SUBJECT:

Living Center West,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

I decide that the Centers for Medicare & Medicaid Services (CMS) has not met its burden to present a prima facie case that it is authorized to impose a civil money penalty (CMP) against Petitioner, Living Center West, in the amount of $50.00 per day from April 7, 2000 to June 26, 2000. Therefore, I enter summary judgment for the Petitioner in this case.

I. Factual and Procedural Background

This matter is before me on cross motions for summary judgment. ⁽¹⁾ The case began on April 7, 2000, when the Iowa Department of Inspections & Appeals (State agency) surveyed Petitioner and determined the facility was not in substantial compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs. The State agency conducted revisit surveys on May 16 and 17, 2000 and June 26, 2000. The Petitioner was found out of substantial compliance on May 17, but back in compliance as of June 26. The State agency recommended a CMP of $50 per day from April 7, 2000 to June 26, 2000. CMS Ex. 1. On July 14, 2000, CMS sent Petitioner a notice letter advising Petitioner that CMS had accepted the State agency's recommendations. On September 12, 2000, the Petitioner timely filed its request for a hearing.

Thereafter, the parties filed the following:

•On February 14, 2001, the parties filed a Joint Notice of Issues for which Summary Judgment will be Requested.

•On June 19, 2001, the parties filed Stipulations.

•On June 19, 2001, Petitioner filed Petitioner's Motion for Summary Judgment and Petitioner's Memorandum in Support of its Motion for Summary Judgment.

•On July 30, 2001, CMS filed CMS's Motion for Summary Judgment and Memorandum in Support of CMS' Motion for Summary Judgment.

•On August 30, 2001, Petitioner filed Petitioner's Reply to Respondent's Memorandum in Support of its Motion for Summary Judgment.

At issue are the State agency survey findings from May 16 - 17, 2000. At the conclusion of the survey, CMS cited the facility with a single deficiency, Tag F-281, listing several examples to support its contention that the facility failed to be in substantial compliance at this revisit. Stip. 8. The only contested issues on appeal relate to the alleged deficiency cited as a failure to meet the requirements of 42 C.F.R. § 483.20(k)(3)(i). Stip. 9.

Although the Petitioner disagreed with the conclusions arrived at by the surveyor (i.e., a failure to be in substantial compliance at revisit), it did not contest the factual findings contained in the Statement of Deficiencies, Form 2567 (P. Ex. 1), as also set forth in the parties' stipulations and restated as follows:

a. On May 16, 2000, at 11:02 a.m., a random check of the medication cassettes for Resident #6 was completed with the Director of Nursing. The check revealed one remaining Aricept, 5 milligram pill, which was scheduled to be given to Resident #6 on May 13, 2000 at 8:00 p.m. The resident was to receive Aricept once daily. The employee who failed to administer the missed dose was a registered nurse. There was no documentation in the medication administration record or in the nurse's notes which would have indicated why the medication had not been given. According to the diagnosis on the medication administration record, the resident was receiving the medication for Alzheimer's disease. A facsimile from the physician dated May 16, 2000, documented no harm to the resident was evident and no changes in the medication administration were indicated. Missing one dose of this medication would not be harmful, nor would it cause the resident discomfort or jeopardize the resident's health or safety.

b. On May 16, 2000, at 11:05 a.m., a random check of the medication cassettes for Resident #7 was completed with the Director of Nursing. The check revealed one remaining Lorazepam, 0.5 milligram pill, which was scheduled to be given on May 11, 2000, at 4:00 p.m. The resident was to receive Lorazapam three times daily. The employee who failed to administer the missed dose was a licensed practical nurse. There was no documentation in the medication administration record or in the nurse's notes which would indicate why the medication had not been given. According to the diagnosis on the medication administration record, the resident was receiving the medication for anxiety. A facsimile from the physician dated May 16, 2000 documented no harm to the resident was evident and no changes in the medication administration were indicated. Missing one dose of this medication would not be harmful, nor would it cause the resident discomfort or jeopardize the resident's health or safety.

c. On May 16, 2000, at 11:14 a.m, a random check of the medication cassettes for Resident #2 was completed with the Director of Nursing. The check revealed one remaining antibiotic, Doxycycline, 100 milligram capsule, which was scheduled to be given on May 15, 2000, at 8:00 p.m. The resident was to receive the Doxycycline twice a day indefinitely. The employee who failed to administer this dose was a licensed practical nurse. There was no documentation on the medication administration record or in the nurse's note which would have indicated why the medication had not been given. According to the diagnosis on the medication administration record, the resident was receiving the medication for bulbous pemphigoid. A facsimile from the physician dated May 16, 2000, documented no harm to the resident was evident and no changes in the medication administration were indicated. Missing one dose would not be harmful, nor would it cause the resident discomfort or jeopardize the resident's health or safety.

d. Resident #7, noted above, also did not have a medication for skin excoriation started in a timely manner. The nurse's notes dated May 12, 2000, at 10:10 a.m., documented the resident had a 2.5 by 1.5-centimeter open area on the right side of his scrotum. His physician was notified by facsimile and he ordered Silvadene ointment twice a day for 10 days. The return facsimile from the physician was dated May 12, 2000, but, according to the Director of Nursing, the physician did not return the facsimile until May 15, 2000. ⁽²⁾ Although nursing measures for cleanliness and repositioning were documented in the nurse's notes on May 14 and May 15, the first Silvadene treatment was not documented until May 16 at 5:45 a.m. There was no documentation to indicate the staff had made further attempts to obtain a more timely order for treatment initiation. On May 17, 2000, at 9:50 a.m., the excoriated area was observed to be smaller than when originally identified. The area appeared to be a skin excoriation which measured 2.2 by 1.0 centimeters.

Stips. 11 and 12.

II. Legal Authorities

The Social Security Act (Act) authorizes CMS to impose against a long-term care facility that participates in the Medicare or Medicaid programs a civil money penalty of up to $10,000 for each day that the facility is found not to be complying substantially with federal Medicare and Medicaid participation requirements. Act, sections 1819 and 1919. This case was brought pursuant to the Act and its implementing regulations at 42 C.F.R. Parts 483, 488, and 498. CMS is authorized to impose a civil money penalty in an amount ranging from $50 to $3,000 per day for each day that a facility's noncompliance is more than minimal, but not at the immediate jeopardy level. 42 C.F.R. § 488.438(a)(2). Relying on these authorities, CMS determined to impose a civil money penalty against Petitioner of $50 per day from April 7, 2000 to June 26, 2000.

The implementing regulations at 42 C.F.R. Part 483, Subpart B, set forth requirements for long term care facilities. In section 483.20, entitled "Resident Assessment," and in a subsection entitled "Comprehensive care plans," the regulations require that:

The services provided or arranged by the facility must -

(i) Meet professional standards of quality; and

(ii) Be provided by qualified persons in accordance with each resident's written plan of care.

42 C.F.R. § 483.20(k)(3)(i) and (ii).

Pursuant to another regulatory section, section 483.25, entitled "Quality of Care," and in a subsection entitled "Medication Errors," a facility is required to ensure that:

(1) It is free of medication error rates of five percent or greater; and

(2) Residents are free of any significant medication errors.

42 C.F.R. § 483.25(m)(1) and (2).

In this case, CMS cited Petitioner for failing to meet the requirements of 42 C.F.R. § 483.20(k)(3), i.e., a failure to ensure that services provided to residents pursuant to their comprehensive care plans met professional standards of quality. Although the deficiencies cited result from missed medications, CMS did not cite Petitioner for failing to meet the requirements of 42 C.F.R. § 483.25(m).

Summary judgment in a case is appropriate where there are no disputed issues of material fact and the only questions that must be decided involve application of law to the undisputed facts; or, where the moving party must prevail as a matter of law even if all disputed facts are resolved in favor of the party against whom the motion is made. Both parties filed motions for summary judgment in this case indicating both felt there were no material facts at issue. I agree. No one is disputing what actually occurred in this case. The parties disagree on the legal import of the facts. Thus, summary judgment is appropriate.

The burden of proof for this case is allocated as established in Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEB), at 25 (D.N.J. May 13, 1999). CMS has the burden of presenting evidence sufficient to establish a prima facie case, and Petitioner has the burden to come forward with evidence sufficient to establish affirmative arguments or defenses. Except as provided by 42 C.F.R. § 498.60(c)(2), which states that CMS's finding as to the level of noncompliance must be upheld unless it is clearly erroneous, the preponderance of evidence standard applies.

III. The Parties' Arguments

Primarily, Petitioner argues that medication errors may not be properly cited under 42 C.F.R. § 483.20(k)(3)(i), a section requiring facility services to meet professional standards of quality, when the facility is in compliance with the requirements outlined in 42 C.F.R. § 483.25(m), a requirement specifically geared toward assurances of medication error rates of five percent or less and freedom from significant medication errors. Petitioner alleges that, because CMS cannot show that Petitioner had medication error rates higher than five percent and that it had significant medication errors, CMS is attempting to do indirectly, by citing the alleged non-compliance as a failure to meet professional standards of quality, what it cannot do directly. Basically, Petitioner contends that the standard for medication errors under 42 C.F.R. § 483.25(m) is controlling when evaluating whether alleged medication errors amount to non-compliance.

To further support its argument, Petitioner cites to Appendix P of the State Operations Manual (SOM) as instructing the surveyor to question only practices which have a negative outcome or have a potential negative outcome, and, that, if there are errors in the techniques of medication administration, the surveyor should cite those errors under section 483.25(m). Petitioner argues this section presents CMS's permissible threshold for medication errors. Petitioner points to surveyor training that instructs surveyors to cite deficiencies at the most specific tag possible, especially with respect to specific tags under the main regulatory grouping of quality of care, which includes the regulation regarding medication errors. P. Ex. 26. Because, Petitioner argues, it was in compliance with section 483.25(m) at the time of the May 16 -17 survey, CMS lacks evidence to support a prima facie case that Petitioner was not in substantial compliance, and therefore, as a matter of law, summary judgment should be granted in its favor on the issue of the medication errors.

With respect to the skin excoriation on Resident #7, Petitioner argues that the facility had been applying Desitin ointment to the resident's groin every night since September 22, 1998. Immediately after the nurse noticed an open area on the right side of the resident's scrotum, the nurse notified the resident's physician. The physician did not reply and, therefore, the facility continued to apply Desitin ointment and took nursing measures for cleanliness and positioning until it received an order from the physician, on May 15, 2000, to begin another ointment. Petitioner asserts its obligation was to notify the physician, but it had no duty to question the physician's failure to respond.

CMS argues as follows. The facility's staff members responsible for the failures to give medications as ordered included a registered nurse and two licensed practical nurses. Section 483.20(k)(1) - (3) provides that the services furnished to a resident as part of the resident's comprehensive care plan must "meet professional standards of quality." CMS asserts that neither the registered nurse nor the licensed practical nurses met the minimum standards for their professions when they missed medication doses and failed to contact the residents' physicians or document the missed doses and the reasons. CMS also relies on the SOM and its guidance to surveyors. The SOM instructs surveyors, when considering professional standards of quality, to refer to quality care standards as published by a professional organization, licensing board, accreditation body or other regulatory agency. P. Ex. 14, at 2.

CMS contends that the Iowa Board of Nursing is one of the licensing boards that could properly be used to determine professional standards of quality. CMS set forth the Iowa Board of Nursing's minimum standards of practice for registered and licensed practical nurses. With respect to the need for accountability for both registered and licensed practical nurses, the Iowa Board of Nursing provides that if the medical regimen prescribed by the physician is not carried out, "based on the nurse's professional judgment," accountability shall include timely notification of the physician who prescribed the medical regimen that the order was not executed and the reasons therefor, and documentation on the medical record that the physician was notified and the reasons for not executing the order. CMS. Ex. 4.

CMS argues that Petitioner's failures to meet minimum standards of nursing practice are evidenced by its professional employees' medication errors and failures to notify physicians and to document the medical records as set forth in the Iowa Board of Nursing's minimum standards requirements. CMS thus asserts that, because the deficiencies were properly cited under section 483.20(k)(3), and Petitioner has not denied the underlying facts, the evidence establishes a basis for the CMP, and that the CMP is reasonable. Therefore, CMS concludes, summary judgment should be granted in its favor.

Petitioner responds to CMS's contentions by arguing that the professional standards of the Iowa Board of Nursing cited by CMS do not refer to the factual situation at hand. Petitioner contends that the "accountability" standards quoted by CMS refer to a nurse's need to be accountable when the nurse, in his or her professional judgment, decides not to medicate according to the physician's plan of care in situations where the nurse concludes circumstances require an immediate change in the plan. Petitioner denies that the standards quoted by CMS are applicable in situations where the nurse has made a medication error. Petitioner reiterates that CMS has failed to present a prima facie case that Petitioner was not in substantial compliance.

IV. Issues

The two basic issues before me are (1) whether CMS has shown a basis to impose a CMP against Petitioner, and (2) whether the $50 per day CMP is reasonable. ⁽³⁾

V. Findings of Fact and Conclusions of Law

A. The pertinent facts are as stipulated by the parties and as restated in Section I, a-d, above.

B. I list below, in italics and in numbered paragraphs, my legal conclusions, and I explain my rationale for each conclusion in the following paragraph.

1. CMS has not shown - nor has it tried to show - that Petitioner was deficient in meeting the requirements of 42 C.F.R. § 483.25(m) for medication errors.

The record lacks any proof, with respect to the missed medication doses to which Petitioner stipulated, that Petitioner had medication errors in excess of five percent or that the missed doses were significant medication errors. I find affirmatively that Petitioner did not have medication errors in excess of five percent and that the missed doses in this case were not significant.

2. CMS is not barred from imposing a penalty for medication errors pursuant to the regulatory requirements for a facility to provide services meeting professional standards of quality; i.e., 42 C.F.R. § 483.20(k)(3)(i) & (ii).

Although Petitioner cites the SOM that guides surveyors to cite medication errors under 42 C.F.R. § 483.25 (m), CMPs based on medication errors cited under the professional standards section have been upheld by ALJs and affirmed by the Departmental Appeals Board (DAB). In Emerald Oaks, DAB No. 1800 (2001), the petitioner argued - as Petitioner in this case does - that CMS had treated the professional standards "tag" as a "catchall" to cite a set of facts that failed to support any more specific deficiency finding and that the alleged errors cited were all trivial and none exposed any resident to a risk of harm. One of the cited deficiencies in Emerald Oaks resulted from a resident who received two doses of Aricept and one of Calcium daily when she, instead, had been prescribed the reverse. This occurred on only one day and the petitioner in Emerald Oaks argued that it did not meet the standards for citations for excessive medication errors.

In Emerald Oaks, the DAB pointed out that the fact-finder's job is to determine whether a preponderance of the evidence shows a facility's failure to comply with the cited regulatory requirement in a way that presented a risk of more than minimal harm. Based upon the particular record evidence in Emerald Oaks, the DAB upheld the ALJ's finding that the recurrence of medication errors meant that the facility could not assure that residents would receive the medications ordered by their physicians from the facility nurses, and that this condition violated the professional standard that nurses must carry out physician orders. The DAB specifically noted it agreed with the ALJ that the absence of physical harm as a result of a brief mix-up in dose was not dispositive of the risk to residents presented by the systemic failure at the Emerald Oaks facility. Emerald Oaks, at 43.

Nonetheless, I have not concluded, as explained below, that the missed doses in this case reflect Petitioner's nurses' failure to meet professional standards. My legal conclusion is only that, indeed, surveyors can properly cite medication errors as a failure of the facility's staff to meet professional standards. ⁽⁴⁾

3. With respect to the extra pills in residents' medication cassettes, CMS failed to provide prima facie evidence that Petitioner failed to ensure its services met professional standards of quality.

CMS had several ways to show that the stipulated acts of Petitioner's professional employees did not meet the standards of their professions, but CMS failed to do so. First, CMS could have submitted an applicable standard from a professional organization, licensing board, accreditation body or other regulatory agency. It submitted some paragraphs from the Iowa Board of Nursing minimum standards of practice for registered and licensed practical nurses that relate to RN and LPN "accountability" when an RN or LPN decides circumstances warrant a change from a physician's prescribed plan of care. In that situation, according to the "accountability" section, the RN or LPN must notify the prescribing physician and document the medical record why the change was made and that the physician was notified. This "accountability" section is inapposite to the case at hand, where the RN and LPNs missed medication doses. I did not find CMS's paragraphs from the Iowa Board of Nursing helpful in determining whether Petitioner's employees failed to provide services meeting the standards of their profession.

Second, CMS might have submitted reliable evidence from a surveyor or other professional to show that an RN or LPN must always document missed doses of medication or call a prescribing physician, even when the RN or LPN feels, in his or her professional judgment, that the missed dose created no potential for more than minimal harm. CMS did submit the affidavit of Rebecca Rena Shafer, a Nurse Consultant for CMS. Ms. Shafer stated her job duties included providing technical direction and oversight to state survey and certification staff to ensure long term care facilities' compliance with federal regulations. I did not find Ms. Shafer's affidavit to be particularly reliable because it is basically a reiteration of the Iowa code paragraphs discussed above. I did not interpret Ms. Shafer's affidavit as saying that in every situation where an RN or LPN finds an extra pill in a medications cassette, be it a vitamin supplement or chemotherapy dose, that the nurse, regardless of the nurse's own professional judgment as to the effect of the "possibly" missed dose, must notify the resident's physician and document the medical records. Moreover, when Petitioner tried to confirm that Ms. Shafer was indeed a nurse registered in Iowa, the state could only find a registered nurse with a slightly different name, that is, Rebecca R. Schafer-Alberts. P. Ex 32. While I suspect this is CMS's employee and affiant, CMS submitted no confirming evidence.

Third, CMS might have shown that Petitioner's missed doses and documentation errors reflected a systemic failure, as was shown in Emerald Oaks, at 43, and that it was the systemic failure that presented the potential for more than minimal harm. CMS has not made such a showing in this case. Although not at issue in this case, CMS did submit as an exhibit the Summary of Deficiencies, Form 2567, from the survey of Petitioner completed on April 7, 2000. CMS Ex. 3. After the April 7 survey, Petitioner was also cited under Tag F281 for a failure to provide services meeting professional standards of quality. For purposes of this decision, I find the Statement of Deficiencies from April 7 to be an accurate statement of what occurred during that survey. As in the case of the May 17 survey, the surveyor during the April 7 survey discovered, for one resident, medications in the resident's medication cassette that should have been administered several days earlier. The facility's Medication Administration Record showed the resident had been out on that date and her medications had not been sent with her. Nor were the medications administered to her after the resident returned to the facility.

I find the error cited from the April 7, survey together with the errors at issue here do not constitute the type of systemic failure found in Emerald Oaks. Even the deficiency cited from the April 7 survey was more problematical than the errors at issue during the May 17 resurvey. The medication and documentation errors at issue herein have been stipulated to have caused no discomfort or risk to the residents. The medication and documentation errors in Emerald Oaks were qualitatively different. For example, in Emerald Oaks, incorrectly-entered orders were reviewed and signed off on by several nurses under the facility's quality control system and still went uncorrected. As other examples, in Emerald Oaks, an artificial nutrition bag was to be changed every 24 hours to prevent the risk of infection but the facility's temporary staff did not do so, and, the facility failed to assure that a medication to prevent seizures was administered at the proper time.

Even though, in this case, Petitioner was not cited for failing to meet the standards for medication errors, this case is about missed medications and documentation. What CMS has cited in this case does not rise to the level of a failure in a quality control system, or a failure to administer seizure medication appropriately, or a failure to instruct temporary staff to change a feeding bag. Therefore, the standards for medication errors that must be met, as set forth in 42 C.F.R. § 483.25(m), within the "Quality of Care" requirements, cannot but be instructive as to the tolerance for, or the potential for, harm caused by medication errors. In this case, Petitioner did not exceed the less than five percent requirement for medication errors. Nor did any of the four medication errors constitute significant errors.

Obviously, even one missed dose of medication could be harmful to a resident. Absent, however, a regulatory standard or ruling that any "missed dose" should be considered a significant medication error as contemplated in 42 C.F.R. § 483.25(m)(2), or a regulation or ruling of strict liability for any "missed dose," I feel I must consider all of the factual circumstances of the alleged deficiencies. The medications missed in this case were not the type of medicine required for sustaining life, such as insulin or even over-the-counter pain prevention medications. The medication errors at issue herein were not harmful, nor did they cause discomfort to the residents, or jeopardize the residents' health or safety. Stips. 11 and 12. Without a showing of a systemic breakdown, CMS has not shown Petitioner's "missed doses" had the potential for more than minimal harm.

4. CMS has not presented prima facie evidence that Petitioner's failure to re-contact a resident's physician during a four-day period violated professional standards or presented a potential for more than minimal harm.

Based on the stipulated record, when the Petitioner's staff discovered a skin excoriation on a resident, the staff person immediately contacted the resident's physician. The parties have stipulated also, however, that Petitioner did not start the physician's newly prescribed medication until the morning after the new prescription was acknowledged. Nonetheless, CMS provided no evidence that, to meet professional standards of quality, a nurse must re-contact a physician not heard from over a weekend in the situation of a small skin excoriation which appeared to be healing. Nor has CMS shown that this incident had a potential for more than minimal harm or that it was part of a systemic failure with the potential for more than minimal harm. After being contacted by Petitioner's staff, the resident's physician substituted Silvadene for the ointment of Desitin, which the resident had been using for several years. CMS provided no evidence that Silvadene is substantially different in strength or appropriate use than Desitin. The lack of such evidence supports my finding that CMS has failed to show Petitioner's actions presented a potential for more than minimal harm or evidenced Petitioner's failure to ensure its residents were provided services meeting professional standards of quality.

VI. Conclusion

I have carefully reviewed the relevant laws and regulations, the record evidence and the pleadings in this case. Based on that review, as explained above, I find CMS failed to present a prima facie case that Petitioner was not in compliance with federal Medicare and Medicaid participation requirements during the survey completed May 17, 2000, and

I grant Petitioner's motion for summary judgment. Therefore, CMS has no basis for assessing a civil money penalty against the Petitioner for the period from April 7, 2000 to June 26, 2000.

Anne E. Blair

Administrative Law Judge

1. The Petitioner submitted proposed exhibits marked P. Ex. 1 - 33. CMS submitted proposed exhibits marked CMS Ex. 1 - 5. There being no objection, I have admitted all proposed exhibits into the record.

2. CMS merely stipulated that Petitioner's Director of Nursing said the facility received the facsimile on May 15, 2000. CMS did not stipulate that the transmission was actually sent or received on May 15, 2000. The facsimile copy suggests - but is somewhat ambiguous - that the physician's office tried to send the facsimile on May 12, 2000. CMS Ex. 5. Nonetheless, the parties stipulated the new medication was not started in a timely manner.

3. If I were to find CMS had a basis to impose a CMP, the least CMP possible is $50 per day and the ALJ has no authority to reduce a CMP to zero. 42 C.F.R. § 488.438 (e).

4. See also, Barn Hill Care Center, DAB CR902 (2002), aff'd Barn Hill, DAB No. 1848 (2002), in which an ALJ found that a facility failed to comply with four federal nursing home requirements including "staff treatment of residents," "resident assessments," "quality of care," and "administration" (and not "medication errors") because the facility's temporary employee, who did not have a state license, administered overdoses of insulin to four facility residents.