Skip Navigation


CASE | DECISION |JUDGE | FOOTNOTES

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


SUBJECT:

Northeast Center for Special Care,

Petitioner,

DATE: October 20, 2004
                                          
             - v -

 

Centers for Medicare & Medicaid Services.

 

Docket No.C-04-265
Decision No. CR1237
DECISION
...TO TOP

DECISION

No deficiencies have been proven in this case and there is no basis for the termination of the participation agreement of Northeast Center for Special Care (Petitioner).

I. PROCEDURAL HISTORY

Petitioner is a 280-bed facility located in Lake Katrine, New York. It was certified to participate in the State of New York Medicaid program as a nursing facility (NF) and in the federal Medicare program as a skilled nursing facility (SNF). On September 26, 2003, surveyors from the Centers for Medicare & Medicaid Services (CMS) conducted a complaint survey of Petitioner and found that Petitioner was not in substantial compliance with program participation requirements. On October 8, 2003, CMS notified Petitioner that its participation in Medicare and Medicaid would be terminated effective March 26, 2004, if substantial compliance was not achieved before that date. Revisit surveys were done on October 16 and 20, 2003 and February 6, 2004. A final revisit survey was conducted in March 2004 - the on-site survey was done March 15 to 19, 2004 and the statement of deficiencies (SOD) was issued with the date March 23, 2004. CMS subsequently notified Petitioner that its participation was terminated effective March 26, 2004.

Petitioner requested a hearing by an administrative law judge (ALJ) by letter dated March 26, 2004. Petitioner also filed a motion for an expedited hearing on March 26, 2004. The request for hearing and motion were received at the Civil Remedies Division (CRD) of the Departmental Appeals Board (DAB or the Board) on March 31, 2004. The case was assigned to me for hearing and decision on April 2, 2004. On April 5, 2004, I issued an Order requesting an expedited CMS response to Petitioner's motion for expedited hearing and setting a telephonic prehearing conference. CMS responded by letter dated April 9, 2004, indicating no objection to an expedited hearing. A telephonic prehearing conference was conducted on April 14, 2004, the substance of which is set forth in my Order of April 16, 2004. The parties agreed to an expedited schedule for the hearing and they also agreed that the only issues before me are related to the survey with the SOD dated March 23, 2004.

A hearing was conducted in this case in Kingston, New York on May 18, 19, and 20, 2004. A 933-page transcript (Tr.) of the proceedings has been prepared. During the hearing, CMS offered and I admitted CMS exhibits (CMS Exs.) 1 through 33 and 36 through 39. CMS reserved exhibit numbers 34 and 35 to be used for two depositions taken the week before hearing. Tr. at 16 -18. (1) The transcripts of the depositions were received post hearing and marked as CMS Exs. 34 and 35. No objection was made to the admissibility of CMS Exs. 34 and 35 and they are received as evidence. At the beginning of hearing, Petitioner offered Petitioner's exhibits (P. Exs.) 1 - 5, 10 - 17, 20 - 26, 30 - 33, 40 - 44, 50 - 53, 60 - 64, 70 - 73, 80 - 82, 90 - 93, 100 - 103, 110 - 113, 120 - 123, 130 - 134, 140 - 146, 150 - 155, 155A, 156 - 159, 159A, 160 - 166, 170 - 175, 180 - 182, 182A, 183 - 190, 200 - 208, 210 - 217, 220, 230 - 232, and 240 - 244. (2) Tr. at 21. Petitioner's exhibits were admitted. Tr. at 23-27. Petitioner subsequently offered the following exhibits that were also received as evidence: P. Exs. 167 (Tr. at 328), 245 - 248 (Tr. at 326), 249 (Tr. at 424), 250 A - J (Tr. at 819-820), 251 (Tr. at 577) (3), 252 (Tr. at 805), 253 (Tr. at 808), 254 (Tr. at 810), and 255 - 256 (Tr. at 812). Patricia Tuckerson, Susan Albrecht, and Michele Clinton testified for CMS. Richard A. Hodder, M.D., Gerry Brooks, Alicia Aldridge, Jane Keating, Director of Nursing, Christopher Melcer, M.D., and Donald Policastro, Administrator, testified for Petitioner. Petitioner filed its post hearing brief (P. Brief ) and post hearing reply brief (P. Reply) on July 15 and 29, 2004, respectively. CMS filed its post hearing brief (CMS Brief) on July 16, 2004 and its reply brief (CMS Reply) on August 2, 2004.

II. FINDINGS OF FACT AND CONCLUSIONS OF LAW

A. FINDINGS OF FACT

The following findings of fact are based upon the evidence of record, including the exhibits admitted at hearing and testimony. Citations to exhibit numbers related to each finding of fact may be found in the analysis section of this decision if not indicated here.

1. Petitioner was subject to a fifth revisit survey which resulted in an SOD dated March 23, 2004, and the deficiencies discussed herein.

2. CMS determined, based upon the March 2004 survey, that Petitioner did not achieve substantial compliance within six months of the first survey that cited deficiencies in the survey cycle.

3. CMS terminated Petitioner's participation agreement effective March 26, 2004, because Petitioner did not achieve substantial compliance within six months.

4. Petitioner requested a hearing by an ALJ by letter dated March 26, 2004.

5. Finding related to Tag F225, the alleged violation of 42 C.F.R. § 483.13(c)(1)(ii): the abrasion of Resident 1's toes was not an injury of unknown source.

6. Findings related to Tag F281, the alleged violation of 42 C.F.R. § 483.20(k)(3)(i).

a. There was not always a nurse on duty who had received Petitioner's in-service training on the use of the wound vacuum when the wound vacuum was in use.

b. The wound vacuum was tended by a nurse who did not attend Petitioner's in-service training on the use of the wound vacuum.

c. The evidence does not show that a nurse who did not attend Petitioner's in-service training on the use of the wound vacuum was not competent to use the machine.

d. The evidence does not show that the wound vacuum was not properly and competently used for treatment of Resident FL9.

e. The evidence does not show that FL9 suffered any actual or potential negative outcome.

7. Findings related to Tag F309, the alleged violation of 42 C.F.R. § 483.25.

    a. It is undisputed that Petitioner did not have a five percent medication error rate.

    b. Alleged medication errors were determined by the surveyors based on their review of Medication Administration Records (MAR) for the residents involved.

    c. In the case of some residents, medications were administered outside the parameters for administration established by the prescribing physician.

    d. The surveyors did not assess the significance of the alleged medication errors in this case by considering drug category, resident condition, and frequency of the alleged medication error.

    e. The credible testimony of the prescribing physician for each of the residents is that there was no actual or potential harm for the residents involved due to Petitioner's failure to always comply with all the parameters he specified for the administration of the particular medications involved for these residents.

    f. Petitioner was managing Resident FL2's complaints of pain, which were appropriately assessed and care planned.

    g. FL2 did not stop occupational therapy due to pain, but, rather, due to lack of motivation.

    h. Dr. Melcer, Resident SV5's treating physician, did assess him upon his return from a failed attempt to perform a colonoscopy on March 1, 2004.

    i. SV5 was not suffering from fecal impaction on March 1, 2004.

    j. Petitioner's staff did determine the facts related to Resident 1 squeezing her Intravenous (IV) bag and recorded those facts in her clinical record.

      k. The evidence shows that Resident 1 was assessed after the incident involving her squeezing her IV bag and before her doctor authorized her to participate in her care by self-administering some therapies and the record does not show Resident 1 was ever authorized to self-administer medication.

8. Findings related to Tag F311, the alleged violation of 42 C.F.R. § 483.25(a)(2).

    a. Resident 32 was continent of bladder and able to control her urine.

    b. Resident 32 had a toileting plan that she agreed to satisfy her needs.

    c. Resident 32 intentionally urinated in her bed because the certified nurse assistant (CNA), who was attempting to comply with Resident 32's care plan, refused to assist her with a bedpan.

    d. There was no adverse impact upon Resident 32's toileting ability or to her achieving the highest practicable state.

9. Finding related to Tag F324, the alleged violation of 42 C.F.R. § 483.25(h)(2): Petitioner actively supervised Residents RV8, SV3, FL11 and Resident 57.

B. CONCLUSIONS OF LAW

1. Petitioner's request for hearing was timely filed and I have jurisdiction over the survey of March 2004 and the resulting termination, but I have no jurisdiction over prior surveys in the survey cycle which began September 26, 2003, or related remedies for which no request for hearing was filed.

2. The Secretary is not limited to terminating a provider agreement in only those cases where there is immediate jeopardy, but may terminate a provider agreement whenever the provider no longer meets participation requirements.

    3. Pursuant to 42 C.F.R. §§ 488.412(a) and 489.53(a)(4), CMS must terminate a facility's provider agreement if the facility does not achieve substantial compliance in no more than six months from the date of the first survey in the cycle that identified noncompliance.

    4. Long-term care facility regulations at 42 C.F.R. §§ 483.10 through 483.75 and CMS interpretive rules as set forth in the State Operations Manual (SOM), require consideration of the needs of residents, including what is required to ensure their protection and to ensure that they achieve the highest practicable state consistent with their conditions.

    5. There is no prejudice to Petitioner due to the incorrect citation of the surveyors to 42 C.F.R. § 483.13(c)(1)(ii) rather than 42 C.F.R. § 483.13(c)(2) as to the deficiency alleged under Tag F225.

    6. There is no violation of 42 C.F.R. § 483.13(c)(1)(ii) because the abrasion of Resident 1's toes was not from an unknown source.

    7. There is no violation of 42 C.F.R. § 483.20(k)(3)(i).

    8. The correct standard to apply to the medication errors alleged in this case regarding administration of medication outside parameters established by the prescribing physician, is the specific standard established by 42 C.F.R. § 483.25(m)(2) and the interpretive guidance of the SOM at Tag F333, which relate specifically to medication errors, rather than under the general quality of care standard established by 42 C.F.R. § 483.25 and the SOM under Tag F309.

    9. A significant medication error must be shown to find a violation of 42 C.F.R. § 483.25(m)(2), and that showing has not been made in this case.

    10. Even if a significant medication error had been initially shown as to some of the residents, the credible testimony of their treating physician who is familiar with the residents, their medication, and its effects, shows that there was no harm or potential harm to these residents in this case.

    11. A resident has the right to refuse to participate in an occupational therapy program.

    12. There is no violation of 42 C.F.R. § 483.25, based upon any of the examples cited in the SOD.

    13. There is no violation of 42 C.F.R. § 483.25(a)(2) because there is no showing that the incident alleged adversely impacted upon Resident 32 achieving the highest practicable state.

    14. There is no violation of 42 C.F.R. § 483.25(h)(2) because Petitioner took reasonable steps to supervise RV8, SV3, FL11 and Resident 57, consistent with their needs and treatment goals and with due regard for their safety and the safety of other residents.

    15. The surveyors recollection and her observations of the CNA performing incontinent care for FL5 are not credible and CMS has not established the factual basis for a prima facie showing of a violation of 42 C.F.R. § 483.65(a)(1)-(3).

    16. There is neither a factual nor a legal basis for finding a violation of 42 C.F.R. § 483.75.

    17. There is no basis for the termination of Petitioner's participation agreement.

III. ANALYSIS

A. ISSUES

The issue in this case is whether Petitioner's participation agreement must be terminated. Generally, long-term care enforcement cases also involve the issue of whether or not the remedies CMS seeks to impose are reasonable. However, in this case the termination was mandated by regulation based upon a finding of continuing noncompliance six months after a first survey determined noncompliance. Thus, there is no issue as to whether termination was a reasonable remedy. There was a civil money penalty (CMP) of $95,700 imposed based on a survey earlier in the survey-cycle that was not appealed and is not before me for review or decision. Accordingly, my decision has no effect upon the civil money penalty which CMS alleges is due in its letter of March 26, 2004. CMS Ex. 1; P. Ex. 3.

B. APPLICABLE LAW

Petitioner is a long-term care facility participating as a provider of services in both the Medicare program as a SNF and in Medicaid as a NF. Pursuant to section 1866 of the Social Security Act (Act) a provider seeking to participate in Medicare must enter an agreement with the Secretary. The Secretary may refuse to enter an agreement, may refuse to renew an agreement, or may terminate such an agreement with such reasonable notice as is specified by regulation upon, inter alia., determination that the provider fails to comply substantially with the provisions of the agreement, the Act or applicable regulations. Act, § 1866(b)(2). The statutory and regulatory requirements for participation specifically applicable to a long-term care facility are found at sections 1819 and 1919 of the Act, and at 42 C.F.R. Part 483.

Sections 1819(h)(2) and 1919(h)(3) of the Act, authorize the Secretary to impose the remedies specified in those sections when a provider is found not in substantial compliance. The Act and regulations authorize the Secretary and his delegee to impose remedies to ensure prompt compliance with program requirements. Act, §§ 1819(h) & 1919(h); 42 C.F.R. §§ 488.400 - 488.456. The Secretary has delegated to CMS the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements.

In construing the termination provisions of the Act and regulations, the Board has concluded that where immediate jeopardy is not abated promptly or if substantial compliance is not achieved after six months from the first survey in a survey cycle, CMS has no discretion not to terminate the facility from participation. Beechwood Sanitarium, DAB No. 1906, at 27 - 28 (2004). Title 42 C.F.R. § 488.456(b)(i) provides that CMS may terminate a facility's provider agreement if the facility is not in substantial compliance whether or not immediate jeopardy is present. Similarly, 42 C.F.R. § 489.53(a)(4) provides that CMS may terminate the agreement with any provider that no longer meets the participation requirements for SNFs or NFs. Pursuant to 42 C.F.R. § 488.412(a), CMS may give a facility no more than six months to achieve substantial compliance if the facility's deficiencies do not pose immediate jeopardy to its resident's heath and safety. Petitioner argues in its prehearing brief, page 31, that pursuant to sections 1819(h)(2)(A) and 1819(h)(4) (42 U.S.C. §§ 1395i-3(h)(2)(A) & (4)) the Secretary is only authorized to terminate a provider when cited deficiencies pose immediate jeopardy to resident health and safety. Petitioner cites Mountainview Nursing and Rehabilitation Center, Inc. v. Department of Heath and Human Services, No. 93 CV 1692 (M.D. Pa. Nov. 18, 1993) and Claridge House, Inc. v. Department of Health and Human Services, 795 F.Supp. 1393 (S.D. Ohio 1991) for the proposition that there is a conflict between the Act and the Secretary's regulations that permit termination even though there is no immediate jeopardy. I do not agree with Petitioner that the language of sections 1819(h)(2)(A) & (4) limit the Secretary to terminating a provider agreement to those situations where there is immediate jeopardy or that the regulatory process for terminating a provider agreement, even though there is no immediate jeopardy, are defective. My conclusions are consistent with prior comments by the Board and several federal courts. See Beverly Health and Rehabilitation - Spring Hill, DAB No. 1696 (1999) n.5, aff'd sub nom Beverly Health and Rehabilitation Services, Inc. v. Thompson, 2002 WL 31109618 (D.D.C. 2002); Northern Health Facilities, Inc, D/B/A, Greenbelt Nursing and Rehabilitation Center v. U.S., 39 F. Supp. 2d 563, 574-575 (S.D. MD. Dec. 28, 1998) (if there is immediate jeopardy, Secretary must terminate, if no immediate jeopardy, Secretary has discretion not to terminate); Vencor Nursing Center, L.P. v. Shalala, 63 F. Supp. 2d 1, 9-10 (D.D.C. Jul. 8, 1999) (facility did not show that court was likely to hold that Secretary lacked authority to terminate absent immediate jeopardy); Lake County Rehabilitation Center v. Shalala, 854 F. Supp. 1329, 1340-1341 (N.D. IN Jun. 10, 1994) (Secretary has discretion to terminate even absent immediate jeopardy).

When a remedy is imposed and appealed, CMS must make a prima facie case that the facility has failed to comply substantially with federal participation requirements. To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999). A preponderance of evidence is "superior evidentiary weight that, though not sufficient to free the mind wholly from all reasonable doubt, is still sufficient to incline a fair and impartial mind to one side of the issue rather than the other." Black's Law Dictionary(7th ed. 1999) (cited by the Board in Beechwood, at 38).

The Act and regulations make a hearing before an ALJ available to a long-term care facility against whom CMS has determined to impose a remedy. Act, § 1128A(c)(2); 42 C.F.R. §§ 488.408(g); 498.3(b)(12), (13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F2d. 678 (8th Cir. 1991). A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. § 488.408(g)(1); see also 42 C.F.R. §§ 488.330(e) and 498.3. However, the choice of remedies by CMS or the factors CMS considered when choosing remedies are not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the CMP that could be collected by CMS or impact upon the facility's nurse aide training program. 42 C.F.R. §§ 498.3(b)(14) and (d)(10)(i). CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. § 498.60(c)(2). Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd Woodstock Care Center v. Thompson, 363 F. 3d 583 (6th Cir. 2003). The Board has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). The Board has held that an ALJ has no authority to review whether termination of a provider agreement is an appropriate remedy where a legal basis for the imposition of a remedy exists. Furthermore, the existence of single deficiency may be sufficient legal basis for termination. Beverly Health and Rehabilitation - Spring Hill at 20-21; Emerald Oaks, at 39; Carmel Convalescent Hospital, DAB No. 1584, at 25 (1996). While an ALJ may not review the CMS scope and sufficiency determination, the Board has recognized that an ALJ must determine whether a deficiency poses "no greater risk to resident health or safety than the potential for causing minimal harm" the regulatory definition of substantial compliance under 42 C.F.R. § 488.301. Beechwood, at 36 - 37.

C. DISCUSSION

Petitioner has stressed throughout these proceedings that it is a unique facility, an assertion not disputed by CMS. Petitioner's patients range from 35 to 50 years of age. Petitioner asserts that its patients have needs which are much different than the needs of the typical elderly patient found in a long-term care facility. Petitioner's patients have needs related to both physical and cognitive impairments and Petitioner's goal is to "break the cycle of institutional dependence" of its residents. Petitioner's Prehearing Brief at 2; P. Brief at 1. It is not disputed that Petitioner's facility is a 209,000 square foot facility that was formerly an IBM executive training center. Petitioner's facility includes a locked "neurobehavioral" unit (NBI unit) that provides services to patients with significant behavioral disorders resulting from traumatic or organic brain injuries. One goal of the NBI unit is to attempt to transition patients to other less restrictive areas of the facility or back to the community. Petitioner emphasizes, and it is not disputed by CMS, that a resident must be deemed a danger to himself and/or others to be assigned to the NBI. Petitioner's facility also includes a 40-bed unit for ventilator dependent residents which has the goal of weaning patients off mechanical ventilators. Some of Petitioner's residents are also permitted to leave the facility regularly to attend college classes, to shop, to bank, and to participate in community functions. Petitioner, as part of its discharge planning process, engages in a process of community reintegration before discharge. Petitioner notes it is also different from most long-term care facilities as there are two house physicians with special expertise in the area of brain injuries and related disorders, two full-time nurse practitioners, a neuropsychologist, and a psychiatrist. Petitioner's Prehearing Brief at 3-4.

Petitioner does not deny that to participate in Medicare and Medicaid and to receive money from those programs, it agreed to be bound by the requirements of the Act and the Secretary's regulations related to long-term care facilities. Petitioner does not ask that I treat it as being exempt from the law pertaining to long-term care facilities. Rather, Petitioner asks that I apply the law recognizing the nature of its patients, the services they require, and the services Petitioner purports to deliver. Id. at 4; P. Brief at 1-2; P. Reply at 2-3. My review of the long-term care facility regulations and CMS interpretive rules as set forth in the SOM, shows that most of the rules and regulations do require consideration of the needs of residents, including what is required to ensure their protection and to ensure that they achieve the highest practicable state consistent with their conditions. See 42 C.F.R. §§ 483.10 - 483.75. Thus, I find Petitioner's request reasonable and I consider the alleged violations of participation requirements in the context of the nature of Petitioner's residents and what is required for their protection and to ensure that they attain the highest practicable state.

I have already noted that the survey before me is the fifth in the survey cycle (4) involving this facility. Petitioner was subject to a complaint survey by CMS personnel on September 26, 2003. Petitioner was found to be in violation of 42 C.F.R. §§ 483.13(c) (F224); 483.25(h)(2) (F324); 483.75 (F490); and 483.75(d)(2)(l) (F493). The surveyors found immediate jeopardy to resident health or safety. CMS imposed a directed plan of correction, denial of payment for new admissions (DPNA) effective October 1, 2003, and a CMP. CMS further advised Petitioner that its Medicare provider agreement would be terminated October 21, 2003, if the immediate jeopardy was not removed. CMS Exs. 10 and 11. Petitioner did not request a hearing. A revisit survey on October 16, 2003, found that immediate jeopardy had not been removed and cited Petitioner with additional violations including: 42 C.F.R. §§ 483.483.13(b) (F223); 483.13(c)(i) (F224); 483.20(k)(2) (F280); 483.25 (F309); 483.25(h)(2) (F324); 483.75 (F490); 483.75(d)(1)-(2) (F493); and 483.75(j)(2)(ii) (F505). CMS Ex. 9. A second revisit survey on October 20, 2003, found that immediate jeopardy had been removed as of that date, but that deficiencies remained. CMS advised Petitioner that the DPNA remained in effect and that Petitioner's Medicare provider agreement would terminate March 26, 2004, six months from the original complaint survey unless Petitioner achieved substantial compliance by that date. The CMP continued but was reduced based upon the elimination of the immediate jeopardy. CMS Exs. 7 and 8. Petitioner did not request a hearing, but offered to waive the right to hearing in exchange for a 35 percent reduction in the CMP. CMS Ex. 6. A third revisit survey conducted on February 6, 2004, found the following violations: 42 C.F.R. §§ 483.483.13(c)(1)(ii); 483.15(e)(1); 483.20(k); 483.20(k)(2); 483.25; 483.25(a)(2); 483.25(c); 483.65(a)(1)-(3); 483.65(b)(3); 483.75; 483.75(j); 483.75(k)(1); and 483.75(l)(1). CMS Ex. 5; P. Ex. 2. Informal dispute resolution did not result in any change in the cited deficiencies. CMS Ex. 12. The fourth and final revisit survey was completed in March 2004, and resulted in the termination of Petitioner's provider agreement effective March 26, 2004, a total CMP of $95,700 (5), and this appeal. CMS Exs. 1, 2, and 13; P. Exs. 1, 3, and 4. This fourth revisit survey is the one survey before me on appeal.

CMS alleges in the SOD dated March 23, 2004, that Petitioner violated the following regulations at the scope and severity level (SS) (6) indicated: 42 C.F.R. §§ 483.13(c)(1)(ii) (Tag F225), SS-D; 483.20(k)(3)(i) (Tag F281), SS-D; 483.25 (Tag F309), SS-E; 483.25(a)(2) (Tag F311), SS-D; 483.25(h)(2) (Tag F324), SS-G; 483.65(a)(1)-(3) (Tag F441), SS-D; and 483.75 (Tag F490), SS-F. None of these deficiencies were alleged to involve immediate jeopardy. There is no dispute that termination occurred in this case because Petitioner did not achieve substantial compliance within six months following the survey that ended on September 26, 2003. As previously discussed, CMS must terminate a facility's provider agreement if the facility does not achieve substantial compliance in no more than six months from the date of the first survey in the cycle that identified noncompliance. 42 C.F.R. §§ 488.412(a); 489.53(a)(4). There is also no dispute that had Petitioner been found in substantial compliance during the March 2004 survey, no termination would have occurred. Petitioner contends that no deficiencies should have been cited during the March 2004 survey, either because its practices were not deficient given the unique nature of it residents and services or, if deficient, there was no possibility for more than minimal harm. Thus, it is necessary for me to consider the individual deficiencies cited during the March 2004 survey.

1. F225 - The alleged violation of 42 C.F.R. § 483.13(c)(1)(ii).

The SOD (CMS Ex. 2, at 1) indicates that the surveyors cited Petitioner for a violation of 42 C.F.R. § 483.13(c)(1)(ii), which provides:

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. . . .

However, the gist of the alleged violation is that Petitioner failed to investigate an incident related to Resident 1 involving an abrasion to the second and third toes on her right foot. CMS Ex. 2, at 2. There are no facts alleged that Petitioner hired an individual with a conviction for neglecting or abusing a resident or who had a finding of neglect, abuse, mistreatment, or misappropriation of property entered on the nurse aide registry. The correct citation should be a violation of 42 C.F.R. § 483.13(c)(2), which provides:

The facility must ensure that all alleged violations involving mistreatment, neglect, or abuse, including injuries of unknown source, and misappropriation of resident property are reported immediately to the administrator of the facility and to other officials in accordance with State law through established procedures (including to the State survey and certification agency). (7)

I find no prejudice to Petitioner due to the surveyors' incorrect citation to the regulation. Petitioner has not made any objection of alleged prejudice due to the incorrect citation. The factual allegations and statement of the alleged violation set out in the SOM are clear. Petitioner addressed the substance of the alleged violation regarding Resident 1 in its prehearing brief at pages 14 to 15, at hearing, and in its post hearing briefing. P. Brief at 17-19; P. Reply at 23-24. Accordingly, it is appropriate for me to consider the violation alleged despite the incorrect citation to the regulation by the surveyors. See Cedar View Good Samaritan, DAB No. 1897, at 7-9 (2003).

On March 13, 2004, at 10:30 AM, Resident 1, who is a wheelchair bound paraplegic, departed the facility to go to the mall, as she was permitted to do. Resident 1 returned from the mall about 4:30 PM on March 13, and was noted to have a torn sock and a bleeding abrasion to the third toe of her right foot, which was treated. P. Ex. 14, at 1-2. According to the SOD, the surveyor asked Resident 1 about the toe abrasion and she indicated she did not know how it happened. The unit manager told the surveyor that the abrasion happened outside the facility and that there was no policy for reporting events that occurred outside the facility. The Administrator and Director of Nursing (DON) advised the surveyor that no investigation was done, but the abrasion occurred while the resident was on the bus. The facility subsequently provided the survey team a document that explained that the bus driver reported the abrasion when he returned Resident 1 to the facility. CMS Ex. 2, at 3-4; CMS Ex. 34, at 15-16. In its plan of corrective action following the March 2004 survey, Petitioner provided information that shows that on Resident 1's return from the mall on March 13, 2004, she had a torn sock on the right foot with abrasions to both the second and third toes with bleeding from the latter. Resident 1 reported that she brushed her toes on the curb while getting on the bus to return from the mall. CMS Ex. 30, at 1-2, 11-12. Jane Keating explained that when Resident 1 returned from the mall, the bus driver reported to facility staff at the front desk what had happened to Resident 1. Tr. at 614-615.

CMS argues that Resident 1 suffered an injury of unknown origin that required investigation. CMS Brief at 26; CMS Reply at 25. CMS suggests that Petitioner's explanation that the bus driver reported the occurrence to the front desk upon returning Resident 1 is not credible, based upon the facts that when the resident was interviewed by the surveyor she could not recall how she hurt her toes; that the unit manager interviewed by the surveyor did not seem to know how the injury occurred; and that nursing notes did not indicate the cause of the injury. Id. I note that Resident 1's diagnoses include a traumatic brain injury with a personality change, bipolar disorder, depression, a mood disorder, and an anxiety disorder (P. Ex. 11) all of which might impact her ability to recall even recent events or which might otherwise affect the reliability of her statements to the surveyor. Further, the unit manager the surveyor interviewed was not present when Resident 1 returned to the facility with the abraded toe and she was not advised of the incident until after the weekend during which the injury occurred. Based on all the evidence, I find credible Petitioner's version of the events, i.e., Resident 1 returned from the mall with the bus driver who advised staff of what had occurred. I conclude that the preponderance of the evidence is that Resident 1's injury to her toes was not an injury of unknown source. The regulation that Petitioner allegedly violated, 42 C.F.R. § 483.13(c)(2), requires that there be an investigation for an injury of unknown source, it does not require an investigation for injuries of known source unless there is an allegation of mistreatment, neglect, abuse, or misappropriation of resident property. The injury to Resident 1's toes had a known source and there is no allegation of mistreatment, neglect, abuse, or misappropriation of resident property. Accordingly, 42 C.F.R. § 483.13(c)(2) has no application and was not violated in this case.

2. F281 - The alleged violation of 42 C.F.R. § 483.20(k)(3)(i), which provides:

The facility must conduct initially and periodically a comprehensive, accurate, standardized, reproducible assessment of each resident's functional capacity.

* * * *

(k) Comprehensive care plans.

* * * *

(3) The services provided or arranged by the facility must-- (i) Meet professional standards of quality. . . .

CMS explains to surveyors in the SOM that the intent of the regulation is to ensure that services "meet professional standards of quality" and are "provided by appropriate qualified persons (e.g. licensed, certified)." SOM, App. P, F281, at PP-82.3.

"Professional standards of quality" means services that are provided according to accepted standards of clinical practice. Standards may apply to care provided by a particular clinical discipline or in a specific clinical situation or setting. Standards regarding quality care practices may be published by a professional organization, licensing board, accreditation body or other regulatory agency. Recommended practices to achieve desired resident outcomes may also be found in clinical literature.

Id. at PP-82.4.

The surveyors allege in this case that Resident FL9 had a physician's order to use a wound vacuum with continuous pressure on any stage four ulcer; to change canister and tubing weekly or when full; and to check for airtight seal each shift. The SOD indicates that the surveyor requested and reviewed "staff inservices/education for the use of this treatment and copies of nursing schedules for staff as worked." CMS Ex. 2, at 4-5. Based on her review of the requested materials, the surveyor concluded that: some of Petitioner's staff did receive training in the use of the wound vacuum on March 12 and 15, 2004; eight other nurses who worked shifts on the unit where the wound vacuum was in use did not attend training on March 12 or 15, 2004; the policy for use of the wound vacuum was not on the unit, but was with the assistant director of nursing (ADON); and a video on the use of the wound vacuum was available to staff, but Petitioner provided no evidence that any of the eight nurses had viewed it. The surveyor noted that while the wound dressing need only be changed every three days, there is a requirement that the dressing be checked for an airtight seal and that the machine be monitored and assessed for correct setting every shift. CMS Ex. 2, at 4-6. The surveyor does not indicate in the SOD the time-frame that concerned her. The surveyor also does not allege in the SOD that there were any shifts during the period of concern to her where no one trained on March 12 or 15, 2004 was present. The surveyor was apparently concerned and cited this deficiency because eight nurses who worked during the unspecified period, might not have been trained and able to use the wound vacuum when no one trained on March 12 or 15 was present.

I conclude that CMS has not made a prima facie showing with regard to this citation. An appellate panel of the Board defined the requirements for a prima facie case in its decision in Hillman, at 8:

HCFA [CMS] did not dispute that it has the burden of coming forward with evidence establishing a prima facie case that Hillman substantially failed to comply with program requirements. This is appropriate because HCFA's determination to terminate a provider agreement must be legally sufficient under the statute and regulations. We agree with the ALJ that HCFA must identify the legal criteria to which it seeks to hold a provider. Moreover, to the extent that a provider challenges HCFA's findings, HCFA must come forward with evidence of the basis for its determination, including the factual findings on which HCFA is relying and, if HCFA has determined that a condition of participation was not met, HCFA's evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

If a provider appeals a termination decision, CMS has the initial burden of showing that its decision to terminate is legally sufficient under the statute and regulations. See e.g. Beverly Health and Rehabilitation Center - Williamsburg, DAB No. 1748 (2000). As a panel of the Board stated in Meadow Wood Nursing Home, DAB No. 1841, at 7 (2002),

It is true that, in order to put a provider to its proof, CMS must produce evidence sufficient to establish a prima facie case that, in the absence of any conflicting evidence, would constitute a legal basis for the proposed remedies. This requirement can be characterized as a production burden to establish that the factual allegations raised are legally sufficient and are not simply asserted without some evidentiary basis. This prima facie showing in no way represents a shifting of the ultimate burden of proof to CMS.

Another panel of the Board explained in the earlier Emerald Oaks decision that:

It follows . . . that, in determining whether a prima facie case has been presented, the ALJ looks only at the evidence put forward by CMS. VITAS Healthcare Corp. of America, DAB No. 1782, at 11-19 (2001). Absent a showing sufficient standing alone to support the basis for CMS's action, no further evaluation of conflicting evidence is necessary. Assuming a prima facie case exists, the ALJ must review all the evidence in the record and apply the preponderance of the evidence standard to determine whether the facility has proven that it was in substantial compliance with the applicable standards. The preponderance of the evidence standard means that the party with the burden, . . . had to show that it was more likely than not that it was in substantial compliance as to each disputed deficiency finding. Under this standard, if the evidence in the record as a whole is in equipoise as to a disputed fact, that fact is resolved against the party with the burden to prove it. Hillman, at n.7.

Id. at 16.

Thus, the initial analysis required is whether or not CMS has made its prima facie case as to a disputed deficiency. The foregoing DAB decisions make clear that there are several issues inherent in the general issue of whether or not CMS has made a prima facie showing as to any alleged deficiency, including: (1) whether CMS has identified a statute, regulation, or other legal criteria to which it may hold the provider; (2) whether CMS has come forward with evidence to support its factual conclusions that show, absent consideration of other evidence, that a violation exists; and (3) whether CMS has shown with its evidence that the deficiencies or violations of law amount to noncompliance that warrants an enforcement remedy. I conclude as to this deficiency that CMS has failed to make a prima facie showing of a violation.

The SOD cites no period of time during which the wound vacuum was in use by untrained and unqualified staff. (8) The SOD does not allege that Resident FL9 even had a wound that required the use of the vacuum during whatever period concerned the surveyor. The SOD cites no professional standard of quality or professional standard for training or competence that was violated, which is the standard specified by the SOM for this deficiency. The SOD does not include any allegation of an observed or documented incorrect use of the wound vacuum. The SOD does not allege an actual or potential negative outcome.

Considering further the evidence presented by CMS plus the allegations of the SOD, it is clear that CMS has not made a prima facie case of a violation. Sharon Roberson was the CMS surveyor who collected the evidence, made the findings and conclusions, and drafted this alleged violation. CMS Ex. 35, at 24. Her testimony was secured during a deposition conducted May 14, 2004, the transcript of which has been admitted as CMS Ex. 35. Ms. Roberson testified that she cited the deficiency because she was not provided evidence that "all nursing staff caring for the resident with this wound vac had been in-serviced to the device." Id. However, Ms. Roberson never identified for herself, Petitioner, or me what staff who cared for Resident FL9 were not trained and competent in the use of the machine for the care of FL9. Ms. Roberson assumes that staff who did not receive the in-service training on the dates it was presented by Petitioner, were not competent in the use of the machine and that some staff who were not competent to use the machine delivered treatment to FL9 with the machine. These assumptions are an inadequate basis for a deficiency citation - CMS must point to some facts that support the factual conclusions that are the basis for the deficiency citation.

Ms. Roberson points to no nursing notes or other documents to show who cared for Resident FL9 during the period of concern to her except CMS Ex. 15, at 39-40, a treatment administration record which contains initials she identified as being those of someone who did not attend Petitioner's in-service training. CMS Ex. 35, at 27. A physician's order dated March 12, 2004, initiated the use of the wound vacuum on that date. CMS Ex. 15, at 3. Because the on-site survey was completed on March 19, 2004, I conclude that the period in issue under this deficiency was actually March 12, 2004 through March 19, 2004. The initials on the MAR show that the wound vacuum cannister and tubing were being checked every shift beginning with the 7 AM to 3 PM shift on March 12, 2004 and ending on the 11 PM to 7 AM shift on March 18, 2004. Id. at 39. Petitioner conducted in-service training on March 12 and 15, 2004. Id. at 4. Staffing schedules for March 12 through 17, 2004 are found at CMS Ex. 15, at 27-28, 31-38, and 41-42. (9) Based on my comparison of the wound vacuum in-service list, with the relevant staffing schedules for traumatic brain injury (TBI) unit 5 where Resident FL9 was housed, I conclude that there was not always a nurse who attended the in-service on duty for each shift when the wound vacuum was in use. Because the wound vacuum required some tending every shift, I infer that on some shifts a nurse who did not attend Petitioner's in-service tended to the machine as Ms. Roberson alleges. However, Ms. Roberson did not observe the wound vacuum in use by anyone and cannot allege as to anyone's level of competence. Ms. Roberson also does not point to any evidence of a negative outcome or potential negative outcome in the use of the wound vacuum during the period in issue. Ms. Roberson does not cite to any evidence that the staff who attended the wound vacuum, but did not attend in-service training, were not competent to tend to the wound vacuum. I find no support for Ms. Roberson's conclusion that there was a violation of professional standards of care because someone who tended to or used the wound vacuum did not attend Petitioner's in-service training. Ms. Roberson, testified that it is a "professional standard of practice" for a nurse to be familiar with any treatment modality that they are responsible for. CMS Ex. 35, at 28. However, the fact that there were nurses who might have checked the wound vacuum or dressing, but did not attend the in-service does not establish that they were not familiar or, more importantly, that they were not competent to use the vacuum. In fact, Ms. Roberson never specifically alleges that any of the nurses were not competent, only that they did not attend the in-service training.

The regulatory requirement is that services provided must meet professional standards of quality. In this case, the service was the application of the wound vacuum to aid the healing of a stage four ulcer. The allegations in the SOD and the evidence CMS presented does not amount to a prima facie showing that the wound vacuum service did not meet professional standards of quality. Accordingly, I conclude that there is no violation of 42 C.F.R. § 483.20(k)(3)(i).

3. F309 - The alleged violation of 42 C.F.R. § 483.25, which provides:

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.

The surveyors allege four examples to show that Petitioner violated 42 C.F.R. § 483.25: Example A - for ten (10) residents, Petitioner failed to follow physician's orders for the administration of medication; Example B - Petitioner failed to give Resident FL2 enough pain medication; Example C - Petitioner failed to assess Resident SV5 upon his return from a failed colonoscopy and did not disimpact him until four days later; and Example D - Petitioner failed to investigate whether Resident 1 was safe for self-administration of medication after the resident squeezed her IV bag.

a. Example A - The allegations that Petitioner failed, for ten residents, to follow physician's orders for the administration of medication.

It is alleged as to residents FL10, FL13, FL16, Resident 33, FL18, SM2, FL1, FL21, FL19, and FL15, that Petitioner's staff failed to comply with physician's orders in administering medication by not calling the physician and/or administering medication when one or more of the following conditions existed: the resident's blood pressure was above or below a certain systolic or diastolic reading or both; the resident's heart rate was above or below a certain rate; or the resident's blood pressure or heart rate was not determined and the treating doctor had instructed to withhold based on blood pressure or heart rate.

Before getting to the facts related to individual residents, it is necessary to determine what standard to apply in assessing those facts. Petitioner argues that the CMS allegations for Example A are incorrectly cited under the general quality of care provision 42 C.F.R. § 483.25, Tag F309, rather than under the more specific medication administration error provision at 42 C.F.R. § 483.25(m), Tag F333. CMS asserts that it is not limited to citing medication errors under 42 C.F.R. § 483.25(m), either tags F332 or F333, but that it can cite under the general quality of care provision of 42 C.F.R. § 483.25, Tag F309, and rely upon the testimony of its surveyors to show that there was a potential for more than minimal harm for residents in order to make its prima facie showing. CMS Reply at 8, n.8. A violation of the regulatory requirements of 42 C.F.R. § 483.25(m) related to the administration of medication falls within the general regulatory requirement for quality of care established by 42 C.F.R. § 483.25. Thus, a violation of subsection 483.25(m) is a violation of section 483.25. However, the issue raised by Petitioner is not insignificant because CMS has established in the SOM different standards applicable to a violation of 42 C.F.R. 483.25(m)(1) (identified in the SOM as Tag F332) or (2) (Tag F333) and 42 C.F.R. § 483.25 (Tag F309). The standards CMS has adopted, dictate the evidence that CMS must present to make a prima facie showing of a regulatory violation.

Determining which standard applies was complicated by the survey protocol followed in this case and caused confusion for the surveyors. Susan Albrecht testified that she was responsible for portions of the citation under Tag F309 with input from Sharon Roberson. Tr. 166-167. She testified that Peggy Kosherzenko did a medication pass review and observed that either heart rate or blood pressure was not taken prior to administration of medication. Due to that observation, Ms. Albrect, Ms. Kosherzenko, Pat Tuckerson, and Ms. Roberson then did a review of the MAR for all the residents of the facility. Ms. Albrecht testified that based upon the MAR reviews they reached the conclusions set out in the SOD, Tag F309, Example A. She testified that she and the other surveyors discussed whether to cite the alleged deficiencies under F309 or F333. Tr. 167-168; P. Ex. 35, at 34. They concluded that F333 "has to do with medication pass, and in order to cite it you have to have greater than five percent. What we did was reviewed all the MARs, and this was a record review. It was not actual observations of the med pass." Tr. 168-169. Ms. Albrecht clarified that the surveyors did not find a five percent error rate and believed they could not cite the alleged deficiency under F333. (11) Tr. 169. On cross-examination, Ms. Albrecht testified that she made no judgment as to whether any resident cited as an example was subject to any harm because a medication was administered without establishing heart rate or blood pressure or because a medication was administered when heart rate or blood pressure was out side parameters set by the physician. She testified that her concern was that nurses did not follow physician's orders. Tr. 230-231. Surveyor Margaret Kosherzenko also testified during her deposition that the deficiency was "that the nurses weren't following the physicians' orders." CMS Ex. 34, at 37. The fact that the surveyors cited a deficiency under F309 indicates that they concluded that the failure to follow physicians orders posed the potential for more than minimal harm. (12)

Neither the Act, nor the regulation addresses the issue of whether CMS has the option of citing medication errors under either F309 or F332 and F333. The obvious reason is that the Act and regulation do not establish the system of tags used by surveyors -- that system is established by CMS in the SOM. Furthermore, a violation of the specific regulatory subsection, i.e. 42 C.F.R. § 483.25(m) which is related to F332 and F333, arguably constitutes a regulatory violation of the section, i.e. 42 C.F.R. § 483.25 which relates to F309. As I have already noted, the matter of concern here, is that CMS has established different standards or elements applicable to these tags in the SOM and it is necessary to actually decide which standard to apply.

A facility is required by 42 C.F.R. § 483.25(m) to: (1) ensure that it does not have a medication error rate of five percent or greater; and (2) ensure that residents are free of any significant medication errors. A medication error is defined in the guidance to surveyors as:

The observed preparation or administration of drugs or biologicals which is not in accordance with:

(1) Physician's orders;

(2) Manufacturer's specifications (not recommendations) regarding the preparation and administration of the drug or biological;

(3) Accepted professional standards and principles which apply to professionals providing services. Accepted professional standards and principles include the various practice regulations in each State, and current commonly accepted health standards established by national organizations, boards, and councils.

SOM, App. P at PP-129.

The allegations here, confirmed by the surveyor's through their testimony, is that physician orders were not followed or there is no evidence the orders were followed in the administration of drugs. The surveyors' allegations fall squarely within the definition of a medication error as defined by the SOM under F332 and F333. The allegations do not fit the description of the general quality of care requirement as set forth in the regulation or SOM under F309. The guidance to surveyors in the SOM instructs surveyors to "(u)se F309 when the survey team determines there are quality of care deficiencies not covered by §§ 483.25(a)-(m)." SOM, App. P at PP-83. The guidance to surveyors further instructs "(u)se Tag F309 to cite quality of care deficiencies that are not explicit in the quality of care regulations." Id. The CMS statement of the requirement under F309 is that "(t)he facility must ensure that the resident obtains optimal improvement or does not deteriorate within the limits of a resident's right to refuse treatment, and within the limits or recognized pathology and the normal aging process." Id. Surveyors are instructed to determine whether any lack of improvement or decline was unavoidable or avoidable considering the resident assessment, care plan, and evaluations of the results of interventions and revised interventions. The surveyors are instructed to determine whether the facility is providing the necessary care and services, evaluating outcome, and changing interventions when appropriate. Id.

If I were to evaluate the surveyors allegations under 42 C.F.R. § 483.25 (F309) , the issue would be whether or not CMS has made a prima facie showing that Petitioner did not "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" of each of the residents involved. 42 C.F.R. § 483.25. The SOM uses a slightly different formulation under F309, i.e. the CMS prima facie showing would need to be that the facility failed to "ensure that the resident obtains optimal improvement or does not deteriorate within the limits of a resident's right to refuse treatment, and within the limits or recognized pathology and the normal aging process." SOM, App. P at PP-83. I do not need to resolve whether the two standards under F309 are the same or in conflict. I simply observe that neither formulation is helpful to CMS in this case because the CMS evidence does not address either. The focus of the CMS case with regard to this example is that nurses failed to follow physicians' orders which allegedly posed the potential for more than minimal harm to residents. CMS does not address any impact upon resident improvement or decline. Furthermore, CMS has instructed surveyors twice in the general quality of care provisions of the SOM to only use that provision when the more specific quality of care provisions do not apply. Accordingly, I concur with Petitioner that it is appropriate to evaluate the surveyors' allegations as medication errors under 42 C.F.R. § 483.25(m) (F333) rather than the more general 42 C.F.R. § 483.25 (F309). (13)

The surveyors in this case were concerned about citing their allegations under F332 and F333 because they admittedly could not establish a five percent error rate and because their allegations were not based on a medication pass review. Subsection 483.25(m) of Title 42 C.F.R. imposes two different requirements upon long-term care facilities: a facility's medication error rate may not exceed five percent (Tag F332 in the SOM) and there can be no significant medication errors (Tag F333). The SOM instructs surveyors to observe the administration of drugs during a medication pass to determine medication errors and further instructs that they should not rely solely upon a paper review. The SOM states specifically that the detection of blank spaces on a MAR does not amount to the detection of an actual medication error. SOM, App. P at PP-135.4. In this case, a medication pass was observed and it was noted that a medication was administered without first taking one resident's pulse or blood pressure. Prompted by the one observed error during the medication pass review, the surveyors reviewed the medication records for all the facility residents and they discovered that heart rate and/or pulse were outside parameters or were not recorded when medication was administered as they have alleged for ten residents in the SOD. Tr. 167-168. Because there is no dispute that there was no five percent error rate in this facility, as confirmed by the medication pass review and a review of MARs for all Petitioner's residents, 42 C.F.R. § 483.25(m)(1) (F332) clearly has no application in this case. However, 42 C.F.R. § 483.25(m)(2) (Tag F333) does apply.

The applicable regulatory provision, 42 C.F.R. §483.25(m)(2), requires that Petitioner ensure that there are no "significant" medication errors. A significant medication error is one that causes a resident "discomfort or jeopardizes his or her health and safety." SOM, App. P at PP-129. I do not read the SOM to required a medication pass review as a predicate to finding a significant medication error. A medication pass review might be an efficient method for determining whether or not a facility has a five percent error rate, but I am not persuaded that a medication pass review is the only CMS approved method for discovering a significant medication error. Indeed, it is unreasonable to read the SOM to preclude citing a facility for a significant medication error because the error was discovered during the observation of administration of medication to a single resident or upon the review of a resident's records rather than a facility-wide medication pass review. The problem with the alleged deficiency as evaluated under F333 in this case, is that the surveyors failed to develop facts related to the significance of the medication errors observed with respect to each resident. Significance is an issue and an element of the CMS prima facie case for only a "significant medication error" provides a basis for a deficiency citation under 42 C.F.R. § 483.25(m)(2). In this case, the surveyors testified that they cited the deficiency because nurses failed to follow physicians orders. The surveyors did not testify that they found the medication errors to be significant and they did not identify any particular harm to residents, except that a surveyor expressed concern about a resident who might become dizzy and fall. Tr. 230-231; CMS Ex. 34, at 37.

The Board recently discussed 42 C.F.R. § 483.25(m), including its regulatory history and SOM provisions, in Northern Montana Care Center, DAB No. 1930 (2004). Several principles regarding the citation of significant medication errors may be extracted from the Board's analysis: (1) a finding of a significant medication error must be based on a specific error for a specific resident, the potential for errors with other residents is not sufficient; (2) significance is judged based on drug category, resident condition, and frequency of the error; (3) a significant error is one that jeopardizes or has serious potential for jeopardizing the health and safety of a resident; and (4) significance is an element of the CMS prima facie case. In this case, the CMS evidence is that medication was administered without first establishing heart rate or blood pressure or that medication was administered when either one or both were outside parameters established by physicians' orders. The surveyors admitted that they cited the deficiency because the nurses failed to follow orders. The surveyors did not evaluate for individual residents whether or not the medication error was significant considering the factors of drug category, resident condition, and frequency of the error. Id. The significance of a medication error is a matter of professional judgment that considers the resident's condition, the type of drug, and the frequency of the error with respect to the particular resident. See SOM, App. P at PP-130-131. Thus, significance is a very fact specific determination which requires the application of medical expertise. (14) The surveyors did opine generally that there was a potential for more than minimal harm due to the alleged medication errors. The surveyors' opinions on scope and severity are distinguishable from the determination of significance because the scope and severity determination does not require the surveyors to assess impact for individual residents considering the factors of drug category, resident condition, and frequency of the error. To the extent that the nurse surveyors' opinions regarding scope and severity might also be construed to be opinions regarding significance, it is necessary to address them briefly.

It is alleged in the SOD that Resident FL10 had an order for Metoprolol 50 mg. daily administered as one-half tablet of 25 mg. every 12 hours with the instruction to hold for blood pressure of less than 130/80. A surveyor observed a nurse administer Metoprolol after taking FL10's blood pressure which was 122/70. The surveyors reviewed FL10's MAR and found that Metoprolol was administered when his blood pressure was less than 130/80 on eight occasions and five times no blood pressure was recorded in the MAR. Surveyor Margaret Kosherzenko testified during her deposition that there was a potential for more than minimal harm to FL10 because he was also receiving another medication that could reduce blood pressure and he might experience hypotension that could cause him to become dizzy and fall. (15) CMS Ex. 34, at 31-32. Resident FL13 had an order for Lopressor 75 mg., three times per day, and Vasotec 2.5 mg., twice per day. The surveyors allege that a physician's order directed to hold Vasotec and Lopressor for a systolic pressure of less than 110. Based on their review of the MAR, the surveyors allege that blood pressure was not recorded, and thus not taken, 55 of 68 times between March 1 and March 17, 2004. Resident FL16 had an order for Diovan 160 mg. daily with an order to hold for a systolic pressure less than 110 and to call the doctor if systolic was greater than 170 and the diastolic was greater than 100. On March 10, 2004, Diovan was administered even though the diastolic pressure was above 100 and the doctor was not called. Resident 33 had an order for Inderal 60 mg., four times per day, for mood instability, but to hold if blood pressure is 90/60. The surveyors concluded that blood pressures were not recorded for 16 of 64 opportunities. Resident 33 also had an order for Metoprolol 25 mg. for hypertension, but to hold if blood pressure was less than 110/60. The surveyors allege that the medication was administered twice even though blood pressures were recorded as 108/76 and 108/70. Resident 33 also had an order for Hydralazine 10 mg., two times per day, but with an order to hold if blood pressure was less than 110/60. No blood pressure was recorded for one occasion. Resident FL18 had an order for Midodrine 10 mg., three times per day, for hypertension with an instruction to hold if systolic was greater than 130. The surveyors allege that blood pressures were not taken four times. Resident SM2 had an order for Metoprolol 50 mg., twice a day, with instruction to hold for systolic pressure of less than 110, but blood pressures were not taken on 13 of 34 occasions. Resident FL1 had an order for Cardizem 60 mg. every eight hours with instructions to hold for blood pressure of less than 110/60 and heart rate less than 60. The surveyors allege that there was no evidence that blood pressure and heart rate were taken for 13 of 16 occasions. Resident FL21 had an order for Inderal 60 mg., two tablets four times a day, but to hold if blood pressure is 90/60. The surveyors allege that blood pressures were not recorded on the MAR on 14 occasions. Resident FL19 had an order for Metoprolol 25 mg., twice a day, but to hold if apical pulse was less than 51. The surveyors allege that no pulse was recorded from March 1 to March 17, 2004. Resident FL 5 had an order for Atenolol once a day, but with instructions to hold if pulse was less than 60. The surveyors allege that pulses were not recorded for March 4 to March 9, 2004 and March 12, 2004. CMS Ex. 2, at 7-13. (16)

Petitioner presented the testimony of two physicians both of whom are specifically familiar with the residents in issue: Richard Hodder, M.D., the medical director for Petitioner, and Christopher Melcer, M.D., the house or staff physician for Petitioner. Dr. Hodder opined that even if the surveyors' conclusions were correct, there was no risk of harm to residents from these medications given the presence of trained staff and Dr. Melcer who issued the orders and the fact that blood pressures and pulses were taken routinely throughout the day. Tr. 376 - 379. Dr. Melcer testified that he is the attending physician for each of Petitioner's residents. Tr. 822, 875. He testified regarding the orders for checking blood pressure and pulse and that he never intended that checks be done each time medication was administered. Tr. 836. He also testified that it was his intent that the parameters he set were only approximate guidelines and that he intended medications be given so long as blood pressure was reasonably close to parameters. Tr. 834. Dr. Melcer testified that there was no instance of harm or even the possibility for harm based upon the nurses' failure to take or record blood pressure or pulse. Tr. 836-837.

Petitioner has never disputed the accuracy of the majority of the surveyors observations regarding this example. Tr. 420-421. Rather, Petitioner takes the position that there is no harm or potential for harm to the individual residents given the facts cited. With the exception of FL10, the surveyors did not assess individual impact for the residents, but, rather, they simply opined that failure to follow doctors orders could result in more than minimal harm. With regard to FL10, it is clear from Surveyor Kosherzenko testimony that the chance of harm was attenuated and, contrary to the suggestion of CMS, the evidence does not establish any causal connection between administration of blood pressure medication and the resident's two falls. Even if the CMS evidence was viewed as sufficient to constitute a prima facie showing under either F333 or F309, the testimony of the treating source for these residents supported by the testimony of the medical director outweighs the testimony of the nurse surveyors. The treating source is specifically familiar with the situation of each resident concerned and the medication prescribed. The nurse surveyors based their conclusions upon limited contact with one resident and a review of records. As a medical doctor, I presume Dr. Melcer has a greater knowledge of drugs and their possible effects upon his patients. Dr. Melcer's qualifications are unchallenged in this case. CMS does allude to the fact that Dr. Melcer is employed by Petitioner and thus has a financial interest. However, I do not see the evidence as establishing a financial interest significant enough to affect Dr. Melcer's credibility as a doctor. Furthermore, Dr. Melcer's testimony at trial is consistent with what he told Surveyor Kosherzenko during the survey. Compare CMS Ex. 34, at 142-143 and Tr. 836.

I conclude that CMS has failed to make a prima facie showing of a significant medication error and there is no violation of 42 C.F.R. § 483.25 or subsection 483.25(m) on the facts alleged by this example. I agree with CMS that the failure of a nurse to follow a physician order is evidence that may support a deficiency citation, but that evidence alone is not sufficient to establish a prima facie showing of a violation of 42 C.F.R. § 483.25 or § 483.25(m). Even if I found the surveyors opinions regarding the potential for minimal harm sufficient to satisfy the "significance" element, their opinions were reputed by the more probative testimony of the treating source for the residents involved.

b. Example B - The allegation that Petitioner failed to give Resident FL2 enough pain medication.

CMS alleges under this example, that FL2 received pain medication that did not entirely relieve the resident's pain, the resident refused to participate in occupational therapy (OT) due to her pain, and Petitioner implemented no additional interventions to reduce the resident's pain. My review of the allegations and the evidence leads me to the conclusion that the surveyors misconstrued the evidence and arrived at erroneous conclusions.

The surveyors were concerned that the resident, who was receiving narcotic pain medication, was not receiving enough pain medication or another intervention to eliminate her pain so that she would willingly participate in OT. The surveyors assume that participation in OT, even if heavily medicated, would help the resident "attain or maintain the highest practicable physical, mental, and psychosocial well-being" within the meaning of 42 C.F.R. § 483.25.

The facts alleged in the SOD are not in dispute. Resident FL2, a 57 year-old female, was admitted to the facility on June 23, 2003, with diagnosis of respiratory failure and ventilator dependence, chronic obstructive pulmonary disease, anemia, decubitus ulcer, hypertension, and anxiety. FL2's MDS for March 1, 2004 showed that she suffered from moderate pain daily during the assessment period. FL2 complained of pain from her low back, her right hip due to a prior fracture, the sacral/coccyx area due to an ulcer, and general discomfort. The resident's care plan set a goal that FL2's pain would be managed with no signs or symptoms of pain for 90 days. According to her December 1993 care plan, FL2 was to participate in OT five times a week to include activities of daily living training, therapeutic exercise and activities, and mobility training. FL2 wanted to be pain free. Petitioner had a policy dated October 17, 2003, that provided that the goal was to maintain residents as pain free as possible while allowing them to function at their highest practicable state. OT weekly progress notes reviewed by the surveyors showed that FL2 was not cooperative on several occasions indicating she wanted to go back to bed and also indicating that she had pain due to her ulcer while sitting in a wheelchair. The resident was given Percocet and Tylenol for pain. A Duragesic patch was also used for a time, but was discontinued due to lethargy. The surveyors note that FL2's MAR for March 2004 shows that on March 1, 2004, she was given Percocet at 12:00 PM for complaints of pain at level 7 on a scale of 1-10, with 10 being the most extreme pain. The Percocet reduced FL2's self-reported pain level to 3. The surveyors allege that no other medication was given or interventions attempted on March 1, 2004, despite the fact that the treatment goal for FL2 was to render her pain free. The surveyor's only found one instance on March 3, 2004 when FL2 was given Tylenol. The surveyors found that on March 1, 2004, FL2 refused to get out of bed to attend OT and she was ultimately discharged from OT without accomplishing her OT goals. See CMS Ex. 2, at 13-19.

The first paragraph under Example B, Tag F309, is the key to understanding the gist of the deficiency cited regarding FL2 and the surveyors' erroneous interpretation of the evidence:

Resident #FL2 received pain medication which did not entirely relieve the resident's pain, the resident refused Occupational Therapy secondary to her sacral decubitus pain, and no additional interventions were implemented to reduce the resident's pain.

I construe the surveyors' allegation of deficiency to be that Petitioner did not do enough to control FL2's pain which provoked her to quit OT, and therefore, Petitioner failed to provide FL2 the "necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being," which is the standard set by 42 C.F.R. § 483.25. I conclude that the surveyors arrived at an erroneous conclusion that FL2 quit OT due to pain. FL2's OT weekly progress notes indicate that FL2 needed maximum encouragement to participate. The February 2, 2004 note indicates that FL2 was difficult to engage in treatment due to her complaints that she just wanted to go back to bed. The March 1, 2004 note indicates that FL2 refused to get out of bed indicating that she needed a rest. It was also noted in each progress note that FL2 complained of pain while sitting due to her coccyx ulcer. However, my reading of the progress notes is that her coccyx pain was, for her, a secondary factor to her lack of motivation to participate in OT. The surveyors recognize in the SOD (CMS Ex. 2, at 17) that FL2 told the therapist on March 1, 2004, that she refused to get out of bed to attend OT because she needed a rest and that she just did not want to get out of bed. See P. Ex.155, at 7 (OT Progress Note, 3/1/04). The March 1, 2004 note includes a note that FL2 complained of pain from her sacral ulcer, but the note does not indicate FL2 refused therapy for that reason. Despite the fact that there is no statement of FL2 or other indication that she refused OT at any time due to pain, the surveyors attribute her lack of participation substantially to her pain. (17) The surveyors' conclusion is inconsistent with the resident's clinical records which show little evidence of any significant pain at the time. Nurses notes from March 1, 2004 indicate that FL2 was not noted to be in distress during checks at 8:00 AM, 11:00 AM, 2:00 PM, 5:00 PM, 7:00 PM, and 11:10 PM. P. Ex. 157, at 1. According to the nursing notes, FL2 was up in her wheelchair at 11:00 AM on March 1 and no distress was noted. At 2:00 PM, no distress was noted and FL2 was watching a movie in the lounge (the notes do not indicate whether she was sitting up or lying down). P. Ex. 157, at 1.

Despite the fact that contemporaneous nursing notes from March 1, 2004 indicate that FL2 was in no distress, the surveyors concluded that the nurses simply did not recognize or were unaware of FL2's pain and thus made no intervention. CMS Ex. 2, at 17. The surveyors do not specifically state why they reject the contemporaneous nursing notes, but the only possibly contradictory evidence I identify is the March 1st OT note which indicates that FL2 complained of sacral pain while seated in a wheelchair and a March 17, 2004 interview of an occupational therapy aide. The surveyors apparently read the March 1st OT note as a current complaint of pain even though the note itself clearly indicated that FL2 was refusing to get out of bed at the time and was not even sitting in her wheelchair. Regarding the interview with the OT aide, the only record of the interview between the surveyor and the OT aide is the surveyor's note at CMS Ex. 23, at 77. The surveyor's note indicates that the aide confirmed FL2 was in bed and not in her wheelchair when approached by the aide on March 1st. The surveyor's note does not indicate that the aide said FL2 was experiencing pain, but does indicate the aide could not remember which nurse she spoke to regarding FL2's pain. The aide's calendar book simply indicated that FL2 refused OT on March 1 at 4:00 PM stating, "I just want to get my ass fixed so that I can get out of here." CMS Ex. 23, at 77. The summary in the SOD is misleading to the extent it indicates that the aide said that FL2 refused to participate and complained of pain and that the aide said she reported the complaint of pain to the medication nurse. The surveyor's rejection of the contemporaneous nursing notes from March 1, 2004, which consistently indicated no distress throughout that day, in favor of the vague recollection of the OT aide more than two weeks later and the surveyors vague notes of the conversation with that aide is unreasonable. The weight of the evidence is that FL2 was in no distress on March 1, 2004; thus, there was no need for further intervention by Petitioner's staff to mitigate pain. The weight of the evidence is that FL2 was not motivated to participate in OT, she had the right to refuse to participate in OT, and she did refuse to participate so she was dropped from OT. Thus, there is no factual basis for alleging a violation of 42 C.F.R. § 483.25.

I also am satisfied that there was no failure by Petitioner to provide FL2 "necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being" as required by 42 C.F.R. § 483.25, with regard to pain control in general. My review of FL2's clinical records, particularly those at P. Exs. 151, 152, 153, 154, 155, 155A, 157, 158, 159, and CMS Ex. 23, shows that FL2 was assessed for pain and care planned for managing her chronic complaints of pain from various locations including the ulcer on her coccyx, low back pain, right hip pain, and general discomfort. FL2 was regularly administered Tylenol for complaints of pain. Despite her history of respiratory failure and ventilator dependence, she was administered the narcotic, Percocet, a combination of Oxycodone (the narcotic) and Actaminophen. The Duragesic Transdermal System, which administers an opiod narcotic through a skin patch, was also attempted, but discontinued due to lethargy. (18) The records also show that staff used other interventions, such as repositioning and distraction, to help mitigate FL2's complaints of pain. In most all instances, pain control was accomplished through use of Percocet and Tylenol and, though self-reported levels of pain were not always reduced to 0 on a scale of 1-10, they were reduced to manageable levels.

Accordingly, I conclude that no violation of 42 C.F.R. § 483.25 (F309) is established with regard to Example B.

c. Example C - The allegation that Petitioner failed to assess Resident SV5 upon his return from a failed colonoscopy and did not disimpact him until four days later.

CMS alleges regarding this example that 42 C.F.R. § 483.25 (Tag F309) was violated because Resident SV5 was not assessed upon his return from a failed colonoscopy and he was not disimpacted. Petitioner responds that SV5 was assessed by his treating doctor upon return from the failed colonoscopy and that there was no fecal impaction.

It is not disputed that SV5 is a a fifty-two year old male in a vegetative state with diagnoses including traumatic brain injury and quadriplegia with spasticity. SV5 is fed through a tube in his stomach and suffers from nuerogenic bowel (due to nerve disfunction there is not normal motility (CMS Ex. 34, at 165; Tr. 842-844). He is incontinent of bowel and bladder with a urinary catheter, and has a large decubitus ulcer from his spine to his anus. On March 1, 2004, SV5 was sent out for a colonoscopy at the local hospital at approximately 9:30 AM. SV5 was returned to Petitioner on March 1, 2004 with no colonoscopy having been done. The gastroenterology report from Kingston Hospital dated March 2, 2004, shows that as the doctor was preparing to do the colonoscopy, it was discovered that SV5 "had some solid stool emanating from the rectum. Digital exam showed him to be completely impacted with formed stool, and it was felt that a colonoscopy would be futile in this setting." P. Ex. 166, at 1. A hand written note dated March 1, 2004, to Dr. Melcer from the gastroenterologist indicates that if the colonoscopy is still desired SV5 needed to be reprepared with enemas and disimpaction. Id. at 2.

The surveyors allege that: (1) SV5 was not assessed by Petitioner's staff until about 10:00 PM on March 1, 2004, several hours after his return from the hospital; and (2) SV5 was not disimpacted until March 5, 2004. After reviewing all the evidence, I conclude that the surveyors misinterpreted the facts.

As a general proposition, when there is no documentation of an action by a long-term care facility's staff, we infer and presume that the action was not done. In this case, nurses notes for SV5 show that he was prepared for a colonoscopy on February 29, 2004. He was assessed at 8:00 AM on March 1 and at 9:30 AM he was taken by ambulance to the hospital for a colonoscopy. The next entry dated March 1, 2004 bears no time but states: "NO-resume all meds as before colonoscopy." The next timed entry is 10:00 PM on March 1 when SV5 was assessed. P. Ex. 162, at 11. Thus, the surveyors are correct that there is no nursing note that says SV5 was returned from the hospital and that his vital signs were taken. This triggers the inference that no assessment was done. However, an inference or presumption is subject to being rebutted, as it is in this case.

Surveyor Kosherzenko interviewed Dr. Melcer during the survey. He told her that he saw SV5 after his return from the colonoscopy, that he determined that SV5 was not impacted, even though he did not do a digital examination, and he did not do a progress note. CMS Ex. 34, at 75. Surveyor Kosherzenko interviewed the charge nurse, Peggy Lee, who was on duty when SV5 was returned on March 1. Ms. Lee said that she would normally assess a resident on return to the facility, but she did not in this case and she could not explain why. Id. at 67-68. The fact that Ms. Lee did not do and record the assessment is consistent with her knowing that Dr. Melcer did the assessment. I note the untimed entry in the nurses notes for March 1, 2004, which records the order to resume the same medications as before the colonoscopy is also consistent with Dr. Melcer seeing SV5 and giving a verbal order to resume medication. P. Ex. 162, at 11. Dr. Melcer testified at hearing that he assessed SV5 upon his return from the hospital on March 1, 2004, including visual inspection, palpation of the belly, auscultation and percussion, and the ambulance attendant gave him SV5's vital signs. Dr. Melcer testified that he did not document his assessment at the time, but created a later note. Tr. 861- 863. Dr. Melcer's testimony is unrebutted and is consistent with Ms. Kosherzenko's recollection of her interview of Dr. Melcer during the survey and just a couple weeks after SV5's failed colonoscopy. Dr. Melcer's conducting the assessment upon SV5's return also explains why Ms. Lee, who would normally do the assessment, did not do so on this occasion. Further, Dr. Melcer doing the assessment is consistent with the untimed nurses note that records the order to resume medication. I find Dr. Melcer's testimony on this point credible and conclude that Dr. Melcer did assess SV5 upon his return from the hospital on March 1. Accordingly, I conclude that there is no factual basis for the surveyors allegations that no assessment was done.

I also find unsupported, the surveyors factual conclusion that SV5 was suffering a fecal impaction upon his return from the failed colonoscopy on March 1, 2004. Dr. Melcer testified at hearing that he did not make a note of his assessment of SV5 on March 1, 2004, because there was no clinical event occurring, i.e. SV5 was not impacted. (19) Tr. 845-850, 864. Dr. Melcer tesitified that there were no clinical signs or symptoms consistent with fecal impaction and he concluded the gastrointerologist, Dr. Steckman, who reported fecal impaction, simply incorrectly used that phrase. Tr. 850. Dr. Melcer testified that someone passing stool is not impacted. Tr. 851. Dr. Hodder, Petitioner's medical director, testified that he was very concerned about the suggestion of the gatrointerologist that SV5 was impacted so he contacted Dr. Steckman who advised him that he did not mean in his report that SV5 was impacted, all he meant to convey was that there was stool in the colon. Tr. 372-373. (20) Surveyor Kosherzenko described fecal impaction during her deposition and tesitified that if someone is impacted, only a little watery stool might seep around the impaction. Tr. 64-65. However, Dr. Steckman's report about the attempted colonoscopy and his hand written note both indicate that when SV5 was rolled on his side, he had "solid stool emanating from the rectum." P. Ex. 166, at 1-2. A nurses note from February 29, 2004, the day before the attempted colonoscopy indicates that SV5 passed large amounts of loose stool following his preparation. P. Ex. 162, at 11. A nurses note from March 2, 2004, the day after the failed colonoscopy, indicates that SV5 was incontinent of bowel and bladder in bed. Id. at 12. The foregoing facts show that SV5 was not impacted either before, during, or after the attempted colonoscopy on March 1, 2004. (21)

The credible evidence shows that SV5 was assessed by Dr. Melcer upon his return from the hospital and the failed colonoscopy on March 1, 2004. The credible evidence also shows that SV5 was not suffering from impacted stool on March 1, 2004. Accordingly, I conclude that there is no factual basis for the surveyor's allegation that Petitioner violated 42 C.F.R. § 483.25 with respect to SV5.

d. Example D - The allegation that Petitioner failed to investigate whether Resident 1 was safe for self-administration of medication after the resident squeezed her intravenous bag.

The factual allegations in the SOD are that on March 5, 2004, Resident 1 was receiving an antibiotic through an IV bag attached to her Peripherally Inserted Central Catheter (PICC) intravenous line. (22) When the IV bag emptied faster than staff expected, Resident 1 was questioned and she admitted she squeezed the bag in an attempt to make it run faster. The ADON counseled Resident 1 about leaving the IV alone. The surveyors interviewed staff on March 17, 2004 and learned that no report was done on the incident. A social service staff member was interviewed by the surveyors on March 18, 2004; she had not been advised of the event, but was not concerned because the incident did not manifest any behaviors that would require a report. CMS Ex. 2, at 25-26; CMS Ex.17, at 6-7, 8, 10; P. Ex. 16, at 2-3.

This alleged deficiency is cited under Tag F309, 42 C.F.R. § 483.25. Thus, the issue is whether Petitioner provided "the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being" of Resident 1. The surveyors allege in the SOD, based upon the foregoing facts, that Petitioner failed in its duty to Resident 1 because: (1) Petitioner did not investigate Resident 1's tampering with her IV bag; and (2) Petitioner failed to determine if Resident 1 remained safe to "self-administer medications." CMS Ex. 2, at 26. In its post hearing brief, CMS argues that Petitioner failed to reassess Resident 1's ability to self-administer her medication. CMS Brief at 12. In its post hearing reply brief, CMS more clearly states that it does not allege that Petitioner's handling of the IV bag tampering incident was inappropriate; rather, it contends that the facility should have been "on notice that the resident's ability to self-administer her medications or treatments needed to be reevaluated." CMS Reply at 15. The CMS arguments seem to be that the care and services Petitioner failed to deliver was the reassessment and that that impacted Resident 1's ability to attain or maintain the highest practicable state. I perceive that there may be a legal issue here regarding whether the CMS allegations even amount to an allegation of a violation of 42 C.F.R. § 483.25. However, it is not necessary to engage in a lengthy legal analysis given that the facts of record do not show either a failure to investigate or assess.

The important facts that I have already set forth are not disputed and are consistent with Surveyor Roberson's testimony at her deposition. CMS Ex. 35, at 34-41, 75-82. Considering first the allegation of the surveyors that no investigation was done, I conclude that the surveyors were in error. CMS presented as evidence the nurse notes related to the IV bag incident from March 5, 2004 and a memorandum prepared during the survey by one of the nurses involved, which more fully explained what happened. CMS Ex. 17, at 6-8. The nurse note and memorandum indicate that after the incident was discovered, Petitioner's staff interviewed the resident, examined the equipment, reached conclusions about the true facts, and then made an intervention to remedy the problem. This was an investigation. CMS does not allege that there were undiscovered facts that might have changed the Petitioner's course of conduct. CMS does not point to any statutory or regulatory requirement for another form of documentation of the investigation that was conducted. CMS does not allege how the investigation was deficient and, in fact, CMS, in its reply brief, states that it does not allege at this point that the handling of the IV bag incident was inappropriate.

CMS is also in error regarding facts related to the assessment or reassessment allegation. First, Surveyor Roberson agreed during her deposition that Resident 1 was not self-administering medications via IV line. CMS Ex. 35, at 75-76. Second, it is undisputed that the IV bag incident occurred on March 5, 2004 at around 2:00 PM and the results of the inquiry or investigation as well as the intervention were entered into the nurses notes at that time. (23) CMS Ex. 17, at 5-6. Third, Dr. Melcer, Petitioner's house physician and Resident 1's treating physician, issued an order at 4:00 PM on March 5, 2004, two hours after the incident, authorizing Resident 1 to self-administer Fleet's enemas, to do her own colostomy and urostomy care, and to use her incentive spirometer as needed. (24) CMS Ex. 17, at 12. Given this sequence of events and the fact that Dr. Melcer was a house physician and treating source, it may be inferred that Dr. Melcer and staff were fully aware of the IV bag incident before the order allowing some self-care was issued. If this inference is correct, then the issue is what if any further assessment would be required? It is important to recall that CMS bears the initial burden to establish a prima facie case, i.e. to identify the legal criteria to which it seeks to hold Petitioner and the facts that allegedly show that Petitioner violated the legal criteria. Hillman at 8. CMS has two problems here: (1) CMS has not identified the legal requirement under 42 C.F.R. § 483.25 to do any assessment or how failure to assess on the facts alleged negatively impacted the resident attaining her highest practicable state (the legal issue I elected not to pursue in detail); and (2) CMS has failed to allege facts that lead to a different conclusion than that the order for self-care was issued by Resident 1's treating physician after and with knowledge of the incident. (25)

Accordingly, I conclude that there is no factual basis for the surveyor's allegation that Petitioner violated 42 C.F.R. § 483.25 with respect to Resident 1 and the IV bag incident.

I conclude as to all examples alleged by CMS as violations of 42 C.F.R. § 483.25 that no violation has been established for the reasons already discussed.

4. F311 - The alleged violation of 42 C.F.R. § 483.25(a)(2), which provides:

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.

(a) Activities of daily living. Based on the comprehensive assessment of a resident, the facility must ensure that--

(1) A resident's abilities in activities of daily living do not diminish unless circumstances of the individual's clinical condition demonstrate that diminution was unavoidable. This includes the resident's ability to-- (i) Bathe, dress, and groom; (ii) Transfer and ambulate; (iii) Toilet; (iv) Eat; and (v) Use speech, language, or other functional communication systems.

(2) A resident is given the appropriate treatment and services to maintain or improve his or her abilities specified in paragraph (a)(1) of this section . . . .

CMS advises its surveyors through the SOM that:

The intent of this regulation is to stress that the facility is responsible for providing maintenance and restorative programs that will not only maintain, but improve, as indicated by the resident's comprehensive assessment to achieve and maintain the highest practicable outcome.

SOM, App. P at PP-91.

Resident 32 is a quadriplegic, continent of bowl and bladder, but requiring assistance with using a bedpan. A nurse note (CMS Ex. 18, at 7) indicates that on March 12, 2004 at 9:00 AM, Resident 32 asked a certified nurse assistant (CNA) for a bedpan. The CNA told Resident 32 that it was not time for her to use the bed pan. Resident 32 reportedly responded "[w]ell I'll just pee the bed then" and she did. Resident 32's care plan dated January 1, 2003, shows that she was continent of bowel and bladder, that she could ask for toileting assistance, but that she preferred "to have a smoke before toileting and will wait until meal trays are delivered to have needs met . . . ." CMS Ex.18, at 8; P. Ex. 175, at 27. Interventions listed on the care plan included toileting and incontinence care every 3 hours and as necessary; providing the total assistance of 1 with an increase as necessary; and maintaining a toileting schedule, among other things. Id. Surveyor Albrecht, who was responsible for this deficiency citation testified that she discovered this incident on a records review and that she then interviewed the resident and staff. Surveyor Albrecht testified that the resident told her that she used the call bell to get someone to help her. The CNA who responded to the call bell went to ask whether Resident 32 could be toileted and when she returned, she advised Resident 32 that she had to wait until 10:00 AM. The resident then wet the bed. Ms. Albrecht could not say how quickly after the resident was told to wait that she wet the bed. Ms. Albrecht also did not testify to when the resident was last toileted. Ms. Albrecht testified that in her opinion it was unreasonable to require the resident to wait when she had just had breakfast, but she did not point to any evidence that Resident 32 had actually had breakfast. In Ms. Albrecht's opinion, toileting when necessary, as used in this care plan, meant when the resident asked. Ms. Albrecht also testified that Resident 32 ended up lying in her own urine, but when pressed she had no information as to how long before Resident 32 was attended to. Ms. Albrecht testified that Resident 32 told her that she was uncomfortable physically and emotionally as a result of the incident. Ms. Albrecht testified that she was told by staff that Resident 32 was told to wait because they were serving breakfast and had no time to toilet her. Ms. Albrecht did not testify whether, in accordance with Resident 32's care plan, she was also requesting to smoke before she used the bed pan, which seems to have been a usual pattern given the fact that it was actually care planned. Tr. 203-217. On cross-examination, Ms. Albrecht testified that she was informed that Resident 32 had agreed to her toileting schedule but had made a practice of insisting upon toileting at different times than agreed to. Tr. 220.

The surveyor's allege that these facts constitute a violation of 42 C.F.R. § 483.25(a)(2), because the denial of assistance to Resident 1 with toileting impacted her achieving the highest practicable level of well-being. CMS Ex. 2, at 27. Although Ms. Albrecht alluded to Resident 32's dignity, this incident was not alleged to be a violation of the resident's right to dignity or as neglect.

My understanding of the facts is that Resident 32 asked to use the bedpan at a time different than that provided on her care plan. Rather than simply assist the resident, the CNA went to ask permission from a nurse, which is consistent with there being a care plan and the CNA being aware of the care plan. Resident 32 held her urine until the CNA returned and advised her that she had to wait for approximately an hour. The resident is continent and has the ability to control her urine and, in fact, the care plan provides for her to be taken to a smoking area to smoke before using the bedpan. The surveyor did not develop evidence for me regarding when the resident last urinated, when the resident had breakfast, or what she had for breakfast, so I can make no finding regarding the urgency of the resident's request to urinate and decline to do so based upon the surveyor's speculation. Given the evidence before me, I have no basis to conclude that Resident 32 released her urine in an uncontrolled fashion, but simply intentionally "peed the bed" as reflected in the nurse's note.

The issue is whether these facts show that Petitioner violated its responsibility "to provide maintenance and restorative programs that will not only maintain, but improve, as indicated by the resident's comprehensive assessment to achieve and maintain the highest practicable outcome" - the intent of the regulation as articulated by CMS in the SOM. The SOM instructs surveyors to make this determination by addressing these questions:

Was the care plan consistently implemented? What changes were made to treatment if the resident failed to progress or when initial rehabilitation goals were achieved, but additional progress seemed possible?

SOM, App. P at PP-91. Certainly, the care plan was implemented to the extent that Petitioner's staff attempted to comply with the agreed to toileting schedule rather than simply toileting on request. There is no suggestion that Resident 32 failed to progress or that there was a need to reassess or change her rehabilitation goals due to this incident. CMS has not shown that this incident had any adverse impact upon Resident 32's toileting ability. Accordingly, I conclude that there is no violation of 42 C.F.R. § 423.25(a)(2), given the facts.

5. F324 - The alleged violation of 42 C.F.R. § 483.25(h)(2), which provides:

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--

* * * *

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

The Board has been consistent in its interpretation of this regulatory requirement. This regulation does not make a facility strictly liable for accidents that occur. The regulation does require that a facility take "reasonable" steps to ensure that a resident receives supervision and assistance devices designed to meet the resident's assessed need and to "mitigate foreseeable risks of harm from accidents." Woodstock Care Center, DAB No. 1726, at 26-27 (2000), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003). After considering the drafters rational in the preamble for the regulation, the Board in Woodstock elaborated that while facilities are not "unconditional guarantors of favorable outcomes," they do have an "affirmative duty to provide services . . . designed to achieve those outcomes to the highest practicable degree." Id. at 28 (citing 54 Fed. Reg. at 5316, 5332 (Feb. 2, 1989). See Florence Park Care Center, DAB No. 1931 (2004); Northeastern Ohio Alzheimer Research Center, DAB No. 1935 (2004). However, the Board also recognized in Woodstock that the current focus of the regulation of long-term care facilities is actual facility performance in meeting program goals or purposes, and facilities have the flexibility to use a variety of methods to achieve the required results. Woodstock at 28-29. There is no dispute that Woodstock is applicable to the case before me. There is also no dispute as to the key facts. The issue is whether Petitioner's conduct met the requirements of the regulation as elaborated upon by the Board in Woodstock, i.e., whether Petitioner took reasonable steps to mitigate foreseeable risks of harm to its residents in the two examples cited in the SOD. The CMS allegation is that Petitioner did not do enough to supervise Residents FL11 and SV3 to protect other residents such as Residents 57 and RV8. CMS Brief at 13.

Two residents are the focus of Example 1 under F324, Resident RV8 and Resident SV3.

a. Example 1 - Resident RV8

It is alleged in the SOD that RV8 suffered from the residuals of a traumatic brain injury and was diagnosed as suffering pre-senile dementia. He had severely impaired cognitive skills and moved about with no rational purpose and was deemed to be oblivious to needs or safety. He was assessed as being at risk for victimization and lived on the locked NBI unit where he was subject to visual checks every 15 minutes. It is alleged in the SOD that Petitioner's records indicate that on February 25, 2004, RV8 was pushed to the floor and choked by an unidentified aggressor. On March 3, 2004, RV8 was struck and his glasses were broken after he took food from Resident FL20. Petitioner's staff noted on RV8's care plan that he was to be seated separate from FL20 during meals. Surveyor Roberson, who wrote the deficiency finding as to RV8, testified that separating FL20 and RV 8 at meals was an appropriate intervention. CMS Ex. 35, at 51. On March 5, 2004, RV8 was reported to have been choked by an unidentified resident. On March 8, 2004, RV8 was found with two abrasions on his forearm from an unknown cause. RV8's treatment team met on March 10, 2004, and decided to obtain more information about RV8 from his Cognitive Behavioral Technician (CBT). On March 15, 2004, at 7:15 AM, RV8 was involved in an altercation with Resident SV3 and sustained a superficial skin tear on the bridge of his nose. Petitioner's records show that RV8 was placed on increased supervision for prevention and he was continued on his current care plan pending treatment team review. At 10:00 AM on March 15, 2004, RV8 was assaulted by SV3 and sustained a laceration to his cheek. CMS Ex. 2, at 28-30. Ms. Roberson noted that both RV8 and SV3 were on the locked unit and subject to 15-minute visual checks. She opined that Petitioner could have placed RV8 on one-to-one or close visual observation to better protect him. CMS Ex. 35, at 53-54.

Ms. Roberson's surveyor notes and copies of records she took from Petitioner's files related to RV8 are at CMS Ex. 19. Petitioner also provided me copies of some of RV8's records. According to his records, RV8 was 41 years old at the time of the survey and was admitted to Petitioner's facility in May 1999. His diagnosis included cerebral dysfunction due to traumatic brain injury, a seizure disorder, personality disorder, impulse control disorder, a history of substance abuse, and various skin problems. P. Ex. 180. RV8 had a behavior care plan dated June 5, 2003 and updated through March 11, 2004. Problems addressed were RV8's inappropriate touching, invading peers' space, wandering into peers' rooms, risk for elopement, and his physical aggression including spitting, punching, and chasing others. RV8's problems also included stealing, appearing naked in public areas, and attempting to kiss female staff. Interventions included, a Wanderguard; calling the resident by name, approaching slowly while explaining in simple terms what was needed or required; approaching slowly and assessing the resident's mood prior to being within arms reach; greeting the resident verbally and saluting rather than actually touching; speaking to the resident in a calm manner and maintaining personal space; sending the resident for a psychiatric evaluation as needed; redirecting the resident to his own room when needed; praising the resident for positive interactions; and encouraging resident to participate in unit activities. One incident of RV8 punching a CBT is recorded on June 30, 2003. The determination is made repeatedly by the treatment team that the interventions are effective and to be continued with RV8 housed in the locked unit for his and others safety. P. Ex. 182, at 1-2. RV8's victimization/elopement care plan was admitted as P. Ex. 182, at 7-8 and CMS Ex. 19, at 9-10. The problem noted in the care plan dated November 3, 2003 and updated through March 11, 2004, is that RV8 is at risk for victimization due to inappropriate touching, wandering, and invading peers' space. RV8 is at risk for elopement due to confusion, lack of useful self-awareness and wandering. The victimization/elopement (26) care plan includes 17 interventions: staff to monitor for signs or symptoms of victimization; staff will observe interactions with peers and remove RV8 from over-stimulating environments; staff will document episodes of victimization in accordance with facility policy and procedures; staff will praise/positively reinforce all positive/appropriate interactions; staff will encourage to engage in programs and activities; staff will observe for changes in mood/affect/behavior; psychiatric evaluations will be done as necessary; staff will allow RV8 time to express feelings regarding incidents of victimization; RV8 will wear the Wanderguard at all times; RV8 will be supervised at all time when off the unit; staff will redirect RV8 from unit doors when necessary; RV8 will be encouraged to salute or put hands in pockets; a discontinued intervention was for staff to keep RV8 three feet from other residents at all times; RV8 is to have a snack with other residents to decrease inappropriate touching and invading others space; as of December 15, 2003, staff would encourage RV8 to move away from other neighbors as they pass in the hallway; as of February 10, 2004, RV8 was not to sit at the dining room table with resident DB; and as of March 3 or 4, 2004, RV8 was to be seated a few tables away from DB in the dining room. P. Ex. 182, at 7. The evaluation/comments page of the care plan documents 14 separate incidents in which RV8 was assaulted by other residents between November 1, 2003 and March 15, 2004. It is also documented that the care plan was reviewed regularly by RV8's treatment team including regular psychological reviews. Id. at 8. RV8's psychotropic medications included Seroquel, Thorazine, Ativan, and Depakote, all related to his impulse control disorder. Id. at 13. A March 3, 2004, event report shows that another resident struck RV8 for taking a third resident's piece of cake. The recommended intervention was to keep the residents separated. P. Ex. 183, at 1-2. An event report for March 5, 2004, indicates that RV8 was choked (P. Ex. 184, at 1). However, the witness statement related to that event report indicates that the witness saw another resident with his hands at RV8's throat, but there was no struggling and no apparent distress. Id. at 7. An event report for March 15, 2004 indicates that RV8 was choked by another resident at 7:45 AM - RV8 had apparently been trying to enter the other resident's room. RV8 suffered a skin tear on the bridge of his nose when his glasses were knocked from his face. The recommended intervention was to continue with the current care plan until reviewed by the case management team. P. Ex. 185, at 1-2, 4-5. Later, at about 10:00 AM on March 15, 2004, RV8 was struck again by the same resident who choked him earlier in the morning. RV8 suffered a laceration on his cheek. The proposed intervention was to continue the current care plan until the case management team could meet. P. Ex. 186, at 1-2 . For each of the event reports there is also a form that indicates that RV8 was placed on 72-hour charting to assess for adverse reactions; RV8 was placed on increased supervision for prevention; family was notified; social work was notified; and the care plan was reviewed and interventions revised and updated. P. Exs. 183, at 4; 184, at 5; 185, at 6; 186, at 4. An Interim Interdisciplinary Team Meeting Summary dated March 10, 2004, reflects that RV8 was found on March 9 with two abrasions on his forearms of unknown cause. The team decided to initiate pet therapy, possibly off the unit, depending upon input from RV8's CBT escort. It was also decided that RV8 remained a danger to himself and others and would continue to reside on the locked unit. P. Ex. 190. Social work progress notes from March 22, 2004 indicate that RV8 was involved in another resident to resident incident that placed him at risk and it was decided to place him on close visual observation (CVO). CVO was continued on March 26, 2004. On April 1 and 2, 2004, it is reported that RV8 was physically aggressive with his CBT with continuing agitation. P. Ex. 188, at 2.

b. Example 1 - Resident SV3

It is alleged in the SOD that SV3 suffered from the residuals of a head injury, dementia, psychosis, depression, and seizures. During his seven-day assessment, upon which his MDS with a reference date of March 10, 2004 was based, SV3 was noted to be physically abusive and socially inappropriate/disruptive one to three times. SV3 was reported to have choked a resident on March 13, 2004. The incident report included a recommendation for a psychiatric review and Depakote. An order for Depakote was written on March 15, 2004. SV3's care plan did not list other interventions after the March 13 choking incident. On March 15, 2004, SV3 was reported to have choked and hit RV8 in two separate incidents, hours apart. CMS Ex. 2, at 31-33. Surveyor Michele Clinton testified for CMS regarding findings related to SV3 under F324. Ms. Clinton testified that on March 13, 2004, SV3 had an altercation with another resident and interventions were recommended by staff at that time. Then, on March 15, 2004, SV3 assaulted RV8 at 7:15 AM and again at 10:00 AM, both times causing injury to RV8. SV3 had a history of aggressive or assaultive behavior according to Ms. Clinton. CMS Ex. 25 includes Surveyor Clinton's notes and other documents she relied upon to make her findings and conclusions. SV3 was a resident on the locked NBI unit and subject to 15-minute visual checks. Ms. Clinton testified that she cited a deficiency related to SV3 because he did not have sufficient supervision to prevent him from harming another resident. Ms. Clinton determined that at the time of the survey, SV3's order for Lithium was on hold and he was being given Depakote. After the March 13 incident, there was a recommendation that SV3's Depakote be increased and for a psychiatric evaluation or review that was not done until after the incidents with RV8 on March 15. SV3 was also seen by social work on March 16. Ms. Clinton clarified, on my questioning, that her allegation under F324 included both a failure to supervise SV3 and to implement recommended interventions. Ms. Clinton testified that Petitioner's nurses notes indicate that after the March 13 incident, SV3 was continued on 15-minute checks on the closed unit, but no psychiatric review or increase in medication was accomplished until after the incidents with RV8 on March 15. Surveyor Clinton opined that a psychiatric review and increased medication should have been accomplished, as recommended, immediately after the March 13 incident and that SV3 should have been placed on close visual observation. Ms. Clinton noted that after the 7:15 AM incident with RV8 on March 15, Petitioner did not take action before the 10:00 AM incident. Tr. 267-289. SV3's MDS with a reference date of February 27, 2004, shows that during the seven-day evaluation period SV3 displayed both physically abusive and socially inappropriate and/or disruptive behavior, but also that he was at ease interacting with others with no unsettled relationships. CMS Ex. 25, at 8, 10. Nurses notes dated March 14, 2004, include a late entry for March 13, 2004 that at 6:15 AM on March 13, an agitated resident yelled at SV3; SV3 grabbed the other resident by the neck; and SV3 was thrown to the floor by the other resident, but on assessment there were no signs or symptoms of injury to SV3. SV3 claimed to have hit the other resident. Id. at 16. The nurses notes reflect that on March 15, 2004 at 7:15 AM, SV3 choked another resident (RV8) who was trying to enter his room. SV3 refused to have his vital signs taken. RV8's glasses were knocked off during the incident, causing a skin tear. The nurses notes included the language "(s)cheduled TBS by MD, Will continue to monitor." Id. at 17. No definition of TBS was provided. A nurses note dated March 15, 2004 with a time of 12:30 PM, indicates that at 10:00 AM, SV3 struck another resident (RV8) without provocation. SV3 was given Risperdal which he was authorized to receive, as necessary. SV3 was also scheduled for "TBS" by a physician and counseled about different methods for dealing with his frustrations. At 1:30 PM on March 15, 2004, SV3 was seen by Dr. Shutzman (27), who discontinued his Lithium and increased his Depakote to 500 mg three times per day. Id. at 18. The notes indicate that SV3 was given increased attention and there were no further incidents of aggression through March 16. Id. On March 17, 2004, SV3 punched the wall in his room, but he was calmed by increased attention. SV3's treatment team recommended giving him a communication board to help reduce his aggression and frustration with his garbled speech and attendance at Alcoholics Anonymous. Id. at 19. The event report for the March 13, 2004 incident is consistent with the nurses notes and includes the recommendation for prevention of a psychiatric review and increased Depakote. Id. at 21-22; P. Ex. 201. The event report also indicates that, at the time of the incident, SV3 was on increased supervision and had been last checked at 6:00 AM. CMS Ex. 25, at 24. SV3's behavior care plan dated September 16, 2003 and updated through March 15, 2004, indicates a goal of stabilizing his mood and behavior with no assaultive behaviors for 30 days. Interventions include: 15-minute checks; redirection from groups if there are signs of agitation; redirecting him to his room when he becomes agitated; listening actively while he is allowed to express his feelings; maintaining him at arms distance and directing him to a quiet area when he makes statements indicating potential for aggressive acts; reporting all changes of mood, affect behavior, confusion or physical complaints to the charge nurse 100 percent of the time; providing a picture card that he should use when frustrated or angry; providing him a paper and pen to aid communication; and placing a stop sign at his door. The evaluation/comments section of the care plan shows that between September 28, 2003 and March 15, 2004, SV3 was involved in 12 or more incidents of aggression. His behavior care plan was modified in December 2003 to include new interventions. On about December 22, 2003, he was transferred to the secure unit and monthly reviews concluded that he should remain on the unit as he continued to be a danger to himself and others. On March 8, 2004, the week before the survey, the treatment team decided to continue with the behavior care plan as written. The March 13, 2004 assault is recorded, as is the psychiatric review on March 15, with a note that Depakote was increased due to aggression. Id. at 28-29; CMS Ex. 38; P. Ex. 208, at 3-4. The Victim Form dated March 13, 2004, which is part of the event report, indicates that SV3 was placed on 72-hour charting to assess for adverse reactions; was placed on increased supervision for prevention; the care plan was reviewed; the altercation was listed on the nursing report; the social worker was notified; and a team meeting was scheduled. CMS Ex. 25, at 30. The resident event form for the March 15, 2004 assaults on RV8 was admitted as CMS Ex. 37. The recommendation for prevention related to the 7:15 AM incident was to continue the current care plan until the team could review and for review by Dr. Schutzman on March 15. As with the March 13 event form, the March 15 event form indicates that SV3 was under increased supervision but he was also under the direct view of staff at the time of this incident. CMS Ex. 37, at 3. The aggressor form indicates that SV3 was placed on increased supervision for 72 hours to stop and prevent further incidents; an investigation was conducted with interviews and statements. The recorded staff intervention was separation of the residents. The form also indicates the social worker was notified within 24 hours and the care plan was reviewed. Id. at 5. The 10:00 AM incident included recommendations for prevention similar to those for the earlier incident. Id. at 9; P. Ex. 202. SV3 was on increased supervision and had last been checked at 9:45 AM. CMS Ex. 37, at 10. The aggressor forms indicates interventions similar to those on the earlier form, except that SV3 stopped the assault himself and returned to his room when RV8 fell to the floor. Id. at 12. A social work progress note dated March 16, 2004 reflects the altercations of March 15; that efforts to counsel were unsuccessful; and that SV3 was to be presented to the team on March 17 and the doctors on March 19. CMS Ex. 36, at 1. A social work note dated March 18, records that the team did its monthly review on March 17, determined the number one cause for SV3's frustration and recommended referral to CMC (no definition provided) and speech. Id. Psychiatry progress notes show that SV3 was seen on March 9, 2004, and SV3 was friendly, but confused. Id. at 2. SV3 was seen on March 15, 2004, and it is noted that he has had increased aggression since his Lithium was held. Doctor Schutzman ordered that Lithium be discontinued and Depakote be increased. Id. at 2. A physician progress note dated March 19, 2004 shows that SV3's treating physicians met as a group on March 19, and based on his unpredictable aggression, assaulting other residents, punching walls, and being upset, ordered: a neurology consult; neuropsychiatric evaluation; and anger management group. It also was ordered that SV3 continue on the same medications and continue on the locked unit for his and others safety. Id. at 3. A psychotherapy service note, dated March 30, 2004, indicates SV3 agreed to participate in the anger management group. P. Ex. 207, at 2.

The two residents involved in example 2 under Tag F324 are FL11 and Resident 57.

c. Example 2 - Resident FL11

The surveyors allege that Petitioner failed to adequately supervise FL11 to prevent him from verbally and physically assaulting other residents. It is alleged in the SOD that FL11 suffers from a traumatic brain injury, hepatitis C, and an organic personality disorder. According to his MDS from January 2004, he was 6 feet 2 inches tall and weighed 325 pounds in early January 2004, but by February 1, he had gained 14.9 pounds and weighed approximately 340 pounds. CMS Ex. 34, at 81. The resident's MDS did not reflect any mood or behavior issues. The resident's care plan dated January 5, 2004 did indicate that he had a history of physical, verbal and sexual behaviors, and he spits. FL11 was transferred from the TBI-2 unit to the TBI-5 unit on February 13, 2004, because staff felt he would benefit from a less restrictive environment. Nurses notes from February 3 and 4, 2004, indicate that FL11 made several sexually inappropriate behaviors toward staff and he threatened to punch another resident in the face. Notes from February 10, 2004 indicate that FL11 continued to make sexually inappropriate behaviors toward staff. The move from TBI-2 to the less restrictive TBI-5 is recorded on February 13. On February 15, 2004, FL11 found another resident in his bed who he threatened to hit. When the other resident was removed, FL11 demanded that his sheets be changed and the nurse complied. However, when FL11 demanded that his comforter be washed, the nurse told him he needed to wash his own laundry. FL11 then cursed at the nurse and spit in the nurse's face. On February 16, 2004, FL11 was observed in the laundry room yelling and cursing at another resident. A nurse and CBT encouraged FL11 to leave the area and he went to his room. The resident receiving the cussing from FL11 told staff that FL11 wanted to use the washer, but when he was told that it was already in use, FL11 went off. Notes from February 18, 2004, indicate that FL11 was to have a psychiatric consult for aggressive behaviors. The psychiatric consult occurred on February 19, 2004 and resulted in an order for an increase of Inderal to 40 mg., four times per day. The note from the psychiatric consult also indicates that a mood stabilizer might be appropriate in the future to control explosivity. A note from February 28 indicates that FL11 asked for a hearing aid battery and became very upset when none was available. A March 4, 2004 occupational therapist report indicates that FL11 asked for a room change because his roommate smelled and, if he did not have a room change, he would do something about it. A March 4, 2004 physicians order directed FL11 back to the more restrictive TBI-2 and ordered a psychiatric consult and medication evaluation. The interdisciplinary team meeting summary for March 4, 2004, indicated that FL11 had a problem with verbal aggression. Team actions included returning FL11 to a more structured environment (TBI-2), social work counseling, and psychiatric consult, with a goal of reducing his verbal aggression. The transfer to TBI-2 occurred around 6:00 PM on March 4, 2004. On March 5, 2004, FL11 cursed at a nurse. Notes from March 7, 2004, indicate that FL11 was involved in a physical altercation with another resident in the elevator. FL11 was redirected from the area. When FL11 asked a CBT for a cigarette, which the CBT denied, FL11 cursed at him. FL11 also slammed the rear door hard enough to dent the wall with the door handles. FL11 then reportedly threatened another resident. The nurse practitioner ordered that FL11 be transferred to the hospital emergency room for evaluation. The hospital cleared FL11 medically and psychologically and he was returned to TBI-2 shortly after midnight on March 8, 2004. It is alleged in the SOD that FL11 saw Petitioner's psychiatrist on March 8, 2004, pursuant to the order of March 4, 2004. The psychiatrist ordered an increase of Inderal to 60 mg., four times per day. An interim multidisciplinary team meeting summary from March 8, 2004 shows that the team met, determined that kindness and positive communication are necessary with FL11. The team also concluded that FL11 was not being effectively served and decided to request a psychology referral and a telephone conference with FL11's mother. The team planned to reevaluate after getting input from the two sources. (28) The SOD alleges that on March 8, 2004 at 2:25 PM, FL11 verbally and physically assaulted Resident 57 in the laundry room which resulted in an emergency being called in the facility. The incident related to the use of a dryer in the laundry room. FL11 became angry, tipped Resident 57's wheelchair (without dumping her), he spit on her, cursed at her, and spilled a cup of coffee on her. An order was issued for FL11 to be sent to the hospital and he was placed on close visual observation until the transfer was to occur (as noted hereafter, the transfer was cancelled). FL11 was maintained on close visual observation. FL11 did not receive the psychology referral recommended by the team on March 8, until March 17. The psychology consult recommended continuing close visual observation and return to the locked unit, if violence occurs.

Surveyor Kosherzenko made the observations and drafted the deficiency citation related to FL11 and Resident 57. She testified that Petitioner was cited for failure to supervise FL11 and protect other residents from his verbal and physical assaults. CMS Ex. 34, at 82. Ms. Kosherzenko expressed concern about FL11's move from TBI-2 to the less restrictive TBI-5 given his history of being sexually inappropriate with staff and having threatened to hit another resident. She speculated that FL11's treatment team must not have had the information about FL11's conduct when the team decided that he might benefit from the less restrictive environment of TBI-5. CMS Ex. 34, at 84-87. (29) Surveyor Kosherzenko expressed concern that after the events of March 7, 2004, Petitioner did not do anything to protect the other residents from FL11. More specifically, Ms. Kosherzenko did not think it sufficient that within less than a 24-hour period, FL11 was sent out to the emergency room for a psychiatric evaluation, his medication was increased, he had a psychiatric consult done in the facility, and his treatment team had met and decided to do a psychology referral and to get FL11's mother involved. Ms. Kosherzenko opined that Petitioner's staff should have done the behavior plan recommend by the hospital (30) and that FL11 should have been placed on 15-minute checks or close visual observation. CMS Ex. 34, at 98-105, 113. Ms. Kosherzenko indicated on cross-examination that the key date for her regarding this deficiency was March 7, and on that date Petitioner should have put in place some type of "behavioral plan to help protect other residents from that resident." (31) CMS Ex. 34, at 179.

Clinical records of FL11 are found in CMS Ex. 26 and P. Exs. 210-217. FL11 was admitted to Petitioner on December 30, 2003. He suffered from a traumatic brain injury due to a fall down a flight of stairs; he had a history of pneumonia, verbal abuse, sexually inappropriate behavior, physical aggression, and heroin abuse; he suffered from hypertension, obesity, organic personality syndrome, a depressive disorder, the late effects of his intracranial injury, hepatis C (including a history of hepatic coma), psoriasis, an impulse control disorder, personality disorder, and probable dementia. FL11's initial housing placement was on TBI-2. P. Ex. 210, at 1-2. FL11's MDS, with a reference date of January 5, 2004, indicates no behavioral problems noted during the assessment period. FL 11 was at ease interacting with others and had no unsettled relationships. CMS Ex. 26, at 8. FL11's therapeutic activities care plan dated January 12, 2004 notes that he has a "history" of verbal abuse, sexually inappropriate behavior, and aggression, but, at the time of the plan, his strengths included that he was friendly and cooperative. P. Ex. 211, at 1. FL11 also had a care plan dated January 5, 2004 with the goal that he attain a respectable attitude with staff and peers with minimal or no inappropriate behaviors for 90 days. Interventions listed included monitoring his mood, allowing him to verbalize feelings, removing him from volatile situations, keeping the doctor informed of any changes in mood and behavior, giving medications and monitoring for effectiveness, keeping him busy with unit activities, permitting him to make individual choices when possible, social work counseling as necessary, a referral to CMC dated February 18, 2004, and psychiatric consults as necessary. CMS Ex. 26, at 14. A room change assessment form shows that FL11 moved from TBI-2 to TBI-5 on February 13, 2004 at his treatment team's January 26, 2004 request, for the stated reason that the team believed that FL11 would benefit from a less restrictive unit. Weekly resident adjustment assessments dated February 13 (the day of the transfer), February 20, and February 27, indicate that FL11 was adjusting well with no concerns. Id. at 16. Nurses notes from January 31, 2004 indicate that while in the dining room, FL11 asked a CBT whether he could have a kiss. The CBT declined and responded that that would be inappropriate and FL11 stated that it could be their secret. Id. at 18. A weekly summary from February 3, 2004, shows that FL11 remained restraint free and independent with activities. The summary indicates he had several sexually inappropriate behaviors toward staff, but no detail is provided. Id. A note dated February 4 indicates that on February 3, FL11 told another resident that if he did not shut-up, he was going to punch him in the face. Id. at 19. A weekly summary dated February 10, 2004, indicates that FL11 remained stable, restraint free, and independent with activities, but he continued to have several sexually inappropriate behaviors toward staff (no detail provided). Id. at 19-20. The nurses notes record the incident of February 15, 2004 at 10:30 AM when FL11 found another resident in his bed, threatened to hit the resident if he did not leave, and, when the nurse refused to wash his comforter, he became verbally abusive of her and spat on her. CMS Ex. 26, at 20-21. The notes also record the incident the next day, February 16 at 10:00 AM in the laundry room, when FL11 became verbally abusive of another resident because the washer was in use and staff defused the situation by having FL11 leave. Id. at 21-22. The weekly summary dated February 18, 2004, indicates that FL11 was still independent, but notes the two incidents summarized above. The note also indicates that the treatment team had discussed and orders were issued for a psychiatric evaluation and CMC. On February 19, 2004, FL11 was evaluated by the psychiatrist, Dr. Schutzman, who ordered the increase of FL11's Inderal to 40 mg. Id. at 23, 25. Dr. Schutzman's progress notes indicate FL11 was seen again on March 8, 2004, with another increase in Inderal to 60 mg., four times per day, and again on March 12, 2004, with another increase in Inderal to 80 mg., four times per day. Both notes indicate that FL11 should be referred to him as necessary. CMS Ex. 25, at 26; P. Ex. 214, at 2-3. A Interdisciplinary Team Meeting Summary dated March 4, indicates that FL11 was displaying increased verbal and physical aggression; noted that his Inderal had been increased; considered the confrontation with the nurse regarding his hearing aid and the interventions of repairing the hearing aid, the referral for a psychiatric evaluation and participation in occupational therapy; and determined a transfer to a more structured environment might reduce verbal aggression. CMS Ex. 26, at 38-39. Nurses notes from March 4, 2004 record that FL11 was to be transferred back to TBI-2 because he threatened doing something about the fact that his roommate smelled and the other verbal and physical threats during his stay on TBI-5. A note from March 5, 2004, at 2:00 PM, indicates that FL11 cursed at a nurse during breakfast. A note from March 7, 2004 at 5:00 PM, records the assault of FL11 upon another resident in the elevator, staff intervening and redirecting FL11 from the area, FL11 damaging the facility wall by slamming the backdoor handle into it, and cursing at a CBT for denying him a cigarette. A note from 6:30 PM on March 7, 2004, indicates FL11 was transferred to the hospital emergency room. Id. at 31-32; P. Ex. 212, at 1-3. Nurses notes dated March 8 show that FL11 returned from the emergency room about midnight and a nurse practitioner authorized the late administration of his medication. A note from 10:00 AM on March 8 shows that the nurse practitioner gave a telephone order for a psychiatric evaluation as a follow-up for aggressive behaviors. A note from 11:00, March 8 shows that Dr. Schutzman was in for his evaluation of FL11. At 2:25 PM on March 8, 2004, the emergency code was given due to FL11's assault upon Resident 57 in the laundry room. FL11 was placed under close visual observation. Although the note indicates FL11 was to be transferred to the hospital, that order was cancelled based on the nurse practitioner's discussion with the team. CMS Ex. 26, at 58. On March 9, 2004, a telephone order from the nurse practitioner was received for a neuropsychological evaluation. Nurses notes for March 9 and 10 show that FL11 was continued on close visual observation and there were no other instances of aggression. CMS Ex. 26, at 44-45; P. Ex. 212, at 4. An Interim Team Meeting Summary shows that the treatment team met on March 8, 2004 to consider the incident of March 7, 2004, decided to request a psychology referral and a telephone conference with FL11's mother. (32) It is not indicated what time the team met. CMS Ex. 26, at 51. Nurses notes for March 10 to 18 indicate that FL11 was maintained on close visual observation without incidents noted. Dr. Melcer did change FL11 from close visual observation to 15-minute checks for the 11:00 PM to 7:00 AM shift. On March 12, FL11's Inderal was increased to 80 mg., four times per day. Id. at 80; P. Ex. 212, at 5. Nurses notes from March 15 to March 24, 2004, indicate that close visual observation was maintained days and evenings with 15-minute checks during the night shift, with no behaviors noted. On March 19, 2004, Dr. Schutzman started Risperdal 0.5 mg., twice a day. Id. at 6. Social work notes show that FL11's team met January 26, February 4, February 18, February 23, March 3, March 4, and March 8, 2004. P. Ex. 213 ,at 1-3. The social work notes also reflect the revocation of FL11's previously issued perimeter pass, placement under close visual observation and the subsequent adjustment to include 15-minute checks at night, the involvement of his mother, the determination that he was having paranoid ideations, and that he had few behavioral issues after March 8, the increase of his medication, and the close visual observation. Id. at 2-4.

d. Example 2 - Resident 57

The surveyors interviewed Resident 57 who reported that she did not feel safe around FL11 and that she had reported her concern to the unit manager and social worker. The surveyors reported no other information regarding Resident 57. Surveyor Kosherzenko testified that it was Resident 57 who approached the surveyors and told them about her fear of FL11. CMS Ex. 34, at 82. Ms. Kosherzenko described Resident 57 as "not a little lady," in a low wheelchair, and unable to move below the waist. CMS Ex. 34, at 108. Resident 57 was not considered by either party to be an aggressor or requiring increased supervision.

There is little disagreement between the parties as to any of the facts I have set forth. The real dispute is whether or not the facts show a failure by Petitioner to supervise Residents RV8, SV3, and FL11. I set forth the facts in detail because the determination of whether or not the supervision provided the three residents met the regulatory requirement is fact specific. I conclude that in this case, as to the three Residents RV8, SV3, and FL11, they were adequately supervised consistent with legitimate and reasonable treatment decisions, weighed against the perceived risk for accidental injury to them or other residents.

The regulatory requirement is that each resident receive necessary care and services to attain or maintain his or her highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care, including adequate supervision and assistance devices to prevent accidents. The regulation does not impose strict liability upon a facility, but does require that a facility take "reasonable" steps to ensure that a resident receives supervision and assistance devices designed to meet the resident's assessed need and to "mitigate foreseeable risks of harm from accidents." Woodstock Care Center, at 26-27 (2000), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003). While facilities are not "unconditional guarantors of favorable outcomes," they do have an "affirmative duty to provide services . . . designed to achieve those outcomes to the highest practicable degree." But facilities have the flexibility to use a variety of methods to achieve the required results. Woodstock at 28-29. Woodstock recognizes, what is obvious from the statute and regulations -- that neither Congress, nor the Secretary purport to tell providers how to care for their patients and residents. Providers are free to determine what care and treatment is required for an individual patient or resident within the parameters established by the regulations. Some weighing and balancing is required in these treatment decisions; thus, the issue is whether a provider acted reasonably. For example, it is obvious that if a resident is physically or chemically restrained, or even placed on one-on-one visual observation as advocated by the surveyors in this case, there will be a significant reduction in the risk that the resident will suffer an accident or abuse another resident. However, while the goal of reducing the risk of accident as required by 42 C.F.R. § 483.25(h) may be served by restraining a resident, restraint may not be consistent with a resident attaining the highest practicable physical, mental, or psychosocial well-being as required by 42 C.F.R. § 483.25(h). Restraining a resident must also be weighed against such other considerations as the resident's right to be free from physical or chemical restraints not required to treat medical symptoms (42 C.F.R. § 483.13(a); the right to self-determination and participation (42 C.F.R. § 483.15(b)); and the right to have needs accommodated (42 C.F.R. § 483.15(e)), among others. The burden of doing this weighing and balancing falls upon the treatment team responsible for the care of the resident, not the government.

The CMS surveyors are responsible for assessing compliance with regulatory requirements. The surveyors in this case determined, with regard to 42 C.F.R. § 483.25(h)(2) (F324), that Petitioner knew that RV8, due to his conduct, was at risk to be victimized by other residents and that SV3 and FL11 had the propensity for aggressive acts and that such acts occurred despite the actions of the Petitioner to treat the residents, including supervising them. Each of the surveyors opined in testimony and it is clearly alleged in the SOD, that the surveyors believed that Petitioner should have been more aggressive with treatment of the three residents, particularly regarding increased supervision.

The issue as established by the Board in Woodstock, is whether Petitioner took reasonable steps with regard to each of the three residents. There is no dispute that Petitioner knew the propensity of SV3 and FL11 to be aggressive physically and verbally with others and that RV8 was at risk for being victimized. In fact, RV8 and SV3 were confined to the locked unit because it was recognized that they were a danger to themselves and others. There is also no dispute that the incidents occurred as reflected by the evidence summarized above. Thus, the question is whether Petitioner was taking reasonable steps to treat and supervise these residents. This case is dramatically different from the situation with the brain injured Resident 11 in Woodstock as described by the Board in its decision:

Woodstock's records showed that R. 11 had been agitated 141 times and aggressive 134 times in February 1998 and that interventions were "essentially ineffective." (Exhibit cite omitted.) R. 11 was assigned a roommate with organic brain disorder whom R. 11 proceeded to assault three times in one month, once causing a head wound severe enough to require staples to close the laceration and later pulling out the staples to reopen the wound. (Exhibit and ALJ decision cites omitted.) Additional violent episodes in which R. 11 threatened or struck other residents and staff members were recorded in the nursing notes. (Exhibit and transcript cites omitted.).

Id. at 14. Woodstock argued that Resident 11 had a behavior management program and an individual care plan, he was eventually referred to psychiatry, different medications were tried, and his behavior was monitored on a flowsheet. The Board rejected these as adequate measures, noting that there was an extended delay in his referral for psychological treatment other than medication, there was no evidence of re-evaluations of his care plan or the addition of new services or interventions to address his aggressive behavior other than the restriction on his access to cigarettes was lifted. Even after the survey of Woodstock, Resident 11 continued to demonstrate agitation and aggression. Id. at 15. The Board agreed with the ALJ in Woodstock that "an element of reasonableness is inherent in the regulation's requirements." "The problem is not that Woodstock's supervision fell short of an unattainable perfection but that it fell far short of what could reasonably be considered adequate supervision under the circumstances." Id. at 28. The Board found that the record supported the ALJ's conclusion that Woodstock "essentially made no changes in its practices long after it became clear that the measures it was using were wholly ineffective for the residents it had chosen to admit." Id.

In the case before me, the evidence is clear that as to all three residents, Petitioner's interdisciplinary treatment teams and staff were assessing the problems reflected by the incidents, reviewing care plans, and, either modifying them, or deciding to make no change, adjusting medications, obtaining physician assistance either by sending the resident to the hospital or arranging such assistance in-house, and by incrementally increasing restrictions or supervision by moving to a more restrictive unit, lifting a pass, imposing 15-minute checks, and ultimately by imposing close, visual observation. All the actions of Petitioner's staff to treat these residents occurred within a few minutes, hours, or days. In the surveyors' opinion, Petitioner should have acted more quickly to place these residents under close visual observation. The surveyors speculate that if these residents had been under close visual observation, staff could have intervened to prevent the incidents. The regulation does not, however require that a provider place all its potentially aggressive residents or those residents at risk to be victimized on close visual observation or one-on-one supervision. Rather, the regulations allow providers to tailor treatment to reasonably meet the needs of and protect its residents. In this case, Petitioner acted reasonably.

Accordingly, I conclude that there was no violation of 42 C.F.R. § 483.25(h)(2).

6. F441 - The alleged violation of 42 C.F.R. § 483.65(a)(1)-(3), which provides:

The facility must establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of disease and infection.

(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.

It is alleged in the SOD that Resident FL5 had stool cultures which were positive for Clostridium Difficile (C-Difficile). FL5's unit manager advised the surveyor that FL5 was on contact precautions due to having tested positive for C-Difficile. FL5's MDS's consistently show her to be incontinent of bowel. On March 16, 2004 at about 2:45 PM, surveyor Patricia Tuckerson, observed a CNA and a Licensed Practical Nurse (LPN) provide perineal care for FL5. The SOD states that the CNA applied gloves, removed FL5's gown and then rolled FL5 on to her left side. The LPN also had on gloves and stood to the left side of the bed. The surveyor observed that FL5 had been laying on an incontinent pad in a puddle of stool. The incontinent pad was saturated with stool through to the mattress. FL5's buttocks were covered with stool. The CNA collected a sample of the stool and put it in a specimen jar. The CNA then used a towel saturated with perineal cleaner to clean the resident. The CNA moved the towel from front to back, folded the towel to present the cleaner side and again wiped from front to back. According to the SOD, the LPN removed her gloves and left the room. The CNA completed her cleaning procedure and then repositioned the resident, touching her head and clean bed linen without changing her gloves. The SOD indicates that the surveyor interviewed the CNA and LPN. They told her that they used standard universal precautions by wearing gloves, the CNA said she would have worn a gown if there had been more stool. CMS Ex. 2, at 43-46. The surveyor alleged in the SOD and testimony that staff failed to follow Petitioner's infection control policy and procedure based on: (1) the LPN and CNA did not wear gowns; (2) the CNA did not change towels while cleaning the resident; and (3) the CNA did not change gloves before touching the clean linen and the resident. CMS Ex. 2, at 44; Tr. 95-96. The first two alleged errors are based upon the amount of stool perceived to be present, which is disputed. The third basis is dependent solely upon whether the CNA changed gloves before touching the resident and linens, which is also disputed.

Surveyor Tuckerson testified that she made the observations related to Tag F441 and FL5. She identified her notes and worksheets as part of CMS Ex. 27. Surveyor Tuckerson testified that she determined that FL5 was on contact precautions and she decided to observe how the resident was handled. Tr. at 85-86. Ms. Tuckerson's notes show that she first visited FL5's room on March 15, 2004. At that time, the resident was in bed asleep, but smelled of stool. The unit manager told Ms. Tuckerson that FL5 had one positive and two negative stool cultures for C-Difficile. CMS Ex. 27, at 4, 6. I note that this conflicts with Ms. Tuckerson's statement in the SOD which indicates she was told that FL5 had two positive and one negative stool cultures. CMS Ex. 2, at 44. According to her notes, Ms. Tuckerson visited FL5's room again about 1:40 PM on March 16, 2004, at which time FL5 was sleeping on her left side, and a CNA who was wearing gloves advised Ms. Tuckerson that FL5 had been up in her wheelchair but had just been put back to bed for a nap. CMS Ex. 27, at 6. Ms. Tuckerson testified that at about 2:45 PM on March 16, 2004, she observed CNA Sarah Ford and LPN Torgersen provide care to FL5 and she confirmed that her contemporaneous notes of her observations are at CMS Ex. 27. Ms. Tuckerson testified that when she entered the room, staff was in the process of providing incontinent care, with FL5 lying on her left side. Tr. at 88. The SOD drafted by Ms. Tuckerson is inconsistent to the extent that it indicates that Ms. Tuckerson saw the CNA apply gloves, remove the resident's gown and then turn the resident onto her left side. CMS Ex. 2, at 44. Ms. Tuckerson testified that she saw the CNA get equipment to clean diarrhea from the resident's buttocks. Ms. Tuckerson did not elaborate upon what equipment or from where it was obtained. She testified that there was diarrhea on the residents buttocks, on the incontinent pad below her, and some had seeped through to the sheet below the incontinent pad. Tr. at 88. Ms Tuckerson's notes indicate that there was a puddle of stool on the incontinent pad six inches by four inches and that stool had seeped through to the mattress. CMS Ex. 27, at 6. The CNA removed the incontinent pad and took a sample and put it in a specimen bottle, approximately 30 cc. (33) Ms. Tuckerson testified that the CNA then changed her gloves, but she did not indicate what the CNA did with the incontinent pad. Ms. Tuckerson's notes indicate that the CNA collected the specimen with a tongue depressor and that she did change gloves. CMS Ex. 27, at 6. After changing her gloves, the CNA then proceeded to clean the resident. The CNA applied perineal cleaner to a washcloth, wiped the resident from the front of the perineal area to the back, turning and folding the cloth to clean areas with each wipe. Ms. Tuckerson testified that in her opinion, the CNA should have changed towels and gloves with each wiping pass, because given the amount of stool the towel would have been saturated, causing the risk that excrement might have been introduced into the vaginal area by the wiping. When the CNA finished wiping FL5's bottom, the CNA put the dirty towel with the dirty linen, but Ms. Tuckerson did not clarify what the dirty linen was - the sheets had apparently not been removed yet, the incontinent pad would most likely have been disposable, and the only item of clothing mentioned was FL5's gown. Ms. Tuckerson testified that after the wiping, the CNA removed the soiled bed sheets and incontinent pad. Tr. 89-92. I note that Ms. Tuckerson had indicated previously that the CNA removed the incontinent pad, taking a sample, before the wiping began. Ms. Tuckerson testified that the LPN took the dirty linen and put it on the floor. The LPN then removed her gloves, put them in a trash can with a red bag in it, and left the room returning with a yellow bag, put on fresh gloves and put the soiled linen in the yellow bag. Tr. 93. Ms. Tuckerson did not testify to what the CNA was doing while she was observing the LPN. But Ms. Tuckerson testified that the CNA did not change gloves after she cleaned the resident. She next observed the CNA putting on a clean sheet and then the CNA lifted the resident's head with her gloved hands. Tr. 93-94. Ms Tuckerson testified that touching the clean sheet and the resident's head risked transmitting bacteria to noncontaminated items. Ms. Tuckerson testified that the CNA was not out of her sight during the procedure and that she was standing behind the CNA looking over her shoulder and around the side. Tr. 94-95. Following her observations, Ms. Tuckerson interviewed the CNA and LPN who told her that they were using universal precautions by using gloves and washing their hands. Surveyor Tuckerson's notes at CMS Ex. 27, at page 23, indicate that she spoke with the CNA and LPN. They also explained that FL5 has her own bags for bagging linen. Either the CNA or LPN, which is not indicated in her notes, told her that had she seen more stool, a gown would have been used. There is no indication in her notes and Ms. Tuckerson did not state in her testimony that she asked the CNA about not changing her gloves. Ms. Tuckerson testified on cross-examination that gowns were kept in a cabinet right outside FL5's door. She testified that the CNA decided not to use a gown without first seeing how much stool there was. Tr. 135. Ms. Tuckerson did not explain how she, the CNA, or the LPN knew that there was any stool before entering the room. Ms. Tuckerson explained she felt it was not necessary for her to have a gown because she was standing behind the CNA and she did not feel any diarrhea could splash on her. Tr. 136-137. Ms. Tuckerson testified that given the abundant amount of stool, good nursing practice would have been for the CNA to change the towel and gloves with each wipe of FL5's bottom. Ms. Tuckerson testified that she did not check data on the incidence of urinary tract infections for the facility. Tr. 142. On redirect, Ms. Tuckerson indicated that she agreed with counsel that Petitioner's policy and procedure on infection control says to wear a gown while doing activities that are likely to generate splashes or sprays of blood, secretions or excretions and that the CNA and LPN should have worn gowns with FL5 because there was a large amount of stool. Tr. 156-157. Ms. Tuckerson did not testify that face shields should have been worn.

Petitioner's DON, Jane Keating, testified that there was no risk of urinary tract infection by using the same cloth for wiping an incontinent female resident without changing clothes between wipes. Tr. 621-622. She clarified on cross-examination that given the amount of stool described by the surveyor, the stool would have been contained by the incontinent pad which you just roll up and there would have been little chance for splashing. Tr. 644-651. Ms. Keating testified on redirect that she asked the CNA about changing her gloves and she told her that she had in the bathroom which is near the resident's bed. Tr. 652-653. I note that the statement of the CNA submitted to CMS after the survey does not specifically say that the CNA changed gloves after wiping the resident's bottom and changing sheets. CMS Ex. 32, at 8-9. Donald Policastro, Petitioner's Administrator, testified that he interviewed the CNA and LPN involved within a couple of hours of the incident and the CNA told him that she changed gloves with clean ones from the resident's bathroom. Tr. 906-907. In her statement submitted to the surveyors after the survey, the CNA does indicate that "(w)hen I was done I took my gloves off in the bathroom, washed my hands and whet (sic) to leave the room." CMS Ex. 32, at 8. The CNA does not state that she changed gloves in the bathroom between wiping the resident's bottom and putting on a clean sheet and repositioning the resident.

There is no issue that Petitioner had an infection control program with the required policy and procedures. Further, CMS did not present any evidence related to incidence of infection to show that Petitioner's infection control program was inadequate. The real question under this deficiency as alleged is whether the CNA and LPN were compliant with policy and the regulatory requirement to control and prevent the spread of infection.

Petitioner had at least two policies entered as evidence related to wearing a gown, both extant since April 1999. One specified that gowns were to be worn when there was a risk of splashing or spraying excretions. CMS Ex. 27, at 33. The other specified that gowns are to be worn when the potential for soiling clothing with feces is likely. P. Ex. 232, at 1. (34) Neither policy specifies who is to make the determination as to whether or not there is a risk of splashing or spraying, but logically that call must be made by the staff who must handle the resident, absent directions to the contrary. My view of the facts is that the CNA, LPN and surveyor passed the container of gowns on the way into FL5's room. There is no indication that they knew that FL5 had soiled herself at that time. The CNA and LPN were both wearing gloves as reported by Ms. Tuckerson, consistent with the facility policies in evidence. The CNA rolled FL5 onto her left side whereupon it was discovered that FL5 had had diarrhea. When Ms. Tuckerson interviewed the CNA after the event, the CNA told her that if there had been more diarrhea, she would have gotten a gown. Ms. Tuckerson's opinion was that there was a large amount of stool, but she also reported that it had soaked into the incontinent pad and it was smeared on FL5's buttocks. Ms. Tuckerson did not testify that the diarrhea was so copious or thin as to be dripping off FL5's buttocks or running off the incontinent pad as it was changed. The question is, was it incorrect for the CNA to decide, given the circumstances, that there was little chance of spraying or splashing of feces and no gown was necessary. The same question applies to the LPN. This question I resolve in favor of the CNA who was actually handling the resident, the incontinent pad, and the dirty linen. Petitioner's policies gave the CNA and LPN the discretion to determine whether or not a gown was necessary. CMS has not alleged that it was improper for the Petitioner to give such discretion to the CNA and the LPN. It is clear from the record that little effort would have been necessary to obtain and don gowns which were stored right outside the resident's door. Furthermore, Ms. Tuckerson testified that she did not gown because she did not fear being splashed because she stood behind the CNA. Ms. Tuckerson's rationalization presents an inconsistency, for if she saw such copious amounts of stool, how could she be confident that the CNA would not move while performing her duties thus exposing Ms. Tuckerson to being sprayed or splashed with feces. The fact that Ms. Tuckerson was very close to the CNA is confirmed by her testimony which is consistent with the statements of the LPN and the CNA submitted to CMS subsequent to the survey. CMS Ex. 32, at 7-9.

Regarding the use of the washcloth to clean FL5's bottom, Ms. Tuckerson was clear that in her opinion, the cloth should have been changed between wipes along with the gloves. Ms. Keating, Petitioner's DON saw no problem with using a cloth for multiple swipes, but did indicate a change of cloths might be appropriate if there was a large amount of stool and the cloth became so dirty that no clean side could be used and it was not effective in cleaning the area. Ms. Tuckerson testified that the CNA saturated the cloth with perineal cleaner. The CNA then wiped the resident from front to back, turned the cloth to a clean side, and then wiped the resident from front to back again. Ms. Tuckerson did not testify that all visible stool was not effectively removed by the CNA's technique and there is no allegation to that effect. Ms. Tuckerson testified that her concern was that the wiping could cause vaginal or urinary tract infections, but there is no evidence that FL5 had such problems. Ms. Tuckerson also did not testify as to whether she actually saw any excrement on or around the vaginal area, even though she did testify that she saw diarrhea or stool on the resident's buttocks. Neither Ms. Tuckerson nor Ms. Keating could answer my question as to whether the perineal cleaner used would have been an effective deterrent to the spread of the bacteria. (35) There is no regulation that requires that a clean cloth be used for each wipe across a resident's bottom or that there be a change of gloves with each wipe. Ms. Tuckerson's suggestion that that is a nursing standard is disputed by Ms. Keating who indicates in her testimony that the standard is to clean away the feces, not to sterilize the area. Tr. 621-622. Both witnesses are qualified nurses, but Ms. Keating's testimony is the more credible on this point. The resident is already suffering the effects of the bacteria; in most instances, the diarrhea would have already contaminated the vaginal area, given the proximity of the vagina and the nature of diarrhea, and the goal is to clear away the feces, not to sterilize the area. I appreciate Ms. Tuckerson's point that a cloth could become so saturated with stool that it soaked through to the clean side that was being applied to the resident's bottom for the next wipe, and Ms. Keating did not dispute that that situation could occur. But Ms. Tuckerson never testified that she actually saw that occur; she only testified that she was concerned that it could occur. Ms. Tuckerson's opinion that it would have been better to use a clean cloth and fresh gloves for each wipe, is an opinion and nothing more.

Regarding Ms. Tuckerson's allegation that the CNA did not change gloves between cleaning FL5's bottom and changing the sheet and repositioning the resident, I conclude that Ms. Tuckerson's observations were not reliable. There is no question that both practice and policy (see e.g. CMS Ex. 27, at 31) dictate that between clearing stool from FL5's bottom and changing the sheet the CNA should have changed gloves. Ms. Tuckerson is adamant that the CNA did not change gloves. Petitioner is equally adamant that the CNA did change gloves. The CNA and LPN did not say whether or not a change of gloves occurred in the statements submitted to CMS after the survey. Ms. Tuckerson did not ask the CNA about changing gloves at the time of the incident. The issue I must resolve initially is whether or not Ms. Tuckerson's conclusion that no change of gloves occurred is credible. I have already noted concerns about the accuracy of Ms. Tuckerson's observations and documentation of her observations, e.g. was FL5 on her left side when she entered the room or did she see the CNA roll FL5 to her left side; if there was such a large amount of stool as she alleges, why did she not note whether it was dripping off FL5's buttocks and running off the incontinent pad; if she was so concerned about splashes and sprays due to copious amounts of stool, why did she not request a gown and how could she be confident that the CNA's body would protect her; the deficiency citation in the SOD for F441 drafted by Ms. Tuckerson indicates that FL5 had two positive and one negative tests, but her notes indicate two negative and one positive; Ms. Tuckerson testified and her notes indicate that the CNA changed gloves after taking a stool specimen, but this fact is not reflected in the SOD; CMS argues that because both the CNA and LPN were observed to change gloves in the room, there must have been a box of gloves in the room (CMS Reply at 23), but Ms. Tuckerson did not mention that; and Ms. Tuckerson is inconsistent in her rendition of when the incontinent pad was actually removed from the bed. I note that while Ms. Tuckerson can describe in detail what she observed the LPN doing, there are clear inconsistencies and omissions in her observations of the CNA's actions who she alleges she was observing most closely. Furthermore, there is no dispute that the CNA did change gloves after taking the stool specimen and handling the incontinent pad, indicating she recognized when a glove change was required. So why would the CNA then forget to change gloves after wiping FL5's bottom and before handling a clean sheet, particularly when gloves were apparently readily available and Ms. Tuckerson was present. (36) Ms. Tuckerson never indicates how the CNA came to possess that clean sheet either. Finally, Ms. Tuckerson has never asserted that she saw any excrement or stains on either the clean sheet or FL5's body due to the CNA touching both with gloves that were allegedly contaminated by the wiping of large amounts of diarrhea from FL5's bottom. Given all these concerns about the accuracy of Ms. Tuckerson's observations and the recording of her observations, I do not find those observations as recorded or related in testimony to be reliable and credible. (37)

Accordingly, I conclude that CMS has failed to establish a factual basis for a violation of 42 C.F.R. § 483.65(a)(1)-(3).

7. F490 - The alleged violation of 42 C.F.R. § 483.75, which provides:

A facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.

This alleged deficiency is what is often referred to as a derivative deficiency because it is derivative of the other deficiencies cited in the SOD. The allegations of the SOD clearly reflect that to be the case with the citation under Tag F490 in this case. However, I have not found any of the other deficiencies alleged in the SOD to be founded. Accordingly, there is neither a factual nor legal basis for finding a violation of 42 C.F.R. § 483.75.

IV. CONCLUSION

For the foregoing reasons, I conclude that none of the deficiencies cited by CMS during the March 2004 have been proven. Absent any findings of deficiency on the March 2004 survey, 42 C.F.R. § 488.412(a) does not require termination of Petitioner's participation agreement. Furthermore, absent some deficiency, CMS has no basis for termination of Petitioner's participation agreement.

JUDGE
...TO TOP

Keith W. Sickendick

Administrative Law Judge

FOOTNOTES
...TO TOP

1. The table of contents for the transcript incorrectly indicates that Petitioner's exhibits were received at Tr. 18.

2. Counsel for Petitioner explained that the gaps in exhibit numbering are caused by counsel's assignment of blocks of exhibit numbers to issues or residents, without regard to whether all numbers in the block might be necessary for marking exhibits related to an issue or resident. Tr. at 19 - 20.

3. The transcript does not show that P. Ex. 251, the resume of Ms. Keating, was admitted as evidence. However, counsel for CMS indicated he had no objection to my consideration of the document as evidence. (Tr. at 576 - 577). Accordingly, I treat the document as admitted in evidence.

4. The first survey that resulted in a deficiency finding triggered the running of the six-month period during which Petitioner had the opportunity to effect corrections and undergo revisit surveys for verification that deficiencies had been corrected - this is what I refer to as the survey cycle.

5. The CMP imposed was $3,000 per day for the 24-day period of immediate jeopardy from September 26, 2003 through October 19, 2003, plus $150 per day for the 158-day period from October 20, 2003 through March 25, 2004. P. Ex. 3, at 3.

6. Scope and severity levels are used by CMS and a state when selecting remedies. The scope and severity level is designated by an alpha character, A through L, selected by CMS or a state from the scope and severity matrix published in the SOM, § 7400E. A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm. Facilities with deficiencies of a level no greater than C remain in substantial compliance. 42 C.F.R. § 488.301. A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy. A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy. Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety. The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency. See SOM, § 7400E.

7. The surveyors reference to Tag F225, is not affected by the incorrect citation as both alleged violations are encompassed by the tag. See SOM, App. P at PP-52.1-52.2.

8. Whether or not the SOD may be correctly analogized with a charging document (information, compliant or indictment) in a criminal case, it is fundamentally insufficient when it does not put Petitioner or me on notice of the period in issue.

9. CMS also had admitted as evidence, Petitioner's daily staffing schedule for the period March 1 through 11, 2004. Id. at 5-26, 29-30. The relevance of those schedules has not been established since the order to initiate the wound vacuum is dated March 12, 2004. Id. at 3.

10. The SOD actually alleges 11 residents, but CMS indicates in its post hearing brief that it is not pursuing the allegation regarding Resident FL17 under this deficiency citation. CMS Brief at 4.

11. On cross-examination, Ms. Albrecht confirmed that MARs for all 230 plus residents were reviewed and she acknowledged that thousands of medications are administered in the facility each day. Tr. 228.

12. A deficiency is a failure to meet a participation requirement. Noncompliance is any deficiency that causes a facility not to be in substantial compliance. Substantial compliance means a facility has no identified deficiency that poses a risk for causing more than minimal harm. Thus, a deficiency only amounts to substantial noncompliance and may only be the basis for a certification of noncompliance and a remedy when it poses a risk for more than minimal harm. 42 C.F.R. §§ 488.301, 488.330.

13. This case does not present a situation similar to that addressed by Judge Anglada in Parkway Manor Health Care Center, DAB CR1146 (2004) where the allegation under F309 was based on facts other than the medication error. This case also presents different facts from those addressed in Montrose Bay Health and Rehabilitation Center, DAB CR1186 (2004) where allegations under F309 included allegations related primarily to treatment of a seizing resident and secondarily to failure to medicate. I note here as in Montrose, that there is a separate regulatory requirement for the provision of pharmacy services on a timely basis pursuant to 42 C.F.R. § 483.60 (F426). However that requirement is not placed at issue in this case, for while the drugs here all appear to be prescription drugs, there is no allegation they were not timely administered. The showing required under that regulation is that failure to timely provide a prescribed drug causes the resident discomfort or endangers his or her health or safety. See SOM, App. P at PP-162.

14. CMS does not address in its briefing whether or not the medication errors should be considered significant. CMS does assert that the deficiency cited presents more than minimal harm, however, minimal harm is a scope and severity determination to be made by CMS when a deficiency is found. Arguing that the alleged deficiency presents more than minimal harm does not address whether the medication errors were significant. The significance determination is a required element of the CMS prima facie case to show the existence of the deficiency.

15. According to FL10's minimum data set with a reference date of December 19, 2003, he was ventilator dependent and did not walk. P Ex. 20, at 8-10. FL10 had a history of a fall while attempting to get out of bed in December 2003. P. Ex. 31, at 20. Surveyor Kosherzenko also testified that FL10 fell again on March 22, 2004 while transferring himself from a commode. CMS Ex. 34, at 33-35. Ms. Kosherzenko did not testify to and the records do not reflect whether either fall was secondary to medication side affects, hypotension or dizziness.

16. It is not clear for all these examples that physicians' orders were actually violated, for in some cases readings exceeded only one parameter rather than two or three as specified by the physician. However, it is not necessary, given my resolution of this deficiency, to discuss in detail the sufficiency of the surveyors' observations and allegations.

17. Neither party addresses the resident's recognized right to refuse treatment such as OT. See SOM, App. P at PP-83 ("facility must ensure that the resident obtains optimal improvement or does not deteriorate within the limits of a resident's right to refuse treatment, and within the limits of recognized pathology . . . .").

18. Narcotics (synthetic or opioid) are respiratory depressants and must be administered with great caution, particularly for someone in FL2's condition. See Physician's Desk Reference (58 th ed. 2004), pp. 1245-1246 (Percocet) and pp. 1751-1755 (Duragesic Transdermal System). It is not alleged by the surveyors that use of Percocet may have contributed to FL2's lethargy, which caused her not to want to leave her bed to participate in OT, thus, causing her not to attain and maintain her highest practicable state.

19. CMS alludes to record-keeping requirements in its post hearing reply brief at page 14, but points to no statutory or regulatory requirement violated by the doctor's failure to immediately document under these circumstances. CMS bears the burden of establishing what regulatory or statutory provision is violated as part of its prima facie case. Hillman, at 8.

20. Usually, I look upon such hearsay testimony with a jaundiced eye. However, consideration of hearsay evidence is not precluded in these administrative cases, particularly where there are indicia of reliability. In this case, the extra record statement attributed to Dr. Steckman is consistent with much evidence of record that indicates that SV5 was not impacted on his return from the hospital.

21. There is no dispute that the resident was disimpacted on March 5, 2004, but that was four days after the attempted colonoscopy on March 1 and three days after the resident was incontinent of bowel in bed on March 2, 2004. The fact SV5 was disimpacted on March 5, 2004, does not reflect upon his bowel status on March 1, particularly given the evidence of incontinence on March 2 and the absence of objective signs of impaction before March 5.

22. A PICC line is a catheter nonsurgically inserted into an arm vein for the administration of medication for periods of up to three months. See www.medical dictionary.com (PICC line).

23. There is no allegation or evidence that the notes were done at a later time.

24. Dr. Melcer does not indicate that there is no need to supervise Resident 1 in her self-care; indeed, he directs that enemas are to be done as per a schedule and enemas are to be kept in locked storage.

25. Nurses notes from March 18, 2004 indicate that Resident 1 left her room without completing a nebulizer treatment. CMS mischaracterizes the nebulizer treatment as self-administration of medication as there is no evidence that Resident 1 was allowed to set-up the nebulizer by loading the medicine or to start the generation of medicated vapor. Obviously, Resident 1 was left unsupervised in her room to inhale the medication. CMS does not allege that this was a violation of any legal criteria, but only asserts that this incident would not have occurred had an assessment been done on March 1 regarding self administration of medication. These facts neither prove, nor disprove that an assessment was or was not required, necessary, or done.

26. RV8 had a separate elopement care plan (P. Ex. 182, at 9) but since elopement is not in issue, I will not summarize it here.

27. Dr. Schutzman is a psychiatrist according to Dr. Hodder. Tr. at 403.

28. The surveyor commented in the SOD (CMS Ex. 2, at 40), that while the team recognized that FL11 was not being effectively served, no new interventions were implemented to protect staff and residents from FL11. I understand this to be the gist of the alleged deficiency as it relates to FL11.

29. A social work progress note from January 26, 2004, shows that the team decision to move FL11 was actually made before the incidents in early February 2004. The note also shows that the team was aware at the time that FL11 had a verbal altercation with a CBT and nurse aide, but concluded he was appropriate to the situation and would benefit from the move. P. Ex. 213, at 1. Ms. Kosherzenko's speculation that the team did not know about the events before the transfer occurred is based only on her opinion that the transfer should not have occurred and that the team would have agreed with her conclusion in this regard had it been aware of the incidents of early February. Given the evidence of the team's management of this resident, the documentation of the incidents, and the absence of any evidence the team did not see his records, I find it more likely that the team knew of the incidents of early February, but made a treatment decision to transfer FL11 to the less restrictive TBI-5 anyway.

30. Surveyor Kosherzenko did not clarify whether she felt a plan should have been done in addition to the care plan that already existed (CMS Ex. 26, at 14) or whether the existing plan should have been updated.

31. I note from my official U.S. government calendar that March 6, 2004 was Saturday and March 7, 2004 was Sunday.

32. A social work note dated February 18, 2004, shows that FL11's mother was contacted to assist the team with his care. P. Ex. 213, at 1.

33. Counsel for CMS represents in the CMS Reply Brief that 30 cc is approximately 2 tablespoons. CMS Reply at 21, n.28.

34. CMS Ex. 39, a document from the Centers for Disease Control and Prevention (CDC) internet site, titled Part II. Recommendations for Isolation Precautions in Hospitals, includes the recommendation that gowns are to be worn by personnel during the care of patients infected with epidemiologically important microorganisms to reduce the chance for transmission to other patients or items. However, the CDC material indicates that the "efficacy of gowns for this purpose . . . is not available." CMS Ex. 39, at 5. I note that the CDC is a component of the Department of Health and Human Services as is CMS. I also note that the CDC materials submitted indicate they are recommendations and do not purport to be regulations with the force of law or nursing standards.

35. The CDC, which has been cited by CMS as authoritative, indicates in its Clostridium Difficile Fact Sheet dated August 2004 and updated September 23, 2004 (www.cdc.gov/ncidod/hip/gastro/ClostridiumDifficileHCP_print.htm) that soap and water should be used for hand washing as alcohol-based hand rubs may not be as effective. I construe this statement to be that soap and water are effective against the bacteria. The CDC also indicates that gowns should be used if soiling of clothes is likely.

36. There is no dispute that Ms. Tuckerson was close to the CNA, according to the CNA, so close that there was actual physical contact. Perhaps Ms. Tuckerson was so distracting that she caused the CNA not to change gloves, thus interfering with care to a resident.

37. Even if I found Ms. Tuckerson's observations credible, CMS argued, but has never explained what harm to FL5 or other residents was presented by the touching of FL5's sheet and head with a contaminated glove. CMS Reply at 24. FL5 was already suffering symptoms and she had one positive test, thus, spreading the bacteria to her was not an issue. According to the CDC fact sheet, the concern with C-difficile is the potential for spreading it to other residents. However, there is no allegation by CMS that either the LPN or CNA failed to observe proper precautions when they left FL5's room or in handling contaminated linen. According to FL5's care plan, she was in a vegetative state, required total assist for all activities of daily living, and was nonambulatory, so there was little chance she was going to leave her room spreading bacteria to others in the facility. P. Ex. 231; see also CMS Ex. 27, at 8-11.

CASE | DECISION | JUDGE | FOOTNOTES