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CASE | DECISION |JUDGE | FOOTNOTES

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


SUBJECT:

Western Care Management Corporation,

d/b/a/ Rehab Specialities Inn,


Petitioner,

DATE: March 31, 2003
                                          
             - v -
 

Centers for Medicare & Medicaid

 

Docket Nos.

C-99-363, C-00-160;C-00-223

Decision No.CR1020

DECISION
...TO TOP

DECISION

I decide that Western Care Management Corporation (doing business as Rehab Specialties Inn) (Petitioner) was not in substantial compliance with Medicare 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 penalty of $8,000 per day from November 3, 1998 through November 6, 1998, for each of the four days that immediate jeopardy in residents' health and safety existed, and $2,500 per day from November 7, 1998 through February 7, 1999. 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.

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 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. CMS, not a State survey agency, makes the determination as to whether a facility is eligible to participate or remain in Medicare. 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 California Department of Health Services (State Survey Agency) completed a Medicare Survey of Petitioner which resulted in a finding that Petitioner was not in substantial compliance with the applicable Federal requirements for nursing homes participating in the Medicare and/or Medicaid programs under Title XVIII of the Act, 42 C.F.R. Part 483. The survey documented deficiencies which posed immediate jeopardy to residents' health and safety from November 3, 1998, through November 6, 1998, when the jeopardy was abated. The state survey agency provided documentation of the deficiencies cited in a form CMS-2567L which was forwarded to the facility subsequent to the survey. The State Survey Agency notified Petitioner that it would recommend to CMS that certain remedies should be imposed.

On December 15, 1998, Petitioner was notified by CMS that it had approved a certification/finding of noncompliance premised on its conclusion that Petitioner was not in substantial compliance with nursing home participation requirements at 42 C.F.R. Part 483 as documented by the survey which was completed on November 6, 1998. CMS also concluded that the deficiencies cited in the November 6, 1998 survey posed immediate jeopardy to residents' health and safety for a four-day period from November 3, 1998 through November 6, 1998. The notice further informed petitioner that it was imposing a civil money penalty in the amount of $8,000 a day, effective November 3, 1998 through November 6, 1998, for each of the four days that immediate jeopardy to residents' health and safety existed. In addition, Petitioner was notified that, although the immediate jeopardy had been abated on November 6, 1998, the facility remained out of "substantial compliance" as the term is defined at 42 C.F.R. � 488.301. 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.

Petitioner subsequently submitted an allegation compliance and plan of correction representing that the facility had achieved substantial compliance with the nursing home participation requirements. The State Survey Agency conducted a follow-up survey which was completed on December 22, 1998. That survey documented evidence that Petitioner was not in substantial compliance with participation requirements at 42 C.F.R. Part 483 and Petitioner was also alleged to have provided substandard quality of care as the term is defined at 42 C.F.R. �488.301.

CMS notified Petitioner on January 21, 1999, that certain sanctions were being imposed against Petitioner based on findings documented during the survey completed on December 22, 1998. CMS imposed a denial of payment for new admissions effective February 5, 1999, pursuant to 42 C.F.R. � 488.417(a) and also imposed a CMP in the amount of $2,500 per day, effective November 7, 1998, pursuant to 42 C.F.R. � 488.430. Petitioner was notified that the denial of payment for new admissions and the civil money penalty would remain in effect until CMS either terminated the facility's Medicare provider agreement or determined that Petitioner was in substantial compliance with federal health and safety requirements.

The January 21, 1999 letter from CMS also notified Petitioner that CMS would terminate Petitioner's Medicare provider agreement no later than May 5, 1999, six months from the last day of the November 6, 1998 survey, if substantial compliance with Medicare participation requirements was not promptly achieved and maintained. 42 U.S.C. � 1395(h)(2)(C) and 42 C.F.R. � 488.412(d). The January 21, 1999 letter, mistakenly stated that the effective date of imposition of the denial of payment for new admissions was February 3, 1999, rather than February 5, 1999. CMS corrected the error by letter dated January 21, 1999.

Petitioner subsequently represented that all of the documented deficiencies had been corrected; that Petitioner was in substantial compliance with all applicable participation requirements. However, based upon a self-reporting incident, CMS conducted an incident investigation which was completed on January 14, 1999. That survey found that Petitioner was still not in substantial compliance with nursing home requirements at 42 C.F.R. Part 483.

A subsequent survey was conducted and completed on February 8, 1999. This survey initially found that the facility continued to be out of substantial compliance. Petitioner pursued informal dispute resolution (IDR) as to F Tag 248 from the February 8th survey. As a result of the IDR, the State Survey Agency determined on April 22, 1999 to amend the deficiency, the effect of which was to establish that Petitioner was in substantial compliance as of February 8, 1999. By letter dated May 4, 1999, Petitioner was advised of the amendment by CMS, and that the amendment effectively This amendment nullified the May 5, 1999 termination date, and rescinded the denial of payment for new admissions determination. Petitioner was further advised in the May 5th notice that all remedies previously imposed prior to February 8th remained in effect.

By letter dated June 30, 1999, Petitioner requested a hearing, and the case was assigned to me for a hearing and decision. I conducted an in-person hearing on July 10-13, 2000 in Sacramento, California. At that time, I received into evidence CMS (HCFA) Exhibits 1-187, and deferred ruling on the objections previously raised by Petitioner in pleadings filed on June 8, 2000 and July 7, 2000. At this time, I hereby overrule Petitioner's objections to the CMS exhibits referenced. I also received into evidence Petitioner's Exhibits (P. Exs.) 1-69, without any objections from CMS. Both parties were forwarded a copy of the transcript (Tr.) of these proceedings.

III. Issues

The issue in this case is:

1. Whether Petitioner was in substantial compliance with Medicare participation requirements at the times of the November 1998, December 1998, and January 1999 surveys; 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 not in substantial compliance with Medicare participation requirements at the time of the November 1998 survey. Section B of Discussion below.

3. Petitioner was not in substantial compliance with Medicare participation requirements at the time of the December 1998 survey. Section C of Discussion below.

4. Petitioner was not in substantial compliance with Medicare participation requirements at the time of the January 1999 survey. Section D of Discussion below.

5. CMS was authorized to impose the CMPs assessed against Petitioner. Section E of Discussion below.

6. The CMPs imposed are 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 are three surveys in controversy in this case. The November 1998 survey alone cited a total of 33 deficiencies. CMS Ex. 2. 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, . . .

We conclude that this exercise of judicial economy is within the ALJ's discretion.

Beechwood, at 22.

Additionally, at the hearing, neither party presented evidence which addressed every single deficiency cited. Therefore, in the exercise of judicial discretion, in the Discussion section which follows, I address only those deficiencies argued during the course of the hearing as they pertain to all three surveys. As to the remaining deficiencies, I make no determination - favorable or otherwise - to either party.

B. Petitioner was not in substantial compliance with participation requirements at the time of the November 1998 survey.

Following the November 1998 survey, CMS cited Petitioner with 33 deficiencies. This discussion will focus on those argued at hearing, specifically the subsection of the regulations concerning a deficiency, specifically the subsection of the regulations concerning Notification of Rights and Services, 42 C.F.R. � 483.10(b)(11) (F Tag 157); Staff Treatment of Residents, 42 C.F.R. � 483.13(c)(1)(ii) (F Tag 225); Infection Control, 42 C.F.R. � 483.65(a)(1) (F Tag 441); and Physical Environment, 42 C.F.R. � 483.70(h) (F Tag 465).

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

Resident Rights

(11) 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 psychsocial 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); or

(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);

(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.

42 C.F.R. � 483.10(b)(11); CMS Ex. 2, at 1-2.

In the same survey, Petitioner was also cited with a deficiency, specifically the subsection of the regulations concerning Staff Treatment of Residents, 42 C.F.R. � 483.13(c)(1)(ii), which states:

(c) Staff treatment of residents. The facility must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property.

(1) The facility must -

(ii) Not employ individuals who have been -

(A) Found guilty of abusing, neglecting, or mistreating residents by a court of law; or

(B) Have had a finding entered into the State nurse aide registry concerning abuse, neglect, mistreatment of residents or misappropriation of their property; . . .

42 C.F.R. � 483.13(c)(1)(ii); CMS Ex. 2, at 4.

In the November 1998 survey, Petitioner was also cited with a deficiency, specifically the subsection of the regulations concerning Infection Control, 42 C.F.R. �� 483.65(a)(1)-(3), which state:

(a) Infection control program. The facility must establish an infection control program under which it -

(1) Investigates, controls, and prevents infections in the facility;

(2) Decides what procedures, such as isolation, should be applied to an individual resident; and

(3) Maintains a record of incidents and corrective actions related to infections.

42 C.F.R. � 483.65(a)(1)-(3); CMS Ex. 2, at 45.

In the November 1998 survey, Petitioner was cited with a deficiency, specifically the subsection of the regulations concerning Physical Environment, 42 C.F.R. � 483.70(h)(4), which requires that:

(h) Other environmental conditions. The facility must provide a safe, functional, sanitary, and comfortable environment for the residents, staff and the public. The facility must -

(4) Maintain an effective pest control program so that the facility is free of pests and rodents.

42 C.F.R. � 483.70(h)(4); CMS Ex. 2, at 52.

      1. F Tag 157

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 situation of Resident (R) 1 is detailed at F Tag 157 on the CMS Form 2567. CMS Ex. 2, at 2-4. The specific allegations are that Petitioner failed to immediately inform the resident's physician when there was a significant change in the resident's physical condition. Id., at 2.

        a. R1

The November 1998 survey was a multi-part complaint investigation in which, among others, R1's daughter proclaimed that her mother had a bowel obstruction. CMS Post-hearing Brief (CMS Br.) at 3; Tr. at 39.

R1 was an 84-year old female, who was admitted to Petitioner's facility on May 27, 1998. CMS Br. at 3; Tr. at 40. At the time of admission, R1 was diagnosed with Alzheimer's Disease, senile dementia, anemia, and cataracts. CMS Ex. 2, at 3; Tr. at 40; CMS Br. at 3. Petitioner had also had a colostomy and psychogenic constipation in which she would refuse to have a bowel movement (BM). CMS Ex. 2, at 3. Petitioner was dependent upon staff for daily living assistance, and she had an order for doses of Milk of Magnesia as needed if she did not have a BM every day. Tr. at 49.

In late October 1998, Surveyor Pamela Valencia, R.N., among others, conducted a complaint investigation which eventually expanded into a partial extended survey. Tr. at 39; CMS Br. at 3. Ms. Valencia testified that upon review of the certified nursing assistant's (CNA's) Activities of Daily Living (ADL) flow sheets, she discovered that R1 had not had a BM for a 19-day period (covering the period of September 19, 1998 through October 8, 1998). Tr. at 41; P. Ex. 11, at 3; CMS Ex. 2, at 3; CMS Ex. 183, at 59-61. Subsequently, in the CNA's notes on October 13, 1998, it was noted that R1 had a swollen abdomen which was painful when touched. CMS Ex. 183, at 59; Tr. at 42. The CNA's entry was reported to and countersigned by the licensed nurse on duty. Tr. at 42. However, even in light of this particular development, there is no written notation which would indicate that R1's physician was contacted regarding the swollen abdomen, or the lack of a BM for a 19-day period, until October 21, 1998 - eight days later. CMS Ex. 14, at 8; Tr. at 43.

On October 21, 1998, the attending physician was finally contacted and he ordered x-ray of the problem area. Tr. at 43; CMS Ex. 183, at 14. The x-rays showed "moderately severe constipation and possible fecal impaction." P. Ex. 57, at 3. R1 was ultimately prescribed additional medication (laxatives) which would remove the bowel obstruction. Tr. at 51; CMS Ex. 183, at 13.

CMS alleges that Petitioner could have avoided the resulting harm done to R1 had the resident's lack of a BM for a 19-day period, and subsequent swollen/tender abdomen, been reported to her physician in a timely manner. CMS further asserts that the referenced physical conditions were in fact significant changes in the resident's physical condition, and therefore should have been immediately reported to her physician. CMS concludes that Petitioner's failure to immediately consult with R1's physician resulted in actual harm being caused to the resident -- in violation of 42 C.F.R. � 483.10(b)(11). CMS Br. at 4-5.

In response to the allegations, Petitioner argues that there were no significant changes in R1's physical condition during the period at issue; and that the surveyors were unaware of all of the facts; therefore, there was no violation of the relevant regulation. P. Br. at 13. Specifically, Petitioner contends that not only is there documentation which shows that R1 did in fact have numerous BMs (between the period covering October 9-16, 1998), but also she was examined by her attending physician on October 16, 1998, and he did not note that the resident's abdomen was swollen at that time. P. Br. at 13-14. Petitioner closes its argument by concluding that because of her diagnosis, it was not unusual for Petitioner not to have a BM for days at a time; so therefore, there was no actual harm and no potential for more than minimal harm. P. Br. at 15, 16.

I am not persuaded by Petitioner's arguments. CMS is correct in its response that the dates cited by Petitioner are irrelevant, and there is no documentation that R1's physician assessed her abdomen condition on the October 16th visit. Furthermore, the relevant point here is that the attending physician should have been immediately notified of the resident's change in condition once noted by the CNA. Ms. Valencia testified that, in her professional opinion, it was below the nursing standard of practice for a licensed nurse not to immediately consult with the attending physician. Tr. at 48. Her professional opinion is uncontroverted by any form of expert or lay testimony presented by Petitioner. Petitioner has not met its burden of proving that it was in substantial compliance with the requirements of 42 C.F.R. � 483.10(b)(11) as to R1.

      2. F Tag 225

        a. R1

In the same November 1998 survey report, the surveyor alleged that Petitioner failed to ensure that all alleged violations involving mistreatment, including injuries of [an] unknown source are reported immediately to the administrator of the facility. CMS Ex. 2, at 4-5.

As discussed above, the November 1998 survey was initiated due to a complaint filed by R1's daughter. Among other things, R1's daughter reported unexplained bruises on her mother's arms. The surveyor, Ms. Valencia, saw and examined the bruises present on R1 and asked her about them. CMS Br. at 6-7; CMS Ex. 2, at 5; Tr. at 52. In response to the surveyor's question, R1 stated that the staff, in essence, forced her down to make her go to bed before she was ready to go. Tr. at 52. There were notations in the record which indicated that R1's daughter advised the staff that her mother should be allowed to stay up as long as she wanted. Tr. at 54; CMS Ex. 185, at 77. The surveyor took pictures of the bruises and asked the administrator if an investigation was conducted relative to the bruises. The administrator indicated that an investigation had not ben initiated because he was unaware of the bruises. Tr. at 54.

At the hearing, in addition to the surveyor Ms. Valencia, CMS called as an expert witness Dr. Robert Watson, M.D., Medical Consultant, California Department of Health Services. Tr. at 360. Dr. Watson testified that, upon review of the photographs taken by the surveyor and the Form 2567, he was able to deduce that:

A: . . . [t]here's various hues of discoloration of her arm. Some of the discoloration is a reddening and some is a . . . bluish discoloration of her arms. Some of it looks like it may be a brown discoloration of her arms.

It's fairly extensive in the forearms, less so in the upper arms, and it's located on the outer surfaces of the forearms.

Q: What is the significance, if anything of the different hues you mentioned, the different colors on the resident's arm?

A: If these are caused by trauma and are bruising then it would indicate that this happened repeatedly rather than a single event.

Tr. at 363.

As to R1's bruises, Dr. Watson further testified that based upon the record and information presented to him, he was able to conclude that R1's injuries were of an unknown origin in that "there's no history of any witnesses that observed what happened to this resident that would produce these skin changes." Therefore, "[o]n looking at these photographs and seeing this large area of discoloration of the resident's arms and especially since the cause of it is unknown, there's no witnessing to this, then I think that the administrator should be told about this immediately so that an investigation could be started, could be concluded in order to protect this resident and maybe other residents that could be at risk if indeed there's elder abuse going on in the nursing home. Tr. at 367-368, 369.

The thrust of Petitioner's defense is that CMS has not proven that the staff abused the resident. P. Br. at 16. R1's statement as to how the bruises occurred should not be taken seriously because of her dementia, and that the resident could have caused the bruises herself. Id., at 17. Petitioner also argues that CMS's expert witness is not qualified to render an opinion as to the bruises. Id., at 17, 18. Petitioner contends that they were in compliance because the record indicates that they knew of R1's daughter's request that her mother be allowed to stay up late. Id., at 16.

Petitioner's arguments are unconvincing, and I conclude that CMS has made its prima facie case as to this tag. CMS has proven that Petitioner did not comply with the regulation in that the bruises of unknown origin should have been reported to the administrator. In support, CMS has presented the testimony of the surveyor Ms. Valencia as to what she saw; they have photographs of the bruises which were taken at the time of the survey, all of which were unknown to the administrator. CMS also provided the credible expert testimony of Dr. Watson. He is a medical doctor (M.D.), qualified to testify about medical matters. The fact that Dr. Watson's area of expertise was in the field of obstetrics, prior to becoming a State consultant, does not diminish his qualifications as an M.D. to testify as to medical matters. The defense presented by Petitioner is nothing more than uncorroborated argument presented by counsel. Petitioner provided no staff testimony or, more importantly, the testimony of the facility's administrator to rebut CMS's case. I have also concluded that actual harm in fact has been proven by CMS.

      3. F Tag 441

In the November 1998 survey report, the surveyor alleged that Petitioner failed to:

. . . establish an effective infection control program under which the facility investigates, controls, and prevents the spread of infections.

CMS Ex. 2, at 45.

Specifically, the survey report cited three separate immediate jeopardy instances whereby Petitioner was in violation of this regulatory requirement.

CMS alleges that Petitioner was not in substantial compliance at the time of the November survey, as to Tag 441, in that Petitioner failed to establish an infection control program under which it investigated, controlled, and prevented the spread of infections in the facility. CMS Br. at 44-49. CMS cites three instances of noncompliance to support this tag.

      a. Finding 1

Finding 1 pertained to treatment of scabies on three separate days in October 1998. Upon review of the facility's resident charts, the surveyors were able to determine that:

� On October 21, 1998, R5 and R27 were treated for scabies;

�On October 22, 1998, R32 was treated for scabies; and

�On October 27, 1998, R8 and R33 were treated for scabies.

CMS Ex. 54, at 1; Tr. at 177-178.

Upon the surveyors' review of Petitioner's infection control policies and procedures manual, the manual required that an infected person was to be put into "contact isolation" for a 24-hour period. CMS Ex. 42, at 5; Tr. at 179-189. In addition, the manual required that county and/or state health departments were to be notified. Id. Ms. Mattern testified that neither of these measures were taken, nor was there any other type of surveillance conducted of the facility overall to monitor possible outbreak of scabies in other parts of the facility. Tr. at 180-181. Additionally, there was also the possibility of exposure to other residents and the community at large, which would require expansive monitoring of the situation beyond just the five residents infected.

The basis for the "immediate jeopardy" citation was the surveyor's determination as to the nature of scabies, and the inappropriate treatment administered by Petitioner. Scabies "causes itching and is very irritating," and the application of Kwell as a treatment is ineffective and potentially toxic to residents in long-term care facilities, and especially seniors with frail skin. CMS Br. at 48; Tr. at 187-188.

Contrary to CMS's position, Petitioner asserts that an infection control program was in fact in place at the time of the survey, and that the program was established as far back as 1996. Petitioner's Post-hearing Brief (P. Br.) at 4. Petitioner contends that CMS's own infection control witness, Christine Cahill, testified that if the infection control manual (P. Ex. 33) was in the possession of the facility during the survey period, an infection control program was effectively established. Tr. at 345; P. Br. at 4.

Petitioner also disputes the immediate jeopardy citation. Petitioner argues that, if there was an immediate jeopardy situation during the survey investigation in late October, 1998, the surveyors would have immediately advised Petitioner of such. But instead, according to Petitioner, immediate jeopardy was not declared until the surveyors' return on November 3, 1998. P. Br. at 5-6; Tr. at 188, 238. However, Petitioner concludes this argument by stating that a "number of plans of correction" were submitted in order to "remove the allegation of immediate jeopardy." P. Br. at 7; P. Ex. 40.

Lastly, Petitioner asserts that the choice to treat the residents with Kwell is irrelevant. P. Br. at 9. Petitioner argues that this issue was not cited by the surveyors, and therefore no notice was given to Petitioner. Id. at 9. Petitioner concludes by stating that even if the treatment with Kwell is considered, no proof has been presented to show any complications from the application of Kwell instead of Elemite, and therefore no proof of any actual harm to the residents. Id.

I am not persuaded by Petitioner's arguments. I do not read the testimony of the CMS witnesses as an admission that Petitioner had an adequate infection control program established. The witness Christine Cahill testified that if the infection control manual was at the facility at the time of the survey investigation, it would be adequate. Tr. at 354. Petitioner alleges it established that the infection control manual had been at the facility since 1996; however, it presented no witnesses in corroboration of this assertion. Petitioner only argues that CMS incorrectly assumed that the manual was at all of the nursing stations within the facility during the survey. The evidence does not support this contention. The survey report (Form 2567), which included Petitioner's plan of correction, indicates that as of November 6, 1998 the Policy and Procedure Manual (along with the included infection control program) had been adopted, adapted, and implemented and would be reviewed and revised as needed. CMS Ex. 2, at 48. Petitioner also says that it has purchased the right to use the manual from Regency Health Services ( Id.), which indicates that the infection control manual has not been with the facility since 1996.

I found CMS's witnesses to be most credible, and I do not find credible Petitioner's arguments that the infection control policy was in effect at the time of the survey investigations. Petitioner presented no witnesses to rebut the findings of the surveyors.

    b. Finding 2

The second finding under Tag 441 related to Petitioner's method of keeping track of infections within the facility. On November 3, 1998, Petitioner's process for investigating infections was reviewed by the surveyor (Ms. Mattern) with Alane Fife, the infection control (IC) nurse. CMS Ex. 2, at 47. CMS's witness, Ms. Mattern, testified that when she interviewed the IC nurse regarding methods for tracking and communicating information relating to facility infections, the IC nurse advised that there was no system for daily identification of residents placed on antibiotics and culture results as a means for monitoring infections; nor was there any formal method of communicating such information established within the facility. Id., at 48; Tr. at 184. I find CMS's witness to be credible and I am convinced by her professional opinion that Petitioner's failure constituted immediate jeopardy in that the procedure failed to protect residents from disease and infections. CMS Ex. 11, at 1-2; Tr. at 186-187. Again, Petitioner provided no testimony or professional opinion as to the existence or efficacy of their program.

    c. Finding 3

Finding 3 relates to the surveyors' observation of the medication room at station 2 on November 4, 1998. Specifically, 14 multidose vials of influenza vaccine were found in the refrigerator. CMS Ex. 2, at 48. The date on the pharmacy label indicated that the vaccine was delivered to the facility on October 22, 1998. The IC nurse was interviewed regarding administration of the vaccine to the residents. She advised that although in charge of the administration process, she did not become aware of the vaccine's delivery to the facility until November 4, 1998. Id.; Tr. at 189-190.

I concur with CMS's assertion that Petitioner did not implement the flu vaccine program. The surveyor Carol Mattern testified that she asked the IC nurse why the vaccine was still in the refrigerator, and had not been administered to the residents. Ms. Mattern was told by the IC nurse (Ms. Fife) that she was responsible for coordinating the vaccination process; however, she was unaware that the vaccine had even been delivered to the facility. Tr. at 190-191. Petitioner did not initiate the vaccination program by the first of November to afford the residents the opportunity to build up the necessary antibodies to combat the flu virus.

Petitioner argues, unconvincingly, that the "allegation of the violation" was premature in that there was no evidence presented to show when the vaccine was scheduled to be distributed, or that there was even a "technical" delay. P. Br. at 12. Furthermore, according to Petitioner, it only takes 2-3 weeks to build up the necessary antibodies to fight the flu, so there was time enough for the vaccine to take effect prior to the flu season. Id.

Based upon the presented evidence and the credible, unrebutted witness testimony, I sustain CMS's finding of immediate jeopardy.

      4. F Tag 469

The requirement at F Tag 469 requires that:

The facility must maintain an effective pest control program so that the facility is free of pests and rodents.

42 C.F.R. � 483.70(h)(4)

In the November 1998 survey report, the surveyor alleged that Petitioner failed to:

. . . . maintain an effective pest control program so that the facility is free of pests and rodents.

CMS Ex. 2, at 52.

During the October 1998 investigation, a surveyor (Henry Martin) reviewed Petitioner's records which tracked the location of ants within the facility (ant log). CMS Ex. 2, at 53. Review of the ant log revealed infestations of ants in residents' rooms during the months of May, July, August, September and October of 1998. Id.; Tr. at 386-387. The ant log further documented that in September 1998, two residents (R28 and R29) were reported to have had ants either in their beds or on their persons in seven different instances. CMS Ex. 2, at 53; Tr. at 387. Further, as to R29, the ant log documented that, on September 22, 1998, she not only was reported to have ants in her bed, but also on her body and in her mouth. Tr. at 388. Petitioner was cited by CMS under this tag for alleged actual harm to R29 in that any reasonable person would experience fear, anxiety, and psychological harm.

Petitioner argued that there were no pests or rodents, such as rats, mice, bedbugs, cockroaches, or even flies within the facility. P. Br. at 40. Petitioner then goes further to assert that "ants" are not included in the definition of "pests," which is defined as an insect or small animal which harms or destroys. Id. Petitioner goes on to demonstrate that it, in fact, had a pest control system in place, that it maintained an ant log, and that the facility had corrected whatever problems may have existed. Id. at 41. Petitioner concludes by opining that no resident had been bitten by any of the ants, so therefore, there was no violation of the regulations, nor was there the potential for more than minimal harm. Id.

Again, I am not convinced by Petitioner's arguments. CMS has met its burden of proof and made a prima facie case in this instance. The facility may have had a pest control system in place, however it was ineffective. The ants were in the residents' beds and in at least one resident's mouth. The surveyor, Henry Martin, testified that he witnessed the infestation and spoke with a group of residents, three of whom actually complained of the ant problem. Tr. at 388; CMS Ex. 46, at 3. The facility should have been more diligent in its effort to control such an infestation. Petitioner has not presented sufficient evidence to rebut the prima facie case established by CMS.

C. Petitioner was not in substantial compliance with participation requirements at the time of the December 1998 survey.

In the December 1998 survey, Petitioner was cited by CMS with 16 deficiencies. This discussion will focus on five of those deficiencies, three of which are repeat citations and were statutorily defined in the Discussion section above (i.e., Notification of Rights and Services, 42 C.F.R. � 483.10(b)(11); Staff Treatment of Residents, 42 C.F.R. � 483.13(c)(1)(ii); and Physical Environment, 42 C.F.R. � 483.70(h)). In addition to the previously referenced deficiencies, I will also focus on the subsections of the regulations concerning Quality of Care, 42 C.F.R. �� 483.25(h)(1) and 483.25(h)(2).

The subsection of the regulations concerning Quality of Care, 42 C.F.R. �� 483.25(h)(1) and (2) requires that:

Quality of care.

Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

(h) Accidents. The facility must ensure that -

(1) The resident environment remains as free of accident hazards as is possible; and

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

To support the allegations that the provider failed to comply with these requirements, the situations are detailed at F Tags 157, 225, 323, 324, and 469 on the Form 2567. CMS Ex. 85, at 2-5, 17-19, 20. The specific allegations are that:

    �Petitioner failed to immediately inform the resident's physician when there was a significant change in the resident's physical condition in 1 of 14 sampled residents. Id., at 5;

    �Petitioner failed to ensure that all alleged violations involving mistreatment, including injuries of [an] unknown source, are reported immediately to the administrator of the facility. Id., at 7;

    �Petitioner failed to ensure that the resident environment remained free of accident hazards. Id., at 20;

    �Petitioner failed to ensure that R8 received adequate supervision to prevent accidents in 1 of 14 sampled residents. Id., at 21; and

    �Petitioner failed to maintain an effective pest control program. Id., at 29.

    1. F Tag 157

The December 1998 survey report represents the results of a revisit investigation. This particular citation is a repeat deficiency relating to R1. On December 15, 1998, the medical records of R1 were reviewed by the survey team. CMS Ex. 85, at 2. The review disclosed that, on December 8, 1998, R1 was examined by the attending physician who documented that the vaginal area showed no abnormalities. Id., at 2-3; CMS Ex. 95, at 18. The surveyor, Pam Valencia, testified that on December 9, 1998, the nursing notes indicated that there was a white, milky discharge, and that the resident complained of itching in the vaginal area. Tr. at 475-476; CMS Ex. 85, at 3. Again on December 10, 1998, the nursing notes indicate that R1 again complained of itching. CMS Ex. 95, at 47; Tr. at 476. R1's attending physician was not advised of the change in condition until December 16th - one week after the onset of the symptoms. The doctor treated the symptoms as a yeast infection.

CMS argues that such developments constitute a significant change in the resident's condition, and should have immediately been reported to her attending physician. CMS Br. At 61. CMS medical expert Robert Watson testified that the symptoms were a significant change in the resident's condition, and that her attending physician should have been notified to that effect. Tr. at 575-576.

Petitioner claims that R1 had other instances of vaginal discharges and itching, as well as other rashes. P. Br. at 43. One such instance was on November 23, 1998. Petitioner contends that the Minimum Data Set requires that "there be two major elements that change in a resident's condition to equal a significant change in condition." Id. According to Petitioner, R1 not only had experienced previous vaginal discharge and itching, but also itching not related to the vaginal discharge. Therefore, Petitioner concluded, there was no need to contact R1's attending physician. Petitioner neglects to address the fact that, on December 8th, the attending physician recorded that there was no (1) discharge or (2) itching observed in R1. Petitioner also argues that there is no proof that the resident suffered a yeast infection, and that Dr. Watson is not qualified to conclude that it was a yeast infection. Petitioner continues to maintain there was no yeast infection.

I am satisfied by the testimony of CMS's medical expert over the argument of Petitioner's legal counsel. There was no direct evidence or expert testimony to rebut the assertion that R1 experienced a significant change in her condition, nor was there testimony presented by Petitioner to rebut the medical opinion of the expert or nurse surveyor.

      2. F Tag 225

The deficiency cited at F Tag 225 is also a repeat deficiency from the November survey report. Based upon review of Petitioner's records, as well as interviews with some of the residents, the surveyor was able to determine that Petitioner failed to "ensure that all alleged violations involving mistreatment, including injuries of unknown source[s], are reported immediately to the administrator of the facility." CMS Ex. 85, at 3-5; Tr. at 479-481. After the issuance of the November survey and the citation of numerous deficiencies, Petitioner filed a plan of correction which stipulated, among other things, that:

Upon receipt of any indication of rough treatment or bruising of a resident the Administrator shall immediately investigate the situation and report findings to other officials in accordance with State law (including to the State survey and certification agency) within 5 working days of the incident. If the alleged violation is verified appropriate corrective action must be taken by the Administrator.

CMS Ex. 85, at 4.

The repeat deficiency again involves R1 and the bruises she sustained, which were reported to the nursing staff by family members. The bruises were alleged to have been made while R1 was made to return to her bed when she was unwilling to do so. CMS Ex. 85, at 5. The surveyor Pam Valencia testified that she interviewed nurse Autumn Novak on December 15, 1998. Nurse Novak was the staff member who was knowledgeable about the care of R1. Id.; Tr. at 480. Ms. Valencia testified that the facility medical records showed no evidence of any bruises being reported to the administrator except those which occurred on December 5, 1998 to R1's upper forearm. Tr. at 481; CMS Br. at 62. Ms. Valencia further testified that, in her interview with Nurse Novak, she was advised that the facility did not have a formal system for reporting injuries. Furthermore, Nurse Novak informed Ms. Valencia that she was not aware of any bruising injury being reported to the administrator. Tr. at 480; CMS Ex. 85, at 5.

CMS argues that Petitioner was not in substantial compliance with regulatory requirements at F Tag 225 in that Petitioner failed to ensure that all instances of mistreatment, neglect, or abuse were immediately reported to the administrator. CMS contends that, in this instance, there was actual harm to R1 in that she did sustain the bruises and experienced the resulting pain. CMS Br. at 63.

Petitioner counters CMS's argument by asserting that CMS does not meet its burden of proving any abuse on the part of Petitioner. P. Br. at 44. However, Petitioner does not respond to the allegation that it failed to report the injuries in question to the facility administrator. Petitioner's basic argument is that, even though there were bruises found on R1, there are other plausible reasons for their existence aside from abuse or neglect. Id.

In the absence of any rebuttal evidence presented by Petitioner in support of its arguments, I find that CMS has met its burden of showing Petitioner's noncompliance under this tag.

      3. F Tag 323

The prerequisites specified at F Tag 323 (42 C.F.R. � 483.25(h)(1)) require that a "facility must ensure that the resident environment remains as free of accident hazards as is possible." CMS Ex. 85, at 17. CMS contends that, during a tour of Petitioner's facility on December 16, 1998, a janitor's closet was found unlocked in the Tehachapi Wing resident care area. Id.; CMS Br. at 78. Ms. Mattern, one of the surveyors, testified that upon opening the unlocked closet door, she discovered various cleaning supplies, some of which had been opened. Tr. at 616; CMS Ex. 85, at 17; CMS Ex. 132, at 8. Ms. Mattern further testified that:

. . . . with this door having a broken lock, . . . it's left open so that wandering, confused residents could possibly go in and either ingest, spill, do all kinds of things with the chemicals.

Tr. at 616-617. Based upon her observations, Ms. Mattern testified that she was able to conclude that Petitioner did not ensure that the resident environment remained as free as possible of accident hazards. Id. at 617.

Petitioner argues that 42 C.F.R. � 483.25(h)(1) "is not a strict requirement in that accidents would never happen, but a realistic requirement that the facility remains as free from those hazards as is possible." Petitioner's Post-hearing Reply Brief (P. Reply) at 41 (emphasis included). Petitioner makes an attempt to justify its position by arguing that there would have been a violation if there had been confused residents in the area of the open closet, and if that confused resident in fact ingested any one of the opened cleaning solutions. However, Petitioner concludes, that scenario did not occur and CMS's position is "too speculative to support a regulatory violation." Id.

I do not agree with Petitioner's supposition. The door should have been made safe by having a working lock, and the potential for harm does exist if a confused resident wanders into the closet and spills, or ingests, the cleaning solutions. CMS has met its burden of proving a prima facie case. Petitioner has not presented evidence which rebuts the CMS prima facie case.

      4. F Tag 324

42 C.F.R. � 483.25(h)(2) requires that:

The facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents.

This tag pertains to events which took place relating to R8. R8 was a 93-year old female who required supervision, with limited assistance, in her daily living activities. CMS Ex. 96, at 5; Tr. at 487. During the December 1998 revisit, R8 was observed asleep in her room with her legs hanging off the side of the bed, the side rail of her bed lowered, and a wheel chair next to the bed and her legs. CMS Ex. 85, at 18. Pam Valencia testified at hearing that she reviewed R8's medical records and found that R8 had seven falls in December 1998, the last incident documented as having taken place on December 15th, at 1:15pm. Tr. at 488; CMS Ex. 85, at 19; CMS Ex. 96, at 5, 7-10. R8's care plan indicated that the resident could ambulate with one assist. CMS Ex. 96, at 39. As of December 3, 1998, R8 was to have supervised transfers and visual checks every one to two hours. Tr. at 488-489; CMS Ex. 85, at 19; CMS Ex. 96, at 40. R8 was found on the floor at 1:15pm on December 15th. Later that afternoon, R8 complained of severe back pain and the attending physician ordered x-rays. The x-rays revealed a second lumbar (L2) compression fracture. CMS Ex. 85, at 19; CMS Ex. 96, at 46. CMS cited Petitioner for not providing adequate supervision to prevent accidents, which resulted in actual harm to R8.

Petitioner contends there is no proof that R8 was not supervised. P. Br. at 53. Petitioner concedes that R8 was found on the floor on December 15th, and the compression fracture was identified. Id. at 52, 53. However, Petitioner claims that the "mild compression fracture" injury was of an undetermined age. Thus, Petitioner argues, there is no proof of harm. Additionally, Petitioner asserts that the facility was also attempting to ensure the resident's independence. Petitioner however does not provide any documentation to prove that the resident was seen every two hours and assisted with her transfers. Nor did Petitioner provide any testimony from the staff or the attending physician to rebut the testimony of CMS witnesses.

The fact that R8 was found on the floor so many times during the month of December makes it more probable than not that R8 was not supervised, and that one of her numerous falls resulted in the compression fracture. Neither the argument of Petitioner's counsel nor the documents advanced by Petitioner alone rebut CMS's prima facie case.

      5. F Tag 469

This tag is a repeat deficiency from the November 1998 survey. The surveyor observed live ants in room 2 along the baseboard at the windows, as well as on the pillows and bed sheets of the bed closest to the window. CMS Ex. 85, at 26; Tr. at 493. Room 2 is occupied by R29 and was the subject of review during the November survey investigation. Tr. at 494. Ms. Valencia testified at the hearing that she also inspected the facility's kitchen and found ants in the drawers crawling over the utensils. Tr. at 493.

Petitioner argues that it had an effective pest control program in place, and "one ant does not qualify as pests or rodents." P. Br. at 55. Petitioner further asserted that, since there were no ants found on any resident or in the food supply during this survey period, it was in compliance with the regulations, and that the "good faith efforts put forth by the facility to ensure compliance" should not be diminished. Id. Finally, Petitioner asserts that, as of December 8th, it had entered into a new contracting arrangement with a pest control company. Id. at 56.

Again, in the absence of the presentation of any rebuttal testimony or convincing evidence by Petitioner, CMS has successfully met its burden and made a prima facie case of Petitioner's noncompliance with the regulations.

    D. Petitioner was not in substantial compliance with participation requirements at the time of the January 1999 survey.

The January 1999 "focused enforcement investigation" and survey report was the result of Petitioner's action of self-reporting several incidences to the State Survey Agency. P. Br. at 56; CMS Ex. 142, at 1; Tr. at 697. In the January survey, Petitioner was cited by CMS with nine deficiencies. For the purpose of this discussion, I have elected to focus on two of the nine deficiencies cited at F Tags 223 and 426.

      1. F Tag 223

The subsection of the regulations concerning Resident Behavior and Facility Practices, 42 C.F.R. � 483.13(b), delineated at F Tag 223, requires that:

(b) Abuse. The resident has the right to be free from verbal, sexual, physical, and mental abuse, corporal punishment, and involuntary seclusion.

To support the allegations that the provider failed to comply with these requirements, the situations involving R5, R11, R12, and R14 are detailed at F Tag 223 on the Form 2567 under three separate findings. CMS Ex. 142, at 6-9.

        a. Finding 1

Finding 1 relates to R12, a 93-year old female diagnosed with depression and dementia. Tr. at 658. According to the record, on December 31, 1998, Petitioner reported the following incident to the State Survey Agency:

On December 30, 1998, Certified Nursing Assistant (CNA) Glenda Solus entered R12's room to find the resident in the bathroom. Upon entering the bathroom, R12 began to kick the CNA. The CNA was reported to have said "[n]ow that you kicked me, maybe we should stand you up so I can kick you."

Id., at 6-7; CMS Ex. 144, at 5; Tr. at 658-659

As a result of the incident report, the surveyors returned to the facility on January 13, 1999 to investigate the alleged incidents. Surveyor Pam Valencia testified during this particular visit she reviewed the CNA's personnel file. Tr. at 659. Upon review, the

surveyor noted that the CNA had been on staff since February 1997; however during that time period, a performance evaluation had not been conducted. Id. Also within Ms. Solus' personnel file were five employee warning slips relating to:

    �on May 2, 1997, it was documented that Ms. Solus did substandard work when she did not report to the charge nurse the fall of a resident sustained when she was transferring him;

    �on October 24, 1997, several family members and residents complained that Ms. Solus did not always give showers or change sheets, that she was not helpful to residents and that she told residents not to complain to the charge nurse;

    �on December 9, 1997, it was again documented that Ms. Solus did substandard work involving documentation;

    �on March 1, 1998, it was further documented that Ms. Solus did substandard work when she refused to shave patients; and

    �on August 22, 1998, Ms. Solus made comments in the dining room in front of staff and other residents about the staff not doing their job.

Id. at 659, 661-662; CMS Ex. 142, at 7.

It was the incident with R12 that resulted in Ms. Solus' termination on December 31, 1998.

CMS argues that it was the five previously reported incidents, along with the matter involving R12, which caused actual harm to the resident, and resulted in Ms. Solus' termination. According to CMS, the actual harm suffered by R12 was emotional/mental in nature resulting from the CNA threatening to kick her while she was in the bathroom. CMS Br. at 96.

Petitioner argues that it was in substantial compliance. It contends that the warning notices in the CNA's personnel file were in fact "performance evaluations," and none of the warnings made note of any resident abuses by the CNA. P. Br. at 59. Petitioner further asserts that, at any rate, the CNA was terminated for verbal abuse to a resident prior to the January incident investigation. Id.

    b. Finding 2

Finding 2 pertains to a situation, observed by a surveyor, which took place on January 13, 1999, and involved R14. On this particular day, R14 was observed walking toward a community area located near nurse's station 1, in which he took a seat, and said that his feet were cold. Tr. at 665. A CNA, Johanna Markham, offered R14 a blanket and R14 initially refused. Id. Almost immediately, R14 told the CNA, as she walked away from him, that he changed his mind and wanted a blanket for his cold feet. Id. Ms. Markham was observed telling R14 that:

I already offered you. Too late now.

CMS Ex. 144, at 5; Tr. at 665.

R14 reiterated that his feet were cold and he needed a blanket. The resident was eventually given a blanket, but not by Ms. Markham. Tr. at 666.

CMS alleges that the CNA (Ms. Markham) disregarded the resident's request for the blanket, and argues that R14's right to be free from verbal and mental abuse was violated. CMS Br. at 96-97. Pam Valencia, the surveyor, testified at hearing that in her opinion, Petitioner violated the regulatory provision prescribing that a resident be free from mental or verbal abuse. Tr. at 666. Ms. Valencia determined that the resident suffered actual emotional harm (i.e., emotional anxiety) which was evidenced by his literal begging for a blanket to cover his cold feet. Tr. at 669.

Petitioner contends that there is no violation because there is no abuse. P. Br. at 60-61. Petitioner argues that Ms. Valencia never asked the CNA whether or not she intended to cause harm to R14, nor did Ms. Valencia ask R14 if he had a fear of not getting a blanket for his feet. Id., at 60. Petitioner further asserts that, even though there were employee warnings contained in the CNA's personnel file, they had "nothing to do with any type of abuse to any resident." Id.

    c. Finding 3

The third incident cited under F Tag 223 is one which I consider to be the most serious of the three cited. R11 is a 78-year old female who was diagnosed as suffering from Alzheimer's Disease and depression. CMS Ex. 142, at 7; CMS Ex. 151, at 1; Tr. at 744. R11 was documented in the Minimum Data Set (MDS) as being abusive. CMS Ex. 151, at 3. On December 22, 1998, the interdisciplinary team quarterly review noted that R11 was becoming increasing hostile. Tr. at 745. In fact, a nurse's progress note, dated December 22, 1998, noted that R11 wandered into the room of another resident (R5) and pushed her down. CMS Ex. 142, at 8; CMS Ex. 151, at 12, 14. Additionally, on January 2, 1999, a nurse's progress note indicated the R11 was found in the room of another resident (R10), hitting and kicking the other resident. R10 was found screaming with her hands in front of her in an effort to ward off the attack. Tr. at 747; CMS Ex. 151, at 10. The necessary action to be taken by the facility, with regard to R11's behavior, would be to communicate with the resident's family as to prospective placement in an Alzheimer's care facility. CMS Ex. 142, at 8. However, when the surveyor spoke with the social service's designee on January 12, 1999, the social services designee indicated that she was not aware of R11's December attacks, so therefore she had not commenced any dialog with the family regarding Alzheimer's placement. Tr. at 745-746.

CMS alleges that Petitioner failed to ensure that R5 and R10, specifically, were free from mental and physical abuse, as delineated at 42 C.F.R. � 483.13(b). CMS's medical expert, Dr. Robert Watson, testified that the facility is responsible for protecting its residents from any type of abuse, including abuse from an Alzheimer's resident against another resident. Tr. at 831. Dr. Watson also testified that he concurred with the surveyor's opinion that the Petitioner failed to ensure that the residents were free from physical and mental abuse. Id. at 829.

Petitioner argues that, in this instance, the abuse is strictly patient to patient. There are no allegations of staff abuse. P. Br. at 61. Again Petitioner, through counsel, makes an argument that CMS has not shown the intent to inflict harm. Id. at 61-62. Specifically, Petitioner contends that, since R11 suffered with Alzheimer's and the associated dementia, there is no "requisite intent in order to substantiate a[ny] violation. Id. at 62. Petitioner summarizes its argument by concluding that none of the residents attacked suffered any emotional abuse, and therefore Petitioner was in substantial compliance as to this tag. Id. However, CMS did not allege mental abuse as to this finding; the allegation related to physical abuse.

I find the testimony of CMS's witnesses to be persuasive. Petitioner did not present any testimony which shed any light on any of these three findings. The only evidence that Petitioner advances are the arguments of counsel. Based upon the record before me, I have determined that CMS has met its burden of proof and made its prima facie case. The abuse of R11 certainly supports Finding 3. The other Findings are not as compelling and may at first blush seem secondary. However, in examining the totality of the circumstances, the residents are dependent upon the facility for maintenance and care. It is imperative that they be protected from such adverse treatment by individuals upon whom they must rely. Additionally, I have determined that Petitioner's argument that intent is required to prove this tag is without merit. CMS is not required to prove specific intent to meet its burden. Nowhere in the provision in question does it require the facility's actions to be deliberate or intentional, nor does CMS attempt to make such an argument. CMS has more than substantiated that, in any of the three findings, Petitioner did not ensure the residents' right to be free from abuse, albeit unintentionally.

    2. F Tag 426

As a result of the January 1999 survey, Petitioner was cited with a deficiency relating to Pharmacy Services, 42 C.F.R. � 483.60(a), which states:

The facility must provide routine and emergency drugs and biologicals to the residents, or obtain them under an agreement described in � 483.75(h) of this part. The facility may permit unlicenced personnel to administer drugs if State law permits, but only under the general supervision of a licensed nurse.

(a) Procedures. A facility must provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident.

Specifically, the surveyor alleged at F Tag 426 of the January 1999 survey that Petitioner failed to comply with the requirements of 42 C.F.R. � 483.60(a) in that: (1) R7 was made to self-administer his medication when he specifically indicated his desire not to do so; and (2) R12 did not receive the medication needed for depression in a timely manner. CMS Ex. 142, at 15-16.

      1. Finding 1

R7 is a 67-year old male resident diagnosed with, among other things, insulin-dependent diabetes and an infected right knee. CMS Ex. 52, at 1; Tr. at 764. On January 12, 1999, one of the surveyors (Carol Mattern) observed a paper cup with two pills inside placed on the night stand next to R7's bed. CMS Ex. 142, at 15; Tr. at 764. Carol Mattern testified that, when she asked the resident about the contents of the paper cup, she was told that it contained his before lunch medications. Id. On January 13, 1999, again the surveyor observed a paper cup with one pill on the night stand next to R7's bed. Id. Again, the resident was asked about the contents of the cup, and stated that the paper cup contained his antibiotic. Id. Subsequent to the second incident, the surveyor reviewed R7's "self-administration" record to see whether R7 was to self-administer his own medications. Tr. at 764. Upon review, the surveyor noted that R7 had indicated that he did not want to self-administer his medications. CMS Ex. 152, at 4. Dr. Loriann DeMartini, Chief of the Pharmaceutical Consultant Unit, Department of Health Services, testified at hearing that where an individual declines the right to self-administer his own medications, then it becomes the responsibility of the facility to ensure that the individual receives and takes the prescribed medications. Tr. at 801-802. Dr. De Martini went on to testify that:

The interdisciplinary team must determine that the resident is safe to engage in that practice. If they are not or they decline, then the nurse must administer the medication. And that includes being present for complete administration of the medication whether it be by an oral route, an intramuscular route, subcutaneous, IV, rectal, whatever. The medication must be completely administered before they leave.

Tr. at 802.

Dr. DeMartini indicated that simply leaving medication by a resident's bedside in the hope that they will in fact take the medical is not the standard of practice for a nurse who passes medications. There is always the potential danger that another resident might ingest the medications instead of the intended recipient. Id. at 803.

CMS argues that Petitioner did not complete the cycle of administration of R7's medications, and alleges the potential for more than minimal harm in that:

    �R7 may not take his medications at all for the necessary curative effect;

    �R7 may incorrectly take the medication, i.e., not within the designated time frame for optimal healing effect; or

    �another resident may take the medication instead.

CMS Br. at 110; see also Tr. at 808-809.

Petitioner argues that CMS did not produce the record which would substantiate its position that R7 declined to self-administer his medications. P. Br. at 66. Petitioner further asserts that CMS did not present any proof to show that R7 did not receive appropriate instructions as to the procedures for self-administering medications, nor that R7 did not timely take his medications. Id.

However, in the same vein, Petitioner did not produce any evidence to support any of its aforementioned arguments. Petitioner does not provide any rebuttal evidence, aside from the arguments of counsel, except to assert that CMS did not provide substantiating documentation.

      2. Finding 2

Finding 2 under this tag relates to R12, who was diagnosed with depression and prescribed the anti-depressant Doxepin. CMS Ex. 156, at 1, 12. On January 4, 1999, an order for the Doxepin was placed with the pharmacy. CMS Ex. 156, at 11. On January 5th, the nursing staff was advised by the pharmacy that the Doxepin would not be available until late the following day. CMS Ex. 142, at 16; CMS Ex. 156, at 11; Tr. at 693. Upon review of the Medication Administration Record (MAR), it was noted by the surveyor that the medication was not given to R12 until January 6th. CMS Ex. 156, at 5. Ultimately, R12 was forced to go without her medications for a 48-hour period.

CMS argues that Petitioner clearly was not in substantial compliance with the regulations at F Tag 426, and that there was the potential for more than minimal harm. CMS Br. at 112. CMS contends that the Doxepin should have been administered to R12 on January 4th and its failure to do so in a timely manner created the potential for more than minimal harm. Id., at 111. At hearing, Pam Valencia testified that the consequence for not receiving her anti-depressants as prescribed only intensified R12's already depressed state. Tr. at 694. In corroboration, Dr. DeMartini testified that it became the facility's responsibility to find another source for the Doxepin when the pharmacy advised of its unavailability. Tr. at 811. Dr. DeMartini further indicated that it is standard practice to seek other sources for necessary medications when the primary source is unable to comply with a given request. Id.

Petitioner argues that Doxepin does not cure depression, but merely relieves its symptoms. P. Br. at 67. Petitioner contends that no evidence was presented to show a change in R12's symptoms for the better or worse, and at any rate, it takes up to 12 weeks before a geriatric recipient would even respond to the Doxepin. Id. Again, I am not persuaded by Petitioner's arguments.

In that Petitioner provided no documentary or testimonial evidence to prove it was in substantial compliance as to these two Findings, I have determined the CMS's expert and surveyor testimony to be credible and compelling. CMS has met its burden of proof, and Petitioner has not successfully rebutted or proven itself to be in compliance.

E. The amount of the CMP imposed by CMS was reasonable and appropriate.

The amount of the CMP imposed in this case is reasonable and appropriate. Petitioner argues that CMS did not consider the facility's financial condition, and was incorrect regarding Petitioner's prior history of compliance. Petitioner further argues that it should not have been placed in the focused enforcement program. That issue is something I do not have jurisdiction to consider. As CMS correctly asserted, that issue is not an "initial determination." My only concern is whether the CMP is reasonable. CMS provided the credible testimony of Ms. Paula Purse, relative to what she considered regarding the imposition of the CMP in this case. CMS also provided the testimony of Mr. McVicker, an accountant who opined that Petitioner could afford to pay the CMP imposed. Mr. McVicker testified that Petitioner had assets it could liquidate, which were available, and were not being used for patient care. While Petitioner's financial statement indicated it was operating at a loss, the accounting firm that prepared the financial statement indicated that the determination was based not on an audit of the books, but rather upon information provided to the accounting firm by Petitioner. The accounting firm essentially assumed that the documentation was true and accurate. I do not find that financial statement to be reliable. I find the testimony of the witness presented by CMS on this issue to be credible. CMS considered the financial condition of Petitioner, and their analysis that Petitioner was capable of paying the imposed CMP is sound. I find CMS's determination as to the CMP imposed in this case to be reasonable.

VI. Conclusion

Petitioner was not in substantial compliance with Medicare participation requirements at the time of the November 1998, December 1998, and January 1999 surveys. Therefore, CMS was authorized to impose the CMPs against Petitioner. I further find that the CMPs imposed were reasonable and in accordance with 42 C.F.R. � 488.438(f).

JUDGE
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Alfonso J. Montano

Administrative Law Judge

FOOTNOTES
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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."

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