Findings Of Fact Case History On April 10, 1987, Petitioners filed a Petition for Formal Administrative Hearing and for Administrative Determination of Invalidity of a Rule as described in the Issues statement to this Order. On April 20, 1987, Intervenors requested intervention. On April 20, 1987, Respondent Board moved to dismiss the petition filed by the Petitioners and to stay the proceedings. On April 27, 1987, oral argument was held on the petition to intervene, the motion to dismiss, and the request to stay proceedings. On April 29, 1987, an order was entered which granted the intervention, and denied the motions to dismiss and to stay. The case was originally scheduled to be heard on May 5 and 6, 1987. Upon stipulation and agreement of the parties to waive the requirement set forth in Section 120.56, Florida Statutes, calling for the conduct of the final hearing within 30 days of assignment of this matter to a Hearing Officer, the case was rescheduled for hearing to be held on June 11 and 12, 1987. The First District Court of Appeal in Dept. of Professional Regulation, et al. v. William J. Broussard, M.D., et al., Case Nos. 87-238/87-260, issued an order staying the conduct of the hearing to be held on June 11 and 12, 1987. The stay was eventually dissolved as a result of an order entered by the First District Court of Appeal on July 23, 1987, in the aforementioned appellate court cases. The administrative case was then returned to an active status before the Division of Administrative Hearings and scheduled for hearing on dates including October 5 and 6, 1987, the eventual dates for hearing. Prior to the commencement of the hearing, Intervenors sought action on a motion to dismiss the Florida Medical Association as a petitioner. That motion was denied. Another preliminary matter related to the September 2, 1987, request for production of documents from the physician petitioners. On October 2, 1987, Petitioners had objected to that request for production. On October 5, 1987, Intervenors had filed a motion to compel physician petitioners to produce certain economic information and financial records related to allegations of standing. Prior to the commencement of the hearing on October 5, 1987, and in the face of remarks by counsel for the Petitioners, it was determined that the physician petitioners did not intend to advance a claim of economic injury in the sense of a change in economic circumstances in their practices with the advent of the licensure of certified optometrists. As a consequence, the requested production became a moot question and the motion to compel was denied. Enabling Legislation In 1986, the Florida Legislature reenacted the Optometry Practices Act, as Chapter 86-289, Laws of Florida. Section 6 of that Act set forth the opportunity for practitioners licensed as certified optometrists to administer and prescribe topical ocular pharmaceutical agents for the diagnosis and treatment of ocular conditions of the human eye and its appendages. The specific provisions which establish the requirements for certification are announced in Section 463.0055(2), Florida Statutes (1986 Supp.) as: The board shall issue certification for the administration and prescription of topical ocular pharmaceutical agents in the diagnosis and treatment of ocular conditions to licensed practitioners who have completed the appropriate forms as required by the board and who have submitted proof of fulfilling all of the following requirements: Successful completion of at least 110 hours of approved transcript-quality coursework and clinical training in general and ocular pharmacology, as determined by the board. However, no course in pharmacology shall be approved by the board unless the course is conducted by an institution which has facilities for both the didactic and clinical instructions in pharmacology and which is accredited by a regional or professional accrediting organization that is recognized and approved by the Council on Post-secondary Accreditation or the United States Department of Education. Completion of at least 1 year of supervised experience in differential diagnosis of eye disease or disorders as part of the optometric training or in a clinical setting as part of optometric experience. Successful completion of an examination approved by the board which tests knowledge of general and ocular pharmacology with particular emphasis on the topical applica- tion of pharmaceutical agents for the eye and the side effects of such pharmaceutical agents. A related provision at Section 463.002(9), Florida Statutes (1986 Supp.), describes "transcript-quality" as follows: (9) "Transcript-quality" means a course which is in conjunction with or sponsored by a school or college of optometry or equivalent educational entity, which course is approved by the board and requires a test and passing grade. Section 463.0055(3), Florida Statutes (1986 Supp.), pertains to the payment of fees associated with becoming a certified optometrist. It states: (3) The board shall establish by rule an application fee, not to exceed $250, and an examination fee, not to exceed $250, for certification pursuant to this section. Section 463.0055(4), Florida Statutes (1986 Supp.), establishes a formulary committee which will assist DPR in identifying those topical ocular pharmaceutical agents that may be utilized by the certified optometrist in his or her practice. The decision to enact legislation providing for certification of optometrists to use topical ocular pharmaceutical agents for the diagnosis and treatment of ocular conditions in the human eye was passed in a setting in which optometrists within Florida had historically been involved with the administration and prescription of diagnostic and therapeutic drugs. The overall facts of this case demonstrate that this legislation was designed to specifically set forth the framework for allowing the employment of those pharmaceutical agents or drugs in the future. Adoption of Rule 21Q-10.001, Florida Administrative Code, etc. In an attempt to effectuate the purposes of Section 463.0055(2), Florida Statutes (1986 Supp.), the Board adopted Rule 21Q-10.001, Florida Administrative Code. The rule was first noticed for adoption in Vol. 12, No. 38 of the Florida Administrative Weekly, published September 19, 1986. The rule was adopted by the Board and filed with the Secretary of State on October 31, 1986. The effective date of Rule 21Q-10.001, Florida Administrative Code, is November 20, 1986. In the issue of the Florida Administrative Weekly described in the previous paragraph, the Board published amendments to the rule pertaining to fees which is Rule 21Q-6.001, Florida Administrative Code. Those amendments were filed with the Office of the Secretary of State on October 31, 1986. They became effective on November 20, 1986. Within that set of amendments on fees, the Board created a $100 application fee "for certification as a certified optometrist" and a $250 examination fee "for certification as a certified optometrist." The text of Rule 21Q-10.001, Florida Administrative Code, states: 21Q-10.001 Application for Certification. To be certified to administer and prescribe topical ocular pharmaceutical agents a licensed practitioner must submit a completed application form provided by the Board, remit the application fee for certification speci- fied in Rule 21Q-6.001(9), and demonstrate compliance with the following requirements: Successful completion of at least 110 hours of Board approved transcript quality coursework and clinical training in general and ocular pharmacology conducted by an accredited institution which has facilities for both didactic and clinical instruction in pharmacology. The institution must document the applicant's successful completion. The Board will accept coursework and clinical training in general and ocular pharmacology received by the applicant during his basic optometric curriculum or at postgraduate courses if this coursework and training was provided by a Board approved school of optometry or equivalent educational entity; Completion of at least one (1) year of supervised experience in differential diagnosis of eye diseases or disorders. The one year of supervised experience shall be received either during optometric training or in a clinical setting as part of optometric experience. The requisite one year of supervised experience in a clinical setting may be obtained in an academic or non- academic environment. For the purpose of this rule, one year of supervised experience in an academic setting is understood to mean three (3) quarters or two (2) semesters and one (1) year of supervised experience in a non-academic setting is understood to mean a twelve month period; Successful completion of a Board approved examination testing knowledge of general and ocular pharmacology with particular emphasis on the topical application of pharmaceutical agents. In order to be approved by the Board, the examination must have been administered in a Board approved school of optometry or at the conclusion of a post- graduate course conducted by a Board approved school of optometry, and the examination must be approved by the Board. Board Activities in Certifying Optometrists In preparation for implementing the statute, in July 1986 Board Chairman Edward K. Walker, O.D., appointed Jon S. Jacobs, O.D., as an ad hoc committee of one to begin gathering information from the schools and colleges of optometry. Dr. Jacobs' mission was to gather information from the schools and colleges to present to the Board so that it could determine whether the level and quality of the education, curriculum, examinations and supervised clinical experience in differential diagnoses received by optometry graduates of the various schools satisfied the criteria contained in Section 463.0055(2), Florida Statutes (1986 Supp.). Licensed practitioners of optometry in Florida have been educated at eighteen different schools and colleges of optometry. Dr. Jacobs contacted either the president or dean of each of these institutions in order to obtain information for the Board's consideration. On August 1, 1986, Dr. Jacobs wrote each of the schools and colleges. In his letter Jacobs cited the language of the statute and asked the schools to respond to the different sections of the law by providing the Board with information concerning whether and when graduates of their institution satisfied the statutory criteria. He requested specific information from the schools concerning how many clock hours of coursework in general and ocular pharmacology they required and in what years they required them. He inquired whether or not students had to pass the pharmacology courses in order to graduate. He asked that the schools provide the Board with the pharmacology examinations given to their graduates. Dr. Jacobs also requested that the schools provide the Board with the information which would establish the beginning year in which the institution required of their graduates one year of supervised experience in differential diagnosis of eye disease or disorders. In addition to requesting information concerning the school's basic curricula leading to the O.D. degree, Dr. Jacobs also requested information on postgraduate and continuing education coursework offered by the institutions. The Board interprets the 110-hour requirement as referring to "clock hours" and not to "credit hours." The Board has determined that the accreditation of a school is evidence of its having facilities for both the didactic and clinical instructions in pharmacology. The optometric schools in question are accredited. All of the schools responded with information from which the Board could determine if and when the school met the 110 clock hour requirement and the requirement of one year of supervised experience in differential diagnosis. All of the schools provided information to the Board which indicated that their students were required to pass the pharmacology courses in order to graduate and therefore satisfied the "successful completion of at least 110 hours" criterion. Follow-up correspondence and telephone conversations with the presidents or deans were necessary to clarify the Board's request and verify the school's response. Many of the schools and colleges expressed concern about the confidentiality of the examinations which the Board had requested. The Board assured the schools that it would not be reviewing the exams for any purpose other than complying with its statutory responsibilities. The information was submitted to the Board in various forms by the schools and colleges and included catalogs, lists of pharmacology courses, and narrative or individual curriculum descriptions of pharmacology courses offered by the institutions. All of the schools and colleges submitted examinations to the Board, but not all examinations given in the relevant courses. Some of the schools submitted as many as eight examinations. The exams submitted were administered by the schools at various times. Many of the schools submitted information which indicated that they maintain computerized banks of examination questions from which they draw randomly in constructing examinations. In some instances, the Board received representative examinations because all of the exams the school had ever administered were not available. With the assistance of the Board's executive director, Dr. Jacobs compiled the information he had gathered from the various schools in chart form and presented it to the Board for its consideration. The ad hoc committee of one composed of Dr. Jacobs evolved into a three member certification committee. In August of 1986, Peter Liane, O.D., became chairman of the Board and appointed Dr. Jacobs as chairman of the Board's Certification Committee. Dr. Liane also appointed himself and Dr. Walker to the committee. The mission of the certification committee was to determine the minimum requirements of the statute, further organize the information Jacobs had gathered, and recommend to the Board those who were to be certified or not based upon documentation and evidence of what they deemed to be compliance with the statute. In reviewing the information it had gathered, the Board viewed the statutory criteria as requiring it to answer three questions: (1) Have applicants for certification received the requisite quantity and quality of coursework?; (2) Have applicants obtained the requisite differential diagnosis experience?; and (3) Are applicants safe to prescribe and administer topical ocular pharmaceutical agents based on passage of a Board approved examination which tested their knowledge of pharmacology and the side effects related to topically applied pharmaceutical agents? The Board reviewed the curriculum and the catalogs and information it received from the schools of optometry. The Board was satisfied about the accuracy of the information it received from the schools and colleges based upon the Board's knowledge of the programs in the schools, including experiences of four members of the Board who sit on the boards of trustees of various colleges of optometry. The Board relied upon the information, statements, and representations they received from the deans and colleges concerning when their graduates complied with certain statutory criteria. The Board determined that it would accept education, training, and examinations from the schools and colleges of optometry and other equivalent entities in order to satisfy statutory criteria for certification. When asked to describe in general terms what the Board was looking for in reviewing the exams to determine if the coursework in pharmacology was in compliance with Section 463.0055(2)(a), Florida Statutes (1986 Supp.), Board members identified that they reviewed examinations to determine whether the course content, as set forth in the exam instrument, was at least 75 percent related to general and ocular pharmacology. The 75 percent standard was chosen by the Board as an arbitrary number which represented "a substantial portion of the test." A number of courses and their exams were not recommended for approval on the basis that the examinations lacked enough questions related to pharmacology to meet this requirement established by the Board. Although the deans and colleges assured the Board that their school's coursework satisfied the pharmacology criterion, it was the Board's understanding that the Legislature intended for the Board to "approve" the coursework by looking at it to determine the quality and level of that coursework. The Board was of the view that, even though an applicant took a course for the requisite number of hours, unless the Board specifically approved the course and determined that it was of sufficient quality, the course would not satisfy the first statutory criterion. Therefore, the Board reviewed the material each institution submitted on an individual basis, and approved portions of that material as satisfying the criterion for coursework. The Board believed that the best way to evaluate the quality of a course was to look at the examination which was required in that course. The Board reviewed each of the examinations which they received from the schools or colleges. Although the Board did not review each and every exam administered by all schools, it did review exams from all schools. Each Board member received copies of the exams. The exams were reviewed and discussed question by question at public meetings. The Board conducted its review based on the expertise of its members who are practicing optometrists with a knowledge of optometric education and professional practice. The statutory term "successful completion" was determined by the Board to mean successful passage of an examination for the course. The deans of the schools certified to the Board that their graduates were required to have taken 110 hours of coursework in pharmacology and had passed an exam in such coursework. With regard to the "110 hours," the Board determined that even if an applicant indicated that he or she had received that quantity of coursework, at least 75 percent of the 110 hours (83 hours) would need to be satisfied in a core course. None of the exams which the Board reviewed for the 83 hour core courses were "take home" exams. Some examinations for which partial credit was given were of that type. In satisfying the statutory criterion of "transcript-quality coursework," the Board determined whether the coursework was given by a school or college of optometry or equivalent entity, and whether the student had taken and passed an examination on the coursework. The Board also determined that the coursework which was submitted in satisfaction of the 110 hour requirement, in fact, included "clinical training." The Board made this determination by observing that information in the curriculum presented by the various schools and colleges. As to the specific clinical training criterion for certification, Dr. Jacobs assumed that the schools "automatically would have their clinical training in their curriculum." Also, Dr. Jacobs indicated that, because the schools were accredited, "we could then assume that these were the quality schools and, therefore, would be administering quality coursework and quality testing." The courses which were approved by the Board as having satisfied the 110 hours of "pharmacology" criterion were courses which dealt with the properties, chemistry, actions and uses of drugs. The courses approved also dealt with the effects of drugs on the body and on the eye, the diagnostic use of drugs, the therapeutic use of drugs, and the side effects of drugs. The Board also determined that the pharmacology coursework was "conducted by an institution which has facilities for both the didactic and clinical instruction in pharmacology." The Board did not approve courses taught by individuals, but only recognized courses conducted by colleges of optometry with both the physical facilities and faculty expertise in teaching and research necessary to provide didactic and clinical instruction in pharmacology. The Board also determined that each approved course was conducted by an institution accredited by the Council on Post-secondary Accreditation. This information was readily accessible to the Board because of the Board's continuing responsibility to review the accreditation status of various optometry schools in order to enforce the Board's existing requirement that applicants for licensure in Florida be graduates of accredited schools. Accreditation, however, did not mean a school's coursework was automatically accepted as satisfying the statutory criterion. Of the eighteen accredited schools of optometry recognized for licensure purposes in Florida, coursework from only sixteen were approved for certification purposes. Two accredited schools, the University of Montreal and Interamerican University of Puerto Rico, were disqualified because they did not meet the statutory requirements for certification. However, the Board believes that the statutory and rule requirement that approved coursework must be "conducted by" an accredited institution which has facilities for both didactic and clinical instruction in pharmacology does not require that such courses be taken at that institution or at a location that, in fact, has didactic and clinical instruction facilities. The Board also reviewed and approved continuing education courses and postgraduate courses which could be used in partial satisfaction of statutory criterion number one. The Board went through the same process with regard to reviewing and approving the examinations for the continuing and postgraduate courses. However, unlike the groups of representative exams which the Board was sent by schools and colleges, the Board reviewed each and every one of the continuing education and postgraduate examinations. Although the Board had previously reviewed and approved the continuing education course exams when the courses were approved for continuing education credit, the Board reviewed the exams a second time to determine if they satisfied the certification criterion concerning appropriate coursework. The Board has approved approximately forty continuing education, seminar, extension and postgraduate courses. The Pennsylvania College of Optometry continuing education course referred to as "PCO 701" is an example of this type of course approved by the Board. The "PCO 701" course was designed for practicing optometrists. The instructors for the course were Ph.D.s in pharmacology and ophthalmologists from the Jefferson Medical School in Philadelphia. The instructors flew in to several areas of Florida every weekend to conduct the three month continuing education course. As to the requirement of one year of supervised experience in differential diagnosis, the Board has determined that this may be obtained in either an academic or a non-academic environment. In order to determine compliance with the "one year of supervised experience" criterion, the Board requested the schools and colleges to provide it with the year in which the institution required at least one year of clinically supervised training in differential diagnosis of their graduates. The catalogs and curricula submitted by the schools to the Board also indicated that clinical training was provided as part of pharmacology coursework. The third criterion requires an examination approved by the Board. The Board did not prepare or administer an examination in order to determine an applicant's compliance with this criterion. Concerning the requirement of successful completion of an examination which tests knowledge of general and ocular pharmacology, the rule implements the Board's policy decision to not prepare and administer a separate pharmacology exam for certification purposes. The Board has determined that examinations administered in optometry school or in postgraduate courses suffice. In order to determine whether applicants satisfied the third criterion, the Board reviewed and approved the examinations which applicants had been required to pass either at the end of their coursework in optometric school or at the end of their postgraduate education. Since 1972, the Board has tested for the side effects of pharmaceutical agents as required by criterion three on the pharmacology portion in its general licensing examination, to become a "licensed practitioner." The pharmacology portion of the Board's exam is a prerequisite to obtaining licensure in Florida. Part I of the examination tests ocular pathology and pharmacology. Applicants must obtain a score of 70 percent or better in each subject in Part I of the exam in order to obtain a passing grade. Part II of the exam consists of the clinical portion and a pharmacology/ocular disease portion. An applicant must obtain a score of 80 points or better in order to secure a passing grade on the clinical portion of the practical exam. The National Board of Examiners in Optometry Education also tests ocular pathology, ocular pharmacology, and treatment and management of ocular disease. The NBEO exam tests: Clinical science which measures a candidate's application of the fundamental knowledge base to the prevention, diagnosis, management, and treatment of clinical conditions within the scope of optometric practice and consists of the following subject areas: systemic conditions; ocular disease/trauma. The International Association of Boards of Examiners in Optometry examination on the treatment and management of ocular disease (IAB examination) is an examination which must also be passed by Florida applicants in order to obtain general licensure. The IAB examination is designed to assess the cognitive skills deemed essential in utilizing pharmacologic agents for therapeutic purposes. A passing score is 75. The subject areas tested on the IAB examination include selection of the therapeutic regime; dosage and/or duration; contraindications/side effects; and the follow-up prognosis. The Board of Optometry approves the Florida examinations for general licensure. This function includes reviewing all of the examinations, working with DPR staff in the design of those examinations, actual selection of examination questions, and determination of the scope of the exam. The Board has approved all of the general licensure examinations which have been administered subsequent to 1972. Although Board members have been aware that since 1972 applicants for general licensure have been required to pass the Board approved examination in pharmacology which tests for side effects, the Board has never specifically stated or adopted a policy that this examination satisfies the third criterion to become a certified optometrist. While the Board seems satisfied that the post-1972 licensure exam would be sufficient to satisfy that criterion, the Board relied on and approved the exam which the applicant took either in school or at the end of their postgraduate training as the exam which satisfied the third criterion. Eight hundred seventy three (873) optometrists had been certified in Florida at the point of final hearing. Each of the 873 optometrists who have been certified were existing licensed practitioners in Florida at the time they were certified. Paradoxically, though the Board did not rely on the general optometric examinations for certification, it did rely on the 1972 and forward examination results in classifying the successful candidates for certification. The Board related that 570 of the 873 certified optometrists took the Florida licensure exam in 1972 or thereafter. Three hundred three (303) took the Florida licensure exam prior to 1972. Two hundred sixty three (263) of the 303 took and passed the PCO 701 course for which the Board reviewed each examination and determined that it satisfied the third criterion because it tested for the use of topical application of pharmaceutical agents and side effects. Of the remainder of the applicants who were examined for general licensure prior to 1972, 37 took the PCO 750-B course which was another course in pharmacology for which the Board had reviewed exams and found that they satisfy the third criterion. Of the remaining three applicants, one took the New England diagnostic pharmacology course and one took the Indiana DBF course in ocular pharmacology. The Board reviewed and approved each of these exams as having satisfied the third criterion. The lone applicant remaining of the 873 was a 1971 graduate from the University of Houston. The Board did not review the actual exam which the University of Houston applicant took, although the Board reviewed a number of representative exams which were sent by the University of Houston. Based on its review of the representative exams provided by the University of Houston, the Board determined that the one applicant for certification who had taken an examination which tested for side effects, but which actual exam was not approved by the Board, was sufficiently qualified to demonstrate compliance with the third criterion. The Chairman of the Board personally knows the single candidate from the University of Houston and has a personal knowledge of his practice abilities and competence. The Application/Certification Form The application form, which is challenged as an unpromulgated rule, sets out an activity section for the benefit of the Board which would indicate if a candidate has been approved for certification, the assigned certification number if approved, and other items related to this review. The application form contains a place where the applicant sets forth his or her name and the mailing address. The application form identifies the fact that $100 fee for application is required. The form asks that the candidate name the school or college of optometry which he or she attended and the year of graduation, and to provide and 8 1/2 X 11 inch photocopy of the diploma received from that school. The application form provides for the applicant's signature which is to be notarized. The application form in its second page gives further instruction and cites the text of Rule 21Q-10.001, Florida Administrative Code, and Rule 21Q-10.002, Florida Administrative Code. The latter rule deals with the administration and prescription of topical pharmaceutical agents. The application form in its substance, set out in Sections 1 through 4 of the first page, establishes the exact formula for obtaining certification to practice optometry, beyond the payment of fees and other preliminary matters which have been addressed in these factual findings. In effect, there are four alternatives by which a candidate may obtain certification. This has formed the basis for examining the credentials of candidates since the inception of the certified optometrist program within the State of Florida. The only changes that have been made concern the fact that the application form has been expanded upon through the recognition of additional postgraduate courses which could count toward the obtainment of 110 hours of approved coursework in general and ocular pharmacology. The form does not contemplate the idea of independent testing to address the third statutory criterion. The details of the four alternatives are as set forth below: 1. I am applying to become a certified optometrist based on graduation from an approved school or college of optometry which his certified to the Board that graduates received 110 hours of approved coursework in general and ocular pharmacology, including clinical training, and passed a Board approved examination (463.0055(1)(a)(c)). At least one year of supervised experience in differential diagnosis of eye diseases or disorders was included as part of the optometric training for graduation (463.0055(1)(b)). Optometrists who graduated from the following schools in the year listed below, or in subsequent years, have been approved by the Board as meeting all of the requirements of 463.0055(1)(a)(b)(c) F.S. PLEASE CHECK THE APPROPRIATE BOX, IF THIS IS YOUR CATEGORY. Univ. of Alabama 1973 Univ. of Houston 1975 U. of CA at Berkley 1977 Illinois College 1976 Southern California 1979 Indiana Univ. 1976 Ferris State College 1979 Univ. of Missouri 1984 Pennsylvania College 1976 Southern College 1976 Waterloo, Canada 1976 New England College 1977 Northeastern State 1983 Ohio State 1972 Pacific University 1977 State Univ., New York 1975 I am applying to become a certified optometrist based on graduation from an approved school or college of optometry which has certified to the Board that graduates received 88 or more hours of approved coursework in general and ocular pharmacology, including clinical training, and passed a Board approved examination. At least one year of supervised experience in differential diagnosis of eye disease or disorders which included as part of the optometric training for graduation. I graduated from the school checked below and have attended the following approved courses, as indicated, to meet the 110 hour requirement for certification. SCHOOLS Univ. of Houston 1966-74 90 hours Illinois College 1974-75 102 hours Waterloo, Canada 1972-76 84 hours COURSES (attach verification of passing the exam) FOA/Univ. of AL-2/7-8/87 10 hours FOA/Univ. of AL-10/83 6 hours FOA/Univ. of AL-10/85 6 hours FOA/Univ. of AL-10/86 6 hours FOA/PA College-5/78 6 hours FOA/PA College-10/84 6 hours I am applying to become a certified optometrist based on 88 or more hours of approved transcript quality courses in general and ocular pharmacology, which included clinical training and passing a Board-approved examination. At least one year of supervised experience in differential diagnosis of eye diseases or disorders was included as part of my optometric training for graduation. The following courses have been approved by the Board as meeting the criteria above: (Check any courses you attended and attach proof of passing the exam.) PA College Course 750B 110 hours Illinois College Courses 1986-87 85 hours PA College Course 701 98 hours PA College Course 701 105 hours Florida Optometric Assoc/ PA College 1/31/87 110 hours If applicable to meet the 110 hours, the following approved courses may be included in your documentation for certification: FOA/Univ. of AL-2/7-8/87 10 hours FOA/Univ. of AL-10/85 6 hours FOA/PA College-5/78 6 hours FOA/Univ. of AL-10/85 6 hours FOA/PA College-10/84 6 hours FOA/Univ. of AL-10/86 6 hours I do not fit into any of the above categories. However, my educational coursework and clinical training meet all three (3) requirements of 463.055(2)(a)(b) and (c). I have attached a detailed report and all required documentation as necessary. Sections 1-4 within the application form are based upon the information gathered by Dr. Jacobs from the schools of optometry and concerning postgraduate coursework. The Certification Committee reviewed the information which Dr. Jacobs had gathered, and made a recommendation to the Board pertaining to how the information should be used. Dr. Jacobs presented a suggested format for the application form to the Board's office based upon the charts he prepared which summarized the information he had gathered. The Board's office modified Dr. Jacobs' suggested format and sent it to the Board members for their approval. After the Board approved both the use of the information gathered and the format of the application, the Board office prepared the application form for printing and distribution. By including the information concerning the school and year attended by the applicant, the Board was able to avoid having to search through existing Board licensure files which already contain this information and also enabled the Board to refer to the data which the Board had already gathered and analyzed, without the necessity to do it for each applicant. The Board did not accept the form alone in its decision-making process. The associated documentation was reviewed by the Board prior too approval for certification. Applicants were disqualified if they did not provide proper documentation. The Certification Committee reviewed all individual applications and made recommendations to the Board. Each application was reviewed individually by two different committee members. If the two committee members disagreed on certifying the applicant, the third member of the committee reviewed the application and cast the deciding vote concerning whether to recommend certification or not to the Board. The Board then voted on the application and decided whether or not to certify the applicant. The form was designed to act as a facilitator. Nonetheless, it is the substantive standard for review in all instances. The application form implements the Board's previous decision to accept the substantive information which it had been provided. Within the form, Section 1 applicants are those optometrists relying solely on their graduation from one of sixteen optometry schools in the United States and Canada on or after the year designated on the form for that school. Section 2 applicants are those optometrists relying on graduation from the University of Houston (1966-1974), Illinois College of Optometry (1974-1975), or University of Waterloo (1972-1976), in conjunction with completion of courses sponsored by the Florida Optometric Association. Section 3 applicants are those optometrists seeking certification based on completion of one post-graduation "core course" of 83 hours or more, and additional continuing education courses necessary to achieve the 110-hour total. Section 4 was created for applicants who may not fit in any of the three previously-described sections, but who may be able to establish their qualification for certification through other means. An example of use of the form is that when an applicant checked Section 1 on the form indicating the school and year of graduation, the Board reviewed the diploma to determine whether the graduation date on it coincided with the date of graduation, and the school checked in Section 1. Having previously determined that graduates of that institution subsequent to the year indicated on the form satisfied the statutory criteria, the Board used the form to confirm the applicant's credentials in the request for certification. The determination as to whether or not to certify the applicant was made after the Board examined the application form and verified that the applicant had graduated from that particular school by checking the diploma, signature, and notary certificate. Section 3 of the form shows eleven courses. As mentioned before, there are other courses that since have been determined by the Board to be acceptable towards the 110 hour total. These courses were not listed on the form because the Board was unaware of them at the time the form was printed. An applicant under Section 3 who wanted to claim credit for courses which were not listed, could write in those courses and send documentation from the school in the form of a letter or transcript which indicated that the applicant had been tested on the course and had passed the exam. The Board would then confirm that the course was given and would review the exam for course quality. With respect to applicant who checked Section 3, the Board also determined satisfaction of the one year of supervised clinical experience requirement by referring back to the information which had been provided previously by the optometry schools. For Sections 2 and 3 applicants, the continuing education courses relied on to supplement optometric school coursework or post-graduation "core courses" were all sponsored by the Florida Optometric Association in conjunction with optometric schools. Section 4 of the application form afforded applicants who did not fit categories 1, 2 or 3 an opportunity to demonstrate that they satisfied the statutory criteria. For instance, one applicant who applied under this category was a pharmacist before he was an optometrist. He did not fit into any of the other categories because his coursework was obtained in pharmacy school, and he wished to rely on that training to satisfy requirements for certification. A review of the minutes of the Board meetings from the amendment of Chapter 463 in June, 1986, through August, 1987, indicates that the certification form was not adopted as a Board rule. Dr. Walker, Board member, in his testimony confirmed that the application form was not adopted as a Board rule. The certification form-was first used by the Board at the first meeting at which it certified optometrists, April 11, 1987. It certified 455 optometrists at that first meeting; 200 more at its May 9, 1987 meeting; 174 more at its July 6, 1987 meeting; and 45 more at its August 28, 1987 meeting. Of the continuing education courses for which information is available, the "smaller courses" of 10 hours or less were offered in a "seminar" setting, with faculty from optometry schools, most notably UAB, Pennsylvania, Southern College, New England, Indiana, and Houston. In addition to the Florida Optometric Association, other non-school entities such as the Southern Council of Optometrists, the American Academy of Optometry, the Southwest Florida Optometric Association, the Northeast Florida Optometric Society, and the Bay Point Anterior Segment Symposium, Inc., sponsored some of these continuing education courses. Some of the approved continuing education courses described in the form were given at resorts, hotels, or meeting centers. Legislative Intent Petitioners' Composite Exhibits Nos. 6 and 7 were offered in an attempt to describe legislative intent related to Senate Bill 3-B, which forms the basis of the amendments to Chapter 463, Florida Statutes, which took place in 1986. This included Section 463.0055, Florida Statutes (1986 Supp.). Having considered those exhibits and the proposed facts of the parties, the intent which the Legislature had in the passage of Section 463.0055, Florida Statutes (1986 Supp.) cannot be gleaned. Therefore, conclusions about the meaning of that legislation must be made based upon a literal reading of its text, together with other provisions within Chapter 463, Florida Statutes. In a related vein, the Board of Optometry and the Intervenors have suggested facts concerning an April 15, 1987, Senate Committee on Economic, Community and Consumer Affairs request for information from the State of Florida, Department of Professional Regulation, on the topic of the Board of Optometry's implementation of the certification process. In particular, reference is made to that committee's request concerning which schools and coursework satisfied the 110 hour and one year of supervised clinical experience requirements contained within the statute. The committee also wanted documentation of the procedures and standards used in approving examinations which satisfied the requirement for examination set forth in the third criterion. The Secretary of DPR requested the Board of Optometry to prepare the report and it was prepared and delivered to the Senate Committee. That report generally describes the activities of the Board of Optometry in its efforts at certification, as announced in the fact findings herein. Because the Senate Committee did not respond to the report made by the Department of Professional Regulation, the Intervenors and the Board urge that the silence by the Senate Committee somehow recognizes the acceptability of the procedures employed by the Board of Optometry in its certification process. Likewise, the Intervenors and the Board of Optometry seem to take some comfort in the fact that no further legislation was passed in 1987 pertaining to Section 463.0055(2)(c), Florida Statutes (1986 Supp.), which dealt with the need to have the Board prepare an independent examination document as opposed to the technique which has been employed of using other examination instruments to satisfy the terms of that statutory reference. The exact position of the Senate Committee concerning this dispute and the need for independent testing to address the third criterion is not described in this record, nor can its silence or that of the full Legislature in its 1987 Session be seen as creating any inference about the proper construction to be given the language within Section 463.0055, Florida Statutes (1986 Supp.), and especially Section 463.0055(2)(c), Florida Statutes (1986 Supp.). Standing Ophthalmologists and optometrists who practice their professions in Florida are to a significant extent offering similar health care. In particular, the opportunities provided the certified optometrist for practice coincide with part of the practice available to ophthalmologists. Petitioner, Florida Society of Ophthalmology, is an organization concerned with, among other things, the educational interests of ophthalmologists and the quality of eye and health care delivered to the patients of ophthalmologists. It is also concerned on behalf of its members about the quality of eye care and health care of Floridians treated with medication by optometrists. Petitioner Florida Medical Association has the same concerns, responsibilities and purposes. Petitioner, Tully C. Patrowicz, M.D., is a physician and ophthalmologist practicing in Mount Dora, Florida, since 1972. Dr. Patrowicz is a Board-certified ophthalmologist since 1974, and is also a past officer and president of Petitioner Florida Society of Ophthalmology. He is currently a member of both Florida Society of Ophthalmology and Florida Medical Association. Petitioner, William J. Broussard, M.D., is a physician and ophthalmologist who has practiced in Melbourne, Florida, since 1967. He is a Board-certified ophthalmologist since 1966. Dr. Broussard is also a member and former office of Petitioner Florida Society of Ophthalmology. Florida Optometric Association is a not-for-profit organization with membership comprised of licensed optometrists in Florida. The purpose of Florida Optometric Association is to promote and protect the general public in ensuring the availability of high quality optometric services at affordable prices. Approximately 850 of the 1,100 practicing optometrists in Florida are members of Florida Optometric Association. Approximately 650 certified optometrists are members of Florida Optometric Association. Florida Optometric Association participates in administrative proceedings, legislative activities, and court litigation on behalf of optometry. The president of Florida Optometric Association has authorized retention of counsel for those purposes with the permission of the Executive Board and a vote of the membership. Florida Optometric Association members who are certified optometrists are subject to Rule 21Q-10.001, Florida Administrative Code. Florida Optometric Association participated in the legislative activities which resulted in the Optometric Practice Act of 1986. Dr. Howard J. Braverman, O.D., is President of the Florida Optometric Association and is a certified optometrist engaged in the active practice of optometry in Florida. If the certified optometry rule is invalidated, it will have a significant impact on the practice of certified optometry by Dr. Braverman and by the members of the Florida Optometric Association who are certified optometrists. It would also significantly affect their patients. Petitioner Baxter H. Byerly, M.D., and Intervenor Frank A. Broome, O.D., did not appear at the hearing and no indication was given concerning the exact nature of their claims as petitioner and intervenor, respectively. Respondent State of Florida, Board of Optometry, is an agency of the State of Florida within the Department of Professional Regulation with authority to regulate the practice of optometry. Sections 463.001, 463.003, 463.005, Florida Statutes (1986 Supp.). Activities subject to the Board's regulatory and rulemaking authority include standards of practice of optometry, the administration and prescription of topical ocular pharmaceutical agents, and the certification of optometrists to administer and prescribe such drugs in their practice. See Sections 463.005(1)(a) and (g), and 463.0055, Florida Statutes (1986 Supp.). Respondent State of Florida, Department of Professional Regulation, is an agency of the State of Florida that generally assists the various professional regulatory Boards, such as the Respondent Board of Optometry, in the examination and licensure of professionals. See Section 455.217, Florida Statutes.
The Issue Whether Petitioner's application for reenrollment in the Medicaid program should be granted.
Findings Of Fact Petitioner, Agency for Health Care Administration (AHCA), is the executive agency with the responsibility of administering the Florida Medicaid Program pursuant to Section 409.902, Florida Statutes. Petitioner, Rodolfo Alonso (Alonso), provided optical services to Medicaid recipients on behalf of the Agency pursuant to a Medicaid provider contract and Medicaid provider number 0864550100. AHCA determined that Alonso had a felony criminal record. Alonso pled no contest to a felony charge of practicing optometry without a license. Adjudication was withheld, and Alonso was placed on probation. On March 17, 1997, AHCA sent Alonso a letter stating that AHCA was denying Alonso's request to reenroll in the Florida Medicaid Program because of a criminal record of possession of narcotics. The March 17 letter was amended by a letter dated April 8, 1997, stating that the felony referenced was incorrect and the felony record related to carrying a concealed weapon and practicing optometry without a license. Both the March 17 and the April 8 letters stated: Your Medicaid provider number, 086450100, will be canceled on April 16, 1997, pursuant to the terms of Section 409.907(9)(f) and your Medicaid Provider Agreement.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered granting Petitioner's application for reenrollment in the Medicaid program DONE AND ENTERED this 2nd day of February, 1998, in Tallahassee, Leon County, Florida. SUSAN B. KIRKLAND 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 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of February, 1998.
The Issue Whether Sandra Ann Lindstrom (“Ms. Lindstrom” or “Respondent”), a licensed physician assistant, prescribed Lorcet, a medication containing a controlled substance (hydrocodone), in violation of the Florida Statutes and the Florida Administrative Code as charged in the Amended Administrative Complaint filed at the Department of Health in DOH Case No. 2006-36542 on October 27, 2014. If so, what is the appropriate discipline?
Findings Of Fact The Parties The Department of Health is the state agency responsible for regulating the practice of physician assistants in the State of Florida. The regulation is pursuant to both chapter 456 (“Health Professions and Occupations, General Provisions”) and chapter 458 (“Medical Practice”), Florida Statutes. Respondent is licensed as a physician assistant by the Board of Medicine. Her license number is PA 9103823. The license was effective on August 3, 2006, with an expiration date of March 31, 2008. Her license has been continuously renewed since its effective date. See Pet’r’s Ex. A. Ms. Lindstrom is not licensed to practice medicine as a physician. Id. Physician Assistants Physician assistants are governed by section 458.347, a section within the chapter of the Florida Statutes that governs Medical Practice. Physician assistant licensure is provided for in section 458.347(7), and the Board of Medicine is authorized to “impose any of the penalties authorized under ss. 456.072 and 458.331(2) upon a physician assistant if the physician assistant or the supervising physician has been found guilty of or is being investigated for any act that constitutes a violation of this chapter [Ch. 458] or chapter 456.” § 456.347(7)(g), Fla. Stat. A physician assistant’s supervisory physician may delegate authority to conduct aspects of medical practice to a physician assistant under circumstances expressed in the statutes. The limited medical practice that may be delegated to a physician assistant includes certain practices at county health departments. Whether conducting the delegated practice of medicine at a county health department, or not, physician assistants may be delegated authority to prescribe medications provided they are not listed on a formulary created pursuant to section 458.347(7)(f). See § 458.347(7)(d) and (e), Fla. Stat. The formulary must include “controlled substances as defined in chapter 893.” § 458.347(7)(f)1., Fla. Stat. In sum, physicians may not delegate to physician assistants the prescription of medications which are controlled substances as defined in chapter 893, Florida Statutes. The Department’s Investigative Office The Department has an investigative office charged with looking into regulatory complaints. In a typical regulatory investigation, the investigator discloses his identity to any party interviewed, whether the party is the source of the complaint, a witness, or, if amenable to an interview, the licensee who is the subject of the complaint. Aside from interviews, the investigations include record reviews, the obtaining of evidence, and the preparation of an investigative report. In addition to investigating complaints of regulatory violations by licensed health care practitioners, the investigative office looks into cases of unauthorized practice by unlicensed individuals. Investigations of unlicensed activity are conducted by what is known as the “ULA” section of the office. Commonly, ULA investigations are done by investigators who are “undercover,” that is, the investigators hide their identity as investigators and use pseudonyms rather than their actual names. Typically, undercover ULA investigators present at the offices of the subjects of investigation. If the unlicensed subject of the investigation offers to perform services that require a license or engages in practice that requires a license, the Department pursues remedies, including an order that the subject cease and desist from the unlawful, unlicensed activity. Investigations of a licensee for practicing outside the scope of the licensed activity may be viewed as something of a hybrid of a typical regulatory investigation and a ULA investigation. It is regulatory since the subject is a licensee, but it is usually done undercover in the same manner in which a ULA investigation is conducted. One such investigation was conducted by Ryan Heal, an employee of the Department between August and December of 2006. Mr. Heal conducted the investigation undercover using a pseudonym referred to in Department documents as “RJ.” RJ and the 2006 Investigation of JHS Mr. Heal has been a medical malpractice investigator for the Department since November 2000. During the course of his more than 15 years as a Department investigator, Mr. Heal has investigated both regulatory violations and unauthorized practice violations. In 2006, allegations reached the Department that prescriptions were being written at Jacksonville Health Systems (“JHS”), a clinic located on Baymeadows Road in Jacksonville, Florida, by a physician assistant without the supervision of a physician. In response, the Department launched an investigation. The investigation was conducted undercover by Mr. Heal using his pseudonym RJ. Commenced in August of 2006, the investigation lasted until the following December. August 10, 2006 On August 10, 2006, Mr. Heal, using his fictitious name, presented at JHS. A woman behind the counter in the reception area accepted a cash payment for the visit. She took RJ’s blood pressure and requested the name of the pharmacy for any medicine prescribed. To the best of Mr. Heal’s recollection, the receptionist recorded some of the information. After the interaction with staff in the reception room, Mr. Heal took a seat and waited to be called back to the examination room. Shortly thereafter, Ms. Lindstrom emerged and asked for RJ. Mr. Heal “stood up and went over to her.” Hr’g Tr. 19. Ms. Lindstrom identified herself by her first name and said, “I’m the provider here.” Id. Ms. Lindstrom accompanied Mr. Heal to the examination room where only she and Mr. Heal were present. After Mr. Heal complained of back pain, Ms. Lindstrom asked where in his back the pain was located and what caused it, but she did not conduct a physical examination. As Mr. Heal testified at hearing, “[t]here was no examination. She never touched my back. Never took vitals or anything.” Hr’g Tr. 20. Ms. Lindstrom suggested that Mr. Heal use a chair with lumbar support, try stretching, lose weight, and have an MRI. Ms. Lindstrom then stated that she would prescribe medication to treat the pain: Lorcet, Flexeril, and Motrin. With the visit in the examination room concluded, Ms. Lindstrom took Mr. Heal back to the receptionist. The meeting in the examination room and his first visit to the JHS offices being over, Mr. Heal departed the JHS facility. He did not return until the following October. October 31, 2006 Mr. Heal returned to the JHS facility on October 31, 2006. The process during the second visit was similar to the one followed during the visit the previous August. He presented as “RJ.” A staff member took his blood pressure in the reception area and he paid her $90 in cash. Mr. Heal sat down and waited to be called. Again, Ms. Lindstrom appeared in the reception area and took him to the examination room in the back. The visit was shorter than it had been in August. Ms. Lindstrom asked if his pain had improved and if an MRI had been done. With the intention of calling in his prescriptions, Ms. Lindstrom showed Mr. Heal a list of five pharmacies from which to choose. Mr. Heal, however, took a tack that was different from Ms. Lindstrom’s intention and from his first visit: I explained to her that I did not have reliable transportation and asked [for] . . . handwritten prescriptions . . . so that I could take them to whatever pharmacy was convenient . . . . She agreed that she could write them that time, but that on the next visit, I would have to arrange for proper transportation to get to the pharmacy or wherever they needed to be called into. Hr’g Tr. 23. Ms. Lindstrom wrote out three prescriptions: Two of them were for “Flexeril 10mg (ten) #30 (thirty)” and “Ibprofen (sic) [Ibuprofen] 800mg #120 (one twenty).” Pet’r’s Ex. B. The third prescription was for “Lorcet 10/650 #90 (Ninety).” Id. Ms. Lindstrom explained to Mr. Heal that he should use one of the five pharmacies on her list because “several [of the Clinic’s patients] had been kicked out of pharmacies . . . [that] were refusing to fill the prescriptions.” Hr’g Tr. 25. Ms. Lindstrom also “mentioned that a couple of her patients had been arrested for forging prescriptions.” Hr’g Tr. 25-6. At no time during his visit to JHS on October 31, 2006, did Mr. Heal see a physician. No one entered the examination room where Ms. Lindstrom met with Mr. Heal that day. Nor did Ms. Lindstrom leave the examination room while Mr. Heal was present in the room. Like the first visit the previous August, Ms. Lindstrom recommended that Mr. Heal have an MRI. She explained that results from an MRI were needed “in case the DEA wanted to look at the file, to show that [she and JHS] were actually treating [Mr. Heal] for something.” Hr’g Tr. 28. December 1, 2006 Little more than a month later on December 1, Mr. Heal made a third visit to JHS. The reception process was the same. The receptionist took his blood pressure, he paid $90 in cash, and waited in the reception area for Ms. Lindstrom to call him back. While waiting, he was informed that the number of pharmacies that would accept JHS prescriptions had been drastically reduced. Only one pharmacy would now accept JHS prescriptions: a pharmacy called New Horizon. Subsequent to the third visit, Mr. Heal presented to the pharmacy identified as New Horizon. In the company of law enforcement and with its supervision, Mr. Heal had the prescriptions filled for three medications: Flexeril, Ibuprofen at a prescription-strength dosage, and Lorcet. Supervising Physician and Other Claims At hearing under oath, Ms. Lindstrom admitted that she treated Mr. Heal once at the JHS facility and admitted that she prescribed Flexeril and Ibuprofen for him. She claimed under oath that the supervising physician for the 2006 visit in which she prescribed the two medications was James Hendrick, M.D. The Department produced documentation in the Department’s official business records that shows that Dr. Hendrick cancelled his Professional Liability Insurance Policy effective October 1, 2005, the year before Ms. Lindstrom claims to have seen Mr. Heal at the JHS facility under Dr. Hendrick’s supervision. The reason for the cancellation of the policy is listed on the letter from the insurer to the Department as “Retired.” Pet’r’s Ex. F, letter dated October 17, 2005, from FPIC, First Professionals Insurance Company. Department records also include an “Address Change” form that contains a section entitled “Financial Responsibility” dated November 21, 2005, the year before the incidents in this case. No boxes are checked in the section that shows “Financial Responsibility Coverage.” Under a section on the form entitled, “Category II: Financial Responsibility Exemptions,” Dr. Hendrick checked a box that indicated he was “retired or maintain[ed] part-time practice,” id., at least as of late November 2005, 11 months or more before the October 31, 2006, visit by Mr. Heal. Ms. Lindstrom made other claims with regard to RJ’s visit that she asserted occurred on October 3, 2006, rather than October 31, 2006, as charged. Among them was that she left the examination room after completing the prescriptions for Flexeril and Ibuprofen and partially completing a third prescription by inserting all the information, including her signature, except for the medicine to be prescribed and how often it should be taken. Ms. Lindstrom claimed that she intended to write a prescription for Lodine, but failed to write down “Lodine” on the third prescription form because she was distracted by a discussion with Mr. Heal about the need for RJ to have an MRI. She says she left the room to make arrangements for an MRI and when she returned, RJ was gone, together with the two filled out prescriptions, the third incomplete prescription, and her prescription pad. Ms. Lindstrom’s testimony about the theft of the pad and other details about the event, including when it occurred, is not credible. In contrast, Mr. Heal’s testimony about the visits he made to the JHS facility, seeing Ms. Lindstrom, and her prescription of Lorcet, is credited as truthful. Lorcet Lorcet contains hydrocodone, which is a controlled substance.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order: Finding that Respondent Sandra A. Lindstrom, P.A., violated section 458.331(1)(nn), Florida Statutes (2006), by violating Florida Administrative Code Rule 64B8-30.008 (2006), as charged in the Amended Administrative Complaint; Imposing a $2,500 fine; and Revoking Respondent’s license as a physician assistant. DONE AND ENTERED this 30th day of March, 2016, in Tallahassee, Leon County, Florida. S DAVID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of March, 2016. COPIES FURNISHED: Sandra Ann Lindstrom 6726 Pomeroy Circle Orlando, Florida 32810 Yolonda Y. Green, Esquire Maciej Lewandowski, Esquire Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-3265 (eServed) Andre Ourso, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C03 Tallahassee, Florida 32399-3253 (eServed) Nichole C. Geary, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 (eServed)
The Issue The central issue in this case is whether Richard Koenig, D.P.M., should be licensed as a podiatrist in the State of Florida. More specifically, this case must determine these issues: whether Richard Koenig, D.P.M., has practiced podiatry in the past at an acceptable standard of care as required by Section 461.013(1)(s), Florida Statutes; whether he fraudulently misrepresented material facts on his application for licensure as a podiatrist in violation of Section 461.013(1)(a), Florida Statutes; and whether his application to become licensed as a podiatrist is barred on grounds of administrative res judicata because of the Board of Podiatry's denial of his application in 1994-1995.
Findings Of Fact Dr. Koenig is an applicant for licensure as a podiatrist in the State of Florida. He is presently licensed to practice podiatry in the State of Missouri and was previously licensed in Illinois and Florida. Both of the latter licenses have expired. Dr. Koenig meets all criteria for licensure in Florida other than the grounds for denial cited by the Board in its Notice of Intent to Deny and described in the Statement of the Issues, above. The Board is responsible for certifying individuals who are qualified to become licensed as podiatrists and the Department of Health is responsible for issuing the licenses after the Board's certification. Dr. Koenig permitted his Florida license to lapse while he practiced in Missouri. He initially sought to be licensed again in this state in 1994. At that time, his application to sit for the examination, and thereafter to be licensed, was denied by the Board. Dr. Koenig requested a hearing on the denial before the Division of Administrative Hearings (DOAH) and a case was opened as DOAH Case No. 95-0570. Dr. Koenig later dismissed his petition and the DOAH file was closed. The earlier denial thus became final. Dr. Koenig reapplied for licensure in 1997. It is this application which is the subject of the instant proceeding. Dr. Koenig has already taken and passed the national podiatric licensure examination in Louisiana in 1997, thus meeting the examination requirement. Dr. Koenig was involved in approximately eleven podiatric malpractice cases during his practice in Missouri in the 1980's and early 1990's. Eight of the cases were settled by his insurance carrier. Three additional cases were pending at the time of Dr. Koenig's initial application in 1994. Of these three, Dr. Koenig prevailed at trial in two cases. The third case has been voluntarily dismissed by the plaintiff and has not been refiled. Dr. Koenig has not been engaged in the practice of podiatry as his primary professional activity since 1993-1994. He occasionally provides podiatric services as part of his commitment to the U.S. Navy, but he has primarily been engaged in developing and marketing two devices for use in podiatric and related services and has been teaching. Dr. Koenig received and reviewed the 1994 Board Notice of Intent to Deny Application for Examination and Licensure prior to filing his 1997 licensure application. In addition, he was aware that he had dismissed his petition to review that decision and the Board's decision was thus final. Nevertheless when called upon to state in the 1997 application whether he had ever been denied licensure as a podiatrist, Dr. Koenig answered "No." (Petitioner's Exhibit No. 1) This answer was false. Question five of the application for podiatry licensure reads: "Has any podiatry license held by you ever been acted upon, suspended or revoked, or have you ever been denied licensure?" Dr. Koenig's explanation concerning his negative answer to this question was that he thought he was being denied the right to take the examination, which was a condition required before he could be licensed. His understanding is supported by a reading of the minutes of the Board meeting at which the decision was made: "Dr. Simmonds moved to deny Dr. Koenig from taking the examination based on not having the ability to practice Podiatric Medicine at a level of care and safety." (Petitioner's Exhibit No. 1) However, the Board sent, and Dr. Koenig received, a Notice of Intent to Deny Application for Examination and Licensure. While that document plainly states that he was both being denied the right to take the examination and the right to be licensed, he did not focus on the second point--the right to be licensed. Dr. Koenig offered his explanation to the Board at its meeting on July 25, 1997, and when asked about the application question, he stated, "Because it is a misunderstanding. I make a differentiation between being denied a license and being denied the opportunity to sit for a license, and I may be wrong, and I stand corrected if I am, but that's what my intention was." (Petitioner's Exhibit No. 1, Transcript pp. 21-22). He understood that the Board was denying him the right to take the examination, an essential element of his application process. Dr. Koenig's explanation has been consistent throughout this proceeding, both before the Board and in the formal hearing. Although Dr. Koenig did answer the question incorrectly, his explanation that he did so without any fraudulent intent is entirely credible. Had there been an intent to defraud the Board regarding his application, Dr. Koenig might have avoided disclosing the malpractice suits which resulted in the Board's earlier decision to deny him licensure. Those malpractice suits are no longer an appropriate basis to deny licensure. Dr. Koenig is a Board-certified podiatrist and is a Fellow of the American College of Foot and Ankle Surgeons. One becomes Board-certified by taking an examination, by meeting practice requirements, and by submitting a number of medical cases to the Board for evaluation. Only about 10 percent of all podiatrists are Board-certified. Dr. Koenig's specialty is foot surgery and he has operated more often than a podiatrist in standard practice. Dr. Koenig has written several articles in peer- reviewed journals, and has spoken widely in the United States and elsewhere at various continuing medical education seminars. A frequent topic of his speeches involves the use of an implant which he developed to replace the big toe joint. This implant is patented, approved as a safe device by the FDA, and is covered by Medicare and Medicaid. Dr. Koenig has developed and marketed a special shoe for patients who have had foot surgery. There have been no Medicare or Medicaid complaints brought against Dr. Koenig and he maintains Medicare and Medicaid provided numbers. The two lawsuits which went to a jury verdict were decided in his favor and there are no lawsuits pending now. The multiple claims of malpractice occurred when he was actively engaged in foot surgery practice in Missouri. His insurance carrier, without consulting him, settled those claims. After he changed carriers and contested the claims, he has prevailed. The Board in this proceeding presented no evidence that Dr. Koenig has practiced below the standard of care. Nor did it refute his credible testimony.
Recommendation Based on the foregoing, it is hereby RECOMMENDED: that a Final Order be entered granting Dr. Koenig's license to practice podiatry in the State of Florida. DONE AND ENTERED this 24th day of April, 1998, in Tallahassee, Leon County, Florida. MARY CLARK 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 Filed with the Clerk of the Division of Administrative Hearings this 24th day of April, 1998. COPIES FURNISHED: John J. Rimes, III Office of Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050 Eric B. Tilton Gustafson, Tilton, Henning & Metzger, P.A. Suite 200 204 South Monroe Street Tallahassee, Florida 32301 Angela T. Hall, Agency Clerk Department of Health Building 6 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Eric G. Walker, Executive Director Board of Podiatry Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0792
Findings Of Fact Petitioner is the state agency charged with regulating the practice of osteopathic medicine pursuant to Section 20.165, Florida Statutes; Chapter 455, Florida Statutes; and Chapter 459, Florida Statutes. Respondent is, and has been at all times material hereto, a licensed osteopathic physician, having been issued license number OS 006021 by the State of Florida. Dispensing practitioner inspections are conducted by Petitioner to evaluate compliance with the legal requirements imposed on dispensing practitioners. The complete legal requirements imposed upon dispensing practitioners are listed on the "Investigative Services Inspection Form for Dispensing Practitioners", with citations to the proper authority. Practitioners subject to inspections are provided with copies of the inspection forms. On July 19, 1991, Jeannie Lewis, a Department investigator, conducted a routine dispensing practitioners inspection of Respondent's office and prepared an inspection form. During the July 19, 1991 inspection, the following violations were discovered and reported: Respondent was not writing prescriptions for dispensed medication; Respondent was not certifying drugs prior to patient receipt; Respondent was not on the premises when dispensing of drugs occurred; Respondent failed to post a generic drug sign; Respondent failed to initial and date all controlled drug prescriptions dispensed; Respondent's controlled substance prescriptions failed to include the patient's address; Respondent's controlled substance prescriptions failed to include Respondent's DEA number; Respondent failed to place dispensed medication in a child proof container; Respondent's controlled substance prescriptions were not properly maintained. Respondent had no prescriptions for controlled substances dispensed. A deficiencies form was issued and signed by Respondent, following the July 17, 1991 inspection. A second inspection of Respondent's office was conducted on December 17, 1992, and a second dispensing practitioners inspection form was completed. During the December 17, 1992 inspection, Investigator Lewis was accompanied by Charles C. Lewis, then Senior Pharmacist for Petitioner. During the December 17, 1992 inspection by Investigator Lewis and Charles C. Lewis, the following violations were discovered and reported: Respondent was not writing prescriptions for dispensed medication; Respondent was not certifying drugs prior to patient receipt; Respondent was not on the premises when dispensing of drugs occurred; Respondent failed to post a generic drug sign; Respondent failed to initial and date all controlled drug prescriptions dispensed; Respondent's controlled substance prescriptions failed to include the patient's address; Respondent's controlled substance prescriptions failed to include Respondent's DEA number; Respondent's controlled substance prescriptions were not properly maintained; Respondent's controlled substance purchase records were not properly maintained or readily retrievable; Respondent's DEA 222 forms were not completed properly and not available. Respondent's nurse refilled and dispensed medications when Respondent was not on the premises. On February 9, 1993, a Final Order of the Board of Osteopathic Medicine was entered in the case of DPR v. Richard Heston Beers, D.O., DPR Case Number 00-95528. This Final Order adopted the provisions of a Consent Agreement signed by Respondent on November 6, 1992, in which Respondent agreed to receive a Letter of Concern, pay a $2,000 fine, attend a Continuing Medical Education course on the ethical prescription of abusable drugs, and to utilize sequentially numbered triplicate prescription forms for a year following the date of the Order. The Consent Agreement, adopted into the Final Order, also provided that copies of the triplicate prescription forms were to be made available to Petitioner's investigators upon request. Following the second inspection of Respondent's office and the issuance of the Final Order, Respondent sent a letter to Lewis dated March 26, 1993, claiming compliance with the dispensing practitioners requirements and inviting her to re-inspect his office at any time. At the request of the Board of Osteopathic Medicine, a third inspection of Respondent's office was conducted on July 7, 1993, and a third dispensing practitioners inspection form was completed. During this third inspection, the following violations were discovered and noted: Respondent failed to properly label medication for dispensing; Respondent was not properly maintaining his controlled substance prescriptions, in that Respondent did not stamp them with a red letter "C" and store them separately from non-controlled drug prescriptions; Respondent's DEA 222 forms were not completed properly (not available). Respondent failed to utilize sequentially numbered triplicate prescription forms when dispensing medications.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Respondent be found guilty of violating Sections 459.015(1)(g) and (bb), Florida Statutes. It is further RECOMMENDED that: Respondent shall pay an administrative fine in the amount of five thousand dollars ($5,000.00) to the Board of Osteopathic Medicine within one hundred eighty (180) days of the Final Order of the Board. Respondent shall receive a reprimand from the Board of Osteopathic Medicine. Respondent shall surrender his DEA license for a minimum of two (2) years, and not reapply unless or until he appears before the Board and demonstrates that he can prescribe, maintain, and inventory controlled substances with skill, safety, and within the legal requirements imposed upon dispensing practitioners. Respondent's license to practice medicine shall be placed on probation for a period of one (1) year, including indirect supervision, a review of Respondent's medical records by a monitoring physician, and any additional terms deemed reasonable and necessary by the Board. DONE and ENTERED this 12th day of September, 1994, in Tallahassee, Florida. DANIEL M. KILBRIDE 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 12th day of September, 1994. APPENDIX The following constitutes my specific rulings, in accordance with section 120.59, Florida Statutes, on proposed findings of fact submitted by the parties. Proposed findings of fact submitted by Petitioner. Accepted in substance: paragraphs 1 through 20. Proposed findings of fact submitted by Respondent. Respondent did not submit proposed findings of fact. COPIES FURNISHED: Hugh R. Brown, Esquire Agency for Health Care Administration 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Richard Heston Beers, D.O. 7505 Aloma Avenue Winter Park, Florida 32792 Harold D. Lewis, Esquire Agency for Health Care Administration 325 John Knox Road Tallahassee, Florida 32303 Sam Power, Agency Clerk Agency for Health Care Administration 325 John Knox Road Tallahassee, Florida 32303
The Issue Whether Respondent committed the violations alleged in the Amended Administrative Complaint and, if so, what penalty should be imposed.
Findings Of Fact AHCA is the agency responsible for the licensing and regulation of assisted living facilities in Florida pursuant to chapters 429 and 408, Part II, Florida Statutes. At all times material hereto, Kipling Manor was licensed by AHCA as an assisted living facility. Kipling Manor is located in Pensacola, Florida, and operates a 65-bed facility, license number 7285, and holds a specialty limited health license. Norma Endress is a registered nurse employed by AHCA. She conducts surveys of nursing homes and assisted living facilities for compliance. Ms. Endress is supervised by Patricia McIntire, a nurse consultant supervisor for AHCA. Ms. McIntyre has been with AHCA for 13 years. Belie Williams is the administrator of Kipling Manor. He has been involved with health care services for approximately 35 years, and has been an administrator of ALFs for approximately 15 years. He has been involved with the Florida Assisted Living Association (FALA) and served on its board. Mr. Williams helped implement training sessions for ALFs in conjunction with FALA for the past eight years. Kipling Manor has two nurses who visit the facility to provide care to the residents. Elizabeth McCormick is an advanced nurse practitioner (ARNP) in family, psychiatric and mental health. She has been a nurse since 1983 and has extensive experience dealing with inpatient and outpatient psychiatric residents in long-term facilities. Nurse McCormick works with a VA facility providing inpatient and outpatient care on a high intensity psychiatric unit. She was also an assistant professor at the University of West Florida in the Mental Health Nursing Program. Nurse McCormick provides medical and mental healthcare for residents at several ALFs in Pensacola, including Kipling Manor. She sees patients at Kipling Manor several times a month. She manages the healthcare of residents, diagnoses illnesses, and writes prescriptions as needed. She describes Kipling Manor as not being a typical setting because her patients there are seriously mentally ill, which presents huge challenges. Angela Lavigne is a registered nurse certified by Medicare to provide psychiatric care to patients. She is employed by a company called Senior Care. Among other things, she works with assisted living facilities providing therapeutic counseling, assisting doctors with adjusting medication, and providing in-service training to staff of these facilities in regard to psychiatric care. Nurse Lavigne has been seeing patients at Kipling Manor for almost three years. She visits Kipling Manor approximately four times a week. At the time of the survey, she visited the facility once or twice a week. She provides patient care as well as in-service training to the staff regarding psychiatric issues. She also runs group sessions with the residents to make them feel more independent and feel more like they are in their homes. On July 12 through 14, 2011, Nurse Endress conducted an unannounced complaint survey of Kipling Manor that gave rise to the Amended Administrative Complaint and to this proceeding. Count I--Resident 8 Count I alleges that Kipling Manor failed to provide incontinent care for Resident 8 and failed to provide nail and facial care for Resident 6. Ms. Endress observed Resident 8 walking with a "med tech" to the "med room" to receive her medications. Ms. Endress observed wetness on Resident 8's clothes, and noticed the smell of urine. The med tech gave Resident 8 her medications, then assisted her to an open area where Resident 8 sat down. Ms. Endress observed Resident 8 for about two hours. Ms. Endress approached a personal care assistant (PCA), who was a new employee, and inquired of the PCA as to whether the resident was incontinent. As a result of this inquiry, Ms. Endress believed that this resident was incontinent. After approximately two hours had passed, Ms. Endress called this to the attention of the PCA, who then changed Resident 8 immediately. Ms. Endress determined that Respondent was "not providing care for this lady, incontinent care. They were not monitoring her." This determination was based in large part on her belief that Resident 8 was incontinent. However, Resident 8's health assessment indicates that Resident 8 needed supervision while toileting, but did not carry a diagnosis of incontinence. Ms. Endress acknowledged at hearing that supervision with toileting is not the same thing as being diagnosed with incontinence. Resident 8's health assessment also reflects diagnoses of personality disorder, dementia, and Alzheimer's among other conditions. Ms. McCormick provided health care services to Resident 8. She quite frequently is involved with residents who have toileting issues. Had Resident 8 developed skin problems because of toileting issues, she would have been aware of it. Ms. McCormick noted that the records indicated that Resident 8 received a skin cream three times a day to prevent such skin problems. Both Ms. Endress and Ms. McCormick are of the opinion that, while it is better to change a resident as soon as possible, a two-hour check is appropriate for someone with toileting issues. According to Ms. McCormick, if she were looking to determine whether there existed a direct physical threat to Resident 8, there would be monitoring for skin breakdown, redness or irritation, or a possible urinary tract infection (UTI). Neither Ms. McCormick nor Ms. Lavigne were notified or saw any signs of a skin infection, other skin problems, or a UTI regarding Resident 8. There was no evidence presented that Resident had any skin problems or UTI as a result of this incident or her toileting issues. Erica Crenshaw is a "med tech" and a supervisor employed by Kipling Manor. She provided care for Resident 8 and was on duty the days of the survey in question. Ms. Crenshaw verified that Resident 8 was on a two-hour check at the time of the survey. This involved checking to see if Resident 8 was wet or dry. If she were found to be wet, staff would take off the resident's brief, change and wipe the resident, put on a new brief noting the date and time, as well as recording the staff person's initials. When changing Resident 8, staff would apply a barrier cream, and check to see if any bed sores developed. Ms. Endress determined that this was a Class II violation because of the potential for skin breakdown and infection as well as potential for emotional harm, in that she perceived this as a dignity issue for Resident 8. Ms. Endress based this opinion in large part on her mistaken belief that Resident 8 was incontinent. Her supervisor, Ms. McIntyre, reviewed the classification recommended by Ms. Endress and concurred that Class II was appropriate because "[r]esidents, in particular elderly residents, left sitting in urine, there is a great potential for them to experience skin breakdowns, which would certainly have a severe negative impact on their physical health." Mr. Williams saw Resident 8 while Ms. Endress was conducting her inspection. He saw that she was wet from urine on the back of her clothes. He did not detect any strong odor of urine although he was close to her. Count I--Resident 6 Count I also includes allegations regarding Resident Ms. Endress observed Resident 6 with long facial hair (Resident 6 is female) and long, dirty fingernails. Ms. Endress interviewed Resident 6 regarding these observations. Based upon this interview, Ms. Endress believed that staff did not cut her facial hair or trim her nails, despite Resident 6 wanting them to do so. Ms. Endress estimated Resident 6's nails to be approximately one-quarter inch long but could not recall the length of her facial hair. Resident 6's health assessment reflects a diagnosis of dementia with poor short term memory, and that she needs assistance bathing, dressing, and grooming. Erica Crenshaw described Resident 6 as "a little difficult to work with." Staff works on nails, hands and feet, two days a week. If at first Resident 6 was resistant to having her nails trimmed, they would "give her space" then approach her again later. She described Resident 6's nails as "pretty decent." Resident 6 received health care from both Ms. Lavigne and Ms. McCormick. Both nurses are of the opinion that staff worked with Resident 6 to keep her nails in good shape. As a resident of an ALF, Ms. McCormick noted that Resident 6 had the right to refuse nail care and decide whether her nails needed to be trimmed. Ms. Lavigne informed staff that they needed to work with Resident 6 at her own pace, and to be careful not to make her combative. Ms. Lavigne treated Resident 6 for a wrist problem in mid-summer of 2011, when Resident 6 was in a splint for approximately six weeks, and received physical therapy. She described Resident 6's nails as "nice, round, nothing broken, nothing chipped. Every once in a while she's actually let staff put nail polish on them but as far as cutting them down, it's like an act of Congress to get her to sit down enough to trim them." There is no evidence as to what could have been under Resident 6's nails when Ms. Endress saw her. However, the evidence establishes that Resident 6's nails were tended to by staff on a regular basis, and that her treating nurse was not aware of any problem with them. Regarding facial hair, Ms. Lavigne never noticed any facial hair on Resident 6 other than having "a couple little whiskers here and there." Ms. Lavigne was Resident 6's treating nurse in the general time-period around the survey in question, and was never informed about any problems with Resident 6 regarding nails or facial hair, nor noticed any. Ms. Endress classified the findings she made regarding Resident 6's nails and hair as a Class II violation because she perceived it as a "dignity issue because women do not like facial hair on them." Ms. McIntyre confirmed the class determined by Ms. Endress, although the record is not clear why. Count II--cleanliness and maintenance Count II of the Amended Administrative Complaint alleges that Kipling Manor failed to honor the rights of residents by not providing a safe and decent living environment to prevent the spread of disease for all residents. The Amended Administrative Complaint alleges in pertinent part as follows: In an interview resident #3 on 7/12/11 at 9:00 am stated this place was not clean. He stated the cook will have gloves on his hands when he leaves the kitchen. The cook continues rolling the food down the hallway to the dining room while simultaneously rolling the open garbage container which is soiled. Without changing his gloves he will serve the food to the residents.1/ An observation of lunch on 7/12/11 at 12:00 pm revealed the cook serving turkey with gloved hands not using a utensil. Without changing his gloves he handled silver ware, moved a gallon of milk and was touching the dining room table. He was using the same gloved hand to serve corn bread. While serving food he never changed his gloves between clean and dirty. Other staff wearing gloves were serving lunch to residents and cleaning tables and pouring beverages without changing gloves. They were serving beverages touching the rims of glasses without changing clothes [sic]. During the survey, the following was seen: Bathroom floor for room 9 on wing 1 was dirty with build-up of dirt in the corners. Lounge area at the end of wing 1 had a broken recliner that was being used by a resident. The floor and furniture were soiled. Room and bathroom #3 on wing 1 had dirty floors with build-up of dirt along baseboards and the toilet lid was too small for the tank. Vents were clogged with dust. The door was too short for the opening; wood was missing on door frame and the threshold had broken tile. Dining room bathroom at the end of wing 2 had dirty floors with build-up of dirt along baseboards; around bottom of the toilet was black and the seal was cracked. Dining room floors were dirty and walls had dried food on them. Room 27 had filthy floors with build up along baseboards; dried spills were noted and the drywall had a hole in it. Wing 2 had drywall that was pulling away from ceiling and the ceiling had brown water spots: soiled dirty walls; dirty baseboards with build up of dust; spills on walls and vents dusty. Wing 2 had no baseboard near the shower; the cabinet had mildew on the outside surface; the wood was warped and peeling. The sink was soiled with dried brown substance. The door to the cabinet would not close. The baseboard wood near sink was split and the drywall had an indentation of the door knob. Room 21 floors were filthy and smelled of urine. Soiled clothes laid on the floor with soiled underwear which were observed while medication technician was assisting resident. No action was taken by the medication technician. Laundry room floors were filthy. There was no division between clean clothes and dirty clothes. Clothes were lying on the floor.2/ Based upon this complaint, Ms. Endress observed the dining room during a meal and toured the building. At hearing, Ms. Endress acknowledged that she did not see the cook touch the garbage pail or garbage and then touch food. She maintained, however, that she observed the cook while wearing gloves, touch food then touch "dirty surfaces," then go back and touch food on plates and touch the rims on glasses. Ms. Endress did not specify at hearing what she meant by "dirty surfaces," but in her report which was the basis for the Amended Administrative Complaint, she noted that the cook would touch food and then touch surfaces such as moving a gallon of milk, touching the dining room table, and handling silver ware. She also testified that she saw other staff wearing gloves who were serving residents, cleaning tables, and serving beverages without changing their gloves. Deborah Jackson is a personal care assistant (PCA), food server, and laundry worker at Kipling Manor. Ms. Jackson and one other PCA serve meals for about 60 residents. She received training in food service. She was working at Kipling Manor the days Ms. Endress was there for the survey. Ms. Jackson always wears gloves when serving the residents. If she touches anything besides food she changes gloves. For example, if she moves chairs, she changes gloves before resuming food service. She has never seen the other PCA touch other items then serve food. She was trained never to touch the rims of the glasses but to pick up glasses and cups from the side. She goes through "probably a whole box" of gloves in a day. According to Ms. Jackson, the cook stands behind the area and puts the food on the plates, preparing two plates at a time. She watches him prepare the plates of food. She and the other PCA then serve the food to the residents. The garbage can is kept in the back, not where food is being served. She has never seen the cook touch the garbage can then prepare plates of food. When he has finished, he takes all "his stuff" out on a cart, while the PCAs clean up. If a resident spilled food, the PCAs, not the cook, would clean it up. L.N. was the cook at the time of the survey inspection. L.N. was hired in April 2011 and received training in infectious control and food service sanitation. L.N. no longer works for Kipling Manor.3/ Billie Williams, as administrator of Kipling Manor, confirmed Ms. Jackson's description of the cook's role in serving dinner. That is, that the cook prepared plates of food and the PCAs then served the residents. At hearing, Ms. Endress essentially reiterated her findings regarding the other allegations in count II dealing with the cleanliness and condition of the facility. No further proof was offered regarding these or any other allegations in the Amended Administrative Complaint. Mr. Williams' testimony contradicted much of what Ms. Endress described regarding the cleanliness and condition of the facility. Specifically, Mr. Williams noted that on the day of the survey inspection, maintenance men were repairing a ceiling leak. The ceiling leak was the cause of the "drywall pulling away from the ceiling" and the "brown water spots" on the ceiling cited in the Amended Administrative Complaint. These conditions were the result of the water leak and were in the process of being repaired at the time of the survey. The workers arrived early in the morning and cut drywall from the ceiling where the water dripped down on it. They necessarily used a ladder to do the ceiling repair work. A maintenance man stood at the bottom of the ladder and, if a resident approached, would escort the resident around the ladder. Regarding the issues of cleanliness, Mr. Williams has two housekeepers, a person who does the laundry, and two maintenance men. Mr. Williams acknowledged that there may be a small wax buildup along baseboards or on the inside corner of a door. However, the two maintenance men wax, strip, and buff the floors throughout the building. The floors are swept and buffed every day. The baseboards (wall to floor) are dust mopped twice a day. Regarding the allegation that there was black around the bottom of the toilet and the seal was cracked in the bathroom off the dining room area, Mr. Williams went to that room with the maintenance men to personally inspect it. He observed some discoloration on the floor where the toilet may have overflowed at some time and got underneath the tile. The maintenance men cleaned this immediately and replaced the tile. Regarding the allegation that there was mildew on a bathroom cabinet, Mr. Williams inspected the black mark and found it to be a tire mark from a wheelchair. He found no mold or mildew. The black mark was removed. There is a separate laundry room where washers and dryers are located. Any clothes on the floor are for sorting or separating by color or other reason prior to washing. Once clothes are washed, they are taken back to the residents' rooms immediately. Clean sheets, towels, and wash cloths are placed on wooden shelves that were built for that purpose. There is no evidence that establishes that clean and dirty clothes were mixed on the floor. Mr. Williams also inspected the recliner. The recliner has snap-on armrests and one had been snapped off. The maintenance men snapped the armrest back on the chair, and it was easily repaired. Regarding the allegation that the drywall in a bathroom had an indentation of the door knob, Mr. Williams inspected that and found that the doorstop on the bottom had broken off. There was an indentation in the wall the size of a doorknob where the door had been opened hard. This was repaired by the maintenance men. Regarding the allegation of vents being clogged with dust in a room and bathroom, Mr. Williams found "a little" dust on a vent which was cleaned immediately by staff. He then instructed staff to check the vents daily for dust build-up. Mr. Williams could not find a door that was too short for the opening, and noted that this would be a fire code violation. Kipling Manor is current on fire and health safety inspections. In general response to the allegations regarding cleanliness and maintenance and to a question asking whether he keeps a well-maintained building, Mr. Williams stated: We try our best. I mean, I have--you know, when you have incontinent residents who are demented, who are bipolar or suffering from depression, they will do things. And, yes, they do. And like, I think in one of the reports she wrote up, there was wet clothes on the floor. Well, if a resident, some of them are semi-independent, too. I mean, they take care of their own needs. If they had an incontinent issue that morning, and they took their clothes off and left it there on the floor, you know, they expect the staff to pick it up and take it to a laundry room when they come through. You know, we do, I think, we do a darn good job given the -- a lot of my residents have been homeless, have never had any structured living. Nobody else in town takes them, but I have. Ms. Endress classified the alleged violations in Count II as Class II "because of the potential for harm to residents which could occur from an unsafe environment and potential spread of infection." Ms. McIntyre agreed with Ms. Endress that "the totality of all the findings are what drove the deficiency to be considered a Class II." Count III--Resident 4 medications Count III alleges that Kipling Manor failed to administer medications according to the medication observation record (MOR) for 1 out of 9 sampled residents (Resident 4). During lunch, Ms. Endress observed Resident 4 become agitated, rub his face, and complain loudly in the dining room. Following an observation of this resident and a conversation with him, Ms. Endress reviewed Resident 4's medication observation record (MOR) and health assessment. Ms. Endress determined that Resident 4 had not been given one of his medications, Interferon, when scheduled. The MOR shows a time for administration as 8 a.m. According to Ms. Endress, on the date this took place, July 12, 2011, the MOR was blank in the box that should be initialed when the medication was administered. The MOR in evidence, however, reflects initials in that box (i.e., it is not blank). When a drug is self-administered, the staff member initials the box for that day. Erica Crenshaw recognized and identified the initials in the box for that day as those of former unit manager Tekara Levine, who trained Ms. Crenshaw. According to Mr. Williams, Ms. Levine, was certified in the self- administration of medications and was a trustworthy employee. Ms. Endress observed Resident 4 wheel himself from the dining room to the medication room and self-administer his medication. This occurred around noon that day. Ms. Endress determined this to be a Class II violation as she believed it directly threatened the resident emotionally. She based this in part on the resident's demeanor before the medication and afterwards, and the comments the resident made to her. Resident 4 is one of Nurse Lavigne's patients. Resident 4 has a diagnosis of MS, major depression, post traumatic stress disorder, a paranoid psychosis, and anxiety and affective disorder. He receives Interferon for his MS. It is injectable and he self-administers it every other day. According to Nurse Lavigne, there is no doctor's order stating that the Interferon must be given at 8 a.m. or any other particular time. The injection can be administered at any time during the day. Resident 4 sometimes gets confused about his medications. He gets extremely upset if he thinks he has not gotten his medications. He will sometimes tell her (Nurse Lavigne) that he did not receive a particular medication when he, in fact, did receive it. Once he is shown the MOR indicating that he has received his medication, he visibly calms down. He does not like to leave his room because he thinks somebody is changing stations on his TV. Regarding his once-a- day medications, staff will wait until he is ready to come out of his room because he can get agitated. He sometimes gets upset if there are a lot of people around him, such as in the dining room. Nurse Lavigne does a full assessment when she sees Resident 4. She was not aware of any problems with Resident 4 during that time period regarding his medications. While the record is unclear as to why Resident 4's MOR shows an administration time of 8 a.m., the evidence established, through Nurse Levine, his treating nurse, that there is no doctor's order requiring that the drug be administered at that particular time. The evidence also established that Resident 4 self-administered his medication at noon on July 14, and that this was initialed by a staff member on his MOR. Count IV--Resident 1 medications As a result of a complaint received, Ms. Endress interviewed residents about their medications and spoke to a new staff member. Based upon these interviews, Ms. Endress determined that one of Resident 1's medications (Flexeril) had not been available for one dose on July 13, 2011, and another of this resident's medications (Visteril) had not been available from June 23 until July 12, 2011). Ms. Endress classified this alleged violation as a Class II because she determined that that it directly affected the resident psychologically and physically. Resident 1 had a diagnosis of COPD and has an anxiety disorder. She is alert and oriented. Resident 1 was prescribed Flexeril to be administered every evening, and Vistaril and Ativan for anxiety. She is to receive Ativan twice a day and PRN (as needed) and Visteril before bed and PRN. Each day a medication is administered, the residents' MORs are initialed by staff in a box indicating each day of the month. However, if the resident runs out of a drug, the staff member will put a circle in the box representing that day and makes a note on the back of the MOR. No circles or notes appear on Resident 1's MOR indicating that either drug was not available. Resident 1 is a patient of Nurse McCormick. Resident 1 becomes anxious or agitated if she does not receive her medication for her anxiety disorder. Nurse McCormick considered Resident 1's anxiety disorder well controlled by the medications. Resident 1's MOR reflects that she received Visteral from June 1 through 30 at night as ordered and received it PRN several times prior to June 23, 2011, but did not receive it PRN the rest of the month of June or July 1 through 14. She also received Ativan twice a day routinely in June and July and five times PRN during the period June 23 through 30, 2011, and four times during the period July 1 through 14. According to Nurse McCormick, either medication was appropriate for controlling Resident 1's anxiety disorder. Resident 1's MOR reflects that she received Flexeril on June 30, 2011. Nurse McCormick was not made aware at any time that Resident 1 was not receiving any of her medications. As the treating and prescribing nurse, missed or unavailable medications would have come to Nurse McCormick's attention. Resident 1 was not anxious, nervous or agitated when interviewed by Ms. Endress on July 12, 2011. There is no competent evidence that Resident 1 displayed any signs of anxiety, nervousness or agitation during the survey or during the times that the Amended Administrative Complaint alleges that she did not receive her medication. Nurse McCormick found the staff of Kipling Manor to be careful with all residents. She has been to the facility at various times of the day from early in the morning to late into the evening. Nurse McCormick is of the opinion that the staff takes care of all its residents and provides them with dignity. Despite Kipling Manor's resident population of seriously mentally ill residents, Nurse McCormick is of the opinion that the facility manages its residents with dignity and care. Count V--Background Check The Amended Administrative Complaint alleges that one staff member of Kipling Manor, the cook, had not been background screened. Based upon record review and staff interview, Ms. Endress determined that the facility did not complete a level 2 background check for 1 out of 8 sampled staff members. A record review revealed that this employee had been hired in April 2011. On April 26, 2011, the employee in question signed an Affidavit of Compliance with Background Screening Requirements, using AHCA form #3100-0008. By signing this form, the employee attested to never having been arrested for, pled nolo contendere to, or convicted of certain disqualifying offenses. Mr. Williams did not complete a background check on the cook because he did not think the cook was covered under the law. That is, he did not think the law applied to the cook because of the lack of personal contact with the residents. The cook is present during meal times serving plates of food to the dining workers who then directly serve the residents. The living areas are accessible to the cook. This employee no longer works at Kipling Manor. The record is not clear as to when he stopped working there. Ms. Endress determined that this constituted a Class II deficiency as she believed that it could potentially lead to harm to residents of the facility. According to Ms. McIntyre, AHCA always imposes a Level II deficiency for failure to have a level 2 background screening for employees. Both Ms. Endress and Ms. McIntyre testified at hearing regarding what constitutes Class II and Class III deficiencies. In several instances, Ms. Endress classified a violation or deficiency that could potentially result in harm to a resident as a Class II. Ms. McIntyre testified that "a potential harm to a resident could be a class II deficiency." She described a Class III as one that "indirectly threatens the physical, emotional health or safety of a resident. . . . indirectly or potentially." The Agency provided a mandatory correction date of August 1, 2011, for all five counts in the Administrative Complaint.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is RECOMMENDED: That the Agency for Health Care Administration enter a final order imposing a fine of $2,000, imposing a survey fee of $500, and dismissing the remaining allegations of the Amended Administrative Complaint against Respondent, Kipling Manor. DONE AND ENTERED this 1st day of May, 2012, in Tallahassee, Leon County, Florida. S BARBARA J. STAROS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of May, 2012.
The Issue Validity of Respondent's policy that applicants to retake the examination administered for licensure as an optometrist must have passed all portions of the national board examination within five years prior to the filing of the application. This rule challenge arises under Section 120.56, Florida Statutes. It was consolidated for purposes of hearing with another case involving the same parties, DOAH Case No. 84-2647, wherein Petitioner is seeking to have his application to retake part of the state examination for optometrists approved. In that case, the Petitioner has provisionally denied his request based on the policy being challenged as a rule in this proceeding. At the hearing, Petitioner testified in his own behalf and called Mildred Gardner, Executive Director of the Board of Optometry, as a witness. Petitioner submitted 12 exhibits in evidence and the Respondent submitted one exhibit. The parties have submitted posthearing findings of fact pursuant to Section 120.57(1)(b)4, Florida Statutes. A ruling on each proposed finding of fact has been made either directly or indirectly in this Recommended Order, except where such proposed findings of fact have been rejected as subordinate, cumulative, immaterial, or unnecessary.
Findings Of Fact Petitioner Samuel Scardino is an optometrist who is currently licensed as such in the states of California, Illinois, Kentucky, and Michigan. He graduated from the Illinois College of Optometry in 1978, and successfully passed all parts of the National Board of Optometry examination in the same year. He has been a practicing optometrist in Battle Creek, Michigan, since 1978. (Testimony of Petitioner, Petitioner's Exhibit 4) By application dated May 10, 1983, Petitioner applied to take the Florida optometry examination. His application was received by Respondent on May 13, 1983. Petitioner's application was approved pursuant to Respondent's Rule 21QER83-1 which amended Rule 21Q-4.01, Florida Administrative Code, on May 19, 1983, to provide that an applicant must have obtained a qualifying score on the national examination within five years prior or two years subsequent to the date of passage of the state examination. It also provided that a passing score of 75 must be obtained on the pharmacology section of the national examination in 1983, or subsequent thereto, within five years prior or two years subsequent to passage of the state examination. By letter of May 18, 1983, Respondent acknowledged receipt of Petitioner's application and $250.00 fee, but indicated that the application was incomplete in that a final transcript must be sent by his school, and also that the National Board report of passing grades within the past five years and the pharmacology section in 1983 with a score of 75 or above were required. Petitioner complied with these requirements and received an admission card for the optometry examination to be held in July of 1983. Petitioner took the examination at that time and received notice in September 1983 that he had failed the pharmacology/pathology portion of Part II of the examination with a grade of 61. A review of Petitioner's objections to the grade resulted in a further letter from Respondent, dated December 23, 1983, which advised Petitioner that the Board of Optometry review committee had reviewed the matter and changed his final grade for the pharmacology/pathology portion of the examination from 61 to 65, but that a final grade of 70 percent or better was required to achieve a passing status. He was thereupon advised of his right to a hearing under Section 120.57, Florida Statutes. (Testimony of Petitioner, Petitioner's Exhibit 1, 5-8, Respondent's Exhibit 1) On March 19, 1984, Petitioner filed an application for optometry reexamination with the Respondent, together with the $250.00 reexamination fee. The state application form for reexamination did not ask for any information concerning the National Board of Optometry examination, as did the original application form. Respondent's Rule 21Q-4.02, Florida Administrative Code, pertaining to reexamination, provided pertinently as follows: 21A-4.02 Reexamination.-- An applicant who fails either Part I or Part II of the state examination for licensure shall be required to retake only that part of the examination on which he failed to achieve a passing grade, provided that the applicant shall be limited to two retakes within a two year period from the date of original failure. If the applicant fails to achieve a passing grade as provided above, he shall be required to take the complete state examination for licensure in order to be entitled to be licensed as an optometrist. Reexamination shall be conditioned on payment of the reexamination fee. Respondent advised Petitioner by an undated letter which he received on April 7, 1984, that his National Board scores were no longer valid to take the Florida examination since they had been obtained more than five years prior to his application to take the 1984 examination. The letter further stated that 1983 was his last year of eligibility for examination under his 1978 National Board scores and that he had not been successful in his 1983 Florida examination. The letter enclosed an application for refund of his $250.00 fee for the 1984 examination. Petitioner thereafter spoke with the Executive Director of the Board of Optometry who indicated that the card would be evaluating his and other questions of candidates at their May 4, 1984 meeting. (Testimony of Petitioner, Gardner, Petitioner's Exhibits 2, 9, 11) The minutes of a meeting of the Board of Optometry on May 3, 1984, contains the following item: Examination 1984 - After discussion with Board Counsel, the Board reiterated that Examination candidates must have passed all parts of the National Board within 5 years prior to application to take the Florida examination in order that all candidates who pass the Florida examination are immediately eligible to apply for licen sure. Any candidate who applies to retake the Florida examination must also meet the requirements of passing the National Board within 5 years of applying to retake the Florida examination. All requirements of 21Q-4.01 apply to all candidates and no waiver of requirements shall be granted. Motion by Dr. Walker, seconded by Mrs. Chambers. Passed unanimously. The Board's Executive Director advised Petitioner of the action taken by the Board in a letter of May 14, 1984. He was also informed by this letter that if he completed the National Board requirements prior to the 1985 examination and applied for such examination, he would be required only to take the practical portion of Part II of the Florida examination, but that if he were not licensed in 1985, he would be required to take the entire Florida examination. After receiving the letter, Petitioner submitted his application for refund of the $250.00 reexamination fee which was approved on April 4, 1984 and thereafter paid to Petitioner. By Petition dated June 19, 1984, Petitioner requested an administrative hearing to contest the Respondent's denial of his application to retake the Florida optometry examination which was scheduled for August 1984. The instant rule challenge was subsequently filed in September 1984. (Testimony of Petitioner, Gardner, Petitioner's Exhibit 10) The policy statement announced by the Board at its May 3, 1984, meeting that applicants for reexamination must have passed the National Board examination within a period of five years prior to such application was first applied in 1984 and was uniformly applied to all applicants for reexamination who had not taken the National Board examination within the requisite period prior to application. (Testimony of Gardner)
The Issue This is a license discipline case in which the Petitioner, by means of a one-count Administrative Complaint, seeks to take disciplinary action against the Respondent on the basis of his alleged violation of Section 458.331(1)(c), Florida Statutes (2002).
Findings Of Fact The Respondent, Eduardo S. Mendez, M.D., was born in Cuba, was reared in Cuba, and was educated in Cuba. His education in Cuba included a degree in Medicine. He came to the United States of America in 1995. Shortly after moving to this country, the Respondent became the owner of a retail pharmacy and medical equipment business in Florida. The Respondent did not have a license to practice pharmacy in Florida. On the basis of conduct which took place between July of 1998 and June of 2000, an Information was issued in Case No. 02-20859 in the United States District Court for the Southern District of Florida charging the Respondent with engaging in a conspiracy to pay and receive health care kickbacks in violation of Title 18, United States Code, Section 371. The basic facts forming the basis for the criminal charge are described as follows in the Information: Medicare was a "Federal health care program" as defined in Title 42, United States Code, Section 1320a-7b(f)(1). Confortec D.M.E., Inc. ("Confortec") was a pharmacy located in Miami, Florida. Confortec was authorized by Medicare to submit claims to Medicare Part B for reimbursement of the cost of certain medications that Confortec dispensed by prescription to Medicare beneficiaries. Defendant EDUARDO S. MENDEZ was a resident of Miami and the sole owner of Confortec. Defendant EDUARDO S. MENDEZ offered to pay kickbacks to various patient recruiters so that they would provide the names and Medicare identification numbers of Medicare beneficiaries, along with prescriptions relating to these beneficiaries. Confortec filled these prescriptions and then filed claims with Medicare for reimbursement of the cost of the prescribed medications. After receiving payment on these claims from Medicare, defendant EDUARDO S. MENDEZ used a portion of the payments to pay kickbacks to the patient recruiters or their associates. * * * 12. Using a portion of the money received from Medicare payments, defendant EDUARDO S. MENDEZ paid or caused to be paid approximately $200,000 in kickbacks to the patient recruiters or their associates so that the recruiters would continue to refer Medicare beneficiaries and related Medicare prescription business to Confortec. Following his arrest, the Respondent cooperated extensively with the Federal Bureau of Investigation (FBI) and assisted the FBI in their investigation of his own activities, as well as in their investigation of similar criminal activities by others. Because of the Respondent's assistance to the FBI, the federal prosecutor recommended a substantial reduction in the sentence that might otherwise have been imposed on the Respondent. On November 14, 2000, the Respondent entered into a plea agreement in which he agreed "to plead guilty to an Information or an Indictment that charges him with the crime of conspiracy to commit an offense against the United States, namely, a violation of Title 42, United States Code, Section 1320a-7b(b)(2)(knowingly and intentionally offering and paying kickbacks and bribes to any person to induce the referral of individuals for the furnishing of services or items for which payment may be made under a Federal health care program), in violation of Title 18, United States Code, Section 371." On or about February 12, 2003, a United States District Judge signed a judgment in which the Respondent was adjudicated guilty of the criminal offense described above. The Respondent's sentence was three years of probation, three months of home confinement (with electronic monitoring), 150 hours of community service, and a fine of $100.00. The Respondent has fulfilled all of the terms of his sentence. Although the recruitment methods described above are prohibited by federal law and are a crime, that criminal activity does not involve any element of fraudulent billing seeking reimbursements from the Medicare program for services or items that were not provided. To the contrary, all of the prescriptions for which Confortec sought Medicare reimbursement were prescriptions that were actually filled for medications that were actually provided to the Medicare beneficiaries. During the period from July of 1998 through June of 2000, the Respondent did not have a license to practice medicine in Florida. Accordingly, the criminal conduct described above was not related to the Respondent's practice of medicine, because the Respondent was not practicing medicine at that time. As discussed in greater detail in the conclusions of law, the criminal conduct described above was directly related to the practice of medicine by the physicians who wrote the prescriptions that were filled in the course of the subject criminal activity. As also discussed in greater detail in the conclusions of law, the criminal conduct described above was directly related to the ability to practice medicine. The Respondent is presently a physician licensed to practice medicine in the State of Florida. He has been so licensed since November of 2001. His license number is 83615. The criminal charges described above are the only criminal charges that have ever been filed against the Respondent. There has never been any prior disciplinary action taken against the Respondent's license to practice medicine.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that a final order be entered finding the Respondent guilty of violating Section 458.331(1)(c), Florida Statutes (2002), and imposing the following penalties: Suspending the Respondent's license to practice medicine for a period of nine months; Imposing an administrative fine in the amount of five thousand dollars; and When the Respondent is reinstated following the nine- month period of suspension, placing the Respondent on probation for a period of two years subject to such terms of probation as may appear to the Board of Medicine to be necessary and appropriate. DONE AND ENTERED this 16th day of September, 2005, in Tallahassee, Leon County, Florida. S MICHAEL M. PARRISH 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 16th day of September, 2005.
