The Issue The issues are whether Respondents committed the acts or omissions alleged in four administrative complaints, and, if so, what penalty should be imposed against Respondents' licenses.
Findings Of Fact Petitioner proved the grounds alleged in paragraphs 1 through 3 of each Amended Complaint and the grounds alleged in paragraphs 1 through 5 of each Administrative Complaint. Petitioner is the state agency responsible for regulating the practice of pharmacy in Florida pursuant to Section 20.43 and Chapters 456 and 465. Rx and Gordon are each licensed in Florida, respectively, as a community pharmacy and pharmacist pursuant to license numbers PH 17718 and PS 27618. Rx is a community pharmacy located at 5400 South University Drive, Suite 107, Davie, Florida 33328. Gordon is the pharmacy manager. Rx operates an Internet pharmacy. Rx fills prescriptions received over the Internet and dispenses the prescribed medications. A website company identified in the record as USAPrescriptions.com (USAP) obtains personal information from individuals responding to USAP advertisements on the Internet. USAP transmits the patient information to physicians who prescribe medication for the individuals and transmit the prescriptions and patient information to Rx by e-mail. Rx prints a written record of the electronically transmitted prescription, but the written record of the prescription is not the actual prescription. Rx then enters the patient information into its computer system; fills the prescription; labels the medication in accordance with the requirements of Section 893.04(1)(e); obtains a written confirmation of the prescription from the physician; and dispenses the medication to the patient by private courier. Petitioner conducted on-site inspections of Rx on April 6 and October 18, 2001. Petitioner proved the grounds alleged in paragraph 4(b) of the Amended Complaints. Many of the medications in evidence are controlled substances within the meaning of Section 893.03. None of the controlled substances are Schedule I or Schedule II drugs defined in Section 893.03(1) and (2). Most of the medications are Schedule III, IV, or V drugs defined in Section 893.03(3)-(5). The remaining medications are legend drugs that are not scheduled by statute. Most of the medications in evidence are controlled substances identified in the record as obesity drugs and marketed under the brand names Adipex, Bontril, Didrex, Ionamin, Meridia, Phentermine, and Tenuate. Other medications include Celebrex, Ultram, Valtrex, Viagra, Xenical, and Zyban. Petitioner failed to prove the allegation in subparagraph 4(a) of the Amended Complaints that Respondents filled prescriptions written by out-of-state physicians who prescribed medication based on Internet questionnaires. Rx and Gordon do not fill "written" prescriptions. Respondents fill electronic prescriptions that physicians transmit by e-mail. The electronic prescriptions are transmitted by "other means of communication" authorized in Section 893.02(20). Respondents reduce each electronic prescription to a written record referred to in Section 893.04(1)(a). The evidence is not clear and convincing that physicians prescribe based on Internet questionnaires. None of the prescribing physicians testified. The content of the Internet questionnaire is not established by clear and convincing evidence. The prescribing physicians provide Respondents with patient profiles that include medical information for each patient. Evidence that the patient profiles are an inadequate basis for the prescriptions is less than clear and convincing. Petitioner's experts relied on the adequacy of the patient profiles, in relevant part, to opine that Respondents failed to properly consult patient profiles before dispensing obesity drugs. Evidence that patient profiles were an adequate source of medical information to consult before dispensing drugs is inconsistent with allegations that the patient profiles received from the prescribing physicians were an inadequate basis for the prescription or that the Internet questionnaires did not include sufficient information. Inconsistent evidence and allegations are not clear and convincing. The allegation in paragraph 4(a) that an "out-of-state physician" transmitted the referenced prescription is not material to the statutory mandate for Respondents to determine the validity of the prescription. The statute requires a pharmacist to determine the validity of the prescription only when the prescribing physician is "licensed" in a state other than Florida. The physical location of the physician is immaterial. The trier of fact cannot infer that Petitioner intended to allege a material fact. The fact must be alleged in the plain language of the Amended Complaint. It may be reasonable for the fact-finder to infer that the physician is licensed in the state where he or she is located, but such an inference is less than clear and convincing. The ALJ has ruled that any ambiguity in the factual allegation must be construed in favor of the licensee because this is a license discipline proceeding. The evidence is less than clear and convincing that Gordon was present at Rx on April 6, 2001. The investigator's testimony that he interviewed Gordon on April 6, 2001, is not persuasive. That testimony conflicts with evidence that the investigator customarily documents interviews in his investigative report and did not document an interview with Gordon on April 6, 2001. Such inconsistent evidence is less than clear and convincing. Even if Gordon were found to be present during the inspection, the evidence does not show how long she was present or the nature and scope of her personal conduct concerning the alleged acts or omissions. The evidence is less than clear and convincing that the alleged acts or omissions were caused by misconduct on the part of Rx. The alleged acts or omissions are limited to April 6, 2001. Evidence relevant to the inspection conducted on April 6, 2001, consists primarily of the testimony of one inspector and two exhibits. The evidence is insufficient to show that unidentified employees of Rx engaged in the alleged acts or omissions in a persistent and practiced manner. The evidence is insufficient to support an inference that Rx is vicariously responsible for the alleged acts or omissions of its employees on April 6, 2001. Paragraph 4(c) in the Amended Complaints alleges that the prescriptions filled by Respondents were not valid because there was no patient-physician relationship upon which to base a treatment plan or "to justify prescribing medications." The evidence does not establish standards applicable to Respondents. The investigator's testimony makes clear that the alleged grounds are based on a rule promulgated by the Board of Medicine that is applicable only to physicians licensed in Florida. The ALJ has ruled in the Conclusions of Law that Petitioner has no jurisdiction to discipline Respondents for violating a rule applicable to physicians. No further findings are made concerning the grounds alleged in the Amended Complaints. Paragraph five in the Amended Complaints charges a violation based on facts alleged in the preceding four paragraphs of the complaint. The remaining references in the Recommended Order to a "paragraph" refer to paragraphs in the Administrative Complaints. Paragraph 5 alleges that the "inspection team observed" four technicians and one pharmacist dispensing medications on October 18, 2001, in violation of the maximum ratio of 3:1 prescribed in Section 465.014. The observations of the "inspection team" are a method of proof but, in this instance, include the fact sought to be proven. On October 18, 2001, Gordon was the only pharmacist on duty during the inspection. Four other employees were present at the time, but the evidence is less than clear and convincing that all four employees were technicians. Two members of Petitioner's inspection team found that Respondents maintained the correct ratio. One member is a licensed pharmacist. A third member found the ratio to be improper. Such inconsistent evidence is less than clear and convincing. As to paragraph 6, Petitioner proved that mislabeled drugs were present in the offices of Rx on October 18, 2001. The evidence is clear and convincing that a potentially dangerous pre-packaging procedure occurred on that day. The deficient procedure failed to properly label medications during the re-packaging process. The evidence of personal misconduct by Gordon on October 18, 2001, is less than clear and convincing. Although Gordon was present during the inspection, there is little detailed evidence of her personal conduct. The facts are similar for Rx. The evidence is less than clear and convincing that Rx directed its employees to commit the deficiencies or knew of the deficiencies. Uncontroverted admissions by Rx employees indicate they were instructed to use the deficient procedure to label vials. However, the evidence is insufficient to show that the instructions came personally from Gordon, the owners of Rx, or some other employee or manager. The evidence does not support an inference by the trier of fact that Rx or Gordon is vicariously responsible for the deficiencies. The evidence is insufficient to show that the labeling deficiencies on October 18, 2001, were persistent and practiced. The allegation is limited to a specific day, and the inspection team was not in the offices of Rx all day. The evidence established the standards required for Respondents to exercise due care. The medications were improperly labeled in vials loaded in bins prior to the time that an employee filled a specific prescription. The bins were labeled with the name of the medication and the number of pills. However, the vials did not contain a label stating the strength of the drug, dosage form, manufacturer's lot number or control number, and expiration date as required in Section 499.006(3) and Rule 64F-12.006(1). The standard of care is that the vials must be labeled with the requisite information before filling the vial rather than afterward. The potential for harm from mislabeled drugs is great. It is unsafe and dangerous to keep unlabeled prescription vials containing medications. However, the evidence is not clear and convincing that any actual harm occurred. No finding is made concerning the grounds alleged in paragraph 7. If the facts expressly alleged in paragraph seven were proven, those grounds would not prove any of the remaining charges. Paragraph 7 alleges virtually every fact related to the misuse of a Kirby-Lester machine except that Respondents actually misused the machine by not cleaning it after counting one type of medication and before counting a different type of medication. The allegation is that contamination can occur if the machine is not cleaned between medications. Paragraph 7 does not allege that any member of the inspection team observed Respondents using the machine to count different medications without cleaning the machine between medications. The trier of fact cannot draw an inference that facts not expressly stated were intended to be alleged. The allegation must appear in the plain language of the paragraph. Petitioner failed to prove the grounds alleged in paragraph 8. The evidence is less than clear and convincing that Respondents prepared, packaged, or held drugs under conditions that could contaminate the drugs with filth or render the drugs injurious to health. The evidence is less than clear and convincing that the drugs and drug packaging material referred to in the allegation were part of the dispensing process. The materials were being held for return to the manufacturer. Petitioner submitted no evidence showing that Respondents used the empty vials or vial tops to package medications or that Respondents actually dispensed pills that had been dropped on the floor. The evidence of Gordon's personal conduct concerning the alleged grounds is less than clear and convincing. The evidence does not show that the acts or omissions occurred in a persistent and practiced manner. The evidence is less than clear and convincing that Rx operated an unsanitary, unsafe, or unclean pharmacy or that Gordon managed such a pharmacy. It is reasonable for a busy pharmacy to accumulate debris and clutter on the floor in the course of a busy day. Routine clutter does not render a pharmacy unsafe, unclean, or unsanitary. Petitioner proved the allegation in paragraph 9 that unnamed employees at Rx received approximately 764 prescriptions on October 5, 2001, and that the prescriptions were not signed. Petitioner failed to prove that the prescriptions were written and required by law to be signed. The unsigned documents are not prescriptions within the meaning of Section 893.02(20). They are the written record of prescriptions that are transmitted electronically over the Internet. Paragraph 9 refers to Rule 64B8-9.012(4). That rule is promulgated by the Board of Medicine and applies to physicians. Respondents are not physicians. Petitioner proved part of the grounds alleged in Paragraph 10 but failed to prove a material ground. No finding is made regarding the remaining ground. Petitioner proved that Section 893.02(20) contains the provision quoted in paragraph 10. For reasons stated in paragraphs 9 through 11 of the Findings of Fact, evidence of the basis upon which the prescribing physicians ordered medications is less than clear and convincing. No finding is made concerning the allegation that "many of these . . . controlled substances . . . were prescribed. . . ." The prescribing physicians did not testify, and Respondents do not prescribe medications. Respondents fill prescriptions and dispense medications. No finding is made concerning paragraph 11. Paragraph 11 does not allege that Respondents committed any specific act or omission. Paragraph 11 recites Section 465.003(14). No finding is made concerning paragraphs 12 and 13. The grounds alleged in both paragraphs pertain to physicians rather than pharmacists. In relevant part, paragraph 14 alleges: Accordingly, Respondent is dispensing obesity medications prescribed without benefit of a valid patient/physician relationship in violation of Section 465.016(1)(i). . . For purposes of Section 465.016(1)(i) . . ., it shall be legally presumed that the . . . dispensing of . . . drugs in excessive or inappropriate quantities is not in . . . the course of the professional practice of pharmacy. Also, the practice constitutes violations of sections 894.04(1) and 893.02(20). . . for dispensing controlled substances outside the course of the professional practice of pharmacy by failing to determine whether the prescriptions were issued pursuant to a valid patient/physician relationship, and by failing to determine that the drugs so ordered are considered necessary for the continuation of treatment of a chronic or recurrent illness. (emphasis supplied) Paragraph 14 charges that Respondents violated the referenced statutes based on antecedent facts alleged in paragraphs 9 through 13 and incorporated by reference through terms such as "accordingly" and "the practice." Related counts in paragraphs 66-88 or 90 contain substantially similar charges based on facts alleged in paragraphs 1-65. The charges in paragraph 14 and related counts are read together to include relevant factual allegations in paragraphs 1-65. Section 893.02(20), in relevant part, requires a pharmacist to determine whether prescriptions from a physician licensed in a state other than Florida are issued pursuant to a valid patient-physician relationship, are authentic, and are necessary for the continuation of treatment of a chronic or recurrent illness (the validity test). The terms of the validity test are susceptible to different interpretations. The validity test could be construed to require a pharmacist to determine whether the physician considers the patient-physician relationship to be valid, the prescription authentic, and the drugs necessary. Alternatively, the validity test could require the pharmacist to substitute the pharmacist's judgment for that of the physician. The ALJ has determined that any ambiguity in the terms of the validity test must be construed in favor of Respondents and against the imposition of discipline. The ALJ has also determined that a requirement for a pharmacist to substitute her or his judgment to determine the medical necessity of medication may, in some cases, require the licensee to practice medicine. Respondents exercise reasonable care to ensure that the validity test has been satisfied, when applicable, by requiring the prescribing physician to sign a written verification of the prescriptions ordered by that physician. Respondents do not fill any prescription before Respondents receive a "site fill list" or "daily log" signed by the prescribing physician to verify the authenticity of the prescription, the validity of the patient-physician relationship, and the medical necessity of the medication. If pharmacists were required to substitute their judgment for that of prescribing physicians, the standards for exercising that judgment are less than clear and convincing. The requirement for a licensee to determine the validity of the patient-physician relationship applies only if the physician is licensed in a state other than Florida. Standards used to determine the validity of a patient-physician relationship vary from state to state. Clear and convincing evidence does not indicate whether a Florida pharmacist must apply Florida law to make the necessary determination or must apply the law of the state where the prescribing physician is licensed. Petitioner relies on an unwritten agency statement by the Board of Pharmacy to explicate the standards that pharmacists must use in determining the validity of a patient- physician relationship. The agency statement requires licensees to determine whether a prescribing physician, licensed in any state including Florida, has conducted an in-person examination of the patient prior to prescribing a medication. The agency statement holds that the absence of an in-person examination renders the prescription invalid. Findings pertaining to the agency statement are discussed further in the Conclusion of Law because continuity requires a simultaneous discussion of both findings of fact and conclusions of law. The charge in paragraph 14 that Respondents dispense excessive or inappropriate quantities of legend drugs is equivalent to charges in Count Two against Rx and Count Four against Gordon. Facts relevant to those charges are alleged in paragraphs 9, 15, 16, 17, and 20 through 22 of the Administrative Complaints. Paragraphs 25, 26, and 29 in the Administrative Complaint against Rx allege additional relevant facts, as do paragraphs 26, 27, and 30 in the Administrative Complaint against Gordon. In relevant part, paragraph 9 alleges that on October 5, 2001, Respondents received 764 prescriptions from three physicians identified in the record as Drs. Rosenkrantz, Rivera, and Thompson. Paragraphs 15 through 17 allege that two drugs marketed under the names Phentermine and Bontril are controlled substances that have a high potential for abuse. Respondents stipulated to paragraphs 15 through 17. Paragraph 20 alleges that many of the controlled substances are for a three-months' supply per purchase. Paragraph 21 alleges that the PDR states that tolerance for the anorectic effect of many obesity drugs occurs after a "few weeks," and that the drug should be discontinued at that time rather than increased to overcome tolerance. Paragraph 22 alleges that Respondents filled hundreds of prescriptions for obesity drugs each day included in the business practices described in paragraphs 1 through 21. The business practices described in paragraphs 1 through 21 are for the dates that occurred from October 5 through 18, 2001. Paragraphs 25 and 26 pertaining to Rx, and paragraphs 26 and 27, pertaining to Gordon, allege that Petitioner's investigator obtained the written record of additional prescriptions when an employee for Rx produced the documents on October 24, 2001. Paragraph 29, pertaining to Rx, and paragraph 30, pertaining to Gordon, allege that the computer operated by Rx showed that Rx and its employees dispensed 17,410 tablets of Phentermine on December 5, 2001; and that a daily log dated September 4, 2001, showed that Rx employees received 300 prescriptions from Dr. Rivera. The facts alleged to support the charges of dispensing excessive or inappropriate quantities of legend drugs involve dates from September 4 through December 6, 2001 (the relevant period). Within the relevant period, the enumerated paragraphs together allege that Rx and Gordon dispensed excessive and inappropriate quantities of legend drugs including: hundreds each day; 17,410 tablets on December 5, 2001; and 300 from Dr. Rivera on September 4, 2001. The relevant paragraphs also allege that many of the legend drugs were obesity drugs such as Bontril and Phentermine; and that many drugs were dispensed pursuant to prescriptions for 90 days' supply per purchase. The relevant paragraphs further allege methods of proof, including documents received on October 24, 2001, provisions of the PDR, and documents collected by the inspectors. The evidence is less than clear and convincing that Gordon personally dispensed drugs during the relevant period. There is insufficient evidence, or allegations, to show when Gordon was present at the pharmacy, for how long, or if her duties required her to fill prescriptions and dispense drugs. The evidence is less than clear and convincing that Gordon is vicariously responsible for drugs that others dispensed during the relevant period. Although the evidence is clear that drugs were dispensed in a persistent and practiced manner, there is insufficient evidence for the trier of fact to draw an inference that Gordon was vicariously responsible. Petitioner did not prove that Gordon was the only manager during the relevant period. Paragraph 5 of the Administrative Complaints alleges that, on October 18, 2001, Gordon identified another person present at the pharmacy as the owner. The next allegations concerning Gordon's management control over pharmacy operations pertain to the inspection conducted on January 31, 2002. The allegations and evidence are insufficient to differentiate the duties of Gordon and others with management control. The evidence is insufficient to show which days various managers were present, what specific duties each performed, and how the managers allocated management responsibilities among themselves. The evidence is less than clear and convincing that Gordon had any management control over those who dispensed medications during the relevant period. There is no doubt that Rx dispensed large quantities of medication during the relevant period. Employees at Rx dispensed approximately 1,942 legend drugs during the relevant period. That is a practiced and persistent manner of dispensing drugs regardless of which employees dispensed the drugs. Large quantities of drugs are not necessarily excessive or inappropriate quantities. Petitioner stipulated during the hearing that a determination of whether quantities are excessive or inappropriate must be made "per patient" and not by reference to the pharmacy. The evidence of prescriptions filled by Rx consists of Petitioner's Exhibits 59, 62, 63, 76, 77, 87, 88, 90, 92, and 94 (P59, P62, etc.). The prescriptions were filled from January 11, 2001, through April 26, 2002. Prescriptions evidenced in P87, P88, and P92 are outside the relevant period. Of the remaining prescriptions, the prescriptions that are essential to the opinion of Petitioner's expert are set forth in P94. That exhibit consists of a Site Fill List, or daily log, maintained by Rx for the period from September 4 through October 10, 2001. Petitioner's expert identified 102 instances in P94 in which he opined that medications were dispensed to individual patients in excessive or inappropriate quantities. The instances relied on by Petitioner's expert may be fairly summarized as follows: Item Date Patient Drug Dose/Quantity 1. 9/20 L.A. Phentermine(P) 30mg/30 2. 9/20 L.A. P 30mg/30 3. 9/20 L.W. P 30mg/90 4. 9/20 L.W. Meridia (M) 15mg/90 5. 9/4 K.Co. Diethylpropion(DP) 75mg/90 6. 9/4 K.Cu P 30mg/90 7. 9/10 A.J. Adipex (A) 37.5mg/90 8. 9/10 A.J. Didrex (D) 50mg/30 9. 9/10 A.J. Adipex (A) 37.5mg/90 10. 9/10 A.J. Didrex (D) 50mg/30 11. 9/11 D.B. Bontril (B) 105mg/90 12. 10/2 D.B. B 105mg/90 13. 10/2 K.Sg. P 15mg/90 14. 10/1 K.Sg. P 30mg/90 15. 9/4 I.To. P 30mg/30 16. 9/26 I.To. P 37.5mg/90 17. 10/1 I.Tr. A 37.5mg/90 18. 10/5 I.Tr. A 37.5mg/90 19. 10/3 I.Tr. Celebrex 200mg/50 20. 10/5 I.Tr. Xenical 120mg/270 21. 9/10 D.Ha. A 37.5mg/90 Item Date Patient Drug Dose/Quantity 22. 9/6 D.Ha. P 30mg/90 23. 10/10 J.H. M 10mg/30 24. 10/5 J.H. P 30mg/90 25. 9/6 D.Ht. D 50mg/30 26. 9/7 D.Ht. D 30mg/30 27. 9/28 L.M. Viagra 100mg/30 28. 9/28 L.M. Viagra 100mg/30 29. 9/5 J.S. P 30mg/30 30. 9/24 J.S. P 30mg/30 31. 10/1 J.S. P 30mg/90 32. 9/25 Z.H. P 30mg/30 33. 9/25 Z.H. P 30mg/30 34. 9/5 D.I. A 37.5mg/30 35. 9/6 D.I. A 37.5mg/30 36. 10/10 L.Z. D 50mg/90 37. 10/8 L.Z. P 30mg/90 38. 9/17 T.W. A 37.5mg/30 39. 9/14 T.W. P 37.5mg/90 40. 9/20 L.A. P 30mg/30 41. 9/20 L.A. P 30mg/30 42. 9/17 A.E. P 30mg/30 43. 9/24 A.E. P 30mg/90 44. 9/27 D.P. A 37.5mg/90 45. 9/26 D.P. P 30mg/90 46. 10/5 K.Sh. A 37.5mg/30 47. 10/5 K.Sh. P 37.5mg/30 48. 10/5 P.S. P 30mg/90 49. 9/27 P.S. P 37.5mg/30 50. 9/10 M.F. P 30mg/90 51. 9/10 M.F. P 30mg/90 52. 9/24 A.G. A 37.5mg/30 53. 9/6 A.G. B 105mg/30 54. 9/4 B.A. DP 75mg/30 55. 9/4 B.A. DP 75mg/30 56. 9/17 M.S. P 37.5mg/90 57. 9/20 M.S. P 37.5mg/90 58. 10/9 V.S. P 30mg/90 59. 9/24 V.S. P 37.5mg/90 60. 9/17 D.Cd. P 37.5mg/90 61. 9/4 D.Cf. P 37.5/90 62. 9/26 J.Ws. P 30mg/90 63. 9/27 J.Ws. P 37.5mg/90 64. 9/25 R.R. B 105mg/30 65. 9/24 R.R. B 105mg/90 66. 9/10 A.J. A 37.5mg/90 Item Date Patient Drug Dose/Quantity 67. 9/10 A.J. D 50mg/30 68. 9/28 K.J. P 30mg/90 69. 10/1 K.J. P 30mg/90 70. 9/12 S.F. P 30mg/30 71. 9/12 S.F. P 30mg/30 72. 10/3 S.F. P 30mg/30 73. 10/3 D.M. A 37.5mg/30 74. 10/5 D.M. A 37.5mg/30 75. 9/14 P.G. DP 75mg/30 76. 9/14 P.G. DP 75mg/90 77. 9/17 M.I. P 30mg/30 78. 9/21 M.I. P 30mg/90 79. 9/19 T.H. Viagra 100mg/20 80. 9/18 T.H. Viagra 100mg/30 81. 9/12 C.C. Ionamin (I) 30mg/90 82. 9/5 C.C. P 37.5mg/30 83. 9/21 M.P. D 50mg/30 84. 9/25 M.P. D 50mg/90 85. 9/4 K.H. A 37.5mg/30 86. 9/28 K.H. A 37.5mg/30 87. 10/10 K.H. A 37.5mg/30 88. 10/3 A.C. Viagra 100mg/10 89. 10/3 A.C. Viagra 100mg/10 90. 9/24 K.K. P 37.5mg/30 91. 10/2 K.K. P 37.5mg/90 92. 9/6 J.Wi. A 37.5mg/30 93. 9/19 J.Wi. D 37.5mg/30 94. 9/5 T.W. A 37.5mg/30 95. 9/19 T.W. A 37.5mg/30 96. 10/8 T.W. A 37.5mg/30 97. 9/28 A.M. P 30mg/30 98. 10/9 A.M. P 30mg/30 99. 9/17 S.K. Viagra 100mg/10 100. 9/17 S.K. Viagra 100mg/10 101. 10/5 C.K. Ultram 50mg/30 102. 10/8 C.K. ULtram 50mg/90 The appropriateness of a quantity of medication is determined by reference to the medical profile of a particular patient. The evidence is less than clear and convincing that the quantities of dispensed medication were inappropriate. Evidence and allegations concerning patient profiles are inconsistent. Petitioner alleges in its complaints that information in patient profiles provided an insufficient basis for the prescribing physician to order medication. However, witnesses for Petitioner opined that Respondents deviated from the professional practice of pharmacy by failing to consult the profiles. The necessary implication is that the profiles contained sufficient medical information for Respondents to consult before dispensing medication. There would be no rational reason to consult an invalid patient profile. Other evidence suggests the patient profiles contain insufficient medical information. The apparent inconsistency was confusing, contributed to a hesitance in the mind of the trier of fact that either proposition was true, and eroded the credibility of expert testimony that Rx employees dispensed medication in inappropriate quantities to particular patients. A medication is dispensed in an excessive quantity if the quantity dispensed exceeds the maximum recommended quantity for the medication. Petitioner cited no statute or rule that defines the term "quantity." The plain and ordinary meaning of the "quantity" of a drug is the "measurable [or] countable . . . property" of the drug. The American Heritage Dictionary of the English Language, 1432 (4th ed. 2000). The trier of fact measured the total medication dispensed pursuant to a single prescription by the total milligrams of medication dispensed. Rx employees dispensed obesity drugs evidenced in P94 in the form of pills. The total medication dispensed by pill is a mathematical product equal to the strength of each pill multiplied by the number of pills, including refills. The evidence is less than clear and convincing that prescriptions in P94 included refills. Petitioner cited no statute or rule that identifies the maximum recommended quantity for the obesity drugs at issue. Rather, a combination of expert testimony and the maximum strengths evidenced in P94 establish a maximum recommended quantity for the obesity drugs at issue. The trier of fact determined that obesity drugs in P94 were dispensed in excessive quantities if the total medication dispensed to a patient within 90 days exceeded the total medication in 90 pills, at the maximum strength for each pill, taken once a day for 90 days (the 90-day standard). Evidence of which obesity drugs have a lower quantity standard is less than clear and convincing. It is clear, however, that any of the obesity drugs in P94 are dispensed in excessive quantities if the total dispensed medication exceeds the total medication in the 90-day standard. The evidence is less than clear and convincing that the total dispensed medication was excessive in item numbers 1, 2, 7 through 10, 40, 41, 66, and 67. Items 1, 2, 40, and 41 may be duplicates as may be the case for items 8, 10, and 67; and 7, 9, and 66. The trier of fact has sufficient doubt as to whether the opinions based on the enumerated items are true. The evidence is less than clear and convincing that the total dispensed medication was excessive in items 19, 20, 27, 28, 79, 80, 88, 89, and 99 through 102. Those items show that the medications are not obesity drugs. Evidence of the quantity standards for legend drugs other than obesity drugs is less than clear and convincing. The evidence is less than clear and convincing that total dispensed medication was excessive in connection with items 5, 6, 25 and 26, 32 through 35, 46 and 47, 52 through 55, 60, 61, 70 through 74, 85 through 87, and 92 through 98. Patient names in items 5 and 6 and 60 and 61 are different. Where patient names are the same for two prescriptions, the total medication dispensed pursuant to both prescriptions does not exceed the 90-day standard. The evidence is clear and convincing that the total dispensed obesity medication exceeded the 90-day standard in several instances. Those instances are evidenced in items 3 and 4, 11 through 18, 21 through 24, 29 through 31, 36 through 39, 42 through 45, 48 through 51, 56 through 59, 62 through 65, 68 and 69, 75 through 78, 81 through 84, and 90 and 91. Neither the strength of each pill nor the number of pills dispensed pursuant to a single prescription caused total dispensed medication to exceed the total medication in the 90- day standard. Total dispensed medication generally exceeded total medication in the 90-day standard when employees dispensed an obesity drug to a patient pursuant to a second prescription within 90 days of the first. In items 29 through 31, however, the excess occurred when obesity drugs were dispensed pursuant to a third prescription in item 31 within 90 days of the first two prescriptions in items 29 and 30. Therefore, the 49 items enumerated in the preceding paragraph evidence only 24 instances of excessive quantities of obesity drugs. The total dispensed medication exceeded the total medication in the 90-day standard in three types of fact patterns. In one fact pattern, Rx employees dispensed the same brand name obesity drug to a patient at the maximum strength pursuant to two prescriptions within 90 days. In item 11, for example, Rx employees dispensed 90 pills of Bontril at the maximum strength of 105 milligrams per pill. In item 12, they dispensed the same quantity approximately 22 days later. The total dispensed medication within 90 days is equal to the product of 180 pills multiplied by 105 milligrams, or 18,900 milligrams. The total medication in the 90-day standard is 90 pills at 105 milligrams, or 9,450 milligrams. The excessive quantity is the excess of the dispensed medication (18,900) over the medication in the 90-day standard (9,450). The excessive quantity evidenced in items 11 and 12 is 9,450 milligrams. By similar calculations, the excessive quantity in items 56 and 57 is 3,375 milligrams. The excessive quantity in items 64 and 65 is 3,150 milligrams. In items 75 and 76, 83 and 84, and 90 and 91, the excessive quantities are 2,250, 1,500, and 1,125 milligrams, respectively. In the second fact pattern, Rx employees dispensed the same brand name obesity drug to a patient at less than the maximum strength pursuant to two or more prescriptions within 90 days. In item 14, for example, Rx employees dispensed 90 pills of Phentermine at a strength of 30 milligrams per pill. In item 13, they dispensed 90 pills of the same drug the next day at 15 milligrams per pill. The total medication dispensed within 90 days is equal to the sum of the total milligrams dispensed in each instance, or 4,050 milligrams. The total medication in the 90-day standard is 90 pills at 37.5 milligrams, or 3,375 milligrams. The excessive quantity is the excess of the dispensed medication (4,050) over the medication in the 90-day standard (3,375). The excessive quantity evidenced in items 13 and 14 is 675 milligrams. By similar calculations, the excessive quantities in items 15 and 16, 29 through 31, 42 and 43, 48 and 49, 50 and 51, 58 and 59, 62 and 63, 68 and 69, and 77 and 78, respectively, are 900, 1,125, 225, 450, 2,025, 2,700, 2,700, 2,025, and 225 milligrams. In the third fact pattern, Rx employees dispensed different brand name obesity drugs in different strengths pursuant to two prescriptions within 90 days. In item 3, for example, Rx employees dispensed 90 pills of Phentermine at 30 milligrams per pill. In item 4, they dispensed 90 pills of Meridia on the same day at 15 milligrams per pill. The total medication dispensed within 90 days is equal to the sum of the milligrams dispensed in each instance, or 4,050 milligrams. The total medication in the 90-day standard is 90 pills at 37.5 milligrams, or 3,375 milligrams. The excessive quantity is the excess of the dispensed medication (4,050) over the medication in the 90-day standard (3,375), or 675 milligrams. By similar calculations, the excessive quantities in items 21 through 24, 36 through 39, 44 and 45, and 80 and 81, respectively, are 2,975, 1,575, 2,700, and 450 milligrams. Rx employees dispensed obesity drugs in the three fact patterns just discussed in an aggregate excessive quantity of 42,275 milligrams. The average excessive quantity for each of the 24 instances found in P94 is 1,761 milligrams. The average excess quantity correlates to a 90-day excess of approximately 17 pills at a maximum strength of 105 milligrams, 23 pills at 75 milligrams, 35 pills at 50 milligrams, 47 pills at 37.5 milligrams, and 117 pills at 15 milligrams. The ALJ has concluded that Section 465.016(1)(i) creates a legal presumption that the excessive quantities of obesity drugs dispensed by Rx employees were not dispensed in the course of the practice of pharmacy. Rx did not rebut the statutory presumption with persuasive evidence that explains the quantities of medications dispensed or rebuts the quantity standards in evidence. Respondents' expert relied on substantially the same evidence as that relied on by Petitioner's expert and opined that Respondents dispensed medication in accordance with the professional practice of pharmacy. However, that opinion was an ultimate conclusion that was not fact specific and did not cast doubt on the details that gave rise to the statutory presumption. That opinion was not persuasive. Rx argues that Petitioner did not show that the prescriptions were actually filled, did not sufficiently identify the patients, and did not show that the patients actually received the medications. Those arguments are neither credible nor persuasive. They do not create a hesitance in the mind of the trier of fact concerning the details supporting the statutory presumption. Information in P94 is part of the QS1 system. The instances of excessive quantities of medications provide a sufficient basis for the trier of fact to find that Rx is vicariously liable for Rx employees who dispensed obesity drugs in excessive quantities in the 24 instances evidenced in P94. The instances are not isolated events. During the 26 days evidenced in P94, the 24 instances of excessive quantities occurred, on average, almost once a day. That evidence shows that Rx employees dispensed excessive quantities of obesity drugs in a persistent and practiced manner. Rx did not require its employees to comply with the standard of conduct evidenced in expert testimony. In the absence of an adequate alternative, Rx employees must personally review site fill lists to ensure that quantities are not excessive. Rx employees do not personally review site fill lists. Rather, Rx permits its employees to rely on the QS1 computer system for that and other purposes. Reliance on the QS1 computer system was reasonable and was made in good faith. The QS1 is a computer system commonly utilized by pharmacies. The system maintains inventory, patient profiles, and patient addresses and phone numbers. The QS1 system enables Rx to capture and monitor patient profiles in dispensing medications. The evidence is less than clear and convincing that the information in the patient profiles is inaccurate or inadequate. Rx employees enter a prescription into the QS1 system and then retrieve the prescribed medication from inventory. If the medication has not been pre-packed, the employee counts the medication and places it in a vial. If the medication has been pre-packed, Rx labels the medication. The QS1 system alerts Rx employees to any particular problems that a patient may have as a result of the prescribed medication. If an Rx employee receives an alert, she or he reviews the patient profile and resolves the problem. Once the prescription is prepared for dispensing, Rx pharmacists compare the prescription with the vial label to ensure accuracy. Rx employees then place the medication in an envelope for shipping but do not actually ship the medication until they receive a signed copy of the daily log from the prescribing physician verifying that the physician has not prescribed medication in excessive quantities. The daily log is not a prescription but is an extra step taken by Rx to ensure the accuracy of the order for medication. The QS1 system performed its purpose well when measured by statistical standards. There are approximately 1,942 prescriptions listed in P94. Only 24 of those were for excessive quantities of obesity drugs. The QS1 system achieved an error rate of approximately 1.23 percent. That rate of error, however, produced excessive quantities of medication almost once a day for 26 days. Rx relied on the QS1 system in filling approximately 154,773 prescriptions between October 19, 2001, and April 26, 2002. If the QS1 system were to maintain an error rate of 1.23 percent during that period, the mathematical probability is that Rx would have dispensed excessive quantities of medication in 1,903 instances over approximately 190 days for an average of approximately 10 instances a day. If the excess quantity in each instance were equal to 1,761 milligrams, according to the average determined in paragraph 76 of the Findings of Fact, Rx would have dispensed 17,644 milligrams of excess medication each day and 3,352,429 milligrams of excess medication in 190 days. An error rate of 1.23 percent represents a significant potential for harm. However, the evidence of actual harm is less than clear and convincing. Rx dispensed excessive quantities of obesity drugs in 24 instances evidenced in P94. Rx dispensed the medication irrespective of whether the patients actually received it. Receipt is a relevant inquiry to determine harm to an identified recipient. Receipt does not determine whether Rx employees dispensed obesity drugs from the pharmacy. The grounds alleged in paragraphs 15 through 17 are not disputed. Paragraph 18 alleges, in relevant part: The concept of dispensing . . . scheduled drugs by permitting them to be specifically requested and 'ordered' over the internet is a potentially dangerous method of allowing . . . medications to be 'taken on the user's own initiative rather than on the basis of professional medical advice. ' Dispensing controlled . . . drugs in this manner by Respondent[s] runs contrary to the spirit, intent, and purpose of chapter 893 with regard to protecting the safety of the public. (emphasis supplied) No findings are made concerning the grounds alleged in paragraph 18. The trier of fact cannot discern what specific acts or omissions paragraph 18 alleges. Paragraph 18 implies that Respondents somehow transformed a "concept" into a "method" but does not allege any specific acts or omissions by which Respondents effectuated the transformation. Paragraph 18 is devoid of patient names, dates, specific transactions, details, and other allegations of essential facts. Several allegations in paragraphs 19 through 21 concern the "Physician's Desk Reference" (PDR). Other than those findings already made, the trier of fact is uncertain what Petitioner intends to allege in paragraphs 19 through 21. The PDR is a method of proving a fact not alleged. Evidence of the legal effect of the PDR in this proceeding is less than clear and convincing. Petitioner failed to sufficiently evidence the specific standards allegedly enunciated in the PDR. The allegation is that the PDR states that obesity drugs should be discontinued within a "few weeks." Petitioner failed to define a "few weeks" with clear and convincing evidence as any period less than 90 days. The remaining grounds alleged in paragraphs 19 through 21 recite or paraphrase provisions of the PDR. No further findings are made concerning paragraphs 19 through 21. Petitioner proved the allegation in paragraph 22 that Rx dispensed hundreds of medications each day from October 5 through 18, 2001. Petitioner did not prove the remaining grounds alleged in paragraph 22. For reasons stated in paragraphs 9 through 11 of the Findings of Fact, evidence of the allegation in paragraph 22 that prescribing physicians wrote and submitted prescriptions based solely on information received from Internet questionnaires is less than clear and convincing. Information included in the Internet questionnaires is not established by the requisite standard of proof. No finding is made concerning the grounds alleged against Rx in paragraphs 23 through 24 or those alleged against Gordon in paragraphs 23 through 25. Petitioner concedes in its PRO at pages 27 through 28 that Petitioner did not prove grounds supporting the charges that: Respondents failed to report violators to Petitioner; and used USAP to promote or advertise the use or sale of controlled substances. Petitioner proved the grounds alleged against Rx in paragraphs 25 and 26 and those alleged against Gordon in paragraphs 26 and 27. Respondents produced the written record of prescriptions requested by the inspector. Respondents conferred with their attorney before producing the documents. The grounds alleged in paragraphs 27 through 36 against Rx and in paragraphs 28 through 37 against Gordon pertain to an inspection conducted by Petitioner on December 6, 2001. Petitioner proved some of the grounds alleged against Rx in paragraphs 27 and 28 and some of those alleged against Gordon in paragraphs 28 and 29. The evidence shows that Gordon was not present at the pharmacy during the inspection on December 6, 2001. The evidence is less than clear and convincing that Gordon worked at the pharmacy that day. The evidence is insufficient to prove that Gordon committed the acts or omissions alleged in paragraphs 28 through 31 or that the acts or omissions of others were so persistent and practiced during that period that Gordon was vicariously responsible for their acts or omissions. Petitioner proved some of the grounds alleged against Rx in paragraph 27. When the inspector first arrived, two technicians and an administrator were visible to the inspector. Two pharmacists greeted the inspector within 15 minutes of his arrival at Rx. No sign was posted that the pharmacists were out to lunch or on break. The evidence is less than clear and convincing that both pharmacists were out to lunch or on break. One of the pharmacists may have been in the bathroom or otherwise available for questions from technicians. Respondents argued during the hearing that legislation identified in the record as the "potty bill" carves out an exception to the requirement to post a sign when a pharmacist goes to the bathroom. Although the argument does not evidence the "potty bill," the argument creates sufficient doubt in the mind of the trier of fact concerning the issue of whether both pharmacists were out to lunch. Evidence of the whereabouts of the second pharmacist is less than clear and convincing. Evidence defining the term "[l]ater" is less than clear and convincing. Petitioner failed to prove the allegations in paragraph 28 that a technician was working "alone" or was "unsupervised." If it were found that Rx committed the charged violation, there would be no potential or actual harm. The requirement for a sign has little meaning for an Internet pharmacy such as Rx. The testimony of several witnesses for Petitioner makes clear that Rx is not open to patients who physically walk into the pharmacy and present written prescriptions. The front door is frequently locked. At least one investigator had to knock on the front door to gain access. Patients who fill their prescriptions at Rx "walk in" electronically and are unable to read any sign posted inside the pharmacy. The only persons who would benefit from such a sign would be those employed at the pharmacy. More likely than not, Rx employees do not need a sign to tell them a pharmacist is not in the same room with them. The evidence is less than clear and convincing that Rx employees failed to properly label drugs on December 6, 2001. The plain terms of paragraph 28 admit that Rx complied with all but one of the labeling requirements in Rule 64F-12.006(1)(a) by ensuring that its employees place pills in vials labeled with all of the requisite information except dosage form. The evidence is less than clear and convincing that the labels did not include dosage form. The evidence is less than clear and convincing that Rx placed the labeled vials with "unsigned prescriptions." Rather, the preponderance of evidence shows that the unsigned documents are the written record of electronic prescriptions and not unsigned written prescriptions. Petitioner proved the allegations against Rx in paragraph 29. The dates alleged in paragraph 29 are included in previous findings that Rx dispenses large numbers of medications ordered by Drs. Rosenkrantz, Rivera, and Thompson. Petitioner did not prove substantially similar allegations against Gordon in paragraph 30. Petitioner did not prove the allegations in paragraph 30 and 31 that Rx and Gordon knowingly possessed mislabeled drugs. The evidence is less than clear and convincing that Rx employees possessed mislabeled drugs or, if so, that Rx or Gordon are vicariously responsible for that deficiency. The grounds alleged to have occurred on December 6, 2001, are not supported by the quantum or quality of evidence that supports the finding of mislabeled drugs on October 18, 2001. Evidence of grounds arising from the inspection on December 6, 2001, primarily consists of the testimony of one inspector and three exhibits. The photographs in evidence pertain to the inspection conducted on October 18, 2001. Petitioner's experts relied on those photographs, in relevant part, in rendering their opinions concerning allegations that Rx knowingly possessed mislabeled drugs. Expert opinions are unnecessary to assist the trier of fact in determining whether Rx possessed mislabeled drugs on any date. The trier of fact is capable of making that determination based on the standards enunciated in the applicable rules, the testimony of the fact witnesses, and the pictures and documents that support their testimony. Grounds alleged against Rx in paragraphs 31-36, and those alleged against Gordon in paragraphs 32-37, arise from a re-inspection conducted on January 31, 2002. Like the evidence pertaining to the inspection on December 6, 2001, grounds arising from the inspection on January 31, 2002, are not supported by the quantum or quality of evidence that supports the inspection of October 18, 2001. Petitioner must prove the grounds arising from each inspection by clear and convincing evidence. The trier of fact cannot draw an inference from the findings pertaining to October 18, 2001, to bolster the evidence submitted for the other inspections. If it were found that evidence concerning each inspection satisfied the clear and convincing standard of proof, it would be appropriate for the trier of fact to consider all of the inspections in determining whether the alleged deficiencies were so persistent and practiced that they supported an inference of vicarious responsibility. The evidence is less than clear and convincing that the alleged grounds arising from the inspection on January 31, 2002, are true. The preponderance of evidence shows a bin containing unlabeled vials of medication was on top of a counter on one side of a room in the pharmacy. On the other side of the room, all of the medication vials and bins were labeled. The medication in the bin by itself was separated from medication in the pharmacy's active stock. Bins of medication containing active stock were labeled. It is unlikely the separated medication would be inadvertently dispensed. Medication in the separated bin was not labeled because it was being returned to the manufacturer. Respondents did not hold medication in the separated bin to be dispensed. The grounds alleged against Rx in paragraphs 37 through 65 and against Gordon in paragraphs 38 through 65 pertain to complaints filed by T.M. and J.W. For convenience, a finding pertaining to the cited paragraphs may contain references to more than one paragraph. References to a lower numbered paragraph, or group of paragraphs, refer to the grounds alleged against Rx. References to a higher numbered paragraph, or group of paragraphs, refer to grounds alleged against Gordon. Petitioner proved the grounds alleged in paragraphs 37 (against Rx) and 38 (against Gordon). Petitioner proved some of the grounds alleged in paragraphs 38 through 48 and 39 through 49 and portions of the grounds alleged against Rx in paragraph 52. On October 21, 2001, T.M. opened an e-mail from USAP and responded with information about her. T.M. purchased 90 tablets of Phentermine and paid $169 to USAP by credit card. T.M. subsequently returned the medication and received a refund. T.M. received the medication by overnight delivery. The vial label indicated Rx dispensed the medication. The label listed Dr. Rivera as the prescribing physician. T.M. never saw Dr. Rivera or heard of Rx or Gordon before receiving the medication. T.M. did not choose Rx as a pharmacy and did not choose Gordon as a pharmacist. T.M. attempted to return the medication for a refund. T.M. spoke by telephone to a representative of USAP. The representative denied T.M.'s request for refund. T.M. telephoned Rx at the number provided on the prescription label. T.M. spoke to a female who identified herself as a pharmacist and answered with a heavy accent. It is not clear that Gordon has a heavy accent. T.M. had no technical questions of the medication dispensed by Rx. The pharmacist stated that she could not help T.M. with her refund and referred T.M. back to USAP. The remaining testimony of T.M. is less than clear and convincing. On cross examination, T.M. distinctly recalled few, if any, facts. Her testimony was neither precise nor specific. T.M. was confused as to material facts in issue. Petitioner failed to prove the remaining grounds alleged in paragraphs 38 through 48 and 39 through 49. The ALJ ruled that evidence of the statements made in the USAP website is hearsay and that Sections 120.57(1)(c) and (l) prohibit the trier of fact from basing a finding on anything less than competent and substantial evidence. There is less than clear and convincing evidence that the website does not afford patients a choice in pharmacies. If it were found that the USAP website failed to offer a choice of pharmacies, the evidence is less than clear and convincing that Respondents knowingly participated in a system that does not afford a choice in pharmacies. USAP is located in the same building that Rx occupies at 5400 University Drive. Any further findings would require the fact-finder to draw an inference based on insufficient evidence. The evidence is less than clear and convincing that Rx controls the operations of USAP; that Rx and USAP are sibling or related companies, or share common officers, managers, directors, or employees; or that Rx has any legal or actual influence in the management or operation of USAP. The evidence is less than clear and convincing that Respondents had editorial control or input into the content and operation of the website used by USAP in the conduct of USAP's business; or that Respondents knew the content of the website. For similar reasons, evidence of the grounds alleged in paragraphs 53 through 65 concerning the content of the USAP website is less than clear and convincing. Petitioner failed to prove the grounds in paragraphs 43 and 44 alleging that the obesity medication prescription for T.M. was not written within the course of the professional practice of medicine. The prescriptions were not written. Petitioner failed to prove the grounds alleged in paragraphs 49 through 51 and 50 through 52. Operative terms in Section 893.02(20) apply to a pharmacist and not to a pharmacy. A pharmacist and a pharmacy are defined separately in Section 465.03(10) and (11). Section 893.02(20) does not require a pharmacy, including Rx, to make any determination regarding the validity test defined in paragraph 42 of the Findings of Fact. Section 893.02(20) requires Gordon to apply the validity test only if Gordon receives a prescription ordered by a physician licensed in a state other than Florida. While the statute necessarily requires Gordon to determine the state in which the prescribing physician is licensed before Gordon can know whether to apply the validity test, the evidence is less than clear and convincing that Gordon failed to perform her statutory duty. Petitioner did not submit any competent substantial evidence that Drs. Rosenkrantz, Rivera, and Thompson are licensed in a state other than Florida. Sufficient evidence of the statutory prerequisite to the charged violation is missing from the record. The prescriptions evidenced in P92 list a Florida address for Drs. Rosenkrantz and Rivera and a Missouri address for Dr. Thompson. It may be reasonable for the fact-finder to infer that the physicians are licensed in the state where they are located, but such an inference is less than clear and convincing. If Drs. Rosenkrantz and Rivera were licensed in Florida, Section 893.02(20) would impose no statutory duty on Gordon concerning their prescriptions. Dr. Thompson is not licensed in Florida. It is unclear that Dr. Thompson is licensed in a state other than Florida. Sufficient evidence of the statutory prerequisite to the charged violation is missing from the record. If it were found that Drs. Rosenkrantz, Rivera, and Thompson are licensed in a state other than Florida, the evidence is less than clear and convincing that Gordon failed to correctly apply the validity test prescribed in Section 893.02(20). Before employees of the pharmacy managed by Gordon dispensed any medications ordered by these physicians, the employees required each physician to sign a site fill list, or daily log, verifying the validity of the professional relationship, the authenticity of the prescription, and the medical necessity for the drugs. An unwritten agency statement prohibits Gordon from dispensing any controlled substance pursuant to a prescription transmitted by a physician who has not conducted an in-person examination of the patient. The unwritten agency statement requires Gordon to determine whether the physician has conducted an in-person examination regardless of the state in which the physician is licensed. It is clear from the record that Drs. Rosenkrantz, Rivera, and Thompson did not physically examine their patients prior to ordering the prescriptions evidenced in P92. Drs. Rosenkrantz, Rivera, and Thompson transmitted substantially all of the prescriptions evidenced in P92. The prescriptions list Florida addresses for Drs. Rosenkrantz and Rivera and a Missouri address for Dr. Thompson. The prescriptions are for patients located in more than 36 states and the District of Columbia. By negative proof, three prescribing physicians in Florida and Missouri could not have physically examined all of the patients in a single day. For purposes of continuity, further findings regarding the agency statement are made in the Conclusions of Law. Petitioner failed to prove the allegations in paragraphs 64 and 65 that Respondents engage in a fee splitting, commission, kickback, rebate, or split fee arrangement with USAP. Standards defining the prohibited arrangement are not defined clearly and convincingly. No evidence shows that Gordon receives anything from USAP or pays anything to USAP. Rx and USAP are located in the same building and maintain a business relationship. USAP pays Rx a fee for filling prescriptions plus any costs incurred by Rx. USAP pays Rx the costs of each prescription filled plus a fee of either $5 or $10 for each prescription. From October 19, 2001, through January 18, 2002, Rx filled approximately 66,217 prescriptions and billed USAP approximately $584,460 for fees, exclusive of costs. From January 25 through April 26, 2002, Rx filled approximately 88,556 prescriptions and billed USAP approximately $416,100 for fees, exclusive of costs. The evidence is less than clear and convincing that Rx paid any amount to USAP for referring patients to Rx or otherwise. The evidence is less than clear and convincing that USAP paid Rx for anything other than the costs incurred and services performed in filling prescriptions.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding Gordon not guilty of the allegations in the two administrative complaints against her; Rx guilty of violating Section 465.016(1)(i); imposing an administrative fine of $24,000 for the 24 instances of dispensing excessive quantities of controlled substances; placing Rx on probation for one year, subject to the condition that Rx utilize personal review or some other system adequate to prevent its employees from dispensing excessive quantities of controlled substances; and requiring Rx to pay the costs directly related to that part of the investigation and prosecution required to prove that Rx dispensed excessive quantities of controlled substances. DONE AND ENTERED this 10th day of January, 2003, in Tallahassee, Leon County, Florida. DANIEL MANRY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 10th day of January, 2003. COPIES FURNISHED: Rosanna M. Catalano, Esquire David Herman, Esquire John Raymaker, Esquire Bureau of Practitioner Regulation - Legal Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Sean M. Ellsworth, Esquire Mark A. Dresnick, Esquire Monica L. Felder, Esquire Dresnick, Ellsworth & Felder, P.A. 201 Alhambra Circle Sun Trust Plaza, Suite 701 Coral Gables, Florida 33134-5108 John Taylor, R.Ph., Executive Director Board of Pharmacy Department of Health 4052 Bald Cypress Way, Bin C-04 Tallahassee, Florida 32399-1701 S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701
Findings Of Fact Respondent John E. Nichols is licensed by Petitioner and was in the private practice of dentistry in Marianna, Florida from 1975 to December, 1978. He attended undergraduate school at the University of Florida and, while there, saw a psychiatrist on several occasions for treatment of depression. He graduated from dental school at Western Reserve University in 1968 and thereafter served two years as a dentist in the United States Air Force in Okinawa. During this period, he visited an Air Force psychiatrist on a regular basis for treatment of depression, and upon discharge received a Veterans Administration service connected disability rating with diagnosis of anxiety reaction. In 1971, while employed as a private practitioner in Miami, Florida, he consulted and received treatment from a psychiatrist there for the complaint of depression. In 1972, he went to Marianna where he worked for three years in a boy's school prior to entry into private practice there. He had episodes of depression during his employment at the school and sought treatment at a guidance clinic in Marianna. In 1975 or 1976, Respondent sought treatment at the Oshner Clinic in New Orleans and psychiatrists there were of the opinion that his depression might be organic in nature. He has been under the treatment of Dr. John F. Mason, Jr., a psychiatrist in Panama City, Florida, since January, 1977 until the present date. (Testimony of Respondent, Mason (Deposition)) Respondent experienced difficulties with his marriage after going into private practice in Marianna, which led to a divorce in December, 1977. However, Respondent appealed the divorce decree and the matter was not finally settled until the latter part of 1978. He closed his office for approximately a six-month period prior to May, 1978. this time, Respondent was taking drugs prescribed by his psychiatrist which consisted of Valium and Parnate to treat his diagnosed conditions of schizophrenia and depression. Additionally, he was drinking alcoholic beverages to excess during this period due to difficulties in sleeping at night. (Testimony of Respondent, Mason) During the period May through December, 1978, there were a number of times when Respondent's employees cancelled appointments of patients due to his inability to perform dental services. A primary cause for such inability was Respondent's drinking alcoholic beverages the previous night with resulting intoxication. On such occasions, he would awaken in the morning feeling very depressed and unsure of himself. He would either notify his staff to cancel appointments or come to the office prepared to keep appointments, but be advised by his employees that he was in no condition to perform dental work. In such instances, he normally would not see patients. Sometimes he solicited employees' opinions as to his ability to work and other times they would volunteer such information to him. He appeared to be intoxicated at these times with a puffy face, lack of equilibrium, slurred speech, and red eyes. On one occasion, an employee smelled alcohol on his breath. Once he was observed by an employee coming to the office in the morning and staggering past a patient who was in the waiting room. Respondent had about forty child patients who were provided dental services through the auspices of the Department of Health and Rehabilitative Services. In 1978, he cancelled twelve appointments with HRS patients, ten of which were due to his mental or physical condition. These cancellations were normally made on the day of the appointment and thus caused inconvenience to HRS social workers who transported the children to and from their appointments. Although Respondent did not perform dental work on patients at times when he was intoxicated, he was observed by an employee on one occasion treating a patient when he "wasn't at himself" and didn't have "a straight chain of thought." (Testimony of Respondent, Adkins, Daffin, Welch, DeVane, Sellers, Respondent's Exhibits 1-2. (Respondent's Exhibit 2 was erroneously received in evidence at the hearing as Respondent's Exhibit 1. It has therefore been renumbered.)) In August, 1978, Respondent was at his home and received a call one evening from a male who stated that his female friend had a bad toothache. Respondent told him to bring her to his house and, when they arrived, he examined the girl, Sherry Ratner, and found her to have large decay in a tooth. Respondent suggested that he write a prescription for Demerol to alleviate the pain and that she make an appointment with his office on the next working day. The girl told him that she did not want anything that strong, but mentioned that she had previously taken Dilaudid which had been adequate for dental pain in the past. Respondent was unfamiliar with the drug, but determined through a reference work that it was an acceptable medication for pain relief. Respondent therefore gave her a prescription and the couple indicated that she would come into Respondent's office the next day. The couple came into Respondent's office on two subsequent occasions to obtain another prescription for Dilaudid and went into Respondent's back office without having a previous appointment or filling out a medical history statement. Later, a pharmacist called one of Respondent's employees and stated that he didn't carry the medication in as strong a dosage as shown on the prescription. Then queried by his employees concerning the matter, Respondent told them that the girl was coming in for an appointment the next day and they told him that she did not have an appointment. Respondent then said that she was on a drug rehabilitation program and that he wrote the prescription to keep her from obtaining the drug on the streets. Respondent testified that after he discovered that the girl was in a drug rehabilitative program in Kentucky, he felt that there was a problem in prescribing medication for her because she might have been using the drugs to "get high," and that he was further concerned that she had not made an appointment for dental care. (Testimony of Respondent, Adkins, Daffin, Cliff, Petitioner's Exhibit 3) On November 30, 1978, Respondent obtained thirty 100 mg Seconal tablets from a pharmacy by means of writing a prescription in the name of Shelta Jean Pacock, who was one of his patients in Marianna. On December 4, 1978, Respondent took over twenty of the tablets in a suicide attempt for which he was hospitalized for several weeks. Respondent testified that the suicide attempt was made because of his depressive state. He further testified that he wrote the Seconal prescription in someone else's name because he had been told by a local pharmacist that he could not prescribe drugs for himself. (Testimony of Respondent, Peacock, Petitioner's Exhibit 1) After release from hospitalization, Respondent closed his dental office and referred records of patients upon request to other dentists in the vicinity. He remarried in January, 1979, and, except for one instance in January or February, 1979, has not indulged in alcoholic beverages this year. His medication was changed by his psychiatrist and he is presently taking varying amounts of Elavil, Cogentin, Haldol and Antabuse. Respondent testified that he believes he does not presently have the self-confidence necessary to practice either by himself or with another dentist. He is of the opinion that after a few months he could resume practice, but would prefer to associate with another dentist who could help him at times when he felt insecure as a result of his illness. He is further of the opinion that the problems that he has experienced in the past psychologically can be eliminated by proper treatment and medication which will enhance his self-confidence. (Testimony of Respondent, M. Nichols.) Respondent's psychiatrist, Dr. John F. Mason, testified that throughout 1977-78, Respondent was at times very depressed and potentially suicidal, somewhat paranoid, and on occasion used alcohol to excess. He believes that Respondent's divorce was the precipitating cause for the depressive condition. Dr. Mason saw Respondent on "crisis consultation" a number of times and hospitalized him during acute episodes when he was suicidal until the period had passed. Since his suicide attempt in December, 1978, Respondent has been hospitalized only once, which occurred after he received a letter from Petitioner concerning licensing proceedings. He thereafter started drinking to excess and voluntarily hospitalized himself for treatment. At the present time, he is doing very well and his stable and supportive relationship with his present wife assists in providing strong elements of support to improve his prognosis to "reasonably good" for the future. Dr. Mason believes that Respondent should avoid the pressure of private practice which plays a part in his condition, by employment as a dentist in an institutional setting which would have a structured program. He diagnoses Respondent's condition as schizophrenia with depression as a complication of the basic elements. His condition is maintained on anti-psychotic drugs such as Stelazine, Haldol and Nalvane, and antidepressant drugs, including Elavil. He has not been psychotic while under treatment by Dr. Mason. Dr. Mason testified that Respondent's prior use of alcohol complicated the treatment of the depression, but he does not characterize him as an alcoholic because his use of alcohol was secondary to his psychiatric illness. At times during 1977-78, Respondent's medication was not properly balanced, causing some tremor of his hands and side effects as to concentration and memory. However, a puffy face, slurred speech, and bloodshot eyes are side effects of alcoholic beverages. (Testimony of Mason (Stipulated Admission of Deposition)) Several years ago, Respondent obtained counseling services concerning his alcohol problem with a fellow church member who was a former alcoholic and had worked in counseling programs. Several of Respondent's former patients and employees attested at the hearing to their belief that Respondent is a capable and considerate dentist. Respondent's wife testified that his present medication agrees with his system and that he has shown a tremendous improvement in his condition since December, 1978, and that he has gained more self- confidence during the past few months. (Testimony of Adkins, Daffin, Welch, Cheesborough, Gause, Conner, Wester, M. Nichols)
Recommendation That the Petitioner suspend Respondent's license to practice dentistry pursuant to the authority contained in Section 466.24(1) and (3)(a), Florida Statutes, under the conditions stated in paragraph 6 of the foregoing Conclusions of Law. DONE and ENTERED this 6th day of July, 1979, in Tallahassee, Florida. THOMAS C. OLDHAM Hearing Officer Division of Administrative Hearings 101 Collins Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: Armando Garcia and Joseph Boyd, Esquires 131 North Gadsden Street Post Office Box 1501 Tallahassee, Florida 32302 Dean Bunch, Esquire Ervin, Varn, Jacobs, Odom and Kitchen Post Office Box 1170 Tallahassee, Florida 32302 Florida State Board of Dentistry 2009 Apalachee Parkway Tallahassee, Florida 32301
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of allegations contained in a five-count Administrative Complaint. The charges against the Respondent may be summarized as follows: Count One charges the Respondent with violating Section 458.331(1)(h), Florida Statutes (1985) , by failing to perform any statutory or legal obligation placed on a licensed physician. Count Two charges the Respondent with violating Section 458.331(1)(1), Florida Statutes (1985), by making deceptive, untrue, or fraudulent representations in the practice of medicine when such scheme or trick fails to conform to the generally prevailing standards of treatment in the medical community. Count Three charges the Respondent with violating Section 458.331(1)(n), Florida Statutes (1985), by failing to keep written medical records justifying the course of treatment of the patient. Count Four charges the Respondent with violating Section 458.331(1)(q), Florida Statutes (1985), by 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. Count Five charges the Respondent with violating Section 458.331(1)(t), Florida Statutes (1985), by gross or repeated malpractice, or the failure to practice medicine with that level of care, skill, or treatment which is recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances. The Respondent filed an answer to the Administrative Complaint. In his answer, the Respondent admits some of the factual allegations in the Administrative Complaint, but denies all allegations of wrongdoing. Following the hearing, a transcript of the proceedings at hearing was filed on September 16, 1987, and the parties were allowed fifteen days from that date within which to file proposed recommended orders. The Respondent filed a proposed recommended order on October 1, 1987, and the Petitioner filed one on October 2, 1987. Careful consideration has been given to the parties' proposed recommended orders, and specific rulings on all findings of fact proposed by the parties are contained in the Appendix which is attached to and incorporated into this recommended order.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes, Chapter 455, Florida Statutes, and Chapter 458, Florida Statutes. Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME0004527. Respondent's last known address is 463 Emerald Road, Ocala, Florida 32672. Ionamine is a brand name for a scheduled controlled substance as defined by Chapter 893, Florida Statutes. Respondent's treatment of patients for obesity included B-12 vitamin injections. Approximately two-thirds of the Respondent's practice is devoted to the treatment of obesity. The other third of the Respondent's practice is devoted to a general practice of medicine. The Respondent graduated from Indiana University Medical School in 1945, interned in 1946, and became licensed in the State of Florida in 1951. The Respondent served for two years in the Air Force during the Korean War, and then returned to Florida where he established a practice in Miami. He practiced in Miami until 1970, at which time he moved to Ocala, where he has practiced since 1970. The Respondent is a board certified anesthesiologist and graduated at the top 10 percent of his class from Indiana University. The Respondent subscribes to and reads many medical journals and articles, including those concentrating on bariatrics. The Respondent has purchased and reviewed the American Medical Association video and study guide concerning the treatment of obesity. The Respondent also has continued his post graduate studies. When a new patient comes to the Respondent's office for treatment for obesity, the patient is first given a questionnaire to fill out. Subsequently a medical history is obtained from the patient, and the patient is given a thorough physical examination. Usually, but not always, blood and urine samples are obtained from this patient for testing, and the patient is given an EKG. If this patient appears to be in good health, the Respondent puts the patient on a weight loss program consisting of a reduction of calories, an exercise program consisting of a thirty minute walk each day, and an appetite suppressant, usually Phentermine or Diethylpropion. Phentermine and Diethylpropion are both helpful in the treatment of obesity. The Respondent also encourages each patient to take a vitamin injection on a weekly basis, regardless of whether there is any evidence of vitamin deficiency or pernicious anemia. Thereafter, the patient is instructed to return to the Respondent's office once a week, at which time an R.N. or L.P.N. checks their blood pressure, pulse, respiration, and weight. The nurse questions each patient to find out how they are reacting to the weight loss program. If everything appears to be satisfactory, the patient receives another seven-day supply of diet suppressant medication and a vitamin injection. The Respondent sees the patient every fourth visit (once a month) to determine what progress the patient is making. The Respondent routinely commences treatment of obesity patients, including the prescription of or dispensing of Phentermine or Diethylpropion, before reviewing the results of blood and urine tests. The Respondent continues obesity patients on an appetite suppressant (usually Phentermine or Diethylpropion) at the rate of seven 30 mg. pills per week as long as the patient continues to lose one percent of their body weight per week until their ideal weight is reached. In January of 1986, the Respondent saw a patient by the name of Sandy Wilson who came to his office for the treatment of obesity. The Respondent gave Ms. Wilson a thorough physical examination. The Respondent also questioned Ms. Wilson about her medical history. During the course of relating her medical history, Ms. Wilson complained of swelling of her hands and feet. The Respondent did not obtain blood or urine samples from Ms. Wilson, nor did he do an EKG on Ms. Wilson. Following his examination of Ms. Wilson, the Respondent placed her on a 1000 calorie per day diet, recommended that she exercise by walking 30 minutes each day, and dispensed to her a seven-day supply of Ionamine, which is a form of Phentermine. The Respondent also wrote a prescription for Ms. Wilson for thirty tablets of Furosemide 40 mg. Furosemide is a rather potent diuretic. The Respondent also suggested that Ms. Wilson have a vitamin injection, but she refused the injection. Ms. Wilson also refused to have blood drawn, saying she was afraid of needles. The Respondent told Ms. Wilson if she changed her mind she could have the blood drawn and the vitamin injection on her next visit. The Respondent's records of Ms. Wilson's treatment during January of 1986 do not contain sufficient information to show that Ms. Wilson received a thorough physical examination. The Respondent's records of Ms. Wilson's treatment during January of 1986 do not show that an adequate medical, social, or family history was obtained from Ms. Wilson. The Respondent's records of Ms. Wilson's treatment during January of 1986 do not mention that Ms. Wilson had or complained of edema. The Respondent's records of Ms. Wilson's treatment during January of 1986 do not contain the results of any blood or urine tests or the results of any EKG. Ionamine and Furosemide should not be dispensed or prescribed to a patient for obesity and edema without first giving the patient a thorough physical exam, obtaining an adequate medical history, and obtaining the results of laboratory analysis of blood and urine samples and obtaining an EKG. This is in part because a patient may have the beginnings of some illness, such as diabetes or hypothyroidism, that are not detectable by a physical examination alone. The dispensing of Ionamine and the prescription of Furosemide to Ms. Wilson without first obtaining the results of laboratory analysis of blood and urine samples and obtaining an EKG is a failure to practice medicine with that level of care, skill, and treatment which is recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances. A physician's records must be sufficient to justify the treatment given to the patient. In particular such records should contain complete information regarding examinations, histories, and laboratory tests. Because the Respondent's records regarding Ms. Wilson did not contain complete information in this regard, the Respondent has failed to keep written medical records justifying the course of treatment of the patient. Vitamin injections do not have any direct therapeutic effect in the treatment of obesity. They do not cause weight loss, nor do they contribute to weight loss. Nevertheless, periodic vitamin injections are commonly given to patients who are being treated for obesity as a form of "behavior modification." The goal of the behavior modification is to have the patient return for follow- up treatment on a regular basis. Vitamin injections do not pose any significant risk to the patient.
Recommendation Based on all of the foregoing, it is recommended that the Board of Medicine issue a final order in this case to the following effect: Dismissing Counts One and Two of the Administrative Complaint; Finding the Respondent guilty of the violations charged in Counts Three, Four, and Five of the Administrative Complaint; and Imposing the following penalty on the Respondent: (1) an administrative fine in the amount of one thousand dollars ($1,000.00), and (2) placement of Respondent's license on probation for a period of two years under conditions to be prescribed by the Board. DONE and ENTERED this 4th day of February, 1988, at Tallahassee, Florida. MICHAEL M. PARRISH Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of February, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-2031 The following are my specific rulings on all of the findings of fact proposed by the parties. As the parties are well aware, there is a large amount of conflict in the testimony in this case, especially in the expert witness testimony. To the extent that the testimony of the expert witnesses on behalf of the Petitioner (Dr. Clark and Dr. Weiss) conflicts with the testimony of the expert witnesses on behalf of the Respondent (Dr. Haimes and Dr. Asher), I have for the most part been persuaded by, and have incorporated into the findings of fact, the version set forth by the Petitioner's witnesses. Among other things, the version set forth by the Petitioner's expert witnesses more often appeared to be more logical, more reasonable and well reasoned, and more consistent with other evidence in the case. Findings proposed by the Petitioner: Paragraph 1: Accepted. Paragraph 2: Accepted in substance, with some irrelevant details deleted. Paragraph 3: Accepted in substance with some additional findings in the interest of clarity and accuracy. Paragraphs 4 and 5: Accepted. Paragraphs 6 and 7: Accepted in substance with additional clarifying details. Paragraph 8: Rejected as not fully supported by competent substantial evidence. Paragraphs 9 and 10: Accepted in substance with additional clarifying details. Paragraph 11: Accepted. Paragraph 12: Rejected as not supported by persuasive competent substantial evidence. Paragraph 13: Accepted. Paragraphs 14 and 15: Rejected as constituting argument rather than proposed findings of fact. (The failure to include argument in the findings of fact is not a comment upon the merits of the argument.) Paragraphs 16 and 17; Accepted in substance. Findings proposed by the Respondent: By way of clarification of some of the rulings which follow, it is noted that a substantial number of the findings proposed by the Respondent begin with the words "Dr. So-and-so testified" or the words "Dr. So-and-so believes." Such findings are, in most cases, nothing more than summaries of the testimony and might well have been rejected on that basis alone. However, I have chosen to direct attention to the substance of such proposals, overlooking their form, and have treated each such proposal as a proposed finding of the fact testified to or the fact believed by the witness. Accordingly, when such proposals are rejected as being contrary to the greater weight of the evidence, that is not to say that the witness did not so testify or did not so believe, but that the fact testified to or believed by the witness is contrary to the greater weight of the evidence. Paragraphs 1, 2, 3, 4, and 5: Accepted. Paragraph 6: Most of this paragraph has been accepted, but many of the statements have been made subject to additional qualifications to be fully consistent with the evidence. Some details have been omitted as not supported by competent substantial evidence. A major qualification is that the procedures described in this paragraph are performed on many, but not all, of the Respondent's patients. Paragraph 7: Rejected as subordinate and unnecessary details. It has already been found that the Respondent gives thorough physical examinations. Paragraph 8: Accepted. Paragraphs 9 and 10: Rejected as irrelevant. Paragraph 11: Accepted in substance. Paragraph 12: First sentence is accepted in substance. Second sentence is rejected as constituting an opinion which is contrary to the greater weight of the evidence. Paragraphs 13 and 14: Rejected as constituting subordinate and unnecessary details. Paragraph 15: Rejected as constituting subordinate and unnecessary details. Also, last clause of first sentence is not supported by competent substantial evidence. Paragraph 16: Rejected as constituting subordinate and unnecessary details. Paragraph 17: Rejected as irrelevant. Paragraphs 18, 19, 20: Rejected as irrelevant and as constituting subordinate and unnecessary details. Paragraph: 21: Rejected as subordinate and unnecessary details. Also rejected as inaccurate because there were other reasons for the opinion. Paragraphs 22, 23, 24, 25, 26, 27, and 28: Rejected as irrelevant. Paragraph 29: First two sentences rejected as subordinate and unnecessary details. Third sentence rejected as irrelevant because it ignores and omits the context of the statement. Paragraph 30: Rejected as unnecessary. Paragraphs 31 and 32: Accepted in substance with additional clarifying details. Paragraph 33: Rejected because an important detail of the proposal is not supported by competent substantial evidence. Paragraph 34: Rejected as not supported by competent substantial evidence and as contrary to the greater weight of the evidence. Paragraphs 35 and 36: Rejected as irrelevant. Paragraph 37: Rejected as contrary to the greater weight of the evidence. Paragraph 38: Rejected as subordinate and unnecessary details. Paragraph 39: Rejected as irrelevant and as subordinate and unnecessary details. Paragraph 40: Rejected as irrelevant. Paragraph 41: Rejected as subordinate and unnecessary details, because Dr. Haimes did not witness the examination and treatment of the patient. Paragraph 42: Rejected as irrelevant. Paragraph 43: Rejected because the witness's use of vitamin injection is irrelevant in light of other evidence and because the witness's opinion that vitamin injections are acceptable world wide is rejected as not persuasive. Paragraph 44: Rejected as contrary to the greater weight of the evidence. Paragraph 45: Rejected as irrelevant; the witness's beliefs notwithstanding, the greater weight of the evidence is to the contrary. Paragraph 46: Rejected as subordinate and unnecessary. Paragraph 47: First three sentences rejected as irrelevant. Last sentence rejected as contrary to the greater weight of the evidence. Paragraph 48: Rejected as contrary to the greater weight of the evidence. Paragraph 49: The first, second, and fourth sentences are rejected as contrary to the greater weight of the evidence. The third sentence is rejected as irrelevant. Paragraph 50: Rejected as contrary to the greater weight of the evidence. Paragraph 51: First two sentences rejected as contrary to the greater weight of the evidence. Last sentence accepted in substance. Paragraph 52: First sentence is rejected as contrary to the greater weight of the evidence. Second sentence is accepted in substance. Third and fourth sentences are rejected as subordinate and unnecessary details. Paragraph 53: First sentence rejected as irrelevant. Second sentence rejected as contrary to the greater weight of the evidence. Paragraph 54: Rejected as contrary to the greater weight of the evidence. Paragraph 55: Rejected as irrelevant. Paragraph 56: First sentence is rejected as contrary to the greater weight of the evidence. The second sentence is rejected as irrelevant. Paragraph 57: Rejected as subordinate and unnecessary. Paragraph 58: Rejected as contrary to the greater weight of the evidence. Paragraph 59: Rejected as subordinate and unnecessary details. Paragraph 60: Rejected as contrary to the greater weight of the evident. Paragraph 61: Rejected as irrelevant. Paragraph 62: First two sentences rejected gas contrary to the greater weight of the evidence. Third sentence accepted in substance. Last sentence rejected as irrelevant. Paragraph 63: First sentence rejected as irrelevant. Second sentence accepted in substance. Third sentence rejected as contrary to the greater weight of the evidence. Paragraph 64: Rejected as irrelevant. Paragraph 65: Rejected because the opinions in this paragraph are contrary to the greater weight of the evidence. Paragraph 66: First and third sentences rejected as subordinate and unnecessary details. Second and fourth sentences rejected as contrary to the greater weight of the evidence. Paragraph 67: Rejected as contrary to the greater weight of the evidence. Paragraph 68: Rejected as irrelevant. Paragraphs 69 and 70: Rejected as contrary to the greater weight of the evidence. Paragraph 71: Rejected as subordinate and unnecessary details. COPIES FURNISHED: Francine C. Landau, Esquire Inman and Landau, P.A. 2252 Gulf Life Tower Jacksonville, Florida 32207 H. Edward Dean, Esquire 201 Northeast Eighth Avenue Suite 100 Ocala, Florida 32670 William O'Neil, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Ms. Dorothy Faircloth Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
Findings Of Fact At all times material hereto, Respondent has been a medical doctor having been issued license number 0029773 by the State of Florida. At all times material hereto, Respondent was an employee of the Atlantic Stress and Obesity Clinic, Inc., located in North Miami Beach, Florida. While employed there, Respondent treated Daniel Wolfenstein, Cindy Vegazo, Neal Schoenberg, James F. McDonald, Scott Brown and Virginia Hagerty at the Clinic. On or about October 9, 1981, Respondent prescribed 45 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Daniel Wolfenstein. Respondent did not prescribe the above-described controlled substance to Daniel Wolfenstein for a medically justifiable purpose. That prescription was inappropriate and in an excessive or inappropriate quantity. Between the dates of approximately March 10, 1981, and February 8, 1982, Respondent prescribed 405 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Cindy Vegazo. Respondent did not prescribe the above-described controlled substance to Cindy Vegazo for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. Between the dates of approximately October 9, 1981, and January 5, 1952, Respondent prescribed 90 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for Neal Schoenberg. Respondent did not prescribe the above-described controlled substance to Neal Schoenberg for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. Between the dates of approximately September 9, 1981, and January 22, 1952, Respondent prescribed 225 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for James F. McDonald. Respondent did not prescribe the above-described controlled substance to James F. McDonald for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. On or about October 13, 1981, Respondent prescribed 45 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for Scott Brown. Respondent did not prescribe the above-described controlled substance to Scott Brown for a medically justifiable purpose. Said prescription was inappropriate and in excessive or inappropriate quantity. Between the dates of approximately August 4, 1981, and December 29, 1981, Respondent prescribed 135 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Virginia Hagerty. Respondent did not prescribe the above-described controlled substance to Virginia Hagerty for a medically justifiable purpose. Said prescriptions were inappropriate and in excessive or inappropriate quantities. The medical records of each of the above-listed patients indicate that each patient was given a prescription for 45 methaqualone tablets each time that patient came to the Atlantic Stress and Obesity Clinic to see Respondent. All patients indicated on the form checklist given to them at the Clinic that they were seeking medical aid because they were depressed, tense, unable to sleep, and/or without ambition. The progress notes for each patient are identical to the notes from prior visits, all progress notes appear in two different handwritings, and all patients are diagnosed as suffering from anxiety and insomnia, thereby requiring 45 more methaqualone tablets. There appears no variation in dosage or in diagnosis. Methaqualone is a depressant, and, therefore, prescribing methaqualone to depressed patients is contraindicted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent guilty of Counts I through XIX of the Administrative Complaint and permanently revoking Respondent's license to practice medicine in the State of Florida. DONE and RECOMMENDED this 27th day of July, 1983, in Tallahassee, Leon County, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of July, 1983. COPIES FURNISHED: Charlie L. Adams, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Adolfo Z. Aguila, Esquire Midway Professional Building 55 Grand Canal Drive, Suite 404 Miami, Florida 33144 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy J. Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact Upon consideration of the evidence presented at the hearing, the following relevant findings of fact are made: The Respondent, Dora Retirement Home, is located at 4727 Brooksdale Drive, Sarasota, Florida. At all times material to this proceeding, Respondent has been licensed by the Agency to operate a ACLF (facility) at 4727 Brooksdale Drive, Sarasota, Florida, housing a maximum of six residents. Idora Rawlings is and has been the owner and operator of the facility since its initial licensure in March, 1990. By letter dated August 12, 1993, the Agency denied Respondent relicensure to operate the facility the license for which was scheduled to expire on August 22, 1993. Respondent is presently operating under a conditional license pending the disposition of this administrative proceeding in accordance with Section 400.417(2), Florida Statutes. On January 29, 1991, the Agency reported the results of its January, 1993, annual survey of the facility and cited the Respondent for several deficiencies. These deficiencies were corrected within the specified time allowed by the Agency. However, some of the same type deficiencies were cited in the January 19, 1993, annual survey that is alleged not to have been corrected in either the March 22, 1993, or the June 11, 1993, follow-up visits or the January 10, 1994, appraisal visit. In January 1993, the Agency performed an annual survey of the facility and reported the results on January 19, 1993. Several deficiencies were cited by the Agency in this annual survey. The Agency provided the Respondent with a specified time within which the alleged deficiencies were to be corrected. It is alleged that some of the deficiencies were not corrected within the specified time allowed by the Agency. Listed below are the Class III deficiencies that are alleged in the administrative complaint as violations of statutes or rules and the findings regarding those deficiencies. For convenience, the alleged deficiencies and the findings of fact concerning those deficiencies are listed in the same alphabetical order {(a) through (bb)} as in the administrative complaint. The facility failed to provided proof that liability insurance was maintained. It is alleged that this deficiency was cited at the January 29, 1991, annual survey, was recited at the January 19, 1993, annual survey and is a repeat deficiency. The Respondent had certificates of insurance for its liability insurance issued on June 18, 1990 and January 30, 1991, for the period of July 27, 1990 - July 27, 1991, and certificates of insurance for liability insurance issued on August 19, 1992, and January 20, 1993, for the period of July 27, 1992 - July 27, 1993. It is unclear whether the Agency requested and was not provided copies of the certificates of insurance at the 1991 and 1993 annual surveys or whether the Agency was just unable to locate copies of the certificates of insurance in the Respondent's files during the 1991 and 1993 annual surveys. In either case, the Respondent had certificates of insurance and the facility was insured during the applicable periods. The Agency failed to establish that a deficiency existed at the 1991 annual survey or the 1993 annual survey or that there was a repeat deficiency. The facility failed to post the last Agency inspection report. It is alleged that this deficiency was cited at the January 19, 1993, annual survey and was not corrected at the March 22, 1993, follow-up visit. At the time of the annual survey in January 1993, and the March 1993, follow-up visit, Respondent had a copy of the last Agency inspection report (issued April 1991) in a file folder with other facility papers. These papers, including the latest Agency inspection report, were available for inspection by the residents and the public. However, the latest inspection report was not posted separately in a prominent location. The Agency established that a deficiency did exist in this regard. The facility failed to maintain the admission/discharge records in a complete manner. It is alleged that this deficiency was cited at the January 19, 1991, annual survey, was recited at the January 19, 1993, annual survey, was recited at the June 11, 1993, follow-up visit, was recited at the January 19, 1994, appraisal visit and is a repeat deficiency. The Summary of Deficiencies for the January 29, 1991, and January 19, 1993, annual surveys indicate that the deficiencies cited at those surveys were corrected within the specified time allowed by the Agency. The Summary of Deficiency for the follow-up visit of June 11, 1993, does not provide a specified time within which the Agency allows the facility to correct the deficiency cited at the June 11, 1993, follow-up visit. The cited deficiencies concern the unavailability of admission/discharge records, the lack of required resident information in the admission/discharge records that were available and the failure to post admissions. At all times material to this proceeding, Respondent kept a separate register of the admission/discharge of the facility's residents which was available to the Agency for its inspection. Some of the information contained in the current register had been transferred to the current register from the old register. The reason for transferring the information was the new forms furnished by the Agency for this purpose better accommodated the information required by the Agency to be on the forms. In transferring the information from the previous register to the current register certain errors and omissions did occur, along with some of the admissions and discharge dates not being in chronological order. The January 19, 1994, appraisal visit alleges that two of the six residents present in the facility at the time of the January 19, 1994, appraisal visit were not listed in the register. The Agency failed to identify which two of the six residents present were not listed in the register. The names of the six residents present in the facility on December 6, 1993, with no discharge date, were listed in the register. There was no evidence that the Respondent had added any names to the register after the January 19, 1994, appraisal visit. As to the January 29, 1991, and the January 19, 1993, annual surveys and the June 11, 1993, follow-up visit, the Agency failed to establish that Respondent's admission/discharge records were not maintained in a complete manner, notwithstanding the testimony of the Agency's witness to the contrary. While the Respondent's admission/discharge register was somewhat "sloppy", the evidence shows that the register contained the required information. As to the January 19, 1994, appraisal visit, the Agency failed to establish or identify which, if any, of residents present in the facility at the time of the January 19, 1994, appraisal visit were not listed in the register. The Agency failed to establish that a deficiency existed in this regard at the 1991 or 1993, annual survey, the June 11, 1993, follow-up visit or the January 19, 1994, appraisal visit or that there was a repeat deficiency. The facility failed to maintain a record of resident weights at admission and semiannually thereafter. It is alleged that this deficiency was cited at the January 29, 1991, annual survey, recited at the January 19, 1993, annual survey and is a repeat deficiency. Respondent failed to record either the weight or the height of some of the residents admitted before the January 29, 1991, annual survey. However, this deficiency was corrected at or before the March 22, 1991, follow-up visit. There is insufficient evidence to show that Respondent failed to record the weight and height of any resident admitted between the January 29, 1991, annual survey and the January 19, 1993, annual survey, notwithstanding the testimony of the Agency's witnesses to the contrary. The Agency failed to establish or identify which, if any, resident that was admitted to or living in the facility during the applicable times that required or received individual assistance with their activities of daily living (ADL) as defined in Rule 10A-5.0131(2)(c), Florida Administrative Code. Likewise, the Agency failed to establish or identify which, if any, of the residents whose weight Respondent failed to record semiannually were receiving individual assistance with their ADL's. The Agency has failed to establish that a deficiency existed at the January 29, 1991, annual survey or the January 19, 1993, annual survey or that it was a repeat deficiency. The facility did not have a disaster plan and did not have the plan coordinated with the local disaster preparedness authority. It is alleged that this deficiency was cited at the January 19, 1993, annual survey, was not corrected at the March 22, 1993, follow-up visit, was recited at the January 19. 1994, appraisal visit and is a repeat deficiency. The Respondent had a written disaster plan but the plan had not been coordinated with or reviewed by the local disaster preparedness authority at any of the visits by the Agency in January and March, 1993, or January, 1994. Although the local authority was slow to act on these matters, the Respondent failed to act timely or in a responsible manner in initially presenting the plan or making the changes required by the authority. The Agency established that the alleged deficiency existed at the January 19, 1993, annual survey, was not corrected at the March 22, 1993, follow-up visit and still existed at the January 19, 1994, appraisal visit, and it was a repeat deficiency. The facility did not develop written job descriptions for staff who provide personal services. It is alleged that this deficiency was cited at the January 19, 1993, annual survey and was not corrected at the March 22, 1993, follow-up visit. Although some of the Respondent's staff did not have written job descriptions at the time of the January 19, 1993, annual survey or at the March 22, 1993, follow-up visit, the Agency failed to establish or identify which, if any, of the facility's employees without written job descriptions were providing personal services to the residents during the applicable time or which residents required assistance with personal services. Furthermore, the Agency failed to establish that the staff without any job descriptions at the January 19, 1993, annual survey was the same staff without job descriptions at the January 24, 1993, follow-up visit. The Agency failed to establish that a deficiency existed in this regard. The facility did not maintain required staff documentation and qualifications in the personnel record. It is alleged that this deficiency was cited at the time of the June 11, 1993, follow-up visit and was not corrected at the January 10, 1994, appraisal visit. The Agency failed to advise the facility in the Summary of Deficiencies of the specified time within which the facility must have the deficiency corrected. The facility was basically a one person operation. Idora Rawlings, being the owner and administrator, was usually that person. However, other personnel was hired from time to time. Although there was at least a part-time employee working at the time of the June 11, 1993, follow-up visit or had worked previously, this employee was never identified by the Agency and it was never established that this employee's personnel record did not contain the required staff documentation and qualifications. Other than the administrator, the Agency failed to identify any other part-time or full-time employees that had previously worked or were working at the facility at the time of the June 11, 1993, follow-up visit or at the January 19, 1994, appraisal visit. While the personal records of employees of the facility were sketchy, the Agency failed to establish which of those personnel records failed to meet the required staff documentation and qualifications, and thereby result in a deficiency. The Agency failed to establish that a deficiency existed in this regard. The administrator did not ensure that staff providing assistance with personal hygiene received training in personal hygiene. It is alleged that this deficiency was cited at the January 19, 1993, annual survey, and was not corrected at the March 22, 1993, follow-up visit. As stated above, the facility was a one person operation and the administrator was usually that person. Other than the administrator, the Agency failed to establish or identify which, if any, of the facility's employees were furnishing residents assistance with personal hygiene. Likewise, the Agency failed to establish or identify which, if any, of the facility's employees had not received training in personal hygiene. The Agency failed to establish that a deficiency existed in this regard. The administrator did not ensure that each staff person that comes into contact with potentially infectious materials is trained in infection control procedures for blood and other body fluids. It is alleged that this deficiency was cited at the January 19, 1993, annual survey, and was not corrected at the March 22, 1993, follow-up visit. The Agency failed to establish that any of the facility's resident posed a threat of exposing any staff member to potentially infectious materials. As stated above, the facility was a one person operation and the administrator was usually that person. Other than the administrator, the Agency failed to establish or identify which, if any, of the facility's employees were required by their employment to expose themselves to any potentially infectious material that may be present in the facility. Likewise, other than the administrator, the Agency failed to establish or identify which, if any, of the facility's employees that were required to be trained in infection control procedures for blood and other body fluids had not been trained. The Agency failed to establish that a deficiency existed in this regard. Each person admitted to the facility was not covered by a contract executed at admission or prior thereto. It is alleged that this deficiency was cited at the January 19, 1991, annual survey, was recited at the January 19, 1993, annual survey and is a repeat deficiency. The Agency failed to establish and identify which, if any, of the residents that did not have a properly executed contract prior to, or at the time of admission. The Agency's witnesses could not identify any resident by name that did not have a properly executed contract prior to, or at the time of admission. The Agency failed to establish that a deficiency existed in this regard at any time or that there was a repeat deficiency. Each resident had not been examined by a health care provider within sixty (60) days prior to or thirty (30) days after admission. It is alleged that this deficiency was cited in the January 19, 1991, annual survey, recited at the January 19, 1993, annual survey and is a repeat deficiency. The Health Assessment for Adult Congregate Living Facilities, HRS-AA Form 1823 (health assessment) is the form completed by the health care provider upon completion of the medical examination and forwarded to the ACLF facility to assist the administrator in determining the appropriateness of admission. Lawrence C. Huffman admitted to the facility on December 23, 1990, had an undated health assessment. Martin C. Huber admitted to the facility on May 6, 1990, had a health assessment dated December 11, 1990, completed approximately seven months after admission. Pearl Rauchat admitted to the facility on October 9, 1990 had a health assessment dated November 19, 1990, completed 41 days after admission. This deficiency was corrected on March 7, 1991, well within the specified time for correction set by the Agency. Fred Dutt admitted July 10, 1992 had a health assessment dated August 14, 1992 - December 10, 1992, completed 35 days after admission. The Agency's presented no evidence of any other resident whose health assessment was untimely at the January 19, 1993, annual survey or at any other time.. The facility is required to rely on the health care provider to timely examine the resident, and to prepare and file the health assessment. Dutt's health assessment being only five days over due does not constitute a deficiency. Although the Agency established a deficiency in January, 1991, it was timely corrected, and there was no deficiency established in January, 1993. Therefore, there is no repeat deficiency. The administrator did not ensure that the criteria for continued residency was followed. It is alleged that this deficiency was cited at the January 19, 1993, annual survey, recited at the January 19, 1994, appraisal visit and is a repeat deficiency. The Agency failed to establish or identify which, if any, of the residents where the Respondent failed to follow the criteria for continued residency, notwithstanding the testimony of the Agency's witnesses. The Agency failed to establish that a deficiency existed in this regard or that there was a repeat deficiency. The facility did not insure that staff knew how to implement the disaster plan. It is alleged that this deficiency was cited at the January 29, 1991, annual survey, recited at the January 19, 1994, appraisal visit and is a repeat deficiency. Other than the administrator, the Agency failed to establish that there were other employees prior to or at the time of the January 29, 1991, survey or that the Respondent had failed to insure that the staff, if there were any, knew how to implement the disaster plan. Although there may have been staff, other than the administrator, working at the facility between the January 29, 1991, annual survey and the January 19, 1994, appraisal visit, the Agency failed to establish or identify which, if any, of the staff did not know how to implement the disaster plan. The Agency failed to establish that a deficiency existed in this regard or that there was a repeat deficiency. The administrator did not ensure that the staff certified in first aid are present in the facility at all times. It is alleged that this deficiency was cited at the January 19, 1993, annual survey and was not corrected at the March 22, 1993, follow-up visit. The Agency failed to establish or identify which, if any, of the facility's employees that were not certified in first aid were left in charge of the facility. During the applicable time, the administrator and a part-time employee were the only employees of the facility. Both the administrator and the part- time employee had been certified in first aid. Either the administrator, the part-time employee or both were always present at the facility. The Agency failed to establish that a deficiency existed in this regard. The administrator did not ensure that the staff have documentation of freedom from communicable diseases. It is alleged that this deficiency was cited at the January 19, 1993, annual survey, was not corrected at the March 22, 1993, follow-up visit or the January 19, 1994, appraisal visit. The Agency failed to establish or identify which, if any, of the staff did not have documentation of freedom from communicable diseases. During the applicable period there was only one part-time employee and the administrator working at the facility. The Agency failed to establish that either the part- time employee or the administrator did not have documentation of freedom from communicable diseases. The Agency failed to establish that a deficiency existed in this regard. The administrator had not designated in writing a staff person to be in charge during the temporary absence of the administrator. It is alleged that this deficiency was cited at the January 19, 1993, annual survey and was not corrected at the March 22, 1993, follow-up visit. During 1993, Evelyn Rhoden was designated in writing by the administrator as the staff member to be in charge of the facility in the administrator's absence. This authorization was posted on the bulletin board near the telephone in the small dining room by the kitchen. During 1994, Chistine St. Amand was designated in writing by the administrator as the staff member to be in charge of the facility in the administrator's absence. This authorization was posted on the same bulletin board as the 1993 written authorization. The authorizations were available to the Agency's surveyors during the applicable surveys and follow-ups. The Agency failed to establish that a deficiency existed in this regard. The administrator did not ensure that the staff supervise the self-administered medications as specified by procedures spelled out in the regulations. It is alleged that this deficiency was cited at the June 11, 1993, follow-up visit and was not corrected at the time of the January 19, 1994, appraisal visit. The Agency failed to advise the facility in the June 11, 1993, Summary of Deficiencies of the specified time within which the facility must have the deficiency corrected. The Agency failed to establish or identify which, if any, of the facility's residents required supervision of self-administered medication and thereby require the facility to document staff supervision of self- administered medication. The Agency failed to establish that a deficiency existed in this regard. The administrator did not ensure that the staff restricted the assistance with self-administered medication process as allowed in the regulations. It is alleged that this deficiency was cited at the January 1993, annual survey, was not corrected at the March 22, 1993, follow-up visit, was recited at the January 19, 1994, appraisal visit and is a repeat deficiency. It appears that this is the same deficiency as listed in 4(q) above. However, in any event the Agency has failed to establish or identify which, if any, of the facility's staff did not restrict the assistance with the self- administered medication process as allowed by the regulations. The Agency failed to establish that a deficiency existed in this regard or that there was a repeat deficiency. The administrator did not hire or ensure that only licensed staff administered medications. It is alleged that this deficiency was cited in the January 19, 1993, annual survey, recited at the January 19, 1994, appraisal visit and is a repeat deficiency. As to the deficiency cited at the January 19, 1993, annual survey, the Agency failed to establish the identity of patient #5 whose health assessment indicated she needed her medications administered or that staff was administering medication to patient #5. As to the deficiency cited at the January 19, 1994, appraisal visit, the administrator who is not licensed to administer medication admitted to popping the medication out of individual bubble packs into individual souffle cups for several of the residents who would then take the medication or would place the souffle cups on a cabinet shelf in front of the resident's name on the shelf to be taken at a later time - such as lunchtime. The Agency failed to establish or identify which, if any, of these residents required their medication to be administered as oppose to those who could self-administer medication, with or without supervision. There was insufficient evidence to show that the administrator was administering medication. The Agency failed to established that a deficiency existed in this regard at the January 19, 1993, annual survey or the January 19, 1994, appraisal visit. The administrator did not ensure that no prescription drug is kept by the facility unless it had been legally dispensed and labeled for the resident for whom it was prescribed. It is alleged that this deficiency was cited at the January 19, 1993, annual survey, was recited at the June 11, 1993, follow-up visit, not corrected at the January 19, 1994, appraisal visit and is a repeat deficiency. As to the deficiency cited at the January 19, 1993, annual survey, the Agency has established that a month's supply of vitamins for Viola Shupp had been placed in a "daily pill container" by the resident's daughter. This "daily pill container" was placed in the same plastic box as prescription medication containers in the cabinet where the Respondent kept medication. The prescription medication containers were properly labeled with the required information. This deficiency was corrected within the time specified by the Agency for correction. As to the deficiency cited at the June 11, 1993, follow-up visit, the Agency establish that the centrally stored medication was not locked up. The Respondent admitted that the centrally stored medication included such items as vitamins, merthiolate, dramamine, Shaklee alfalfa, ointments, creams, tinctures, and two prescription medications (Synthroid, 0.5mg and Cipro) in containers with prescription labels with the required information for resident Henry Shadle. Other than the Synthroid and Cipro, none of the other containers had prescription labels. However, there was no evidence that any of the other medications (vitamins, ointments, merthiolate, etc.) were prescribed medications. None of the other medications (vitamins, ointments, merthiolate, etc.) were labeled to identify the resident owning the medication. The Agency did not advise the facility in the June 11, 1993, Summary of Deficiencies of the specified time within which the facility must have the deficiency corrected. As to the deficiency cited at the January 19, 1994, appraisal visit, the Agency has shown that five souffle cups of medication without covers or prescription labels were on a shelf in an unlocked cabinet. The souffle cups had been placed on a shelf by the patient shortly before time to take the medication after the administrator has assisted the residents in getting the medication out of bubble packs as set forth in 4(s) above. The Agency established that (1) a deficiency existed at the January 19, 1993, annual survey but was timely corrected, (2) a similar deficiency existed at the follow-up visit of June 11, 1993 and, (1) a similar deficiency existed at the annual survey of January 19, 1994. The Agency has established a repeat deficiency. The administrator did not ensure that no person other than the pharmacist shall alter a prescription label, and transfer medications from one storage container to another. Medication orders changed by the physician must be re-labeled by the pharmacist. The administrator did not make every effort to ensure that residents whose medications are supervised by the facility are refilled in a timely manner. It is alleged that this deficiency was cited at the June 11, 1993, follow-up visit and was not corrected at the January 19, 1994, appraisal visit. The Agency failed to advise the facility in the Summary of Deficiencies of the specified time within which the facility must have the deficiency corrected. There was no evidence that any prescription label on any medication container for any resident had been altered in any fashion at any time. There were some plastic baggies containing non-prescription medication or the individual container of the non-prescription medication that had written instructions or the name of the resident on them. During the January 19, 1994, appraisal visit a plastic box was found to contain several prescription medications that were in properly labeled containers. However, there was a "daily pill container" in the plastic box which contained a month's supply of vitamins. The vitamins in the "daily pill container" had been placed there by the resident's daughter. The "daily pill container", along with the individual prescription medication containers had been placed in the plastic box and placed in the facility's medication cabinet by the resident's daughter. The Agency failed to establish or identify any medication order changed by a physician that had not been properly rebelled by the pharmacist or had been rebelled by an employee or the administrator of the facility Likewise, the Agency failed to establish or identify any resident whose medication was supervised by the facility that the administrator failed to ensure that that resident's medications were not refilled in a timely manner. The Agency failed to establish that a deficiency in this regard existed at the June 11, 1993, follow-up visit or January 19, 1994, appraisal visit. The administrator did not dispose of medications as allowed by regulations. It is alleged that this deficiency was cited in the January 19, 1993, annual survey and recited again at the June 11, 1993, follow-up visit. At the January 19, 1993, annual survey the Agency surveyor found a bottle of Tylenol that was alleged to belong to a resident that had been discharged from the facility longer than 15 days. The Agency failed to establish or identify the resident that the Tylenol belonged to or when that resident was discharged. However, the facility had disposed of the Tylenol by the March 22, 1993, follow-up visit and the Agency considered the matter corrected within the specified time the facility was allowed to correct the deficiency. As to the follow-up visit of June 11, 1993 concerning this deficiency, the Agency failed to establish or identify any resident that had been discharged from the facility whose medication had not been disposed of, or disposed of improperly by the facility. The Agency failed to establish that a deficiency existed at the June 11, 1993, follow-up visit and thereby establish a repeat deficiency. The administrator did not ensure that the facility had no stock supply of over-the-counter (OTC) medications, OTC medications are labeled as required, and supervised as ordered by the physician. The Agency failed to advised the facility in the Summary of Deficiencies of the specified time within which the facility must have the deficiency corrected. It is alleged that this deficiency was cited at the June 11, 1993, follow-up visit and was not corrected at the January 19, 1994, appraisal visit. The Agency established that the Respondent did keep a stock supply of OTC medications in that such items as Tylenol, milk of magnesia, vaseline, Mylanta, Easy Lax, and other assorted OTC medications were kept in the facility without any resident's name on the medication. This deficiency still existed at the January 19, 1994, appraisal visit. Likewise, the Agency established that OTC medications were kept for residents with the resident's name on the medication in with other residents' OTC medication stored in the facility's cabinet. However, the Agency failed to establish that any of these OTC medications were not labeled as ordered by the physician or that the manufacturer's label with directions for use were not kept with the OTC medications or that the supervision of the OTC medication was not as order by the physician where there were such orders. The Agency established that a deficiency in this regard existed at the June 11, 1993, follow-up visit and was not corrected at the time of the January 19, 1994, appraisal visit. The facility did not employ a Consultant Pharmacist within fourteen (14) days of the documentation of an uncorrected Class III medication violation, and did not retain the Pharmacist for on-site quarterly updates until the department verified after written notification by the Administrator and Consultant Pharmacist the correction of the medication violations. It is alleged that this deficiency was cited at the June 11, 1993, follow-up visit and recited at the January 19, 1994, appraisal visit. By letter dated June 17, 1993, the Agency advised the administrator that "[b]ecause of the uncorrected and new deficiencies related to Medications according to 10A5.034 of the administrative code you are now required to employ a pharmacist consultant. The initial on site pharmacist consultant visit must take place within 14 working days and quarterly thereafter." The administrator hired a pharmacist consultant who visited the facility on July 6, 1993, this was within 14 working days allowed by the Agency. However, the consultant pharmacist was not retained after July 6, 1993. The administrator did not submit the Consultant pharmacist's quarterly corrective action plan to the Agency. After the January 19, 1994, appraisal visit, the administrator again employed a consultant pharmacist. The Agency established that a deficiency in this regard existed at the June 11, 1993, follow-up visit and was not corrected at the time of the January 1994, appraisal visit. The administrator did not ensure that opportunities are provided for social and leisure activities by planned activities. It is alleged that this deficiency was cited in the January 19, 1993, annual survey, was not corrected at the March 22, 1993, follow-up visit and was recited at the January 19, 1994, appraisal visit. Contrary to the testimony of the Agency's witnesses, the administrator did provide the residents opportunities for social and leisure activities by planning activities. However, the administrator was limited in what could be offered in that the facility was mainly a one person operation, and the age and physical condition of the residents limited their participation to certain social and leisure activities. Also, contrary to the testimony of the Agency's witnesses, the administrator did prepare, keep and post an activities calendar - albeit not an elaborate or sophisticated one. The Agency failed to establish that a deficiency in this regard existed at the January 19, 1993, annual survey or the January 19, 1994, appraisal visit. The administrator did not develop and implement or arrange for an ongoing activities program at a minimum ten (10) hours a week, and did not ensure resident participation in the planning activities. It is alleged that this deficiency was cited at the January 19, 1993, annual survey, was not corrected at the March 22, 1993, and June 11, 1993, follow-up visits and was recited at the January 19, 1994, appraisal visit. The Agency failed to establish that the activities planned by the administrator for the residents as set out in 4(y) above did not total a minimum of 10 hours a week. The administrator had developed and implemented or arranged for an ongoing activities program and provided for resident participation in the planning activities. While the administrator's program was not elaborate or sophisticated, it met the requirements for an ACLF with a resident capacity such as Respondent's facility. (aa) The administrator did not ensure that monthly fire drills were documented. It is alleged that this deficiency was cited at the January 19, 1991, annual survey, was recited at the January 19, 1993, was not corrected at the March 22, 1993, follow-up visit, was recited at the January 19, 1994, appraisal visit and is a repeat deficiency. At the January 19, 1993, annual survey there was no documentation of monthly fire drills for the past year. At the January 19, 1994, appraisal visit, it was established that although monthly fire drills from April, 1993 through December, 1993, had been documented, the documentation did not contain the required information. The dates of the fire drills were provided. However, information specified by regulation such as time required to evacuate, location of simulated fire, fire escape paths used and notation of residents who resisted or failed to participate was not provided. The Agency established that a deficiency in this regard existed at the times alleged and is a repeat deficiency. (bb) The administrator did not maintain documentation available regarding the testing and operation of the smoke detectors. It is alleged that this deficiency was cited in the January 19, 1993, annual survey, recited at the January 19, 1994, appraisal visit and is a repeat deficiency. As to the deficiency cited at the January 19, 1993, annual survey, the monthly testing of smoke detectors was not documented. Smoke detectors in room #3 and the hallway were inoperable when tested by the surveyor at the January 19, 1993, annual survey. This deficiency was corrected within the time specified by the Agency. At the time of the January 19, 1994, appraisal visit the Respondent had failed to document the monthly testing of smoke detectors. The Agency established that a deficiency in this regard existed at the times alleged and is a repeat deficiency. By letter dated January 12, 1994, the Agency advised the administrator that a moratorium on admissions to the facility had been imposed effective January 10, 1994, in accordance with Section 400.415, Florida Statutes. At the time the moratorium was imposed January 10, 1994, the resident census was six. The letter of January 12, 1994, advised the administrator of the right to request a formal administrative hearing on the issue of the moratorium. The administrator made no request for a formal administrative hearing. Sometime in the latter part of June, 1994, a resident of the facility was discharged bringing the resident census to five. Shortly thereafter, on July 9, 1994, the facility admitted a new resident. Upon being advised by the Agency that the admission was in violation of the moratorium, the facility discharged the resident on August 31, 1994. It was the administrator's understanding that the moratorium was on any admissions above the resident census of six. By letter dated August 23, 1994, the Agency advised the administrator that the January 12, 1994, letter was being supplemented and amended. Among other matters, the letter advised the administrator that the moratorium would run concurrently with the facility's licensure denial and remain in effect until the denial issue was resolved. The letter also advised the administrator of the right to a formal administrative hearing. The administrator made no request for an administrative hearing. On September 9, 1994, a Final Order was entered by the Agency imposing a moratorium effective January 10, 1994, that would remain in effect until no longer necessary, affirming the Agency's action set forth in the January 12, 1994, letter. On October 12, 1994, a Final Order was entered by the Agency imposing a moratorium effective January 10, 1994, that would run concurrently with the licensure denial and remain in effect until the denial issue was resolved, affirming the Agency's action set forth in the August 23, 1994, letter.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, and considered the factors set forth in Section 400.419(2), Florida Statutes, concerning the imposition of a penalty, it is recommended that the Agency for Health Care Administration enter a Final Order finding the Respondent to have committed the violations set forth in paragraphs 3(b), 3(e), 3(t), 3(w), 3(x), 3(aa) and 3(bb) of the Administrative Complaint and for such violations shall pay an administrative fine of $100, $200, $300, $250, $250, $250, and $250, respectively, for a total administrative fine of $1,600, to be paid on terms the Agency deems appropriate. It is further recommended that the Agency grant the Respondent's application for renewal of its license with conditions the Agency deems appropriate, including, at the minimum, that the moratorium remain in place until such time as the Respondent employs a consultant pharmacist, on staff or by contract, and corrects the medication violations as found in this Recommended Order to the satisfaction of the Agency. RECOMMENDED this 27th day February, 1995, in Tallahassee, Florida WILLIAM R. CAVE 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 27th day of February, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-5515 AND 94-4101 The following constitutes my specific rulings, pursuant to Section 120.59(2), Florida Statutes, on all the proposed findings of fact submitted by the parties in these cases. Petitioner's Proposed Findings of Fact: Proposed finding of fact 1 is adopted in substance as modified in Finding of Fact 1. The introductory portion of Proposed finding of fact 2 is adopted in substance as modified in Findings of Fact 2 and 3. Proposed findings of fact 2(a), 2(c), 2(d), 2(f) through 2(r), 2(t), 2(u), and 2(x) are rejected as not being supported by the evidence in the record. Proposed findings 2(b), 2(e), 2(s), 2(v), 2(w), 2(y)and 2(z) are adopted in substance as modified in Findings of Fact 4(b), 4(e), 4(t), 4(w), 4(x), 4(aa) and 4(bb), respectively. Proposed finding of fact 3 is adopted in sustance as modified in Finding of Fact 4. Proposed finding of fact 4 is adopted in substance as modified in Findings of Fact 5, 6, 8-10. Proposed finding of fact 5 is adopted in substance as modified in Finding of Fact 7. Proposed finding of fact 6 is adopted in substance as modified in Finding of Fact 4(t). Proposed finding of fact 7 is covered in the Preliminary Statement. Respondent's Proposed Findings of Fact: 1. Proposed finding of fact 1 is adopted in substance as modified in Finding of Fact 1. The balance of Respondent's proposed findings of fact are intermingled with cited rules and statutes, the allegations and argument. Some paragraphs are numbered and some paragraphs are unnumbered. Where it is possible, a response has been made to what might be considered proposed findings of fact. However, the proposed finding of fact may be one of many unnumbered paragraphs under a single number. 2. Proposed findings of fact 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 18, 19, 21, 23, 24, 25, 37 and 40 are adopted in substance as modified in Findings of Fact 4(c), 4(a), 4(d), 4(j), 4(b), 4(l), 4(m), 4(k), 4(n), 4(aa), 4(x)(z), 4(q), 4(n), 4(s), 4(u), 4(v), 4(g), 4(p), 4(o) and 4(u), respectively 3. Proposed findings of fact 2, 4, 26 - 30, 32, 36, 39 and 43 - 48 are either not material or relevant, or unnecessary, or subordinate, or cumulative. 4. Proposed findings of fact 16, 20, 22, 28, 31, 33, 34, 35, 38, 41 and 42 are rejected as not being supported by the evidence in the record. COPIES FURNISHED: Sam Power, Agency Clerk Agency For Health Care Administration The Atrium, Ste. 301 325 John Knox Road Tallahassee, Florida 32303 Tom Wallace, Assistant Director Agency For Health Care Administration The Atrium, Ste. 301 325 John Knox Road Tallahassee, Florida 32303 Linda Parkinson, Esquire Agency For Health Care Administration Division of Health Quality Assurance 400 West Robinson Street, Suite S-309 Orlando, Florida 32801 William Witt, Esquire 4625 East Bay Drive, Suite 210 Clearwater, Florida 34624
