Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
|IN THE CASE OF|
Montrose Bay Health and Rehabilitation Center,
|DATE: June 02, 2004|
- v -
Centers for Medicare & Medicaid Services.
| Docket No.C-02-550
Decision No. CR1186
Montrose Bay Health and Rehabilitation Center (Petitioner) was not in substantial compliance with Medicare conditions of participation governing nursing home facilities at an immediate jeopardy level from April 11, 2002 to May 5, 2002.
Further, a civil money penalty (CMP) of $120,000 ($5,000 per day for the period April 11, 2002 to May 5, 2002) is reasonable.
Petitioner is a skilled long-term care nursing facility located in Montrose, Alabama that participates in the Medicare and Medicaid programs. On April 9 - 12, 2002 the Alabama Department of Public Health (the state agency) conducted a complaint and follow-up survey. (1) The state agency cited Petitioner for numerous alleged deficiencies, four of which were categorized as immediate jeopardy, and recommended remedies including a $5,000 per day CMP beginning April 11, 2002, and termination of Petitioner's Medicare/Medicaid participation effective May 5, 2002. On May 1 and 2, 2002, the state agency conducted its final complaint and follow-up survey and found that Petitioner was still out of compliance with several federal participation requirements and that immediate jeopardy continued.
The Centers for Medicare & Medicaid Services (CMS) terminated Petitioner from participation in Medicare and Medicaid effective May 5, 2002. Petitioner was re-certified to participate in Medicare and Medicaid effective June 14, 2002. Joint Stipulations of Undisputed Fact, August 15, 2002. CMS also imposed a CMP of $5,000 per day effective April 11, 2002, to the date of termination and a denial of payment for new admissions effective April 11, 2002.
Petitioner timely requested a hearing and the case was assigned to me for hearing and decision.
On September 17 and 18, 2002, I held a hearing in Mobile, Alabama as reflected by the 503-page transcript of proceedings. During the hearing, CMS offered into evidence CMS Exhibits (CMS Ex.) 1 - 50. (2) Petitioner objected to CMS Ex. 44 because it duplicated one of Petitioner's exhibits. Transcript (Tr.) 17 - 21. I admitted into evidence all of CMS's exhibits, except CMS Ex. 44. Tr. 21. Petitioner offered into evidence Petitioner's Exhibits (P. Ex.) 1 - 12, which were admitted without objection from CMS. Tr. 23.
Both parties were sent a copy of the hearing transcript. On November 15, 2002, CMS submitted a list of errata in the form of a motion to correct the transcript. I find no action necessary on the motion to correct the transcript, but rather the list of errata will be appended to the transcript for reference.
At the end of the hearing I asked the parties to submit post hearing briefs. CMS submitted a post hearing brief (CMS Br.) and a post hearing reply brief (CMS R. Br.). Petitioner submitted a post hearing brief (P. Br.) and a post hearing reply brief (P. R. Br.)
Petitioner is a long-term care facility participating in both the Medicare program as a skilled nursing facility (SNF) and in Medicaid as a nursing facility (NF). The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Social Security Act (the Act) and at 42 C.F.R. Part 483.
Sections 1819 and 1919 of the Act vest the Secretary of Health and Human Services (Secretary) with authority to impose CMPs against a long-term care facility for failure to comply substantially with federal 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 488 provides that facilities that participate in Medicare may be surveyed on behalf of CMS by state survey agencies in order to determine whether the facilities are complying with federal 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 per instance or per day civil money penalty against a long-term care facility when a state survey agency concludes that the facility is not complying substantially with federal participation requirements. 42 C.F.R. §§ 488.406, 488.408, and 488.430. The regulations in 42 C.F.R. Part 488 give CMS a number of different remedies that can be imposed if the facility is not in compliance with Medicare requirements. Id.
The regulations specify that a civil money penalty that is imposed against a facility will fall into one of two broad ranges of penalties. The upper range of civil money penalties, of 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. The lower range of civil money penalties, of 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. §§ 488.408, 488.438.
Pursuant to 42 C.F.R. § 488.301, "[i]mmediate jeopardy means a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." (Emphasis in original). Further, "[s])ubstantial compliance means 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." 42 C.F.R. § 488.301. (Emphasis in original).
When a penalty is imposed and appealed, CMS must make a prima facie case that the facility has failed to comply substantially with federal participation requirements. To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. 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, No. 98-3789 (GEB) (D.N.J. May 13, 1999).
The Act and regulations make a hearing before an administrative law judge (ALJ) available to a long-term care facility against whom CMS has determined to impose a civil money penalty. 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 F2d. 678 (8th Cir. 1991).
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 affect 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 (Board) 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).
FINDINGS OF FACT AND CONCLUSIONS OF LAW
I make the following findings of fact and conclusions of law in support of my decision in this case. Each conclusion of law is set forth followed by my findings of fact and detailed analysis.
Two surveys, the April 2002 and May 2002 surveys, and the resulting remedies are at issue in this case. I have examined closely all of the evidence of record to determine whether Petitioner was complying with participation requirements. As discussed hereafter, I conclude that Petitioner was out of compliance with participation requirements at the immediate jeopardy level. Petitioner was also cited for failing to meet seven requirements for participation at a level less than immediate jeopardy. The alleged non-immediate jeopardy deficiencies, identified by "tag number" and regulatory authority, are as follows:
I conclude the evidence establishes multiple deficiencies at the level of immediate jeopardy and it is not necessary that I make findings concerning the non-immediate jeopardy deficiencies inasmuch as the presence or absence does not impact my decision in this case.
The applicable regulations authorize termination of a provider agreement if a provider is found to be out of substantial compliance with even a single program requirement and whether or not immediate jeopardy is present. 42 C.F.R. § 488.456 (b)(1)(i). Additionally, I have the discretion to exercise judicial economy and not discuss every alleged deficiency. Beechwood Sanitarium, DAB No. 1824 at 22 (2002); Western Care Management Corp., DAB No. 1921 (2004).
This deficiency involves the elopement of Resident 7 on March 28, 2002. The surveyor alleged that Petitioner failed to "alarm/lock" all doors and failed to adequately monitor Resident 7, whom the surveyor believed had a "history of attempts to leave the facility." CMS Ex. 1, at 16.
The applicable regulation at 42 C.F.R. § 483.25 entitled "Quality of care" provides:
Regarding the prevention of accidents, 42 C.F.R. § 483.25(h)(2) provides that a facility must ensure that "[e]ach resident receives adequate supervision and assistance devices to prevent accidents."
At the time of the survey, Resident 7 was a 77-year-old man originally admitted to Petitioner's facility on February 19, 2002. He was diagnosed with diabetes insipidus, Parkinson's disease, rheumatoid arthritis, dementia, and a history of stroke and seizures. P. Ex. 4, at 156, 185.
On the evening of March 28, 2002, Resident 7 was found outside of Petitioner's facility on the ground near the kitchen door with a laceration to the head and shoulder bruises. P. Ex. 4, at 3- 4; CMS Ex. 1, at 3. Resident 7 exited the facility through an unlocked and unalarmed kitchen door without the knowledge of staff. P. Ex. 4, at 3-4; CMS Ex. 1, at 20. Resident 7 was sent to the emergency room where he was treated and released. P. Ex. 4, at 4.
CMS maintains that Petitioner's failure to properly supervise Resident 7 pursuant to 42 C.F.R. § 483.25(h)(2), led to his elopement and subsequent injury. Specifically, CMS charges that there were many indications that Resident 7 was in need of closer supervision and that Petitioner failed to make appropriate interventions to prevent an immediate jeopardy situation.
The evidence shows the following:
These facts clearly indicate that Resident 7 was agitated and confused during the period leading up to the night of March 28, 2002, and on that night, he expressed the desire to leave the facility. While the surveyor indicated in the Statement of Deficiencies, (SOD) dated April 12, 2002, her belief that there was some history of prior elopements (CMS Ex. 1, at 16), there is no competent evidence that Resident 7 attempted a prior elopement. The surveyor refers in the SOD (CMS Ex. 1, at 19) to comments of a Certified Nurses Aide (CNA) she interviewed on April 10, 2002, in which he apparently stated that Resident 7 tries to leave "all the time" and "will transport himself to just about every exit, pack his clothes and head to any door he can find . . . ."
Neither the SOD nor the surveyor's notes (CMS Ex. 11) clarifies this hearsay evidence and whether the CNA was referring to Resident 7's activity prior to March 28, 2002 or during the period between the March 28 elopement and April 10, 2002 the date of the interview. My review of Resident 7's clinical records at P. Ex. 4 reveals that the CNA's comments would be accurate if he was referring to the period between March 28, 2002 and April 10, 2002. I find, however, no evidence that supports the surveyor's assertion that Resident 7 had a history of elopements or attempts prior to March 28, 2002.
Petitioner contends that Resident 7 did not have a history of attempts to leave the facility or wandering before the elopement on March 28, 2002, and argues that "[P]etitioner had no reason to believe that [Resident 7] was an elopement risk and had no basis for exercising any heightened level of supervision." P. Br., at 16. I disagree with Petitioner's argument that it should be absolved because Resident 7 had no history of elopement.
The regulations do not require a skilled nursing facility to have a staff member watch every resident, twenty-four hours a day. The regulation does require that a facility ensure that "[e]ach resident receives adequate supervision and assistance devices to prevent accidents." 42 C.F.R. § 483.25(h)(2). 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)(2), 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); Koester Pavilion, DAB No. 1750, at 25-26 (2000).
42 C.F.R. § 483.25(h)(2) of the Act 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. Woodstock, DAB No. 1726, at 26-27.
Based on the regulations and the case law in this area, 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.
CMS clearly made a prima facie showing in this case. Although Resident 7 had no past history of elopement, his erratic behavior in the period leading to March 28, 2002, and his expressed desire to leave the facility on that date put the facility on notice that more supervision was required for Resident 7. Petitioner argues that "staff was in the process of addressing Resident 7's actual ongoing behavioral problems - agitation - when he wheeled his wheelchair out the back kitchen door." P. Br., at 16. This, of course, is an admission that Petitioner recognized the need for assessment and intervention for Resident 7, but does not address why increased supervision was not being provided during the "process of addressing" Resident 7's situation.
Dr. Richard Powers, a CMS witness, qualified as an expert in the area of "proper management for cognitively impaired residents in nursing homes," succinctly assessed the situation when he said, "[w]hen you believe that you have a situation like this, you need to keep an eye on that individual." Tr. at 71.
Petitioner does not take issue with the notion that immediate jeopardy existed for the elderly, wheelchair confined, demented, Resident 7 as he exited the kitchen door and crashed his wheelchair. However, Petitioner disputes that immediate jeopardy extended beyond the day following the elopement and accident. Petitioner asserts that "there was no immediate crisis or risk to safety on the date of the survey." P. Br. at 16. Petitioner's perspective is that this problem arose because the elderly cook, Miss Laura, could not lock the back kitchen door and the problem was fixed the very next day on March 29, when the lock was fixed and staff was in-serviced on how to lock the door. Id.
Certainly, the defective lock and the fact that Miss Laura did not report it reflect poorly on the state of repair and maintenance of the facility and the facility's administration, but Petitioner misses the true issue and basis for this deficiency citation under 42 C.F.R. § 483.25(h)(2) - Petitioner failed to provide necessary supervision for Resident 7.
Petitioner does not discuss in its briefs how this deficiency was remedied with regard to Resident 7 or how it would handle future similarly situated residents in the future, i.e., how the facility will more quickly, accurately and competently deliver the necessary assistance devices and supervision contemplated by the regulation for the protection of its residents.
Furthermore, Petitioner's plan of correction for this deficiency (CMS Ex. 1, at 16-18, right column) indicates that the lock was repaired on March 29, 2002, but the other remedial actions all appear to have been taken after the survey was completed on April 12, 2002.
I find that CMS established a prima facie case of non-compliance with 42 C.F.R. § 483.25(h)(2), which Petitioner did not rebut by a preponderance of the evidence. Further, I find that the determination that the level of non-compliance was at the immediate jeopardy level was not clearly erroneous and that the immediate jeopardy was on going and existed at the time of the survey.
This deficiency citation involves two separate incidents involving Resident 7. The surveyors alleged: (a) that the facility failed to "ensure safe and appropriate techniques were performed" when Resident 7 was having a seizure and choking; and (b) that the facility failed to "ensure that Resident 7 was given the correct dose of Dilantin" (an anti-seizure medication). CMS Ex. 1 at 7.
The applicable regulation at 42 C.F.R. § 483.25 is part of a broad "quality of care" regulation which basically requires that a facility must provide care and services in a manner which is in the best interest of each resident.
On March 3, 2002, Stephanie Watson, a facility CNA, saw Resident 7 choking and seizing in the facility dining room. CNA Watson testified at the hearing that she was working at Petitioner's facility on March 3, 2002, and was in the dining room when she observed that:
CNA Watson elaborated that upon entering the dining room she saw Resident 7 in his wheelchair; a nurse was behind him attempting to do the Heimlich maneuver, another nurse had tilted his head back; another nurse was sticking a knife in his mouth; and CNA Watson saw blood in his mouth. Tr. 112, 115. CNA Watson testified that at the time, Resident 7 was blue. CNA Watson testified that she grabbed the knife from Resident 7's mouth. She was able to remove Resident 7's dentures, conduct a finger sweep of his mouth, and remove a piece of meat that had lodged in his throat. Resident 7 then began to breath. Tr. 112 - 113, 115.
CMS argues that Petitioner failed to use a safe or appropriate technique to remove food from the mouth of Resident 7 while he was choking and/or having a seizure. CMS Br. at 15-17.
Specifically, CMS insists that the use of a knife by the director of nursing in Resident 7's mouth/throat to clear his air passageway was harmful and caused bleeding to Resident 7, thereby placing him in immediate jeopardy.
More fundamentally, CMS maintains that the incidence of patients choking in nursing homes is sufficiently common, that Petitioner should have been better prepared to handle the situation. CMS Br. at 16-17.
According to Petitioner, CMS failed to make out a prima facie case because the SOD contains conflicting accounts of the choking/seizing incident. P. Br. at 10. Petitioner points out that a licenced practical nurse who witnessed the incident stated that, "she saw an RN grab a butter knife off the table and pry the resident's mouth open with the knife." CMS Ex. 1, at 10.
In contrast, CNA Watson testified that the director of nursing had a knife down the residents throat. Tr. 112. Therefore, Petitioner reasons that the apparent inconsistency means that CMS has failed to establish the elements of Tag F-309. P. Br. 10.
I am not persuaded by Petitioner's attempt to discredit the testimony of CNA Watson (Tr. at 116 - 118; P. Br. at 10) or to present the evidence as being in conflict. There is no dispute and no inconsistency in the evidence that a knife was placed in Resident 7's mouth by a member or members of Petitioner's nursing staff. It is the use of the knife and its placement in Resident 7's mouth rather than some more appropriate device or procedure that is the gist of the deficiency citation and the basis for CMS's determination of immediate jeopardy.
Why Petitioner's nursing staff chose to use a butter knife or the purpose of its use is not determinative and I note that Petitioner called no witness to explain.
Petitioner argues that CMS offered no evidence that the use of the knife by the director of nursing to attempt to open Resident 7's air passage way was ill-advised. P. Br. at 10. Petitioner is in error. On direct examination, Dr. Powers was very clear about his opinion regarding placing a knife in the mouth of a seizing resident:
Tr. at 85.
Dr. Powers opined that Petitioner failed to have the necessary management, staff training, and equipment in place in order to handle such emergencies that are a common occurrence in skilled nursing facilities. Tr. 81-85.
Petitioner's suggestion that CMS needed to show that placing a knife in a resident's mouth was ill-advised, also reflects a misunderstanding of the burden of persuasion. It is undisputed that a knife was placed in Resident 7's mouth by a member of Petitioner's staff while Resident 7 was seizing or in distress. It is a matter of common knowledge and common sense, in this case supported by expert opinion, that placing an object such as a butter knife in the mouth of a seizing resident could cause injury to that resident. This intervention was hazardous to the resident's health and safety and is sufficient in this case to make out a prima facie violation of the regulation.
Petitioner's point is well taken that in an emergency, one does what is necessary to save a life. However, Petitioner misses the point that a facility should have proper equipment and procedures in place so as not to unnecessarily exacerbate an emergency situation, particularly in a long-term care environment where swallowing problems are not uncommon, particularly in the dining room. Petitioner's plan of correction (CMS 1 at 7- 9) indicates that after the April survey staff received training on seizure and choking incidents and that a higher percentage of staff would receive cardio pulmonary resuscitation (CPR) training.
Petitioner further maintains that even if there is a deficiency in this instance, the facts of this incident do not justify an immediate jeopardy finding, nor do they serve as a basis for a prospective per-day civil money penalty. P. Br. 10. Indeed, Petitioner repeats this argument throughout its brief regarding every alleged deficiency. Given the facts, I cannot find that the immediate jeopardy determination was clearly erroneous. Petitioners' in the cases of Barnhill Care Center, DAB No. 1848 (2002), and Regency Gardens Nursing Center, DAB No. 1858 (2002) made similar arguments. In both those cases the Board held that CMS does have the authority to impose remedies at the end of a survey cycle for instances of non-compliance that occur before the survey, and that the remedies may continue until the facility has corrected the deficiencies. A facility may avoid on-going per day remedies if it can demonstrate that corrective action was taken.
Here, there is nothing in the record that indicates that Petitioner took any corrective action until after the survey. See CMS Ex. 1, at 7-9; P. Br. at 10; P. R. Br. at 4. I conclude similarly with regard to each of the other deficiencies discussed in this decision unless otherwise noted.
Therefore, I find that CMS established a prima facie case that Petitioner was not in substantial compliance with participation requirements at 42 C.F.R. § 483.25, at the immediate jeopardy level. Petitioner did not rebut the prima facie case or show an affirmative defense by a preponderance of the evidence.
The surveyors cited Petitioner under the general "quality of care regulation", 42 C.F.R. § 483.25, for the alleged failure to give Resident 7 his anti-seizure medication as prescribed. There is no indication by CMS as to why the deficiency is alleged under 42 C.F.R. § 483.25 rather than the more specific 42 C.F.R. § 483.60(a) which provides:
See also State Operations Manual, Appendix P (Guidance to Surveyors) at PP 162, F Tag F 426. 42 C.F.R. § 483.25 appears to impose a greater burden on CMS in establishing a prima facie case to the extent that it requires a showing that Petitioner did not provide "care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being" of the resident while 42 C.F.R § 483.60(a) only requires a showing that the Petitioner failed to provide needed drugs. Of course on the facts of this case, if Petitioner failed to administer Dilantin as ordered with resulting seizures, it is but a small step to infer that a seizing resident is not at the state of "highest practicable physical, mental, and psychosocial well-being."
Petitioner is not incorrect in its complaint that the SOD is not a model of clarity on this alleged deficiency. P. R. Br. at 4. However, parsing the allegation carefully, the surveyor alleges that on admission, Resident 7 had an order for Dilantin, 100 mg three times per day. The doctor's orders dated March 1, 2002, required Dilantin 100 mg by mouth every morning and 250 mg of Dilantin by mouth at bedtime. CMS 1, at 7.
The surveyor's review of the orders for Dilantin is consistent with what the records reflect. See P. Ex. 4, at 168, 174. I note that the order signed by the doctor on March 19, 2002, (P. Ex. 4 at 168), which first records the March 1, 2002 order for Dilantin, specifies that the 100 mg morning dose was to be by tablet; however, the 250 mg bedtime dose includes no such specification by the doctor. The surveyor refers to a March 3, 2002 note in Resident 7's records that requested to check the Dilantin order for Resident 7 because the order required 250 mg, but the facility only had 100 mg tablets/capsules. Id. at 8. The surveyor reviewed the medication administration records for Resident 7 and found that on March 1 and 2, 2002 at 8 p.m. a nurse administered Dilantin to Resident 7.
During an interview with the surveyor the nurse reported that she could not find 50 mg tablets and so contacted the pharmacy which reported that the tablets had already been sent to Petitioner for Resident 7. The nurse admitted that she used another resident's liquid Dilantin on March 1 and 2, 2002. The nurse then found Resident 7's full card of Dilantin 50 mg tablets and she gave him one on March 3, 2002. The nurse advised the surveyor that when she next worked with Resident 7 on March 9, 2002, no other 50 mg tablets had been used. CMS Ex. 1, at 9 - 10. A different nurse told the surveyor that on March 7, 2002, she used another resident's liquid Dilantin for Resident 7 and that it sometimes took two to three days to get medications from the pharmacy. Id. at 10.
Petitioner does not dispute that liquid Dilantin was used rather than 50 mg tablets several times during the period March 1 through March 8, 2002. P. Br. at 11-12. Resident 7's MAR for March 2002 reflects no missed morning doses of 100 mg of Dilantin between March 1 and March 30 (March 31 was apparently cut-off when a copy was made of the original document which was not presented at hearing). P. Ex. 4 at 64. The March 2002 MAR does not contain initials for the bedtime dose on March 5, 19, 23, and 30, 2002. Id. The absence of initials establishes that no dose was given. The February MAR for Resident 7 shows no initials in the block for his third dose of Dilantin on February 28, 2002. P. Ex. 4 at 49.
The missed doses on February 28, March 5, 19, 23, and 30, 2002 are sufficient alone to establish a violation of 42 C.F.R. § 483.60(a) (Tag F 426), but CMS did not elect to proceed under this provision. Petitioner's failure to clarify what the treating physician intended by the prescription for 250 mg of Dilantin may also be sufficient to constitute a violation of 42 C.F.R. § 483.60(a). (3) Thus, the question is whether or not CMS has made a prima facie showing that the missed doses amount to Resident 7 not receiving the care and service necessary to achieve and maintain his highest practicable state of physical, mental, and psycho social well-being - the additional element required under 42 C.F.R § 483.25.
I conclude CMS has made the prima facie showing. In the early morning of March 2, 2002, Resident 7 suffered his first known seizure since entering the facility on February 19, 2002. P. Ex. 4, at 110 - 118. On March 3, 2002, the seizure/choking incident in the facility dining room occurred. Id. at 119; Tr. 53-54. Whether or not the missed dose on February 28 or the substitution of liquid Dilantin for tablet form, caused a seizure is subject to some speculation. (4)
The fact is that Resident 7 had seizures after having been seizure free for at least a brief period and the seizures occurred shortly after a missed dose and during the period when the facility admitted administering liquid Dilantin when 50 mg tablets were misplaced.
Therefore, it is not unreasonable to infer that the failure to properly medicate the resident either caused or contributed to his seizure activity. I accept that a resident having seizures after having been seizure free for even a brief period, is not a resident at his highest practicable state of physical, mental, and pschosocial, well-being.
Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.25. Petitioner has failed to establish a defense by a preponderance of the evidence.
Further, I reject Petitioner's remaining arguments that the immediate jeopardy and the per day civil money penalty is arbitrary for the same reasons stated supra. Barnhill Care Center, DAB No. 1848 (2002); Regency Gardens Nursing Center, DAB No. 1858 (2002).
This deficiency was cited by the surveyors on both the April and May surveys. Both citations of deficiency involve Resident 6. On the April 2002 survey, the surveyor alleged that Petitioner "failed to assess and identify a potentially hazardous condition of a resident's bed . . . (and) failed to identify the potential for entrapment and accidents related to the resident's use of . . . siderails, and the resident's extremity tremors and physical functioning limitations." CMS Ex. 1, at 12.
On the May 2002 survey, the surveyor alleges with respect to Resident 6 that Petitioner again "failed to identify the potential for entrapment and accidents related to the use of side rails", and Petitioner failed to follow its plan of correction from the April 2002 survey, "by consistently implementing interventions, (Spenco mat, bed alarm, and low bed in lowest position) to ensure the safety of the resident while in bed." CMS Ex. 22 at 9.
The applicable "quality of care" regulation at 42 C.F.R. § 483.25(h)(1) provides that:
At the time of the April 2002 survey, Resident 6 was a 67-year-old male originally admitted to Petitioner's facility Bay on October 21, 2000. P. Ex. 3, at 40 - 41. Resident 6 had an unsteady gait, and a history of falls brought on by progressively worsening Parkinson's disease. Id. at 184. Parkinson's disease caused him to have erratic, involuntary, and uncontrollable movements. Tr. 394. He also had a history of strokes and hypertension. Id. His Minimum Data Set (MDS) from March 2002 reflects that he was totally dependent on staff for bed mobility and transfers during the seven-day assessment period, and that bed rails were used for bed mobility and transfers. P. Ex. 3, at 143 - 144.
Resident 6's MDS from April 22, 2002, originally reflected the same assessment, but bed mobility was subsequently changed to reflect that while he required extensive assistance, he did perform some turning side-to-side and changed position while in bed. Id. at 148 - 149. The April 2002 MDS has an attached Resident Assessment Protocol (RAP) Review Report Summary dated April 22, 2002, that includes the comment that "he did slide into bed rail and due to his inability to pull self up he got stuck there." Id. at 163.
A review of incident/accident reports and interdisciplinary progress notes reveal that Resident 6 had several incidents involving the side rails of his bed. On January 29, 2002, at about 30 minutes past midnight, he was found wedged between the side rail and bed frame, with bruises to the left side of his face. Progress notes indicate he was placed in a bed with better side rails about 10:30 a.m. that same day. P. Ex. 3, at 227.
On March 20, 2002, Resident 6 was found either on the floor of his room (P. Ex. 3 at 37) or nearly on the floor of his room ( Id. at 38). Resident 6 was "flipping off one side onto the other" and the side rail gave way (Id. at 37) or he knocked down the foot board and rail when he tried to hop the rail (Id. at 38). See also, id. at 232. After the April 2002 survey, on April 16, 2002, Resident 6 was found with his left leg wedged between the side rail and bed frame with bruising on his left knee. Id. at 36, 242.
Resident 6's comprehensive plan of care was updated on April 16, 2002, to reflect that he thrashes his legs "against + in side rails" and he was at risk for injury. Id. at 9. Soft pads were applied to his side rails on April 16, 2002, and the soft pads were continued on April 19 when he was moved to a new "hi/low bed" with 3/4 length rails. Id. The hi/low bed with 3/4 length rails and soft pads was discontinued on May 2, 2002, when Resident 6 was placed on a low bed (frame is nine inches from floor) with no side rails, but with a soft mat against the wall and a mattress on the floor on the open side. Id. at 26-27, 249.
CMS presented the testimony of Cyndi Green Ashley, the surveyor who made the observations reflected in the SOD related to Resident 6 in both the April 2002 and May 2002 surveys. Tr. at 146. Ms. Ashley testified that she found no evidence that Petitioner had done a comprehensive assessment of the use of side rails for Resident 6. Id. at 146 -147. Ms. Ashley's testimony was consistent with her observations as recorded in the SOD (CMS Ex. 1, at 11-16; CMS Ex. 22 at 9 - 12. Her testimony was also consistent with the information recorded in Resident 6's facility records set out above from P. Ex. 3.
Ms. Ashley confirmed her personal observation of April 11, 2002, that the addition of a specialty mattress on top of Resident 6's standard mattress left only 2.5 inches to the top of the side rail with a 28-inch drop from the top of the mattress to the floor. Tr. at 148.
Ms. Ashley opined that this presented a hazard to Resident 6 because it was known that he was restless in bed and draped his leg over the side rail, had fallen and been entrapped before, and pulled himself over in bed using the side rail. Tr. at 147 - 150.
Ms Ashley confirmed on cross-examination her statements in the May 2002 SOD that she personally observed a 5-inch gap between Resident 6's mattress and the side rail while he was lying in the bed. Tr. 180; CMS Ex. 22, at 11. Ms. Ashley testified that in her opinion the use of side rails as observed during the April 2002 survey and the continued use during the May 2002 survey, despite changes during the interim, continued to present immediate jeopardy for Resident 6. Tr. 150. Ms. Ashley also testified that the facility's failure to recognize and assess the problems with Resident 6 reflected that the risk extended to other similarly situated residents. Tr. at 151. Ms. Ashley also confirmed her observations as recorded in the SOD that interventions listed in Petitioner's April plan of corrections were not being consistently implemented during the May 2002 survey. Tr. 155 - 162; CMS Ex. 22, at 11.
CMS also presented the testimony of an expert in bed rail safety, Elizabeth Capezuti, Ph.D., who characterized as significant that Resident 6 had three entrapments in a three- month period and that Resident 6 was clearly at high risk for entrapment. Tr. at 265, 270. Dr. Capezuti also opined that bed rails should not have been used with Resident 6. Tr. at 271.
CMS contends that given Resident 6's limited physical capabilities, Petitioner failed to identify the potential for entrapment and accidents related to Resident 6's use of side rails, and that this failure placed him in immediate jeopardy. CMS Br.at 21-22.
Petitioner argues that:(1) the state agency surveyor's failure to inform the administrator during the four-day survey that the side rails posed immediate jeopardy to Resident 6, indicates that the surveyor is not credible; (2) the fact that no deficiencies regarding Resident 6's bed rails were cited at the March or January surveys indicates that the surveyor is not reliable; (3) CMS failed to make out a prima facie case to support this citation; (4) in both incidents involving side rails (January 29, 2002, and March 20, 2002) Resident 6 was not injured; (5) CMS's contention that Resident 6 could have gotten his head entrapped in a 16-inch gap that exited between the end of the side rail and the foot of his bed is ludicrous; (6) the surveyor's testimony that the top of the side rail was only two inches above the top of the mattress is not credible because Resident 6 would have constantly fallen over the rails and out of bed; (7) the regulations do not prohibit the use of side rails, nor do they require a facility to eliminate all potential risk of accidents; (8) the benefits of side rails out weighed the potential risk of harm; (9) when Resident 6 relocated to Florida, the new facility placed him on a bed with side rails; (10) Resident 6's bed and side rails had no gaps that could pose a risk of entrapment; and (11) CMS's citation of the alleged deficiency at an immediate jeopardy level was arbitrary and capricious.
Petitioner's arguments are without merit. Dr. Capezuti was qualified as an expert in bed rail safety in the long-term care setting. Dr. Capezuti indicated that she had reviewed the relevant medical charts and facility records in this case and offered her opinion as to whether or not the facility took the necessary action to protect Resident 6 from injury:
Dr. Capezuti's opinion testimony which was based upon her review of Resident 6's records and her opinions regarding the risks to Resident 6 are credible. Her expert opinion is unrebutted. Petitioner notes that Dr. Capezuti never interviewed Resident 6 and never personally observed him (P. Br. at 18) and Petitioner suggests that her opinion is thus, "not particularly probative." Dr. Capezuti's opinions are based on her expertise, which Petitioner conceded at hearing (Tr. at 255 - 259), and upon Petitioner's own records of its treatment of Resident 6, the accuracy of which has not been disputed by Petitioner.
Thus, Dr. Capezuti's opinion is probative and weighty. Her opinion standing alone would be sufficient to find a prima facie case of a violation, but there is also much other evidence in support of this deficiency.
The evidence, including Dr. Capezuti's opinions, establish that Resident 6 was subject to a significant risk of injury in two respects: (1) from the positioning of mattresses on his bed and use of side rails during the April 2002 survey which presented risks for falls and entrapment; and, (2) during the May 2002 survey, the continued use of side rails and Petitioner's failure to consistently implement the interventions it proposed in its plan of correction to the April 2002 survey, i.e. observations of the bed in the high position, mats and pads not in correct position, alarm on the floor, also creating the potential for more falls and entrapment.
Petitioner also argues that both surveyor Ashley and Dr. Capezuti are against the use of side rails. P. Br. at 18-19. Actually, both these witnesses emphasized that the use of side rails is perfectly legitimate for many residents, but for some residents it is not. Surveyor Ashley and Dr. Capezuti indicated that Resident 6's uncontrollable movements and rigid body made it more likely he could get caught in between the side rail and the mattress, posing a danger to his life. Tr. 163-164; Tr. 260-261. Surveyor Ashley testified that there was a five inch gap between the side rail and the mattress when she visited Resident 6's room the morning of May 1, 2002. Tr. 159-160. Petitioner attempts to refute this allegation by presenting photos of Resident 6's bed indicating a gap of much less than five inches. P. Ex. 5. Petitioner also presented contradictory testimony from its Director of Nursing, Travis Raynor, who began working at Petitioner's facility on April 16, 2002, after the survey and Ms. Ashley's observations . Tr. at 453. I find Petitioner not persuasive in its attempt to discredit Ms. Ashley regarding her observations. Petitioner did not present the testimony of an eye witness who made direct observations contemporaneous with those of Ms. Ashley. Rather, Petitioner attempts to create inconsistency by staged photographs and opinions from one who made observations at different times and under different conditions.
My decision does not, in fact, turn upon Ms. Ashley's observations regarding mattress height and gaps. What is critical is that:Resident 6 had diagnoses that put him at risk for falls; he had at least one entrapment incident and a fall and/or entrapment incident prior to the April 2002 survey; and he had another entrapment shortly after the April survey. Clearly Petitioner and its staff should have been on notice that there was a risk of falls and entrapment with Resident 6 both before and after the April survey.
Petitioner made some efforts to minimize these risks with bed changes and pads, indicating it was on notice of the risks to Resident 6. After the April survey, Petitioner proposed even further interventions to reduce the recognized risks to Resident 6 and Ms. Ashley's observations indicate that many of the interventions were being attempted.
However, it is also clear and undisputed that during the May 2002 survey, pads were not in place, the bed was not in the lowest position when no care was being provided, the bed alarm was disconnected, and the call light button was on the floor. Thus, Petitioner cannot credibly argue that during either the April or May surveys, Resident 6's environment was as free of accident hazards as possible, as required by the regulation.
Therefore, I find that CMS established a prima facie case, which Petitioner did not rebut by a preponderance of the evidence, that Petitioner was not in substantial compliance with participation requirements at 42 C.F.R. § 483.25(h)(1).
The immediate jeopardy determination is not clearly erroneous. I reject Petitioner's arguments that the immediate jeopardy determination and the per day civil money penalty is arbitrary for the same reasons stated supra. Barnhill Care Center, DAB No. 1848 (2002); Regency Gardens Nursing Center, DAB No. 1858 (2002).
The applicable regulation at 42 C.F.R. § 483.75 entitled "Administration" provides that:
CMS contends that Petitioner violated this requirement as alleged during the April 2002 survey and that the violation poised immediate jeopardy for Petitioner's residents. CMS points to numerous examples of what it alleges to be poor administration by Petitioner:
CMS Ex. 1, at 21-23.
This is a derivative deficiency to the extent that each allegation is also the basis for a separately cited violation of another regulatory requirement, all of which save the first, have already been analyzed in this decision and have been found to constitute deficiencies that presented immediate jeopardy for Petitioner's residents.
Petitioner does not dispute CMS' claim regarding the administration deficiency, but rather argues that the state agency and CMS failed to give adequate notice of this immediate jeopardy deficiency in the April 15, 2002 notice letter. P. Br. at 17; CMS Ex. 48.
It is true that the state agency failed to include this immediate jeopardy deficiency (Tag F-490) in its April 15, 2002 notice of deficiency letter with the other immediate jeopardy tags listed. CMS Ex. 48. Clearly the state committed an error in its letter.
However, Petitioner was clearly on notice of the alleged immediate jeopardy deficiency by its undenied receipt of the SOD (CMS Ex. 1, at 21). Therefore, this error was not prejudicial to Petitioner and I will not find it a bar to CMS pursuing this deficiency.
I find no prejudice as Petitioner was very much aware of what CMS intended to plead and prove in this case.
First, CMS stated very clearly and thoroughly the administration deficiency allegation in the SOD, including the notation that it was being cited at the J level indicating immediate jeopardy. CMS Ex. 1, at 21.
Second, CMS witnesses testified specifically regarding the Petitioner's administration and management problems. See Powers, Tr. 81-85; Tr. 260-261.
Third, and perhaps most importantly, Petitioner has never alleged (until its posthearing brief) that it was not given sufficient notice regarding the 42 C.F.R. § 483.75 deficiency. Nor, for that matter, has Petitioner alleged or attempted to prove that it was some how prejudiced by CMS's failure to include this deficiency in its notice letter.
Thus, I find that 42
C.F.R. § 483.75, F Tag 490, was violated, and lack of notice is no defense
in this instance. The immediate jeopardy determination was not clearly
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; and (4) the facility's degree of culpability.
CMS determined to impose civil money penalties at the immediate jeopardy level of $5,000 a day from April 11, 2002, to May 5, 2002. (5) CMS bases its determination to impose these penalty amounts largely on the history, seriousness, and repeated nature of the deficiencies at Petitioner's facility. CMS Prehearing Brief at 18-19. A review of Petitioner's "History Facility Profile" indicates that Petitioner has had its share of deficiencies dating back to 1998. P. Ex. 43.
However, I do not conclude that Petitioner's problems were due to indifference or gross negligence. Although not always successful, Petitioner made an effort during this survey cycle to correct its deficiency problems. Contrary to Petitioner's assertions, however, each of the deficiencies I discussed presented a situation of continuing immediate jeopardy for its residents throughout the period I approve for the accrual of the civil money penalty.
I have considered what would be reasonable as civil money penalties for non-compliance that Petitioner manifested from April 11, 2002, through May 5, 2002, at the immediate jeopardy level. I conclude that $5,000 per day is a reasonable penalty for each day of Petitioner's noncompliance. I make my decision based on the factors cited at 42 C.F.R. §§ 488.438(f) and 488.404 (incorporated by reference into 42 C.F.R. 488.438(f)(3)). I have considered the following:
The upper range of civil money penalties, of 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 $5,000 per day civil money penalty amount that CMS proposed to impose against Petitioner is in the lower range of the immediate jeopardy scale, and I find it to be reasonable.
Petitioner points out that it was found deficient by surveys conducted in January and March 2002, findings of deficiency that Petitioner elected not to appeal or dispute. Based on the January and March 2002 surveys, Petitioner had been notified that its participation agreement would be terminated effective July 11, 2002, if it did not achieve substantial compliance before that date. P. Br. at 3.
Although not specifically addressed in its post hearing briefs, Petitioner suggested in its prehearing brief that it was improper for CMS to effect termination on May 5, 2002 since notice of a July 11, 2002 termination date had previously been given. Petitioner's Prehearing Brief at 14.
no legal authority for the suggestion that CMS cannot terminate immediately
when the situation warrants or that CMS is somehow limited by its prior
notices of termination dates. 42 C.F.R. §§ 488.456(c)(1) and 489.53(c)(2)
only require that CMS give a minimum of two calendar days notice of termination
when immediate jeopardy exists. In this case, immediate jeopardy existed
and I find no error in the termination of the provider agreement being
effected on May 5, 2002.
Based on my review of the entire record in this case, I find that Petitioner failed to comply substantially with federal participation requirements for the period April 11, 2002 through May 5, 2002, at the immediate jeopardy level.
Termination is appropriate
effective May 5, 2002, and a civil money penalty of $5,000 per day for
the period April 11, 2002 through May 5, 2002, a total CMP of $120,000,
KEITH W. SICKENDICK
Administrative Law Judge
1. The state agency conducted a complaint survey on January 9, 2002, and a follow- up survey on March 5, 2002. The January 9 survey resulted in a finding of non-compliance, however, no civil money penalties were imposed. The March 5 survey resulted in a finding of non-compliance and the imposition of a $50 per day CMP. The January 9 and March 5 surveys were not challenged by Petitioner and are not at issue in this appeal.
2. The first CMS exhibit was incorrectly marked as "R. Ex. 1". All other CMS exhibits were properly marked. I treat the first CMS exhibit as if it was marked correctly and read any reference to "R. Ex. 1" as "CMS Ex. 1."
3. CMS's expert pharmacist, Lieutenant Commander Nita Sood, discussed the problems with the prescription in detail. Tr. at 223 - 224.
4. Petitioner's own witness Dr. Roddam, testified that he believed that the missed doses probably led to Resident 7's seizures on March 7. Tr. 371-372.
5. Pursuant to 42 C.F.R. § 488.440(g)(2), the accrual of a per day CMP stops on the day the provider agreement is terminated, i.e. the CMP accrues through the day prior to the termination date and then stops effective the date of termination.