04-004506 Agency For Health Care Administration vs. Ruleme Center Status: Closed Recommended Order on Friday, June 17, 2005.

Summary: Petitioner failed to establish by preponderant or clear and convincing evidence that even though nursing deficiencies may have occurred, they did not cause nor were they likely to cause harm or death.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

AGENCY FOR HEALTH CARE )

ADMINISTRATION, )

)

Petitioner, )

)

vs. ) Case Nos. 04 - 4506

) 05 - 0388

RULEME CENTER, )

)

Respondent. )

)

RECOMME NDED ORDER

Pursuant to notice, the Division of Administrative

Hearings, by its designated Administrative Law Judge, P. Michael

Ruff, held a final hearing in the above - styled case on

February 9, 2005, in Tavares, Florida. The appearances were as

follows:

APPEARANCES

For Petitioner: Thomas J. Walsh, II, Esquire

Agency for Health Care Administration

525 Mirror Lake Drive, 330G

St. Petersburg, Florida 33702

For Respondent: Alfred W. Clar k, Esquire

117 South Gadsden Street, Suite 201

Post Office Box 623

Tallahassee, Florida 32302 - 0623

STATEMENT OF THE ISSUES

The issues to be resolved in this pro ceeding concern

whether the Respondent should be subjected to administrative

fines and a conditional licensure for alleged violations of 42

Code of Regulation (CFR) Section 483.20(k)(3)(i) and 42 CFR

Section 483.25, adopted by reference in Florida Administ rative

Code Rule 59A - 4.1288.

PRELIMINARY STATEMENT

This cause arose when the Agency issued a "Notice of

Assignment of Conditional Licensure Status" which was transmitted

to the Respondent on or about October 20, 2004. In that

"charging document" the Age ncy seeks to assign a conditional

licensure status to the Respondent (Ruleme) commencing July 29,

2004 (Case No. 04 - 4506). Through an Administrative Complaint

filed January 26, 2005, the Agency seeks to impose administrative

fines in the total amount of $ 20,000.00, based upon two purported

"Class I deficiencies," pursuant to Section 400.23(a), Florida

Statutes (2004), and seeks to impose a "six month survey cycle

fee" of $6,000.00 in accordance with Section 400.19(3), Florida

Statutes (2004).

A formal p roceeding was requested by Ruleme in both cases

and the two cases were consolidated by Order of February 3, 2005.

In Count I of its Administrative Complaint the Agency contends

that Ruleme failed to ensure that services provided by its

facility met profes sional standards of quality by failing to

document in accord with professional standards, and in violation

of the facility's policy and procedures requiring notification of

a resident's physician upon significant change in the condition

of a resident. In Count II, it is alleged that Ruleme did not

ensure that the resident (Resident 14) received necessary care

and services to attain or maintain the highest practicable

physical, mental, and psycho - social well - being, in accordance

with the comprehensive asses sment and plan of care in that the

facility failed to provide nursing services meeting professional

standards of practice. Specifically, the Agency contends that

nursing services provided to Resident 14 were not documented in

accordance with professional standards and in violation of the

facility's policies and procedures, and that the Respondent

failed to properly monitor the resident, who had experienced an

incident of respiratory distress. The monitoring failures

purportedly included the failure to obs erve the resident at

appropriate intervals, the failure to assess the effectiveness of

the prescribed treatment, the failure to monitor the resident's

diabetic status and the failure to adequately monitor the

resident's vital signs.

Ruleme contested the A gency's intent to assign a conditional

licensure status by its Petition for Formal Proceeding dated

November 2, 2004 (Case No. 04 - 4506), and the imposition of the

intended administrative fines and six - month survey cycle, with

fine, in its petition filed Ja nuary 27, 2005. (Case No. 05 -

0388). The consolidated cases that came before the undersigned

for formal proceeding and hearing.

The cause came on for hearing as noticed. The testimony of

three witnesses was presented by the Agency: Ms. Marsha Lisk, a

registered nurse specialist, accepted as an expert in

professional nursing standards and practices and long - term

nursing care; Ms. Denise Godfrey, an Agency surveyor and Public

Health Nutrition Consultant; and Mr. Steven Burgin, an Agency

surveyor. The A gency presented a Composite Exhibit that was

admitted into evidence by stipulation of the parties.

Ruleme presented the testimony of three witnesses:

Ms. Laura Runnels, a Licensed Practical Nurse (LPN), Dr. Braxton

Price, M.D. qualified as an expert in l ong - term care, by

stipulation of the parties, and Ms. Joyce Kadziolka - Long, the

Administrator of the Ruleme facility. Ruleme introduced a

Composite Exhibit which was admitted into evidence upon

stipulation of the parties. Upon conclusion of the proceedin g

the parties requested a transcript thereof and the opportunity to

submit proposed recommended orders. The Proposed Recommended

Orders were timely submitted, after one stipulated extension of

time, and have been considered in the rendition of this

Recomm ended Order.

FINDINGS OF FACT

1. The Agency for Health Care Administration (AHCA); is the

state agency charged with licensing nursing homes in Florida

under Section 400.021(2), Florida Statutes (2004), and the

assignment of licensure status pursuant to Section 400.23(7),

Florida Statutes (2004). The Agency is thus charged with

evaluating nursing home facilities to determine their degree of

compliance with rules as a basis for making required licensure

assignments. Additionally, it is responsible for conducting

federally - mandated surveys of long - term care facilities which

receive Medicare and Medicaid funds in order ascertain compliance

with federal statutory and regulatory rule requirements. The

federal requirements are made applicable to Florida Nu rsing Home

Facilities by Florida Administrative Code Rule 59A - 4.1288, which

states in pertinent part,

[N]ursing Homes that participate in Title

XVIII or XIX must follow certification rules

and regulations found in 42 CFR 483,

R equirements for Long Term Car e Facilities,

September 26, 1991, which is incorporated by

reference.

2. Ruleme is a licensed nursing facility with long - term

care facility located in Eustis, Florida. Section 400.23(8),

Florida Statutes (2004), requires AHCA to classify deficiencies

a ccording to their nature and scope under the criteria

established in Section 400.23(2), Florida Statutes (2004). The

classification of any deficiencies is determative of whether the

licensure status of a nursing home is standard or conditional

licensure and relates to the amount of administrative fine that

may be imposed.

3. Surveyors of nursing homes note their findings on a

standard form prescribed by the "Center for Medicare and Medicaid

Services" (CMS), Form 2567. That form is entitled "Statement

Deficiencies and Plan of Correction." It is commonly referred to

as a "2567 form." When a nursing home facility is surveyed, if

violations are found, the violations are reported as "tags." A

numbered "tag" identifies the applicable regulatory standard t hat

the surveyors believe has been violated. It provides a summary

of the violation, sets forth specific factual allegations that

the surveyors believe support a violation and indicates the

federal scope and severity of the non - compliance or violation.

4 . The Agency alleged that Ruleme was not in compliance

with certain of those requirements, two of which are significant

in this proceeding; 42 CFR Section 483.20 (Tag F281) (Count I),

for failing to meet professional standards of quality; and 42 CFR

Secti on 483.25 (Tag F309) (Count II), for failing to provide the

necessary care and services to attain or maintain a resident's

highest practicable physical, mental, and psycho - social well -

being. As to each, the Agency alleged that the deficient

practices were of an isolated scope because the deficiencies

alleged were only determined with regard to one resident out of

42 residents who were the subjects of the Ruleme survey at issue.

5. The Agency determined that the facility allegedly did

not comply with the state requirements of Section 400.23(7) and

(8), Florida Statutes (2004), and Florida Administrative Code

Rule 59A - 4.1288. Under the Florida classification system, it

classified the federal Tag F281 and Tag 309 deficiencies as state

Class I deficiencies o f isolated scope.

6. On or about July 26, 2004, the Agency conducted a

licensure recertification survey of Ruleme Center. Resident 14

was a lady with a diagnosis of diabetic mellitus requiring

insulin coverage; congestive heart failure; end - stage fail ure to

thrive; hypertension; a history of colon cancer and gastric

resection; gastric reflux disease; depression, and osteoporosis.

The resident was verbal and aware and had a history of non -

compliance with medications. Her recent prescription for

psycho tropic medication (haldol) seemed to have calmed her mood

somewhat. The resident had also executed a "DO NOT RESUSCITATE"

(DNR) order as well as a Living Will.

7. The resident's medication orders included "accuchecks"

to be conducted three times daily t o monitor blood sugar levels,

related to diabetes, with a concomitant sliding scale for the

administration of insulin, depending upon the blood sugar count.

Further medications included an order for glucagan to be

administered on an "as needed" basis for hypoglycemia, and

phenergan, to be administered as needed for nausea and vomiting.

In order to address the gastro - reflux disease, three medications

were prescribed: metoclapramide, protonix, and sucralfate.

8. The medication administration records (MAR ) for this

resident reflected that on July 26, 2004, she had refused the

prescribed and offered medications for gastro - reflux disease.

The MAR reflected that the 11:30 a.m., check of the blood sugar

revealed a blood sugar count of 236. Two units of insul in were

prescribed and administered for this. At 4:30 p.m. the next

prescribed time for monitoring of blood sugar, the resident

refused to have her blood sugar test conducted. At 9:00 p.m.

that night, the last daily - prescribed time for blood sugar

testin g, the blood sugar test revealed a blood sugar reading of

222. Two insulin units were prescribed for such a reading. The

MAR however does not reflect whether the prescribed insulin was

administered to the resident or not.

9. Resident 14 vomited at some time between 11:00 and 11:30

p.m., on July 26, 2004. The CNA on duty cleaned the resident

elevated the head of her bed to a 45 degree angle and notified

the LPN on duty, Nurse Laura Runnels of the event. Nurse Runnels

documented in the resident's chart at 11:30 p.m., the following:

Patient vomited a large amount of emesis,

contained food particles.

Nurse Runnels then directed a CNA to take vital signs of the

resident. The resident's vital signs were recorded as: blood

pressure, 88 systolic over 46 dia stolic; pulse of 124 beats per

minute; temperature of 96.1 and respiration at 30 breaths per

minute. Nurse Runnels also listened to the resident's lung

sounds with a stethoscope.

10. At 12:00 a.m., July 27, 2004, Nurse Runnels entered the

following no te in the nurses' note:

Patient moaning in bed, raspy, gurgling

breath signs. States she does not feel well

but can't pinpoint what it is that doesn't

feel well. Will continue to monitor.

11. Nurse Runnels telephoned Dr. Braxton Price, the

treating ph ysician and medical director of Ruleme. After waiting

approximately 10 minutes for a return call she then paged

Dr. Price on his pager. He then returned her call and she

explained that the resident had vomited and communicated the

resident's vital signs. She also indicated to the doctor that

the congestion in the resident's lungs was low in the lungs.

Nurse Runnels told the doctor that she did not feel suctioning

would be effective. Dr. Price apparently agreed with that

assessment and ordered that the resident be administered oxygen.

Nurse Runnels and a CNA then provided the administration of

oxygen as ordered by Dr. Price.

12. After the administration of oxygen, the resident's

anxiety and restlessness seemed to alleviate. Nurse Runnels

believed t he patient had stabilized and she thereafter was

sleeping. Nurse Runnels conducted visual checks of Resident 14

three times from midnight until 3:50 a.m., when the patient was

observed to have expired. She conducted the visual checks each

time noting tha t the resident appeared to be sleeping, by

standing in the patient's room and observing the patient. The

room was lit by a single light located over a sink across the

room from the patient's bed.

13. No further entries were made by Nurse Runnels on th e

nursing notes until 3:50 a.m., on July 27, 2004, at which time

she noted, "CNA reported [resident] didn't seem to [be]

breathing, when I checked for breath sounds there were none, no

heart sounds/pulse. M.D. and family notified."

14. Dr. Price execute d the resident's death certificate.

He stated that the cause of death was senescence, a term roughly

meaning death as a natural result of the aging process. It was a

cause of death accepted by the medical examiner.

15. Nurse Runnels did not document the care or services

provided to the resident from the midnight entry she made until

the resident's death at approximately 3:50 a.m. There was an

absence of documentation concerning her consultation with

Dr. Price, his order for administration of oxygen o r the

monitoring Nurse Runnels conducted. Documentation is a critical

responsibility for the provision for professional nursing

services, as it is the basis for future decisions regarding

patient care by all the care providers who treat a patient at any

o ne time and for subsequent care providers of the patient, as,

for instance, those on the following shift.

16. Ruleme's physician notification policy requires that,

upon the observance of a significant change in the medical

condition of a resident, a nurs e must contact the physician,

report the nursing assessments and observations, complete a

physician's notification and nurse's note prior to contacting the

physician, document the reason for notification, obtain new

orders from the physician and transcribe these to the MAR or

treatment administration record (TAR), and update the resident's

care plan. A significant change is defined as respiration above

30 breaths per minute and a pulse in excess of 120 beats per

minute. When Nurse Runnels decided to conta ct the physician

Dr. Price, Resident 14's respirator rate was 30 breaths per

minute with a pulse of 124 beats per minute. This was a

significant change under this policy. Although not documented,

in fact Nurse Runnels observed the significant change in t he

resident's condition, did promptly contact Dr. Price, and

reported to him her nursing assessment and observations. She

obtained new orders from the physician, the administration of

oxygen, and promptly carried them out, particularly, but she

acknowledg ed in her testimony that she failed to document these

matters after 12:00 a.m., on the night in question. Later

entries to the relevant records regarding Resident 14 would have

been a standard and accepted practice in the provision of

professional nursing services.

17. The resident was diabetic. Her blood sugar was checked

according to normal procedure at approximately 9:00 p.m., on the

evening in question. Her blood sugar at that time resulted in a

reading of 222. That would indicate the need for t he provision

of approximately two units of insulin. The records, however, do

not reflect whether she received any insulin at that time and it

is presumed that she did not. A reading of 222 is not

substantially elevated, and the failure to provide insulin at

that time would not likely result in any health crisis. The

resident thereafter, however, vomited and expelled food. This

could have resulted in a decline in her glucose or sugar level.

Further readings were apparently not taken, or at least not

doc umented, so it is not known whether her glucose levels

declined markedly thereafter on the evening in question.

18. A hypoglycemic condition can result in sweating and

decline in consciousness and, if low enough, can result in a

lapse into unconsciousn ess. Conversely, a hyperglycemic

condition, with excessively high blood sugars can result in

irritability, dry skin, and possibly mental confusion.

Hyperglycemia was unlikely to result because the resident had

vomited and expelled food from her digestive system which would

more likely result in a lowering of glucose levels in her blood.

In any event, Nurse Runnels knew of the diabetic condition and

knew of the vomiting which had occurred shortly after the

beginning of her shift at 11:00 p.m. She apparen tly had been

told that the resident had vomited earlier that evening, on the

proceeding shift, although that was not confirmed and was not

documented at the time it occurred. She did not, however, check

the resident's blood sugar and did not review the re sident's MAR

to determine the status of the blood sugar levels. In fact, the

physician's orders provided for the last daily blood sugar

reading to be taken at 9:00 p.m.

19. Although she monitored and observed the resident three

or four times between 1 1:30 p.m., and 3:50 a.m., these were

visual observations only and she did not touch the resident.

They were conducted in a dimly lit room while the resident

appeared to be sleeping. This reduced the opportunity for Nurse

Runnels to adequately assess the resident's status concerning

such indicators as changes in temperature, sweating, confusion or

irritability, or reduced consciousness. In fact, some of these

factors would not have been observed because the resident was

sleeping.

20. Nurse Runnels did not conduct or cause to be conducted

further checks of the resident's vital signs after the vital

signs were taken at approximately midnight. Two of the four

vital signs, respiration and pulse, were above the level which

would require that the facility, through its staff, assess a

resident, monitor vital signs, initiate appropriate medical

interventions, document all assessments, and contact a physician.

Although the physician was contacted and his orders were

followed, further checks of blood pressure, pulse, and

respiration were apparently not made. Nurse Runnels indicated

that she did not wish to awaken the resident because she appeared

to be stable and was sleeping comfortably after the

administration of oxygen. She had a history of being irritable

and even combative if awakened from sleep to have medication

administered or tests performed. However, respiration and pulse

are vital signs that require minimal intrusion on the resident.

It would even be possible to check them while the resident was

sl eeping comfortably. In view of the fact that the resident had

had elevated pulse and respiration prior to administration of

oxygen, and substantially low blood pressure, at approximately

12:00 a.m., proper professional nursing practice would dictate

that the vital signs be checked periodically after that time.

21. Nurse Runnels did not check, or cause to be checked,

Resident 14's oxygenation level after oxygen was administered in

accord with the physician's orders. Proper professional

standards of nursi ng practice would dictate that the oxygenation

level be checked to determine if the administration of oxygen was

providing the desired effect on the patient. Professional

standards of nursing practice require the assessment of the

patient on an ongoing ba sis, including the assessment of any

prescribed treatment to ensure its effectiveness. Nurse Runnels

did not undertake such an assessment concerning the provision of

oxygen to this resident.

22. Nurse Runnels did not administer or required to be

adminis tered the prescribed phenegran medication designed to

alleviate nausea and vomiting. Nurse Runnels had been told

verbally that the resident had experienced an episode of vomiting

once earlier in the evening on the previous shift, as well as the

one which Nurse Runnels knew had occurred on her own shift. She

determined, however, that the medication should not be

administered, unless two episodes of vomiting occurred and did

not consider the information of the earlier episode as being

reliable since it had not been charted by the duty nurse at that

time. However, when she reported the vomiting episode on her

shift to the physician and the gurgling noises she heard in the

resident's lungs thereafter, the physician did not order the

provision of the anti - naus ea medication and, after the

administration of oxygen the resident appeared to be stable and

resting comfortably. Thus, it has not been demonstrated that the

failure to administer the anti - nausea medication was a departure

from proper professional standar ds of nursing practice and with

the facility's polices and procedures under these circumstances.

The resident had no nausea or vomiting after the event around

11:30 p.m., and one of the side effects of the anti - nausea

medication is sedation and interferen ce with mental alertness.

The anti - nausea medication was not shown to be needed and would

be inappropriate for the resident who was comfortable and no

longer nauseous, given that the sedative side effect could have

had a deleterious effect on the patient' s blood pressure and

respiration. The physician did not order the administration of

the anti - nausea medication.

23. AHCA contends that Resident 14 should have been

monitored more frequently. AHCA's expert witness, Ms. Lisk,

suggested that monitoring sh ould have been every 15 to 30

minutes, and indeed Dr. Price, Resident 14's physician, gave a

similar estimate. After oxygen was administered at approximately

12:30 to 12:45 a.m., Resident 14 became calm, her breathing was

no longer labored although audibl e lung sounds remained. She

appeared comfortable and sleeping with no signs of distress each

time she was monitored by Nurse Runnels and the CNA. Nurse

Runnels checked on the resident three more times after oxygen was

administered. Additionally, the CNA assigned to Resident 14

checked on the resident at least every 30 minutes. The CNA and

the LPN did not check on the resident at the same time; therefore

the resident was monitored at intervals averaging less than 30

minutes. Although the evidence reflec ts that Nurse Runnels could

recall little about any discussion she might have had about the

resident's care with the CNA, the evidence shows she regarded the

CNA as one of significant experience, knowledge, and judgment.

She trusted the CNA's ability to p roperly monitor the resident.

24. Ms. Marsha Lisk is a registered nurse and was accepted

as an expert witness in the professional standards of nursing and

long - term nursing care. She opined that the professional

standards of nursing require that a nurse document care and

observation, assess a patient both before and after a treatment

is provided, and regularly monitor a patient who has exhibited

signs or symptoms that require medical attention.

25. Dr. Price was accepted as an expert in long - term care.

He established that Resident 14 was a frail, 84 - year - old female

in poor physical condition. She had numerous health problems

which included congestive heart failure, deep vein thrombosis

(blood clots) and "end - stage failure to thrive." Any of these

thr ee conditions can cause death. In consideration of these

three life - threatening diagnoses, Dr. Price considered the

incident on the night in question to be an "end - of - life event"

for Resident 14. The Living Will and DNR Order limited the

available interv entions for her care, even if it were known

specifically that the cardiopulmonary systems was failing during

those hours. The treatments for these life - threatening diagnoses

would, in the doctor's expert opinion, be considered

extraordinary means of treat ment which would be prohibited by the

Living Will and the DNR order. In his expert opinion he

considered that there was "nothing else to do" for the resident.

26. The Agency's expert did not know or establish the cause

of the resident's death. In the a bsence of the knowledge of the

cause of death it is not possible to attribute her death to the

action or inaction of the Respondent's staff, and the expert did

not testify that the staff's conduct "caused" or was "likely to

cause" death or serious harm to the resident. Dr. Price

certified on the death certificate that the "immediate cause

(final disease or condition resulting in death)" was due to

"senescence" which had been experienced "for months." By this he

meant that the death was due to multiple cau ses and body failure

due to the resident's advanced age. The death certificate shows

that the "probable manner of death" was "natural." Dr. Price's

expert opinion, which is accepted, was that the facility staff

had not failed to do something which result ed in a serious and

immediate threat to Resident 14.

27. The Agency's surveyors must access the effect of an

alleged violation on the resident and assign a "classification"

to the violation. In this instance they classified the

violations as Class I. A Class I violation is one which "has

caused or is likely to cause serious injury, harm, impairment, or

death to a resident." See § 400.23(8)(a), Fla. Stat. The survey

team determined not that there was a potential for harm but that

actual harm, in effe ct the death, resulted because the physician

was not notified of the resident's condition or because of the

charged failures in professional nursing care involving

monitoring, documenting, and assessing. The physician was

notified however, and there is no evidence that any action or

inaction by the staff "caused the death." AHCA expert Ms. Lisk

opined that the failure to meet professional nursing standards

would "increase the potential" for harm, injury, or death. She

did not testify or establish however , that staff action or

inaction had "caused" or were "likely to cause" serious injury or

death. The potential for an event does not rise to the level of

a likelihood of an event. Webster's New Word Dictionary of the

American Language , Second College Edit ion, 1978, defines "likely"

as "probable" (at page 819) and defines "potential" as

"possible", "latent" or "unrealized" (at page 1114). There is no

persuasive evidence that staff inadequacies in conforming to

professional nursing standards were a probable cause of the

resident's death.

28. The gravamen of Count I of the complaint and Tag F281

concern the alleged failure to notify the resident's physician as

a basis for that violation. The evidence establishes however,

that the physician was notified, gave orders, and that his orders

were followed by the staff. The staff monitored and assessed the

resident at 15 to 30 - minute intervals and found her in no

distress and resting comfortably. To the extent that failure to

document, monitor, or access is ch arged in this count and

concerns this Tag, there is no persuasive evidence that

establishes how the failure to document the physician

notification process caused or was likely to cause the resident's

death.

29. Count II of the complaint and Tag F309 of Form 2567L

alleges that "necessary care and services" were not provided.

The evidence concerning the staff's alleged inadequacies related

to failure to document, monitor properly, or to assess properly

(i.e. perform additional vital sign checks and oxyge n checks,

etc.). There is no persuasive evidence, however, which describes

how the failure to perform documentation, assessment, or

monitoring properly, or any nonconformance to nursing standards

under the circumstances of this resident and this incident,

caused or were likely to cause Resident 14's death, serious

injury, harm, or impairment.

CONCLUSIONS OF LAW

30. The Division of Administrative Hearings has

jurisdiction of the subject matter of and the parties to this

proceeding. §§ 120.569 and 120.57( 1), Fla. Stat. (2004).

31. The regulatory and statutory authority relied upon by

the Agency in this proceeding is as follows:

32. 42 CFR Section 483.20, resident assessment, which

states in pertinent part:

The facility must conduct initially and

period ically a comprehensive, accurate,

standardized, reproducible assessment of

each resident's functional capacity. . . .

(K) The services provided or arranged by

the facility must . . .

(I) Meet professional standards of quality.

33. 42 CFR Section 483. 25, quality of care, states in

relevant part:

Each resident must receive and the facility

must provide the necessary care and services

to attain or maintain the highest

practicable physical, mental, and

psychosocial well - being, in accordance with

the compr ehensive assessment and plan of

care.

34. Section 400.23(7), Florida Statutes, 2004, states in

relevant part:

The Agency shall assign a licensure status

of standard or conditional to each nursing

home.

(a) A standard licensure status means that

a faci lity 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 deficien cies, 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 facility 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.

35. Section 400.23(8)(a), Florida Statutes, (2004), states

in relevant part:

A Class I deficiency is a deficiency that

the agency de termines presents a situation

in which immediate corrective action is

necessary because the facility's non -

compliance has caused, or is likely to

cause, serious injury, harm, impairment, or

death to a resident receiving care in the

facility. A Class I def iciency is subject

to a civil penalty of $10,000.00 for a

isolated deficiency. . . .

36. Florida Administrative Code Rule 59A - 4.1288, states in

relevant part:

Nursing homes that participate in Title

XVIII or XIX must follow certification rules

and regula tions found in 42 CFR 483,

requirements for long - term care facilities,

September 26, 1991, which is incorporated by

reference.

37. The Agency is required to prove the alleged violations

and the justification for an administrative fine by clear and

convi ncing evidence. Department of Banking and Finance v.

Osborne Stern , 670 So. 2d 932 (Fla. 1996); Latham v. Florida

Commission on Ethics , 694 So. 2d 83 (Fla. 1st DCA 1997);

Heritage Health Care and Rehabilitation Center - Naples v. AHCA ,

DOAH Case No. 99 - 1892 (AHCA 1999).

38. Numerous recommended and final orders entered by AHCA

have followed the standard of proof of a preponderance of the

evidence, when AHCA is seeking to impose a conditional licensure

status on a nursing home facility. In this case the Res pondent

proved that its operations would be negatively affected in terms

of its reputation as a facility providing quality of care and in

terms of its ability to retain and to hire competent

professional staff, if a conditional licensure status were

impose d. Therefore, it established that it would be penalized

by the imposition of a conditional license. Thus, it would

seem, as the Respondent contends, that removing a standard

license held without strictures and replacing it with a

conditional license woul d be an Agency act with is "penal in

nature and implicates significant property rights." See

Gulfview Nursing Home v. AHCA , 859 So. 2d 581 (Fla. 1st DCA

2003); Gulfcrest Nursing Home v. AHCA , 662 So. 2d 1330 at 1332

(Fla. 1st DCA 1995). See also discussi on in Recommended Order

in AHCA v. Health Care and Retirement Corporation of America ,

DOAH Case No. 03 - 2569, Conclusions of Law 82 - 86, Recommended

Order entered December 22, 2003 (exceptions to Recommended Order

granted and Final Order entered June 2, 2004 ). Regardless of

the legal logic of the Respondent's position, however, even if

the standard of proof is by preponderance of the evidence for

imposition of conditional licensure, the Agency failed to prove

the alleged violations. If no violations are pro ven (only

charged as Class I violations), then conditional licensure

cannot be imposed.

39. Count I of the complaint Tag F281 of the notice allege

a violation of 42 CFR Section 483.20(k)(3)(i) and are based upon

the essential alleged fact that Resident 14 's physician was not

notified of her condition by the staff. Additionally, Count I

and Tag F281 set forth the pertinent regulatory requirements

regarding documentation of physician notification and the

circumstances surrounding it, but did not specificall y allege

that the documentation requirements concerning physician

notification were not complied with. While AHCA cited the

regulation concerning the requirement services that provided by

the facility must meet "professional standards of quality," it

did not allege what services provided or not provided

constituted a failure to meet professional standards of quality.

Rather, at final hearing, AHCA supported the violation alleged

in Count I and Tag F281 by evidence of the LPN's failure to

adequately monito r, assess, and document the care and assessment

maintains should have been done and should have been documented.

The essential fact alleged as constituting a violation in this

count really concerns the alleged lack of notification to the

physician of the resident's condition and change of condition as

was documented in the nurse's note at approximately 11:30 p.m.,

and 12:00 a.m., on the evening in question. This alleged fact

was simply not proven. It was established that the Respondent

staff member, the LPN, did indeed notify the physician promptly

upon observing the change in the resident's condition, involving

respiratory distress, including elevated breathing rate, pulse

rate, and lowered blood pressure. Upon the physician's being

notified, he gave or ders to the LPN and the evidence shows that

those orders were carried out. Although these events, including

the physician's orders and the fact that the physician was

notified was not documented, and should have been under the

regulations, that element of the Agency's position is not

supported by factual allegations in this above portion of the

Administrative Complaint.

40. Count II of the Administrative Complaint and Tag F309

of the notice allege violation of 42 CFR Section 483.25,

alleging a "failure to provide necessary care and services."

Count II and Tag F309 do not clearly allege and identify the

"care and services" which it maintains were not provided.

Substantial detail is alleged of the events concerning Resident

14. Although factual allegation s detailing all contended

deficiencies are not made in this count, it is possible to infer

some or most of them based upon the detailed narrative taken

from the survey report and inserted in Count II of the

Administrative Complaint. The Agency sought to s upport this

alleged violation in Count II and Tag F309 with the same

evidence of alleged failure to properly monitor, assess, and

document the medical situation concerning Resident 14 that was

offered in support of Count I.

41. An agency is limited in i ts evidence to the

allegations made in its administrative complaint, the charging

document. See Tampa Health Care Center v. Agency for Health

Care Administration , DOAH Case No. 01 - 0734 (August 2001).

"Notice of intent to assign conditional licensure stat us

constitutes the charging document which . . . only matters

placed in issue by the notice of intent to assign conditional

licensure status were considered during the hearing and in the

preparation of this recommended order." See Vista Manor v.

Agency fo r Health Care Administration , DOAH Case No. 00 - 0547

(September 2000). "Evidence of any alleged deficiency not

contained in the expressed terms of the charging document are

not relevant and material to the allegations in the charging

document."

42. AHCA has found that it cannot find a Respondent guilty

of a violation "based on evidence of facts not alleged in the

administrative complaint" and that "to do so would negate the

right to an administrative hearing to contest the allegations in

an administrativ e complaint, and it would eviscerate fundamental

principles of due process (citations omitted)." AHCA v. Lake

Mary Health Associates, Inc. , DOAH Case No. 04 - 0335, Recommended

Order at paragraph 24, entered June 8, 2004; Final Order entered

August 25, 2004 .

43. If it be assumed arguendo that the allegations of fact

made in the Administrative Complaint were sufficiently specific

to accord with principles of notice pleading, which is not the

case with regard to Count I at least, AHCA did not prove a

violat ion of either regulation. The Respondent proved that it

did monitor and assess the resident and provide all the care and

services which were ordered by the resident's attending

physician. The resident's physician, who testified at final

hearing as an exp ert in long - term care, demonstrated through his

testimony that none of the additional forms of assessment or

additional instances of such assessment which AHCA argued would

be appropriate (oxygen saturation assessment, blood sugar test,

and more frequent a ssessment of vital signs), as well as

additional documentation by the LPN on duty, would have provided

any information which would have changed his orders for this

resident, given what he knew of the resident's medical

circumstances, unless the resident we re in distress. After the

administration of oxygen, which was provided at the physician's

order and as a result of the LPN properly reporting the

resident's medical situation to him, the resident was not

thereafter in distress. The physician established that although

such information may have been interesting, it would not have

resulted in any change in his orders and treatment of the

resident, knowing what he knew of the resident's medical

circumstances. Indeed, given the resident's underlying

diagnoses , particularly the diagnosis of cardiopulmonary failure

or congestive heart failure, Dr. Price established that any

additional orders which he might have given, if additional

assessments were made would have had to involve "extraordinary

measures" which th e resident's DNR and Living Will had already

effectively precluded. The administration of oxygen was already

being provided which would have been the ordered treatment if an

oxygen saturation assessment had shown a deficient oxygen level.

In the doctor's words, there was "nothing else to be done."

44. AHCA's contention through the testimony of its expert

witness, that the Respondent's monitoring of Resident 14 was

inadequate does not sufficiently address the fact that the

resident was monitored approxi mately every 15 to 30 minutes by

the assigned CNA and the LPN. The LPN monitored the resident at

least three times between 12:30 a.m. and 3:50 a.m., and the CNA

monitored the resident in between those observations or no less

frequently than every 30 minut es. Thus, the resident was

monitored by one or the other of these staff personnel at least

every 15 minutes to 30 minutes which the evidence in this case

established was appropriate under the circumstances of this

resident. When the resident was monitore d after the provision

of oxygen at around 12:30 a.m., the resident was observed to be

resting comfortably and not in distress.

45. Although AHCA's testimony describes assessments and

monitoring which it contends should have been done or done more

frequent ly, it did not establish any preponderant evidence that

the care and services it contends were not provided, or were not

provided frequently enough caused or were likely to cause death.

AHCA in essence contends that some unspecified knowledge which

might have been gleaned concerning the resident's condition from

more frequent assessments or the institution of an oxygen

saturation assessment or blood sugar assessment might have

resulted in some provided care not specified in the evidence.

That does not suf ficiently address the fact, established by the

DNR status and the Living Will and the physician's expert

testimony, which is accepted, that any care which might have

been possible as a result of such additional unspecified

knowledge, would not have made an y difference or would have

constituted "extraordinary measures," which the physician and

the staff were not at liberty to provide. As established by

Dr. Price, what occurred with the resident was clearly an "end

of life event" and there was really nothing more that could have

been done for the resident with her diagnoses, medical history,

and medical condition.

46. Even if AHCA had established that there were care and

services which should have been provided but were not and that

professional nursing stan dards were not met, which last was

partly true, at least, in terms of documentation deficiencies,

no preponderant evidence was presented by AHCA that these

deficiencies "caused or [were] likely to cause death or serious

harm to the resident" as required by Section 400.23(8)(a),

Florida Statutes.

47. The Agency has the burden of proof in this proceeding

and the standards of proof may differ because of two sanctions

being involved, a conditional license and the imposition of a

fine for an alleged Class I def iciency. In the fine case the

Agency must prove by clear and convincing evidence that the

deficiencies existed. Department of Banking and Finance

Division of Securities and Investor Protection v. Osborne Stearn

and Co. , supra. "Clear and convincing evid ence" requires that

evidence:

. . . must be found to be credible, the

facts to which the witnesses testified must

be distinctly remembered, the testimony must

be precise and explicit and the witnesses

must be lacking confusion as to the fact in

issue. The evidence must be of such a

weight that it produces in the mind of the

trier of fact a firm belief or conviction,

without hesitancy, as to the truth of the

allegations sought to be established.

Inquiry concerning Judge Davey , 645 So. 2d 398, 404 (Fla. 199 4)

(quoting Slomowitz v. Walker , 429 So. 2d 77, 800 (Fla. 4th DCA

1983)).

48. The Agency must demonstrate by clear and convincing

evidence both the existence of a violation and that the

deficiency/violation is properly classified. Id. ; Agency for

Healt h Care Administration v. Blue - Haven Retirement, Inc. , DOAH

Case No. 02 - 4170 (Final Order pending).

49. If the deficiency exists and it is a Class I

deficiency, a fine is appropriate. A Class I deficiency is what

has been alleged in this proceeding. I f either one of these

elements is not established by clear and convincing evidence,

then the Agency cannot levy the fine. This issue is also raised

in Beverly Enterprises, Inc., - Eastbrooke v. Agency for Health

Care Administration , 20 FALR 873, 880 (Final Order March 12,

1998) where the secretary found that the Agency has the burden

of proof to show by the evidence that each of the allegations is

true in order to establish a deficiency.

50. Here the evidence presented, especially the testimony

of the phys ician, which is accepted, establishes that Resident

14 died a natural death at the end of what the physician

established was an "end of life" event, in accordance with the

resident's right to choose that no extraordinary means be

employed to prolong her li fe. The Agency did not prove, even by

a preponderance of the evidence, a Class I deficiency within the

meaning of Section 400.23(7)(b), Florida Statutes, which would

authorize a conditional license, or any violation under Section

400.23(8), Florida Statut es, which would authorize an

administrative fine. Therefore, the Agency has shown no basis

for levying a fine or imposing a conditional license on Ruleme.

RECOMMENDATION

Based on the foregoing Findings of Fact, Conclusions of

Law, the evidence of record, the candor and demeanor of the

witnesses, and the pleadings and arguments of the parties, it

is, therefore,

RECOMMENDED that a final order be entered by the Agency for

Health Care Administration, dismissing the Administrative

Complaint and the notice and d etermining that the alleged

violations have not been established.

DONE AND ENTERED this 17th day of June, 2005, in

Tallahassee, Leon County, Florida.

S

P. MICHAEL RUFF

Administrative Law Judge

Division of Administrativ e Hearings

The DeSoto Building

1230 Apalachee Parkway

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 17th day of June, 2 005.

COPIES FURNISHED:

Thomas J. Walsh, II, Esquire

Agency for Health Care Administration

525 Mirror Lake Drive, 330G

St. Petersburg, Florida 33702

Alfred W. Clark, Esquire

117 South Gadsden Street, Suite 201

Post Office Box 623

T allahassee, Florida 32302 - 0623

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

Fort Knox Buildin g, Suite 3431

2727 Mahan Drive

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 sho uld be filed with the agency that

will issue the Final Order in this case.