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CASE | DECISION |JUDGE | FOOTNOTES

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


SUBJECT:

Lutheran Ministries d/b/a Twin Lakes,

Petitioner,

DATE: November 14, 2006
                                          
             - v -

 

Centers for Medicare & Medicaid Services.

Docket No.C06-277
Decision No. CR1528
DECISION
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DECISION

I find that Petitioner, Lutheran Ministeries d/b/a Twin Lakes, was deficient in providing care to a resident on November 18, 2005. I sustain the determination of the Center for Medicare & Medicaid Services (CMS) that, on that date, Petitioner's noncompliance placed a resident of its facility at immediate jeopardy. For that reason I sustain the imposition of a civil money penalty of $3,050 for one day, November 18, 2005. However, I find no basis to conclude that Petitioner was noncompliant after November 18, 2005 and, consequently, there is no basis for me to impose remedies after that date.

I. Background

Petitioner is a skilled nursing facility in Burlington, North Carolina. It participates in the Medicare program. Its participation in Medicare is governed by sections 1819 and 1866 of the Social Security Act (Act) and by regulations at 42 C.F.R. Parts 483 and 488.

Petitioner was surveyed for compliance with Medicare participation requirements on December 1, 2005 (December survey). The surveyors concluded that Petitioner was noncompliant in several respects. They cited Petitioner for three deficiencies at the immediate jeopardy level of noncompliance and for one non-immediate jeopardy level deficiency. (1) CMS accepted the surveyors' findings and imposed civil money penalties against Petitioner consisting of amounts of: $3,050 per day for each day of a period that began on November 18, 2005 and which ran through November 30, 2005; and $100 per day for each day of a period that began on December 1, 2005 and which ran through December 26, 2005.

Petitioner requested a hearing and the case was assigned to me for a hearing and a decision. At my direction the parties exchanged proposed exhibits, including the written direct testimony of proposed witnesses, and pre-hearing briefs. I then scheduled the case to be heard in person. However, the parties agreed that the case could be heard and decided based on their written submissions and pre-hearing briefs. Consequently, I canceled the in-person hearing. I base my decision in this case on the parties' pre-hearing submissions.

CMS submitted proposed exhibits consisting of CMS Exhibit (Ex.) 1 - CMS Ex. 27 as part of its pre-hearing exchange. Petitioner submitted proposed exhibits consisting of Petitioner (P.). Ex. 1 - P. Ex. 38. Neither party objected to my receiving any of the proposed exhibits into evidence. Therefore, I receive into evidence CMS Ex. 1 - CMS Ex. 27 and P. Ex. 1 - P. Ex. 38.

II. Issues, findings of fact and conclusions of law

A. Issues

The issues in this case are whether:

1. Petitioner was not complying substantially with Medicare participation requirements as of November 18, 2005;

2. CMS's determination was clearly erroneous that Petitioner's noncompliance as of November 18, 2005 was at the immediate jeopardy level of noncompliance;

3. Petitioner's noncompliance persisted after November 18, 2005; and

4. A civil money penalty of $3,050 is reasonable as a matter of law.

B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each Finding below as a separate heading. I discuss each Finding in detail.

CMS asserts that Petitioner was deficient in four respects on November 18, 2005 and thereafter. All of the deficiencies emanate from facts relating to an incident that occurred on November 18. On that date a wheelchair bound resident of Petitioner's facility, who I identify throughout this decision as Resident # 1, sustained an accident while being transported in a van that was being driven by a member of Petitioner's staff. The wheelchair - ostensibly secured to the floor of the van - tipped over backwards causing the resident to fall along with the chair and to strike his head against the interior of the van. The resident sustained injuries as a consequence of the fall, injuries that were not immediately apparent to Petitioner's staff, but which became evident a short time after the accident.

Using these facts as a basis for its findings, CMS alleges that Petitioner was deficient in the following respects:

� Petitioner failed to comply with 42 C.F.R. � 483.13(c)(4), which requires a facility to report an incident of resident neglect or abuse to appropriate State authorities. (2) Characterizing the accident as an act of "neglect" CMS contends that Petitioner did not report it.

� It failed to comply with 42 C.F.R. � 483.25, which requires that each resident of a facility receive the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well being, in accordance with the resident's comprehensive plan of care. CMS contends that Petitioner's staff should not have moved Resident # 1 before assessing him after the fall that occurred on November 18, 2005, and failed adequately to assess the resident's condition.

� Petitioner failed to comply with 42 C.F.R. � 483.25(h)(2), which requires that each resident of a facility be supplied with adequate supervision and assistance devices in order to prevent accidents from occurring. CMS argues that the events of November 18, 2005 establish that Petitioner failed to provide adequate supervision and assistance devices to Resident # 1.

� It failed to comply with the requirements of 42 C.F.R. � 483.75, which requires that a facility be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well being of each resident. CMS charges that the events of November 18, 2005 establish that Petitioner suffered from management deficits.

Of these alleged deficiencies CMS asserts that Petitioner's noncompliance with 42 C.F.R. �� 483.25, 483.25(h)(2), and 483.75 was so egregious as to be at the immediate jeopardy level. It contends that immediate jeopardy at Petitioner's facility persisted through November 30, 2005, and that Petitioner was deficient thereafter, albeit at a level of noncompliance that is less than immediate jeopardy, through December 26, 2005.

I find that the weight of the evidence establishes that Petitioner was noncompliant with the requirements of 42 C.F.R. � 483.25(h)(2) on November 18, 2005, and that CMS's finding of immediate jeopardy on that date is not clearly erroneous. I do not find that Petitioner was deficient in other respects. I also find that Petitioner's deficiency did not persist after November 18. Consequently, November 18 is the only date for which CMS is authorized to impose a remedy. I conclude that a civil money penalty of $3,050 for November 18, 2005 is reasonable as a matter of law because it is the minimum amount that is prescribed for an immediate jeopardy level deficiency.

1. On November 18, 2005, Petitioner failed to assure that one of its residents received adequate supervision and assistance devices in order to prevent an accident.

The following facts are essentially undisputed. Petitioner utilizes a van in order to transport its residents to medical appointments outside of Petitioner's facility. The van is equipped with locking mechanisms that are designed to hold a wheelchair-bound resident securely in place while the van is in motion. P. Ex. 29, at 1. These consist of four devices attached to the floor of the van that lock to a resident's wheelchair in order to immobilize it while the van is being driven. P. Ex. 3, at 2; P. Ex. 29, at 1; P. Ex. 34, at 1. In order for a wheelchair to be secured, the van driver must manually activate each of the four locking devices. See Id. In addition, a seat belt is supposed to be fastened to a resident while he or she is being transported in order to assure that the resident does not fall from his or her wheelchair during transport. P. Ex. 29, at 1.

Resident # 1 was scheduled to see a podiatrist on November 18, 2005. At about 1:30 that afternoon, Ms. Angela Matkins, a driver employed by Petitioner, loaded Resident # 1 into the van. P. Ex. 3, at 2. Moments after leaving the facility, Ms. Matkins made a right turn at an intersection. Id. As she made the turn she heard Resident # 1's wheelchair move. P. Ex. 28A, at 1. She looked into the rear view mirror and saw that the resident's wheelchair had tipped over backwards. P. Ex 3, at 2. The driver immediately pulled into a parking lot across the street from Petitioner's facility. Id. at 2-3; P. Ex. 28A, at 1. She found Resident # 1 still in his wheelchair, on his back, with the seatbelt fastened. P. Ex 3, at 3. The resident denied being injured. Id. Ms. Matkins extricated the resident from the chair, placed the resident on the floor of the van in a seated position. Id. She then called the facility and was instructed by Petitioner's staff to return immediately to the facility.

The resident was met at the facility by Tracy Smith, R.N., and by two nursing assistants. P. Ex. 6, at 2. The resident continued to deny that he had been injured. Id. at 3. Ms. Smith examined the resident. Id. She examined his head and found no sign of injury. Id. at 2-3. The resident's reflexes appeared to be normal, his breathing was normal, and there was no sign of increased confusion or disorientation. Id. at 3. Ms. Smith called the resident's personal physician to advise him of the accident and her assessment of the resident's condition. Id., at 4. Petitioner's staff returned the resident to his wheelchair and the resident was transported to his appointment with his podiatrist. Id.

Later on the afternoon of November 18, 2005, Resident # 1's daughter advised Petitioner's staff that the resident had been badly injured by his accident The resident was taken to a local hospital emergency room where he was examined by a physician. The resident's injuries included: a four by six centimeter contusion to his occipital scalp; back and neck bruises; and a bruise and swelling of his right wrist. P. Ex. 11, at 3. The emergency room report also stated that the resident had sustained a closed head injury. Id. However, no neurological injuries were detected, and a CT scan of the resident's head and spine was negative. Id.; P. Ex. 13, at 3. The resident's contusion was not reported to be bleeding and it was not sutured. See Id. The resident was discharged that evening with a prescription for Demerol and Phenergan. P. Ex. 11, at 4; P. Ex 13, at 3. There is no evidence that the resident experienced lasting ill effects from his injuries. (3)

However, although there is no real disagreement between the parties as to what happened on November 18, 2005, the parties disagree as to the reasons for the events. CMS asserts that the resident's fall was the consequence of negligence on the part of Petitioner's staff. Petitioner argues that, to the contrary, the fall occurred for reasons unknown and that negligence is not the root cause of the resident's fall.

I am satisfied by the weight of the evidence that Resident # 1's fall was caused by human error. The plausible explanation for the resident's fall was that Ms. Matkins failed to secure all of the van's locking devices on November 18 before leaving Petitioner's premises. The consequences of that error are that Resident # 1's wheelchair was unstable and that it tipped over while the van was in motion.

The accident was not a consequence of equipment failure. Petitioner's staff checked the van shortly after the accident occurred in order to ascertain whether the locking devices had malfunctioned. They determined that they were all working properly. P. Ex. 28C, at 1. Given that, the only way the accident could have occurred was if all of the locking devices were not fastened. As Petitioner concedes, the wheelchair could not have tipped backward in the van on November 18, 2005 had all four of the locking devices been fastened at the time of the accident. CMS Ex. 24, at 1.

Petitioner argues that it would have been possible for Resident # 1 to lean forward while seated in his wheelchair and detach the front two locking devices after Ms. Matkins had attached them. See P. Ex. 30 - P. Ex. 32. But, while that is possible I do not find it to be the plausible explanation for what happened on November 18. More reasonable is that, as a consequence of simple human error, Ms. Matkins failed to attach the front two locking devices. There is nothing in the record to show that Resident # 1 had the propensity to unlock the devices or that he knew how to do so.

There is no evidence to show that the mistake made by Ms. Matkins evidenced a chronic failure by her to follow safety precautions or that there was a systemic problem at Petitioner's facility in training staff to implement safety procedures. As I discuss in more detail below, Ms. Matkins had an exemplary record as an employee and Petitioner had carefully trained Ms. Matkins and other staff in the implementation of safety procedures.

It is therefore clear that the error that Ms. Matkins committed on the 18th of November was an isolated error and not evidence of a pattern of laxness on the part of Petitioner or its staff.

However, the error was an instance of deficient conduct by Petitioner's staff. In order to comply with 42 C.F.R. � 438.25(h)(2). Petitioner and its staff were required to take all reasonable measures to protect residents against sustaining accidents. The consequence of Ms. Matkins' error was foreseeable. Leaving the wheelchair not completely fastened would make it vulnerable to tipping while the van was in motion. Failure by Ms. Matkins on the 18th of November to foresee that likely consequence of not securing the wheelchair was an obvious failure to provide Resident # 1 with adequate supervision and assistance devices.

I have considered the possibility that Ms. Matkins' error was so isolated as to not constitute a deficiency. I conclude that in this case, Petitioner was deficient even if the accident resulted from an isolated instance of error by an otherwise conscientious and well-trained employee. Even an isolated instance of failure to provide care may constitute a deficiency if the failure is preventable. The accident may in fact have been the consequence of a one-time lapse in judgment by Ms. Matkins. But, it was, nonetheless, a preventable judgment error. Had Ms. Matkins followed her training more closely the accident would not have occurred. Ms. Matkins should have observed the locking devices before driving the van to assure that they were attached correctly. As is evident from Petitioner's exhibits, a visual inspection would have verified whether the devices were attached. P. Ex. 28 - P. Ex. 34.

2. Petitioner complied substantially with neglect and abuse reporting requirements.

There is no dispute between the parties that Petitioner failed to notify State authorities about the November 18, 2005 accident within five days of its occurrence. CMS's argument that Petitioner's failure to make notification was a violation of regulatory requirements hinges on its characterization of the accident as constituting "neglect" of a resident.

However, CMS has provided no analysis or argument explaining why the accident is an episode of neglect. Its pre-hearing brief merely asserts the conclusion that Petitioner failed to comply with notification requirements without discussing the underlying premise. CMS's pre-hearing brief at 4. CMS's assumption notwithstanding, I am not persuaded that the accident in this case was an incident of neglect.

"Neglect" is defined in applicable regulations to mean:

failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness.

There was no failure to provide services here. Nothing was withheld from Resident # 1. The deficiency in this case lies in the mental lapse of an employee while she provided a service. In other words, the necessary service was provided to the resident but it was not provided competently. That is not neglect. (4)

Moreover, even if Petitioner failed to comply with regulatory reporting requirements there is no prima facie showing in this case that its failure posed the potential for more than minimal harm to residents. As I discuss below, Petitioner was more than diligent in ensuring that the mishap involving Resident # 1 did not recur. Failure to report in this case posed no possibility of harm to residents because Petitioner did all that any reasonable facility could do to ensure that the episode did not happen again.

3. Petitioner's staff assessed Resident # 1 after the November 18, 2005 accident consistent with regulatory requirements.

CMS argues that Petitioner's staff inadequately assessed Resident # 1 for injuries immediately after the November 18, 2005 accident, in contravention of regulatory requirements, but also in contravention of Petitioner's own internal policy which provides that:

when witnessing a fall or when a resident is found on the floor and presumed to have fallen, an initial assessment which must be done includes a range of motion, head to toe assessment and taking vital signs.

CMS Ex. 17.

According to CMS, Petitioner contravened these requirements because: its staff moved Resident # 1 after the accident but before he could be assessed; and the staff did not do the required head to toe assessment.

There is nothing in the regulations which addresses with specificity how a facility staff should respond to an accident involving a resident much less to an accident that occurs off the facility's premises. The regulations essentially leave it to the staff's professional judgment as to how to deal with the aftermath of an accident.

I find nothing in the record of this case to show that the staff acted inappropriately by moving Resident # 1 back to facility premises immediately after he sustained his accident on November 18. The resident denied being injured and the distance that the van had to move was only feet. CMS has not provided any expert testimony that the resident, given the circumstances of his accident or his condition after the accident, was at risk for additional harm by being driven the extremely short distance back to Petitioner's premises.

Moreover, moving the resident back to the facility so that he could be assessed was not a violation of the letter of the facility's policy. It is apparent from the written policy that it applies to accidents that occur on the premises of Petitioner's facility. CMS Ex. 17. Here, the accident occurred off premises.

Nor is there evidence showing that the resident was inadequately assessed. The resident was met by a registered nurse who immediately assessed him. The uncontradicted testimony of Tracy Smith, R.N., is that, on November 18, 2005, she received a call from Ms. Matkins advising her about the accident involving Resident # 1. She met the van as it returned to Petitioner's facility. Without moving Resident # 1 she asked him if he was hurt and he denied any injury. P. Ex. 6, at 2. She observed the resident's upper torso and the back of his head. Id. She found no sign of injury. She observed the resident move his upper extremities and his legs without evidencing pain or discomfort. Id. at 3. She observed the resident's eye movement. Id. The resident's reflexes appeared to be normal and responsive, his breathing was normal, and he showed no increased confusion or disorientation from his normal baseline status. Id. Ms. Smith assisted the resident back into his wheelchair and the resident was able to use his hands and feet to position himself comfortably. Id. Ms. Smith completed an incident report which reflected her assessment that the resident was alert and responsive and showed no apparent injury. P. Ex. 4, at 1.

It is true that, subsequently, the resident complained of pain and soreness and that he was found to have sustained a contusion to the back of his head. However, the failure of Ms. Smith to observe and assess these injuries is not a basis for me to conclude that her assessment of Resident # 1 was inadequate. First, the injuries sustained by Resident # 1 - a contusion and bruising - would not necessarily have been apparent to a professional who examined the resident moments after the accident. P. Ex. 14, at 2. Second, Ms. Smith's assessment was within professionally recognized standards of care in that it was entirely consistent with the resident's denial of injury and with the fact that the resident was neurologically unchanged. Id. at 3.

4. There is no prima facie evidence that Petitioner's facility was inadequately managed.

CMS seems to be arguing that the accident of November 18, 2005 is prima facie proof that Petitioner's facility was not managed adequately. I fail to understand the logic of CMS's argument and I find no prima facie evidence supporting its contention that Petitioner's facility was inadequately managed.

The isolated accident that occurred in this case says nothing about the quality or effectiveness of Petitioner's management. As I conclude above, it was an isolated episode caused by human error. CMS has offered no persuasive evidence to show that Ms. Matkins was inadequately trained or supervised in the performance of her duties or that Petitioner's management was lax in implementing policies to ensure that safety precautions were met in transporting residents.

There are cases in which overall management deficiencies may be inferred from incidents of neglect or poor care. In some instances a pattern of pervasive poor care can be attributed to a failure of management to discharge its obligations. In other cases a single incident may be so egregious that it establishes that a facility's management has failed to develop or to implement policies sufficient to protect residents from harm. But evidence of that nature is singularly lacking in this case.

5. Petitioner did not prove to be clearly erroneous CMS's determination that Petitioner's failure to provide Resident # 1 with adequate supervision and assistance devices was at the immediate jeopardy level of noncompliance.

CMS offered prima facie evidence establishing that there was a likelihood that the failure of Petitioner's employee to assure that Resident # 1 was transported safely would cause the resident to experience serious injury, harm, impairment, or death. The danger to the resident was apparent. The injuries he sustained would have been much more serious had the accident occurred while the van was traveling at a higher rate of speed or had the van had to brake sharply.

Petitioner did not rebut this evidence by showing that CMS's determination was clearly erroneous. (5) Petitioner argues that Ms. Matkins and other van drivers had received training sessions prior to November 18, 2005 which made it highly unlikely that serious injury, harm, impairment, or death would occur. Petitioner's pre-hearing brief at 26. However, that assertion does not overcome the fact that an accident did occur on November 18, 2005, and that, even assuming the accident to be an isolated occurrence, it occurred in spite of the training that Ms. Matkins and other van drivers received prior to that date. Obviously, Ms. Matkins was not trained as thoroughly as she needed to be prior to the 18th.

6. The preponderance of the evidence establishes that Petitioner's noncompliance did not persist after November 18, 2005.

There is a presumption that, when a deficiency is established, a facility remains noncompliant until it proves, by the preponderance of the evidence, that it has attained compliance with participation requirements. I find that the preponderance of the evidence in this case proves that Petitioner immediately addressed the error committed by Ms. Matkins in transporting Resident # 1 on November 18, 2005. Consequently, there is no basis for me to conclude that Petitioner remained deficient after that date. (6)

The weight of the evidence is that Ms. Matkins' error on November 18, 2005 was an isolated failure on her part to implement training and safety techniques that Petitioner had provided to her. There was nothing about the accident that occurred on November 18, 2005 that would lead a reasonable individual to conclude that there was a generalized problem with the way in which Petitioner transported residents or with the training and safety guidance that Petitioner provided to its van drivers. Petitioner had transported thousands of residents safely, since 1983, without ever experiencing an accident resulting in injury to a resident. P. Ex. 1, at 5.

Ms. Matkins received training as a driver beginning on September 22, 2005. P. Ex. 3, at 1. She had been instructed in all of the requirements and precautions for operating a vehicle, including instruction and training on how to safely load, secure and unload residents in wheelchairs and in emergency procedures. Id. Ms. Matkins had successfully completed over 200 resident transports prior to November 18 including 49 that involved wheelchair-bound residents. P. Ex. 1, at 5.

Petitioner's staff reacted appropriately and immediately to the November 18 accident by focusing on Ms. Matkins' discharge of her job responsibilities. Immediately after the accident Ms. Matkins met with responsible staff and demonstrated to them how she loaded and secured the wheelchair in the van. P. Ex. 3, at 4. On Monday, November 21, 2005, Ms. Matkins also met with responsible staff and reviewed safe loading, securing and unloading of residents in wheelchairs and emergency procedures. Id.; P. Ex. 19, at 2. (7)

I do not find that Petitioner's deficiency was prolonged past November 18, 2005 by the two-day delay in providing refresher training to Ms. Matkins. November 18, 2005 was a Friday and no transports were scheduled for the weekend that followed. P. Ex. 19, at 2. Thus, Ms. Matkins received retraining the first working day after November 18, 2005.

7. A civil money penalty of $3,050 is reasonable as a matter of law.

The minimum civil money penalty that I may impose for an immediate jeopardy level deficiency is $3,050. 42 C.F.R. � 488.438(a)(1)(i). That is the amount that CMS determined to impose and which I sustain here, but only for November 18, 2005, and not for any subsequent dates.

JUDGE
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Steven T. Kessel

Administrative Law Judge

FOOTNOTES
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1. An immediate jeopardy level deficiency is one in which a facility's noncompliance with participation requirements is so egregious as to cause serious injury, harm, impairment, or death to a resident or as to cause a likelihood of serious injury, harm, impairment, or death to a resident. 42 C.F.R. � 488.301.

2. In its pre-hearing brief CMS incorrectly avers that Petitioner failed to comply with 42 C.F.R. � 483.13(c)(i) - (iii). However, its intent to charge Petitioner with noncompliance with 42 C.F.R. � 483.13(c)(4) is evident from the content of its argument. I find no prejudice to Petitioner from this error.

3. The resident returned to the emergency room early on the morning of November 19, 2005, due to signs of weakness, increased confusion, and sudden onset of bowel and bladder incontinence. P. Ex. 12, at 1. The assessment of the emergency room staff was that the resident was suffering from probable side effects of medication. Id. at 2. He returned to Petitioner's facility later on the morning of the 19 th and experienced no additional complications from his injuries.

4. If CMS's premise - that a simple act of negligence by a facility employee in carrying out his or her assigned duty is an act of "neglect" triggering reporting requirements - is carried to its logical conclusion then every deficiency by a nursing facility could be characterized as neglect.

5. The requirement that Petitioner establish CMS's determination of immediate jeopardy to be "clearly erroneous" is a much higher burden than simply proving the determination to be erroneous by the preponderance of the evidence. I make no finding in this decision as to whether CMS's determination would survive based on a preponderance of the evidence analysis.

6. CMS offered no explanation as to why it concluded that Petitioner's noncompliance persisted after November 18. See CMS's pre-hearing brief.

7. In the ensuing 10 days Petitioner also engaged in extensive refresher training with its other drivers. However, although this was laudable and appropriate I do not find these actions to have been a necessary response to the isolated act of negligence by Ms. Matkins. There is no evidence in this case establishing that there was a generalized failure prior to November 18, 2005 by Petitioner's van drivers to follow safety precautions or to implement the training that Petitioner's management had given to them previously.

 

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