FOOTNOTES

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


SUBJECT:

Maine Veterans' Home - Scarborough,

Petitioner,

DATE: March 22, 2004
                                          
             - v -

 

Centers for Medicare & Medicaid Services

 

Docket No.C-03-395
Decision No. CR1157
DECISION
...TO TOP

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a civil money penalty (CMP) against Petitioner, Maine Veterans' Home - Scarborough, for failure to comply substantially with federal requirements governing participation of long term care facilities in Medicare and State Medicaid programs. The CMP of $700 per day for the 45-day period from February 3, 2003 through March 19, 2003, for a total CMP of $31,500, is based on a finding of substandard quality of care.

I. Background

This case came before me pursuant to a request for hearing filed by Petitioner on April 17, 2003, in accordance with section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R. §§ 488.408(g), 498.40.

Petitioner is a skilled nursing facility located in Scarborough, Maine. On February 21, 2003, CMS informed Petitioner that, based on a February 3, 2003 complaint survey by the Maine Department of Human Services (DHS), it was adopting the recommendation of the Maine DHS and imposing selected remedies due to Petitioner's failure to be in substantial compliance with the applicable federal requirements for nursing home participants. Specifically, Petitioner was found to be providing substandard quality of care at survey Tags F272 and F323, based on a survey finding regarding a resident at Petitioner's facility who died as a result of entrapment between the air mattress on his bed and the rails of the bed, and a survey finding regarding the use of such air mattresses in connection with bed rails for other residents without a proper assessment.

CMS concurred with the Maine DHS recommendation and imposed the following remedies: \

    Termination of the provider agreement effective August 3, 2003.

      •Denial of payment for new admissions effective May 3, 2003.

      A CMP in the amount of $700 per day effective February 3, 2003.

The only issue before me, however, is the imposition of the CMP. (1)

The parties have agreed to waive their right to an in-person hearing and have the case decided on the basis of documentary evidence and written memoranda. P. Br. at 4; CMS Br. at 3. CMS proposed 19 exhibits. These have admitted into the record without objection, as CMS exhibits 1 to 19. (CMS Exs.1 - 19). Petitioner also proffered 19 exhibits. These were admitted into the record without objection as P. exhibits 1 to 19. (P. Exs. 1 - 19). I have also included in the record an "Alert" issued by the Michigan Department of Consumer & Industry Services as ALJ Exhibit 1. Each party submitted written briefs and response briefs in support of their respective contentions.

Based on the documentary evidence, affidavits, the written arguments of the parties, and the applicable law and regulations, I find that from February 3, 2003 through March 19, 2003, Petitioner was not in substantial compliance with Medicare participation requirements. Accordingly, I sustain the imposition of the CMP.

II. Applicable Law and Regulations

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

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

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

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

The regulations, at 42 C.F.R. § 488.301, define the term "substantial compliance" to mean:

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

Substandard quality of care, as defined at 42 C.F.R. § 488.301, means:

one or more deficiencies related to participation requirements under 42 C.F.R. § 483.13, Resident behavior and facility practices, § 483.15, Quality of life, or § 483.25, Quality of care . . . which constitute either immediate jeopardy to resident health or safety; a pattern of or widespread actual harm, but less than immediate jeopardy, with no actual harm.

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

1. The facility's history of non-compliance, including repeated deficiencies.

2. The facility's financial condition.

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

4. The facility's degree of culpability.

In a CMP case, CMS must make a prima facie case that the facility has failed to comply substantially with participation requirements. To prevail, a long term care facility must overcome CMS's showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999).

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

III. Issues

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

B. Whether the amount of the penalty imposed by CMS is reasonable, if non-compliance is established.

IV. Findings and Discussion

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

A. The facility was not in substantial compliance with federal participation requirements from February 3, 2003 through March 19, 2003.

B. The facility failed to assess all residents at the time of admission for the use of quarter rails. (Tag F 272)

The applicable regulation at 42 C.F.R. § 483.20(b), entitled "Comprehensive assessments," provides:

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.

* * *

At approximately 2:20 p.m. on January 24, 2003, Resident #1 was found with his head and chin stuck between the air mattress and the quarter length rail of his bed. In an interview with DHS surveyors, a certified nursing assistant (CNA) revealed that air mattresses in use at the facility were very slippery and that staff were constantly pulling up in bed the residents who used these mattresses.

An interview with the Registered Nurse (RN) Manager on January 28, 2003, established that the air mattress on Resident #1's bed had only been in place for a couple of days. CMS Ex. 4, at 4. The RN Manager also confirmed that quarter length bed rails were utilized on both sides of the bed. Id. There was no assessment found for use of the quarter rails in Resident #1's medical record. According to the RN Manager, assessments for the use of quarter rails were not conducted because they are not considered restraints. Id.

In a January 28, 2003 interview, the Assistant Director of Nursing (ADON) stated that it was a facility practice to have quarter rails on all residents' beds at the time of admission. CMS Ex. 4, at 4. She indicated that assessments are conducted only on the use of half rails and full rails. Id. According to the ADON, other than addressing the use of bed rails in the facility's physical restraint policy, there was no other policy that addressed the use of bed rails. CMS Ex. 4, at 4 - 5.

Seven residents were observed on January 24, 2003, in beds with air mattresses. Five of those residents (#s 1 - 5) had quarter length rails in place, and the other two (#s 6 and 7) had full rails. At different times on February 3, 2003, Residents # 3-5 were observed on air mattress beds with both quarter rails in the raised position. Resident #6 was observed on the same day lying on an air mattress with full rails on both sides of the bed in the raised position.

The surveyors found no evidence in any of the above mentioned residents' records that an assessment on the potential risk for entrapment was conducted prior to implementation of the air mattresses in conjunction with the use of bed rails.

In a January 28, 2003 interview, Petitioner's Administrator noted that all 120 beds in the facility had been checked in October 2001 for the potential of entrapment between the standard mattress and bed rails. CMS Ex. 4, at 5. All 120 beds were measured and found to be in compliance with the gap allowance. In another interview that same day, the RN Manager revealed that no measurements were done prior to implementing the air mattresses. Id. Both the Administrator and the RN Manager stated that air mattresses tended to be wider than standard mattresses, and, therefore, they were not assessed for potential entrapment by a resident. Id.

CMS contends that the regulation directs that assessments must be conducted for the use of "special treatments and procedures" such as bed rails pursuant to 42 C.F.R. § 483.20(b)(1)(xv). CMS notes that the State Operations Manual (SOM) underscores that a facility is responsible for addressing all needs and strengths of residents regardless of whether the issue is included in the Minimum Data Set (MDS) or the Resident Assistance Protocol (RAP). Thus, the MDS as well as the RAP has prompts for assessments of the use of items that may be classifiable as mobility and transfer aids and/or restraints. CMS Br. 9 - 11.

Petitioner contends that the deficiency at Tag F272 was improperly cited because it performed all assessments legally required. Petitioner notes that there is no specific RAP for entrapment risk, nor even for the use of quarter rails other than as restraints. Thus, reasons Petitioner, inasmuch as it was employing bed rails for mobility or transfer, assessments for their use were not required. P. Br. at 5 - 7.

42 C.F.R. § 483.20(b) requires long term care facilities to make an assessment of a resident's needs, using the RAI specified by the State. However, the assessment must include, among others, an assessment regarding special treatments and procedures. The guidelines (State Operation Manual or SOM) provided by the State to its surveyors properly defines the parameters of 42 C.F.R. § 483.20(b). CMS Exs.10, at 5, 8; and 9, at 6. The SOM does not carry the weight of law, but is readily available to the public and is widely relied on in the nursing home industry. The purpose of the SOM is not to add or detract from the language of published regulations, but to facilitate their understanding and application. I find that CMS's reliance on the SOM in this case, as well as that publication's rendering of 42 C.F.R. § 483.20(b), is in keeping with the principle I have enunciated above.

The SOM states that the facility is responsible for addressing all needs and strengths of residents regardless of whether the issue is included in the MDS or RAPs. CMS Ex. 10, at 5. The SOM adds that the scope of the RAI does not limit the facility's responsibility to assess and address all care needs of the resident from the moment of admission. Id. Consequently, special treatment and procedures is defined as referring to treatments and procedures that are not part of the basic services provided. CMS Ex. 10, at 8. In this regard, treatment for pressure sores, nasogastric feedings, specialized rehabilitation services, respiratory care, or devices and restraints are mentioned as examples of matters that are not part of the basic services. Id. Furthermore, in discussing the use of bed rails as positioning devices or restraints, the SOM cautions as follows:

In classifying any device as a restraint, the assessor must consider the effect the device has on the individual, not the purpose or the intent of its use. It is possible for a device to improve the resident's mobility and also have the effect of restraining the individual. (Emphasis in original)

CMS Ex. 9, at 5.

For residents who have no voluntary movement, the staff needs to determine if there is any appropriate use of bed rails. Bed rails may create a visual barrier and deter physical contact from others. Some residents have no ability to carry out voluntary movements, yet they exhibit involuntary movements. Involuntary movements, resident weight, and gravity's effects may lead to the resident's body shifting towards the edge of the bed. (2) For this type of resident, clinical evaluation of alternatives (e.g., a concave mattress to keep the resident from going over the edge of the bed), coupled with frequent monitoring of the resident's position, should be considered. While 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.

The above rendering of employment of bed rails in certain circumstances is not a deviation from regulatory requirements, but a common sense approach to an understanding of a facility's duty to make comprehensive assessments of all residents' needs. Facilities should, therefore, view these issues with the purpose of providing the most broad and complete assessments possible, rather than with the purpose of evasion or limiting the scope of their responsibilities. In the final analysis, it makes little sense to require a facility to assess a resident for use of bed rails when employed as a restraint, but to dispense with such requirement when the purpose is to provide mobility. Moreover, from the time Resident #1 was discharged from the hospital and re-admitted to Petitioner's facility on January 8, 2003, until he became entrapped between the mattress and side rail, he had no mobility. Although the MDS noted that at that time bed rails were not being employed for mobility or transfer, there is an absence of documentation to show that the facility assessed whether the use of bed rails was appropriate for Resident #1. P. Br. at 7.

Petitioner argues that it properly completed the RAI, which comprised MDS assessments for the surveyed residents, together with any triggered RAPs, and that CMS cannot minimize the significance of that fact by labeling those completed assessments as a "ministerial act." CMS posits that the absence of detailed clinical documentation to support the data included in the MDS form leads to a reasonable inference that none exists, and that such documentation should be expected if assessments were in fact conducted. Petitioner, on the other hand, argues that CMS's assertion that "the absence of detailed documentation supports a reasonable inference that none exists" controverts the agency's own guidance which states, "CMS has always accepted the MDS as a primary data source, and duplicative documentation is not required." P. Ex.10, at 5. I cannot agree with Petitioner's conclusion here because it is based on language taken out of context. The appropriateness of CMS's position is evident from a complete reading of the text in question:

CMS has always accepted the MDS as a primary data source, and duplicative documentation is not required. However, clinical documentation that furnishes a picture of the resident's care needs and response to treatment is an accepted standard of practice, is part of good resident care, and staff care planning. For this reason, it is always expected that information contained in the clinical record supports rather than conflicts with the MDS. Completion of the MDS does not remove the facility's responsibility to document a more detailed assessment of particular issues of relevance for the resident . . .

Nursing facilities are required to document the resident's care and response to care during the course of the stay, and it is expected that this documentation would chronicle, support and be consistent with the findings of each MDS assessment. Always keep in mind that government requirements are not the only or even the major reason for clinical documentation. The MDS has simply codified some documentation requirements into a standard format.

P. Ex.10, at 5.

In view of the above, I find that CMS has established a prima facie case that the facility failed to assess all residents at the time of admission for the use of quarter rails. In fact, the ADON confirmed on January 28, 2003, that it was the facility's practice to have quarter rails on all residents at time of admission, and that assessments were conducted only on the use of half rails and full rails. CMS Ex. 4, at 4. Petitioner has not overcome CMS's showing by a preponderance of the evidence.

C. The facility failed to ensure that the resident environment remained as free of accident hazards as is possible. (Tag F323)

The applicable regulation at 42 C.F.R. § 483.25(h)(1), entitled "Quality of care," provides:

The facility must ensure that the resident environment remains as free of accident hazards as is possible.

Resident #1 was readmitted to the facility on January 8, 2003, after a brief hospitalization for treatment of urosepsis. The resident's care plan included interventions consistent with the determination that he was at "high risk for falls." The CNA Kardex directed staff to use quarter rails for bed mobility, and a TAB alarm at all times. The use of an air mattress was also identified on the care plan and Kardex, secondary to skin breakdown.

In an interview on January 28, 2003 with DHS surveyors, a CNA stated that while doing her charts on the afternoon of January 24, 2003, she was told by the unit helper that Resident #1 had fallen. CMS Ex. 4, at 3. Upon entering the resident's room she observed him in a seated position on the floor with his head and chin stuck between the bed rail and the air mattress. The CNA stated: "I 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. During a further interview with the CNA, she stated that the air mattress used in the facility was very slippery, and residents using those mattresses had to be constantly pulled up by staff. CMS Ex. 4, at 5. Resident #5, who had an air mattress similar to the one used by Resident #1, stated in a January 28, 2003 interview that her mattress was very slippery and that she was always sliding down. CMS Ex. 1, at 5.

A January 24, 2003 interview with the RN Manager determined that the air mattress on Resident #1's bed had only been in place for a couple of days. CMS Ex. 4, at 4. No evidence was advanced that an assessment had been conducted for the use of quarter side rails for this resident. The RN Manager stated that the use of quarter rails for Resident #1 was not assessed as the rails were not considered restraints. Id. She also confirmed that no safety assessments were conducted regarding the use of the air mattress and quarter rails prior to their use. CMS Ex. 4, at 5.

On July 9, 2002, Resident #6, who had an air mattress and quarter side rails, was found sitting upright on the floor at the side of the bed. CMS Ex. 17, at 6, 29. An assessment was conducted and a decision was made to replace the quarter rails with full rails to prevent the resident from sliding out of bed. The care plan was changed accordingly. CMS Ex. 17, at 26. Thus, as of July 9, 2002, the facility was aware of the safety risk to residents using air mattresses in conjunction with side rails. However, there was no evidence that the facility evaluated the increased risk to all residents who used side rails with air mattresses.

CMS contends that skilled nursing facilities have a duty to do everything that is reasonable to prevent accidents by providing an environment that is free from hazards over which it has control. CMS argues specifically that Petitioner had knowledge of a Patient Safety Alert on bed rail entrapment issued by the Veterans Health Administration. CMS Ex. 7. Notwithstanding this awareness, CMS maintains, Petitioner made no risk analysis and took no risk mitigation steps when it replaced the standard mattress on certain beds with compressed air mattresses. Petitioner contends that it was improperly cited for the deficiency at Tag F323 inasmuch as the facility took all the reasonable accident prevention measures and that the death of Resident #1 occurred in spite of Petitioner's compliance with the standard of care. Specifically, Petitioner argues that the low air loss mattress employed to treat Resident #1's pressure sores was used in accordance with the manufacturer's specifications, and that it was not put on notice of an entrapment hazard.

A facility must ensure that the resident environment remains as free of accidents hazards as is possible. 42 C.F.R. § 483.25(h)(1). Gaps between side rails and mattresses pose a real risk of harm, injury or even death to residents in nursing homes. These risks are unequivocally real, and not merely imagined. In Wellington Specialty Care & Rehabilitation Center, DAB CR548 (1998), the ALJ stated that:

[S]ide rails can be dangerous to residents of long term care facilities. There exists a risk that some residents under certain circumstances may suffer injuries from side rails. . . . On occasion, individuals have become wedged in the gaps between side rails, resulting in injuries or death to those individuals. The dangers posed by side rails impose on long-term care facilities a duty to assess and address the risk of using side rails.

Wellington Specialty Care at 11. In the same decision, the ALJ went on to say that:

On August 21, 1995 the Food and Drug Administration (FDA) sent an "Alert" to hospitals and long-term care facilities which warned them of the dangers that side rails posed. . . . This Alert stated that since January, 1990, the FDA had received 102 reports of incidents involving entrapment of individuals in hospital bed side rails. . . . The FDA noted that it had received reports of 68 deaths, 22 injuries, and 12 entrapments without injuries occurring in hospitals, long-term care facilities, and private homes.

Wellington Specialty Care at 12. See also CMS Ex. 8.

In CMS's SOM, which contains guidelines for surveyors, an "accident hazard" is defined as "a physical feature in the [nursing facility's] environment that can endanger a resident's safety." CMS Ex. 10, at 9. Entrapment hazards in nursing home environments have been at the forefront of discussion for a number of years. Petitioner recognizes the existence of entrapment concerns associated with the use of side rails when it references FDA's Safety Alert issued on August 23, 1995, and the Safety Alert issued by the Veterans Administration (VA) on July 13, 2001. P. Br. at 10. Consistent with the guidance provided in the VA Safety Alert, Petitioner conducted a survey of the 120 beds in its facility in October 2001, and found the use of its standard mattresses in combination with bed rails to be in compliance with the precautionary measures contained in the VA Alert. CMS Ex. 7, at 1. However, when standard mattresses were replaced with air mattresses, no assessment for risk of entrapment was conducted. The reason for not conducting an assessment given by the Administrator and the RN Manager was that air mattresses tended to be wider than the standard mattresses, and, therefore, were not assessed for potential entrapment by residents. CMS Ex. 4, at 5. Notwithstanding, the RN Manager admitted that no measurements were done prior to implementing the air mattresses. Id

In order to determine whether Petitioner complied with the requirement to ensure that the resident environment remained as free of accident hazards as is possible, I need to engage in "an examination of whether the facility did all it could to prevent foreseeable accidents." Coquina Center, DAB No. 1860, at 11 (2002). In this regard, Petitioner argues that the low air loss mattress provided to Resident #1 was used in accordance with the manufacturer's specifications and that the manufacturer's representative acted as a consultant on the use of the air mattress to make sure it was used appropriately. Additionally, Petitioner submitted as an exhibit a letter from Dr. Jeffrey Levine who concurred that the use of the low air loss mattress was appropriate, inasmuch as the benefits of its use clearly outweighed the risks. P. Ex. 11. Finally, Petitioner states that it did everything that was reasonably possible under the circumstances, and that Resident #1's death occurred despite all reasonable precautions.

While Petitioner argues that it used the air mattress in accordance with the manufacturer's specifications, it fails to indicate how that was related to the prevention of side rail entrapment. Other than alleging that it followed the manufacturer's specifications, Petitioner does not present any evidence to demonstrate that it did everything in its power to prevent Resident #1's entrapment. See Coquina Center,supra,at 11. Dr. Levine's assertion, at page 3 of his letter, that Petitioner assessed all beds for bed rail safety, overlooks the fact that such assessment was conducted for the standard mattress and not for the air mattress. For the reasons that follow, I conclude that CMS established a prima facie case that Petitioner did not ensure that the resident environment remain as free of accident hazards as is possible.

It has been already established that Petitioner was well aware of the risks associated with the use of side rails in long term care facilities. According to the FDA Safety Alert issued in August 1995, cited by Petitioner in its brief at page 10, the residents at high risk for entrapment include those with pre-existing conditions such as confusion, restlessness, lack of muscle control, or a combination of those factors. CMS Ex. 8, at 2. Petitioner describes Resident #1 as being a very vulnerable individual at high risk for side rail entrapment. Specifically, Petitioner states that Resident #1 was an extremely debilitated 83-year-old male, with a list of 25 discharge diagnoses. His risk factors included decreased mobility, poor judgment, and frequent falls. P. Ex. 1, at 2. In fact, Petitioner states that when the resident was discharged from the hospital on January 8, 2003, he "was not mobilizing at all." P. Br. at 7. Thus, both the FDA and the VA Alerts mentioned above were issued with individuals such as Resident #1 in mind.

In spite of being well advised of the perils associated with the use of side rails for individuals whose physical and cognitive functions were very compromised, Petitioner provided Resident #1 with an air mattress without conducting a risk assessment for possible side rail entrapment. Moreover, the CNA, who found Resident #1 caught between the side rail and air mattress and had to wrestle with the help of others to get him free, stated that the air mattresses used in the facility were very slippery, and that the staff was constantly pulling up the residents who used them. CMS Ex. 4, at 3. Also, Resident #5 revealed in an interview conducted on January 28, 2003, that she was always sliding down in the bed due to the slippery nature of the air mattress. The facility failed to act on the knowledge that the air mattresses were very dangerous because of their slippery nature. In fact, as far back as July 9, 2002, Resident #6, a bilateral amputee, who had an air mattress and quarter rails in place, was found sitting upright on the floor at the side of the bed. CMS Ex. 4, at 5. An assessment was conducted and a decision was made to replace the quarter rails with full rails to prevent that resident from sliding out of the bed. Thus, when the facility placed Resident #1 in a bed fitted with an air mattress and quarter rails in January 2003, it was already on notice of the dangers associated with the use of side rails as well as the fact that its air mattresses were very slippery. Given its knowledge of the FDA and VA Safety Alerts, its staff experience with the slippery characteristic of the air mattress, and the specific incident involving Resident #6 in July 2002, Petitioner should have foreseen that Resident #1 was in danger of side rail entrapment. Furthermore, the facility should have anticipated that, given Resident #1's immobilized condition, he would not be able to extricate himself if he became entrapped. Notwithstanding all of the information at its disposal, Petitioner did not conduct an assessment of the appropriateness of placing Resident #1 on a bed equipped with a slippery air mattress and quarter rails.

I am cognizant of Dr. Levine's assertion, as expressed on page 4 of his letter, that there have been only occasional reports of death associated with entrapment of individuals between air mattresses and bed rails, and that although entrapment injuries are known to occur with these devices, in his opinion, the benefits of pressure relief clearly outweigh the risks. I could not disagree more.

I give more credence to the objective study by Dr. Steven H. Miles, undertaken as an academic endeavor rather than an opinion offered in the context of litigation. CMS Ex. 6. After reviewing data from the FDA's online database of adverse medical events from 1994 to 2001, Dr. Miles, of the University of Minnesota in Minneapolis, found 35 deaths linked to air mattresses. Dr. Miles found that these fatalities were similar to those occurring when a patient becomes trapped between the bed rails and an ordinary mattress. However, air mattresses pose special challenges: an air mattress can become compressed, forming a gap next to a bed rail, and that gap will close when the mattress re-inflates. The data compiled by the FDA is in contrast with the baseless claim of Dr. Levine that there have been only occasional reports of death associated with entrapment of individuals between air mattresses and bed rails. Moreover, the statute and regulations that govern the protection of residents in long term care facilities is infused with a deep sense of purpose, such that the occurrence of one death due to entrapment, as a result of a facility's dereliction of duty, is one death too many.

I also take serious issue with the opinion that, although entrapment injuries are known to occur with the use of air mattresses in conjunction with side rails, the benefits of pressure relief outweigh the risks. Dr. Levine misses the point. The issue here under consideration does not leave a facility in quandary whereby it would have to forego treatment of its residents for skin breakdown if it removed the side rails from their beds. The thrust of my analysis is that a facility cannot use an air mattress (or any other type of mattress) in combination with bed side rails without first conducting an appropriate assessment for potential risks. Long term care providers have a duty to assess each person individually and use proper, individualized, protective and preventative measures for each person.

Petitioner appears to be oblivious to the gravity of its wrongdoing. It fails to perceive the urgency of the FDA and VA Alerts dealing with side rail entrapment. (3)

In view of the foregoing, I find that Petitioner did not do all that was reasonably possible to protect Resident #1 from accident hazards. I am aware, as Dr. Levine says, that falls and their attendant consequences will always occur in nursing homes even in the best of circumstances. Unfortunately, the tragedy in this case is that the needless demise of Resident #1 occurred in what may possibly be considered the worst of circumstances.

I therefore conclude that CMS has established a prima facie case that Petitioner was in noncompliance with the requirements at 42 C.F.R. § 483.25(h). Petitioner has not overcome that showing by a preponderance of the evidence.

D. A basis exists to impose remedies against Petitioner for deficiencies that are at the less than immediate jeopardy level of noncompliance.

It has been clearly established that Petitioner failed to assess all residents prior to implementing the use of quarter rails, and that it also failed to ensure that the resident environment remain as free of accident hazards as is possible.

In an attempt to evade responsibility, Petitioner devises several excuses for its noncompliance. Petitioner argues that it was not required to conduct an assessment prior to deploying quarter rails in its facility. At the same time it argues that it did in fact conduct such an assessment. As to its failure to maintain an environment as free as is possible of accident hazards, Petitioner states that it was not provided a regulatory standard containing definitive guidance. In the absence of such standard, argues Petitioner, it applied a "standard of reasonable care," and, within that framework, ensured that the equipment was properly used and maintained.

The record demonstrates that Petitioner was well aware of the risks associated with the use of bed rails. It acknowledges having received a VA Safety Alert treating the subject of bed rail entrapment. In fact, the VA Alert of July 13, 2001 was an addendum to a previously issued publication dated December 20, 2000. The VA Alert also directed Petitioner to other publications regarding the subject matter of bed rail use, such as the 1995 FDA Alert. Additionally, the previously cited law and regulations, the guidance contained in the SOM, as well as the long line of Departmental Appeals Board (DAB) precedents dealing with bed rail safety, are ample sources of information for any diligent health care professional with a willingness to be informed. It is not a farfetched expectation that long term care facility owners, operators, and administrators will have the good sense to exercise appropriate professional judgment in the application of devices that have a likelihood of exposing nursing home residents to injury or death. In this case, I fail to see an aggressive posture on the part of Petitioner to take preventative action to protect those residents that may be too weak, frail, or cognitively impaired to correct his or her position as a life saving measure. It should be known to these professionals that entrapment can occur with all types of side rails, and can easily result in obstructed airway or circulatory compromise and quickly lead to death. Consequently, when 42 C.F.R. § 483.20(b) requires that facilities make a comprehensive assessment of a resident's needs, and a facility decides to apply special treatments and procedures (42 C.F.R. § 483.20(b)(xv)), the facility cannot blindly deploy any device without first conducting an appropriate assessment and putting in place relevant interventions and monitoring procedures. The applicable regulations, operations manual, and case precedents are far from opaque as to the duty of long term care facilities when it comes to the deployment of devises such as bed rails, regardless of the intended purpose with which they are employed.

The DAB has consistently held that long term care facilities must do everything in their power to prevent foreseeable accidents. Coquina Center supra. The record is devoid of any assertive action on the part of Petitioner to prevent accident hazards of the type that took Resident #1's life. Petitioner had several opportunities to protect its residents from accidents, but failed to do so. First, it did not assess the use of air mattresses when these replaced the standard mattresses. When the air mattress was applied to Resident #1's bed, no individualized assessment was done to protect that resident from harm or injury. When Resident #6 slid off the slippery air mattress, action was taken to protect that individual, but nothing was implemented to protect others similarly situated. Finally, Petitioner equipped Resident #1 with a combination of air mattress and quarter rails without conducting a risk assessment, although its staff was aware that the air mattress was very slippery, and it could easily be foreseen that Resident #1 was at risk of slipping into the gap between the mattress and bed rail.

In view of the foregoing, I conclude that CMS satisfied the criteria for imposing remedies at the less than immediate jeopardy level. First, CMS established a prima facie case, which Petitioner did not rebut, that as of February 3, 2003, it was not complying substantially with the participation requirements at 42 C.F.R. §§ 483.20(b) and 483.25(h). Second, Petitioner did not show it had eliminated the noncompliance on any date prior to March 19, 2003. Thus, I find that CMS may impose a CMP in the range of from $50 to $3,000 per day beginning February 3, 2003, and continuing through March 19, 2003.

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

CMS imposed a $700 per day CMP for the period beginning February 3, 2003, and continuing through March 19, 2003. I sustain the penalty imposed. A penalty of $700 per day falls within a reasonable range of penalties which may be imposed for deficiencies that are at the less than the immediate jeopardy level of noncompliance, but constitute substandard quality of care. 42 C.F.R. § 488.438(a)(ii). The beginning date of the penalty is the date that CMS first determined Petitioner not to be complying substantially with participation requirements. 42 C.F.R. § 488.440(a).

CMS argues that the reasonableness of the CMP imposed is supported by the following factors specified in 42 C.F.R. § 488.438(f):

    The facility's history of noncompliance.

    The facility's financial condition supports the reasonableness of the CMP.

    The seriousness of the deficiency and the facility's culpability support the reasonableness of the CMP.

During the prior standard survey conducted in December 2002, the facility was found out of compliance with participation requirements at the less than immediate jeopardy level. Petitioner has not come forward with any evidence that, as a result of its financial condition, the payment of the CMP imposed would interfere with its operations. Petitioner was aware of the risks associated with side rail entrapment and placed Resident #1 in a bed equipped with an air mattress and quarter rails without performing an individualized assessment as to the appropriateness of that device for that particular resident, and, once having placed Resident #1 in such a bed, failed to implement interventions to prevent entrapment. In fact, Petitioner was merely content with its visual appreciation that once placed on the bed, the air mattress was in very close proximity to the side rail. Such a crude assessment is totally unacceptable. There is no documentation (nor claim) that the compressible characteristic of the air mattress was tested, although reliable studies have shown that air mattresses can become compressed to create a gap into which residents can slip and become entrapped. CMS Ex. 6. Additionally, nothing was done to address the slippery characteristic of the air mattress being used by the facility. Petitioner appears to choose to ignore the evidence that unequivocally points to its culpability, but to ignore the facts does not change the facts.

V. Conclusion

I conclude that CMS correctly determined that beginning February 3, 2003, through March 19, 2003, Petitioner was not complying with federal requirements governing participation of long term care facilities in Medicare and State Medicaid programs at the less than immediate jeopardy level, and that the imposition of a CMP of $700 per day is reasonable.

JUDGE
...TO TOP

José A. Anglada

Administrative Law Judge

FOOTNOTES
...TO TOP

1. Although neither party submitted any documentation to this effect, it is apparent that Petitioner's revised plan of correction dated March 20, 2003 (P. Ex. 7) was deemed acceptable by the Maine DHS, thereby removing the recommended remedies of termination of Petitioner's provider agreement and the denial of payment for new admissions.

2. At the time of the entrapment that resulted in his death, Resident #1 had no mobility, and was equipped with a slippery air mattress that caused residents to slide off the bed. P. Br. at 7; CMS Ex.1, at 2. However, there is an absence of documentation to show that an assessment was conducted for the use of the air mattress and quarter side rails on an immobilized resident.

3. Concern about bed rail entrapment has not just been limited to federal agencies such as the FDA and VA. States are also taking initiatives on this issue. For example, in 2000 Michigan enacted legislation to require nursing homes to offer residents the option of using bed side rails. M.C.L.A. § 333.21734. This legislation followed a May 12, 2000 Alert issued by the Michigan Department of Commerce & Industry on the "Use of Side Rails in Nursing Homes." This Alert found that bed rails used as restraints added risks to residents, with potentially an increase of more significant injury from a fall from a bed with raised bed rails than from a fall from a bed without bed rails. The Alert suggested numerous alternatives to bed rails in care planning and called for a detailed assessment if the bed rails were to be used to enable a resident's mobility.

 

CASE | DECISION | JUDGE | FOOTNOTES