01-000734 Tampa Health Care Center vs. Agency For Health Care Administration Status: Closed Recommended Order on Wednesday, August 22, 2001.

Summary: Respondent`s issuance of conditional licensure for Class III violation by nursing home improper. Petitioner`s monitoring of patients taking psychotropic drugs adequate; failure to put opening date on vial of insulin not violation of federal regulations.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

TAMPA HEALTH CARE CENTER, )

)

Petitioner, )

)

vs. ) Case No. 01-0734

)

AGENCY FOR HEALTH CARE )

ADMINISTRATION, )

)

Respondent. )

)

RECOMMENDED ORDER

A formal hearing was held in this case before Daniel M.

Kilbride, Administrative Law Judge, Division of Administrative

Hearings, on May 24, 2001, in Tampa, Florida.

APPEARANCES

For Petitioner : Donna H. Stinson, Esquire

Broad and Cassel

2 15 South Monroe Street, Suite 400

Post Office Drawer 11300

Tallahassee, Florida 32302

For Respondent : Patricia J. Hakes, Esquire

Agency for Health Care Administration

525 Mirror Lake Drive, North

Room 310J

St. Peters burg, Florida 33701

STATEMENT OF THE ISSUES

Whether Petitioner was in violation of 42CFR 483.25(l)(1),

42CFR 483.60(d), Rules 59A-4.112(5) and 59A-4.1288, Florida

Administrative Code, at the time of its annual survey in July

2000, and, if so, whether those violations were uncorrected at

the time of resurvey in September 2000, in order to justify the

issuance of a Conditional licensure rating.

PRELIMINARY STATEMENT

The Agency for Health Care Administration (Respondent)

conducted an annual survey on July 27, 2000, and a follow-up

survey on September 5, 2000, of Petitioner's premises.

Based on these survey results, and pursuant to Subsection

400.23(7)(b), Florida Statutes, the facility was assigned a

conditional licensure rating effective September 9, 2000, which

continued until the facility's receipt of a standard license on

December 1, 2000. The conditional rating was based on

Respondent's determination that Petitioner had deficiencies in

the first survey and uncorrected deficiencies in the second

survey relating to (1) administration of unnecessary drugs, in

that their use was not adequately monitored, and (2) failure to

properly label drugs.

Petitioner filed a petition under Section 120.57, Florida

Statutes, challenging the conditional license and this matter

was referred to the Division of Administrative Hearings.

Following discovery, a formal administrative hearing was held on

May 24, 2001. At the hearing Respondent presented testimony

from four witnesses, Barbara Bearden, R.N.; Katherine Benson,

R.N.; Trish Gold, Health Facility Evaluator; and Marie Maisel,

R.N., and offered two exhibits which were admitted in evidence.

Petitioner's witnesses were Pam Johnson, a pharmacist, and

Cheryl Cobb-Tullos, R.N., and Petitioner's six exhibits were

admitted into evidence. During the testimony of Maisel,

Petitioner moved for the admission of the witness' deposition,

dated May 14, 2001. Said motion was denied. Following the

hearing, Petitioner filed a motion to submit deposition, dated

August 6, 2001, seeking re-consideration of this tribunal's

ruling at the hearing. Upon further consideration, pursuant to

Section 90.803(18)(d), Florida Statutes, and Florida Rules of

Civil Procedure 1.330 and 1.390; Lee v. Department of Health and

Rehabilitation Services , 698 So. 2d 1194, 1200 (Fla. 1997) ;

Costa v. School Board of Broward County , 701 So, 2d 414 (Fla.

4th DCA 1997), said motion is granted and the deposition of the

witness, Marie Maisel, taken on May 14, 2001, is admitted in

evidence.

A Transcript of the hear ing was filed on June 6, 2001. The

parties filed a motion for extension of time to file their post-

hearing submittals. The motion was granted, and both parties

filed Proposed Recommended Orders on August 6, 2001. Both

parties' proposals have been give careful consideration in the

preparation of this Recommended Order.

FINDINGS OF FACT

1. Tampa Health Care Center (Petitioner) is a licensed

nursing home in Tampa, Florida.

2. Pursuant to Chapter 400, Florida Statutes, Respondent

surveys Petitioner to determine whether it is in compliance with

applicable laws and regulations. If there are deficiencies, it

determines the level of deficiency. When Respondent conducts a

survey of a nursing home, it issues a survey report, commonly

called by its form number, a "2567." The particular regulation,

and the allegedly deficient practices which constitute a

violation of that regulation, are cited in a column on the left

side of the paper. After receiving the 2567, the facility is

required to develop a plan of correction which is put in the

right hand column corresponding to the alleged deficiency. The

facility is required to develop this plan regardless of whether

it agrees that it is in violation of any regulations, and it is

prohibited from being argumentative.

3. Respondent conducted its annual survey of Petitioner,

ending July 27, 2000, and issued a 2567 survey report noting

certain deficiencies. The deficiencies are designated as tag

numbers. Among those noted were Tag F329, which is the

shorthand reference to 42 C.F.R. Subsection 483.25 (1)(1), and

Tag F431, which incorporates 42 C.F.R. Subsection 483.60(d).

Respondent rated these deficiencies as Class III deficiencies.

4. Respondent conducted a follow-up survey on September 5,

2000, and determined that the deficiencies under tags F329 and

F431 were uncorrected, and, as a result, issued a Conditional

rating to the facility.

5. On December 2000, Respondent conducted another follow-

up survey and determined that all deficiencies had been

corrected and therefore issued a Standard license to Petitioner

effective that date.

6. The 2567 constitutes the charging document for purposes

of issuing a Conditional license. No other document was offered

to describe the offenses, or deficiencies, which resulted in

imposition of the Conditional license. The parties stipulated

at the hearing that Tags F329 and F431 were the only ones at

issue in this proceeding.

7. In conducting its survey, Respondent uses a document

developed by the Health Care Financing Administration (HCFA),

called the State Operations Manual. It indicates guidance on

how are to interpret regulations.

TAG F 329

8. The 2567 from the July survey asserts, under Tag F 329,

that the facility "failed to monitor psychotropic medications

for 5 of 5 sampled residents." The regulation states that

residents are to be "free from unnecessary drugs," and

elaborates that a drug given without adequate monitoring is

considered unnecessary. The guidelines establish that

monitoring is expected only for residents on psychotropic

medications. Therefore, for a violation to occur, there must

first be a resident who is receiving psychotropic medications,

and secondly, a lack of monitoring of the use of that drug.

9. Respondent alleged and put on evidence that certain

residents (numbers 1, 9, 19, and 21) identified in the July

survey did not have "behavior monitoring records" in their

files. Specific forms are not mandatory, and evidence of

monitoring can be documented elsewhere in a resident's clinical

record. Monitoring can be documented in nurses' notes, and

those notes were not thoroughly reviewed, as Respondent's

surveyors only had limited time for the survey.

10. Respondent presented no evidence that Residents 9, 19,

or 21 were receiving psychotropic medications.

11. Petitioner presented evidence of numerous systems in

place to monitor residents, including those receiving

psychotropic medications. Residents are given a complete

clinical assessment within 24 hours of admission; there is then

a 14-day more thorough observation and assessment process,

culminating in the development of care plans which address

particular issues and direct staff to care for residents in

particular ways. Nurses regularly document issues or concerns

in nurses notes; a physician visits the residents at least once

a month, which, as all drugs are ordered by the physician,

includes review of the resident's medication. If necessary, a

psychiatric evaluation is completed. Once a week a

transdisciplinary team meets to discuss any residents "at risk,"

which includes those receiving psychotropic medications.

12. Additionally, a consultant pharmacist reviews all

residents' medications once a month. This review is to

determine how well the resident is doing on the drug regimen.

It includes reviewing nurses' notes, physicians' notes, the

medication administration record, the record of dosages taken on

an "as needed" basis, and discussions with nursing staff. The

pharmacist reviews whether there are medications administered in

excessive doses, in excessive duration, without adequate

monitoring, without adequate indications for use, or in the

presence of adverse consequences.

13. With regard to the September survey, Respondent

alleged in the Form 2567 that "Residents numbers 3, 4, 9, 11,

and 13 lacked Behavior Monitoring Forms in their records" and

that all were on psychotropic medications which required

monitoring. Respondent presented the testimony of Barbara

Bearden who stated that Residents 3 and 4 were on psychotropic

medications, and that there were no behavior monitoring forms.

With regard to Resident 4, Respondent asserted that there was no

assessment of behaviors in any records after August 14. Bearden

acknowledged that both Residents 3 and 4 received reasonable

doses, and that there was no reason to believe the level of

medication was too high. Respondent's witness also asserted

that there was no "AIMS" assessments, no initial assessment, and

no indication of the reason for or effectiveness of the

medications. These matters were not alleged in the charging

document, which only asserted the lack of behavior monitoring

forms. During her testimony, Respondent's witness acknowledged

that there was no standard to determine how often there should

be behavior monitoring.

14. Mari e Maisel testified for Respondent regarding

Residents 9, 11, and 13. With regard to Resident 9, she

testified that the resident received Restoril, a sleeping

medication, and also Zoloft, an anti-depressant, and that there

was no "systematic behavior monitoring." Sleeping medications

do not require behavior monitoring, according to the State

Operations Manual, and at deposition, the surveyor indicated

that the only medication the resident received was Restoril.

Petitioner therefore had no notice of the additional allegation

regarding Zoloft and this fact cannot be considered.

15. With regard to Resident 11, Maisel testified that the

resident received Risperdal, a psychotropic medication, and

that, in her opinion, the behavior monitoring was not adequate.

16. At hearing the surveyor testified that Resident 13 was

receiving Haldol and there was no systemic behavior monitoring.

However, the witness acknowledged that when her deposition was

taken, she did not know why Resident 13 had been cited.

Petitioner therefore had no notice of these allegations

regarding Resident 13.

17. Petitioner presented evidence, including excerpts from

the resident's clinical record, that Resident 3 had been

assessed for drug use, and that behaviors were monitored. The

resident had been admitted less than three weeks before the

September survey, which means that an initial assessment had

been performed, as well as the complete 14-day assessment, just

prior to survey. Respondent admitted that it would be

inappropriate to reduce medication soon after admission. There

was a care plan which addressed the resident's use of Risperdal,

and another which addressed the resident's ability to function

with the activities of daily living. These care plans directed

staff to monitor the resident's condition and behavior.

Numerous nursing notes documented the resident's condition and

behaviors.

18. Resident 3 was not noted in the pharmacist's monthly

report, meaning the review revealed no problems with

medications. Furthermore, the resident's medications were

significantly reduced while in Petitioner's care, and her

condition improved dramatically, from being nearly comatose, to

being alert and oriented, and needing only limited assistance

with mobility.

19. Resident 4 had been admitt ed just a month before the

survey and had also just undergone an extensive assessment

process. Her medications were also reduced from those she had

been receiving on admission, and nurses notes clearly documented

her condition and behaviors throughout the period up to the

survey. These notes document not only the monitoring of

behaviors, but the reason and need for the medication, as she

exhibited combative behaviors. Resident 4 also did not appear

on the pharmacist's report.

20. With regard to Residen t 9, Petitioner presented

evidence that there was a care plan specifically addressing the

resident's use of Zoloft, that there were other care plans which

addressed behaviors and condition which required that the

resident be monitored, and that there was periodic consideration

of reductions. Resident 9 did appear on the pharmacist's

report, suggesting consideration of a reduction in dosage; thus

demonstrating the effectiveness of the system.

21. Resident 11 had a care plan addressing her use of

Risperdal, which required monitoring and other interventions.

Monthly nursing summaries reflected that she was monitored, as

did nursing notes. Generally, nurses notes indicate when there

are problems or unusual occurrences, not when everything is

routine.

22. Petitioner also presented evidence with regard to

Resident 13's use of Haldol, which showed the reason for its use

(wandering, verbal abusiveness), numerous efforts to reduce the

dosage, review by the pharmacist, a care plan to address its

use, which required monitoring, and monthly summaries

summarizing her condition and behaviors.

23. Respondent presented sufficient evidence to show that

Residents 3, 4, 9, 11, and 13, cited in the September survey,

were appropriately monitored and were not receiving unnecessary

drugs.

TAG F431

24. Respondent charged in the September 2000 survey that

several insulin vials in the medication room were not marked

with the date they were opened. The regulation under Tag F431,

42 C.F.R. Subsection 483.60(d), requires that drugs be labeled

"in accordance with currently accepted professional principles"

and "the expiration date when applicable." The surveyor

guidelines indicate that the critical elements of labeling are

the name of the drug and its strength. Additionally, the

guidelines advise that drugs approved by the Federal Drug

Administration ( F.D.A.) must have expiration dates on the

manufacturer's container.

25. Respondent's witness acknowledged that all insulin had

the manufacturer's expiration date. Although there is a chance

of contamination after opening a vial of insulin, it was

acknowledged that it is customary to have a policy allowing use

for six months after opening.

26. Petitioner has a policy of discarding insulin 60 days

after opening. While it is customary to write the opening date

on the vial, a failure to do so will only reduce the amount of

time it can be used, because of other systems in place. The

pharmacy which dispenses the insulin puts a dispensing date on

it, and the pharmacist reviews, monthly, stored medications.

Within every three months, all medications are checked, and if

there is no date of opening, the pharmacist looks to the

dispensing date. If the vial was dispensed more than 60 days

prior , it is given to the nurse for discarding. Instead of

being able to be used for six months beyond the date opened, the

medication is discarded sixty days, or at most ninety days,

after it was dispensed.

27. Writing the date opened on the vial is not an item

encompassed by the regulation as explicated in the guidelines.

Furthermore, there is no potential for harm, as there are

redundant systems in place.

CONCLUSIONS OF LAW

28. The Division of Administrative Hearings has

jurisdiction over the parties and subject matter of this cause,

pursuant to Section 120.569 and Subsection 120.57(1), Florida

Statutes.

29. Subsection 120.569(1), Florida Statutes, applies to

all proceedings in which the substantial interests of a party

are determined by an agency. Subsection 120.57(1), Florida

Statutes, applies in those proceedings involving disputed issues

of material fact.

30. A facility is substantially affected by a conditional

rating and/or an administrative fine. For example, Section

408.35, Florida Statutes, governing certificates of need,

provides that an applicant's ability and record of providing

quality of care are among the criteria for competitive review.

Additionally, a facility cannot for the Gold Seal program if it

has had a conditional rating within the previous thirty months,

Section 400.235, Florida Statutes. A conditional rating can

substantially affect the reputation of a facility in the

community and have a negative impact on staff morale and

recruiting. See Spanish Gardens Nursing & Convalescent Center

(Beverly Health & Rehab Svcs., Inc.) v. Agency for Health Care

Administration , 21 FALR 132 (AHCA, 1998).

31. Respondent is authorized to license nursing home

facilities in the State of Florida, and pursuant to Chapter 400,

Part II, Florida Statutes, is required Respondent to "at least

every 15 months, evaluate all nursing home facilities and make a

determination as to the degree of compliance . . . "

Respondent's evaluation must be based on the most recent

inspection report, taking into consideration findings from other

official reports, surveys, interviews, investigations and

inspections. It must assign either a standard or conditional

licensure rating to each facility after it is surveyed.

Subsection 400.23(7)(b), Florida Statutes.

32. Subsection 400.23(7)(b), Florida States ( Supp. 2000 ),

provides:

"[C ] onditional licensure status means that a

facility due to the presence of one or more

class I or class II deficiencies, or class

III deficiencies not corrected within the

time established by the agency, is not in

substantial compliance at the time of the

survey with criteria established under this

part, . . . If the facility comes into

substantial compliance at the time of the

follow-up survey, a standard licensure

status may be assigned."

33. Subsection 400.23(8)(c), Florida Stat utes ( Supp.

2000), provides:

"Class III deficiencies are those which

Respondent determines to have an indirect or

potential relationship to the health, safety

or security of nursing home facility

residents, other than class I and class II

deficiencies. A class III deficiency shall

be subject to a civil penalty . . . for each

and every deficiency. . . ."

34. Conditional licensure is authorized by law for

facilities with class III deficiencies which are not corrected.

Subsection 400.23(7)(b), Florida Statutes.

35. Tag 329 incorporates:

(a ) 42 C.F.R. 483.25(l)(1) which states

that each resident's drug regimen must be

free from unnecessary drugs. An unnecessary

drug is any drug when used: . . . (iii)

without adequate monitoring.

(b ) Rule 59A-4.1288, Florida

Administrative Code, which requires that

nursing homes which participate in Title

XVIII or XIX must follow 42 C.F.R. 483.

36. Tag 431 incorporates:

(a ) 42 C.F.R. 483.60(d) which requires

that drug and biologicals used in the

facility must be labeled in accordance with

currently accepted professional principles.

(b ) Rule 59A-4.112(5), Florida

Administrative Code, which requires that

drugs and biologicals be labeled in

accordance with currently accepted

professional principles.

(c ) Rule 59A-4.1288, Florida

Administrative Code, which requires that

nursing homes which participate in Title

XVIII or XIX must follow 42 C.F.R. 483.

37. Respondent has the burden of proving by a

preponderance of the evidence the basis of changing Petitioner's

licensure rating to Conditional and the basis for imposing an

administrative fine. Florida Department of Transportation v.

J.W.C. Company , Inc., 396 So 2d 778 (Fla. 1st DCA 1981) ; Balino

v. Department of Health and Rehabilitative Services , 348 So 2d

349 (Fla. 1st DCA 1977).

38. In the instant case, Respondent alleges that it was

proper to issue Petitioner a Conditional licensure on

September 5, 2000, because Class III deficiencies cited in the

July survey were allegedly uncorrected at the time of the

September survey. Under Section 400.23, Florida Statutes, a

Conditional license can be imposed for Class III deficiencies

only if they are not corrected within the time frame established

by Respondent. Accordingly, it is Respondent's burden to

establish by at least a preponderance of evidence the existence

of the deficiencies cited by the surveys of both July and

September 2000.

39. The only charges made by Respondent under Tag F329

relate to adequate monitoring and the absence of certain forms

which could be used to monitor residents' behavior. However,

there was agreement that use of these forms is not required by

the regulation, and there was also a lack of evidence about what

monitoring is "adequate." In the light of evidence presented by

Petitioner that various systems existed to ensure that residents

were monitored and that the particular residents noted in the

September survey had considerable documentation of monitoring,

Respondent failed to demonstrate a violation of this regulation.

40. R espondent's assertion that Petitioner did not fulfill

its "plan of correction" to the July survey is without probative

value of the underlying question of whether Petitioner complied

with the regulation. The evidence was unrefuted that Petitioner

had no choice, even if it disagreed with the assertions, about

submitting a plan of correction to address the allegations.

41. Petitioner is entitled to a succinct and

understandable statement of the charges. See Cottrill v.

Department of Insurance , 685 So. 2d 1371, 1372 (Fla. 1st DCA

1996). As the charges are made through the 2567, the

allegations of that document are what must be proven, and what

Petitioner is required to defend. Though details may be filled

in through discovery, if those details are withheld in

discovery, they may not be added at hearing. This is relevant

to the allegations regarding Residents 9 and 13 from the

September survey. The charging document stated only that they

"lacked Behavior Monitoring Forms in their records" and received

psychotropic medications. The type of medication was not named.

At deposition, Respondent offered the information that

Resident 9 received only a sleeping pill, not covered by the

regulation, and that it was not known why Resident 13 had been

cited. There was an agreement between counsel that this

witness' deposition would be used in lieu of live testimony, yet

Petitioner presented the witness at hearing, and at hearing she

added previously undisclosed information regarding those two

residents. That information, presented at hearing without prior

notice in spite of Petitioner's efforts to obtain it, cannot be

used to support Respondent's charges in this case. Respondent

bears the responsibility for identifying the specific grounds

for the proposed agency action. Agency for Health Care

Administration v. Beverly Health and Rehabilitation Center-Coral

Trace , 22 FALR 673 (AHCA 1999). It cannot, consistent with the

Administrative Procedures Act and fundamental due process, fail

to provide specifics in the charging document, withhold them

during discovery, and then produce them at hearing.

42. Respondent charges, under Tag F431 in the September

survey, that Petitioner violated this regulation because "opened

insulin vials were not dated with the date opened." This

allegation does not state a violation of the regulation as it is

written. Furthermore, the guidance given to surveyors does not

suggest this as a requirement, requiring only manufacturer's

expiration dates for F.D.A. approved drugs.

43. Additionall y, there is no potential for any harm if a

vial is not labeled on the date opened, as the only result is

discarding the insulin sooner rather than later, based on the

date of dispensation. The law, Section 400.23, Florida

Statutes, requires that a nursing home be in substantial

compliance. Federal Regulations, adopted in Florida through the

same statute, Section 400.23, Florida Statutes, define minor

deficiencies, with which a facility remains in substantial

compliance, as those with "no greater risk to resident health or

safety than the potential for causing minimal harm," 42 C.F.R.

Section 488.301. Though the use of contaminated insulin could

obviously cause harm, this is not the question. The issue is

whether the failure to put an opening date on the vial has

potential, other than the most speculative and conjectural, to

result in harm from use of contaminated insulin. See discussion

of foreseeability in Washington Manor v. AHCA , DOAH Case

Nos. 00-4035 and 4735, Recommended Order, dated May 7, 2001,

p. 33. There is no reasonably foreseeable harm from the failure

to document insulin with date of opening; therefore, even if

this were required by the regulation, a failure to do so does

not equate to lack of substantial compliance. Respondent failed

to demonstrate that Petitioner was not in substantial compliance

with this regulation.

RECOMMENDATION

Based of the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMENDED that the Director of the Agency for Health Care

Administration enter a final order revising the July 27 and

September 5, 2000, survey reports by deleting the deficiencies

described under Tags F329 and F431, and issuing a Standard

rating to Respondent to replace the previously issued

Conditional rating.

DONE AND ENTERED this 22nd day of August, 2001, in

Tallahassee, Leon County, Florida.

___________________________________

DANIEL M. KILBRIDE

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488- 9675 SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 22nd day of August, 2001.

COPIES FURNISHED :

Patricia J. Hakes, Esquire

Agency for Health Care Administration

525 Mirror Lake Drive, North

Room 310J

St. Petersburg, Florida 33701

Donna H. Stinson, Esquire

Broad and Cassel

215 South Monroe Street, Suite 400

Post Office Drawer 11300

Tallahassee, Florida 32302

Sam Power, Agency Clerk

Agency for Health Care Administration

2727 Mahan Drive

Fort Knox Building Three

Suite 3431

Tallahassee, Florida 32308

Julie Gallagher, General Counsel

Agency for Health Care Administration

2727 Mahan Drive

Fort Knox Building Three

Suite 3431

Tallahassee, Florida 32308

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this Recommended Order. Any exceptions

to this Recommended Order should be filed with the agency that

will issue the Final Order in this case.