SUBJECT:

St. Francis Home,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I decide that St. Francis Home was not in substantial compliance with Medicare and Medicaid participation requirements. Consequently, the Center for Medicare & Medicaid Services (CMS, formerly known as the Health Care Financing Administration or HCFA) ⁽¹⁾ had the authority to impose civil money penalties of $4,900 per day from February 16, 2000 through February 24, 2000, for each of the nine days that immediate jeopardy in residents' health and safety existed, and $550 per day from February 25, 2000 through March 23, 2000 for continuous noncompliance that was not immediate jeopardy. I also decide that the civil money penalties (CMP) that were imposed against the Petitioner were authorized and reasonable.

I. Applicable law

Medicare, a federally-subsidized health insurance program for the elderly and disabled, was established under Title XVIII of the Social Security Act (Act). Medicare provides reimbursement for certain services rendered by providers, such as a skilled nursing facility (SNF) like Petitioner, who participate in the Medicare program under "provider agreements" with the United States Department of Health and Human Services (DHHS). In order to enter into such an agreement, SNFs must meet certain requirements imposed by applicable statute and regulations. Section 1819 of the Act [42 U.S.C. � 1395i - 3]; 42 C.F.R. Parts 483, 488, and 489. The requirements for participation in Medicare by SNFs are set forth at 42 C.F.R. Part 483. A SNF is subject to the survey, certification, and remedies provisions of 42 C.F.R. Part 488, and to the provisions governing provider agreements at 42 C.F.R. Part 489.

Title XIX of the Social Security Act (Act) provides for grants to states for medical assistance programs (Medicaid). Section 1903 of the Act permits federal participation in amounts expended as medical assistance at a rate set for each state by a formula at section 1905(b). The Act provides that medical assistance means payment of the costs of certain listed services, as well as "any other medical care . . . specified by the Secretary." Act, sections 1905(a) and (a)(27).

The survey process is the means by which DHHS (through CMS) assesses providers' compliance with participation requirements. State survey agencies, under agreements with CMS, perform the surveys of SNFs and make recommendations to CMS as to whether such facilities meet federal requirements for Medicare and Medicaid participation. Act, section 1864(a); 42 C.F.R. �� 488.10, 488.11, and 488.20. The results of these surveys are used by CMS as the basis for its decisions regarding a SNF's initial or continued participation in Medicare and Medicaid. CMS, not a State survey agency, makes the determination as to whether a facility is eligible to participate or remain in Medicare and Medicaid. Id.

The regulations define "substantial compliance" as "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. � 488.301.

The regulations define "noncompliance" as "any deficiency which causes a facility to not be in substantial compliance." 42 C.F.R. � 488.301. A deficiency is "a skilled nursing facility's failure to meet a participation requirement." Id.

The regulations define "immediate jeopardy" as follows:

Immediate jeopardy means a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident."

42 C.F.R. � 488.301.

The regulations specify that a CMP that is imposed against a provider will fall into one of two broad ranges of penalties. 42 C.F.R. �� 488.408, 488.438. The lower range of CMPs, from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or cause no actual harm, but have the potential for causing more than minimal harm. 42 C.F.R. � 488.438(a)(2). The upper range of CMPs, from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a provider's residents, and, in some circumstances, for repeated deficiencies. 42 C.F.R. �� 488.438 (a)(1) and 483.438(d)(2).

The preponderance of the evidence standard is applied to resolve disputed issues of fact, except as provided by 42 C.F.R. � 498.60(c)(2), which states that in CMP cases, CMS's determination as to the level of noncompliance of a provider must be upheld unless it is clearly erroneous. CMS bears the burden of coming forward with evidence sufficient to establish a prima facie case that the provider was not in substantial compliance with the participation requirements at issue. Once CMS has established a prima facie case, the provider has the ultimate burden of persuasion: to prevail, the provider must prove by a preponderance of the evidence that it was in substantial compliance with each participation requirements at issue. See Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. United States, Department of Health and Human Services, Health Care Financing Administration, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999).

II. Background

The Ohio Department of Health (State survey agency) completed a standard and extended survey of Petitioner's facility on February 16, 2000, which resulted in a finding that Petitioner was not in substantial compliance with the applicable Federal requirements for nursing homes participating in the Medicare (Title XVIII of the Act) and Medicaid (Title XIX of the Act) programs (42 U.S.C. �� 301 - 1397jj). The survey documented 11 deficiencies which posed immediate jeopardy to residents' health and safety from February 16, 2000 through February 24, 2000, and from February 25, 2000 through March 23, 2000 for continuous noncompliance which was not immediate jeopardy. Subsequent to the February 16^th survey, a monitoring survey was conducted on February 19, 2000, at which time it was found that the immediate jeopardy situation remained. A second monitoring survey was conducted on February 25, 2000, when it was determined that the immediate jeopardy had subsided. Petitioner's noncompliance continued through March 24, 2000, but was not at the immediate jeopardy level.

On March 10, 2000, Petitioner was notified by CMS that it agreed with the findings of noncompliance as documented by the State survey agency in the February 16^th survey. CMS also concluded that the isolated deficiency cited during the February 16^th survey posed immediate jeopardy to residents' safety and health. CMS's notice further advised Petitioner that it was imposing a civil money penalty (CMP) effective February 16, 2000 through February 24, 2000 in the amount of $5,400 per day for the immediate jeopardy and, effective February 25, 2000, continuing at the amount of $550 per day until Petitioner attained substantial compliance. The notice also informed Petitioner that denial of payment for new Medicare and Medicaid admissions would go into effect as of March 14, 2000. All of the documented deficiencies had to be promptly corrected, and the facility had to attain and maintain substantial compliance with all applicable participation requirements or further remedial action (including termination) would be taken by CMS.

On March 29, 2000, a revisit survey was conducted at which time Petitioner was found to be in substantial compliance as of March 24, 2000.

In its amended notice of imposition of remedies dated April 6, 2000, CMS advised Petitioner of the reduction of the CMS from $5,400 to $4,900 for the days of immediate jeopardy, as well as revision of the level of the most serious deficiency found during the February survey.

By letter dated May 5, 2000, Petitioner requested a hearing, and the case was assigned to me for hearing and decision. I conducted an in-person hearing on August 27 - 29, 2001 in Columbus, Ohio. At that time, without objections from Petitioner, I received into evidence CMS Exhibits (CMS Exs.) 1 - 66 ⁽²⁾. I also received into evidence Petitioner's Exhibits (P. Exs.) 1 - 17 without objections from CMS. Both parties were forwarded a copy of the transcript (Tr.) of these proceedings. CMS's posthearing brief (CMS Br.) was received on December 3, 2001. Petitioner's posthearing brief (P. Br.) and Proffer of Testimony, accompanied by proffer exhibits marked A, and A-1 through G, were received on February 1, 2002. CMS's reply brief (CMS Reply) was received on March 6, 2002.

III. Issues

The issues in this case are:

1. Whether Petitioner was in substantial compliance with Medicare and Medicaid participation requirements for the period of February 16 through March 23, 2000;

and

2. Whether the CMP imposed is reasonable if Petitioner is found not to be in substantial compliance.

IV. Findings of fact and conclusions of law

The findings of fact and conclusions of law, identified here, are discussed in detail in section V below, the Discussion section.

1. There is no statutory or regulatory mandate which requires an ALJ to enter a decision as to each deficiency cited against Petitioner. Section A of Discussion below.

2. Petitioner was out of substantial compliance with Medicare and Medicaid participation requirements, at the immediate jeopardy level, during the February 16^th standard and extended surveys and the February 19^th monitoring survey (from February 16 - 24, 2000). Section B of Discussion below.

3. Petitioner was out of substantial compliance with Medicare and Medicaid participation requirements, at the non-immediate jeopardy level, during the February 25^th second monitoring survey (from February 25 - March 23, 2000). Section C of Discussion below.

4. CMS was authorized to impose the CMP assessed against Petitioner. Section D of Discussion below.

5. The CMP imposed was reasonable.

V. Findings, Conclusions and Analysis

A. It is not necessary to address each individual deficiency cited in order to render a decision in this matter.

There is one standard survey, two monitoring surveys, and a revisit survey in controversy in this case. The standard survey cited a total of 11 deficiencies. CMS Ex. 7. In support of my decision, I am not mandated to address each and every deficiency cited. Specifically, the Act and the regulations establish that a facility must meet all of the standards established by both statutory and regulatory provisions. Furthermore, the noncompliance with even one participation requirement authorizes the imposition of CMPs by CMS. See Act, section 1819(d)(4)(A) (A skilled nursing facility must operate and provide services in compliance with all Federal, State, and local laws and regulations . . . and with accepted professional standards and principles which apply to professionals providing services in such a facility. Emphasis added.); 42 C.F.R. � 488.430(a) (CMS . . . may impose a civil money penalty for . . . the number of days a facility is not in substantial compliance with one or more participation requirements . . . . )

This preliminary issue has recently been examined by an appellate panel of the Departmental Appeals Board (Board). The issue before the Board in Beechwood Sanitarium, DAB No. 1824 (2002), questioned whether an administrative law judge (ALJ) of the Civil Remedies Division (CRD) had the authority to base his decision upon certain deficiencies cited against the petitioner and make no determination as to the deficiencies cited in the survey, but not addressed in the decision. The Board in Beechwood concluded that:

The possibility of reversal of the deficiency findings on review . . . does not persuade us that the ALJ should be required to make more findings than is necessary to support the remedies imposed. The ALJ exercised his judgment and chose to discuss several deficiencies that he determined to be persuasively established . . . . [W]e conclude that this exercise of judicial economy is within the ALJ's discretion.

Beechwood at 22.

Therefore, in the exercise of judicial discretion, in the Discussion section which follows, I address eight of the 11 deficiencies cited. As to the remaining deficiencies, I make no determination - favorable or otherwise - to either party.

B. Petitioner was out of substantial compliance, at the immediate jeopardy level, at the time of the February 16^th standard and February 19^th monitoring surveys.

Following the completion of the February 16^th standard survey, Petitioner was cited with 11 deficiencies, one at the level K - immediate jeopardy level. This discussion will focus on those relating to the immediate jeopardy citation, specifically the subsection of the regulations concerning Quality of Care, 42 C.F.R. � 483.25(h)(2) (F Tag 324).

The subsection of the regulations concerning Quality of Care requires that:

Quality of care.

(h) Accidents. The facility must ensure that -

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

42 C.F.R. � 483.25(h)(2) CMS Ex. 7, at 17.

1. F Tag 324

The Statement of Deficiencies (SOD) cites specific findings of noncompliance with respect to F Tag 324 for Resident No. 71 (R71), Resident No. 93 (R93), Resident No. 100 (R100), and Resident No. 126 (R126). CMS Ex. 7, at 17 - 24. The specific allegations are that Petitioner failed to provide adequate supervision and/or properly apply and use effective assistance devices to prevent falls for four of 28 targeted residents. Id. at 17.

At the hearing, Petitioner attempted to introduce Edward Martell as its primary expert witness. In an effort to qualify Mr. Martell as an expert, Petitioner's counsel, Geoffrey Webster, questioned Mr. Martell as to his educational and professional background. Rule 702 of the Federal Rules of Evidence state that:

[i]f scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.

Fed. R. Evid. 702.

Upon direct questioning, Mr. Martell testified, among other things, that he received an undergraduate degree in Industrial Management with an emphasis on Industrial Engineering and Accounting. Tr. at 773. In addition, Mr. Martell testified that he previously owned, operated, and was chief administrator of nursing home facilities for approximately 19 years, and that he previously held an administrator's license for approximately 20 years. Tr. at 775. The direct voir dire continued with the following line of questioning by Mr. Webster:

Q: Have you examined the nursing practices of nursing facilities in Ohio for the purposes of expressing opinions?

A: Yes, I have.

Q: And have you performed examination of facilities infection control practices for purposes of forming and expressing an opinion?

A: Yes, I have.

* * * *

Q: Have you held any trade association positions in the past?

A: Yes . . . somewhere between 10 and 15 years on the Board of Directors of the Ohio Academy of Nursing Homes and was the president or chairperson.

* * * *

Q: And how about care planning and resident review, patient assessment, whatever the terms were called or are called?

A: Yes.

Q: What types of work have you done on those?

A: Well, everything from analyzing the systems to trying to determine the relative value of the systems and whether they, in fact, were measuring what the goal was of an individual system, whether it was the patient assessment system, the OPAs, or anything that was being done in regard to trying to quantify the - - or measure the services being needed and delivered.

Q: Do you have experience with the survey and certification process for Medicare, Medicaid participating long-term care facilities?

A: Yes, as a chief administrator. Of course, that was a regular part of the function.

Tr. at 778 - 780.

It was at the conclusion of this line of questioning that Petitioner's counsel sought to tender Mr. Martell as an expert "regarding the compliance of the facility, St. Francis, with F Tag 324, specifically with respect to supervision, the provision of adequate supervision and assistive devices to prevent accidents in a manner in compliance with the requirements of the Omnibus Reconciliation Act of 1987 and regulations thereunder enacted." Tr. at 782. CMS objected to Petitioner's expert request arguing that the expert subject area cited by Petitioner must be in a specific discipline or academic field in order to qualify the witness as an expert. Tr. at 782; CMS Br. at 5. At that time, I concurred with CMS's objection and inquired as to what type of expert exactly was Mr. Martell being held out to be. Mr. Webster stated that:

Mr. Martell was retained because of the unique combination of factors presented, as a trained person by education, background and experience. He's an industrial engineer who is trained to examine the human systems functioning of a business, trade or profession. He's familiar with the survey and certification enforcement process and the required standards that a facility must meet. He's examined the identical records and other records of St. Francis that the state's surveyors examined that are at issue here, and has been asked to form and express an opinion about his findings of his examination of those records, his tour of the facility and his performance of the same functions that surveyors perform, to come to a conclusion as the surveyors had and to express that as an expert opinion, based upon his education, background, training and experience.

Tr. at 783 - 784.

In essence, Petitioner's counsel made several attempts to qualify Mr. Martell as an expert of one type or another, all over the objections of CMS. Tr. at 800 - 801. Mr. Webster elaborated on his argument by asserting that Mr. Martell had been previously recognized in the Franklin County Commonplace Court as an expert in facility operations and infection control. Tr. at 785 - 786. CMS countered by insisting that, if Mr. Martell was being offered as an expert in the field of infection control, the issue of infection control was not one before this tribunal. Tr. at 786. At the conclusion of this discussion, CMS commenced its voir dire. During voir dire, Mr. Martell confirmed that his highest level of education was a Bachelor's Degree, he did not earn a Master's Degree or a Ph.D. Tr. at 790 - 791. Mr. Martell also stated that he had not written any books or articles in the areas of nursing home administration, industrial engineering, or efficiency in nursing homes, nor did he possess any formal nurse's training. Tr. at 791. CMS also inquired:

Q: And other than St. Francis Home in Tiffin, Ohio, have you ever consulted with a nursing home in the area of the adequacy of supervision?

A: I don't know that you could directly say that, no.

* * * *

Q: But you've never been retained as a consultant by any other nursing home, other than St. Francis, in the area of the adequacy of supervision.

A: No, that would be correct.

Q: And you've never been retained as a consultant by any other nursing home other than St. Francis in the area of alarms?

A: As alarming as that may seem, no, I have not.

Q: Other than St. Francis, you've never consulted on the issue of personal alarms?

A: Since they're a relatively new intervention, the answer to that would be no.

Q: Have you ever taught any courses at a university or any formal school regarding fall prevention or fall protocol?

A: Only probably as a peripheral issue.

It was based on Mr. Martell's responses to the questions of Petitioner's counsel, and CMS's voir dire, that I determined that the witness could not be tendered as an expert witness. No information elicited from the witness could establish him as an expert in any recognized discipline area. As the record indicates, numerous attempts were made to establish such a foundation, however without success. Tr. at 773 - 776, 777 - 787, 790 - 798, 800 - 805. I further determined that Mr. Martell would be allowed to provide testimony as a lay person. Tr. at 805.

a. R71

R71 was a 97-year-old male who had been a resident of Petitioner's facility since June 1997. CMS Ex. 15, at 1; Tr. at 622. Petitioner was known to be "confused and requiring extensive assistance of two staff for transfer and toileting," and identified as a high risk for falls. CMS Ex. 7, at 23 - 24. Petitioner's staff was aware of the occurrence of falls by R71 in that he had a habit of getting out of bed by himself, as well as unfastening the velcro belt and getting out of the wheelchair. Id. at 24. As a result of R71 being at high risk for falls, a care plan was implemented on November 2, 1999 which addressed these concerns. CMS Ex. 16, at 20. R71 also had a documented history of long and short-term memory loss, resulting in impairment in his decision-making function. CMS Ex. 15, at 2, 7; Tr. at 623, 626.

Upon review of the patient records for R71, it was noted that R71's attending physician ordered an alarm, in early January 1999, to be worn at all times. CMS Ex. 7, at 24; CMS Ex. 16, at 25, 26. The surveyors also noted that, in the resident's records, 12 falls were documented between January 23, 1999 and February 10, 2000. CMS Ex. 7, at 24; Tr. at 626. The injuries resulting from these fall incidents included:

�multiple skin tears and abrasions;

�a laceration above the right eyebrow which required emergency room treatment, a swollen lip;

�a 3 cm. laceration to the top of his head, a "gash" to his forehead; and

�a 1 cm. laceration to his left temple and a hematoma to his head.

Id.; CMS Ex. 16, at 3, 4, 5.

At the hearing, Surveyor Colleen Keaton, R.N. testified that, because of R71's cognitive impairment, he was not in a position to make decisions and therefore the facility was obligated to make all decisions regarding his safety. Tr. at 609 - 11, 623. Nurse Keaton testified that one of the falls, which occurred on August 6, 1999, in which R71 received a head injury was especially serious in that when examined the resident's pupils were "sluggish." Tr. at 637. Nurse Keaton explained that, when a person's pupils are sluggish, it's indicative of a concussion or a subdural hematoma. Id. Nurse Keaton stated that the staff, based upon R71's fall record, should have been aware that the safety measures in place were ineffective and that more stringent intervention was required. Id. at 649. According to Nurse Keaton, the personal alarms being utilized with R71 would sound; however, the resident had already fallen and was injured before there was any staff response. Id. at 648 - 649. Nurse Keaton concluded that, in spite of these facts, Petitioner's staff continued to rely upon such alarm systems and resident call lights which were not effective. Id. at 651 - 653.

CMS alleges that Petitioner did not effectuate any new preventive measures to protect R71 until after the last fall incident, which occurred on February 7, 2000, and that measure was insufficient. CMS Br. at 30.

For R71, Petitioner advances no affirmative defense or argument except for the general argument that R71 (as well as three other residents discussed below) had a right to refuse treatment. However, as CMS points out, the right to refuse treatment does not excuse the facility of its obligation to supervise residents and use assistance devices to prevent falls, as discussed by an appellate panel of the Departmental Appeals Board (Board) in Koester Pavilion, DAB No. 1750 (2000). In Koester Pavilion, the Board determined that:

[W]hile there is no dispute that the resident had a right to refuse treatment, the facility had a countervailing duty to protect the dependent individual under its care against accidents. Certainly, if the facility was sufficiently aware of the resident's proclivity for falling to have installed an alarm to begin with, then appropriate alternative measures should have been put in place if the body alarm was discontinued.

Id. at 28.

Petitioner's sole argument relative to this resident is without merit, legally or factually, in that no evidence has been presented to draw a conclusion that R71 ever refused to cooperate with any treatment at the facility.

At the hearing, Nurse Keaton testified that, although assistive devices were in place and being utilized by the staff, the protective devices were being utilized ineffectively. Tr. at 649 - 651. She further testified that, given that the preventive measures initiated were ineffective, alternative measures should have been implemented: to remind R71 to use his call button when trying to stand was "inappropriate" in that he did suffer from cognitive impairment. Tr. at 649 - 655. Nurse Keaton opined that, since the resident had already suffered three prior head injuries, he was in immediate jeopardy and, should R71 experience another such injury, it could very well result in his death. Tr. at 655, 660, 662.

b. R93

At the time of the survey, R93 was an elderly female resident diagnosed with impaired circulation as a result of peripheral vascular disease, osteopenia (weak bones), organic brain syndrome, and depression which results in psychiatric problems, and a record of a past stroke. R93 also suffers from insulin-dependent diabetes which, due to hyperglycemic reactions, may result in dizziness or loss of balance when standing up. R93 has had her first and second digits amputated. All of the aforementioned conditions, separate and together, put the resident at risk of falls. CMS Br. at 10; CMS Ex. 17, at 1; Tr. at 66 - 68.

According to the survey report, the Minimum Data Set (MDS) assessment for the period from April 1999 through December 19, 1999 made reference to the resident's potential for accidents, and her need for assistance for ambulation and transfer. CMS Ex. 7, 20; Tr. at 70 - 71. A care plan was developed to address, among other things, the issue of fall potential. Id. The MDS further indicated that R93 suffered from impaired short-term/long-term memory loss as well as moderately impaired decision-making skills. CMS Br. at 11; CMS Ex. 17, at 6; Tr. at 69. From the period beginning May 1, 1999 through January 28, 2000, R93 is recorded as having experienced six falls consisting of:

�A fall on May 1, 1999 during an attempted transfer when she tried to stand by her bedside and fell to her knees. CMS Ex. 17, at 4;

�A fall on August 14, 1999 resulting from the resident's attempt to transfer herself from her bed to her wheelchair without assistance. She was found on the floor next to her bed by the staff. Id.;

�A fall on December 20, 1999 when R93 slipped and fell in an attempt to transfer herself (without assistance) from the toilet to her wheelchair. Again, staff found her on the floor. Id.;

�Another fall on December 20, 1999 when the resident fell in the bathroom and was discovered lying on her right side, complaining of pain in that area. Id.;

�A fall on December 31, 1999 when the resident tried to transfer herself into her bed without assistance and was found lying on the floor by staff. Id.; and

� A fall on January 28, 2000 when, attempting to transfer herself (unassisted) from her bed to the wheelchair, the unlocked wheels on the wheelchair rolled out from under her causing the fall. Id.

In three of the six falls, R93 suffered injuries which included: 1) head injuries (8/14/99); skin tears on her leg (12/20/99); and fracturing two ribs (second fall - 12/20/99).

R93 was assessed as needing the assistance of one staff member for transfers, walking in her room and around the facility. CMS Br. at 10; CMS Ex. 17, at 6; Tr. at 70 - 71. A personal alarm was ordered to be used with the resident at all times. CMS Ex. 18, at 5, 6. However, on February 15, 2000, R93 was observed by the surveyor in her wheelchair without the personal alarm. CMS Ex. 7, at 21. The surveyor questioned the charge nurse (Nurse Janet Shilling) during the survey period on this matter. The charge nurse advised that the personal alarm was used for one week in December 1999, but was discontinued after that time because of the resident's refusal to cooperate with the use of the Posey alarm. Tr. at 82; CMS Ex. 17, at 3; CMS Ex. 7, at 21. The charge nurse further told the surveyor that the current fall prevention plan at the time of the survey was to remind the resident to use the call button for locomotive assistance. Tr. at 82; CMS Ex. 17, at 3.

CMS asserts that the preventive measures in place for R93 were ineffective and put the resident at immediate jeopardy for continued falling with the strong likelihood of serious injury, and that further measures should have been implemented to prevent and/or monitor the resident. CMS Br. at 67 - 71.

Petitioner counters with the proposition that Petitioner's care plan for R93 was sufficient to meet the resident's needs and to prevent falls; however, in the event of a resident's refusal to accept any or all of the preventive measures, Petitioner can do no more than what has been done. P. Br. at 17 - 21. In particular, Petitioner contends that R93 had the right to refuse use of the Posey alarm and, based upon such a refusal, under state law, Petitioner could do no more to enforce the use of the personal alarm. Id. at 21. Petitioner also makes reference to a laundry list of actions and preventive measures taken by Petitioner which, inter alia, include:

�Trying to anticipate a sudden loss of balance for a resident with syncope.

* * * *

�Trying to figure out whether to call instances where a resident is lowered to the floor by themselves or staff "falls."

* * * *

�How to address combative residents or those who refuse and/or hide personal alarms.

* * * *

�Checking on residents on a more frequent basis.

Id. at 21 - 22. To support its argument, Petitioner relies largely on the cross-examination testimony of Surveyor Suzanne Moss regarding a paitent's Bill of Rights and the refusal of treatment. Id. at 21; Tr. at 233 - 234. At the hearing, Surveyor Moss was asked on cross-examination:

Q: . . . Isn't it a provision of state law in the resident's bill of rights that the resident has the right to refuse treatment?

A: Yes, it is.

Q: And the facility is obligated to honor that?

A: To a degree.

Q: And the failure to honor that would be a deficiency under 42 C.F.R. section 483.10, federal resident's rights, wouldn't it?

A: Depending on the situation, yes.

Tr. at 233 - 234.

Based upon this line of questioning, Petitioner is quick to conclude that measures taken by Petitioner were sufficient to meet the resident's needs and there is nothing more to be done when a resident exercises his/her right to refuse the implementation of such measures.

I concur with CMS's contention that Petitioner's arguments miss the mark. With regard to the testimony of Surveyor Moss, Petitioner takes a few questions from a line of testimony and draws an incomplete conclusion based on the responses to those questions. When taken as a whole, the complete testimony acquired from the witness concluded that:

The facility has made a commitment to the resident and their family to provide the care that is necessary to keep them healthy and safe and, yes, they do have rights. But if a person is not cognitively aware and able to make good safety judgments, it then falls in to the lap of the facility to make nursing judgments on behalf of the residents and intervene for the residents to keep the resident safe.

If the resident doesn't like the particular intervention, certainly that is not the only one that they can attempt. You need to move on and find something that works and is agreeable to everyone while keeping the resident safe. That is the ultimate goal.

Tr. at 347.

There were countless alternatives available for Petitioner's considerations pertaining to R93's care plan. Petitioner does not have an absolute duty to make sure that no falls occur in the facility. However, Petitioner does have a duty to take all reasonable measures in an attempt to prevent the occurrence of falls in its facility. See Woodstock Care Center, DAB No. 1726, at 27. There is evidence in the record that Petitioner did not take all reasonable measure to meet the Woodstock end. First and foremost would be revision of a resident's care plan to implement a new fall protocol after a fall has occurred. Specifically, R93's care plan was not revised after the resident experienced a fall on August 14, 1999 and, thus, the resident experienced yet another fall on December 20, 1999 at which time she broke two ribs. Tr. at 245.

Petitioner also attempts to assert that R93 may have suffered from syncope episodes which would account for the resident's falling. P. Br. at 23. "Syncope" is defined as "loss of consciousness resulting from insufficient blood flow to the brain." Merriam-Webster's Collegiate Dictionary, 10^th Edition, 1196 (1998). Petitioner's assertion is clearly not supported by the record. R93's neurobehavioral assessment indicates that the resident denies syncope. CMS Ex. 18, at 13. However, for the sake of argument, even if the resident did suffer from syncope, that would not relieve Petitioner of any responsibility for addressing this potential medical issue in the resident's care plan.

Petitioner has not met its burden of proving that it was in substantial compliance with the requirements of 42 C.F.R. � 483.25(h)(2) as to R93. Surveyor Moss's testimony is uncontroverted by any form of expert or lay testimony presented by Petitioner.

c. R100

At the time of the survey, R100 was an 89-year-old female resident. CMS Ex. 19, at 1. R100 was diagnosed as being cognitively impaired, having impaired balance did, therefore, at a high risk for falls, and being unaware of safety needs. It was also noted that she had a history of falls, generalized weakness, and was prescribed antidepressant drugs. Id. at 1 - 2; CMS Ex. 20, at 3; Tr. at 474. R100's fall history was noted on the MDS assessments dated November 30, 1999 and January 12, 2000, and documented the need for transfer and ambulation assistance. Tr. at 405 - 406. A care plan was created to address the risk for falls. CMS Ex. 20, at 21. R100 was required to wear a Posey alarm and had done so since February 1998. CMS Ex. 7, at 18; CMS Ex. 19, at 6. Petitioner was also aware of R100's ability and practice to remove the Posey alarm and move about her room unassisted, and that during these times the staff was unaware that she was not in bed. Tr. at 408. Between August 1999 and February 16, 2000, R100 is reported to have fallen four times and the falls were documented as follows:

�On August 4, 1999, R100 was found by staff to be sitting on the floor of her room beside her bed without her Posey alarm. Nursing notes indicated that the resident "possibly" removed the alarm herself; Tr. at 409; CMS 19, at 7;

�On October 11, 1999, it was reported that R100 removed her Posey alarm and fell to the floor while attempting to sit herself in a wheelchair. Tr. at 410; CMS Ex. 20, at 1;

�On December 14, 1999, it was documented in nursing notes and an incident report that R100 fell while carrying her Posey alarm, which did not sound, and sustained three abrasions on her left knee. Tr. at 413 - 414; CMS Ex. 19, at 6; and

�On January 5, 2000, in response to yelling emanating from R100's room, staff found the resident on the floor complaining of pain in her left hip while attempting to walk to the bathroom. The resident had removed the Posey alarm. Tr. 418; CMS Ex. 19, at 5; CMS Ex. 7, at 19.

As a result of the January 5^th incident, R100 was taken to the hospital emergency room where she was treated for a compression fracture of the left hip. Tr. at 408 - 409, 418, 419; CMS Ex. 20, at 3. R100 was released from the hospital and returned to Petitioner's facility on January 8, 2000 where the attending physician ordered that the resident should be "non-weight bearing" for six weeks. Tr. at 420; CMS Ex. 20, at 36. On February 10, 2000, it was documented that R100 was found moving about her room and the Posey alarm had been removed, presumably by the resident. CMS Ex. 7, at 19; Tr. at 420; CMS Ex. 19, at 8. The nursing staff instructed the resident to use her call button for assistance. Tr. at 420. On February 15, 2000, R100 was found sitting in her wheelchair wearing her Posey alarm. However, the alarm was not connected properly and, therefore, would not function in the event of emergency. Tr. at 432; CMS Ex. 7, at 19.

CMS asserts that Petitioner failed to provide adequate supervision and appropriate assistive devices by continuing to rely upon the use of the Posey alarm for monitoring the resident's movements when, in fact, they knew as far back as August 1999 that R100 was capable of removing the device. CMS Br. at 6 - 7. CMS concludes that Petitioner's failure to take action resulted ultimately in the resident sustaining a broken hip during the 4^th fall, while still relying upon the Posey alarm as sufficient intervention, thus, posing an immediate jeopardy threat to the resident. Id.

I am persuaded by CMS's evidence and the testimony presented during the hearing. Surveyor Mary Ann Deming Dyke, R.N., (Surveyor Dyke) testified that Petitioner's continued reliance on the preventive measures in place during the time period at issue was inappropriate. Tr. at 428, 429. Surveyor Dyke testified that, in reviewing the nurse's notes, there was a "detectable pattern." Id. She further stated that, based upon her observations, the resident had a history of removing the Posey alarm and moving about her room unassisted which made the preventive measures in place ineffective. Tr. at 428. The surveyor concluded by opining that R100 was in immediate jeopardy at the time of the survey in that:

Based upon the resident's ability to remove the Posey alarm and the facility's not putting more appropriate interventions into place and continuing to use the Posey alarm, and because of her hip fracture, because of her cognition, I feel that she was in immediate jeopardy. Also, based on the observation that I made of the resident where the tabs alarm that they continued to use was not even appropriately applied - - the string was hanging down her back, I felt that the likelihood that she would fall again and suffer injury.

Tr. at 432.

I am not convinced by the propositions put forth by Petitioner. First, Petitioner attempts to assert that R100 suffered from syncope. Tr. at 266 - 267, 473; CMS Br. at 21. However, the resident's medical file did not record any history of syncope. CMS Ex. 19, at 1; Tr. at 528. Again, as previously stated, even if R100 did suffer from syncope, Petitioner still has a duty address the condition in the care plan, particularly if the resident is at risk for falls because of the condition. Petitioner also makes an attempt to suggest that R100's August 4, 1999 fall was not a "fall" at all. P. Br. at 22. Instead, Petitioner suggested that the resident deliberately "lowered" herself into the floor. Id.; Tr. at 476 - 477. CMS convincingly demonstrated that the resident did not have a history of "lowering" herself into the floor. Tr. at 529. More importantly, I concur with CMS's argument of the irrelevance of the descriptive label attached to the August 4^th incident. What is significant is that the event:

[P]ut Petitioner on notice that R100 was removing her Posey alarm herself and ambulating unsafely with a risk of falling. The fact that Petitioner failed to respond to this event and subsequent events by attempting to put more effective interventions in place is undisputed.

CMS Br. at 10.

Finally, Petitioner indicates that R100 was put on a "toilet in advance of need" program in December 1999 and January 2000, as well as being "appropriately" provided with occupational and physical therapy in an effort to increase her endurance and strength, these being the proper and appropriate interventions. P. Br. at 23; Tr. at 480, 486; CMS Ex. 20, at 5 - 6. Again, I am not convinced by this proposition. The evidence shows that a physician's order directing that the resident be put on the program was given on December 29, 1999. CMS Ex. 20, at 5. However, the physician's instructions were not incorporated into R100's care plan for fall prevention. Tr. at 524 - 525. Surveyor Dyke testified that without such instructions being incorporated into the care plan, the "direct care staff or other nursing staff would not know what care to give the resident." Id. at 525. As for Petitioner's providing therapy for the resident, CMS contends that whereas such measures are appropriate for the rehabilitation of a broken hip, it is not an appropriate measure when the issue is the prevention of future falls.

I found CMS's witnesses to be most credible. Petitioner presented no witnesses who could rebut the findings of the surveyors and the evidence presented by CMS. Clearly Petitioner has not met its burden of proving that it was in substantial compliance with the requirements of 42 C.F.R. � 483.25(h)(2) as to R100.

d. R126

R126 was a male resident who had been diagnosed with:

�chronic renal failure;

�congestive heart failure;

�cardiomegaly (enlargement of the heart);

�chronic obstructive pulmonary disease;

�osteoporosis;

�Alzheimer's disease; and

�suffered from bouts of depression and agitation.

CMS Ex. 7, at 22; CMS Ex. 21, at 1; Tr. at 121 - 122.

As a result of the culmination of health issues, R126 was generally in a weakened state of health, subject to risk of falls. Tr. at 122. The facility's care plan for R126 indicated that the resident was at risk for falls due to balance and coordination difficulties, impaired judgment, and generalized weakness and lack of endurance. CMS Ex. 21, at 7; Tr. at 122 - 123. The resident's history of past falls was also noted in the care plan. Id. R126's MDS assessment identified the need for two staff members for the purpose of transfers and ambulation CMS Ex. 21, at 11; Tr. at 124.

R126 was identified, in March and June of 1999, as being at high risk for falls. CMS Ex. 7, at 22. During the period from August 1999 through February 2000, R126 experienced seven falls. CMS Ex. 21, at 3,4; Tr. at 125 - 126. The falls were identified as follows:

�On August 21, 1999, R126 was found on the bedroom floor with the personal alarm attached, but not sounding. The resident sustained a laceration above the right eye and a bruise to the forehead;

�On September 6, 1999, the resident was found crawling at the bedside with the personal alarm on the floor;

�On September 7 and 29, 1999, R126 was found on the floor with the personal alarm still attached. However, on September 29^th, the alarm was not sounding;

�On October 2, 1999, the resident was found on the floor with the alarm attached. The resident sustained an abrasion to the back;

�On October 31, 1999, the nurse's notes stated that the alarm failed to sound, but the staff were alerted to the resident's fall by a "crash sound;"

�On November 11, 1999, the staff "heard a thud" and found the resident on the floor, with the wheelchair tipped over. The alarm was on the floor, but not attached to the resident. The resident sustained a head injury.

CMS Ex. 7, at 22 - 23; CMS Br. at 18, 19 - 20.

Petitioner attempts to make allusions to R126's "uncooperative" nature in that he repeatedly disabled his personal alarm and got out of bed without asking for assistance. P. Br. at 23 (citing Tr. at 293 - 294). Petitioner therefore concludes that, because of the resident's uncooperative tendencies, the otherwise adequate fall preventive measures were rendered insufficient. Furthermore, relative to fall intervention/preventive measures, Petitioner asserts that the facility had an effective fall tracking system in place which tracked falls through review of incident reports. P. Br. at 23 (citing Tr. at 308, 491 - 492); CMS Ex. 10, at 1 - 4. However, Petitioner's arguments are not supported by the evidence of its own witness. At the hearing, Petitioner called Sister Donetta Meier to give testimony. Prior to and during the survey period, Sr. Meier was the facility's President, Chief Executive Officer (CEO), and Administrator. Tr. at 750. Relative to the issue of the facility's fall tracking system, on cross-examination, Sr. Meier testified that prior to December 1999, falls were monitored through quarterly review of incident reports by the quality assurance committee. Tr. at 764. Sr. Meier went on to testify that subsequent to December 1999, a fall tracking system was implemented. Id. Sr. Meier further indicated that she was unaware as to whether it was the practice of the facility to include "interventions that are appropriate to prevent future falls on that incident report." Id. at 765. Thus, Petitioner's arguments that it effectively tracked falls are unconvincing.

Again, CMS does not dispute that Petitioner made attempts at fall prevention. Instead, CMS argues that the interventions in place at Petitioner's facility were inadequate to address the risk of falls, and that alternative measures should have been attempted when it became apparent that those measures presently in place were ineffective. Tr. at 151 - 152. Specifically, fall assessments should have been conducted on the resident, and each incident should have been recorded and investigated. Petitioner offered no evidence of incident reports relative to the seven falls at issue. At the hearing, Surveyor Moss stated that she was informed by the R.N. Supervisor, Melanie Carrel, that a fall assessment had not been done on R126 since June 1999. Tr. at 132; CMS Ex. 21, at 4. Surveyor Moss further testified that no assessments had been made after any of the seven falls, nor had there been any revisions to R126's care plan after any of the falls revising fall intervention techniques. Tr. at 132, 135 - 136, 138 - 140; see CMS Ex. 21, at 5, 7.

Petitioner's cross-examination of CMS witnesses without support testimony of any of the medical personnel who provided services at the facility is not sufficient to prove that CMS's findings were clearly erroneous as to the immediate jeopardy citation. Further, Petitioner's arguments do not sustain its burden of proving substantial compliance with participation requirements. Therefore, I sustain CMS's determination of immediate jeopardy as to F Tag 324.

C. Petitioner was out of substantial compliance with participation requirements at the non-immediate jeopardy level.

Following the completion of the February 16^th standard survey, Petitioner was cited with 10 non-immediate jeopardy deficiencies. This discussion will focus on seven of those deficiencies, specifically the subsection of the regulations concerning Notification of Rights and Services, 42 C.F.R. � 483.10(b)(11) (F Tag 157); Resident Assessment, 42 C.F.R. � 483.20(b) (F Tag 272); Resident Assessment, 42 C.F.R. �� 483.20(h), (i), (i)(2), (j)(1) (F Tag 278); Resident Assessment, 42 C.F.R. � 483.20(k) (F Tag 279); Resident Assessment, 42 C.F.R. � 483.20(k)(2) (F Tag 280); Quality of Care, 42 C.F.R. � 483.25(c) (F Tag 314); and Quality of Care, 42 C.F.R. � 483.25(i)(1) (F Tag 325)

1. F Tag 157

The subsection of the regulations concerning Notification of Rights and Services, 42 C.F.R. � 483.10(b)(11) requires that

Notification of changes. (i) A facility must immediately inform the resident; consult with the resident's physician; and, if known, notify the resident's legal representative or an interested family member when there is -

(A) An accident involving the resident which results in injury and has the potential for requiring physician intervention;

(B) A significant change in the resident's physical, mental, or psychosocial status (i.e., a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications);

(C) A need to alter treatment significantly (i.e., a need to discontinue an existing form of treatment due to adverse consequences, or to commence a new form of treatment);

(D) A decision to transfer or discharge the resident from the facility as specified in � 483.12(a).

(ii) The facility must also promptly notify the resident and, if known, the resident's legal representative or interested family member when there is -

(A) A change in room or roommate assignment as specified in � 483.15(e)(2);

or

(B) A change in resident rights under Federal or State law or regulations as specified in paragraph (b)(1) of this section.

(iii) The facility must record and periodically update the address and phone number of the resident's legal representative or interested family member.

CMS Ex. 7, at 1 - 2.

To support the allegations that the provider failed to comply with the requirements set forth at 42 C.F.R. � 483.10(b)(11), the SOD details the situations of Resident No. 100 (R100) and Resident No. 129 (R129) at F Tag 157 of the CMS Form 2567. CMS Ex. 7, at 2 -3. The specific allegations are that Petitioner failed to notify the residents' attending physician when the residents experienced significant weight loss. Id. at 2.

a. R100

In January of 2000, R100 was documented as weighing 125� pounds. Tr. at 444; CMS Ex. 19, at 4. At the hearing, Surveyor Dyke testified that the ideal weight for R100 was between 130 to 150 pounds. Tr. at 443; CMS Ex. 19, at 5. On February 2, 2000, R100's weight was recorded as being 117� pounds. Tr. at 444; CMS Ex. 7, at 2; CMS Ex. 19, at 4. R100 was re-weighed on February 2^nd confirming the seven and one half pound weight loss. CMS Ex. 19, at 4, 8. Petitioner's policy, as it relates to resident weight loss/gain, is that a reweight shall be conducted within 24 hours, and the resident's physician should be notified in instances where is a five pound weight loss or gain. CMS Ex. 19, at 14. The resident's physician was not advised of the weight loss until February 14, 2000 - 12 days later. Tr. at 445; CMS Ex. 19, at 4.

CMS argues that Petitioner's failure to take the requisite action put the resident "at risk of continued wight loss and a delay in the healing of her hip fracture because of the facility's failure to address the problem." CMS Br. at 35. CMS's witness, Surveyor Dyke, testified that R100 was 5.9% below the ideal weight range. Surveyor Dyke opined that a weight loss of more than five percent of the total body weight in a single month is considered a significant change in condition and, therefore, should have been reported to the resident's attending physician immediately. Tr. at 448 - 449. Surveyor Dyke further testified about the importance of notifying a physician of significant changes in a patient's condition so that previous orders may be amended to accommodate changes in the resident's condition. Tr. at 445, 448. Additionally, revision of previous orders to accommodate such a weight loss would have also resulted in adjustments to the resident's care plan and dietary requirements. Tr. at 445, 448; CMS Ex. 19, at 5. Surveyor Dyke indicated that, since R100 was recovering from hip surgery, her dietary plan should have been revised to include increases of protein to aid in the healing process. Tr. at 448. The dietary plan was not revised until February 14, 2000. Id.

Petitioner claims the resident's physician was, in fact, notified of the weight loss; however, "just not in as 'timely' a manner as contemplated by the surveyors." P. Br. at 5. Petitioner further asserts that CMS did not take into consideration that the weight loss may have been the result of an 89-year-old person recovering from surgery, and that a weight loss is to be expected under these circumstances. Id. at 6.

I am satisfied by the testimony of CMS's surveyor witness over the arguments of Petitioner's legal counsel. There was no direct evidence or expert testimony to rebut the assertion that R100 experienced a significant change in her condition, nor was there testimony presented by Petitioner to rebut the medical opinion of the nurse surveyor.

b. R129

As of January 2000, R129 (a 100-year-old female) had a recorded weight of 113 pounds. Tr. at 452; CMS Ex. 7, at 35; CMS Ex. 23, at 3. On February 2, 2000, R129's weight was recorded as 106� pounds. Id.; Tr. at 453. Additionally, among her other medical conditions, R129 had a stage II pressure sore on her coccyx. CMS Ex. 7, at 3; CMS Ex. 23, at 3; CMS Ex. 24, at 1. The resident's physician was not notified until eight days later, on February 10, 2000. Tr. at 453; CMS Ex. 7, at 3; CMS Ex. 23, at 4.

Again, CMS contends that R129's physician should have been contacted immediately of the resident's weight loss. CMS Br. at 35. CMS argues that Petitioner's failure to contact the physician put the resident at risk of further weight loss and caused delay in the healing of R129's pressure sore. Id. Surveyor Dyke testified that, since R129 experienced a 5.9% weight loss in a one-month period, the physician should have been contacted immediately. Tr. at 453. The physician was not notified until February 10, 2000, and a response was not received by the physician until February 14, 2000. Tr. at 454; CMS Ex. 23, at 4.

Petitioner asserts that advanced age, accompanied by suspected basal cancer, contributed to R129's weight loss. P. Br. at 6. Petitioner goes further to contend that the weight loss was not a significant change, and that the dispute in question is whether the physician was notified in a timely manner. Id. Petitioner concludes that the physician was advised of all issues relating to the resident's weight; however, the surveyors have determined that notice was given to the physican as timely as they would have liked it. Id.

Petitioner presented no evidence or testimony in support of its proposition. However, CMS's witness, Surveyor Dyke, testified that the interventions put into place on February 10, 2000 by the dietician to address the weight loss should have been implemented immediately after the weight loss was first documented. Tr. at 456 - 457. CMS has met its burden for proving that Petitioner was not in substantial compliance as to F Tag 157 with regard to R100 and R 129, and Petitioner failed to prove by a preponderance of the evidence that it was in substantial compliance with respect to F Tag 157.

2. F Tag 272

Petitioner was also cited with a deficiency with respect to the regulatory requirement concerning Resident Assessment at 42 C.F.R. �� 483.20(b). The regulation provides that:

(b) Comprehensive assessments.

(1) Resident assessment instrument. A facility must make a comprehensive assessment of a resident's needs, using the resident assessment instrument (RAI) specified by the State. The assessment must include at least the following:

(i) Identification and demographic information.

(ii) Customary routine.

(iii) Cognitive patterns.

(iv) Communication.

(v) Vision.

(vi) Mood and behavior patterns.

(vii) Psychosocial well-being.

(viii) Physical functioning and structural problems.

(ix) Continence.

(x) Disease diagnoses and health conditions.

(xi) Dental and nutritional status.

(xii) Skin condition.

(xiii) Activity pursuit.

(xiv) Medications.

(xv) Special treatments and procedures.

(xvi) Discharge potential.

(xvii) Documentation of summary information regarding the additional assessment performed through the resident assessment.

(xviii) Documentation of participation in assessment.

The assessment process must include direct observation and communication with the resident, as well as communication with licensed and nonlicensed direct care staff members on all shifts.

(2) When required. Subject to the timeframes prescribed in � 413.343(b) of this chapter, a facility must conduct a comprehensive assessment of a resident in accordance with the timeframes specified in paragraphs (b)(2)(i) through (iii) of this section. The timeframes prescribed in � 413.343(b) of this chapter do not apply to CAHs.

(i) Within 14 calendar days after admission, excluding readmissions in which there is no significant change in the resident's physical or mental condition. (For purposes of this section, "readmission" means a return to the facility following a temporary absence for hospitalization or for therapeutic leave.)

(ii) Within 14 calendar days after the facility determines, or should have determined, that there has been a significant change in the resident's physcial or mental condition. (For purpose os this section, a "significant change" means an major decline or improvement in the resident's status that will not normally resolve itself without further intervention by staff or by implementing standard disease-related clinical interventions, that has an impact on more than one area of the resident's health status, and requires interdisciplinary review or revision of the care plan, or both.)

(iii) Not less often than once every 12 months.

42 C.F.R. � 483.20(b); CMS Ex. 7, at 3 - 4.

To support the allegations that the provider failed to comply with the requirements set forth at 42 C.F.R. � 483.20(b), the SOD cites the situation of R129 at F Tag 272. CMS Ex. 7, at 4 - 5. The specific allegations are that Petitioner failed to appropriately assess pressure sores for R129. Id. at 4.

a. R129

In the same February 16^th survey report, Petitioner was cited for allegedly failing to appropriately assess pressure sores for one of its residents. CMS Ex. 7, at 4.

On December 19, 1999, R129 was diagnosed with a stage II pressure sore on the coccyx. Id. at 5; Tr. at 462 - 463; CMS Ex. 23, at 8. The pressure sore was first assessed and measured on December 21, 1999. Tr. at 460. Assessments of the wound area on December 24 and 31, 1999 noted that "the resident continued to have an open area to the buttocks." Id. at 5. Petitioner did not develop a care plan to treat the pressure sore until December 27, 1999. Tr. at 463; CMS Ex. 23, at 8. The pressure sore area is recorded as having been assessed and measured on January 5, 2000, January 21, 2000, and February 4, 2000. Id.; Tr. at 460 - 461; CMS Ex. 23, at 6, 8.

Petitioner, in essence, argues that, because it provided treatment to promote healing of the pressure sore, it should be "excused for failing to measure the pressure sore." P. Br. at 10. Petitioner insists that there was no risk of harm to the resident since the resident received treatment while, at the same time, "avoiding the increased agitation to this resident solely for the purpose of 'assessing' a pressure sore that is already being treated." Id.

Again, Petitioner has presented no medical evidence or testimony to support its contention. CMS's position, as propounded by Surveyor Dyke, is convincing. The surveyor testified stage II pressure sores must be measured on a weekly basis in order to:

[b]e able to assess the wound appropriately, to know if it's healing, if it's getting better, if it's getting worse. Possibly if the treatment needs to be changed to promote healing of the pressure sore.

Tr. at 461.

3. F Tag 278

Petitioner was also cited with a deficiency with respect to the regulatory requirement concerning Resident Assessment at 42 C.F.R. �� 483.20(c). ⁽³⁾ The appropriate regulatory requirements provide that:

(h) Coordination. A registered nurse must conduct or coordinate each assessment with the appropriate participation of health professionals.

(i) Certification. (1) A registered nurse must sign and certify that the assessment is completed.

(2) Each individual who completes a portion of the assessment must sign and certify the accuracy of that portion of the assessment.

(j) Penalty for falsification. (1) Under Medicare and Medicaid, an individual who willfully and knowingly -

(i) Certifies a material and false statement in a resident assessment is subject ot a civil money penalty of not more than $1,000 for each assessment; or

(ii) Causes another individual to certify a material and false statement in a resident assessment is subject to a civil money penalty of not more than $5,000 for each assessment.

42 C.F.R. �� 483.20(h), (i), and (j).

To support the allegations that the provider failed to comply with these requirements, the SOD detaied the situation of Resident 126 (R126) at F Tag 278. CMS Ex. 7, at 6 - 7. The specific allegations are that Petitioner failed to accurately assess and report fall accidents as they relate to R126. Id. at 6.

a. R126

On November 28, 1999, Petitioner noted in R126's Minimum Data Set (MDS) assessment that the resident had not sustained any falls since October 29, 1999. Tr. at 129; CMS Ex. 21, at 6. The statement was, in fact, inaccurate. Surveyor Moss testified at the hearing that the resident had experienced falls on October 31 and November 11, 1999, prior to the November 28^th assessment. Tr. at 159; CMS Ex. 21, at 3, 6. Furthermore, the inaccuracy was confirmed by facility staff on February 14, 2000. Tr. at 160; CMS Ex. 21, at 5. Surveyor Moss opined that necessity for accuracy in reporting in that:

[a]ccurate tracking of the frequency of falls on the MDS is necessary in order [to] develop the proper care and treatment to prevent falls in the future.

Tr. at 160.

Petitioner asserts that, although the regulations require that resident assessments must be conducted, signed and certified as accurate, "a CMP is imposed only if an individual knowingly and willfully certifies a material and false statement in a resident assessment." P. Br. at 13 - 14. Petitioner concludes that, since the error was not deliberate or willful, then there was substantial compliance.

I concur with CMS's argument in its reply brief, which takes into consideration the citation errors contained in the survey report. CMS Reply at 28 - 29. From the arguments of the parties, it is undisputed that the inaccuracy of the resident's assessment was not willfully intentional. However, CMS argues that the issue is not the deliberate falsification of records, and thus "willfullness" is not an issue. According to CMS, the argument at hand relates to the regulatory requirement regarding certification as to the accuracy of resident assessments, as delineated at 42 C.F.R. �� 483.20(g) and (i)(2). Section 483.20(g) was not cited in the survey report and, therefore is not subject for review. See Golden State Manor, DAB CR412, at 84 (1996) (a party will not be responsible for deficiencies where there is not sufficient notice for which to prepare a defense.). CMS has successfully demonstrated that, based upon the evidence, Petitioner was not in substantial compliance pursuant to 42 C.F.R. �483.20(i)(2).

4. F Tag 279

Petitioner was also cited with a deficiency with respect to the regulatory requirement for Resident Assessment at 42 C.F.R. � 483.20(d). ⁽⁴⁾ The correct provision at 42 C.F.R. � 483.20(k)(1) provides that:

(k) Comprehensive care plans. (1) The facility must develop a comprehensive care plan for each resident that includes measurable objectives and timetables to meet a resident's medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment. The care plan must describe the following -

(i) The services that are to be furnished to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being as required under � 483.25; and

(ii) Any services that would otherwise be required under �483.25 but are not provided due to the resident's exercise of rights under � 483.10, including the right to refuse treatment under � 483.10(b)(4).

CMS Ex. 7, at 7.

To support the allegations that the provider failed to comply with the requirements set forth at above-referenced regulation, the SOD details the situation of R129 at F Tag 279. CMS Ex. 7, at 7 - 8. The specific allegations are that Petitioner failed to develop a care plan for pressure sore treatment of R129. Id. at 7.

a. R129

The surveyor noted that R129 was documented as having developed a stage II pressure sore on the left buttocks on December 19, 1999. CMS Ex. 7, at 8. On February 14, 2000, the Assistant Director of Nursing (ADON) advised the surveyor that the resident's care plan for the pressure sore was not developed until December 27, 1999. CMS Ex. 7, at 7. As of the survey period, R129's pressure sore was still present. Id.

Petitioner contends that CMS inaccurately cited the wrong tag relative to the facts. In particular, Petitioner asserts that the evidence relates to a failure to develop an "episodic or acute" care plan rather than a "comprehensive" care plan. P. Br. at 12 - 13.

CMS makes the point that there was an eight-day delay between the identification of a pressure sore and the development of a care plan to treat it which, in their opinion, is a violation of F Tag 279. CMS Br. at 40; CMS Reply at 27; Tr. at 463. Surveyor Dyke testified that a facility must develop a care plan for pressure sore treatment after learning of the development of the sore in a timely manner. Tr. at 464. CMS concedes that the deficiency could have been just as easily cited as a violation under F Tag 280. CMS Reply at 28. However, CMS goes further to argue that, whether the deficiency is cited under F Tag 279 or F Tag 280, the deficiency should be upheld in line with the decision in Golden State Manor, DAB CR412 (1996). In Golden State Manor, the petitioner claimed that it was not given sufficient notice as to the deficiencies to be defended due to HCFA's [CMS] "vague, uncertain and inappropriate . . . manner in which this deficiency was set forth." Golden State at 83 (citing Petitioner's Brief at 44 - 45). The ALJ hearing this matter determined that:

HCFA 2567 sets forth the alleged deficiencies which were identified by the surveyors during the survey. The surveyors testified concerning the underlying facts supporting the deficiencies cited in the HCFA 2567.

* * * *

I did not consider allegations in the HCFA 2567 against which Petitioner could not adequately defend due to a lack of specificity or notice.

Id. at 84.

I do not find that Petitioner has been so prejudiced by the fact that the deficiency could have been cited under F Tag 279 or F Tag 280. Petitioner had sufficient notice of the facts underlying the deficiency for which he would need to defend. Petitioner's argument, therefore, is without merit.

Petitioner also asserted that there are alternate means, other than care plans, for providing care for a resident. P. Br. at 15. Petitioner contends that a care plan is unnecessary if assignment sheets will do just as well to deliver the care needed. Id. (citing Tr. at 553 - 554). A facility is not at liberty to pick and choose its preferred means of care if it is contrary to established regulations. In this instance, a facility is required to develop a care plan for the treatment of pressure sores. Furthermore, Petitioner's argument has been previously rejected in Kelsey Memorial Hospital, DAB CR583 (1999). In Kelsey Memorial, the overall question was whether the petitioner was out of compliance when additional assessment information was omitted from the documentation assigned to house such information (in this case, a RAPS summary sheet). Id. at 10. The petitioner argued that:

. . . its assessments of residents should have been found comprehensive because additional pieces of assessment information appeared in other types of records as well.

Id.

The ALJ in the Kelsey Memorial case rejected the petitioner's affirmative defense and determined that its rationale was not "fully consistent with the intent or mandate of the regulations." Id. at 11. The ALJ concluded that "one would expect to see all that [p]etitioner considered to be RAPS assessment data at the time of their creation to be entered on documents denoted as such by [p]etitioner." Id. The ALJ's analysis and conclusions in Kelsey is applicable in the instant case.

5. F Tag 280

Petitioner was also cited with a deficiency with respect to the regulatory requirement for Resident Assessment at 42 C.F.R. � 483.20(d)(2). ⁽⁵⁾ The correct regulation provides that:

(2) A comprehensive care plan must be -

(i) Developed within 7 days after completion of the comprehensive assessment;

(ii) Prepared by an interdisciplinary team, that includes the attending physician, a registered nurse with responsibility for the resident, and other appropriate staff in disciplines as determined by the resident's needs, and, to the extent practicable, the participation of the resident, the resident's family or the resident's legal representative; and

(iii) Periodically reviewed and revised by a team of qualified persons after each assessment.

42 C.F.R. � 483.20(k)(2); CMS Ex. 7, at 5 - 9.

In support of the allegations that the provider failed to comply with these requirements, the SOD detailed specific findings with respect to R71, R93, R100, R126, and R129. CMS Ex. 7, at 9 - 13. The specific allegations are that Petitioner failed to revise the residents' care plans as they relate to weight loss and fall prevention. Id. at 9.

a. R71

The survey report indicates that review of R71's medical records noted 12 falls, the last two occurring on February 7 and 10, 2000. CMS Ex. 7, at 12. The survey report further states that the resident was observed to be recovering from two head lacerations and extensive bruising to the left side of his head. Id. R71's care plan indicates that it was last revised on November 2, 1999. Id. The care plan relating to falls was not reviewed and revised again until February 15, 2000. Id. at 12; CMS Ex. 16, at 20; Tr. at 666. In fact, the care plan was revised one week after R71's February 10^th fall. Tr. at 667.

At the hearing, CMS witness Surveyor Colleen Keaton testified that a care plan should be revised as soon as there is a change in the resident's status, meaning after each fall. Tr. at 668. Surveyor Keaton also stated that the result of not updating in a timely manner is that the staff is unaware of what care or interventions to provide (or not provide) to a resident. Tr. at 669.

b. R93

The February 16^th survey report states that review of R93's medical records revealed six falls between the period of May 1, 1999 and January 28, 2000. CMS Ex. 7, at 9. The survey report further notes that the resident's care plan was not updated to include revised interventions for additional assistive devices and upgraded intervention. Id.; Tr. at 111. At the hearing, CMS elicited the testimony of Surveyor Moss who stated that the facility should have revised R93's care plan after the falls to indicate measures to be taken in order to prevent future falls. Tr. at 111. Surveyor Moss also testified that the physical therapy and Posey alarm interventions remained a part of R93's care plan when, in fact, utilization of the Posey alarm was discontinued in December 1999 after one week of usage. Tr. at 112. Surveyor Moss opined that the rationale for updating a resident's care plan is so that all of the staff members who interact with a resident are all on the "same page" when it comes to the resident's care. Id. at 112.

c. R100

As for R100, the survey report noted that R100 had two falls on October 11, 1999 and December 14, 1999. CMS Ex. 7, at 11. The resident's care plan was not updated to reflect the falls in October and December. Id. On January 5, 2000, R100 fell and suffered a broken hip. Id. The resident's care plan in January noted the incident; however, it did not update the care plan or list any updated interventions relating to the fall. Id. In fact, Petitioner did not update the resident's care plan until the omission was brought to its attention by the surveyors. Tr. at 425, 441. After a discussion with the surveyors, on January 15, 2000, Petitioner implemented the use of a pressure sensitive alarm pad for R100. CMS Ex. 7, at 11 - 12. However, as of January 16, 2000, Petitioner had not updated the resident's care plan to reflect the revised intervention of the pressure alarm pad. Id. Surveyor Dyke testified that Petitioner should have updated R100's care plan after each fall, on October 11, 1999, December 14, 1999, and January 5, 2000, and that new interventions should have been introduced after each occurrence. Tr. at 441.

Petitioner also failed to update R100's care plan relating to a significant weight loss during a one-month period. Tr. at 442. Specifically, in February 2000, a 7� pound weight loss was recorded in R100's medical record. CMS E. 19, at 4; Tr. at 444. Petitioner did not address the weight loss in the resident's care plan, save for re-weighing the resident on the same day. Tr. at 444, 445. The resident's care plan was not updated until the omission was brought to the attention of Petitioner's staff. CMS Ex. 19, at 4. Surveyor Dyke testified that failure to address the resident's weight loss situation put R100 at continued risk of weight loss. Tr. at 450.

d. R126

The February 16^th survey report notes that R126's medical record indicates that the resident was at risk for falls and that a care plan was implemented on January 15, 1999. CMS Ex. 7, at 10. Between August 21 and November 11, 1999, the resident experienced seven falls. Id. The surveyor records that the nursing notes show the use of a personal alarm by R126 as early as June 1999. Id. However, the resident's care plan does not reference use of the personal alarm until September 20, 1999. Id. The care plan was revised as of November 11, 1999 to include a notation for adjustment of the bed alarm for a quicker movement reaction. Id. at 11.

Surveyor Moss testified that Petitioner was not in substantial compliance by its failure to assess the causal factors relative to the resident's seven falls and revising the care plan accordingly. Tr. at 156 - 157. The witness also indicated that the resident's care plan noted that use of the personal alarm was commenced on September 20, 1999 when, in fact, usage had been in place since June 1999. Id.

e. R129

Petitioner is cited for failure to update R129's care plan for weight loss. CMS Ex. 7, at 11. CMS asserts that Petitioner's omission to note the weight loss put the resident at risk for continued weight loss, as well as a delay in and/or administering of inappropriate treatment and care. CMS Br. at 38; CMS Ex. 7, at 11. On February 2, 2000, it was noted that R129 experienced a 6.75-pound weight loss during a one-month period. CMS Ex. 7, at 11; Tr. at 453; CMS Ex. 23, at 3. During the survey period, the surveyor was advised by one of the registered nurses (RNs) that R129's care plan had not been revised to show the weight loss. Id.; Tr. at 457.

For F Tag 280, Petitioner appears to make a broad across-the-board argument. Unfortunately, it is unclear to this tribunal (as well as CMS) what precisely Petitioner's arguments are. See P. Br. at 15 - 16. CMS makes a concerted attempt to interpret Petitioner's argument in its Reply Brief, and I am in agreement with CMS's interpretation of Petitioner's assertion. See CMS Reply at 29 - 30. Petitioner appears to contend that F Tag 280 is, in essence, repetitive in that the tag is representative of the underlying core issues contained in F Tags 324 and 325. P. Br. at 16. Petitioner concludes that, if found to be in substantial compliance with F Tags 324 and 325, then F Tag 280 should be removed. Id.

If this is indeed an accurate recitation of Petitioner's argument, then it is without merit. CMS has clearly met its burden of proving Petitioner's noncompliance as discussed above as to F Tag 280. Petitioner has not presented any evidence to support its assertion of substantial compliance.

6. F Tag 314

In the same survey, Petitioner was also cited with a deficiency with respect to the requirement concerning Quality of Care at 42 C.F.R. � 483.25(c), which states:

(c) Pressure sores. Based on the comprehensive assessment of a resident, the facility must ensure that:

(1) A resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they are unavoidable; and

(2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

CMS Ex. 7, at 13.

To support the allegations that the provider failed to comply with the requirements set forth at above-referenced regulation, the SOD detailed the findings with respect to R93 at F Tag 314. CMS Ex. 7, at 15 - 16. The specific allegation is that Petitioner failed to apply pressure reducing devices for R93 (determined to be a high-risk resident) who had the potential for risk of development for new pressure ulcers. Id. at 16.

a. R93

Under F Tag 314, Petitioner was cited for, among other things, failing to provide a foam cushion as part of the necessary treatment to prevent the development of new pressure sores by R93. CMS Ex. 7, at 15; CMS Ex. 17, at 10; Tr. at 114 - 117. R93's medical records noted that the resident had a history of resolved pressure ulcers. CMS Ex. 7, at 15; CMS Ex. 17, at 10. R93 was identified as "at risk" for skin breakdown due to incontinence, peripheral vascular disease, diabetes mellitus, and reduced mobility. Id. The resident's care plan indicates that a physician's order was entered instructing that a foam cushion be placed in the resident's wheelchair for pressure relief. CMS Ex. 7, at 15. At the time of the survey in February 2000, R93 did not have a pressure sore. Tr. at 115.

Surveyor Moss testified at hearing that on February 15, 2000, during the survey period, she witnessed R93 sitting in a wheelchair without the foam cushion. Tr. at 116 - 117. The witness also testified that the lack of foam cushion was confirmed by the charge nurse (Janet Shilling). Id. at 117. Nurse Shilling indicated to Surveyor Moss that the cushion was probably removed from the resident's wheelchair due to her incontinence; however, it was never replaced. Id.

Petitioner argues that it is not a violation because the resident did not have a pressure sore at the time of the survey. P. Br. at 12. Petitioner also argues that the foam cushion was just missing for a short period. Id. However, Petitioner failed to provide any testimony, for example from a caregiver, in support of its assertions. Therefore, I find that Petitioner has not sufficiently demonstrated that it was in substantial compliance as to F Tag 314.

7. F Tag 325

Petitioner was additionally cited with a deficiency with respect to the requirement for Quality of Care at 42 C.F.R. � 483.25(i)(1), which states:

(i) Nutrition. Based on a resident's comprehensive assessment, the facility must ensure that a resident -

(1) Maintains acceptable parameters of nutritional status, such as body weight and protein levels, unless the resident's clinical condition demonstrates that this is not possible; and

(2) Receives a therapeutic diet when there is a nutritional problem.

CMS Ex. 7, at 24 - 25.

To support the allegations that the provider failed to comply with the requirements set forth at above-referenced regulation, the SOD detailed findings with regard to R100 and R129 at F Tag 325. CMS Ex. 7, at 25 - 27. The specific allegation is that Petitioner failed to ensure that two of its residents maintained acceptable parameters of body weight. Id. at 25.

a. R129

The February 16^th survey report indicates that, according to R129's medical records, her ideal body was 115 pounds. CMS Ex. 7, at 25. The resident was weighed every month, and her weight was recorded in her medical records. Tr. at 506. When R129 was weighed in January 2000, her weight was recorded as 113 pounds. Tr. at 453. On February 2, 2000, the resident was weighed again and her weight was recorded as 106.25 pounds. Id. According to Petitioner's policy, when a resident experiences a weight loss of five pounds or more, the resident if to be re-weighed the same day and the attending physician and dietician are to be notified within 24 hours. CMS Ex. 7, at 25; Tr. at 454. R129 lost 6� pounds (or 5.9% of her body weight) between January and February 2000. Id.; Tr. at 453. The resident's medical record indicates that the dietician was not notified about the weight loss until February 10, 2000. CMS Ex. 7, at 25. Upon notice, the dietician recommended that R129's supplement be increased, and also noted that her pressure sore appeared to be worsening. Tr. at 456; CMS Ex. 23, at 4. The resident's attending physician was also notified by facsimile of the resident's weight loss on February 10, 2000. Tr. at 453. Petitioner did not re-weigh R129 until February 14, 2000 at the request of the surveyor, only to discover that the resident had lost an additional 1� pounds. Id. at 455. At the hearing, Surveyor Dyke stated that Petitioner put R129 at risk by delaying the implementation of interventions for an eight-day period. Tr. at 458. Dyke further stated that timely implementation of interventions would have diminished the resident's weight loss and promoted healing of the pressure sore through the increased supplements. Id. at 456 - 457.

Petitioner contends that the resident's clinical condition (possible basel cell cancer), in conjunction with her age (R129 was 100 years old at the time of the survey), "made it impracticable and impossible to maintain her weight." P. Br. at 6, 9. However, Petitioner's argument without supporting evidence or testimony does not make a case for substantial compliance. On this point, I accept as fact CMS's representation that:

. . . basel cell cancer is a type of nonmelanoma skin cancer usually located on the face that grows slowly, spreads locally and rarely metastasises. Because basal cell cancer does not metastasize, weight loss would not be a symptom of the disease.

CMS Reply at 21 - 22 (citing Anthony F. Jerant, Early Detection and Treatment of Skin Cancer, 62 American Family Physician at 357 - 387 (July 15, 2000)).

And, inasmuch as Petitioner has not presented any evidence or testimony to rebut CMS's representation, I find that Petitioner has not met its burden of proving by a preponderance of the evidence that it was in substantial compliance with the requirements of 42 C.F.R. � 483.25(i)(1) insofar as Resident 129 is concerned.

b. R100

As to R100, the surveyor alleged that Petitioner failed to follow its own policy for weight loss, which provided that the facility will promptly inform the attending physician and dietician of significant weight loss. CMS Ex. 7, at 27. R100's medical record indicates that her ideal body weight was between 130 and 150 pounds. Tr. at 443. In January 2000, the resident's weight was recorded as 125.25 pounds, and in February 2000 was noted to be 117.75 pounds. CMS Ex. 7, at 26. The resident was re-weighed on February 2, 2000, confirming the weight loss between January and February (which amounted to a total of 7� pounds or 5.9% of the resident's body weight). Tr. at 444, 445, 448. During the survey period, the charge nurse confirmed that neither the attending physician nor the dietician had been notified within 24 hours of the resident's re-weighing, in accordance with the facility's policy. Id. at 27. The physician and dietician were not notified of R100's weight loss until February 14, 2000. Id. Upon notice, the dietician recommended that R100's breakfast intake, which included a double portion of eggs and eight-ounces of whole milk (protein), and supplemental drinks be increased. Id. The dietician also noted that the resident's "protein status was slightly depressed." Id. The resident experienced a fall on January 5, 2000 and fractured her hip; therefore, additional protein was needed to aid in the healing process. Id.

Petitioner admits that the facility staff did not address the issue of weight loss for this resident (as well as R129) in "a manner as timely as the surveyors, in hindsight, would have preferred. P. Br. at 7. However, Petitioner argues that the weight loss by R100 (and R129) was not a significant change in the resident's "'physical, mental, or psychosocial status (i.e., a deterioration in health, mental or psychosocial status in either life-threatening conditions or clinical conditions),' as contemplated by the intent of the regulation." Id. Petitioner asserts that R100's temporary weight loss (due to recovery from recent surgery) does not fall under the definition contemplated by the regulation. Id. at 7, 9. In essence, Petitioner argues that R100 was not at risk for ongoing weight loss. P. Br. at 6. Petitioner argues that the resident, an 89-year-old female, may not have been at (what the surveyors considered to be) an ideal weight. Id. However, Petitioner concludes, R100's weight was stable prior to her surgery. Id. Lastly, overall, Petitioner contends that CMS is "blaming" it for the resident's weight loss. Id. at 8.

Petitioner's defense is not convincing. First and foremost, Petitioner is not being "blamed" for the weight loss experienced by the residents at issue under this tag. As succinctly stated by CMS, Petitioner is not being held liable for the initial weight loss. CMS Reply at 20. Petitioner is being held accountable for its failure to "respond to the initial weight loss." Id. CMS accurately points out that the State Operations Manual (SOM) explains that "in order to evaluate whether a facility is in compliance with the requirement, a surveyor must determine 'the accuracy of the facility's response to weight loss.'" CMS Reply at 21 (citing State Operations Manual (SOM), App. P at 44 - 45). Surveyor Dyke testified at the hearing that Petitioner was cited the deficiency because it failed to immediately notify the attending physician and dietician of the resident's weight loss, or to update the resident's care plan to incorporate new interventions which addressed the weight loss. Tr. at 450. The surveyor also testified that having known that the resident was, in fact, recovering from recent surgery, Petitioner should have been even more stringent in monitoring her weight. Tr. at 447.

CMS has made a prima facie case of non-compliance as to F Tag 325. Petitioner has presented no evidence to support its arguments or rebut CMS's arguments and findings.

D. The CMP is reasonable in this case.

Petitioner argues that CMS did not consider the facility's financial condition and its inability to pay the CMP and, further, that CMS was incorrect in its reliance on the facility's prior history of noncompliance in determining the amount of the CMS tp be assessed. P. Br. at 25 - 28. Based upon the evidence and arguments set forth below, I find that the amount of the CMP imposed in this case is reasonable and appropriate.

1. Petitioner's Financial Condition.

As to the financial condition of the facility, I believe CMS presented the more compelling and documented evidence that the facility has the capacity to pay the CMP imposed. Sister Meier testified that Petitioner suffered a profit loss for the years 1998 and 1999 totaling over $400,000 and $300,000 respectively. Tr. at 753, 762. However, Sister Meier also testified that she did not have any financial documentation with her at the hearing supporting the figures mentioned. Id. at 762. Neither did Petitioner, at any point, provide evidence in the form of financial statements or audits.

CMS provided documentary evidence in the form of cost reports which indicated profits in 1998 and 1999 and net assets of over $2,000,000 in 1999. CMS Ex. 4, at 1 - 2; Tr. at 579 - 580. They further argued that, even if Petitioner did in fact suffer a profit loss, there are sufficient assets to be liquidated in order to pay the CMP. Further, Petitioner has not presented any evidence or testimony which would indicate that payment of the CMP would cause financial hardship such that Petitioner would go out of business. To the contrary, Sister Meier testified that the facility presently had 93% occupancy. Tr. at 769. One can reasonably conclude that, based upon Petitioner's high occupancy rate, there is a steady source of income. While it is difficult to argue that a witness of religious personage is not credible, I can say that Sister Meier's testimony, without corroborating financial statements or audit reports, does not sustain Petitioner's burden of proving that it was not financially capable of paying the CMP amount in this case.

2. Hermina Traeye decision.

As authority for its position as to the imposition of CMPs, Petitioner strongly relies on the Board's decision in Hermina Traeye Memorial Nursing Home, DAB CR756 (2001). Specifically, Petitioner relies on the language in Hermina Traeye which notes:

Generally, a civil money penalty may fall within an upper range of from $3,050 to $10,000 per day for each day of noncompliance where a facility fails to comply substantially with a participation requirement or requirements if its noncompliance puts its residents in a state of immediate jeopardy. 42 C.F.R. � 488.438(a)(1)(i). I discuss what constitutes an immediate jeopardy level deficiency below at Finding 5.a. A civil money penalty may fall within a lower range of from $50 to $3,000 per day for each day of noncompliance where a facility fails to comply substantially with a participation requirement or requirements but its noncompliance does not put its residents in a state of immediate jeopardy. 42 C.F.R. � 488.438(a)(1)(ii).

The regulations establish the criteria to be used for determining the appropriate amount of a civil money penalty to be imposed within the upper and lower ranges of civil money penalties. These criteria are stated at 42 C.F.R. �� 488.438(f) and 488.404 (which is incorporated by reference into 42 C.F.R. � 488.438(f)(3)). The relevant criteria are as follows:

� The facility's history of noncompliance, including the presence, if any, of repeat deficiencies. 42 C.F.R. � 488.438(f)(1);

� The facility's financial condition. 42 C.F.R � 488.438(f)(2);

� The factors that are specified at 42 C.F.R. � 488.404. 42 C.F.R. � 488.438(f)(3). These include the seriousness of a facility's deficiencies, the relationship between deficiencies, and the facility's prior history of noncompliance; and,

� The facility's culpability for its deficiencies. 42 C.F.R. � 488.438(f)(4).

P. Br. at 24 (citing Hermina Traeye at 7).

Petitioner insists that, based upon the decision in Hermina, an ALJ has the ability to "appropriately adjust downward the CMP for the immediate jeopardy citation under tag F-324 if it determines that a deficiency exists. Similarly, the CMP for the non-'immediate jeopardy' citations should be lowered in accordance with the pertinent regulations if deficiencies are determined to exist." P. Br. at 25.

CMS argues that it made the determination before the Herminia Traeye case and was, therefore, following the law as it existed at the time and therefore did nothing wrong. CMS Reply at 32. CMS also contends that, even if the lower range deficiency was not considered, the immediate jeopardy tags in and of themselves would support the CMP imposed in the case. Id. CMS argues that the scope and severity level (level K) of F Tag 324, and the fact that the facility had been cited previously for the same tag at the immediate jeopardy level, alone supports the $ 4,900 CMP range. Id. at 32 - 33. Therefore, I determine that the facts of this case, which involve multiple falls and multiple injuries sustained by each of the four residents, and included the immediate jeopardy tag (coupled with the fact that the facility had previously been cited at the immediate jeopardy level for the same tag), support the $4,900 range independent of the other non-immediate jeopardy tags.

3. Considerations relating to the immediate jeopardy CMP.

Based upon its interpretation of the case law, Petitioner has concluded that Timothy Weidler, CMS's Program Representative, improperly took into consideration (for the purposes of determining a CMP) the fact that Petitioner had an actual harm level deficiency for F Tag 325 on the same survey, and therefore did not take the Hermina Traeye concept into consideration. P. Br. at 26 - 27.

Petitioner asserts that CMS improperly used a prior immediate jeopardy finding under F Tag 324, from a survey conducted in December of 1997 (two years prior), with an intervening survey in which only two deficiencies were cited. P. Br. at 25. Petitioner argues that, in relying on the previous survey, CMS is attempting to represent Petitioner as some type of "recidivist deserving of punishment as a 'culpable' actor. Id. However, contrary to Petitioner's beliefs, the regulations requires that CMS review, among other things, the facility's prior history of non-compliance which includes repeated deficiencies. 42 C.F.R. � 488.438. Further, Petitioner does not cite any authority to support the argument that the intervening survey with few findings should prohibit CMS from considering an earlier immediate jeopardy finding on the same tag. CMS therefore reasonably and correctly relied on the immediate jeopardy citation contained in the December 1997 survey report.

4. Considerations relating to the non-immediate jeopardy CMP.

As to analyst Timothy Wiedler's testimony relating to the $550 non-immediate jeopardy CMP, I found him credible and the evidence he relied upon supported a $550 CMP for the non-immediate jeopardy tags. Petitioner's cross-examination of Mr. Wiedler, through medical questions, was not successful at supporting its case. See Tr. at 596. Mr. Wiedler is an accountant, not a nurse or a physician. Tr. at 566 - 567, 599. Based upon Mr. Weidler's response on cross-examination, Petitioner is highly critical of Mr. Weidler's lack of knowledge as it related to facility-related questions. P. Br. at 26; Tr. at 592 - 594, 603 - 608. In response to Petitioner's line of questioning, Mr. Weidler indicated that, in formulating his conclusions in this case, he relied on the nursing judgment of the surveyors and a nurse surveyor who worked with him at CMS on medical matters. Tr. at 568, 594, 601. On the other hand, Petitioner continuously made medical judgments and arguments, throughout these proceedings, without the benefit of a nurse or other medical expertise. CMS is accurate in its assessment of the factors which I should consider in determining the reasonableness of the non-immediate jeopardy CMP. Those factors include: 1) the actual harm which resulted from the F Tag 325 deficiency; 2) the relationship between the F Tag 325 deficiency and the two other Quality of Care citations (F Tags 314 and 324) in the February 2000 survey; and 3) the fact that Petitioner had been previously cited in December 1997 for two Quality of Care deficiencies at the immediate jeopardy level. CMS Reply at 37. Therefore, based upon the evidence on this issue, I find the $550 CMP for the non-immediate jeopardy deficiencies is reasonable.

VI. Conclusion

I sustain the amount of the CMPs imposed in this case. I decide that Petitioner was not in substantial compliance with Medicare and Medicaid participation requirements. Consequently, CMS had the authority to impose civil money penalty of $4,900 per day from February 16, 2000 through February 24, 2000, for each of the nine days that immediate jeopardy to residents' health and safety existed, and $ 550 per day from February 25, 2000 through March 23, 2000, for each of the 28 days of continuous non-compliance that was not immediate jeopardy. I also decide that the CMP imposed against the Petitioner was authorized and reasonable.

Alfonso J. Montano

Administrative Law Judge

1. Since "HCFA" was used to refer to the agency at the time that the actions at issue were taken, references from documents use the old acronym. However, for the sake of clarity, I will refer to the governmental entity and any related documentation as "CMS."

2. Prior to the hearing, on August 6, 2001, August 10, 2001 and August 14, 2001 respectively, CMS filed supplemental proposed exhibits, CMS Exs. 67 - 69, 70 - 74 and 75. On August 10, 2001, Petitioner filed a motion to exclude CMS's supplemental exhibit submissions, arguing that they were filed beyond the deadline established by the January 17, 2001 amended exchange order. On August 17, 2001, I granted Petitioner's motion to exclude CMS Exs. 67 - 69, 70 - 74 and 75 into evidence.

3. At F Tag 278, the survey report cites to the regulation at 42 C.F.R. � 483.20(c), followed by a description of the violations contained within this provision. Additionally, throughout these proceedings, both parties refer to section 483.20(c). Upon review of the regulations and cross-referencing with the descriptive text contained in the Form 2567, I find that the surveyors erred in the citation referenced. The violations at issue correspond with the regulations at 42 C.F.R. �� 483.20(h), (i)(1), (i)(2), and (j)(1).

4. As with regulatory citation at F Tag 278, the survey report has inaccurately cited and both parties refer to the corresponding citation. The correct citation is 42 C.F.R. � 483.20(k).

5. As with F Tags 278 and 279, there is an error in the regulatory citation which has been referenced by both parties. The correct citation for F Tag 280 is 42 C.F.R. � 483.20(k)(2).