Agency Clerk IN RE:
DEPARTMENT OF HEALTH The Emergency Restriction of the License of Harold M. Bass, M.D.
License Number: ME 16754 Case Number: 2011-09136
ORDER OF EMERGENCY RESTRICTION OF LICENSE
H. Frank Farmer, Jr., M.D., Ph.D., F.A.C.P., State Surgeon General, ORDERS the Emergency Restriction of the license of Harold M. Bass, M.D. (Dr. Bass) to practice as a physician in the State of Florida. Dr. Bass holds license number ME 16754. His address of record is 4300 North University Drive, Suite A-202, Lauderhill, Florida 33351. The following Findings of Fact and Conclusions of Law support the Emergency Restriction of Dr. Bass's license to practice medicine in the State of Florida.
INTRODUCTION
Dr. Bass was scheduled to perform Level II surgical procedures on Patient R.W. During the first 55 minutes of the procedure, Dr. Bass ordered the administration of 7 mg of Versed and 175 mg of Demerol, which were administered by a registered nurse. Shortly thereafter, Patient R.W. went into cardiac and pulmonary arrest and was transported to the Florida Medical Center (FMC), where she ultimately died. The Department retained an independent medical expert who opined that Dr. Bass's treatment of the patient fell below the standard of care because he administered inappropriate quantities and combinations of sedatives to the patient and failed to conform to the rule regarding office surgeries.
FINDINGS OF FACT
1. The Department of Health ("Department") is the state agency charged with regulating the practice of medicine, pursuant to Chapters 20, 456 and 458, Florida Statutes (2010-2011). Section 456.073(8), Florida Statutes (2011), empowers the State Surgeon General to summarily restrict Dr. Bass's license to practice as a physician in the State of Florida in accordance with Section 120.60(6), Florida Statutes (2011).
2. At all times material to this Order, Dr. Bass was licensed to practice as a physician in the State of Florida, pursuant to Chapter 458, Florida Statutes (2010), and treated patients at the Strax Rejuvenation & Aesthetics Institute (Strax) located at 4300 North University Drive, Suite E-200, Lauderhill, Florida 33351. At all times material to this Order, Dr. Bass was board certified in plastic surgery by the American Board of Plastic Surgery but not certified in anesthesiology.
3. On May 16, 2011, Patient R.W., a 61-year-old female, whose height was approximately 4'10" and weight was approximately 120 pounds, presented to Dr. Bass at Strax to undergo lower beipharoplasty (eyelid revision), anterior platysmaplasty (tightening of the neck muscles) and neck lift procedures. Prior to the procedure, Patient R.W. disclosed her medical history, which included prescriptions for Pristiq 50 mg, a serotonin-norepinephrine reuptake inhibitor (SNRI) prescribed to treat anxiety and depression, and Gabapentin, which is prescribed to treat neuropathic pain.
4. Patient R.W. consented to undergo the surgical procedures listed above as Level II office surgeries, in which anesthesia is administered to reduce anxiety and pain to produce a semi-conscious state that allows the patient to respond purposefully to
verbal commands or tactile stimulation. R.W. also consented to the administration, maintenance and termination of anesthesia by K.R., a registered nurse, in accordance with the standards for Level II surgeries.
5. At approximately 14:50, medical staff took Patient R.W. to the operating room and placed a cardiac monitor on her. Patient R.W. received Marcaine, a local anesthetic, and began receiving intravenous dosages of Versed and Demerol for anesthesia at approximately 14:55.1 During the first 55 minutes of the procedure, Dr. Bass ordered the administration of 7 mg of Versed and 175 mg of Demerol, which were administered by K.R.
6. Versed is a brand of midazolam (benzodiazepine) is commonly prescribed to provide sedation prior to medical procedures. According to Section 893.03(4), Florida Statutes (2010), midazolam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule III and has a currently accepted medical use in treatment in the United States. Abuse of midazolam may lead to limited physical or psychological dependence relative to the substances in Schedule III.
7. Demerol is a brand name for meperidine (opioid) and is prescribed to treat pain. According to Section 893.03(2), Florida Statutes (2010), meperidine is a Schedule II controlled substance that has a high potential for abuse and has a currently
The combination of sedatives Dr. Bass administered to Patient R.W. was similar to the medications he administered to her on August 20, 2010, when he placed R.W. under general anesthesia for similar plastic surgery procedures. At that time, Dr. Bass ordered the preoperative administration of 50 mg of Demerol intramuscular and the administration 2 mg of Versed, 2 cc of Fentanyl and 120 mg of Demerol during the procedure.
accepted but severely restricted medical use in treatment in the United States. Abuse of meperidine may lead to severe psychological or physical dependence.
8. Dr. Bass failed to document Patient R.W.'s level of consciousness during her sedation. However, medical records indicate that Patient R.W.'s oxygen saturation and blood pressure levels fell at approximately 16:07, and she went into cardiac and pulmonary arrest. Dr. Bass and medical staff began resuscitative efforts, including Advanced Cardiac Life Support (ACLS) treatments and intubation. R.W. was then transferred to the Florida Medical Center (FMC) via emergency transport. Patient R.W. remained unresponsive during her admission at FMC. Life-sustaining measures were withdrawn, and Patient R.W. died on May 19, 2011.
9. The Department retained an independent medical expert, who is a medical doctor board certified in Critical Care Medicine by the American Board of Anesthesiology. The Department's expert opined that Dr. Bass's treatment of Patient R.W. fell below the standard of care in several manners. The expert opined that Dr. Bass ordered dosages of Demerol and Versed that were inappropriate for the performance of a Level II procedure.
10. The expert also opined that Demerol was a substandard option for Patient R.W.'s procedure. The expert stated that many institutions only use Demerol.in limited amounts due to its poor pharmacologic profile and the wide availability of other alternatives. The expert opined that Demerol was even contraindicated in this patient based upon her current prescriptions of Prestiq, Gabapentin and Xanax, with which Demerol can negatively interact and create life-threatening conditions, such as
Serotonin Syndrome. The expert also opined that the use of Demerol in combination with Versed creates a synergistic effect that can result in greater sedation than the use of those drugs individually.
11. The expert opined that Dr. Bass's use of sedatives was inappropriate in the quality and quantities of the drugs administered. The expert stated that the amount of sedatives administered to the patient indicated a Level III procedure, to which the patient did not consent and for which Dr. Bass had inadequate medical personnel assisting him. The expert also stated that Dr. Bass's use of Marcaine as a local anesthetic was problematic due to the medication's significant cardiac toxicity at higher doses and the wide availability of other local anesthetics.
12. Finally, the expert opined that Dr. Bass's medical records for the procedure were insufficient because he failed to adequately document the patient's responses to stimuli, titration goal of the sedatives, the course of treatment when the patient decompensated and the response of medical providers.
CONCLUSIONS OF LAW
Based on the foregoing Findings of Fact, the State Surgeon General concludes as follows:
1. The State Surgeon General has jurisdiction over this matter pursuant to Sections 20.43 and 456.073(8), Florida Statutes (2011), and Chapter 458, Florida Statutes (2011).
2. Section 120.60(6), Florida Statutes (2011), authorizes the Department to suspend or restrict a physician's license if the Department finds that the physician presents an immediate, serious danger to the public health, safety, or welfare.
3. Section 458.331(1)(t)1, Florida Statutes (2010), subjects a physician to discipline for committing medical malpractice as defined in Section 456.50, Florida Statutes (2010). "Medical malpractice" is defined by Section 456.50(1)(g), Florida Statutes (2010), as "the failure to practice medicine in accordance with the level of care, skill, and treatment recognized in general law related to health care licensure." Section 456.50(1)(e), Florida Statutes (2010), provides that the "level of care, skill, and treatment recognized in general law related to health care licensure" means the standard of care that is specified in Section 766.102(1), Florida Statutes (2010), which is set forth as follows:
The prevailing professional standard of care for a given health care provider shall be that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers.
Section 458.331(1)(t)1, Florida Statutes (2010), directs the Board of Medicine to give "great weight" to this provision of Section 766.102 Florida Statutes (2010).
4. Dr. Bass failed to meet the prevailing standard of care in one or more of the following manners:
a. By prescribing or administering inappropriate doses of Demerol, Versed and/or Marcaine to Patient R.W.;
b. By prescribing or administering high doses of Demerol to Patient R.W. despite her current prescribed medications; and/or
c. By failing to adequately monitor Patient R.W.
5. Section 458.331(1)(q), Florida Statutes (2010), allows the Board of Medicine to discipline a physician for prescribing, dispensing, administering, mixing or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's professional practice. For the purposes of this paragraph, it shall be legally presumed that prescribing, dispensing, administering, mixing, or otherwise preparing legend drugs, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician's professional practice, without regard to his or her intent.
6. Dr. Bass violated Section 458.331(1)(q), Florida Statutes (2010), in one or more of the following manners:
a. By prescribing or administering inappropriate doses of Demerol, Versed and/or Marcaine to Patient R.W. ; and/or
b. By prescribing or administering inappropriate doses of Demerol to Patient R.W. despite her current use of an SNRI medication.
7. Section 458.331(1)(nn), Florida Statutes (2010), allows the Board of Medicine to discipline a physician for violating any provision of Chapters 456 or 458, Florida Statutes, or any rules adopted pursuant thereto.
8. Rule 64B8-9.009, Florida Administrative Code, sets forth the standard of care for office surgery, in part, as follows:
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(4) Level II Office Surgery. (a) Scope.
1. Level II Office Surgery is that in which peri-operative medication and sedation are used by any means altering the level of consciousness, thus making intra and post-operative monitoring necessary. Such procedures shall include, but not be limited to: hemorrhoidectomy, hernia repair, reduction of simple fractures, large joint dislocations, breast biopsies, colonoscopy, and liposuction involving the removal of up to 4000cc supernatant fat.
2. Level II Office surgery includes any surgery in which the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation. Patients whose only response is reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition.
(b) Standards for Level II Office Surgery.
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4. Assistance of Other Personnel Required. The surgeon must be assisted by a qualified anesthesia provider as follows: An Anesthesiologist, Certified Registered Nurse Anesthesist, or Physician Assistant qualified as set forth in subparagraph 64B8-30.012(2)(b)6., Florida Administrative Code, or a registered nurse may be utilized to assist with the anesthesia, if the surgeon is ACLS certified. An assisting anesthesia provider cannot function in any other capacity during the procedure. If additional assistance is required by the specific procedure or patient circumstances, such assistance must be provided by a physician, osteopathic physician, registered nurse, licensed practical nurse, or operating room technician. A physician licensed under Chapter 458 or 459, F.S., a licensed physician assistant, a licensed registered nurse with post-anesthesia care unit experience or the equivalent, credentialed in Advanced Cardiac Life Support or, in the case of pediatric patients, Pediatric Advanced Life Support, must be available to monitor the patient in the recovery room until the patient is recovered from anesthesia.
(6) Level III Office Surgery. (a) Scope.
1. Level III Office Surgery is that surgery which involves, or reasonably should require, the use of a general anesthesia or major conduction anesthesia and pre-operative sedation. This includes the use of:
a. Intravenous sedation beyond that defined for Level II office surgery;
b. General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of pulmonary or cardiac functions; or
c. Major conduction anesthesia.
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(b) Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following:
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4. Assistance of Other Personnel Required. An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in subparagraph 64B8-30.012(2)(c)6., Florida Administrative Code, must administer the general or regional anesthesia and an M.D., D.O., Registered Nurse, Licensed Practical Nurse, Physician Assistant, or Operating Room Technician must assist with the surgery. The anesthesia provider cannot function in any other capacity during the procedure. A physician licensed under Chapter 458 or 459, Florida Statutes, a licensed physician assistant, or a licensed registered nurse with post-anesthesia care unit experience or the equivalent, and credentialed in Advanced Cardiac Life Support, or in the case of pediatric patients, Pediatric Advanced Life Support, must be available to monitor the patient in the recovery room until the patient has recovered from anesthesia.
9. Dr. Bass violated Section 458.331(1)(nn), Florida Statutes (2010), by violating Rule 64B8-9.009, Florida Administrative Code, in one or more of the following manners:
a. By performing a Level III surgery with anesthesia being administered by a registered nurse; and/or
b. By performing a Level III surgery without the surgical assistance of a physician, osteopathic physician, registered nurse, licensed practical nurse, physician assistant or operating room technician.
10. Rule 64B8-9.007, Florida Administrative Code, sets forth the standards for the practice of medicine, in part, as follows:
The Board of Medicine interprets the standard of care requirement of Section 458.331(1)(t), Florida Statutes, and the delegation of duties restrictions of Section 458.331(1)(w), Florida Statutes, with regard to surgery as follows:
(1) The ultimate responsibility for diagnosing and treating medical and surgical problems is that of the licensed doctor of medicine or osteopathy who is to perform the procedure. In addition, it Is the responsibility of the treating physician or an equivalently trained doctor of medicine or osteopathy or a physician practicing within a Board approved postgraduate training program to explain the procedure to and obtain the informed consent of the patient.
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11. Dr. Bass violated Section 458.331(1)(nn), Florida Statutes (2010), by violating Rule 64B8-9.009, Florida Administrative Code, by failing to obtain informed consent from Patient R.W. for a Level III surgery.
12. Rule 64B8-9.003(3), Florida Administrative Code, Sets forth the requirements for maintaining medical records, in part, as follows:
The medical record shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request of the physician and relied upon by the physician in determining the appropriate treatment of the patient.
13. Dr. Bass violated Section 458.331(1)(nn), Florida Statutes (2010), by violating Rule 64B8-9.003, Florida Administrative Code, in one or more of the following manners:
a. By failing to set forth an adequate treatment plan, including a titration goal for the patient;
b. By failing to document the patient's response to stimuli;
c. By failing to document the events leading to the patient's decompensation; and/or
d. By failing to document the medical staff's responses to the patient's decompensation.
14. The foregoing supports the conclusion that Dr. Bass is using his medical license to improperly anesthetize patients without any regard for the health, safety and welfare of his patients. Dr. Bass's acts manifest a propensity to practice below the appropriate standard of care such that a continuation of this practice poses an immediate serious danger to the public health, safety or welfare.
15. A physician licensed in the State of Florida is one of a Small number of licensed professionals allowed to conduct surgical procedures and to administer controlled substances. The Legislature has vested a trust and confidence in these licensed professionals by permitting them to prescribe and administer drugs with a high potential for abuse and harm. The inappropriate administration , Of anesthesia medications to, and monitoring of, patients presents a danger to the public health, safety or welfare and does not correspond to that level of profeSsional conduct expected of one licensed to practice medicine in this state.
16. Dr. Bass's practice of prescribing and administering anesthesia and monitoring of patients constitutes a breach of the trust and confidencei that he enjoys as a physician licensed to practice medicine. Dr. Bass's practice of mediCine constitutes an immediate, serious danger to the public because he uses inappropriate dosages and sedatives in his office surgeries and has inadequate personnel to assist him. Dr. Bass utilized large doses of Demerol and combined Demerol and Versed on Multiple medical procedures. Dr. Bass's inappropriate use of anesthesia demonstrates that his violation of the standards governing the practice of medicine is likely to continue.
17. Dr. Bass's continued unrestricted practice as a physician constitutes an immediate serious danger to the health, safety or welfare of the Public, and this summary procedure is fair under the circumstances to adequately protect the public. The restriction against Dr. Bass's license to practice medicine is least restrictive reasonable means of protecting the public.
In accordance with Section 120.60(6), Florida Statutes (2011), it is ORDERED THAT:
1. The license of Harold M. Bass, M.D., license number ME 16754, is hereby immediately restricted as follows:
a) Dr. Bass may not perform Level II surgical procedures unless an anesthesiologist licensed in the State of Florida administers all sedatives to the patient and monitors the patient; and
b) Dr. Bass may not perform Level III surgical procedures unless an anesthesiologist licensed in the State of Florida administers all sedatives to the patient and monitors the patient.
2. A proceeding seeking formal restriction or discipline of the license of Harold M. Bass, M.D., to practice as a physician will be promptly instituted and acted upon in compliance with Sections 120.569 and 120.60(6), Florida Statutes (2011).
DONE and ORDERED this
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day of St..-pvichArt , 2011.2-/
H. Frank Farmer, Jr., M.D., Ph. S., F.A.C.P. State Surgeon General
Department of Health
PREPARED BY: Gavin D. Burgess
Assistant General Counsel Florida Bar No. 0013311 Prosecution Services Unit
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (850) 245-4640 - Telephone (850) 245-4662 - Facsimile
NOTICE OF RIGHT TO JUDICIAL REVIEW
Pursuant to Sections 120.60(6), and 120.68, Florida Statutes, the Department's findings of immediate danger, necessity, and procedural fairness shall be judicially reviewable. Review proceedings are governed by the Florida Rul es of Appellate Procedure. Such proceedings are commenced by filing one copy of a Petition for Review, in accordance with Florida Rule of Appellate Procedure 5.100, with the Department of Health and a second copy of the petition accompanied by a filing fee prescribed by law with the District Court of Appeal within thirty (30) days of the date this Order is filed.
