This matter is before the Administrative Law Court (“Court” or “ALC”) pursuant to a
petition filed by Ezra Riber, M.D. (“Respondent”) with the South Carolina Department of Health
and Environmental Control (“Department”) on November 4, 2004. The petition was transmitted
to this court and filed on November 5, 2004. Respondent seeks an expedited assignment and
hearing of the Department’s determination which prohibits him, for the remainder of the 2004
calendar year, from participating as a “registrant” in procedures involving any source of ionizing
radiation.
The parties agreed that the Court would set this matter for an expedited hearing as a
contested case at 9:30 a.m. on Tuesday, November 9, 2004. Also, the parties stipulated that the
hearing would be a full evidentiary hearing and any statutory requirements for notice, as required
by the Administrative Procedures Act (“APA”), would be waived.
Although the Agency Transmittal Form as prepared by the Department indicated that Dr.
Riber was the Petitioner and the Department was the Respondent, the Court found that the
Department in its action prohibited Dr. Riber from participating in procedures involving ionizing
radiation for the remainder of the 2004 calendar year, alleged that he violated certain regulations
and sought enforcement of its determination. In response, Respondent requested a contested
case hearing pursuant to S.C. Code Ann. § 1-23-320(a) (Supp. 2003). This statute requires that
all parties be afforded an opportunity for a contested case hearing. Basic administrative law
principles establish that an agency bears the burden of proof in an enforcement action. See
Peabody Coal Co. v. Ralston, 578 N.E.2d 751 (Ind. Ct. App. 1991); Randy R. Lowell and
Stephen P. Bates, South Carolina Administrative Practice and Procedure, 200-201 (2004).
Because the Department is seeking an enforcement of its regulations, this matter constitutes an
enforcement action and the Department bears the burden of proof in establishing that
Respondent committed any violations. At the commencement of the hearing, the Court ordered
that the caption be amended to reflect the Department as the Petitioner and Dr. Riber as the
Respondent. The Court further instructed the Department that it bore the burden of proof in this
case.
After listening to the testimony of the witnesses and reviewing the evidence placed into
the record at the hearing, I issued my decision at the conclusion of the trial. In my verbal order, I
authorized Dr. Riber to continue as a registrant of x-ray machines and to participate in
procedures involving any source of ionizing radiation, subject to certain conditions only for the
remainder of the 2004 calendar year.
FINDINGS OF FACT
Having observed the witnesses and exhibits presented at the hearing and closely passed
upon their credibility, taking into consideration the burden of persuasion by the parties, I make
the following Findings of Fact, by a preponderance of the evidence:
1.The Court has personal and subject matter jurisdiction and notice of the
date, time, place and nature of the hearing was timely given and agreed to by the parties.
2.Dr. Ezra B. Riber, a graduate of the Marshall School of Medicine, is a
medical doctor licensed by the Medical Board of the South Carolina Department of Labor,
Licensing and Regulation. He has practiced as a specialist in anesthesiology and pain
management for approximately nineteen years in Florence and Columbia, South Carolina. His
office is presently located adjacent to the Providence Hospital (“hospital”) in Columbia.
3.Respondent is also licensed by the Department as an x-ray “registrant”
which authorizes him to provide fluoroscopically-guided procedures, both at his office and at the
hospital. He provides these procedures to clients at his office Monday through Thursday and at
the hospital each Friday. During each procedure, both at his office and at the hospital, he uses a
C-Arm machine. Dr. Riber also wears special eyeglasses to prevent damage to the retinas of his
eyes, and he wears a lead shield vest, a lead skirt/apron and a lead shield neckpiece to shield his
body and his thyroid from radiation. Dr. Riber brought these garments to court and placed them
on his person for review by the Court.
4.
During all times he is conducting a fluoroscopically-guided procedure, Respondent wears
a special badge to monitor exposure to radiation. Each quarter the badge is sent to Landauer, a
company located in Glenwood, Illinois, which “reads” the badge and prepares a report that
details the extent of Respondent’s radiation exposure for that quarter. The report is provided to
Respondent and to the hospital, dependent on where the procedures were performed. Dr. Riber
often places his badge in the breast pocket of his lead shield vest where it is directly exposed to
radiation (without the benefit of any lead shielding). Also, he has often left his badge in the
breast pocket of the lead vest after completing his procedures in the operating room. These
garments have been worn on occasion since mid-August, 2004 by Dr. Jennifer Feldman, a
cardiologist with the Columbia Heart Clinic, as well as other doctors, while they performed
radiation procedures at the hospital.
5.The badge used by Respondent, as well as all similar badges assigned to
and used by other doctors at the hospital, are kept on a wooden board outside the surgery room.
They are accessible to all doctors, technicians and other hospital staff who have authorization to
visit the general area. The lead garments (vests and skirts) are located in the same locale and are
equally accessible to others.
6.Dr. Riber is assisted by Rollie Addison Huffstetler, a radiology
technologist employed by the hospital, during approximately 98 % of all fluoroscopic procedures
he performs at the hospital.During these procedures in the operating room, Mr. Huffstetler (as
is the practice with all radiology technologists and as required by the Department), keeps a
fluoroscopic time sheet for each procedure. It contains various information for each procedure,
including the name of the patient, the type of exam, the date, amount of fluoro time, the name of
the technologist and doctor, the names of any others in the room, and whether the personnel wear
the lead apron and badge.
7.Mr. Huffstetler testified at the hearing and was a credible witness. He
explained the various procedures performed by Dr. Riber, their physical positions beside the C-Arm (see Resp. # 5) and the patients while performing procedures, and the nature of their
professional relationship both inside and outside of the operating room. As part of his duty, Mr.
Huffstetler moves the C-Arm while Dr. Riber performs a procedure. He testified that there is a
clock on the C-Arm which registers the time of any radiation emission; further, he noted that Dr.
Riber does not stand next to the machine when he (Mr. Huffstetler) turns it on to emit radiation.
Mr. Huffstetler stated that he has a duty to protect Dr. Riber’s hands from any exposure to
radiation and that Dr. Riber’s hands are exposed only about 2% of the time. Finally, Mr.
Huffstetler provided testimony concerning the time sheet log and explained the information
entered there.
8.Respondent has no history of any previous complaints by the Department
for a violation of any statutes or regulations applicable to his providing these procedures and
using x-ray equipment.
9.Following an investigation on November 2, 2004, the Department wrote a
letter to Respondent on November 3, 2004 which informed him that he was in violation of S.C.
Code Regs 61-64, RHB 3.4. The letter stated that the Department had reviewed reports
concerning radiation levels taken from Respondent’s badges at both Providence Hospital and his
office and that they revealed that he had exceeded his annual dose limit of five (5) rem for the
year 2004. The letter further provided that Dr. Riber could not participate in any procedure
involving any source of ionizing radiation nor receive any occupational exposure to radiation for
the remainder of calendar year 2004. Finally, the letter provided that Dr. Riber had twenty (20)
days to provide written notification to the Department of any action taken to correct the
violation.
During the hearing, the Department posited that the letter constituted an administrative
order. Later in its closing argument, the Department stated that as a result of its investigation on
November 2, 2004, it found that an emergency existed which required immediate action to
protect the public health and safety and that its letter constituted an “emergency order” by the
Department.
In both cases, the Department concluded that its Director of the Division of
Electronic Products could issue both an administrative order and an emergency order on behalf
of the Department.10.
Subsequent to conversations between Respondent and the Department, on November 2,
2004 Respondent wrote a letter to the Department asking it to consider allowing him to continue
performing fluoroscopically-guided procedures. He noted that mobile lead shields were
available that he could stand behind to view the monitor and which would shield him from any
scatter. Further, he stated that he would use an electronic dosimeter to monitor the radiation
exposure to his person on each case. Respondent stated that he would be careful with his badge
during the restrictive period and thereafter. He also noted the many procedures that his office
had scheduled for this time period. Also, Respondent, at his own expense, was examined by two
physicians who reported that Respondent exhibited no indications of increased levels of
radiation exposure.
CONCLUSIONS OF LAW
Based upon the foregoing findings of fact, I conclude, as a matter of law, the following:
Title 1
1.S.C. Code Ann. § 1-23-600 (Supp. 2003) grants jurisdiction to the Administrative
Law Court to hear contested cases under the Administrative Procedures Act.
2.S.C. Code Regs. 61-72 § 201.A authorizes a person aggrieved by a decision by
the Department to request an adjudicatory hearing by filing a petition following receipt of an
administrative order. S.C.Code Regs. 61-72 § 101.I defines “Order” as:
A written document, other than a license, which embodies a final staff decision imposing
sanctions or requirements. It may be, but need not be, denominated an “Order.” It
includes, but is not limited to, administrative orders so denominated; a staff decision to
deny a license; or any decision from which appeal may be taken pursuant to other
applicable law or regulation.
3.The Administrative Law Court has subject matter jurisdiction in this case pursuant to
Article I, § 22 of the South Carolina Constitution, the South Carolina Administrative Procedures
Act, Regs. 61-72 and the Rules of Procedure of the Court.
4.This Court may find facts in accordance with the preponderance of the evidence. Glass
v. Dow Chem. Co., 482 S.E.2d 49, 325 S.C. 198 (1997); Givens v. Steel Structures, Inc., 279
S.C. 12, 301 S.E.2d 545 (1983).
5.Basic administrative law principles establish that an agency bears the burden of proof in
an enforcement action. See Peabody Coal Co. v. Ralston, 578 N.E.2d 751 (Ind. Ct. App. 1991);
Randy R. Lowell and Stephen P. Bates, South Carolina Administrative Practice and Procedure,
200-201 (2004).
Title 13
6.Chapter 7 of Title 13 of the S.C. Code of Laws is titled “Nuclear Energy.”
7.The Department is the agency within the State of South Carolina which is
authorized and directed to implement the provisions of the Atomic Energy and Radiation Control
Act (AERCA) contained in Article 1 of Chapter 7, Title 13. Further, it must apply the provisions
of S.C. Code Regulation 61-64 titled “X-rays.”
8.“Ionizing radiation” is defined as “gamma rays and X rays, alpha and beta
particles, electrons, neutrons, protons, and other atomic particles; but not sound or radio waves,
or visible, infrared, or ultraviolet light.” S.C. Code Ann. § 13-7-10(2) (1976).
Emergency Action
9.Whether the action taken by the Department in the letter signed by the director of
the Division of Electronic Products was based either upon its statutory authority to issue
emergency orders pursuant to S.C. Code Ann. § 13-7-50, or was based upon its authority in its
regulations to issue an enforcement letter or an administrative order, in all instances the
Department has failed to show that an emergency exists. Its rationale and basis for its
determination are not discussed in the letter.
The Department has not shown any risk or imminent likelihood of harm either to Dr.
Riber or to the general public. It based its determination solely on the readings of Dr. Riber’s
badges, as shown in the reports from Landauer. At most, these readings are only prima facie
evidence of an elevated exposure to radiation to Respondent, but they do not constitute any
evidence of danger to the public. In addition, the Department failed to consider other relevant
factors such as Dr. Riber’s desire to protect his health, the possibility that other doctors may
have used Respondent’s badge, the hospital’s lack of security procedures for the badges, lead
vests and skirts,
the review of the logs at the hospital which show that Dr. Riber did not perform
fluoroscopic procedures to any greater degree in 2004 versus earlier years, and the monitoring of
the radiation emissions by a hospital staff person who must write down the times of X-ray
emissions before the machine can be turned off.
All these considerations, together with the October 2004 report from Landauer which
showed the Respondent was exposed to a much smaller amount of radiation than in the spring
and summer, support the conclusion that the higher readings were the result of others using Dr.
Riber’s badge at the hospital rather than an accurate measure of the radiation exposure received
by Dr. Riber.
Accordingly, I find that the Department’s determination/administrative order/emergency
order to prohibit Respondent from participating in any procedure involving any source of
ionizing radiation for the remainder of the 2004 calendar year, as set forth in its letter dated
November 3, 2004, is without evidentiary support and is reversed. Notwithstanding, to ensure
the safety of Respondent, he must:
(1) wear an electronic dosimeter while operating any fluoroscopic devices or while
exposed to radiation either in his office or at the hospital, and must make written reports
to the Department bi-weekly, commencing on Friday, November 19, 2004, which must
contain the dosimeter readings; and
(2) ensure that the fluoroscopic devices, either in his office or at the hospital, are in the
“pulse” or “low dose” mode while in operation or while Respondent is otherwise subject
to exposure to radiation; and
(3) maintain the maximum available distance from emanations of radiation, consistent
with best practices for the delivery of the medical services he provides, when operating
the fluoroscopic devices or while exposed to radiation, both at his office and at the
hospital.
ORDER
Accordingly, it is hereby
ORDERED that the limitations on Respondent’s practice of providing medical services,
as contained in the letter of the Department dated November 3, 2004, are vacated; and it is
further
ORDERED that the Respondent may immediately resume providing procedures at the
hospital involving any source of ionizing radiation, subject to the conditions aforementioned in
conclusion of law # 9; and it is further
ORDERED that Respondent henceforth must exercise some level of security over his
badge, lead skirt and vest to ensure they are no longer worn by others; and it is further
ORDERED that a copy of this Order must be served by Respondent on the chief
operating officer of Providence Hospital within five days of its receipt.
AND IT IS SO ORDERED.
________________________________________
Marvin F. Kittrell
Chief Administrative Law Judge
November 24, 2004
Columbia, South Carolina
