02-001659 Agency For Health Care Administration vs. Casa Febe Rtmt Home, Inc., D/B/A Home Is Where The Heart Is Status: Closed Recommended Order on Monday, October 21, 2002.

Summary: Facility that failed to remind physician to write prescription did not violate rule requiring facility to ensure that existing prescriptions are refilled. Agency cannot amend term "refill" to mean "fill."

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

AGENCY FOR HEALTH CARE )

ADMINISTRATION, )

)

Petitioner, )

)

vs. ) Case No. 02 - 1659

)

CASA FEBE RETIREMENT HOME, )

INC., d/b/a HOME IS WHERE THE )

HEART IS, )

)

Respondent. )

)

RECOMMENDED ORDER

Administrative Law Judge (ALJ) Daniel Manry conducted the

administrative hearing of this case on August 1, 2002, in

St. Petersburg, Florida, on behalf of the Division of

Administrative Hearings (DOAH).

AP PEARANCES

For Petitioner: Michael P. Sasso, Esquire

Agency for Health Care Administration

525 Mirror Lake Drive, North

Suite 330K

St. Petersburg, Florida 33701

For Respondent: Colleen O'Rourke, Esquire

Riley Law Firm, P.A.

48 05 West Laurel Street

Suite 230

Tampa, Florida 33607

STATEMENT OF THE ISSUES

The issues for determination are whether Respondent failed

to make reasonable efforts to ensure that a prescription for a

resident was refilled in a timely manner in viola tion of Florida

Administrative Code Rule 58A - 5.0185(7)(f); and, if so, whether

Respondent should reclassify Respondent's license from standard

to conditional, impose an administrative fine of $2,000, and

impose a survey fee of $500 pursuant to Sections 400 .419(1)(b)

and 400.419(9), Florida Statutes (2001). (All references to

chapters and statutes are to Florida Statutes (2001) unless

otherwise stated. Unless otherwise stated, all references to

rules are to rules promulgated in the Florida Administrative

C ode in effect on the date of this Recommended Order.)

PRELIMINARY STATEMENT

Petitioner filed an Administrative Complaint against

Respondent some time in February 2002. Respondent timely

requested an administrative hearing. On April 29, 2002,

Petitioner referred the matter to DOAH to conduct the

administrative hearing.

At the administrative hearing, Petitioner presented the

testimony of three witnesses and submitted eight exhibits for

admission into evidence. Respondent presented the testimony of

four witnesses and submitted two exhibits for admission into

evidence.

The identity of the witnesses and exhibits and any

attendant rulings are set forth in the Transcript of the hearing

filed on August 20, 2002. The Transcript identifies the

resident involv ed in this case as Resident 2 in order to protect

the confidentiality of the resident.

At the conclusion of the hearing, the ALJ required each

party to file a proposed recommend order (PRO) no later than 10

days from the date that the Transcript was file d with DOAH. On

August 26, 2002, the parties filed an Agreed Upon Motion for

Extension of Time in which to file their respective PROs. By

order issued on August 26, 2002, the ALJ extended the deadline

for filing PROs until September 6, 2002. The parties timely

filed their respective PROs on September 6, 2002.

FINDINGS OF FACT

1. Petitioner is the state agency responsible for

regulating assisted living facilities (ALFs) and for

investigating complaints received anonymously by a state hotline

in a ccordance with Chapter 400, Part III, and Rule 58A - 5 .

Respondent is an ALF located at 312 East 124th Avenue, Tampa,

Florida 33612 (the facility).

2. Petitioner conducted a complaint survey of the facility

on August 10, 2001. Petitioner noted the r esults of the survey

on a form entitled Form 3020 - 0001 "Statement of Deficiencies and

Plan of Correction" (the 3020).

3. The 3020 is the document used to charge ALFs with

deficiencies that violate applicable law. The 3020 identifies

each alleged def iciency by reference to a tag number. Each tag

number on the 3020 includes a narrative description of the

allegations against the ALF and cites a provision of the

relevant rule or rules that the alleged deficiency violates.

4. The 3020 in this case invol ves one allegation in Tag

A630. Tag A630 alleges that Respondent violated Rule 58A -

5.0185(7)(f) by failing to make every reasonable effort to

ensure that prescriptions for residents who receive assistance

with self - administration or medication administrat ion are

"refilled" in a timely manner.

5. Resident 2 receives assistance with the self -

administration of medication. Resident 2 suffers from dementia

and chronic obstructive pulmonary disease. Tag A630 alleges

that Respondent failed to make reasona ble efforts to ensure that

a prescription for an antibiotic known as Tequin was refilled in

a timely manner on or about August 2, 2001.

6. University Community Hospital (the hospital) admitted

Resident 2 on June 27, 2001, with relevant diagnoses of urinary

tract infection and sepsis. The hospital administered Tequin to

Resident 2 intravenously and discharged Resident 2 to the

facility on August 2, 2001. On August 6, 2001, the hospital

readmitted Resident 2 for treatment of the urinary tract

infecti on.

7. The discharge instructions from the hospital on

August 2, 2001, included instructions for several medications.

The instructions indicated that Resident 2 was to continue

taking Tequin 200 mg one tab a day for 11 days; Prednisone 20 mg

tab take a s needed; Albuterol and Atrovent nebulizer every 6

hours as needed; and home O2 2 liters by nasal canula [sic] 24

hours. Resident 2 had prescriptions for all of the medications

included in the discharge instructions except Tequin.

8. The hospital dischar ged Resident 2 late in the evening

on August 2, 2001. The next morning, the facility manager faxed

the new prescriptions for Resident 2 to the pharmacy that the

facility used in the ordinary course of its business. The

pharmacy timely filled the new pres criptions.

9. Facility staff never saw a written prescription for

Tequin. Resident 2 was in good spirits and had no signs of a

urinary tract infection or other signs of infection such as a

change in mental status or a loss of appetite. Facility

personne l reasonably believed that the hospital had successfully

treated the urinary tract infection.

10. Petitioner's surveyor testified that he saw a

prescription for Tequin in the facility files for Resident 2 and

wrote down the exact wording of the presc ription. That

testimony is neither credible nor persuasive.

11. Even if the testimony of Petitioner's surveyor were

credible and persuasive, other evidence in the case outweighs

that testimony. Neither Petitioner's agents, the facility

Manager, the fa cility administrator, the owner of the facility,

the hospital, the discharging physician, nor the pharmacy, is

able to produce a prescription for Tequin, a copy of the

prescription, or a record that the physician ever wrote such a

prescription. In additio n, a discharge instruction is not a

prescription. Finally, Petitioner admits in its PRO that a

prescription for Tequin was "missing" when Resident 2 returned

to the facility. Respondent could not have failed to refill a

prescription for Tequin because th ere is no credible and

persuasive evidence that a prescription for Tequin ever existed

between August 2 and 6, 2001.

12. The facility Manager did not compare the discharge

instructions with the written prescriptions that accompanied

Resident 2 on her d ischarge from the hospital. While that

omission may constitute a violation of some law or rule, it is

not the violation alleged in the Administrative Complaint and

Tag A630.

13. The omission alleged in the Administrative Complaint

and Tag A630 is that Respondent failed to ensure that an

existing prescription for Tequin was "refilled." That

allegation, in the context of this case, requires Petitioner to

show that Respondent failed to ensure that the pharmacist

refilled an existing prescription previousl y issued by a

physician and on file with the pharmacist. Petitioner failed to

prove that factual allegation.

14. The factual allegations that Petitioner sought to

prove in the administrative hearing are substantially different

from those contained in eit her the Administrative Complaint or

Tag A630. The Administrative Complaint alleges at paragraph 8

that Respondent failed to make reasonable efforts to ensure that

a prescription for Resident 2 was refilled. Tag A630 alleges in

relevant part:

Based on a r eview of resident records and on

interview with the facility's Owner,

Administrator and Manager, the facility

failed to fill a prescription for one

resident upon the resident's return from the

hospital.

Per interview with the three employees noted

above , on 8/10/01 at 12:45pm, and based on a

review of the Resident's files, Resident #2

was admitted to University Community

Hospital on 7/27/01, and was there diagnosed

with a urinary tract infection and sepsis

. . . The Resident was discharged from UCH

on 8 /2/01, with the following medication

instructions; Tequin 200mg one tab a day for

11 X days. . . . These discharge

instructions were found in the Resident's

file. Also observed in the Resident's file

were the prescriptions for the above - noted

medications . However, when asked, none of

the three employees noted above were aware

of the prescription for the wide - spectrum

antibiotic; each stated the belief that the

Resident's infections had been treated and

resolved in the hospital and that an

antibiotic wasn 't needed. A review of the

Resident's Medication Observation Record for

8/01 showed the entry of the other

medications per the discharge instructions

except for the Tequin. On 8/7/01 the

Resident was readmitted to the hospital with

symptoms of a urinary tract infection, per

Owner, the Administrator and the Manager.

(emphasis supplied)

It can be reasonably assumed that the

facility's failure to note either the

Resident's discharge instructions or the

prescription slip for the antibiotic

(Tequin) resulted in the Resident's

continued suffering of a urinary tract

infection and the Resident's return to the

hospital. Regardless of whether this

failure to give the Resident his prescribed

medication was primarily responsible for the

Resident's continued UTI, the facility

failed to properly note the physician's

orders and to fill the prescription.

Petitioner's Exhibit 4 at pages 2 - 3.

15. Before the administrative hearing, Tag A630 expressly

alleged that a prescription for Tequin existed in the file of

Resident 2 at the facility and charged that Respondent failed to

fill the existing prescription. The Administrative Complaint

alleges that the failure to fill an existing prescription

violates the requirement in Rule 58A - 5.0185(7)(f) to ensure that

prescriptions are refilled.

16. At the hearing, Petitioner sought to prove factual

allegations that are different from those in Tag A630 and the

Administrative Complaint. Rather than proving that Respondent

failed to fill a prescription that existed in the file of

Res ident 2, as alleged in Tag A630, Petitioner sought to prove

that Respondent failed to compare the discharge instructions

with the prescriptions issued by the treating physician, remind

the physician that he or she failed to issue a prescription for

Tequin, retrieve the pretermitted prescription, deliver it to

the pharmacist, and then ensure that the pharmacist timely

"filled" the new prescription.

17. Petitioner cannot put Respondent on notice in the

Administrative Complaint and Tag A630 that Respondent must be

prepared to defend the factual allegation that Respondent failed

to refill an existing prescription and then prove at the

administrative hearing that Respondent committed acts or

omissions not alleged in either the Administrative Complaint or

Tag A 630. To do so, is a violation of fundamental notions of

due process and adequate notice of the charges against

Respondent in a penal proceeding.

CONCLUSIONS OF LAW

18. DOAH has jurisdiction over the parties and subject

matter in this proceeding. Sections 120.569 and 120.57(1).

DOAH provided the parties with adequate notice of the

administrative hearing.

19. Petitioner has the burden of proof. Petitioner must

show by a preponderance of the evidence that Respondent

committed a Class II defi ciency for which a change in

Respondent's license from standard to conditional is authorized.

Petitioner must show by clear and convincing evidence that

Respondent committed the acts and omissions alleged in the

Administrative Complaint and Tag A630 for w hich an

administrative fine is authorized. Department of Banking and

Finance v. Osborne Stern , 670 So. 2d 932 (Fla. 1996); Ferris v.

Turlington , 510 So. 2d 292 (Fla. 1987).

20. Petitioner failed to show by a preponderance of the

evidence that Respondent failed to make reasonable efforts to

ensure that a prescription for Tequin in the facility file of

Resident 2 was refilled. Petitioner admits in its PRO at

paragraph 26 that no prescription for Tequin existed. In

relevant part, Petitioner states:

The ev idence adduced at the hearing

demonstrate [sic] that the Respondent,

through its agent, failed to compare the

discharge summary with the actual

prescriptions present at the time of the

resident's re - admittance to the facility on

August 2, 2001, and deter mine that there was

a prescription for Tequin missing . (emphasis

supplied)

Respondent could not have failed to ensure that the pharmacist

refill a prescription that did not exist.

21. Petitioner cannot charge in the Administrative

Complaint and Tag A630 that Respondent failed to fill an

existing prescription and then find Respondent guilty of failing

to remind the physician to write the prescription and then fill

it; a different offense for which Respondent had no notice

either in the Administrative Comp laint or Tag A630. The charges

against Respondent in a penal proceeding must be specific and

any ambiguities in the charging documents must be construed

against the prosecuting agency. Ghani v. Department of Health ,

714 So. 2d 1113, 1115 (Fla. 1st DCA 19 98); Davis v. Department

of Professional Regulation , 457 So. 2d 1074, 1078 (Fla. 1st DCA

1984); Lester v. Department of Professional Regulation , 348

So. 2d 923, 925 (Fla. 1st DCA 1977).

22. Even if the factual allegations against Respondent

were suff icient to provide Respondent with adequate notice of

the charges against it, Petitioner's case fails because

Petitioner bases its prosecution upon two flawed interpretative

statements of Rule 58A - 5.0185(7)(f).

23. The first interpretive statement constr ues the term

"refilled" in Rule 58A - 5.0185(7)(f) to include a requirement for

Respondent to ensure that new prescriptions are "filled." At

paragraph 28 of the PRO Petitioner states in relevant part:

The evidence also adduced indicate [sic]

that the clear intent of Rule

58A5.0185(7)(f) [sic] is to ensure that all

prescriptions for medications for facility

residents who are either receiving

supervision of medications or administration

of medications, are filled or refilled in a

timely manner.

24. Assumin g arguendo that a prescription for Tequin were

to exist, the agency's interpretive statement of Rule 58A -

5.0185(7)(f) effectively amends the promulgated requirement for

Respondent to ensure that a previously issued prescription is

refilled to include the u npromulgated requirement for Respondent

to ensure that a new prescription is "filled." The distinction

between filling and refilling a prescription may have little

difference for a pharmacist. However, Respondent is not a

pharmacist.

25. An interpret ation of the refill requirement to include

a requirement to fill a prescription enunciates distinctly

different standards of compliance when considered in the context

of the facts and circumstances surrounding this case. The

requirement to ensure that a p rescription is refilled requires

Respondent to ensure that the pharmacist used by Respondent in

the ordinary course of business actually refills a prescription

previously issued by a physician and on file with the

pharmacist. The requirement to ensure tha t a new prescription

is filled requires Respondent to ensure that a new prescription

actually received by Respondent is delivered to the pharmacist

and filled by the pharmacist. The different requirements

involve not only different standards, but the viol ation of each

standard involves different types of omissions that involve

different facts and that vary in severity.

26. Petitioner's interpretive statement that Rule 58A -

5.0185(7)(f) requires Respondent to ensure both the filling and

refilling of a p rescription modifies and enlarges the literal

terms of the promulgated rule. An agency statement that amends

a promulgated rule is itself a rule. Section 120.52(15). An

agency statement is itself a rule if the statement interprets a

promulgated rule in a manner that is clearly contrary to the

unambiguous language of the promulgated rule. Kearse v.

Department of Health and Rehabilitative Services , 474 So. 2d

819, 820 (Fla. 1st DCA 1985)(agency must comply with its own

rules).

27. An agency is not fre e to deviate from a valid existing

rule but must follow its own rules. See , e.g. , Section

120.68(7)(e)2; Vantage Healthcare Corporation v. Agency for

Health Care Administration , 687 So. 2d 306, 308 (Fla. 1st DCA

1997)(agency statement that does not follow its own rules is an

invalid rule); Cleveland Clinic Florida Hospital v. Agency for

Health Care Administration , 679 So. 2d 1237, 1242 (Fla. 1st DCA

1996)(change in procedure expressed in adopted rule must be

undertaken by rulemaking), reh'g denied ; Regal Kitchens, Inc.

v. Florida Department of Revenue , 641 So. 2d 158, 162 (Fla. 1st

DCA 1994)(agency cannot use declaratory statement to alter

exemption authorized in rule); Florida H - Lift v. Department of

Revenue , 571 So. 2d 1364, 1366 - 1367 (Fla. 1st DCA 1990) (agency

statement imposing requirements not in agency rule is an invalid

rule); Decarion v. Martinez , 537 So. 2d 1083, 1084 (Fla. 1st DCA

1989)(agency interpretation of its own rule to impose different

requirements is an invalid rule); Williams v. Departme nt of

Transportation , 531 So. 2d 994, 996 (Fla. 1st DCA 1988)(agency

deviation from a rule is an invalid rule).

28. Petitioner has not promulgated its explicated

amendment of Rule 58A - 5.0185(7)(f) in accordance with the

rulemaking procedures prescribed in Section 120.54.

Petitioner's amendment of its existing rule is an unpromulgated

rule. An agency cannot rely on an unpromulgated rule in a

proceeding that is penal in nature. Anglickis v. Department of

Professional Regulation , 593 So. 2d 298 (Fla. 2d DCA 1992).

29. The purpose of rejecting unpromulgated standards as

invalid rules is to ensure the transparency that Chapter 120 is

intended to achieve. Courts have long held that Chapter 120 has

as one of its principal goals:

. . . the abolition of "unwritten rules" by

which agency employees can act with

unrestrained discretion to adopt, change and

enforce governmental policy. . . .

Straughn v. O'Riordan , 338 So. 2d 832, 834 n. 3 (Fla. 1976).

The requirement to invalidate an unadopted rule is intend ed to:

. . . close the gap between what the agency

and its staff know about the agency's law

and policy and what an outsider can know.

McDonald v. Department of Banking and Finance , 346 So. 2d 569,

580 (Fla. 1st DCA 1977). The transparency intended as on e of

the principal goals of Chapter 120 is a significant

consideration in any administrative hearing, including one that

is penal in nature.

30. The second flawed interpretive statement of Rule 58A -

5.0185(7)(f) construes the refill requirement in a man ner that

requires Respondent to ensure that the physician writes the

prescription. Petitioner's argument in its PRO is illuminating.

The evidence . . . demonstrate [sic] that the

Respondent . . . failed to compare the

discharge summary with the actual

p rescriptions present . . . and determine

. . . there was a prescription for Tequin

missing.

Petitioner's PRO at paragraph 28.

31. The second interpretive statement by Petitioner seeks

to further amend the terms of Rule 58A - 5.0185(7)(f). Petitioner

arg ues that Respondent violated the refilling requirement by

failing to: review the discharge notes, remind the treating

physician to write the missing prescription, retrieve the

missing prescription, deliver the prescription to the

pharmacist, and then ensur e that the pharmacist timely filled

the new prescription. The second interpretive statement of

Petitioner's existing rule is also rejected.

32. The ALJ does not have jurisdiction in this proceeding

to determine the validity of Petitioner's promulgated r ule.

Respondent did not file a rule challenge in this case. However,

the ALJ does have jurisdiction to interpret the promulgated rule

in a manner that preserves the validity of the rule under

Chapter 120.

33. The legal principle that guides an ALJ in the

interpretation of a rule is similar to that which guides an ALJ

in the interpretation of a statute. Although an ALJ does not

have jurisdiction to determine that a statute is invalid under

the state or federal constitutions, an ALJ should interpret a

s tatute, whenever possible, in a manner that preserves the

validity of the statute under the applicable constitution. A

properly adopted and promulgated rule has the force and effect

of law. State v. Jenkins , 469 So. 2d 733, 734 (Fla. 1985);

Florida Lives tock Board v. Gladden , 76 So. 2d 291, 293 (Fla.

1954); Canal Insurance Company v. Continental Casualty Company ,

489 So. 2d 136, 137 (Fla. 2d DCA 1986). The ALJ should

interpret a properly adopted and promulgated rule, whenever

possible, in a manner that p reserves the validity of the rule

under Chapter 120.

34. Petitioner's interpretative statement of its

promulgated rule would render the rule invalid under Chapter 120

and is therefore rejected. Alternatively, the interpretative

statement itself is an inv alid, unpromulgated rule on which

Petitioner cannot rely in a penal proceeding.

35. The requirement in Petitioner's promulgated rule for

Respondent to ensure the timely refilling of a prescription does

not require Respondent either to ensure that a new prescription

is filled or to remind a physician to write the prescription.

Such omissions may violate other rules but do not violate Rule

58A - 5.0185(7)(f).

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMENDED that Petitioner enter a Final Order finding

Respondent not guilty of the acts and omissions alleged in the

Administrative Complaint and Tag A630 and restoring Respondent's

previous license rating nunc pro tunc .

DONE AND ENTERED this 21st day of October, 2002, in

Tallahassee, Leon County, Florida.

___________________________________

DANIEL MANRY

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675 SUNCOM 27 8 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 21st day of October, 2002.

COPIES FURNISHED :

Colleen O'Rouke, Esquire

Riley Law Firm, P.A.

4805 West Laurel Street, Suite 230

Tam pa, Florida 33607

Michael P. Sasso, Esquire

Agency for Health Care Administration

525 Mirror Lake Drive, North

Suite 330K

St. Petersburg, Florida 33701

Lealand McCharen, Agency Clerk

Agency for Health Care Administration

2727 Mahan Drive, Mail Stop 3

T allahassee, Florida 32308

Valda Clark Christian, General Counsel

Agency for Health Care Administration

2727 Mahan Drive

Fort Knox Building, Suite 3431

Tallahassee, Florida 32308

Rhonda M. Medows, M.D., Secretary

Agency for Health Care Administration

2727 Mahan Drive

Fort Knox Building, Suite 3116

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 Rec ommended Order should be filed with the agency that

will issue the Final Order in this case.