Disciplinary Action against
Carol Roberts, M.D.


Carol Roberts, M.D, who operates the Wellness Works clinic in Brandon, Florida, has been charged with failing to maintain acceptable infection control procedures at her clinic. In 2010, it was determined that an outbreak of hepatitis C was caused by a nurse who improperly administered intravenous chelation therapy. The complaint (shown below) states that the intravenous solutions got contaminated by vitamins taken repeatedly from single-use vials without cleaning the tops of the vials. The complaint (shown below) mentions only one patient, but press reports indicate tht there were at least eight. [Martin R, Lehman H. Hepatitis C outbreak at Brandon holistic clinic blamed on syringes. St. Petersburg Times, March 20, 2010] Wellness Works is listed as a study site for the NIH-sponsored but ethically dubious Trial to Assess Chelation Therapy. The case was settled in 2012 with a stipulation under which she admitted no wrongdoing but the board reprimand her and ordered her to pay a $15,000 fine plus costs of about $10,000.


STATE OF FLORIDA
DEPARTMENT OF HEALTH

DEPARTMENT OF HEALTH,

PETITIONER,

v.

CAROL ROBERTS, M.D.,

RESPONDENT.


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CASE NO. 2010-03687

AMENDED ADMINISTRATIVE COMPLAINT

Petitioner, Department of Health, by and through its undersigned counsel, files this Administrative Complaint before the Board of Medicine against Respondent, Carol Roberts, M.D., and in support thereof alleges:

1. Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes.

2. At all times material to this Complaint, Respondent was a licensed physician within the state of Florida, having been issued license number ME 32984.

3. Respondent's address of record is 8022 Mays Avenue, Riverview, Florida 33578-4427.

4. Respondent is board certified in Otolaryngology.

5. From about April 6, 2009 through April 24, 2009, Respondent held herself out as the medical director of Well ness Works Holistic Medicine Center (Well ness Works) in Brandon, Florida.

6. Because Respondent was holding herself out as the medical director of Wellness Works, she was responsible for all activities related to treatment provided at the facility. Respondent was also responsible for ensuring compliance with the respective practice acts and rules adopted under Chapter 400.

7. Well ness Works offered chelation therapy and the administration of supplements, vitamins, and minerals by intravenous injection (IV).

8. Well ness Works purchased supplies of vitamins and pharmacological agents used in the IV therapies provided by the clinic. Many of the vitamins were supplied in 50 milliliter single dose vials. The label on the front of the vial stated "single dose vial" indicating that the vial should only be accessed once to administer one dose to one patient.

9. Multi-dose vials are labeled accordingly and contain additives that inhibit the growth of bacteria.

10. Single dose vials are labeled accordingly and do not contain additives that inhibit the growth of bacteria.

11. In or about July 2008, Nurse B.M. was hired as a registered nurse by Well ness Works. Nurse B.M. was responsible for, among other things, drawing patients' blood, inserting intravenous (IV) catheters, and the IV injection or IV infusion of supplements, minerals, and vitamins.

12. On or about April 22, 2009, Patient M.F. presented to Well ness Works for an evaluation for hormone therapy. A physician at Wellness Works recommended that M.F. undergo vitamin IV fusion to give M.F. energy.

13. On that same date, M.F. was instructed to go to the infusion room where Nurse B.M. would administer the treatment. Nurse B.M. administered the vitamin IV fusion treatment to M.F.

14. At all times material to this complaint, the supply of vitamins and agents used in IV therapies at Well ness Works were stored in the patient treatment area.

15. Nurse B.M. used a syringe and needle combination, to draw fluid from each vial. Nurse B.M. did not cleanse the tops of the vials with a sterile alcohol wipe.

16. Nurse B.M. mixed IV solutions with vitamins and/or other pharmacological agents at the table at which she injected the solution mixture of vitamins.

17. Nurse B.M. used the single dose vials as multi-dose vials, accessing the vials multiple times to administer multiple doses to multiple patients.

18. Nurse B.M. injected the vitamins into a bag of IV fluids and connected the vitamin solution to M.F.'s IV catheter and infused the solution through M.F.'s IV.

19. The patient treatment room did not have a sink as required under Florida Statutes.

20. In or about May 2009, M.F. began to have symptoms of pain in her side, a stomach ache and vomiting. On or about June 30, 2009, M.F. presented to the Mayo Clinic where she was tested and diagnosed with HCV.

21. Nurses are obligated to follow, Universal Precautions, as described by the Occupational Safety and Health Standards (OSHA) regulations located in Title 29, Code of Federal Regulations, Section 1910.1030. Universal Precautions is an approach to infection control where all human blood and certain human body fluids are treated as if known to be infectious for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and other blood borne pathogens.

22. Hepatitis C virus (HCV) is another known blood borne pathogen.

23. According to Title 29, Code of Federal Regulations, Section 1910.1030(b), contaminated means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface.

24. According to the principles of Universal Precautions, any item that has the presence, or reasonably anticipated presence, of blood, must be treated as if known to be infectious for bloodborne pathogens such as HI\!, HB\!, or ucv

25. Pursuant to Rule 64B8-9.0075, Florida Administrative Code, (1) Standards of care and standards of practice require that Florida licensed physicians and physician assistants provide their patients appropriate medical care under sanitary conditions .... (3) Licensed physicians and physician assistants in a clinic registered under Chapter 400, Part XIII, ES., may reasonably rely upon a Florida licensed medical director to ensure compliance with the responsibilities set forth in Section 400.991, Floria Statutes ....

26. Section 458.331(1)(nn), Florida Statutes (2009), sets forth grounds for disciplinary action by the Board of Medicine and provides that violating any provision of chapter 458 or chapter 456, or any rules adopted pursuant thereto constitute grounds for discipline.

27: Respondent failed to comply with Rule 64B8-9.0075, Florida Administrative Code, by failing to ensure compliance with standards of care and standards of practice in provision of appropriate medical care under sanitary conditions in one or more the following ways:

a. by failing to verify that sterile equipment and sterile techniques were used when IV injection were performed; and/or

b. by failing to institute acceptable infection prevention practices; and/or

c. by failing to monitor acceptable infection prevention practices.

28. Respondent violated Section 458.331(1)(nn), Florida Statutes (2009), by failing to comply with Rule 64B8-9.0075, Florida Administrative Code.

WHEREFORE, Petitioner respectfully requests that the Board of Medicine enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate.

SIGNED this 7 day of March, 2012.

H. Frank Farmer, Jr., M.D., Ph.D., F.A.C.P.
State Surgeon General

____________________________
Yolanda Y. Green, Esq.
Assistant General Counsel
DOH Prosecution Services Unit
4052 Bald Cypress Way, Bin C-65
Tallahassee, FL 32399-3265
Florida Bar # 0738115
(850) 245-4640, Ext. 8144
(850) 245-4681 FAX

NOTICE OF RIGHTS

Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counselor other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested.

NOTICE REGARDING ASSESSMENT OF COSTS

Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution of this matter. Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition to any other discipline imposed.

This page was posted on November 1, 2012.

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