Judges: CHARLES C. ADAMS
Agency: Agency for Health Care Administration
Latest Update: Jan. 31, 1985
Summary: The issues in this case concern the challenge by Orange Park Care Center, Inc. (Orange Park) to the classification of certain deficiencies discovered in an inspection of the nursing home facility as conducted by the State of Florida, Department of Health and Rehabilitative Services (HRS). In particular, Orange Park believes that the choice by HRS to classify the NH-148(2) and (3), deficiencies as class II, in contrast to Class III, was inappropriate. Finally, Orange Park requests that it be reco
Summary: The issues in this case concern the challenge by Orange Park Care Center, Inc. (Orange Park) to the classification of certain deficiencies discovered in an inspection of the nursing home facility as conducted by the State of Florida, Department of Health and Rehabilitative Services (HRS). In particular, Orange Park believes that the choice by HRS to classify the NH-148(2) and (3), deficiencies as class II, in contrast to Class III, was inappropriate. Finally, Orange Park requests that it be recognized as a superior facility, assuming that the classification scheme in question, as posed by HRS, is found to be incorrect.Violations detected in inspection of nursing home facility not such to remove superior rating.
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vs. ) CASE NO. 84-1379
Respondent. )
Notice was given and a formal Section 120.57(1), Florida Statutes hearing was conducted in Jacksonville, Florida, on November 27, 1984. Charles C. Adams presided as the Hearing Officer. This Recommended Order is being entered following the receipt and review of proposed recommended orders as offered by the parties. To some extent, those proposals have been utilized. Otherwise they are rejected for reason that they are not substantiated by credible evidence, based upon a lack of relevance or materiality or for reasons that they tend to be cumulative and subordinate to facts found in the Recommended Order.
For Petitioner: Michael O. Mathis, Esquire
For Respondent: Karen L. Goldsmith, Esquire
The issues in this case concern the challenge by Orange Park Care Center, Inc. (Orange Park) to the classification of certain deficiencies discovered in an inspection of the nursing home facility as conducted by the State of Florida, Department of Health and Rehabilitative Services (HRS). In particular, Orange Park believes that the choice by HRS to classify the NH-148(2) and (3), deficiencies as class II, in contrast to Class III, was inappropriate. Finally, Orange Park requests that it be recognized as a superior facility, assuming that the classification scheme in question, as posed by HRS, is found to be incorrect.
At all times relevant to this cause, Orange Park was licensed as a nursing home through recognition by HRS and thereby certified to participate in the Medicaid program.
On December 12, thru 14, 1983, an annual license survey/ inspection was conducted in the nursing home facility. This survey was by officials within HRS. Prior to that survey Orange Park had been rated as a superior facility.
In the course of the survey, deficiencies were discovered to include two deficiencies described as NH-156 and NH-157. Those deficiencies were characterized by HRS as Class II deficiencies, which if an accurate depiction would cause Orange Park to lose its superior rating as a nursing home facility.
Other deficiencies included a deficiency known as NH- 148. There were several aspects to that deficiency. The first part of the deficiency pertained to a contention that no documentation could be found indicating that the consulting pharmacist to Orange Park had reviewed the matter of controlled drugs accountability. The second item related to a claim that Lidocaine and Isuprel, medications related to cardiac care were in the Emergency Medication kit, notwithstanding the fact that the effective date of those medications has passed or expired. The expiration dates were in February and July, 1983, respectively. The final contention related to the NH-148 deficiency dealt with the substance Benadryl, as prescribed for a patient within the nursing home on a p.r.n.
basis. This substance bore an expired date of September, 1983. All substances were placed in the Emergency Medication Kit, based upon a decision of the pharmaceutical services committee within the nursing home. Although David Hodge, pharmacist and consultant to HRS testified that outdated drugs may promote harm to the patient when administered, he was not certain of the implications of using the outdated or expired medications described in this paragraph.
Certain conferences or exit interviews were conducted between staff members of HRS and the nursing home and through those conferences the impression was gained that the NH-148 violations described constituted Class III violations or deficiencies. The NH-156 and 157 deficiencies continued to be perceived by HRS staff as Class II violations. On that subject, effective February 29, 1984, correspondence was forwarded to the administrator of Orange Park, acknowledging corrections which had been made to the deficient conditions including NH-148, 156, and 157. Those items had been corrected effective February 20, 1984. In this correspondence there is attached a sheet classifying the deficiencies, reflecting NH-148 as Class III and NH-156 and 157 as Class II.
Prior to the February 29, 1984 correspondence discussed above, namely on February 17, 1984 Orange Park had challenged the classification of NH-156 and
157 as being Class II deficiencies, which challenge was referred to the Division of Administrative Hearings for consideration.
On June 21, 1984, correspondence was addressed to the administrator of Orange Park from Ivan B. Owen, Supervisor, Area I, Office of Licensure and Certification, of HRS. That correspondence stated,
during a recent review of our files it was discovered that a typographical error was made
on page 2 of your survey report of December 12-14, 1983, (copy attached). The revised page 2 has
been altered to indicate that NH-148(2) and (3), are classified as Class II deficiencies and
NH-158 and 157 are Class III deficiencies.
This adjustment occasioned an amended petition by Orange Park challenging NH-148(2) and (3) as being Class II deficiencies. That amendment to the position of HRS defined the nature of the hearing for which the Recommended Order is being entered. It gave definition in the sense that Orange Park accepted the characterization of NH-156 and 157, as being Class III deficiencies; however, it took issue with the classification of NH-148(2) and
(3) as being Class II deficiencies.
Having considered the testimony of the witnesses for HRS, it is not clear why the decision was made to change the proposed classification of NH-148 from a Class III to a Class II deficiency. Therefore, in terms of placing due regard or deference on the interpretation or policy choice of HRS, related to decision to change its position on the classification, deference cannot be afforded, there being no record basis supporting this policy decision. As a consequence, the decision on the question of classification must be made based upon a review of the underlying evidential facts measured against the statute and rules pertaining to the classification of deficiencies, without the benefit of an HRS policy statement. The HRS change in position is made more bewildering given the fact that in the inspection of another nursing home facility, known as the Green Cove Springs Geriatric Center, as conducted on November 14 through 16, 1984, an NH-147 violation was found and classified as Class III based upon the fact that an outdated ampule of Meperidine was found in the Emergency Medication Kit, a similar circumstance to that of the present case.
In examining the conditions in existence at the time of inspection there were other containers of Lidocaine and Isuprel in the Emergency Medication Kit which were not outdated and could have been utilized for the benefit of patients, assuming that the appropriate medical professional followed the facility procedures and read the expiration dates on the expired containers of Lidocaine and Isuprel prior to the administration of those substances and discarded those which had expired. The history of those particular items within the Emergency Medication Kit indicated that neither of the substances had ever been administered for the benefit of a patient. The issue of the ability of the nursing home to properly utilize the two substances in the nursing home setting was also presented, and left some question about the ability to use those substances and the willingness to use the substances given that uncertainty.
The likelihood of pursuing their utilization is further put to question given the close proximity of a hospital wherein the medications could be given without that quality of concern.
The questioned Benadryl has not been administered to the patient for whom it was prescribed during that patients stay in the facility between December, 1982 and October, 1984. This medication could have been given by a duly licensed professional, however to use this expired medication it would be necessary to disregard the policy of reading the label and discovering the expired condition. Additional Benadryl was found in the Emergency Medication Kit which was in date. Should the Class II deficiencies pertaining to NH-148, be set aside, Orange Park would be entitled to receive a superior rating as a nursing home, per stipulation of the parties.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter and the parties to this action pursuant to Section 120.57(1) Florida Statutes.
The parties, in the person of their counsel, have requested the receipt into the record of an item referred to as Classification of Deficiencies for Nursing Home Licensure Requirements, page 2 of 4 pages related to an inspection or survey of Green Cove Springs Geriatric Center, conducted on November 14 through 16, 1984. That motion is granted and the item is received into the record.
Section 400.23, Florida Statutes, empowers HRS to establish the classification of deficiencies found in surveys conducted on various nursing homes' licensed by HRS. Orange Park is such a nursing home. Having determined the classification to be assigned to a given deficiency and in the face of a challenge to that classification scheme, it is incumbent upon HRS to prove the efficacy of that choice of classification when challenged by the facility.
On this occasion, in the allegation of deficiencies as set forth in the notice of deficiencies served upon Orange Park at the conclusion of the survey of December, 1983, HRS alleges that Orange Park was deficient in that its consulting pharmacist failed to comply with the statement of responsibilities set forth in Rule 10D-29.12(4)(c), Florida Administrative Code. Contained within that provision is the requirement of assuring that the contents of the Emergency Medication Kit which have been established by the Pharmaceutical Services committee of the nursing home are maintained.
In the letter of acknowledgment of corrections of February 29, 1984, in the form related to the claim of deficiencies and acknowledgment of corrections reference is also made to Rule 10D-29.112(9)(h), Florida Administrative Code, pertaining to the need beyond the beginning of the next work day following the destruction of the seal of an Emergency Medication Kit, to check the contents and replace the necessary items and reseal the Kit.
Counsel for the Petitioner, in his argument, alludes to the provisions set forth in Rule 10D-29.112(9)(i), Florida Administrative Code, related to the posting of the contents of the Emergency Medication Kit at all nursing stations and on the outside of the kit and need for quarterly inventory of those contents. HRS, through the argument of its counsel, also makes reference to Rule 10D-29.112(9)(e), Florida Administrative Code which deals with the need to seal the Emergency Medical Kit and maintain it in accordance with federal and state laws pertaining to specific items included.
Having reviewed the code references in the context of proof offered, they establish the need to maintain the substances selected by the pharmaceutical services committee. No proof has been given on the question of how one maintains those substances in accordance with federal and state laws. Reference to the contention pertaining to checking, replacing and resealing does not relate to this case, nor has any contention been made on the subject of the failure to keep an inventory in appropriate places within facilities such as nursing stations and the outside of the Kit and the companion topic of the need for inventory of the substances on a quarterly basis. This leaves for consideration the question of whether maintenance as described in Rule 10D- 29.112(4)(c)5 , Florida Administrative Code encompasses the concept of keeping the substances up to date i.e. not allowing the expiration of the effective
date. The word maintenance in that provision is found to include that concept. The question then becomes one of how this deficiency of keeping expired medication should be classified.
Section 403.23(4)(b) Florida Statutes, defines Class II deficiencies
as:
. . . those which the department determines have a direct or immediate relationship to the health, safety or security of the nursing home facility residents . . .
This definition is as distinguished from the definition pertaining to
Class III deficiencies, found at Section 400.23(4)(c), Florida Statutes, to be:
. . those which the department determines
to have an indirect or potential relationship to the health, safety or security of the nursing home facility residents . . .
Given the fact that the patient must first develop a condition requiring the administration of the medications at issue, followed by an attempt by professionals to administer those medications in violation of policies on the subject of review of the expiration dates of those substances and the failure in turn for those professionals to use the in date substances which were found in the Emergency Medication Kit, in substitution for the out of date substances; the deficiencies, NH-148(2) and (3) are best described and are described as Class III deficiencies. There is a potential relationship to the health of the residents contrasted with a direct or immediate relationship as envisioned in the Class II category. HRS having failed to offer any compelling policy reason to the contrary this determination in law has been reached. The decision is bolstered by the initial response within this action in which the HRS staff had found the NH-148 violation to be Class III and as seen in a related matter pertaining to a Class III for out of date medication in the Emergency Medication Kit, at Green Cove Springs Geriatric Center.
Finally, in the February 29, 1984, statement of HRS related to its perception of the NH-148 deficiencies and notation of the date of corrections, reference is made to Rule 10D- 29.112(2), Florida Administrative Code. That provision relates to assuring that drugs and non-prescription medications for the benefit of patients within the facility are prescribed by the attending physician and insuring that the pharmacuetical services are provided in keeping with professional principles in appropriate federal, state, and local laws. This reference did not have application to the claim of deficiency related to NH-148 when considered against the evidential facts and contentions made by HRS in its efforts to support the reclassification of the NH- 148 violation from Class III to Class II.
beta Class III deficiency and rating Orange Park Care Center, Inc., a superior facility.
DONE and ORDERED this 31st day of January, 1985, at Tallahassee, Florida.
CHARLES C. ADAMS
FILED with the Clerk of the Division of Administrative Hearings this 31st day of January, 1985.
Karen L. Goldsmith, Esquire
1323 Winewood Blvd.
Michael O. Mathis,Esquire
P.O. Box 210
