03-003349 Florida Academy Of Cosmetic Surgery, Inc. vs. Department Of Health, Board Of Medicine Status: Closed Recommended Order on Thursday, April 15, 2004.

Summary: Respondent properly denied Petitioner`s application for renewal of its status as an approved physician office surgery accrediting organization.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

FLORIDA ACADEMY OF COSMETIC )

SURGERY, INC., )

)

Petitioner, )

)

vs. ) Case No. 03 - 3349

)

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE, )

)

Respondent. )

)

RECOMMENDED ORDER

A formal hearing was held in this case on November 17, and

December 3 - 4, 2003, in Tallahassee, Florida, before Suzanne F.

Hood, Administrative Law Judge with the Division of

Administrative Hearings.

APPEARANCES

For Petitioner: A lfred W. Clark, Esquire

117 South Gadsden Street, Suite 201

Post Office Box 623

Tallahassee, Florida 32302 - 0623

For Respondent: Edward A. Tellechea, Esquire

Office o f the Attorney General

The Capitol, Plaza Level 01

Tallahassee, Florida 32399 - 1050

STATEMENT OF THE ISSUES

The issues are as follows: (a) whether Respondent acted

upon Petitioner’s application for renewal as an office surgery

accrediting organization within the time frames established

under Section 120.60(1), Florida Statutes; and (b) whether

Respondent properly denied Petitioner’s application for renewal

of its status as an approved physician office surgery

a ccrediting organization.

PRELIMINARY STATEMENT

By letter dated December 12, 2002, Petitioner Florida

Academy of Cosmetic Surgery, Inc. (Petitioner/FLACS) submitted

to Respondent Department of Health, Board of Medicine

(Respondent/the Board) an applicatio n for renewal of its status

as an approved physician office accrediting organization,

pursuant to Florida Administrative Code Rule 64B8 - 9.0092. After

Respondent requested additional information, Petitioner

submitted a complete application on January 17, 2 003.

Respondent considered Petitioner's application on

February 8, 2003, in Orlando, Florida; on June 7, 2003, in

Miami, Florida; and on August 2, 2003, in Orlando, Florida. At

the August 2, 2003, meeting, Respondent voted to deny the

renewal applicatio n.

On August 28, 2003, Respondent issued a Notice of Intent to

Deny for the following violations of Florida Administrative Code

Rule 64B8 - 9.0092: (a) failing to provide copies of

accreditation reports and corrective action plans within 30 days

of comple tion of accrediting activities; (b) failing to

immediately report conditions in physicians' offices that posed

a potential immediate threat to patients; (c) issuing letters of

unconditional accreditation and sending Respondent copies of

such letters when P etitioner found deficiencies during the

inspection and had not received follow - up material showing full

compliance; and (d) leaving items unchecked or checking items

"yes" and "no" on the inspection check list, so that Respondent

was unable to determine wh ether the facility complied with the

inspection criteria.

During the hearing, Petitioner presented the testimony of

three witnesses. Petitioner offered 30 exhibits, all of which

were received into evidence.

Respondent presented the testimony of three wi tnesses.

Respondent offered 27 exhibits, all of which were received into

evidence.

At the conclusion of the hearing the parties were

instructed to file proposed orders by February 2, 2004.

Volumes 1 and 2 of the hearing transcripts were filed on

Dec ember 31, 2003. Volumes 3, 4, and 5 of the hearing

transcripts were filed on January, 5, 2004.

On January 21, 2004, Petitioner filed a Joint Motion for

Extension of Time to file proposed orders. An Order Granting

Joint Motion for Extension of Time set Ma rch 5, 2004, as the new

deadline for filing proposed orders.

On March 4, 2004, Petitioner filed a second Joint Motion

for Extension of Time to file proposed orders. An Order

Granting Joint Motion for Extension of Time set March 11, 2004,

as the new dea dline for filing proposed orders.

FINDINGS OF FACT

Background

1. In Florida, physicians who perform certain surgical

procedures in their offices are required to register the office

and have the office inspected by Respondent unless the office is

accred ited by a nationally recognized accrediting agency or an

accrediting organization approved by Respondent. § 458.309(3),

Fla. Stat. (2003); Fla. Admin. Code R. 64B8 - 9.0091.

2. In order to avoid physician office inspection by

Respondent, a physician mus t submit written documentation of a

current office - accreditation survey by one of the nationally

recognized or Board - approved accrediting organizations. Fla.

Admin. Code R. 64B8 - 9.0091(2)(a) and 64B8 - 9.0091(3)(a). A

physician is also required to submit a copy of a current

accreditation survey within 30 days of accreditation of the

office. Fla. Admin. Code R. 64B8 - 9.0091(3)(b).

3. Florida Administrative Code Rules 64B8 - 9.0092(1)(b) and

64B8 - 9.0092(7) list the approved national and Board - approved

accre diting organizations. Petitioner is the only Board - approved

accrediting organization.

4. Florida Administrative Code Rule 64B8 - 9.0092(1)(a)

provides that "accredited" means that an office has achieved

either "full" accreditation or "provisional" accre ditation when

the office is in "substantial compliance" with accrediting

standards.

5. Petitioner provided Respondent with a complete

application for renewal as an office surgery accrediting agency

on January 17, 2003. Florida Administrative Code Rule 64B8 -

9.0092(5) specifies that such entities must apply for renewal

every three years and shall submit their applications for

renewal at least three months prior to the third anniversary of

their initial approval. Petitioner conducted office surgery

accred itation inspections for approximately three years prior to

the final hearing in this matter.

6. Physicians who conduct office surgery are required to

comply with Florida Administrative Code Rule 64B8 - 9.009 regarding

the Standard of Care for Office Surger y. Florida Administrative

Code Rule 64B8 - 9.0091(2)(a) specifically provides that all

nationally recognized and Board - approved accrediting organizations

shall be held to the same surgery and anesthesia standards for

Florida office surgery sites as adopted by rule.

7. Petitioner's accreditation standards, as outlined in

its original application for approval as an accrediting agency

and its subsequent application for renewal, include the

requirement that physicians comply with the standard of care

rules f or office surgery as outlined in Florida Administrative

Code Rule 64B8 - 9.009. In fact, Petitioner asserts that its

standards meet or exceed the requirements of Chapters 455 and

458, Florida Statutes (2003), and rules promulgated there under.

8. Petiti oner's accreditation standards should have

remained the same throughout the three years preceding the

submission of its renewal application. Petitioner did not file

any changes or amendments to its accreditation standards prior

to submitting its renewal a pplication on January 17, 2003.

Submission of Corrective Action Plans

9. Throughout the first three years of its operation,

Petitioner provided Respondent with copies of all the

accreditation reports for the facilities it inspected and

accredited as re quired by Florida Administrative Code Rule 64B8 -

9.0092(4)(e). That same rule also required Petitioner to

furnish Respondent copies of any corrective action plans within

30 days of receipt from the inspected physician office.

10. Petitioner did not prov ide Respondent with any

corrective action plans or any compliance information until

after Petitioner filed its renewal application. Petitioner did

not offer any corrective action plans as evidence during the

hearing even though Petitioner found deficienci es (non -

compliance with accreditation standards) in 24 of the 25 office

inspection files entered as evidence by the Respondent in this

hearing. The only materials submitted by Petitioner that

address the deficiency corrections are copies of photographs,

i nvoices, packing slips, order forms, and correspondence from

the inspected offices, which are supposed to constitute evidence

of subsequent compliance accreditation standards.

11. Beth Sautner is Petitioner's Executive Secretary.

Ms. Sautner's du ties required her to submit the requisite

accreditation materials to Respondent and to communicate with

Respondent regarding such activities when needed. The greater

weight of the evidence indicates that Respondent's staff never

told Ms. Sautner to only s end the facility inspection form and

that submission of corrective action plans and compliance

materials was unnecessary.

12. Ms. Sautner knew that a rule required the submission

of corrective action plans. Nevertheless, Petitioner never

filed an y petition seeking a waiver of such rule.

Action on the Application

13. Respondent considered Petitioner's renewal application

on three separate occasions. It was first considered on

February 8, 2003, in Orlando, Florida, at Respondent's regularly

scheduled meeting. At that meeting Petitioner waived the 90 - day

provision in Section 120.60(1), Florida Statutes (2002), until

after Respondent's August 2003 meeting.

14. Respondent next considered Petitioner’s renewal

application at a regularly sched uled meeting on June 7, 2003, in

Miami, Florida. Finally, Respondent voted to deny the

application at the August 2, 2003, meeting in Orlando, Florida.

15. Respondent filed the Notice of Intent to Deny

Petitioner's application for renewal as an office s urgery

accrediting organization on August 28, 2003.

Accreditation Process

16. Upon the request and payment of an accreditation fee,

Petitioner arranges for the inspection of an office by an

inspector. Inspection is required when the physician conducts

level II office surgery lasting more than five minutes or level

III office surgery. The inspectors are physicians affiliated

with Petitioner who personally visit the facility to conduct the

inspection.

17. The inspectors use an inspection form when con ducting

the accreditation inspection. The form contains a pass or fail

check - off space next to each statement reflecting an

accreditation standard. The form contains comment sections

following the standards and at the end provides for a pass or

fail desi gnation along with two additional sections. The

inspectors use the final sections for outlining minor

deficiencies to be corrected within 20 working days and for

major deficiencies requiring a second inspection. The form has

signature lines for the inspe ctor and the physician being

inspected.

18. After completing the inspection, the inspector

forwards the form to Ms. Sautner. Next, the inspector and

Ms. Sautner review the form to determine what is needed in order

to complete the process. The inspecto r tells Ms. Sautner what

is needed and she attempts to collect the requisite compliance

documentation from the inspected facility. The appropriate

materials are then forwarded to Ms. Sautner who sends them to

the inspector for a final accreditation determ ination. The

final accreditation determination is always made by an inspector

and never by Ms. Sautner.

19. Once the final accreditation determination is made,

Ms. Sautner orders an accreditation certificate from Scribes,

Inc. Scribes, Inc. sends the certificate directly to the newly

accredited facility. At times, Ms. Saunter orders the

certificate in advance but places it on hold until she is

notified that an accreditation determination has been made.

Ms. Sautner usually contacts Scribes, Inc. by e - mail to request

release (delivery) of the certificate. Scribes, Inc. then sends

Petitioner a facsimile copy of the physician’s accreditation

certificate.

20. Petitioner accredits offices for three years. The

accreditation period begins to run from th e date of the original

office inspection. The certificate that Petitioner issues

through Scribes, Inc. contains a month and year which reflect

the final month of the facility accreditation. Therefore, if a

facility’s accreditation certificate has a May 2 005 date, it

reflects an accreditation from May 2002 through May 2005. This

is true even when the physician did not document that his or her

facility fully complied with Petitioner's accreditation

standards until, in some cases, months after the initial

i nspection.

21. After Petitioner requests Scribes, Inc. to send a

certificate to a newly accredited facility, Petitioner sends a

copy of the facility inspection form, the accreditation

certificate, and a cover letter to Respondent. This

documentation noti fies Respondent that Petitioner has inspected

the physician's office and that the office is entitled to

recognition as an accredited facility.

22. Throughout the hearing Petitioner's witnesses

testified that physicians' offices were not accredited until

t hey demonstrated that they had met all of the accreditation

standards. The weight of the evidence indicates that Petitioner

routinely accredited a facility retroactive to its inspection

date.

23. A review of every accreditation certificate in

evidence shows that each facility’s period of accreditation

starts the month Petitioner performed the inspection and ends

three years later. This is true even when the inspection form

reveals that the physician’s office did not fully comply with

Petitioner's accre ditation standards at the time of inspection

and the physician did not demonstrate compliance until months

after the initial inspection.

24. Ms. Sautner's testimony adds support for the

proposition that Petitioner gave physicians accreditation credit

re troactively to the inspection date. She was responsible for

notifying Scribes, Inc. to release accreditation certificates

bearing specific months and years exactly three years after the

date of the inspections, as opposed to three years after the

date of compliance with standards.

25. Petitioner's inspectors considered the inspection date

to be the accreditation date. They knew the subsequently issued

accreditation certificates would reflect compliance with

accreditation standards for a period of time before the

physicians actually demonstrated compliance.

26. It is noteworthy that, upon completion of the

inspections, Petitioner gave a "pass" or, in a couple of cases,

a provisional pass, to every physician’s office that Petitioner

inspected before it submitted its renewal application. This

adds credence to the supposition that Petitioner considered the

inspection date to be the date that a facility was entitled to

accreditation, even though the physicians did not demonstrate

compliance until some tim e after the inspection.

27. It is clear that Petitioner was not routinely

accrediting physicians' offices without requiring some evidence

of demonstrated compliance with accreditation standards.

Instead, Petitioner usually required the physicians to f urnish

some documentation showing compliance after an inspection

revealed deficiencies but allowed the new period of

accreditation to begin retroactively on the date of the

inspection.

28. The most persuasive evidence indicates that the date

Petitioner completed the accreditation process occurred sometime

after the inspection: (a) on the date Ms. Sautner authorized

Scribes, Inc., to release the physician's accreditation

certificate; or (b) the date that Scribes, Inc., faxed

Ms. Sautner a copy of the ac creditation certificate sent to the

physician. Therefore, the information provided to Petitioner

was inaccurate to the extent it reflected that physicians'

offices were in full compliance as of their inspections date.

29. Given the above, Respondent pr esented ample evidence

which demonstrates that Petitioner's accreditation process was

misleading. At the very least, Petitioner lacked sufficient

quality assurance policies and procedures to ensure that

physicians were not recognized as accredited before they were

entitled to such recognition. Regardless of whether any

physicians were actually performing surgery in their offices

between the inspection dates and the dates of compliance,

Petitioner's accreditation procedure created a false impression

of the adequacy of the facilities that Petitioner inspected.

This mischaracterization of the status would lend support for

the acceptability of procedures performed in that setting when

the physician was not entitled to that recognition, with

potential conseque nces to the health and well being of the

patients.

Marwan Shaykh, M.D.

30. Petitioner inspected Dr. Shaykh’s facility on May 30,

2002. The date that appears on his accreditation certificate is

May 2005. Hence, his accreditation covers May 2002 thro ugh May

2005. During the inspection, Petitioner determined that

Dr. Shaykh’s office did not have the following required

medications: adrenalin (expired), dextrose (expired), verapamil

hydrochloride (expired), succinylcholine, and nitroglycerin.

Petition er also discovered that Dr. Shaykh’s office did not have

the following required monitoring and/or emergency equipment:

ambu bag and emergency power able to produce adequate power to

run required equipment for a minimum of two hours. (hereinafter

“emergenc y power”).

31. After the inspection, Dr. Shaykh provided Petitioner a

copy of an invoice from the Apothecary at Memorial. The invoice

indicated that Dr. Shaykh ordered adrenalin (ephedrine),

dextrose, verapamil hydrochloride, succinylcholine, and

nitr oglycerin (nitroquick) on July 2, 2002. The invoice was

dated August 15, 2002.

32. Dr. Shaykh also provided Petitioner a copy of an

invoice from Physician Sales and Services, Inc. The invoice

reflected that Dr. Shaykh ordered an ambu bag (resuscitato r

adult disp) on July 16, 2002. The invoice was dated July 16,

2002.

33. Finally, Dr. Shaykh provided Petitioner a copy of a

letter which read in part:

Please find enclosed the copies of the

anesthesia record where the EBL is recorded,

the physician j ob description and a copy of

the surgery log.

In addition, invoices indicate the

replacement of Dextrose 50 percent, Isuprel

1:5000, Verapamil 5mg/2ml, succinylcholine

20mg/ml to the crash cart and Administration

sets (Micro drips) and Adult Resuscitator

bag (Ambu Bag) to the surgery room.

The letter appears to be a cover letter that accompanied the

above - discussed invoices. The letter is undated and does not

indicate when Petitioner received it. However, if it

accompanied the medication invoice from th e Apothecary,

Dr. Shaykh must have sent it to Petitioner on or after

August 15, 2002.

34. Ms. Sautner ordered and placed a hold on Dr. Shaykh’s

accreditation certificate on June 6, 2002. She released the

hold on July 16, 2002.

35. The certificate itself has a fax date of June 11,

2002. It appears that Scribes, Inc., faxed it to Petitioner on

that date.

36. Based on the foregoing, it is not clear whether the

fax date on Dr. Shaykh’s certificate of June 11, 2002, or

Ms. Sautner's stated release date of July 16, 2002, is the

actual release date. Nevertheless, regardless of which date is

the correct release date, it is apparent that Petitioner sent

Dr. Shaykh an accreditation certificate before he documented

compliance with Petitioner's accreditat ion standards because the

Apothecary invoice was dated after both possible release dates.

Karen Chapman, M.D.

37. Petitioner inspected Dr. Chapman’s facility on

April 6, 2002. The date that appears on her accreditation

certificate is April 2005. H ence, her accreditation covers

April 2002 through April 2005. During the inspection,

Petitioner determined that Dr. Chapman’s office did not have

multiple (14) medications, one of which was inderal. Petitioner

also discovered that Dr. Chapman’s office di d not have a

required ambu bag among other missing monitoring and/or

emergency equipment.

38. After the inspection, Dr. Chapman provided Petitioner

copies of invoices from Southern Anesthesia Surgical dated

April 11, 2002, which reflected that Dr. Ch apman ordered all the

missing medications with the exception of inderal. Dr. Chapman

also provided Petitioner a copy of undated correspondence which

asserted that Karen Chapman ordered and received inderal 1mg/mL,

on April 11, 2002.

39. Both the South ern Anesthesia Surgical invoice copies

and the undated correspondence regarding the inderal contain a

fax strip across the top. The date on the fax strip indicates

that Dr. Chapman sent the invoice copies and the inderal

correspondence to Petitioner on February 12, 2003.

40. Ms. Sautner was unable to provide an order or release

date for Dr. Chapman’s accreditation certificate. However, the

inspection file contained an accreditation certificate which had

a fax date across the top of May 10, 2002.

41. The Southern Anesthesia Surgical invoice copies and

the undated correspondence regarding the inderal were obviously

faxed to FLACS over seven months after the accreditation

certificate was sent to Dr. Chapman. Petitioner attempts to

explain this di screpancy away by claiming that it had all

compliance documentation prior to issuing accreditation but in

some cases it could not find the documents when it conducted an

audit in 2003. In those instances, Petitioner contacted the

physicians and asked them to send the compliance materials again

after the fact. Such an explanation is unacceptable because it

does not explain why the compliance documentation was not in the

file in the first place. Additionally, Petitioner has provided

no documentation of com pliance materials from Dr. Chapman

disclosing whether she ever obtained a required ambu bag.

Lucien Armand, M.D.

42. Petitioner inspected Dr. Armand’s facility on June 8,

2001. The date that appears on his accreditation certificate is

June 2004. H ence, his accreditation covers June 2001 through

June 2004. During the inspection, Petitioner determined that

Dr. Armand’s office did not have the following required

medications: adrenalin (epinephrine) 1/10,000 dilution, calcium

chloride, dextrose, dilan tin (phenytoin), dopamine, and inderal

(propranolol).

43. After the inspection, Dr. Armand provided Petitioner

on some unknown date a copy of an invoice from Medical III

Pharmacy. The invoice reflected that on April 23, 2001,

Dr. Armand ordered dilant in, dopamine, and inderal. The invoice

was dated April 30, 2001.

44. Dr. Armand also provided Petitioner, on some unknown

date, unsigned correspondence indicating that he had “re -

supplied” his emergency cabinet with adrenalin, calcium

chloride, dextro se, dilantin, dopamine, and inderal.

45. Ms. Sautner placed Dr. Armand’s accreditation

certificate on hold on June 22, 2001. The certificate had a fax

date across the top of June 28, 2001.

46. The above - referenced invoice from Medical III Pharmacy

is of course not probative as to whether Dr. Armand obtained the

missing crash cart medications after the inspection because the

invoice indicates that the drugs were ordered before the

inspection. Furthermore, Dr. Armand’s unsigned correspondence

indica ting that he had “resupplied” his emergency cabinet with

adrenalin, calcium chloride, dextrose, dilantin, dopamine, and

inderal is obviously problematic because it is unsigned and

provides no objective proof of compliance.

Scott Warren, M.D.

47. Petit ioner inspected Dr. Warren’s facility on

April 11, 2001. The date that appears on his accreditation

certificate is May 2004. Thus, his accreditation covers May 2001

through May 2004. During the inspection, Petitioner determined

that Dr. Warren’s office d id not have required intubation

forceps.

48. After the inspection, Dr. Warren provided Petitioner a

copy of an order receipt from an unknown pharmaceutical vendor.

The order receipt reflected that, on an unknown date, Dr. Warren

ordered adult and child sized McGill Forceps (a type of

intubation forceps). The invoice was not dated but a fax strip

across the top reveals that Dr. Warren's office faxed a copy of

the receipt to Petitioner on July 11, 2001.

49. Ms. Sautner placed a hold on Dr. Warren’s

ac creditation certificate on June 22, 2001. The certificate had

a fax date across the top of June 29, 2001.

50. The copy of the Magill Forceps receipt was faxed to

Petitioner ten days after Petitioner released the accreditation

certificate to Dr. Warren . Therefore, Petitioner could not have

verified compliance prior to the awarding of accreditation.

Furthermore, this discrepancy cannot be attributed to

Petitioner's 2003 audit because the fax receipt date was

approximately one and a half years prior to the audit.

Juan Flores, M.D.

51. Petitioner inspected Dr. Flores' facility on July 21,

2002. The date that appears on his accreditation certificate is

July 2005. Accordingly, his accreditation covers July 2002

through July 2005. During the inspect ion, Petitioner

determined that Dr. Flores’ office did not have inderal

(propranolol) or nasal airways.

52. Dr. Flores provided Petitioner correspondence dated

July 30, 2002, from a Laura Leyva. The correspondence indicated

that Dr. Flores’ facility h ad acquired the requisite nasal

airways.

53. On November 14, 2003, Petitioner received a fax copy

of an invoice numbered 9927 from Prime Medical Care, Inc. The

invoice dated July 15, 2002, documents Dr. Flores' acquisition

of inderal.

54. Dr. Flor es’ accreditation certificate had a fax date

of September 6, 2002, across its top.

55. The Prime Medical Care, Inc., invoice copy was faxed

to Petitioner on November 14, 2003, over a year after the

accreditation certificate was sent to Dr. Flores. Pe titioner

again explains this discrepancy by raising the 2003 audit

excuse. However, the explanation does not explain why the

compliance documentation was not in the file in the first place.

Mina Selub, M.D.

56. Petitioner inspected Dr. Selub’s faci lity on May 17,

2002. The date that appears on her accreditation certificate is

May 2005. Therefore, her accreditation covers May 2002 through

May 2005. During the inspection, Petitioner determined that

Dr. Selub’s office did not have heparin, nasal air ways, and

intubation forceps.

57. Dr. Selub sent Petitioner a copy of a customer packing

slip on an unknown date. The customer packing slip revealed

that Dr. Selub ordered heparin from McKesson Medical Surgical on

May 3, 2002. The packing slip had a handwritten note

indicating that the heparin was received on June 1, 2002.

58. Dr. Selub also submitted a copy of a second customer

packing slip to Petitioner on an unknown date. The second

customer packing slip revealed that Dr. Selub ordered Magill

Forceps from McKesson Medical Surgical on May 13, 2002. The

packing slip had a handwritten note indicating that Dr. Selub

did not receive the forceps, which were reordered from Henry

Schein. Petitioner never received any other documentation

indicating t hat Dr. Selub actually ordered or received

intubation forceps. Additionally, Dr. Selub also failed to

provide any documentation of compliance with the nasal airway

requirement.

59. Ms. Sautner placed a hold on Dr. Selub’s accreditation

certificate on June 6, 2002. She released the hold on July 12,

2002. The accreditation certificate has a July 15, 2002, fax

date across the top.

60. The above - referenced invoice for heparin from McKesson

Medical Surgical indicates that the medication was ordered

be fore the inspection. However, the hand written notation on

that same invoice indicates that Dr. Selub's office received the

heparin on June 1, 2002. The lack of any documentation

regarding the ordering and/or receipt of the intubation forceps

is more pro blematic. Apparently Petitioner issued Dr. Selub's

office an accreditation certificate without obtaining further

written verification of compliance with accreditation standards.

Abelardo Acosta, M.D.

61. Petitioner inspected Dr. Acosta’s facility on

November 17, 2001. The date that appears on his accreditation

certificate is November 2004. Hence, his accreditation covers

November 2001 through November 2004. During the inspection,

Petitioner determined that Dr. Acosta’s office did not have the

follo wing required medications: succinylcholine, magnesium

sulfate, heparin, dopamine, inderal (propranolol), and dilantin

(phenytoin). Petitioner also discovered that Dr. Acosta’s

office did not have the following required monitoring and/or

emergency equipme nt: tonsillar suction and nasal airways.

62. After the inspection, Dr. Acosta provided Petitioner

with the following documentation: (a) a copy of a packing slip

from Southern Anesthesia Surgical dated November 26, 2001,

reflecting that Dr. Acosta or dered dopamine, succinylcholine,

dilantin, magnesium sulfate, and heparin; (b) a copy of a

statement from Southern Anesthesia Surgical dated July 15,

2002, which reflected that Dr. Acosta had ordered inderal

(propranolol); (c) a copy of an invoice from A rmstrong Medical

Industries, Inc., with an order date of January 2, 2002, which

reflected that Dr. Acosta ordered a suction unit; and (d) a copy

of a packing slip from Physician Sales & Service dated

December 3, 2001, reflecting that Dr. Acosta ordered num erous

types of airways and a yankuar suction unit.

63. Ms. Sautner placed a hold on Dr. Acosta’s

accreditation certificate on December 5, 2001. She released the

hold on December 12, 2001. The certificate has a December 12,

2001, fax date across the t op.

64. The statement from Southern Anesthesia Surgical

dated July 15, 2002, which reflected that Dr. Acosta ordered

inderal, constitutes undisputed evidence that Petitioner did not

verify Dr. Acosta’s full compliance with Petitioner's crash cart

acc reditation requirements prior to the awarding of actual

accreditation on December 12, 2001.

Charles Graper, M.D. (Level II Accreditation)

65. Petitioner inspected Dr. Graper’s facility for level

II accreditation on March 25, 2001. The date that appear s on

his accreditation certificate is March 2004. Thus, his

accreditation covers March 2001 through March 2004. During the

inspection, Petitioner determined that Dr. Graper’s office did

not have dextrose 50 percent, a required medication.

66. Dr. Grape r failed to provide Petitioner with any

subsequent documentation to demonstrate compliance with

accreditation standards regarding the need to have dextrose 50

percent as part of the office’s crash cart.

67. Ms. Sautner released Dr. Graper’s accreditation

certificate on April 4, 2001. The certificate has a April 19,

2001 fax date across the top.

68. Petitioner failed to verify that Dr. Graper obtained

dextrose 50 percent for his crash cart after his inspection for

level II surgery and before the relea se of his accreditation

certificate by Petitioner on April 4, 2001.

Leigh Phillips, III, M.D.

69. Petitioner inspected Dr. Phillips' facility for level

II and III surgery on January 31, 2002. The date that appears

on his accreditation certificate is January 2005. Hence, his

accreditation covers January 2002 through January 2005. During

the inspection, it was determined that Dr. Phillips' office did

not have the following required medications: dextrose 50

percent and 36 ampules of dantrolene (missin g 18).

70. After the inspection, Dr. Phillips provided Petitioner

a copy of an order acknowledgment form from Southern Anesthesia

Surgical dated February 7, 2002. The order acknowledgment

form reflected that Dr. Phillips ordered dextrose 50 percent.

71. Dr. Phillips' inspection file also contained a

handwritten letter from Dr. Mel Propis dated January 31, 2003.

The letter indicated that Dr. Propis had just returned from the

office of Dr. Phillips and while there he had counted 36 ampules

of dant rolene and the dextrose 50 percent in the crash cart.

72. Ms. Sautner did not know the date that she advised

Scribes, Inc., to release Dr. Phillip’s accreditation

certificate. However, her records indicate that the certificate

was faxed to her on Febr uary 19, 2002.

73. Dr. Propis’ correspondence dated January 31, 2003,

verifying Dr. Phillips' receipt of the requisite dantrolene was

provided to Petitioner approximately 11 months after Petitioner

received a copy of Dr. Phillips' accreditation certifi cate.

Such constitutes further undisputed evidence that FLACS did not

verify Dr. Phillips' full compliance with accreditation

standards prior to awarding him accreditation.

Brandon Kallman, M.D. and Francisco Prado, M.D.

(combined inspection)

74. Pe titioner inspected Drs. Kallman and Prado’s facility

on June 2, 2002. The date that appears on their accreditation

certificates is June 2005. Hence, their accreditation covers

June 2002 through June 2005. During the inspection, Petitioner

determined tha t the physicians’ office did not have the

following required medications: adrenalin (1:10,000 dilution),

magnesium sulfate, heparin, dopamine, pronestyl (procainamide),

and dilantin (phenytoin).

75. Drs. Kallman and Prado provided Petitioner with a co py

of a packing slip from Southern Anesthesia Surgical dated

July 12, 2002. The packing slip reveals that Drs. Kallman and

Prado ordered the missing adrenalin (epinephrine), dopamine,

pronestyl (procainamide), and dilantin (phenytoin). However, as

evid enced by the fax strip across the top of the packing slip

copy, the documentation was provided to Petitioner via fax

transmission on July 22, 2002.

76. Drs. Kallman and Prado also provided Petitioner with a

copy of a packing slip from Henry Schein. Th e packing slip is

dated July 18, 2002. The packing slip has a date of July 23,

2002, on the fax strip across the top. The packing slip in the

record is illegible. Therefore, one cannot determine whether

the packing slip served as documentation for recei pt of the

missing magnesium sulfate and heparin.

77. Additionally, Drs. Kallman and Prado provided

Petitioner with copies of an e - mail dated October 14, 2002, and

multiple photos dated October 11, 2002. The photos depict the

facility’s crash cart, its drawers, and the presence of

dantrium. The original inspection form dated June 2, 2002, did

not reveal any missing dantrium.

78. Finally, Dr. Kallman provided one more document which

purports to be some attempt at curing the deficiencies that were

di scovered during the inspection. The document in question is a

short handwritten letter on Dr. Kallman’s letterhead signed by

Dr. Kallman and dated July 16, 2002. The body of the letter

reads as follows:

Herewith are the documents requested. I

will fax t omorrow a copy of Ms. Mad. Katz

RN ACLS certification. Let this letter

also reflect that we have ordered from

Henry Schein the appropriate missing drugs

for the crash cart. They are currently on

back order. I will send a copy of the

shipping slip upon a rrival.

79. Ms. Sautner released Drs. Kallman and Prado’s

accreditation certificate on July 17, 2002. The certificate

contains a July 23, 2002, fax date across the top.

80. It may be that the illegible packing slip from Henry

Schein verifies the receipt of magnesium sulfate and heparin by

Drs. Kallman and Prado. Even so, the packing slip was dated

July 18, 2002, one day after Ms. Sautner released the

accreditation certificate on July 17, 2002. Additionally, the

packing slip from Southern Anesthe sia Surgical was provided to

Petitioner after the accreditation certificate release date.

Needless to say, the e - mail and multiple photos are dated almost

three months after the release of the accreditation certificate.

81. The inspection file for D rs. Kallman and Prado is

particularly problematic because the handwritten correspondence

from Dr. Kallman put Petitioner on notice that he and Dr. Prado

did not yet have the requisite drugs needed to meet the

accreditation standards. Nevertheless, the ver y next day, with

no further verification, Petitioner released the accreditation

certificate.

Dr. Luis Zarate, M.D.

82. Petitioner inspected Dr. Zarate’s facility for level

II and III office surgery on September 14, 2002. The date that

appears on his ac creditation certificate is September 2005.

Hence, his accreditation covers September 2002 through September

2005. During the inspection, Petitioner determined that

Dr. Zarate’s office did not have the required 36 ampules of

dantrolene.

83. Petitioner 's inspection file for Dr. Zarate does not

contain any documentation of ordering or receipt of dantrolene

by Dr. Zarate or by anyone else on his behalf.

84. Ms. Sautner did not have a release date for

Dr. Zarate’s accreditation certificate. The certif icate had an

October 3, 2002, fax date.

85. When Petitioner inspected Dr. Zarate, he was working

in the same facility as Drs. Kallman and Prado. It is possible

that the dantrolene photo contained in Drs. Kallman and Prado’s

inspection file was meant t o document Dr. Zarate’s compliance

with the dantrolene requirement. Even if that is the case,

Drs. Kallman and Prado's dantrolene photos were dated

October 11, 2002, which means that the photos were taken after

Petitioner released Dr. Zarate’s accreditati on certificate.

Dr. Andrew Weiss and Dr. Anthony Rogers

86. Petitioner inspected Drs. Weiss and Rogers’ facility

on December 6, 2001. However, the date that appears on their

accreditation certificates is November 2004. Hence, their

accreditation c overs December 2001 through November 2004.

During the inspection, Petitioner determined that the

physicians’ office did not have two required medications:

pronestyl (procainamide) and inderal (propranolol).

87. Drs. Weiss and Rogers provided Petition er with a copy

of an invoice from Henry Schein dated February 6, 2003. The

invoice reveals that Drs. Weiss and Rogers ordered the missing

pronestyl (procainamide) and inderal (propranolol).

88. The inspection file also contains a printed statement

und er the title “Andrew Weiss, M.D.” which states that “[a]ll

ACLS approved drugs were present at the time of accreditation.

Inspector found no deficiencies.” However, during the hearing,

Ms. Sautner admitted that the statement was inaccurate and

inserted i nto the file by error.

89. Ms. Sautner placed a hold on the certificates for

Drs. Weiss and Rogers on December 5, 2001 and December 10, 2001.

She did not know the release dates of the certificates. The fax

date on the certificates was December 12, 20 01.

90. The above - mentioned Henry Schein invoice dated

February 6, 2003, is persuasive evidence that Drs. Weiss and

Rogers ordered and received the requisite pronestyl

(procainamide) and inderal (propranolol) over one year after

Petitioner received a co py of Drs. Weiss and Rogers’

accreditation certificates. Such constitutes undisputed

evidence that FLACS did not verify Drs. Weiss and Rogers’ full

compliance with FLACS’s accreditation standards prior to

awarding accreditation.

Richard Edison, M.D.

9 1. Petitioner inspected Dr. Edison’s facility on

April 22, 2001. The date that appears on his accreditation

certificate is April 2004. Thus, his accreditation covers April

2001 through April 2004. During the inspection, Petitioner

determined that Dr. E dison’s office did not have the following

required medications: adrenalin (1:10,000 dilution),

succinylcholine, dilantin (phenytoin), and lanoxin (digoxin).

Petitioner also discovered that Dr. Edison’s office did not have

the following required monitorin g and/or emergency equipment:

intubation forceps.

92. Dr. Edison’s inspection file contains a handwritten

letter dated May 7, 2001, from Pam Rolm, R.N. Ms. Rolm wrote

the letter on the letterhead for Dr. Edison’s facility, Cosmetic

Surgery Center. T he letter reads in part as follows:

This letter is in response to request for

information for certification. The

following medications have been updated and

the expired ones disposed of: 1) phenytoin,

2) Lanoxin, 3) succinycholine, and 4)

Albuterol Inha ler.

We have a McGill forceps in both anesthesia

carts and an extra pair in the ORI

medication cart.

93. Dr. Edison’s inspection file also contains three

invoices from Prime Medical Care, Inc. All three invoices have

a fax strip across the top with a February 14, 2003, date and

the sender name of Cosmetic Surgery Center. The first invoice

dated December 11, 2000, indicates that Dr. Edison ordered

ephedrine sulfate 50mg/ml. The second invoice dated October 30,

2001, indicates that Dr. Edison ordered l idocaine, heparin,

verapamil, procainamide, and phenylephrine. The third invoice

dated April 25, 2001, indicates that Dr. Edison ordered

succinylcholine, albuterol inhaler, phenytoin, and digoxin.

94. Ms. Sautner testified that she ordered and placed a

hold on the certificate for Dr. Edison on May 4, 2001. She

released the hold on May 10, 2001. The certificate has a

May 22, 2001, fax date across the top.

95. The above - referenced correspondence dated May 7, 2001,

does not address whether Dr. Edison ordered/obtained the missing

adrenalin (1:10,000 dilution). Additionally, the first invoice

is dated four months prior to the inspection. The second

invoice is dated months after Petitioner released the

accreditation certificate. The third invoice is ap propriately

dated but does not show that Dr. Edison ever ordered/obtained

the missing adrenalin (1:10,000 dilution). Accordingly,

Petitioner released Dr. Edison’s accreditation certificate

before he documented compliance with the requirements that he

poss ess adrenalin (1:10,000 dilution) and intubation forceps.

Dr. Alton Ingram, M.D.

96. Petitioner inspected Dr. Ingram’s facility on

April 28, 2002. The date that appears on his accreditation

certificate is April 2005. Therefore, his accreditation cov ers

April 2002 through April 2005. During the inspection,

Petitioner determined that Dr. Ingram’s office did not have a

required tonsillar suction unit with backup suction.

97. Dr. Ingram’s inspection file contains a copy of a

photograph of a tonsilla r suction unit with a hand - written date

of July 29, 2002.

98. Ms. Sautner placed the certificate for Dr. Ingram on

hold on June 6, 2002. She released the hold on July 19, 2002.

The date on the certificate is not legible.

99. The date on the photo graph of the tonsillar suction

unit is after Petitioner released the accreditation certificate.

Petitioner accredited Dr. Ingram before he documented full

compliance with accreditation standards.

Mont Cartwright, M.D. (Heathrow Facility)

100. Petiti oner inspected Dr. Cartwright’s Heathrow

facility on March 3, 2001. The date that appears on his

accreditation certificate is March 2004. Thus, his

accreditation covers March 2001 through March 2004.

101. During the inspection, Petitioner determined that

Dr. Cartwright’s Heathrow office did not have the required

dopamine, heparin, and inderal. In an undated letter,

Dr. Cartwright’s staff advised Petitioner that Dr. Cartwright’s

Heathrow facility had obtained the missing medications.

102. Ms. Saut ner released the hold on Dr. Cartwright’s

accreditation certificate on April 4, 2001. The fax date on

the certificate is April 19, 2001.

Mont Cartwright, M.D. (Orlando Facility)

103. Petitioner inspected Dr. Cartwright’s Orlando

facility on May 13, 2001. The date that appears on his

accreditation certificate is May 2004. Hence, his accreditation

covers May 2001 through May 2004. During the inspection,

Petitioner determined that Dr. Cartwright’s Orlando office did

not have the required dilantin and heparin.

104. Dr. Cartwright’s office staff sent Petitioner

correspondence dated June 7, 2001. The letter claims that the

“crash cart” in Dr. Cartwright’s Orlando facility had been

“brought up to standards in accordance with compliance. . . .”

105. Ms. Sautner testified that she released the hold on

Dr. Cartwright’s accreditation certificate on June 22, 2001.

The fax date on the certificate is June 28, 2001.

Inadequate Quality Control

106. Petitioner asserts that it has appropriate quality

assu rance programs and processes which Respondent reviewed

without objection. Dr. R. Gregory Smith, one of Petitioner’s

current co - directors for facility inspections, describes

Petitioner's quality assurance program in the following manner:

A. Right. We hav e regular board meetings.

We go over the forms and changes and things

like that. We talk to inspectors and say,

you know, try to check all the boxes and

that type of thing.

Q. You basically go over your work again –

A. Yes.

Q. – make sure everythi ng is accurate?

A. Right. Plus, I think the actual meeting

with the Board of Medicine to iron out any

issues is also quality assurance.

107. Petitioner's renewal application included a two - page

document titled, “Quality Improvement Plan.” The docume nt can

best be described as a description of the quality assurance

exercises for physicians' offices. The document does not

describe Petitioner's internal quality assurance program.

108. Other than the above - quoted description provided by

Dr. Smith, P etitioner failed to present any evidence that

outlines Petitioner’s own quality assurance program. In fact,

the manner in which Petitioner deals with its own errors

indicates that Petitioner has inadequate quality assurance

processes.

109. In situations where an inspector fails to check yes

or no on an item when conducting an inspection, Petitioner takes

the position that an inspector is not to make any changes after

the fact. Rather, Petitioner claims that it assumes the worse,

treats the blank as a no answer, and asks the physician

undergoing inspection to provide a letter of attestation, a

packing slip, or some other material that documents compliance

with the accrediting standard.

110. Petitioner's inspection files reveal instances where

Petition er did not follow the above - referenced quality assurance

policy. For example, the inspection form for Harold Reed, M.D.,

revealed no check under yes or no on page 3 under the crash cart

medication succinylcholine. After the inspection, Dr. Reed did

not p rovide Petitioner with any materials documenting compliance

with the requirement to have succinylcholine on the facility's

premises. It may be that the inspector made a clerical error

during the inspection or he may have remembered seeing the

medication i n Dr. Reed's refrigerator after the inspection. In

any event, Petitioner did not follow its alleged quality

assurance policy of requiring the physician to show compliance

after the inspection.

111. Dr. Leonard Rubinstein’s inspection file presents

ano ther example of Petitioner's failure to follow its alleged

quality assurance policies. The inspection form reveals no

check under yes or no on page 3 under the crash cart medications

lasix and magnesium sulfate and on page 4 under oximeter in the

monitori ng and emergency equipment section. After the

inspection, Dr. Rubinstein did not provide Petitioner with any

documentation showing the presence of the missing items.

Petitioner did not attempt to determine whether the inspector

had made a “clerical error ” or whether Dr. Rubinstein procured

the missing items. In other words, Petitioner did not follow

its own policy regarding the treatment of situations where the

inspector fails to check no or yes on an inspection item.

112. Dr. Michael Freeman’s inspe ction file presents

another example of Petitioner’s failure to follow its alleged

quality assurance policies. Dr. Freeman’s inspection form

reveals no check under yes or no on page 3 under the crash cart

medication mazicon. The inspection file contains n o deficiency

documentation, and thus, does not address the mazicon issue.

Again, Petitioner did not follow its own policy regarding the

treatment of situations where the inspector fails to check no or

yes on an inspection item.

Conditions Posing a Poten tial Immediate Threat

113. Dr. Hector Vila, Jr., a licensed Florida physician

and an Assistant Professor of Anesthesiology and Oncology at the

University of South Florida, H. Lee Moffitt Cancer Center,

testified during the final hearing on the issue of w hether any

of the facilities inspected by Petitioner posed a potential

immediate threat to patients due to the deficiencies discovered

during the inspection. Dr. Vila has administered anesthesia in

office surgery settings in the past and currently serves as an

office surgery inspector for the Respondent. Dr. Vila is an

expert in office surgery and anesthesia. His testimony

regarding Petitioner's failure to report conditions posing a

potential immediate threat to patients is persuasive.

114. For examp le, the office of Marwan Shaykh, M.D, posed

a potential immediate threat to patients because it did not have

nitroglycerin and epinephrine (adrenalin) on the premises. Such

medications are necessary to resuscitate a patient who may

suffer a respiratory ar rest due to either a surgical or

anesthetic complication. It would be nearly impossible to

resuscitate a patient without such items.

115. Dr. Shaykh failed to provide documentation of

compliance with the nitroglycerin and adrenalin

requirement until A ugust 15, 2002, or sometime thereafter.

Dr. Shaykh demonstrated compliance approximately two months

after Petitioner recognized Dr. Shaykh as being accredited.

116. It is true that Dr. Shaykh’s office was located

adjacent to a hospital. Therefore, it is possible that the same

teams that respond to emergencies in the hospital could go to

Dr. Shaykh's office if he needed them. It is also true that

Dr. Shaykh performs in vitro fertilization procedures, which

could be terminated in case of an emergency.

117. However, after Petitioner recognizes Dr. Shaykh as

being accredited, he could practice any type of medicine and

perform any procedure as long as he is properly trained to do

so. Furthermore, the office surgery accreditation rules do not

provide a ny type of exemption based on the location of the

physician’s office because to do so would undermine the reason

for the rule. Office surgery facilities are not hospitals no

matter how close to the hospital they may be located. If Dr.

Shaykh felt that hi s close proximity to the hospital did not

make compliance with the office surgery rules necessary, he

should have filed a petition for waiver or variance from the

relevant rules rather than ignore the need to have crucial

resuscitative drugs in his crash c art.

118. The office of Karen Chapman, M.D., posed a potential

immediate threat to patients because it lacked 16 of the 22

medications required in an office surgery facility’s crash cart.

The office also lacked an ambu bag, a piece of equipment used to

resuscitate patients. Two of the 16 missing medications were

the nitroglycerin and adrenalin, which are absolutely necessary

to resuscitate a patient who may suffer a respiratory arrest due

to either a surgical or anesthetic complication. The ambu bag

i s also used on patients under respiratory arrest and it is

considered a crucial piece of equipment.

119. Dr. Chapman’s office failed to provide documentation

of compliance with the crash cart requirements until

February 12, 2003. She did not demonstra te compliance until

approximately nine months after she obtained her accreditation.

120. Dr. Chapman may have informed Petitioner that she did

not intend to open her new practice until she obtained

accreditation. However, Dr. Chapman obtained her accr editation

and presumably opened her practice almost nine months before she

provided Petitioner with documentation of her compliance with

the crash cart medication requirements. She never provided any

materials documenting whether she obtained the required ambu

bag.

CONCLUSIONS OF LAW

121. The Division of Administrative Hearings has

jurisdiction over the parties and the subject matter presented

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

Statutes (2003).

122. Petitioner asserts that its application for renewal

as an office surgery accrediting agency must be approved as a

matter of law because Respondent failed to take action within

the time frames established by Section 120.60(1), Florida

Statutes. The statute in question reads in part as follows:

Every application for a license shall be

approved or denied within 90 days after

receipt of a completed application unless a

shorter period of time for agency action is

provided by law. The 90 - day time period

shall be tolled by the initiation of a

proceeding under ss. 120.569 and 120.57.

Any application for a license that is not

approved or denied within the 90 - day or

shorter time period, within 15 days after

conclusion of a public hearing held on the

application, or within 45 days after a

rec ommended order is submitted to the agency

and the parties, whichever action and

timeframe is latest and applicable, is

considered approved unless the recommended

order recommends that the agency deny the

license.

123. Petitioner presented a complete app lication to

Respondent on January 17, 2003, and waived the 90 - day

requirement of Section 120.60(1), Florida Statutes, until after

Respondent’s August 2003 meeting. Such waiver was made on the

record at Respondent's meeting on February 8, 2003. Respondent

took action on Petitioner's application on August 2, 2003, when

it voted to deny the application. The evidence presented by the

parties supports the conclusion that Respondent acted within the

time frames set forth in Section 120.60(1), Florida Statutes

(2003). See State Dept. of Transportation v. Calusa Trace

Development, Corp. , 571 So. 2d 543 (Fla. 2nd DCA 1990).

124. Respondent has the burden of proving by clear and

convincing evidence that Petitioner is not entitled to renewal

of its status as a bo ard - approved accrediting organization. See

Coke v. Department of Children and Family Services , 704 So. 2d

726 (Fla. 5th DCA 1998); Dubin v. Department of Business

Regulation , 262 So. 2d 273 (Fla. 1st DCA 1972).

125. Respondent is the state agency charge d with

regulating the practice of allopathic medicine pursuant to

Chapters 456 and 458, Florida Statutes. Respondent is

responsible for approving organizations that accredit

physicians' offices where level II procedures lasting more than

five minutes and all level III surgical procedures are performed

pursuant to Section 458.309(3), Florida Statutes (2003).

126. The Petitioner has applied for renewal as an office

surgery accrediting agency pursuant to Florida Administrative

Code Rule 64B8 - 9.0092(5), wh ich reads as follows:

(5) Renewal of Approval of Accrediting

Organizations. Every accrediting

organization approved by the Board pursuant

to this rule is required to renew such

approval every three years. Each written

submission shall be filed with the Board at

least three months prior to the third

anniversary of the accrediting

organization's initial approval and each

subsequent renewal of approval by the Board.

Upon review of the submission by the Board,

written notice shall be provided to the

accredi ting organization indicating the

Board's acceptance of the certification and

the next date by which a renewal submission

must be filed or of the Board's decision

that any identified changes are not

acceptable and on that basis denial of

renewal of approval as an accrediting

organization.

127. Florida Administrative Code Rule 64B8 - 9.0092(4), sets

forth the requirements/standards for approval in relevant part

as follows:

(4) Requirements. In order to be approved

by the Board, an accrediting organizatio n

must comply with the following requirements:

(a) The accrediting agency must have a

mandatory quality assurance program approved

by the Board of Medicine.

(b) The accrediting agency must have

anesthesia - related accreditation standards

and quality a ssurance processes that are

reviewed and approved by the Board of

Medicine.

(c) The accrediting agency must have

ongoing anesthesia - related accreditation and

quality assurance processes involving the

active participation of anesthesiologists.

(d) Accre ditation periods shall not exceed

three years.

(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 accreditation 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.

(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

imme diately report the situation to the

Department.

(g) An accrediting agency or organization

shall send to the Board any change in its

accreditation standards within 30 calendar

days after making the change.

(h) An accrediting agency or organization

shall comply with confidentiality

requirements regarding protection of patient

records.

128. Respondent denied the Petitioner’s renewal

application on four different grounds. Respondent based the

first reason for denial on Petitioner's failure to comply wit h

Florida Administrative Code Rule 64B8 - 9.0092(4)(e). Clear and

convincing evidence indicates that Petitioner failed to provide

Respondent with any corrective action plans for the inspected

facilities within the required 30 calendar days.

129. Respond ent's staff did not advise Petitioner that it

did not have to comply with the requirements of Florida

Administrative Code Rule 64B8 - 9.0092(4)(e) to file corrective

action plans. Petitioner did not request a variance or a waiver

of the rule pursuant to Sec tion 120.542, Florida Statutes

(2003).

130. Respondent's second reason for denial is that

Petitioner failed to comply with Florida Administrative Code

Rule 64B8 - 9.0092(4)(g). In some instances, Petitioner inspected

offices, found deficiencies, reviewe d compliance documentation,

and awarded accreditation retroactive to the inspection date.

In other instances, Petitioner awarded accreditation retroactive

to the inspection date before the physicians submitted

compliance documentation addressing all the n oted deficiencies.

Petitioner recognized some facilities as being accredited even

though the physicians never furnished required compliance

materials.

131. It is clear that Petitioner ignored its written

accreditation standards and failed to provide t he Respondent

with the accreditation standards under which it was actually

operating. In other words, Petitioner was not abiding by its

acknowledged accreditation standards, and thus, de facto changed

its accreditation standards without notifying Responde nt.

132. Respondent’s third reason for denial is based on

Petitioner's failure to comply with Florida Administrative Code

Rule 64B8 - 9.0092(4)(a). Petitioner's internal quality assurance

program is inadequate and applied inconsistently as evidenced by

the following:

a. Petitioner routinely awarded accreditation to the

inspection date even though the physicians' offices did not

comply with accreditation standards at that time. In some

instances, Petitioner awarded accreditation to physicians before

t hey submitted materials documenting compliance with all the

deficiencies discovered during the inspection.

b. Petitioner employed an inconsistent approach to the

treatment of what the inspectors referred to as “clerical

errors” on the inspection forms. These errors occurred when the

inspector failed to mark off either a yes or a no on a specific

item on the inspection form. The evidence shows that in

multiple instances, Petitioner did not comply with its own

policy of requiring compliance documentatio n, but rather treated

the item as if it were checked off yes based solely upon the

inspector’s claim that the item was in place.

133. Respondent’s final reason for denial is based on

Petitioner's failure to comply with Florida Administrative Code

Rule 64B8 - 9.0092(4)(f). In at least two instances, physicians

operated their office surgery practices after Petitioner noted

during the inspection process that they were missing essential

resuscitative medications and equipment. The physicians failed

to docum ent that they obtained the missing items before

Petitioner awarded them accreditation. The lack of such

materials posed a potential immediate threat to these

physicians’ patients. Petitioner failed to report the

conditions in the offices that posed a pot ential immediate

threat to patients.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMENDED:

That Respondent enter a final order denying Petitioner’s

application for renewal as an office surgery accrediting age ncy.

DONE AND ENTERED this 15th day of April, 2004, in

Tallahassee, Leon County, Florida.

S

SUZANNE F. HOOD

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahas see, 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 15th day of April, 2004.

COPIES FURNISHED :

Alfred W. Clark, Esquire

117 Sout h Gadsden Street, Suite 201

Post Office Box 623

Tallahassee, Florida 32302 - 0623

Edward A. Tellechea, Esquire

Office of the Attorney General

The Capitol, Plaza Level 01

Tallahassee, Florida 32399 - 1050

Rosanna Catalano, Esquire

Office of the Attorney Gen eral

The Capitol, Plaza Level 01

Tallahassee, Florida 32399 - 1050

William W. Large, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

R. S. Power, Agency Clerk

Department of Health

4052 Bald Cypress Way , Bin A02

Tallahassee, Florida 32399 - 1701

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 submit writt en 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.