The Issue The issue for determination is whether Respondent committed the offenses set forth in the Administrative Complaint and, if so, what action should be taken.
Findings Of Fact At all times material hereto, David James Pesek (Respondent) was licensed in the State of Florida as a nutrition counselor, having been issued license number NC 0000199 on February 21, 1990. Respondent’s last known address is 375 Paradise Lane, Waynesville, North Carolina 28786. At all times material hereto, Respondent was the owner of the Center for Effective Living (Center) in Deerfield Beach, Florida. On June 11, 1992, Patient A. S. presented to the Center for treatment of an eating disorder. Patient A. S. was overeating and wanted to lose weight. Patient A. S. was examined by Dr. Schocoff, M.D. that same day. Dr. Schocoff performed a brief physical examination of Patient A. S. Dr. Schocoff’s medical impression was that Patient A. S. suffered from a food addiction, food allergy, and aerophagia. At no time did Dr. Schocoff diagnose Patient A. S. as suffering from fatigue, hypercholesterolemia, or abnormal liver function. At no other time did Dr. Schocoff evaluate Patient A. S. At no other time was Dr. Schocoff involved in any way in the treatment of Patient A. S. Dr. Schocoff was employed by Respondent and the Center. Dr. Schocoff’s duties were to obtain patient history and perform physical examinations only. At no time did Dr. Schocoff give any opinion as to a patient’s health or perform any treatment of a patient or supervise patient treatment. On July 29, 1992, lab work was performed on Patient A. S., as ordered by Dr. Schocoff. The lab work consisted of blood and urine chemistry tests. The results of the tests did not indicate a need for nutritional supplements. Patient A. S. was referred to Respondent for a supervised nutritional and dietary program. On September 1, 1992, Patient A. S. presented to Respondent for the supervised program. After reviewing the blood test results, Respondent informed Patient A. S. that his liver was breaking down and that something had to be done for his liver problem immediately. Respondent had diagnosed Patient A. S. with suffering from a liver disorder. Patient A. S.’ medical records indicate that, among other things, the levels of three substances were tested by the blood test: two liver enzymes (GGT and SGPT) and cholesterol. The blood test results indicated that the levels of all three substances were elevated; however, increased levels of GGT, SGPT, and cholesterol are not conclusive indices of liver disorder. A nutrition counselor is not qualified to make a diagnosis of a liver disorder. It is below the acceptable standards of practice2 as set forth by the Board of Medicine and Nutrition Council for a nutrition counselor to diagnose a liver disorder. Respondent failed to maintain acceptable standards of practice as set forth by the Board of Medicine and Nutrition Council for a nutrition counselor by inappropriately diagnosing Patient A. S. with a liver disorder. Respondent did not refer Patient A. S. to a physician for his suspected liver disorder. Instead, Respondent prescribed treatment for the disorder in the form of nutrients and dietary supplements. It is below the acceptable standards of practice as set forth by the Board of Medicine and Nutrition Council for a nutrition counselor to fail to refer a patient to a physician for diagnosis and treatment of a suspected liver disorder. Respondent failed to maintain acceptable standards of practice as set forth by the Board of Medicine and Nutrition Council for a nutrition counselor by inappropriately attempting to treat Patient A. S. for a liver disorder. Eventually, Respondent suggested iridology analysis to Patient A. S. On October 28, 1992, Respondent performed iridology analysis on Patient A. S. Iridology is not an accepted diagnostic procedure by the Board of Medicine and Nutrition Council. Respondent treated and undertook treatment of a human ailment by means other than dietetics and nutrition practice. It is below the acceptable standards of practice as set forth by the Board of Medicine and Nutrition Council for a nutrition counselor to use forms of treatment and diagnosis which are not accepted. On October 28, 1992, Respondent also ordered testing of Patient A. S.’ nutrient mineral levels. The testing of Patient A. S.’ nutrient mineral levels was performed by Analytical Research Labs, Inc., on November 5, 1992. The test results were inconclusive, since they failed to reflect specific units based on amount/volume in which each mineral was measured, and no determination of nutritional recommendations could be effectively made, or, stated differently, the results did not support a need for nutritional supplements. Notwithstanding, Respondent ordered and sold to Patient A. S. multiple nutritional supplements. It is below the acceptable standards of practice as set forth by the Board of Medicine and Nutrition Council for a nutrition counselor to diagnose and undertake to treat nutrient mineral deficiencies from inconclusive test results. Respondent failed to maintain acceptable standards of practice as set forth by the Board of Medicine and Nutrition Council for a nutrition counselor by diagnosing Patient A. S. with nutrient mineral deficiency from inconclusive test results. On November 13, 1992, as ordered by Respondent, food sensitivity testing was performed on Patient A. S. at Immuno Laboratories, Inc. The results of the test included foods that Patient A. S. should and should not eat, and Immuno Laboratories provided a diet for Patient A. S. Respondent’s assessment of the lab work performed by Analytical Research Labs and Immuno Laboratories was insufficient to determine the appropriateness of the diet provided for Patient A. S. Furthermore, Respondent failed to develop a personalized, specific diet plan for Patient A. S., which included a target weight and caloric intake requirements. It is below the acceptable standards of practice as set forth by the Board of Medicine and Nutrition Council for a nutrition counselor to fail to develop a personalized diet plan which includes a target weight and caloric intake requirements. Respondent failed to maintain acceptable standards of practice as set forth by the Board of Medicine and Nutrition Council for a nutrition counselor by allowing someone other than himself to develop a diet for Patient A. S. and by failing to develop a personalized diet plan for Patient A. S., which included a target weight and caloric intake requirements. During Respondent’s treatment of Patient A. S., Respondent advised him that his addictive behavior was caused by nutrient imbalances. This advice from Respondent was false. During the first two months under Respondent’s care and treatment for an overeating disorder and to lose weight, Patient A. S. gained 17 pounds. During the three-month period from June to September 1992, Patient A. S. gained a total of 25 pounds. For the period from September 1, 1992 through February 22, 1993, Respondent submitted insurance claims for the services and treatment that he provided to Patient A. S., utilizing the medical diagnoses determined by Respondent. Moreover, Respondent filed the claims under the name of the Center's physician, Dr. Schocoff, with a signature purporting to be that of Dr. Schocoff. However, Dr. Schocoff was not aware that his name appeared on the claim forms; and neither did he sign the claim forms nor authorize Respondent to use or sign his name on the claim forms. Claims paid by the insurance company were paid to the Center, which was wholly owned by Respondent. An inference is made and a finding of fact is made that Respondent knowingly used Dr. Schocoff's name and signature on the claim forms without Dr. Schocoff's knowledge and authorization. Moreover, due to this finding of fact, it is further found that Respondent knew that he was fraudulently submitting claims to an insurance company for the payment of services provided by himself, not by a physician. By submitting claims for services provided to Patient A. S. under the name of the Center's physician, Dr. Schocoff, Respondent committed an act of fraud or deceit in the practice of dietetics and nutrition.3
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order revoking Respondent's license as a nutrition counselor. DONE AND ENTERED this 15th day of January, 1999, in Tallahassee, Leon County, Florida. ERROL H. POWELL 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 15th day of January, 1999.
The Issue Whether Respondent violated section 500.147(1), Florida Statutes (2020),1 when it refused entry to Petitioner's inspectors unless the inspectors agreed 1 Unless stated otherwise, all references to statutes and administrative rules are to the 2020 versions that were in effect during the conduct at issue. Childers v. Dep't of Envtl. Prot., 696 So. 2d 962, 964 (Fla. 1st DCA 1997). to Respondent's "no camera" policy; and, if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency charged with regulating food establishments pursuant to chapter 500, Florida Statutes (the Food Safety Act), and Florida Administrative Code Chapter 5K-4. At all times relevant, Tampa Maid was permitted as a food establishment (Food Permit No. 28143) by the Department.4 Tampa Maid operates a shrimp and shellfish processing plant at 1600 Kathleen Road in Lakeland, Florida (Facility). As a seafood processor, Tampa Maid is subject to the jurisdiction of the federal Food and Drug Administration (FDA), and specifically to seafood Hazard Analysis Critical Control Points (HACCP) inspections. The Department contracts with the FDA to perform various types of inspections including HACCP inspections. The Department's FDA contract contemplates that (1) Department inspectors will collect information and 3 An official word index to the Transcript was submitted on March 31, 2021. 4 Section 500.03(p) defines "Food establishment" as "factory, food outlet, or other facility manufacturing, processing, packing, holding, or preparing food or selling food at wholesale or retail." evidence, (2) evidence can be in the form of photographs, and (3) evidence collected is not subject to public records requests, but rather must be kept confidential. 5 It states: All information collected during the performance of this contract shall be considered as confidential commercial information, including the Establishment Inspection Report (EIR), FDA 483, or equivalent forms, evidence collected, and all other supporting documentation. Evidence and supporting documentation may include supplier, receiving, and distribution records, photographs, complaint records, laboratory results, and other documents collected during the performance of the contract. The Contractor shall notify the Division Technical Advisor within three (3) business days after receipt of a public records request for information obtained during the performance of the contract is received. The Contractor is not authorized to release confidential commercial information. (emphasis added). The Department trains staff to conduct various types of inspections of food establishments. The Department also issues inspectors equipment to be used to perform their duties. This includes tools such as a flashlight, probe thermometer, test strips for sanitizers, and mobile phones. The Department- issued phones have a camera to take photographs during an inspection. The Department has developed the Manufactured Food Inspection Protocol (Protocol) which contains the following instructions for inspectors: 6.5 Refusal of Inspection Notify a manager immediately if you are denied entry to any part of the establishment including being restricted from taking photographs of violative conditions, collecting samples, or if the 5 Chapter 500 is to be interpreted to be consistent with the FDA's rules and regulations. See § 500.09(3), Fla. Stat. Additionally, the Department has adopted federal regulations and other standards. Fla. Admin. Code R. 5K-4.002. Article 5.3.4 of the FDA's Investigation Operations Manual (2021) provides further instructions and guidance to inspectors of documenting conditions using photographs during inspections. See FDA website at: https://www.fda.gov/media/113432/download (last visited April 6, 2021). establishment management or person in charge refuses to provide access to required food records; this may constitute a refusal of inspection. * * * 7.1 FIMS Review [Before an inspection] review recent inspection reports … for attached files, documents, photographs, etc. * * * 8.1.1. Signing of Non-FDACS Documents Circumstances may arise in which a food establishment requests the [inspector] to sign documents during the inspection. Listed below are specific guidelines for these circumstances. Contact a manager f you encounter a situation not listed. 8.1.2 Proprietary Documents Florida Statute Chapter 500.147 authorizes the Department to have access to any food establishment … for the purposes of inspecting such establishment … to determine whether this chapter or any rule adopted under this chapter is being violated. Documents including, but not limited to, waivers, nondisclosure, confidentiality agreements may include language that inhibits our authority to conduct the inspection. If you are asked to sign these types of documents inform the person in charge that you are not authorized to sign the documents. If they persist and /or deny you entry, contact a manager as this may constitute a refusal of inspection. * * * 8.1.4 Sign-In and Sign-Out Rosters All FADCS employees are authorized to sign-in and sign-out at food establishments, so far as they sign- in document does not include language that would impede the inspection. * * * 13. Inspection Techniques and Evidence Development Collect adequate evidence and documentation in accordance with FDACS procedures to support inspectional observations such as those listed below: * * * 13.2 Photographs Photographs serve as supporting evidence when documenting violative practices or conditions. Photographs should be related to conditions contributing to adulteration of the finished product. Excessive amounts of photographs are not necessary to support your documentation. Ensure photographs clearly represent the conditions observed. These photographs must be uploaded to the FIMS inspection visit. As explained by Inspectors Frank Kilgore and Bhisham Ojha it is "not uncommon" for inspectors to take photographs during an inspection for various reasons. The most obvious reason is to document violative conditions. An example given at the hearing was of an inspector using a camera to take photographs of rodent droppings (which are presumably a health and safety violation in a food establishment) to show they existed inside a particular facility. Another reason an inspector would take photographs would be to establish whether the product is interstate commerce. An inspector could take a photograph of the packing materials on the box in a food establishment to later determine whether it had been shipped from out of state. Inspectors can also document through photographs whether a facility is operating beyond the scope of its permit or license. For example, an entity may be permitted to operate as a warehouse, but during the inspection it may be discovered that the entity is also repacking seafood or spices. A photograph of the unlicensed activity can be included in the inspection report to establish the improper activity. Finally, photographs are helpful for follow-up inspections to establish whether a violation still exists. For example, a piece of equipment may be broken or dirty in violation of safety regulations during an inspection. On the follow-up inspection, a comparison can be made to a photograph taken during the original visit to establish if it has been repaired or cleaned. Inspectors are trained to take photographs during an inspection and how they can be used. As stated in the Protocol and supported by the testimony of the inspectors, an inspector must have a need for taking a picture, such as a suspected violation, and cannot take pictures for no reason. In addition to instructing inspectors on how to use photographs, the Protocol advises inspectors on what types of documents they can sign as long as there are no restrictions on their ability to conduct the inspection. Although they are allowed to sign a "Sign-In/Sign-Out" sheet, they are not to sign "waivers, nondisclosure, confidentiality agreements may include language that inhibits our authority to conduct the inspection." If faced with these documents, they are to refuse to sign them; if denied entry by the entity being inspected, the inspector is instructed to contact the Department. March 9, 2020 On March 9, 2020, Mr. Kilgore and Mr. Ojha visited Tampa Maid's facility to conduct an HAACP and FDA contract inspection. Mr. Kilgore was the lead inspector and was training Mr. Ojha. Upon arrival, the inspectors were asked to sign a COVID protocol acknowledgment or questionnaire. When the inspectors refused to sign the document, Tampa Maid accepted their verbal answers to the COVID questions. Then, as a prerequisite to entering the part of the Facility the inspectors were to inspect, Rod Stokes, Tampa Maid's Director of Food Safety and Quality Assurance, asked the inspectors to sign a ledger titled "Visitors Register," located at a desk in the office of the Facility. The Visitors Register was located on a desk next to a large placard which stated, "FOOD DEFENSE. PLEASE SIGN IN." Next to the Visitors Register and underneath the placard was a document titled, "Visitor's Information" and is copied below: The "Visitor Information" sheet included a list of 14 items typed in "ALL CAPS" including instructions (such as "sign in," "be careful of moving equipment," "do not touch the equipment," and "report any intestinal illness") and prohibitions (for jewelry, gum, food, tobacco, open-toed shoes, and weapons). The item at issue is located in the middle of the list: "8. No Cameras Allowed." At the very bottom of this document, after being instructed to "enjoy your visit," in a smaller font and not capitalized, was a conclusion that, by signing the visitor's log (presumably the same as the "Visitor's Register") a visitor was agreeing to follow the 14 listed statements. Both inspectors had visited the Facility on previous occasions and both had signed the Visitors Register. Mr. Ojha claimed he did not recall the "no camera" instruction listed as number eight on the Visitor Information sheet and did not agree to it, nor did he follow the instructions. Rather, he kept the Department-issued phone, which had the camera, in his back pocket during the inspection. Mr. Kilgore remembered previously signing the Visitors Register, but he did not notice the Visitor Information language. He explained that the Visitor Information sheet was not attached to the Visitors Register. If he had noticed the language, he would not have signed the ledger. He also claimed that he always kept the Department issued phone with him during inspections. When the Department inspectors refused to perform the inspection without their cameras on March 9, 2020, Mr. Stokes would not allow them to proceed. Mr. Stokes did not believe the inspectors had the authority to use a camera during the inspection, and he demanded that the inspectors or the Department give him the legal basis for the Department's authority to bring cameras into a facility. Although there was a discussion between Mr. Stokes and Department staff, nothing was provided to Mr. Stokes to change his mind. Ultimately, Mr. Kilgore informed Mr. Stokes that they would not conduct the inspection without their phones and that prohibiting them from entering the Facility with cameras could result in a refusal of inspection. Mr. Stokes continued to refuse to let the inspectors proceed into the Facility with their Department-issued phones. No inspection took place on March 9, 2020, and there is no evidence the Tampa Maid Facility has been inspected since that time.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered as follows: Finding that Tampa Maid denied the Department free access to its facility in violation of section 500.147, Florida Statutes, as alleged in the Administrative Complaint, when it refused to let inspectors enter with cameras. Requiring Tampa Maid to pay an administrative fine in the amount of $1,000. Suspending Tampa Maid's Food Permit (Food Permit No. 28143) until such time that access to the food establishment is freely given to the Department. DONE AND ENTERED this 12th day of April, 2021, in Tallahassee, Leon County, Florida. S HETAL DESAI Administrative Law Judge 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 12th day of April, 2021. COPIES FURNISHED: Allan J. Charles, Esquire Department of Agriculture and Consumer Services Suite 520 407 South Calhoun Street Tallahassee, Florida 32399 Magdalena Ozarowski, Esquire Department of Agriculture and Consumer Services Suite 520 407 South Calhoun Street Tallahassee, Florida 32399 Honorable Nicole "Nikki" Fried Commissioner of Agriculture Department of Agriculture and Consumer Services The Capitol, Plaza Level 10 Tallahassee, Florida 32399-0810 Daniel J. Fleming, Esquire Johnson Pope Bokor Ruppel & Burns, LLP Suite 3100 401 East Jackson Street Tampa, Florida 33602 Steven Hall, General Counsel Department of Agriculture and Consumer Services 407 South Calhoun Street, Suite 520 Tallahassee, Florida 32399-0800
Findings Of Fact The Petitioner is a not-for-profit Florida corporation, licensed by the Florida Department of Insurance to do business as a Health Maintenance Organization (HMO). It enrolls members and provides them with direct medical care. Petitioner was acquired by the Halifax Hospital Taxing District, a special taxing district and political sub-division of the State of Florida, in 1994. Respondent is the state agency authorized to implement the collection and enforcement of Florida tax laws. Petitioner is a staff model HMO which enrolls people who become members and provides direct medical aid to these members. This medical aid is provided by physicians employed by Petitioner, as well as some outside physicians who have contracted with Petitioner. Membership consists of these major groups: Medicare subscribers, school children enrolled in the Florida Healthy Kids Programs and private employers. Petitioner enrolls two classes of members that would fall into the category of "persons unable to pay", i. e. Medicare beneficiaries and Healthy Kids participants. Petitioner has two Medicare Programs for Medicare beneficiaries. One in which the member pays nothing and receives medical aid and a reduced prescription benefit, and another in which the member pays $15.50 per month and receives medical aid and additional benefits such as a prescription benefit, hearing aid benefit, and optometry benefit with small co-pays. Petitioner provides this comprehensive medical aid under a contract with the Health Care Financing Administration at a HCFA-approved capitation rate. Prescription benefits provided to Petitioner's Medicare members cost Petitioner $36.18 per member, per month, approximately fifty percent of average wholesale price. Non-members of Petitioner seeking their Medicare benefits through traditional Medicare, would pay an average of $70.00 per month for their prescription benefit. Approximately eight percent of the Medicare population in Petitioner's service area fall below Federal Poverty Guidelines. The economic make-up of Petitioner's Medicare membership is inferred to be reflected in its Medicare membership. Petitioner infers that eight percent of its membership falls below Federal Poverty Guidelines and are persons unable to pay. Petitioner's total expenses for the nine-month period ending March 31, 1995, were $64,675,533.32. The Medicare costs for that period were $37,421,480.36. Eight percent or $2,993,718.40, were spent for persons who were unable to pay. Petitioner provides comprehensive medical aid to children in its Healthy Kids Program. The Healthy Kids Program is a state-subsidized program in which children, who were not eligible for medicaid but whose parents do not have health insurance for them, could obtain health coverage. Petitioner was the HMO selected by the Healthy Kids Corporation, the corporation created by the Florida Legislature to operate the Healthy Kids Program, to provide this comprehensive medical aid under a monthly capitation. Petitioner operates its Healthy Kids Program at a loss ratio of approximately 101 percent, i. e. over one hundred cents of every dollar collected goes to direct medical aid to Healthy Kids participants. HMO's traditionally operate with a loss ratio of eighty percent, i. e. eighty cents of every dollar collected goes to the provision of medical care and the other twenty percent would go into administrative expenses. Eighty two point two (82.2) percent of participants in Petitioner's service area fall below Federal Proverty Guidelines and are persons unable to pay. The Healthy Kids' costs for the period ending March 31, 1995 were $3,890,964.65; 82.2 percent, or $3,198,372.90, was spent for persons who were unable to pay. For the nine-month period ending March 31, 1995, a total of $6,192,091.30, or 9.6 percent, was spent on persons who were unable to pay. Any surplus generated from the activities of Petitioner, other than through its participation in the Healthy Kids Program, is turned over to the Halifax Hospital Taxing District. Any surplus generated from participation in the Healthy Kids Program contract is returned to the Healthy Kids Corporation. Petitioner spends in excess of fifty percent of its expenditures on medical aid for the relief of disease, injury, or disability. Medicare is a federally sponsored program available to people sixty- five and over who do not receive medical benefits through an employer. It is available without regard to the person's income level. Medicare is also available to persons under sixty-five who are totally disabled for two months or longer. Medicare subscribers accounted for 12,917 of Petitioner's total of 45,759 subscribers during the relevant nine month period. Petitioner is reimbursed by the federal government at the fixed capitation rate of $365 per month for each Medicare subscriber enrolled as a member of the HMO. Thus, for a nine month period corresponding to Petitioner's financial data, the Petitioner received $42,432,345 from the federal government attributable to Medicare subscribers. Medicare expenses for a nine month period were $37,421,000. Petitioner's federal Medicare revenue exceeded its total Medicare cost by $5,011,345 for the relevant nine month period. This figure is understated because it does not reflect revenue received from the $15.50 supplemental premium for additional benefits. There are two competitors for Medicare subscribers in the Petitioner's market area. Each provider receives the same capitation rate from the federal government. The competitors offer Medicare recipients different programs in which they may enroll. The competitors offer a slightly different product at a higher premium. No testimony was introduced to compare the premium charged and the plans offered by other providers with that offered by other providers with that offered by Petitioner. Prescription medicine is not being provided free of charge or at a substantially reduced cost to those unable to pay. It is not Petitioner's policy to waive the supplemental premium based upon the subscriber's income level, although some Medicare subscribers who get behind on the co-payment are not terminated for that reason. Petitioner's prescription benefit plan is part of a marketing strategy intended to attract Medicare subscribers. Petitioner subsidizes the prescription benefit to attract subscribers. Without the necessary subscriber base, Petitioner would be forced to lay off a portion of its physician employee workforce. Another portion of the Petitioner's subscriber base consists of school age children enrolled in the Healthy Kids Program (the Program). During the nine month period reflected in Petitioner's financial data, 7,130 children were enrolled in the Program. Enrollment in the program is open to all Volusia County school children who do not have health insurance and are not eligible for federal Medicaid health coverage. Approximately 80 percent of those enrolled fell below 135 percent of the federal poverty guideline. The Florida Healthy Kids Corporation is empowered to enter into contracts with health care providers to provide health care benefits to participants. The idea is to provide children who would not otherwise receive coverage with regular health care. Petitioner entered into a competitive bidding process to act as the Volusia area provider for the Healthy Kids Program. Participation in the Program requires the Petitioner to provide health care services to those children who qualify for admission into the program. The Petitioner receives a monthly premium payment per child based upon enrollment. This rate is set by the competitive bidding process. For the period of time reflected in the Petitioner's nine month financial data, the rate was $46.50 per month. This rate generated a surplus. The rate is presently $43 per month. The Program is funded by a combination of state and local tax dollars and premium contributions from parents. Parental contributions are based on a sliding scale which adjusts for income. Parents with incomes below federal poverty guidelines do not have to contribute towards the premium payment; any difference is made up by state and local tax dollars. That a percentage of children live at or below a federal poverty guideline has no demonstrated affect on the cost of Petitioner's services to those children. Petitioner does not establish the economic guidelines used to fix a parent's share of the premium. Petitioner does not receive more or less revenue based upon the income status of a parent or child. Petitioner is not aware of the particular economic status of individual children enrolled in the Program. Petitioner does not provide children in the Program with medical services for free or at a substantially reduced cost to those unable to pay. The Healthy Kids Corporation, in cooperation with state and local governments, provides the subsidy for enrollment of children in families with an income at or below the federal poverty guidelines.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Department of Revenue enter a Final Order denying a consumer's certificate of exemption to Petitioner. DONE and ORDERED this 26th day of November, 1996, in Tallahassee, Florida. DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 26th day of November, 1996. COPIES FURNISHED: Pamela J. Thomas, Esquire Florida Health Care Plans 1340 Ridgewood Avenue Holly Hill, Florida 32117 Kevin J. O'Donnell, Esquire Department of Revenue Post Office Box 6668 Tallahassee, Florida 32314-6668 Linda Lettera Department of Revenue 204 Carlton Building Tallahassee, Florida 32399-0100 Larry Fuchs Executive Director Department of Revenue 104 Carlton Building Tallahassee, Florida 32399-0100
The Issue This issues in this proceeding are whether Respondent, in violation of Chapter 509, Florida Statutes (2004), committed acts alleged in the Administrative Complaint dated April 16, 2004, and, if so, what disciplinary action should be taken against the license held by Respondent.
Findings Of Fact Based upon observation of the witnesses and their demeanor while testifying in person and the documentary materials received in evidence, stipulations by the parties, evidentiary rulings made during the final hearing, and the entire record compiled herein, the following relevant and material facts are found: At all times material hereto, Respondent, Bacco's Restorante Italliano, a food service and eating establishment, was licensed and regulated by Petitioner, Department of Business and Professional Regulation, Division of Hotels and Restaurants, having been issued license number 6804773-R, type 2010, a Permanent Food Service license. Respondent's facility is located at 23 North Lemon Avenue, Sarasota, Florida. Andrea Posani testified that he was a "party of interest" in the proceeding because he had a financial interest in Bacco's Restorante Italliano, a food service and eating establishment, and he possessed authority to speak on behalf of (and represent) Respondent, Bacco's Restorante Italliano, licensee. Petitioner's witness, Daniel Erdman, deputy district manager (for three months) and senior sanitation safety specialist for the preceding five years (1999 through 2004) in Manatee and Sarasota counties, earned his Bachelor of Science degree from Florida State University with a major in hospitality administration. Mr. Erdman conducts more than 1,500 inspections annually. Mr. Erdman described a "critical violation" in the food business as violation of any of the Florida Statutes, the Florida Administrative Code rules, and the Food Code, that "has more of a potential for food borne ailments." Mr. Erdman has been Petitioner's inspector of Respondent's business for more than four years in both locations, first, on Main Street and, now, on Lemon Street, in Sarasota, Florida. Mr. Erdman, on March 1, 2004, inspected Respondent's business, noted violations on DBPR Form HR 5022-014 that was signed by Mr. Erdman and Claudia Zecchin-Moschini (Claudia Zecchin at the time of signing), and a copy was given to Ms. Zecchin-Moschini. Thereon was the "callback date/time that informs Respondent of both the time to correct noted violation(s) and the inspection return date. The Administrative Compliant alleged the following critical violations of Chapter 509, Florida Statutes (2003), Florida Administrative Code, and/or rules of the Division of Hotels and Restaurants noted during the March 1, 2004, inspection: 27-22 5-202.12 FC Handwashing Facility, Installation. (A) A handwashing lavatory shall be equipped to provide water at a temperature of at least . . . (110 degrees Fahrenheit) through a mixing valve or combination faucet. (B) A steam mixing valve may not be used at a handwashing lavatory. (C) A self-closing, slow-closing, or metering faucet shall provide a flow of water for at lease 15 seconds without the need to reactivate the faucet. (D) An automatic handwashing facility shall be installed in accordance with manufacturer's instructions. Observed no cold water provided at handsink (Bar) 2. 31-10 5-204.11 & 6-401.10 FC Handwashing Facility. Conveniently Located. A handwashing facility shall be located: (A) To allow convenient use by employees in food preparation, food dispensing, and warewashing areas; and (B) in, or immediately adjacent to, toilet rooms. Observed missing handsink at dishwashing machine/cold prep area (removed) 3. 31-10 5-204.11 & 6-401.10 FC Handwashing Facility. Conveniently Located. A hadwashing facility shall be located: (A) To allow convenient use by employees in food preparation, food dispensing, and warewashing areas; and (b) in, or immediately adjacent to, toilet rooms. Observed no handsink provided in prep area, bread station service area in dining room without a handwashing sink. Bread station was removed from dining room on 3.15.2004 on reinspection evidence of bread station observed on 4.02.04 4. 53B-01 509.049 FS Food Service Employee Training. The Division shall adopt, by rule, minimum food safety protection standards for the training of all food service employees who are responsible for the storage, preparation, display, or serving of foods to the public in establishment regulated under this chapter. These standards shall not include an examination, but shall provide for a food safety training certificate program for food service employees to be administered by a private nonprofit provider chosen by the Division. Any food safety training program established and administered to food handler employees prior to the effective date of this act shall be submitted by the operator to the Division for its review and approval. It shall be the duty of the licensee of the public food service establishment to provide training in accordance with the described rule to all employees under the licensee's supervision or control. The licensee may designate a certified food service manager to perform this function as an agent of the licensee. Food service employees must receive certification pursuant to this section by January 1, 2001. Food service employees hired after November 1, 2000, must received certification within 60 days after employment. Certification pursuant to this section shall remain valid for 3 years. Observed no proof or required employee training 11 employees over 60 days employed (Reihou, Terrence, Paolo) [Emphasis added] Mr. Erdman, on March 15, 2004, returned and inspected the facility, finding violations 27-22, 31-10, and 45-14. These violations were granted time extension for correction to April 2, 2004. Mr. Erdman returned on April 2, 2004, and inspected the facility, identifying seven violations (two 27-22s, three 31- 10s, and two 53B-01s). During this reinspection, Mr. Erdman entered, in the comment section of his inspection report "note plumber scheduled for sink installation, water to bar tomorrow. Employee food safety training booklets ordered [training not completed]. Bread baskets, plated [sic], bread warmer, crumbs etc. observed in dining area/no hand sink provided." This report was not a warning as were the prior inspection reports; this report recommended filing of an administrative complaint. Respondent's witness, Ms. Zecchin-Moschini, when asked by Respondent, could not recall circumstances pertaining to each alleged violation. Her answers, on both direct and cross examinations, consisted primarily of "I don't remember," on four separate occasions. "I don't remember" is the answer given when Ms. Zecchin-Moschini was asked about the location of the sink and the present location of the beer cooler. This witness acknowledged that she did not have food management training: Yes, I don't have the training for these people. They were being coming from another restaurant, working there for a couple years, and I didn't ask them if they have any. I never got it. The only one that was there was Paolo that he didn't have. Mr. Posani admitted having no personal knowledge of the sink location violation and having no personal knowledge regarding the food management training violations for three of his employees. The record was left open for ten days for post- hearing submission of documentation of training, and none was submitted at the entry of this Recommended Order. Mr. Posani offered no credible and material evidence that could be considered a legal challenge to violations itemized in the Administrative Complaint and established by Respondent's witness' unrefuted testimony and exhibits in evidence. Petitioner proved, by clear and convincing evidence, each specific allegation against Respondent contained in the Administrative Complaint filed in this cause. Petitioner's compliance with cited Florida Statutes and cited rules of the Florida Administrative Code permits the imposition of penalty against Respondent for violations hereinabove found.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order: Finding Respondent guilty of violating Subsection 509.049(5), Florida Statutes (2004), and Sections 5-202.12, 5-204.11, and 6-401.10 of the Food Code, incorporated by reference and applicable to Florida Administrative Code Chapters 61C-1, 61C-3, and 61C-4; and Imposing an administrative penalty in the amount of $250.00 per violation for a total penalty amount of $1,000.00, due and payable to: Division of Hotels and Restaurants, 1940 North Monroe Street, Tallahassee, Florida 32399-1011, within 30 calendar days of the date the final order is filed with the agency clerk. DONE AND ENTERED this 5th day of July, 2005, in Tallahassee, Leon County, Florida. S FRED L. BUCKINE 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 5th day of July, 2005. COPIES FURNISHED: Charles F. Tunnicliff, Esquire Department of Business and Professional Regulation 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-2202 Andrea Posani 23 North Lemon Avenue Sarasota, Florida 34236 Geoff Luebkemann, Director Division of Hotels and Restaurants Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Leon Biegalski, General Counsel Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-2202
The Issue Whether Respondent, a licensed nutritional counselor, committed the offenses alleged in the administrative complaint and the penalties, if any, that should be imposed.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of nutritional counseling pursuant to Section 20.42, Florida Statutes; Chapter 455, Florida Statutes, and Chapter 468, Florida Statutes. Respondent was licensed as a nutritional counselor at all times pertinent to this proceeding. Respondent was issued license number NC 0000427 in 1990. At the time of the formal hearing, Respondent’s address was 6661 Royal Palm Boulevard, Margate, Florida 33063-2108. At all times pertinent to this proceeding, C. B. was a female cancer patient of Franciso Bellette, M.D., a physician specializing in the field of oncology. Before Dr. Bellette moved to Florida in 1993, C. B. was treated by another physician in the practice group that Dr. Bellette subsequently joined. Prior to 1993, C. B. had chemotherapy, which she tolerated poorly. In October 1995, Dr. Bellette diagnosed C. B. as having Stage 4 breast cancer with bony metastasis. Although the preferred treatment was chemotherapy, C. B. refused further chemotherapy because of her poor prior experience with chemotherapy. As the alternative treatment, Dr. Bellette prescribed the drug Tamoxifen for C. B., and she began taking that medicine. Tamoxifen has been used to treat cancer patients for several years. There are documented side effects and risks associated with taking the drug. Dr. Bellette was aware of those side effects and risks and explained them to C. B. before she began taking Tamoxifen. It was Dr. Bellette’s opinion that for C. B. the benefits of taking Tamoxifen outweighed the known side effects and risks. In January 1996, C. B. traveled to Mexico to investigate an alternative treatment plan that included special diets. Because of the language barrier, she was not certain she understood the nutritional counseling she had received in Mexico. After she returned from Mexico, C. B. made an appointment with Respondent to discuss her nutritional needs. C. B. and Respondent met only on one occasion in late January or early February 1996. Respondent’s nutritional counseling typically includes three visits. The first visit is typically an informal meeting during which he explains nutritional counseling to the prospective client, which includes a discussion as to the client’s nutritional needs and goals. If the client wants to continue with the other two visits, Respondent prepares and thereafter implements a nutritional plan for the client. C. B. decided that she did not want to pursue the other two visits with Respondent. Consequently, Respondent did not prepare a nutritional assessment of C. B., did not prepare a nutritional plan for C. B., and did not become her nutritional counselor. During his meeting with C. B., Respondent discussed her illness and the fact that she was taking Tamoxifen. C. B. testified in her deposition that Respondent told her that Tamoxifen was a killer drug and that she should stop taking the drug. C. B. also testified that she was sure Respondent had told her to stop taking Tamoxifen. Respondent testified, credibly, that he did not tell C. B. to stop taking Tamoxifen, but that he discussed the drug and its severe side effects with her so she could make an informed decision as to her course of treatment. C. B. was in hospice at the time of her deposition and heavily medicated. C. B. readily conceded that the medication she was on impaired her memory. It is not clear whether C. B. accurately recalled the statements made by Respondent, as opposed to recalling her interpretation of what Respondent had said. This conflict in the evidence is resolved by finding that Respondent discussed with C. B. the severe side effects of Tamoxifen in a manner designed to discourage C. B. from taking the medicine. The testimony of C. B. is insufficient to establish by clear and convincing evidence that Respondent told her to stop taking Tamoxifen. Respondent did not hold himself out as a physician or as a pharmacist.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order that adopts the findings of fact and conclusions of law contained herein. It is further recommended that the final order dismiss the administrative complaint against Respondent. DONE AND ENTERED this 5th day of June, 1997, in Tallahassee, Leon County, Florida. Hearings Hearings CLAUDE B. ARRINGTON Administrative Law Judge Division of Administrative The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative this 5th day of June, 1997
