SUBJECT:

Darby Square Nursing Home,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

This matter is before me on the Centers for Medicare & Medicaid Services (CMS's) Motion for Summary Judgment (CMS Br.). ⁽¹⁾ I sustain CMS's determination for the imposition of a per instance civil money penalty (CMP) of $3,050 for the period covering December 18, 1999, and grant its motion for summary judgment.

I. Background

Darby Square Nursing Home (Petitioner) is a skilled nursing facility located in Lexington, Kentucky. On January 13, 2000, the Kentucky Cabinet for Health Services (Kentucky State survey agency) conducted a survey at Petitioner's facility to determine whether it was in compliance with federal requirements for nursing home participants. The survey found that the nursing services provided by the facility did not meet the professional standards of quality, and that the facility failed to ensure that residents were free of significant medication errors. The survey cited deficiencies that constituted past immediate jeopardy. By revised notice dated January 8, 2001, CMS advised Petitioner of its determination to impose a per instance CMP of $3,050 based on the instance of noncompliance. CMS Exhibit (CMS Ex.) 6.

On March 7, 2001, Petitioner filed a request for hearing. This case was assigned to me for a hearing and decision.

My decision is based on the memoranda and other pleadings filed by both parties, and on the documents attached to those memoranda. CMS submitted 10 proposed exhibits (CMS Exs. 1-10) with its initial brief. Petitioner submitted what it indicated to be three proposed exhibits (P. Exs.) with its Opposition Memorandum (P. Opp.) on July 20, 2001. Petitioner's first exhibit contained a multitude of documents which complicated my ability to make reference to any one document individually. Therefore, I have re-marked Petitioner's proposed exhibits as follows: P. Ex. 1 - Lisa Kincaid Testimony Transcript; P. Ex. 2 - Hollis/Grant/Delles Testimony Transcript; P. Ex. 3 - Debra Hogan Deposition; P. Ex. 4 - Douglas Rogers Deposition; P. Ex. 5 - Kentucky State Proceeding Exhibits; P. Ex. 6 - January 13, 2000 Survey Report; P. Ex. 7 - March 7, 2001 Request for Hearing Letter. CMS filed a reply brief in this case. Without objections from either party, I have admitted the proposed exhibits as CMS Exs. 1-10 and P. Exs. 1-7.

The issues in this case are:

•Whether the facility was in substantial compliance with federal participation requirements set forth at 42 C.F.R. §§ 483.20(k)(3)(i) and 483.25(m)(2);

• Whether CMS's determination of "immediate jeopardy" is appropriate;

and

•Whether the amount of the CMP imposed by CMS is reasonable, if noncompliance is established.

III. Applicable Law and Regulations

The Social Security Act (Act) (42 U.S.C. § 1320a-7a(c)(4)) sets forth requirements for nursing facility participation in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions. Act, sections 1819, 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. 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. 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); 42 C.F.R. § 483.25. The regulations also mandate that a facility "must ensure that residents are free of any significant medication errors. 42 C.F.R. § 483.25(m)(2). The services provided or arranged by the facility must meet professional standards of quality. 42 C.F.R. § 483.20(k)(3)(i).

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 the imposition of a CMP. See Act, section 1819(h). The regulations specify that a CMP that is imposed against a facility will fall into 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), (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)(2).

"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." Id.

In determining the amount of the CMP, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:

1. The facility's history of noncompliance, including repeated deficiencies;

2. The facility's financial condition;

3. The factors specified at 42 C.F.R. § 488.404; and

4. The facility's degree of culpability.

When a CMP is imposed, 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. United States Department of Health & Human Services, Health Care Financing Administration, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999).

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. Act, section 1128A(c)(2); 42 C.F.R. §§ 488..408(g), 498.3(b)(12), (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).

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

A. CMS is entitled to summary judgment in this case.

Summary judgment is appropriate when there is no genuine issue as to any material fact and one of the parties is entitled to judgment as a matter of law. Fed. R. Civ. P. 56. If the moving party meets this burden, the onus shifts to the opposing party to establish that a genuine issue does exist. The opposing party will have shown that genuine issues of fact are present "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 249 (1986). To accomplish this, the opposing party must go beyond mere allegations, and come forward with factual evidence that creates a genuine issue of material fact. All reasonable inferences are to be drawn in the opposing party's favor. Pollock v. American Tel. & Tel. Long Lines, 794 F.2d 860, 864 (3^rd Cir. 1986). I have considered all of the evidence set forth in the papers submitted, and conclude that all inferences drawn from such evidence, casts no doubt as to the propriety of granting CMS's motion for summary judgment inasmuch as there is no issue of material fact to be tried. CMS's motion is properly supported by the documentary evidence.

In the case before me, CMS has filed a request for summary judgment and Petitioner responded by filing a response brief. Petitioner concedes that the events in question did occur, and that a "significant medication error did, in fact, take place" as set forth in the Form 2567 statement of deficiencies (January 13^th survey report) prepared by the Kentucky State survey agency on January 13, 2000. P. Opp., at 9; CMS Ex. 1; P. Ex. 6. CMS does not dispute those facts. Inasmuch as there are no material facts in dispute, and the findings made by the State survey agency are sufficient to resolve the issues in this case, summary judgment is proper without an evidentiary hearing.

B. Petitioner was not in substantial compliance with program participation requirements, specifically 483.20(k)(3)(i) (Resident Assessment), and 42 C.F.R. § 483.25(m)(2) (Quality of Care).

1. Petitioner failed to ensure that services provided by the facility met the professional standards of quality.

The regulation at issue requires that a facility must meet certain requisite standards. At F Tag 698 of the January 13^th survey report, CMS determined that Petitioner was not in substantial compliance with the regulation concerning resident assessments, 42 C.F.R. § 483.20(k)(3)(i), at an immediate jeopardy level. The regulation at 42 C.F.R. § 483.20(k)(3)(i) requires that:

The services provided or arranged by the facility -

(i) Meet professional standards of quality, . .

The facts are undisputed. As of December 18, 1999, Nurse Lisa Kincaid, a Licensed Practical Nurse (LPN) with 10 years experience, had been employed by Petitioner for a period of three months. CMS Ex. 3, at 5. On December 18, 1999, Nurse Kincaid gave a facility resident (R1) her prescribed medications, which included the antihypertensive drugs Trazodone, Zestril and Spironolactone, while eating breakfast in the dining hall. Upon R1's return to her room, the same facility nurse administered medications to R1 which were prescribed for R1's roommate. Id., at 4; P. Br., at 1-2. These medications included, among others, two antihypertensive drugs, Adalat and Atenolol, as well as an antipsychotic drug, Thorazine, which has the potential for lowering the blood pressure. CMS Exs. 1, at 4; 2; and 3, at 15-19. Nurse Kincaid was unable to identify or distinguish R1 from her roommate in that R1 did not have an identification bracelet on her wrist; nor was there a photograph attached to her Medication Administration Record (MAR); and finally, the name plate on the door of R1's room was incorrectly marked. CMS Exs. 3, at 68, 70-71; 10. Within 12 hours of administration of the drugs, R1's blood pressure dropped significantly. R1 was taken to a local hospital where she was diagnosed with medication-induced hypotension. CMS Br., at 4; CMS Exs. 1, at 6; 4, at 1. Upon R1's recovery, she was released from the hospital three days later. CMS Br., at 4; CMS Ex. 4, at 1.

Petitioner does not dispute that there was a breach of "professional standard of quality" in that one of its nurse's administered the wrong medications to a resident. However, Petitioner makes a valiant attempt to obviate all responsibility for the occurrences of December 18^th. Nurse Kincaid has been more than candid in her admissions as they pertain to the medication error. She readily accepts liability for her negligent behavior, and she has done so at significant professional risk. She testified before the Kentucky State survey agency that such an error could jeopardize her ability to become licensed as a Registered Nurse. CMS Ex. 3, at 81. In contrast, Petitioner makes a concerted effort to disassociate itself from Nurse Kincaid's actions. Throughout the state proceeding, and in arguments before this tribunal, Petitioner sought to demonstrate that the appropriate policies and safeguards were in place and that Nurse Kincaid deliberately chose to disregard them. P. Br., at 5; CMS Exs. 3, at 56-61; 7, at 1; 8, at 159-166; P. Ex. 2, at 3-4. I cannot accede to Petitioner's argument. From the evidence presented, it is apparent that, but for the missing/incorrect place of the armbands, the absence of photo identification on the MAR, and the inaccuracy of the door name plate, the medication error which occurred on December 18^th more than likely could have been prevented. There is no question of Petitioner's part in the chain of events leading up to the medication error.

In essence, the brunt of Petitioner's argument is focused on showing that everything that could have been done was done to ensure the adequate training, supervision, and oversight of facility staff. To substantiate its position, Petitioner relies heavily on a string of DAB decisions which dismiss the applicability of a "strict liability" standard is such cases. See Koester Pavilion, DAB No. 1750 (2000); Heath Nursing and Convalescent Center, DAB CR610 (1999); Woodstock Care Center, DAB CR623 (1999); Care House Convalescent Hospital, DAB CR729 (2001); Price Hill Nursing Home, DAB CR745 (2001); Hermina Traeye Memorial Nursing Home, DAB CR756 (2001). The issues in the cases cited by Petitioner may be factually analogous to the instant case, but the deficiencies cited were done so based upon a different regulatory provision. The present case relates to a violation of 42 C.F.R. § 483.20(k)(3)(i). The provision at issue in the cases cited was 42 C.F.R. § 483.25(h)(2). Section 483.25(h)(2) addresses the degree or sufficiency of institutional oversight or "anti-accident" procedures, which is not an issue before me. CMS's argument is clearly on point, and one in which I concur. Petitioner has not, at any given point, disputed that the services provided by Nurse Kincaid on December 18, 1999 met professional standards of quality. In fact, during the State proceeding, Nurse Kincaid admitted that she did not follow standard nursing procedures for identification of a patient prior to administering prescribed medication. CMS Ex. 3, at 19-20, 57-61, 82. Instead, Petitioner creates an interpretation of the regulatory provision which obviates Petitioner of any liability for Nurse Kincaid's actions. However, Petitioner's interpretation is totally contrary to the purpose for the regulations -- namely to protect and safeguard individuals under a facility's care. The regulations require that a nursing home meet the professional standards of quality in all aspects of its services. That regulatory requirement would include a facility being responsible "for the quality of care provided by its nursing staff." CMS Br., at 6. CMS is correct in its conclusion that "professional standards of quality require that nurses administer medications only to the individuals for whom they are prescribed." Id., at 7.

Therefore, based upon the arguments and evidence, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.20(k)(3)(i) on December 18^th.

2. Petitioner failed to ensure its resident was free from significant medication errors.

Likewise, Petitioner does not dispute that a significant medication error did occur. P. Opp., at 9. The applicable regulations at 42 C.F.R. § 483.25, entitled "Quality of care" provide:

[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive plan of care.

Consistent with that requirement, 42 C.F.R. § 483.25(m)(2) provides that:

[t]he facility must ensure that -

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

As previously argued, again Petitioner asserts that it is not accountable for the medication error caused by Nurse Kincaid based upon its prior strict liability argument. P. Br., at 9.

Petitioner contends that:

. . . the facility's obligation is not to absolutely guarantee that significant medication errors will never occur. It is not required to warrant that some well-trained nurse will never fail to follow policy and never fail to identify a resident before administering medications. The facility's responsibility is to do everything within its power to prevent such errors.

P. Br., at 10-11.

As CMS asserts, and I concur, 42 C.F.R. § 483.25(m)(2) does not "concern measures, processes, or policies designed to prevent medication errors, . . . the regulation addresses directly an outcome that must not happen . . ." CMS Reply, at 4. If I gave credence to Petitioner's contention, I would be, in effect, rendering the regulation pointless. In interpreting the plain language of the regulation, it is clear that where a facility's staff perpetrate significant medication errors, then the facility does not meet the substantial compliance requirement. In a ruling on a motion for summary judgment, another administrative law judge in Ridge Terrace, Docket No. C-00-438 (February 8, 2001), determined that "[o]n its face, [42 C.F.R. § 483.25(m)(2)] addresses the circumstances under which medications are administered to residents and not the qualifications of the staff who administer medication," or in this instance, whether adequate policy was in place to prevent medication errors. See also, Ridge Terrace, DAB CR866 (2002), aff'd, DAB No. 1834 (2002). An appellate panel of the Departmental Appeals Board (Board) concurred with Judge Kessel's determination in his ruling and subsequent decision, and opined further to conclude:

. . . . [Petitioner] could not disavow responsibility for the nurse's act. Contrary to [Petitioner's] suggestion, the requirement in section 483.25 that a facility provide to each resident "the necessary care and services to attain or maintain the highest practicable physical, mental, and psycho social well-being" means that a facility must provide care and services so that a resident attains the highest level of well-being the resident is capable of attaining, not that a facility is excused from providing such care and services if it is not "practicable" to monitor its staff to ensure compliance. Moreover, the Act specifically provides that "[a] principal is liable for penalties, assessments, and an exclusion under this section for the actions of the principal's agent acting within the scope of the agency." Section 1128A(/) [sic] of the Act, made applicable to CMPs by section 1819(h)(2)(B)(ii) of the Act.

Ridge Terrace, DAB No. 1834, at 7-8 (2002).

The Board's decision in Ridge Terrace makes it clear that, under 42 C.F.R. § 483.25(m)(2), it is irrelevant what proactive, preventive measures a facility may or may not have in place in an attempt to prevent significant medication errors. If a medication error occurs as a result of the actions of a facility's staff, then that facility is out of compliance with the regulation. In fact, the Board emphatically stated that "even one isolated instance of non-compliance having potential for more than minimal harm may be the basis for a finding that the petitioner is not substantially complying with the applicable participation requirement." Id., at 6 (citing to Lake City Extended Care Center, DAB No. 1658 (1998)).

Based upon the arguments and evidence, I affirm CMS's determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(m)(2) on December 18, 1999, and that the undisputed facts of this case established an immediate jeopardy level deficiency in that R1 suffered serious injury and harm from the ingestion of another patient's prescribed medications.

V. Conclusion

For the reasons discussed above, I grant CMS's motion for summary judgment. I find that Petitioner was not in substantial compliance with program participation requirements for Resident Assessment and Quality of Care. I further find that Petitioner's deficiency posed immediate jeopardy to resident health and safety, and the amount of the per instance CMP imposed ($3,050) is reasonable.

Richard J. Smith

Administrative Law Judge

1. Effective July 5, 2001, the Health Care Financing Administration (HCFA) was renamed the Centers for Medicare & Medicaid Services (CMS). 66 Fed. Reg. 35,437 (2001). Although the agency's name change became effective subsequent to the events at issue in this case, it will simplify matters if I refer to the agency as CMS when discussing proceedings in this forum.