STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF BUSINESS AND ) PROFESSIONAL REGULATION, )

BOARD OF MEDICINE )

)

Petitioner, )

)

vs. ) CASE NOs. 92-0228

) 92-1156

JEFFREY G. TARDIFF, M.D. )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, William R. Dorsey, Jr., held a formal hearing in the above-styled case on January 14, 1993, in Miami, Florida. On August 16, 1993, due to the unavailability of Hearing Officer Dorsey, the above-styled case was assigned to Hearing Officer William J. Kendrick. Section 120.57(1)(b)11, Florida Statutes.

APPEARANCES

For Petitioner: Arthur B. Skafidas, Esquire

Richard A. Grumberg, Esquire Department of Business

and Professional Regulation

1940 North Monroe Street, Suite 60

Tallahassee, Florida 32399-0792

For Respondent: Robert J. Bryan, Esquire

815 North West 57th Avenue, Suite 201 Miami, Florida 33126

STATEMENT OF THE ISSUE

At issue in these consolidated cases is whether respondent committed the offenses alleged in the amended administrative complaints and, if so, what disciplinary action should be taken.

PRELIMINARY STATEMENT

By amended administrative complaint filed January 11, 1993, petitioner charges respondent, a licensed physician in the State of Florida, with three counts of violations of the Medical Practice Act; Chapter 458, Florida Statutes. Count I alleges that respondent failed to post proper notice, as required by Section 458.320(5)(f)(7), Florida Statutes, concerning his financial responsibility to pay claims and costs associated with medical malpractice.

Count II alleges that respondent failed to keep written records justifying the course of treatment of Patient #1 by failing to make notations about the

patient's vital signs before, during and after anesthesia and surgery, contrary to the provisions of Section 458.331(1)(m), Florida Statutes. Count III alleges that respondent violated Section 458.331(1)(t), Florida Statutes, by gross or repeated malpractice or the failure to practice medicine with the appropriate level of care, skill and treatment because he did not have a second person assist him in monitoring Patient #1's vital signs during the procedure, and did not utilize a pulse oximeter to measure Patient #1's oxygen saturation level during the procedure.

By amended administrative complaint filed January 5, 1993, petitioner charges respondent, a dispensing practitioner, violated the provisions of Section 893.07, Florida Statutes, by failing to maintain a complete and adequate record of the stock of controlled substances on hand, and failed to maintain a current and accurate record of each controlled substance he received and dispensed; violated the provisions of 21 CFR Section 1301.75 and Rule 21S- 28.109(2) and (3), Florida Administrative Code, by failing to secure controlled substances under lock and key; violated the provisions of 21 CFR 1305, Section 893.07(2), Florida Statutes and Rule 21S-28.203(1)(d), Florida Administrative Code, by failing to maintain required Drug Enforcement Form 222; violated Rule 21S-28.110, Florida Administrative Code, by possessing expired medications; and violated Rule 21S-27.104(4), Florida Administrative Code, by possessing pharmacy dispensed medications prescribed to another person.

At hearing, petitioner called as witnesses: Robert Bruick, M.D.; Louis A. Collado; Dahna Schaublin; and, Diane Robie. Petitioner's exhibits 1-5 were received into evidence. Respondent testified on his own behalf, and called Karen Raben, M.D.; Rodolfo Schneer, M.D.; Robert Sean Timco; Christine Draznin and Bertha Diaz, as witnesses. Respondent's exhibits 1-6 were received into evidence.

The transcript of hearing was filed February 8, 1993, and the parties were granted leave until March 25, 1993, to file proposed findings of fact.

Respondent subsequently requested and was granted leave until April 9, 1993, to file his proposed findings of fact. Consequently, the parties waived the requirement that a recommended order be rendered within thirty days after the transcript is filed. Rule 60Q-2.031, Florida Administrative Code. The parties' proposed findings of fact are addressed in the appendix to this recommended order.

Pursuant to the provisions of Section 120.57(1)(b)11, Florida Statutes, an order was entered by the Director, Division of Administrative Hearings, on August 16, 1993, notifying the parties of the unavailability of the Hearing Officer who had previously heard this case, and of the assignment of the undersigned, "who shall use any existing record and receive any additional evidence or argument, if any, which . . . [such] . . . new hearing officer finds necessary," to conclude this matter. The order further provided:

The parties are accorded ten (10) days from the date of this order to advise the Hearing Officer as to whether they contend any additional evidence or argument is warranted. Failure to so advise the new Hearing Officer will be construed as a party's acknowledgment that no additional evidence or argument is necessary, and that the Hearing Officer may write the recommended order based on the existing record.

By letter filed August 25, 1993, petitioner acknowledged receipt of the foregoing notice, and opined that no additional evidence or argument was warranted and that the record was sufficient. Although not timely, respondent replied to the notice by "motion to dismiss and/or motion for order requiring resolution of this matter by William R. Dorsey," the previously assigned hearing officer. Respondent's motions, denied by separate order entered contemporaneously with this recommended order, did not request that additional evidence or argument be considered. Upon review of the record, the Hearing Officer concurs that it is unnecessary to receive any additional evidence or argument.

FINDINGS OF FACT

Background

1. Respondent, Jeffrey G. Tardiff, was, at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME 0021567. His office address is 2950 Crystal View Court, Miami, Florida.

   
   

2. Respondent graduated from George Washington Medical School in 1967; completed his internship at Jackson Memorial Hospital, Miami, Florida, rotating in internal medicine and surgery; and, completed a two-year residency program in internal medicine, surgery and emergency medicine, at the University of California at Los Angeles Medical Center, Los Angeles County Harbor General Hospital, Jackson Memorial Hospital, Miami, Florida, and Veterans Administration Hospitals in Long Beach, California, and Wadsworth, Virginia.

   
   

3. Currently, much of respondent's practice involves removing tumors of the face, both benign and cancerous, as well as micro surgery to repair the results of acne.

   
   

4. During the approximately 19 years respondent has been licensed to practice medicine in Florida, he has never previously been the subject of any disciplinary proceeding.

   
   

   Facts relating to Patient #1 (Case No. 92-0228, Counts Two and Three)

   
   

5. On September 11, 1989, Patient #1 (the "patient") was first seen by respondent.

   
   

6. When he presented himself, the patient's chief complaint was a very large number of skin growths, which had the appearance of small black warts, on his face, neck and upper body, and which were spreading rapidly. The patient indicated that people were talking about these growths, and that he wanted to "get them taken care of before they cover me."

   
   

7. Respondent took a history from the patient. At the time, the patient was 54 years of age, 69.5 inches tall, weighed 199.5 pounds, and had a blood pressure of 140/90 and a temperature of 98.0. The patient was described as very health, and expressed no allergic reaction or adverse side effects from penicillin or other known medications.

   
   

8. During this initial visit, respondent excised one of the lesions on the patient's right cheek for pathology. Pathology characterized the lesion as "intradermal nevus." Respondent diagnosed the condition as "multiple viral premalignant facial verroucose papillomas to the neck and below."

9. On September 20, 1989, the patient returned to respondent's office, and respondent removed approximately 197 skin lesions from the patient by hyfercation. During the procedure in which the lesions were removed, the patient was administered Meperidine, 210 mgs., and Diphenhydramine, 150 mgs., by micro drip I.V., to the point of twilight anesthesia. Additionally, the patient was administered Nitrous Oxide 75 percent and Oxygen 25 percent by inhalation during the procedure, and each lesion was injected with Xylocaine and 2 percent epinephrine locally before it was removed.

   
   

10. While respondent administered the patient Meporidine and Diphenhydramine by micro drip I.V. during the course of the two and one half hour procedure, the proof demonstrates that the medications were administered at moderate levels necessary to relieve pain and nausea, and that the patient remained alert throughout the procedure. Respondent, although unassisted throughout the procedure, had immediate control of the I.V. flow, such that he could increase or decrease its administration as necessary for pain, and continuously monitored the patient during the course of the procedure.

    
    

11. Regarding the techniques applied by respondent to monitor the patient, the proof demonstrates that before the procedure began respondent took the patient's blood pressure and pulse, and periodically checked the patient's pulse during the course of the procedure. Moreover, respondent engaged the patient in a continuing dialogue concerning a matter of common interest, automobiles, and compelled the patient to respond to requests that he reposition himself, as a means of monitoring the patient's alertness. Finally, respondent visually observed the patient for any signs of respiratory distress or changes in skin tone.

    
    

12. During the course of the foregoing procedure, respondent had available numerous items of monitoring equipment which he elected not to use, and numerous items of emergency requirement which he was not required to use, including: blood pressure cuffs, an EKG, an Edak plethysmograph, a power breather, amu bags and masks, a heart rate monitor, a Debidick Life Pack 6 monitor defibrillator, and Narcon and other drugs needed to reverse the effects of a medication or to revive a patient. Respondent did not, however, have on hand or use a pulse oximeter during the procedure, did not utilize any of his equipment to take or monitor the patient's vital signs during the course of the procedure, did not record the patient's vital signs during or after the procedure, and did not have a second person present to assist him in monitoring the patient's vital signs during the procedure.

    
    

13. The patient tolerated the procedure well and, as heretofore noted, was cognizant and alert during its course. Following completion of the surgery, the patient was released without ill effect, and has expressed satisfaction with the results of respondent's labors.

    
    

14. Here, petitioner charges that respondent failed to practice medicine with that level of care, skill, and treatment which a reasonably prudent similar physician recognizes as acceptable under similar conditions and circumstances because he failed to have a second person assist him in monitoring the patient's vital signs during the course of the September 20, 1989, procedure, and because he failed to use a pulse oximeter to measure the patient's oxygen satiation level during the course of such procedure. Petitioner further charges that respondent failed to keep written medical records justifying the course of treatment of the patient because he failed to record the patient's vital signs before, during or after the anesthesia and surgery. In response, respondent

    contends that due to the nature of the procedure, the type and level of sedation, and the alertness of the patient, it was appropriate to monitor the patient in the manner he elected, without resort to utilizing a pulse oximeter; that, under the circumstances, it was unnecessary to have a second person present to monitor the patient's vital signs; and that, under the circumstances, his failure to record the patient's vital signs before, during and after the anesthesia and surgery does not evidence a failure to keep medical records justifying the course of treatment of the patient.

    
    

15. To support its position, petitioner offered the testimony of Dr. Bruick, a board certified plastic surgeon, and, through deposition, Dr. Kruse, a board certified anesthesiologist. Dr. Bruick opined that to comport with the requisite standard of care in circumstances where I.V. anesthesia is employed, a pulse oximeter must be used, an assistant must be present to monitor the patient's vital signs, and such signs must be recorded before, during and after the anesthesia and surgery. Dr. Bruick was not, however, totally familiar with the combination of drugs used in the subject procedure, and based his opinion regarding the use of a pulse oximeter on a rule of the Department of Health and Rehabilitative Services relating to minimum requirements for licensing of ambulatory surgical centers, a matter not pertinent to this case. Dr. Kruse rendered opinions consistent with Dr. Bruick, but was familiar with the combination of medications used in the subject case and did not rely on any rules of the Department of Health and Rehabilitative Services. Dr. Kruse further opined, however, that if practitioners in South Florida did not routinely use a pulse oximeter during this type of procedure then the standard of care would not mandate its use.

    
    

16. Juxtaposed with the proof offered by petitioner, the proof offered on behalf of respondent consisted of his own testimony, as well as the opinions of two local physicians, a registered nurse/trauma nurse specialist, and one of petitioner's own investigators, who offered persuasive proof that pulse oximeters were not routinely used during the course of procedures like that at issue in this case, and that considering the nature of the procedure, the type and level of sedation, and the alertness of the patient it was within the accepted level of care for respondent to have monitored the patient in the manner he elected, without the utilization of a pulse oximeter, without having a second person present to monitor the patient's vital signs, and without the necessity of recording the patient's vital signs before, during and after anesthesia and surgery.

    
    

17. Considering the proof, it cannot be concluded, with the requisite degree of certainty required by law, which opinions accurately reflect the appropriate standard of care prevalent within the State of Florida. Therefore, considering the fact that the burden of proof in these proceedings rested on petitioner, as discussed infra, it must be concluded that the proof fails to support the conclusion that respondent is guilty of having committed the offenses charged in Counts Two and Three of the amended administrative complaint filed under Case No. 92-0228.

    
    

    Facts relating to the notice requirements of Section 458.320(5), Florida Statutes, relating to a practitioner's election not to carry

    malpractice insurance. (Case No. 92-0228, Count One)

    
    

18. By Count One of the amended administrative complaint filed in Case No. 92-0228, petitioner charges that respondent "failed to post notice in the form of a sign prominently displayed in the reception area or to provide a written

    statement in the language required by Section 458.320(5) . . ., Florida Statutes, to Patient #1 in regard to respondent's financial responsibility to pay claims and costs ancillary thereto arising out of the rendering of, or the failure to render, medical care or services."

    
    

19. Regarding the notice provided by respondent, the proof demonstrates that respondent had taped on the counter where all patients presented themselves upon arrival at his office a photo copy of Section 358.380, Florida Statutes, which bore the following language prominently printed above the statutory provisions:

    
    

    TO ALL DR. TARDIFF'S PATIENTS

    
    

    I have elected not to carry medical malpractice insurance or otherwise demonstrate financial responsibility; however, I have agreed to satisfy any adverse judgments up to the

    minimum amounts pursuant to s 458.320(5)(g)1,

    F.S. I understand that I must post notice in the form of a "sign" prominently displayed in the reception area or provide a written statement to any person to whom medical services are being provided that I have decided not to carry medical malpractice insurance or otherwise demonstrate financial responsibility. I understand that such a sign or notice must contain the wording specified in s. 458.320(5)(g), F.S.

    
    

    No other "sign" or notice was posted in respondent's reception area.

    
    

20. Numerous portions of Section 458.320, Florida Statutes, which was reproduced immediately under the foregoing statement, were underlined, including portions of the subsections dealing with the notice requirement. The specific notice requirements were not, however, emphasized in toto or in such a manner as to be readily discernible. Rather, the apparent random underlining was confusing and did little, if anything, to emphasize the required statutory notice.

    
    

21. In addition to the foregoing notice, respondent provided each patient, including Patient #1, a form which provided them with various information and disclaimers regarding respondent's practice. Prominently displayed at the top of such form was the following statement:

    
    

    TO ALL OUR PATIENTS:

    BE IT KNOWN THAT DR. TARDIFF DOES NOT CARRY ANY MAL-PRACTICE INSURANCE AND ALL ASSETS HAVE BEEN PROTECTED EXTENSIVELY.

    
    

    Receipt of such form was routinely acknowledged by the patient's signature thereon, including that of Patient #1.

    
    

22. Patient #1 acknowledged, through his testimony, his awareness that respondent did not carry malpractice insurance. Such awareness was gleamed from the foregoing form, as well as the notice he observed taped to the counter in respondent's reception area. Whether Patient #1 specifically noted the

    disclaimer's language set forth in the statute does not, however, appear of record.

    
    

    Facts relating to respondent's possession of expired medications and record keeping

    regarding controlled substances. (Case No. 92-1156)

    
    

23. On July 19, 1990, the petitioner's investigators made an inspection of the respondent's office located at 2950 Crystal View Court, Miami, Florida. Follow-up inspections were conducted by petitioner's investigators on October 29, 1990, and May 3, 1991.

    
    

24. At the time of the aforesaid inspections, the respondent was a dispensing practitioner and registered with the Drug Enforcement Administration (DEA), having been issued DEA number AT589553.

    
    

25. At the conclusion of the inspection of July 19, 1990, petitioner's investigators were critical of certain aspects of petitioner's practices. These concerns related to petitioner's record keeping, or lack thereof, with regard to controlled substances; his possession of pharmaceuticals bearing an expiration date that had been reached; his failure to maintain DEA Form 222 as required by Federal law; and, his storage of controlled substances, which included Dilaudid, Demerol, Morphine and Fiorinal with codein number three, in what the investigators perceived to be an unlocked double door refrigerator.

    
    

26. With regard to respondent's record keeping with respect to controlled substances, the proof demonstrates that respondent failed to maintain a record of controlled substances received that showed the date of receipt, name and address of the person from whom received, and the kind and quantity of controlled substances received, except to the extent respondent's DEA Forms 222 could be construed to satisfy, in part, such requirements. Respondent's DEA Form 222's do not, however, as hereinafter discussed, reflect the date he received the controlled substances ordered, if at all, and do not account for the variety of controlled substances in his possession. Moreover, respondent failed to maintain any log or record that reflected the controlled substances he sold, administered, dispensed or otherwise disposed of.

    
    

27. Regarding the DEA Forms 222, the proof demonstrates that the federal government strictly controls the acquisition of controlled substances and that for a practitioner, such as respondent, to legally order such substances he must be registered with DEA and utilize DEA Form 222 when ordering such substances. See, 21 CFR Sections 1305.01, et seq. The DEA Form 222's issued to practitioners, such as respondent, are sequentially numbered, and each form consists of three copies. The practitioner in ordering controlled substances with the form, fills in the name and address of the supplier from who he is ordering, the number of packages and size of the package ordered, the name of the item, and signs the form. Pursuant to 21 CFR 1305.09(a), the practitioner, as the purchaser, "shall submit Copy 1 and Copy 2 of the order form to the supplier, and retain Copy 3 in his own files." The supplier, pursuant to 21 CFR 1305.09(d), retains "Copy 1 of the order form for his own files and forward[s] Copy 2 to the Special Agent in Charge of the Drug Enforcement Administration in the area in which the supplier is located." The practitioner, pursuant to 21 CFR 1305.13(a), is required to "retain Copy 3 of each order form which has been filled . . . [as well as] . . . all copies of each . . . defective order form .

    . . ." for a period of two years.

28. The DEA Form 222's produced by the respondent, which total four in number, were not issued in sequential order; Order Form number 861093790 was not retained by respondent; the copy of Order Form number 861093789, retained by respondent, was the Supplier's Copy 1, as opposed to the Purchaser's Copy 3; none of the forms reflect the number of packages received or the date received by respondent; and the forms retained by respondent do not, as discussed infra, account for all controlled substances found in his office. Regarding the missing Order Form number 861093790, respondent averred at hearing that, because he made an error in filling out the form, he destroyed it.

    
    

29. Regarding the investigator's concerns regarding expired pharmaceuticals located on respondent's premises, the proof demonstrates that at the time of the July 19, 1990, inspection of respondent's office, the investigators observed a "[l]arge amount of medications over the counter, such as Tylenol, nasal sprays, birth control, antibiotics, muscle relaxants, pain medication covering 21 open shelves about four feet wide each and shelves inside cupboards between five and ten feet. Approximately 40 percent of these medications were expired" [Tr. p. 154]. As to the quantitative amount of expired medications, petitioner's investigator estimated it to be in excess of one hundred medications [Tr. p. 185]. The investigators did not, however, inventory all the medications and the record fails to persuasively demonstrate which of the medications listed on the shelves, if any, carried an expiration date at least four months old. There were, however, expired medications, with an expiration date at least four months old located in the refrigerator, along with current medications, including: Acidophilus culture (expiration date 1986) and Small pox vacine (expiration date May 1978). The expired medications were not, however, shown to be co-mingled with similar medications and the location (the refrigerator) was not shown to be within the "prescription department," as that term is commonly known.

    
    

30. Respondent concedes that there were several boxes of expired medications, approximately 80 to 90 pounds worth, at the time of the July 19, 1990, inspection, and certainly some of them carried an expiration date over four months old. Respondent denies, however, that any drugs with an expiration date of over four months were co-mingled with current medications destined for dispensing to patients in Florida and, but for the two items located in the refrigerator, there is no competent or persuasive proof to the contrary.

    
    

31. At hearing, respondent offered proof, which is credited, regarding his rational for possession of such large quantities of expired medications. According to respondent, in addition to being licensed to practice medicine in the State of Florida, he is also licensed as a surgeon under the Health Practitioners Law of 1974 in the Cayman Islands, and collects expired medications and samples from other physicians and drug reps which he transports to the Cayman Islands for dispensation or donation to the local hospital or clinic. Use of such medications is apparently permissible under the laws of the Cayman Islands, and it was not suggested or demonstrated in this proceeding to be contrary to the laws of the United States or the State of Florida.

    Respondent has not, however, been charged or shown to have ever dispensed any expired medications during the course of his practice in Miami, Florida.

    
    

32. Finally, regarding the observations of the investigators regarding the storage of controlled substances in an unlocked double door refrigerator, the proof is conflicting. The investigators averred that when they inspected the premises on July 19, 1990, the refrigerator was not locked and that respondent, upon questioning, advised it was never locked. Respondent averred that no such question was posed to him and that had it been he would have advised the

    investigators that it was his practice to lock the refrigerator with a large combination lock, similar to those used on bicycles, through the double handles on the front of the refrigerator when he was absent from the office or when the office was closed. Moreover, after hours, the operating suite, where the refrigerator is located is locked and the office is locked. Here, the conflict in the proof is resolved to accord deference to respondent's testimony.

    
    

33. During the reinspection of October 29, 1990, most of respondent's expired medications were segregated from current medications within the open shelving or boxed. The majority of such expired medications were expectorant, antihistamine and similar medications. There is, however, no competent or persuasive proof as to which, if any, of the medications bore an expiration date of over four months, except for Haldol (expiration date 1981), and as to the Haldol there was no competent or persuasive proof that it was co-mingled with current medications.

    
    

34. As with the expired medications observed on the first inspection, respondent averred that the expired medications, as well as others that were not expired, were acquired from other physicians and drug reps for use in the Cayman Islands, and that he did not dispense expired medications to his patients in Miami, Florida. Respondent's testimony is credited.

    
    

35. As with the first inspection, the reinspection of October 29, 1990, revealed deficiencies in respondent's record keeping with respect to controlled substances. Respondent still did not have a record of controlled substances received that showed the date of receipt, name and address of the person from whom received, and the kind and quantity of controlled substances received, except to the extent respondent's preexistent DEA Form 222's, heretofore discussed, could be construed to satisfy such requirements. There was, however, no proof that respondent had received any additional controlled substances since the initial inspection. Moreover, while respondent now had a record or log to reflect the controlled substances he sold, administered, dispensed or otherwise deposed of, it had but one entry and that entry was limited to the patient's name, the date dispensed, and an itemization of the medications and the quantities dispensed.

    
    

36. During the reinspection of May 3, 1991, petitioner's investigator located only a few medications, approximately six or seven, that were expired. The nature of such medications was not disclosed of record, and whether such medications bore an expiration date at least four months old was not disclosed of record. Respondent was also found to be in possession of pharmacy dispensed medications prescribed to other people. The investigator did not know the nature of such medications but was advised by respondent that it was "expensive" AIDS medication that had been prescribed for his AIDS patients, who had died.

    It was respondent's intention, which is accepted, to use such medications in the Cayman Islands, and not to distribute such medications to his patients in Miami, Florida.

    
    

37. As with the first inspection and the reinspection of October 29, 1990, the reinspection of May 3, 1991, again revealed deficiencies in respondent's record keeping with respect to controlled substances. Respondent had still not compiled a record of controlled substances received that showed the date of receipt, name and address of the person from whom received, and the kind and quantity of controlled substances, except to the extent respondent's preexistent DEA Form 222's, heretofore discussed, could be construed to satisfy such requirement. There was, however, no proof that respondent had received any additional controlled substances since the initial inspection.

38. While respondent's record of controlled substances received was deficient, he had inventoried the controlled substances he purportedly had on hand as of October 30, 1990, and entered such information in the log he maintained to reflect controlled substances sold, administered, dispensed or otherwise disposed of. Neither such inventory nor respondent's DEA Form 222's account, however, for the controlled substance Dilaudid then in his possession, and dispensed subsequent to October 30, 1990, according to his log. As to the log itself, it continued to only reflect the patient's name, the date dispensed, and type and quantity of drug dispensed.

    
    

    CONCLUSIONS OF LAW

    
    

39. The Division of Administrative Hearings has jurisdiction over the parties to, and the subject matter of, these proceedings. Sections 120.57(1), 120.60(7) and 455.225(4), Florida Statutes.

    
    

40. In a case of this nature, the petitioner bears the burden of proving the charges set forth in the amended administrative complaints by clear and convincing evidence. Ferris v. Turlington, 510 So.2d 292 (Fla. 1987). The nature of clear and convincing evidence has been described in Slomowitz v. Walker, 429 So.2d 797, 800 (Fla. 4th DCA 1983), as follows:

    
    

    We therefore hold that clear and convincing evidence requires that the evidence must be found to be credible; the facts to which the witnesses testify must be precise and explicit and the witness must be lacking in 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.

    
    

    See also, Smith v. Department of Health and Rehabilitative Services, 522 So.2d 956 (Fla. 1st DCA 1988).

    
    

41. In determining whether the provisions of law set forth in the amended administrative complaints have been violated in the manner alleged, one must bear in mind that such statutory and rule provisions are penal in nature. "This being true the[y] must be strictly construed and no conduct is to be regarded as included within [them] that is not reasonably proscribed by [them].

    Furthermore, if there are any ambiguities included such must be construed in favor of the . . . licensee." Lester v. Department of Professional and Occupational Regulations, 348 So.2d 923, 925 (Fla. 1st DCA 1977). Finally, the grounds proven must be those specifically alleged in the amended administrative complaints. See, Kinney v. Department of State, 501 So.2d 129 (Fla. 5th DCA 1987), and Hunter v. Department of Professional Regulation, 458 So.2d 842 (Fla. 2d DCA 1984).

    
    

42. Pertinent to this case, Section 458.331(2), Florida Statutes, empowers the Board of Medicine to revoke, suspend, or otherwise discipline the license to practice medicine of any physician found guilty of certain acts enumerated in that statutory provision, including:

    
    

    (g) Failing to perform any statutory or legal obligation placed upon a licensed physician.

    * * *

    
    

    (m) Failing to keep written medical records justifying 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 consultants and hospitalizations.

    
    

    * * *

    
    

    (t) Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances . . . As used in this paragraph, "gross malpractice" or "the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances," shall not be construed so as to require more than one instance, event, or act . . . .

    
    

    * * *

    
    

    (x) Violating any provision of this chapter [or] a rule of the board or department . . . .

    
    

43. Count One of the amended administrative complaint, Case No. 92-0228, charges the respondent with a violation of Section 458.320(5)(f)7, Florida Statutes, which requires a practitioner who has elected to exempt himself from the financial responsibility requirements of Section 458.320, Florida Statutes, to "post a notice in the form of a sign prominently displayed in the reception area and clearly noticeable by all patients or provide a written statement to any person to whom medical services are being provided" containing the specific language required by the statute.

    
    

44. Here, while there is no dispute that respondent has elected to exempt himself from the financial responsibility requirements of Section 458.320, Florida Statutes, the proof is unclear as to whether his exemption is under the provisions of Sections 458.320(5)(f), as charged, or 458.320(5)(g), Florida Statutes, as evidenced by the notice he posted. Such uncertainty is not, however, fatal to the resolution of the charges where, as here, respondent's notice fails to comply with the specific requirements of both provisions. See generally, Hunter v. Department of Professional Regulation, 458 So.2d 843 (Fla. 2d DCA 1984), and Farzad v. Department of Professional Regulation, 443 So.2d 373 (Fla. 1st DCA 1983), [While the allegations of the administrative complaint must be specific enough to inform the accused with reasonable certainty of the charges, a mere misdesignation of statute or rule as grounds for disciplinary action is generally harmless where, as here, the respondent was charged with conduct which violated the statute or rule, and such misdesignation is apparent or of no consequence.]

45. Section 458.320(5)(f)7, Florida Statutes, obligates a practitioner who has exempted himself under the provisions of Section 458.320(5)(f) to do the following:

    
    

    A licensee who meets the requirements of this paragraph shall be required either to post notice in the form of a sign prominently displayed in the reception area and clearly noticeable by all patients or provide a written statement to any person to whom medical services are being provided. Such sign or statement shall state that: Under Florida law, physicians are generally required to carry medical malpractice insurance or otherwise demonstrate financial responsibility to cover potential claims for medical malpractice.

    However, certain part-time physicians who meet state requirements are exempt from the financial responsibility law. YOUR DOCTOR MEETS THESE REQUIREMENTS AND HAS DECIDED NOT CARRY MEDICAL MALPRACTICE INSURANCE. This

    notice is provided pursuant to Florida law.

    
    

    And, Section 458.320(5)(g)4, Florida Statutes, obligates a practitioner who has exempted himself under the provisions of Section 458.320(5)(g) to do the following:

    
    

    A licensee who meets the requirements of this paragraph shall be required to either post notice in the form of a sign prominently displayed in the reception area and clearly noticeable by all patients or provide a written statement to any person to whom medical services are being provided. Such sign or statement shall state that: Under Florida law, physicians are generally required to carry medical malpractice insurance or otherwise demonstrate financial responsibility to cover potential claims. YOUR DOCTOR HAS DECIDED NOT TO CARRY MEDICAL MALPRACTICE INSURANCE. This

    is permitted under Florida law subject to certain conditions. Florida law imposes penalties against noninsured physicians who fail to satisfy adverse judgments arising from claims of medical malpractice. This notice

    is provided pursuant to Florida law.

    
    

46. The evidence in this case demonstrated that the written statement respondent routinely supplied his patients, and particularly Patient #1, failed to include the statutory language mandated by either Section 458.320(5)(f)7 or 458.320(5)(g)4, Florida Statutes. The evidence further demonstrated that the notice respondent had taped to the counter in the reception area, discussed supra, failed to comply with the statutory mandate "to post notice in the form of a sign prominently displayed in the reception area and clearly noticeable by all patients" containing the express language required by law. [Emphasis added].

47. Where, as here, the language of a statute is not otherwise defined, the words chosen are accorded their ordinary meaning. Metropolitan Dade County

    v. Green, 596 So.2d 458 (Fla. 1992), ("The general rule of construction is that [statutory] words not expressly defined are given their plain and ordinary meaning."), and Green v. State, 604 So.2d 471, 473 (Fla. 1992), ("If necessary, the plain and ordinary meaning of the word can be ascertained by reference to a dictionary.") A "sign," in the context of the statutory language, is "a posted command, warning, or direction"; "to post" is "to affix to a usual place (as a wall) for public notices"; "prominently displayed" is to be "readily noticeable" or an "eye-catching arrangement by which something is exhibited"; "noticeable" applies to something "unlikely to escape observation"; and "clearly" implies "freedom from obscurity, ambiguity, or undue complexity." Websters Ninth New Collegiate Dictionary (1986). Here, the notice respondent chose to post, as observed in the findings of fact, failed to comply with the statutory mandate. Mitigating against the gravity of respondent's failure is, however, the fact that respondent clearly advised his patients that he had decided not to carry medical malpractice insurance.

    
    

48. Count Two of the amended administrative complaint, Case No. 92-0228, charges the respondent with a violation of Section 458.331(m), Florida Statutes, which authorizes disciplinary action against a physician upon proof of a "failing to keep written medical records justifying the course of treatment of the patient." The failure charged in Count Two relates to the alleged failure of respondent to note in his records Patient #1's vital signs before, during and after the anesthesia and surgery. Count Three of the amended administrative complaint, Case No. 92-0228, charges the respondent with a violation of Section 458.331(t), Florida Statutes, which authorizes disciplinary action against a physician upon proof of a "failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar circumstances." The failures charged in Count III relate to the failure of respondent to have a second person assist him in monitoring Patient #1's vital signs during the procedure and failing to use a pulse oximeter to measure Patient #1's oxygen saturation level during the procedure. Counts Two and Three of the amended administrative complaint, Case No. 92-0228, should be dismissed for petitioner's failure, as noted in the findings of fact, to meet its burden of proof.

    
    

49. The amended administrative complaint filed under Case No. 92-1156 is not separated into counts but addresses a number of failings petitioner's investigators noted during the course of inspections of respondent's office on July 19, 1990, October 29, 1990, and May 3, 1991, which petitioner contends constitute a violation of statutory or other legal obligations placed upon respondent and, therefore, a violation of Section 458.331(2)(g) and (x), Florida Statutes.

    
    

50. With regard to the inspection of July 19, 1990, the deficiencies alleged included: (1) a failure to maintain, on a current basis, a complete and accurate record of all controlled substances received, and a failure to maintain a complete and accurate record of all controlled substances sold, administered, dispensed, or otherwise disposed of in violation of Section 893.07, Florida Statutes, (2) possession of expired medications in violation of Rule 21S.28.110, Florida Administrative Code, (3) storage of controlled substances "in a refrigerator which was not securely locked or padlocked" in violation of 21 CFR Section 1301.75, and (4) failure to retain a required DEA Form 222 contrary to

    21 CFR Section 1305, and Section 893.07(2), Florida Statutes.

51. Pertinent to these charges, Section 465.0276, Florida Statutes, provides, with regard to the dispensing of medicinal drugs by a physician, as follows:

    
    

    1. A person may not dispense medicinal drugs unless licensed as a pharmacist or otherwise authorized under this chapter to do so, except that a practitioner authorized by law to prescribe drugs may dispense such drugs to his patients in the regular course of his practice in compliance with this section.

    2. A practitioner who dispenses medicinal drugs for human consumption for fee or remuneration of any kind, whether direct or indirect, must:

       1. Register with his professional licensing board as a dispensing practitioner . . .

       2. Comply with and be subject to all laws and rules applicable to pharmacists and pharmacies, including, but not limited to, this chapter, chapter 499, and chapter 893 and all federal laws and federal regulations.

          
          

          And, Section 893.07, Florida Statutes, provides, with regard to required record keeping for controlled substances received or dispensed by a physician, as follows:

          
          

          1. Every person who engages in the manufacture, compounding, mixing, cultivating, growing,

             or by any other process producing or preparing, or in the dispensing, importation, or, as a wholesaler, distribution, of controlled substances shall:

             
             

             * * *

             
             

             (b) On and after January 1, 1974, maintain, on a current basis, a complete and accurate record of each substance manufactured, received, sold, delivered, or otherwise disposed of by him, except that this subsection shall not require the maintenance of a perpetual inventory.

             
             

             Compliance with the provisions of federal law pertaining to the keeping of records of controlled substances shall be deemed a compliance with the requirements of this subsection.

          2. The record of controlled substances received shall in every case show:

             1. The date of receipt.

             2. The name and address of the person from whom received.

             3. The kind and quantity of controlled substances received.

          3. The record of all controlled substances

             sold, administered, dispensed, or otherwise disposed of shall show:

             1. The date of selling, administering, or dispensing.

             2. The correct name and address of the person to whom or for whose use, or the owner and species of animal for which, sold, administered, or dispensed.

             3. The kind and quantity of controlled substances sold, administered, or dispensed.

          4. Every inventory or record required by this chapter, including prescription records, shall be maintained:

             1. Separately from all other records of the registrant, or

             2. Alternatively, in the case of Schedule III, IV, or V controlled substances, in such form that information required by this chapter is readily retrievable from the ordinary business records of the registrant.

                
                

                In either case, records shall be kept and made available for a period of at least 2 years for inspection and copying by law enforcement officers whose duty it is to enforce the laws of this state relating to controlled substances.

                
                

52. Also alleged to be pertinent to these charges are the provisions of Rule 21S-28.110, Florida Administrative Code, and 21 CFR Sections 1301.75 and 1305. Rule 21S-28.110, Florida Administrative Code provides:

    
    

    Outdated Pharmaceuticals. Persons qualified to do so shall examine the stock of the prescription department of each pharmacy at a minimum interval of four months, and shall remove all deteriorated pharmaceuticals, or pharmaceuticals which bear upon the container

    an expiration date which date has been reached, and under no circumstances will pharmaceuticals or devices which bear upon the container an expiration date which has been reached be sold or dispensed to the public.

    
    

    21 CFR Section 1301.75 provides:

    
    

    Physical security controls for practitioners:

    1. Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.

    2. Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet.

    And, 21 CFR Section 1305.13, provides:

    
    

    Preservation of order forms.

    (a) The purchaser shall retain Copy 3 of each order form which has been filed. He shall also retain in his files all copies of each unaccepted or defective order form and each statement attached thereto.

    
    

    * * *

    
    

    (c) Order forms must be maintained separately from all other records of the registrant. Order forms are required to be kept available for inspection for a period of 2 years . . . .

    
    

53. The evidence presented with regard to the inspection of July 19, 1990, compels the conclusion that respondent violated the provisions of Section 893.07(1)(b), (2) and (3), Florida Statutes, by failing to maintain, on a current basis, a complete and accurate record of each controlled substance received, sold, delivered, or otherwise disposed of by him as required by law. As to the charge that respondent violated the provisions of Rule 21S-28.110, Florida Administrative Code, by having expired medications in his possession, the law fails to support the contention that mere possession of expired medications constitutes a violation of such rule provision.

    
    

54. Under the provisions of Rule 21S-28.110, Florida Administrative Code, the obligation to examine the stock of a prescription department, and to remove those drugs with an expired label, is established at "a minimum interval of four months." Implicit within such mandate is the understanding that during the period between examinations drugs may exist within the prescription department that have expired since the last examination, however, the physician is constrained from dispensing them. Here, the only medications persuasively demonstrated to have had an expiration date at least four months old and located with current medications, although not similar medications, were the Acidophilus culture and Small pox vaccine located in the refrigerator. Such location was not, however, as heretofore found, shown to be within the "prescription department," as that term is commonly known. Accordingly, respondent has not been shown to have violated the provisions of Rule 21S-28.110, Florida Administrative Code.

    
    

55. With regard to the contention that respondent violated the provisions of 21 CFR Section 1301.75 by storing controlled substances "in a refrigerator which was not securely locked or padlocked" the evidence, as noted in the findings of fact, fails to support such conclusion. Finally, with regard to the contention that respondent failed to retain the defective DEA Form 222, numbered 861093790, as required by law, the evidence supports such charge.

    
    

56. With regard to the reinspection of October 29, 1990, the deficiencies alleged included: (1) possession of expired medications in violation of Rule 21S-28.110, Florida Administrative Code, and (2) a failure to maintain, on a current basis, a complete and accurate record of all controlled substances received, and a failure to maintain a complete and accurate record of all controlled substances sold, administered, dispensed, or otherwise disposed of in violation of Section 893.07, Florida Statutes. As heretofore noted in the findings of fact, the proof failed to persuasively demonstrate that respondent possessed any expired medications with an expiration date over four months old,

    except Haldol, and as to the Haldol, failed to demonstrate that it was co- mingled with current medications. Therefore, respondent was not shown to have violated Rule 21S-28.110, Florida Administrative Code. The proof did, however, demonstrate that respondent continued to be in violation of Section 893.07(1)(b), (2) and (3), Florida Statutes, by failing to maintain, on a current basis, a complete and accurate record of each controlled substance received sold, delivered, or otherwise disposed of, as required by law.

    
    

57. Finally, with regard to the reinspection of May 3, 1991, the deficiencies alleged included: (1) possession of expired medications in violation of Rule 21S-28.110, Florida Administrative Code, (2) a failure to maintain, on a current basis, a complete and accurate record of all controlled substances received, and a failure to maintain a complete and accurate record of all controlled substances sold, administered, dispensed, or otherwise disposed of in violation of Section 893.07, Florida Statutes, (3) failure to have the required DEA Form 222 to account for all controlled substances in his possession in violation of 21 CFR Section 1305, and (4) possession of pharmacy dispensed medications prescribed for another person in violation of Rule 21S-27.104(4), Florida Administrative Code.

    
    

58. As observed in the findings of fact, the proof fails to support the conclusion that respondent was in possession of medications with an expiration date at least four months old during the reinspection of May 3, 1991.

    Respondent was, however, although making an effort to account for the controlled substances received and dispensed, still in violation of Section 893.07, Florida Statutes, by having failed to maintain, on a current basis, a complete and accurate inventory of each controlled substance received, sold, delivered, or otherwise disposed of as required by law. Moreover, respondent did not have the required DEA Form 222 to account for the controlled substance Dilaudid in his possession. Assuming, without deciding, that Rule 21S-27.104(4), Florida Administrative Code, was applicable to respondent's circumstances, respondent's possession of pharmacy dispensed medications prescribed for another person did not violate such provision of law since respondent did not place such medication in stock to be dispensed to another client in the State of Florida.

    
    

59. In the course of making the penalty recommendations which follow, consideration has been given to the provisions of the rules at Chapter 21M-20, Florida Administrative Code.

RECOMMENDATION

Based on the foregoing findings of fact and conclusions of law it is Recommended that a final order be rendered consistent with the foregoing

findings and conclusions, and that for those violations for which respondent has

been found guilty, that respondent's license to practice medicine be reprimanded, that a fine in the amount of $5,000 be assessed, and that respondent's license to practice medicine be placed on probation for a period of two (2) years subject to such terms and conditions as the Board of Medicine might reasonably prescribe, including continuing medical education courses in record keeping with regard to controlled substances.

DONE AND ENTERED in Tallahassee, Leon County, Florida, this 28th day of September 1993.

WILLIAM J. KENDRICK

Hearing Officer

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-1550

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 28th day of September 1993.

ENDNOTES

1/ Respondent offered four exhibits at hearing, which were received into evidence, and was authorized to file two late-filed exhibits, which were filed April 12, 1993, marked respondent's exhibits 5 and 6, and received into evidence.

2/ The lesion removed by respondent appeared to be the oldest, and the most probable source of the other lesions, which were apparently spread by shaving.

3/ While respondent's medical record for the patient fails to record the patient's blood pressure and pulse before the procedure of September 20, 1989, respondent's testimony that he took them is accepted, and is consistent with his practice to take such vital signs as recorded on other days he saw the patient.

4/ According to Doctors Bruick and Kruse, the minimum monitoring equipment required in a setting such as the instant case is a blood pressure cuff, pulse oximeter and electro cardiogram. Here, the complaint charges only that respondent fell below the accepted standard of care because he failed to use a pulse oximeter, notwithstanding his failure to also use a blood pressure cuff and electrocardiogram. The rational for such limited charge does not appear of record.

5/ At hearing, respondent testified that he has instructed his staff to segregate expired medications from current medications at least every four months, but that they actually do it two and three times a week [Tr. p. 246]. At his deposition before trial, he testified that he had his secretary go through his medications on her lunch hour every four months to make sure that out-of-date drugs were removed from current stock. [Petitioner's exhibit 4, p. 49] Such testimony is inherently inconsistent. Considering, the proof, it is

concluded that as of the first inspection, respondent had no policy to routinely inventory medications to assure expired medications were not co-mingled with current medications. Such conclusion does not, however, affect the resolution of the dispute.

6/ Petitioner also relied on Rule 215-28.109(2) and (3), Florida Administrative Code. Such rules would appear, facially, to be inapplicable to respondent's circumstances; however, to the extent they could be deemed applicable respondent

has complied therewith by locking the refrigerator, as well as the operating suite within which it was located, when he was absent from the premises.

7/ Petitioner also relied upon Rule 215-28.203(1)(d), Florida Administrative Code. Such provision is clearly not applicable to the facts of this case.

8/ The Hearing Officer has assumed for purposes of this discussion the applicability of Rule 21S-28.110 to respondent's circumstances. Such provision would, however, appear to have little or no relevance to respondent's circumstances. Rather, it appears petitioner has mischarged respondent, and relied upon the wrong rule provisions in this case. See, e.g., Section 499.005, Florida Statutes, and Chapter 10D-45, Florida Administrative Code, e.g. Rule 10D-45.0535(5) and (6), Florida Administrative Code. Petitioner has not, however, advanced such rule provisions, promulgated under Section 499.005, Florida Statutes, as authority for disciplining respondent, and they are not here relied upon.

9/ Petitioner never charged or suggested that the refrigerator was not a "substantially constructed cabinet" as required by 21 CFR Section 130175 but, merely, that it was not locked.

10/ Rule 215-27.104(4), Florida Administrative Code, provides:

No pharmacist, employer, employee of a pharmacy may knowingly place in stock of any pharmacy any part of any prescription compounded for, or dispensed to, any customer of any pharmacy and returned by said customer

. . . .

APPENDIX TO RECOMMENDED ORDER, CASE NO. 92-228

Petitioner's proposed findings of fact are addressed as follows:

1 & 2: Adopted in paragraph 1.

1. Rejected as not relevant to the pending charges.

2. Adopted in paragraph 7.

5 & 6. Addressed in paragraph 8.

1. Rejected as not relevant to the pending charges.

2. First sentence addressed in paragraph 9. Second sentence rejected as not relevant to the pending charges.

3. Addressed in paragraph 6.

4. Addressed in paragraph 8.

11 & 12. Addressed in paragraph 9.

1. Addressed in paragraphs 10 and 12.

2. Addressed in paragraph 12.

3. Addressed in paragraph 19.

4. Addressed in paragraph 21.

5. Addressed in endnote 3.

18 & 19. Adopted in paragraphs 14-17.

1. Adopted in paragraph 24.

2. Adopted in paragraph 23.

22-26. Adopted in paragraphs 25-32, and 38.

27 & 28. Addressed in paragraphs 33-35. 29-32. Addressed in paragraphs 36-38.

Respondent's proposed findings of fact are addressed as follows:

1. Addressed in paragraphs 1 and 4.

2. Addressed in paragraph 2.

3. Addressed in paragraphs 5 and 7.

4. Addressed in paragraph 7, otherwise unnecessary detail.

5. Addressed in paragraphs 6 and 8.

6. Addressed in paragraph 9.

7-10. Addressed in paragraph 10.

1. Addressed in paragraph 11.

2. Addressed in paragraph 12.

3. To the extent pertinent, addressed in paragraph 12.

4. Adopted in paragraphs 10 and 11. 15-21. Addressed in paragraphs 14-17.

22. Addressed in paragraphs 19 and 20.

23 & 24. Addressed in paragraphs 21 and 22.

1. Accepted, but addressed111 in paragraphs 14-17.

2. Adopted in paragraph 24.

3. Addressed in paragraph 23.

28 & 30. Addressed in paragraphs 28 and 38, otherwise contrary to the proof.

29. Not at issue or otherwise relevant.

1. Rejected as contrary to the proof. See respondent's exhibit 6, and paragraphs 26, 35, 37 and 38.

2. Not relevant or unnecessary detail.

3. Addressed in paragraphs 29, 30, 31, 33, 34 and 36.

4. Addressed in endnote 5.

5. Addressed in paragraph 31.

6. Addressed in paragraph 32.

COPIES FURNISHED:

Arthur B. Skafidas, Esquire Richard A. Grumberg, Esquire Department of Business

and Professional Regulation

1940 North Monroe Street, Suite 60

Tallahassee, Florida 32399-0792

Robert J. Bryan, Esquire

815 North West 57th Avenue, Suite 201 Miami, Florida 33126

Dorothy Faircloth Executive Director Board of Medicine Department of Business

and Professional Regulation

1940 North Monroe Street, Suite 60

Tallahassee, Florida 32399-0792

Jack McRay General Counsel

Department of Business

and Professional Regulation

1940 North Monroe Street, Suite 60

Tallahassee, Florida 32399-0792

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions to this recommended order. All agencies allow each party at least 10 days in which to submit written exceptions. Some agencies allow a larger period within which to submit written exceptions. You should contact the agency that will issue the final order in this case concerning agency rules on the deadline for filing exceptions to this recommended order. Any exceptions to this recommended order should be filed with the agency that will issue the final order in this case.

Docket for Case No: 92-000228

Orders for Case No: 92-000228