Rosewood Care Center (Petitioner or facility) is a nursing facility located in Peoria, Illinois, that is certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare & Medicaid Services' (CMS) determination that, from January 26 through April 25, 2001, it was not in substantial compliance with Medicare requirements. For the reasons set forth below, I conclude that from January 26 through April 25, 2001, the Facility was out of substantial compliance with the program participation requirements for quality of care (42 C.F.R. � 483.25) and resident rights (42 C.F.R. � 483.10), and that the amount of the civil money penalty (CMP) imposed, $300 per day, is reasonable.

I. Background

Resident #1 was admitted to the facility on December 28, 2000, to recuperate from gall bladder surgery. The next day he became acutely ill and was sent to the emergency room. His family, apparently dissatisfied with the action (or inaction) of facility staff, complained to the Illinois Department of Public Health (State Agency), which conducted a complaint investigation survey on January 26, 2001. CMS Exhibit (Ex.) 1. Following that investigation, the State Agency concluded that the facility was not in substantial compliance with program requirements, specifically Resident Rights (Notification of Rights and Services), 42 C.F.R. � 483.10(b)(11) (Tag F157), and Quality of Care (Significant Medication Errors), 42 C.F.R. � 483.25(m) (Tag F333). CMS Exs. 1, 4. By letter dated February 15, 2001, the State Agency advised the facility of its findings, directed the facility to conduct additional inservice training on medication administration and prevention of medication errors, and advised the facility that it would recommend that CMS impose additional remedies. CMS Ex. 4.

CMS concurred with the state findings and, by letter dated March 7, 2001, advised the facility that it was imposing additional remedies: 1) denial of payment for new admissions (DPNA), effective March 22, 2001; 2) a CMP of $300 per day, effective January 26, 2001, continuing until the facility achieved substantial compliance with program requirements or was terminated; and 3) termination, effective July 27, 2001. CMS Ex. 5.

In the meantime, the State Agency revisited the facility to conduct a more comprehensive annual survey. It completed that survey on February 28, 2001, and concluded that the facility had additional deficiencies. CMS Ex. 2. After several revisits, the State Agency found that the facility achieved substantial compliance as of April 26, 2001. CMS Ex. 11. CMS reviewed the state findings and, by letter dated June 29, 2001, advised Petitioner that, based on the survey findings and considering the results of Informal Dispute Resolution: 1) termination would not be pursued; 2) the DPNA, effective March 22, 2001, was discontinued effective April 26, 2001; and 3) the $300 per day CMP, which began on January 26, 2001, continued through April 25, 2001 (90 days). Id.

Petitioner timely requested a hearing, ultimately limiting its appeal to the deficiencies cited during the January 26, 2001 survey: failure to ensure that Resident #1 was free from significant medication errors (42 C.F.R. � 483.25(m)(2)), and failure to notify the resident's family of a significant decline in his medical condition and subsequent transfer to an acute care hospital (42 C.F.R. � 483.10(b)(11)). Petitioner's Brief (P. Br.) at 1.

I held a prehearing conference by telephone on November 14, 2002. Mr. Daniel Maher appeared on behalf of Petitioner, and Mr. Craig Herkel appeared on behalf of CMS. In the absence of objection, I admitted into evidence CMS Exhibits 1-29 and 31-45 (CMS did not offer CMS Ex. 30), and Petitioner Exhibits (P. Exs.) 1-3. The parties agreed: 1) that the facility had not contacted Resident #1's family about his decline and transfer, and, as of the time the family arrived at the facility, had not attempted to contact the family; and 2) that administering twice the amount of medication prescribed has the potential for causing more than minimal harm. Inasmuch as no material facts remained in dispute, I closed the record and issue this decision based on the written submissions. Summary of Prehearing Conference and Order Establishing Disposition of Case (Summary of Prehearing Conf.); see also 42 C.F.R. � 498.50(b)(Prehearing Conference Order and Opportunity to Object).

II. Issues

Whether, from January 26 through April 25, 2001, the facility was in substantial compliance with program participation requirements, specifically, 42 C.F.R. �� 483.25(m)(2) and 483.10(b)(11); and

If the facility was not in substantial compliance, was the amount of the CMP imposed, $300 per day (for a total of $27,000), reasonable?

III. Statutory and regulatory background

The Social Security Act (Act) sets forth requirements for nursing facility participation in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483.

To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements. To be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm." 42 C.F.R. � 488.301.

Under the statute and the "quality of care" regulation, each resident must receive, and the facility must provide, the necessary care and services to allow a resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, section 1819(b)(2); 42 C.F.R. � 483.25. Among other quality of care requirements, the facility must insure that residents are free of any significant medication errors. 42 C.F.R. � 483.25(m)(2).

A resident has a right to a dignified existence, self-determination, and communication with and access to persons and services inside and outside the facility. A facility must protect and promote the rights of each resident. This includes notification of changes.

The facility must immediately inform the resident; consult with the resident's physician; and, if known, notify the resident's legal representative or interested family of:

42 C.F.R. � 483.10(b)(11).

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. � 488.406, which include imposing a CMP. Act, section 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more program requirements or for each instance that a facility is not in substantial compliance. 42 C.F.R. �� 488.430(a); 488.440.

In situations where the deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for causing more than minimal harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day. In setting the amount of the CMP, CMS considers: 1) the facility's history of noncompliance; 2) the facility's financial condition; 3) 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 section 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.

IV. Findings of fact, conclusions of law and discussion

I make findings of fact and conclusions of law to support my decision in this case. I set forth each finding below, in italics and bold, as a separate heading.

The facts in this case are not in dispute. See P. Br. at 1. ("Rosewood concedes that the chronological history of this case contained in CMS introduction section is correct.") Resident #1 was an 87-year old man who transferred from St. Francis Hospital and was admitted to the facility at 3:15 p.m. on December 28, 2000, for a rehabilitative stay following a laproscopic cholecystectomy (removal of his gall bladder). CMS Ex. 16, at 14, 16. Among his other difficulties, Resident #1 had atrial fibrillation and was status post cerebral vascular accident. He had had a stroke. At the time of his admission to the facility, his medication orders included the anti-coagulant drug, Coumadin, 4 mg. every day. CMS Ex. 15, at 33. The medication discharge sheet from St. Francis Hospital indicates that he received his December 28 Coumadin at 3:00 p.m., prior to his discharge from St. Francis. CMS Ex. 16, at 2. Nevertheless, at 8:00 p.m. on the same day, facility staff administered 4 mg. of Coumadin to him. CMS Ex. 16, at 22.

According to his progress notes, the following morning he exhibited disturbing symptoms. At 9:55 a.m. the occupational therapist reported that his eyes were rolling back and his responses were slow. His pulse was very irregular. At 10:30 a.m. his pulse was still irregular and his blood pressure was up. He was transferred to the emergency room and subsequently admitted to the Intensive Care Unit with a diagnosis of retroperitoneal hematoma (internal bleeding in the area of the kidney, toward the rear of the abdominal cavity). CMS Ex. 16, at 14-15; CMS Ex. 17. At 11:10 a.m. the facility received the results of his lab tests, showing what staff characterized as a "critical" prothrombin time of 43.7 (above 30 is considered "panic"). ⁽¹⁾ The facility called the lab results in to the emergency room. CMS Ex. 16, at 14, 21, 36.

The family learned of the change in Resident #1's condition and subsequent transfer to the emergency room when they arrived to visit Petitioner at about 12:30 p.m. CMS Ex. 16, at 14.

Petitioner acknowledges that its staff administered a dose of Coumadin to Resident #1 at 8:00 p.m. on December 28 (CMS Ex. 16, at 22) but, notwithstanding the entry on the hospital's medication transfer sheet, Petitioner questions whether Resident #1 actually received the Coumadin at St. Francis Hospital on December 28. P. Br. at 2-3. Petitioner also strongly disputes the suggestion that its administration of the medication caused Resident #1's retroperitoneal hematoma and other difficulties. Id. at 3-4

According to the hospital's medication discharge record, Resident #1 received his last dose of Coumadin at what appears to be 1500 hours or 3:00 p.m. CMS Ex. 15, at 66. Petitioner, however, points out Resident #1's 3:15 p.m. admission to the Facility, and presents evidence that it would have been "physically impossible" for him to transfer from St. Francis to the facility in 15 minutes. P. Br. at 2; P. Ex. 3. Unfortunately, I have only photocopies of the St. Francis records and, on my copies, the time entry certainly looks like "1500." CMS Ex. 15, at 66; CMS Ex. 16, at 2. The surveyor notes also suggest that St. Francis administered the medication at 3:00 p.m. CMS Ex. 14, at 9. On the other hand, in a written statement dated January 25, 2001, Mark Baylor, M.D., the facility's medical director, says that Resident #1 transferred from St. Francis Hospital to the facility on December 28, 2000. He received 4 mg. of Coumadin at 1300 hours (1:00 p.m.) and 4 mg. of Coumadin at 2000 hours (8:00 p.m.). CMS Ex. 18, at 1. The entry on the hospital's medication discharge record looks like a 5 but could conceivably be a 3, which would be consistent with the Baylor statement that the last dose was given at 1:00 p.m. CMS Ex. 15, at 66.

Petitioner also points to other apparent errors in St. Francis' medication administration record (MAR), including an entry that suggests the administration of Clindamycin at 5:00 p.m. on December 28. CMS Ex. 15, at 62. ⁽²⁾

If, in fact, the St. Francis record contains an error, I find it at least as likely that the error is in the recorded time of the medication administration rather than the fact that it had been given. Moreover, the quality and accuracy of St Francis' documentation is not an issue before me. That St. Francis' medication records may contain errors does not justify the facility's ignoring those records and acting as though no medications were given. Further, no evidence suggests that the administering nurse reviewed St. Francis' medication discharge record, much less questioned its accuracy. At a minimum, staff should have reviewed the medication discharge sheet, and, if questions arose, should have verified whether the medication had already been administered. In the face of evidence that the dosage had already been administered, staff's administering an additional dose of a potentially dangerous medication was a serious deficiency. ⁽³⁾

Petitioner also raises questions as to whether Resident #1's retroperitoneal hemorrhage was directly attributable to facility staff's administration of the Coumadin, and I agree that the question is debatable, certainly based on the record before me. See, e.g. CMS Ex. 17, at 1. ("Is retroperitoneal hemorrhage due to falls or due to coagulopathy (over coagulation with Coumadin?")) ⁽⁴⁾ However, I need not address this question because the regulations do not require any showing of actual harm. A facility is not in substantial compliance if its deficiencies create more than "the potential for causing minimal harm." 42 C.F.R. � 488.301. Here, staff more than likely gave Resident #1 a second dose of Coumadin on December 28, 2001, because they failed to review his transfer documents. This was a dangerous practice with potential for significant harm. As the parties agree, administering twice the amount of a prescribed medication has the "potential for more than minimal harm." See Summary of Prehearing Conf. I therefore find substantial noncompliance with the quality of care regulation.

Petitioner concedes that its staff did not notify Resident #1's family of his decline and transfer until they arrived at the facility to visit him. See Summary of Prehearing Conference. Nevertheless, Petitioner argues that it notified Resident #1's family "in a timely manner." P. Br. at 5. Somewhat inconsistently, it also asserts that it disciplined the employee responsible for failing to notify Resident #1's family. P. Br. at 5; CMS Ex. 18, at 3.

The regulations require that the facility "immediately inform" the resident's family of his change in condition and transfer to the hospital. 42 C.F.R. � 483.10(b)(11). Here, facility policy is wholly consistent with the regulation. It requires the "wing nurse" to notify the physician and the resident's family of any significant change in the resident's condition "at the time the change is noted." (Emphasis added). The Social Service staff may assist with family notification. CMS Ex. 18, at 5.

The evidence establishes that staff noticed the deterioration in Resident #1's condition before 10:00 a.m. CMS Ex. 16, at 14. The record does not show exactly when the facility contacted the physician or when Resident #1 was transferred, but it does show that facility staff neglected to contact the family and had no plan to contact the family. In a written statement, an employee of the Social Services Department describes a "considerable amount of confusion that morning." One of the other residents presented significant behavior problems, requiring constant supervision. The responsible nurse was trying to supervise him, pass medications, and communicate with doctors as to Resident #1's condition. CMS Ex. 18, at 2.

While it was fortuitous that they arrived when they did, nothing in this record suggests that facility staff had any plan to contact Resident #1's family, who apparently only learned of these events because they came to visit him sometime later in the day and found him gone. The evidence thus establishes that the facility failed to inform them "immediately" of the change in condition and transfer, which violates the regulation.

Having found a basis for imposing a CMP, I now consider whether the amount imposed is reasonable, applying the factors listed in 42 C.F.R. � 488.438(f). It is well-settled that, in reaching a decision on the reasonableness of the CMP, I may not look into CMS's internal decision-making processes. Instead, I consider 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 (i.e. financial condition, facility history, culpability). I am neither bound to defer to CMS's factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS's discretion. Barn Hill Care Center, DAB No. 1848, at 21 (2002); Community Nursing Home, DAB No. 1807, at 22 et seq. (2002); Emerald Oaks, DAB No. 1800, at 9 (2001); CarePlex of Silver Spring, DAB No. 1683, at 8 (1999).

CMS has imposed a penalty of $300 per day, which is at the lower end of the mandatory range for non-immediate jeopardy situations ($50 - $3,000 per day). With respect to the section 488.438(f) factors, CMS cites findings from the facility's earlier surveys, which show a significant history of noncompliance. Three earlier surveys since 1996 resulted in findings of substantial noncompliance, and, for the annual survey immediately preceding this survey, a $200 per day CMP was imposed. CMS Ex. 44. Petitioner has not challenged CMS's assertion as to its history of noncompliance.

The record is silent as to the facility's financial solvency. Petitioner has not claimed that its financial condition makes the amount of the CMP unreasonable. See Community Nursing Home, DAB No. 1807, at 22 et seq. (2002); Emerald Oaks, DAB No. 1800 (2001).

Applying the remaining factors, I find that the quality of care deficiency was not insignificant. Petitioner argues that it was not as culpable as CMS determined in setting the amount of the fine, pointing to purported errors by St. Francis Hospital which, Petitioner contends, led to Resident #1's difficulties. First, as noted above, in this de novo review, I do not review the method by which CMS reached its CMP determination. Second, that St. Francis may have erred does not make the facility less culpable in giving a medication because it should have known that the medication had already been given. Finally, I note that these were not the facility's only deficiencies. The subsequent annual survey, completed February 28, 2001, found additional problems which amounted to substantial noncompliance and which Petitioner has not appealed.

Considering these factors, I do not find unreasonable CMS's determination to impose a $300 per day CMP.

V. Conclusion

For all of the reasons discussed above, I uphold CMS's determination that from January 26 through April 25, 2001, the facility was not in substantial compliance with program participation requirements, specifically 42 C.F.R. � 483.25 (Quality of Care) and 483.10 (Resident Rights). The amount of the CMP imposed, $300 per day, is reasonable.

1. Tierney, McPhee & Papadakis, Current Medical Diagnosis and Treatment, 33d Ed. at 1351 (Appleton & Lang 1994).

2. Curiously, although an X on the MAR suggests that the medication was administered at 5:00 p.m., unlike the other entries on the chart, a set of initials does not accompany the X.

3. A subsequent puzzling progress note indicates that "another guest" was given Resident #1's vitamin K and Resident #1 would receive that treatment at the emergency room. CMS Ex. 16, at 14-15.