04-003249 Florida Academy Of Cosmetic Surgery, Inc. vs. Department Of Health, Board Of Medicine Status: Closed Recommended Order on Tuesday, August 9, 2005.

Summary: Petitioner is not entitled to approval as an office surgery accrediting organization because it failed to include all relevant adverse incident reports with its application.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

FLORIDA ACADEMY OF COSMETIC )

SURGERY, INC., )

)

Petitioner, )

)

vs. ) Case No. 04 - 3249

)

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE, )

)

Respondent. )

)

RECOMMENDED ORDER

A formal hearing was conducted in this case on April 26,

2005, in Tallahassee, Florida, before Suzanne F. Hood,

Administrative Law Judge with the Division of Administrative

Hearings.

APPEARANCES

For Petitioner: Alfred W. Clark , Esquire

Post Office Box 623

Tallahassee, Florida 32302 - 0623

For Respondent: Edward A. Tellochea, Esquire

Office of the Attorney General

Department of Legal Affair s

The Capitol, Plaza Level 01

Tallahassee, Florida 32399 - 1050

STATEMENT OF THE ISSUE

The issue is whether Respondent properly denied

Petitioner's application for approval as an office surgery

accrediting o rganization pursuant to Section 459.309(3), Florida

Statutes, and Florida Administrative Code Rule 64B8 - 9.0092.

PRELIMINARY STATEMENT

On July 12, 2004, Petitioner Florida Academy of Cosmetic

Surgery (FLACS) filed an application for approval as an office

s urgery accrediting organization pursuant to Section 458.309,

Florida Statutes (2004) and Florida Administrative Code Rule

64B8 - 9.0092. On August 20, 2004, Respondent Department of

Health (DOH), Board of Medicine (Board), issued a Notice of

Intent to Deny the application.

On or about September 2, 2004, FLACS filed a Petition for

Formal Administrative Proceedings pursuant to Sections 120.569

and 120.57(1), Florida Statutes (2004). On September 17, 2004,

the Board referred the petition to the Division of

A dministrative Hearings (DOAH). DOAH assigned the case DOAH

Case No. 04 - 3249.

On September 28, 2004, the undersigned issued a Notice of

Hearing, scheduling DOAH Case No. 04 - 3249 for hearing on

December 13, 2004. Pursuant to the Board's unopposed Motion f or

Continuance dated December 1, 2004, the undersigned rescheduled

DOAH Case No. 04 - 3249 for hearing on February 23 and 24, 2005.

On February 4, 2005, FLACS filed a Petition for an

Administrative Determination of the Invalidity of Florida

Administrative Code Rule 64B8 - 9.0092. DOAH assigned the rule

challenge DOAH Case No. 05 - 0402RX.

On February 4, 2005, FLACS filed an unopposed Motion to

Consolidate DOAH Case Nos. 04 - 3240 and 05 - 0402RX. An Order of

Consolidation dated February 15, 2005, granted the m otion.

On February 14, 2005, the Board filed an unopposed

Motion for Continuance. An Order Granting Continuance and

Re - scheduling Hearing was entered on February 17, 2005,

rescheduling the hearing for April 25 and 26, 2005.

By letter dated April 18, 200 5, the parties advised the

undersigned that they required only one day for hearing and

requested that the hearing commence on April 26, 2005. The

undersigned granted the parties' request via telephonic

communication.

During the hearing, the parties offe red one joint exhibit,

which was accepted as evidence. FLACS presented the testimony

of two witnesses and offered four exhibits that were accepted as

evidence. The Board presented the testimony of two witnesses

and offered five exhibits that were accepte d as evidence. At

the conclusion of the hearing, the parties agreed to file late -

filed depositions and exhibits in lieu of testimony during the

hearing.

During the final hearing, the parties also agreed to file

separate proposed orders for DOAH Case Nos . 04 - 3249 and 05 -

0404RX. Accordingly, the cases are hereby deconsolidated. 1

On May 13, 2005, the court reporter filed the Transcript of

the proceedings.

On May 17, 2005, the Board filed the deposition of

Charles E. Grapper, M.D., D.D.S.

On May 19, 200 5, the undersigned issued an Order Granting

Agreed Motion for Extension of Time to file proposed orders.

On May 27, 2005, FLACS filed the deposition of R. Gregory

Smith, M.D.

The Board filed the deposition of Jerry A. Cohen, M.D. and

Rina A. Palladino on M ay 31, 2005, and June 1, 2005,

respectively.

On June 13, 2005, the Board filed an unopposed Motion for

Extension of Time to file proposed recommended orders.

FLACS filed its Proposed Recommended Order on June 21,

2005. The Board filed its Proposed Reco mmended Order on

June 22, 2005.

All citations hereinafter shall refer to Florida Statutes

(2004) unless otherwise indicated.

FINDINGS OF FACT

1. In Florida, physicians who perform certain surgical

procedures in their offices are required to register the o ffice

with DOH. Additionally, DOH must inspect such offices unless a

nationally recognized accrediting agency or an accrediting

organization approved by the Board inspects and accredits the

offices every three years. See § 458.309(3), Fla. Stat. and

Fla. Admin. Code R. 64B8 - 0.0091.

2. Florida Administrative Code Rule 64B8 - 9.0092, entitled

"Approval of Physician Office Accrediting Organizations,"

purports to establish requirements that FLACS must meet in order

to achieve the Board's approval to operate as an accrediting

organization.

3. FLACS is a not - for - profit corporation, organized for

the following purposes: (a) to promote office safety through

its accreditation activities; (b) to promote cosmetic surgery;

and (c) to provide continuing education co urses related to

office surgery. FLACS was formed in 1999 and, since that time,

has participated actively in office surgery issues considered by

the Board.

4. The Board approved FLACS as an accrediting organization

early in 2001. In January 2003 FLACS filed a complete renewal

application, seeking the Board's approval to continue operating

as an office surgery accrediting organization. The Board denied

the application and, after a formal administrative hearing,

entered a Final Order denying FLACS's app lication. See Florida

Academy of Cosmetic Surgery, Inc. v. Board of Medicine , Case No.

DOH - 04 - 0661 - FOF - MQA (Final Order, June 18, 2004)(adopting

Recommended Order in DOAH Case No. 03 - 3349, April 15, 2004.)

5. FLACS filed a new application for approval a s an office

surgery accrediting organization on July 12, 2004. The Board

never advised FLACS whether its application was complete or

incomplete. There is evidence that a member of the Board's

staff, Melinda Grey, reviewed the application, finding it

inco mplete in many respects.

6. On August 5, 2004, Ms. Grey prepared a spreadsheet

entitled "Board of Medicine Staff Issues Regarding FLACS

Application." The spreadsheet compared the application with the

requirements of the applicable provisions of the Fl orida

Administrative Code, including Florida Administrative Code Rule

64B8 - 9.0092.

7. Larry McPherson, the Board's Executive Director, was

aware that Ms. Grey was reviewing FLACS's application. She did

not tell Mr. McPherson that the application was i ncomplete.

Instead, she informed the Board's legal counsel that FLACS had

filed the application. Subsequently, Ms. Grey placed the

application on the agenda for the Board's next scheduled

meeting.

8. On August 7, 2004, the Board voted to deny the new

application. On August 23, 2004, the Board entered an Notice of

Intent to Deny FLACS's new application on the following grounds:

1. When participating in accrediting

activities in the past, the applicant

violated Section 458.331(1)(nn), Florida

St atutes, by failing to comply with rules of

the Board in the following manner:

a. The applicant failed to provide

copies of accreditation reports and

corrective action plans to the Board office

within 30 days of completion of accrediting

activities in violation of Rule 64B8 -

9.0092(4)(e), Florida Administrative Code.

b. The applicant failed to immediately

report to the Department conditions in

physicians' offices that posed a potential

immediate threat to patients in violation of

Rule 64B8 - 9.0092( 4)(f), Florida

Administrative Code.

c. When inspecting and accrediting

facilities the applicant ignored its written

accreditation standards and failed to

provide the Board office with accreditation

standards under which it was actually

operating. Su ch facts reveal that the

applicant operated in violation of Rule

64B8 - 9.0092(4)(g), Florida Administrative

Code.

d. When inspecting the facilities, the

applicant operated with inadequate or

applied inconsistently its quality assurance

program in viol ation of Rule 64B8 -

9.0092(4)(a), Florida Administrative Code.

2. The applicant failed to provide

evidence of an adequate quality assurance

program as required by Rule 64B8 -

9.0092(4)(a), Florida Administrative Code.

3. The applicant failed to pr ovide

evidence of an adequate ongoing anesthesia

related accreditation and quality assurance

processes as required by Rule 64B8 -

9.0092(4)(c), Florida Administrative Code.

4. The applicant failed to submit

copies of all incident reports filed with

the state that originated at FLACS

accredited facilities as required by Rule

64B8 - 9.0092(4)(f), Florida Administrative

Code.

Uncorrected "Prior Errors"

9. After FLACS submitted its January 2003 "renewal"

application, the Board's staff met several times wi th FLACS to

discuss and "work out" problems that the Board had with FLACS's

office surgery accrediting procedures. These meetings, which

took place between January 2003 (when FLACS filed its renewal

application) and August 2003 (when the Board denied the renewal

application,) were supposed to result in changes to FLACS's

inspection procedures and to alleviate the Board's concerns

about FLACS' renewal application.

10. Apparently FLACS successfully implemented some changes

between the time that the Board denied FLACS's renewal

application in August 2003 and the time that the Board issued

the June 2004 Final Order in DOAH Case No. 03 - 3349. There is no

evidence in the instant case that FLACS committed the following

prior violations: (a) failed to provide D OH with accreditation

reports and corrective action plans required by Florida

Administrative Code Rule 64B8 - 9.0092(4)(e); and (b) awarded

accreditation retroactive to the inspection date.

11. Despite FLACS's effort to make needed changes in its

inspecti on processes, it failed to do so on several occasions.

First, on May 23, 2004, FLACS inspected the office of Anthony

Rogers, M.D. Even though Dr. Rogers had one crash cart

deficiency (missing the drug isuprel), FLACS's facility

inspection form indicates that Dr. Rogers passed the inspection.

FLACS did not receive confirmation that Dr. Rogers was in 100

percent compliance with the Board's rules regarding the mandated

crash cart medications until May 27, 2004. FLACS accredited

Dr. Rogers on that date base d on a packing slip/boxed content

list, showing receipt of the isuprel.

12. Second, FLACS inspected the office of Rodolfo Binker,

M.D., on May 22, 2004. FLACS's facility inspection form

indicates that Dr. Binker passed the inspection even though he

was m issing intubation forceps (McGill). FLACS did not receive

confirmation that Dr. Binker's monitoring and emergency

equipment included intubation forceps (McGill) until May 24,

2004. FLACS accredited Dr. Binker that same day based on an

invoice, showing th at the forceps had been ordered and shipped

to Dr. Rogers. The invoice does not indicate the date that

Dr. Rogers received the forceps.

13. Third, FLACS prefers for physicians who fail an

inspection to verify compliance with the Board's rules by

provid ing FLACS with a packing slip, showing receipt of the

missing drugs or equipment. However, the evidence indicates

that one of FLACS's inspectors sometimes accepts purchase

orders/invoices, which do not show actual receipt of the missing

items.

14. Four th, there is no evidence that FLACS failed to

advise DOH about conditions in any physician's office that posed

potential immediate jeopardy to patients as required by Florida

Administrative Code Rule 64B8 - 9.0092(4)(f). FLACS's application

states that "[a] ll deficiencies, including those which pose

potential immediate jeopardy, will be immediately reported to

the Department of Health and the Board." However, as a

practical matter, FLACS does not believe it is necessary to make

such a report as long as it n otifies the Board by telephone for

any circumstance that it believes constitutes an "immediate

threat" to a patient and provides the Board with copies of all

inspection materials, facility surveys, and compliance materials

on all FLACS accreditations. In other words, unless a patient

is in immediate danger, FLACS will leave it to DOH and the Board

to review all documentation and determine whether a physician's

office poses a "potential immediate threat."

15. Finally, Bruce Hirshman, D.O, is an anesthesi ologist

who participates in FLACS's ongoing anesthesia - related

accreditation and quality assurance processes. At some point in

time, FLACS accredited Dr. Hirshman's office surgery facility.

As of June 3, 2003, FLACS was aware that Dr. Hirshman had not

re gistered with the Board of Osteopathic Medicine and advised

him to do so. FLACS took no further action regarding

Dr. Hirshman's failure to register until May 2005. FLACS's

May 5, 2005, letter to Dr. Hirshman, stated as follows in

relevant part:

As of Apr il 28, 2004, the Florida Academy of

Cosmetic Surgery was informed by Ms. Rina

Palladino at the Florida Board of

Osteopathic Medicine that you had not

registered with the Florida Board of

Osteopathic Medicine to perform office

surgery. The Florida Academy of Cosmetic

Surgery is withdrawing your accreditation .

. . .

Rule 64B8 - 9.0092(2)(f) -- Adverse Incident Reports

16. Florida Administrative Code Rule 64B8 - 9.0092(2)(f)

requires an application for approval as an office surgery

accrediting organization to in clude copies of all incident

reports that accredited physicians file with the state. The

incident reports are defined by Section 458.351(4), Florida

Statutes, which reads as follows:

(4) For purposes of notification to

the department pursuant to thi s section, the

term "adverse incident" means an event over

which the physician or licensee could

exercise control and which is associated in

whole or in part with a medical

intervention, rather than the condition for

which such intervention occurred, and w hich

results in the following patient injuries:

(a) The death of a patient.

(b) Brain or spinal damage to a

patient.

(c) The performance of a surgical

procedure on the wrong patient.

(d) 1. The performance of a wrong -

site surgical procedure;

2. The performance of a wrong surgical

procedure; or

3. The surgical repair of damage to a

patient resulting from a planned surgical

procedure where the damage is not a

recognized specific risk as disclosed to the

patient and docume nted through the informed -

consent process if it results in: death;

brain or spinal damage; permanent

disfigurement not to include the incision

scar; fracture or dislocation of bones or

joints; a limitation of neurological,

physical or sensory function; or any

condition that required transfer of the

patient.

(e) A procedure to remove unplanned

foreign objects remaining from a surgical

procedure.

(f) Any condition that required

transfer of a patient to a hospital licensed

under Chapter 395, Flo rida Statutes, from

any facility or any office maintained by a

physician for the practice of medicine which

is not licensed under Chapter 395, Florida

Statutes.

17. The incident reports are further defined by Florida

Administrative Code Rule 64B8 - 9.001(1 )(a), which states as

follows in relevant part:

. . . an event over which the physician or

other licensee could exercise control and

which is associated in whole or in part with

a medical intervention, rather than the

condition for which such interventio n

occurred, and which results in the following

patient injuries:

1. The death of a patient.

2. Brain or spinal damage to a

patient.

3. The performance of a surgical

procedure on the wrong patient.

4. The performance of a wrong - site

surgical procedure, the performance of a

wrong surgical procedure; or the surgical

repair of damage to a patient resulting from

a planned surgical procedure where the

damage is not a recognized specific risk as

disclosed to the patient and documented

throu gh the informed - consent process and if

one of the listed procedures in the

paragraph results in: death; brain or

spinal damage; permanent disfigurement not

to include the incision scar; fracture or

dislocation of bones or joints; a limitation

of neurologi cal, physical or sensory

function; or any condition that required

transfer of the patient.

5. A procedure to remove unplanned

foreign objects remaining from a surgical

procedure.

6. Any condition that required

transfer of a patient to a hospi tal licensed

under Chapter 395, Florida Statutes, from

any facility or any office maintained by a

physician for the practice of medicine which

is not licensed under Chapter 395, Florida

Statutes.

18. FLACS understood that the "incident reports"

reference d in Florida Administrative Code Rule 64B8 - 9.0092(2)(f)

are the same as the "reports on adverse incident" defined by

Section 458.351, Florida Statutes, and Florida Administrative

Code Rule 64B8 - 9.001(1)(a). FLACS's application specifically

references adve rse incident reports as defined by Section

458.351, Florida Statutes. FLACS provided two such adverse

incident reports with its new application: (a) one filed by

Fabio Arturo Castro, M.D., from an incident that occurred on

November 24, 2003; and (b) one filed by Kurt S. Dangl, M.D.,

from an incident that occurred on September 25, 2003.

19. The new application did not include the following

incident reports that FLACS included with its January 2003

renewal application: (a) one filed by Robert Gregory Sm ith,

M.D., from an incident that occurred on August 16, 2001; and (b)

one filed by Rafael A. Fleites, M.D., from an incident that

occurred on March 9, 2002.

20. As of July 12, 2004, DOH had received a total of nine

(9) office incident reports from doctors ' offices that are, or

were at the time the incidents occurred, accredited by FLACS.

FLACS's accredited physicians did not provide it with the

following incident reports: (a) one filed by Michael Patipa,

M.D., from and incident that occurred on March 29, 2004; (b) one

filed by Constantino F. Mendieta, M.D., from an incident that

occurred on February 2, 2004; (c) one filed by Edward J. Gross,

M.D., from an incident that occurred on July 22, 2003; (d) one

filed by Timothy Fee, M.D., from an incident that oc curred on

November 11, 2003; and (e) one filed by Ramiro Morales, Jr.,

M.D., from an incident that occurred on April 9, 2002. The

Board's staff discovered that FLACS's application did not

provide copies of these five incident reports by reviewing

individu al physician office registration files.

21. FLACS has several methods to use in collecting

incident reports. First, FLACS requires its accredited

physicians and office surgery facilities to attest and

acknowledge that they are required to provide FLACS with any and

all adverse incident reports related to or following surgery in

the accredited offices. Second, FLACS requires the staff of

accredited offices to perform self - evaluation surveys after the

first and second year of accreditation, said surveys to include

such incident reports. Third, FLACS watches for information

about adverse incidents as reported by news media or complaints

from the public.

22. Most important, FLACS can make quarterly public record

requests for the reports even though the state system of record

keeping for adverse incident reports is not computerized. There

is no persuasive evidence that FLACS ever made an oral or

written public records request for copies of incident reports

related to its accredited physicians and office surgery

facilities.

23. There is no statutory or rule requirement for

physicians to file copies of incident reports with their

accrediting organization. However, at least two of the

nationally recognized accrediting agencies, Joint Commission on

Accred itation of Healthcare Organization (JACHO) and American

Association for Accreditation of Ambulatory Surgical Facilities

(AAAASF), have provisions in their accreditation manuals related

to adverse incidents.

24. JACHO's "Accreditation Manual for Office - B ased Surgery

Practices," Second Edition (2005), defines a "sentinel event" as

follows:

A sentinel event is an unexpected occurrence

involving death or serious physical or

psychological injury, or the risk thereof.

Serious injury specifically includes lo ss of

limb or function. The phrase "or risk

thereof" includes any process variation for

which a recurrence would carry a significant

chance of a serious adverse outcome.

Such events are called "sentinel" because

they signal the need for immediate

inves tigation and response.

The terms "sentinel event" and "medical

error" are not synonymous; not all sentinel

events occur because of an error, and not

all errors result in sentinel events.

25. JACHO requires each accredited practice to define

"sentinel ev ent" for its own purposes in establishing mechanisms

to identify, report, and manage these events. JACHO encourages,

but does not require, its clients to report "sentinel events" to

the accrediting agency within 45 days of the event or of

becoming aware o f the event. The report should include a root

cause analysis and an action plan. If JACHO becomes aware of an

unreported "sentinel event," JACHO will advise the accredited

practice to prepare and submit the report within a certain

timeframe. If the accr edited practice fails to file an

appropriate report within that time frame, JACHO will not revoke

accreditation, but will place the accredited practice on an

"Accreditation Watch" list.

26. AAAASF's "Standards and Checklist for Accreditaion of

Ambulatory Surgery Facilities" contains forms for accredited

surgery facilities to use in reporting "unanticipated sequela."

The forms refer one to AAAASF's "Quality Assurance and Peer

Review Manual" for questions relative to their completion. The

record indicates that "unanticipated sequela" are the equivalent

of adverse incident reports, including but not limited to,

events that result in unplanned hospital admissions.

27. In Florida, physicians are required to file adverse

incident reports with DOH's Consumer Services Unit (CSU), which

is part of DOH's Medical Quality Assurance Program. On at least

a quarterly basis, the Board's staff requests CSU to provide it

with copies of adverse incident reports filed during a certain

timeframe.

28. The staff of the CS U has access to medical consultants

who review the incident reports to determine whether there might

have been a violation of law or a violation of a standard of

care. If so, the matter is referred for further investigation,

determination of probable caus e, and possible disciplinary

prosecution by the Board.

29. The Board's staff places the incident reports in

physician registration files and in office surgery

inspection/accreditation files. The Board's staff also places

copies of incident reports inv olving physicians or facilities in

the respective file of their accrediting agency or accrediting

organization.

30. The Board's staff provides copies of adverse incident

reports to DOH's state inspectors before they make office

inspections of non - accred ited facilities or facilities formerly

accredited by a national agency or FLACS. The state

inspector/risk manager uses the incident reports during

inspections to recommend improvements so that such incidents can

be avoided in the future.

31. The Board' s Surgical Care Committee, uses the incident

reports for statistical purposes. The Surgical Care Committee

reviews the reports to determine whether changes need to be made

in administrative rules, including but not limited to, rules

related to standard of care or physician registration.

32. It is important for FLACS to be aware of adverse

incident reports filed by its accredited physicians and office -

surgery facilities. Such reports are an essential part of any

accreditation program. Without such know ledge, FLACS cannot be

assured that its accredited physicians and offices are taking

steps to prevent such incidents in the future. Moreover, if

FLACS is not aware of the adverse incidents occurring in the

offices it inspects, FLACS cannot implement chang es in its own

policies to improve the accreditation process.

33. The Board has no policy or practice for routinely

sharing incident reports with accrediting organizations.

Nevertheless, requiring FLACS to file copies of incident reports

with the Board could alert the Board to incidents that were

known to FLACS but never reported to the state and vice versa.

As stated above, FLACS could make routine public records

requests for copies of reports filed with the Board but not

reported directly to FLACS.

Rules 64B8 - 9.0092(4)(a) and 64B8 - 9.0092(4)(c)

34. Florida Administrative Code Rules 64B8 - 9.0092(4)(a)

and 64B8 - 9.0092(4)(c) were declared invalid in Florida Academy

of Cosmetic Surgery, Inc. v. Department of Health, Board of

Medicine , DOAH Case No. 05 - 040 2RX (Final Order, August 8, 2005).

For the reasons set forth below in the Conclusions of Law, it is

unnecessary to report facts related to a mandatory quality

assurance program or the ongoing anesthesia - related

accreditation and quality assurance processe s involving the

active participation of anesthesiologists.

CONCLUSIONS OF LAW S IONS OF LAW

35. The Division of Administrative Hearing has

jurisdiction over the parties and the subject matter of this

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

Statutes (2005).

36. FLACS has the burden of proving by a preponderance of

the evidence that it is entitled to approval as an office

surgery accrediting organization. See Florida Department of

Transportation v. J.W.C. Company, Inc. , 396 So. 2d 778 (Fla.

1st DCA 1981).

37. In Florida Academy of Cosmetic Surgery, Inc. v.

Department of Health, Board of Medicine , DOAH Case No. 05 - 0402RX

(Final Order, August 8, 2005), the undersigned concluded that

Florida Administrative Code Rules 64B8 - 9.0092(4)(a ) and 64B8 -

9.0092(4)(c) were invalid exercises of delegated legislative

authority. Consequently, the Board is precluded from relying

upon these rules as a basis for denial of FLACS's present

application.

38. Section 458.309(3), Florida Statutes, states a s

follows:

(3) All physicians who perform level 2

procedures lasting more than 5 minutes and

all level 3 surgical procedures in an office

setting must register the office with the

department unless that office is licensed as

a facility pursuant to chapter 395. The

department shall inspect the physician's

office annually unless the office is

accredited by a nationally recognized

accrediting agency or an accrediting

organization subsequently approved by the

Board of Medicine. The actual costs for

re gistration and inspection or accreditation

shall be paid by the person seeking to

register and operate the office setting in

which the office surgery is performed.

39. Section 458.309(3), Florida Statutes, gives the Board

authority to approve office surg ery accrediting organizations

and broad discretion to establish criteria for such approval.

However, the statute in its substance does not include a

reference to "mandated quality assurance program" or an "ongoing

anesthesia - related accreditation and qual ity assurance processes

involving the active participation of anesthesiologists." There

is no other statute that addresses the requirements relative to

office surgery accrediting organizations. Without the rules

held invalid or some statutory language re garding the

requirements, the Board cannot deny FLACS's application based on

inadequate quality assurance program and/or processes.

Accordingly, quality assurance programs and processes are not

discussed here.

PRIOR ERRORS

40. One reason for denial of FLACS's application was its

failure to correct errors it made when participating in

accrediting activities in the past. The relevant period is

between the time that the Board denied FLACS's renewal

application in August 2003 and the time that the Board is sued

the June 2004 Final Order in DOAH Case No. 03 - 3349.

41. There is no evidence that FLACS failed to provide

copies of accreditation reports and corrective action plans to

the Board in violation of Florida Administrative Code 64B8 -

9.0092(4)(e), which st ates as follows:

(e) The accrediting organization shall

obtain authorization from the accredited

entity to release accreditation reports and

corrective action plans to the Board. The

accrediting organization shall provide a

copy of any accreditati on report to the

Board office within 30 days of completion of

accrediting activities. The accrediting

organization shall provide a copy of any

corrective action plans to the Board office

within 30 days of receipt from the physician

office.

FLACS appear s to have corrected this past violation.

42. Florida Administrative Code Rule 64B8 - 9.0092(4)(f)

provides as follows:

(f) If the accrediting agency or

organization finds indications at any time

during accreditation activities that

conditions in the physician office pose a

potential immediate jeopardy to patients,

the accrediting agency or organization will

immediately report the situation to the

Department.

43. There is no evidence of a situation where FLACS

actually failed to report conditions in a physician's office

that posed a "potential immediate jeopardy to a patient."

However, FLACS admits that its current policy is to notify the

Board by telephone as to any "immediate threat" to a patient and

otherwise to file all inspection materials with the Board so

that the Board can make the determination whether conditions in

a physician's office pose a "potential immediate threat."

FLACS's current policy clearly does not comply with Florida

Administrative Code Rule 64B8 - 9.0092(4)(f) and constitutes a

basis for denying FLACS's application.

44. Florida Administrative Code Rule 64B8 - 9.0092(4)(g)

states that "[a]n accrediting agency or organization shall send

to the Board any change in its accreditation standards within 30

calendar days after making t he change." FLACS has not corrected

its prior violations of this rule.

45. After allegedly changing its standards, policies and

procedures to address the Board's concerns, FLACS ignored its

written accreditation standard, which requires accredited

phys icians and offices to be in total compliance with all

statutes and rules. On at least two occasions FLACS gave

passing grades on inspections even though the inspections

revealed at least one deficiency for each office. FLACS allowed

one physician to rema in accredited without being registered from

June 2003 through May 2005. FLACS admits that it sometimes

relies on purchase order/invoices to verify a physician's

compliance with the Board's rules even though the documents do

not show receipt of the deficie nt items. FLACS obviously was

not operating under its approved accreditation standards. The

failure to do so constitutes a basis for denial of FLACS's

application.

INCIDENT REPORTS

46. Florida Administrative Code Rule 64B8 - 9.0092(2)(f)

requires an ap plication to include copies of all incident

reports filed with the state. FLACS provided two such reports

with its January 2003 renewal application and two reports with

the instant application. FLACS failed to provide copies of

another five incident repo rts that its accredited physicians had

filed with the Board.

47. FLACS argues that the Board cannot disapprove the

application for failing to include all nine incident reports

that FLACS's accredited physicians filed with the Board. In

support of this argument, FLACS relies on Section 120.60,

Florida Statutes, which states as follows in relevant part:

(1) Upon receipt of an application for

a license, an agency shall examine the

application and, within 30 days after such

receipt, notify the appli cant of any

apparent errors or omissions and request any

additional information the agency is

permitted by law to require. An agency

shall not deny a license for failure to

correct an error or omission or to supply

additional information unless the agency

timely notified the applicant within this 30

day period.

* * *

(3) Each applicant shall be given

notice either personally or by mail that the

agency intends to grant or deny, or has

granted or denied, the application for

license. The notice must state with

particularity the grounds or basis for the

issuance or denial of the license, except

when issuance is a ministerial act . . . .

48. In this case, FLACS's application did not contain any

apparent omissions on its face. The Board discovered the

failure to include all nine incident reports only after the

Board's staff reviewed the registration files of FLACS's

accredited offices.

49. One of the most important reasons for requiring

applications to include copies of incident reports is to

demonstr ate that the applicants have been diligent in their

efforts to review the negative outcomes in accredited offices,

to prevent future adverse incidents, and to make improvements in

the accreditation process. Informing FLACS that it needed to

supplement its application with copies of incident reports might

make the application "complete" but would not change the reality

that FLACS was unaware of at least five adverse incidents during

the critical time for FLACS to determine whether it needed to

make changes in its policies or procedures.

50. FLACS cannot be sure that physicians are sending it

copies of incident reports unless it makes a public records

record to the Board or DOH on at least a quarterly basis. There

is no persuasive evidence that FLACS made such a request during

the time that it operated as an approved accrediting

organization or before it filed its new application. Under the

circumstances of this case, the Board did not violate Section

120.60, Florida Statutes, and was justified in denyi ng FLACS's

application.

RECOMMENDATION

Based on the foregoing Findings of Fact and

Conclusions of Law, it is

RECOMMENDED:

That the Board issue a Final Order denying FLACS's

application for approval as an office surgery accrediting

organization.

DONE AND ENTERED this 9th day of August, 2005, in

Tallahassee, Leon County, Florida.

S

SUZANNE F. HOOD

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 (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 9th day of August, 2005.

ENDNOTE

1/ The Exhibits and Transcript in DOAH Case No. 04 - 3249 are

located with the record in DOAH Case No. 05 - 0402RX.

COPIES FURNISHED :

Alfred W. Clark, Esquire

Post Office Box 623

Tallahassee, Florida 32302 - 0623

Edward A. Tellochea, Esquire

Office of the Attorney General

Department of Legal Affairs

The Capito l, Plaza Level 01

Tallahassee, Florida 32399 - 1050

Larry McPherson, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to subm it 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.