SUBJECT:

Crestview Parke Care Center,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

Petitioner, Crestview Parke Care Center (Petitioner or Facility), is a long term care facility certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare & Medicaid Services' (CMS's) determination that, from August 13 until October 21, 1999, it was not in substantial compliance with program participation requirements. For the reasons set forth below, I conclude that, from August 13 until October 21, 1999, the facility was not in substantial compliance. Petitioner also challenges the amount of the Civil Money Penalty (CMP) imposed, $400 per day. I conclude that the amount of the CMP is reasonable.

I. Background

A. The Survey

As a condition for participation in the Medicare and Medicaid programs, skilled nursing facilities (SNFs) (Medicare) and nursing facilities (NFs) (Medicaid) periodically undergo surveys to determine whether they are in substantial compliance with program requirements, and the Secretary of the Department of Health and Human Services contracts with state survey agencies to conduct those surveys. Social Security Act (Act), section 1864(a); 42 C.F.R. § 488.20. The regulations require that each facility be surveyed at least once every 12 months, and more often, if necessary, to ensure that identified deficiencies are corrected. 42 C.F.R. § 488.20(a).

In this case, on August 12, 1999, the Ohio Department of Health (hereafter, "State Agency") completed a Life Safety Code (LSC) survey of the facility, and concluded that it did not satisfy LSC requirements for emergency lighting. LSC §§ 5-102, 10-1293, 10-1294, 10-2272 (incorporated by reference in 42 C.F.R. § 483.70(a)). CMS Ex. 2. On the following day, the State Agency completed a standard compliance survey, finding that the facility did not meet requirements for Environment (42 C.F.R. § 483.15), Quality of Care (42 C.F.R. § 483.25), Dietary Services (42 C.F.R. § 483.35), and Administration (42 C.F.R. § 483.75). CMS Ex. 3.

In a letter dated August 30, 1999, the State Agency advised Petitioner that it was not in compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs. In addition to the remedies of termination and denial of payment for new admissions (DPNA), the State Agency recommended that CMS impose a civil money penalty of $400 per day, effective August 13, 1999. The State Agency also advised that if, prior to October 2, 1999, the facility alleged compliance, the State Agency would accept that allegation and would not recommend imposition of the proposed remedies unless it subsequently determined by follow-up survey that the substantial noncompliance continued. CMS Ex. 1.

Thereafter, the facility submitted a plan of correction, alleging substantial compliance as of October 1, 1999. On October 5, 1999, the State Agency conducted a follow-up survey to verify compliance, but determined that the facility still did not meet requirements for Environment (42 C.F.R. § 483.15). CMS Ex. 6. By letter dated October 8, 1999, the State Agency advised the facility that, because of the deficiencies found during the August 13, 1999 survey and the follow-up survey of October 5, it recommended that CMS 1) impose the DPNA; 2) impose a CMP of $400 per day from August 13, 1999, until the facility achieved substantial compliance or its provider agreement terminated; and 3) terminate the facility's provider agreement. CMS Ex. 4.

By letter dated November 1, 1999, CMS advised the facility that it agreed that the facility was not in substantial compliance with federal requirements for participation in the Medicare and Medicaid programs; that, at the time of the August 13, 1999 survey, the facility's most serious deficiencies constituted actual harm that was not immediate jeopardy; and that, at the time of the October 5, 1999 survey, its most serious deficiencies constituted no actual harm with the potential for more than minimal harm that was not immediate jeopardy. CMS also concurred with the State Agency recommendations to impose a DPNA effective November 16, 1999, and to impose a CMP of $400 per day. CMS Ex.7.

The State Agency subsequently conducted a second follow-up survey on October 21, 1999, and, by letter dated November 2, 1999, advised the facility that it had achieved substantial compliance as of October 21. CMS Ex. 8. By letter dated November 19, 1999, CMS advised Petitioner that neither the DPNA, nor termination would be imposed, and the CMP of $400 per day was discontinued as of October 21, 1999, the day the facility achieved substantial compliance. The CMP was thus imposed for 69 days, and totaled $27,600.00. CMS Ex. 10.

B. The Appeal

The facility timely appealed, and the case was assigned to Administrative Law Judge Marc R. Hillson. At Petitioner's request, and in the absence of objection, Judge Hillson stayed the matter to allow the parties to pursue settlement negotiations. Apparently, settlement efforts were not successful. Following Judge Hillson's departure from the Civil Remedies Division, the case was re-assigned to Judge Marion T. Silva. In June 2000, the parties filed readiness reports and, in an order dated August 7, 2000, Judge Silva set deadlines for the parties' initial and final exchanges of proposed exhibits, exhibit lists, witness lists, and statements in lieu of testimony, to be completed by December 4, 2000. Thereafter, on December 6, 2000, this matter was re-assigned to me. I directed the parties to indicate their availability for an in-person hearing. Incredibly, the parties advised me that they would not be available for hearing until at least September 2001, and so the case was scheduled for hearing the week of September 18, 2001. On August 28, 2001, we notified the parties of a prehearing telephone conference scheduled for September 10, 2001, at which they were expected to stipulate to uncontested factual matters, to delineate the issues in controversy, to identify the evidence and witnesses to be presented at hearing, and to voice any objections to proposed witnesses or exhibits. See 42 C.F.R. § 498.47.

At the September 10, 2001 prehearing conference, I admitted into the record CMS Exhibits (Exs.) 1 through 48, and Petitioner's Exhibits (P. Exs.) 1 through 6. The parties were not, however, prepared to stipulate uncontested facts, nor to delineate with any degree of specificity the issues in controversy. In an effort to learn the findings and conclusions that Petitioner challenged, as well as the specific bases for its challenges, I referred Petitioner to CMS Exs. 2 and 3, the Statements of Deficiencies for the August 1999 surveys, and asked pointed questions about the deficiencies cited, many of which the surveyors articulated with great specificity.⁽¹⁾

However, with limited exception⁽²⁾, Petitioner was unable to say whether it challenged any of the specific findings of fact contained in the survey report forms. I therefore continued the prehearing conference to the following day, directing the parties to stipulate to certain obvious facts, such as times and circumstances of surveys, the individuals present during the surveys, and, as possible, to qualifications of witnesses and other facts. I also directed that Petitioner review the survey report form for the October 1999 survey, and to be prepared to indicate whether it challenged as untrue the specific facts asserted, and to provide the specific reasons for challenging the findings. See Summary of Results of Prehearing Conference (Sept. 10, 2001).

History intervened on September 11, 2001. The scheduled telephone conference could not be held, and we were unable to convene the scheduled in-person hearing on September 18, 2001. Instead, I scheduled the continued prehearing conference call for September 19, 2001. However, the parties had not complied with my September 10, 2001 instructions. CMS had, on September 13, 2001, forwarded proposed stipulations to Petitioner, but Petitioner had not responded. Moreover, Petitioner was still unable (or unwilling) to disclose the specific survey findings it challenged and the bases for those challenges. I therefore ordered the parties to submit prehearing briefs for the purpose of delineating clearly the issues in dispute. In a written order dated September 21, 2001, I directed the parties to submit briefs, and to include 1) a statement of each of the facts that the party intends to prove at hearing; 2) a discussion of the relevant law and how it relates to the facts; 3) an explanation of how the evidence that has been admitted into the record proves the facts that the party alleges; and 4) an explanation of how the testimony the party proposes to elicit from each witness proves the facts that are alleged. I directed each party to include affidavits or declarations from its witnesses. Summary of Results of Prehearing Conference and Order to Submit Briefing (Sept. 21, 2001).
The parties thereafter fully briefed the issues. Upon review of Petitioner's submission, it appeared that certain material facts were not in dispute, that an in-person hearing was unnecessary, and that this matter could be decided on the written submissions, declarations, and exhibits. The in-person hearing, scheduled for January 8, 2002, was therefore unnecessary, and, in a letter dated December 12, 2001, we so advised the parties. CMS independently arrived at the same conclusion, and included a motion for summary judgment with its reply brief, which was due and filed on December 17, 2001.⁽³⁾ In a letter dated December 19, 2001, Petitioner objected to the cancellation of the in-person hearing, arguing that denial of the right to confront and examine witnesses is inconsistent with due process. On December 27, 2001, CMS responded to Petitioner's objections, citing case law for the proposition that due process does not require an in-person hearing (as opposed to a hearing on the basis of the written record, i.e. briefs, documentary exhibits, affidavits, and declarations), particularly where there are no disputed issues of material fact.

We did not initially receive Petitioner's December 17, 2001 letter, and when we received CMS' December 27 response, we contacted Petitioner via e-mail, sent January 2, 2002, asking that it provide a copy of its December 17 submission. At the same time, we asked if Petitioner intended to respond to CMS's summary judgment motion, and reminded Petitioner that such response would be due no later than January 7, 2002.⁽⁴⁾ Petitioner thereupon submitted a request for briefing schedule and an extension of time, until February 7, 2002, for its response, professing ignorance, prior to its receipt of the January 2 e-mail, of the deadline for responding. In a January 4, 2002 Order, I pointed out that deadlines for rebuttal are set by regulation, 42 C.F.R. § 498.17. Nevertheless, I granted Petitioner an extension until January 15, 2002 to submit its response.⁽⁵⁾ On January 16, 2002, we received Petitioner's Memorandum in Opposition to Respondent's Motion for Summary Judgment (hereafter, Petitioner's Surreply).

CMS then sought leave to reply to Petitioner's Surreply (in effect, to file a sur-surreply) which I have denied. With the filing of Petitioner's Surreply, the record is closed.

Before addressing the merits of the parties' arguments, I first consider whether an in-person hearing is required.

C. The requirement to afford Petitioner the opportunity for an evidentiary hearing is not contravened by a summary disposition where, as here, Petitioner has not demonstrated any dispute over genuine issues of material fact.

In objecting to cancellation of the in-person hearing, Petitioner argues that-

the Due Process rights of Petitioner are not accorded with the denial of the opportunity for confrontation and examination of witnesses. The Administrative Law Judge is denied the opportunity to assess and determine the credibility of the witnesses[,] creating a substantial risk of an erroneous decision.

Petitioner's Notice of Objection to Cancellation of Hearing (December 19, 2001). This echoes the position argued in its brief, where Petitioner claims the "right to mandate that CMS carry its burden of proof and persuasion under Gold Country, as well as its right to cross-examine each of CMS' witnesses with respect to their observations and interpretive application of the regulatory authority for which Crestview was cited." Petitioner's Brief (hereafter, P. Brief) at 2.⁽⁶⁾

In Gold Country, Judge Leahy set forth the evidentiary process, articulated by the Board in Hillman Rehabilitation Center, DAB No. 1611 (1997); aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (D.N.J. May 13, 1999).⁽⁷⁾ However, nothing in Gold Country nor any other authority compels an in-person hearing where material facts are not in dispute. As Judge Leahy recognized, the evidentiary standards are separate from questions of whether material facts are in dispute, compelling an in-person hearing. That CMS has an initial burden does not in itself compel an in-person hearing. Unless the parties have raised a genuine issue of material fact, summary disposition is appropriate. Everett Rehabilitation and Medical Center, DAB No. 1628, at 3 (1997); Carmel Convalescent Hospital, DAB No. 1584, at 27 (1996). Thus, in Carmel Convalescent, where the petitioner had the opportunity to present its case with briefs and supporting documentation, but did not demonstrate a genuine dispute of material fact, the Board affirmed summary disposition. Carmel Convalescent, DAB No. 1584, at 22. See also Glenburn Home, DAB No. 1806, at 17 (2002) ("[I]n reviewing a case where an ALJ failed to either obtain a written waiver or hold an oral hearing, we may nonetheless uphold the decision if the affected party either had conceded all of the material facts or proffered testimonial evidence only on facts which, even if proved, clearly would not make any substantive difference in the result.") and Cherrywood Nursing and Living Center, DAB CR845 (2001) ("Where inferences made from facts which are averred to support a motion must be made in a manner most favorable to the party that opposes the motion, it is not sufficient for a party simply to state that it disputes allegations of fact in order to avoid possible entry against it of summary disposition. That party must describe the asserted facts credibly in order to establish a dispute.")

Thus, where facts are in dispute, a judge may, nevertheless, issue a decision on the written record. If material facts are in dispute (as in Glenburn Home), and the parties waive the in-person hearing, then the judge resolves those disputes of fact based on the weight of the evidence. This is not summary judgment. Where, as here, Petitioner does not waive its in-person hearing, and has raised some factual disputes, the judge determines whether those facts are material by resolving all legitimate factual disputes in favor of the non-moving party, in this case, Petitioner. If, after so resolving all factual disputes, CMS establishes substantial noncompliance that justifies the penalties imposed, the disputed facts are not material and CMS is entitled to summary judgment.

Here, CMS has come forward with a detailed list of its findings⁽⁸⁾ and has set forth its rationale for determining substantial noncompliance. Petitioner was afforded ample opportunity to show, through argument and supporting documentation, the bases for its challenges to these findings. Indeed, my September 21, 2001 order required each party to set forth the facts it intended to prove at hearing, and to explain how its evidence, the documents admitted and the declarations of its witnesses, prove the facts alleged.⁽⁹⁾

And, as discussed in more detail below, with respect to several critical issues, Petitioner has not raised a dispute of material fact: namely, whether its back-up generator was in good working order at the time of the survey; whether its documentation demonstrated that required periodic testing of that generator had been performed; whether specific environmental conditions existed at the facility at the time of the surveys; whether it followed physician orders designed to protect from skin break-down certain at-risk residents; whether its documentation established adequate in-service training of nurses' aides. Whether these undisputed facts amount to substantial noncompliance is a conclusion of law, not an allegation of fact.

In this regard, it is important to distinguish between facts and conclusions. Conclusions and legal arguments do not establish material facts in dispute. For example, Petitioner's claim that it "provided each resident with 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," is a conclusion. The surveyor's observation that at 8:30, 9:15, and 11:30 A.M. on August 12, 1999, Resident #90 lacked elbow protectors or a hand splint is a fact that Petitioner has not disputed. Similarly, that the facility maintained a sanitary, orderly and comfortable interior is a legal conclusion. The surveyors' findings of "brown, caked-on substances" on medication cart drawer pulls and a big hole in the wall in Room 17 are facts; again, not challenged by Petitioner.

With respect to Petitioner's purported right to cross-examine each of CMS' witnesses, no party has an absolute right to conduct cross-examination. My inquiry is limited to matters at issue, and, like all other evidence, I am directed to receive into the record only that testimony, including cross-examination testimony, and those documents that are relevant and material. 42 C.F.R. § 498.60(b). Moreover, with respect to denying the ALJ the opportunity to assess credibility, witness credibility is plainly not an issue where the facts to which those witnesses attest are not in dispute.

Having determined that Petitioner has not raised a genuine issue of material fact, I now address the merits of this case, based on the uncontroverted facts.

1. Whether, from August 13, 1999, until October 21, 1999, the facility was in substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.15 (Environment), 42 C.F.R. § 483.25 (Quality of Care), 42 C.F.R. § 483.35 (Dietary Services), 42 C.F.R. § 483.75 (Administration), and 42 C.F.R. § 483.70(a) (Life Safety Code).

2. If the facility was not in substantial compliance, is the amount of the Civil Money Penalty imposed, $400 per day from August 13 until October 21, 1999 (total of $27,600), reasonable?

III. Statutory and Regulatory Background

The Act sets forth requirements for nursing facility participation in the Medicare and Medicaid programs, and authorizes the Secretary of the Department of Health and Human Services to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483.

To participate in the Medicare and Medicaid programs, facilities periodically undergo surveys to determine whether they comply with applicable statutory and regulatory requirements for Medicare (SNFs) and/or Medicaid (NFs). They must maintain substantial compliance with program requirements, and, to be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm." 42 C.F.R. § 488.301.

The facility must be designed, constructed, equipped, and maintained to protect the health and safety of its residents, personnel, and the public. 42 C.F.R. § 483.70. By statute and regulation, a skilled nursing facility must meet the provisions of the Life Safety Code (LSC) of the National Fire Protection Association, as applicable to nursing homes, unless the Secretary determines that resident or personnel health and safety will not be affected and waives the requirement. Act, section 1819(d)(2); 42 C.F.R. § 483.70(a). Both the 1967 and the 1981 versions of the LSC require that the facility have the ability "automatically" to provide emergency lighting in the event of an interruption in normal lighting. 1981 LSC § 5-9.2.3; 1967 LSC § 5-10221.

The "quality of life" regulation includes an environmental requirement that the facility provide housekeeping and maintenance services necessary to maintain a sanitary, orderly, and comfortable interior. 42 C.F.R. § 483.15(h)(2).

The facility must also store, prepare, distribute, and serve food under sanitary conditions. 42 C.F.R. § 483.35(h)(2).

Under the statute and "quality of care" regulation, each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychological well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, section 1819(b); 42 C.F.R. § 483.25. Accordingly, the facility must conduct an initial and periodic resident assessment of functional capacity. The assessment must be comprehensive, accurate, standardized, and reproducible. Based on the comprehensive assessment, the facility must ensure that a resident who enters the facility without pressure sores does not develop them unless the individual's clinical condition shows that they were unavoidable, and a resident having pressure sores receives treatment and services necessary to promote healing, prevent infection, and prevent new sores from developing. 42 C.F.R. § 483.25(c).

The facility must also be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychological well-being of each resident. 42 C.F.R. § 483.75. More specifically, with respect to its nurse aides, the facility must provide regular in-service education of no less than 12 hours per year that is sufficient to ensure their continuing competence. Training must address areas of weakness as determined by performance reviews, and may address special needs of residents. 42 C.F.R. § 483.75(e)(8).

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, which include imposing a Civil Money Penalty (CMP). See Act, section 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more program requirements or for each instance that a facility is not in substantial compliance. 42 C.F.R. § 488.430(a).

In situations where the deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for more than minimal harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day. Penalties in the range of $3,050 to $10,000 per day are imposed for deficiencies constituting immediate jeopardy. 42 C.F.R. § 488.438.

In setting the amount of the CMP, CMS considers 1) the facility's history of noncompliance; 2) the facility's financial condition; 3) 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 in section 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 and specifically with reference to the cited deficiencies.

IV. Findings of Fact And Conclusions of Law⁽¹⁰⁾

A. From August 13, 1999, until October 21, 1999, the facility was not in substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.15 (Environment), 42 C.F.R. § 483.25 (Quality of Care), 42 C.F.R. § 483. 35 (Dietary Services), 42 C.F.R. § 483.75 (Administration), and 42 C.F.R. § 483.70(a) (Life Safety Code).

1. At the time of the Life Safety Code survey, August 12, 1999, the facility was unable to provide emergency power for lighting or other purposes.

As discussed above, by statute and regulation, provisions of the Life Safety Code have been incorporated into the program participation requirements. Act, section 1819(d)(2); 42 C.F.R. § 483.70(a). The 1967 Life Safety Code, applicable to two of the facility buildings, and the 1981 Code, applicable to the third building, both require that the facility be able to provide emergency lighting in the event of a power failure.⁽¹¹⁾ Emergency lighting must "be arranged as to provide the required illumination automatically in the event of any interruption of normal lighting, such as any failure of public utility or other outside electrical power supply, opening of a circuit breaker or fuse, or any manual acts, including accidental opening of a switch controlling normal lighting facilities." 1981 LSC § 5-9.2.3; accord 1967 LSC § 5-10221. The system must "be either continuously in operation or capable of repeated automatic operation without manual intervention." 1981 LSC § 5-9.2.4.

Surveyor Leann Slusher surveyed the facility's compliance with the LSC. Her declaration and the survey documents set forth her specific observations: On August 12, 1999, between 11:00 A.M. and 11:04 A.M., while touring the building with the facility administrator, Michael Campbell, and the Director of Maintenance, Mervon Hickson, the emergency generator failed to start two out of two times when the test button was pushed in the main panel in the upstairs courtyard. She then observed a facility employee attempt, unsuccessfully, to start the emergency generator by pushing a button on the generator itself. She reviewed the facility's generator log, which did not show that, since January 1999, any weekly tests had been performed on the emergency generator, nor that the emergency generator had been run under a load monthly as required by the LSC. The administrator and two maintenance employees verified her observation. The facility subsequently called for repairs; a repair man came to the facility; and at 2:07 P.M. they were able to start the emergency generator. CMS Ex. 2 at 1-2; CMS Ex. 15 at 8, 20, 35; Slusher Declaration.

Petitioner does not challenge any of these specific factual findings. With respect to the surveyor observation that the generator did not function when tested on the day of the survey, Petitioner characterizes that failure as "a serendipitous and unforeseen event which, practically speaking, would not present even a reasonable risk of minimal harm." P. Brief at 2.

In her declaration, Julie Hrybiniak, Regional Administrator for Regal Care,⁽¹²⁾ the entity that operates the facility, does not deny that the generator failed during the survey. Rather, she asserts that after the survey, corporate maintenance was called, and on "every test, both before and after the survey, the generator functioned appropriately. Why it did not at that particular time is unknown and unexplained." Hrybiniak Declaration at 1, para. 2. She also asserts, generally, that the generator "does run, is tested routinely, and is documented as such." In her second declaration she claims "per staff the generator did function prior to survey." Second Hrybiniak Declaration at 1, para. 1.

First, I find it noteworthy that Petitioner offered no statements from the individuals who were in the best position to comment on the surveyor finding, Facility Administrator Campbell and Director of Maintenance Hickson.⁽¹³⁾ More significant, it has not produced the facility's generator log, nor any other documentation establishing when, how often, and under what conditions the generator was tested. In her second declaration, Regional Administrator Hrybiniak asserts that the facility had recently changed ownership and concedes that its new owners "did not have adequate time to implement our generator test log." Second Hrybiniak Declaration, para. 1.⁽¹⁴⁾

To say that the generator functioned appropriately on "every test" before and after the survey says nothing about when it was tested prior to the survey. Moreover, Regional Administrator Hrybiniak does not directly dispute Surveyor Slusher's specific declaration as to the contents of the generator log; Ms. Hrybiniak does not even claim to have reviewed the prior owner's log book. Further, the Hrybiniak assertion that the "generator does run, is tested routinely, and is documented as such" does not establish how often tests have been performed (annually? monthly?), nor what those tests involve, and does not establish program compliance. I also note that her assertion is written in the present tense. Inasmuch as CMS subsequently found the facility in substantial compliance, it is hardly surprising - though not relevant to this inquiry - that the generator does run, is tested, and the testing is documented. The Hrybiniak declarations tell us nothing about what was going on with the generator between January 1999 and the date of the survey, August 12, 1999. See Price Hill Nursing Home, DAB No. 1781, at 19 (2001) (where the facility was unable to document that it inspected and tested its emergency generator on a regular basis, the Board sustained the deficiency finding that the facility did not make adequate provision for emergency lighting). Accepting Regional Administrator Hrybiniak's general assertions as true thus does not undermine the survey findings.

In its Surreply, Petitioner also asserts, for the first time, that "the malfunctioning generator was only one of several generator's (sic) at the facility. Other generators were available." However, nothing in the record supports this assertion, or the apparent inference that emergency power was therefore available at all times. Regional Administrator Hrybiniak makes no such claim in either of her declarations. No exhibit refers to any other generators. See e.g., CMS Ex. 2. Presumably, Petitioner, in its plan of corrections, would have mentioned the availability of an alternative source of power. Again, counsel's assertions about events are not competent evidence and are properly disregarded. Community Nursing Home, DAB No. 1807, at 13-14 n.5 (2002). I therefore disregard counsel's gratuitous assertion.

Finally, with respect to potential harm, which Petitioner characterizes as not "even a reasonable risk of minimal harm," Regional Administrator Hrybiniak notes that no residents were on respirators, and those on oxygen concentrators had battery backups. Hrybiniak Declaration, para. 2. The requirement for emergency power goes well beyond protecting residents with special respiratory needs. Indeed, the rules here address specifically the need for emergency lighting, and with good reason. Implicit in these LSC requirements for emergency lighting is the recognition that a nursing facility cannot safely be plunged into darkness without jeopardizing resident health and safety.

Thus, with respect to the facility's alleged failure to provide emergency lighting, CMS has presented uncontradicted evidence that on the day of the survey, the generator did not function, so that the facility could not provide emergency lighting or power, and that the facility's emergency generator log showed no indication that, since January 1999, the facility had run weekly tests, nor that the emergency generator had been run under a load. Although they purport to address the emergency lighting issue, neither the Hrybiniak declarations nor any other credible evidence or argument disputes these specific surveyor findings. I therefore conclude that CMS has satisfied its prima facie case, and that the facility has not met its burden of establishing by a preponderance of the evidence that it was in substantial compliance with federal LSC requirements for emergency lighting.

2. The Facility Did Not Provide Housekeeping and Maintenance Services Necessary to Maintain a Sanitary, Orderly, and Comfortable Interior.

During the survey ending August 13, 1999, and again during the October 5, 1999 revisit survey, the surveyors cited conditions inconsistent with a sanitary, orderly, and comfortable interior.

Specifically, in August:

1) On all days of the survey, a dirty, cracked patient mattress sat on the floor beside the bed of Resident #93. The mattress had areas of dried brown substance and black marks.

CMS Ex. 3 at 3; Beuschlein Declaration at 2, para. 5. Surveyor Beuschlein explains that the plastic mattress cover was cracked open, and that the mattress and cover were stained. Review of Resident #93's records disclosed that he had diarrhea and bowel incontinence. Id.; CMS Ex. 28 at 1.

2) In the lower level dementia unit, the floor along the base boards down both sides of the halls was layered with brown dirt, grime, and lint.

CMS Ex. 3 at 3; McClure Declaration at 2, para. 5.

3) In the lower level dementia unit, the hand rails on both sides of the halls had a layer of grime, were rough on the tops, and had lint and food debris in the crevices between the rail and the wall.

CMS Ex. 3 at 3; Cobb Declaration at 2, para. 6.

4) In the lower level dementia unit, the ice machine had a rusty grate and white build-up along the black molding.⁽¹⁵⁾

CMS Ex. 3 at 3; McClure Declaration at 2, para. 6.

5) there was a hole in the floor tile by the rest room near the nurses station in the lower level dementia unit.

CMS Ex. 3 at 3; McClure Declaration at 2, para. 7.

6) Twelve ceiling tiles in the dining/lounge area by the nurses station were stained from water damage.

CMS Ex. 3 at 4; McClure Declaration at 2, para. 8.

7) Room 66 had black marks over the walls, tape residue and old tape on the walls, and the radiator in that room was rusty at the bottom.

CMS Ex. 3 at 4; McClure Declaration at 2, para. 9.

8) The corner of the hand rail by the radiator at the exit door was full of cobwebs.

CMS Ex. 3 at 4; McClure Declaration at 2, para. 10.

9) Carpet panels on the walls from the baseboards to the handrails were laden with lint.

CMS Ex. 3 at 4; McClure Declaration at 3, para. 11.

10) The door of room 68 was held open with a latex glove under the door.

CMS Ex. 3 at 4; McClure Declaration at 3, para. 12.

11) Both shower floors were dirty with brown streaks.

CMS Ex. 3 at 4; McClure Declaration at 3, para. 13.

12) Room 67 had a grimy buildup on the wood cabinet under the sink.

CMS Ex. 3 at 4; McClure Declaration at 3, para. 14.

13) Exposed wire hung from the wander guard system beneath the handrail between rooms 69 and 71.

CMS Ex. 3 at 4; McClure Declaration at 3, para. 15.

14) The frame around the clock in the lounge area was broken, with sharp plastic edges exposed.

CMS Ex. 3 at 4; McClure Declaration at 3, para. 16.

15) The drinking fountain near the restorative dining area was dirty, with thick, gummy substance covering the drain.

CMS Ex. 3 at 4; Cobb Declaration at 2, para. 7.

When a survey team returned to the facility for the October 5, 1999 revisit, it listed the following specific observations:

1) Two medication carts were dirty and grimy, with brown, caked-on substances on the drawer pulls.

CMS Ex. 4 at 7; Grimes Declaration at 6, para. 12.

2) Throughout the facility, floors around the baseboards were caked with thick black dirt, dust, and loose dirt.

CMS Ex. 4 at 7; Grimes Declaration at 6, para. 13.

3) Room 17 had a big hole in the wall; Colored wires hung from the wall heaters onto the floor in Rooms 28 and 32; the bathroom in room 28 had a broken towel rack and loose commode.

CMS Ex. 4 at 7; Grimes Declaration at 7, para. 14.

4) Dried food, dirt, and debris were on the floor of Room 23, and dried spills were on the walls. The microwave oven had a broken and loose handle, with dried food and dust. A fan was dusty and dirty.

CMS Ex. 4 at 7; Cobb Declaration at 8-9, para. 29.

5) 15 of 17 chairs in the sunshine dining room were soiled with dried food stains and spills; the arms of the geri chair had dirty tape covering splits.

CMS Ex. 4 at 7; Cobb Declaration at 9, para. 30.

6) Dried brown spills and stains were on the walls of rooms 32 and 37.

CMS Ex. 4 at 7; Grimes Declaration at 7, para. 15.

7) Throughout the facility, handrails had loose dirt and debris in the crevices.

CMS Ex. 4 at 7; Grimes Declaration at 7, para. 16.

8) The wall heater in room 58 was dirty and rusty.

CMS Ex. 4 at 8; Cobb Declaration at 9, para. 31.

9) The floors in Room 61 were dirty, stained, and sticky. Behind both beds, the baseboards were missing, exposing unfinished rough walls.

CMS Ex. 4 at 8; Grimes Declaration at 7, para. 17.

10) The floors in room 68 were dirty; the baseboard heater was rusty, and there was a hole in the bathroom door.

CMS Ex. 4 at 8; Grimes Declaration at 8, para. 18.

11) Ceiling tiles in the downstairs dining room had brown water stains. Chairs were soiled with dried food and spills.

CMS Ex. 4 at 8; Grimes Declaration at 8, para. 19.

12) The wall heater in the hallway was chipped, dusty, and rusty.

CMS Ex. 4 at 8; Grimes Declaration at 8, para. 20.

Petitioner does not challenge any of these specific findings, nor, with one exception, argue that the findings do not constitute deficiencies.⁽¹⁶⁾ In her declaration, Regional Administrator Hrybiniak, who was present for the August survey, does not challenge any of these surveyor observations. Instead, Petitioner asserts that the facility provides full time housekeeping staff who maintain a regular cleaning schedule of the facility; points out that the rate of facility-generated infections is low; argues that the August survey was conducted within two days after Petitioner began operation of the facility, so it was cited for conditions over which it had no control; and argues that, because the facility is used continuously, "at any given time areas within the facility may be observed to be unclean." P. Brief at 3; Hrybiniak Declaration at 2, para. 3.

Petitioner offers no specific comment on the deficiencies found during the October survey.

Thus, in August, the surveyors found a facility layered with dirt and grime, sorely in need of substantial cleaning and repairs. And when the survey team returned for the October revisit, the facility was still neither clean, nor in good repair. Throughout the facility, floors around the baseboards were caked with thick black dirt, and handrails had dirt and debris in the crevices. The surveyors described numerous instances of stains and dried spills on walls, chairs, and floor, and stained ceiling tiles. In both August and October, the survey findings describe a facility interior that was not sanitary, orderly, and comfortable. Such conditions do not satisfy regulatory requirements. 42 C.F.R. § 483.15. See Community Nursing Home, DAB No. 1807, at 18 (Surveyor observations, as recorded in the survey report form, found credible in the absence of any evidence from the Petitioner that refuted the findings).

That Petitioner may have had in place a full-time housekeeping staff, as well as policies and procedures for cleaning and maintaining the facility, does not satisfy the requirement that the facility actually be kept clean and orderly. 42 C.F.R. § 483.15(h)(2). Community Nursing Home, DAB No. 1807, at 18 ("Assertions that efforts are being made to come into compliance or that Petitioner's staff is overworked do not constitute a meaningful defense to the allegations of noncompliance.") That, notwithstanding its conditions, the rate of facility-generated infection might have been low is fortuitous, but that fact⁽¹⁷⁾ does not establish facility compliance and does not indicate the absence of potential harm to residents. The potential dangers posed by an ill-maintained environment are not limited to increased risk of infection: holes in the floor tile, sharp edges, exposed wires, chipped and rusty metal all increase the risk of injury. Moreover, even if I accept the suggestion that living in an unsanitary and disorderly environment does not by itself represent actual harm to residents, neither the statute nor regulation requires that actual harm to residents be demonstrated as a prerequisite for imposing a remedy on a provider who is not in substantial compliance with participation requirements. The potential for more than minimal harm is sufficient to demonstrate a failure of substantial compliance without a finding of actual harm. Koester Pavilion, DAB No. 1750, at 37 (2000); CarePlex, DAB 1627, at 10 (1997).

Nor do I accept Petitioner's suggestion that these conditions are inevitable because the facility is "in constant use." The surveyors were not citing an occasional spill, speck of dust, or scrap of clutter; they described the kinds of conditions resulting from inadequate cleaning and repair over time. That the facility (like all other participating facilities) is "in constant use" does not excuse Petitioner from maintaining a sanitary, orderly, and comfortable interior.

3. A change of ownership/management does not relieve the facility of its obligation to meet program participation requirements.

Finally, Petitioner suggests that its environmental and other deficiencies be excused because of its recent acquisition of the facility.⁽¹⁸⁾ However, in its CarePlex decisions, CarePlex of Silver Spring, DAB No. 1683 (1999) and DAB No. 1627 (1997), the Appellate Panel, relying on statutory and regulatory construction, as well as sound policy reasoning, concluded that a new owner does not enjoy immunity from compliance with participation requirements simply because it acquired a deficient facility. In CarePlex, the facility was surveyed the day after it changed ownership, and many of its significant deficiencies were the result of long-standing conditions that required significant time and effort to correct.

As the Appellate Panel noted there, the statute provides no "grace period" during which a new owner may operate in violation of the participation requirements by showing good faith efforts to begin to improve the facility. If anything, the Act suggests Congressional concern that facilities undergoing changes in ownership might need additional scrutiny. Thus, by statute, if a standard survey has not already been conducted under normal time frames, a special survey may be conducted within two months of a change in ownership to determine if the change caused any decline in the quality of care. Act, section 1819(g)(2)(A)(iii)(II). The Board observed that a survey conducted within two months or less of a change in ownership "obviously" may pick up deficiencies caused by conditions that began under a prior regime. Yet Congress made no special provision to reduce the responsibility of new owners for deficiencies found during these surveys.

The regulations provide that, upon a change of ownership, the existing provider agreement is automatically assigned to the new owner, subject to all applicable statutes and regulations and to the terms and conditions under which it was originally issued, including, but not limited to (1) any existing plan of correction; and (2) compliance with applicable health and safety standards. 42 C.F.R. § 489.18(c) and (d). The regulation plainly holds new owners to compliance with all participation requirements from the time of the assignment of the agreement and therefore supports the conclusion that all providers are subject to the normal enforcement authorities, regardless of how long they have owned or operated the facilities.

The Appellate Panel also noted that CarePlex could have declined assignment of the existing provider agreement, and instead applied to participate in the program once it was able to meet the participation requirements.

However, once CarePlex chose to take over the facility's provider agreement, it also undertook to operate the facility in compliance with the applicable participation requirements from that point.

DAB No. 1627, at 7; DAB No. 1683, at 5.

The Appellate Panel concluded that the legal basis for imposition of the CMP is not undercut by the uncontested evidence that the facility engaged in efforts to improve the operation and upgrade the facility during the period. The purpose of notifying a noncompliant provider that a CMP may be imposed until it achieves substantial compliance is to provide an incentive for prompt improvements and corrections. DAB No. 1683, at 5. See 42 C.F.R. § 488.402(a). The fact that such efforts were undertaken does not preclude the enforcement of a CMP for the period of noncompliance; to rule otherwise would render notice that a CMP may accrue until substantial compliance is achieved a toothless threat. DAB No. 1683, at 5.

From the point when CarePlex accepted assignment of the provider agreement, it undertook to represent to Medicare that it was capable of complying with the terms of the agreement and operating in accordance with the participation requirements. Careplex was undeniably responsible for its correction of or its perpetuation of inadequate conditions, regardless of who initially created the conditions.

DAB No. 1627, at 4.

Petitioner here is thus responsible for the facility conditions, regardless of who initially created them.

4. The facility did not provide necessary care and services to ensure that each resident maintained the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

Resident #44 was bedfast; she had severe muscle contractures, including in her arms, and the parties agree that she was at high risk for skin breakdown. Indeed, according to Petitioner, her diagnoses -- CVA, hypertension, osteoarthritis, dysphasia, congestive heart failure, and diabetes -- made skin breakdown unavoidable. P. Brief at 5, Hrybiniak Declaration at 2-3, para. 4a. See also McClure Declaration at 3-4, para. 18.⁽¹⁹⁾

Resident #44's physician therefore ordered "heel protectors on at all times (w/ankle rings)[and] bilateral elbow protectors on at all times." P. Ex. 1 at 1. Resident #44's care plan, responding to her risk for skin break-down, called for "heel protectors and elbow protectors as ordered." P. Ex. 1 at 8.

Similarly, Resident #90 had a history of skin breakdown, and also had orders in place for bilateral heel protectors "at all times," bilateral elbow protectors "at all times for preventive measure," and for a cone splint for his hand to be worn from 7 AM to 7 PM, then taken off at bedtime. Resident #90 had paralysis on his right side as the result of a stroke, and his right hand was severely contractured. The cone splint was designed to hold his hand partially open to avoid worsening the contractures. P. Ex. 2 at 2, 4, 6, 9; Cobb Declaration at 3, para. 8. Resident #90's care plan acknowledged these problems, and, among other measures, called for "heel protectors as ordered," "elbow protectors as ordered," and "cone splint as ordered." P. Ex. 2 at 16-17.

Yet on three days of the survey, the surveyors observed Resident #44 without elbow protectors. Specifically, at 2:00 P.M. on August 10, 1999, she was lying on her elbow on her right side without protectors. Throughout the day on August 11, 1999, she was observed without the protectors. On August 12, at 8:15 AM she had no protectors; and at 8:55 AM she was observed lying on her elbow on her left side without the elbow protectors. CMS Ex. 3 at 5-6; CMS Ex. 23; McClure Declaration at 4, para. 18.

The surveyors observed Resident #90 on August 12 at 8:30 AM (awake and in bed), 9:15 AM (sleeping), and 11:30 AM (up in a chair with his arms on the arm rest) without elbow protectors. They observed him in a geri chair in the dining room at 1:50 PM without elbow protectors, heel protectors, or hand splint. CMS Ex. 3 at 6, CMS Ex. 22 at 4.

Petitioner does not deny the surveyor observations, but asserts that such observation "does not mean much," because

[t]he facility nursing staff makes treatment rounds during the 8:00 o'clock and 2:00 o'clock times. The purpose of that is to provide treatment and care and it is a matter of facility routine that the heel/elbow protectors will be removed.

Hrybiniak Declaration at 2, para. 4a. Petitioner also asserts that "there is no requirement for a physician's order for elbow/heel protectors. It is nursing judgment whether or not these need to be applied;" that residents can and do remove, shift, or displace the protectors. They "are anticipated to be routinely moved, dislodged, or out of place;" and that elbow/heel protectors are not needed when in bed because the resident is on a pressure relief mattress. P. Brief at 5-6; Hrybiniak Declaration at 2-3. Petitioner also points out that Resident #90, a hospice patient who died in October 1999, was routinely agitated and uncooperative, but was "nonetheless" on a pressure-relieving mattress, "which obviates the need for heel and elbow protectors." P. Brief at 5-6.

I accept, for purposes of this decision, that nursing staff made their rounds at 8 AM and 2 PM, but that fact does not mean, and Petitioner does not assert, that the surveyors just happened, consistently, to observe these residents during those limited moments that nursing staff had removed protectors in order to provide care. Indeed, the timing of the nursing rounds would not explain the absence of Resident #44's protectors throughout the day on August 11, nor as late as 8:15 and 8:55 AM on August 12, nor the absence of Resident #90's protectors at 8:30 AM, 9:15 AM, 11:30 AM, and 1:50 PM.⁽²⁰⁾

I note also that Petitioner has not challenged the surveyors' specific observations -- that Resident #90 was awake and in bed at 8:30, sleeping at 9:15, sitting up in a chair with arms on the arm rest at 11:30, and that Resident #44 was twice observed lying on an elbow without protectors -- and those observations are inconsistent with the suggestion that the residents were being examined and treated at those times. Thus, the record establishes that the protectors were not in place at all times, as ordered by the treating physicians and dictated by the plans of care.

Petitioner suggests, without citing actual support for the suggestion, that nursing staff appropriately determined that the protectors were not necessary. Again, counsel's assertions about events or standards of medical care are not competent evidence and are properly disregarded. Community Nursing Home, DAB No. 1807, at 13-14 n.5. Moreover, for each of these individuals, the treating physician determined that the resident required protectors and ordered them. The interdisciplinary team agreed, and incorporated the physician orders into the resident's plan of care. The regulations require that the facility provide care "in accordance with the comprehensive assessment and plan of care." 42 C.F.R. § 483.25. That Petitioner failed to do so violates the regulation, and creates a risk for more than minimal harm to individuals who were at high risk for developing pressure sores. Petitioner also suggests, again without support, that the residents themselves might have removed the protectors. If, for any reason, the facility is unable to keep the protectors in place, as required by physician order and the care plan, that fact should be documented, and then considered by the interdisciplinary team in developing the plan of care. The resident medical records suggest no problems with keeping the protectors in place, much less any consideration of such problem by the interdisciplinary teams. P. Exs. 1 and 2.

5. The facility failed to ensure that its residents not develop avoidable pressure sores, and did not ensure that a resident having pressure sores received the treatment and services necessary to promote healing, prevent infection, and prevent new sores from developing.

Resident #68 was diagnosed with multiple sclerosis, dysphagia (difficulty swallowing), iron deficient anemia, and dermatitis. P. Ex. 3 at 1. She had a gastrostomy tube for feeding, was bed-ridden, and had multiple contractures, such that she was unable to reposition herself. P. Ex. 3 at 12, 43, 84; CMS Ex. 21; Grimes Declaration at 2, para. 5. The parties agree that she was at high risk for developing pressure sores, and, in August 1999, she had a stage II open sore on her left buttock, and a stage II open sore on her left hip.⁽²¹⁾ P. Ex. 3 at 48-73, 81; Grimes Declaration at 2, para. 5. According to treatment records, a pressure sore on her left elbow had healed, so the facility stopped treatment for that on July 23, 1999. P. Ex. 3 at 60-61; Grimes Declaration at 2, para. 5. Resident #68's physician ordered pillowed pressure relieving devices on both feet and both elbows at all times. P. Ex. 3 at 18; Grimes Declaration at 2, para. 5.

Yet at 1:00 PM and again at 2:00 PM on August 10, 1999, the surveyor observed Resident #68 in bed, turned on her left side, with pressure relieving devices on her right elbow and both feet, but none on her left elbow, which was resting directly on the mattress. On August 11, 1999, at 10:30 AM, 3:00 PM, and 5:30 PM, the surveyor, with the nurse, observed the resident's left hip had a 6 cm by 4 cm pressure sore with thick yellow slough. The left buttock area had an 8 cm by 4 cm stage II red and bloody pressure sore. The surveyor observed dried, yellow drainage on the resident's gown directly under her left elbow, and the left elbow had a 2 cm by 3 cm stage II pressure sore with yellow slough. CMS Ex. 3 at 7-8; P. Ex. 3 at 8, 13; Grimes Declaration at 2-3, para. 6; see P. Ex. 3 at 10.

Although Petitioner suggests in its brief that Resident #68 "can still remove or protest the wearing of protective padding," (P. Brief at 6), it offers no evidence to support this assertion. The medical record does not mention her protesting or removing protective padding; no evidence is proffered from any of the staff who cared for her; and even the Hrybiniak Declaration makes no such claim.⁽²²⁾ Regional Administrator Hrybiniak simply states that the sores were unavoidable and that the provider did what was reasonable -- provided a pressure-relieving mattress -- to prevent sores from developing. Hrybiniak Declaration at 3, para. 6.

Resident #93 had open pressure sores on his heels and ankles, with physician orders for heel protectors while in bed, and a history of pushing his heel/ankle bandages out of place. P. Exs. 4 at 3, 7, 14, 21, 31, 36, 37; CMS Ex. 3 at 8; CMS Ex. 28. At approximately 3:00 PM, August 11, 1999, a surveyor observed his return from the whirlpool to his room. The surveyor watched as a nurse removed from his feet two pillowed heel protectors, soiled with dried bloody drainage. These dirty heel protectors had been applied directly against Resident #93's open pressure sores on his ankles and heels following his whirlpool bath. According to the surveyor, the nurse was upset that the dirty heel protectors had been reapplied in this way. The nurse cleansed the areas on the ankles and heels, and bandaged the open sores. She then reapplied the same dirty heel protectors against the clean bandages. CMS Ex. 3 at 8; CMS Ex. 28. Beuschlein Declaration at 2-3, para. 7, 8.

Petitioner makes no effort to challenge or defend staff actions in applying the bloody heel protectors directly to Resident #93's open sores immediately following his whirlpool treatment. With respect to the nurse reapplying the protectors after bandaging the areas, Petitioner asserts in its brief that the soiled heel protectors were replaced with fresh protectors. But no evidence supports this claim. Only two people had first hand knowledge as to whether the dirty heel protectors were re-applied, the surveyor and the nurse. The facility provided no declaration from the nurse. Moreover, in her declaration, Regional Administrator Hrybiniak does not claim that the nurse applied clean protectors. Instead, she, whose background and training are in social work, asserts that applying the bloody heel protector to the bandaged foot "merely establishes that the heel protector had contact with the outside of the surface of a bandage." Hrybiniak Declaration at 3, para. 6.

Although I do not doubt that, after dressing the pressure sores, the nurse reapplied the soiled heel protectors, I make no finding regarding the appropriateness of the application of the soiled heel protectors to the bandaged sores. Petitioner offers no credible evidence to counter the CMS declarations as to the dangers presented by applying contaminated heel protectors to the dressed wounds; however, on cross examination, Petitioner might have been able to undermine the surveyor opinions.

Nor is it necessary to make such a finding in order to conclude that the facility was out of compliance with 42 C.F.R. § 483.25. The relevant question here is: did the facility "take all necessary precautions" to promote healing, prevent infection, and to prevent new sores from developing. If so, and the resident develops sores anyway, I could find no deficiency. But, if the evidence establishes that the facility fell short of taking all necessary precautions and the resident develops pressure sores, then the regulation is violated. Koester, DAB No. 1750, at 32.

Petitioner argues that it "did what was reasonable;" however, the Appellate Panel rejected that standard in Koester. The facility is obliged to go beyond what seems reasonable to, instead, always furnish what is necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as needed. Koester, DAB No. 1750, at 32. Allowing Resident #68, a high-risk individual to lie, unprotected, on vulnerable points, in contravention of physician orders, does not establish that the facility took "all necessary precautions." Similarly, applying soiled heel protectors directly on to Resident #93's open sores does not establish that the facility took "all necessary precautions" to prevent infection.

6. The Facility Did Not Store, Prepare, Distribute, and Serve Food under Sanitary Conditions.

The surveyors cited a long list of deficiencies in dietary services. Petitioner challenges some, but not all, of these, raising factual disputes that, for these purposes, I resolve in Petitioner's favor.

Specifically, first, at 9:55 AM on the morning of August 10, 1999, Surveyor Carole Cobb observed that the floors throughout the kitchen and behind equipment were dirty with spills and debris. CMS Ex. 3 at 9; Cobb Declaration at 4, para. 11. Petitioner does not challenge the observation, but, in his declaration, Food Service Manager Alejandro Bayalan explains that the facility's practice is to clean the dishes first, then the floor, so as to avoid having to clean areas twice. The surveyor happened to observe the area after the morning meal, during the time that the kitchen and the dishes were being cleaned. Bayalan Declaration at 2, para. i. According to Petitioner's exhibits, breakfast is served at between 7:15 and 8:15 (P. Ex. 6 at 1); the kitchen floor is mopped between 1:15 to 2:30, (P. Ex. 6 at 2) and mopped again at 7 PM. P. Ex. 6 at 8. This raises some factual questions, which, for purposes of summary judgment, must be resolved in Petitioner's favor.

Second, Surveyor Cobb noted that, on August 10, 1999, paper supplies were stored on the floor in the dry storage area, and were still there on the following day. CMS Ex. 3 at 9; Cobb Declaration at 4, para. 11. Again, Petitioner does not deny the observation, but questions its significance. Food Service Manager Bayalan notes that Tuesday is delivery day for the facility so if paper supplies were observed on the floor, it was from the delivery. Of course this does not explain why the supplies were still there on the following day. More significant, however, Manager Bayalan also asserts that all such supplies were wrapped inside a cardboard box, presenting no risk of contamination. This creates a genuine controversy, so, for summary judgment purposes, I will accept that the supplies were stored on the floor, but, because of the way they were packed, presented no deficiency.

Third, Surveyor Cobb describes a box of sugar cookies open to the air and potential contamination. CMS Ex. 3 at 9-10; Cobb Declaration at 5, para. 15. Manager Bayalan responds that the facility purchases only individually wrapped cookies, so any cookies the surveyor observed would have been individually wrapped and sealed. Bayalan Declaration at 1, para. d. Again, this raises a genuine controversy which, for purposes of summary judgment, must be resolved in the Petitioner's favor. I therefore assume that these cookies were appropriately wrapped and sealed.

Fourth, Surveyor Cobb reports that uncovered coffee filters were stored in the area with unclean items and clutter. CMS Ex. 3 at 10; Cobb Declaration at 7, para. 21. Food Service Manager Bayalan points out that 190 degree water is poured over coffee filters, which essentially sterilizes them at the time of use. Bayalan Declaration at 1, para. e. For summary judgment purposes, I accept his claim.

Fifth, Surveyor Cobb reports that the water faucets in the hand wash sink in the dishroom were not working. CMS Ex. 3 at 10; Cobb Declaration at 7, para. 22. Food Service Manager Bayalan denies the charge, asserting that all faucets worked. Bayalan Declaration at 2, para. k. This is a dispute of fact, and, for purposes of the summary judgment, I accept his assertion.

Sixth, Surveyor Cobb notes that three of four dishes inspected at the tray line were stored wet and had specks of egg and food on them. CMS Ex. 3 at 10; Cobb Declaration at 7-8, para. 25. Food Service Manager Bayalan responds that, before racking, plates are washed in 120 degree plus water with a sterilizer/sanitizer and are rinsed in water at not less than 140 degrees. According to Manager Bayalan, city codes require the facility to air dry plates before use. Anything remaining on the plates after the washing process has been sanitized. Bayalan Declaration at 2, para. h. For purposes of summary judgment, I will consider this in Petitioner's favor, and do not find this a deficiency.

Finally, Surveyor Cobb observed two trays of cooked chicken on the stove without heat. She reports staff statements that it was out to cool so that it could be handled. CMS Ex. 3 at 11; Cobb Declaration at 8, para. 26. According to Manager Bayalan, the chicken was on the table "in the typical method of transfer from the oven to move to the steam table container." Bayalan Declaration at 2, para. f. Again, this appears to present a factual dispute, which I resolve in Petitioner's favor for purposes of summary judgment.

On the other hand, Petitioner does not challenge other significant deficiencies cited by the survey team:

Surveyor Cobb is a registered and licensed dietician of long-standing. Cobb Declaration at 1, para. 2. She observed a previously opened container of hot bacon dressing, dated March 19, 1999, stored in the dry storage area. The container label instructed that it be refrigerated after opening, and the top of the container was bulging. Surveyor Cobb notes that the bulging container indicates likely contamination and the growth of bacteria or mold, and that such improper storage of a perishable product puts residents at risk for food poisoning, infection, or allergic reactions. CMS Ex. 3 at 9; Cobb Declaration at 4-5, para. 13. Petitioner does not challenge the observation, nor the dietician's opinion.

Second, Surveyor Cobb observed, stored on a shelf in the dry storage area, a container of previously opened soy sauce with a label stating that it was to be refrigerated after opening. Again, she explains that such manner of storage creates a risk of bacteria or mold growth, that could cause food poisoning or other infection. CMS Ex. 3 at 9; Cobb Declaration at 5, para. 14. Again, Petitioner does not challenge the findings.

Third, Surveyor Cobb reported that a measuring cup was stored in a large container of sugar. She explains that the measuring cup comes into direct contact with a kitchen worker's hands, which could contaminate the cup with bacteria that would be transferred to the sugar. CMS Ex. 3 at 10; Cobb Declaration at 5, para. 16. Petitioner does not challenge these findings.

Fourth, Surveyor Cobb observed that the microwave had dried-on food spills inside, and noted that this creates a breeding ground for bacteria that could contaminate food placed in the microwave, unless the food is cooked for a long enough time at temperatures hot enough to kill the bacteria. CMS Ex. 3 at 10; Cobb Declaration at 6, para. 17. Again, Petitioner does not challenge these findings.

Fifth, the hand wash sink and the cover of the garbage container below it were dirty with old food spills and debris. CMS Ex. 3 at 10. Petitioner does not challenge this observation, nor Surveyor Cobb's assertion that this dirt and debris increases the risk of kitchen workers contaminating their hands, and attracts insects and rodents. Cobb Declaration at 6, para. 18.

Sixth, potholders on the shelf next to the serving area were dirty. CMS Ex. 3 at 10. Again, Petitioner does not challenge this observation, nor Surveyor Cobb's opinion that they could be breeding grounds for bacteria, which could contaminate dishes with which they come into contact. Cobb Declaration at 6, para. 19.

Seventh, the table on which the steamer was stored had dried food spills and debris on it. Again, Petitioner does not challenge this observation, nor Surveyor Cobb's opinion that this presents a potential breeding ground for bacteria, which could contaminate plates, utensils, or food placed on the table, and that such food spills can attract insects and rodents that spread disease and contamination. Cobb Declaration at 6, para. 20.

Eighth, the facility had no ceiling in the dishwashing area to protect clean dishes. As surveyor Cobb explains, this condition creates the risk of contamination because the dust, grease, and other grime, which builds up on the difficult-to-clean overhead pipes, can fall on to the dishes or utensils below. CMS Ex. 3 at 10; Cobb Declaration at 7, para. 23. Petitioner disputes neither the observation, nor Surveyor Cobb's opinion.

Ninth, the underside of the shelf over the steam table had dried food splatters, which, according to Surveyor Cobb, provides a breeding ground for bacteria that could contaminate utensils or food placed on the table below, and could attract insects and rodents. CMS Ex. 3 at 11; Cobb Declaration at 8, para. 27. Petitioner challenges neither the observation, nor Surveyor Cobb's opinion.

Finally, the meat slicer was covered with a black plastic bag that was not identified to be safe for use on food contact surfaces. CMS Ex. 3 at 10. Food Service Manager Bayalan admits that the meat slicer was covered, but declares, irrelevantly, that the facility's failure to cover it could be considered a deficiency as well. Bayalan Declaration at 2, para. g. Petitioner, however, misses the point of the deficiency, which was that the facility had not assured that the plastic used to cover the slicer was safe for use on food contact surfaces. The slicer must be covered, when not in use, but the facility must also ensure that the covering itself is safe. As Surveyor Cobb explains, some plastics contain harmful chemicals that can leech into foods and cause adverse reactions in people consuming those foods. Cobb Declaration at 7, para. 24. Even though Petitioner responds, it has not challenged the finding or the deficiency. I therefore find no fact in dispute here.

Thus, even after resolving all disputed facts in Petitioner's favor, the undisputed evidence establishes significant instances of unsanitary conditions that created the potential for causing more than minimal harm to facility residents. The facility was therefore not in substantial compliance with program participation requirements for dietary services. 42 C.F.R. § 483.35.

7. The facility failed to ensure that its nurse aides received the required in-service education.

The regulations are explicit that the facility must provide regular in-service education, of no less than 12 hours per year, to its nurse aides. In reviewing the facility's in-service training records, the surveyor, a registered nurse, determined that during calendar year 1998, 14 of the facility's 29 nurse aides had received fewer than the required 12 hours of in-service training. All of these employees were hired prior to January 1998. She verified this finding with the administrative nursing staff. CMS Ex. 3 at 11-12; Pierce Declaration at 2, para. 5.

Petitioner offers no evidence to counter the surveyor finding,⁽²³⁾ except the declaration from Regional Administrator Hrybiniak that, as new owners, Petitioner "cannot therefore speak to what condition the facility's records may or may not have been in nor the policies, procedures or practices of the prior operator." Hrybiniak Declaration at 4, para. 7.

As discussed at length above, a new owner does not enjoy immunity from compliance with participation requirements simply because it acquired a deficient facility. New owners are subject to the normal enforcement authorities, regardless of how long they have owned and operated the facility. CarePlex of Silver Spring, DAB No. 1683 and DAB No. 1627.

Thus, the undisputed evidence establishes that the Petitioner did not provide its nurse aides with the required in-service training.

For all of these reasons, I conclude that from August 13, 1999, until October 21, 1999, the facility was not in substantial compliance with program participation requirements, specifically 42 C.F.R. §483.15 (Environment), 42 C.F.R. §483.25 (Quality of Care), 42 C.F.R. § 483. 35 (Dietary Services), 42 C.F.R. § 483.75 (Administration), and 42 C.F.R. § 483.70(a) (Life Safety Code).

I next consider whether the amount of the CMP, $400 per day, is reasonable.

B. The Amount of the CMP Imposed against Petitioner, $400 per day, is reasonable.

Having found a basis for imposing a CMP, I now consider whether the amount imposed is reasonable, applying the factors listed in 42 C.F.R. § 488.438(f). My "inquiry should be whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved." CarePlex of Silver Spring, DAB No. 1683, at 8.

Petitioner limits its argument to the facility's financial condition, one of the factors set forth in 42 C.F.R. § 488.438(f). However, evidence of the facility's financial condition are not appropriately before me because Petitioner neither timely raised the issue, nor timely presented its evidence relevant to the issue.

If a facility contends that its financial condition or some other factor makes a CMP unreasonable, the facility must raise that contention on a timely basis before any question would arise as to CMS's responsibility for producing evidence as to that factor. Community Nursing Home, DAB No. 1807, at 22, et seq.; Emerald Oaks, DAB No. 1800 (2001). Where either party fails to take advantage of its opportunity to submit evidence of a facility's financial condition, that opportunity is waived. Community Nursing Home, DAB No. 1807, at 15-16.

In Community Nursing Home, the Appellate Panel affirmed an ALJ refusal to admit untimely evidence of a facility's financial condition. The Appellate Panel noted that, while CMS must and the ALJ may consider a facility's financial condition in determining whether the amount of a CMP is within a reasonable range, the facility must initially raise that issue as a basis for disputing the reasonableness of the amount of the CMP. Where Petitioner did not raise the issue in its request for hearing, its response to CMS's motion for summary disposition, or its initial brief, the Board reasoned that the evidence of its financial condition was not relevant to any timely-raised issue in dispute before the ALJ, and the ALJ properly exercised his discretion by excluding it.

Here, Petitioner's hearing request, filed December 30, 1999, does not raise the issue of the facility's financial condition affecting the reasonableness of the CMP. I do not consider its general challenge to the amount of the CMP sufficient to raise the issue under the Emerald Oaks and Community Nursing Home analysis. Nor did Petitioner attempt to add the issue when it submitted its readiness report, filed June 27, 2000. Petitioner did not raise the issue until it filed its brief, almost two years after filing its hearing request.

Moreover, even if the issue had been properly raised, Petitioner supports its claim with evidence that I decline to admit because it is untimely. Petitioner bases its case on the declaration of Bert A. Cummins, accompanied by a document that purports to be an income statement report, which were submitted for the first time with Petitioner's brief on November 29, 2001. The parties were expected to file their complete prehearing exchanges by December 4, 2000, almost a full year earlier. The matter was scheduled for hearing on September 18, 2001. We held a prehearing conference on September 10, 2001, prior to which Petitioner should reasonably have been expected to review its exhibits and witness list. During the continuation of the conference call on September 19, 2001, I specifically advised the parties that no additional exhibits or witnesses would be allowed without a showing of good cause. On September 21, 2001, Petitioner moved to amend and supplement its witness list, which I denied in a ruling dated October 3, 2001, concluding that Petitioner failed to show good cause for supplementing its witness lists, and even that proposed supplement did not list Mr. Cummins as a proposed witness, nor include this financial document.

Now, without even asking leave, Petitioner attempts to add an additional witness and an additional exhibit. The Civil Remedies Division procedures provide for the exchange of exhibits and witness lists in advance of hearing. Under those procedures, if a party attempts to call a witness who was not listed or offer an exhibit that was not listed or timely furnished, and the other party objects,

the offering party must persuade the judge why the testimony should be allowed or exhibit admitted, inasmuch as the party did not comply with prehearing requirements for providing the judge and other party with the name of the witness or a copy of the proposed exhibit. The judge may require the offering party to demonstrate that there are extraordinary circumstances (such as surprise or rebuttal) which explain the failure to comply with prehearing requirements, and that there is a lack of substantial prejudice to the objecting party.

Civil Remedies Division Procedures, Section 4.

I therefore decline to admit Petitioner's evidence or testimony regarding its financial condition and strike the Cummins' Declaration from this record. Of course, I also strike CMS's documents and declarations responding to Petitioner's assertions regarding its financial condition. Further, any argument or evidence submitted by CMS addressing the facility's financial condition is irrelevant, as the issue was never properly raised. I consider the record silent as to Petitioner's financial condition.

I now consider the evidence properly before me. In reaching a decision on the reasonableness of the CMP, I may not look into CMS's internal decision-making processes. Instead, I consider whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved (financial condition, facility history, and culpability). I am neither bound to defer to CMS's factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS's discretion. Community Nursing Home DAB No. 1807, at 22, et seq.; CarePlex, DAB No. 1638, at 8.

CMS has imposed a penalty of $400, which is at the lower end of the mandatory range for non-immediate jeopardy situations. With respect to the section 488.438(f) factors, the record shows a facility history of failure to provide services to prevent the formation of pressure sores, and to promote the healing of pressure sores. During the prior survey cycle (1998), CMS found deficiencies in this area that resulted in actual harm. CMS Ex. 13; Weidler Declaration at 4, para. 8. Housekeeping and maintenance services, which were not corrected until after the October revisit, had also been cited as deficient during the prior year, as were dietary services and administration. Id.

The deficiencies cited were not insignificant. They directly affected resident comfort and safety. Because of these factors as well as the facility history, I am not able to find CMS's determination unreasonable.

V. Conclusion

For all of the reasons discussed above, I uphold CMS' determination that from August 13, 1999, until October 21, 1999, the facility was not in substantial compliance with program participation requirements, specifically 42 C.F.R. §483.15 (Environment), 42 C.F.R.§ 483.25 (Quality of Care), 42 C.F.R. § 483. 35 (Dietary Services), 42 C.F.R. § 483.75 (Administration), and 42 C.F.R. § 483.70(a) (Life Safety Code). The amount of the CMP imposed, $400 per day, is reasonable.

Carolyn Cozad Hughes

Administrative Law Judge

1. I note that Petitioner's hearing request, though technically satisfying the requirements of 42 C.F.R. § 498.40(b), as articulated by the Board in Fairview Nursing Plaza, DAB No. 1715 (2000), is very broad. The prehearing conference is the appropriate forum in which to narrow the issues and focus the inquiry. See 42 C.F.R. § 498.47; Fairview, DAB No. 1715, at 16 n.7.

2. As discussed below, with respect to Tag K-046, Petitioner conceded that it has no log book or other documentation demonstrating that its emergency generator had been tested or run under a load from January 1999 until the date of the survey. With respect to Tag F-314, Petitioner also indicated that it did not challenge the surveyor finding that Resident #68 did not have a protector on her left elbow. Responding to Tag F-497, Petitioner asserted that its documentation established that it provided in-service training to its nurse aides. I therefore directed Petitioner to identify where among its exhibits such documentation could be found. Summary of Results of Prehearing Conference (Sept. 10, 2001). As discussed below, Petitioner has not identified any documentation of nurse aide training.

3. In its Memorandum in Opposition to Respondent's Motion for Summary Judgment (hereafter, Petitioner's Surreply), filed January 16, 2002, Petitioner, citing my December 12, 2001 letter, characterizes CMS's submission as "untimely and unauthorized," and argues that it should be stricken. In fact, my September 21, 2001 order required CMS to file its prehearing brief and supporting documentation first. I gave Petitioner more than 30 days to respond with its own prehearing brief and supporting affidavits or declarations of witnesses. I then gave CMS three weeks in which to file a reply. We sent the December 12 letter before the due date for CMS' reply brief in order to give the parties maximum notice that the in-person hearing would be canceled. However, it was not intended to foreclose CMS's filing the already-scheduled reply brief. That CMS added a motion for summary judgment to its reply does not render the submission "untimely and unauthorized." In any event, I subsequently afforded Petitioner the opportunity to respond to CMS's Summary Judgment Motion/Reply Brief. I note also that, in reaching my decision here, I do not rely on any of the submissions that accompany CMS's Reply.

4. At the time, since Petitioner received CMS's motion by Federal Express on December 18, 2001, and sent its own Notice of Objections on December 19, 2001, it did not appear that Petitioner intended to file any additional response.

5. Petitioner's claim that the press of business precluded its responding before February rings hollow inasmuch as the week of January 7 was set aside for the in-person hearing in this case. Presumably, the time counsel would have spent preparing for and conducting the in-person hearing became available for responding to CMS's motion. I note also that, in its motion, CMS raised no new issues and made no new arguments aside from pointing out that in its submission Petitioner had raised no issues of material fact.

6. Although Petitioner's brief does not include a citation for Gold Country, we assume it refers to Gold Country Health Center, DAB CR533 (1998).

7. Initially, CMS must set forth the basis for its determination with sufficient specificity for the provider to respond. The provider must then identify which of the findings material to the determination it disputes, and any additional facts that it is asserting. At hearing, "whether or not in-person testimony is introduced as evidence," CMS has the burden of coming forward with evidence which, "when viewed together with any undisputed findings and relevant legal authority," is sufficient to establish a prima facie case that it had a legally sufficient basis for termination. Gold Country, DAB CR 533, at 2. The Petitioner has the burden of coming forward with evidence sufficient to establish the elements of any affirmative arguments or defenses, and bears the ultimate burden of persuasion. To prevail, Petitioner must 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, DAB No. 1611, at 8. In Cross Creek Health Care Center, DAB No. 1665 (1998), and South Valley Health Care Center, DAB No. 1691 (1999), the Board confirmed that the Hillman standards apply to CMP determinations as well as termination cases.

8. These findings, discussed in more detail below, are very specific: see, e.g., CMS Ex. 2 at 1-2 ("Between 11:00 and 11:04 AM, in the presence of two staff, the generator failed to start two of two times when the test button was pushed at the main panel in the upstairs courtyard."); CMS Ex. 3 at 3 ("A dirty, cracked regular size patient mattress was placed on the floor beside the bed of resident #93 on all days of the survey. The mattress had areas of dried brown substances and black marks.")

9. Given the plain language of this order, I find puzzling Petitioner's claim that its submissions were "designed to summarize the facts, witnesses, and exhibits" it intended to prove at hearing, but "not intended to be a motion for summary judgment or a complete dissertation of the facts that would be established at hearing." Petitioner's Surreply at 3.

10. I make Findings of Fact and Conclusions of Law (Findings) to support my decision in this case. I set forth each Finding as a separately numbered heading, and explain each Finding in detail.

11. Petitioner accurately points out that the presence of only one generator for three buildings is not a deficiency. On the other hand, Petitioner is incorrect in declaring "no point to the contention that 'only' one generator serving (sic) three buildings." P. Brief at 2. Inasmuch as one generator provided emergency power to all three buildings, each constructed at a different time, that power source had to comply with both the 1967 and 1981 versions of the LSC. Of course, to meet program requirements, the generator also had to be operational at all times.

12. Until Petitioner filed its Surreply, the record consistently identified Michael Campbell as the facility (Crestview) administrator at the times of the surveys. See CMS Exs. 1, 2, 3, 4, 6, 7, 8, 10, 40, 45. Each facility has only one "administrator," whose qualifications and responsibilities are defined by regulation. 42 C.F.R. § 483.75(d). In her declaration, Regional Administrator Hrybiniak identifies herself as the Regional Administrator for Regal Care. Hrybiniak Declaration at 1, para. 1. Yet, without any support, in its Surreply, Petitioner claims that Regional Administrator Hrybiniak "was Administrator of the facility at the time of the survey." Petitioner's Surreply at 5. Counsel's assertions are not competent evidence and, where unsupported, are properly disregarded. Community Nursing Home, DAB No. 1807, at 13-14 n.5 (2002).

13. Nor were these individuals ever included on Petitioner's witness lists.

14. I discuss below why the facility's change of ownership does not relieve Petitioner of its obligation to meet program participation requirements.

15. Petitioner admits to the white build-up along the black molding, but describes this as the cleaning solution used by the facility. For purposes of a summary judgment ruling, I accept Petitioner's representation.

16. During the August survey, the surveyors cited a rusty grate and white build-up along the black molding of an ice machine. Petitioner argues that the white build-up was the result of cleaning solution, suggesting that such was not a deficiency. For purposes of summary judgment, I accept Petitioner's position.

17. Petitioner offers no solid foundation for Regional Administrator Hrybiniak's assertion, but, for purposes of this decision, I will assume that Petitioner would have been able to lay one.

18. The Hrybiniak declarations are not wholly consistent as to when Petitioner began operating the facility. In her initial declaration, she maintains that the facility was surveyed "within two days after Petitioner started operating [the facility] after a previous owner." Hrybiniak Declaration at 2, para. 3. In her second declaration, she declares that the new owner "had just taken over operation on 8/01/1999," which would have been 11 days prior to the LSC survey. Second Hrybiniak Declaration at 1, para. 1. However, because the change of ownership does not relieve Petitioner of its obligation to demonstrate substantial compliance, the exact timing of that change is not significant.

19. Although Petitioner denies that Resident #44 had pressure sores, and claims instead that she had unavoidable diabetic foot ulcers, her medical records indicate the opposite. In listing the type of ulcer, the facility consistently lists "pressure ulcer" and specifically denies the presence of stasis ulcers (open lesions caused by poor circulation in the lower extremities). P. Ex. 1 at 9, 10, 11, 12, 13. In either case, the facility was bound to follow the plan of care to ensure that she maintained the highest practicable physical well-being.

20. These documented instances, along with the surveyor observations of Residents #68 and #93 (see discussion, infra), suggest a pattern rather than an isolated incident, but even an isolated incident, if serious enough, may indicate problems in the facility since a survey can only be a sample of facility conditions, especially given that this deficiency would not necessarily have been detectable in a record review. Koester, DAB No. 1750, at 37.

21. A stage II pressure sore is characterized by partial loss of skin thickness in the epidermis and/or dermis skin layers. It presents as an abrasion, blister or shallow crater.

22. Again, counsel's assertions about events or standards of medical care are not competent evidence and are properly disregarded. Community Nursing Home, DAB No. 1807 at 13-14 n.5 (2002).

23. In its brief, Petitioner also gratuitously declares that--

at all times, Crestview provides regular in-services and education training sufficient to ensure the continuing competence of the nurse aides. The mandatory hours are met by Crestview, which also audits all personal files as a check to assure compliance with the regulation.

P. Brief at 9. As noted above, counsel's unsupported assertions are properly disregarded. Commuity Nursing Home, DAB No. 1807, at 13-14 n.5. Moreover, during the September 10, 2001 prehearing conference, I specifically advised counsel of the need for documentation to establish facility compliance with the in-service training requirement. See Summary of Results of Prehearing Conference (September 10, 2001).