CASE | DECISION |JUDGE | FOOTNOTES

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


SUBJECT:

Life Care Center of Bridgeton,

Petitioner,

DATE: April 21, 2004
                                          
             - v -

 

Centers for Medicare & Medicaid Services.

 

Docket No.C-02-727
Decision No. CR1169
DECISION
...TO TOP

DECISION

I uphold the Centers for Medicare & Medicaid Services' (CMS) determination to impose two remedies, a civil money penalty and denial of payment of for new admissions, against Life Care Center of Bridgeton (Petitioner or Facility). Petitioner failed to comply substantially with the requirement for participation in Medicare that each resident receive the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care. 42 C.F.R. § 483.25 (this requirement is referred to by CMS as F-Tag 309 (F-309)).

CMS determined also that Petitioner's deficiency constituted immediate jeopardy. (1) And, CMS assessed the per instance civil money penalty at the highest amount allowable: $10,000. I decide that the amount of the civil money penalty is unreasonable; $2,000 is a reasonable amount.

I. Procedural History

Pursuant to CMS's authority to enforce compliance with the participation requirements for Medicare and Medicaid, the Missouri Division of Health and Senior Services, the State survey agency (Surveyors), conducted a survey from April 21 through April 26, 2003. CMS Exhibit (CMS Ex.) 1. In a notice letter to Petitioner, dated May 17, 2002, CMS indicated that it had determined the Facility failed to comply substantially with program requirements, and that " . . . the conditions in your facility constituted immediate jeopardy . . . to resident health and safety." CMS Ex. 3, at 1. CMS imposed a per instance civil money penalty of $10,000 for the deficiency cited at F-309. Another deficiency alleged by CMS, but not explicitly addressed in the notice letter, was a finding that the Facility failed to comply substantially with Physical Environment requirements provided for at 42 C.F.R. § 483.70. CMS cited this deficiency for the Facility's alleged failure to test its emergency generator under load every 30 days (CMS referred to this deficiency as F-Tag 454 (F-454)). CMS Ex. 1, at 6.

CMS informed Petitioner further, "[i]t is our intent to impose a denial of payment for new admissions if your facility fails to achieve substantial compliance by the revisit." CMS Ex. 3, at 1. CMS's letter notified Petitioner also that the denial of payment would commence July 26, 2002. Id. As indicated by CMS's subsequent letter, dated August 21, 2002, the Surveyors had returned to the Facility on August 15, 2002 and established to CMS's satisfaction that substantial compliance had been achieved. Therefore, CMS notified Petitioner, the denial of payment for new admissions was lifted as of August 15, 2002. CMS Ex. 8. Thus, the denial of payment for new admissions ran from July 26, 2002 to August 15, 2002.

Petitioner timely requested review of CMS's determination by submitting a request for hearing dated July 26, 2002. I convened a hearing at Kansas City, Missouri, on April 14, 2003, and I concluded the hearing on April 15, 2003. At the hearing, I admitted CMS's Exhibits 1-11 and Petitioner's Exhibits (P. Exs.) 1-24 into the record. Hearing Transcript (Tr.) 16-17. Subsequent to the hearing, on August 18, 2003, I received CMS's brief. I received Petitioner's brief on September 25, 2003. I received also reply briefs from each party, CMS's on October 7, 2003 and Petitioner's sur-reply brief on November 3, 2003.

Petitioner filed a letter dated May 23, 2003 noting several errors and omissions in the hearing transcript. CMS did not object to these and I, therefore, emend the record to reflect the errors and omissions described in Petitioner's letter.

At the close of CMS's presentation of its case, Petitioner moved for a decision citing CMS's failure to present prima facie evidence to support the two deficiencies cited. I reserved ruling on Petitioner's motion until the conclusion of all the evidence. Tr. 109-112. Additionally, Petitioner objected to the introduction of rebuttal evidence offered by CMS concerning F-454. I reserved ruling also on that objection and allowed the parties to brief that evidentiary matter posthearing, separately from the briefing of the case-in-chief. Petitioner filed its written objection to rebuttal evidence on April 23, 2003. CMS filed a response on July 21, 2003. And, Petitioner filed a reply on August 5, 2003. I address Petitioner's motion and objection in the statement of the issues (below).

II. Issues, Authority, Findings, Conclusions and Analysis

A. Issues

The issues are: (1) Whether Petitioner substantially complied with the participation requirements; and (2) Whether, if Petitioner did not substantially comply with participation requirements, the amount of the civil money penalty is reasonable.

I conclude that Petitioner failed to comply substantially with F-309, and that this deficiency supports the imposition of the civil money penalty and the denial of payment for new admissions. I note that CMS imposed the $10,000 civil money penalty based solely on Petitioner's failure to comply substantially with F-309. But, I note also, based on CMS's notice letters, either F-309 or F-454 would provide a basis for the imposition of denial of payment for new admissions. CMS's notice letter informed Petitioner that, as a result of the survey findings (i.e, F-309 and F-454), the Surveyors had recommended the imposition of both a civil money penalty and denial of payment for new admissions. CMS's notice letter dated May 17, 2002 informed Petitioner that CMS concurred with the Surveyors' recommendations. CMS Ex. 3, at 1. And in the same letter, CMS emphasized that it was assessing the civil money penalty for the F-309 deficiency only. Id. The letter explained also that the period of denial of payment for new admissions would commence only if the Facility fails to achieve substantial compliance by the revisit survey. Id. CMS's subsequent letter, dated August 21, 2002, makes evident that Petitioner was not deemed compliant early enough to avoid imposition of the denial of payment for new admissions. This latter notice shows that the denial of payment for new admissions was applied from July 26, 2002 (presumably the date of the first revisit survey) to August 15, 2002 (the date of the revisit survey at which substantial compliance was regained). CMS Ex. 8.

It is not necessary for me to decide whether Petitioner was compliant with the requirements under F-454 because the amount of the civil money penalty would not be affected if I concluded Petitioner substantially complied with the deficiency alleged under F-454. I exercise my discretion, therefore, to limit my decision to the deficiency alleged under F-309. My judgment to so limit the decision is consistent with the holding in Beechwood Sanitarium, DAB No. 1824 (2002). In Beechwood, an appellate panel of the Departmental Appeals Board (Board) held that the administrative law judge's (ALJ) decision not to make findings on all the deficiencies disputed by the petitioner was an exercise of judicial economy that is within an ALJ's discretion. The ALJ in that case chose to discuss several deficiencies that he determined to be established persuasively. But, he chose to leave unaddressed several other alleged deficiencies that had been appealed, and about which the parties had presented evidence and argument. The ALJ determined that based on section 1866(b)(2) of the Social Security Act (Act), and 42 C.F.R. § 488.456(b)(1)(I), he needed only to make findings on enough of the deficiencies to support the remedy because the Act and the regulation authorize a remedy when a provider is out of compliance with even a single requirement. Although, unlike the instant matter, the remedies at issue in Beechwood were solely denial of payment for new admissions and termination of the provider agreement, it is logical to extend the principle of judicial economy espoused in Beechwood to appeals of civil money penalties. The relevant regulation at 42 C.F.R. § 488.430 provides that CMS or the State may impose civil money penalties for days or instances when a participating facility does not comply substantially with "one or more participation requirements." Thus, I need only make findings and conclusions concerning a sufficient number of the F-Tags (in this case one F-Tag) to support the remedies in this case. And, as I indicated above, while CMS affixed the civil money penalty to F-309 only, it is evident from the notice letters (see CMS Exs. 3 and 8) that either F-309 or F-454, alone, would support imposition of the denial of payment for new admissions. Thus, my decision to uphold F-309 is sufficient to support both the civil money penalty and the denial of payment for new admissions.

Because it is unnecessary for me to decide the merits of the deficiency alleged under F-454, Petitioner's motion made at hearing, for a decision based on CMS's failure to present evidence of a prima facie case is, insofar as the motion concerned F-454, moot. To the extent that Petitioner's motion challenged CMS's prima facie case concerning F-309, the motion is denied. As I discuss in the Findings, Conclusions and Analysis section (below), I conclude that CMS has presented a prima facie case that Petitioner failed to comply substantially with the requirements described by F-309.

The mootness of Petitioner's motion and the merits of CMS's allegations concerning F-454 notwithstanding, I note that the record appears to exhibit confusion by the parties about which Life Safety Code provisions would apply. In the Statement of Deficiencies (a CMS form filled out by surveyors repotting on the deficiencies and commonly referred to as form-2567 or '2567'), CMS alleged the deficiency under the applicable edition, the 1981 edition of the Life Safety Code (NFPA 101-1981), but referenced also the incorrect edition, NFPA 99 (which applies to facilities newer then Petitioner's). The confusion was highlighted by the Surveyor, Ms. DeKoster's, testimony about which edition is applicable to Petitioner. Confusion is understandable due to the structure of the Life Safety Code and its incorporation into the Code of Federal Regulations, so I note the following as clarification.

The Life Safety Code is developed, published and maintained by the National Fire Protection Association (NFPA). The NFPA's code is incorporated by reference into the Code of Federal Regulations at 42 C.F.R. § 483.70. Determining what specific provisions of the NFPA code apply to a facility is, however, complicated by exceptions allowing certain facilities to rely on superceded editions (grandfathering); the great number of editions of the NFPA codes; and, the tendency of the various NFPA editions to incorporate earlier editions and other publications in lengthy appendixes. It is not surprising that lawyers and laypersons alike will likely find penetrating the Life Safety Codes daunting.

Nonetheless, despite CMS having incorrectly cited both the applicable edition and an inapplicable edition of the Life Safety Code in the 2567, it is evident from the testimony of both parties' witnesses that the parties agree that the edition of the Life Safety Code applicable to Petitioner is NFPA 101-1981. See, Tr. 86-87, 269, and 288. The Surveyor, Ms. DeKoster, testified for CMS that the correct edition, NFPA 101-1981, incorporates by reference NFPA-76A, which she said was an appendix to NFPA 101-1981, and that therein are found the requirements that generators be tested under load. Tr. 88. Petitioner's witness, Mr. Perry, an expert on the development of the Life Safety Code, testified that the NFPA 101-1981 does not require testing generators under load. Tr. 281. CMS's rebuttal witness, Mr. Cleeton, testified that NFPA-76A is the correct place to look for the applicable rule regarding load testing generators, and that NFPA-76A does require testing power generators under load. But he admitted on cross-examination that nursing homes subject to NFPA 101-1981 are not required to have electrical generators unless they have residents on life support. Tr. 291.

I suggest, concerning essential electrical systems requirements, that a different appendix to NFPA 101-1981, NFPA 70-1981, the National Electric Code, is the applicable code. And I suggest that whether Petitioner would meet the exception to certain electrical power requirements, as mentioned by Mr. Cleeton, would be relevant to whether Petitioner was required to test its generator under load, or whether Petitioner was required to provide any electrical generator at all.

Chapter 13 of NFPA 101-1981 concerns 'Existing Healthcare Occupancies.' It separately defines nursing homes, at section 13.1-1.3(b), and ambulatory healthcare centers, at section 13.1-1.3(c), and provides different requirements for each of these two types of facilities. Section 13.5-5 concerns 'building services' and section 13-5.1 addresses 'utilities.' That section provides that utilities shall comply with the provisions of section 7-1. Section 7-1 provides at section 7-1.2, that all electrical wiring and equipment installed shall be in accordance with the National Electric Code: NFPA 70. Concerning nursing homes, NFPA 101-1981 provides that each facility within 13-1.1.1.2, shall be provided with emergency lighting in accordance with section 5-9. NFPA 101-1981, at 13-5. Section 5-9 concerns only emergency lighting, not generators. Thus, there appear to be no requirements in the main text of NFPA 101-1981 that nursing homes posses or test electrical generators.

To distinguish the applicable NFPA section from the similar but inapplicable section, section 13-6, which concerns existing ambulatory healthcare centers, provides that "[w]here general anesthesia or life support equipment is used each ambulatory healthcare center shall be provided with an essential electrical system in accordance with essential electrical systems for healthcare facilities." NFPA 101-1981, at section 13-6.2.9. That section cites NFPA 76A as the applicable resource regarding essential electrical systems. NFPA 101-1981, at section 13-6.2.9.2. And, NFPA 101-1981 provides an exception to that requirement: "where battery operated equipment is provided a generator is not required for emergency power." NFPA 101-1981, at section 13-6.2.9.2. Thus, it appears that NFPA 76A pertains to existing ambulatory care centers subject to NFPA 101-1981, not nursing homes.

Moreover, the appropriate NFPA document for nursing homes subject to NFPA 101-1981, NFPA 70-1981, exempts from certain electrical system requirements, including the requirement to have and maintain an electric generator, some facilities, inter alia nursing homes, which facilities have in place certain preclusionary policies. Exempted from those requirements are those facilities that maintain policies that preclude care of residents who may need to be sustained by electrically operated or mechanical life support devices, offer no surgery requiring general anesthesia, and have battery equipment for certain emergency lighting, communications and alarm systems. Thus, assuming NFPA 70 is applicable to existing nursing homes subject to NFPA 101-1981, the requirement concerning back-up power generators might not apply to Petitioner in this case. The requirement might not apply because, as I discuss further in the Findings, Conclusions and Analysis section (below), Petitioner satisfied at least some of the factors necessary to meet the exception (an ancillary result would be that no generator load testing requirements applied either).

Finally, even were it NFPA 76A that were applicable to nursing homes, that document has exceptions to emergency and critical systems requirements very similar to those in NFPA 70. To meet the exceptions under NFPA 76A, a facility must have policies in place to preclude care of residents who need to be sustained by electro-mechanical means such as electric respirators, suction apparatus, external heart pacers and other life support apparatus; provide no surgical treatment requiring general anesthesia; and have battery systems or equipment for emergency lighting and alarm systems. NFPA 76A at section 4, 411.A.

Concerning Petitioner's objection to CMS's rebuttal evidence, my exercise of discretion to issue no findings concerning F-454 renders Petitioner's objection moot as well because the rebuttal evidence addresses only the allegations concerning F-454. (2)

B. Authority

Title XVIII (Medicare) and Title XIX (Medicaid) of the Act (42 U.S.C. §§ 301-1397jj) set forth requirements for long-term care facilities, both skilled nursing facilities and nursing facilities, participating in the Medicare and Medicaid programs, and authorize the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions. Act, sections 1819, 1919. The Secretary's regulations governing skilled nursing facility and nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483.

If CMS finds 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 42 C.F.R. § 488.406, which include imposing civil money penalties. See Act, section 1819(h). CMS is authorized to assess civil money penalties when a facility is not in compliance with one or more participation requirements. 42 C.F.R. § 488.430(a). The civil money penalties range from $50 to $3,000 per day for deficiencies that do not constitute immediate jeopardy, but either cause actual harm, or cause no actual harm, but have the potential for causing more than minimal harm. Civil money penalties range from $3,050 to $10,000 per day for deficiencies which constitute immediate jeopardy. 42 C.F.R. §§ 488.438(a)(i) and (ii). Or, CMS may impose civil money penalties ranging from $1,000 to $10,000 for a per instance deficiency that constitutes immediate jeopardy. 42 C.F.R. §§ 488.408(d)(3)(ii) and 488.438(a)(2).

The purpose of the authorized remedies is to "ensure prompt compliance with program requirements." 42 C.F.R. § 488.402(a). The remedies are applied in light of the scope and severity of the noncompliance found during a survey. In setting the amount of the civil money penalties, CMS considers: 1) the facility's history of noncompliance; 2) the facility's financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. 42 C.F.R. § 488.438(f). The factors found at 42 C.F.R. § 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility's prior history of noncompliance in general, specifically with reference to the cited deficiencies.

When CMS imposes an enforcement remedy on a skilled nursing facility or nursing facility, the facility has a right to appeal the "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), 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 civil money penalty CMS could collect or affect the facility's nurses' aide training program. 42 C.F.R. § 498.3(b)(14).

CMS's determination regarding the level of noncompliance must be upheld unless clearly erroneous. 42 C.F.R. § 498.60(c)(2). This includes instances where CMS has determined that the level of noncompliance is at the immediate jeopardy level. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000).

In this case the following program requirement is at issue:

42 C.F.R. § 483.25 (F-309). This requires that each resident receive the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

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. 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), slip op. at 25 (D.N.J. May 13, 1999); see also Cross Creek Health Care Center, DAB No. 1665 (1998) (framework allocating the burden of proof provided in Hillman applies in appeals of civil money penalties).

C. Findings, Conclusions and Analysis

1. Petitioner failed to substantially comply with 42 C.F.R. § 483.25 (F-309).

CMS determined that Petitioner failed to comply substantially with the requirement provided in section 483.25 that each resident receive the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care. CMS determined that the Facility failed this requirement as evidenced by its care of Resident 1. I conclude that CMS presented evidence that shows, prima facie, that CMS's determination is correct, and I conclude also that Petitioner failed to rebut CMS's case by a preponderance of the evidence. My findings of fact are incorporated in the following discussion.

The parties do not dispute that Resident 1suffered a stroke while visiting Mississippi in February 2002. Nor do the parties dispute that Resident 1 had numerous and serious health problems that persisted after he was transferred from the hospital in Mississippi to the Facility. Resident 1 was documented as having suffered intra-cerebral hemorrhage, having undergone a tracheostomy, and as suffering from chronic renal failure and hypertension. CMS Ex. 1, at 1,52; CMS Ex. 11, at 58-85; P. Ex. 16, at 11, 14, 15 and 71. While treated at the hospital in Mississippi, Resident 1 was weaned from a ventilator. CMS Ex. 1, at 10; CMS Ex. 11, at 65, 68; P. Ex. 16, at 12; Tr. 49, 178. After Resident 1 was transferred to the Facility on April 12, 2002, which entailed his being flown from Mississippi to Missouri, he was treated for possible infections starting on April 14, 2002. P. Ex. 14, at 7; P. Ex. 15, at 1, 11, and 15. Additionally, Resident 1 had a gastronomy tube, pressure sores on his buttocks and heels, a Foley catheter and a rectal tube. P. Exs. 9-12, 15, and 16. Resident 1 was in do-not-resuscitate status. P. Ex. 13, at 2; P. Ex. 16, at 56.

Resident 1 was provided an oxygen concentrator from the time of his stroke in February 2002 until the events of April 20, 2002. Tr. 196.

On April 20, 2002, there were thunderstorms in the vicinity of the Facility and the power went out at 2:51 a.m., 3:22 a.m., 6:19 a.m., and 6:23 a.m. to 7:28 a.m. CMS Ex. 1, at 2; CMS Ex. 11, at 119; Tr. 32. It is not disputed that, due to the power outage, the Facility did not provide Resident 1 oxygen for a period of time, estimated to have been 30 minutes. Resident 1 dies on April 20, 2002 at approximately 7:00 a.m. CMS Ex. 11, at 149; see also Petitioner's brief at 3.

It is not disputed either that providing him oxygen was a necessary part of the care and services Resident 1 was due to receive from the Facility, in accordance with his plan of care; although, whether the oxygen was beneficial to Resident 1 independent from its utility as a delivery device for humidified air is disputed by Petitioner. The parties focused their arguments on several factors concerning the significance of the oxygen to Resident 1. The factors I have identified are: whether the provision of oxygen to Resident 1 was crucial to his well-being or merely a comfort measure; whether, based on the significance of the oxygen to Resident 1, he required supplemental oxygen immediately after the power failed; and whether, if Resident 1 needed oxygen immediately, the Facility took too long to provide it to him. I find, as I discuss fully below, that the oxygen or humidified air -- and perhaps both -- was essential to Resident 1's well-being and was more than a mere comfort measure that Resident 1 could do without. I find also that Resident 1's need for supplemental oxygen was immediate. Finally, I find that the Facility took too long to provide Resident 1 with a back-up source of oxygen.

First, to dispel confusion, I note that this case is not properly a dispute over whether Petitioner is responsible for cutting off Resident 1's air supply and thereby killing him. Resident 1 received oxygen dispensed from an oxygen concentrator pursuant to his physician's order. CMS Ex. 11, at 46. The record suggests that at the outset of its investigation, CMS was under the mistaken impression that Resident 1 was dependent on the oxygen provided via the concentrator to breathe and that his death was due to respiratory failure brought on by the loss of power to the oxygen concentrator. This impression is understandable because reports from the paramedics who responded to the Facility and reports from the county Medical Examiner indicate that the paramedics and the Medical Examiner operated, at least initially, under the assumption that Resident 1 had required a ventilator or "life support" to breathe, and that his death was a result of the power failure. See CMS Ex. 11, at 115-116; P. Exs. 18 and 19. Additionally, the Surveyor investigating Resident 1's death spoke to Resident 1's attending physician, Dr. Singh, who indicated that Resident 1 could (as recorded by the Surveyor in a telephone memo) 'go' 10-20 minutes or less without the oxygen, and, Dr. Singh informed the Surveyor, the period without the oxygen would be 'detrimental' to Resident 1. CMS Ex. 11, at 105.

Moreover, the undisputed fact is that Resident 1's death coincided, at least approximately, with the power failure and cessation of the mechanical oxygen concentrator. Thus, it would have been reasonable for CMS to move forward as if the alleged deficiency concerned the failure to provide oxygen to a resident who needed it to breathe; although, I find that the evidence does not support that Resident 1 needed oxygen to breathe - at least not in the short term (i.e., the cessation in the oxygen supply would not have led immediately to respiratory distress). Nevertheless, despite the apparent misapprehension, CMS's description of the alleged deficiency in the pleadings is broad enough that it encompasses necessary care and services that, while necessary, are not as significant as a ventilator-dependent residents air supply would be. As CMS indicated, Resident 1 was a resident "who required oxygen during a power outage emergency." CMS Ex. 1, at 1. That is accurate. As I discuss below, Resident 1 "required" oxygen, but it should be understood that he could breathe, at least for a period of time, without it.

CMS has tacitly conceded that its initial assumption was mistaken by not pressing the contention in its briefs that Resident 1 was a ventilated resident, and by avoiding the explicit argument that Resident 1 died from respiratory failure. See for example, CMS's reply brief, n. 1 ("CMS does not regard the cause of death a [sic] crucial to its case"). The facts were clarified at hearing where Petitioner successfully demonstrated that Resident 1 was not on a ventilator and persuaded me also that the Facility did not accept patients needing such care. Nurse Frederick, the charge nurse on duty during the crucial events on April 20, 2002, testified that there were no residents on life support, ventilators, or respirators, including Resident 1 - a point that CMS did not rebut. Tr. 120. Thus, I am persuaded that when the power went out on April 20, 2002, it was not the case that Resident 1's air supply was abruptly cut off and that he would have been expected to die in seconds or a very few minutes. This does not, however, eliminate the possibility that the cessation of the oxygen was likely to cause Resident 1 serious harm. To persuade me that Resident 1 was not at risk for serious harm, it would need to be shown that the oxygen was superfluous, or at least a minor part of Resident 1's care. Indeed, Petitioner attempted to characterize the delivery of oxygen to Resident 1 as a mere delivery vehicle for humidity that was of no consequence to Resident 1's condition (perhaps meaning his death). Petitioner's brief at 4. I find, however, that the oxygen delivered to Resident 1 was neither superfluous nor minor.

As I mentioned above, the parties agree that Resident 1 was provided oxygen via a mechanical oxygen concentrator as a means to deliver humidity. However, they dispute whether the oxygen provided a benefit to Resident 1 in addition to the benefit provided by the delivery of humidity. And, as I noted above also, the parties dispute the degree of benefit to Resident 1 from receiving the humidity. I find that the oxygen provided a benefit to Resident 1 independent from the humidity, although I make no determination as to the degree of the benefit. I find also that the humidity was a significant part of Resident 1's care, and was more significant than a mere comfort measure.

Resident 1 required humidified air because, due to his tracheostomy, he was at risk for developing a mucous plug. As Nurse Frederick explained, the humidified air "keeps secretions loose so that [the tracheostomy] doesn't plug." Tr. 122. Thus, as I discuss further below, Facility staff understood that the humidity was a necessary part of Resident 1's treatment. That the oxygen was a delivery method for humidity, however, does not preclude that the oxygen itself was a necessary part of Resident 1's care. Neither party addressed that the Facility's plan of care for Resident 1, dated April 17, 2002, indicates that Resident 1 is at risk for "SOB" related to his tracheostomy. CMS Ex. 11, at 46. "SOB" is a medical abbreviation for shortness of breath. Dorland's Medical Abbreviations 260 (Margaret M. Biblis ed., 1992). The immediate plan of care specifies that the intervention for the "SOB" risk is tracheostomy care as ordered and oxygen as ordered. The plan of care is a document that was created by the Facility and it appears to have been signed by Resident 1's attending physician, Dr. Singh. CMS Ex. 11, at 46. Whether the risk of shortness of breath was purely oxygen-related or could arise if a mucous plug developed is unclear. Regardless, that a specific concern for Resident 1 was shortness of breath is suggestive that the oxygen contributed a benefit independent from delivering humidity because one suspects other terms could have been used to indicate the risk was mucous plugging. Furthermore, Petitioner's expert medical witness, Dr. Martin, testified concerning the utility of humidified air and oxygen. Dr. Martin confirmed that Resident 1 was not dependent on oxygen to breathe; however, he could not rule out the independent utility of oxygen to Resident 1, testifying, " . . . he needed humidified air of some type . . . I don't know if he needed humidified oxygen." Tr. 183. In fact, Petitioner seemed to concede early in this case that oxygen would prove to have some independent benefit to Resident 1. In its prehearing report Petitioner averred,

[t]he resident [Resident 1] was able to breathe on his own and make adequate respiratory effort, the very low level of supplemental oxygen was not needed to support life. It simply raised the saturation level of oxygen in the blood to a more normal physiological level so the patient may have a higher quality of life.

Petitioner's prehearing report at 2. Moreover, the hospital where Resident 1 was weaned from a ventilator treated him with oxygen, CMS Ex. 11, at 81, 82-84; Resident 1 required oxygen through his tracheostomy during his transfer from the hospital to the Facility, Id. at 25; and, both Resident 1's immediate plan of care and his interim plan of care, incorporating his attending physician's orders, called specifically for Resident 1 to receive oxygen, Id. at 45 and 46. Thus, the Facility had notice that the physicians responsible for Resident 1's care directed that Resident 1 receive oxygen. Based on this evidence, I find that oxygen was a necessary care and service for Resident 1.

Even if I did not find that oxygen was a necessary part of Resident 1's planned care and services, however, the evidence shows that the delivery of humidity, to prevent mucous plugs, via oxygen or otherwise, was more than a mere comfort measure. I base this finding on the opinions of both Dr. Singh and Dr. Martin. The evidence, undisputed by Petitioner, is that Dr. Singh told the Surveyor, Ms. DeKoster, that Resident 1 could go 10-20 minutes or less without oxygen and that going without oxygen would be detrimental to Resident 1. CMS Ex. 11, at 105. Were I to assume that Dr. Singh was not speaking of the loss of oxygen but of the humidity alone, my conclusion would be the same: Resident 1 would be harmed (suffer some detriment) after 10 - 20 minutes without the humidity. Based on the consensus between the parties that humidity was provided to prevent mucous plugs, I could assume the detriment Dr. Singh spoke of would be mucous-plug related. Petitioner did not present evidence which persuades me that the risk to Resident 1 from forming a mucous plug should be discounted. In fact, Dr. Martin's testimony concerning the utility of humidified air is not very different from what Dr. Singh is reported to have said. First, Dr. Martin concurs that Resident 1 received humidified air because he was at risk for developing mucous plugs. Tr. 181. But, more compelling was his assessment of the risk to Resident 1. In Dr. Martin's opinion, "you're not going to dessicate [dry out] a secretion . . . in 20, 30, 40, 50 minutes or an hour even." Tr. 184. Although Dr. Martin's testimony could be interpreted to mean a mucous plug could form in as little as 20 minutes, if I read Dr. Martin's testimony in a light most favorable to Petitioner, dessication would not occur for at least an hour. Whether dessication is synonymous with a mucous plug forming, Dr. Martin did not say, but because it is the effect the therapy is intended to prevent, I can assume dessication is at least the condition antecedent to mucous plug creation. Nonetheless, the fact that Dr. Martin conceded the risk of mucous plugs formation, and that he was compelled to put a time limit, however imprecise, on how long Resident 1 had until dessication occurred (perhaps an hour), demonstrates that both physicians agreed that Resident 1 would eventually be harmed. Both physicians agreed that if Resident 1 were denied humidified air, it was just a matter of whether he would be harmed in as little as 10 minutes, or in as long as "an hour even." Thus, I find that humidified air was a necessary care and service beyond a mere comfort measure.

Addressing next the urgency of Resident 1's need for oxygen and or humidified air, it would be reasonable, because the delivery of oxygen was necessary but Resident 1 was not dependent on it to breathe, to allow for some period of time between the power failure and the restoration of Resident 1's oxygen. In fact, some lapse in the provision of oxygen might not be inconsistent with substantial compliance with the requirement. The question is whether, in light of the relevant circumstances, the period of time was reasonable or too long.

It is uncontested that Resident 1 did not receive oxygen for approximately 30 minutes, between 6:23 a.m. and approximately 6:54 or 6:55 a.m. See Petitioner's sur-reply brief at 3. I conclude, that even when the circumstances presented by the power failure are considered, the Facility took too long to restore Resident 1's oxygen.

The parties have reached opposite conclusions concerning the conduct of the Facility's staff in dealing with the power failure and attending to Resident 1. CMS portrays the Facility as being unprepared and chaotic. CMS argues that the Facility's unpreparedness is partly to blame for the length of time it took staff to restore Resident 1's oxygen. Conversely, Petitioner maintains that the Facility's staff were prepared and responded appropriately by:

simultaneously alerting management, evaluating and reassuring the residents, beginning with those most likely to be impacted, dispensing portable oxygen to those who had been receiving supplemental oxygen, and calling EMS for transport of residents with tracheostomies and on supplemental oxygen. All residents, including Resident #1, received appropriate care and services in an extremely unusual situation.

Petitioner's brief at 1-2. Petitioner asserts also that the Facility had prepared by conducting emergency drilling. Petitioner's brief at 7. And, Petitioner introduced the testimony of Judith Kidd. Nurse Kidd, a registered nurse with consulting and other experience concerning the investigation and quality of care in nursing homes (see Tr. 202-203), testified that the Facility's staff acted appropriately. Tr. 209-211. Nurse Kidd opined that a facility cannot be expected to plan for every contingency. Tr. 229. Finally, the Facility argued that it provided appropriate care to Resident 1 under the circumstances, emphasizing that during the power outage Resident 1 was evaluated by and assessed by staff appropriately. Petitioner's brief at 5. I find, however, that the Facility was not adequately prepared for the power failure and that this was a preventable contribution to the length of time Resident 1 was without oxygen.

Nurse Frederick testified that when it became evident to her that the power was not coming back on, she stopped what she had been doing (checking on residents), and went to "the desk" yelling instructions to her staff to check "oxygen people." Tr. 128. She testified also that she was simultaneously checking on residents on the north hall of the Facility as she made her way to the desk. Tr 128. Nurse Frederick testified that "oxygen people" needed to be checked on because if they became anxious their oxygen would not work. Tr. at 129. Nurse Frederick indicated that there were two flashlights "one that sat on north and always one that sat on south . . . that way we can go through the rooms and start filling portable tanks because the time had started going." Tr. 129. Next, Nurse Frederick testified, " . . . we started filling up portable tanks . . . [a]nd I called the D-O-N . . . I called the Administrator . . [i]t was a few phone calls that were called. Tr. 129. According to Nurse Frederick, the Director of Nursing instructed her to "Call 9-1-1 . . . [m]ake sure you have portable tanks filled and passing them out . . . [a]nd check on all of our trach and our O2 patients." Tr. 130. In her conversation with the Director of Nursing, Nurse Frederick testified, she reported that she was pulling tube-feeding patients, in their beds, into the hallways to plug their equipment into outlets connected to the Facility's back-up generator. Tr. 132. Nurse Frederick testified that she sent one nurse (Nurse Yorbe) and two nurse aides to the south wing of the Facility to check on residents. Tr. 132. And, Nurse Frederick testified that she and the three other nurse aides went to check on residents in the north hallway. Tr. 132. Nurse Frederick testified that she wanted to assess "trach" patients first. Tr. 133. Asked what was involved in getting auxiliary oxygen tanks ready for the residents, Nurse Frederick testified:

[y]ou connect them to the larger concentrators . . . It's like a flip switch and it fills . . . [a]nd as I was pushing them down, flipping them, filling them, handing them off . . . [a]nd most of the ones on the south hall, they had portable tanks, but I wanted full portable tanks cause I don't know how long this is going to go on . . . [s]o I need to have full tanks . . . [s]o I just filled up new ones, passed them out, connecting them to these . . . [a]nd that was pretty much it as far as what I delegated for them to do.

Tr. 133. Nurse Frederick testified also that she further prioritized "trach" patients over the oxygen patients. She testified that she wanted her "trach" patients transferred to the hospital first. Tr. 130. There were four "trach" patients, three on humidified air, and two of the four on humidified air with oxygen. Tr. 131.

Nurse Frederick explained that while she was on the telephone with the Director of Nursing, one of the nurse aides reported that Resident 1 had a weak pulse. Nurse Frederick testified that she responded by sending Nurse Yorbe to assess Resident 1. Tr. 135; see also CMS Ex. 11, at 89. Nurse Frederick testified that she sent Nurse Yorbe because she was "on the telephone trying to make sure that we can get the residents out of there." Tr. 134-135. Nurse Yorbe came out from the assessment and reported to Nurse Frederick that Resident 1's vital signs were faint. Tr. 135. At hearing this report, Nurse Frederick testified, she "hung up the telephone, grabbed another CNA that was standing in the hallway . . . [a]nd we grabbed the large concentrator tank cause - and ran it to his room . . . he was still breathing." Tr. 135. Nurse Frederick explained that as she was hooking up the oxygen to Resident 1, paramedics arrived. Tr. 136.

I conclude, based in part on Nurse Frederick's testimony, that the Facility took too long to get Resident 1 oxygen. If the power went out at 6:23 a.m, as Petitioner accepts (see Petitioner's brief at 6), and it took staff approximately 30 minutes to get the portable oxygen to Resident 1, as seems also to be agreed (see Petitioner's brief at 7), that means that it took the Facility from 6:23 a.m. to approximately 6:53 a.m. to fill one of the oxygen tanks Nurse Frederick described, and bring it to Resident 1's room. Granted, the staff had other residents to attend to; however, Resident 1 was one of a few priority residents. As Nurse Frederick indicated, he was one of four "trach" residents who were "more high needs than any of [the] other residents." Tr. 131. Apparently, there were three other residents who also needed supplemental oxygen. Tr. 130-31. Yet, it took seven staff members 30 minutes to get one of the four priority residents oxygen. And, when the task was finally undertaken, it was done by Nurse Frederick herself, who had been busy on the telephone, despite the fact, according to Nurse Frederick's testimony, that a nurse aide was available (as it was a nurse aide who reported Resident 1's weak pulse), and Nurse Yorbe was available (as it was Nurse Yorbe whom Nurse Frederick dispatched to follow-up on the nurse aide's report). These facts present to me the impression that staff were attending to other - I deduce from the Facility's own prioritization of Residents - lower priority residents than Resident 1.

Moreover, whether Nurse Frederick filled oxygen tanks before or after talking on the phone with the Director of Nursing (on cross-examination Nurse Frederick testified that she could not say whether she was filling oxygen tanks before or after calling the Director of Nursing (Tr. 142-143)), the evidence is that Nurse Frederick spent some unspecified time filling oxygen tanks, 5-10 minutes checking on residents and 10 minutes talking on the phone. Petitioner's brief at 6. And, when Nurse Yorbe indicated concern about Resident 1's vital signs, it was Nurse Frederick herself who immediately "grabbed" a nursing aide and "grabbed" the oxygen tank and "ran" it to Resident 1's room. Tr. 135. It is clear, of course, that Nurse Frederick's urgent action took place very near the end of the 30-minute period following the power outage because Nurse Frederick indicates she took the action immediately, and while she was linking Resident 1 to the oxygen tank, paramedics arrived, who, it is also clear, arrived after 6:50 a.m. See Petitioner's brief at 6. This means for most of the half hour from the time of the power failure, Nurse Frederick and the six other staff people were doing things other than bringing oxygen to Resident 1, one of the four highest-priority residents. Petitioner indicates that Resident 1 was checked at about 6:35 a.m. by the nurse aide who reported Resident 1's pulse was weak, and Nurse Frederick immediately sent Nurse Yorbe to assess him. Petitioner's brief at 5. So it took approximately ten minutes from the power outage for a nurse (Nurse Yorbe) to assess Resident 1, but then another 15 minutes to bring Resident 1 the oxygen. This chronology is not persuasively compatible with the fact that during the 30-minute time period staff was supposed to have been distributing oxygen, yet Nurse Frederick ended up bringing the oxygen to Resident 1 herself. Based on these facts I conclude that the Facility caused an unreasonably long lapse in the provision of the oxygen to Resident 1.

2. The amount of the civil money penalty is not reasonable

My conclusion that Petitioner failed to comply substantially with F-309 provides the basis for the imposition of the civil money penalty and the denial of payment for new admissions. The issue remaining is whether the amount of the civil money penalty proposed by CMS is reasonable.

If a facility is found to be out of substantial compliance with participation requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a civil money penalty (either per instance or per day). 42 C.F.R. § 488.408. Reasonableness of the amount of a civil money penalty is determined by applying the factors listed in 42 C.F.R. §§ 488.438(f) and 488.404. Emerald Oaks, DAB No. 1800, at 10 (2001); CarePlex of Silver Spring, DAB No. 1683, at 16-17 (1997). These factors include a facility's history of noncompliance; a facility's financial condition; a facility's degree of culpability, and the factors specified in section 488.404 which are considered in the selection of any remedy. The regulation calls for an initial assessment of the seriousness of the deficiency, which includes the degree or risk of harm that the deficiency presents and whether the deficiency is isolated, part of a pattern, or widespread. 42 C.F.R. § 488.404(b). CMS may also consider "other factors, which may include, but are not limited to," how the deficiencies relate to each other and the prior history of compliance of the facility. 42 C.F.R. § 488.404(c). In this case, CMS has proposed a per instance civil money penalty of $10,000. A civil money penalty ranging from $1,000 to $10,000 is authorized for a per instance deficiency that constitutes immediate jeopardy. 42 C.F.R. §§ 488.408(d)(3)(ii) and 488.438(a)(2). The proposed civil money penalty is thus the maximum allowable.

CMS argues that the amount of the civil money penalty is reasonable in light of the factors set forth in sections 488.404 and 488.438(f). Specifically, CMS argues that the factors supporting the $10,000 civil money are the seriousness of the deficiency and the culpability of the facility. CMS avers that the seriousness of the deficiency is evident because it constituted immediate jeopardy. To buttress this point CMS states the definition of immediate jeopardy. CMS's brief at 11-12. And CMS argues that Petitioner's culpability justifies the $10,000 civil money penalty because Resident 1 was in a precarious medical condition but Facility staff neglected or disregarded the need to have a replacement source of oxygen and the need for rapid emergency care when the power failed. CMS's brief at 12. And Petitioner is culpable, CMS argues, for not properly caring for Resident 1 during the power outage. CMS's prehearing memorandum at 6.

The sum of Petitioner's argument concerning the civil money penalty is that, if there was a deficiency, the deficiency did not constitute immediate jeopardy and therefore, the civil money penalty should be reduced to the minimum: $1,000. Petitioner's brief at 11; Petitioner's reply at 4. Petitioner presented no evidence or testimony concerning the Facility's history of compliance or its financial condition.

Considering CMS's arguments, I note that the fact a deficiency constitutes immediate jeopardy is not sufficient by itself to support the reasonableness of the maximum amount of penalty. The regulation provides a range of possible penalty amounts for both per day and per instance civil money penalties; thus, stating that a deficiency constituted immediate jeopardy places the reasonable amount within the range specified by regulation, but not at the maximum amount without further justification.

The civil money penalty proposed by CMS is the maximum allowable and, as I discussed above, the record is suggestive that CMS imposed the remedies in this case while under the impression that Petitioner was responsible for the death of a ventilator-dependent resident. A $10,000 civil money penalty might be reasonable where a facility fails to safeguard a ventilator-dependant resident's air supply. In the instant case, however, the Facility's deficiency is serious, but to a lesser degree than if Resident 1 had required a ventilator to breathe. Considering all the relevant factors in light of the evidence, I conclude that the proposed civil money penalty is not reasonable. A civil money penalty of $2,000 is sufficient for the remedial purpose of bringing Petitioner into compliance with the requirement to provide residents the necessary care and services, including responding appropriately to power outages and the related circumstances.

IV. Conclusion

In view of the foregoing I uphold CMS's determination to assess a civil money penalty against Petitioner for its failure to substantially comply with a requirement of participation in Medicare. I conclude also that the amount of the civil money penalty, $10,000, is unreasonable. I conclude that $2,000 is reasonable.

JUDGE
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Richard J. Smith

Administrative Law Judge

FOOTNOTES
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1. CMS's immediate jeopardy severity level determination is not an issue because scope and severity may only be challenged if a decision favorable to the petitioner would effect the range of possible civil money penalty amounts. 42 C.F.R. § 498.3(b)(14). The range of possible per instance civil money penalty amounts, however, is the same for both immediate jeopardy and non-immediate jeopardy severity determinations. 42 C.F.R. §§ 488.408(d)(3)(ii) and 488.438(a)(2).

2. CMS's rebuttal evidence concerns which NFPA requirements are applicable to the Facility. I note that I can take official notice (i.e., judicial notice) of what the applicable law is. See, Toth v. Grand Trunk R.R., 306 F.3d 335, C.A.6.Mich. (2002) (Administrative regulations fall within the category of facts capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned, as required for regulations to be subject to judicial notice). On the other hand, when the law is obscure and unknown it may be appropriate for existence of the law to be treated as a question of fact. See, for example, U.S. v. Bedgood, 49 F. 54, S.D. Ala., 1891 (Regulations of the land office, prescribed by the Secretary of the Interior or by the Commissioner, are not known judicially and must be pleaded). So whether the law is easily accessible to the judge may be the determining factor in whether to treat the law as a fact question that must be proved or as an unquestioned foundational fact that may be noticed. The unavailability of the law may be to an extent an anachronistic concern. The question which NFPA requirement applies what facility is, however, potentially obscure enough a fact to require proof.

Were I to treat which NFPA requirement applies as a question of fact to be proved, I could admit CMS's rebuttal evidence regardless of whether it would be inadmissable under the Federal Rules of Evidence. 42 C.F.R. § 498.61.

Additionally, Petitioner asserts that it would be unfair (i.e., would constitute "sandbagging," (Petitioner's amended objection and sur reply to CMS's response, at 2)) to allow the rebuttal evidence because CMS could have more properly presented the evidence in its case-in-chief. But, Petitioner has not proffered what evidence or theory it has been prevented from developing. And, I note that Fed. R. Evid. 611(a) invests judges with discretion to allow rebuttal, including rebuttal concerning evidence that could have been made in the case-in-chief, in the interests of ascertaining the truth and avoiding needless consumption of time. See, U.S. v. Wilson, C.A.7th, 1998, 134 F.3d 855, 866-867, 119 S.Ct. 216, 525 U.S. 894, 142 L.Ed.2d 178 (citing United States v. Gaertner, 705 F.2d 210, 217 (7th Cir. 1983), cert. denied, 464 U.S. 1071, 104 S.Ct. 979, 79 L.Ed.2d 216 (1984)).

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