STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF HEALTH, BOARD OF MEDICINE,
Petitioner,
vs.
PAUL M. GOLDBERG, M.D.,
Respondent.
/
Case No. 14-3507PL
RECOMMENDED ORDER
This case came before Administrative Law Judge Todd P. Resavage for final hearing by video teleconference on
November 13, 2014, at sites in Tallahassee and Lauderdale Lakes, Florida.
APPEARANCES
For Petitioner: Diane K. Kiesling, Esquire
Department of Health
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265
For Respondent: Paul M. Goldberg, M.D., pro se
8180 Valhalla Drive
Delray Beach, Florida 33446 STATEMENT OF THE ISSUES
Whether Respondent, a medical doctor, in his treatment of Patient M.A., failed to keep legible medical records in violation of section 458.331(1)(m), Florida Statutes (2007); prescribed or administered inappropriate or excessive quantities of controlled
substances in violation of section 458.331(1)(q), Florida Statutes (2007); committed medical malpractice by practicing below the standard of care in violation of section 458.331(1)(t), Florida Statutes (2007); failed to perform a statutory or legal obligation placed upon a licensed physician in violation of section 458.331(1)(g), Florida Statutes (2007); and violated any provision of chapter 458 or chapter 456, or any rules adopted pursuant thereto in violation of section 458.331(1)(nn), Florida Statutes (2007), as Petitioner alleges in the Third Amended Administrative Complaint; if so, whether (and what) disciplinary measures should be imposed.
PRELIMINARY STATEMENT
On July 23, 2012, Petitioner, Department of Health, issued an Amended Administrative Complaint against Respondent, Paul M. Goldberg, M.D. Thereafter, Respondent timely filed an Election of Rights disputing certain material facts alleged in the Amended Administrative Complaint and requested an administrative hearing. On September 21, 2012, Petitioner referred the matter to the Division of Administrative Hearings ("DOAH") and the case was assigned DOAH Case number 12-3153PL. On March 22, 2013, Petitioner filed a Motion to Relinquish Jurisdiction, and same was granted.
On December 18, 2013, the case was re-opened and assigned DOAH Case Number 13-4894PL. On February 5, 2014, Petitioner
filed a Motion to Relinquish Jurisdiction. On February 6, 2014, an order was issued closing the file and relinquishing jurisdiction.
On July 25, 2014, the case was re-opened and assigned
DOAH Case No. 14-3507PL. On August 1, 2014, Petitioner filed an unopposed motion to consolidate all pleadings and discovery taken in the prior proceedings with the instant matter. On August 4, 2014, the motion to consolidate was granted.
The final hearing was originally scheduled for September 30, 2014. On August 25, 2014, the final hearing was rescheduled for November 13, 2014. On October 27, 2014, the case was transferred to the undersigned for all further proceedings.
The final hearing proceeded as scheduled. The final hearing Transcript was filed on December 12, 2014. The identity of the witnesses and exhibits and the rulings regarding each are as set forth in the Transcript. On December 15, 2014, the parties filed a Joint Motion for Extension of Time to File Proposed Recommended Orders, and said motion was granted. Petitioner and Respondent timely filed Proposed Recommended Orders, which were considered in preparing this Recommended Order. Unless otherwise indicated, all rule and statutory references are to the versions in effect at the time of the alleged violation.
FINDINGS OF FACT
INTRODUCTION
At all times relevant to this case, Respondent was licensed to practice medicine in the State of Florida, having been issued license number ME 93957. Respondent was previously licensed in New York and New Jersey; however, these licenses were voluntarily surrendered upon relocation to Florida. Respondent is not board certified in any specialty. Respondent's unrefuted testimony establishes that he has performed more than 10,000 cosmetic surgery procedures during his medical career.
Petitioner has regulatory jurisdiction over licensed physicians such as Respondent. In particular, Petitioner is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense.
On May 13, 2008, Patient M.A. ("M.A.") presented to Strax Rejuvenation & Aesthetics Institute ("Strax"), located at 4300 North University Drive, Suite A-202, Lauderhill, Florida, for a surgical consultation. At the time, Respondent practiced cosmetic surgery at Strax.
On that date, M.A. consented to Respondent performing a rhytidectomy, blepharoplasty, and liposuction.1/ On May 13, 2008,
Respondent prescribed several medications for M.A. to bring to the office on the date of surgery. Specifically, Respondent prescribed Percocet 5/325 mg (quantity 30); Valium 10 mg (quantity 10); Phenergan 25 mg (quantity 30); and Keflex 500 mg
(quantity 9).
On June 20, 2008, M.A. presented to Strax and Respondent performed the above-noted procedures, as more fully discussed below.
OFFICE SURGERY REGISTRATION
Strax was not successfully registered with the Department of Health to perform Level II surgical procedures in Florida with a maximum planned duration of more than five (5) minutes or any Level III office surgery, as fully defined in Florida Administrative Code Rule 64B8-9.009, until September 23, 2008, over three months after the subject surgery.
Respondent was not successfully registered with the Department of Health to perform Level II surgical procedures in Florida with a maximum planned duration of more than five (5) minutes or any Level III office surgery, as fully defined in Florida Administrative Code Rule 64B8-9.009, until November 26, 2008, over four months after the subject surgery.
The Agency for Health Care Administration did not issue a license to Strax to operate as an ambulatory surgical center for the period of May 13 through June 20, 2008, and Strax was not
licensed to operate as an ambulatory surgical center during that time period.
OFFICE SURGICAL LEVELS
A brief discussion of office surgical "levels" is a necessary exercise to an understanding of the specific facts in this matter. A Level I office surgery is defined, in Florida Administrative Code Rule 64B8-9.009(3)(a), as minor procedures such as excision of skin lesions, moles, warts, cysts, lipomas, and repair of lacerations or surgery limited to the skin and subcutaneous tissue. In a Level I office surgery, pre-operative medications are not required or used other than for minimal pre- operative tranquilization and anesthesia is local, topical, or none. In a Level I office surgery, no other personnel assistance is required.
A Level II office surgery is defined in rule 64B8- 9.009(4)(a) to include 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. Such procedures include, but are not limited to, hemorrhoidectomy, hernia repair, reduction of simple fractures, breast biopsies, and certain liposuctions. A Level II office surgery places other requirements on the physician such as
a transfer agreement, specific training, necessary equipment and supplies, and the assistance of other personnel.
JUNE 28, 2008, SURGERY
On June 28, 2008, M.A. presented to Strax for Respondent to perform a face and neck lift and an upper and lower blepharoplasty. The Pre-Op Checklist provides that, at
10:20 a.m., M.A. was administered 18 mg of Dilaudid, 20 mg of Percocet, 20 mg of Valium, and 25 mg of Phenergan. Respondent's Operative Report documents that said medications and dosages were given orally; however, the Operative Report documents that 14 mg, not 18 mg, of Dilaudid was administered.
Dilaudid is the brand name for hydromorphone, an opioid. The intended purpose of Dialudid is analgesia, or relief of pain. Percocet is the brand name for oxycodone/APAP, a combination of oxycodone and acetaminophen. It is an opioid that provides analgesic relief. Valium is the brand name for diazepam, a benzodiazepine drug. Generally, it is used as a sedative hypnotic and may be used as a pre-anesthetic drug. Phenergan, a form of promethazine, is principally an antihistamine-like drug, but often is prescribed to counteract nausea.
The Intra-Op Record documents that M.A.'s surgical procedures began at 11:00 a.m. and ended at 1:32 p.m. Respondent's Operative Report documents that M.A. tolerated the
procedure well and was returned to the recovery room in satisfactory condition. The elective cosmetic procedures performed by Respondent on M.A., which involved drug-induced alteration of consciousness, constitute a Level II office surgery. During the surgical procedures, Respondent was not assisted by an anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in Florida Administrative Code Rule 64B8-30.012(2)(b)6. Respondent was ACLS certified and was assisted by a Registered Nurse; however, the Registered Nurse was not functioning solely as an assisting anesthesia provider.
At the time of the subject surgery, Respondent did not have a transfer agreement with a licensed hospital within reasonable proximity to Strax. Respondent also did not have staff privileges to perform the subject procedures at a licensed hospital within reasonable proximity to Strax.
The Intra-Op Record documents that 100 ml L.R. (lactate ringers) IV fluids and 1 ampule of Narcan .4 mg were provided to
M.A. by the Registered Nurse. This record does not provide when the fluid or the ampule were given. A document entitled "Pre/Post-Operative-Recovery Room Record," and dated June 21, 2008 (the day after surgery), provides that Respondent was notified of M.A.'s oxygen saturation of 65 percent. Said record
further documents that an ampule of Narcan was administered at 2:10 p.m. M.A.'s oxygen saturation thereafter improved to
98 percent on room air. M.A.'s oxygen saturation was thereafter monitored until 3:20 p.m.
Narcan is a narcotic antagonist that works by blocking opiate receptor sites, thus reversing or preventing the toxic effects of narcotic analgesics.
M.A.'s daughter ("L.F.") arrived at Strax at approximately 4:00 p.m. When L.F. picked M.A. up at 4:45 p.m.,
M.A. could not walk without assistance. On the forty-five minute drive home, M.A. slept in the vehicle despite loud crying from L.F.'s young child. Once home, L.F. assisted M.A. in walking from the vehicle to the home and assisted her into bed.
L.F. credibly testified that thereafter she checked on
M.A. on an hourly basis. M.A. was typically asleep when L.F. entered the room to change ice pads on her eyes. M.A. would rouse from sleep during this exercise. When changing the pads,
M.A. reported some pain in her legs.
L.F. recalls that M.A. walked with assistance (from
L.F. and the wall) to use the restroom. At approximately
7:30 p.m., L.F. spoke with an unknown Strax nurse. According to L.F., the nurse advised that after M.A. ate dinner, she could receive one Valium pill to help her sleep; however, she was not to receive any additional pain medication.
L.F. assisted M.A. from the bedroom to the living room couch to eat. L.F. served M.A. some chicken soup and crackers around 8:00 p.m. L.F. recalls that M.A. ate a few of the crackers, and a small amount of the soup. L.F. made M.A. drink the soup broth. At approximately 8:15 p.m., L.F. assisted M.A. in returning to the bed. At approximately 8:30 p.m., L.F. gave
M.A. one tablet of Valium.
Thereafter, L.F. continued to check on M.A. hourly until 11:00 p.m. At 11:00 p.m., M.A. did not wake up when L.F. checked on her, and L.F. witnessed heavy breathing——like a snore. After this occasion, L.F. went to sleep. When L.F. checked on
M.A. at 1:00 a.m., she took off M.A.'s eye pads, and M.A. felt stiff. L.F. alerted her husband, who called 911. M.A. was subsequently transported to North Broward Medical Center where she was pronounced dead on June 21, 2008, at 2:07 a.m.
POST-MORTEM
On June 21, 2008, at 8:20 a.m., M.A.'s body was released to the Broward County Medical Examiner's Office ("BCME"). The body was refrigerated at 10:03 a.m. At
11:41 a.m., the Florida Lions Eye Bank harvested M.A.'s corneas and ocular fluid at BCME. At 10:31 p.m., M.A.'s body was received at the Dade County Medical Examiner's Office ("DCME") for tissue recovery by the University of Miami Tissue Bank.
On June 22, 2008, at 3:02 a.m., M.A.'s body was returned to the BCME. There is no evidence that M.A.'s body was not properly handled or refrigerated.
The following day, June 23, 2008, at 8:30 a.m., Associate Medical Examiner Iouri Boiko, M.D., performed an autopsy on M.A.'s body. In the process of conducting the autopsy, Dr. Boiko collected M.A.'s central blood and urine for analysis. The samples were taken to the secure toxicology lab. Said specimens were stored in a toxicology lab refrigerator.
On October 1, 2008, forensic toxicologist Michael Wagner performed an ABN procedure (acid, basic and neutral drugs) on M.A.'s collected blood. The procedure was performed on the gas chromatography-mass spectrometer. This testing revealed the presence of acetaminophen, caffeine, MGEX-the metabolite of Lidocaine, Atropine, Promethazine .40 mg/L, Diazepam .27 mg/L, and Oxycodone .25 mg/L.
On October 6, 2008, Mr. Wagner performed a propryl derivation to detect the presence or absence of any opiates. This testing revealed Hydromorphone .11 mg/L. Based on these results, Mr. Wagner prepared a Final Toxicology Report on October 10, 2008. On October 28, 2008, Dr. Boiko issued his final anatomical diagnoses and opined that M.A. died as a result of combined drug toxicity and that coronary artery atherosclerosis was a factor contributory to death. Dr. Boiko
did not offer any expert testimony concerning whether Respondent met the prevailing professional standard of care.
EXPERT WITNESS TESTIMONY
The record evidence in the instant matter reveals very little concerning Respondent's practice. From the record, the undersigned can conclude that Respondent was issued a license to practice medicine in the State of Florida on or about August 2, 2005. From Respondent's unrefuted testimony, he has performed more than 10,000 cosmetic surgery procedures during his medical career (which ostensibly includes his tenure in New York and New Jersey). Petitioner's Third Amended Administrative Complaint alleges that Respondent "is not board certified in any particular specialty area of medical practice."
In support of the allegations contained in Count III, that Respondent committed medical malpractice by practicing below the standard of care in violation of section 458.331(1)(t), Florida Statutes, Petitioner presented the testimony, via deposition, of Scott Berger, M.D. Dr. Berger is Board Certified by the American Board of Anesthesiology and the American Academy of Pain Management. On multiple occasions, Dr. Berger opined that various acts or omissions of Respondent did not meet the standard of care; however, Dr. Berger never articulated the applicable standard of care owed by Respondent. Accordingly, the undersigned is precluded from considering Dr. Berger's testimony
in making any findings of fact concerning whether Respondent's conduct fell below the standard of care, as alleged in Count III.
Petitioner also presented the testimony of forensic toxicologist Bruce A. Goldberger, Ph.D., DABFT. He holds both a Master's degree and a Ph.D in forensic toxicology and is trained in pathology. Dr. Goldberger, despite his qualifications, is not qualified to give expert testimony concerning the prevailing standard of care.2/
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties and subject matter of this cause, pursuant to section 120.57(1), Florida Statutes.
This is a disciplinary proceeding in which the Department seeks to discipline Respondent's license to practice medicine. Accordingly, the Department must prove the allegations contained in the Administrative Complaint by clear and convincing evidence. Dep't of Banking & Fin., Div. of Secs. & Investor
Prot. v. Osborne Sterne, Inc., 670 So. 2d 932, 935 (Fla. 1996);
Ferris v. Turlington, 510 So. 2d 292, 294 (Fla. 1987).
Regarding the standard of proof, in Slomowitz v.
Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983), the Court
developed a "workable definition of clear and convincing evidence" and found that of necessity such a definition would
need to contain "both qualitative and quantitative standards." The Court held that:
[C]lear and convincing evidence requires that the evidence must be found to be credible; the facts to which the witnesses testify must be distinctly remembered; the testimony must be precise and explicit and the witnesses must be lacking confusion as to the facts in issue. The evidence must be of such weight that it produces in the mind of the trier of fact a firm belief or conviction, without hesitancy, as to the truth of the allegations sought to be established.
Id. The Florida Supreme Court later adopted the Slomowitz court's description of clear and convincing evidence. See In re
Davey, 645 So. 2d 398, 404 (Fla. 1994). The First District Court of Appeal also has followed the Slomowitz test, adding the
interpretive comment that "[a]lthough this standard of proof may be met where the evidence is in conflict . . . it seems to preclude evidence that is ambiguous." Westinghouse Elec. Corp. v. Shuler Bros., Inc., 590 So. 2d 986, 988 (Fla. 1st DCA 1991);
rev. denied, 599 So. 2d 1279 (Fla. 1992)(citations omitted).
Section 458.331(1), Florida Statutes, authorizes the Board of Medicine to impose penalties ranging from the issuance of a letter of concern to revocation of a physician's license to practice medicine in Florida if a physician commits one or more acts specified therein.
In its Complaint, the Department alleges that Respondent is guilty of: failing to keep legible medical records
(Count I); administering legend drugs other than in the course of his professional practice (Count II); committing medical malpractice (Count III); failing to perform statutory or legal obligations placed upon a licensed physician (Count IV); and violating provisions of chapter 458 or chapter 456, or any rules adopted pursuant thereto (Count V).
Petitioner contends, in Count I of the Complaint, that Petitioner has violated section 458.331(1)(m) which provides:
The following acts constitute grounds for denial of a license or disciplinary action, as specified in s. 456.072(2):
* * *
(m) Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician or the physician extender and supervising physician by name and professional title who is or are responsible for rendering, ordering, supervising, or billing for each diagnostic or treatment procedure and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations.
As noted in section 458.331(1)(m), legibility of medical records is to be determined in reference to a defined (Department of Health) rule. Here, Petitioner's Complaint sufficiently sets forth the factual allegations underpinning a violation of section 458.331(1)(m); however, it fails to
reference the specific applicable board rule. Accordingly, the undersigned is constrained to reviewing the allegations of Count I solely by the plain text of section 458.331(1)(m).
Petitioner alleges Respondent violated section 458.331(1)(m) in several aspects. First, Petitioner alleges that Respondent failed to accurately record how much Dilaudid was administered to patient M.A. The amount of Dilaudid administered varies between the Operative Report authored by Respondent
(14 mg) and the Pre-Opertive Checklist (18 mg) authored by a nurse. Respondent maintains that 14 mg is the correct amount administered and Petitioner has failed to present evidence to the contrary. Petitioner failed to present clear and convincing evidence that this discrepancy is a violation of section 458.331(1)(m).
Next, Petitioner alleges that, with respect to Narcan, Respondent failed to document the quantity, time, and personnel associated with its administration. Here the Intra-Op Record dated June 20, 2008, and signed by Respondent, documents that one ampule of Narcan was given by the nurse. This medical record fails, however, to document when the ampule was administered or who administered the same. The Pre/Post-Operative-Recovery Room Record, dated either incorrectly as June 21, 2008, or alternatively a late entry, documents that one .4 mg ampule of Narcan was administered at 2:10 p.m. Construing the records
together, the undersigned concludes that Petitioner failed to present clear and convincing evidence that this discrepancy is a violation of section 458.331(1)(m).
Finally, Petitioner alleges that Respondent failed to document the results of the continuous evaluation of the patient's oxygenation, ventilation, circulation, and temperature. While Respondent may have had an obligation to continually evaluate M.A.'s oxygenation, ventilation, circulation, and temperature while performing office surgery, the undersigned is unaware of, and Petitioner has neither pled nor cited to any authority for, the proposition that Respondent was required to document the same. The undersigned concludes that Petitioner failed to present clear and convincing evidence that this discrepancy is a vioaltion of section 458.331(1)(m).
In Count II of the Complaint, Petitioner alleges Respondent violated section 458.331(1)(q) by prescribing or administering excessive or inappropriate quantities or combinations of Dilaudid, Percocet, or Valium to M.A. on June 20, 2008. Section 458.331(1)(q) provides
The following acts constitute grounds for denial of a license or disciplinary action, as specified in s. 456.072(2):
* * *
(q) 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.
Assuming arguendo that Petitioner established by clear and convincing evidence that Respondent prescribed or administered excessive or inappropriate quantities or combinations of Dilaudid, Percocet, or Valium to M.A. on June 20, 2008, it would be legally presumed that it was not in the best interest of M.A. and not in the course of Respondent's professional practice, without regard to his intent. The undersigned finds, however, that the clear and convincing evidence establishes that Respondent was, in fact, practicing medicine in his treatment of M.A. on June 20, 2008, and, therefore, the legal presumption was rebutted. Accordingly, Petitioner failed to prove a violation of section 458.331(1)(q).
In Count III of the Complaint, Petitioner alleges that Respondent's conduct violated section 458.331(1)(t)1., Florida Statutes, which provides:
The following acts constitute grounds for denial of a license or disciplinary action, as specified in s. 456.072(2):
* * *
(t) Notwithstanding s. 456.072(2) but as specified in s. 456.50(2):
1. Committing medical malpractice as defined in s. 456.50. The board shall give great weight to the provisions of s. 766.102 when enforcing this paragraph. Medical malpractice shall not be construed to require more than one instance, event, or act.
Section 456.50(1)(g), in turn, defines "medical malpractice," 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 766.102(1) provides, in pertinent part, 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 766.102(5) governs the requisite qualifications of expert witness testimony regarding the prevailing professional standard of care. Section 766.102(5) provides as follows:
A person may not give expert testimony concerning the prevailing professional standard of care unless that person is a licensed health care provider and meets the following criteria:
If the health care provider against whom or on whose behalf the testimony is offered is a specialist, the expert witness must:
Specialize in the same specialty as the health care provider against whom or on whose behalf the testimony is offered; or specialize in a similar specialty that includes the evaluation, diagnosis, or treatment of the medical condition that is the subject of the claim and have prior experience treating similar patients; and
Have devoted professional time during the
3 years immediately preceding the date of the occurrence that is the basis for the action to:
The active clinical practice of, or consulting with respect to, the same or similar specialty that includes the evaluation, diagnosis, or treatment of the medical condition that is the subject of the claim and have prior experience treating similar patients;
Instruction of students in an accredited health professional school or accredited residency or clinical research program in the same or similar specialty; or
A clinical research program that is affiliated with an accredited health professional school or accredited residency or clinical research program in the same or similar specialty.
If the health care provider against whom or on whose behalf the testimony is offered is a general practitioner, the expert witness must have devoted professional time during the 5 years immediately preceding the date of the occurrence that is the basis for the action to:
The active clinical practice or consultation as a general practitioner;
The instruction of students in an accredited health professional school or
accredited residency program in the general practice of medicine; or
A clinical research program that is affiliated with an accredited medical school or teaching hospital and that is in the general practice of medicine.
If the health care provider against whom or on whose behalf the testimony is offered is a health care provider other than a specialist or a general practitioner, the expert witness must have devoted professional time during the 3 years immediately preceding the date of the occurrence that is the basis for the action to:
The active clinical practice of, or consulting with respect to, the same or similar health profession as the health care provider against whom or on whose behalf the testimony is offered;
The instruction of students in an accredited health professional school or accredited residency program in the same or similar health profession in which the health care provider against whom or on whose behalf the testimony is offered; or
A clinical research program that is affiliated with an accredited medical school or teaching hospital and that is in the same or similar health profession as the health care provider against whom or on whose behalf the testimony is offered.
Petitioner presented the testimony, via deposition, of Scott Berger, M.D., who is Board Certified by the American Board of Anesthesiology and the American Academy of Pain Management. Respondent did not object to Dr. Berger's testimony on the
grounds that Dr. Berger failed to satisfy the criteria of section 766.102.3/
To prevail on its medical malpractice claim, Petitioner must first establish the standard of care owed by Respondent. Gooding v. Univ. Hosp. Bldg., Inc., 445 So. 2d 1015, 1018 (Fla.
1984); Hollywood Med. Ctr. v. Reed, 82 So. 3d 122, 125 (Fla. 4th DCA 2012). "[W]hat the standard of care requires is a question of fact, not a question of law." Torres v. Sullivan, 903 So. 2d
1064, 1067 (Fla. 2d DCA 2005). On multiple occasions, Dr. Berger opined that various acts or omissions of Respondent did not meet the standard of care; however, Dr. Berger never articulated the applicable standard of care owed by Respondent.
In Torres, the court properly noted that, "[t]he standard of practice and treatment within a particular medical specialty when physicians in that field are presented with a particular set of circumstances is a subject well beyond the [factfinder's] expertise, not a matter within the comprehension of laymen." Torres, 903 So. 2d at 1067 (internal citations omitted). "As a result, expert testimony is generally required to establish the standard of care prevalent in a particular medical field." Id.; see also Pervis v. Dept. of Prof. Reg., Bd.
of Veterinary Medicine, 461 So. 2d 134 (Fla. 1st DCA 1984) (holding that in disciplinary proceedings, the board has the
burden of proving the applicable standard by competent substantial evidence).
Petitioner failed to present sufficient evidence to establish the standard of care owed by Respondent. Accordingly, Petitioner failed to establish Respondent violated section 458.331(1)(t)1.
In Count IV of the Complaint, Petitioner alleges Respondent violated section 458.331(1)(g) by failing to perform any statutory or legal obligation upon a licensed physician. Petitioner alleges Respondent committed eight separate failures. First, Petitioner alleges Respondent failed "to ensure that Strax was registered as an OSR on June 20, 2008, when he performed Level II surgery on MA." If proved, such a failure would be a violation of Florida Administrative Code Rule 64B8-9.0091(1)(a). Rule 64B8-9.0091(1)(a) provides, in pertinent part, as follows:
Registration.
(a) Every licensed physician who holds an active Florida license and performs Level II surgical procedures in Florida with a maximum planned duration of more than five (5) minutes or any Level III office surgery, as fully defined in Rule 64B8-9.009, F.A.C., shall register the office with the Department of Health. It is the physician's responsibility to ensure that every office in which he or she performs Levels II or III surgical procedures as described above is registered, regardless of whether other physicians are practicing in the same office or whether the office is non-physician owned.
Petitioner proved by clear and convincing evidence that Respondent failed to ensure that Strax was properly registered as set forth above.
Petitioner next alleges that Respondent failed to ensure that Strax was inspected as required by Florida Administrative Code Rule 64B8-9.0091, prior to performing
Level II surgery on M.A. on June 20, 2008. Rule 64B8-9.0091(2) provides as follows:
(2) Inspection.
Unless the physician has previously provided written notification of current accreditation by a nationally recognized accrediting agency or an accrediting organization approved by the Board the physician shall submit to an annual inspection by the Department. Nationally recognized accrediting agencies are the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), Accreditation Association for Ambulatory Health Care (AAAHC) and Joint Commission on Accreditation of Healthcare Organizations (JCAHO). All nationally recognized and Board-approved accrediting organizations shall be held to the same Board-determined surgery and anesthesia standards for accrediting Florida office surgery sites.
The office surgery inspection fee set forth in the Department's Rule 64B-4.002, F.A.C., shall be remitted for each practice location.
The inspection conducted pursuant to this rule shall be announced at least one week in advance of the arrival of the inspector(s).
The Department shall determine compliance with the requirements of Rule 64B8-9.009, F.A.C.
If the office is determined to be in noncompliance, the physician shall be notified and shall be given a written statement at the time of inspection. Such written notice shall specify the deficiencies. Unless the deficiencies constitute an immediate and imminent danger to the public, the physician shall be given
30 days from the date of inspection to correct any documented deficiencies and notify the Department of corrective action. Upon written notification from the physician that all deficiencies have been corrected, the Department is authorized to re-inspect for compliance. If the physician fails to submit a corrective action plan within 30 days of the inspection, the Department is authorized to re-inspect the office to ensure that the deficiencies have been corrected.
The deficiency notice and any subsequent documentation shall be reviewed for consideration of disciplinary action under any of the following circumstances:
When the initial notice of deficiencies contain deficiencies that constitute immediate and imminent danger to the public;
The physician fails to provide the Department with documentation of correction of all deficiencies within thirty (30) days from the date of inspection;
Upon a finding of noncompliance after a reinspection has been conducted pursuant to paragraph (2)(e) of this rule.
Documentation of corrective action shall be considered in mitigation of any offense.
Nothing herein shall limit the authority of the Department to investigate a complaint without prior notice.
Petitioner proved by clear and convincing evidence that Respondent did not ensure that Strax was inspected as required by rule 64B9-9.0091(2).
Petitioner next alleges that Respondent failed to comply with Florida Administrative Code Rule 64B8-9.009, Standard of Care for Office Surgery. This general allegation fails to set forth with requisite specificity how Respondent failed to comply with said standard of care. Specific standard of care violations regarding said rule are subsequently alleged and will be addressed below.
Petitioner next alleges that Respondent failed to perform a statutory or legal obligation by performing Level II surgery on M.A., at Strax, when it had not been registered or inspected for the performance of office surgery. This allegation is simply a combination of two allegations addressed above. As previously addressed, Petitioner proved said allegations by clear and convincing evidence.
Petitioner further alleges that Respondent failed to comply with the requirements of Florida Administrative Code Rule 64B8-9.009(2)(g). Rule 64B8-9.009(2)(g), provides:
(2) General Requirements for Office Surgery.
* * *
(g) The Board of Medicine adopts the "Standards of the American Society of Anesthesiologists for Basic Anesthetic Monitoring," approved by House Delegates on October 21, 1986, and last amended on October 21, 1998, as the standards for anesthetic monitoring by any qualified anesthesia provider.
These standards apply to general anesthetics, regional anesthetics, and monitored anesthesia care (Level II and III as defined by this rule) although, in emergency circumstances, appropriate life support measures take precedence. These standards may be exceeded at any time based on the judgment of the responsible supervising physician or anesthesiologist. They are intended to encourage quality patient care, but observing them cannot guarantee any specific patient outcome. They are subject to revision from time to time, as warranted by the evolution of technology and practice. This set of standards address only the issue of basic anesthesia monitoring, which is one component of anesthesia care.
In certain rare or unusual circumstances some of these methods of monitoring may be clinically impractical, and appropriate use of the described monitoring methods may fail to detect untoward clinical developments. Brief interruptions of continual monitoring may be unavoidable. For purpose of this rule, "continual" is defined as "repeated regularly and frequently in steady rapid succession" whereas "continuous" means "prolonged without any interruption at any time."
Under extenuating circumstances, the responsible supervising physician or anesthesiologist may waive the requirements marked with an asterisk (*); it is recommended that when this is done, it should be so stated (including the reasons) in a note in the patient's medical record. These
standards are not intended for the application to the care of the obstetrical patient in labor or in the conduct of pain management.
Standard I.
Qualified anesthesia personnel shall be present in the room throughout the conduct of all general anesthetics, regional anesthetics and monitored anesthesia care.
OBJECTIVE. Because of the rapid changes in patient status during anesthesia, qualified anesthesia personnel shall be continuously present to monitor the patient and provide anesthesia care. In the event there is a direct known hazard, e.g., radiation, to the anesthesia personnel which might require intermittent remote observation of the patient, some provision for monitoring the patient must be made. In the event that an emergency requires the temporary absence of the person primarily responsible for the anesthetic, the best judgment of the supervising physician or anesthesiologist will be exercised in comparing the emergency with the anesthetized patient's condition and in the selection of the person left responsible for the anesthetic during the temporary absence.
Standard II.
During all anesthetics, the patient's oxygenation, ventilation, circulation and temperature shall be continually evaluated.
OXYGENATION.
OBJECTIVE. To ensure adequate oxygen concentration in the inspired gas and the blood during all anesthetics.
METHODS.
Inspired gas: During every administration of general anesthesia using an anesthesia machine, the concentration of oxygen in the patient breathing system shall be measured by an oxygen analyzer with a low oxygen concentration limit alarm in use.*
Blood oxygenation: During all anesthetics, a quantitative method of assessing oxygenation such as a pulse oximetry shall be employed.* Adequate illumination and exposure of the patient are necessary to assess color.*
VENTILATION.
OBJECTIVE. To ensure adequate ventilation of the patient during all anesthetics.
METHODS.
Every patient receiving general anesthesia shall have the adequacy of ventilation continually evaluated. Qualitative clinical signs such as chest excursion, observation of the reservoir breathing bag and auscultation of breath sounds are useful. Continual monitoring for the presence of expired carbon dioxide shall be performed unless invalidated by the nature of the patient, procedure or equipment. Quantitative monitoring of the volume of expired gas is strongly encouraged.*
When an endotracheal tube or laryngeal mask is inserted, its correct positioning must be verified by clinical assessment and by identification of carbon dioxide analysis, in use from the time of endotracheal tube/laryngeal mask placement, until extubation/removal or initiating transfer to a postoperative care location, shall be performed using a quantitative method such as capnography, capnometry or mass spectroscopy.*
When ventilation is controlled by a mechanical ventilator, there shall be in continuous use a device that is capable of detecting disconnection of components of the breathing system. The device must give an audible signal when its alarm threshold is exceeded.
During regional anesthesia and monitored anesthesia care, the adequacy of ventilation shall be evaluated, at least, by continual observation of qualitative clinical signs.
CIRCULATION.
OBJECTIVE. To ensure the adequacy of the patient's circulatory function during all anesthetics.
METHODS.
Every patient receiving anesthesia shall have the electrocardiogram continuously displayed from the beginning of anesthesia until preparing to leave the anesthetizing location.*
Every patient receiving anesthesia shall have arterial blood pressure and heart rate determined and evaluated at least every five minutes.*
Every patient receiving general anesthesia shall have, in addition to the above, circulatory function continually evaluated by at least one of the following: palpation of a pulse, auscultation of heart sounds, monitoring of a tracing of intra- arterial pressure, ultrasound peripheral pulse monitoring, or pulse plethysmography or oximetry.
BODY TEMPERATURE.
OBJECTIVE. To aid in the maintenance of appropriate body temperature during all anesthetics.
METHODS. Every patient receiving anesthesia shall have temperature monitored when clinically significant changes in body temperature are intended, anticipated or suspected.
Petitioner provided by clear and convincing evidence that Respondent did not continually evaluate M.A.'s oxygenation, ventilation, circulation, and temperature, as required (and as applicable to the subject procedures) by rule 64B8-9.009(2)(g).
Petitioner further alleges Respondent failed to comply with the requirements of Florida Administrative Code Rule 64B8- 9.009(4)(b)1., by failing to have an appropriate transfer agreement. Rule 64B8-9.009(4)(b)1. provides
(4) Level II Office Surgery.
* * *
(b) Standards for Level II Office Surgery.
1. Transfer Agreement Required. The physician must have a transfer agreement with a licensed hospital within reasonable proximity if the physician does not have staff privileges to perform the same procedure as that being performed in the out- patient setting at a licensed hospital within reasonable proximity. "Reasonable proximity" is defined as not to exceed thirty (30) minutes transport time to the hospital.
Petitioner proved by clear and convincing evidence that Respondent did not have a transfer agreement as required by rule 64B8-9.009(4)(b)1.
Finally, Petitioner alleges that Respondent committed violations that, if proven, would violate rule 64B8-9.009(4)(b)4. Rule 64B8-9.009(4)(b)4. provides:
Assistance of Other Personnel Required. The surgeon must be assisted by a qualified anesthesia provider as follows: An Anesthesiologist, Certified Registered Nurse Anesthesist [sic], or Physician Assistant qualified as set forth in subparagraph 64B8- 30.012(2)(b)6., F.A.C., 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.
Petitioner proved by clear and convincing evidence that, during the subject surgery, Respondent was not assisted by an anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in subparagraph
64B8-30.012(2)(b)6., F.A.C. The evidence established that Respondent was ACLS certified and that a Registered Nurse was present during the surgical procedures; however, the evidence further established that the nurse was not functioning solely as an assisting anesthesia provider. Accordingly, Petitioner established by clear and convincing evidence a violation of rule 64B8-9.009(4)(b)4.
Based on the above-noted violations of Florida Administrative Code Rules 64B8-9.009 and 64B8-9.0091, Petitioner established that Respondent violated section 458.331(1)(g), Florida Statutes.
In Count V of the Complaint, Petitioner sets forth the exact factual allegations contained in Count IV. In Count V, however, Petitioner alleges that the same allegations contained in Count IV support a violation of section 458.331(1)(nn). Section 458.331(1)(nn) provides that violating any provision of [chapter 458] or chapter 456, or any rules adopted pursuant thereto, is grounds for disciplinary action. Consistent with the anaylsis regarding Count IV, Petitioner has established by clear and convincing evidence that Respondent violated section 458.331(1)(nn), Florida Statutes.
The Board of Medicine imposes penalties upon licensees in accordance with the disciplinary guidelines prescribed in Florida Administrative Code Rule 64B8-8.001. As it relates to
Respondent's violation of section 458.331(1)(g), rule 64B8- 8.001(2)(g) provides a range (for a first offense) from a letter of concern to revocation or denial and an administrative fine from $1,000 to $10,000. As it relates to Respondent's violation of section 458.331(1)(nn), rule 64B8-8.001(2)(x)1. provides a range (for a first offense) from a reprimand to revocation or denial and an administrative fine from $1,000 to $10,000.
Rule 64B8-8.001(3) provides that, in applying the penalty guidelines, the following aggravating and mitigating circumstances shall be considered:
Exposure of patient or public to injury or potential injury, physical or otherwise: none, slight, severe, or death;
Legal status at the time of the offense: no restraints, or legal constraints;
The number of counts or separate offenses established;
The number of times the same offense or offenses have previously been committed by the licensee or applicant;
The disciplinary history of the applicant or licensee in any jurisdiction and the length of practice;
Pecuniary benefit or self-gain inuring to the applicant or licensee;
The involvement in any violation of Section 458.331, F.S., of the provision of controlled substances for trade, barter or sale, by a licensee. In such cases, the Board will deviate from the penalties
recommended above and impose suspension or revocation of licensure.
Where a licensee has been charged with violating the standard of care pursuant to Section 458.331(1)(t), F.S., but the licensee, who is also the records owner pursuant to Section 456.057(1), F.S., fails to keep and/or produce the medical records.
Any other relevant mitigating factors.
Having considered the potential aggravating and mitigating factors, the undersigned does not find compelling reasons to deviate from the guidelines and, therefore, recommends that the Board of Medicine impose a penalty that falls within the
recommended range.
Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order:
Finding that Paul M. Goldberg, M.D., violated sections 458.331(1)(g) and (nn), Florida Statutes, as charged in Counts IV and V of the Complaint;
Dismissing Counts I-III of the Complaint;
Imposing $20,000 in administrative fines; issuing a reprimand against Dr. Goldberg's medical license; requiring
Dr. Goldberg to complete the "Laws and Rules" Course; suspending Dr. Goldberg's medical license until such time as Dr. Goldberg undergoes a "UF CARES" evaluation; and placing Dr. Goldberg's
license on probation for three years under indirect supervision with 100 percent chart review of cosmetic surgery patients and
25 percent chart review of all other patients.
DONE AND ENTERED this 4th day of March, 2015, in Tallahassee, Leon County, Florida.
S
TODD P. RESAVAGE
Administrative Law Judge
Division of Administrative Hearings The DeSoto Building
1230 Apalachee Parkway
Tallahassee, Florida 32399-3060
(850) 488-9675
Fax Filing (850) 921-6847 www.doah.state.fl.us
Filed with the Clerk of the Division of Administrative Hearings this 4th day of March, 2015.
ENDNOTES
1/ Rhytidectomy is the technical term for what is commonly referred to as a face lift. Blepharoplasty is the surgical modification of the eyelid.
2/ The deposition testimony of Michel Samson, M.D., who was retained as an expert by Respondent, was admitted without objection by either party. Dr. Samson is certified by the American Board of Plastic Surgery. Dr. Samson opined that the type and dosages of drugs administered to M.A. were within the standard of care; however, Dr. Samson also failed to properly articulate the appropriate standard of care owed by Respondent. Respondent also presented the testimony of toxicologist Ralph Harbison, Ph.D. Dr. Harbison, despite his qualifications, is not qualified to give expert testimony concerning the prevailing standard of care.
3/ Respondent's objection, which was overruled, was based solely on the ground that Respondent did not feel Dr. Berger was
qualified to comment on anesthesia because Dr. Berger "really doesn't deliver anesthesia in an operative setting. He does pain management."
COPIES FURNISHED:
Diane K. Kiesling, Esquire Department of Health
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 (eServed)
Paul M. Goldberg, M.D. 8180 Valhalla Drive
Delray Beach, Florida 33446
Jennifer A. Tschetter, General Counsel Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 (eServed)
Andre Ourso, Executive Director Board of Medicine
Department of Health
4052 Bald Cypress Way, Bin C03 Tallahassee, Florida 32399-3253 (eServed)
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.
| Issue Date | Document | Summary |
|---|---|---|
| Aug. 18, 2015 | Agency Final Order | |
| Apr. 29, 2015 | Agency Final Order | |
| Mar. 04, 2015 | Recommended Order | Petitioner established Respondent violated sections 458.331(1)(g) and (nn), Florida Statutes, as charged in Counts IV and V of the Administrative Complaint. |
