04-004633 Agency For Health Care Administration vs. Manor Care Of Sarasota, Inc., D/B/A Manor Care Nursing Center Status: Closed Recommended Order on Friday, August 26, 2005.

Summary: Petitioner failed to prove a Class II deficiency for missed doses of prescribed medication, where the resident in question appeared to suffer only minimal discomfort from missing the medication.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

AGENCY FOR HEALTH CARE )

ADMINISTRATION, )

)

Petitioner, )

)

vs. ) Case No. 04 - 4633

)

MANOR CARE OF SARASOTA, INC., )

d/b/a MANOR CARE NURSING )

CENTER, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a formal hearing was held in this case

before Lawrence P. Stevenson, Administrative Law Judge of the

Division of Administrative Hearings, on March 23, 2005, in

Lakeland, Florida.

APPEARANCE S

For Petitioner: Eric Bredemeyer, Esquire

Agency for Health Care Administration

2295 Victoria Avenue, Room 346C

Fort Myers, Florida 33901

For Respondent: Alfred W. Clark, Esquire

117 South Gadsden Street, Suite 201

Post O ffice Box 623

Tallahassee, Florida 32302 - 0623

STATEMENT OF THE ISSUES

Whether Respondent, Manor Care of Sarasota, Inc., d/b/a

Manor Care Nursing Center, committed a Class II deficiency at

the time of a survey conducted on August 10 through 12, 20 04, so

as to justify the issuance of a "conditional" license and the

imposition of an administrative fine of $2,500.

PRELIMINARY STATEMENT

An Administrative Complaint dated November 23, 2004, was

filed by Petitioner, Agency for Health Care Administration

("AHCA"), against Respondent, Manor Care of Sarasota, Inc.,

d/b/a Manor Care Nursing Center ("Manor Care"), alleging an

isolated Class II deficiency, seeking to change Manor Care's

license rating from "standard" to "conditional," and seeking to

impose an administrative fine of $2,500 against Manor Care.

Manor Care denied the allegations and timely requested a formal

hearing. The matter was forwarded to the Division of

Administrative Hearings ("DOAH") for hearing on December 27,

2004. The case was schedu led for hearing on March 9, 2005. A

joint motion for continuance was granted by O rder dated

February 2, 2005. The O rder rescheduled the final hearing for

March 23, 2005, when it was held.

At the hearing, AHCA presented the testimony of Barbara

Pescatore , a registered nurse ("RN") accepted as an expert

registered nurse specialist; Anne Dolan, an RN accepted as an

expert in long - term care nursing; and Franklin E. May, Ph.D.,

accepted as an expert pharmacist and as an expert in pharmacy

surveying for long - t erm care nursing. AHCA's Exhibits A

through K were accepted into evidence. Manor Care presented the

testimony of Diane Hinrichs, a licensed practical nurse ("LPN")

supervisor at Manor Care; Angela Miguel, an RN supervisor at

Manor Care; Jane Sargent - Jeff erson, a certified dietary manager

("CDM") at Manor Care; Sharon Broders, an RN and director of

nursing at Manor Care; and Nancy Caras, an RN and licensed

nursing home administrator at Manor Care. Manor Care's

Exhibits 1 through 7 were admitted into evide nce.

A Transcript of the hearing was filed at DOAH on April 7,

2005. The parties timely submitted Proposed Recommended Order s,

which have been given careful consideration in the preparation

of this Recommended Order.

FINDINGS OF FACT

Based upon the evi dence presented at the final hearing, the

following relevant findings of fact are made:

1. At all times material hereto, AHCA i s the state agency

charged with licensing of nursing homes in Florida under

Subsection 400.021(2), Florida Statutes (2004), and the

assignment of a licensure status pursuant to Subsection

400.23(7), Florida Statutes (2004). AHCA is charged with

evaluating nursing home facilities to determine their degree of

compliance with established rules as a basis for making the

required lice nsure assignment. AHCA is also responsible for

conducting federally - mandated surveys of long - term care

facilities receiving Medicare and Medicaid funds for compliance

with federal statutory and rule requirements pursuant to Florida

Administrative Code Rul e 59A - 4.1288.

2. Pursuant to Subsection 400.23(8), Florida Statutes

(2004), AHCA must classify deficiencies according to the nature

and scope of the deficiency when the criteria established under

Subsection 400.23(2), Florida Statutes (2004), are not met . The

classification of any deficiencies discovered determines whether

the licensure status of a nursing home is "standard" or

"conditional" and the amount of the administrative fine that may

be imposed, if any.

3. Surveyors note their findings on a sta ndard prescribed

Center for Medicare and Medicaid Services (CMS) Form 2567

entitled, "Statement of Deficiencies and Plan of Correction,"

which is commonly referred to as a "Form 2567." During the

survey of a facility, if violations of regulations are foun d,

the violations are noted and referred to as "Tags." A tag

identifies the applicable regulatory standard that the surveyors

believe has been violated, provides a summary of the violation,

and sets forth specific factual allegations that the surveyors

be lieve support the violation.

4. Manor Care is a 178 - bed nursing home located at 5511

Swift Road, Sarasota, Florida. Manor Care is licensed as a

skilled nursing facility.

5. On August 10 through 12, 2004, AHCA 's staff conducted a

survey at Manor Care. The Form 2567 completed during this

survey found the facility in violation of Tag F425. This

alleged violation formed the basis of AHCA 's Administrative

Complaint.

6. Tag F425 relates to pharmacy services. The federal

regulation with which Manor Care allegedly failed to comply is

42 C.F.R. Section 483.60, which provides in relevant part:

The facility must provide routine and

emergency drugs and biologicals to its

residents, or obtain them under an agreement

described in Sec. 483.75(h) of this part.

42 C.F.R. Section 483.75 provides generally that a facility

"must be administered in a manner that enables it to use its

resources effectively and efficiently to attain or maintain the

highest practicable physical, mental, psychosocial well - being of

each res ident." 42 C.F.R. Section 483.75 (h) provides:

(h) Use of outside resources.

(1) If the facility does not employ a

qualified professional person to furnish a

specific service to be provided by the

facility, the facility must have that

service furnis hed to residents by a person

or agency outside the facility under an

arrangement described in section 1861(w) of

the Ac t [1/] or (with respect to services

furnished to NF residents and dental

services furnished to SNF residents) an

agreement described in pa ragraph (h)(2) of

this section.

(2) Arrangements as described in section

1861(w) of the Act or agreements pertaining

to services furnished by outside resources

must specify in writing that the facility

assumes responsibility for --

(i) Obtaining se rvices that meet

professional standards and principles that

apply to professionals providing services in

such a facility; and

(ii) The timeliness of the services.

7. Resident 10, a female who was 51 years old at the time

of the survey, was initially admitted to Manor Care on

December 19, 2003, with diagnoses that included diabetes

mellitus, arteriosclerotic heart disease, peripheral vascular

disease, depression, chronic obstructive pulmonary disease, and

cerebral vascular accident with hemiparesis and intercerebral

hemorrhage.

8. Resident 10 was admitted to Sarasota Memorial Hospital

for a surgical procedure on her leg, then re - admitted to Manor

Care on August 2, 2004. The hospital's medical impression

history and background included status post bi lateral iliac

angioplasty and stent, hypertension, a history of nicotine

addiction, cigarette abuse, status post previous coronary stent,

severe osteoarthritis, a history of lumbosacral disk disease

with chronic pain syndrome, status post left thoracotomy, lower

lobectomy for adenocarcinoma, a history of seizure disorder, and

a history of moderate carotid stenosis on the right and left.

9. Upon her re - admission to Manor Care on August 2, 2004,

Resident 10 had an intravenous morphine pump at 25 mg per day

for severe pain and a clonopin pump at 250 mg per day for back

pain. She was also prescribed oxycodone (Percocet) "prn ," or as

needed, for breakthrough pain. Finally, she was prescribed

fentanyl citrate (Actiq), a narcotic analgesic, in the form of a

lo zenge often referred to as a "lollipop ," every three hours , as

needed , for breakthrough pain. As a potent opiate, fentanyl is

a Schedule II controlled substance that is subject to misuse,

abuse, and addiction.

10. The nurses ' notes for August 2, 2004, i ndicated that

Resident 10 was offered Percocet for her pain, but that she

declined it.

11. On August 3, 2004, the attending physician changed

Resident 10's fentanyl prescription from "3 hr. prn" to "q. 2h ,"

meaning from every three hours , as needed , to every two hours

regardless of her expressed need.

12. Manor Care's pharmaceuticals were provided by an

outside pharmacy pursuant to a contract comporting with

42 C.F.R. Section 483.75 (h). On August 7, 2004, Manor Care's

staff faxed a refill order to the contract pharmacy requesting a

refill of Resident 10's fentanyl. During the day shift on

August 9, 2004, Diane Hinrichs, the LPN performing the narcotics

count, noticed that the fentanyl count was low and that the

pharmacy had not filled the August 7 refi ll order. She faxed a

repeat refill order and phoned the pharmacy, which assured her

that the fentanyl would be included in the pharmacy's 4:00 p.m.

delivery to Manor Care. When the fentanyl was not delivered at

4:00 p.m., another Manor Care nurse phoned the pharmacy again.

The pharmacy assured the nurse that the fentanyl would be

included in the next scheduled delivery, at about 2:00 a.m. on

August 10, 2004. Shortly before 2 :00 a.m., Ms. Hinrichs was

back on duty and phoned the pharmacy, asking whether she could

obtain the fentanyl at Walgreens or some other alternate source.

The pharmacist told her that she could not, but assured her that

the fentanyl was "on its way." The fetanyl was not included in

the 2:00 a.m. delivery. The duty nurse called the pharmacy

immediately, then again at approximately 5:20 a.m., and was

again told that the fentanyl was "on its way ."

13. The last dose of fentanyl in the facility was

administered to Resident 10 at midnight on August 9, 2004.

Resident 10 did not receiv e fentanyl , as ordered , at 2:00 a.m.,

4:00 a.m., and 6:00 a.m. on August 10, 2004. She continued to

receive the morphine and clonopin on the intravenous pump

throughout the night.

14. During the night, Resident 10 was offered Percocet as

a substitute for the unavailable fentanyl. She declined the

Percocet , stating that "it does not help at all." Manor Care's

medication administration records indicated that Resident 10 had

never taken Percocet. As noted above, Resident 10's physician

had prescribed Perc ocet for breakthrough pain.

15. The pharmacy delivered the fentanyl at approximately

7:40 a.m. on August 10, 2004, and the nursing staff administered

the medication to Resident 10 at about 8:30 a.m. The pharmacy

later investigated the situation and infor med Manor Care that a

pharmacy technician had miscalculated the amount of fentanyl

that Manor Care was allowed to keep on hand and had placed the

refill order in a "holding bin" for later delivery.

16. The Manor Care nursing notes indicate that Resident

1 0's physician was notified of the unavailability of the fetanyl

at some time on August 10, 2004. On August 11, 2004, the

physician discontinued his order for Percocet and instead

prescribed oral morphine (Roxanol) for Resident 10's

breakthrough pain. The physician continued the prescription for

fetanyl.

17. One of Resident 10's diagnoses was a "history of

nicotine addiction, cigarette abuse." Her night and early

morning routine was sleep punctuated by frequent trips in her

wheelchair to an outdoor gazeb o designated by Manor Care as a

smoking area. During the early morning hours of August 10,

2004, Resident 10 followed this routine.

18. During the early morning hours of August 10, 2004,

Resident 10 was observed by an experienced RN, Angela Miguel,

and a n experienced LPN, Diane Hinrichs, both of whom were

familiar with Resident 10's condition, personality, and habits.

Resident 10 did not complain to either nurse regarding pain

caused by the missed doses of fentanyl. Neither nurse observed

Resident 10 to exhibit any behavior indicative of pain.

Resident 10 appeared to be going about her usual routine of

sleeping, then going outside to smoke. Under the circumstances,

neither nurse saw any reason or need to conduct a formal pain

evaluation of Resident 10.

19. Jane Sargent - Jefferson, the food service director,

arrived at Manor Care at her usual time of 5:00 a.m. on

August 10, 2004. She found Resident 10 asleep in her wheelchair

outside in the smoking gazebo, which is adjacent to the Manor

Care dining room . Ms. Sargent - Jefferson often found Resident 10

asleep in the gazebo during the early morning hours and would

wake up Resident 10 and talk to her. She did s o on the morning

of August 10, 2004.

20. Ms. Sargent - Jefferson testified that "the first thing

out of [Resident 10's] mouth" was that "she was mad because her

meds had been missed." Ms. Sargent - Jefferson stated that it was

not unusual for Resident 10 to be angry and to complain when she

was unhappy. Just the day before, Resident 10 had "stormed ou t"

of the dining room when the chef's salad was not to her liking.

21. Ms. Sargent - Jefferson had frequent conversations with

Resident 10. On the morning of August 10, 2004, she spoke with

Resident 10 on three separate occasions between 5:00 a.m. and

noon . Resident 10 did not say that she had been in pain during

the previous night. Ms. Sargent - Jefferson testified that

Resident 10 "would tell you" if she was in pain. Ms. Sargent -

Jefferson observed nothing out of the ordinary in Resident 10's

appearance o r behavior on the morning of August 10, 2004.

22. On the morning of August 10, 2004, AHCA surveyor

Barbara Pescatore was in the smoking gazebo when she was

approached by a resident subsequently identified as Resident 10,

who complained that she had not rec eived prescribed pain

medication from midnight until 8:30 a.m. Ms. Pescatore

transferred the inquiry to Anne Dolan, the RN who had been

assigned to survey the care of Resident 10.

23. Ms. Dolan reviewed the facility's records and

interviewed the staff. She learned that Resident 10's fentanyl

doses were missed at 2:00 a.m., 4:00 a.m. , and 6:00 a.m. on

August 1 0, 2004, and that the 8:00 a.m. dose on that date was

administered at about 8:30. She further learned the

circumstances surrounding the lack of f entanyl in the facility in

the early morning hours of August 10, 2004.

24. At the hearing, Ms. Dolan, an expert in long - term care

nursing, opined that Manor Care and its nurses had an absolute

responsibility to ensure that Resident 10 had her medication a nd

had it on time. She testified that at 10:00 p.m. on August 9,

2004, the nursing staff knew that there was only one dose of

fentanyl remaining to administer and that it was the staff's

responsibility to do whatever was needed to ensure there would be

mo re medication to give Resident 10 after the last dose at

midnight. Ms. Dolan testified that missed doses of a routine

pain medication can cause unnecessary pain and a delay in the

medication's effect when the doses are resumed.

25. Ms. Dolan testified th at she could see Resident 10

grimacing and wincing when she would feel pain in her leg. She

testified that Resident 10's pain was relieved immediately when

she received the fetanyl "lollipop." 2/ However, Ms. Dolan was

not present on the night in question , and the record gives no

indication whether Ms. Dolan or any other AHCA surveyor simply

asked Resident 10 whether she experienced increased pain when she

missed the doses of fentanyl. No direct evidence was presented

that Resident 10 expressed pain or co mplained of pain or

discomfort due to the missed doses of fentanyl, either at the

time or later.

26. Dr. Franklin May, a senior pharmacist for AHCA, offered

expert testimony and testified that the nursing staff's actions

during the night of August 9, 2004 , evidenced a "very severe"

failure to deliver pharmaceutical services. He based this

opinion on the fact that the regulations require that medication

be provided in a timely manner. Dr. May was not involved in the

survey process and did not interview Re sident 10. Based on the

records he reviewed, Dr. May testified that he could not say

whether Resident 10 "needed" the fentanyl for pain between

midnight and 8:00 a.m.

27. Dr. May opined that when the dose of fentanyl was

missed due to its unavailability and Resident 10 refused to take

the alternative drug Percocet, the staff nurses should have

performed an immediate pain evaluation and contacted the

resident's physician for instructions. If the attending

physician had been unavailable, then the nurses sh ould have

contacted Manor Care's director of medicine for instruction.

Dr. May emphasized that the staff nurses did not have the

discretion to allow the resident to simply miss doses of

prescribed medicine.

28. The contracting pharmacy's policy and proce dure manual

set forth the following policy: " When medication orders are not

received or unavailable, the licensed nurse will immediately

initiate action in cooperation with the attending physician and

the pharmacy provider. All medication orders unavaila ble to the

customer will be managed with urgency." The manual set s forth

the following process to implement the policy, in relevant part

(emphasis in original):

2. If a medication shortage is discovered

during normal pharmacy hours :

2.1 A licens ed nurse calls the pharmacy

and speaks to a registered pharmacist to

determine the status of the order. If not

ordered, place the order or re - order to be

sent with the next scheduled delivery.

2.2 If the next available delivery

causes delay or missed d ose in the customer's

medication schedule, take the medication from

the emergency stock supply to administer the

dose.

2.3 If medication is not available in

the emergency stock supply, notify the

pharmacist and arrange for an emergency

delivery.

3. If a medication shortage is discovered

after normal pharmacy hours :

3.1 A licensed nurse obtains the

ordered medication from the emergency stock

supply.

3.2 If the ordered medication is not

available in the emergency stock supply, a

licensed nurse ca lls the pharmacy ' s emergency

answering service and request to speak with

the registered pharmacist on duty to manage

the plan of action. Action may include:

3.2.1 Emergency delivery.

3.2.2 Use of emergency (back - up) pharmacy.

4. If an emergency de livery is unavailable,

a licensed nurse contacts the attending

physician to obtain orders or directions

which may include:

4.1 Holding the dose/doses.

4.2 Use of an alternative medication

available from the emergency stock supply.

4.3 Change in o rder (time of

administration or medication).

* * *

6. When a missed dose is unavoidable:

6.1 Document missed dose on the

Medication Administration Record (MAR) or

Treatment Administration Record (TAR):

6.1.1 Initial and circle to indicate

any mi ssed dose. Document explanation for

missed dose according to physicians order:

e.g. "hold dose" on back of MAR/TAR and

indicate "See nurses notes for explanation."

6.2 Document explanation of missed dose

in the Nurses Notes:

6.2.1 Describe circumsta nce of medication

shortage.

6.2.2 Notification of pharmacy and response.

6.2.3 Action(s) taken.

29. Manor Care staff did not completely fulfill the

requirements of the quoted procedures. The MAR for Resident 10

complied with the documentation requ irement that missed doses be

initialed and circled, but made no reference to explanatory

nurses ' notes. The records indicate that the nurses ' notes

regarding the missed doses were not made contemporaneously, but

were completed later in the morning of Augu st 10, 2004. As noted

above, the nursing staff made several attempts to have the

pharmacy deliver the fentanyl, but never proceeded to the next

step of using a back - up pharmacy or contacting the attending

physician because of the attending nurses' observa tions that

Resident 10 was not in pain or discomfort.

30. The federal CMS issues a "State Operations Manual"

containing guidelines that are relied upon by surveyors when

assessing compliance with regulatory requirements. The State

Operations Manual provi des , as follows regarding alleged

violations of 42 C.F.R. Section 483.60:

A drug, whether prescribed on a routine,

emergency, or as needed basis, must be

provided in a timely manner. If failure to

provide a prescribed drug in a timely manner

causes the resident discomfort or endangers

his or her health and safety, then this

requirement is not met.

31. There was no allegation made nor evidence presented

that Resident 10's health or safety was endangered by the missed

doses of fentanyl. Thus, the iss ue , as framed by the Guidance

to Surveyors documents , is whether Resident 10 experienced

"discomfort . " The evidence presented at hearing did not

establish that Resident 10 experienced pain or more than minimal

additional discomfort due to the missed medic ation.

32. At most, the evidence proved that Resident 10 was

upset by the fact that she missed doses of fentanyl. She did

not tell anyone that she was in pain and displayed few , if any ,

outward behavioral indications of pain. Resident 10 went about

he r normal routine, including sleeping for a time and going

outside to smoke cigarettes on the gazebo. Subsequently, in

September 2004, Resident 10 was discharged from Manor Care and

returned to her own residence.

33. The alleged violation of C.F.R. Sectio n 483.60 was

classified by the surveyors as an isolated "Class II"

deficiency. Subs ection 400.23(8)(b), Florida Statutes (2004) ,

provides, in relevant part:

A class II deficiency is a deficiency that

the agency determines has compromised the

resident's ab ility to maintain or reach his

or her highest practicable physical, mental,

and psychosocial well - being, as defined by

an accurate and comprehensive resident

assessment, plan of care, and provision of

services. A class II deficiency is subject

to a civil penalty of $2,500 for an isolated

deficiency . . . A fine shall be levied

notwithstanding the correction of the

deficiency.

34. Subs ection 400.23(7)(b), Florida Statutes (2004) ,

provides that the presence of one or more Class II deficiencies

requires AH CA to assign a conditional licensure status to the

facility. Conditional licensure means that a facility " is not

in substantial compliance at the time of the survey with

criteria established under this part or with rules adopted by

the agency ."

35. Subs e ction 400.23(8)(c), Florida Statutes (2004) ,

defines a "Class III" deficiency as follows, in relevant part:

A class III deficiency is a deficiency that

the agency determines will result in no more

than minimal physical, mental, or

psychosocial discomfort t o the resident or

has the potential to compromise the

resident's ability to maintain or reach his

or her highest practical physical, mental,

or psychosocial well - being, as defined by an

accurate and comprehensive resident

assessment, plan of care, and prov ision of

services. A class III deficiency is subject

to a civil penalty of $1,000 for an isolated

deficiency . . . A citation for a class III

deficiency must specify the time within

which the deficiency is required to be

corrected. If a class III defici ency is

corrected within the time specified, no

civil penalty shall be imposed.

36. Under all the facts and circumstances set forth above,

it is found that Manor Care did not provide Resident 10 with her

prescribed fentanyl during the late night hours of August 10,

2004. It is further found that though Manor Care's nursing

staff made repeated efforts to obtain the fentanyl through its

contracted pharmacy and received repeated assurances that the

medication was "on its way , " Manor Care's nursing staff did not

follow all of the procedures set forth in the pharmacy's policy

and procedure manual to secure the medication on an urgent

basis. However, the evidence did not establish that Resident

10's " ability to maintain or reach . . . her highest practicable

p hysical, mental, and psychosocial well - being " was compromised

by the missed doses of fentanyl. At most, Resident 10 suffered

" minimal physical, mental, or psychosocial discomfort , " and the

alleged violation should have been classified as an isolated

Class III deficiency.

CONCLUSIONS OF LAW

37. The Division of Administrative Hearings has

jurisdiction over the parties and subject matter of this case

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

Statutes (2004).

38. The burden of proof is on AHCA . See Beverly

Enterprises - Florida v. Agency for Health Care Administration ,

745 So. 2d 1133 (Fla. 1st DCA 1999). The burden of proof to

impose an administrative fine is by clear and convincing

evidence. Department of Banking and Finance v. Osbo rne

Stern & Co . , 670 So. 2d 932 (Fla. 1996). The burden of proof

for the assignment of licensure status is by a preponderance of

the evidence. See 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). 3/

39. Subsection 400.23(7), Florida Statutes (2004), states

in relevant part:

(7) The agency shall, at least every 15

months, evaluate all nursing home facilities

and make a determination as to the degree of

compliance by each licensee with the

established rules adopted under this part as

a basis for assigning a licensure status to

that facility. The agency shall base its

evaluation on the most recent inspection

re port, taking into consideration findings

from other official reports, surveys,

interviews, investigations, and inspections.

The agency shall assign a licensure status

of standard or conditional to each nursing

home.

(a) A standard licensure status me ans

that a facility has no class I or class II

deficiencies and has corrected all class III

deficiencies within the time established by

the agency.

(b) A conditional 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 or with rules adopted by the agency.

If the fac ility has no class I, class II, or

class III deficiencies at the time of the

follow - up survey, a standard licensure

status may be assigned. . . .

40. AHCA has alleged that Manor Care violated 42 C.F.R.

Section 483.60, adopted by reference by Florida Adm inistrative

Code Rule 59A - 4.1288, because Resident 10 did not receive a pain

medication on the schedule prescribed by her attending

physician.

41. Section 400.23, Florida Statutes (2004) , provides, in

relevant part:

(1) It is the intent of the Legisl ature

that rules published and enforced pursuant

to this part shall include criteria by which

a reasonable and consistent quality of

resident care may be ensured and the results

of such resident care can be demonstrated

and by which safe and sanitary nursi ng homes

can be provided. It is further intended

that reasonable efforts be made to

accommodate the needs and preferences of

residents to enhance the quality of life in

a nursing home . . . .

(2) Pursuant to the intention of the

Legislature, the age ncy, in consultation

with the Department of Health and the

Department of Elderly Affairs, shall adopt

and enforce rules to implement this part,

which shall include reasonable and fair

criteria . . . . (Emphasis added)

42. The emphasized portions of the q uoted statute make it

clear that Florida Administrative Code Chapter 59A - 4,

establishing minimum standards for nursing homes, does not

impose strict liability on nursing homes. The regulations must

be interpreted as requiring nursing homes to make reasona ble

efforts and to exercise reasonable care to ensure resident

safety .

43. In similar fashion, the State Operations Manual

promulgated by the federal CMS does not impose strict liability

on nursing homes for providing medications in a timely manner.

Rathe r, the State Operations Manual provides that the

requirements of 42 C.F.R. Section 483.60 are not met only if

"failure to provide a prescribed drug in a timely manner causes

the resident discomfort or endangers his or her health and

safety."

44. AHCA did not establish that Resident 10's health or

safety was endangered. At most, Resident 10 suffered the

" minimal physical, mental, or psychosocial discomfort "

associated with a Class III deficiency. A Class III deficiency

cannot be the basis for a fine or a "conditional" license unless

it is not timely corrected by the nursing home. No evidence was

presented that Manor Care's admitted deficiency in providing the

fentanyl to Resident 10 was ever repeated. Thus, there was no

proof that the deficiency was severe enough to support any

penalties.

45. Regardless of whether AHCA's burden of proof was the

preponderance of the evidence or clear and convincing evidence,

AHCA failed to prove that a Class II deficiency existed at Manor

Care's facility. Thus, ther e was no basis for the imposition of

either conditional licensure or an administrative fine.

RECOMMENDATION

Based on the foregoing Findings of Facts and Conclusions of

Law, it is

RECOMMENDED that AHCA enter a final order dismissing the

Administrative C omplaint.

DONE AND ENT ERED this 26th day of August , 2005 , in

Tallahassee, Leon County, Florida.

S

LAWRENCE P. STEVENSON

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee P arkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675 SUNCOM 278 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 26th day of August , 2005 .

ENDNOTES

1/ Codified at 42 U.S.C. 13 95x(w).

2/ Ms. Dolan's observations have not been disregarded, but have

been considered in light of the facts that fentanyl is potent,

highly addictive, and takes effect gradually over the 15 minutes

the "lollipop" is consumed and for approximately one h our

thereafter, according to the Physician's Desk Reference entry

admitted into evidence at the hearing. Thus, it may be inferred

that the immediate relief Resident 10 appeared to experience

when she received the "lollipop" could be related to a

psycholog ical, if not physical, dependence on the drug rather

than an actual lessening of pain. Such an inference would be

consistent with the observations of Manor Care's staff, i.e. ,

Resident 10 did not appear to be in pain but was angry at not

receiving her reg ular dose of fentanyl and unwilling to accept

an alternative pain reliever.

3/ Manor Care contends that conditional licensure constitutes an

even greater penalty on a facility than does the imposition of

an administrative fine. The impact of conditional licensure on

Manor Care's property interest in its business, while not

quantified at the hearing, cannot be denied. Thus, Manor Care

urges that the assignment of licensure status be subject to the

same burden of proof as the imposition of an administrati ve

fine: clear and convincing evidence. In at least one Final

Order, AHCA has rejected the contention that assignment of

licensure status is subject to the clear and convincing evidence

standard. Agency for Health Care Administration v. Health Care

and R etirement Corporation of America , Case No. 03 - 2569 (DOAH

December 22, 2003)(Final Order June 2, 2004). In this case, it

is unnecessary to determine the standard of proof because ACHA

failed to prove the material allegations under the preponderance

standar d.

COPIES FURNISHED :

Eric Bredemeyer, Esquire

Agency for Health Care Administration

2295 Victoria Avenue, Room 346C

Fort Myers, Florida 33901

Alfred W. Clark, Esquire

117 South Gadsden Street, Suite 201

Post Office Box 623

Tallahassee, Florida 3230 2 - 062 3

Richard Shoop, Agency Clerk

Agency for Health Care Administration

2727 Mahan Drive, Mail Station 3

Tallahassee, Florida 32308

William Roberts, Acting General Counsel

Agency for Health Care Administration

2727 Mahan Drive

Fort Knox Building, 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 agen cy that

will issue the final order in this case.