Judges: ROBERT E. MEALE
Agency: Agency for Health Care Administration
Latest Update: May 16, 1988
Summary: Hospital is person holding clinical lab license so it may conduct clinical lab work in nuclear lab
87-5361STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF HEALTH AND )
REHABILITATIVE SERVICES, )
)
Petitioner, )
)
vs. ) CASE NO. 87-5361
) HOLMES REGIONAL HEALTH CARE ) SYSTEM, INC., d/b/a JAMES E. ) HOLMES REGIONAL MEDICAL CENTER, )
)
Respondent. )
)
RECOMMENDED ORDER
Pursuant to notice, final hearing in the above-styled case was held on March 1, 1988, in Melbourne, Florida, before Robert E. Meale, Hearing Officer of the Division of Administrative Hearings.
The representatives of the parties were as follows: For Petitioner: Lynn Porter-Carlton, Esquire
District VII Legal Counsel
400 West Robinson Orlando, Florida 32801
For Respondent: Elting L. Storms, Esquire
Storms, Krasny, Normile & Dettmer, P.A.
Post Office Box 1376 Melbourne, Florida 32902-1376
BACKGROUND
By Administrative Complaint dated October 15, 1987, Petitioner alleged that Respondent was performing clinical tests in its nuclear medicine laboratory without a valid clinical laboratory license. Petitioner alleged that the conduct of Respondent would justify the denial or revocation of a license to operate a clinical laboratory and stated the intent to impose a $500 fine. By letter dated November 10, 1987, Respondent requested a formal hearing.
Petitioner presented one witness. Respondent presented one witness. Petitioner offered into evidence five exhibits. Respondent offered into evidence three exhibits. All exhibits were admitted into evidence, except for Petitioner's Exhibit Number 3.
Neither party filed a proposed recommended order.
FINDINGS OF FACT
Petitioner has licensed Respondent to operate the James E. Holmes Regional Medical Center located at 1350 South Hickory Street, Melbourne, Florida ("Hospital").
Petitioner's Office of Licensure & Certification performed a license- renewal inspection of the Hospital on April 7, 1987. Petitioner discovered during this inspection that Schilling tests and blood volume tests were performed in the nuclear medicine laboratory. These tests have been performed continuously since 1962 by Respondent in its nuclear medicine laboratory without previous criticism from Petitioner.
On April 8, 1987, Petitioner notified Respondent that its nuclear medicine laboratory was not licensed as required by Section 483.091, Florida Statutes, to perform Schilling and blood volume tests and that the performance of laboratory procedures by "an unlicensed laboratory" must cease immediately. The letter further advised Respondent that failure to cease could subject "your laboratory/hospital" to legal action.
The Schilling test is a diagnostic procedure to determine if the patient has an absence of B-12 factor in his body. The test is performed by having the patient ingest radioactive B-12 orally at the same time that he receives an injection of nonradioactive B-12. Over the next 24 to 48 hours, urine samples are then collected from the patient, who may remain at the hospital or go home. The urine is then analyzed in order to count the radioactivity and thereby determine the rate of absorption of B-12 by the patient.
The blood volume test is a diagnostic procedure to determine the volume of blood in the patient. There are two forms of the test. In one, radioactive material is injected into the patient's blood. A sample of blood drawn from the patient is analyzed for radioactivity and dilution of the radioactive material. The blood volume can then be calculated. In the other form of the blood volume test, red blood cells are drawn from the patient and tagged with a radioactive material. They are then re-injected into the patient and their dilution is tracked, again to determine the patient's blood volume. Respondent performs both types of blood volume tests.
In vivo means "in the living body." In vitro means "outside the living body and in an artificial environment." The Schilling test is in vitro to the extent of the urinalysis, although the ingesting of B-12 is an in vivo procedure. The blood volume test in which the radioactive material is injected directly into the patient is in vitro, insofar that blood is drawn from the patient for analysis, and in vivo, insofar as radioactive material is injected into the patient's blood. The blood volume test in which the blood is removed, tagged with a radioactive tracer, and then returned to the body is exclusively in vivo because the analysis takes place while the blood is in the patient's body.
The Hospital contains a clinical laboratory and a nuclear medicine laboratory, which are on different floors in the same building. By letter dated June 25, 1987, Petitioner informed Respondent that in vitro analyses of patient specimens could only be performed in its clinical laboratory. By letter dated August 21, 1987, Petitioner elaborated by stating that licensure by its Office of Radiation Control Radiologic Technologist Program did not authorize individuals to perform in vitro analyses.
Respondent is licensed by Petitioner's Office of Radiation Control "to receive, acquire, possess and transfer [certain] radioactive materials ... and to use such radioactive material[s] for the purpose[s] and at the place[s] designated below." The location designated is the street address of the Hospital. Paragraph 9 of the license expressly authorizes Respondent to perform "in vitro studies" and diagnostic procedures as described in Groups I, II, and III of Schedule C, Part III, Chapter 10D-91, Florida Administrative Code. The Schilling test and blood volume tests are described within Groups I and II above. Paragraph 12 of the license also states that the licensed radioactive material described in Groups I and II may be used "by, or under the supervision of," among others, Dr. Laudie McHenry.
The clinical laboratory license held by Respondent for the Hospital was not produced at the hearing. At all relevant times, the clinical laboratory license authorized Respondent to conduct, maintain, or operate a clinical laboratory at the Hospital and to perform the Schilling test and blood volume tests.
Dr. McHenry is the director of the clinical laboratory, as well as the nuclear medicine laboratory. At all relevant times, all personnel of the nuclear medicine laboratory, with possibly one exception, held certification as nuclear medicine technicians and clinical laboratory technicians. The qualifications of the personnel in the two laboratories are identical in terms of conducting the Schilling test and blood volume tests.
Respondent's performance of the Schilling test and blood volume tests in the nuclear medicine laboratory did not and could not result in death or serious harm to the health or safety of any person. Respondent had no previous violations and received no financial benefit from the conducting of the Schilling test and blood volume tests in its nuclear medicine laboratory rather than its clinical laboratory.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter and the parties. Section 120.57(1), Florida Statutes, and Rule 10D-41.093, Florida Administrative Code.
Petitioner is responsible for the licensing and regulation of persons conducting, maintaining, or operating a clinical laboratory in Florida. Section 483.091, Florida Statutes. Petitioner is also responsible for the licensing and regulation of persons using radioactive materials. Chapter 404, Florida Statutes.
Chapter 404 is "cumulative and ... intended to supplement existing laws." Sections 404.022(2)(a) and 404.171, Florida Statutes. Chapter 404 may not be "construed to repeal any existing law, specifically enacted for the protection of public health and safety ..." Section 404.171, Florida Statutes.
Notwithstanding any language to the contrary in the Radioactive Materials License issued by Petitioner's Office of Radiation Control, Respondent was not thereby licensed to perform clinical laboratory procedures. Dual licensing is required under the law.
A "clinical laboratory" is a "laboratory where examinations are performed on materials or specimens taken from the human body to provide
information or materials for use in the diagnosis ... of a disease or the assessment of a medical condition." Section 483.041(1), Florida Statutes.
"Persons" are prohibited from conducting, maintaining, or operating a clinical laboratory without a license. A "person" means the state or "any individual, firm, partnership, association, corporation, county, municipality, political subdivision, or other entity ..." Section 483.041(9), Florida Statutes.
A clinical laboratory license authorizes "the performance of one or more clinical laboratory procedures ... Separate licenses are required of all laboratories maintained on separate premises ..." Section 483.101, Florida Statutes. "Separate licensure shall not be required for separate buildings on the same or adjoining grounds." Rule 10D-41.080(3), Florida Administrative Code.
"A license shall be issued to a clinical laboratory [emphasis supplied] to perform only those clinical laboratory procedures ... that are within the specialties ... in which the clinical laboratory personnel are qualified. A license shall not be issued unless [Petitioner] determines that the clinical laboratory is adequately staffed and equipped ..." Section 483.111, Florida Statutes.
Petitioner may take disciplinary action "against a clinical laboratory [emphasis supplied]" for "[v]iolating or aiding or abetting in the violation of any provision of [Part I, Chapter 483] or the rules promulgated thereunder" or "[p]erforming and reporting tests in a specialty ... in which the laboratory [emphasis supplied] is not licensed." Section 483.201(6) and (9), Florida Statutes.
For the violation of any provision of Part I, Chapter 483, Petitioner may suspend, revoke, annul, limit, or deny renewal of a license or impose an administrative fine of not more than $500 per violation, with each day of a violation constituting a separate violation for determining the maximum amount of the fine. Section 483.221(a)(a), Florida Statutes. In determining the amount of the fine, Petitioner is required to consider the "severity of the violation, including the probability that death or serious harm to the health or safety of any person will result or has resulted; the severity of the actual or potential harm; and the extent to which the provisions of this part were violated." Section 483.221(b)(1), Florida Statutes. Petitioner must also consider, in setting the amount of the fine, the licensee's corrective actions, previous violations, and financial benefit inuring from the violation. Section 483.221(b)(2), (3), and (4), Florida Statutes.
Petitioner must prove the allegations of the Administrative Complaint by clear and convincing evidence. Ferris v. Turlington, 510 So.2d 292 (Fla. 1987).
Only legal entities may obtain licenses. Such entities are defined as "persons" for this part of Chapter 483. An activity or a laboratory is not a "person" and thus may not obtain a license.
Notwithstanding the statutory references to the issuance of a license to, and disciplining of, a "clinical laboratory," Respondent, which is a "person," holds the clinical laboratory license. Holding this and other licensure, Respondent owns and operates the Hospital, which comprises, inter alia, the clinical laboratory and nuclear medicine laboratory.
By statute, separate licenses are required when a licensee maintains laboratories "on separate premises." By rule, one license is sufficient for all of a licensee's clinical laboratories located in different buildings but on the same grounds. Thus, when clinical laboratory procedures performed in the nuclear medicine laboratory render the nuclear medicine laboratory, by statutory definition, a clinical laboratory, the single clinical laboratory license held by Respondent covers its additional "clinical laboratory."
Two sets of circumstances underscore the difficulties inherent in interpreting Part I, Chapter 483 to require Respondent to obtain two clinical laboratory licenses for clinical laboratory procedures performed in two locations within the Hospital. First, the blood volume test in which the blood is analyzed while in the patient is not subject to licensure under Part I, Chapter 483; it is not a clinical laboratory procedure because the blood is examined in vivo. Given the obvious similarities between the two types of blood volume tests, it is difficult to understand why Respondent could perform one type of blood volume test in its nuclear medicine laboratory and not the other type, especially because the purpose of Part I, Chapter 483, which "is to protect the public health, safety and welfare from the hazards of improper performance by clinical laboratories." Section 483.021, Florida Statutes.
Second, and more important, the same person serves as director of the clinical laboratory and the nuclear medicine laboratory at the Hospital. Personnel in both laboratories are equally qualified to perform the subject tests. Petitioner produced no evidence as to why the scope of Respondent's clinical laboratory license should be limited, especially under these circumstances, so as to prohibit personnel in the nuclear medicine laboratory from performing the Schilling test and blood volume tests.
In sum, Petitioner has failed to prove, as alleged in the Administrative Complaint, that Respondent was performing clinical laboratory procedures in the nuclear medicine laboratory without a clinical laboratory license or, more accurately, a second clinical laboratory license. If Petitioner believes that clinical laboratory procedures are being performed under improper conditions in Hospital, the proper procedure would be to discipline Respondent's present clinical laboratory license, not require that Respondent apply for more such licenses.
Based on the foregoing, it is hereby
RECOMMENDED that a Final Order be entered finding Respondent not guilty and dismissing the Administrative Complaint.
ENTERED this 16th day of May, 1988, in Tallahassee, Florida.
ROBERT E. MEALE
Hearing Officer
Division of Administrative Hearings The Oakland Building
2009 Apalachee Parkway
Tallahassee, Florida 32399-1550
(904) 488-9675
Filed with the Clerk of the Division of Administrative Hearings this 16th day of May, 1988.
COPIES FURNISHED:
Lynn Porter-Carlton, Esquire District VII Legal Counsel Department of Health and Rehabilitative Services
400 West Robinson Street Orlando, Florida 32801
Eliting L. Storms, Esquire Storms, Krasny, Normile
& Dettmer, P.A.
Post Office Box 1376 Melbourne, Florida 32902-1376
Gregory L. Coler Secretary
Department of Health and Rehabilitative Services 1323 Winewood Boulevard
Tallahassee, Florida 32399-0700
John Miller General Counsel
Department of Health and Rehabilitative Services 1323 Winewood Boulevard
Tallahassee, Florida 32399-0700
Sam Power Clerk
Department of Health and Rehabilitative Services 1323 Winewood Boulevard
Tallahassee, Florida 32399-0700
=================================================================
AGENCY FINAL ORDER
=================================================================
STATE OF FLORIDA
DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES
DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES,
Petitioner,
vs. CASE NO.: 87-5361
HOLMES REGIONAL HEALTH CARE SYSTEM, INC. d/b/a JAMES E. HOLMES REGIONAL MEDICAL CENTER,
Respondent.
/
FINAL ORDER
This cause came on before me for the purpose of issuing a final agency order. The Hearing Officer assigned by the Division of Administrative Hearings (DOAH) in the above-styled case submitted a Recommended Order to the Department of Health and Rehabilitative Services (HRS). A copy of that Recommended Order is attached hereto.
FINDINGS OF FACT
The department hereby adopts and incorporates by reference the findings of fact set forth in the Recommended Order.
CONCLUSIONS OF LAW
The department hereby adopts and incorporates by reference the conclusions of law set forth in the Recommended Order except for conclusion of law number 11 wherein the Hearing Officer concluded that Ferris vs. Turlington, 510 So2d 292 (Fla. 1957) requires the department to prove the allegations of the complaint by clear and convincing evidence. Ferris is applicable to revocation of a professional license, not imposition of a fine as in the present case. The correct burden of proof is the preponderance test. American Insurance Association vs. Department of Insurance, 518 So2d 1342 (Fla. 1st DCA 1987).
Based upon the foregoing, it is
ADJUDGED, that the administrative complaint be dismissed.
DONE and ORDERED this 31st day of May, 1988, in Tallahassee, Florida.
Gregory L. Coler Secretary
Department of Health and Rehabilitative Services
by Deputy Secretary for Operations
COPIES FURNISHED:
Lynn Porter-Carlton, Esquire District 7 Legal Counsel
400 West Robinson Orlando, Florida 32801
Elting L. Storms, Esquire STORMS, KRASNY, NORMILE
& DETTMER, P. A.
Post Office Box 1376 Melbourne, Florida 32902-1376
Robert E. Meale Hearing Officer
Division of Administrative Hearings The Oakland Building
2009 Apalachee Parkway
Tallahassee, Florida 32301
CERTIFICATE OF SERVICE
I HEREBY CERTIFY that a copy of the foregoing was sent to the above-named people by U.S. Mail this 1st day of June, 1988.
R. S. Power, Agency Clerk Assistant General Counsel Department of Health and
Rehabilitative Services 1323 Winewood Boulevard Building One, Room 407
Tallahassee, Florida 32399-0700 904/488-2381
NOTICE OF RIGHT TO JUDICIAL REVIEW
A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF HRS, AND A SECOND COPY, ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED.
Docket for Case No: 87-005361
Orders for Case No: 87-005361
| Issue Date |
Document |
Summary |
|
May 31, 1988 |
Agency Final Order
|
|
|
May 16, 1988 |
Recommended Order
|
Hospital is person holding clinical lab license so it may conduct clinical lab work in nuclear lab
|
