SUBJECT:

Barbourville Nursing Home,

Petitioner,

Centers for Medicare & Medicaid

A. Issues

The issues are: (1) Whether Petitioner substantially complied with the participation requirements during the period June 14 to June 19, 2001; (2) Whether, if Petitioner did not substantially comply with participation requirements, CMS's determination that residents were in immediate jeopardy was clearly erroneous; and (3) Whether, if Petitioner did not substantially comply with participation requirements, the amount of the civil money penalty is reasonable.

As I noted above, CMS initially determined that Petitioner failed substantially to comply with 29 participation requirements. By the time of the hearing, however, the Parties agreed that only 17 F-tags remained for my consideration: F-tags 157, 241, 246, 281, 282, 309, 312, 314, 316, 318, 322, 353, 371, 441, 469, 490 and 505. Tr. 20-24. Because Petitioner did not pursue its appeal of some of CMS's F-tags (F-164, F-252,F-278, F-279, F-280, F-311, F-332, F-333, F-431, F-432, and F-514), they became final by operation of law prior to the hearing. Tr. 20-22. Thus, a basis for imposition of some amount of civil money penalty above $50, the minimum, is established. See Petitioner's response brief at 2.

Moreover, I conclude that Petitioner failed substantially to comply with F-314 and F-441, and that these deficiencies, togther with the relevant factors concerning the civil money penalty, support the imposition of the civil money penalty and the reasonableness of its amount. I do not therefore, as explained below, address 12 of the remaining 17 F-tags. I do, however, make findings and discuss F-157, F-281 and F-316 because these determinations are supported by the same facts underlying F-314 and F-441.

It is not necessary for me to decide whether Petitioner was compliant with the requirements under the 12 remaining F-tags because the amount of the civil money penalty would not be affected if I concluded Petitioner substantially complied with those requirements. I therefore exercise my discretion to limit this decision to the aforementioned five F-tags. My judgement to so limit the decision is consistent with the holding in Beechwood Sanitarium, DAB No. 1824 (2002). In Beechwood, an appellate panel of the Departmental Appeals Board (Board) held that the administrative law judge's (ALJ) decision not to make findings on all the deficiencies disputed by the petitioner was an exercise of judicial economy that is within an ALJ's discretion. The ALJ in that case chose to discuss several deficiencies that he determined to be persuasively established. He chose, however, to leave unaddressed several other alleged deficiencies that had been appealed, and about which the parties had presented evidence and argument. The ALJ determined that based on section 1866(b)(2) of the Social Security Act (Act), and 42 C.F.R. § 488.456(b)(1)(i), he needed only make findings on enough of the deficiencies to support the remedy because the Act and the regulation authorize a remedy when a provider is out of compliance with even a single requirement. Although, unlike the instant matter, the remedies at issue in Beechwood were denial of payment for new admissions and termination of the provider agreement, it is logical to extend the principle of judicial economy espoused in Beechwood to appeals of civil money penalties. The relevant regulation at 42 C.F.R. § 488.430 provides that CMS or the State may impose civil money penalties for days or instances when a participating facility does not substantially comply with "one or more participation requirements." Thus, I need only make findings and conclusions concerning a sufficient number of the F-tags to support the amount of the civil money penalty in this case.

B. Authority

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

If CMS finds a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, which include imposing civil money penalties. See Act, section 1819(h). CMS is authorized to assess civil money penalties when a facility is not in compliance with one or more participation requirements. 42 C.F.R. § 488.430(a). The civil money penalties range from $50 to $3,000 per day for deficiencies that do not constitute immediate jeopardy, but either cause actual harm, or cause no actual harm, but have the potential for causing more than minimal harm. And, the civil money penalties range from $3,050 to $10,000 per day for deficiencies which constitute immediate jeopardy. 42 C.F.R. § 488.438(a)(i) and (ii).

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

When CMS imposes an enforcement remedy on a skilled nursing facility or nursing facility, the facility has a right to appeal the "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. § 488.408(g)(1); see also 42 C.F.R. §§ 488.330(e), 498.3. However, a facility may not appeal the choice of remedies by CMS or the factors CMS considered when choosing remedies. 42 C.F.R. § 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the civil money penalty CMS could collect or affect the facility's nurse's aide training program. 42 C.F.R. § 498.3(b)(14).

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

In this case the following program requirements are at issue:

42 C.F.R. § 483.25(c) (F-tag 314 (F-314)). This requires the facility to ensure that a resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable. And, a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

42 C.F.R. § 483.65(a)(1)-(3) (F-tag 441 (F-441)). This requires that 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. This provision specifies that the facility must establish an infection control program under which it: (1) Investigates, controls, and prevents infections in the facility; (2) Decides what procedures, such as isolation, should be applied to an individual resident; and (3) Maintains a record of incidents and corrective actions related to infections.

42 C.F.R. § 483.10(b)(11)(i)(B) (F-tag 157 (F-157)). This requires that a facility, when there is a significant change in the resident's physical, mental, or psychosocial status (i.e., a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications), must immediately inform the resident; consult with the resident's physician; and if known, notify the resident's legal representative or an interested family member.

42 C.F.R. § 483.20(k)(3) (F-tag 281(F-281)). This requires that the services provided or arranged by the facility must meet professional standards of quality; and be provided by qualified persons in accordance with each resident's written plan of care.

42 C.F.R. § 483.25(d)(2) (F-tag 316 (F-316)). This requires that, inter alia, based on the resident's comprehensive assessment, the facility must ensure that a resident who is incontinent of bladder receives appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible.

CMS bears the initial burden of producing evidence sufficient to establish a prima facie case for each alleged violation of the regulations. CMS must set forth the basis for its determination with sufficient specificity for a petitioner to respond and come forward with evidence related to the disputed findings. The evidence set forth by CMS must be sufficient to establish a prima facie case that CMS had a legally sufficient basis to impose a remedy. In order for a petitioner to prevail, the petitioner must then prove by a preponderance of the evidence on the record as a whole that it was in substantial compliance with the relevant statutory and regulatory provisions. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999); see also Cross Creek Health Care Center, DAB No. 1665 (1998) (framework allocating the burden of proof provided in Hillman applies in appeals of civil money penalties).

C. Findings, Conclusions and Analysis

1. Petitioner failed to substantially comply with participation requirements during the period from June 14 to June 19, 2001.

a. F-314

CMS determined that Petitioner failed substantially to comply with the requirement provided in section 483.25(c) that residents having pressure sores receive necessary treatment and services to promote healing, prevent infection and prevent new sores from developing. CMS determined that the Facility failed this requirement as evidenced by its care of Residents 2, 4 and 13. Specifically, CMS alleges that Residents 2, 4 and 13 were not accorded appropriate infection control techniques during pressure sore treatment, and that appropriate policy and procedures were not followed to prevent Resident 2 from suffering new skin breakdown. CMS's brief at 27. CMS further determined that Petitioner's failure to comply with this requirement reached the immediate jeopardy degree of severity in the immediacy and seriousness of the danger to the residents. I conclude that CMS's evidence presents a prima facie case that Petitioner was noncompliant, and I conclude also that Petitioner failed to prove to the contrary by a preponderance of the evidence.

i. Resident 4

CMS's case concerning the pressure sore care provided to Resident 4 is that one of the Facility's nurses was observed using techniques likely to cause infection. Petitioner argues in response that some of the actions taken by the nurse are not evidence of a deficiency, and that to the extent there were imperfections in the nurse's technique, for example, allowing feces to contaminate Resident 4's wound, they were harmless because the Facility provided consistent care that mitigated any likely increase in infection risk.

Surveyor Leslie Wyatt observed the pressure sore related care provided to Resident 4 on June 13, 2001. Ms. Wyatt testified that treatment and dressing supplies were placed on Resident 4's over-bed table without any protective covering, and that the scissors that the attending nurse kept in her pocket were used to cut materials for dressing Resident 4's sores. Ms. Wyatt testified also that she observed the nurse attending to multiple pressure sores on Resident 4, but also observed that the nurse failed to wash her hands with soap and water each time she gloved and un-gloved, and that the nurse used alcohol gel to wash her hands instead of soap and water. Tr. 98; CMS's brief at 27. Ms. Wyatt testified that "universal precautions" require washing hands between donning gloves and after wearing gloves to provide wound care. Tr. 99-100. Ms. Wyatt testified that alcohol hand gels are acceptable in some instances, but that when hands are heavily soiled, e.g., with feces, standard practice should be for nursing staff to wash their hands with soap and water. Tr. 114-115.

Ms. Wyatt testified that during her observation of the treatment provided for the pressure sore on Resident 4's coccyx, Resident 4 experienced a bowel movement resulting in feces getting on Resident 4's peri-anal area and on the bed linen. Tr. 102. Ms. Wyatt testified that the nurse did not clean the feces, but continued providing pressure sore treatment. Ms. Wyatt explained that the nurse applied a dressing to the pressure sore that covered the sore and some of the feces. Tr. 98, 103. After the dressing was completed, Ms. Wyatt explained, the nurse attempted to clean the feces by wiping the material toward the pressure sore. As a result some feces were pushed under the dressing covering the sore, and some feces were wiped toward the supra-pubic area (Resident 4 is a female resident who had a Foley catheter and a history of urinary tract infections). Tr. 107. Based on this testimony, CMS argues that contamination of Resident 4's catheter could have occurred as there was no catheter care provided. CMS's brief at 28. Ms. Wyatt testified also that there are organisms in human feces, the most common being e. coli, that can cause infections, and that wounds are conducive to the growth of infectious organisms because they are warm and moist. Tr. 103-104.

Ms. Wyatt testified that the nurse contaminated dressing supplies when she failed to wash her hands between glove changes. Tr. 98-103; 106-108. Ms. Wyatt explained that placing supplies on the over-bed table presented a problem because the surface of the table could have been contaminated by the placement of clean and unclean supplies. Tr. 101-102. Ms. Wyatt concluded that these practices could lead to Resident 4 developing an infected wound or urinary tract infection. Tr. 108.

Citing Ms. Wyatt's testimony, CMS argues that any nervousness on the part of the nurse, (as explained below, Petitioner asserts that this is a factor I should consider regarding the care provided to Resident 4), is negated because the nurse sought out Ms. Wyatt when she was ready to begin the treatment to have Ms. Wyatt observe her. CMS's brief at 29; Tr. 105.

Ms. Wyatt testified that she told Resident 4's treating physician her concerns about the Resident's dressing change and the physician ordered that Resident 4's wound be irrigated and redressed. Tr. 128-29. CMS argues that the Physician's conduct shows his concern that the wound could be contaminated, and that I should not construe the fact he did not take the additional measure of ordering antibiotics for Resident 4 to mean that Resident 4 was not at risk for developing infection. CMS's brief at 29. In light of the foregoing evidence, CMS argues, Petitioner provided inadequate wound care to Resident 4 that placed her at risk for infection. CMS's brief at 29.

Petitioner challenged CMS's conclusion that the techniques Ms. Wyatt observed the nurse using was deficient pressure sore care. Concerning the supplies the nurse placed on the over-bed table, Petitioner presents evidence that they were in or on plastic packaging- a condition that Ms. Wyatt conceded is an acceptable barrier against contamination consistent with "clean technique." Clean technique was identified by Petitioner as technique incorporating an acceptable level of caution for treating pressure sores, and the Surveyors agreed clean technique is an acceptable standard. Tr. 119-20; 429.

Concerning glove changes and hand washing sanitation, Petitioner presented evidence to support its argument that glove changes are not necessary nor required between caring for multiple pressure sores on a single patient. And, Petitioner presented evidence also that using alcohol gel for hand washing instead of soap and water is effective and accepted. To buttress this point, Petitioner cites a U.S. Department of Health and Human Services publication, putatively intended as a Clinical Practical Guideline, called 'Treatment of Pressure Ulcers'. Petitioner offers the guideline to show that there is no research evidence supporting a need to change gloves when caring for multiple ulcers on the same patient. P. Ex. 9, at 31. Based on the information in the guideline, Petitioner was able to elicit from Ms. Wyatt on cross-examination that a nurse who changes gloves between treating pressure sores on the same patient, with or without washing his or her hands, is doing more that the standard requires. Tr. 118. So, on this point it does appear that Ms. Wyatt was holding the nurse to a higher standard than what is required for pressure sore treatment.

Similarly, Petitioner supported the Facility's use of alcohol gel for hand washing by introducing evidence that authorities on infection control, the CDC, and the Association of Professionals in Infection Control and Epidemiology (APIC), hold that in many cases alcohol gels are more effective against certain organisms than soap and water and that is why they are used by medical professionals in surgery. And, Petitioner argues further, one advantage of alcohol gels over soap and water is that antimicrobial products that do not require water can be used in areas where no sinks are available. See P. Ex. 15; Petitioner's brief at 10. Moreover, Petitioner explained, the nurse Ms. Wyatt observed was adhering to the Facility's policy that permitted the use of alcohol gels instead of soap and water; and, Petitioner noted, the Facility made alcohol gel available in each resident room. Tr. 426. Petitioner presented evidence that the alcohol gel products used by the Facility reduced microbes by 99.99 percent immediately after use. P. Exs. 20-21; Petitioner's brief at 10-11.

I am persuaded of the general concepts Petitioner avers: supplies placed on a table can be acceptably safeguarded by plastic packaging, donning gloves once to provide care to a resident with multiple sores is acceptable practice, and alcohol gels are an acceptable substitute to washing hands with soap and water in certain circumstances. Accordingly, I do not weigh some of the nurse's acceptable or innocuous treatment techniques in considering whether the Facility was out of substantial compliance with F-314 concerning Resident 4's pressure sore treatment. These factors that Petitioner raises, however, are insufficient to bear Petitioner's burden to show compliance. While Ms. Wyatt agreed that alcohol hand gel is acceptable to use when gloves or hands are not obviously soiled, Tr. 114-115, the crucial fact, un-refuted by Petitioner, is that in the relevant instance there was obvious soiling.

Concerning the introduction of feces into Resident 4's sore during treatment, Petitioner attempts to cast the incident as unlikely to lead to infection and to depict the scenario as within the acceptable range of wound contamination. Ms. Wyatt testified that the introduction of feces into the sore increased the potential for Resident 4 to develop an infection. Tr. 103. Ms. Wyatt did agree with Petitioner that all pressure sores have contaminants present in them, and that this fact does not equate with infection. Tr. 121. Petitioner asserts that pressure sores are expected to be colonized by bacteria, but that bacteria colonization should be minimized through effective wound cleansing and debridement. Petitioner's brief at 12; P. Ex. 9. Petitioner argues that the fact Ms. Wyatt contacted Resident 4's treating physician, and he ordered Resident 4's wound irrigated and re-dressed is consistent with clinical guidelines. Petitioner's brief at 12; P. Ex. 9. And, Petitioner argues, the fact the Physician did not order treatment with an antibiotic, Tr. 129, is telling. Petitioner's brief at 12. Petitioner also raises the possibility that after Ms. Wyatt stopped observing the nurse providing care to Resident 4, the nurse or another staff member could have returned to provide additional care. Id.; Tr. 126-127. Finally, Petitioner argues that because Resident 4 received routine care, at least every day, and usually more often than that, Tr. 423, it is unlikely an infection would have developed because the pressure sore would have to remain untreated and the dressing left contaminated for an extended period of time for an infection to develop. Petitioner's brief at 12.

I take Petitioner's point that the introduction of feces into a pressure sore is an occurrence that is not identical to the infection of a pressure sore. Contamination and infection are not the same thing. Nonetheless, I find that the introduction of fecal matter, a substance very obviously a contaminant, is a basis to find that Petitioner failed to provide Resident 4 with the necessary services to heal, prevent infection and prevent new sores, as required by section 483.25(c).

The physician's reaction to the contamination of Resident 4's pressure sore, prompted apparently by Ms. Wyatt's calling his attention to the matter, while indicating, as Petitioner argues, that the Physician did not assume Resident 4 suffered instantaneous infection, also supports CMS's point: proper pressure sore care requires at a minimum that a facility wash feces out of a sore, and ideally that it not allow the material in the sore at all.

As for the possibility Petitioner raises that the Facility provided some additional care after the fact of Ms. Wyatt's observations, this argument leaves unanswered the underlying question: did it? This is not a criminal justice proceeding and it is not a productive exercise for Petitioner to raise phantoms of doubt around the facts. Because Petitioner presents no evidence that the care it suggests was later provided was in fact provided, I find that it was not provided.

Concerning Petitioner's assertion that, due to the overall assiduousness of the Facility's care for Resident 4, the pressure sore would not have remained contaminated long enough to become infected, I observe that while it is plausible that Resident 4's sore would have been cleaned at the next regular interval, it is prima facie deficient for the Facility to have considered adequate care rendered when staff knew or should have known Resident 4's pressure sore was contaminated. The standard in the regulation requires doing everything reasonably possible to provide care right the first time. The risk of infection may be mathematically reduced by the periodic regularity of staff attention, but the harm is already done in the interim when the contaminant is left free to take its best shot at infecting the vulnerable resident's pressure sore.

ii. Resident 2

Surveyor Paula O'Bannon, testified concerning treatment she observed being provided to Resident 2. Resident 2 had three pressure sores, two if which, Ms. O'Bannon testified, were Stage IV sores. Tr. 143. As with Resident 4, CMS alleges that Facility used techniques that placed Resident 2 at risk for developing an infection. Specifically, Ms. O'Bannon testified that she observed a nurse putting treatment supplies on Resident 2's over-bed table without a protective barrier between the supplies and the table. Tr. 138. The nurse used personal cleansing wash cloths, not alcohol gel or soap and water, to wash her hands when gloving and un-gloving during treatment; Ms. O'Bannon testified that the nurse explained that the wash cloths were less irritating. Tr. 145. Ms. O'Bannon testified also that the nurse used scissors taken from her pocket to cut away the old dressings on Resident 2's wound and then used the scissors to cut new dressings without cleaning them first. The nurse then put the old dressings into a plastic bag sitting on Resident 2's bed. Tr. 139, 145. Ms. O'Bannon testified that the plastic bag was pulled into an open container of wipes that was sitting on Resident 2's bed, Tr. 139, and that the nurse put the container of wipes back on the treatment cart. Ms. O'Bannon testified that the wipes could have been contaminated with germs from the bed so that if they were used to treat other residents the wipes could have spread the germs leading to the infection of other residents. Tr. 139-141. Ms. O'Bannon concluded that the techniques the nurse used to treat Resident 2's wound could have caused infection. Tr. 142.

In addition to questioning the techniques employed by Facility staff, CMS further alleges that the Facility failed prevent Resident 2 from developing new pressure sores because the Facility failed to adequately assess Resident 2's condition. CMS argues that Resident 2's medical record shows that he was at high risk for pressure sores. CMS's brief at 33, citing CMS Ex. 19, at 85. Yet, CMS claims, the Facility had no documentation showing that a weekly skin report was completed for Resident 2 for the period from November 17 to November 30, 2000. CMS's brief at 33. CMS attributes the fact Resident 2 developed a new pressure sore while at the Facility to this lapse. CMS's brief at 33.

Petitioner counters that some of the techniques Ms. O'Bannon asserted were deficient do not bear on the pressure sore requirement at section 483.25(c). As it did with Ms. Wyatt, Petitioner elicited from Ms. O'Bannon on cross-examination that packaging serves as a barrier between treatment supplies and the surface of an over-bed table. Tr. 143-144. And Ms. O'Bannon agreed that professional standards of care do not require washing hands with soap and water and changing gloves between caring for multiple wounds on a single resident. Tr. 144.

Regarding Ms. O'Bannon's concern that the nurse used scissors taken from her pocket to cut bandages for Resident 2, on cross-examination Ms. O'Bannon conceded that she entered Resident 2's room after the nurse had set up the treatment supplies and, therefore, Ms. O'Bannon did not know if the scissors were cleaned prior to her entering the room. Tr. 145. Petitioner argues that the wipes Ms. O'Bannon testified could be contaminated were the kind treated with chemicals to kill contaminants and that it is speculative of CMS to conclude they would have been used to clean other residents. Petitioner's Brief at 15. David Dietz, the Facility Administrator, testified that Resident 2's dressings were changed numerous times a day. Tr. 422-423; see also Petitioner's brief at 15.

Although certain of Petitioner's arguments are convincing, for instance that CMS's evidence concerning supplies placed on the over-bed table and hand washing and glove use practices should not be weighed against the Facility, I conclude nonetheless that Petitioner has not proved that the Facility was compliant with F-314 concerning its pressure sore related care of Resident 2. Petitioner leaves unanswered the question whether the scissors the nurse used where contaminated, whether the wipes were used on other residents, and whether Petitioner disputes there was a failure in the skin assessment for Resident 2. To bear its burden of proof successfully in this matter it is not enough for Petitioner to suggest the scissors the nurse used were cleaned prior to Ms. O'Bannon entering the room. If it had affirmative evidence to support that assertion, Petitioner should have offered it. To offer an unsupported theory is essentially the same as leaving CMS's prima facie case un-rebutted. Similarly, if CMS's assumption that the box of wipes would be used to clean other residents was incorrect, Petitioner bears the burden to prove it. And, I find unpersuasive the suggestion that because the wipes were chemically treated to be antibacterial or anticontaminant they presented no risk of spreading infection. The logical inference from that suggestion is that there is no risk, or that it is not a deficient practice to use a treated wipe on one resident and then use the same wipe on another. Perhaps the chemicals in the wipes would reduce the risk of infection to some degree, but I doubt that Petitioner would assert that reusing wipes in this manner would be acceptable practice. Finally, the allegation that the Facility failed to prevent new pressure sores by failing to properly assess Resident 2's skin is left unanswered. To the extent Mr. Dietz' testimony that Resident 2's pressure sores were treated frequently was offered to refute this allegation, I conclude it is insufficient. I see no evidence that Resident 2 did not in fact develop a new pressure sore in the Facility, nor do I conclude that evidence of consistent dressing changes is proof that the pressure sore Resident 2 developed was clinically unavoidable.

iii. Resident 13

CMS alleges that wound care techniques similar to those observed during the care of Residents 4 and 2 were observed during the care of Resident 13. Surveyor Phyllis Monhollen testified that Resident 13 had four pressure sores ranging in severity from Stage II to Stage IV. Tr. 153. Ms. Monhollen testified that when she observed Nurse Betsy Smith, who testified at the hearing, providing treatment to Resident 13, Nurse Smith used Kendall wipes to clean her hands during gloving and un-gloving, and did not clean her hands three times after un-gloving despite CDC guidelines and the surveyors' training books that call for washing hands after un-gloving. Tr. 153. Ms. Monhollen testified also that there was fecal matter on Resident 13's body during the treatment. And she testified that a nursing assistant helping the Nurse Smith with Resident 13 worked without wearing gloves and subsequently left Resident 13's room without washing her hands. Ms. Monhollen observed that Nurse Smith, who was wearing gloves, moved feces out of the way so she could provide pressure sore treatment. Tr. 164. Ms. Monhollen testified that she was concerned the feces on Resident 13's skin would contaminate the pressure sore. And Ms. Monhollen stated that she did not know how long the feces were present but clinical guidelines concerning pressure sore treatment recommends that incontinent residents be cleaned immediately after they experience incontinence. Tr. 166-167. CMS asserts that the Facility's witness, Kathy Arnett, Director of Nursing, corroborated that immediate cleaning is proper technique. Ms. Arnett testified that if she were treating a resident's open wound and the resident became incontinent she would cover the wound until the incontinent episode was over, clean the resident, and then resume the wound treatment. Tr. 295; CMS's brief at 31.

Similar to Surveyors Wyatt and O'Bannon's observations, Ms. Monhollen observed Nurse Smith put dressing supplies on Resident 13's over-bed table without a protective barrier between the supplies and the surface of the table. Ms. Monhollen found fault also with Nurse Smith's moving a box of gloves from the table to the bed and back to the table, increasing, in Ms. Monhollen's opinion, the risk of contamination to gloves from the bed. Tr. 154-156. And Ms. Monhollen alleged that Nurse Smith did not clean Resident 13's most contaminated wound last. Tr. 156. Ms. Monhollen testified also that Nurse Smith contaminated a tube of Bactroban ointment by placing the tip of the ointment tube directly on Resident 13's wound, and she testified that when some of the ointment placed on the wound rolled off it, Nurse Smith scraped the ointment off Resident 13's skin and placed it back on the wound. Ms. Monhollen testified that this technique could have introduced organisms from the Resident's skin into the wound. Tr. 157-58. Finally, Ms. Monhollen testified that the Nurse Smith used scissors to cut dressings for Resident 13 and then placed the scissors back into her pocket without cleaning them. Tr. 159.

Petitioner asserts that, as with the previous two residents, supplies placed on the over-bed table is a non issue because Ms. Monhollen conceded that the supplies were still in or on their plastic packaging. Petitioner's brief at 16; Tr. 165. Petitioner also disputes Ms. Monhollen's assertion that Nurse Smith failed to clean the most contaminated area on Resident 13 last. Petitioner argues that Nurse Smith cleaned Resident 13's right hip last which is consistent with cleaning the most contaminated area last and that this fact is reflected in the 2567 (CMS Ex. 3) at pages 40-41. Petitioner's brief at 16.

In response to CMS's allegations, Petitioner offered also the testimony of Nurse Smith who provided the pressure sore treatment to Resident 13. Petitioner elicited from Nurse Smith that she was made nervous by the Surveyors observing her work. Tr. 388-389. Nurse Smith testified that she did not touch the tip of the Bactroban ointment tube to Resident 13's pressure sore. Tr. 390. Nurse Smith also explained that the Facility designated a single tube of ointment for each individual pressure sore. Tr. 390. Concerning Ms. Monhollen's allegation about feces on Resident 13's skin, on cross-examination Ms. Monhollen agreed that she did not observe feces enter Resident 13's wounds or the dressing supplies. Tr. 165-166. Nurse Smith testified that she decided to continue with treatment during the Resident's incontinence to protect his wound from feces. Nurse Smith said that she used the bed sheet to move the feces away from the wound but she did not touch any feces with her glove. Tr. 390-392; 400-401. Nurse Smith claims that after she completed dressing Resident 13's wound she left the room, washed her hands, and then instructed a nurse aid to have Resident 13 cleaned up. Whereafter, Nurse Smith returned to Resident 13's room, removed the dressing, cleaned and irrigated the wound and replaced the bandage. She did this, she said, so there was no possibility of the wound being contaminated. Tr. 392-394. Ms. Monhollen did not observe Nurse Smith perform any of this follow-up treatment. Tr. 168-169.

As with Ms. Wyatt's and Ms. O'Bannon's observations concerning Residents 4 and 2, it appears that some of the actions noted by Ms. Monhollen do not support a finding of noncompliance. For instance, it does not appear that placing supplies in or on their plastic packaging presents a risk to residents. Nor does Ms. Monhollen's testimony justify a finding that the nurses or other staff failed to meet standards concerning hand-washing or standards related to glove changes. Nonetheless, based on Ms. Monhollen's observations, coupled with the testimony of Ms. Arnett, I find that some of Nurse Smith's actions contributed unnecessary risk of infection to Resident 13. Nurse Smith's testimony that she proceeded with the pressure sore care despite the presence of feces on Resident 13, and then, unbeknownst to Ms. Monhollen, decided to return after the fact and do the treatment all over again is unpersuasive. Both Ms. Monhollen and Ms. Arnett agreed that presented with the circumstances Nurse Smith faced, the proper procedure is to cover the wound, remove the contaminant, and then proceed with wound care. While I am respectful of Nurse Smith's discretion to make a nursing decision, Ms. Monhollen and Ms. Arnett are equally qualified to make these judgments. Under the circumstances, I weigh the decision to continue Resident 13's wound care while feces were present on his body and the bedclothes to be inconsistent with the requirements under F-314.

iv. Several other arguments presented by Petitioner in support of its case regarding F-314

In concluding that the Facility failed to substantially comply with F-314, I considered also Petitioner's broader arguments set forth in its brief. Specifically, Petitioner argued that CMS did not offer evidence that appropriate preventive measures concerning pressure sores were lacking, or evidence that residents developed pressure sores unexpectedly, or that treatment was not scheduled appropriately, performed on schedule or without proper supplies. And Petitioner argued that CMS presented no evidence that the Facility failed to provide pressure sore treatment and services. Petitioner's brief at 6.

Petitioner contends that it had been healing Residents 4 and 13's pressure sores effectively. And, Petitioner argues that if it had provided ineffective pressure sore control and treatment, the Resident's pressure sores would not have healed. Petitioner's brief at 6-7, citing the Testimony of Ms. Arnett at Tr. 356-57. Petitioner asserts that to treat and prevent pressure sores it took the following measures: it provided turning/repositioning for the residents every two hours, the staff hierarchy was made aware of physicians' orders for wound care, pressure relieving devices were used as needed, wound care was provided by nurses according to physicians' orders, and wound care was provided as needed. Additionally, Petitioner asserts, dressings were checked every shift, at every incontinence episode or provision of incontinence care, and at every repositioning - which entailed checks at least every two hours. Petitioner explains that incontinent residents frequently get urine or feces into their dressings. When this occurs nurse aides inform the nurses so that wound treatment will be redone. Furthermore, Petitioner avers, the Facility underwent two in-service training sessions in March 2001 concerning wound care and infection control; wound care is monitored by supervisors and the Director of Nursing; and, a Braden skin assessment is performed on each admission and readmission to assess pressure sore risk, and skin assessments are performed weekly thereafter to check progress. Petitioner's brief at 6-8.

Petitioner argues that CMS has not established a prima facie case because it has based its findings of deficiencies on standards that do not exist, for example requiring sterile technique for wound care instead of ordinary clean technique; requiring hand-washing with soap and water which is not the standard; and, erroneously assuming nurses do not re-dress wounds as insurance. Petitioner's brief at 17-18. Petitioner argues also that if any staff made mistakes it should be attributed to their unusual nervousness in the presence of the Surveyors.

None of these general arguments alters my conclusion that Petitioner failed to comply with its duty to provide services to heal sores, prevent sores becoming infected and prevent new sores as required by section 483.25(c). Assertions of staff nervousness, unsubstantiated claims of remedial efforts made just after the Surveyors' departure, and the fact the Surveyors made some superfluous observations mingled with their essential ones do nothing to surmount the instances of deficient care of the Residents 2, 4 and 13. Moreover, Petitioner's protestations that it provided consistent care overall in compliance with the regulation betrays a misunderstanding of the standard. Findings of lapses in pressure sore care cannot be mitigated by balancing a generally good record against the instances of deficient care. Whether the Facility had a generally good record or not is not an issue before me, but the reasonableness of the Facility's actions in the specific instances cited by CMS are: thus, Petitioner's argument to the effect that it had a generally competent approach to pressure sore care is unavailing.

b. F-441

I conclude that the evidence that CMS presented concerning Petitioner's infection control techniques and policy shows, prima facie, that the Facility failed substantially to comply with the requirement provided at 42 C.F.R. § 483.65(a)(1)-(3). And Petitioner has not presented evidence that overcomes CMS's case by a preponderance of all the evidence. Thus I conclude that Petitioner failed substantially to comply with the requirement at section 483.65(a)(1)-(3).

CMS alleged that the Facility failed to ensure that staff utilized appropriate infection control techniques when administering pressure sore treatment (which also gave rise to the CMS's determination that the Facility was deficient under F-314), and when administering medication and handling possibly-contaminated bodily fluids. CMS further alleged that the Facility failed to ensure that an effective infection control program had been implemented to prevent the spread of infection and to "track and trend" infections through the control program. CMS's brief at 34; CMS Ex. 3, at 60-61.

The program requirement at section 483.65(a)(1)-(3) is that 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. This provision specifies that 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.

CMS presented evidence demonstrating lapses in the Facility's investigation and control mechanisms, and lapses in the Facility's efforts to prevent infections and its record keeping related to infection tracking and control.

Part of CMS's assessment was that certain of the staff employed poor techniques that were counterproductive to infection prevention and control. To this end CMS presented the testimony of Ms. Wyatt that she observed Facility Administrator Dietz remove Resident 3's sling, which appeared to be stained with bodily fluids, without wearing gloves and without washing his hands. Ms. Wyatt asserted that Mr. Dietz' hands could have become contaminated and he could have spread the contamination to other residents. Tr. 174-75.

As another instance of what CMS asserts was inadequate infection control technique, Surveyor Bob Durham testified he observed a nurse administering medication to Resident 9 who was fitted with a gastrostomy tube. Mr. Durham testified that the nurse did not wear gloves as she placed her fingers into a medicine cup and handled the gastronomy tube and connecter and then administered the medications. Mr. Durham said that it is standard practice to use gloves when handling gastrostomy tubes to protect against bodily fluids that can ooze onto the tubes and cause infection to be spread. Tr. 195.

CMS alleges also that Resident 3 developed an infection that was not documented in the Facility's infection control records. Ms. Wyatt testified also that Resident 3 was hospitalized in March 2001 for debridement of the heel, during which treatment the attending physician noted that the tissue on the heel was infected. CMS Ex. 20, at 10-12. Ms. Wyatt testified that she was unable to find evidence of Resident 3's putative infection in the Facility's infection control program records for March 2001. Tr. 176-178. CMS acknowledges that Petitioner disputes that Resident 3 had an infection and that the Physician disavowed his assessment in a statement that has been made part of the record (see P. Ex. 37 (discussed below)). CMS avers, however, that the Physician's statement is self serving, coming after the fact and in support of Petitioner's case, and CMS notes that the physician did not testify at hearing so that his latter statement could not be subjected to cross-examination. CMS's brief at 35.

CMS presented also Surveyor O'Bannon's testimony concerning perceived problems with the Facility's records for tracking and preventing infections. Ms. O'Bannon testified that she reviewed infection control records for Resident 2. Ms. O'Bannon explained that these records bore scrutiny because the records indicated that Resident 2 had experienced elevated temperatures, had been treated with antibiotics, and had cultures performed. CMS Ex. 19, at 4-8, 14. After her review, Ms. O'Bannon was unable to find whether this data had been evaluated for infections and causative agents. Tr. 202. Ms. O'Bannon opined that the Facility is required to look for potential causes of infections and to track infections. Tr. 203. She testified that the Facility should have evaluated Resident 2 in this light because of the occurrences of elevated temperatures. Tr. 204. Ms. O'Bannon testified that an effective infection control program requires tracking the kind of data she found in Resident 2's records. Ms. O'Bannon believed that by failing to track this data in the infection control program, the Facility was unable to effectively track infections and, therefore, was unable to effectively protect residents from infection. Tr. 206, 217-218.

CMS further alleged that the Facility's infection control policy was not followed. Ms. Monhollen reviewed the Facility's infection control policy (see P. Ex. 8) and related records and determined that it was not effective because it was not followed. Tr. 232. Ms. Monhollen testified that the Facility's policy is to identify, investigate, control and prevent infections, causative organisms and the source of infections. Staff is supposed to record data for these things and the records generated are then supposed to be reviewed by the Quality Assurance Committee whose job it is to identify infection clusters, increases in infection, precautionary measures to be taken, risk factors concerning infection, and whether the infections are nosocomial or community acquired. Tr. 234-235. Ms. Monhollen testified that she reviewed the Facility's Infection Control Resident Tracking Sheet ( P. Ex. 10), but the sheet did not indicate that the Facility investigated whether the infections were nosocomial or community acquired. Tr. 237. Ms. Monhollen reviewed also the Facility's Infection Control Report (P. Ex. 11). She testified that from December 2000 until May 2001 the infection rate in one of the Facility's units rose from 1.7% to 12%. The infection control nurse and Mr. Dietz both explained to Ms. Monhollen that the Facility did not have a threshold number for comparison and so they were unable to determine what constituted a high rate of infection. But, based on her review of the records, Ms. Monhollen concluded that there was no information that the Facility had investigated the cause of the increased infection rate. Tr. 241-242.

Ms. Monhollen noted also that her record review revealed that the nurse she had observed providing pressure sore treatment to Resident 2 (discussed above) was absent from the in-service training when hand washing, wound care and infection control were covered. Tr. 238.

Additionally, Ms. Monhollen testified that her record review showed that the Facility failed to follow infection control policy concerning an infection Resident 13 had. Ms. Monhollen testified that the resident tracking form in Resident 13's medical records showed that on June 8, 2001 Resident 13 returned from the hospital after having been diagnosed as infected with Methcillin Resistant Staphylococcus Aureus (MRSA), and that Resident 13 was prescribed Vancomycin, an antibiotic. Tr. 243; CMS Ex. 28, at 47-48. Resident 13's name, however, did not appear on the Facility's infection tracking documents for June 2001. Ms. Monhollen testified that this showed the Facility was not promptly investigating or monitoring Resident 13's infection after his return to the Facility from the hospital. Tr. 244. CMS counters Petitioner's response that Resident 13 did not return to the Facility with an active case of MRSA, by arguing that the Facility's own policy required a resident who returned to the Facility on an antibiotic to be recorded on the Infection Control Resident Tracking Sheet. CMS's brief at 40.

Petitioner's position, broadly, is that CMS misunderstands what an infection is, that CMS has elevated form over substance in its interpretation of the infection control provision under section 483.65(a)(1)-(3), and that Petitioner denies the substantive allegations of infection control lapses. Petitioner argues that none of the items listed in the 2567 (CMS Ex. 3) reflect the failure of the Facility to identify or monitor infection. Petitioner concludes that the Surveyors expected to find certain kinds of information in centralized documents. Petitioner believes, however, that the documents that the Facility did keep, the Infection Control Resident Tracking Log (P. Ex. 10) and the Infection Control Report (P. Ex. 11), contained all the information necessary for the Facility's staff to effectively control infection. Petitioner argues that the law requires nothing more, and that the Facility's track record on infection control is good. Petitioner argues further that CMS failed to present a prima facie case because it has not presented evidence of a deficiency.

Specifically, Petitioner argues that the Facility had a comprehensive and coordinated infection control approach but the Surveyors overlooked it. Petitioner's brief at 20. The Facility presented the testimony of its Director of Nursing, Kathy Arnett, to explain its infection control policy and to refute CMS's determination. Ms. Arnett testified that nurses and nurse aides at the Facility monitor for signs and symptoms of infection as taught in nursing school and at periodic in-services. Tr. 296-297. Ms. Arnett explained that she monitored the Infection Control Resident Tracking Log (P. Ex. 10) which was maintained by the nurses on the floor and which identified new physicians' orders prescribing antibiotics. Tr. 300. At the end of each month, Ms. Arnett testified, the log was forwarded to the Quality Assurance Committee. Tr. 300. Ms. Arnett testified that she reviewed the log to see what residents had been newly treated with antibiotics and why. She testified that she would then follow-up with this review by reviewing laboratory reports. Tr. 297-98

Ms. Arnett testified also that she reviewed a report that catalogued changes in residents' conditions and listed new physicians' orders. Tr. 298. Ms. Arnett said that she fulfilled her duties by reviewing the infection control logs daily and looking for common factors that might indicate any problems. Tr. 301-302. Additionally, Ms. Arnett explained that the Facility had an infection control nurse who reviewed the infection control logs and compiled information for the Quality Assurance Committee to review. Tr. 301.

At the management staff level, Facility Administrator Dietz testified that he monitors infections, and he enters physicians' orders into a computer system so they can be reviewed for indicators of infections; Mr. Dietz testified that he follows up with Ms. Arnett and the Facility's unit supervisors concerning his findings. Tr. 416-417. Mr. Dietz testified that the Facility used weekly skin assessment forms to monitor wounds for signs and symptoms of infection. Tr. 418. Mr. Dietz explained also that he reviews the Infection Control Resident Tracking Log (P. Ex. 10), which is kept at the nurses' station. He testified that he uses the log to prepare a monthly summary of infection rates. Mr. Dietz said that he calculates the percentages of certain categories of infections. Tr. 441; see also, P. Ex. 11. Mr. Dietz testified that some of this information is used by the Quality Assurance Committee at monthly meetings. The Quality Assurance Committee, he explained, examines infection data for trends and unusual events, but, Mr. Dietz added, infection control related issues and concerns are usually spotted and addressed as they arise, so the Facility does not wait until the monthly meetings. Tr. 442-445.

Concerning the infection control process that the Facility asserts was in place and was effective, Ms. Arnett testified that it had not been faulted in previous surveys. Tr. 295-296. And, Ms. Arnett testified that the infection control process had been demonstrated effective, for instance, she asserted, at one point the Quality Assurance Committee had identified a high number of urinary tract infections and that this prompted the Facility to respond to these infections and to control them. Tr. 302-304.

Petitioner responds also to some of the allegations to which Ms. Wyatt testified, concerning the Facility's use of deficient infection control techniques. Concerning Ms. Wyatt's testimony that Mr. Dietz handled a resident's sling without gloves, Petitioner points out that Ms. Wyatt, on cross-examination, agreed that Mr. Dietz did not touch the soiled area of the sling. Tr. 181. And, in response to Ms. Wyatt's testimony that Mr. Dietz washed his hands with alcohol gel only, Petitioner refers to Mr. Dietz' testimony that he used gel and soap and water after that. Tr. 438-439. Petitioner argues that it is reasonable for Mr. Dietz not to have worn gloves because it was reasonable for him to have determined that he would not be in contact with blood or other secretions. Petitioner's brief at 23. Petitioner reasons that the text CMS relies on as an authority on this subject (see P. Ex. 9, at 11) holds that proper technique is to wear gloves for anticipated contact with blood and other bodily secretions and fluids. Id.

Petitioner cross examined Ms. Wyatt concerning her faulting of the Facility for not documenting in the Facility's infection log that Resident 3's discharge summary from the hospital described the Resident's wound as infected. In response to this allegation, Petitioner notes that Ms. Wyatt conceded on cross-examination that there was no evidence Resident 3 had an infection on his readmission to the Facility and he was being treated with antibiotics. Tr. 188. Additionally on this point, Mr. Dietz testified that Resident 3 repeatedly broke his skin graft loose (Tr. 458), and the physician at the hospital did not order a culture or prescribe antibiotics for Resident 3. Tr. 459. Petitioner points to the Physician's disavowal of his description of Resident 3's wound as infected. See P. Ex. 37. Petitioner suggests also that the Physician's first description was influenced by the Physician's attempt to attain Medicaid approval for a longer hospital stay for Resident 3. Petitioner's brief at 23-24; Tr. 461.

Concerning Mr. Durham's testimony about the alleged improper handling of one Resident's gastrostomy tube, Petitioner offers in rebuttal that Mr. Durham did not identify any regulatory infection control standard that was violated, nor did his testimony indicate that the gastronomic tube was in fact oozing. Moreover, Petitioner notes, Mr. Durham testified that in and of itself this example of deficient practice does not reach a high level. Petitioner's brief at 24-25; Tr. 198.

Concerning Petitioner's contention that CMS elevated form over substance and overlooked the Facility's infection control program's effectiveness, Petitioner points to Resident 2's inclusion on the Infection Control Resident Tracking Log (P. Ex. 10). Ms. O'Bannon acknowledged Resident 2's inclusion in the document but she thought that an important element of infection control is to have more documentation in a central location. Tr. 204-205. Ms. O'Bannon conceded, however, as Petitioner notes in its brief, that there is no industry standard requiring one centralized infection log. Tr. 213-214. Petitioner argues that Ms. O'Bannon's conclusions were based on her inability to see the "big picture" (Tr. 204) and that she erroneously assumed the Facility was also incapable of doing so. Petitioner's brief at 25. Petitioner asserts that CMS focused on whether the infection tracking was being accomplished according to the Surveyors' perception of what the formal channels ought to look like, but that this focus prevented CMS from seeing that effective monitoring was taking place. Petitioner's brief at 25. Petitioner contends that CMS's focus on form over substance is evident in that Ms. O'Bannon did not interview staff about their infection knowledge. Tr. 207-208. And that Ms. O'Bannon was mistaken that Resident 2's record of positive cultures and fevers indicated Resident 2 suffered infections, because, as Ms. O'Bannon agreed (Tr. 217-219), if there are signs and symptoms additional to these, the physician will order an antibiotic. Petitioner argues also that, as Ms. O'Bannon agreed on cross-examination (Tr. 219), there is no legal standard requiring a facility to monitor fevers not caused by infections through an infection control log.

Petitioner disputes the allegations conveyed in Ms. Monhollen's testimony that Petitioner did not follow its own policy concerning tracking nosocomial versus communal infections. Petitioner argues that Ms. Monhollen conducted her analysis of the policy without benefit of the whole thing. Petitioner's brief at 27. Petitioner argues that Ms. Monhollen testified that she reviewed the Facility's infection control policy (P. Ex. 8), Tr. 234, and the Infection Control Resident Tracking Log kept at the nurses' station (P. Ex. 10), Tr. 235, and that based on that review she concluded that the Facility failed to follow its infection control program because the records show it did not identify positive organisms and did not investigate whether infections were nosocomial. Tr. 237. Petitioner argues that the Infection Control Resident Tracking Log does in fact show whether infections are nosocomial. Petitioner's brief at 27. As for Petitioner's Exhibit 8, Petitioner claims that this is entirely the infection control policy, nor was it represented as such to the Surveyors, so Ms. Monhollen's assumption that she was analyzing the Facility's infection control policy was erroneous. Id.

Petitioner contends that the nurse whom Ms. Monhollen faulted for hand washing-related and other lapses during the provision of wound care did not miss the March 2001 in-service on infection control. Petitioner argues that the nurse was working at the Facility on the day the in-service was held, so she most likely attended but forgot to sign in. Petitioner's brief at 27-28; Tr. 431-432.

Petitioner disputed Ms. Monhollen's criticism (Tr. 241-242) that the Facility did not use a base number from which to determine what constituted a high rate of infection. Petitioner's brief at 28. Petitioner cites Mr. Dietz' testimony that having a base number was not useful because he considered it more important to investigate every unusual infection outbreak without waiting for a threshold number to be breached. Tr. 445.

Petitioner argues also that CMS is applying too strict a standard to the Facility's infection control program. Petitioner suggests, based on an article published by APIC, that there are few standards for infection control in nursing home settings. Petitioner's brief at 28, citing P. Ex. 16. And, Petitioner asserts, the article it cites supports the principle that calculating rates of infection are more accurate than analyzing absolute numbers of infection. Petitioner's brief at 28-29. Petitioner suggests also that the article indicates that the phenomenon of health care professionals confusing colonization with infection (something Petitioner believes CMS is doing in the instant matter) is contributing to the problem of antibiotic resistance. Petitioner's brief at 29.

Concerning CMS's allegation that the Facility did not investigate the source of Resident 13's MRSA upon his return to the Facility from the hospital, Petitioner avers that Resident 13 was monitored, and that the Facility consulted with the Resident's physician who deemed it appropriate for Resident 13 to return to the Facility. P. Ex. 32, citing the testimony of Ms. Arnett at Tr. 312, 353, 379. Petitioner submits, based on an article published by the Centers for Disease Control (P. Ex. 18), that patients with MRSA do not require separate infection control tracking when they are not documented to be the source of transmission to other patients. Petitioner's brief at 30, citing P. Ex. 18, at 4.

Petitioner disputes also allegations in the 2567(CMS Ex. 3), not testified to by the Surveyors at hearing, that Resident 8 had tested positive in urine cultures performed from October 2000 to June 2001 but there was no evidence that the Facility was investigating these infections for causal agents. CMS Ex. 3, at 66. Petitioner argues that there is no evidence that the positive cultures were infectious. Petitioner's brief at 30. Furthermore, Petitioner argues, the performance of the cultures demonstrates that Resident 8 was being monitored. Petitioner's brief at 30. Petitioner also submits that the evidence shows that the Facility care planned to monitor urine for signs of infection. P. Ex. 28. And, Petitioner argues that, based on a statement signed by the Resident's physician (P. Ex. 29), the evidence is that the Facility's nursing staff discussed possible causative agents for Resident 8's positive urine cultures, and that the Facility attempted all possible interventions for the Resident. Petitioner's brief at 30-31.

Petitioner also disavows the statement made to the Surveyors by one of the nurse aides concerning the use of catheter care kits. CMS Ex. 3, at 66-67. CMS apparently concluded that the statement revealed an inconsistency with Facility policy and procedure and, therefore, contributed to the infection control deficiency. Id. Petitioner counters that, as testified to by Ms. Arnett, the nurse aide was mistaken because the Facility does not use catheter care kits (Tr. 333-334, 346), and, Petitioner argues, nothing about the nurse aide's statement shows that there was deficient infection control. Petitioner's brief at 31.

Petitioner responds to an allegation in the 2567 (CMS Ex. 3, at 67-68) that Resident 4 returned to the Facility from the hospital on May 2, 2001 with an infection and antibiotics were ordered, but the Facility did not record one of those antibiotics: Azactam, on the Infection Control Resident Tracking Log. Petitioner argues that Azactam was recorded but it appears that it was mistakenly written over (P. Ex. 10, at 9). And, Petitioner argues, Ms. Arnett explained that she would have reviewed the Resident's chart to view the actual physician's order (Tr. 314-316). Petitioner's brief at 32.

In the 2567 (CMS Ex. 3), the Surveyors faulted the Facility for not doing enough to identify infectious organisms. Petitioner responds that the Facility performed wound cultures ordered by physicians (Tr. 304), but to perform tests that determine infection required sending samples outside the Facility (Tr. 304-305). Petitioner explained that physician-ordered cultures are used chiefly to help the physician select an antibiotic. Because physicians are generally concerned with antibiotic overuse they do not prescribe them absent other signs or symptoms (Tr. 305-307). Petitioner's brief at 32-33.

I conclude that Petitioner failed substantially to comply with the infection control requirement because I find that CMS presented evidence that, prima facie, the Facility staff used deficient infection control techniques/practices and, while the Facility had a documented infection control program, CMS demonstrated that it was insufficient due to lapses in its implementation. Petitioner failed to rebut that its infection control program was deficient by a preponderance of the evidence.

The infection control techniques cited under this F-tag are those discussed above regarding F-314 and the wound care provided to Residents 2, 4 and 13. In addition, I am persuaded of the deficient nature of two other instances cited by CMS, the instance when Mr. Dietz handled a sling contaminated with bodily fluids and the instance when a nurse was observed to handle a resident's gastrostomy tube and administer medications without adequate precautions. Concerning the latter two instances, Petitioner's response is essentially the same to both. Petitioner argues that Mr. Dietz did not touch the contaminated part of the sling, so glovers were unnecessary in that instance. And, Petitioner asserts, because it is not established that there was oozing on the gastrostomy tube, it was unnecessary for the nurse to wear gloves in that instance. Petitioner argued also concerning the latter instance that the conduct alleged by CMS does not violate any regulation.

I conclude that in both these instances the decision not to wear gloves is inconsistent with the infection control regulation at section 483.65(a)(1)-(3). Mr. Dietz may not have actually touched any of the fluid on the sling, but the standard requiring the appropriate technique is prophylactic. There was the risk that by handling the contaminated sling he could have and spread infection. Similarly, when the nurse handled the gastrostomy tube the nurse may have touched bodily fluid and carried contaminants to other residents. To contest whether there was in fact ooze is Petitioner's burden to bear, but it is beside the point. Using proper technique, i.e., changing gloves between different procedures or tasks, is prophylactic. Its purpose is to reduce the risk of transmission of contaminants and the spread of infection. The use of appropriate techniques is integral to the requirement to control and prevent infection.

Moreover, the Facility failed to adequately investigate and monitor infections. Despite Petitioner's contention that the Surveyors misunderstood what constituted the Facility's infection control policy, even construing the policy as presented by Petitioner, that only page 2 of Petitioner's Exhibit 8 constituted the policy, Petitioner has not presented sufficient evidence to rebut CMS's allegation that the Facility failed to follow the policy. The lapses in following its own policy show that the Facility did not effectively implement the infection control program.

The Facility's program for monitoring and investigating infections calls for, inter alia, identifying each resident infection by causative organism and source of infection. Yet the Facility presents no evidence that it made reasonable attempts to adhere to this tenet of the program. The infection control reports (P. Ex. 11) only list the number of infections by their general category and the percentage each type of infection represents. The Infection Control Resident Tracking logs (P. Ex. 10) are similarly silent concerning causative organisms and sources of infection. Nor do these documents specify some of the other information called for in the program including date of infection, precautionary measures taken to halt the spread of infection and identification of high risk factors (I note that Petitioner is correct that nosocomial infections are documented although the Surveyors asserted they were not). If Petitioner documented this information elsewhere, it has failed to show where. And, if this information can only be gleaned from looking through each resident's individual records, that highlights, contrary to Petitioner's suggestion, a greater fault in the program than a dispute about mere form, i.e., which documents should be centralized and which not. If significant data is left unorganized, the lapse is hardly a matter of form over substance: it is a substantive defect. For data to be useful it must be compiled for analysis. Petitioner has not persuaded me that it complied the relevant data for analysis as part of a comprehensive infection control program despite its showing that it had a rudimentary policy in place.

c. F-157

The requirement at 42 C.F.R. § 483.10(b)(11)(i)(B) is that the Facility must immediately, when there is a significant change in the resident's physical, mental, or psychosocial status (i.e., a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications), inform the resident; consult with the resident's physician; and if known, notify the resident's legal representative or an interested family member. CMS alleges that the Facility failed to notify Resident 2's physician, in contravention of Facility policy, that Resident 2 experienced a temperature of 101degrees that did not respond to Tylenol.

The circumstances of the unreported significant change, as explained by CMS, are that Resident 2 was readmitted to the Facility from the hospital on May 25, 2001 with gram negative sepsis, aspiration pneumonia and urinary tract infection. Resident 2 was supposed to receive an antibiotic for three weeks after readmission to the Facility. After a week of the antibiotic, Resident 2 was observed to have a temperature of 101.5 degrees. Two and one half hours after receiving Tylenol, Resident 2's temperature was recorded at 101.6 degrees. In response, Facility staff applied a cool compress to Resident 2. CMS Ex. 1, at 1-3; CMS Ex. 19, at 8, 10-11, 65.

Two relevant Facility policies were noted by CMS. One is a general temperature policy that requires staff to notify the physician if the resident's temperature is greater than 101 degrees, and one hour after administering Tylenol the temperature has not decreased. CMS Ex. 19, at 29. The other policy concerns elevated temperatures after antibiotic therapy has been administered. That policy requires the Facility promptly to notify the physician if after 48 hours on antibiotic therapy (Resident 2 had been on antibiotics for a week), a resident's temperature is greater than 101 degrees. The policy calls also for the administration of analgesics and for rechecking the temperature one hour after administering them, and then at four hour intervals until the resident is asymptomatic for 48 hours. But it is not clear if this policy is intended to be used only from the initiation of antibiotic therapy for the first 48 hours, or any time after antibiotic treatment has begun and a resident experiences an elevated temperature.

Petitioner does not explain the apparent conflict between the policies. Petitioner argues that the policies are beside the point because failure to follow the Facility policy does not demonstrate that a resident experienced a significant change, and that, based on the testimony of Ms. Arnett, Resident 2 had a higher baseline temperature than the average normal temperature, and, therefore, even though her temperature was recorded above 101 degrees, that did not represent a significant change for the resident. Petitioner's brief at 34-35; Petitioner's response brief at 3-4.

Petitioner is correct that failure to follow its own policy is not per se prima facie evidence that it failed to report a significant change. CMS has, however, set forth a prima facie case that there was a significant change, an elevated temperature unresponsive to Tylenol, and buttressed this evidence by demonstrating that the Facility apparently considered these events significant enough to merit written policies addressing them. I am not persuaded by Ms. Arnett's testimony that Resident 2 had a higher than normal temperature to begin with, particularly in light of the fact that Facility staff who provided the care to Resident 2 did not consider that the Resident had a higher baseline temperature. CMS Ex. 19, at 11. I conclude, therefore, that the Facility failed to report a significant change to the physician as required by section 483.10(b)(11)(i)(B).

d. F-281

Based on my findings and conclusions concerning the deficient pressure sore and infection prevention techniques and procedures provided to Residents 2,3,4, and 13, discussed in the sections addressing F-314 and F-441 above, I uphold CMS's determination that the Facility failed to ensure that services it provided or arranged to residents met professional standards of quality. CMS asserted that the same facts support a prima facie determination of deficiency under F-281. CMS's brief at 17. Petitioner also relied on its case presented on F-314. Petitioner's brief at 35 (mistakenly incorporating "tag 316" by reference); Petitioner's response brief at 5-6.

e. F-316

The facts concerning urine cultures performed for Resident 8 that support in part my conclusion that the Facility was deficient under F-441 also support my conclusion that Petitioner failed to substantially comply with the requirement to prevent urinary tract infections and restore bladder function at 42 C.F.R. § 483.25(d)(2). CMS presented prima facie evidence that Petitioner failed to comply with section 483.25(d)(2). Specifically, CMS showed that the Facility failed to monitor Resident 8 for signs and symptoms of the causal agents of urinary tract infections. And, the Surveyors noted that Resident 8 continuously developed urinary tract infections. CMS Ex. 3, at 44-46; CMS's brief at 20.

Additionally, CMS submitted evidence that Facility records show that Resident 8 was incontinent of bowel and required the used of a Foley catheter, but there is no indication in the Facility records that Resident 8 was assessed for risk of urinary tract infections or tracked through the infection control program. CMS showed that from October 10, 2000 to June 12, 2001, lab results for Resident 8 indicated abnormal urinalyses, urine cultures and vaginal cultures, and cultures were positive for bacteria found in the intestines and bacteria found on the epidermis. CMS Ex. 25, at 7-17.

CMS also questioned the consistency and integrity of the Facility's approach to this area of care. CMS asserts that the Facility's catheter policy (CMS Ex. 25, at 6) requires catheters be cleaned with soap and water every 24 hours and as needed. A Facility nurse, however, explained to the Surveyors that the nurse used something called a "catheter kit" to maintain catheters. Another nurse-aid explained to the Surveyors that she used peri-wash and wipes to clean catheters. In contrast, Ms. Arnett testified that she did not know what a catheter kit was and that the Facility did not use them. Tr. 346.

Petitioner argues that the positive tests cited by the Surveyors do not equate with urinary tract infections. Petitioner's brief at 37. In support of Petitioner's position that Resident 8's care was not deficient under F-316, Petitioner cites a signed statement by the Physician, Dr. Black. P. Ex. 29. In the statement, however, Dr. Black confirms that Resident 8 suffers "chronic, frequent, recurring UTI." Thus, it seems more likely that Resident 8's positive tests did in fact indicate urinary tract infection. Dr. Black's statement, dated July 5, 2001, indicates also that staff has discussed possible causal agents and attempted all possible interventions to prevent urinary tract infections for Resident 8. P. Ex. 29. These assertions, however, made apparently after the survey, require explanation in order for them to support Petitioner's position. What staff? What discussions about causative agents? And, what were all the possible interventions attempted? Without any supporting evidence the statement stands as an unsupported assertion that the Facility complied. I conclude therefore that Petitioner failed to substantially comply with F-316.

2. CMS's determination that Petitioner's deficiencies constituted immediate jeopardy to residents was not clearly erroneous

Petitioner argued that CMS's determination to assess F-314 and F-441 at the immediate jeopardy level of severity was clearly erroneous. I conclude that it was not.

Specifically, concerning F-314 Petitioner argued that, as there were no systemic pressure sore treatment problems, no infected pressure sores and a good overall pressure sore healing record, the record does not support CMS's severity determination. Petitioner asserts that the increased possibility of harm at sometime in the intermediate future is not immediate jeopardy because "any theorized harm is neither likely, immediate or serious." Petitioner's brief at 18. And, Petitioner argues, the 2567 (CMS Ex. 3) shows that the same facts underlying F-314 are the basis for F-281, but CMS sited F-281 at the lower severity level requiring residents be subjected to no actual harm with the potential for more than minimal harm. Petitioner reasons that if F-314 was cited at the immediate jeopardy level, F-281 should have been also, so it is telling that CMS chose not to cite it that way. Petitioner's brief at 19.

Petitioner's argument does not persuade me that CMS committed clear error in determining the pressure sore related deficiency posed immediate jeopardy to residents. Even a credible showing that the Facility provided consistent overall pressure sore care does not demonstrate that CMS's assessment of the risk to the Residents was clear error. Asserting that harm to residents was theoretical, and therefore not likely, immediate or serious, does not carry Petitioner's burden to show that CMS's perspective, that there was a the likelihood of serious harm, was clear error. Petitioner's assertion that harm was not likely, immediate or serious does not establish the fact and, therefore, does not establish that CMS erred. And, as discussed above, a history of generally competent care does not excuse or outweigh specific instances of deficient care. The instances of deficient care are what CMS determined presented the jeopardy - the suggestion that potential harm presented by deficient care would be undone by consistent care provided after the fact is insufficient to demonstrate it was clearly erroneous to determine that Residents were likely to suffer serious harm from infection and or worsening pressure sores or development of new pressure sores.

Concerning F-441, Petitioner argues that even if there were some flaw in the Facility's overall infection control program design that would present only a risk of a delay in recognition of trends in infection. Thus, Petitioner concludes that because no harm would likely befall residents within hours, the immediate jeopardy determination was clearly erroneous. Petitioner's brief at 33. Apparently Petitioner misapprehends its burden to demonstrate the clear error of CMS's severity determination. Petitioner's supposition that no harm would likely befall residents within hours is an alternative, albeit arguably plausible, scenario for what would result from the deficient infection control program, but it is not effective to show the clear error of CMS's judgment that the deficient infection control program would likely cause more, and more prolific infections, i.e., serious harm to residents. In fact, implicit in Petitioner's argument is the apparent harm that is the concern. If the recognition of trends in infection is valuable, presumably it is so because it protects residents from the spread and worsening of infection. What precise harm to residents is presented by a delay in recognizing such trends is hard to say, but it is speculative of Petitioner to assert the delay presents so minimal a risk to residents that it shows that CMS must have been clearly erroneous to determine the delay would likely lead to serious harm. If recognition of trends is infection is important to infection control it is reasonable to surmise that the delay of the recognition, or the failure to apprehend a trend would likely cause serious harm to residents.

3. The amount of the civil money penalty is reasonable

My conclusions discussed above, that Petitioner failed substantially to comply with F-314 and F-441, provide the basis for the imposition of a remedy. The issue remaining is whether the remedy proposed by CMS is reasonable.

If a facility is found to be out of substantial compliance with participation requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a civil money penalty (either per instance or per day). 42 C.F.R. § 488.408. Reasonableness of the amount of a civil money penalty is determined by applying the factors listed in 42 C.F.R. §§ 488.438(f) and 488.404. Emerald Oaks, DAB No. 1800, at 10 (2001); CarePlex of Silver Spring, DAB No. 1683, at 16-17 (1997). These factors include: a facility's history of noncompliance; a facility's financial condition; a facility's degree of culpability, and the factors specified in section 488.404 which are considered in the selection of any remedy. The regulation calls for an initial assessment of the seriousness of the deficiency, which includes the degree or risk of harm that the deficiencies present and whether the deficiencies are isolated, part of a pattern, or widespread. 42 C.F.R. § 488.404(b). CMS may also consider "other factors, which may include, but are not limited to," how the deficiencies relate to each other and the prior history of compliance of the facility. 42 C.F.R. § 488.404(c). In this case, CMS has proposed a civil money penalty of $24,300 ($4,050 per day for six days). A civil money penalty ranging from $3050 to $10,000 is authorized for a deficiency that constitutes immediate jeopardy. 42 C.F.R. § 488.438(a)(i). The proposed civil money penalty is thus at the lower end of the range.

CMS argues that the amount of the civil money penalty is reasonable in light of the factors set forth in sections 488.404 and 488.438(f) as it is at the lower end of the allowable immediate jeopardy range. CMS's brief at 42. Petitioner challenged the immediate jeopardy determination but did not present evidence concerning the reasonableness of the amount of the immediate jeopardy civil money penalty. Petitioner's response brief at 2.

Considering all the relevant factors in light of the evidence, I conclude that the proposed civil money penalty is reasonable.

IV. Conclusion

In view of the forgoing I uphold CMS's determination to assess a civil money penalty against Petitioner for its failure substantially to comply with Medicare participation requirements. I conclude also that CMS's determination that Petitioner's failure placed residents in immediate jeopardy was not clearly erroneous and that the amount of the civil money penalty, $24,300, is reasonable.

Richard J. Smith

Administrative Law Judge