08-000822 Agency For Health Care Administration vs. Dos Of Crystal River Alf, Llc, D/B/A Crystal Gem Alf Status: Closed Recommended Order on Friday, October 31, 2008.

Summary: There was a failure of proof of a Class II deficiency based on overmedication and failure to modify.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

AGENCY FOR HEALTH CARE )

ADMINISTRATION, )

)

Petitioner, )

)

vs. ) Case No. 08-0822

)

DOS OF CRYSTAL RIVER ALF, LLC, d/b/a/ CRYSTAL GEM ALF, )

)

)

Respondent. )

)

RECOMMENDED ORDER

Upon due notice, a disputed-fact hearing was held in this

case July 9-10, 2008, in Inverness, Florida, before Ella Jane P.

Davis, a duly-assigned Administrative Law Judge of the Division

of Administrative Hearings.

APPEARANCES

For Petitioner: James Harris, Esquire

Agency for Health Care Administration

The Sebring Building, Suite 330H

525 Mirror Lake Drive North

St. Petersburg, Florida 33701

For Respondent: Theodore E. Mack, Esquire

Powell & Mack

803 North Calhoun Street

Tallahassee, Florida 32303

STATEMENT OF THE ISSUE

Whether or not Petitioner may impose an administrative fine on Respondent DOS of Crystal River, ALF, LLC d/b/a Crystal Gem

ALF (Crystal Gem) in the amount of $2,000.00 based upon two

cited State Class II deficiencies pursuant to Section

429.19(2)(b), Florida Statutes (2007).

PRELIMINARY STATEMENT

By an Administrative Complaint, dated January 9, 2008, the

Agency sought to levy a $1,000.00, fine against Respondent for

alleged violations of Florida Administrative Code Rule 58A-

5.0185(5)(b), relating to the maintenance of a daily Medication

Observation Record and Controlled Substance Countdown Record

(Count I), and a $1,000.00, fine for alleged violations of

Florida Administrative Code Rule 58A-5.0182(1), relating to the

provision of care and services appropriate to the needs of

residents (Count II). Respondent timely requested a disputed-

fact hearing, and the cause was referred to the Division of

Administrative Hearings on or about February 18, 2008.

The Division’s Case File reflects all pleadings; notices;

and orders, including but not limited to, continuances;

intervening before the July 9-10, 2008, final hearing.

Prior to hearing, the parties filed a joint Pre-Hearing

Stipulation, and Petitioner was granted official recognition of

an April 2007, calendar. The Pre-Hearing Stipulation has been

used, as appropriate, in crafting this Recommended Order.

At hearing, Petitioner presented the oral testimony of

Elaine Hallewell, R.N., an expert in nursing; Debra Downey, an

expert paramedic; Patricia (Patty) Clair; 1/ W.H., daughter of the

resident who was the focus of the Administrative Complaint;

W.H., Jr., the resident’s grandson; W.H., Sr., the resident’s

son-in-law; Richard Brooker, an Agency surveyor and expert in

nursing; and Anna Lopez. Petitioner had seven exhibits admitted

in evidence. Respondent presented the oral testimony of Laurene

Holder and Christine Erick and had one exhibit admitted in

evidence.

A three-volume Transcript was filed on July 31, 2008.

Each party timely filed, by September 9, 2008, a Proposed

Recommended Order (40 and 25 pages, respectively) within the

final extension of time. Each Proposed Recommended Order has

been considered in preparation of this Recommended Order. 2/ The

Findings of Fact herein contain inherent assessments of

credibility.

FINDINGS OF FACT

1. Petitioner AHCA is the state agency responsible for

licensing and evaluating assisted living facilities (ALFs),

pursuant to Sections 408.802(14) and 429.07, Florida Statutes.

2. Respondent Crystal Gem is an ALF located in Crystal

River, Florida.

3. Resident No. One, hereafter referred to as “the

resident,” resided in Respondent ALF from April 5, 2007, to

April 10, 2007.

4. The resident had fallen in her bedroom in the home she

shared with her daughter, son-in-law, and grandson at

approximately 2:00 a.m. on the morning of April 4, 2007.

5. By all accounts, prior to this accident, the resident

was active, orally communicative, capable of performing all

activities of daily living (ADLs), and contributed to the

household by doing familial household work. She had suffered a

single episode of dementia in the past. She was known to drink

large quantities of water but did not eat a lot at any one meal.

She loved to eat and regularly ate between meals.

6. After the fall, the resident had gotten back into bed

by herself, but had been in a lot pain. Her family assisted her

to walk out of the house to the family car. They took her to

Citrus Memorial Hospital, where she walked, with assistance,

into the emergency room. She was placed in a wheelchair and

completed her own admission papers.

7. Hospital records from April 4, 2007, indicate the

resident was 84 years old; had a heart valve replacement; and

had been fitted with a pacemaker. She weighed 91 pounds and was

underweight. She was suffering from osteoporosis,

arteriosclerosis, and chronic obstructive pulmonary disease

(COPD). The hospital records noted abrasions and tenderness on

her left back . X-rays were taken of her ribs. The preliminary

report of the hospital’s diagnostic imaging department indicated

non-displaced fractures to her left eighth and ninth ribs. The

records do not indicate that any other x-rays were taken at that

time. The resident’s right hip, where a fracture was later

found (see Finding of Fact 56), was not x-rayed on April 4,

2007.

8. The resident was sent home from the hospital with a

prescription of the narcotic, Hydrocodone (a generic for

Vicodin), for pain relief. The prescription was later filled.

9. Exiting the emergency room on April 4, 2007, the

resident walked, with assistance, back to the family car for

transport home and walked into the family home the same way.

10. The family had planned to leave on April 5, 2007, for

an out-of-town family celebration. Due to the possibility that

the resident’s ribs might break further and puncture her lungs,

the hospital doctors had recommended that she not travel by car

with her family. After consultation with the resident’s

personal physician, weighing all options, a tour of the facility

by the daughter, and upon good recommendations, the family

elected, with the resident’s consent, to place the resident in

Respondent’s ALF for respite care while they were out of town.

11. By all accounts, the resident was in some discomfort,

but functioned normally in the family home all of April 4, 2007,

during which time she continued to do familial household chores,

and on the morning of April 5, 2007, before departing for

Respondent’s facility. On both days, she was not confused; was

able to bathe herself; and had no diminished intake of either

food or liquids.

12. The resident’s daughter escorted her to Respondent

facility on the morning of April 5, 2007. (Stipulated)

13. The two women arrived at the facility about 10:00 a.m.

on April 5, 2007, and during an extensive tour of the first

floor (both inside and outside), the resident was able to

ambulate and did not complain of pain. The facility’s Resident

Assessment Data Collection Form, filled out upon her admission

into the facility, stated the resident was ambulatory with one-

person assist and full weight-bearing, with bruising and

discomfort on the right side. It further noted that she needed

assistance in transferring and in ambulating. The facility's

Observation Log for that day described her as "extremely small

and frail with poor balance and needs to be monitored closely

during ambulation." The Observation Log is used by Respondent

to record each resident's condition and activities as observed

by staff.

14. Upon the resident’s admission, Respondent facility was

provided only with the resident’s April 4, 2007, hospital

discharge instructions and hospital emergency department after-

care instructions. These indicated “fall/rib fracture,” and did

not specify which ribs were fractured. Nothing on them related

to either hip.

15. The hospital discharge instructions suggested the

resident be checked by her own physician in two to three days

and that she go to her doctor or the emergency room if pain or

shortness of breath were getting worse, for persistent coughing,

for fever or chills, or for abdominal pain, vomiting, severe

weakness or fainting. They suggested she beware of falling

again and report to her doctor if she experienced dizziness,

severe weakness, inability to get up after a fall, abdominal

pain, vomiting, diarrhea, passing black or bloody stools,

headache, vision problems, or numbness or weakness in one arm or

leg.

16. It was anticipated by all concerned that the resident

would only remain in Respondent’s facility for five days, and

would only require personal observation as necessary, assistance

with her ADLs, monitoring of her pain, and assistance taking her

medications. However, the family had selected Respondent’s ALF,

in part, because it was near a hospital in case the resident’s

condition worsened or an emergency of some kind arose while they

were out of town.

17. In addition to the new prescription for Hydrocodone,

the resident previously had been prescribed a number of

medications unrelated to her fractured ribs. Among these were

Lorazepam, Coumadin, Captopril, and Trazodone. Hydrocodone is a

controlled substance, as is Lorazepam.

18. The Lorazepam, an anti-anxiety drug like Activan, is a

sedative. It had been prescribed to be taken twice a day,

morning and evening. The Hydrocodone had been prescribed to be

19. Respondent is not a skilled nursing facility, so its

personnel cannot legally administer prescription medications.

20. Respondent’s written policy and procedures for

facility personnel provide for them to assist residents with

self-administration of drugs, including special procedures for

assistance with controlled substances. Under these procedures,

controlled substances remain under lock and key and are to be

listed on a separate drug inventory sheet called a “Controlled

Substance Countdown Record” (CSCR), and the actual pills are to

be counted before and after each shift.

21. Patty Clair, a Patient Care Advisor at Respondent’s

facility, testified that she knew that facility personnel could

“assist” a resident in taking his/her medications by bringing

the medicine to the resident and placing that resident’s pills

on the resident’s hand, but that the resident was responsible

for actually moving the pill to his/her mouth.

22. Respondent facility also maintains a Medication

Observation Record (MOR), which must be updated immediately each

time a resident takes any medication or refuses a medication.

Petitioner Agency specifies by rule the information that the MOR

must contain.

23. At Respondent’s facility, the Coumadin was incorrectly

charted to eliminate the Sunday, April 8, 2007, dosage, and the

Hydrocodone was incorrectly transcribed on the MOR as “every

eight hours,” instead of “eight hours prn.”

24. Review of the resident's MOR reveals that there is no

documentation that the following medications were taken or

refused by the resident as prescribed on the respective dates:

Coumadin, two tablets on Sunday, April 8,

2007.

Captopril, one tablet on Thursday, April 5,

2007, and two tablets on Friday, April 6,

2007.

Trazodone, two tablets on Thursday, April 5,

2007, and two tablets on Friday, April 6,

2007. (Stipulated)

25. During the period April 5, through April 10, 2007, the

CSCR for Hydrocodone indicates that five tablets were taken from

the resident's supply of Hydrocodone, but the MOR only documents

self-administration of three tablets. (Stipulated)

26. During the period April 5, 2007, through April 10,

2007, the CSCR for Lorazepam indicates that nine tablets were

taken from the resident's supply of Lorazepam. The MOR for that

same period documents the self-administration of nine tablets,

but does not document self-administration at 8:00 p.m. on

April 8, 2007, or 8:00 a.m. on April 9, 2007. It does indicate

self-administration on April 10, 2007, at 8:00 a.m. and 8:00

p.m. (Stipulated)

27. Other than the Lorazepam, there is no documentation

that the resident self-administered any other medication on the

morning of April 10, 2007, which is the day she left the

facility. (Stipulated)

28. Patty Clair did not make any writing on the CSCR, even

though her name appears on the CSCR for assisting the resident

with Lorazepam, on April 6, 7, and 10. (Stipulated)

29. At hearing, Ms. Clair acknowledged assisting the

resident with self-administration of her Lorazepam on April 6,

7, and 9, 2007. Ms. Clair initialed the MOR showing that she

had helped the resident take her Lorazepam on April 6, 7, and 9,

2007. However, Ms. Clair did not sign the CSCR for April 6, or

7, 2007, even though her name and initials appear on the CSCR

for April 6, and her name appears on the CSCR for April 7, 2007.

At no time did Ms. Clair give anyone permission to place her

initials on the CSCR for the Lorazepam. Ms. Clair did not sign

the CSCR for assisting the resident with her Lorazepam on

April 10, 2007, at 8:00 a.m. because she did not even work at

the facility on April 10, 2007.

30. The resident was discharged from Respondent facility

during the morning of April 10, 2007, between 8:30 a.m. and 9:00

a.m. (Stipulated)

31. Because the resident left the facility between 8:30

a.m. and 9:00 a.m. on April 10, 2007, it would have been

impossible for the resident to have self-administered the

Lorazepam at 8:00 p.m. that day, as was indicated on the CSCR.

Also, by that hour, she had been hospitalized. See , infra .

32. Christine Erick, the facility’s resident care

coordinator, testified that because the CSCR sheet was not

consistent with the actual countdown of the medication, she went

back to the MOR to find out who had assisted the resident with

her medication, and finding it had been Patty Clair, signed

Ms. Clair’s name on the CSCR, with her own initials. Her

actions in this regard were contrary to the facility’s record-

keeping procedure.

33. Ms. Erick speculated that the dates apparently got

“messed up” so that the resident had actually received her last

Lorazepam at the facility on April 9, 2007, at 8:00 p.m.

Mr. Booker, Agency surveyor and expert nurse, conceded that one

explanation that fits with the number of missing Lorazepam

tablets (nine), and the number of signed self-administrations of

Lorazepam (nine), is that the resident got all her Lorazepam

doses but the wrong dates went on the records. He further

stated that because the two types of records did not match, no

one can be sure what happened. With regard to the Lorazepam, he

testified that there were no more missing doses than the doses

which were indicated to have been given, and that the doses

which were indicated to have been given to the resident to self-

administer were in accordance with her prescription.

34. According to Mr. Brooker, all that can be said, based

on Respondent facility’s records for Hydrocodone is that

something was not given but not that too much was given. The

facility’s written record in no way indicated an overdose of

Hydrocodone.

35. It is Respondent facility’s protocol that if a

resident falls, the incident must be documented and the facility

administrator, the resident’s doctor (health care provider), and

is also required to be made out 24 hours later. Respondent’s

protocol concerning any injury to a patient is similar, and if

the fall/other injury is severe enough, the facility personnel

must call 911 for medical aid and transport of the resident to a

hospital. There is no reason for facility employees to fail to

report a resident’s fall. This facility had all it needed to

contact this resident's doctor.

36. It was not established that the resident ever fell in

Respondent’s facility.

37. However, on the morning of Sunday, April 8, 2007, the

resident was having difficulty walking. She was unsteady on her

feet and complained of pain consistent with what the facility

knew about her fractured ribs, that from her admission she had

occasionally complained of discomfort or pain on her right side.

( See Finding of Fact 13). She had decreased gait and balance

and was brought to the facility’s dining room for breakfast in a

wheelchair. These observations were recorded in the Observation

Log by "C.E," Ms. Erick.

38. On April 8, 2007, the resident ate only twenty-five

per cent of her breakfast, but that was not unusual. There is

no discernable pattern for her consumption of food while in the

facility. 3/ There is no evidence that the resident lost weight

in Respondent’s facility.

39. On April 8, 2007, Ms. Erick telephoned the resident’s

daughter in Key West and notified her that her mother had

suffered a change of ambulation and was having difficulty

walking, with decreased gait and balance. Further content,

duration, and sequence of the exchange during this telephone

call are in dispute, particularly as to whether Ms. Erik told

the daughter that the resident had right hip pain or informed

her about the use of a wheelchair, and whether the daughter

instructed the facility to take the resident to a hospital if

necessary, but it is undisputed that ultimately, Ms. Erick

suggested to the daughter, and the daughter agreed, that they

give the pain medication, which the Observation Log states had

been self-administered at breakfast-time, a chance to work and

talk later in the day.

40. The daughter did not request, and Ms. Erick did not

offer, to put the resident on the phone at the time of this

initial phone call so that the daughter could get the resident’s

assessment of the situation. However, Ms. Erick and the

daughter concur that the daughter called back that evening to

inquire about her mother, and that during the daughter’s return

phone call, Ms. Erick told the daughter that the resident had no

current complaints of pain and the daughter said she would pick

her mother up on Tuesday.

41. On April 8, 2007, Ms. Erick initialed a single long

comment in the Observation Log covering Findings of Fact 39 and

40.

42. Following Ms. Erick's April 8, 2007, Observation Log

entry, there is a later, April 8, 2007, entry in a different

handwriting, signed by someone else. The entry includes that

the resident complained of slight pain in the rib area and

stated that she was a little stiff. It further states that the

resident ate 75 per cent of her meal and received nourishment

via a snack; that the daughter was told of pain; that the

daughter stated she would be in “tomorrow” to pick up her

mother, and that pain meds were again provided to the resident.

Whether the person who signed this second notation for April 8,

2007, actually spoke with the daughter is unclear, because that

writer did not testify, and both Ms. Erick and the daughter are

clear that only two telephone conversations took place between

them, but this later April 8, 2007, notation in the Observation

Log does confirm that April 8, 2007, is the only day that the

resident ingested two "pain" tablets of Hydrocodone.

43. Based upon the evidence as a whole, including the

candor, demeanor, and reasonableness of the respective testimony

of Ms. Erick and the daughter, and particularly the

contemporaneous Observation Log in its entirety, it is not

credible that pain specifically in the right hip was complained-

of by the resident on April 8. Also, the next day, April 9,

2007, the Observation Log shows a notation of no complaints of

pain from the resident, only stiffness, and this notation is

also signed by a staff member other than Ms. Erick.

44. In summary, the Observation Log shows that

"Hydrocodone prn for pain" is the pain medication, and that on

April 5, one pain pill was given; on April 7, one pain pill was

given; and on April 8, two pain pills were given. The CSCR

shows two, and the MOR shows only one, Hydrocodone pill was

given on April 8, 2007.

45. Respondent did not contact the resident's health care

provider during the period beginning when she entered the

facility on April 5, 2007, and ending when she was discharged

from the Crystal Gem facility on April 10, 2007. (Stipulated)

46. Breakfast at the facility is served in the dining room

at approximately 7:00 a.m. Residents are dressed before they go

to the dining room, but the Observation Log for April 10, 2007,

contains no entry concerning the resident's breakfast. On

April 10, 2007, when the daughter arrived between 8:30 and 9:00

a.m., the resident was lying on her bed, fully clothed.

Ms. Erick assisted the resident into a wheelchair, and the

daughter took the resident to her car, later returning the

wheelchair to the facility. The daughter was not assisted in

this endeavor by any facility employee. The daughter testified

that someone in the parking lot assisted her with getting the

resident into her car. She described the resident as pale,

weak, unresponsive, and confused during this period.

47. Facility protocol calls for Ms. Erick to count out

each of a resident’s medications with the family member who

signs out the resident and to have the family member sign for

the pills being returned. Although neither Ms. Erick nor the

daughter has any memory of counting out the pills, there is a

notation in the Observation Log by another staff person for that

day, stating that medications were given to the daughter.

Because of this contemporaneous notation, and because the

daughter signed for the pills returned to her at the bottom of

the CSCR, it is more likely than not that the pills were counted

out by another staff member and the daughter, than that they

were not counted out at all and were already bagged in the

resident’s luggage, as testified-to by the daughter. This CSCR

sign-out sheet shows that from April 5-10, 2007, five

Hydrocodone tablets were used and nine Lorazepam tablets were

used. (See Findings of Fact 25-26.)

48. On April 10, 2007, during the 25-minute drive home

from Respondent’s facility, the daughter was unable to converse

with the resident, who was moaning and unresponsive.

49. Upon arriving at the home, the daughter realized that

she could not lift or carry the resident to the house.

50. At approximately 11:00 a.m. April 10, 2007, the

daughter appeared at the door of her next door neighbor’s home,

asking for assistance. The neighbor is a registered nurse. The

neighbor went with the daughter and found the resident sitting

on the walkway between the car and the family home, several feet

from the car. The resident was sleepy, difficult to move, and

was unable to stand. The women moved the resident into her

bedroom inside the house, using a rolling computer chair.

51. The resident was put to bed. She was sleepy, but not

comatose. 4/ The daughter denied administering any medication to

the resident that day.

52. The nurse/neighbor stayed for about 30 minutes,

comforting the daughter, and then left for work. She advised

the daughter to wake the resident in about an hour, get her up

and to the bathroom, and give her something to drink so as to

prevent dehydration.

53. At 1:49 p.m. on April 10, 2007, the daughter made a

911 call. A highly trained and skilled paramedic, who arrived

by ambulance at 2:01 p.m., testified that the resident had no

dehydration, had normal blood sugar, and indicated no pain, but

her oxygen level was low. The resident was sleepy, but

responsive to speech. The paramedic rated the resident as being

14 on the Glasgow coma scale, 15 being normal.

54. Upon receiving information concerning the resident’s

medications, it appeared to the paramedic that either

Hydrocodone or Lorezepam was causing the resident to be over-

sedated.

55. The resident’s oxygen level began to drop en route to

the hospital. Narcon is a drug used to counteract narcotics.

Lorezapam does not respond to Narcon, but Hydrocodone does. The

paramedic administered one Narcon “push,” without much result,

at 2:29 p.m. A second Narcon “push” was administered at 2:37

p.m. At that point, the resident became alert and her "stats"

went up. At no point did the paramedic ever conclude that the

delivered to the hospital emergency room 40 minutes after

leaving the family home.

56. Hospital records for April 10, 2007, at 5:10 p.m.,

show the resident as "normotensive" (with normal blood

pressure), 5/ dehydrated, and with a right hip fracture. They

further show that her blood had an abnormal level of Lorazepam

by 510 nanograms per milliliter, a very low abnormality. The

lab did not rate this Lorazepam level as "critical" or "high,

but listed it only as "abnormal."

57. Subsequent to surgery to correct the broken hip, the

resident died at an unspecified date.

58. On or about October 31-November 1, 2007, the daughter

notified Petitioner Agency of suspicions she had concerning her

mother’s care at Respondent facility April 5-10, 2007. The

Agency sent Mr. Brooker to investigate. Mr. Brooker classified

Respondent’s failure to notify the resident’s health care

provider of her change of condition on April 8, 2007, as a Class

II violation, because hospital records on April 10, 2007, showed

a fractured hip. He classified the facility's record-keeping

inaccuracies as a Class II violation, because Hydrocodone and

Lorazepam were involved; because abnormal levels of Lorazepam

were found in the resident’s blood on April 10, 2007; and

because of the serious harm drugs such as Hydrocodone and

Lorazepam can cause. His assessment is not contrary to the

Agency’s charging pattern statewide.

CONCLUSIONS OF LAW

59. The Division of Administrative Hearings has

jurisdiction over the parties and subject matter of this cause,

pursuant to Sections 120.569 and 120.57(1), Florida Statutes

(2007).

60. For the proposed penalties in the Administrative

Complaint, the Agency is required to prove the allegations

against Respondent by clear and convincing evidence. Department

of Banking and Finance Division of Securities and Investor

Protection v. Osborne Stern and Co. , 670 So. 2d 932 (Fla. 1996)

61. Deficiencies from criteria established by rule or

statute for the operation of an ALF are classified in Section

429.19, Florida Statutes (2007).

62. If Respondent Crystal Gem is found to have committed a

State Class II deficiency, Crystal Gem would be subject to a

fine of not less than $1,000.00 and not more than $5,000.00 for

each Class II deficiency pursuant to Section 429.19(2)(b),

Florida Statutes (2007). In this case, the Agency seeks only

$1,000.00 per count.

63. Florida Administrative Code Rule 58A-5.0185(5)(b)

requires:

The facility shall maintain a daily

medication observation record (MOR) for each

resident who receives assistance with self-

administration of medications or medication

administration. A MOR must include the name

of the resident and any known allergies the

resident may have; the name of the

resident's health care provider, the health

care provider's telephone number; the name,

strength, and directions for use of each

medication; and a chart for recording each

time the medication is taken, any missed

dosages, refusals to take medication as

prescribed, or medication error. The MOR

must be immediately updated each time the

medication is offered or administered.

64. Florida Administrative Code Rule 58A-5.0182(1)

provides:

58A-5.0182 Resident Care Standards.

An assisted living facility shall provide

care and services appropriate to the needs

of resident accepted for admission to the

facility.

(1) SUPERVISION. Facilities shall offer

personal supervision, as appropriate for

each resident, including the following:

(a) Monitor the quantity and quality of

resident diets in accordance with Rule 58A-

5.020, F.A.C.

(b) Daily observation by designated staff

of the activities of the resident while on

the premises, and awareness of the general

health, safety, and physical and emotional

wellbeing of the individual.

(c) General awareness of the resident's

whereabouts. The resident may travel

independently in the community.

(d) Contacting the resident's health care

provider and other appropriate party such as

the resident's family , guardian, health care

surrogate, or case manager if the resident

exhibits a significant change ; contacting

the resident's family guardian, health care

surrogate, or case manager if the resident

is discharged or moves out.

(e) A written record, updated as needed, of

any significant changes as defined in

subsection 58A-5.0131(33), F.A.C., any

illnesses which resulted in medical

attention, major incidents, changes in the

method of medication administration, or

other changes which resulted in the

provision of additional services. (Emphasis

supplied)

65. Florida Administrative Code Rule 58A-5.0131 defines:

(10) "Deficiency" means an instance of non-

compliance with the requirements of Part

III, Chapter 400, F.S., and this rule

chapter.

* * *

(15) "Health care provider" means a

physician or physician's assistant licensed

under Chapter 458 or 459, F.S., or advanced

registered nurse practitioner licensed under

Chapter 464, F.S.

* * *

(33) "Significant change" means a sudden or

major shift in behavior or mood, or a

deterioration in health status such as

unplanned weight change, stroke, heart

condition, or stage 2, 3, or 4 pressure

sore. Ordinary day-to-day fluctuations in

functioning and behavior, a short-term

illness such as a cold, or the gradual

deterioration in the ability to carry out

the activities of daily living that

accompanies the aging process are not

considered significant changes. (Emphasis

supplied)

66. Herein, the issue with regard to medications is more

than a little confusing. The CSCR shows five Hydrocodone

tablets were used in four and a half days; the MOR relates that

only three Hydrocodone tablets were used in that period. The

Observation Log shows that four such tablets were used. The

CSCR relates that nine Lorazepam tablets were used in the same

period of time and the MOR matches. The daughter acknowledged

the accuracy of the CSCR upon discharge, but there is now no way

to verify how many pills were in either bottle at the time of

the resident's discharge from the facility or at the time of

admission to the hospital, five or more hours after the resident

was discharged from the facility.

67. The "match" of the MOR and CSCR was achieved by

inaccurate staff record-keeping, contrary to facility protocol.

Respondent's personnel did not follow the facility's own

policies and procedures for assisting residents with self-

administration of Hydrocodone and Lorazepam and the MOR was

inaccurate and not up-to-date for Coumadin, Hydrocodone, and

Lorazepam. Furthermore, absent an actual consultation with

Ms. Clair, Ms. Erick's signing Ms. Clair's name to the CSCR

could be conducive to fraud and/or mistake in the administration

of medications.

68. However, no expert medical evidence was presented to

show that any of the drugs other than Lorazepam and/or

Hydrocodone, ingested or not ingested by the resident, caused or

even threatened her with any harm.

69. Also, based on the credible evidence as a whole,

particularly the paramedic's testimony that the Narcon she

administered would not affect Lorezepam levels and the hospital

test showing Lorezepam was at a negligibly abnormal level at

5:10 p.m., it is not possible to assign "a direct threat," by

the facility, based on the administration of Lorezepam prior to

8:30 a.m., on April 10, 2007.

70. The MOR and CSCR cannot resolve the issue of whether

or not the resident self-administered Hydrocodone and/or

Lorazepam before she left the facility on April 10, 2007. Also,

the Agency's theory that the discrepancy in the MOR and CSCR

showing under-medication automatically results in proof of over-

medication is not persuasive. Despite the probable flushing of

Hydrocodone from the resident's system in the ambulance sometime

between 2:01 and 2:40 p.m., the number of missing tablets, as

presented in this case, does not necessarily establish that

there was an overdose of either drug. Even if the resident had

ingested one Hydrocodone tablet on April 10, before leaving the

facility, as the CSCR shows, that would not have been an

"overdose," pursuant to her prescription. Likewise, if she had

ingested one Lorazepam tablet before leaving the facility, it

would not have been an "overdose," pursuant to her prescription.

Even combining one tablet of the narcotic pain-killer and one

tablet of the sedative for anxiety would have been appropriate

per her prescriptions.

71. As to Count I of the Administrative Complaint,

Respondent has not been proven guilty of a Class II deficiency.

72. As to Count II of the Administrative Complaint, Agency

employees sincerely believed the resident broke her hip on

April 8, 2007, but there is no clear evidence to that effect.

The "clear and convincing evidence" test does not permit

speculation on whether the hip injury occurred at home on

April 4; at the facility on April 8; on the way into the home on

April 10, or at any other time prior to checking into the

hospital on April 10, 2007.

73. Indeed, the Agency has not specifically charged

Respondent with responsibility for the resident's broken hip.

Rather, based on a concept that on April 8, the resident first

complained of right hip pain; first took two Hydrocodone pills;

first used a wheelchair; and had first decreased appetite (or at

least consumed less food than usual), the Agency asserts that

the changes in her condition on April 8, were sufficiently

"significant" for Respondent's staff to have called in her

personal physician. As "evidence" that staff recognized the

change was "significant" enough to require calling the doctor,

the Agency points to Ms. Erick's phone call that day to the

daughter.

74. The symptoms for April 8, 2007, that Ms. Erick

described at hearing and that the Observation Log

contemporaneously memorialized in writing from Ms. Erick and

another staff member, do not show a sudden onset of symptoms in

the right hip ( See Findings of Fact 13 and 37) and do not equate

with anything the April 4, 2007, Hospital Instructions indicated

were significant ( See Finding of Fact 15). If anything, the

wheelchair was a reasonable precaution to prevent future falls.

The resident's prescription permitted ingestion of pain

medication eight hours apart, as needed, and after taking two

Hydrocodone tablets a.m. and p.m. on April 8, the amount of pain

medication requested by the resident decreased on April 9.

There is no evidence of a pattern of decreased appetite or

weight loss or of sustained greater medication. The changes

observed by facility staff on April 8, were more in the nature

of "ordinary day-to-day fluctuations in functioning and

behavior" or "gradual deterioration in the ability to carry out

the activities of daily living that accompanies the aging

process." They were not any of the "significant" changes

specifically enumerated in Florida Administrative Code Rule 58A-

5.0131 (33). Moreover, to hold that simply notifying the family

of a change in ambulation and, by agreement with the family,

monitoring the situation for a short period is equivalent to

failing to report a significant change, would have a chilling

effect on communication of ALFs with families.

75. The facts alleged in Count II of the Administrative

Complaint have not been proven to constitute a deficiency.

RECOMMENDATION

Based on the foregoing Findings of Facts and Conclusions of

Law, it is

RECOMMENDED that the Agency for Health Care Administration

enter a final order finding Respondent not guilty of a Class II

deficiency under Count I of the Administrative Complaint and not

guilty of a Class II deficiency under Count II of the

Administrative Complaint.

DONE AND ENTERED this 31st day of October, 2008, in

Tallahassee, Leon County, Florida.

S

___________________________________

ELLA JANE P. DAVIS

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

[phone] SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 31st day of October, 2008.

ENDNOTES

1/ The Transcript’s “Index” omits mention of Ms. Clair’s

testimony, which may be found at TR-198-208.

2/ Petitioner’s references, expressed as “. . . for example,

Crystal Gem exhibit 1, page 3, is referred to as ‘CG 1, p. 3’;

and line 26 of page 52 of the hearing transcript are referred to

as ‘TR p. 52, l. 26,'” is difficult to follow, mostly because

product. It is respectfully suggested that Petitioner

henceforth adopt the exhibit marking system assigned by the Pre-

hearing Stipulation, at final hearing, or by common usage, and

eliminate isolating “lines” when citing to the Transcript.

Petitioner’s use of decimal points for sub-paragraphs of

proposed findings of fact and conclusions of law is unusual, but

not inappropriate, given that usage in the Pre-hearing

Stipulation.

3/ All the resident's meals were not recorded in percentages.

According to the Observation Log, on April 5, she "ate well" at

mealtime. On April 6, she only ate pudding and juice at

breakfast and 75% of her lunch. On April 7, she ate 45%

breakfast and 50% lunch and refused dinner but opted for an

Ensure milkshake. On April 8, in addition to 25% of breakfast,

she ate 75% of another meal and a later snack. On April 9, she

ate a "fair" lunch. Neither intake nor lack of intake of food

was recorded for April 10, 2007. See also Finding of Fact 5,

for her pre-admission eating history..

4/ Each party has proposed a finding of fact based upon their

contrary interpretations of the nurse/neighbor's testimony at TR

28-30, concerning what the resident told her about medication.

However, even assuming, arguendo , that the resident, a sleepy,

84-year-old woman, with a minor history of dementia, would be a

credible witness, the resident's out-of-court statement to the

neighbor is inadmissible hearsay.

5/ As opposed to "hypertensive,” with high blood pressure, or

“hypotensive,” with low blood pressure,

COPIES FURNISHED:

James Harris, Esquire

Agency for Health Care Administration

The Sebring Building, Suite 330H

525 Mirror Lake Drive North

St. Petersburg, Florida 33701

Theodore E. Mack, Esquire

Powell & Mack

803 North Calhoun Street

Tallahassee, Florida 32303

Richard Shoop, Agency Clerk

Agency for Health Care Administration

2727 Mahan Drive, Mail Station 3

Tallahassee, Florida 32308

Craig H. Smith, General Counsel

Agency for Health Care Administration

Fort Knox Building, Suite 3431

2727 Mahan Drive, Mail Station 3

Tallahassee, Florida 32308

Holly Benson, Secretary

Agency for Health Care Administration

Fort Knox Building, Suite 3116

2727 Mahan Drive, Mail Station 3

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.