00-003356 Quality Health Care Center vs. Agency For Health Care Administration Status: Closed Recommended Order on Friday, March 9, 2001.

Summary: This is a challenge to a change of licensure status for alleged violations of 42 Code of Federal Regulation Section 483.13 (c)(1)(i) and Section 483.20(k)(3)(i). Licensure status restored to standard.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

QUALITY HEALTH CARE CENTER, )

)

Petitioner, )

)

vs. ) Case No. 00-3356

)

AGENCY FOR HEALTH CARE )

ADMINISTRATION, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative

Hearings, by its duly-designated Administrative Law Judge ,

Jeff B. Clark, held a formal hearing in this case on January 16,

2001, in North Port, Florida.

APPEARANCES

For Petitioner : Karen L. Goldsmith, Esquire

Goldsmith and Grout, P.A.

2180 North Park Avenue, Suite 100

Post Office Box 2011

Winter Park, Florida 32790-2011

For Respondent: Michael P. Sasso, Esquire

Agency for Health Care Administration

6800 North Dale Mabry Highway, Su ite 220

Tampa, Florida 33614

John Gilroy, Esquire

Agency for Health Care Administration

2727 Mahan Drive

Fort Knox Building Three, Suite 3431

Tallahassee, Florida 32308

STATEMENT OF THE ISSUES

Whether or not Tags F224 and F281 were appropriately cited

by Respondent, Agency for Health Care Administration, during a

May 25 and 26, 2000, complaint survey; if so, if they warranted

designation as Class I deficiencies with a severity of "J"; and,

as a result, was a "conditional" licensure status appropriately

issued to Petitioner, Quality Health Care Center.

PRELIMINARY STATEMENT

On May 25 and 26, 2000, the Agency for Health Care

Administration (AHCA) surveyed Quality Health Care Center

(Quality), North Port, Florida, and found alleged Class I

deficiencies for violation of 42 Code of Federal Regulation

(C.F.R.) Section 483.13(c)(1)(i), regarding "Staff Treatment of

Residents" cited as "Tag F224," and 42 C.F.R. Section

483.20(k)(3)(i), regarding "Resident Assessment" cited as "Tag

F281." By letter dated June 20, 2000, AHCA advised Quality that

its standard license was replaced with a conditional license

effective May 26, 2000.

Quality filed an Amended Petition for Formal Administrative

Hearing with the Division of Administrative Hearings on

August 11, 2000, contesting the deficiencies as factually and

legally unfounded, or alternatively, changing the classification

of the deficiencies to Class III.

On September 20, 2000, an Amended Notice of Hearing was

entered setting the final hearing for November 15 and 16, 2000.

On November 1, 2000, an Order Granting Continuance and

Rescheduling Hearing was entered resetting the final hearing for

January 16 and 17, 2001, in North Port, Florida.

AHCA presented two witnesses, Marilyn Steiner, M.A., who

was accepted as an expert witness "as a health facility

evaluation surveyor," and Virginia Radtke, R.N, accepted as an

expert witness in "the field of nursing." AHCA presented

Exhibits 1- 3 which were admitted into evidence. Quality

presented ten witnesses, two of whom were accepted as expert

witnesses. Alexia Parker, R.N., was accepted as an expert

witness in "long-term nursing," and Victor Rodriquez, M.D., was

accepted as an expert "in care of death or dying or geriatric

care." Quality presented Exhibits 1- 7 which were admitted into

evidence. Where appropriate, the name of a resident involved in

the incident which gave rise to the complaint survey was

redacted to protect her right of privacy.

At the close of the final hearing, the parties requested

and received an extension of time, until February 19, 2001, to

file proposed recommended orders. The Transcript was filed on

February 6, 2001. After both parties had filed Proposed

Recommended Orders, AHCA filed a Motion for Leave to File

Amended Proposed Recommended Orders, which was granted. AHCA's

Amended Proposed Recommended Order was filed on March 5, 2001.

FINDINGS OF FACT

Based on the oral and documentary evidence presented at the

final hearing, the following findings of facts are made:

1. At all ti mes material hereto, Quality was a licensed

nursing home located in North Port, Florida.

2. AHCA is the state agency charged with periodically

evaluating nursing home facilities and making a determination as

to the nursing home facilities' degree of compliance with

applicable federal regulations, state statutes, and rules. As a

result of an evaluation, the nursing home facility is given a

licensure status described in Subsection 400.23(7), Florida

Statutes (1999).

3. Subsection 400.23(7)(a) and (b), Fl orida Statutes

(1999 ), defines "standard" or "conditional" licensure status

based on the presence of one or more "classified deficiencies."

Subsection 400.23(8)(a)(b) and (c), Florida Statutes (1999),

establishes the deficiency classifications (Classes I, II, and

III).

4. Ralph Ham, Quality Administrator, testified that

"Quality had received superior [sic] ratings for ten years prior

to the May 25-26, 2000, survey" and "had received a zero

deficiency survey a month or a month and a half" prior to the

May 25-26, 2000, survey.

5. As a result of a complaint it received from Florida

Adult Protective Services, a state agency, that a Quality

resident (Resident 1) "had been neglected in that she had been

bitten by fire ants," AHCA conducted the complaint survey on

May 25-26, 2000, to review the care and treatment of Resident 1

concerning the incident.

6. The standard form used by AHCA to document survey

findings is known as a "2567" form, titled "Statement of

Deficiencies and Plan of Correction" (Agency Exhibit 2). A

nursing home facility deficiency is noted on the 2567 form and

referred to as a "tag." The tags cited on the 2567 form for the

May 25-26, 2000, survey were tags F224 and F281.

7. Tag F224 incorporates 42 C.F.R. Section 483.13

regarding "Staff Treatment of Residents" and states:

The facility must develop and implement

written policies and procedures that

prohibit mistreatment, neglect, and abuse of

residents and misappropriation of resident

property.

8. Tag F281 incorporates 42 C.F.R. Sect ion 483.20(k)(3)(i)

regarding "Resident Assessment" and states, "The services

provided or arranged by the facility must meet professional

standards of quality."

9. Resident 1 was an 87-year-old female who was "actively

dying." Upon readmission to Quality on May 15, 2001, from a

hospitalization, her admitting diagnosis included congestive

heart failure, chronic obstructive pulmonary disease, chronic

renal failure, Alzheimer's' Disease/dementia, lung congestion,

edema of both upper and lower extremities, skin tears, bruising,

and weeping through her skin. On the evening of May 17, 2000, a

renal function test indicated "acute renal failure" which

usually means that death is eminent.

10. The following is reported in a summary sheet which is

a part of Resident 1's medical record (Quality Exhibit 1):

She was resting at intervals during the

night of 5/17/00, receiving incontinent care

and was repositioned x2 until approximately

5:00 a.m. on 5/18/00, when she began calling

out to her daughter once again. The CNA

repositioned her and provided incontinent

care. The CNA stated she did not observe

anything unusual at this time. She also

stated that the only thing in . . . bed was

a beige stuffed animal. At 6:30 a.m. it was

noted that she was "resting quietly."

At 8:00 a.m., she was found by a staff

member to have "ants" on her upper body.

Several staff members, including C. Curtis,

LPN, M. Richmond, CNA, (PN) J. Norman, RN,

D. Waszielewski, CNA, J. Derrikson, R.N.,

Jeri Maxfield, R.N. and D. Francois, CNA

entered room and immediately removed her

from the bed and took her to the shower

where all ants were removed. All dressings

were removed to assure there were no further

ants under any dressings. Reddened areas

were noted at this time on her right upper

torso.

11. While the incident of Resident 1's being bitten by

fire ants while bedridden, is characterized as "catastrophic,"

the incident itself is not the subject of this hearing; the

subject of the hearing is Quality's response to the incident.

Tag F224

12. Amplifying the general requirements of 42 C.F.R.

Section 483.13(c) stated in paragraph 7, supra , the 2567 form

indicates that

This Requirement is not met as evidenced

by:

* * *

The facility failed to identify the

catastrophic event of "over a hundred ant

bites" to a terminally ill resident,

continuously assess the severity of the

trauma which resulted from the ant bites,

and satisfactorily eradicate the ant

infestation around the outside of the

building.

13. AHCA provided no evidence rega rding the allegation

that Quality failed to "satisfactorily eradicate the ant

infestation around the outside of the building" other than

statements contained in the 2567 form.

14. Quality offers evidence that it had a monthly pest

control service for both the interior and exterior of the

facility (Quality Exhibit 2) and that the service had been

on-going (Quality Exhibit 3). The Quality maintenance man

testified that he checked the building and grounds for ants

three times per week and that he baited ant mounds when found

outside. He testified that he examined the area immediately

outside Resident 1's room and did not find any ants although

he found ants on the floor of Resident 1's room exiting under a

baseboard after the incident. He removed the baseboard but did

not find a hole. Quality had never had an ant problem prior to

this incident.

15. The Quality nursing staff responded immediately upon

discovery of the ants. No less than seven nursing personnel,

including three registered nurses came to Resident 1's

assistance. She was immediately showered, redressed, and moved

to another room. All dressings were removed to ensure that no

ants were in the dressing.

16. AHCA expert witness, Marilyn Steiner, who was

qualified as a health facility evaluation surveyor, testified

that the facility neglected Resident 1 in that "they did not

identify the incident of the ant bites as separate from her

terminal condition."

17. This opinion is purportedly supported by her opinion

that there was a significant change in Resident 1 that the

facility saw as part of the terminal process and handled it

accordingly, versus seeing it as a significant event of the ant

bites. AHCA suggested in documents and testimony that

Resident 1 suffered anaphylactic shock as a result of the ant

bites.

18. Anaphylactic shock may occur in some individuals

bitten by ants. It is an almost immediate acute allergic

reaction that is characterized by difficulty in breathing,

occasioned by swelling in the laryngeal region, hypothermia

(reduced body temperature), a drop in blood pressure, abdominal

cramping, muscle constriction, and other dramatic physical

reactions.

19. Both Victor Rodriquez, M.D. and Alexia Parker, R.N.,

who were accepted as expert witnesses testified that

Resident 1's record revealed no evidence of anaphylaxis. None

of the treating nurses observed any evidence of anaphylaxis.

Both experts addressed apparent changes in Resident 1's

condition and interpreted those changes as being part of the

Resident 1's general organic failure, not changes caused by

reaction to ant bites. This testimony is accepted as being more

persuasive by the undersigned; no credible evidence has been

presented that Resident 1 suffered anaphylaxis or a severe

allergic reaction to the ant bites.

20. Tag F224, written by AHCA expert witness Steiner,

further states that the facility failed to "continuously assess

the severity of the trauma which resulted from the ant bites."

Ms. Steiner testified that Jean Norman, R.N., Quality's

Assistant Director of Nursing, said that Tammy Lindner, L.P.N.,

documented an assessment in the nurse's notes and that she was

not responsible for the assessment. Steiner was further

critical of the fact that Norman did not have any contact with

Resident 1's treating physician from the time of the ant bites

until Resident 1's death.

21. Norman denies having told the surveyors that she had

no personal contact with Resident 1 and denies having stated

when asked if she did an assessment, "No, the LPN did one."

22. Norman w as one of the seven nursing personnel who

responded to the ant bite call. She was directly involved in

placing Resident 1 in the shower by getting the shower chair.

She went to Station 2 where Resident 1 was to be transferred and

prepared the staff for her arrival. She then assisted in moving

Resident 1. She and two other nurses placed Resident 1 in a new

bed. Her bandages were removed and Resident 1 was moved so

Norman could look at her skin. Reddened areas were observed on

her shoulder, on her upper right body, under her breast and

along her abdomen. Resident 1 was not in distress, pain, nor

did she itch. Norman says that she was observing/assessing

Resident 1 this whole time. She directed LPN Tammy Lindner to

call Resident 1's treating physician. She directed the other

nurse to contact Resident 1's family. About one-half hour

elapsed from the actual incident until Resident 1's treating

physician was called. Norman stayed with Resident 1 to see if

she was going to have any problems. She did not. Resident 1

was "calm," "she had no complaints." Norman stayed with

Resident 1 until LPN Lindner returned and told her what

medications Resident 1's treating physician had ordered. Norman

returned to Resident 1's room three or four times that morning.

Norman continued getting information on Resident 1's condition;

she did not see any indication that would suggest anything other

than the disease process that was already in place. To the

extent that LPN Lindner had direct involvement with Norman's

activities, Norman's testimony is confirmed by her.

23. Norman testified that in her professional opinion the

(ant bite) incident did not require an heightened level of

monitoring or evaluation or assessment to ensure that

Resident 1 was properly cared for and treated.

24. Juanita Martin, LPN, who was involved in Resident 1's

treatment testified that Norman was fully aware of what was

going on with Resident 1 and that she was "orchestrating our

behavior." She (Norman) was on the floor on multiple occasions

speaking with various people.

25. Tammy Lindner, LPN, testified that Norman and another

nurse, Charlene Curtis, brought Resident 1 to Station 2.

Lindner cut away the dressing on both of Resident 1's arms so

Norman could observe. Lindner testified that Norman examined

Resident 1 and did a "hands-on" assessment. Resident 1 said she

had no pain and was not itching. Lindner observed no

anaphylaxis or allergic reaction. Lindner administered Benadryl

and applied Hydrocortisone cream per Resident 1's treating

physician's order. Resident 1 continued to maintain that she

was not in pain and did not itch.

26. Quality has a protocol for the care of terminal

patients (Quality Exhibit 4) which appears to have been followed

in the care of Resident 1.

27. Quali ty appropriately assessed the incident wherein

Resident 1 was bitten by fire ants and provided appropriate

treatment. Resident 1 was not mistreated, neglected, or abused

by the care and services provided by Quality staff.

Tag 281

28. Amplifying the gen eral requirements of 42 C.F.R.

Section 483.20(k)(3)(i) stated in paragraph 8, supra , the 2567

form indicates:

This Requirement is not met as evidenced

by:

* * *

The facility did not ensure that :

1. Assessments were conducted by an RN for

one of one residents. 2. Medications were

given per physician's order for one of one

residents. 3. Licensed nursing staff did

not recognize signs and symptoms of

anaphylaxis/catastrophic event, therefore,

did not report the extent of the incident to

the physician.

29. Subsection 464.003(3)(a)(1), Florida Statutes, limits

the performance of an "assessment" to a "professional nurse"

(Registered Nurse). 42 C.F.R. Section 483.20 similarly requires

that "a registered nurse must conduct and coordinate each

assessment . . . and a registered nurse must sign and certify

that the assessment is completed." In addition, 42 C.F.R.

Section 483.20 lists specific occasions when a facility must

make a comprehensive assessment.

30. 42 C.F.R. Section 483.20(b)(2)(ii) s tates:

Within 14 calendar days after the facility

determines, or should have determined, that

there has been a significant change in the

resident's physical or mental condition.

(For purposes of this section, a

"significant change" means a major decline

or improvement in the resident's status that

will not normally resolve itself without

further intervention by staff or by

implementing standard disease-related

clinical interventions, that has an impact

on more than one area of the resident's

health status, and requires

interdisciplinary review or revision of the

care plan, or both.)

31. Expert witness Alexa Parker, RN, testified that there

is no standard of care which requires that an assessment of a

nursing home patient be done after a significant event unless it

is required by 42 C.F.R. Section 483.20.

32. Resident 1 did not suffer a "significant change" in

her status, as defined in 42 C.F.R. Section 483.20(b)(2)(ii), as

a result of the ant bite incident. She had redness on portions

of her body and some pustules, but there was no evidence of

anaphylaxis or significant allergic reaction.

33. There was no requirement that a registered nurse

conduct a formal assessment and report Resident 1's ant bite

incident in her medical record.

34. At the time of Resident 1's readmission to Quality on

May 15, 2000, LPN Lindner called Resident 1's treating physician

and, after describing her deteriorating condition, was given

orders by the physician that medication was to be given

Resident 1 by mouth.

35. Following the ant bite incident and after RN Norman,

LPN Lindner, and LPN Curtis had examined Resident 1 at

Station 2, Norman directed Lindner to call Resident 1's treating

physician, report the ant bite incident, and request orders.

36. Lindner call Resident 1 's treating physician's office,

spoke to a nurse, described the ant bite incident, and received

medication orders from the nurse for Benadryl and Hydrocortisone

creme. The Benadryl was given to Resident 1 in applesauce or

pudding.

37. Lindner believed th at the nurse in the treating

physician's office who gave her the medication order was a nurse

practitioner. It was not unreasonable for Lindner to assume

that the nurse, having given medication orders, was authorized

to do so.

38. Approximately two hours later, Lindner again called

Resident 1's treating physician, reported Resident 1's current

condition and from the physician's reported comment, "Don't you

have an exterminator," believed that he was aware of the ant

bite incident.

39. Lindner called Res ident 1's treating physician later

on May 18, 2000, and, at the urging of Resident 1's family,

requested Roxanol, a medication given to medicate dying patients

for anxiety, restlessness, agitation, and pain.

40. Quality staff's administration of the medic ations,

Benadryl, Hydrocortisone, and Roxanol, was appropriate given

Resident 1's medical condition and her treating physician's

orders.

41. LPN Juanita Miller testified that she overheard

Lindner's call to Resident 1's treating physician's office staff

and reported that Lindner said that, "Resident 1 had had

multiple ant bites, that we were concerned about her health, and

that we had an emergency."

42. No evidence was presented as to what was reported to

Resident 1's treating physician by his office staff about the

severity of the ant bites.

43. RN Norman did not write anything in Resident 1's chart

about her observations related to the ant bites because her

standard practice is to read the LPN notes, and if she agrees

with those observations, she has no reason to write on the

chart.

44. Expert witness Parker testified that it would not be a

deviation from the standard of care for a supervising registered

nurse to receive verbal information and give verbal instructions

and not record it in the chart.

4 5. Expert witness Parker testified that in reviewing

Resident 1's chart that she found no deviation from the

community standard of care by the nurses at Quality and that the

care of Resident 1 was adequate and appropriate.

CONCLUSIONS OF LAW

46. The Divis ion of Administrative Hearings has

jurisdiction over the parties and the subject matter of this

proceeding. Section 120.57(1), Florida Statutes.

47. Section 400.23(7), Florida Statutes (1999), authorizes

AHCA to evaluate nursing home facilities and make a

determination as to the degree of compliance with established

rules and to assign a licensure status to the facility. AHCA

bases the facilities' licensure status on, among other things,

deficiencies found during the evaluation.

48. Section 400.23(8), F lorida Statutes (1999), directs

AHCA to classify deficiencies in nursing home facilities.

Class I deficiencies are those which AHCA determines present an

imminent danger to residents of the nursing home facility or a

substantial probability that death or serious physical harm

would result therefrom.

49. Section 400.23(7), Florida Statutes (1999), describes

licensure status as follows:

The agency shall assign a licensure status

of standard or conditional to each nursing

home.

(a ) A standard licensure status means

that a facility has no class I or class II

deficiencies, has corrected all class III

deficiencies within the time established by

the agency, and is in substantial compliance

at the time of the survey with criteria

established under this part, with rules

adopted by the agency, and, if applicable,

with rules adopted under the Omnibus Budget

Reconciliation Act of 1987 . . . .

* * *

(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 with in

the time established by the agency, is not

in substantial compliance at the time of the

survey with criteria established under this

part, with rules adopted by the agency, or,

if applicable, with rules adopted under the

Omnibus Budget Reconciliation Act of

1987 . . . .

50. Quality received a letter from AHCA dated June 20,

2000, citing the survey of May 26, 2000, as the basis for a

change in licensure status to conditional. No administrative

complaint was filed by AHCA. Quality commenced the case by

filing an Amended Petition for Formal Administrative Hearing

which incorporated the Form 2567-L, Statement of Deficiencies

and Plan of Correction. This became the charging document in

this case.

51. Form 2567 contains two tags, F224 and F281. Tag F224

cites 42 C.F.R. Section 483.13(c)(1)(i), a regulation directed

to "Staff Treatment Of Residents" and states,

The facility must develop and implement

written policies and procedures that

prohibit mistreatment, neglect, and abuse of

residents and misappropriation of resident

property.

This Requirement is not met as evidenced

by:

Based on staff and physician interview,

record review and observation, the facility

staff did not provide the care and services

to prevent neglect and actual harm to one

resident. The facility failed to identify

the catastrophic event of "over a hundred

ant bites" to a terminally ill resident,

continuously assess the severity of the

trauma which resulted from the ant bites,

and satisfactorily eradicate the an

infestation around the outside of the

building.

52. Tab F281 cites 42 C.F.R. 483.20(k)(3)(I), a regulation

directed to "Resident Assessment" and states,

The services provided or arranged by the

facility must meet professional standards of

quality.

This Requirement is not met as evidenced

by:

Based on record review, staff interview

and physician interview, it was determined

the facility did not ensure that :

1. Assessments were conducted by an RN for

one of one residents. 2. Medications were

given per physician order for one of one

residents. 3. Licensed nursing staff did

not recognize signs and symptoms of

anaphylaxis/catastrophic event, therefore,

did not report the extent of the incident to

the physician.

53. AHCA, as the party asserting the affirmative of the

issue (that is, that there were two Class I deficiencies at

Quality), has the burden of proof and of persuasion in this

proceeding. 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). Absent a demand to revoke or suspend

Quality's license, the standard of proof should be a

preponderance of the evidence. Subsection 120.57(j), Florida

Statutes.

54. While there is the proven occurrence of the

unfortunate and unexplained incident of Resident 1 being bitten

a significant member of times by fire ants, as established by

the Findings of Fact, the allegations of the deficiencies as set

forth in Tags F224 and F281 have not been proved by a

preponderance of the evidence.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions

of Law, it is hereby

RECOMMENDED that the Agency for Health Care Administration

enter a final order finding that Quality Health Care Center did

not violate Tag F224 which incorporates 42 C.F.R. Section

483.13(c)(1)(i) and Tag F281 which incorporates 42 C.F.R.

Section 483.20(k)(3)(i) and restoring Quality Health Care

Center's licensure status to standard for the applicable period

that it was conditional.

DONE AND ENTERED this 9th day of March, 2001, in

Tallahassee, Leon County, Florida.

___________________________________

JEFF B. CLARK

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488- 9675 SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrativ e Hearings

this 9th day of March, 2001.

COPIES FURNISHED :

Karen L. Goldsmith, Esquire

Goldsmith & Grout, P.A.

2180 North Park Avenue, Suite 100

Post Office Box 2011

Winter Park, Florida 32790-2011

Michael P. Sasso, Esquire

Agency for Health Care Administration

6800 North Dale Mabry, Highway 220

Tampa, Florida 33614

John Gilroy, Esquire

Agency for Health Care Administration

2727 Mahan Drive

Fort Knox Building Three, Suite 3431

Tallahassee, Florida 32308

Sam Power, Agency Clerk

Agency for Health Care Administration

2727 Mahan Drive

Fort Knox Building Three, Suite 3431

Tallahassee, Florida 32308

Julie Gallagher, General Counsel

Agency for Health Care Administration

2727 Mahan Drive

Fort Knox Building Three, Suite 3431

Tallahassee, Florida 32308

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

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

to this Recommended Order should be filed with the agency that

will issue the final order in this case.