SUBJECT:

Woodbiine Healthcare and Rehabilitation,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS, formerly known as the Health Care Financing Administration or HCFA), ⁽¹⁾ to impose a civil money penalty (CMP) against Petitioner, Woodbine Healthcare and Rehabilitation (Petitioner or facility), for failure to comply substantially with federal requirements for Medicare participation. As explained below, I conclude that from November 18, 1999 through May 11, 2000, Petitioner was out of compliance with program requirements, and that its deficiencies posed immediate jeopardy to resident health and safety during the period November 18, 1999 through December 9, 1999. I find to be reasonable the CMP of $8,050 per day that CMP determined to impose against Petitioner for Petitioner's noncompliance at the immediate jeopardy level during the period November 18, 1999 through December 9, 1999. I find that a CMP of $300 per day is a reasonable remedy for each day of Petitioner's continued noncompliance with participation requirements from December 10, 1999 through March 27, 2000. Finally, I find that although CMS imposed a CMP of $650 per day for Petitioner's continued noncompliance from March 28, 2000 through May 11, 2000, a lesser CMP of $300 per day for this period is reasonable.

I. Background

Petitioner, Woodbine Healthcare and Rehabilitation, is a long-term care facility located in Gladstone, Missouri. The Missouri Division of Aging (State survey agency) conducted surveys of Petitioner in November 1999, December 1999, and March 2000.

In a Notice letter dated November 24, 1999, CMS advised Petitioner that, on November 18, 1999, a complaint survey was completed by the State survey agency. CMS advised Petitioner that the survey found that the facility was not in substantial compliance with participation requirements and the conditions at the facility constituted immediate jeopardy to resident health and safety. CMS Ex. 205. The letter stated that Petitioner's provider agreement would be terminated on December 11, 1999, and that a denial of payment for new admissions (DPNA) and a CMP would be imposed. CMS advised that the DPNA would be effective November 27, 1999, and the CMP would be effective November 18, 1999, in the amount of $8,050 for each day that Petitioner was not in substantial compliance with participation requirements. Id. ⁽²⁾ The evidence which I shall discuss below also fully supports the DPNA, and I therefore sustain the imposition of that sanction as well.

In a Notice letter dated January 14, 2000, CMS advised Petitioner that the December 10, 1999 revisit established that the facility had removed the immediate jeopardy, and therefore, its participation in the Medicare program would not end on December 11, 1999. CMS Ex. 206. CMS advised that because Petitioner had not attained substantial compliance with federal requirements, further corrective action was required. The letter advised further that as a result of the removal of the immediate jeopardy, the CMP, which was effective November 18, 1999, continued to accrue in the amount of $8,050 per day through December 9, 1999, was reduced to $450 per day effective December 10, 1999, and would continue until Petitioner had achieved substantial compliance or its provider agreement was terminated. In addition, CMS stated that the DPNA remedy, which was effective November 27, 1999, would remain in effect until Petitioner had achieved substantial compliance or its provider agreement was terminated. Id. Further, the letter stated that if Petitioner did not achieve substantial compliance within six months after the last date of the survey identifying noncompliance (i.e. by May 18, 2000), its Medicare provider agreement would be terminated.

In a letter dated April 28, 2000, CMS advised Petitioner that, "[a]fter a careful review of the facts, we have determined that [Petitioner] does not meet the requirements for participation as a skilled nursing facility in the Medicare program under Title XVIII of the Social Security Act." CMS Ex. 207. The letter stated that if a revisit conducted prior to the close of May 18, 2000, verified that Petitioner had achieved substantial compliance with all requirements, termination of its Medicare agreement would not be effectuated. CMS also advised Petitioner that the CMP of $450 per day and the DPNA would continue until either the facility achieved substantial compliance with regulatory requirements or the termination date of May 18, 2000. Id.

In a letter dated June 19, 2000, CMS advised Petitioner that a revisit on May 12, 2000, established that corrections had been made and Petitioner was back in substantial compliance. CMS Ex. 208. CMS advised that Petitioner's participation in the Medicare and Medicaid programs would not be terminated. CMS stated that the DPNA remedy would be removed as of May 12, 2000. The letter also contained a table summarizing the total CMP accrued. According to this table, the total amount of the CMP was $239,050.

Petitioner filed a request for hearing on January 21, 2000, to contest the remedies and alleged deficiencies. ⁽³⁾ The case was docketed C-00-229, and assigned to several administrative law judges (ALJs) before being reassigned to me for hearing and decision on September 26, 2001.

I held a hearing in Kansas City, Missouri, from October 16-19, 2001. CMS offered CMS Exhibits (CMS Exs.) "One through 210." ⁽⁴⁾ Transcript (Tr.) 14. I admitted CMS Exs. 1-210. Tr. 15. Subsequently, I clarified my statement regarding the admission of CMS's exhibits, and stated that I was "admitting [CMS's exhibits] as numbered on the updated exhibit list filed approximately two weeks ago by CMMS. There are obvious laps [sic] between 1 and 210 . . . ." Tr. 37. The exhibits listed on CMS's updated exhibit list, dated September 26, 2001, all of which were admitted into evidence, are as follows: CMS Exs. 1 through 5, 6-1 through 6-8, 6D, 7N, 7D, 31, 32, 36, 37, 40 through 44, 103, 104-5, 106, and 201 through 210.

Petitioner offered Petitioner's Exhibits (P. Exs.) 1 through 8; 100, 102 through 104; and selected pages from the following exhibits: P. Ex. 11, pp. 98, 337, 678, 1071, 1190, 1191, 1195, 1196, 1198, 1610; P. Ex. 13, pp. 117, 119, 369, 370; P. Ex. 14, pp. 61-63, 66, 69, 354, 404, 548, 549, 566, 667, 671, 679, 681, 689; P. Ex. 15, pp. 44, 137-46; 216. I admitted the aforementioned exhibits offered by Petitioner. Tr. 513-17, 521-33; 780; 826-27.

II. Applicable Law and Regulations

Petitioner is a long-term care facility under the Act and regulations promulgated by the Secretary of Health and Human Services (Secretary). The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Social Security Act (Act), and at 42 C.F.R. Part 483.

Facilities must maintain substantial compliance with program requirements. To be in substantial compliance, a facility's deficiencies may "pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. � 488.301. A facility's noncompliance constitutes immediate jeopardy if it "has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." Id. Immediate jeopardy can exist regardless of the scope and severity of the deficiency, so long as the deficiency involves a potential for more than minimal harm. Lake City Extended Care Center, DAB No. 1658, at 17 (1998). CMS's determination as to immediate jeopardy must be upheld unless "clearly erroneous." 42 C.F.R. � 498.60(c)(2); Bergen Regional Medical Center, DAB No. 1832 at 9, n.9 (2002).

Sections 1819 and 1919 of the Act invest the Secretary with authority to impose remedies such as CMPs against a long-term care facility for failure to comply substantially with participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the States the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. The applicable regulations at 42 C.F.R. Part 488 provide that facilities which participate in Medicare may be surveyed on behalf of CMS by State survey agencies in order to ascertain whether the facilities are complying with participation requirements. 42 C.F.R �� 488.10-488.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. �� 488.300-488.335. Under Part 488, a State or CMS may impose a per instance or per day CMP against a long-term care facility when a State survey agency concludes that the facility is not complying substantially with federal participation requirements. 42 C.F.R. �� 488.406, 488.408, and 488.430. The penalty may start accruing as early as the date that the facility was first out of compliance until the date substantial compliance is achieved or the provider agreement is terminated. 42 C.F.R. �� 488.440(a), (b).

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

In setting the amount of the CMP, CMS considers the following factors: (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 in 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 and specifically with reference to the cited deficiencies.

When a penalty 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. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEB) (D.N.J., slip op. May 13, 1999). Under Hillman, CMS bears the burden of coming forward with evidence sufficient to establish a prima facie case that Petitioner failed to comply with participation requirements. Once CMS has established a prima facie case of noncompliance, Petitioner has the burden of proving, by a preponderance of the evidence, that it complied substantially with participation requirements. Hillman, at 3-8. ⁽⁵⁾

The Act and regulations make a hearing before an ALJ available to a long-term care facility against which CMS has determined to impose a CMP. Act, sections 1128A(c)(2); 42 C.F.R. �� 488.408(g), 498.3(b)(13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F.2d 678 (8^th Cir. 1991).

III. Petitioner's prehearing motions

Prior to the hearing, Petitioner filed a Motion to Dismiss Civil Money Penalties for Inadequate Notice and a Motion to Dismiss Remedies Based on Use of an Unlawful Survey and Enforcement Process. CMS submitted a response to Petitioner's pretrial motions after the hearing. In its motions, Petitioner raised several legal issues and constitutional claims, arguing, among other things, that CMS's notice letter provided inadequate notice to Petitioner, and thus, warranted the dismissal of the CMPs; that CMS did not consider Petitioner's financial condition before determining the amount of any CMPs it might impose; that the survey and enforcement process did not comply with the rulemaking procedures of the Administrative Procedure Act; and that the regulations violated Petitioner's due process rights and its Fourth Amendment rights under the United States Constitution in that they promote unconstitutional searches.

I deny Petitioner's pretrial motions because I do not have the authority to decide them. I do not have the authority to hear and decide arguments challenging the lawfulness of regulations or of procedures utilized by CMS or a State survey agency in determining compliance by a long-term care facility with federal participation requirements. Such authority has not been delegated to me as part of my authority to hear and decide cases involving CMS. Further, I do not have the authority to consider whether regulatory language violates due process or is unconstitutional. Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002); Sentinel Medical Laboratories, Inc., DAB No. 1762 (2001). Generally, an ALJ is bound by the regulations promulgated by his administrative agency. See Ids. (Citations omitted.) Toward this end, I have the authority to interpret regulations and procedures and to decide whether CMS has acted properly pursuant to those regulations and procedures. But I am required to assume that regulations and procedures that the Secretary issues are legal. CarePlex of Silver Spring, DAB CR457, at 12 (1997), aff'd in part, rev'd in part, DAB No. 1627 (1997).

While I am not finding that any irregularities occurred during the various surveys at issue, to the extent that any errors occurred in the survey process, the regulations provide that inadequate survey performance "does not relieve a [facility] of its obligations to meet all requirements for program participation; or [i]nvalidate adequately documented deficiencies." 42 C.F.R. � 488.318(b); Forest Glen Skilled Nursing & Rehabilitation Center, DAB No. 1887 (2003). Thus, whether or not there were defects in the survey process is irrelevant, for the findings of a facility's noncompliance with the substantive requirements of 42 C.F.R. Part 483 constitute the basis of any remedies imposed against it. See Hermina Traeye, DAB CR1810 (2002).

Subsequent to filing its posthearing brief, Petitioner filed a Motion to Dismiss Remedies for Failure to Defend (Motion to Dismiss Remedies), claiming that CMS's failure to file a reply brief should result in dismissal of CMS's remedies. In the alternative, Petitioner sought to have the arguments presented in its posthearing brief treated as conceded.

CMS filed a response to Petitioner's Motion to Dismiss Remedies, and a reply brief. In its response to Petitioner's motion, CMS stated that it may have misunderstood the posthearing briefing schedule as it was discussed at the hearing and requested leave to file its reply brief out of time. I am a bit puzzled why CMS refers to the discussion of the posthearing briefing schedule that took place at the hearing, for that discussion was superceded a few months later by an Order I issued that extended the briefing deadlines. In that Order, I set specific deadlines for the parties' briefs.

Nevertheless, I deny Petitioner's Motion to Dismiss. None of the authorities cited in Petitioner's motion remotely suggests that such an action would be appropriate. Because I find that Petitioner has suffered no prejudice from CMS's late filing of its reply brief, I grant CMS's request for leave to file its reply brief out of time and have accepted its reply brief as part of the record in this case.

IV. Bias/Credibility of Witnesses

In its posthearing brief, Petitioner, besides reiterating the aforementioned arguments over which I have no jurisdiction, also made allegations of bias or animus, even conspiracy, on the part of the surveyors and CMS. Petitioner noted that Surveyor Vicky Reasoner had once been employed at Petitioner's facility, but quit without giving any notice. Petitioner's Posthearing Brief (P. Br.) at 31. ⁽⁶⁾ Petitioner attempted to portray Surveyor Reasoner's testimony as less than credible, based on numerous claimed inconsistencies in her account of the alleged deficiencies. Id. at 31-39.

Petitioner's assertions of bias or antagonism on the surveyors' parts do not entitle it to dismissal of the citations. Although Surveyor Reasoner was previously employed by Petitioner and may possibly have had disagreements with her supervisor, I find that her testimony is not impeached by virtue of her past relationship with Petitioner.

While it is true that the attitude or motivations that allegedly guided the surveyors' work would not, even if proven, require the dismissal of the enforcement action against Petitioner, there is more to the question of bias or animus than that fairly straightforward legal proposition, and I cannot let the matter rest without asking whether the credibility of any of the surveyors might be affected by their alleged hostility to Petitioner. Put another way, the question that Petitioner fairly raises in its allegations of bias is this: if the surveyors can be shown to have acted in a hostile or bellicose manner in conducting the surveys and assessing Petitioner's performance, then what effect might those attitudes have on the surveyors' truthfulness and candor, and on the reliability and completeness of their recorded observations?

Those are questions well-understood to be critical in the fact-finding process. In jury trials, bench trials, and hearings such as this one, the finder of fact is entitled to know such things and to use the information in assessing the credibility of the witness or witnesses involved. I emphasize that I have done so in this case: although Petitioner's assertions of the surveyors' antagonism could not, even if established, result in the dismissal of the enforcement action, the assertions have guided my evaluation of each witness involved in the surveys. But I have found no support for the allegations of bias, hostility, or any other improper motivation in or for the surveyors' conduct. I have found nothing untoward in their motivation, attitude, or activities, and nothing whatsoever on which I might rely to justify any reduction in the credibility I assign to their testimony.

V. Issues

The issues in this case are: (1) whether CMS had a factual basis to impose remedies against Petitioner for failing to comply substantially with federal requirements; (2) whether, if the deficiencies are established, any deficiency posed immediate jeopardy; and (3) whether the amounts of the CMP imposed by CMS are reasonable, if noncompliance is established.

VI. Findings of Fact and Conclusions of Law

I make findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each Finding below as a separate heading. I discuss each Finding in detail.

I do not discuss herein every F-Tag that was cited by the surveyors at the three surveys in issue. The Departmental Appeals Board (DAB) has previously approved an ALJ's discretion to exercise judicial economy and not discuss every alleged deficiency. Beechwood Sanitarium, DAB No. 1824 (2002), at 22; Beechwood Sanitarium, DAB No. 1906 (2004); Western Care Management Corp., d/b/a Rehab Specialties Inn, DAB No. 1921 (2004). Substantial noncompliance with only one participation requirement can support the imposition of a penalty. Beechwood Sanitarium, DAB No. 1824 (2002).

In general, the F-tags and residents I have focused on and discussed in this decision are those which, in my opinion, sustain the immediate jeopardy level finding for the period November 18, 1999 through December 9, 1999, thus invoking the "upper range" of the CMP. Then, since Petitioner remained out of compliance, albeit at lower scope and severity levels, until May 11, 2000, I have chosen to address certain of the remaining F-tags which, in my opinion, sustain the rest of the CMP (set at two varying levels) that was imposed against Petitioner. The deficiencies I have found herein provide a sufficient basis to affirm the finding of immediate jeopardy and the imposition of the CMP, as modified, against Petitioner.

Resident 1

A. With respect to Resident 1 (R1), Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.10(b)(11) (F-157) and 42 C.F.R. � 483.70(h)(4) (F-469).

F-157

F-157 of the November 1999 Statement of Deficiencies (Statement of Deficiencies or SOD) alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.10(b)(11). CMS Ex. 201, at 1-2; P. Ex. 4, at 1-2. This regulation requires, in relevant part, that a long-term care facility immediately inform the resident and consult with that resident's physician, and, if known, notify the resident's legal representative or an interested family member 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) or there is a need to alter treatment significantly.

In the November SOD, F-157 incorporates by reference the pressure sore allegations under F-314 (relating to 42 C.F.R. � 483.25(c)). Many of the allegations under F-314 with respect to R1 concern incidents of maggot infestation that occurred in and around R1's wounds. ⁽⁷⁾ CMS alleges that Petitioner's noncompliance under F-157 results from its failure to notify R1's physician with respect to these maggot infestations.

The records show the following:

� R1, a 79-year-old woman, suffered from a number of medical problems, including diagnoses of a left leg fracture, decubitus ulcer, diabetes mellitus, coronary artery disease, Parkinson's disease, and hypercalcemia. CMS Ex. 201, at 11; P. Ex. 4, at 11; See CMS Ex. 1, at 1, 140. Additionally, the SOD describes this Resident as suffering hemiparesis, but I have been unable to find corroborating references to this condition in the clinical evidence. R1 was readmitted to the facility from a hospital stay on July 10, 1999. She had a fracture brace on her left lower leg, and pressure areas were noted on her left foot. CMS Ex. 201, at 11; P. Ex. 4, at 11. The nursing notes state that R1 had an area on her left heel that was necrotic, with no deep tissue involvement, a red area on the dorsum of her foot, an open pressure area on the ball of her left foot, and an open pressure area on her right buttock. CMS Ex. 1, at 6-7.

� A physician's order dated July 10, 1999, stated that the fracture brace was "to be removed daily for inspection of skin for possible pressure sores." CMS Ex. 1, at 14; see CMS Ex. 201, at 12; P. Ex. 4, at 12.

� On August 8, 1999, the physician gave a telephone order stating the Resident's left leg brace must be kept on for 23 hours and 45 minutes, and could only come off for 15 minutes a day for hygiene. CMS Ex. 201, at 12; P. Ex. 4, at 12; see CMS Ex. 1, at 15.

� On August 30, 1999, nurses, while performing perineum care, found an open pressure sore on R1's coccyx and observed "multiple maggots" on her thigh area. CMS Ex. 201, at 13; P. Ex. 4, at 13; see CMS Ex. 1, at 22, 133. They removed the brace, and the stocking underneath was soiled with a dark brown stain, and had a foul-smelling odor. According to one nurse, when they removed the stocking, approximately 150 maggots were on R1's thigh area. CMS Ex. 201, at 13; P. Ex. 4, at 13; see CMS Ex. 1, at 24. R1's thigh had a small puncture opening, her ankle dressing had a dark brown stain and was foul-smelling. When the dressing was removed, a five cm x five cm open area with scabs was underneath. CMS Ex. 201, at 13; P. Ex. 4, at 13; see CMS Ex. 1, at 22.

� The nurses cleaned R1's left leg with hydrogen peroxide, betadine, and soap and water. CMS Ex. 201, at 13; P. Ex. 4, at 13; see CMS Ex. 1, at 24. After R1's leg was clean, the nurses applied towels to the inside of the brace and put her brace back on. CMS Ex. 201, at 13-14; P. Ex. 4, at 13-14; CMS Ex. 1, at 24.

� One of the nurses stated that she informed the shift supervisor and the unit manager, but did not notify the physician because "it was not life threatening" and the situation had been taken care of. ⁽⁸⁾ CMS Ex. 201, at 13-14; P. Ex. 4, at 13-14; see CMS Ex. 1, at 24. The staff did not find maggots anywhere else on R1's body. CMS Ex. 201, at 14; P. Ex. 4, at 14; see CMS Ex. 1, at 25.

� On September 23 or 24, 1999, while removing the dressing on R1's left heel, the physical therapist saw significant drainage on the dressing, and two maggots in the layers. CMS Ex. 201, at 15-16; P. Ex. 4, at 15-16; see CMS Ex. 1, at 35. She showed the maggots to a LPN, and reported the incident to her supervisor. CMS Ex. 201, at 16; P. Ex. 4, at 16. The physical therapist cleaned the wound. CMS Ex. 201, at 16; P. Ex. 4, at 16; see CMS Ex. 1, at 35. The LPN stated that she did not notify the physician regarding this incident, nor did she document the finding of maggots in the nursing notes. CMS Ex. 201, at 16; P. Ex. 4, at 16; see CMS Ex. 1, at 45. The LPN stated that she informed the wound nurse of what the physical therapist had found, and thought the wound nurse would follow up. CMS Ex. 201, at 16; P. Ex. 4, at 16; see CMS Ex. 1, at 44-45. The wound nurse stated that she told the LPN to call the physician and did not follow up on the incident. The nurse did not document the conversation because the LPN would have been responsible for doing this. CMS Ex. 201, at 16-17; P. Ex. 4, at 16-17; see CMS Ex. 1, at 58.

� There was nothing in the Resident's records for September 23-24 showing that Petitioner's staff had notified the Resident's physician about the maggots.

� The physical therapy progress notes from September 23 and September 24, 1999, do not contain any documentation that maggots were found in the dressing. See CMS Ex. 1, at 40; P. Ex. 11, at 678.

In light of what I have set forth above, I conclude that the episodes of maggot infestation constituted a significant change in R1's medical condition, which triggered the facility's staff's obligation to notify her physician, as required by 42 C.F.R. � 483.10(b)(11). There is no dispute that Petitioner's staff failed to notify Resident 1's physician of the episodes of maggot infestation on R1. ⁽⁹⁾

Petitioner made several arguments in response to CMS's allegations. Petitioner argued that, given the weather and the physical situation at the facility due to the failure of the facility's air-conditioning, there was no practical way to keep the flies out of the facility. Petitioner asserted also that maggots breed very rapidly and multiplied before anyone could reasonably have detected them. Finally, Petitioner asserted that the presence of maggots did not cause any harm and thus, did not pose any danger to the residents.

In support of its arguments, Petitioner relied on the testimony of its expert witness, Dr. David Jackson. Dr. Jackson downplayed the discovery of maggots, citing the fact that the facility's air-conditioning was not working in August and therefore the facility's windows and doors were opened so that the residents would not suffer heat stress. Tr. 552. He testified that a fly's larvae deposited on the outside of a resident's leg would not constitute a significant change in condition that requires notification. Tr. 553. He stated that he found no evidence in R1's record that any lack of physician or family notification caused any harm to the Resident. Tr. 558.

Dr. Jackson testified that "[n]o one likes to have a fly in the building, but it's a natural stress or risk that you run into." Tr. 553. He questioned the surveyor's decision to cite this deficiency at the immediate jeopardy level, stating that there was "no impact" on R1's care or ultimate outcome. Id. In Dr. Jackson's opinion, the appearance of maggots on R1 was a "self-limiting condition," which "went away when it was cleaned off." Id.

Dr. Jackson stated also that "larvae from flies have been used as treatment for decubitus ulcers since the Civil War, it's actually an area that's being looked at again in medicine because of antibiotic resistance, the larvae do not injure the wound bed." Tr. 552. He stated that he had seen maggot therapy used when he was an intern many years ago. Tr. 626.

When asked on cross-examination whether there was any evidence that maggots were prescribed for R1 as treatment for her wounds, Dr. Jackson responded, "Absolutely not. That was not part of the clinical plan." Tr. 620-21. He agreed that the presence of maggots on R1, beginning on August 30, 1999, could be characterized as an "abnormality." Tr. 621, 623. Dr. Jackson's testimony on cross-examination contains the following colloquy:

Q: If you had a patient such as Resident No. 1 who you've testified you're familiar with and the care team, the nurses, found the 150 maggots in a wound dressing, would you have wanted to have been informed of that fact at the time?

A: I would want to know about it in - not as an emergent issue. You know, it's not life or death clinically relevant to an immediate clinical decision kind of thing. But I would want to be aware of that information, not so much for clinical management, because it didn't recur and it was cleaned up and that wasn't a continuing clinical - but for communications issues, I'd want to know about it in case somebody asked me about it.

Tr. 625.

In marked contrast to Dr. Jackson's testimony, CMS's expert witness, Dr. Courtney Lyder, testified:

[m]aggot infestation is defined by the Agency for Healthcare Policy Research Guidelines to be a complication. Normal nursing practice, or general nursing practice, would be that that is an unusual occurrence and therefore a physician should be - or the nurse practitioner, whomever has the primary responsibility for the patient or resident, would have been notified.

Tr. 673.

When asked whether the maggots were in the wound itself on August 30, 1999, Dr. Lyder stated that the nurse had noted there were maggots and that she had cleaned the wound with saline. Based on this, Dr. Lyder stated it was his assumption that the maggots were in the wound, and this is why the nurse cleaned it. Tr. 676. Dr. Lyder testified further that extreme care must be used so that maggots are removed intact; otherwise, if their membranes are broken, the proteins inside them can be cytotoxic to healthy tissue. Tr. 676-77. Dr. Lyder opined that it was "highly unlikely" for flies to lay eggs or larvae on the outside of a bandage and then for those eggs or larvae to end up inside the bandage. Tr. 678-79.

I find Petitioner's arguments, including Dr. Jackson's testimony, not to be persuasive against Dr. Lyder's testimony. The preponderance of the evidence does not support Petitioner's assertions that the infestation of maggots found on R1 was not a cause for concern. I find Dr. Jackson's view that the flies and maggots were merely a harmless nuisance to be disingenuous, particularly in light of the fact that he conceded that the presence of maggots on R1 could be characterized as an "abnormality."

I accept as credible and persuasive Dr. Lyder's expert opinion that the maggot infestations would be considered a "complication" and an "unusual occurrence." I also accept his testimony, which Petitioner did not challenge, that the maggots could release harmful toxins into healthy tissue if not removed intact.

Once flies entered Petitioner's facility, it was highly probable that they would breed, leading to the appearance of maggots. By taking appropriate measures, Petitioner's staff could have kept the flies from entering its facility, or, at least, minimized the risk of this occurrence. The episodes of maggot infestation were foreseeable and preventable, and therefore well within the area of Petitioner's responsibility.

The maggot infestations plainly met the regulatory definition of "significant change" in 42 C.F.R. � 483.10(b)(11)(i)(B), i.e. "a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications." When the maggots were discovered on R1, this triggered the facility's obligation to notify R1's physician at once because the infestations presented clinical complications that were inherently dangerous.

The fact that R1 apparently did not suffer any adverse effects as a result of the maggots is irrelevant in determining whether Petitioner violated the notification requirements of 42 C.F.R. � 483.10(b)(11) and does not excuse Petitioner's failure to notify her physician. The regulation requires that a resident's physician be notified when there is a "significant change" in a resident's status; it does not make any distinction between residents who have suffered adverse consequences and those who have not. The discovery of maggots on two separate occasions on R1 constituted significant changes in R1's physical status requiring the involvement of R1's physician. The failures by Petitioner's staff to notify R1's physician of these potentially dangerous changes in R1's condition were violations of 42 C.F.R. � 483.10(b)(11).

F-469

F-469 of the November 1999 SOD alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.70(h)(4). CMS Ex. 201, at 33-34; P. Ex. 4, at 33-34. This regulation requires a facility to maintain an effective pest control program so that it is free of pests and rodents.

The allegations of noncompliance made at this tag include the facts described above relating to R1's maggot infestations. CMS Ex. 201, at 34; P. Ex. 4, at 34. Surveyor Vickie Stevens testified, and the SOD notes, that Petitioner did have a pest control program that provided services on a monthly and as needed basis. Tr. 182; CMS Ex. 201, at 34; P. Ex. 4, at 34. According to the SOD, the pest control company provided services to Petitioner's facility on August 31, 1999, September 27, 1999, and September 28, 1999. CMS Ex. 201, at 34; P. Ex. 4, at 34; Tr. 182-83. Surveyor Stevens confirmed that the pest control program was in effect at the time that she conducted the survey, but testified that there were flies in the facility when she was conducting her investigation. Tr. 183.

Despite having a pest control program, Petitioner was unable to keep flies and maggots out of the facility. Based on the evidence discussed above with respect to R1, I conclude that Petitioner failed to maintain an effective pest control program so that it was pest-free, in violation of 42 C.F.R. � 483.70(h)(4). Petitioner's apparent laxness towards flies and maggots in the facility, and the failure of its pest control program to institute measures to address this problem, resulted in R1's maggot infestations.

Resident 3

B. With respect to Resident 3 (R3), Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.10(b)(11) (F-157), 42 C.F.R. � 483.25 (F-309), 42 C.F.R. � 483.20(k)(3)(i) (F-281), and 42 C.F.R. 483.25(c) (F-314).

With respect to R3, the November 1999 SOD alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25(c) (F-314), and its failure to do so also constitutes noncompliance with the requirements of 42 C.F.R. � 483.10(b)(11) (F- 157). (In the SOD, F-157 incorporates by reference the allegations under F-314). CMS Ex. 201, at 1-2, 17-22; P. Ex. 4, at 1-2, 17-22. Additionally, the SOD alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25 (F-309), and its failure to do so also constitutes noncompliance with the requirements of 42 C.F.R. � 483.20(d)(3)(i) (F-281). (F-281 incorporates by reference the allegations under F-309). CMS Ex. 201, at 2-7; P. Ex. 4, at 2-7.

I will first examine the alleged deficiencies under F-314 and F-157, which arise from the same set of factual allegations concerning R3's care. Next, I will examine the alleged deficiencies at F-309 and F-281, which are based on the same factual allegations.

The regulation at 42 C.F.R. � 483.25(c) (F-314) requires that, based on a resident's comprehensive assessment, a facility must ensure that a resident who enters a facility without pressure sores does not develop them unless the resident's clinical condition demonstrates that they were unavoidable. It requires additionally that a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing.

The records show the following:

� R3 was an 81-year-old man admitted to the facility on August 3, 1999, from a local hospital. His admission diagnoses were stroke and hypertension. CMS Ex. 201, at 17; P. Ex. 4, at 17; see CMS Ex. 3, at 1-2. R3 was dependent on staff for bed mobility, transfers, dressing, eating, hygiene, and bathing. He had limitations of range of motion of his arm, hand, leg, and foot. R3 was incontinent of bowel and bladder. CMS Ex. 201, at 17; P. Ex. 4, at 17; see CMS Ex. 3, at 7-8. R3 did not have pressure sores on admission, but had bruises on the tops of both hands. CMS Ex. 201, at 17-18; P. Ex. 4, at 17-18; see CMS Ex. 3, at 9, 103.

� According to a Braden skin risk assessment completed on August 3, 1999, R3 was assessed to be at low risk for developing pressure sores. CMS Ex. 201, at 18; P. Ex. 4, at 18; see CMS Ex. 3, at 12.

� On September 1, 1999, R3 had an open area on his right buttock that was swollen, tender, and bleeding, as well as an excoriated scrotum. Petitioner's staff called R3's physician, who ordered treatment for the area, and that R3 be evaluated by the wound care nurse. On September 3, 1999, the Resident had open areas present on his inner right and left buttocks with black eschar and drainage. R3 continued to have excoriation at his scrotum. CMS Ex. 201, at 18-19; P. Ex. 4, at 18-19; see CMS Ex. 3, at 77. The LPN did not inform R3's physician of R3's change in condition. CMS Ex. 201, at 19; P. Ex. 4, at 19; see CMS Ex. 3, at 78.

� On September 5, 1999, R3 had a red pressure area on his left hip, and necrotic tissue with yellow drainage. The staff notified the physician by fax. Petitioner's staff applied a moisture barrier to the left hip. CMS Ex. 201, at 19; P. Ex. 4, at 19; see CMS Ex. 3, at 82.

� On September 6, 1999, an 8 cm fluid-filled blister was noted on the Resident's left hip. The staff faxed the physician concerning the breakdown on R3's coccyx, and left hip gluteal area. The nurse made a note regarding possibly getting an air bed. Id. On September 7, 1999, the physician added vitamin C and zinc to R3's drug regime. CMS Ex. 201, at 19; P. Ex. 4, at 19; see P. Ex. 13, at 119. On September 8, 1999, R3's physician telephoned an order to discontinue treating R3's coccyx with Polymem and use Santyl instead. CMS Ex. 201, at 20; P. Ex. 4, at 20; see P. Ex. 13, at 117.

� On September 10, 1999, R3 was assessed and found to have five pressure sores, three in the left and right buttock areas, one on his coccyx, and another on his left hip. Two of the pressure sores, on R3's left outer buttock and left hip, were Stage II sores. CMS Ex. 201, at 20; P. Ex. 4, at 20; see CMS Ex. 3, at 85-86. According to the documentation, R3 had acquired the pressure sore on his left hip on September 8, 1999; he had acquired the others on September 6, 1999. CMS Ex. 3, at 85-86.

� On September 11, 1999, a LPN treated R3's coccyx, hips, and scrotum. CMS Ex. 3, at 82, 87. R3's scrotal wound had drainage, and the physician ordered a foley catheter, supplements, aloe vesta ⁽¹⁰⁾, a blood test, a pre-albumin test, and an air mattress overlay for his bed. CMS Ex. 201, at 20; P. Ex. 4, at 20; see CMS Ex. 3, at 87, 88. A pre-albumin test result dated September 13, 1999, was low, and R3 had an elevated white blood cell count, which indicated an infection. CMS Ex. 201, at 20-21; P. Ex. 4, at 20-21; see CMS Ex. 3, at 89.

� By September 14, 1999, R3's coccyx wound had necrotic tissue that covered the entire coccyx, and had drainage. On September 15, 1999, R3's left hip wound had increased in size since September 10, 1999, measured 6 cm x 4 cm, and was necrotic and foul-smelling, with drainage. R3 had a newly acquired intact blister on his right inside heel. CMS Ex. 201, at 21; P. Ex. 4, at 21; see CMS Ex. 3, at 88, 90.

� The physician examined R3 later that day, and wrote a progress note that stated, among other things, "fever [greater than] 101 . . . sacrum - large, black, extremely foul smelling decubitus ulcer [with] significant amount of drainage. He's septic. Apparently new onset dm [diabetes mellitus]. May have pneumonia. May be septic from sacral decub. Needs to go to Hosp for further eval & care." CMS Ex. 201, at 21; P. Ex. 4, at 201; see CMS Ex. 3, at 91. R3 was admitted to the local hospital that day. CMS Ex. 201, at 21; see CMS Ex. 3, at 36.

� R3 was readmitted to the facility on September 18, 1999, with a diagnosis of sepsis. CMS Ex. 201, at 21; see CMS Ex. 3, at 39. At that time, his Braden skin risk assessment indicated that he was at high risk for developing pressure sores. The readmission nurse noted, among other things, that R3 had multiple necrotic areas on his coccyx, Stage III pressure areas on his lower coccyx and sacrum, and he was on an air mattress. CMS Ex. 201, at 21; P. Ex. 4, at 21; see CMS Ex. 3, at 41, 94, and 106.

� On September 21, 1999, a physician examined R3, and ordered that R3 be hospitalized. According to the hospital records, R3 had, among other medical problems, a "large, putrid-smelling decubitus ulcer with heavy eschar over his sacrum and both buttocks," which needed debriding. CMS Ex. 3, at 56-57; CMS Ex. 201, at 22; P. Ex. 4, at 22. R3 expired at the hospital on September 23, 1999. See CMS Ex. 3, at 43-44, duplicated at CMS Ex. 3, at 97-98.

F-314

Based on the evidence stated above, I conclude that CMS has made a prima facie showing that Petitioner violated 42 C.F.R. � 483.25(c) with respect to R3. It is undisputed that when R3 was admitted to Petitioner's facility on August 3, 1999, he had no pressure sores and was assessed at low risk for developing pressure sores. By September 10, 1999, R3 had developed five pressure sores. These pressure sores were widespread, appearing on R3's buttocks, coccyx, and left hip. Two of the pressure sores, on R3's left outer buttock and left hip, were Stage II sores. When R3 was readmitted to the facility from the local hospital on September 18, 1999, he had a diagnosis of sepsis, multiple necrotic areas on his coccyx, and Stage III pressure areas on his lower coccyx and sacrum. He was hospitalized again, and, on September 23, 1999, died at the hospital.

In its posthearing brief, Petitioner acknowledges that R3's condition "plainly deteriorated," and takes the position that "nothing in the SOD demonstrates that [Petitioner] failed to assess or treat." P. Br. at 86. Petitioner appears to suggest that its efforts to "assess" or "treat" R3 demonstrate that it provided appropriate care for R3's pressure sores. However, with respect to prevention and treatment of pressure sores, Petitioner owed a duty to R3 to "go beyond merely what seems reasonable to, instead, always furnish what is necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as needed." Koester Pavilion, DAB No. 1750, at 32 (2000). Based on the evidence concerning R3's pressure sores, I conclude that Petitioner failed to meet its duty.

R3's treatment record suggests the facility was not entirely apathetic to preventing R3 from having skin breakdown. Nursing notes dated August 19, 1999, stated, among other things, "Turned & repositioned." CMS Ex. 3, at 16. There is a physician's order dated August 20, 1999, giving instructions "to increase bed mobility and facilitate self repositioning." CMS Ex. 3, at 21. The aforementioned entries would all be consistent with the type of care intended to prevent pressure sores.

However, despite these measures, R3, who had no pressure sores when he entered the facility and was assessed at low risk for pressure sores, began to suffer skin breakdown beginning September 1999. On September 1 and 3, 1999, he was observed to have an open area on his right buttock, an excoriated scrotum, and open areas on his inner right and left buttocks with black eschar and drainage. Petitioner's staff documented that R3 acquired four pressure sores on September 6, 1999, and another pressure sore on September 8, 1999. Petitioner failed to point to anything in R3's treatment record to demonstrate that it did what was necessary to prevent R3 from developing those pressure sores. Petitioner did not offer any explanation to address R3's skin breakdown nor did it assert that R3's pressure sores were clinically unavoidable. The fact that R3 suffered skin breakdown to such an extent shows that Petitioner's staff was inattentive to R3's condition. It is clear that whatever preventive measures were in place at the time for R3 were ineffective.

Further examination of R3's treatment record shows that on September 6, 1999, a nurse wrote that she made a note "to S/S R/t possibly getting air alternating bed." CMS Ex. 3, at 23. On September 7, 1999, R3's physician ordered vitamin C and zinc for R3. On September 9, 1999, R3's physician ordered an air mattress overlay for R3. CMS Ex. 3, at 99. On September 12, 1999, the nursing notes state, "[r]epositioned q 1 hr side to side." Id. at 24. On September 18, 1999, Petitioner's staff wrote that R3 was on an air mattress and turned side to side every two hours. Petitioner's staff also wrote that he was "[i]n need of air fluidized mattress." CMS Ex. 3, at 41. Nursing notes indicate that, on September 19, 1999, R3 received an air mattress. CMS Ex. 3, at 42. From the dates of these entries, it is evident that Petitioner's staff discussed care plan "approaches" and put these interventions into place only after it was discovered that R3 had developed numerous pressure areas.

However, rather than showing improvement, R3's pressure sores did not heal, but became progressively worse. When R3 was readmitted to the facility from the hospital on September 18, 1999, with a diagnosis of sepsis, he was assessed at high risk for developing pressure sores. Five days later, R3 died during his second hospital stay.

I conclude that R3, a Resident who entered the facility without pressure sores, developed pressure sores while in the facility. Petitioner has offered no evidence that R3's pressure sores were clinically unavoidable. CMS thus established a prima facie showing of a violation of 42 C.F.R. � 483.25(c) with respect to R3. I further find that there was actual harm, in that R3 developed Stage II sores as a result of the facility's failure to provide adequate care and treatment. Clearly, Petitioner failed to meet its duty to "furnish what is necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as needed." Koester Pavilion, DAB No. 1750, at 32 (2000).

F-157

Under F-157, the SOD alleges further that Petitioner failed to notify R3's physician immediately of significant changes in R3's condition, in violation of 42 C.F.R. � 483.10(b)(11). CMS Ex. 201, at 1-2; P. Ex. 4, at 1-2. Because I have previously set forth the text of 42 C.F.R. � 483.10(b)(11) in my discussion of R1, supra, I will not repeat it again here. CMS alleges that the basis for the violation of F-157 derives from the pressure sore allegations relating to R3 under F-314, which tag I have discussed above.

CMS alleges that Petitioner's staff failed to notify R3's physician immediately about R3's change in condition on September 3, 1999. On that date, R3 was found to have open areas present on his inner right and left buttocks with black eschar and drainage. He continued to have excoriation at his scrotum. CMS Ex. 201, at 18-19; P. Ex. 4, at 18-19; see CMS Ex. 3, at 77.

According to the nursing notes, Petitioner's staff had called R3's physician two days earlier, on September 1, 1999, when R3 was assessed to have an open area on his right buttock that was swollen and bleeding, as well as an excoriated scrotum. At that time, R3's physician ordered treatment for the area, and that R3 be evaluated by the wound care nurse.

At the hearing, Dr. Jackson, Petitioner's expert witness, disputed the significance of the drainage coming from R3's wounds on September 3, 1999. Dr. Jackson testified that the PolyMem therapy instituted on September 1, 1999, was a chemical debriding agent, which resulted in "increased amounts of secretion and often that is odorous." Tr. 554. Dr. Jackson stated, "It doesn't smell good, but it is not a sign of infection." Id. He went on to explain that infection is characterized by "swelling and erythema around the edge of a wound, it's progression in the depth of the wound with signs of active inflammation . . . It is not the presence of discharge or odor." Id.

Counsel for Petitioner asked Dr. Jackson whether, based on his review of the Residents' records (which included R3's records), "any lack of physician or family notification cause[d] any harm to any of these residents." Tr. 558. Dr. Jackson testified that he "found no evidence of that in any of the records I looked at." Id. I note that Petitioner's counsel did not specifically ask Dr. Jackson whether R3 experienced a significant change in his condition on September 3, 1999, which warranted immediate notification of R3's physician. Therefore, Dr. Jackson offered no expert opinion on this issue.

I am not persuaded by Dr. Jackson's testimony. The evidence shows that, between September 1 and September 3, 1999, R3 suffered further skin breakdown, which was manifested by open areas, black eschar, and drainage on his buttocks. Dr. Jackson provided no testimony with regard to the open areas and eschar found to be present on R3 on September 3, 1999. Even if I were to accept Dr. Jackson's statement that the drainage was not a sign of infection, I find that his testimony does not adequately counter the fact that new findings were made on September 3, 1999, which showed that the skin condition of R3's buttocks was further compromised since September 1, 1999.

In my discussion of R3 under F-314, I examined the skin breakdown and pressure sores suffered by R3. I noted that R3 was admitted to Petitioner's facility on August 3, 1999, with no pressure sores, and was assessed at low risk for developing pressure sores.

Given R3's status on admission, I find that any appearance of an open area on R3's body would amount to a significant change in his physical status requiring immediate physician notification under 42 C.F.R. � 483.10(b)(11). Even though Petitioner's staff had contacted R3's physician on September 1, 1999, the fact that R3 had new open areas on his buttocks with black eschar and drainage obligated Petitioner's staff to inform R3's physician immediately of R3's change in condition. Petitioner has not offered any evidence to rebut CMS's assertion that its staff failed to contact R3's physician on September 3, 1999. I therefore conclude that Petitioner failed to comply with the requirements of 42 C.F.R. � 483.10(b)(11).

At the hearing, CMS raised the allegation that Petitioner's failure to notify R3's physician concerning R3's necrotic penis was also a violation of the notification requirements of 42 C.F.R. � 483.10(b)(11). Tr. 50. Because the SOD did not rely on this allegation to show that Petitioner violated 42 C.F.R. � 483.10(b)(11), I must first consider the question of whether it would be prejudicial to Petitioner for CMS to raise at the hearing an issue that was not alleged in the SOD. ⁽¹¹⁾ I note that Petitioner did not object to this argument when CMS raised it at the hearing. Moreover, Petitioner had the opportunity to cross-examine CMS's witnesses on this issue and address it in its posthearing briefing. Tr. 131-34. Therefore, I find no prejudice to Petitioner and will not bar CMS from pursuing this additional deficiency allegation.

On September 18, 1999, when R3 was readmitted to the facility from the hospital with a diagnosis of sepsis, he had a foley catheter, and his scrotal area and penis were swollen, with no necrotic areas. CMS Ex. 201, at 6; P. Ex. 4, at 6; see CMS Ex. 3, at 41, 106. The nursing notes indicate that, at 12:00 a.m. on September 20, 1999, R3's penis remained swollen but had a necrotic area with foul-smelling discharge. CMS Ex. 3, at 46. At 7:00 a.m. on the morning of September 20, 1999, a day shift nurse stated that she would inform R3's physician who was making rounds about R3's penis. Id. However, it was not until 11:00 a.m. that R3's physician, Dr. Russell, examined R3 and assessed his penis as having a retracted foreskin. He manipulated the foreskin back into normal position, which resulted in a darkened, blackened penis. CMS Ex. 201, at 6; P. Ex. 4, at 6; see CMS Ex. 3, at 43, 46, and 49. Dr. Russell diagnosed R3 as having gangrene of the penis and paraphimosis. ⁽¹²⁾ CMS Ex. 3, at 43.

I find that CMS established a prima facie case that Petitioner failed to notify R3's physician immediately of significant changes in the condition of R3's genitalia. The swelling of R3's penis, and then the necrotic area that developed on his penis, triggered Petitioner's duty on those two occasions to notify Dr. Russell immediately. Yet, in both instances, Petitioner's staff failed to do so.

CMS's witness, Dr. Lyder, testified that a prudent nurse, upon noticing that R3's foreskin was not in its original position when he was readmitted to Petitioner's facility, would have notified either the hospital or R3's physician. Tr. 688. Dr. Lyder testified further that if R3's foreskin was retracted, strangulation of his penis could occur. Id. He stated that "excruciating pain" can be involved with paraphimosis. Tr. 689.

CMS's argument that Petitioner failed to comply with the physician notification requirements of 42 C.F.R. � 483.10(b)(11) is further bolstered by the following testimony of Dr. Lyder:

Q: Now, do you have an opinion based on your nursing background whether the doctor should have been called during the first - or shortly after the first observation of this necrotic area on the penis, the night of -

A: The 19^th?

Q: - the 19^th. Right.

A: The answer would be resoundingly yes.

Q: And what is that opinion?

A: The opinion is that this is a serious life threatening complication so that any time you're seeing the foreskin of the organ has been retracted and you are seeing necrosis and you are seeing a brown foul-smelling discharge, that is a serious complication that potentially could be life-threatening, especially with this resident who is already compromised.

Tr. 690. ⁽¹³⁾

Petitioner provided no meaningful rebuttal to Dr. Lyder's testimony.

By the time Dr. Russell examined R3 on September 20, 1999, R3's penis had become gangrenous. The record conclusively shows that R3's penis deteriorated such that he suffered a serious, life-threatening complication that resulted in actual harm during the time when Petitioner's staff should have notified his physician. Petitioner's failure to notify R3's physician immediately quite possibly deprived R3 of potentially life-saving care.

F-309

At F-309 of the November 1999 SOD, the surveyors alleged that Petitioner did not comply substantially with the requirements of 42 C.F.R. � 483.25 with respect to R3. CMS Ex. 201, at 3-7; P. Ex. 4, at 3-7. This regulation requires that a facility provide to each resident, and that each resident receives, the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's assessment and plan of care.

The surveyors alleged that Petitioner failed to provide care and services that were necessary to maintain R3's highest practicable physical, mental, and psychosocial well-being. According to the surveyors, Petitioner's staff failed to give necessary care to R3's penis, which became necrotic as a result of a retracted foreskin. They asserted also that Petitioner failed to document that R3 had received daily catheter care. To support these assertions, CMS relies on the following allegations of fact:

� When R3 was readmitted from a local hospital to Petitioner's facility on August 17, 1999, he had a foley catheter in place. CMS Ex. 201, at 4, P. Ex. 4, at 4; CMS Ex. 3, at 15. The foley catheter was removed on August 19, 1999. CMS Ex. 201, at 4; P. Ex. 4, at 4; CMS Ex. 3, at 16.

� On September 11, 1999, the foley catheter was re-inserted because R3 had developed pressure sores. In an interview with a surveyor, the LPN who inserted the catheter stated that R3's scrotum was large and had open areas. She did not recall anything abnormal with the condition of R3's penis. The nurse retracted and cleaned approximately one-half inch of foreskin prior to the insertion of the catheter. She did not have difficulty inserting the catheter, and did not recall anything abnormal at the time. After inserting the catheter, the nurse brought the foreskin back down into the position it had been in before. CMS Ex. 201, at 4-5; P. Ex. 4, at 4-5; see CMS Ex. 3, at 26-27.

� The surveyors alleged that the nursing notes did not include any documentation that the foley had been inserted; the notes only stated that the orders were processed. CMS Ex. 201, at 5; P. Ex. 4, at 5.

� According to the Director of Nursing, catheter care is to be performed every shift, by the direct care staff and charted as completed on the treatment record. R3's record did not have documentation on a treatment sheet or in the nurse's notes as to how often, or when, catheter care was completed. CMS Ex. 201, at 5; P. Ex. 4, at 5.

� Nursing notes dated September 12-15, 1999, documented that R3's foley catheter was patent and draining. CMS Ex. 201, at 5; P. Ex. 4, at 5.

� On September 18, 1999, when R3 was readmitted to the facility from the hospital with a diagnosis of sepsis, he had a foley catheter, and his scrotal area and penis were swollen, with no necrotic areas. CMS Ex. 201, at 6; P. Ex. 4, at 6; see CMS Ex. 3, at 41, 106.

� R3's physician, Dr. Russell, was not notified of R3's swollen penis when R3 was readmitted on September 18, 1999. CMS Ex. 201, at 6; P. Ex. 4, at 6; see CMS Ex. 3, at 43.

� On September 20, 1999, at midnight, the nurse discovered a necrotic area around R3's penis with foul-smelling discharge. The new necrotic area covered approximately one-half inch, on the top side of R3's penis. CMS Ex. 201, at 6; P. Ex. 4, at 6; see CMS Ex. 3, at 46-47.

� The day shift nurse on September 20, 1999, said she would inform the physician who was making rounds about the condition of R3's penis. At 11:00 a.m., the physician, Dr. Russell, examined R3 and assessed his penis as having a retracted foreskin. He manipulated the foreskin back into normal position, which resulted in a darkened, blackened penis. CMS Ex. 201, at 6; P. Ex. 4, at 6; see CMS Ex. 3, at 43, 46, and 49.

� Dr. Russell stated that R3's penis had necrotic areas before the manipulation procedure, and diagnosed R3 with gangrene of the penis caused by retraction of the foreskin. CMS Ex. 201, at 6; P. Ex. 4, at 6; see CMS Ex. 3, at 43. ⁽¹⁴⁾

� Dr. Russell ordered treatment for R3's penis, which included moist heat to the suprapubic area, an intravenous antibiotic, hydrogen peroxide and normal saline cleaning three times a day followed by a gauze wrap, and foley catheter care every shift. CMS Ex. 201, at 6-7; P. Ex. 4, at 6-7; see CMS Ex. 3, at 65-66.

� On September 21, 1999, Dr. Russell examined R3 and ordered that he be transferred to the local hospital. R3 was admitted to the hospital with a diagnosis of urosepsis. Consultation notes stated that R3's penis was necrotic and smelled putrid, and that it was not certain if R3 had suffered a traumatic catheterization. CMS Ex. 201, at 7; P. Ex. 4, at 7; see CMS Ex. 3, at 56, 58, 95.

� A hospital physician's progress notes dated September 22, 1999, stated, "Penis is worse today. Infection now spreading onto the lower abdomen. Patient has Fournier's gangrene [gangrene of the penis.] . . . Wife understands risk of 100% mortality if aggressive treatment is not instituted immediately." CMS Ex. 201, at 7; P. Ex. 4, at 7; see CMS Ex. 3, at 60.

� R3 expired at the hospital on September 23, 1999, from urosepsis. CMS Ex. 201, at 7; P. Ex. 4, at 7; see CMS Ex. 3, at 43-44, duplicated at CMS Ex. 3, at 97-98.

I conclude that the weight of the evidence makes out a prima facie case that Petitioner failed to comply with the requirements of 42 C.F.R. � 483.25 in providing care to R3. The fact that R3 developed necrotic areas on his penis, and was diagnosed as having gangrene of the penis, establishes that Petitioner's staff failed to provide necessary services in caring for R3's genitalia.

Petitioner, somewhat remarkably, contends in its posthearing brief that "as [Surveyor Stevens] and CMS knew, while in Woodbine, [R3] never presented with a catheter care or penis problem." P. Br. at 84. Petitioner states that R3's swollen penis was first observed on the day he was readmitted to the facility from the hospital, and Petitioner's staff called the hospital that day and was told that the hospital was aware of the swelling. Petitioner asserts that the physician who discharged R3 from the hospital was R3's treating physician. Id.; see Tr. 131-32. Petitioner apparently suggests by this that R3's physician would have been aware of R3's swollen penis and therefore, there was no need for staff to notify him of the swelling. See P. Br. at 84. But, this argument is belied by the fact that R3's treating physician, Dr. Russell, who did order R3's discharge from the hospital on September 18, 1999, stated in a telephone interview with a surveyor that he had not been notified of the swelling in R3's penis on September 18, 1999. See CMS Ex. 3, at 43. Dr. Russell stated that he was notified two days later, on September 20, 1999, after R3's penis was discovered to have a necrotic area.

Petitioner contends that its staff appropriately notified R3's physician about the worsening condition of R3's genitalia. However, by failing to notify Dr. Russell immediately that R3's penis was swollen, Petitioner's staff was derelict in its duty to care for R3. The potential that R3 would suffer more than minimal harm existed, and this potential quickly escalated into actual harm. Nursing notes indicated that R3's penis remained swollen, and subsequently developed a necrotic area. By the time Dr. Russell examined R3 on September 20, 1999, after being notified, R3's penis had become gangrenous, due to the retraction of the foreskin. R3 later died of urosepsis.

The SOD also alleged that R3's treatment record did not contain any documentation that daily catheter care had been provided. Petitioner asserts that nothing in the regulations requires documentation of routine care such as catheter cleaning. P. Br. at 84. Moreover, Petitioner, citing the decision in Lake City Extended Care Center, DAB No. 1658 (1998), asserts that a facility's failure to follow its own policy is not a regulatory violation unless the regulation mandates compliance with a policy. Id. Petitioner is correct in that 42 C.F.R. � 483.25 does not address documentation deficiencies per se. A failure by Petitioner to document catheter care, does not, in and of itself, constitute a failure by Petitioner to comply with 42 C.F.R. � 483.25.

Nevertheless, whether or not R3 received catheter care goes directly to the issue of whether Petitioner gave R3 adequate care and services. I note that Petitioner's expert witness, Dr. Jackson, testified that he did not find evidence of poor Foley care. Tr. 577. The fact that the condition of R3's penis went unobserved is powerful and conclusive evidence that R3 was not receiving the catheter care he required. Had R3 received proper catheter care, it is possible that Petitioner's staff would have noticed the retracted foreskin and the worsening condition of R3's genitalia at an earlier point in time. I note that, aside from its contention that the "[a]bsence of documentation does not establish bad care (P. Br. at 85)," Petitioner provided no evidence to the contrary.

Petitioner did not rebut CMS's prima facie evidence of noncompliance by a preponderance of the evidence. The undisputed facts establish that Petitioner committed serious lapses in caring for R3's genitalia. I conclude that Petitioner failed to provide the necessary care and services to allow R3 to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in violation of 42 C.F.R. � 483.25.

F-281

CMS alleges that, with respect to R3, Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(k)(3)(i) (F-281). ⁽¹⁵⁾ CMS Ex. 201, at 2-3; P. Ex. 4, at 2-3. This regulation states that the services provided or arranged by the facility must meet professional standards of quality. The deficiency at F-281 incorporates by reference the allegations under F-309 (42 C.F.R. � 483.25), which I have discussed above.

I find that, with respect to R3, Petitioner failed to comply substantially with this regulation for the same reasons that I found that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25. Petitioner's staff's dereliction of its duty to provide necessary care and services to R3, as evidenced by their failure to notify R3's physician immediately of the significant change in R3's genitalia, the lack of proper catheter care, and the resulting necrosis in R3's penis, points to Petitioner's failure to comport with accepted standards of quality. Indeed, the fact that the infection at R3's penis went undetected until there was necrosis is ipso facto proof that Petitioner violated accepted standards.

Resident 6

C. With respect to Resident 6 (R6), Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(k)(3)(i) (F-281) ⁽¹⁶⁾, 42 C.F.R. � 483.25(c) (F- 314), and 42 C.F.R. � 483.65(a)(1) - (3) (F-441).

F-281

F-281 of the December 1999 SOD alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(k)(3)(i). CMS Ex. 202, at 15-17; P. Ex. 5, at 3-5, 100-102. ⁽¹⁷⁾ This regulation states that the services provided or arranged by a facility must meet professional standards of quality. As the basis for finding a deficiency under F-281 with respect to R6, CMS cross-references F-314 in the December SOD and the pressure sore allegations cited under that F-tag with respect to R6. Specifically, CMS alleges that the dressing covering R6's stage II pressure sore was not changed for three days. CMS Ex. 202, at 16; P. Ex. 5, at 4, 101.

R6's diagnoses included diabetes mellitus, respiratory failure with ventilator dependence, pressure sores, a tracheostomy, and a methicillin-resistant staphylococcus aureus (MRSA) infection, a contagious infection that is resistant to antibiotic treatment. See CMS Ex. 6D, at 1, 7; Tr. 288, 289; CMS Ex. 202, at 50-51; P. Ex. 5, at 35, 84-85, 132.

According to Surveyor Reasoner, R6 had a physician's order that stated that Santyl was to be applied to her coccyx wound every day. This order stated that physical therapy staff would do the treatment Monday through Friday, and nursing staff would do it on Saturday and Sunday. Surveyor Reasoner testified that she observed the physical therapist provide wound care to R6 on December 6, 1999, which was Monday. She observed that the wound dressing removed by the physical therapist was soaked with drainage, and dated December 3, 1999, the previous Friday. See CMS Ex. 202, at 52; P. Ex. 5, at 37; CMS Ex. 6D, at 14; Tr. 289-90. Surveyor Reasoner stated that the physical therapist confirmed the date on the dressing and also confirmed that it was the nursing staff's responsibility to do the treatment over the weekend. Tr. 190. In R6's record, however, Surveyor Reasoner found an entry indicating that treatment had been done over the weekend. Tr. 292. An administrative staff person informed Surveyor Reasoner that the nurse on duty on the weekend had made a false entry in R6's chart that she had done the treatment when in fact, she had not. Tr. 292-93; see CMS Ex. 6D, at 4. The staff person stated that the nurse was fired. Tr. 293.

I note that in questioning Surveyor Reasoner with respect to this deficiency, and also in describing this deficiency in its posthearing brief, CMS refers to a "Facility Exhibit 16" (Tr. 290) and "Pet. Ex. 16" (CMS Posthearing Brief (CMS Br.) at 32), and to certain pages in this exhibit. Petitioner's Exhibit 16, in whole or in part, was not admitted into the record at the hearing. Therefore, I have disregarded any references to Petitioner's Exhibit 16.

In its posthearing brief, Petitioner concedes that R6's dressing covering her Stage II pressure sore was not changed for three days. P. Br. at 89. However, Petitioner contends that R6 did not suffer any harm. Petitioner argues that because it discovered the false entry, fired the nurse who made the entry, and addressed the Resident's treatment needs, it did not do anything wrong. Id.

Petitioner asserts further that "CMS's own guidance dictates that CNA issues are not properly cited under tag F281," and cites to an "Appendix" it attached to its posthearing brief. P. Br. at 89. This "Appendix" consists of three Survey and Certification Regional letters from an official with the Kansas City regional CMS office, each of which appears to provide guidance to surveyors on a particular subject matter, and a fourth letter from a regional CMS official addressed to an attorney, responding to his letter questioning the citation of deficiencies at particular facilities.

I note that Petitioner did not point me to a particular letter in the Appendix; however, based on my review of these letters, it appears that the letter Petitioner is relying on as support for its contention that CMS wrongly cited CNA issues under F-281, is Survey and Certification Regional Letter No. 99-08 (Letter No. 99-08), dated October 7, 1999. Letter No. 99-08 has as its subject line "Tag F281, Professional Standards of Quality." It appears to instruct surveyors as to how to cite this deficiency. At the end of this letter, under "Exceptions," is the following statement: "Note that Professional Standards of Quality is not the appropriate tag for citations of inadequate care provided by unlicensed persons (aides)." Petitioner apparently would have me conclude that the staff person or persons who provided deficient care to R6 as described above, were unlicensed CNAs, and therefore, not subject to a deficiency citation under F-281 in accordance with Letter No. 99-08.

Letter No. 99-08 may constitute official CMS guidance to surveyors; however, in the context of this discussion, I do not find it necessary to address it further, or decide what weight to give it. Petitioner has not offered any evidence to prove that the staff person or persons who provided deficient care to R6 were not licensed, or were even CNAs. Moreover, the plain language of 42 C.F.R. � 483.20(k)(3)(i) states that the services provided or arranged by the facility must meet professional standards of quality. The regulation makes no distinctions between licensed and unlicensed staff members at a facility, and I do not find it unreasonable to read the regulation as requiring that the actions of all facility staff members, both licensed and unlicensed, comport with professional standards of quality.

I find that CMS proved a prima facie case that the services provided or arranged by Petitioner failed to meet professional standards of quality. R6 was to receive daily dressing changes and treatment as required by her care plan and physician's orders. By Petitioner's own admission, R6's dressing on her pressure sore was not changed for three days. Such a lapse in resident care does not comport with accepted standards of quality.

F-314

F-314 of the December 1999 SOD alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25(c). CMS Ex. 202, at 25-57; P. Ex. 5, at 5-42, 58-90, and 102-39. As discussed earlier with respect to R3, this regulation requires that, based on a resident's comprehensive assessment, a facility must ensure that a resident who enters a facility without pressure sores does not develop them unless the resident's clinical condition demonstrates that they were unavoidable. It requires additionally that a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. With respect to R6, CMS alleges that Petitioner failed to prevent and properly treat her pressure sores. CMS Ex. 202, at 50-57; P. Ex. 5, at 35-37, 84-87, and 132-34.

R6 was admitted to the facility on October 7, 1999, with a Stage I pressure sore on her coccyx. CMS Ex. 202, at 50; P. Ex. 5, at 35, 132; see CMS Ex 6D, at 4. As stated above, R6's diagnoses included a MRSA infection, a highly contagious infection. The SOD reflects that a sign at her door directed visitors to report to the nurses' station prior to entering the room. According to instructions on the back of the sign, and the facility's policy, staff members were to wear gowns if they believed there was the likelihood that they would become soiled. The SOD reflects that although gowns were available inside the room, staff did not put them on while providing care to R6. P. Ex. 5, at 35-36, 86, and 132-33.

According to a skin report dated November 30, 1999, R6 acquired a pressure sore on her coccyx on November 5, 1999. As of November 30, the pressure sore was a Stage III sore, measuring 5.0 cm by 3.0 cm. CMS Ex. 202, at 52; P. Ex. 5, at 36, 133; see CMS Ex. 6D, at 6, 11. ⁽¹⁸⁾

Further, CMS alleges that, although R6 had a physician's order to receive daily treatment for her coccyx wound, the dressing covering R6's coccyx wound was observed to be soaked with drainage on December 6, 1999, and had not been changed for three days. CMS alleges also that R6's record contained an entry stating that treatment had been done as ordered. (I have previously discussed the allegations concerning the false entry in R6's record in connection with F-281, above.) As described in the SOD, the coccyx wound had an area of redness measuring approximately 10 cm in circumference. The tissue within this area was observed to be mostly yellow, hard eschar, with some red tissue and black eschar also.

The SOD also reflects that R6 experienced weight loss between October 1999 and December 1999. In October 1999, R6 weighed 115.6 pounds. In November 1999, she weighed 111.4 pounds. R6 weighed 110 pounds in December 1999. CMS Ex. 202, at 51; P. Ex. 5, at 36, 85, 87, 133; see CMS Ex. 6D, at 4. ⁽¹⁹⁾ From October 1999 to December 1999, R6 lost 5.6 pounds. On December 2, 1999, a registered dietician assessed R6. She noted that R6 was receiving one can of supplement with one scoop of a protein powder three times a day, as per physician's orders. The dietician recommended that she receive a multivitamin and 500 mg. of vitamin C to promote wound healing. CMS Ex. 6D, at 6; see CMS Ex. 202, at 52; P. Ex. 5, at 36, 133. CMS alleges that the percentage of supplement consumed by R6 was not documented consistently. See CMS Ex. 6D, at 4; CMS Ex. 202, at 52; P. Ex. 5, at 36, 133.

The final allegation relating to R6 and this F-tag, as reflected in the SOD, is that, according to the DON, bath skin assessments, which were to be completed twice weekly by the CNA, were not done on the Phase III unit where R6 resided. The SOD alleges that "[t]he DON said the licensed nurse is responsible for primary care on Phase III, unless the level of care requires CNA assignment, and then, a bath skin assessment is still not completed." CMS Ex. 202, at 52-53; P. Ex. 5, at 37, 134. CMS alleges that only one bath skin assessment dated November 30, 1999, was done for R6. CMS Ex. 6D, at 5.

Petitioner did not rebut the allegations under this F-tag. In its brief, Petitioner simply asserts that R6 "is miscited under tag F314, and for evens [sic] that predate the PoC [plan of correction]." P. Br. at 89.

I conclude that the evidence offered by CMS establishes a prima facie case that Petitioner did not provide necessary treatment and services for R6's pressure sore condition. The fact that R6's pressure sore worsened markedly over time shows that Petitioner's staff was not attentive to the Resident's condition. As I discussed above with respect to F-281, Petitioner admitted that the dressing on R6's pressure sore was not changed for three days, and that the entry stating that treatment had been done was false.

It is possible that R6's weight loss may have hindered the healing of her skin. Given that her sore was not improving, Petitioner was required to consider changes to her care plan, and implement preventative measures. This Petitioner failed to do. I conclude that Petitioner was unable to demonstrate that it had diligently managed R6's supplemental feeding plan or immediately addressed her weight loss.

Moreover, the absence of regular bath skin assessments is a further indication that whatever level of care Petitioner was providing R6 was deficient. Petitioner has not rebutted the admission by its DON that R6 did not receive bath skin assessments twice a week. Surveyor Reasoner testified that during bath assessments, CNAs are to identify new and current wounds so that they can keep track of the number of wounds the residents have. Tr. 294. She stated that in Phase III, where R6 resided, nurses were responsible for the residents' total care. According to Surveyor Reasoner's interviews with staff, the Phase III unit did not have any CNAs on a normal basis, and because there were no CNAs, the bath assessments were not completed for any resident on Phase III. Tr. 294-95. Regardless of the unit where R6 resided, it was incumbent upon Petitioner's staff to carry out skin assessments on a regular basis as part of its duty to provide necessary treatment and services for her pressure sores.

F-441

F-441 of the December 1999 SOD alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.65(a)(1)-(3). CMS Ex. 202, at 57-59; P. Ex. 5, at 42-44, 90-92, 139-141. This regulation requires that a 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. In citing F-441 in connection with R6, CMS cross-references F-314, and the citation, in relevant part, refers to the facility's failure "to change contaminated dressings." See CMS Ex. 202, at 57-58; P. Ex. 5, at 43, 91, and 140. (I note that one of the SODs contained in P. Ex. 5, at P. Ex. 5, at 91, also mentions the "facility's failure to wear protective gowns," which is not mentioned in the other documents.) ⁽²⁰⁾

In my discussion of F-314 above, I described Petitioner's staff's failure to change R6's dressing on her coccyx wound for three days, despite a physician's order that she was to receive daily treatment for the wound. This dressing was observed to be soaked with drainage. The evidence presented by CMS proves, prima facie, that Petitioner failed to provide proper wound care to R6, in violation of 42 C.F.R. � 483.65(a)(1)-(3). Petitioner's deficient infection control techniques increased the risk that R6's coccyx wound could worsen, and also, created the potential that R6 could be exposed to other infections.

Additionally, because R6 had a MRSA infection, extra precautions were necessary when entering her room and providing treatment. Surveyor Reasoner testified that R6 would be on "contact isolation and the staff would need to take some special precautions in handling this resident's wound drainage, sputum, those types of things." Tr. 289. Surveyor Reasoner stated that such precautions are needed because there is a risk that MRSA could be passed to other residents. Id. She stated that the facility's policy did advise staff to take "precautions to protect themselves against body fluids, wound and sputum." Tr. 293. According to Surveyor Reasoner, the facility's policy did not necessarily mandate the use of gowns but did recommend that staff wear gowns when "they were dealing with - in a close proximity with the resident dealing with some kind of drainage." Id.; see Tr. 416. Surveyor Reasoner testified that if staff had contact with R6, that would be an appropriate time for them to wear gowns. She explained that because R6 had MRSA in her sputum and had a tracheostomy, she could spread the infection through coughing. Tr. 293-94. Surveyor Reasoner observed that staff did not use gowns or gloves when going into R6's room. Tr. 293.

Petitioner does not dispute that staff members failed to put on gowns (and gloves) in R6's room, and appears to concede that it was deficient: "isolated break in infection control technique does not support an inference that a facility lacks an effective infection control program, and there has been no showing that any facility policy prompted the concern, or that the facility ignored it." P. Br. at 89.

Petitioner's staff was directed by a sign on R6's door, and by Petitioner's own policy, to wear gowns if they believed there was the likelihood that they would become soiled. By not wearing gowns (and gloves), Petitioner's staff increased the risk of coming into contact with R6's bodily secretions and transmitting contaminants to other residents, potentially spreading infection to them. The staff's failure to wear gowns (and gloves) during the care and treatment of R6 is inconsistent with the infection control regulation at 42 C.F.R. � 483.65(a)(1)-(3).

I am not persuaded that Petitioner's breaches in infection control technique, from its failure to change R6's dressing to its failure to take appropriate precautions such as wearing gowns and gloves, can be properly described as "isolated" errors. Petitioner's lapses demonstrate conclusively that Petitioner was not adequately carrying out its responsibilities in the area of infection control.

The foregoing evidence establishes a prima facie case that Petitioner employed improper infection control techniques with respect to R6, and thus, had not implemented an effective infection control program. Petitioner did not rebut this evidence.

Resident 7

D. With respect to R7, Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(k)(3)(i) (F-281) and 42 C.F.R. � 483.25(c) (F-314).

F-281

In the December 1999 SOD, as the basis for finding a deficiency under F-281 with respect to R7, CMS, as it did with R6, cross-references F-314 in the December SOD and the pressure sore allegations cited under that F-tag regarding R7. As stated above, F-281 alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(k)(3)(i). CMS Ex. 202, at 16; P. Ex. 5, at 3-4, 49-50, 100-01. This regulation states that the services provided or arranged by a facility must meet professional standards of quality. CMS specifically alleges that R7's pressure sore was not measured and the physician was not notified for nine days after the pressure sore was identified.

According to the SOD, R7's diagnoses included recurrent urinary tract infections and a history of myocardial infarction. R7 had an indwelling Foley catheter and was incontinent of bowel. The SOD alleges that her most current admission to the facility was on June 25, 1999, and she did not have any pressure sores at that time. The most current Braden skin assessment, dated September 29, 1999, assessed R7 as not being a high risk for development of pressure sores. Her most current assessment, dated October 8, 1999, indicated that she needed total assistance to transfer, to turn in bed, and for her perineal care. The MDS did not identify any infection, pressure sores, or callouses on her feet. See CMS Ex. 202, at 53-54; P. Ex. 5, at 37-38, 87, 134-135; CMS Ex. 7D, at 4.

The SOD alleges that, according to the nurses' notes, R7 acquired a pressure sore on her left buttock on November 6, 1999. The pressure sore was not measured, or staged, until November 15, 1999, nine days after it was identified. ⁽²¹⁾ The pressure sore was described as a stage II area and measured 1.7 cm by .8 cm. The SOD reflects that the physician was to be notified so that a pressure relief mattress could be re-instituted. CMS Ex. 202, at 54; P. Ex. 5, at 38-39, 88, 135-36, CMS Ex. 7D, at 4; Tr. 287. A skin report dated November 29, 1999, stated that R7 had a Stage II pressure sore on her left buttock that measured .3 cm by .3 cm, with a .1 cm depth. ⁽²²⁾ R7's family was not notified about the pressure sore until December 2, 1999. CMS Ex. 202, at 54; P. Ex. 5, at 39, 88, 135-36, CMS Ex. 7D, at 4. On December 7, 1999, R7's pressure sore measured approximately 2.5 cm by .5 cm, with surrounding redness about the size of a quarter. The skin report, dated December 8, 1999, did not identify any open areas. CMS Ex. 202, at 56, 57; P. Ex. 5, at 40, 42, 89, 90, 137, 139.

On December 7, 1999, at approximately 6:05 a.m., R7 was observed lying in bed. As reflected in the SOD, R7's bed pad had an area of wetness, and the bed sheet under the bed pad was wet, indicating someone had placed a dry pad over a wet bed. R7 had been incontinent of a moderate amount of stool. A CNA entered her room without knocking and proceeded to give treatment to R7 using improper and unclean techniques. The CNA cleaned R7's rectal area, wiping toward the pressure sore, and then failed to rinse the periwash off. Although the dressing covering the Resident's stage II pressure sore on her left buttock was loose and soiled, the CNA replaced the dressing over the sore. Moreover, as alleged in the SOD, the CNA did not provide catheter care or pericare to the resident's pubic area. The CNA unhooked R7's catheter bag, with the end of the tubing exposed, and let it come into contact with the floor. The catheter bag remained on the floor while the CNA dressed and transferred R7 to her wheelchair. CMS Ex. 202, at 55-56; P. Ex. 5, at 39-40, 88-89, 136-137; CMS Ex. 7D, at 4.

The SOD reflects that, at approximately 2:00 p.m., R7 still had the same soiled dressing over her stage II pressure sore. According to the SOD, the LPN in charge stated that the CNA had not reported that the dressing was soiled or loose. The CNA stated that he had not reported the condition of the dressing to the LPN. See CMS Ex. 202, at 56; P. Ex. 5, at 41, 89-90, 138; CMS Ex. 7D, at 4.

The SOD also reflects that an antibiotic was prescribed for R7 on December 6, 1999, for a urinary tract infection. According to laboratory test results, R7 had a urinary tract infection from E. coli bacteria (derived from bowel movements), on December 18, 1998 and November 8, 1999. See CMS Ex. 202, at 55, 56; P. Ex. 5, at 39, 41, 88, 90, 36, 138; CMS Ex. 7D, at 12, 13.

The SOD alleges further that R7's meal intake records for November and December 1999 were inconsistently documented. Nothing was recorded on 11/1 and 11/12-11/14, and on 11/19-11/24, 11/26-11/28, and 11/30, R7 was documented as eating 25% or less. In December, R7 ate 25% or less on 12/1 - 12/3, and on 12/6. The SOD alleges that the facility's dietary department was not aware of the November and December trends. CMS Ex. 202, at 54, 57; P. Ex. 5, at 38, 42, 87, 90, 135, 139; CMS Ex. 7D, at 7-8.

At the hearing, Petitioner rebutted the allegation in the SOD that its staff did not assess R7's pressure sore for nine days after the pressure sore was identified. On cross-examination, Petitioner's counsel directed Surveyor Reasoner to examine page 233 of P. Ex. 8, which was a nursing note from R7's treatment record. Tr. 426. After doing so, Surveyor Reasoner admitted that the nursing note showed that Petitioner's nursing staff identified R7's pressure sore on November 7, 1999. Id. Surveyor Reasoner admitted further that R7's physician ordered treatment for the pressure sore on November 7, 1999, the same day that the sore was identified. Tr. 426-27; P. Ex. 8, at 232. The treatment consisted of applying a hydrocolloid dressing over the sore, and changing it every three days. Tr. 427; P. Ex. 8, at 232. After examining page 239 of P. Ex. 8, which was a pressure ulcer record, Surveyor Reasoner admitted that the record indicated that a nurse examined R7's pressure sore on November 10, 1999, and measured and described it. Tr. 429. When asked why she made the allegations about the pressure sore in the SOD, Surveyor Reasoner stated that she didn't believe she had seen the pressure ulcer record. Id.

Based on the evidence in the record, I conclude that assessment and treatment of R7's pressure sore was not delayed. Contrary to what was alleged in the SOD, I find that Petitioner's staff treated R7's pressure sore promptly, on the day that it was identified, and followed up with further assessment three days later. Moreover, Surveyor Reasoner acknowledged that a nursing note dated November 15, 1999, indicated that R7 was on a pressure reduction mattress. Tr. 432-33; P. Ex. 8, at 234. I note that, in its posthearing brief, CMS does not address the documents in P. Ex. 8 at all.

Despite the fact that R7 received timely pressure sore care, it is undisputed that R7, who did not have any pressure sores when she was admitted on June 25, 1999, did develop a pressure sore while at the facility. As of October 8, 1999, according to her assessment, R7 did not have any pressure sores. However, by early November 1999, she had developed a pressure sore on her left buttock. The pressure sore care regulation, at 42 C.F.R. � 483.25(c), requires that based on a resident's comprehensive assessment, a facility must ensure that a resident who enters a facility without pressure sores does not develop them unless the resident's clinical condition demonstrates that they were unavoidable. I note that Petitioner did not allege that R7's pressure sore was unavoidable due to her clinical condition.

Because Petitioner failed to prevent R7 from developing pressure sores, I find that CMS established a prima facie case that Petitioner's care of R7 contravened professional standards of quality, in violation of 42 C.F.R. � 483.20(k)(3)(i).

Moreover, I find that Petitioner also failed to meet professional standards of quality based on the improper and unclean techniques utilized by the CNA when administering treatment to R7. The surveyor observed the CNA perform a series of remarkably indifferent acts with R7, consisting of lapses in perineal care; the failure to change a loose, soiled dressing; the failure to provide catheter care; and the inappropriate handling of R7's foley catheter bag, which was put on the floor. I have previously mentioned these allegations in connection with my discussion of the pressure sore care received by R7, above.

In its brief, CMS argues that R7 "was not provided the most basic of care, let alone that level of care which would meet professional standards." CMS Br. at 31. CMS argues further that Petitioner's "failure to provide professional standards of care to [R7] put [her] at risk for serious infections and for continued deterioration and breakdown of [her] skin. Id. I agree. The CNA's lapses in care, which included his failure to change and replace the soiled dressing, represented care that violated accepted standards of quality and that, at every instance, potentially exposed R7 to infection. The CNA's improper administration of perineal care (wiping toward the pressure sore), and then the reapplication of R7's soiled dressing to the sore clearly posed the risk that her wounds could become contaminated by fecal matter, thereby increasing the chance of infection and further skin breakdown. Finally, the CNA's deficient conduct with respect to R7's catheter care and the catheter bag further supports my conclusion that Petitioner failed to comply substantially with the requirement at 42 C.F.R. � 483.20(k)(3)(i).

As with R6 above, Petitioner takes the position that "CMS's own guidance dictates that CNA issues are not properly cited under tag F281" and cites its "Appendix" in support of this assertion. P. Br. at 88. Again, Petitioner appears to be relying on Letter No. 99-08, and the statement under the "Exceptions" section, which I shall reiterate here: "Note that Professional Standards of Quality is not the appropriate tag for citations of inadequate care provided by unlicensed persons (aides)."

Petitioner's argument requires the assumption that the staff, including the CNA, who provided the deficient care to R7 were not licensed, and therefore, not subject to a deficiency citation under F-281 in accordance with Letter No. 99-08. Petitioner has not offered any evidence as to the licensure status of the staff and the CNA, and absent such evidence in the record, I cannot make this assumption. As I discussed above with R6, I am guided by the plain meaning of 42 C.F.R. � 483.20(k)(3)(i).

Petitioner also argues that Surveyor Reasoner's testimony relating to her observation of the CNA is "not credible, not substantiated, and should be dismissed." P. Br. at 88. Petitioner presented no evidence to suggest that the care provided by the CNA was other than what was observed by Surveyor Reasoner and stated in the SOD. Petitioner could have submitted rebutting evidence from the staff members whom Surveyor Reasoner interviewed. Thus, I am not persuaded that Surveyor Reasoner's testimony and observations are not credible.

Finally, Petitioner makes the same assertion that it did in connection with R6: "isolated break in infection control technique does not support an inference that a facility lacks an effective infection control program, and there has been no showing that any facility policy prompted the concern, or that the facility ignored it." P. Br. at 88. While Petitioner may believe this, the evidence points to the contrary - the breaches in the care provided to R7 cannot be considered "isolated" errors, especially when they are examined together with the lapses in care received by R6. Overall, Petitioner's approaches in treatment and care often fell far short of professional standards of quality.

F-314

As discussed above, F-314 of the December 1999 SOD alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25(c). This regulation requires that, based on a resident's comprehensive assessment, a facility must ensure that a resident who enters a facility without pressure sores does not develop them unless the resident's clinical condition demonstrates that they were unavoidable. It requires additionally that a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing.

I have already described the pressure sore allegations concerning R7 in my discussion of Petitioner's failure to comply with the requirements of 42 C.F.R. � 483.20(k)(3)(i) (F-281) above, and will not repeat them here. Based on the evidence and my conclusions under F-281, I uphold CMS's determination that Petitioner failed to comply substantially with 42 C.F.R. � 483.25(c). CMS made a prima facie showing that Petitioner failed to ensure that R7, who entered the facility without pressure sores, did not develop pressure sores unless they were unavoidable. As I stated above, Petitioner did not show that R7's pressure sore was unavoidable.

Resident 103

E. With respect to Resident 103 (R103), Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.65(a)(1)-(3) (F-441).

As discussed above, F-441 of the December 1999 SOD alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.65(a)(1)-(3). Once again, this regulation requires that a 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, it will be recalled, 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. With respect to R103, CMS alleges that a surveyor observed a CNA commit a breach in infection control techniques while providing perineal care to R103. Specifically, the survey report alleges that the CNA was performing perineal cleaning on R103, left the room with urine-contaminated gloves on, retrieved clean linens from the linen cart, and returned to the Resident's room. CMS Ex. 202, at 57; P. Ex. 5, at 42, 91, and 139.

Surveyor Reasoner testified that the nurse aide was providing perineal care to R103 while wearing gloves, and, rather than removing her gloves and washing her hands before leaving the Resident's room, the nurse aide went into the hall with the gloves on, and retrieved items from the linen cart. Tr. 295-96. Surveyor Reasoner testified that the nurse aide went back into the Resident's room without taking her gloves off and washing her hands. Tr. 296. Surveyor Reasoner asserted that the nurse aide contaminated the linens on the linen cart because her gloves had been contaminated from the perineal care. Id.

Petitioner's expert witness, Dr. Jackson, did not dispute that the CNA's actions contravened proper infection control practices, but also stated that there was no evidence that R7 was harmed. He gave the following testimony:

. . . one was with Resident 103, where the CNA was noted by the surveyor to put gloves on, leave the room and come back with linen with the same gloves on. That is not what you would want a CNA to do. It is an appropriate citation . . . I don't think any reasonable clinician would say that you would want to have that practice widespread in a facility, but in this situation there is no evidence that this resident received any harm from that.

Tr. 609-10.

Despite the fact that its own expert witness agreed with the citation, Petitioner attempts to rebut CMS's evidence by arguing that this incident is an isolated break in infection control technique that does not establish a prima facie case of Petitioner's failure to establish and maintain an infection control program. P. Br. at 90. Surveyor Reasoner testified, however, that because of the number of observations that were made under F441, she believed Petitioner had a systemic problem in this area. She stated that, based on the facility's infection control report, the facility had a high incidence of infection. Tr. 296, 438.

I have previously determined that Petitioner breached infection control techniques with respect to R6. The evidence relating to R6 and R103 demonstrates that Petitioner's staff contributed to lapses in infection control through the use of poor techniques on more than one occasion and undercuts Petitioner's position that such breaches were isolated errors.

With R103, I find that CMS offered prima facie evidence which shows that Petitioner was not implementing an effective infection control program. The nurse aide's failure to remove her soiled gloves before retrieving items from the linen cart contaminated the items she retrieved and placed those still on the cart at grave risk of contamination, as well. Other residents might unknowingly receive contaminated items from the linen cart, and as a consequence, contract serious or life-threatening infections.

F. Uncontested Tags

Petitioner's posthearing brief also declined to discuss or debate the March 2000 survey citations based on the circumstances of care given to Residents 36, 37, 40, 41, 42, 43, 44, 45, 104, and 105. As I have explained above, there is before me sufficient evidence to support the CMP imposed in its totality. Thus, it may not be strictly necessary for this Decision to address and analyze CMS's claims concerning these 10 additional residents. But it may be helpful if I review in summary fashion each Resident's history in the context of the citations that arose from it, and indicate what I believe the evidence generally shows.

Resident 36 developed pressure sores, and the facility was obliged to, inter alia, evaluate the Resident's diet in response to assure that the Resident received enough protein and calories to resist skin breakdown. The facility failed to do so, and was cited under F-314. CMS's evidence in support of the citation established a prima facie case, which Petitioner did not successfully refute.

Resident 37 presented a pattern of weight loss and low albumin levels. The Resident's physician directed that nutritional supplements be administered. The facility failed to do so, and was cited under F-325. The Resident subsequently developed pressure sores that were not treated in accordance with the physician's orders and the Resident's care plan, and the facility was cited under F-281 and F-282. CMS' evidence established a prima facie case, which Petitioner did not successfully refute.

Resident 40's physical condition required that her feet and legs be covered with protective slippers and stockings at specified times, but the facility failed to place and remove the items as appropriate. These lapses resulted in a citation based on F-281. The Resident also required restorative care intended to address her range of motion limitations that the facility did not provide, resulting in a citation based on F-318. CMS's evidence established a prima facie case for both citations, which Petitioner did not successfully refute.

Resident 41 was susceptible to falling, and in fact fell eight times during the survey period. Four of the falls resulted in injuries. The facility failed to assess the Resident's condition relative to the falls, failed to develop a care plan to address the problem, and failed to provide supervision adequate to preventing the falls. Citations were issued based on F-272, F-279, and F-325. CMS's evidence established a prima facie case for the citations, which Petitioner did not successfully refute.

Resident 42 demonstrated a sharp weight loss over a short period. The facility was required to perform a comprehensive assessment of the Resident's changed condition, to revise the Resident's care plan accordingly, and to see that the Resident's nutritional status was protected. The facility failed to meet those three obligations, and citations based on F-272, F-279, and F-325 were issued. CMS's evidence established a prima facie case in support of each of the three citations, and Petitioner successfully refuted none of them.

Resident 43 was observed by facility staff to have developed pressure sores on both heels, but several weeks elapsed before dietary interventions were undertaken by the facility, during which time one of the sores grew larger. A citation was issued based on F-314. CMS's evidence established a prima facie case, which Petitioner did not successfully refute.

Resident 44 (R44) enjoyed relatively good health and mental orientation, and was allowed by the facility to take some of her own medications without supervision. The necessary evaluation and assessment to permit this practice had not been performed by the facility, however, and citations based on F-176 and F-281 were issued. CMS's evidence established a prima facie case as to those two citations, which Petitioner did not successfully refute. The facility failed to provide enterostomal therapy to R44 as it had agreed to do, and this failure resulted in the issuance of a citation based on F-272. CMS's evidence established a prima facie case as to this citation as well, and it, too, was not successfully refuted. But CMS did not establish a prima facie case that R44's dignity and self-respect were compromised during the course of an interview among R44, surveyors, and facility staff on or about March 23, 2000; the citation of F-241 based on that incident remains unsupported by the evidence before me.

Resident 45 was the innocent victim of a pharmacy's error and the failure of the facility to look into and correct the error immediately. Improperly-labeled packages of medications were sent to the Resident in response to her physician's orders, and the facility detected the discrepancy. But the facility did not pursue the matter, and 32 days elapsed before R45 again received her medication. The facility was cited based on F-425. CMS's evidence established a prima facie case in support of the citation, which Petitioner did not successfully refute.

Resident 104 (R104) was observed by one of the surveyors during the March 2000 survey. R104 was observed from a hallway outside his room: his door was open, and he was observed seated in a wheelchair, wearing neither trousers nor underclothing. Because of this apparent compromise of R104's privacy, a citation based on F-164 was issued. CMS's evidence established a prima facie case, which Petitioner did not successfully refute.

Resident 105 was observed by the same surveyor during the March 2000 survey; when observed, R105 was receiving catheter care. His trousers were pulled down, and the privacy curtains available to shield him from casual observation by his roommate had not been drawn into place. This apparent compromise of R105's privacy resulted in a citation based on F-164. CMS's evidence established a prima facie case, which Petitioner did not successfully refute.

VII. The Question of Immediate Jeopardy

CMS's determination that Petitioner's noncompliance with Medicare participation requirements for the period November 18, 1999 through December 9, 1999, placed residents in immediate jeopardy was not clearly erroneous.

"Immediate jeopardy" is defined to mean:

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

42 C.F.R. � 488.301. CMS has a burden of showing, prima facie, that its determination that a deficiency met this definition is correct. If it does so, then a facility challenging that determination must prove it to be clearly erroneous. 42 C.F.R. � 498.60(c)(2).

CMS determined that for R1, F-157 and F-469 were immediate jeopardy level deficiencies, and for R3, F-157, F-281, F-309, F-314 were immediate jeopardy level deficiencies; its evidence supported the scope-and-severity determination prima facie. I find that Petitioner did not offer proof establishing that CMS's determinations of immediate jeopardy level deficiencies were clearly erroneous.

The evidence offered by CMS in this case showed that, as a result of acts or omissions by Petitioner's staff, both R1 and R3 were put in situations where they either suffered serious harm or were put at risk for serious harm. Because I have discussed at length the F-tags pertaining to these two Residents, I will not go into them again here, but will summarize the instances of grossly deficient care provided by Petitioner.

With respect to R1, the Resident was put at great risk for serious harm as a result of the maggot infestations on her leg and left heel. The episodes of maggot infestation constituted a significant change in R1's medical condition, presenting an inherently dangerous complication to her wounds. Petitioner's staff was obligated, on two separate occasions, to immediately notify R1's treating physician of the discovery of maggots. Petitioner's staff failed to do so, violating 42 C.F.R. � 483.10(b)(11), F-157. The fact that R1 did not suffer actual harm does not mean that an immediate jeopardy degree of severity did not exist. I find that CMS was not clearly erroneous in determining Petitioner's failure to immediately notify R1's treating physician was an immediate jeopardy level deficiency.

Moreover, although Petitioner played down the appearance of flies and maggots in its facility, the fact is that Petitioner's staff, with diligence and effort, could have taken measures to prevent the maggot infestations from occurring. Petitioner's failure to maintain a pest-free facility resulted in noncompliance with 42 C.F.R. � 483.70(h)(4), F-469. Because this failure created a likelihood of serious harm to R1, I conclude that CMS's immediate jeopardy determination was not clearly erroneous.

With respect to R3, the undisputed evidence showed that R3 suffered from egregious lapses in care, and experienced actual harm as a result. Despite having no pressure sores upon admission to Petitioner's facility and being assessed as at low risk for developing sores, R3 suffered skin breakdown and developed numerous sores, which worsened quickly. In addition to developing sores, R3's genitalia became necrotic and gangrenous. As I stated in my discussion of R3, these changes in R3's condition constituted significant changes that triggered Petitioner's duty, on separate occasions, to notify R3's treating physician immediately. The record established that Petitioner failed to do so, in violation of 42 C.F.R. � 483.10(b)(11), F-157. Moreover, Petitioner's deficient pressure sore care demonstrated noncompliance with 42 C.F.R. � 483.25(c), F-314.

The evidence concerning the necrosis of R3's penis supported a finding that Petitioner had failed to provide R3 with the necessary care and services to attain or maintain his highest well-being, as required by 42 C.F.R. � 483.25, F-309. That Petitioner was remiss in carrying out its duty to R3 also led me to find that Petitioner's services did not comport with professional standards of quality, in violation of 42 C.F.R. � 483.20(k)(3)(i), F-281.

The prima facie evidence showed that R3 was placed in a situation of immediate jeopardy and experienced serious medical complications. Accordingly, I do not find that CMS's determination to assess F-157, F-314, F-309, and F-281 at the immediate jeopardy level of severity was clearly erroneous with respect to R3.

Petitioner asserts that "CMS's allegations in the survey SOD regarding wholly past events and/or observations do not establish a prima facie case that immediate jeopardy was observed on November 18, 1999." P. Br. at 62. Petitioner contends further that the surveyors "based their immediate jeopardy conclusions entirely on closed record reviews of past events. The surveyors did not observe any residents allegedly at risk for immediate jeopardy during a November 18, 1999 survey. Surveyors were not even present then . . . ." Id. at 63.

In response to these arguments, CMS asserts, "it is settled law that an inference of continuing harm, including immediate jeopardy, can be drawn from past occurrences." CMS Reply Brief (R. Br.). at 3 (citing Beverly Health & Rehabilitation - Springhill, DAB CR553, at 11 (1998). CMS asserts further that "[t]his is an appropriate case in which to infer that immediate jeopardy existed throughout October and November, until a re-survey showed that it had been abated." CMS R. Br. at 4.

I do not agree with Petitioner's assertion that immediate jeopardy cannot be found based on past events. I find this case to be an appropriate case in which to infer, based on events that predated the November 18, 1999 SOD, that immediate jeopardy existed at Petitioner's facility. Moreover, the fact that the surveyors may not actually have been in Petitioner's facility on November 18, 1999, does not undermine the finding of immediate jeopardy. Surveyor Stevens testified that while she held an "exit conference" with Petitioner's administrator on October 29, 1999 when she returned to the facility, the survey did not officially conclude on that date. According to Surveyor Stevens, the SOD was dated November 18, 1999, "because there were other processes, complaint investigations, follow-up visits done after the date that I actually existed [sic] and the --." Tr. 62. Moreover, I do not agree with Petitioner's assertion that closed record reviews cannot be the basis for immediate jeopardy determinations. Surveyor Reasoner testified that, although a resident may no longer be in the facility, a finding of immediate jeopardy can be made based on a review of the evidence in the resident's records as to the care that was provided prior to his discharge. Tr. 308. In this case, I do not find that actual observation by the surveyors of residents in immediate jeopardy situations was a prerequisite to making immediate jeopardy findings.

VIII. The Reasonableness of the Civil Money Penalty

A. A CMP of $8,050 per day is a reasonable remedy for Petitioner's failure to comply substantially with participation requirements, at the immediate jeopardy level, for the period November 18, 1999 through December 9, 1999.

Petitioner's noncompliance at the immediate jeopardy level amply justifies a CMP at the upper end of the applicable penalty range ($3,050 to $10,000 per day). I now consider whether the amounts imposed against Petitioner are reasonable, applying the factors listed in 42 C.F.R. �� 488.438(f) and 488.404 (incorporated by reference into 42 C.F.R. � 488.438(f)(3)). The factors include a facility's noncompliance history, its financial condition, its culpability, the seriousness of its deficiencies, and the relationship of one deficiency to another. My "inquiry should be whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved." CarePlex of Silver Spring, DAB No. 1683, at 8 (1999).

Here, CMS determined to impose a penalty in the amount of $8,050 per day for the period November 18, 1999 through December 9, 1999, the period during which it determined Petitioner manifested immediate jeopardy level deficiencies.

With respect to the factors specified in 42 C.F.R. � 488.438(f), Petitioner argued that CMS failed to consider its financial condition and its compliance history in determining the amounts of CMPs to impose. P. Br. at 64, 65, 73. Petitioner asserts that its witness, Steven Moser, the regional vice president of the company that at all material times owned Petitioner, gave unrebutted testimony that indicated that Petitioner lost money "before, and during, each month that remedies ran against [Petitioner.]" Id. at 65-66; see Tr. 655. In Petitioner's view, CMS's failure to provide evidence concerning its consideration of these two factors is an error which requires rescission of the CMPs or their reduction to the minimum level permitted under the regulations. P. Br. at 64.

In response, CMS asserts that Mr. Moser's testimony was not supported by any financial documentation from the facility. CMS R. Br. at 2. Moreover, CMS argues that the regulations do not specify the process by which CMS is to review a facility's financial situation prior to imposing a CMP, and further, that its process is not reviewable by an ALJ. Id. (Citing Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629 (1997)).

That I cannot look behind CMS's internal process in setting a CMP amount is well-settled by Board decisions. In Careplex, the Board held expressly that the ALJ should not look into the "internal decision-making processes of the officials at HCFA or the State." DAB No. 1683, at 8. Moreover, the Board has consistently held that an ALJ is not required to make any finding concerning the procedures CMS used in selecting a remedy or setting the amount of the CMP. Western Care Management Corp., d/b/a Rehab Specialties Inn, DAB No. 1921 (2004) (citing Emerald Oaks, DAB No. 1800 (2001)). In Capitol Hill Community Rehabilitation, DAB No. 1629 (1997), the Board held that ALJ review of a CMP under 42 C.F.R. � 488.438 (e) and (f) does not extend to "the particular process which HCFA utilized to establish the amount of the CMP, including what process HCFA utilized to determine the financial condition of the provider." DAB No. 1629, at 5.

Petitioner's financial losses, even if they are severe, are not enough by themselves to establish an inability of a provider to pay a CMP. The burden in this proceeding is not on CMS to prove Petitioner's ability to pay the CMP but on Petitioner to present evidence that the CMP would render it insolvent or adversely affect its ability to provide its residents with quality care. See Windsor Health Care Center, DAB No. 1902 (2003) ("The key factor in assessing financial condition is whether the facility has adequate assets to pay the CMP without having to go out of business or compromise resident health and safety"); 59 Fed. Reg. 56,116, 56,204 (1994) ("it is the responsibility of the facility to furnish the information it believes appropriately represents its financial status"). Petitioner had access to its financial statements and other records regarding its financial condition. Other than Mr. Moser's testimony, Petitioner chose not to submit any evidence into the record. ⁽²³⁾ Under the circumstances, I conclude that Petitioner did not establish that its financial condition warranted a reduction of the CMP.

Petitioner did not offer any evidence as to its compliance history, and I make no findings concerning this factor. With respect to the seriousness of Petitioner's deficiencies, it is apparent from the evidence pertaining to them that they were extremely serious. R1 and R3 were placed in life-threatening situations as a result of Petitioner's failures to provide adequate care. Several of the deficiencies resulted in actual harm to R3. Petitioner had a high degree of culpability for its noncompliance. I am, therefore, not able to find CMS's determination to impose a CMP of $8,050 per day for the period November 18, 1999 through December 9, 1999, unreasonable.

B. From December 10, 1999 through May 11, 2000, Petitioner continued to fail to comply substantially with Medicare participation requirements, albeit at a level of noncompliance that is less than the immediate jeopardy level.

CMS determined that Petitioner remained out of compliance with participation requirements, at a level of noncompliance that was less than the immediate jeopardy level, between December 10, 1999 and May 11, 2000. CMS determined that a May 12, 2000 revisit by the State surveyors established that Petitioner was in substantial compliance. CMS Ex. 208.

I sustain CMS's determination that Petitioner did not attain substantial compliance with participation requirements before May 11, 2000. Petitioner did not offer any evidence or argument to prove that, assuming it was not complying substantially with participation requirements as of December 9, 1999, it attained substantial compliance with participation requirements at any time before May 12, 2000.

C. A CMP of $300 per day is a reasonable remedy for each day of Petitioner's continued noncompliance with participation requirements from December 10, 1999 through March 27, 2000.

CMPs in amounts of from $50 to $3000 per day are authorized as remedies for deficiencies that are substantial but which do not reach the immediate jeopardy level of noncompliance. CMS determined to impose CMPs of $300 per day for each day of Petitioner's continued noncompliance with participation requirements during the period which ran from December 10, 1999 through March 27, 2000. These penalty amounts are within the amounts that are authorized for non-immediate jeopardy level deficiencies.

I find these amounts to be reasonable. They are at the lower end of the range of penalties that may be imposed for non-immediate jeopardy level CMPs.

D. A CMP of $650 per day is not reasonable as a remedy for each day of Petitioner's continued noncompliance from March 28, 2000 through May 11, 2000. Therefore, I reduce the amount of the CMP to $300 per day for each day of Petitioner's continued noncompliance from March 28, 2000 through May 11, 2000.

For the period March 28, 2000 to May 11, 2000, CMS chose to impose a daily CMP of $650 for Petitioner's continued noncompliance with participation requirements during this period. Like the $300 daily CMP I sustained for the period December 10, 1999 to March 27, 2000, the $650 daily CMP is within the amount that is authorized for non-immediate jeopardy level deficiencies.

I find unreasonable the difference between the two CMP amounts assessed against Petitioner for the period December 10, 1999 to May 11, 2000. Having already sustained a $300 daily CMP for the period December 10, 1999 to March 27, 2000, I am unable to find a rational basis for CMS's determination to impose a higher daily CMP of $650 from March 28, 2000 through May 11, 2000 on very similar evidence. I do not find that the number and seriousness of the deficiencies for the period March 28, 2000 to May 11, 2000 were greater or that Petitioner exhibited a higher level of culpability during this time period than for the period December 10, 1999 to March 27, 2000. Accordingly, I conclude that a $300 per day CMP is a reasonable amount for the period March 28, 2000 through May 11, 2000. Therefore, I reduce the amount of the CMP from $650 per day to $300 per day.

Richard J. Smith

Administrative Law Judge

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

2. The Notice letter also advised Petitioner of the various grounds pursuant to which it could lose its authority to conduct nurse aide training and competency evaluation programs. These grounds included the following: being subject to an extended or partial extended survey; the assessment of a CMP of not less than $5,000; being subject to a denial of payment; the appointment of a temporary manager; and termination. The Notice stated that if any of the grounds were applicable to the facility, it would receive further notification from the state.

3. Petitioner did not explicitly mention the DPNA remedy in its hearing request, but in subsequent correspondence referring to the remedies, Petitioner does mention the DPNA remedy. In its posthearing brief, Petitioner alludes to the DPNA remedy, and the last sentence in the brief states, " . . . the remedies imposed against Petitioner should be dismissed and, at a minimum, substantially modified." As I have noted above, the same evidence that supports the imposition of the CMP fully supports the DPNA. Thus, to the extent that the DPNA is before me in this appeal, I sustain it.

4. At the time of the hearing, CMS's exhibits were labeled using the "HCFA" acronym; however, in this decision, I will refer to the exhibits using the "CMS" acronym.

5. The burden of persuasion set forth in Hillman applies only where the evidence proffered by both sides is "in equipoise." In such cases, the burden of persuasion would be on Petitioner.

6. At the hearing, Surveyor Reasoner testified that she had been employed at Petitioner's facility as a "C & A examiner and instructor" (in context, I take this to mean "CNA examiner") for approximately four to six months in 1994-1995. Tr. 236. When asked why she left the facility, Surveyor Reasoner stated that the director of nursing had asked her to work longer days, and she had been unwilling to do so. Id.; Tr. 300. Surveyor Reasoner stated that she quit without giving any notice, but did write a resignation letter to the director of nursing. Tr. 236, 301, 302-03. She testified that there was no acrimony involved in her leaving. Tr. 326.

7. With respect to R1, I am not addressing the allegations under F-314.

8. The licensed practical nurse (LPN) stated that [t]here were no open areas in the area of the maggots - they were on her thigh." She stated further that "[s]he was afraid the maggots had gotten into the bottom or ankle." CMS Ex. 1, at 25.

9. CMS alleges a third incident of maggot infestation, which apparently occurred while R1 was in the hospital or on the way to the hospital. See P. Br. at 5. Although a hospital physician's report states that "[t]here was a report of the lesion [at the left heel] being infiltrated with maggots when [R1] came in" (CMS Ex. 1, at 140, 199; see CMS Ex. 1, at 43), it is not clear to me whether there was another discovery of maggots on R1 at the time of her hospital admission, or whether the hospital was merely citing one of her earlier episodes of maggot infestation. For this reason, I do not discuss this allegation.

10. This is almost certainly a reference to aloe vera.

11. On page 8 of its posthearing brief, CMS stated, "[t]he SOD alleges the failure of the facility staff to notify the doctor upon the discovery of 1) eschar on the resident's buttocks on September 3, 1999; and 2) necrotic tissue on the resident's penis which was accompanied by foul-smelling white to light brown discharges on September 20, 1999." (Cites omitted). CMS's characterization of the SOD's factual allegations underpinning F-157 is only partly correct. As I have stated above, F-157 of the SOD incorporates only the allegations under F-314, which are the pressure sore allegations, and include the discovery of eschar on R3's buttocks. While the pressure sore allegations mention that R3 had a scrotal wound, nowhere is there any mention of R3 having necrotic tissue on his penis. The allegations concerning Petitioner's care of R3's penis are set forth under F-309. In the SOD, the allegations under F-309 are not cited as support for the citation at F-157.

12. Paraphimosis is the retraction of phimotic foreskin, causing a painful swelling of the glans that, if severe, may cause dry gangrene unless corrected. Dorland's Illustrated Medical Dictionary 1228 (27 ^th ed. 1988).

13. According to the nursing notes, R3's penis was found to have a necrotic area at 12:00 a.m. on September 20, 1999. Thus, the reference in the transcript to the "19 ^th" appears to be an informal reference to the late hours of September 19, 1999 and the early morning hours of September 20, 1999.

14. The document at CMS Ex. 3, at 43-44 (duplicated at CMS Ex. 3, at 97-98) refers to a Resident #1, however, it is clear that Resident #1 is R3. Petitioner has not disputed this.

15. The regulation that is cited in the SOD as corresponding to F-281 is "483.20(d)(3)(i)." P. Ex. 4, at 2. This is incorrect. The correct citation is "42 C.F.R. � 483.20(k)(3)(i)."

16. I reiterate that, in the SOD, at F-281, the regulation is cited incorrectly as 42 C.F.R. � 483.20(d)(3)(i).

17. CMS Ex. 202, which consists of 63 pages, is a SOD from the December 1999 survey and is dated December 8, 1999. P. Ex. 5 consists of 144 pages, and contains three different documents: (1) a SOD dated December 8, 1999; (2) another SOD dated December 8, 1999; and (3) a SOD dated December 8, 1999, with a plan of correction from Petitioner in the right-hand column, which plan is unsigned and appears to be dated January 21, 2000 (a part of the year has been cut off on the copy.) The SODs in P. Ex. 5 are not identical, and none of them is identical to CMS Ex. 202. At the hearing, Surveyor Reasoner, on cross-examination, was unable to state which copy of the December 1999 SOD was provided to Petitioner on December 10, 1999, since "there [were] several floating around." Tr. 312. When asked by Petitioner's counsel to "explain . . . how a 47-page SOD became a 63-page SOD," Surveyor Reasoner stated that she believed the two documents were the same, but when her office combined data from two different computer systems, there was some confusion and the documents came out differently due to a "computer glitch." Tr. 823, see Tr. 820. She did not know why CMS Ex. 202 was 63 pages long. Id.

Based on my experience in these types of cases, I do not think that it is the usual surveying practice for there to be several different SODs for the same survey "floating around." In this case, there are four different December 1999 SODs in the record. Petitioner contends that Surveyor Reasoner wrote CMS Ex. 202 for the hearing. P. Br. at 20 n.17. I will not make a finding on Petitioner's allegation, but will note that the surveyors have exhibited a certain amount of carelessness with regard to the SOD from the December 1999 survey. There is no dispute that the F-tags I will be discussing from the December 1999 survey were actually cited by the surveyors at that survey. To strive for clarity, I will cite to all the December SODs in my analysis where appropriate.

18. In its posthearing brief, CMS alleges that, by December 6, 1999, the pressure sore on R6's coccyx was documented as a Stage IV. CMS Br. at 36. I do not discuss this allegation because it is not mentioned in the December 1999 SOD.

19. On page 85 of P. Ex. 5, the surveyor stated in the SOD, "[t]here was no December weight, as of 12/7/99, to review." On page 87 of P. Ex. 5, in the last paragraph relating to R6, the surveyor wrote in the SOD, "[h]er weight in December, 1999 was 110 pounds, indicating a 5.6 pound weight loss since October, 1999." The other December 1999 SODs do not contain the statement that there was no December weight to review as of December 7, 1999.

20. In the December SODs, under the F-441 citation, the surveyors discussed R6 and Resident 7 (R7) together in one of the examples of allegedly deficient practices. The text of the F-441 citation, as it relates to R6 and R7, is stated in the SODs as follows:

2. Refer to F314, examples #5, and #6, regarding the facility's failure to change contaminated dressings, to provide proper perineal, and Foley care, and failure to handle Foley bags and tubing appropriately.

CMS Ex. 202, at 57-58; P. Ex. 5, at 43, 91, and 140. For the sake of clarity, I wish to note that, based on what is alleged under F-314 for R6 and R7, I believe that the allegation regarding Petitioner's failure to change contaminated dressings is related to care received by R6, and the other allegations relate to care received by R7.

21. As I will discuss later, the pressure sore was identified by Petitioner's nursing staff on November 7, 1999 (P. Ex. 8, at 233); thus, the statement in the SOD that the pressure sore was measured nine days after it was identified is incorrect.

22. It is unclear from the SOD whether the stage II pressure sore described in the November 29, 1999 skin report is the same pressure sore that was acquired on November 6, 1999, or is another one. In its posthearing brief, CMS states that the pressure sore mentioned in the November 29, 1999 skin report is "another Stage II on her left buttock." CMS Br. at 30.

23. Mr. Moser testified that, following his review of Petitioner's financial statements for the period July 1999 through July 2000, he prepared a document in which he indicated the profit and loss for those months. Tr. 654. Petitioner's counsel then showed Mr. Moser the document he had prepared so that Mr. Moser could refer to it in his testimony. Tr. 655. When I asked Petitioner's counsel to identify the document, Petitioner's counsel replied, "The written summary in the record and I've provided a copy for cross-examination purposes." Tr. 657. Petitioner's counsel did not identify the document by exhibit number. I have reviewed Petitioner's exhibits that were admitted into the record, and do not find that a document purporting to be a financial summary prepared by Mr. Moser was admitted as an exhibit.