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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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Northeastern Ohio Alzheimer's Research Center, |
DATE: September 30, 2003 |
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Centers for Medicare & Medicaid
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Docket No.C-00-603
Decision No. CR1092 |
| DECISION | |
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DECISION The citations of deficiencies in this case are not supported by the evidence and there is no basis for the imposition of an enforcement remedy in this case. Accordingly, the civil money penalty (CMP) imposed against Petitioner is unreasonable and not approved. I. PROCEDURAL HISTORY The Ohio Department of Health (the State agency) completed an annual survey and a Life Safety Code survey of Petitioner on February 10, 2000. Petitioner, located in Columbiana, Ohio, is licensed by the State of Ohio and is certified to participate in the Medicare and Medicaid programs as a skilled nursing facility (SNF)/nursing facility (NF). The State agency found Petitioner not in substantial compliance with participation requirements and provided Petitioner with its findings in a statement of deficiencies (SOD). On March 8, 2000, the State agency sent Petitioner a revised SOD. By letter dated March 10, 2000, the Health Care Financing Administration (HCFA) (1) gave Petitioner notice that it agreed with the State agency's findings and advised that it was imposing a per instance CMP of $2,400. A follow-up survey was completed on March 23, 2000, and the State agency determined that Petitioner had achieved substantial compliance as of February 24, 2000. Joint Stipulation of Undisputed Facts, Judge Exhibit 1. Petitioner filed a request for hearing dated June 16, 2000. On July 8, 2000, the case was assigned for hearing and decision to administrative law judge (ALJ) Joseph Riotto. The case was reassigned to ALJ Alfonso Montano on July 18, 2001, and then to Judge Riotto on November 29, 2001. The case was assigned to me for hearing and decision on January 3, 2002. In an order dated April 5, 2002, I denied a CMS motion for summary judgment. A hearing was convened on July 16, 2002 in Cleveland, Ohio. The certified transcript (TR) of proceedings totals 188 pages. The parties submitted lists of errata which will remain with the transcript. The parties joint stipulation was admitted as Judge Exhibit (Ex.) 1. CMS exhibits 1 through 21 and 23 were admitted without objection. Petitioner objected to page 4 of CMS Ex. 22 to the extent that it reflects a subsequent remedial measure and should not be considered an admission of "guilt or liability" by Petitioner. The objection was overruled and CMS Ex. 22 was received. TR 14-17. Petitioner's exhibits (P. Ex.) 1 through 7 were admitted without objection. TR 17-18. Ruth Allen and James Lapp, the surveyors, were called as witnesses by CMS. Petitioner presented the testimony of Jane Richter, Robin Prince, Norman Sommers, Kimberly Guarnieri and John McKay. At the conclusion of the hearing, I requested that Petitioner produce a floor plan that encompassed both the nursing facility and the rest home involved in this case. I also requested that the parties consult regarding the floor plan submitted by Petitioner and stipulate to its accuracy. TR 181-183. Petitioner submitted a copy of the requested floor plan attached to a letter dated July 17, 2002. There is no indication the parties consulted regarding the accuracy of the plans. However, CMS has filed no objection to my consideration of the plans and the floor plans are marked as P. Ex. 8 and they are admitted as evidence. CMS submitted a copy of the Life Safety Code Handbook (7th ed.) which contains the text of the 1997 edition of the Life Safety Code as an attachment to its post hearing brief. CMS did not specifically seek admission of the document but refers to it in its brief. In the event CMS did intend to request admission of the document as evidence, I find the document irrelevant, for reasons discussed hereafter, and it is not admitted as evidence. Petitioner timely filed its post hearing brief on September 16, 2002. On September 17, 2002, CMS moved for leave to file its post-hearing brief one day out-of-time. Counsel for CMS represents in the CMS motion that counsel for Petitioner objected to the delayed filing, but no written opposition to the CMS motion has been received and the CMS post-hearing brief is accepted. Petitioner filed a post-hearing reply brief on October 10, 2002 and CMS filed its post-hearing reply brief on October 16, 2002. II. FINDINGS OF FACT AND CONCLUSIONS OF LAW
The following findings of fact are based upon the exhibits admitted and the transcript of the proceedings. Citations to transcript pages and exhibit numbers related to each finding of fact may be found in the analysis section of this decision.
III. DISCUSSION
The Social Security Act (Act) sets forth requirements for long-term care facilities, including SNFs and NFs, participating in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919 (42 U.S.C. �� 1395i-3; 1396r). (2) The Secretary's regulations governing SNFs and NFs participation in the Medicare program are found at 42 C.F.R. Part 483. Survey, certification and enforcement procedures for all long-term care facilities, including SNFs and NFs, are contained in 42 C.F.R. Part 488. A SNF and/or NF must maintain substantial compliance with program requirements as set forth at 42 C.F.R. Part 483 to participate in the Medicare and Medicaid programs. The State agency or CMS conducts surveys of nursing facilities to determine whether they are in compliance with the requirements of Part 483. A violation of a regulatory requirement is known as a deficiency. No deficiency must be found by surveyors that presents a greater risk to resident health or safety than the "potential for causing minimal harm" or the facility will be found not in substantial compliance and a certificate of noncompliance will issue. 42 C.F.R. �� 488.302 and 488.330. If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in section 1819(h) of the Act (42 U.S.C. � 1395i-3(h)) and 42 C.F.R. � 488.406, including a CMP such as that imposed in this case. The purpose of the authorized remedies is to "ensure prompt compliance with program requirements." 42 C.F.R. � 488.402(a). Remedies are applied on the basis of the scope and severity of the noncompliance found during surveys. 42 C.F.R. � 488.402(b). The factors to be considered by CMS when selecting remedies are set forth at 42 C.F.R. � 488.404. A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. � 488.408(g)(1); see also 42 C.F.R. �� 488.330(e) and 498.3. However, a facility may not appeal the choice of remedies by CMS or the factors CMS considered when choosing remedies. 42 C.F.R. � 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would effect the amount of the CMP that could be collected by CMS or impact upon the facility's nurse aide training program. 42 C.F.R. �� 498.3(b)(14) and (d)(10)(i). CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. � 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000). The Departmental Appeals Board (DAB) has long held that the net effect of these regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). CMS bears the initial burden of producing evidence sufficient to establish a prima facie case for each alleged violation of the regulations. CMS must set forth the basis for its determination with sufficient specificity for a petitioner to respond and come forward with evidence related to the disputed findings. The evidence set forth by CMS must be sufficient to establish a prima facie case that CMS had a legally sufficient basis to impose a remedy. In order for a petitioner to prevail, the petitioner must then prove by a preponderance of the evidence on the record as a whole that it was in substantial compliance with the relevant statutory and regulatory provisions or that it had an affirmative defense. Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, Health Care Financing Administration, No. 98-3789, slip op. at 25 (D.N.J. May 13, 1999). The DAB defined the requirements for a prima facie case in its decision in Hillman, DAB 1611, at 8:
Thus, when a provider appeals an enforcement decision, CMS has the initial burden of showing that its decision to terminate is legally sufficient under the statute and regulations. To make a prima facie case that its decision was legally sufficient in this case, CMS must: (1) identify the statute, regulation or other legal criteria to which it seeks to hold the provider; (2) come forward with evidence upon which it relies for its factual conclusions that are disputed by the Petitioner; and (3) show how the deficiencies it found amount to noncompliance that warrants an enforcement remedy.
CMS alleges two deficiencies or regulatory violations in this case, violation of 42 C.F.R. � 483.25(h)(2) due to the fall of Resident 3 and violation of 42 C.F.R.� 483.70(a) because two stairwell doors did not positively latch in their frames. The issues presented and alleged deficiencies are considered as follows.
The regulation allegedly violated provides:
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In interpreting and applying 42 C.F.R. � 483.25, various panels of the DAB have been consistent in the opinion that providers are not strictly liable as insurers or unconditional guarantors of good outcomes in the delivery of services to nursing home residents. Rather the quality of care provisions of section 483.25 impose an affirmative duty upon providers to deliver services designed to achieve the best possible outcomes to the highest practicable degree. Woodstock Care Center, DAB No. 1726, at 25 (2000). This interpretation is based upon legislative history of the Act and regulations which reflect that the choice was made by Congress and the Secretary to focus upon the desired ends or results of care rather than to impose rigid checklists of technical means, allowing facilities to meet the requirements for individual care in a variety of ways. See Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203; 54 FR 5316 ("The purpose of the revisions is to focus on actual facility performance in meeting residents' needs in a safe and healthful environment, rather than on the capacity of facility to provide appropriate services"). Thus, the specific manner by which facilities are to deliver care and services is not prescribed by the regulations. Rather, a facility is permitted to determine the means to achieve the regulatory ends. In the case of 42 C.F.R. � 483.25(h)(2), the regulatory end is the prevention of accidental injury of nursing facility residents. The issue is whether the quality of the supervision or the use, or lack thereof, of assistive devices at Petitioner's facility was such that residents were subject to the risk of injury from accidental causes in their daily activities. In order to evaluate a facility's compliance with 42 C.F.R. � 483.25(h), it is necessary to examine whether the facility did all it could to "prevent foreseeable accidents" or whether the facility did "everything in its power to prevent accidents." Odd Fellow and Rebekah Health Care Facility, DAB No. 1839, at 6-7 (2002), quoting Asbury Care Center at Johnson City, DAB No. 1815, at 12 (2002) and Koester Pavilion, DAB No. 1750, at 25-26 (2000). Section 483.25(h)(2) requires that a facility provide both "assistive devices" and "adequate supervision" to prevent accidents. What supervision or assistive devices are adequate depends on what kind of measures would be calculated to prevent potential accidents from occurring given the known or reasonably foreseeable risks. In Woodstock, the Board considered whether the facility had notice of, or should reasonably have anticipated, the risk of the kind of events that occurred and whether any reasonable means were available to prevent them without violating the residents' rights. DAB No. 1726, at 26-27. Based on the regulation and the cases addressing this subject, CMS meets its burden to show a prima facie case if: (1) it presents evidence that an accident occurred (with or without harm to a resident); or (2) it shows the facility failed to do what it could to supervise residents or provide assistive devices to minimize risks that could lead to accidents. In this case there is little dispute as to what happened to Resident 3. On February 6, 2000, at about 11:30 AM, Resident 3 was walking down the hall to the dining room with the assistance of Nurse Aide Norman Sommers, an employee of Petitioner. Mr. Sommers heard a bed alarm in a nearby room and went to assist that resident, leaving Resident 3 standing in the hallway. On his return to the hall, Mr. Sommers found Resident 3 lying on her left side on the floor. It was subsequently determined that Resident 3 had a fracture of her hip. Judge Ex. 1. Petitioner suggests that the fall may have been precipitated by the hip fracture which may have been a stress fracture secondary to Resident 3's osteoporosis rather than a hip fracture due to the fall and contact with the floor as CMS urges. Petitioner focuses upon the wrong issue. The real issue is whether Resident 3 should have been left standing in the hall alone at all given the known or reasonably foreseeable risk that she might fall. The surveyor alleged in the SOD that Resident 3 had a fall risk assessment dated August 31, 1999, in which she was assessed as being at risk for falls due to poor safety awareness and her general decline in ambulation. She was assessed as being a two person assist for ambulation due to progression of her Alzheimer's disease. The minimum data set (MDS) assessment of November 21, 1999, identified Resident 3 as requiring extensive assistance of two persons for ambulation. Nursing notes from February 6, 2000 at 11:30 AM describe the circumstances of Resident 3's fall as already set out above. CMS Ex. 2. Petitioner responded in its plan of correction dated February 24, 2000, which appears in the right column of CMS Ex. 2. Petitioner disagreed with the characterization that Resident 3 required a two-person assist for ambulation because the applicable MDS dated November 22, 1999, indicated that a one-person assist was required for ambulation and that reflects the highest level of assistance required during a seven-day evaluation period. Petitioner also urged that Resident 3's fall was due to an error of judgment by an individual employee and not the result of any facility error. The aide involved in the incident was counseled, in-service training was done for all aides, and Petitioner was taking other steps to emphasize following care plans and preventing falls. A revised SOD was issued on March 8, 2000, as a result of informal dispute resolution and reflects that the MDS of November 21, 1999, indicates that Resident 13 was a one person assist for ambulation. CMS Ex. 5. CMS presented the testimony of Ruth Allen, the surveyor who made the observations and prepared the SOD for this deficiency cited as F-324. Ms. Allen testified that she is employed by the State agency as a surveyor. She is a Registered Nurse with training and experience as described in the record. TR 32-34. She participated in the survey of Petitioner's facility February 8 through 10, 2000, and particularly reviewed facility records related to Resident 3. Her testimony was consistent with the SOD she drafted. Ms. Allen testified that the fact, as reflected in the revised SOD, that Resident 3 was a one-person assist for ambulation rather than a two-person assist as stated in the original SOD, did not change her opinion that Petitioner was deficient related to Resident 3's fall. TR 38. Ms. Allen opined that due to her dementia, Resident 3 should not have been left standing alone in the corridor and that the aide that left her was not following her care plan. Id. Ms. Allen opined that there is much difference between Resident 3 standing in her bathroom holding on to a sink and standing alone in the hall holding to the grab bar or rail - particularly since the resident had dementia and was evaluated as having poor judgment. TR 43-44. She further testified that Resident 3 experienced actual harm in the form of the fractured hip. TR 45. On cross-examination, Ms. Allen allowed that she could not opine with 100 percent certainty that Resident 3 did not experience a stress fracture that caused her fall rather than a fracture due to her fall; but, she opined that the fall was most likely the cause of the fracture. TR 50. She testified in response to my questioning that even if Resident 3 fell due to a stress fracture, she would have cited the same deficiency, and she emphasized that the fact the resident was left alone had the greatest bearing upon her decision. TR 57-59. Ms. Allen agreed on cross-examination that facility hallways must be clear of obstructions such as chairs. TR 52. Ms. Allen also agreed with Petitioner's counsel that the aide who left Resident 3 in the hall was responding to the bed alarm of Resident DB who had a history of falling from bed, and a fall from bed could cause significant injury to a resident. TR 56. Ms. Allen's surveyor notes were admitted as CMS Ex. 18 and they are consistent with her testimony. Petitioner called Ms. Jane Richter, a Licensed Practical Nurse, employed by Petitioner as a Restorative Nurse. She testified that she was familiar with Resident 3, who was on a restorative ambulation program in February 2000. According to Ms. Richter, Resident 3 was to walk 300 feet per day with a two-person assist, but that some days she could walk with a one-person assist. She opined that Resident 3 could stand unassisted. Ms. Richter indicated on cross-examination that she knew Resident 3 suffered from dementia, but she did not know whether it was due to Alzheimer's without checking Resident 3's records. TR 115-119. Robin Prince, Petitioner's Director of Nursing (DON) for the last nine years, testified on behalf of Petitioner that she disagreed with the SOD. In her opinion, based on her review of Resident 3's record and her familiarity with Resident 3, she believed that Resident 3 was capable of standing for a period of time and the orderly only left her for a brief period. During January and February 2000, Resident 3 could sometimes walk with no more than a handheld assist but needed more assistance at other times, such fluctuation in mental function being consistent with her diagnosis of Alzheimer's disease. The MDS for the period indicates that Resident 3 was a one-person assist because the MDS requires listing the highest level of assistance required during the seven-day evaluation period. (3) The resident who triggered the bed-alarm that the aide was responding to when Resident 3 fell was Resident DB who had a history of frequent falls secondary to attempting to get out of bed. At the time Resident 3 was left standing in the hall, residents and staff should have been going to the dining room for lunch, except for the staff who were doing tray service and in-room feeding. Both the dining room and the nurse station were a long distance from the place where Resident 3 was left standing. TR 120-125. She testified that in her opinion the aide made an error in judgment by leaving Resident 3 standing in the hall, but he had to make a split-second decision. TR 127-128. Petitioner presented the testimony of Norman Sommers, an employee of Petitioner since 1996, and the aide who left Resident 3 standing in the hall on February 6, 2000. Mr. Sommers testified that on February 6, 2000, he was walking up the hall to the dining room with Resident 3. He heard an alarm sound and knowing that the resident who triggered the alarm had a tendency to try to get out of bed and fall, he left Resident 3 standing in the hall holding the "arm rail" and he ran across the hall to answer the alarm. He testified that he straightened Resident DB in bed, shut-off the alarm, and returned to the hall in two minutes or less and found Resident 3 on the floor. He had cared for Resident 3 and knew her for three years. He believed Resident 3 could stand in the shower or elsewhere, unassisted for a minute to a minute and a half. He knew that she stood holding the sink during personal care and dressing. He saw no danger leaving her in the hall because she was holding tight to the rail. On cross-examination he indicated that the distance from where he left Resident 3 standing to the bed where the alarm was sounding was no more than about 12 feet. In response to my questioning, Mr. Sommers testified that he believed it would have taken longer to take Resident 3 to a seat than it took to respond to the alarm and return. TR 129-134. His written statement dated November 15, 2000, admitted as CMS Ex. 22, at 2-3, is consistent with his testimony. A statement signed by nurse aide Velda Howell and admitted as CMS Ex. 22, at 1 is also consistent with Mr. Sommers' testimony that Resident 3 could stand holding on to a sink while being dressed. CMS had admitted as CMS Ex. 20, a MDS for Resident 3 with an assessment reference date of November 21, 1999, and signed on November 22, 1999. (4) The MDS indicates that Resident 3 was moderately impaired cognitively for daily decision-making with poor decisions, and cuing and supervision were required. CMS Ex. 20, at 2 (section B, 4). Resident 3 was also evaluated as rarely or never understanding verbal information from others. Id. (section C, 6). Three or more times during the seven-day assessment she required extensive assistance while walking in the corridor, but a one person assist was deemed adequate. Id., at 3 (section G, 1, d). She was not able to balance while standing without physical help. Id., at 4 (section G, 3). She was also evaluated as having an unsteady gait. Id. (section J, 1, n). Resident 3 was noted to have fallen within the past 30 days and the past 31 to 180 days. Id., at 5 (section J, 4). She also participated in a restorative plan that involved walking up to 15 minutes per day with a limited one-person assist during the seven-day assessment period. Id., at 6 (section P, 3) and 8 (section T, 2). The MDS does not specifically address standing except with regard to balance with or without physical assistance. Petitioner offered as P. Ex. 2 some of Resident 3's records. Her records indicate that on November 14, 1999, she fell from bed and on December 13, 1999, she fell from a wheelchair. P. Ex. 2, at 37-38. There is no indication in the records produced that Resident 3 fell while standing or attempting to stand. Resident 3's plan of care, original date of September 2, 1999, and updated through May 17, 2000, reflects she was unable to care for self, unable to understand or to be understood, and at risk for falls due to unsteady gait and poor safety awareness. Her care plan does not contain any specific fall prevention interventions except that she is to receive assistance with personal care. (5) CMS argues that Petitioner violated 42 C.F.R. � 483.25(h)(2) by failing to provide adequate supervision and assistance devices to prevent Resident 3 from falling and suffering actual harm in the form of a hip fracture. CMS Brief, at 16. Petitioner argues that CMS failed to establish a prima facie case because CMS did not show that "Resident 3 did not have a stress fracture which caused the fall as opposed to a fall with a resulting fracture." Petitioner's (P.) Brief, p. 14. Petitioner further argues that the standard adopted by the Departmental Appeals Board is "whether Petitioner had notice or should reasonably have anticipated the risk of the kind of event that occurred and whether reasonable means were available to prevent the event without violating resident rights." P. Brief at 17. Petitioner summarily concludes that no violation has been shown. I reject Petitioner's argument that CMS failed to make a prima facie showing of a violation in this instance. The weight of the evidence, indeed it is undisputed, is that Petitioner's staff had determined that Resident 3 required at least a one person assist when ambulating in the halls, that she had difficulty balancing without some physical assistance while standing, that she had poor judgment and safety awareness and required supervision, and that she was unable to understand or make herself understood. (6) It is also undisputed that Petitioner's employee left Resident 3 standing in the hall and she fell. Whether Resident 3's fall was precipitated by a stress fracture which caused her to fall as argued by Petitioner or, whether she fell causing the fracture as argued by CMS, is not a determination I need to make. Even if Resident 3 developed a stress fracture and fell, the fact is that the fall might have been prevented if Resident 3 had the supervision and assistance required by the Petitioner's plan of care for her. The facts that cause me to conclude the regulation was violated are that Resident 3 was left in the hall without supervision, Resident 3 fell, and Petitioner knew or should have known Resident 3 would eventually fall if left standing in the hall with the physical assistance of the arm rail, but without supervision. Accordingly, I conclude that CMS has made a prima facie showing of a regulatory violation. I find unpersuasive Petitioner's suggestion that it did not know or should not have reasonably foreseen that if left standing alone in the hall, there was a probability that Resident 3 was going to fall. I accept as credible Petitioner's evidence that Resident 3 could stand holding on to a sink while being groomed. However, standing at the sink while being groomed is both with the physical assistance of the sink and the supervision of the aide doing the grooming. The undisputed facts are that Resident 3 was left standing in the hall with the physical assistance of the rail, but with no supervision. Given the documented evidence of Resident 3's poor judgment and safety awareness, Petitioner either knew or should have known that Resident 3, while standing with the physical assistance of an inanimate object but without supervision, was eventually going to let go and try to move with the obvious result that she would fall. Although not specifically stated by Mr. Sommers, the aide who left Resident 3 in the hall, it was clearly part of his thinking at the time that he could not leave Resident 3 alone unsupervised for long. I conclude however, that on the facts of this case, the regulatory violation is excused. Criminal law recognizes a defense of necessity. See Model Penal Code � 3.02. The civil law recognizes a similar defense to noncriminal wrongs against others or their property. The Restatement of Torts 3d, � 15 (Tentative Draft) characterizes the defense to a tort as an excused violation where the "actor's compliance with the statute would involve a greater risk of physical harm to that person or to others than noncompliance." The example provided by the Restatement involves the driver who crosses to the left of the center-line to avoid a bicyclist and strikes an on-coming car. In this case, Mr. Sommers left Resident 3 in the hall holding the rail without supervision. Resident 3's care plan and her other records indicated that she required both physical assistance and supervision and these requirements were known to Petitioner and its employee, Mr. Sommers. Resident 3 was left without required supervision for up to two minutes and an accident occurred - a clear violation of 42 C.F.R. � 483.25(h)(2). However, at 11:30 AM on February 6, 2000, Mr. Sommers was walking Resident 3 down the hall when he heard a alarm which he knew meant another resident was likely to fall out of bed causing injury to that resident. The unrebutted evidence is that no other facility staff were available to assist Mr. Sommers and that there were no chairs immediately available on which to seat Resident 3. Mr. Sommers' testimony that in his assessment it would take longer to walk Resident 3 to a place where she could sit than it would take him to respond to the alarm is also unrebutted. (7) It is not disputed that Mr. Sommers' was confronted with a dilemma, either he would not respond to the alarm and hope to get some assistance before the resident who triggered the alarm actually fell from bed with likely injury, or he could do as he did. It is not disputed that Mr. Sommers knew that the resident who triggered the alarm was likely to fall from bed and injure himself. It is also not disputed, that Mr. Sommers had at least some basis to reasonably believe that Resident 3 could stand holding the rail for at least a brief period with supervision. While it was not reasonable to believe that Resident 3 could be without supervision, Mr. Sommers clearly considered the need to make the period without supervision as brief as possible. Both CMS and Petitioner have suggested that Mr. Sommers exercised poor judgment and that there were other options; but, that is not the standard. The issue is whether given all the facts known to Mr. Sommers at the time, did he act reasonably to try to prevent injury to a third-party. I conclude that Mr. Sommers acted reasonably given all the facts. He was confronted with the situation where either of two resident's might be injured by his action or inaction, whether deliberately or not, he effectively calculated that there was less risk for harm to Resident 3 and chose to act to save the other resident. I would not characterize Mr. Sommers judgment as poor, he simply made a choice that neither his employer nor CMS, with the benefit of hindsight, agreed with. Mr. Sommers reasonably believed it necessary for him to prevent injury to the resident who triggered the alarm and he reasonably believed the likelihood of harm to Resident 3 was less than to the other resident. Accordingly, I find the defense of necessity has been established by the facts and excuses the regulatory violation.
CMS alleges that Petitioner violated 42 C.F.R. � 483.70(a)(1)(ii)(1999) by failure to meet the requirements of the Life Safety Code related to doors in vertical openings. Section 483.70(a) provides:
The SOD cites the 1981 edition of the Life Safety Code and alleges that the Life Safety Code (LSC) sections 12-3.1.1 and 13-3.1.1 require that "(v)ertical openings must be enclosed with two hour construction. Only one hour construction is required in one story buildings, sprinklered buildings three stories or less and existing buildings." The violation alleged in the SOD is that the left leaf of a pair of doors from the large basement training room and a second floor door near room 201 would not latch securely. The SOD records the surveyor's concern that the fact the doors would not latch would allow the "rapid spread of smoke and fire-gases between floors" and cause the "20 residents in the area . . . to evacuate." CMS Ex. 3, at 1-2. Petitioner stated in the plan of correction (right column of the SOD) dated February 10, 2000, that the problem was fixed on February 9, 2000, the doors latched securely and the maintenance supervisor would monitor and check weekly. Id. James Lapp, the surveyor who conducted the Life Safety Code inspection, was called to testify by CMS. Mr. Lapp testified consistently with the citation in the SOD. TR 65-114. On cross-examination, Mr. Lapp testified that he used or applied the 1981 edition of the Life Safety Code in this case. TR 92. Mr. Lapp's surveyor notes and worksheets were admitted as CMS Ex. 19. Mr. Lapp completed a "Fire Safety Survey Report - 1981 Code" related to his inspection of Petitioner on February 9, 2000. The report also indicates that he surveyed under the 1981 edition of the Life Safety Code for new construction. CMS Ex. 19, p. 3. The standards of the 1981 edition of the Life Safety Code applicable to vertical openings in new construction are set forth under ID Prefix (Tag) K20 at page 12 of CMS Ex. 19. Mr. Lapp indicates on the form that the standard was not met by Petitioner. The standard titled "81 NEW" provides:
Mr. Lapp's hand-written notes in the remarks column indicate that the left leaf of a pair of stairwell doors and a second floor stairwell door "will not latch." Id. His hand written remarks are consistent with the SOD and his testimony that he cited a deficiency only because the two doors in question would not latch when he inspected them. Based on all the evidence of record, I conclude that CMS has failed to make a prima facie case of any deficiency under any edition of the Life Safety Code in this case. It is clear that the 1985 edition, which was incorporated in the regulation by reference, was not applied in this case. Further, the 1981 edition of the Life Safety Code has not been offered as evidence. The only evidence that I have of the provisions of the 1981 edition that are applicable are on the worksheet (CMS Ex. 19, at 12) used by Mr. Lapp in his survey, and it includes no statement that doors must positively latch as alleged by CMS. My analysis begins with consideration of what exactly CMS must show in order to establish a prima facie case of a violation of the Life Safety Code and 42 C.F.R. � 483.70(a). Based on Hillman and Cross Creek Health Care Center, DAB No. 1665 (1998), CMS has the initial burden of showing that its decision to cite a deficiency and impose a remedy is legally sufficient under the statute and regulations. To make a prima facie case that its decision was legally sufficient in this case, CMS must: (1) identify the statute, regulation or other legal criteria to which it seeks to hold the provider; (2) come forward with evidence upon which it relies for its factual conclusions that are disputed by the Petitioner; and (3) show how the deficiencies it found amount to noncompliance that warrants an enforcement remedy. In Cross Creek, the DAB stated the following:
Cross Creek, at 9-10. The requirements of the Act and the Administrative Procedure Act (APA) must also be considered as controlling law in this case. Section 1819(d)(2)(B) of the Act provides that a SNF must meet the provisions of the edition of the Life Safety Code specified by the Secretary in regulation. Section 1919(d)(2)(B) of the Act imposes the same requirement for nursing facilities. The APA provides that each agency of the federal government must make available to the public by publication in the Federal Register all "substantive rules of general applicability" (5 U.S.C. � 552(a)(1)(D)) and that "except to the extent that a person has actual and timely notice of the terms thereof, a person may not . . . be adversely affected by, a matter required to be published in the Federal Register and not so published." 5 U.S.C. � 552(a)(1). The APA provides that incorporation by reference is sufficient. 5 U.S.C. � 552(a)(1). (8) In this case the problem for CMS is that only the 1985 edition of the Life Safety Code is incorporated by reference in 42 C.F.R. � 483.70(a), not the 1981 edition which CMS seeks to apply. (9)
The requirement of the APA that a regulation must be properly published in the Federal Register in order to be enforceable was considered in Appalachian Power Company v. U.S. Environmental Protection Agency (EPA), 566 F.2d 451 (4th Cir. 1977). The Fourth Circuit Court of Appeals considered the requirements for publication of regulations and incorporation by reference in the context of an EPA regulation challenged by multiple power companies. The regulation in question required the affected companies to comply with a document referred to as the "Development Document." There was no disagreement in the case that the lengthy document was not set forth in the regulations and that, while the EPA intended to incorporate the document by reference in the regulations, the EPA failed to follow the procedures for incorporation by reference specified at 1 C.F.R. Part 51. The court found that the provisions of the "Development Document" were unenforceable against the companies. The court reasoned that 5 U.S.C. � 552(a)(1) of the APA is clear that a person or entity may not be required to "resort to, or be adversely affected" by something that is required to be published in the Federal Register but is not. Id., at 455. Section 552(a)(1)(D) requires agencies to publish in the Federal Register "substantive rules of general applicability." The court found the document in question a substantive rule of general applicability based on the fact that it imposed mandatory obligations upon members of the public. Thus, the court found that for the terms of the document to be enforceable it either had to be published in the Federal Register in its entirety or it had to be incorporated by reference following the procedures specified by and with approval of the Director of the Federal Register, Id. The court agreed with the EPA that if EPA could show that the companies in that case had actual and timely notice of the terms of the document, then the actual knowledge exception of 5 U.S.C. � 552(a)(1) applied. However, the court found that the EPA did not prove that the companies had such actual notice of the contents of the Development Document. The court rejected the EPA argument that it was sufficient that the document was reasonably available on grounds that the APA requires a showing of actual notice and not simply availability. In the case before me, CMS seeks to apply the provisions of the 1981 edition of the Life Safety Code to Petitioner. It is clear from the plain language of 42 C.F.R. � 483.70, that the 1985 edition of the Life Safety Code was incorporated by reference, but not the 1981 edition. Also, the 1981 edition of the Life Safety Code is not set forth in its entirety in the regulation. Furthermore, CMS seeks to apply the 1981 edition as a substantive rule of general applicability to the extent that its application would impose specific obligations upon Petitioner subject to enforcement remedies for failure to comply. Accordingly, pursuant to 5 U.S.C. � 552(a) and based on the analysis of that statute in Appalachian Power, if CMS wants to enforce the 1981 edition as a regulation, CMS either needed to set out that edition in the regulation in its entirety or must have met the requirements for incorporation by reference. CMS did neither. The issue then is whether or not Petitioner had actual knowledge of the requirements of the 1981 edition so that it is enforceable against Petitioner within the exception created by 5 U.S.C. � 552(a). I agree with the court in Appalachian Power that the statute clearly specifies there must be a showing of actual knowledge and that availability alone is not enough. (10) After careful review of all the evidence and pleadings in this case, I find no evidence that Petitioner had actual knowledge of the provisions of the 1981 edition and I find no admission by Petitioner that it knew of the specific provisions of the 1981 edition. Accordingly, I conclude that CMS has failed to show that Petitioner had actual knowledge of the provisions of the 1981 edition. (11) An additional twist in this case arises because it is undisputed that the doors in question were not in Petitioner's SNF/NF. The cited doors were actually in a stairwell in an older building used as a rest home which is attached by a corridor to the nursing facility. CMS concedes that the condition of the cited doors posed no risk to the nursing facility, but argues that because some rooms in the rest home (chapel, hair dresser, and physical therapy) are used by as many as 20 nursing home residents during normal business hours, the doors did pose a risk for those residents. CMS Brief, at 11-14. Although CMS does not dispute that it normally would not have jurisdiction to inspect the rest home, CMS argues that because nursing home residents use facilities within the rest home, their surveyors have authority to conduct a Life Safety Code inspection pursuant to HHS Technical Bulletin No. 31, dated April 21, 1981. CMS Ex. 23. CMS thus seeks to extend the application of the 1981 edition of the Life Safety Code to the rest home based on the language of Technical Bulletin No. 31. However, CMS has, as already discussed, failed to show that Petitioner had actual knowledge of the provisions of the 1981 edition and the requirements of that edition may not be enforced against Petitioner. Similarly, CMS has presented no evidence and has made no argument that Petitioner had actual knowledge of Technical Bulletin No. 31. A showing of actual knowledge is required as Technical Bulletin No. 31 was not published in the Federal Register or incorporated by reference therein. Whether or not CMS recognized it's failure of proof when preparing its post hearing briefing is not clear. However, for the first time in its post hearing brief, CMS argues that the rest home doors cited as deficient could have been cited under 42 C.F.R. � 483.25(h)(2) as a "potential, but preventable," accident. CMS Brief, at 27. Of course, Petitioner strongly opposes such a last minute change by CMS and requests that I ignore the CMS argument. Petitioner asserts that it should receive prior notice of such a change and absent notice, Petitioner's right to due process is violated. The new CMS legal argument raises no new issues of fact that would necessitate further notice or hearing, particularly since the fact that the rest home doors would not latch during the survey has never been disputed. CMS has not disputed, however, that it would have no jurisdiction to survey the rest home except through the application of Technical Bulletin No. 31. The plain language of Technical Bulletin No. 31 only purports to extend the application of the Life Safety Code to adjoining buildings. Technical Bulletin No. 31 does not purport to extend the other participation requirements for SNFs and NFs codified in 42 C.F.R. Part 483 to buildings adjacent to such facilities. CMS has failed to articulate any other legal theory that the provisions of 42 C.F.R. Part 483 apply to the rest home or that a violation of 42 C.F.R. 483.25(a) may be cited against Petitioner for a condition in the rest home. Accordingly, I conclude that CMS has failed to make a prima facie showing of a violation of either 42 C.F.R. � 483.70(a)(1)(ii) or 42 C.F.R. � 483.25(a). CMS has failed to make a prima facie showing in that it failed to establish that there was a legally enforceable standard of which Petitioner had either constructive knowledge through proper publication in the Federal Register or actual knowledge of the provisions allegedly violated.
CMS has shown no regulatory violations that are not excused by a valid defense. Accordingly, there is no basis for the imposition of any enforcement remedy and any remedy imposed is unreasonable. IV. CONCLUSION For the foregoing reasons, no deficiency alleged by CMS has been proven and the CMP is, therefore, reversed. |
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Keith W. Sickendick Administrative Law Judge |
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1. Effective July 5, 2001, the Health Care Finance Administration (HCFA) was renamed the Centers for Medicare & Medicaid Services (CMS). 66 Fed. Reg. 35437. 2. A SNF is a nursing facility under the federal Medicare program and a NF is a nursing facility under the state Medicaid program. The Petitioner participates in both and is referred to as a "dually participating facility." See 42 C.F.R. � 488.301. SNFs are governed by section 1819 of the Act while NFs are subject to section 1919. 3. Her testimony in this regard is consistent with instructions for completing the MDS. P. Ex. 1, at 6. 4. This MDS was also admitted as part of the facility records for Resident 3. P. Ex. 2, at 14-23. 5. Neither the adequacy of Petitioner's care planning nor the sufficiency of staff have been cited as deficient in this case. 6. It is also undisputed that Resident 3 had experienced at least two prior falls, one from bed and one from her wheelchair. However, it is not clear that these falls indicated that Resident 3 would fall if in a different position such as standing with assistance, mechanical or human. 7. Of course, the evidence shows that Resident 3 had a past fall from her wheelchair, so sitting on a chair unsupervised and without restraint may have been no better option for her than standing in the hall. 8. These provisions were added to the APA by the act popularly known as "The Freedom of Information Act." Pub. L. 104-231 � 2(a). 9. Effective March 11, 2003, the Secretary has adopted the 2000 edition of the Life Safety Code to be applicable to all regulated facilities on a phased-in schedule. The 2000 edition of the Life Safety Code is incorporated in 42 C.F.R. � 483.70(a) by reference. 68 FR 1374. In discussing the promulgation of the final rule, the proponent describes the history leading to the final rule including the proposed rule of August 1, 1990 (55 FR 31196) which was withdrawn October 26, 2001 (66 FR 54179). The proponent also specifically discusses the applicability of 5 U.S.C. � 552 and the requirement for the Secretary to adopt a particular edition of the Life Safety Code and the requirement for incorporation by reference of the edition of the code in the regulation with a copy of that edition being on file at the Office of the Federal Register. 10. There is also no evidence that the 1981 edition of the Life Safety Code was generally available to Petitioner prior to the survey. I note that CMS did attach to its Post Hearing Brief a copy of the Life Safety Code Handbook (7 th ed.) which contains the text of the 1997 edition of the Life Safety Code - an edition that has never been adopted by the Secretary. CMS incorrectly refers in its post hearing brief to the sections of the 1997 edition attached to its brief. CMS Brief, at 23. There is no evidence that the provisions of the 1981 edition and the 1997 edition are the same. 11. Clearly, 42 C.F.R. � 483.70(a)(1)(ii) includes a reference to the 1981 edition that indicates a facility will be in compliance with the regulation if on May 9, 1988, it was in compliance with the 1981 edition. However, the language of the regulation does not provide actual knowledge of the provisions of the 1981 edition and it does not set forth the provisions CMS seeks to enforce or meet the requirements for incorporation by reference as established by 1 C.F.R. Part 51. |
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