SUBJECT:

Eastwood Convalescent Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the imposition of civil money penalties (CMP) by the Centers for Medicare & Medicaid Services (CMS) against Petitioner, Eastwood Convalescent Center, for failure to comply substantially with federal requirements governing participation of long-term care facilities in Medicare and state Medicaid programs. For the reasons that follow, I uphold the CMP of $4,000 per day from November 1, 2004 through November 2, 2004, based on a finding of immediate jeopardy, and the CMP of $250 per day for the period from November 3 through December 4, 2004.

I. Background

Petitioner requested a hearing on January 11, 2005, and the case was assigned to me for hearing and decision.

On November 18, 2004, CMS informed Petitioner that it was imposing the remedies pursuant to a November 5, 2004 survey by the Michigan Department of Community Health (MDCH or State survey agency). ⁽¹⁾

I held a hearing on March 14, 2006 in Detroit, Michigan. At the hearing, CMS offered 16 exhibits, identified as CMS Exs. 1-16. I received CMS Exs. 1-16 into evidence without objection. Petitioner offered 15 exhibits, identified as P. Exs. 1-15. I received these exhibits into evidence without objection.

Subsequent to the hearing, the parties submitted post-hearing briefs (CMS Br. and P. Br.) and response briefs (CMS Response and P. Response).

Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that Petitioner was not in substantial compliance on the dates determined by the State survey agency and CMS. I further find that CMS was authorized to impose a CMP of $4,000 for two days of alleged non compliance from November 1, 2004 through November 2, 2004, and a $250 per day CMP thereafter through December 4, 2004.

II. Applicable Law and Regulations

Petitioner is a long-term care facility. Its participation in Medicare and Medicaid is subject to sections 1819 and 1919 of the Social Security Act (Act), and to the regulations at 42 C.F.R. Part 483.

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

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 CMP against a long-term care facility where a state survey agency ascertains that the facility is not complying substantially with 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.

The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two broad ranges of penalties. 42 C.F.R. �� 488.408, 488.438. The upper range of CMP, 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 CMP, 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).

The regulations define the term "substantial compliance" to mean:

[A] level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.

42 C.F.R � 488.301.

"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.

The Act and regulations make a hearing before an administrative law judge (ALJ) available to a long-term care facility against whom CMS has determined to impose a CMP. But the scope of such hearings is limited to whether an initial determination made by CMS is correct. Act, section 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). A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. � 488.408(g)(1); see also 42 C.F.R. �� 488.330(e) and 498.3. However, the choice of remedies by CMS or the factors CMS considered when choosing remedies are not subject to review. 42 C.F.R. � 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the CMP that could be collected by CMS or impact upon the facility's nurse aide training program. 42 C.F.R. �� 498.3(b)(14) and (d)(10)(i). CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. � 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd, Woodstock Care Center v. U.S. Dept. of Health and Human Services, 363 F.3d 583 (6^th Cir. 2003). The Departmental Appeals Board (the Board or DAB) has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). Review of a CMP by an ALJ is governed by 42 C.F.R. � 488.438(e).

III. Issues

A. Whether the facility was complying substantially with federal participation requirements on the dates CMS determined to impose a CMP.

B. Whether CMS's determination of immediate jeopardy was clearly erroneous.

C. Whether the amount of the penalty imposed by CMS is reasonable, if noncompliance is established.

IV. Findings and Discussion

The findings of fact and conclusions of law noted below in italics are followed by a discussion of each finding.

A. The facility was not in substantial compliance with federal participation requirements from November 1, 2004 through December 4, 2004.

B. Quality of Care (Tag F324) Petitioner was not in substantial compliance with the quality of care requirements at Tag F324 by failing to provide adequate supervision and assistance devices to prevent accidents.

The provisions of 42 C.F.R. � 483.25(h)(2) require that a facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents.

State surveyor's findings for 42 C.F.R. � 483.25(h)(2) as reflected at Tag F324 in the Statement of Deficiencies (SOD)(CMS Ex. 1, at 5-15).

Resident 500 (R500) was admitted to the facility on October 19, 2004, following a hospitalization for a shunt (access device for hemodialysis) replacement. Diagnoses included end-stage renal disease, hypertension, diabetes mellitus, and coronary artery disease. According to the admission record, R500 was identified as her own responsible party. A male with a different last name was listed as her husband.

The hospital Transfer Form indicated that the resident underwent placement of a left groin permacath (access device for hemodialysis) and creation of a new anteriovenous (AV) graft (access device for hemodialysis). Hemodialysis was done through the permacath until the AV graft matured, a process that takes about 2 to 4 weeks.

The Minimum Data Set assessment (MDS) dated October 22, 2004, revealed that R500 had some cognitive impairments (difficulty in new situations), short-term memory problems, and experienced confusion at times. The MDS also indicated that the resident needed total assistance with all activities of daily living. She received hemodialysis three times a week.

The October 19, 2004 nursing admission assessment documented that R500 had a feeding tube. According to the Medication Administration Record (MAR), she received accuchecks with regular insulin coverage four times daily (6 a.m., 12 noon, 6 p.m. and 10 p.m.), Heparin (anticoagulant, prophylaxis for deep venous thrombosis/pulmonary embolism) at 10 a.m. and 10 p.m., Lopressor (antihypertensive) at 10 a.m. and 6 p.m., Risperdal (antipsychotic) at 10 a.m. and 6 p.m., and Lantus Insulin at 9 p.m.

The van driver who transported R500 to dialysis was interviewed by the surveyor on October 29, 2004. CMS Ex. 1, at 8. He stated that when he arrived at the dialysis center on October 25, 2004 to get the resident and transport her back to the nursing home, the resident's husband was there. The husband approached the driver and asked him for a ride in the van with a stop at the bank enroute to the nursing home. The driver immediately called his supervisor at facility "B" for guidance. The surveyor interviewed the Administrator of facility "B" who stated that she spoke with the van driver on October 25, 2004, and instructed him that no one except residents were allowed to ride the van, and that there could be no unscheduled stops. Id. She also told the van driver that the husband could ride in the van on October 25, 2004 only, but that no unscheduled stops enroute to the nursing home would be made. The facility "B" Administrator also spoke with the husband by telephone and informed him that he could ride in the van on that day only, and that no stops would be made for banking on the way back to the nursing home.

The facility "B" Administrator spoke with the Administrator responsible for R500 (Administrator "A") and asked him to reinforce the information with the husband because he was agitated. CMS Ex. 1, at 8.

When interviewed on October 29, 2004, the van driver stated that on October 27, 2004 at approximately 3:30 p.m., when he returned to the dialysis center to pick up residents for return to the nursing home, R500's husband was there again. He indicated that R500's husband wheeled her out of the dialysis center. The van driver noted that he reminded the husband that he could not ride in the van. The husband responded: "Okay, whatever, I'm taking her with me. I'll be back in 1� hours." Id. at 9. The van driver added that he immediately called facility "B" Administrator and then called Administrator "A." After that, the driver went inside the center to speak with staff, and when he returned, R500 and her husband were gone. Id.

Mr. Robert Martin, Administrator "A," was interviewed regarding the October 27, 2004 incident and he stated that the husband was listed as R500's emergency contact. Id. at 10. He stated that R500 offered no resistance to going with her husband, and he thought that the husband would return with the resident to the facility after the errand was completed. The Administrator did not know that the resident had not returned to the facility as planned until he returned to work the next day. Id.

In a telephone interview on October 29, 2004, Nurse "B" stated that she worked the afternoon shift on October 27, 2004, but was unaware that the van had returned from dialysis on that day without R500. Id. at 10-11. She added that residents are sometimes late for a variety of reasons, such as treatment complications or unavailability of transportation. According to Nurse "B," R500's absence was not initially a concern, and then she received a call from the hospital at approximately 8:00 p.m., indicating that the resident was there for evaluation of abrasions and fever. Id. at 11.

The hospital records indicated that the resident was found approximately 10 miles from the dialysis center. She had fallen out of her wheelchair and suffered a 1.5 cm abrasion on her nose, an abrasion on her inside upper lip and gum, and had bilateral hand pain. Id. at 11-12.

Discussion

CMS contends that it has established a prima facie case that Petitioner did not undertake all reasonable measures to assure that R500 returned safely from her regularly scheduled dialysis treatment. CMS further argues that the resident was in a vulnerable state due to her medical condition, and that it is uncontroverted that R500 suffered an accident and was injured. CMS Br. at 7, 8.

It is Petitioner's contention that R500 was competent to make her own decisions, and could go on a leave of absence (LOA) with her husband without regard for the latter's ability to care for her. Petitioner also argues that spending time with her husband is R500's personal right with which the facility is prohibited from interfering, according to 42 C.F.R. � 483.10.

The thrust of CMS's argument is that Petitioner failed to ensure R500's safe return to the facility after she underwent dialysis treatment at an offsite location. In fact, Ms. Pat Kaelin, the surveyor, testified that the facility should have prevented the husband from taking the resident with him on a banking errand after she completed her dialysis treatment on October 27, 2004. Transcript (Tr.) at 43. The deficiency, however, is not rooted in the fact that the resident was wheeled away at the conclusion of dialysis, but in the fact that she suffered an accident on their return trip to the nursing home. This is evident from the surveyor's later testimony to the effect that immediate jeopardy would not have likely been imposed if the resident had been returned to the facility without incident. Tr. at 96, 99. This testimony is in obvious contradiction to her earlier testimony that the facility should have prevented the resident from going off with her husband. Thus, it is not appropriate to conclude that the facility was negligent in allowing the resident to go with her husband to run an errand just because, in hindsight, they happened to experience an accident along the way.

In spite of the above, I find that the facility did fail to take further action to determine the whereabouts of the resident after she did not return to the facility within the hour and a half as indicated by her husband. CMS Ex. 1, at 10. This is where the resident's compromised medical condition is pertinent. She had a feeding tube, and received accuchecks with regular insulin coverage four times daily (6 a.m., 12 noon, 6 p.m. and 10 p.m.), Heparin (anticoagulant, prophylaxis for deep venous thrombosis/pulmonary embolism) at 10 a.m. and 10 p.m., Lopressor (antihypertensive) at 10 a.m. and 6 p.m., Risperdal (antipsychotic) at 10 a.m. and 6 p.m., and Lantus Insulin at 9 p.m. Id. at 7. The Lopressor, an antihypertensive medication, was of particular concern, because during dialysis, it loses its effectiveness because it is eliminated. Tr. at 109. Additionally, prior to being contacted by the hospital, the facility should have been concerned that the resident had missed other medications, especially Insulin. Tr. at 138, 139. In this regard, it is important to note that although the afternoon nurse informed the surveyor that a call was received from the hospital at 8:00 p.m. on October 27, 2004, indicating that R500 had been admitted for evaluation and treatment of abrasions and fever, the facility nurse's notes reflect that the call was actually received from Detroit Receiving Hospital at 11:20 p.m. CMS Ex. 8, at 52. Thus, although it may not have been expected that the facility staff harbor any serious concern if the resident was a half hour or an hour late in returning, it was not reasonable for the facility to totally ignore that she was late by more than five hours.

I note that Mr. Martin, Petitioner's Administrator (Administrator "A"), testified that the facility's policy is to allow the resident 24 hours from the time expected back, and then consider the resident gone against medical advice. Tr. at 132. I infer that the 24 hour rule referred to by the Administrator applies to situations where staff has followed the proper procedure for allowing residents to go on "leave of absence" (LOA) from the facility. In the case now before me, R500's LOA was a departure from the policy adopted by the facility. The facility policy requires that:

�The nursing staff should get as much information as possible from the resident regarding the LOA. This includes where the resident is going, how long he or she will be gone, and the method of contact in case of emergency.

�The resident and/or guardian should be given instructions regarding medications, including times and dosages required.

�If a resident does not return as scheduled, the Administrator, the Director of Nursing (DON), and the Physician should be notified.

�If the resident does not return within two hours of the time due, the Charge Nurse will try to locate the resident. If not able to locate the resident, the Nurse must immediately notify the Administrator, the DON, and the Physician.

�If the facility has complied with all of the above and the resident cannot be located, and the resident is his or her own responsible party, then the facility may declare the resident to have abandoned the facility against medical advice (AMA).

P. Ex. 10.

From a reading of the above policy, it is clear that the facility's prerogative to declare a resident as having left the nursing home AMA is not a substitute for taking steps to ensure that a resident continues with the required medication regimen even when on LOA, for knowing where to locate a resident in case of emergency, and for taking diligent steps to locate a resident who fails to return at the expected time. The policy does not say that if the resident is his or her own responsible party, the facility has no duty whatsoever to ascertain the resident's whereabouts and make diligent efforts to ensure his or her well being prior to making a declaration of abandonment AMA. In this case, the onus on the facility to be vigilant regarding the resident's timely return to the facility was even more crucial than the cautionary measures outlined in its policy, inasmuch as the LOA occurred in a manner that was out of the ordinary, and critical safeguards were not established at the time of her departure. As was testified to by the surveyor: "They did have an elopement policy and they did have a leave of absence policy. . . However, there was no plan in place if the resident did not come back in the one and a half hours that the husband said he was going to return. There was no plan to do anything and nothing was done, so neither plan [policy] was implemented." Tr. at 21-22. Furthermore, Administrator A's testimony, that in the case of R500 he applied the 24-hour guidelines for residents who are their own responsible party (Tr. at 132), is baseless because he did not know that the resident had not returned. Thus, there was no contemporaneous deliberation process that led him to apply those guidelines, inasmuch as he did not learn of the resident's failure to return as promised until the following day. CMS Ex. 1, at 13. And, if he had gone through that thought process, it would be a conscious disregard for the well-being of R500 in light of her medical condition and needs, as outlined above.

It is also noteworthy that as a result of a communication breakdown, the charge nurse for the 3 to 11 p.m. shift was unaware of the situation surrounding R500's absence. Tr. at 23. Pertinent to this is the fact that when interviewed on October 29, 2004, she admitted not knowing that the van returned from the dialysis center without the resident on the 27^th of October. The charge nurse added that sometimes residents are late in returning from dialysis for a variety of reasons, such as treatment complications or unavailability of transportation. CMS Ex. 1, at 10, 11. This explanation, however, is gratuitous, in light of the admission that she did not know that the resident had not returned. Moreover, the Administrator knew that R500 would not be returning with the facility van, but failed to relay that information to the staff. In fact, the DON was not well informed of the situation, nor did she get involved with the nursing needs of R500 on October 27, 2004, because the Administrator was handling the matter. Tr. at 22, 23. Thus, in the absence of a communication from the Administrator, the staff was oblivious to the whereabouts of the resident until a phone call was received from the hospital that R500 had been admitted to the hospital at 8:30 p.m. CMS Ex. 1, at 13; CMS Ex. 8, at 52. In the intervening period of time, the facility did nothing to ensure the well-being and safety of R500.

It is not as the Administrator implied, that the facility was applying the 24-hour waiting time, stipulated in its policy, prior to declaring the resident as having left the nursing home AMA. In fact, the staff had no clue that the resident was missing, and displayed a lackadaisical attitude regarding the medical needs of R500.

In view of the foregoing, I find that Petitioner failed to provide R500 with adequate supervision and assistance devices to prevent accidents, and thus, was not in substantial compliance with 42 C.F.R. � 483.25(h)(2).

C. Petitioner failed to administer its facility in a manner that enabled it to use its resources effectively and efficiently to attain the highest practicable physical, mental, and psychosocial well-being of its residents, as required by 42 C.F.R. � 483.75 (Tag F490).

42 C.F.R. � 483.75 requires that a facility be administered in a manner that enables it to use its resources effectively and efficiently to attain and maintain the highest practicable physical, mental, and psychosocial well-being of each resident.

State Surveyor's findings as reflected in the SOD for Tag F490 (CMS Ex. 7, at 31-32).

Based on observations, interviews, and record reviews, it was determined that Petitioner failed to administer its facility's resources in a manner that ensured the safe return of a resident to the facility following dialysis treatment.

There was no evidence that the Administrator made any effort to find R500 or provide appropriate transportation for that resident to return to the nursing home. The resident was removed from the dialysis clinic at 3:30 p.m. on October 27, 2004, and her whereabouts were unknown until 11:20 p.m., when the hospital notified the nursing home that R500 had been admitted to the hospital at 8:30 p.m. ⁽²⁾ CMS Ex. 1, at 19, 20; CMS Ex. 8, at 52 .

Discussion

Petitioner argues that the citation at Tag F490 is to a significant degree based on CMS's contention that the facility had lapses in its policies. However, Petitioner contends that the elopement policy was inapplicable in this case, and the surveyor recognized that had the facility followed its LOA policy, that would have been appropriate. Consequently, no violation could be established under Tag F490, inasmuch as the Administrator confirmed in his testimony that the leave policy was followed. As discussed earlier, however, the leave policy was in fact not followed. The failure to follow the leave policy was addressed by Ms. Kaelin, the surveyor, in her testimony:

They did have an elopement policy and they did have a leave of absence policy. They told me that they didn't consider this to be an elopement. However, there was no plan in place if the resident did not come back in the one and a half hours that the husband said he was going to return. There was no plan to do anything, and nothing was done, so neither plan was implemented.

Tr. at 22-23.

Thus, it is my finding that Petitioner did not effectively and efficiently administer its resources to provide adequate supervision to its residents. It is obvious that the administration of staff resources was so grossly inept that no follow-up was given to the whereabouts and well-being of R 500 to the point that the staff was unaware that she had not returned to the facility until contacted by the hospital at 11:20 p.m. The deficiency discussed here denotes the absence of aggressive administration of facility resources to provide for the well-being of its residents.

I find that CMS established a prima facie case under Tag F490. Petitioner has not overcome that showing.

D. CMS's finding of immediate jeopardy was not clearly erroneous.

In the preceding section, I found that CMS established a prima facie case that Petitioner was not in substantial compliance with federal requirements for skilled nursing facilities participating in the Medicare and Medicaid programs. Petitioner has not overcome CMS's showing by a preponderance of the evidence. Furthermore, I sustain CMS's finding that Petitioner's level of noncompliance constitutes immediate jeopardy under Tag F324 and under Tag F490.

The regulations define immediate jeopardy as a situation in which a provider's non-compliance 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. A finding of immediate jeopardy does not require "a finding of present harm, but also encompasses a situation that is [likely to cause] harm." Britthaven, Inc., d/b/a Britthaven of Smithfield, DAB No. CR1259 (2004) (quoting Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002)). CMS's determination of immediate jeopardy must be upheld unless it is clearly erroneous. 42 C.F.R. � 498.60(c)(2). The burden rests on the petitioner to prove that CMS's determination of immediate jeopardy is clearly erroneous. Petitioner has not met that burden here.

Petitioner contends that the immediate jeopardy Tags were not warranted because it adequately supervised R500 and she was not placed in a situation that could cause serious injury, impairment, harm, or death. P. Br. at 38, 39. As I stated above, however, I have rejected Petitioner's argument that it provided adequate supervision to its residents. I also reject Petitioner's argument that its noncompliance did not place R500, as well as other residents similarly situated, in dangerous situations.

Specifically, Petitioner argues that when R500 fell and suffered injuries, she was on a LOA with her husband, as was her right. Petitioner further points out that the surveyor admitted that immediate jeopardy would not have been justified if the resident had not experienced the misfortune of having an accident. Although the surveyor did testify that immediate jeopardy might not have been imposed except for the resident's accidental fall and ensuing injuries, I am not persuaded that my analysis stops there. I must look at the overarching issue of whether Petitioner did in fact fail to provide R500 with adequate supervision. In particular, I must determine whether Petitioner substantially complied with the requirement to ensure that the resident in question had a safe return to the facility. ⁽³⁾ My analysis, as outlined above, clearly shows that once Petitioner allowed the husband to take the resident from the dialysis center, it failed to continue to exercise adequate supervision to ensure a safe return to the facility. The Administrator did not communicate his decision to the nursing staff, and thus, the staff was unaware of R500's absence. Moreover, the nursing staff exhibited no concern for the resident's well-being. This is evident from the absence of documentation in the record as to whether the resident had her scheduled medications, whether the dialysis site was adequately cared for, and whether she could be tube fed when in the care of her husband and out of the facility. Petitioner should have foreseen that after a prolonged period without her medications, and without being tube fed, and without proper care of the access site for dialysis, R500 was likely to suffer serious injury, harm, impairment, or death. Equally at risk were other residents in similar situations.

E. The facility failed to provide services that met professional standards of quality under Tag F281.

42 C.F.R. � 483.20(k)(3)(i) requires that the services provided or arranged by the facility must meet professional standards of quality.

State surveyor's findings for 42 C.F.R. � 483.20(k)(3)(i) (Resident assessment) as reflected at Tag F281 of the SOD (CMS Ex. 1, at 1-5).

Based on observation, interview and record review, the facility failed to conduct appropriate assessments and care planning for venous access devices for four (R500, R501, R504, and R506) of the residents sampled, placing the residents at risk for complications associated with venous access devices. See CMS Ex. 1, at 1-5.

R500 was admitted to the facility on October 19, 2004, following placement of a left groin permacath (access device for hemodialysis) and creation of a new AV graft (access device for hemodialysis). She received hemodialysis three times a week. The admission nursing assessment on October 19, 2004, documented a left groin permacath, but there was no documentation of the upper extremity AV graft. The venous access sites, following admission, were not addressed in the nurse's notes, on the MAR for October 2004, or in a care plan.

R501 was admitted to the facility on August 27, 2004. A member of the dialysis facility stated that the resident had a surgically inserted subclavian line used for dialysis. There was no documentation in the nurse's notes or care plan regarding the venous access device or site, following admission.

R504 was admitted to the facility on October 14, 2004. The record noted diagnoses of osteomyelitis, anemia, and syphilis. The resident was observed on November 2, 2004, with a PICC (Peripherally Inserted Central Catheter) line in the left upper arm for the administration of intravenous antibiotics. There were no nursing entries documenting the size of the catheter site or assessments which would help warn of complications.

R506 was admitted on October 8, 2004. A hospital history and physical report dated September 13, 2004, indicated that the resident had multiple diagnoses, including cancer with metastases and anemia, with an implanted chest portacatheter in place. The admission nursing assessment documented a "port underneath skin" on the left upper side of the chest, but there was no other nursing documentation about the site or care of the implanted port.

The resident stated that the port was flushed "about two months ago." CMS Ex. 1, at 5. The accepted practice calls for flushing every four weeks.

Discussion

With respect to R500 and R501, Petitioner contends that CMS admitted that the graft sites would have been assessed by the dialysis staff two to three times per week when these residents were taken to the dialysis center for treatment. According to Petitioner, such assessments would detect infection or clots, making the likelihood of harm remote. Petitioner also argues that the surveyor made no effort to investigate whether the staff was actually performing assessments. P. Br. at 33, 34. Petitioner's arguments regarding these two residents are without merit.

In the case of R500, CMS has charged Petitioner with failing to document the care and assessments of a right upper extremity AV graft. Although the nursing assessment documented a left groin permacath following admission to the facility, the venous access site was not addressed in the nurse's notes, on the medication record, or in the care plan.

Ms. Kaelin, the surveyor, confirmed in her testimony that there was no care plan and no assessments had been done to address the resident's AV graft. Tr. at 115.

With respect to R501, there was no documentation in the nurse's notes or care plan regarding the venous access device or site following admission.

I find that CMS has established a prima facie case that the facility failed to provide or arrange services that meet professional standards of quality as required by 42 C.F.R. � 483.20(k)(3)(i). To overcome CMS's showing, Petitioner must demonstrate that it care planned for the venous access site in question, performed appropriate assessments, and documented the care provided in each case. Petitioner has not complied with any of these requirements, and cannot shift its burden to provide services that meet professional standards of quality to the dialysis center where its residents are treated on a regular basis several times a week. This is particularly true in light of Ms. Kaelin's testimony to the effect that in addition to assessing the graft site for other reasons such as malfunction due to a clot, it is important not to apply anything constricting on the graft site. She added that "you are supposed to listen to what is called a bruit on a daily basis. And this is a sound [pulse], which is a distinctive sound which is heard when you place your stethoscope over the graft, and that verifies that it's functioning. And there was no documentation of this." Tr. at 115. Finally, Petitioner's assertion that the surveyor made no effort to investigate whether the staff was actually performing assessments is baseless inasmuch as CMS has no duty to make such a showing. Once CMS establishes that the facility had no documentation that reflected that proper care planning and assessments had been done, the burden shifts to the facility to show that these things were in fact done. Moreover, the failure to document the assessments constitutes a separate deficiency apart from the actual performance of the assessments.

With respect to R504 and R506, Petitioner argues that, apart from the mere submission of the SOD, CMS presented no evidence at the hearing in support of its allegations regarding these two residents. Petitioner concludes, therefore, that CMS has not established a prima facie case to support a deficiency under Tag F281 for R504 and R506. The surveyor's observations, however, as stated in the SOD, suffice to establish a prima facie case of lack of substantial compliance. Therefore, Petitioner's general denial fails to rebut CMS's showing by a preponderance of the evidence.

F. The amount of the penalty imposed by CMS is reasonable.

Petitioner contends that CMS failed to specifically provide any basis for a finding of immediate jeopardy that justifies the imposition of a $4,000 penalty. I have already discussed the basis for a finding of noncompliance. Indeed, there is not only a prima facie case of noncompliance here, but the preponderance of the evidence is that Petitioner was not complying substantially with the regulatory requirements under 42 C.F.R. � 483.25(h)(2). Furthermore, Petitioner has not met its burden of showing that CMS's determination of immediate jeopardy is "clearly erroneous." Moreover, the CMP of $4,000 per day, imposed for two days, commencing November 1, 2004 through November 2, 2004, of noncompliance at the immediate jeopardy level, falls within the low end of permissible monetary penalties.

I also conclude that CMS satisfied the criteria for imposing remedies at the less than immediate jeopardy level from November 3 through December 4, 2004. CMS established a prima facie case that Petitioner was not complying substantially with the participation requirements as of November 3, 2004, and Petitioner did not rebut that case.

Petitioner contends that CMS did not present sufficient evidence to establish the duration of the CMP. However, the burden is on Petitioner to show that it had eliminated the noncompliance on any date prior to December 4, 2004. It has not done so.

V. Conclusion

Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that Petitioner was not in substantial compliance at the immediate jeopardy level from November 1, 2004 through November 2, 2004, and that the imposition of a $4,000 per day CMP is reasonable. Additionally, I conclude that a CMP of $250 per day is reasonable for deficiencies at the less than immediate jeopardy level based on Petitioner's noncompliance from November 3 through December 4, 2004.

José A. Anglada

Administrative Law Judge

1. CMS initially imposed a mandatory denial of payment for new admissions (DPNA) effective February 5, 2005, but Petitioner returned to substantial compliance before the DPNA went into effect.

2. As has been stated earlier, the nurse's notes reflect that, in reality, the call was not received from the hospital until 11:20 p.m. P. Ex. 9.

3. Although I have found, based on the surveyor's testimony, that immediate jeopardy cannot be based on the Administrator's decision to allow the husband to take R500 with him on an errand at the conclusion of dialysis on October 27, 2004, it is not without some reluctance. It would have been better practice had the Administrator instructed the husband to wait until R500 returned to the facility and then request a LOA. That would have permitted the nursing staff to give compliance to the facility's leave policy, and thus, employ measures that would be conducive to the resident's safe return to the nursing home. It is possible that the surveyor was operating under the mistaken notion that immediate jeopardy requires actual harm.