12-000799MPI Agency For Health Care Administration vs. Valary Campbell Status: Closed Recommended Order on Thursday, July 12, 2012.

Summary: $10,000 fine for seven violations of core competency training and three violations of medication administration validation by Medicaid provider whose corporation operates a group home for the developmentally disabled.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

AGENCY FOR HEALTH CARE )

ADMINISTRATION , )

)

Petitioner , )

)

vs. ) Case No. 12 - 0799MPI

)

VALARY CAMPBELL , )

)

Respondent . )

)

RECOMMENDED ORDER

On May 16, 2012, Robert E. Meale, Administrative Law Judge

of the Division of Administrative Hearings, conducted the final

hearing by videoconference in Tallahassee and Miami, Florida.

APPEARANCES

For Petitioner: Jeffries Duvall, Esquire

Assistant General Counsel

Agency for Health Care Administration

Fort Knox Building 3, Mail Stop 3

2727 Mahan Drive

Tallahassee, Florida 32308

For Respondent: Randy A. Fleischer, Esquire

Law Offices of Randy A. Fleischer, P.A.

8258 State Road 84

Davie, Florida 33 324

STATEMENT OF THE ISSUE S

The issues are whether , contrary to section 409.913,

Florida Statutes, and Florida Administrative Code Rule

59G - 9.070, Respondent has committed violations in core -

competency tr aining for nine employees (Eula Brown, Natasia

Bernard, Lorine Smiley - Lewin, Taneish Mayers, Irene Thompson,

Therese Etienne, Adrae McCalla, Marline Ford, and

Cynthia Phinn ), " medication administration/validation tra ining "

for seven employees (Ms. Bernard , Ms. Smiley - Lewin, Ms. Mayers,

Ms. Thompson, Ms. Etienne, Ms. Ford, and Ms. Phinn ), service

authorizations for two consumers (J. B. and L. H.), and Level 2

background sc reening and HIPAA training for one employee

(M s. Ford).

If Respondent is guilty of a ny of these violations , an

additional issue is the fine that should be imposed.

PRELIMINARY STATEMENT

On January 18, 2012, Petitioner mailed to Respondent a

letter stating that it intended to impose a fine of $20,000 for

the violations listed in the Statement of the Issues.

Respondent timely requested a formal hearing.

At the hearing, Petitioner called two witnesses and off ered

into evidence seven exhibits: Petiti oner Exhibits 1 - 6 and 12.

Respondent called one witness and offered into evidence five

exhibits: Respondent Exhibits 4 - 6, 8, and 10. All exhibits

were admitted.

The court reporte r filed the transcript on June 19 , 2012.

The parties filed proposed recomm ended orders on July 6, 2012 .

FINDING S OF FACT

1. At all material times, Respondent owned half of the

shares of Glory House USA, Inc., which, for ten years has

operated one or more group homes for the developmentally

disabled. At all material times, Resp ondent has been a Medicaid

provider of services under the Florida developmental

disabilities waiver program . For 2011, Respondent received

$790,367.16 in Medic aid reimbursements for services provided to

14 Medicaid consumers.

2. At all relevant times, Re spondent has been subject to a

Medicaid Provider Agreement. In this agreement, Respondent

agreed to comply with all federal, state, and local laws,

including rules, regulations, and statements of policy

applicable to the Medicaid program. In particular, Respondent

agreed to comply w ith Petitioner ' s Medicaid h andbooks .

3 . On September 29, 2011, Petitioner ' s inspectors

conducted an unannounced inspection of Glory House. During the

course of the inspection, Petitioner ' s inspectors spoke to

Respondent ' s home manager, who answered the i nspectors '

questions, supplied all of the requested documents that were

readily available, and took the inspectors on a tour of the

facility.

4. The Medicaid Developmental Disabilities Waiver Services

Coverage and Limitations Handbook issued by Petitioner ,

effective May 2010 (Medicaid Handbook) Appendix A identifies the

assurances required by Petitioner and the Agency for Persons

with Disabilities (APD) of providers of services under the

Developmental Disabilities Home and Community - Based Services

Waiver. Appendix A Section 2.1 imposes specific training

requirements on providers and their employees. Appendix A

Section 2.1.G imposes the requirement of core competency

training upon " [a]ll direct service providers . . . within 90

days of employment. "

5 . As of the date of the inspection, seven employees , who

had been employed by Respondent ' s corporation for over 90 days,

had not completed direct - care core competency training :

Ms . Brown, Ms. Bernard, Ms. Smiley - Levin, Ms. Mayers,

Ms. Thompson, Ms. Etien ne, and Ms. Phinn. Petitioner has thus

proved seven of the nine alleged violations of this training

requirement.

6 . Respondent ' s corporation employed Ms. Ford in July

2011, so she was still in her first 90 days of employment at the

time of the inspecti on and was not yet required to have

completed her core competency training . Petitioner seems to

have relied on an earlier date shown in Petitioner Exhibit 3 ,

but this date purports to show the date of the employee ' s

application, not the date of hire. The only evidence of

M s. Ford ' s hire date is the testimony of Respondent ' s daughter,

who is the assistant administrator , and she places the date of

hire in July 2011 .

7 . Ms. McCalla had completed the required training prior

to the site inspection. Certifica tes documenting this training

show that Ms. McCalla completed the APD Core Competency Training

I on September 14, 2006, and APD Core Competency Training II on

September 19, 2006. For the two reason s noted in the

Conclusions of Law, it is irrelevant that Respondent may not

have provided the certificate to the inspectors at the time of

the inspection, so the Administrative Law Judge declines to make

a finding of fact on whether Respondent provided thes e

certificates to Petitioner at the time of the inspection or

within the 15 additional days allowed by the inspector for the

provision of documents, as noted below .

8 . On the other hand, Respondent ' s argument that core

competency training was only require d of employees providing

unsupervised direct care to consum ers is unsupported by the

above - cited provision of the Medicaid Handbook .

9 . The allegation as to " medication

administration/validation training " is a composite allegation.

As noted in the Conc lusions of Law, certain employees of

providers must undergo medication administration training and

validation; these are separate requirements. Also, there is no

requirement of " validation training, " as suggested by

Petitioner ' s allegation.

1 0 . As of the date of the inspection, six of the seven

named employees had completed medicatio n administration

training. Ms. Ford was the only employee who had not completed

medication administration training, but she did not , at the

time, administer medication to consumers or supervise their

self - administration of medication . As explained in the

Conclusions of Law, the Administrative Law Judge has rejected

Petitioner ' s claim that Respondent had to affirmatively

designate those employees who were not allowed to adm inister

medications or supervise the self - administration of medications,

so the Administrative Law Judge declines to make a finding of

fact on whether Respondent so designated any such employees.

Petitioner has thus failed to prove any of the seven allege d

violations of this training requirement.

11 . As of the date of the inspection, three of the seven

named employees had current validation s for medication

administration : Ms. Mayers, Ms. Etienne, and Ms. Phinn. ( Like

Ms. Ford, though, Ms. Etienne did no t, at the time, administer

medication to consumers or supervise their self - administration

of medication , so Petitioner ' s proof as to Ms. Etienne fails on

two grounds . ) Because , as noted above, Ms. Ford was not

designated to administered medications or sup ervise the self -

administration of medications, Petitioner has thus proved three

of the seven alleged violations of the validation requirement :

Ms. Bernard, Ms. Smiley - Lewin, and Ms. Thompson lacked the

required validations .

12 . As of the date of the inspection, one employee -- the

peripatetic Ms. Ford -- had not completed HIPAA training .

However, the record fails to establish the specific details of

this requirement. In its proposed recommended order, Petitioner

has relied on tw o documents: the Non - Institutional Medicaid

Provider Agreement (Petitioner Exhibit 1, p. 16), which states

only: " The provider agrees to comply with local, state, and

federal laws, as well as rules, regulations, and statement of

po l icy applicable to the Medicaid program, including the

Medicaid . . . Handbooks . . . " ; and the Medicaid Handbook,

which states:

Florida Medicaid has implemented all of the

requirements contained in . . . HIPAA.

[A]ll Medicaid providers, including their

staff . . ., must compl y with HIPAA privacy

requirements. Providers who meet the

definition of a covered entity according to

HIPAA must comply with HIPAA Electronic Data

I nterchange (EDI) requirements. . . .

For the reason noted in the Conclusions of Law, Petitioner has

failed to prove its alleged HIPAA - training violation.

13 . As of the date of the inspection, Ms. Ford had

submitted unspecified docum entation sufficient to allow the

Department of Children and Family Services (DCF) to issue a

letter, dated June 29, 2011, documen ting " the final results of a

criminal history records check received by [DCF], required by

Florida Statute for the below stated program, " which is noted as

an " APD Foster/Group Home. " The letter further states: " [DCF]

received the complete criminal histo ry records for [Ms. Ford].

Nothing was found in the Department ' s review that disqualifies

the individual from serving in the program . . . for which this

screening was requested and is required by law. " The letter

adds that " [t]his screening remains valid for five years

providing the applicant does not have a 90 day break in

service . . . . "

14 . T he Medicaid Handbook , at page 55, states:

Direct service provider applicants must

comply with the requirements of a level 2

screeni ng in accordance with section 435.04,

F.S. Compliance with this requirement may

be accomplished through one of two ways:

ƱBack ground screening pursuant to

s. 393.0655, F.S., or Applicants must submit

a fingerprinting card, an affidavit of good

moral char acter, a caretaker information

sheet, and a chec k . . . to DCF for

processing. . . . The results of this

screening will be submitted with the

Medicaid enrollment application.

ƱBackground screenings pursuant to section

409.907, F.S. Applicants must submi t a

fingerprint card with the Medicaid

Enrollment Application and a check made

payable to the Medicaid fiscal agent for

processing; or, if available, the applicant

may submit the screening through an approved

live scan location.

Screening is performed a t the time of

enrollment and every five years thereafter.

It is the responsibility of the applicant or

provider to ensure this request for

screening or rescreening is submitted for

processing in a timely manner.

15 . Assuming that the cited provisions im pose any duty

upon Respondent beside ensuring that the employee or prospective

employee timely submits her request for screening or

rescreening, it is difficult to understand how Ms. Ford ' s

screening document fails to satisfy the second alternative in

the first bulleted paragraph. I t certainly appears that

Ms. Ford submitted the required items to DCF for processing, and

DCF found nothing to prevent her employment at Glory House.

Further confirming its responsiveness to the screening

requirement in the Med icaid Handbook, the DCF letter even notes

that it is good for five years. Petitioner has thus failed to

prove its alleged screening violation.

16 . Medicaid Handbook Appendix A Section 3.6.E states that

a provider may " [b]ill for only those services for which an

approved service authorization has been received. . . . Copies

of service authorizations shall be kept on file by the provider

and shall be made available to APD, [Petitioner], or their

authorized representatives for monitoring purposes. "

17 . As of the date of the inspection, L. H. and J. B. had

c urrent service authorization s. The terms of these

authorizations were July 1, 2011, through June 30, 2012.

Petitioner has thus failed to prove the two service

authorization violations.

18 . By let ter hand delivered to the home manager on

September 29, 2011, Petitioner provided Respondent with an

additional 15 days to provide, among other things, all employee

records, including level 2 background screens. T he letter is

not free f rom ambiguity, larg ely because it is a form for use in

a Medicaid - overpayment case that , in this case, covers a list of

items that Respondent needed to provide Petitioner following the

inspection. In any event, the letter cannot be interpreted as

extend ing the time for comp liance wit h the underlying

requirements. I n other words, if an employee obtained a medical

administration validation on October 5, 2011, it would not

obviate the violation. As the Administrative Law Judge noted at

the hearing, such an interpretation of t he letter would enable

providers to ignore many Medicaid program requirements until

Petitioner conducted an inspection and then avoid any sanctions

by belatedly coming into compliance -- after the inspection

uncovered violations .

19 . There is no indicatio n of prior offenses by Respondent

under the Medicaid program. Thus, as defined in the rule

discussed in the Conclusions of Law, the ten proved vio lations

all are a first offense for the purpose of identifying the

proper fine per violation .

CONCLUSIONS OF LAW

20 . The Division of Administrative Hearings has

jurisdiction. §§ 120.569, 120.57(1), and 409.913(31), Fla.

Stat.

21 . Section 409.913(15)(e), Florida Statutes, authorizes

Petitioner to seek any remedy provided by law if a provider

fails to comply wit h any provision in the Medicaid Handbook, the

provider agreement, or any Florida or federal statute, rule, or

regulation. Section 409.913(16)(c) authorizes Petitioner to

impose a fine of up to $5000 for each act described in Section

409.913(15).

2 2 . Fl orida Administrative Code Rule 59G - 9.070(3)(q)

defines a " violation " as any " omission or act " contrary to the

Medicaid laws. Rule 59G - 9.070(7)(e) provides a fine of $1000

per violation, if a first offense, for a failure to comply with

Medicaid laws. Rule 59G - 9.070(3)(h) defines an " [o]ffense " as

all of the violations contained in an audit report. Rule

59G - 9.070(4)(d) limits the cumulative fine to $20,000 resulting

from a case that involves only " violations " that constitute a

first offense and does not in volve an alleged overpayment.

23 . Florida Administrative Code Rule 59G - 13.083 applies to

Medicaid providers of developmental disabilities waiver

services. As in effect at the time of the September 2011

inspection, r ule 59G - 13.083( 2) incorporated the May 2010 edition

of the Medicaid Handbook into r ule 59G - 4.001 , which requires

that all Me dicaid providers comply with their service - specific

coverage and limitations handbook.

24 . Petitioner must prove the material allegations by

clear and convincing evi dence. Dep ' t of Banking & Fin. v.

Osborne Stern, Inc. , 670 So. 2d 932, 935 (Fla. 1996).

25 . The requirement of core competency training is imposed

by Medicaid Handbook Appendix A Section 2.1.G directly on the

" provider and its employees, " as stated by the above - cited

introdu ctory provision of Section 2.1.G .

26 . It is irrelevant whether Respondent failed to produce

Ms. McCall a ' s core - competency certificate during the inspection

or in the additional 15 days allowed by the letter of

Septe mber 29, 2011. First, Petitioner has predicated its core -

competency allegations on Appendix A Section 2.1.G, which is a

requirement of training, not documentation of training. Second,

even if Section 2.1.G spoke in terms of documentation, t he

present pro ceeding is de novo , as provided by s ection

120.57(1)(k), Florida Statutes, and the de novo nature of this

proceeding overrides any agency requirement that the provider

supply the required documentation during ( or shortly after ) the

inspection. Wistedt v. Dep ' t of HRS , 551 So. 2d 1236, 1237

(Fla. 1st DCA 1989). When applied to a documentation

requirement, Wistedt relieves the regulated party of the

requirement of providing documentation prior to the formation of

proposed agency action. To avoid a violation, the provider or

its employee may produce at hearing the required documentation

that was in effect at the time of the date cited by Petitioner

as the effective date of the alleged violation.

27 . Florida Administrative Code Rule s 65G - 7 .001 and

65G - 7.004 address the administration of medication. Rule

65G - 7.001(13) defines a " medication assistance provider " as:

a direct service provider not otherwise

licensed to administer medication who has

successfully completed an agency - approved

training course and has current validation

to provide clients with medication

administration or to assist clients with

self - administr ation of medication.

Pursuant to r ule 59G - 7.001(30), " v alidation " is obtained from a

physician or registered nurse following a demonstration of

competence in administering medication by an unlicensed direct

service provider who has completed medication ad ministration

training .

28 . An employee is required to updat e her validation

annually. Fla. Admin. Code R. 65G - 7.004(6). Although the rules

do not explicitly so provide, an employee is ordinarily required

to complete successfully medication administration training only

once: Rule 65G - 7.004(7) requires the retaking of medication

administration training only if the employee allows her

validation to lapse. Implicitly appl ying to the employer -

provider, r ule 65G - 7.004(6) warns: " An unlicensed provider may

not under any circumstances administer or supervise the self -

administration of medication before receiving validation or

following expiration of an annual validation. "

29 . The requirements of r ules 65G - 7.001 and 65G - 7.004 are

imposed directly on the employee seeking authority to admi nister

medication or supervise the self - administration of medication ,

and the above - cited prohibition of r ule 65G - 7.004(6) applies

implicitly to the employer - provider . It i s irrelevant whether

certain employees whose validations were not current at the time

of the inspection later obtained their validations . The cited

rules are requirements of training and validation, not

documentation of training and validation. Also, as noted in

the se Conclusions of Law, even if the requirements imposed

duties of documentation, the operative date for determining

compliance is the date of inspection, not the end o f the 15 - day

additional period or any later date.

30 . Petitioner argues th at Respondent failed to

affirmatively designate Ms. Ford as an employee not authorized

to administer medications or supervise the self - administration

of medications. (This issue is moot as to Ms. Etienne because

she had been trained and validated at the t ime of the

inspection.) In support of its argument, Petitioner cites

Medicaid Handbook Appendix A Section 3.0.B.3 , which states:

. . . APD requires that each provider type

and those providing the services below

develop written policies and procedures for

the provision of services to recipients

under the Medicaid waiver:

* * *

B. The provider ' s policies shall address,

at a minimum, the following:

* * *

3. Policies and procedures, which detail

the safe administration and handling of

medication in order to assure the health and

safety of recipients served; if it is the

policy of the provider that the provider or

the provider ' s staff should not administer

or assist in administration of medication,

th is should be clearly stated[.]

31 . Petitioner ' s reliance on this provision from the

Medicaid Handbook is misplaced for two reasons. First, by the

use of " should, " Section 3.0.B.3 fails to state a clear

requirement, whose violation may support a fine. T he alleged

" requirement " that the provider clearly d esignate staff who are

not authorized to administer medication or supervise the self -

administration of medication is in actuality merely a

recommendation .

32 . Second, unlike t he requirement of Section 2.1.G ,

discussed above, the requirement of Section 3.0.B.3 is not

imposed directly on the provider or its staff, in terms of a

requirement to which they must conform, but is imposed on the

provider in terms of policies that it must adopt. If Respondent

ha s failed to designate affirmatively in written materials those

staff who are not authorized to administer medication or

supervise the self - administration of medication, Petitioner

could have cited this failure to adopt a policy (or procedure)

as a violation of Section 3.0.B.3. But Petitioner may not read

this provision of Appendix A into Respondent ' s policy manual

and, citing this otherwise - nonexistent policy, attempt to rebut

Respondent ' s defensive claim that Ms. Ford was not authorized to

deal wi th medications.

33 . Petitioner has failed to identify the legal grounds

for its allegation that Respondent is liable for a failure of

Ms. Ford to complete HIPAA training. Relying on provisions that

effectively subject the provider to all federal law, i ncluding

HIPAA, Petitioner has failed to provide Respondent or the

Administrative Law Judge with the specific detail of the

requirement of HIPAA training, which, at least for Respondent

and the Administrative Law Judge, remains buried within myriad

federal statutes and regulations. A fine may not be predicated

on such vague allegations without violating Respondent ' s due

process rights. See , e.g. , Cottrill v. Dep ' t of Ins. , 685 So.

2d 1371, 1372 (Fla. 1st DCA 1996).

34 . Even assuming that the cited prov isions concerning the

alleged violation of the background screening requirement impose

duties on Respondent, other than to ensure that the employee

timely submits her request for screening or rescreening,

Petitioner has failed to prove that the evidence of screening

for Ms. Ford is in any respect deficient.

35 . Petitioner has failed to prove that Respondent did not

have current service authorizations for L. H. and J. B. at the

time of the inspectio n. For the reasons noted above , in the se

Conclusions of Law, any failure to have the required

documentation available at the time of the inspection itself is

irrelevant because the documentation was in existence as of that

time.

3 6 . Petitioner has thus proved seven violations of the

core competency training requirement and three violations of the

medication administration validation requirement. These ten

violations are a first offense for determining the amount of the

fine, which is $1000 per violation.

RECOMMENDATION

I t is RECOMMENDED that the Agency for Health Care

Administration enter a final order finding Respondent guilty of

seven violations of the core competency training requirement and

three violations of the medication administration validation

requirement and imposing a fine of $10,000.

DONE AND ENTERED this 12th day of July, 2012 , in

Tallahassee, Leon County, Florida.

S

ROBERT E. MEALE

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 12th day of July, 2012.

COPIES FURNISHED :

Jeffries H. Duvall, Esquire

Agency for Health Care Administration

Fort Knox Building 3, Mail Stop 3

2727 Mahan Drive

Tallahassee, Florida 32308

[e-mail]

Randy A. Fleischer, Esquire

Randy A. Fleischer, P.A.

8258 State Road 84

Davie, Florida 33324

[e-mail]

Richard J. Shoop, Agency Clerk

Agency for Health Care Administration

2727 Mahan Drive, Mail Stop 3

Tallahassee, Florida 32308

Stuart Williams, General Counsel

Agency for Health Care Administration

2727 Mahan Drive, Mail Stop 3

Tallahassee, Florida 32308

Elizabeth Dudek, Secretary

Agency for Health Care Administration

2727 Mahan Drive, Mail Stop 1

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.