08-002553 All Florida Medical Supplies vs. Department Of Health Status: Closed Recommended Order on Friday, August 15, 2008.

Summary: Petitioner failed to demonstrate entitlement to a permit to operate a medical oxygen retail establishment.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

ALL FLORIDA MEDICAL SUPPLIES, )

INC., )

)

Petitioner, )

) Case No. 08-2553

vs. )

)

DEPARTMENT OF HEALTH, )

)

Respondent. ) )

RECOMMENDED ORDER

A final hearing was held in this case, pursuant to notice,

on June 24, 2008, by video teleconference at sites in West Palm

Beach and Tallahassee, Florida, by Eleanor M. Hunter an

Administrative Law Judge of the Division of Administrative

Hearings.

APPEARANCES

For Petitioner: Javier Talamo, Esquire

Kravitz & Talamo, LLP

7600 West 20th Avenue, Suite 213

Hialeah, Florida 33016

For Respondent: Jennifer L. Condon, Esquire

Department of Health

4052 Bald Cypress Way, Bin A-02

Tallahassee, Florida 32399-2202

STATEMENT OF THE ISSUE

Whether Petitioner is entitled to a permit to operate a

medical oxygen retail establishment.

PRELIMINARY STATEMENT

On April 10, 2008, Respondent, Department of Health

application filed by Petitioner, All Florida Medical Supplies,

Inc., for a permit to operate a medical oxygen retail

establishment. On May 23, 2008, the Division of Administrative

Hearings received a request to assign an administrative law

judge to hear issues raised in the Petition for Formal

Administrative Hearing dated April 29, 2008. The final hearing

was held on June 24, 2008.

At the hearing, Petitioner submitted its Exhibits 1-6, but

presented no witnesses in its case-in-chief. Respondent

presented the testimony of Bridget Coates and Denean Merritts,

and submitted Respondent’s Exhibits 1 and 2.

The Transcript of the final hearing was received on

July 22, 2008. Proposed Recommended Orders were filed on

July 28, 2008.

FINDINGS OF FACT

1. Petitioner, All Florida Medical Supplies, Inc. located

in Delray Beach, Florida, is the applicant for a permit to

operate a medical oxygen retail establishment. The application

was filed due to a change in the ownership of Petitioner.

2. Respondent, Department of Health (DOH), is the agency

authorized to regulate medical oxygen retail establishments, as

provided in Chapter 499, Florida Statutes (2008).

3. On November 14, 2007, DOH received Petitioner’s

Application for a Permit under Chapter 499, Florida Statutes, to

operate as a medical oxygen retailer. The applicant’s address

was given as: “601 N. Congress Ave. Bldg. 6 Suite Number 606,

Delray Beach, FL 33445.”

4. The handwritten mailing address given appeared to be

“128 Van Gown Way, Royal Palm Beach, FL 33411-1580.” The name

given for the emergency contact at the mailing address was

David L. Ford.

5. On December 11, 2007, and on December 31, 2007, DOH

sent letters to the 128 Van Gown address requesting additional

information to complete the application.

6. On January 8, 2007, one of the owners of Petitioner,

Ellen Gust, sent an address correction to DOH by facsimile,

along with a corrected application providing a new address. The

corrected address was the 601 North Congress Avenue address.

7. On January 11, 2008, another letter citing an

application deficiency was sent to the original Van Gown mailing

address not the corrected mailing address. In the meantime, the

assigned DOH permitting staff person and Mrs. Gust, for

Petitioner, had some telephone and email contacts that

eliminated the remaining deficiency.

8. On January 18, 2008, DOH notified Petitioners that is

application was complete.

9. A DOH inspector received the completed application from

the permitting office and, on February 7, 2008, conducted an

inspection of the business at its location at 601 North Congress

Avenue in Delray Beach.

10. The inspector saw approximately 60 cylinders of oxygen

at the inspection site and determined that they were full, based

on the color of the tape used to seal them. She testified that

Mrs. Gust told her that the cylinders had been filled on site.

11. The inspector found that the full oxygen cylinders

were improperly labeled. That is, the labels on the cylinders

lacked the name of the company and location where filled, as

required by the Food and Drug Administration’s compressed

medical gases guidelines. In addition, the expiration date on

the cylinders was December 2007, and there was no way to

determine the oxygen content because Petitioner failed to

produce any stability testing records. Mrs. Gust told the

investigator that the date on the cylinders was the date they

were filled.

12. The inspector observed cylinders inside a delivery van

that also had an expiration date of December 2007. The lot

numbers on the cylinders inside the business and in the van were

the same, but the validity of the lot numbers could not be

verified by reference to any corresponding business records or

fill logs. Mrs. Gust’s husband told the inspector that the lot

numbers were the numerical date of the year and month the tanks

were filled, which is acceptable except that the methodology was

not listed in any of Petitioner’s policies and procedures.

13. Based on the inability to verify that the oxygen was

safe and effective for use by patients, or to determine the

useful life in the absence of stability test records or fill

logs, the inspector ordered the removal of the seals on the

cylinders and the release of the oxygen.

14. The inspector also found unclear signage to designate

a quarantine area in the warehouse.

15. The inspector recommended, and DOH agreed that

Petitioner failed the site inspection and that its permit

application should be denied.

CONCLUSIONS OF LAW

16. The Division of Administrative Hearings has

jurisdiction over the parties to and subject matter of this

proceeding. §§ 120.569 and 120.57, Fla. Stat. (2008).

17. In license and permit application cases, the burden is

upon the applicant to demonstrate its entitlement by a

preponderance of the evidence. Department of Transportation v.

J.W.C. Company, Inc. , 396 So. 2d 778 (Fla. 1st DCA 1981); Balino

v. Department of Health and Rehabilitative Services , 348 So. 2d

349 (Fla. 1st DCA 1977); State ex rel. Glaser v. Pepper , 155 So.

2d 383 (Fla. 1st DCA 1963).

18. Petitioner, in this case, argues that it is entitled

to the permit for one reason, the requirement in Florida

Administrative Code Rule 64F-12.015(3)(d) that follows:

(d) The department will request from the

applicant written documentation to evidence

compliance with the requirements of Chapter

499, F.S., when an on-site inspection cannot

be completed within 30 days of receipt of a

completed application for a permit requiring

an on-site inspection or a written request

for a change of address.

19. Petitioner claims that its application, having been

filed on November 14, 2007, should be deemed to have been

complete 30 days later, because it did not timely receive a

deficiency letter and have an opportunity to correct any

omissions, or have the required on-site inspection within 30

days.

20. Petitioner's argument ignores three compelling facts.

First, that it was Petitioner that provided an incorrect mailing

address to DOH, and cannot now benefit from its mistake.

Second, that the rule requires "receipt of a completed

application." The application was not complete until

January 18, 2008. Finally, despite DOH's error in continuing to

use the original rather than the corrected mailing address when

it sent the deficiency letter of January 11, 2008, Petitioner

was being given the same information by email and telephone

calls to one of its owners, and the inspection was conducted on

February 7, 2008, within 30 days of the receipt of the completed

application.

21. Petitioner has failed to demonstrate entitlement to a

permit to operate a medical oxygen retail establishment.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law it is RECOMMENDED:

That the Department of Health enter a final order denying

the application of All Florida Medical Supplies, Inc., for a

permit to operate a medical oxygen retail establishment.

DONE AND ENTERED this 15th day of August, 2008, in

Tallahassee, Leon County, Florida.

S

ELEANOR M. HUNTER

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

[phone] SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 15th day of August, 2008.

COPIES FURNISHED :

Javier Talamo, Esquire

Kravitz & Talamo, LLP

7600 West 20th Avenue, Suite 213

Hialeah, Florida 33016

Jennifer L. Condon, Esquire

Department of Health

4052 Bald Cypress Way, Bin A-02

Tallahassee, Florida 32399-2202

R. S. Power, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A-02

Tallahassee, Florida 32399-1701

Dr. Ana M. Viamonte Ros, Secretary

Department of Health

4052 Bald Cypress Way, Bin A-00

Tallahassee, Florida 32399-1701

Josefina M. Tamayo, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A-02

Tallahassee, Florida 32399-1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within 15

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

this Recommended Order should be filed with the agency that will

issue the Final Order in this case.