SUBJECT:

Rose Care Center - Trumann,

Petitioner,

Health Care Financing Administration

I decide that the Health Care Financing Administration (HCFA) is authorized to impose a civil money penalty (CMP) against Petitioner, Rose Care Center-Trumann (Rose Care), in the amount of $3,500 per day for the period of immediate jeopardy which lasts from June 26 - June 28, 1998. Additionally, I decide that HCFA is not authorized to impose a CMP against Petitioner in the amount of $100 per day for a period beginning on June 29, 1998 and ending on July 23, 1998. The total CMP authorized is $10,500.

I. Background

Petitioner is a skilled nursing facility located in Trumann, Arkansas. On July 2, 1998, surveyors from the Arkansas Department of Human Services (ADHS) concluded a survey of Rose Care. The surveyors found that Rose Care was out of substantial compliance with participation requirements of the Medicaid and/or Medicare programs and determined that immediate jeopardy to resident health and safety existed with regard to tag F 282, 42 C.F.R. � 483.20(k)(3)(ii)⁽¹⁾, Resident Assessments and with regard to tag F 328, 42 C.F.R. � 483.25(k)(2), Quality of Care. Rose Care was found to have achieved substantial compliance on July 24, 1998.

Based on the findings of the ADHS, HCFA determined to impose a CMP against Petitioner of $4,000 per day (June 26 - 28, 1998) for the period of immediate jeopardy. HCFA determined that Petitioner remained out of substantial compliance with participation requirements even after the immediate jeopardy was removed on June 28, 1998. HCFA determined to impose a CMP against Petitioner of $100 per day (June 29 - July 23, 1998) until Petitioner achieved substantial compliance with participation requirements, constituting a total CMP of $14,500.

Petitioner requested a hearing and the case was assigned to me for a hearing and decision. The parties jointly requested to resolve this matter by a stipulation of facts (Stipulation) and the submission of written briefs on the legal matters involved. The parties agreed that an in-person hearing would not be necessary.

Petitioner submitted a brief (P. Br.), and a reply brief (P. Reply Br). HCFA submitted a brief (HCFA Br.) accompanied by six proposed exhibits (HCFA Exs. 1 - 6). I determined that I needed further briefing. Subsequently, Petitioner submitted a supplemental brief (P. Supp. Br.) accompanied by two proposed exhibits, designated as exhibits A and B. I have designated Petitioner's exhibits A and B as Petitioner's exhibits 1 and 2 (P. Exs. 1 and 2) to conform to Civil Remedies Procedures. HCFA submitted a supplemental brief (HCFA Supp. Br.) accompanied by two additional proposed exhibits numbered exhibits 1 and 2. I have renumbered these additional proposed exhibits as HCFA exhibits 7 and 8 (HCFA Exs. 7 and 8). Neither party objected to my receiving any of the proposed exhibits into evidence and I receive into evidence P. Exs. 1 - 2 and HCFA Exs. 1 - 8.

II. Applicable law

Medicare, a federally subsidized health insurance program for the elderly and disabled, was established under Title XVIII of the Social Security Act (Act). Medicare provides reimbursement for certain services rendered by providers, such as skilled nursing care facilities (SNFs) like Petitioner, who participate in the Medicare program under "provider agreements" with the United States Department of Health and Human Services (DHHS). In order to enter into such an agreement, a SNF must meet certain requirements imposed by applicable statute and regulations. Act, section 1819 [42 U.S.C. � 1395i-3]; 42 C.F.R. Parts 483, 488, and 489. The requirements for participation in Medicare by SNFs are set forth in 42 C.F.R. Part 483. A SNF is subject to the survey, certification, and remedies provisions of 42 C.F.R. Part 488 and to the provisions governing provider agreements in 42 C.F.R. Part 489.

The survey process is the means by which DHHS (through HCFA) assesses providers' compliance with participation requirements. State survey agencies, under agreements with HCFA, perform the surveys of SNFs and make recommendations to HCFA as to whether such facilities meet federal requirements for Medicare participation. Act, section 1864(a); 42 C.F.R. �� 488.10, 488.11, 488.20. The results of these surveys are used by HCFA as the basis for its decisions regarding a SNF's initial or continued participation in Medicare. HCFA, not a State survey agency, makes the determination as to whether a facility is eligible to participate or remain in Medicare. Id.

HCFA's imposition of the $4,000 per day CMP for the period June 26 - 28, 1998, is premised on its determination that, during this period, Petitioner's noncompliance was so egregious that residents of Petitioner's facility were in a state of immediate jeopardy. Under applicable regulations, "immediate jeopardy" means a situation in which a facility's noncompliance with one or more participation requirements has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident. 42 C.F.R. � 488.301. HCFA is authorized to impose a CMP in an amount ranging from $3,050 to $10,000 per day for each day that a facility's noncompliance poses immediate jeopardy to its residents. 42 C.F.R. � 488.438(a)(1)(i). The rate of $3,050 per day is the lowest amount that may be assessed for noncompliance which is "immediate jeopardy."

HCFA based its imposition of the $100 per day CMP for the June 29 - July 23, 1998 period on its determination that, during this period, Petitioner was not in substantial compliance with participation requirements. HCFA is authorized to impose a CMP 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)(ii). The term "substantial compliance" is defined 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.

There are potentially two issues to be heard and decided in a case where a facility requests a hearing before an administrative law judge from a determination by HCFA to impose a CMP against the facility. The first issue is whether the facility was not complying substantially with federal participation requirements on the date or dates for which HCFA determined to impose a CMP. The second issue is, assuming that noncompliance is established, whether the amount of the penalty imposed by HCFA is reasonable. 42 C.F.R. �� 488.408(g), 498.3(b)(12), (13); see 42 C.F.R. � 488.438(e). The issue of reasonableness of the penalty is not reached unless there is a finding of substantial noncompliance on which a penalty may be predicated. Id.

In a CMP case, a facility has the burden of overcoming, by a preponderance of the evidence, any prima facie case that HCFA might make that the facility is not complying substantially with federal participation requirements. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd., Hillman Rehabilitation Center v. United States, Department of Health and Human Services, Health Care Financing Administration, No. 98-3789 (GEV), slip op. at 25 (D.N.J. May 13, 1999). A facility potentially bears an additional burden of proof where it challenges the level of the deficiency determined by HCFA. The facility must prove that HCFA's determination of the level of noncompliance is clearly erroneous if the record of the case establishes that the facility is not complying substantially with a participation requirement that is the basis for HCFA's CMP determination. 42 C.F.R. � 498.60(c)(2) (this regulation was formerly published as 42 C.F.R. � 498.61(b)). The facility would not have to meet this additional burden in a case where it was able to prove by a preponderance of the evidence that it was complying substantially with the participation requirement or requirements on which HCFA premised its CMP determination.

III. Findings of fact and conclusions of law

1. Petitioner was in substantial compliance with tag F 282 concerning resident assessments, 42 C.F.R. � 483.20(k)(3)(ii).

HCFA determined that Rose Care was out of compliance with tag F 282, concerning resident assessments, 42 C.F.R. � 483.20(k)(3)(ii), at an immediate jeopardy level. The regulation at 42 C.F.R. � 483.20(k)(3)(ii) requires that:

[t]he services provided or arranged by the facility must be provided by qualified persons in accordance with each resident's written plan of care.

This regulation can be broken up into two parts. First, there is a requirement that only qualified persons be involved in providing services and, second, that the services be provided in accordance with the resident's written plan of care.

The first part of this regulation requires that only qualified persons be involved in providing services. In Rose Care of Little Rock, DAB CR532 (1998), the administrative law judge (ALJ) held that where a nurse was licensed by the State nursing authority, that nurse was qualified for purposes of 42 C.F.R. � 483.20(d)(3)(ii). The ALJ came to this determination based on the lack of any standards in the federal regulations for determining the qualifications of nurses. Where the Secretary of DHHS has decided to impose specific qualifications on other nursing personnel, she has done so expressly in the regulations. The ALJ held that in the absence of express federal regulations regarding qualifications for nurses, the State nursing authority must determine who is a qualified nurse in their licensing procedures.

Qualifications for nurses was further discussed in A Pro Home Health Care Agency. DAB CR578 (1999). The ALJ in A Pro held that the best evidence of a nurse's qualifications is their education and experience. Further, the A Pro case held that while education and experience are the best evidence of qualifications:

[t]o meet its prima facie case, HCFA had the obligation to establish by credible evidence what the proper qualifications are for Petitioner's personnel. Only after that showing has been made can a conclusion be drawn as to whether a particular employee lacked the proper qualifications.

A Pro, CR578, at 15.

I find that the decision in A Pro is controlling. In my October 12, 1999 Order, I informed the parties that additional briefing was needed on this point. I informed the parties that HCFA has the burden of proof to establish what the proper qualifications are for a nurse who does IV therapy. In particular, I informed HCFA that it was to address the qualifications required by the Arkansas State Board of Nursing and/or any federal requirements. HCFA was to determine whether a separate IV certificate was required.

HCFA has failed to meet its burden of proof. HCFA provided a letter dated November 22, 1999, from the Arkansas State Board of Nursing which states that the Arkansas Nurse Practice Act does not specifically address IV therapy. HCFA Ex. 7. At most, the November 22, 1999 letter indicates that a licensed nurse who failed to maintain aseptic technique or to use sterile supplies when initiating or maintaining IV therapy, is guilty of unprofessional conduct but this letter does not indicate that a licensed nurse in good standing is not a qualified person. Id.

The November 22, 1999 letter indicates that although IV therapy is not part of the basic training program for a LPN, an LPN could be trained to initiate or maintain IV therapy. The facility policy and procedure should specify tasks to be completed by the LPN. Aseptic technique would be a part of the training program. Id. Rose Care had a policy and procedure in place for training LPNs in correct IV therapy. P. Supp. Br., at 4; P. Ex. 1. HCFA does not deny that Rose Care properly trained the LPNs involved in IV therapy. In fact, it was an LPN who first noticed that the incorrect tubing was being used in Resident 1's IV therapy. The LPNs involved were properly trained and demonstrated their competence by their actions. The medical error in this case was made by the DON, who was a licensed RN in good standing. The undisputed facts are that all the RNs and the LPNs involved were properly licensed and in good standing with the Arkansas State Board of Nursing. HCFA failed to demonstrate that any of the nurses were required to have a separate IV certificate under either the Arkansas State licensing board or under any federal regulation. I find nothing in the record before me to support the need to have a separate IV certificate in the files of the nurses involved. Under both Rose Care of Little Rock and A Pro, all of Petitioner's staff involved were qualified to initiate and maintain IV therapy.

The second part of this regulation is that the services be provided in accordance with the resident's written plan of care. In assessing whether the services, e.g., the IV therapy, were provided in accordance with this resident's plan of care, I must as a first step know what was stated in the plan of care relating to IV therapy. Unfortunately, HCFA did not offer any proof as to what was stated in the plan of care, neither by exhibit nor stipulation of fact. While I agree with HCFA that the plan of care may be amended to include a subsequent physician order (HCFA Br., at 3), without the plan of care in the record, I am unable to determine whether IV services were provided in accordance with the plan of care.

Moreover, even assuming that the plan of care was amended to include the physician's order of June 26, 1998 for IV therapy, there is a lack of evidence to establish that the IV therapy was administered in a manner inconsistent with the plan of care. There is no dispute that the plan of care required that Resident 1 receive IV therapy. HCFA argues that if there is inadequate or incorrect implementation of the care plan then the services were not provided in accordance with the resident's plan or care. HCFA supports this argument by pointing to the State Operations Manual under tag F 282, Guidelines to Surveyors. HCFA Ex. 4. Petitioner argues that the written plan of care specifies what services should be done to address the resident's medical problems but does not contain the particular nursing techniques to be used to implement those services. Petitioner argues that the plan of care called for IV therapy and IV therapy was performed.

Petitioner makes the stronger argument here. The condition of participation raised by 42 C.F.R. � 483.20 pertains to resident assessments, including the preparation of comprehensive care plans for each resident. Under 42 C.F.R. � 483.20(k)(3), the services provided or arranged must:

(i) [m]eet professional standards of quality; and

(ii) [b]e provided by qualified persons in accordance with each resident's written plan of care.

The only issue raised by the tag F 282 is whether the providers of the care were qualified and whether the care provided was in accordance with the plan of care. The quality of the care is not raised by this tag. HCFA offered no proof that the IV therapy administered was not in accord with the plan of care. HCFA could have challenged the quality of the IV therapy services under tag F 282 by relying on 42 C.F.R. � 483.20(k)(3)(i) in addition to 42 C.F.R. � 483.20(k)(3)(ii). However, it chose not to do so. Rather HCFA chose to challenge the quality of IV therapy directly in tag F 328, discussed in Section III B, below.

It is evident that the thrust of tag F 282 was directed at the qualifications of the persons who delivered the IV therapy rather than the quality of the IV therapy that was provided. I find that HCFA's argument is not directly on point under this tag. I further find that how the plan of care was implemented falls more appropriately under tag F 328. Implementation of the care plan is only of tangential concern under tag F 282. Under tag F 282, the main thrust of the regulation is the requirement for qualified persons to be employed by the facility. If qualified persons performed IV therapy and IV therapy was ordered by the physician, then the requirements of this regulation are satisfied. Therefore, I find that Petitioner was in substantial compliance with tag F 282.

2. Petitioner was out of compliance with tag F 328 which concerns quality of care, 42 C.F.R. � 483.25(k)(2). A finding of immediate jeopardy under tag F 328 is appropriate for the period of June 26 - 28, 1998.

HCFA determined that Petitioner was out of compliance with tag F 328, 42 C.F.R. � 483.25(k)(2) at an immediate jeopardy level. The regulation at 42 C.F.R. � 483.25(k)(2)requires that the facility ensure that residents receive proper treatment and care for specialized services which include parenteral and enteral fluids.

HCFA argues that Petitioner was out of compliance with tag F 328 because the facility nurses used an incorrect tubing for the IV infusion, failed to ensure that the tubing was sterile, and failed to properly monitor the administration of fluids per the physician's order. I do not have the factual record before me to support those portions of the deficiency that relate to the IV flow rate or that inadequate monitoring was done. See P. Supp. Br., at 1 - 2. HCFA's main thrust under this tag is the misuse of the non-sterile tubing.

Petitioner counters HCFA's argument by insisting that it hired licensed personnel and that there was no previous act or occurrence that would have alerted the facility that one or more of its personnel was incapable of administering parenteral and enteral fluids. Without such acts or occurrences, Petitioner claims that it was compliant with federal regulations because its staff was licensed by the Arkansas State Board of Nursing and because new nurses were properly oriented to their tasks and expected duties.

Petitioner does not dispute that incorrect tubing was used in Resident 1's IV infusion and should not have been used. P. Supp. Br., at 2. Nowhere in its briefing does Petitioner dispute that the tubing used was not sterile. The tubing was clearly labeled as not for IV use. Petitioner does not dispute that mistakes were made regarding the proper administration of the IV infusion. P. Reply Br., at 3. Petitioner further states that the mistakes made were errors but that errors do not prove that the nurses were unqualified. Id. However, tag F 328 does not involve whether or not qualified personnel are performing the medical services required. Instead, tag F 328 concerns itself with whether proper treatment was received by residents. Tag F 328 directly addresses the issue of the quality of the care that was provided. The use of non-sterile tubing in IV therapy is not proper and is in fact a basis for a finding of unprofessional conduct by the State licensing board. HCFA Ex. 7.

Petitioner argues that Resident 1 was not injured as a result of this error. A finding of a deficiency, even at an immediate jeopardy level does not require actual injury. "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. HCFA has more that adequately met its burden in showing that Petitioner's failure to ensure that proper sterile technique was used in Resident 1's IV therapy "is likely to cause serious injury, harm or impairment, or death to a resident." Id.

HCFA demonstrated that failure to follow sterile technique, in that non-sterile tubing was used, could have resulted in serious injury, harm or impairment, or death of resident. As explained by the Assistant Director of Nursing Practice of the Arkansas State Board of Nursing, "[a]septic technique would be one of the primary points of emphasis in an intravenous therapy-training program. To maintain aseptic technique, sterile supplies must be used including needles, catheters, tubing and solution." HCFA Ex. 7. Sterile technique is required because of the risk of infection. The importance of infection control in IV therapy is supported by the Standards for Infection Control that were developed by the Intravenous Nurses Society. Id. HCFA produced a declaration from Theresa Bennett who is currently a Health Insurance Specialist with HCFA. HCFA Ex. 8. Ms. Bennett also had been a surveyor and reviewer for three years with the Texas Department of Health and has been a registered nurse for 26 years. Id. Ms. Bennett's declaration states that when non-sterile tubing is used in IV therapy, there is a risk of foreign substances being introduced into the bloodstream which could have resulted in septicemia, which is a potentially fatal infection in the blood stream. Id. Ms. Bennett's declaration is also supported by an excerpt from The Merck Manual, 70 - 74 (Robert Berkow ed.,16th ed.,1992) which is attached to her declaration. Id.

Petitioner does not refute this evidence. Instead, Petitioner argues that at the time of the survey the situation had already been remedied. Further, Petitioner argues that no harm or negative outcome was caused by the use of the incorrect tubing and that no serious injury was likely to be caused because HCFA knew at the time it imposed the immediate jeopardy deficiency that Resident 1 had not incurred any injury. P Supp. Br., at 8. However, the time to look at whether immediate jeopardy exists is not after the fact. The regulation requires that one looks at the situation at the time it is occurring. At the time that Resident 1 was receiving IV therapy, a likely outcome of the use of non-sterile tubing could have been septicemia, a possibly fatal infection. Resident 1's physician immediately ordered that the IV be discontinued when notified of the error and ordered that the resident be monitored closely. This indicates that the physician was concerned that some kind of negative outcome could result from the use of the incorrect non-sterile tubing. Therefore, HCFA's determination that immediate jeopardy existed is appropriate because of the adverse outcome that likely could have occurred to Resident 1 from the use of the non-sterile tubing in the administration of the IV therapy.

Additionally, Petitioner argues that Resident 1 was being vigilantly monitored and therefore any potentially fatal infection would have been avoided. P. Supp. Br., at 9. This argument does not address that fact that Resident 1 should not have been put at risk of such a fatal infection in the first place from Petitioner's actions.

The DON was the staff person who started the IV therapy at 3:30 p. m. on June 26, 1998. HCFA Ex. 2. After the IV was started, five different licensed staff members monitored Resident 1's IV therapy and failed to notice the use of the incorrect tubing and failed to correct the error over a period of 39 hours. Id. One LPN reported to the weekend RN on June 27, 1998 that the tubing was for enteral feeding use and not for IV therapy use. Id. The weekend RN failed to correct and/or report the use of the incorrect tubing to the DON. On June 28, 1998, the LPN informed the DON that the tubing was incorrect. Id. According to a Medication Error Report, the physician was contacted on June 28, 1998 to inform him that the wrong tubing had been used for the IV infusion. HCFA Ex. 8. The physician asked if the tubing used was sterile. The RN replied that it was not sterile. On June 28, 1998, at 7:15 a.m., the physician ordered that the IV be discontinued and that the resident be monitored closely. Id.

In assessing the culpability of Petitioner for the deficiency cited in tag F 328, I am cognizant of the fact that the person who committed the error which placed Resident 1 at risk was the DON and it was not until a LPN advised the nursing staff of the error that corrective action was taken. The DON is an important management official for Petitioner in the provision of nursing services to residents. The fact that the error emanates from such a high official for Petitioner imposes a level of culpability on Petitioner which would not arise in different circumstances.

Petitioner argues that the basis for this deficiency is limited to one resident and one specific incident and therefore in the absence of past deficient practice there is no basis for an imposition of a remedy. I disagree. This situation existed for 39 hours. Five staff persons did not notice and correct the error. The error was originally made by the DON who, I would suppose, should have been the most qualified nurse at the facility. It is this person who is responsible for directing and supervising the nursing services rendered by Petitioner for its residents. Assuming the absence of sterile tubing in the facility, it is fortunate that other residents in need of IV therapy were not also subjected to the use on non-sterile tubing. Despite the clear risks, the DON used the non-sterile tubing rather than not instituting the IV therapy until the proper tubing could be procured. The physician immediately ordered that the IV be discontinued when notified of the error and ordered that the resident be monitored closely. Under these circumstances, I find that this was not an isolated occurrence and is appropriately the basis of an immediate jeopardy deficiency for the period of June 26 - 28, 1998.

3. Petitioner was in substantial compliance with tag F 328 which concerns quality of care, 42 C.F.R. � 483.25(k)(2), for the period of June 29 - July 23, 1998.

HCFA alleges that Petitioner remained in non-compliance with tag F 328 even after the immediate jeopardy was removed on June 28, 1998. HCFA alleges that the non-compliance was based on the inappropriate use of equipment for intravenous therapy, inadequate monitoring of parental infusions and preventing undue risk of infection. HCFA Ex. 2. However, once the misuse of the non-sterile tubing ceased, the record does not establish another source of a risk of infection. In addition, I do not have the factual record before me to support those portions of the deficiency that relate to the IV flow rate or that inadequate monitoring was done. See P. Supp. Br., at 1-2. Therefore, there is no basis remaining to support a deficiency of tag F 328 after June 28, 1998.

4. A CMP of $3,500 per day for each day of immediate jeopardy which begins on June 26, 1998 and which runs through June 28, 1998 is reasonable.

I sustain a CMP of $3,500 per day against Petitioner for each day of immediate jeopardy which begins on June 26, 1998 and which runs through June 28, 1998. A penalty of this amount is $500 per day less than the CMP imposed by HCFA but is still more than $3,050, the lowest amount that may be assessed for any immediate jeopardy deficiency.

I base the amount of the penalty on the factors which are prescribed in the regulations for determining the amount of a CMP. 42 C.F.R. �� 488.438 and 488.404. The evidence shows that the deficiency constituted a pattern (not an isolated incident), that the culpability of the DON, as one of Petitioner's high officials, was high and that the harm was likely to be very serious, potentially fatal. On the other hand, I note that Petitioner asserts that this not was a facility-wide problem in that it only involved one resident and that there was no evidence that indicated any past practice of incompetent performance by any of the nurses involved. Additionally, I note that HCFA's imposition of a CMP of $4,000 per day for the period of June 26 - 28, 1998 was premised on two findings at an immediate jeopardy level. In light of the circumstances of this case and the fact that I find only one immediate jeopardy deficiency, I am find that a CMP of $3,500 per day for the period of June 26 - 28, 1998 is reasonable.

IV. Conclusion

I decide that a $3,500 CMP per day is reasonable for the period of immediate jeopardy from June 26, 1998 through June 28, 1998. Additionally, I decide that there is no basis to support a finding of any deficiency after June 28, 1998, the date on which the immediate jeopardy was removed. The total authorized CMP is $10,500.

Edward D. Steinman

Administrative Law Judge

1. The survey cited 42 C.F.R. � 483.20(d)(3)(ii) which was redesignated as 42 C.F.R. � 483.20(k)(3)(ii). 62 Fed. Reg. 67174, 67210.