The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what sanctions should be imposed against him, if any.
Findings Of Fact Petitioner is the State agency responsible for the administration of Medicaid funds in Florida. Respondent is a physician licensed in the State of Florida and practicing in Sunrise, Broward County, Florida. He is a Board-certified dermatologist. Until the Department issued its emergency termination order, Respondent participated in the Medicaid program by treating Medicaid recipients and receiving reimbursement from the Department. He was one of only several Broward County dermatologists who accepted Medicaid patients. As part of his medical practice, Respondent employs a device known as a grenz ray machine to treat certain dermatologic conditions from which his patients, including his Medicaid patients, suffer. Grenz rays (also known as ultra-soft x-rays and Bucky rays) have been used for more than sixty years for the treatment of benign skin diseases. Grenz rays are radiations of very low energy. They are closely related to conventional x-rays but possess very limited penetration abilities. Conventional x-rays and grenz rays are part of the electromagnetic spectrum, with grenz rays bordering the very short wavelength ultraviolent light. The word Grenz is derived from a German word meaning "border." As part of the electromagnetic spectrum, grenz rays are a form of ionizing radiation. Further up the electromagnetic spectrum from the very low energy of grenz rays are the higher energy levels of superficial x-rays and then the higher levels of diagnostic x-rays through such intense ionizing radiation equipment as the linear accelerator. Grenz rays do not penetrate the skin as deeply as even superficial radiation. As grenz rays pass through the outer layer of skin, their energy drops off rapidly. Grenz rays are almost entirely absorbed within the first 1-2 millimeters of skin. Accordingly, grenz rays do not have an energy level capable of penetrating so as to constitute a real risk of biological damage. Grenz ray therapy is a safe, rapid, and painless procedure for the patient. The risk of malignancy from grenz ray therapy appears to be quite small and then only in a few cases involving massive overdoses. Further, the risk factor of grenz rays in the development of non-melanoma skin tumors is small, if any. Any relationship between grenz ray therapy and skin cancer in humans is far from evident as opposed to conventional x-rays further up the electromagnetic spectrum which can be carcinogenic. Long-term studies of substantial numbers of people who have received grenz ray therapy have not documented risk. Although cautions against unnecessary use of ionizing radiation have been issued, the cautions against indiscriminate use of ionizing radiation relate to the use of superficial x-rays and/or higher levels of radiation. Those same recommendations suggest the use of less penetrating grenz rays which offer a wider margin of safety. Those recommendations, such as those issued by the National Academy of Sciences in 1980, in addition to affirming the safety factor inherent in grenz rays, also strongly endorse the concept that it remains the prerogative of the physician to use any form of therapy in which the benefits accruing to the patient from its use are considered to outweigh the risks inherent in its use. For many decades, medical schools have taught dermatologists about the beneficial uses of grenz ray therapy in alleviating benign dermatologic conditions. Medical schools have uniformly included lectures and required reading on grenz ray therapy in their curricula. Although not all have provided their students with "hands-on" experience as part of their studies, by the time dermatologists have completed their residencies, however, most of them have been given "hands-on" training. Respondent was taught the use of grenz ray therapy in medical school. Over the last several decades, the use of grenz ray therapy by dermatologists has declined as antibiotics and topical medications have increased in availability. However, grenz ray therapy has remained an effective weapon in the arsenal of therapeutic modalities available in the treatment of dermatologic conditions. The American Academy of Dermatology is the national organization for Board-certified dermatologists. Its 1991 annual meeting took place during the course of the final hearing in this cause. At its annual meeting, the Academy offered two lectures and a symposium on the beneficial use of grenz ray therapy for many benign conditions. Respondent attended the symposium and one of the lectures. He did not attend the lecture which was a basic introduction to grenz ray therapy. Whether the emphasis placed on grenz ray therapy during the Academy's last annual meeting indicates a resurgence in the use of grenz ray therapy is unknown; however, it is clear that doctors still use that therapeutic modality and are still teaching it to each other. The standard dose of grenz ray therapy ranges from 50 rads to 200 or 300 rads. It is a small dose and requires only a few seconds to administer. The dosimetry cannot be scientifically or logically compared to the dosimetry of diagnostic x-rays, such as a chest x-ray, since such diagnostic x-rays require a much higher level of ionizing radiation than grenz rays. Similarly, grenz rays are not used for the purpose of obtaining x-rays of a human body. They are simply used to treat diseases and conditions of the skin. Some dermatologists use grenz rays to treat benign skin disorders. Respondent is one of them. Some dermatologists do not use grenz rays. Some of the ones who do not use grenz rays refer their patients who would benefit from grenz ray therapy to dermatologists who administer that modality. One of the Department's witnesses does not use grenz ray therapy; one of the Department's witnesses does but for fewer skin disorders than the variety of skin disorders which Respondent treats with grenz ray therapy; and the Department's third witness does not use grenz ray therapy but rather uses superficial therapy, a stronger form of ionizing radiation, to treat at least one of the same conditions that Respondent treats with grenz ray therapy. Until this case arose, Respondent's use of grenz ray therapy had never been questioned by any federal or state regulatory agency. Likewise, no claim for grenz ray services rendered by Respondent had been declined by any third- party payor, and, specifically, all claims for grenz ray therapy which Respondent had submitted to the Department over the years that he had been a Medicaid provider had been paid. There is no statute or rule on the federal or state level prohibiting the use of grenz ray therapy, and the Department has no policy against such use. The Department had been paying Respondent on all claims submitted by him in accordance with the reimbursement schedule utilized by Medicaid, with the current rate being $11 for a grenz ray therapy treatment. Respondent has four grenz ray machines in the medical office which he shares with another dermatologist. Those machines are calibrated annually by a radiation physicist, and they have been inspected and licensed every year by the Department. Respondent's machines are calibrated to deliver the standard minimum dose of 50 rads per treatment. Respondent's use of the minimum dosimetry for grenz ray therapy is conservative. The Department's computer does random utilization audits of services by Medicaid providers in the State of Florida. The computer "flagged" Respondent, one of only several dermatologists providing Medicaid services in Broward County, as having been paid for an "excessive" number of grenz ray treatments. The Department's investigator who received that computer file had never heard of grenz ray therapy. She began a search of the literature to learn about grenz ray therapy. She misunderstood the scientific studies, medical textbook chapters, and other medical articles which she obtained. She did not understand that the biological risks of ionizing radiation discussed in the writings she collected related to higher levels of ionizing radiation than the ultra-soft grenz rays. She also misunderstood the conclusions of the scientific studies specifically related to grenz rays. She did not speak to Respondent regarding the medical services he was providing. Instead, she went to Respondent's office, copied medical records of some of his Medicaid patients, and advised him that his use of grenz ray therapy was an outdated, antiquated modality. She further advised him that grenz ray therapy should never be used on children. The Department then issued an emergency termination order terminating Respondent's Medicaid provider status due to the danger which his use of grenz ray therapy posed to his patients. No one on behalf of the Department contacted Respondent to discuss those patients or his use of grenz ray therapy prior to the Department entering its emergency termination order. As required by Chapter 120, Florida Statutes, the emergency termination order was followed by this Administrative Complaint. There are no statutes, rules, policies or guidelines issued by any federal or state regulatory agency specifying the order in which physicians may select a particular treatment modality, and that decision is properly left to each physician. Although some physicians use grenz ray therapy as the treatment of last resort, some use it as a treatment of first choice, and others use it in an adjunctive manner, i.e., in conjunction with other treatment modalities. Respondent uses grenz ray therapy with other treatments to expedite those other treatments. During the final hearing, the Department was given leave to strike the allegations in the Administrative Complaint as to many of Respondent's patients. What remained were allegations as to improper treatment of 39 children and 4 adults. Although the use of ionizing radiation on children is generally discouraged because of the potential biological effect, such restrictions do not apply to the use of grenz ray therapy. There are no apparent clinical limitations on the use of grenz ray therapy based upon age or sex. The physiological process and the way tissue reacts to grenz rays are the same for adults as for children, including infants. Because the quantity of grenz rays capable of penetrating below the top 1 to 2 millimeters of skin is small and no risk therefrom has been documented, children can benefit from the use of grenz ray therapy as much as adults can. Respondent's use of grenz ray therapy on the 39 children and 4 adults involved herein was appropriate, was medically necessary, was neither excessive nor inferior, and was not harmful to those patients; rather, Respondent's use of grenz ray therapy benefited the patients in question. All of the dermatologic conditions for which Respondent administered grenz ray therapy to the patients involved herein are among the conditions likely to benefit from grenz ray therapy. They are also among the conditions identified during the Academy's 1991 annual meeting as being appropriate for grenz ray therapy. When utilizing ionizing radiation therapy, it is important to note in the patient's record the number of rads administered, the treatment site, and the skin target distance for two reasons. First, there is a cumulative lifetime dose above which ionizing radiation would not normally be administered. Second, the use of ionizing radiation in a particular treatment area may prohibit subsequent use of ionizing radiation in that same treatment area. The same restrictions regarding repeated doses of ultra-soft grenz rays do not appear to apply. There is no certainty that there is a maximum lifetime dose. Although researchers in Denmark have recommended a maximum of less than 2,000 rads per year and 10,000 rads per lifetime and although American literature recommends 5,000 rads as the total lifetime cumulative dose per location, Swedish researchers, who conducted the landmark long-term study of over 14,000 patients who had received ultra-soft grenz ray treatment, have indicated that a schedule of weekly treatments for a total of 800 - 1,000 rads followed by a 6-month rest before additional treatment is given can be followed ad infinitum. Further, due to the meager penetration beyond the surface by grenz rays, research has not established that the administration of grenz ray therapy would be a barrier to subsequent use of additional grenz rays or the stronger forms of ionizing radiation. Grenz ray therapy has a standard minimum protocol attendant to its use. Grenz rays appear to be ineffective at less than 50 rads or with a skin target distance of more than approximately 20 centimeters. Respondent's grenz ray machines are calibrated to deliver the minimum effective dose of 50 rads at the effective skin target distance of 20 centimeters. Respondent noted in the medical records each grenz ray treatment given to each of the patients in question herein. Although Respondent's medical records for the patients involved herein rarely specified that the dose administered was 50 rads, did not recite the skin target distance, and rarely contained a drawing of the area affected, some dermatologists include such information in their medical records, and some do not. In the absence of such detail, subsequent treating physicians would likely assume the standard protocol. In any event, the failure to specify such details does not fall below the acceptable standard of care. Respondent's records do not contain an written informed consent form for any of the patients involved herein to whom he administered grenz ray therapy. There is no federal or state statute or rule or Department policy requiring that a dermatologist obtain a written informed consent form before administering grenz ray therapy. The evidence is uncontroverted that Respondent did explain to the patient or to the patient's parent or guardian grenz ray therapy together with its benefits and risks. The evidence is uncontroverted that he obtained consent in advance of such treatments. Although some dermatologists notate in their records that the explanation was given, some do not, and some do some of the time. Respondent's failure to notate those discussions in the medical records of the patients involved herein does not fall below the acceptable standard of care. The thyroid, the eyes (particularly the cornea), and the testicles are sensitive to even low doses of radiation. Therefore, using cones to collimate the beam and/or shielding the patient are devices normally used to protect patients from receiving ionizing radiation outside the field of treatment. However, the necessity for shielding those organs from the administration of the ultra-soft grenz rays is not so clear. It is not established that there is a risk to the thyroid from grenz ray therapy to the neck or to the testicles from grenz ray therapy to the scrotum due to the lack of penetration abilities of grenz rays. It is also believed that closing the eyelids offers the cornea sufficient protection to avoid risk from grenz ray therapy. It is clear that Respondent did not always use cones or other shielding devices, but there is no evidence that Respondent wanted to limit the field of treatment during those applications of grenz ray therapy. Further, it is Respondent's practice to place his hand over the eyes of any patient receiving grenz ray therapy to the face area who is unable to close his or her eyelids. While such a practice may not be in Respondent's own best interest, there is no evidence that Respondent's use of his hand as a shielding device reduced the benefits or increased the risks of grenz ray therapy for his patients. It has not been shown that Respondent fell below acceptable standards in his use of shielding devices. Although it is well known that exposure to ionizing radiation carries a risk, no safe threshold dose has been established. A safe threshold dose for grenz rays is even more elusive since the existing literature does not document biological harm from the administration of grenz ray therapy in accordance with standard dosimetry. Although grenz rays are incapable of being used to diagnose conditions due to their inability to penetrate beyond the outer layer of skin, grenz rays and the stronger levels of ionizing radiation are used to treat conditions based on a risk/benefit ratio. Stated differently, the use of any form of ionizing radiation is acceptable when the benefit to the patient outweighs the risk. In using grenz ray therapy for the patients involved herein, Respondent determined that in his best medical judgment the benefit to the patients outweighed the risk. In sum, Respondent's treatment of the patients named in the Administrative Complaint was within acceptable standards of care. Further, his records of those treatments are within acceptable standards of care.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent not guilty of the allegations contained within the Administrative Complaint and dismissing the Administrative Complaint filed against him in this cause. DONE and ENTERED this 20th day of April, 1992, at Tallahassee, Florida. LINDA M. RIGOT 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 20th day of April, 1992. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 91-3487 Petitioner's proposed findings of fact numbered 1, 3-6, 8-15, 25, 27, 28, 31, 37, and 40 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed findings of fact numbered 2, 17, 20, 21, 39, 41 and 52 have been rejected as being unnecessary for determination of the issues involved herein. Petitioner's proposed findings of fact numbered 7, 16, 18, 19, 24, 26, 29, 30, 32-36, 38, 42-47 and 53 have been rejected as not being supported by the weight of the evidence in this cause. Petitioner's proposed findings of fact numbered 22, 23 and 48-51 have been rejected as not constituting findings of fact but rather as constituting recitation of testimony, argument of counsel, or conclusions of law. Respondent's proposed findings of fact numbered 1, 2, 4-6, 10-15 and 17-28 have been adopted either verbatim or in substance in this Recommended Order. Respondent's proposed findings of fact numbered 3, 7-9, and 16 have been rejected as being unnecessary for determination of the issues involved herein. COPIES FURNISHED: David G. Pius, Senior Attorney Department of Health and Rehabilitative Services Building Six, Room 234 1317 Winewood Boulevard Tallahassee, FL 32399-0700 Salvatore A. Carpino, Esquire 1 North Dale Mabry, Suite 1010 Tampa, FL 33609 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 John Slye, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700
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.
Findings Of Fact The Respondent, Lionel Resnick, M.D., is a physician licensed to practice medicine in the State of Florida. He has been so licensed at all times material to this case. His license number is ME 0037412. At all times material to this case, the Respondent was the Director of the retrovirology laboratory at Mount Sinai Medical Center. The minimum qualifications for that position required that the Director possess either an M.D. degree or a Ph.D. degree. The Respondent's responsibilities as Director of the retrovirology laboratory were to direct research efforts, to obtain funding for research, serve as principal investigator on research projects, manage personnel, supervise science projects, and organize, analyze, and report scientific findings resulting from research efforts. The Respondent held this position as an employee for the annual salary of $30,000. Mount Sinai Medical Center provided the laboratory site, the laboratory equipment, and the laboratory staff for the retrovirology laboratory. Mount Sinai Medical Center retrovirology laboratory had a contract with the University of Miami Hospital in which Mount Sinai retrovirology laboratory provided the service of testing patient samples for Acquired Immune Deficiency Syndrome ("AIDS") related research protocols. The University of Miami Hospital paid Mount Sinai retrovirology laboratory for this service. All Children's Medical Center had a contract, similar to that of the University of Miami Hospital, with Mount Sinai retrovirology lab to conduct testing of patient samples for AIDS-related research. All Children's Medical Center paid Mount Sinai retrovirology laboratory for the testing. In or about July of 1989, while Director of Mount Sinai's retrovirology laboratory, the Respondent incorporated Vironc, Inc., using the Respondent's residential address as the corporate address. Vironc, Inc., was not a laboratory, it was a dummy corporation with no facilities or employees. Without the knowledge of Mount Sinai Medical Center, the Respondent notified All Children's Hospital and University of Miami Hospital that the services provided by Mount Sinai retrovirology laboratory, i.e., the testing of patient samples for AIDS research, would be conducted at Vironc, Inc., instead of Mount Sinai retrovirology laboratory. Contrary to the Respondent's representations, the specimens sent by the University of Miami Hospital and All Children's Medical Center continued to be tested at Mount Sinai retrovirology laboratory using the facilities and employees of the Mount Sinai retrovirology laboratory. None of the specimens were tested by Vironc, Inc. The Respondent sent invoices to All Children's Medical Center and to the University of Miami Hospital instructing them to send payments for these services directly to Vironc at the Respondent's address and in care of the Respondent. Using this mail fraud scheme, the Respondent diverted funds owed to Mount Sinai retrovirology laboratory in excess of $570,000 for his own personal use. These funds were intended as payment for the services of testing patient samples for AIDS research, which testing was done at the Mount Sinai retrovirology laboratory. On or about August 21, 1996, the Respondent was indicted for forty-nine counts of mail fraud and for two counts of money laundering in violation of 18 U.S.C. 1341 and 1342. On February 22, 1999, the Respondent pled guilty to eighteen counts of mail fraud. Specifically, the Respondent pled guilty to diverting more than $570,000 in funds tendered as payment for services provided by Mount Sinai retrovirology laboratory beginning in or about July 1989 and continuing through in or about September 1994. The purpose of the retrovirology laboratory at Mount Sinai Medical Center was to conduct research which would assist in the treatment of patients with AIDS. Specifically, the laboratory conducted research regarding compounds that would inhibit or stop the AIDS virus as part of the development of drugs that might be useful in the treatment of AIDS. During his tenure with the Mount Sinai retrovirology laboratory, the Respondent also proposed clinical research protocols requiring approval through a hospital Institutional Review Board to insure that patient rights were protected in the medical research being conducted. The Mount Sinai retrovirology laboratory also provided the service of testing patient samples for the University of Miami Hospital and All Children's Hospital. For example, the retrovirology laboratory tested patient blood samples to determine whether cell counts were being maintained and to determine the presence of virus fighters, factors in determining proper methods of treatment. The physicians at the University of Miami Hospital and at the All Children's Hospital sent patient blood samples for testing at the Mount Sinai retrovirology lab in order to obtain test results that could be used for the purpose of making treatment decisions regarding the patients from whom the samples were taken. Characteristics important to a physician's ability to practice medicine include reliability, honesty, and good moral character. Absent these qualities, it is difficult, if not impossible, for a person to fulfill the obligations and responsibilities entrusted to those who are licensed as physicians. The Respondent's pattern of conduct by means of which he converted to himself at least $570,000 that belonged to his employer, demonstrates that he is not reliable, is not honest, and that he lacks good moral character.
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, and revoking his license to practice medicine. DONE AND ENTERED this 21st day of November, 2000, in Tallahassee, Leon County, Florida. 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 21st day of November, 2000.
Findings Of Fact Petitioners, Manasota-88, Inc. and Concerned Citizens of Citrus County, Inc., filed their petition on August 9, 1985, challenging proposed rules 10D-91.1101 through 91.1109. These proposed rules were published in Vol. 11, No. 30., Florida Administrative Weekly, on July 26, 1985. Petitioner's Exhibit 1. The proposed rules cite sections 404.051(4) and 404.056, Florida Statutes, as authority for rulemaking. These sections provide: 404.051 Powers and duties of the Department of Health and Rehabilitative Services. --For protection of the public health and safety, the department is authorized to: * * * (4) Adopt, promulgate, amend, and repeal rules and standards which may provide for licensure, registration, or regulation relating to the manufacture, production, transportation, use, possession, handling, treatment, storage, disposal, sale, lease, or other disposition of radioactive material, including naturally occurring radioactive material and low-level radioactive waste, and radiation machines as may be necessary to carry out the provisions of this chapter. The recommendations of nationally recognized bodies in the field of radiation protection shall be taken into consideration in the adoption, promulgation, amendments, and repeal of such rules and standards. Land radiation emission standards. To preserve and protect the public health, the department is authorized to establish, by rule, and enforce any environmental standards for land which, either in its natural state or subsequent to mineral extraction, emits radiation. In the establishment of such rules, the department shall consider: Existing federal standards. The recommendations of nationally recognized bodies which are expert in the field of radiation protection. The effect on private or public water supplies. The use made, or to be made, of the land. The proposed use of the land for residential dwellings, public or private schools, or commercial buildings. The availability of measures to mitigate the effect of the radiation. (E.S.) Petitioner, Manasota-88, Inc., is an environmental health organization. T. 23. It was established in 1965. Id. Though the petition alleges that this Petitioner is a nonprofit corporation, there appears to be no record evidence of this point. Apparently this Petitioner has "members," see T. 23-24, but the record does not contain evidence of the relationship of those members to the alleged corporation. Some members of Manasota-88 own reclaimed phosphate land in Polk County, and Ms. Raines knew of about five such persons. T. 23. About 150 members of Manasota-88 live on mineralized land in Sarasota County. Members of Manasota- 88 work and shop in areas where commercial structures could possibly be built on reclaimed phosphate or mineralized land. T. 24. There was no proof of the number of "members" of Manasota-88, Inc. Ms. Raines is chairperson of Manasota-88, Inc., and was a member of the Governor's phosphate-related radiation task force. T. 24. Manasota-88, Inc. participated in all of the rule making hearings with respect to the proposed rules in question in this case. T. 26. Petitioner, Concerned Citizens of Citrus County, Inc., is an environmental organization formed to protect the natural resources of Citrus County through proper planning. T. 28. Miriam Cohen is secretary and a member of the board of directors. T. 27. The organization has 1500 members, living in all sections of Citrus County. T. Some members own reclaimed phosphate land in citrus county. Some live on reclaimed phosphate lands. Id. There is no direct evidence of the numbers of such persons, or direct proof of the alleged corporate structure of this Petitioner or its relationship to its members. Proposed rule 10D-91.1104 provides a goal that radiation exposure to the public from naturally occurring radiation be maintained "as close to normal background radiation levels as reasonably achievable," which is 0.009 working levels (WL) for the annual average radon decay product concentration. T. 34. The upper limit mandated by the rule as a ceiling, and not a goal, is 0.02 WL. Id. See Petitioner's exhibit 1, proposed rule 10D-91.1104. The proposed rule, in section 10D-91.1108, requires county health departments having certain defined lands within the county to conduct educational programs to advise the public that dwellings located on such lands have the potential of exceeding the standards set forth above. Such programs must include recommendations for periodic measurement and methods to effect remedial actions. T. 116. The lands are defined by proposed rule 10D-91.1106(1) to include lands which have previously been mined or reshaped as the result of the extraction of phosphate ore and mineralized lands known to contain uranium, thorium, or their decay products in such amounts that radiation could be in excess of the above standards. The proposed rule, in section 10D-91.1106(1)(b) provides that the Department of Natural Resources shall provide HRS with a description of such lands, and that HRS will disseminate such information to building inspection offices affected. The proposed rule has a notification procedure whereby certain test results are provided to owners of newly constructed dwellings when the above standard is exceeded. See proposed rule 10D-91.1106(2)(b) and (d). Other than the foregoing, the proposed rule does not require any other notice to persons. In particular, the proposed rule does not require that sellers or lessors give notice to prospective buyers or lessees. The proposed rule provides that newly constructed dwellings which do not use a construction technique described in section 10D-91.1106(2)(a) or (b), and which exceed the standards set forth above, must be remedied by the owner to comply with the standards. No other mandatory remediation is required. Remediation in these other cases is discretionary with the owners, although, as set forth above, county health offices must publicize remediation methods. New dwelling construction that uses "ventilated crawl spaces" as defined by the rule are exempt from testing. New dwelling construction on reclaimed phosphate land that uses "improved monolithic slab" or "post- tensioned slab" techniques as defined by the rule will be tested by HRS during the first year of occupancy using a track etch device or a thermoluminscent device. If the test results show that the standard is exceeded, the owners will be advised of the result and advised of discretionary remedial action that they can take. No testing is required of existing dwellings. Preoccupancy testing is required only of newly constructed dwellings which do not use one of the three construction techniques set forth above. The International Commission on Radiological Protection (ICRP) is a group of internationally known scientists. T. 105. The IRCP, in a 1983 report on radiation protection, recommended a standard of as low as reasonably achievable not to exceed 0.027 WL, which is higher than that in the proposed rule. T. 105; HRS exhibit 4, p.7. The National Council on Radiation Protection and Measurement (NCRP) recommends a standard of as low as reasonably achievable not to exceed 0.004 WL. T. 106-07; HRS exhibit 5, pp. 88-89; Petitioner's exhibit 25H, p. 13. The Governor's Phosphate Radiation Task Force of 1982 recommended 0.027 WL. Petitioner's exhibit 25F, p. 15. Other states have either considered or adopted the same standard as adopted in this proposed rule: as low as reasonably achievable not to exceed 0.02 WL. T. 98. In February, 1979, in a letter from the Environmental Protection Agency (EPA) to the Governor of Florida, the EPA recommended several standards for radiation levels on Florida phosphate lands. These recommendations were summarized on pp. 38665 and 38666 of Petitioner's exhibit 5. The first recommendation is that remedial action "should be taken" in all residences in which "the initial indoor air concentration of radon decay products exceeds 0.02 Working Level (WL), including normal indoor background." The second recommendation provides: II. When annual average air concentrations of radon decay products are less than 0.02 WL, remedial action required to reduce such concentrations to as low as reasonably achievable levels should be taken. Among the factors to be considered in determining the appropriate degree of reduction are the cost and effectiveness of available remedial measures, the health risk averted, the normal background level, the life expectancy of the structure, and measurement uncertainties. The third recommendation is that remedial action is not warranted in existing residences solely to reduce the indoor gamma radiation exposure rate. The fourth and final recommendation is that development sites for new residences be selected and prepared and the residences designed and sited so that the annual average indoor air concentration of radon decay products and gamma radiation does not exceed average normal background levels (indoor) plus uncertainties of normal background variation and measurement capability. The average normal indoor background level of radiation is about 0.004 WL for annual indoor air concentration of radon decay products, and 6 microroentgens per hour for gamma and x rays. Petitioner's exhibit 5, p. 38666. Uncertainties due to normal variations and measurement capability add 0.005 WL and 6 microroentgens, thus making the EPA "as low as reasonably achievable" standards to be 0.009 WL and 11 microroentgens per hour. Id.; T. 34. The supporting text of Petitioner's exhibit 5 makes it clear that the EPA did not recommend mandatory remediation below 0.02 WL. The technical information section states an attempt to achieve the "as low as reasonably achievable" standard would impose unreasonable costs in 15 percent of the cases. The technical information section further shows that costs and practicality are factors to be considered in trying to achieve lower levels: In order to provide flexibility to bring about remediation when costs are reasonable, remediation is recommended whenever responsible authorities determine that it is practicable to do so in the range between 0.02 WL (including normal indoor background) and 0.005 WL above normal background. (E.S.) Petitioner's exhibit 5, p. 38668. The technical information section describes the recommended standard for radon daughter product level below 0.02 WL as being "discretionary" with respect to remediation: The recommendations provide that when the radon daughter product level in existing homes is less than 0.02 WL (including normal background indoors) action be taken to reduce the radon concentration to as low as reasonably achievable levels. It is recognized that a discretionary policy such as this may complicate implementation of the recommendations since decisions must be made regarding which exposure level can be considered as low as reasonably achievable for each structure. To assist in making such decisions several factors should be considered: * * * 3. The cost to reduce the level should be evaluated . . . . * * * 5. The social and economic inconvenience to the to the inhabitants should be considered. Some inhabitants may find expenditures to install control technology prohibitive and a major disruption to their life styles. (E.S.) Petitioner's exhibit 5, p. 38669. On September 20, 1984, Richard J. Guimond, Director, Criteria and Standards Division, Office of Radiation Programs for the EPA, characterized the 0.02 WL as "a remedial action level," specifically referring to the letter which is Petitioner's exhibit 5, and characterized the reduction of radiation levels to a point not "significantly above normal background levels for Florida" as the goal of construction methods for new housing. In the next paragraph he stated: "We do not believe it is appropriate to establish a remedial action level for new housing different from that for existing housing." Attached to his letter were what Mr. Guimond referred to as "our comments" on the draft of the Governor's phosphate Related Task Force standards. In the last sentence on the first page of those comments, the EPA comments state: The difficulties in enforcement may discourage the incorporation of the ALARA [as low as reasonably achievable] principle in regulations, but the practice should, at a minimum, be encouraged in the text that accompanies the standards. (E.S.) In summary none of the EPA recommendations above explicitly recommend mandatory remediation. Even where more than 0.02 WL is present, the EPA recommendation only says that remediation "should" be taken. See Recommendation I above. Below 0.02 WL, EPA Recommendation II expressly lists factors to be considered in determining whether or not remediation should be taken. Moreover, the EPA did not specifically consider in any great detail what might be needed to achieve Working Levels below 0.02, and saw this as within the discretion of the state. Petitioner's exhibit 25A, p. 12. See findings of fact 21 through 24. By letter dated March 22, 1985, Sheldon Meyers, Acting Director, Office of Radiation Programs for the EPA, wrote to the Respondent to comment on the proposed rules for radiation levels in newly constructed houses. Mr. Meyers stated that "we . . . concur in the numerical standards you have proposed." Petitioner's exhibit 8. Mr. Meyers further praised the Respondent for using design criteria rather than direct radiation standards. Id. Mr. Meyers was critical, however, of the automatic exemption of testing of new houses using monolithic slabs or ventilated crawl spaces. Mr. Meyers stated that they were not aware of any data demonstrating that monolothic slabs have long- term effectiveness in preventing radon entry, that cracks are likely to appear over the normal lifetime of a house, and that there was not enough data to justify using a monolithic slab alone to prevent radon entry. He recommended that the monolithic slab be used only in conjunction "with other radon resistant techniques, such as well-sealed polymer barriers and sub-slab ventilation systems." He also questioned the use of crawl spaces, saying his data was "incomplete." He concluded by recommending that a testing program be used to certify construction techniques, and that while crawl space certification may be easy, that monolithic slab performance may take longer. Mr. Meyers did not expressly state that "all structures be subjected to preoccupancy and long term monitoring," as proposed by the Petitioners in proposed finding of fact 32. The rule requires both types of slab construction to have a polyethylene (or equivalent) soil gas barrier. Petitioner's exhibit 1; Petitioner exhibit 25G, pp. 37-38. Use of ventilated crawl spaces, monolithic slabs, or post-tensioned slabs, is expected to reduce radiation levels to the "as low as reasonably achievable" levels set forth in the rule, based upon current understanding of these building techniques. Petitioner's exhibit 25F, p. 33-34; T. 36-40. It is reasonable, however, for there to be some continued data collection to see how these building techniques perform in future years. Petitioners exhibit 25A, pp. 13-19, 57; T.40 It would not be reasonable to set the mandatory upper limit at the background level of 0.09 WL because as the background level is approached, one cannot tell whether the level of radiation is due to normally expected background or is due to the phosphate caused excess. Petitioner's exhibit 25H, pp. 22, 15; Petitioner's exhibit 25F, pp.35-36. Setting the mandatory upper limit that close to the normal background level would make the rule manageable and difficult to enforce. Id. The problem is not that monitoring devices are inaccurate, but that the readings from such devices, at the background level, increasingly run the risk of overregulation. Id. The "track etch" radon decay products detection device is a simple detection device, without moving parts, that has been almost universally accepted over the past ten years as a measuring device in uranium mines, and is a widely accepted measuring device. T. 109. A second detection device, using a thermoluminscent detector, is the "RPISU," or the radon progency integrating sampling units. The RPISU is widely accepted and used. T. 110. Both devices are recommended by the EPA and by most of the measuring standards organizations, including the Bureau of Standards. T. 111; Petitioner's exhibit 25H, pp.37-38. The Respondent anticipates that it will use the track etch detection device to monitor radon daughter levels when new construction involves either an improved monolithic slab or a post-tensioned slab. T. 113. The Respondent contemplates using the RPISU for monitoring radon levels for newly constructed dwellings tested pursuant to proposed rule 10D-91.1106(2)9(d). Id. Various agents and employees, as well as other persons, expressed varying opinions as to the legal question of whether the Respondent has legal authority to require more rigorous forms of public notification, and the Respondent appears to have considered these various opinions. See HRS exhibit 7; Petitioner's exhibit 10, 17, 25E (p. 4), and 15. Evaluation of problems of enforcement, cost off enforcement, and economic inconvenience to persons regulated are consistent with EPA guidelines. See findings of fact 23 and 24 above. Lifetime residency (75 percent) occupancy of a residence with an air concentration of 0.02 WL is predicted to result in a 70 percent increase in lung cancer, from 2 per 100 to 5 per 100. Petitioner's exhibit 5, p. 38668. If 80 percent reduction of all cases above 0.02 WL is achieved, 60 percent of the excess risk of lung cancer will be eliminated; if 80 percent reduction of all cases above 0.005 WL (plus 0.004 WL background) is achieved, 75 percent of the excess risk of lung cancer will be eliminated. Ibid. Thus, the benefit of going all the way to the as low as reasonably achievable level is to eliminate another 15 percent of the excess risk of lung cancer, or 0.45 cases per 100 persons. The proposed rule does not place any mandatory duties upon local building inspection offices. The proposed rule states: 10D-91.1107 Inspection and Notification of Test Results. (1) Following an evaluation of the test data for dwellings specified in 10D-91.1106(2)(d), the Department shall send the appropriate building inspection office a letter recommending approval or denial of occupancy no later than 5 working days after evaluating the test data. * * * (2) Each building inspection office . . . should give written notice of the prospective building or owner of the dwelling of the requirements of this part and should assure that occupancy of the dwelling is not permitted until confirmation is received from the Department that the dwelling has met the standards contained in 10D-91.1104(2), or until inspection has verified that the dwelling is constructed in accordance with 10D-91.1106(2)(a) or (2)(b). Thus, the County building inspector will receive the recommendations of the Respondent, but has no mandated duties. The proposed rule only suggests what the county building inspector "should" do. The testimony was not in conflict with the proposed rule. The witness who testified on this point stated that "we really would expect" the building office to refuse to issue a certificate of occupancy. He did not testify that the local building inspector was required to withhold the certificate of occupancy. T. 64-65. The Hearing Officer officially recognizes that intervenor, Polk County, is a political subdivision of this state. Findings of fact adopted by reference in the Appendix, as well as explicit findings of fact made in the Appendix, are incorporated herein by reference.
Recommendation Upon consideration of the foregoing, it is ORDERED Petitioner, Concerned Citizens of Citrus County, Inc., have failed to prove standing, and therefore are DISMISSED as a Petitioner in this case. The remaining Petitioner and Intervenor have failed to prove that proposed rules 10D-91.1101 through 10D-91.1109 are an invalid exercise of delegated legislative authority. DONE and ORDERED this 20th day of December, 1985, in Tallahassee, Florida. Hearings Hearings 1985. WILLIAM C. SHERRILL, JR. Hearing Officer Division of Administrative The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative this 20th day of December, APPENDIX TO RECOMMENDED ORDER, CASE NO. 85-2813RP RULINGS UPON ALL PROPOSED FINDINGS OF FACT A. The following, using the same numbers as used by the Petitioners in their proposed findings of fact, pages , are the specific rulings of the Hearing Officer as to each proposed finding of fact. If "adopted," the finding as proposed becomes a finding of fact in this recommended order. If adopted or rejected with qualifying statements, the qualifying statements, to the extent that facts are involved, are additional findings of fact. Adopted. Petitioners fail to give any page reference for the conclusions of fact proposed. The Hearing Officer cannot find any reference to the national average, and therefore rejects the second and third sentences of this proposed finding of fact. The fourth sentence is also incorrect. The report cited, HRS exhibit 3B, states in several places that the mean WL for undisturbed nonmineralized land to be 0.004 WL. The rest of the proposed finding of fact is adopted. Rejected. Petitioners have failed to cite any portion of the record where this fact has been proven, and the Hearing Officer does not recall any such testimony. Further, the policy of the United States with respect to VA and FHA loans has not been shown to be relevant to this rule challenge. Adopted. Additionally, the report noted that in some cases, application of a standard of 0.009 WL to a new structure might not be feasible or reasonable. Footnote 2 is rejected as legal argument. Adopted. The first sentence is adopted. Petitioners fail to cite the portion of the record supportive of the second sentence, and the Hearing Officer has no recollection of any such evidence in the record, and therefore, the proposed finding in the second sentence is rejected. Adopted. Table 12, page 57, of attachment A to Petitioner's exhibit 25A does not establish the proposed fact that use of crawl spaces and monolithic slabs at a cost of $550 will reduce radiation to 0.09 WL and 11 microroentgens/hour; section 5.0 implies this result, but does not state it with sufficient precision for a finding of fact to be made. Only the following statement of fact can be made: that the EPA estimated that it would cost $550 for ventilated crawl spaces, and for improved slab construction to reduce radon radiation by 80 percent, using 1977 dollars. Adopted. The first sentence is adopted. The second sentence is rejected since the record is closed for new exhibits. Adopted. Adopted. There is no citation to the record for the last sentence of this proposed finding, and the Hearing Officer has no recollection of evidence on this point, and therefore the last sentence is rejected. The next to last sentence overstates the text of paragraph 4, page 38665, Petitioner's exhibit 5. The correct statement is as follows: Residents who live a lifetime in these homes [homes having radon levels from 0.03 to 0.1] could experience a risk of lung cancer which is 2-4 times the average risk to a member of the U.S. population. The rest of the proposed finding is adopted. Adopted, including the footnote. As discussed more completely in the findings of fact above, the EPA recommendations I through IV found on pages 38665 66, Petitioner's exhibit 5, do not recommend mandatory remedial action. Proposed finding of fact 15 is adopted, except the word "mandatory." There is no citation to the record to support proposed finding of fact 16, and the Hearing Officer is unable to find record support for this proposed finding, and therefore must reject it. Adopted. Petitioner's proposed finding of fact 18 is rejected for several reasons. First, the citation to Petitioner's exhibit 24 does not support the proposed finding, and the Hearing Officer has no recollection of any other record evidence to support this proposed finding. Second, the finding is not relevant. The task force did not adopt this apparently preliminary standard. Petitioner's proposed finding of fact 19 is rejected in part because there is no citation to the record to support the finding that revisions were made due to "vigorous lobbying by the Florida Phosphate Council and the Florida Home Builders Association." The finding is further rejected because the proposals of the subcommittee are irrelevant. The finding that the task force ultimately adopted a 0.027 WL standard has already been made. Adopted, except the parenthetical "[to the public health]" is rejected. The EPA did not limit its consideration of costs to only the public health, but consistently evaluated the costs to home owners and land owners as well. See e.g. Petitioner's exhibit 5, p. 38669, numbered paragraph 3 and 5; Petitioner's exhibit 25A, attachment A, pages 56-75. Adopted. Rejected because prior drafts rules are not at issue in this case, and have no relevancy or weight as to what the proper standards should be. Rejected for the same reasons as stated in 22 above. Adopted. Rejected because irrelevant. The issue in this case is not whether the Respondent has legal authority to adopt more stringent notice requirements, but whether a rule that fails to do so is an invalid exercise of delegated legislative authority. Adopted. Adopted with the following exception. Petitioner's exhibit 15 does not state that the Office of General Counsel stated any legal opinion as to notice. The exhibit fails to identify "OSLS," and the Hearing Officer cannot make a finding as to what that means. Moreover, the legal opinion stated in the exhibit by the OSLS, is not a fact, but is relevant only argument as to conclusions of law. Adopted. While this proposed finding of fact contains a number of statements that are accurate, if adopted as phrased, the record would be incomplete. "Public health benefits" were not specifically analyzed as such for the construction options for new housing, but it would be incorrect to find that the Respondent did not consider such benefits, given all of the other record evidence that ventilated crawl space or slab construction are reasonably expected to reduce radiation levels to the "as low as reasonably achievable" standard. By limiting options to these construction standards, with the alternative of variance from these construction standards coupled with testing and remediation, the Respondent de facto, has followed a path toward improving public health based upon the 0.02 WL standard. Moreover, with respect to option 1, the the exhibit recommended adoption for three reasons, not just the one proposed by Petitioners. Finally, the last sentence of footnote 6 is rejected for lack of evidence. Petitioner's exhibit 4 does not explain how the thermoluminscent device is proposed to be used, and lacking evidence on the point, the Hearing Officer cannot conclude that the $30,000 cost is an estimate of the cost of preoccupation monitoring of 3,700 new houses. The $30,000 cost only reflects the purchase cost of 100 devices at $300 each. With these exceptions, the proposed finding is adopted. Adopted, except the footnote 7 is rejected. There is no evidence of the expense to the Department of Agriculture to conduct its testing program, or the relevance to this proceeding. Adopted. Adopted, except the last sentence is rejected because Mr. Meyers did not expressly say that in his letter. Adopted. Adopted. Adopted, except proposed finding 36d. The standard proposed is contained in proposed rule 10D- 91.1104, and is "normal background radiation levels as reasonably achievable." The normal background is 0.004 WL and 6 microroentgens per hour. The maximum standard stated in the proposed rule is 0.02 WL and 20 microroentgens per hour. Adopted, except that the second sentence is rejected because irrelevant. The legal authority of the Respondent to do something is a legal question, not a factual question. Rejected. There is no evidence that Dr. Cox's opinions, elicited on cross examination, were intended to state the intentions of the Respondent with respect to testing devices and number and extent of use. The first sentence is rejected. Mr. Guimond stated: "But you'd probably use a number of track etch cups, and you might do them in a various placement within the structure." By qualifying his opinion with "probably" and "might," Mr. Guimond made it clear that he was not expressing a rule. The remainder of the proposed finding is adopted. Adopted, with the addition that Ms. Trott also testified that her duties include processing, development, and coordination of all parts of the rule package other than the rule itself. Adopted, with the following exceptions. Ms. Trott did not testify that she obtained cost figures from a "lobbyist," or from any person of a particular profession other than the "Polk County Association of the Florida Homebuilders Association." The last two sentences are rejected because beyond the expertise of the witness as he himself testified, T. 127, and beyond the expertise certified by the Hearing Officer, T. 91. Adopted. Adopted. Adopted. Adopted. Secretary Pingree made it clear that he deferred to the advice of legal counsel on the notification issue. Otherwise, the proposed finding is adopted. Rejected. The relevance of this proposed finding is not shown by the record. Adopted, except that Dr. Howell, is currently the Deputy Secretary. Rejected. The record cited by Petitioners from these proposed findings of fact do not support the findings in the form proposed. The first sentence of proposed finding 50 is rejected. Dr. Howell simply testified that it would be very hard to subject public health programs to a cost/benefit analysis. The second sentence is adopted. Dr. Howell testified that exposure to 0.02 WL for 70 years would cause a risk of 2 additional lung cancer fatalities per 100 persons, and that that was a high risk. The proposed finding as worded is rejected. Adopted. Rejected. Dr. Howell vaguely testified that "if you had a good building technique, a good informed consent, you actually may allay a lot of fear." Petitioner's exhibit 25B, p. 40. He did not tie this opinion to the proposed rule. Adopted. Adopted. The first sentence is rejected because Dr. King did not make it clear what kind of "standard" he was referring to. All that Dr. King said was "there was no evidence in that literature to support a level other than what could be in fact detected in food, which was again, detection limit was then one per billion." Petitioner's exhibit 25F, p. 13. It is not at all clear that Dr. King was describing a ceiling, and since he was talking about detection thresholds, he was probably only talking about the practical limits of designing a standard. The second sentence is rejected because it is a distortion of what Dr. King said. Dr. King testified: "predominately the issue was the level of risk, but the integral part of balancing was whether or not it was practical to eliminate from the food supply, whether it was possible to technologically, as we understood it, to eliminate from the food supply ethylene dibromide." Id. The last sentence is adopted, but with the addition that such 1,000 persons have been exposed to average levels of EDB for a lifetime. Adopted, except that the goal is one "adverse health effect" per one million, not "one lifetime fatality." Rejected. The citation to the record does not support the proposed finding in the form proposed. Adopted. Adopted. Adopted, with the following exceptions. The record cited does not support a finding that Dr. King recommended 0.02 WL because 1/3 of existing homes would violate 0.01 WL, and does not support the proposed fact that 1/3 of existing homes would violate 0.01 WL. The record further does not support the finding that Dr. King made his recommendation based upon precedential value for other states. What Dr. King said was that he relied upon the precedent of the use of 0.02 WL by the Environmental Protection Agency. Petitioners exhibit 25F, p. 25. The first sentence is adopted. The second sentence is rejected. Petitioner's exhibit 25F, p. 23, 1. 21-25. The third sentence is rejected because it is irrelevant. The proposed finding is a misstatement of the testimony. Dr. King said he looked at the EPA study, but could not remember what it said. Petitioner's exhibit 25F, p.29, 1. 12-13. Rejected as irrelevant. Dr. King's inability to remember this fact at this deposition is not relevant. Dr. King explicitly stated that he "heard a number of numbers," but that he could not recall any. Petitioner's exhibit 25F, p. 31, 32. Rejected as misleading. Dr. King testified that in choosing the Working Level standard, he was more concerned about normal distribution, reliability of monitoring, and the ability to enforce effectively at the chosen standard. Petitioner's exhibit 25F, p. 33, 1. 7-18. Adopted. Rejected. Dr. King did not say that. He only said that the concern about remediation in existing homes was one that "we all felt needed to be addressed." Petitioner's exhibit 25F, p. 44 1. 10-11. He then said "I felt that at sometime soon we would have to deal with that issue. "Dealing with an issue, or "addressing" an issue can mean that it was discussed, encouraged, rejected, mandated, or ultimately ignored after discussion. It does not mean adoption of a mandatory program of remediation. Adopted. Adopted. Rejected. This is a misstatement of the testimony. Dr. King did not testify that he believed lands should be quarantined. Dr. King testified that "maybe" a Mr. Herron with the IMC said that, and "Again, that would have been an ideal situation to be able to make that recommendation, I don't believe that that was within the preview of the charge that we had, however, to make that recommendation." Petitioner's exhibit 25F, p. 51, 1. 17- 20. Adopted. Adopted Rejected. The testimony is equivocal and contains too many qualifications for this categorical proposed fact to be adopted. Petitioner's exhibit 25F, pp. 66, 1. 20-25, to 67, 1. 1-14. Adopted. Adopted. Rejected. The testimony is unclear, and does not support the statement as proposed by Petitioners. Petitioner's exhibit 25H, p. 17, 1.6-12. Rejected. The portion of the record cited for this statement of fact contains comments of counsel, but does not contain clear testimony of the witness to prove this point Adopted. Rejected. The witness did not say anything about "notification of buyers and lessees." He stated: "I think it would be a good idea to let people know in existing structures, which most of them already do." A buyer is not a person in an existing structure, and the issue of notice to buyers or prospective lessees is quite different from general notice to persons residing in structures. Petitioner's exhibit 25H, p. 32, 1. 2-3. Adopted. The first sentence is adopted. The second sentence is misleading. The persons named were clearly not intended by the witness to be the only persons. Petitioner's exhibit 25G, p. 6, 1. 18-21. The second sentence is rejected because it is false as proposed. Rejected. Gordon Nifon did not testify that one of the "principle" considerations of "this group" was the economic impact of the standard on real estate values. He said that he felt that the 0.02 WL standard offered a significant degree of protection to people not now protected and yet it does not bring undue economic hardship to a lot of people. Petitioner's exhibit 25G, p. 5, 1. 1- He was then examined closely about his opinion regarding economic impact, and finally stated that just about everyone who any impact upon the rule standard discussed how to balance economic impact with the public health. Id., p. 6, 1. 13-21. A finding can be made that economic impact was a consideration, but the record fails to support Plaintiff's suggestion that it was one of the principle considerations. As proposed, the finding is rejected. A finding is made that there was some concern that at the 0.01 WL that too many houses would be affected, but the influence of that concern upon the final outcome of the proposed rule is not clear in the record. Petitioner's exhibit 25G, p. 12, 1. 1-3. The first sentence is rejected. The witness was not certain. The second, third and fourth sentences are adopted. Adopted. The first sentence is adopted. The second sentence is rejected as proposed. The witness said that to do a "definitive study of any one home, there might be some reason to use more than one detector." He testified further: "I will only say that it wouldn't hurt, I suppose, to have two or more detectors. But I'm not sure if it would be a great value." Petitioner's exhibit 25G, p. 15, 1. 14-16 and 20-22. This is not sufficient to adopt the proposed finding. The first sentence is rejected. The witness made no representations as to what HRS had done with respect to testing. Petitioner's exhibit 25G, p. 12, 1. 6. The second sentence is adopted. Adopted. Adopted. Adopted, with the addition that "lifetime risk" means exposure at a given number of Working Levels for a lifetime. Rejected as phrased. The following statement is adopted as an alternative: Due to lack of complete data, some data collection was recommended by Mr. Guimond with respect to new construction on phosphate lands. Petitioner's exhibit 25A, pp. 13, 1. 25 to 19, 1. 17. Rejected. The answer is unintelligible, the testimony is that of counsel rather than the witness, no predicate was laid for the witness's degree of familiarity with the study, the levels mentioned in the question are not identified or explained, the witness was not qualified as an expert, the study is hearsay, and the cited passage is otherwise not the sort of evidence that is sufficiently reliable for the purpose proposed by Petitioners. Rejected as irrelevant. Rejected. The N.C.R.P. standards are for both types of structures. Petitioner's exhibit 25A, p. 27, 1. 22-25. Rejected in the form proposed. The following is adopted: (another space) Mr. Guimond thought that the I.R.C.P. document was "pretty confusing," and had "quite a bit of caveats in there which would enable Governments to move the values they use either direction " Petitioner's exhibit 25A, p. 28. The testimony is insufficient to conclude that the I.R.C.P. document is "useless." Adopted. Rejected as phrased. The following is adopted: Mr. Guimond implied that the EPA often tries to get a higher degree protection than it did in these standards, but they felt it was a reasonable compromise based on trying to weigh risk and the absolute need of people for housing. Petitioner's exhibit 25A, p. 30. Adopted. Mr. Guimond was further of the opinion that it would be a "legitimate approach" for HRS to make the suggestion to the Legislature that its authority to give such notice be given consideration. Petitioner's exhibit 25A, p. 34. Adopted. Adopted. Adopted. Rejected as stated. Dr. Jerrett testified that notification was desirable, not that it was "necessary." T. 58, 1. 2-7. The following statements of fact are erroneously included in the Petitioners' "Argument" section, and are ruled upon as if they were proposed findings of fact: Paragraph 103B is adopted only to the extent stated in findings of fact 2 through 9. Paragraph 103C is adopted. Paragraph 103D, is adopted except there was no evidence of the participation of Concerned Citizens of Citrus County in the rule-making public hearings as parties. The following, using the same numbers as used by the Respondent in its proposed findings of fact, pages 1-4, are the specific rulings of the Hearing Officer as to each proposed finding of fact. If "adopted," the finding as proposed becomes a finding of fact in this recommended order. If adopted or rejected with qualifying statements, the qualifying statements, to the extent facts are involved, are additional findings of fact: Adopted. Adopted. Adopted, except the last sentence, which is not fact. Adopted. Petitioner's exhibit 25H, p. 6, 31. Rejected as proposed. HRS is considering amendment to the proposed rule to include schools and public buildings. T. 59, 77-78, 80; Petitioner's exhibit 25E, p. 8. Adopted, except the fifth sentence is rejected. The Hearing Officer cannot conclude from the testimony of Stephen King, M.D., that an upper limit less than 0.02 WL would be unmanageable, unrealistic, or unenforceable. Dr. King was specifically referring to the setting of a ceiling standard at background, and simply indicated that it be both unrealistic and unmanageable to require ideal background when the background number is in fact only a point of distribution on a bell curve that is expected to have some values higher than the standard. Petitioner's exhibit 25F, pp. 35-36. The first sentence is adopted. The second sentence is rejected as proposed. The rule speaks for itself, stating that counties which have lands "within their borders identified in 10D-91.1106(1) shall conduct . . . educational programs to advise the public that dwellings located on such lands have the potential of exceeding the standard . . . ." Proposed rule 10D 91.1108. The testimony is insufficient to conclude that in fact the educational program will include letters, brochures, or that HRS will have a full-time health educator. That was only the vision of the witness, and the full-time health educator was only a "budget issue," which means something HRS intends to ask the Legislature to fund. T. 63. Adopted. Adopted. Rejected because it is a conclusion of law. The Intervenor, Polk County, proposes only two findings of fact, designated paragraphs 7 and 8. Proposed finding of fact 7 is rejected, as more fully explained in the findings of fact, because the proposed rule does not impose any "duty" on the local building inspector since it uses the word "should." Proposed fending of fact 8 has been adopted in the findings of fact, although worded differently. HRS does expect that local building inspectors will follow their recommendations and the suggestion of the proposed rule and withhold the certificate of occupancy. COPIES FURNISHED: Richard A. Patterson, Esquire Department of HRS 1323 Winewood Blvd Building One, Suite 407 Tallahassee, Florida 32301 Thomas W. Reese, Esquire 132 Eight Street North St. Petersburg, Florida 33701 Mark F. Carpanini, Esquire Office of County Attorney Post Office Box 60 Bartow, Florida 33830 David Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32301 Liz Cloud, Chief Bureau of Administrative Code 1802 The Capitol Tallahassee, Florida 32301 Carroll Webb, Executive Director Administrative Procedures Committee 120 Holland Building Tallahassee, Florida 32301 A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW PURSUANT TO SECTION 120.68, FLORIDA STATUTES. REVIEW PROCEEDINGS ARE GOVERNED BY THE FLORIDA RULES OF APPELLATE PROCEDURE SUCH PROCEEDINGS ARE COMMENCED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF THE DIVISION OF ADMINISTRATIVE HEARINGS AND A SECOND COPY, ACCOMPANIED BY FILING FEES PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL, FIRST DISTRICT, OR WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE PARTY RESIDES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED.
The Issue Petitioner Department of Professional Regulation seeks to suspend, revoke, or otherwise discipline respondent's license to practice medicine on charges of professional misconduct violative of Chapter 458 Florida Statutes (1979). The issues for determination are: Whether respondent is guilty of gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, in his treatment of Verdi Hammond Burroughs ("Burroughs") and Charles Kirk ("Kirk") in violation of Section 458.331(1)(t), Florida Statutes (1979); Whether respondent's treatment of Burroughs and Kirk was fraudulent and constituted misrepresentation, and whether the treatment was medically beneficial to the exclusion of other forms of proper medical treatment and was, therefore, harmful to the patient in violation of Section 458.331(1)(1), Florida Statutes (1979); Whether respondent violated Sections 458.331(1)(1), 458.331(1)(h), Florida Statutes (1979) by failing to fully inform Burroughs and Kirk (in his prescribing and administering Amygdalin [Laetrile]) of alternative methods of treatment for their cancer, and the potential of these methods for cure; whether each patient failed to sign a written release releasing respondent from liability; and whether respondent informed each patient, in writing, that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services; Whether respondent's treatment of Burroughs and Kirk, when measured by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject without first obtaining full, informed, and written consent, in violation of Section 458.331(1)(u), Florida Statutes (1979); Whether respondent failed to comply with Sections 458.333 and 458.335, Florida Statutes (1979); Whether metabolic therapy is recognized by a respectable minority of the medical profession as a treatment for cancer. Background By an eight-count administrative complaint dated March 31, 1982, petitioner Department of Professional Regulation, Board of Medical Examiners (Department), charged respondent Daniel J. Clark with multiple violations of Chapter 458, Florida Statutes (1979), the "Medical Practice Act." Respondent disputed the charges and requested a Section 120.57(1) hearing. On April 29, 1982, the Department forwarded this case to the Division of Administrative Hearings for assignment of a hearing officer. Hearing was then set for September 22 and 23, 1982. At hearing, the Department presented the testimony of Evelyn Kuhn, Daniel Clark, Alvin Edward Smith, Tammy Thompson, Brenda Kempton, and Lois Ann White. Petitioner's Exhibit Nos. 1/ 1-5 were received into evidence. The respondent testified in his own behalf and presented the testimony of Rodrigo Rodriquez, Rebecca Scholz, and Allen Bernsten. Respondent's Exhibit Nos. 1-5 were proffered but not received into evidence. The parties filed proposed findings of fact and post- hearing briefs by December 1, 1982. Those proposed findings which are incorporated herein are adopted; otherwise they are rejected as unsupported by the evidence or unnecessary to resolution of the issues. Based on the evidence presented at hearing, the following findings of fact are determined:
Findings Of Fact I. Respondent Since 1976, respondent has been licensed to practice medicine in the State of Florida, holding license number ME0026861. (Tr. 269; Prehearing Stipulation) He received a bachelor of science degree from Georgia Southwestern College and a medical degree from Medical College of Georgia. In 1975, he trained for five months with a gynecological oncologist in Americus, Georgia. In 1978, he completed a three year residency program at University Hospital in Jacksonville, Florida. (Tr. 266-268). Since 1979, he has practiced medicine in Ormond Beach, Florida. Initially, his practice included gynecology, family practice, and general nutrition. He then began to treat cancer patients with metabolic (nutritional) therapy. The purpose of such therapy is to enhance the immunological and biological capacities of a patient--nutritionally, immunologically, and physiologically--in order to improve the patients performance in combating cancer. This cancer treatment includes the administration of Amygadalin (Laetrile), vitamins, herbal teas and detoxifiers, and the application of salves and packs to cause localized hyperthermia. It is not a conventional, orthodox, or widely practiced form of cancer treatment. No other physician in Volusia County uses it. Most accredited medical schools in the United States do not teach it. The American Medical Association (AMA) considers it to be experimental. Eventually, respondent's metabolic treatment of cancer patients began to account for 15 percent to 20 percent of his practice. (Testimony of Clark, Rodriquez; P-3) II. Respondent's Treatment of Verdi Hammond Burroughs In October or November 1979, Nelson Murray, a chiropractor, asked respondent to examine Verdi Hammond Burroughs, a patient who had complained to Dr. Murray about a lump in her right breast. (The offices of Dr. Murray and respondent were close together in the same building. And, in the past, Dr. Murray had referred patients to respondent for medical treatment.) (Testimony of Clark, P-3). Respondent, who considered it an "across-the-hall consult," agreed. He went to Dr. Murray's office, examined Ms. Burroughs' right breast, and noted a small lump. He recommended that she have a biopsy or that she see a surgeon for a second opinion, to make sure that the lump was not malignant. (Subsequently, she failed to follow this recommendation.) Although he did not refer her to a particular surgeon, he looked up the names of several who might be willing to operate on her, as she was a Jehovah's Witness. (Since Jehovah's Witnesses object to blood transfusions, many surgeons refuse to operate on them.) (Testimony of Clark, P-3) During this brief examination, respondent did not perform any diagnostic tests other than to manually examine the breast. Although he kept meticulous patient medical records, he did not open a patient record on Ms. Burroughs or have her complete a patient history form. He took no progress notes during the examination. He did not consider her his patient, did not assume responsibility for her treatment, and did not charge her a fee. (Testimony of Clark; P-1, P-3). Respondent had no contact with Ms. Burroughs until Dr. Murray asked him to reexamine her in February, 1980. The circumstances were similar. Respondent examined her in Dr. Murray's office, noted the breast lump was unchanged, made no medical reports, and charged no fee. He recommended that she undergo a laboratory test, including complete blood chemistry, SMAC 22, CBC, and sedimentation rate. For this purpose, he specifically referred her to Dr. Nelson A. Murray, a medical doctor and pathologist in Jacksonville, Florida. (At that time, she lived in Jacksonville, Florida.) He also recommended, again, that she have a biopsy performed--a recommendation which she, again, failed to follow. (Testimony of Clark; P-3). On September 22, 1980, almost eight months later, chiropractor Murray again asked respondent to come to his office and examine Ms. Burroughs right breast. Respondent's subsequent examination revealed that the entire breast was severely inflamed and the nipple was inverted or sloping downward. The breast had the appearance of an inflamed carcinoma. Respondent strongly suggested that she have laboratory tests (the same tests which he had recommended earlier) done as soon as possible and that she arrange to see him immediately thereafter. He, again, told her that she needed a biopsy and gave a preliminary diagnosis of breast cancer. This time, she followed his recommendation. Two days later, she had the complete lab tests done by Dr. Murray, the Jacksonville pathologist. (Testimony of Clark; P-3). Respondent still did not consider Ms. Burroughs his patient or assume any responsibility for her treatment. During this September 22, 1980, examination, he did not open a patient file, take notes, or charge a fee. There is no evidence that Ms. Burroughs-- at that time--believed that she was his patient--or he, her doctor. Nor is there evidence that either party misunderstood or was confused about their relationship or their respective responsibilities. (Testimony of Clark; P-3). Between the February, ,1980 and September 22, 1980, examinations, respondent did not contact Ms. Burroughs and did not discuss her condition with chiropractor Murray. Between the November, 1979 and the September, 1980, examinations, respondent did not order or perform any further diagnostic tests on Ms. Burroughs and did not attempt to check with her to see if she had followed his recommendations. Neither did he expressly inform her that he was not her doctor. The Department contends that his failure to take these actions violates a generally accepted standard of medical care. (Testimony of Clark; P- 3) This contention, however, is unsubstantiated. The evidence does not demonstrate that the generally accepted standard of medical care required respondent to take such actions. Conversely, it has not been specifically shown how, and in what ways, respondent's treatment of Ms. Burroughs between November, 1979 and September, 1980, fell below an acceptable standard of medical care. 2/ Ms. Burroughs became respondent's patient on October 7, 1980, when she came to his office for medical treatment. He performed a complete work up, physical examination, and medical history, and reviewed the results of the lab blood tests. He concluded that her condition was essentially normal except for her right breast, which was severely inflamed and the nipple retracted. In addition, the lymph nodes under her right armpit' were palpable and enlarged. His initial impression was that she had inflammatory carcinoma (cancer) of the right breast with lymph gland involvement. He then scheduled her for a biopsy, which was necessary before he could determine the type of cancer involved. (Testimony of Clark; P-3) The biopsy was performed on October 9, 1980 by Dr. Kluger, a St. Augustine physician. It indicated an inflamatory intraductal adenocarcinoma of the breast, primary. Dr. Kluger, who felt that surgery was inadvisable because of the lymph node involvement, subsequently recommended to respondent that Ms. Burroughs undergo radiation and chemotherapy. (Testimony of Clark; P-1, P-3). During the October 7, 1980, office visit, respondent explained to Ms. Burroughs the alternative methods of cancer treatment, including their potential for cure. The methods discussed included surgery, radiation, chemotherapy, and metabolic therapy. She refused to undergo radiation or surgical treatment, explaining that her husband died of lung cancer after receiving surgery, radiation, and chemotherapy. She agreed however, to consider chemotherapy in conjunction with metabolic therapy. He explained to her that metabolic therapy was not a treatment against the cancer, per se, but that it would help "build up her body to where her own immune system would help her fight the cancer." (P-1). She agreed to accept this treatment--chemotherapy with metabolic therapy--then signed four separate affidavits on forms provided by respondent. The affidavits acknowledged her consent to the ordering and administration of Laetrile. Respondent, however, did not inform Ms. Burroughs in writing (by these affidavits or any other documents), that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services. She also did not sign a written release, releasing him from any liability from the administration of Laetrile. (Testimony of Clark; P-1, P-3) During the October 7, 1980, visitation--after the affidavits were signed--respondent began treating her with metabolic therapy, consisting of Laetrile I.V., Vitamin C, B Vitamins, B-15, B-12, and crude liver injections. Metabolic therapy was commenced without obtaining her prior written consent. (Testimony of Clark; P-1). Several days later, on October 13, 1980, respondent began treating her with small doses of chemotherapy in conjunction with the metabolic therapy. The chemotherapy treatment plan was based on a phone call to Dr. Donald Cole, a New York oncologist. Respondent described the type and extent of Ms. Burroughs cancer and Dr. Cole recommended small 100 milligram doses of 5-FU twice weekly, two to five milligrams of Laetrile twice weekly, and 50 milligrams of Cytoxin PO orally. Respondent administered this regimen until he discontinued chemotherapy at the end of November, 1980. (Testimony of Clark; P-3). These doses and intervals of chemotherapy did not conform to the manufacturers' recommended doses contained in the Physicians Desk Reference, a standard reference used by practicing physicians. The doses administered by respondent were lower than those normally used in chemotherapy and are considered to be in the research or experimental stage. (Testimony of Clark, Smith). Chemotherapy and metabolic therapy are incompatible-- they work at cross-purposes. Chemotherapy drugs are strong immunosuppressants. They are toxic and intended to poison cancer cells; 3/ their effect is to suppress the body's immunological system. In contrast, the purpose of metabolic therapy is to enhance that same immunological system. (Tr. 215-216). For this reason, the use of chemotherapy is not included within the protocols for metabolic therapy found in International Protocols in Cancer Management. 4/ Respondent concedes that this publication is authoritative and contains the standard protocols for metabolic therapy. (Testimony of Rodriquez, Clark). Ms. Burroughs chemotherapy stopped at the end of November, 1980, but her metabolic therapy continued. By March, 1981, her right arm was beginning to swell because of enlarging lymph nodes. On the March 2, 1981, office visit, respondent told her that Laetrile was not stopping the cancer, and discussed restarting chemotherapy. He increased her Vitamin C, and began administering herbal cleaners and botanical medicines containing red clover, chapparral, myrr, goldenseal, yellow dot, juniper berries, yuva, ursaberries, conch grass, and dandelion. Respondent categorizes these medicines as blood purifiers, lymph purifiers, liver cleaners, and kidney cleaners. (P-3). By June, 1981, respondent believed the cancer had metastasized to Ms. Burroughs' right lung. During office visits in early June, he rubbed herbal ointment or liniment, Vitamins E and F, into her rib cage area. He also prescribed herbal packs and poultices to cause localized hyperthermia (heat increase). He prescribed dark and yellow herbal salves and instructed her to apply them to her right breast and underarm area, explaining that they would draw out and break down the cancer tumor. (Testimony of Clark, Kuhn; P-3). These salves--strong and painful--caused pieces of gray tissue to fall off her breast and underarm area. Respondent reacted by encouraging her, telling her that the salves were breaking down the cancerous tumor. (He now admits, however, that the herbal ointments and salves would have been ineffective in treating the cancer which had metastasized to her lungs.) He also prescribed a tea which tasted like black pepper. She forced herself to swallow it because he had told her that it would break up the cancer in her body. This representation was also untrue. (Testimony of Clark, Kuhn, Smith.) In administering metabolic therapy to Ms. Burroughs, respondent also prescribed whole-body hyperthermia for the purpose of stimulating her immune system. This required her to totally submerge herself in bath water which was as hot as she could tolerate. According to the standardized protocols for metabolic therapy, as stated in International Protocols in Cancer Management, such "whole-body hyperthermia, while successful in some cases, is dangerous and considered experimental." (Tr. 320, Testimony of Clark). Respondent's metabolic and chemotherapeutic treatment of Ms. Burroughs failed to conform to the standard of care recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. It fell below the prevailing and generally accepted standard of care recognized by his peers in the medical community: a.) After the diagnosis, respondent made an improper and incomplete staging 5/ of the disease by failing to take a liver scan, which would have revealed the existence (or nonexistence) of liver lesion. Cancer of the liver is deadly and must be dealt with immediately. (Tr. 89-92). b.) After he diagnosed Ms. Burroughs breast cancer, he failed to prescribe surgery or a combination of surgery and radiation therapy, treatment methods which likely would have been beneficial and controlled the disease. (Surgery, such as a radical mastectomy, does not cause a significant loss of blood, so blood transfusions--something Ms. Burroughs opposed--could have been avoided.) If necessary, chemotherapy--using conventional doses--could also have been administered. The chemotherapy and metabolic therapy which respondent provided Ms. Burroughs was probably worthless. The herbal salves and teas which he prescribed were incapable of drawing out or breaking up the cancerous tumor. c.) When Ms. Burroughs' cancer was diagnosed, it was in an advanced and complicated stage. Under such circumstances, a general practitioner (such as respondent) should have referred her to or obtained a consult from an oncologist, a specialist in the treatment of cancer. Respondent did neither. (Testimony of Smith). Metabolic therapy is not approved or recognized as acceptable for cancer treatment by a respectable minority of the medical profession. This finding is based on the opinion of Alvin Edward Smith, MD., board certified in oncology and internal medicine, and a Fellow of the American College of Physicians. He has treated cancer patients since 1978. His opinion on this issue is considered more credible than the contrary opinion of Rodrigo Rodriquez, M.D., who practices medicine in Tijuana, Mexico, who is not licensed to practice medicine in the United States, and who--other than acting as a guest resident at Kings County Hospital in Brooklyn, New York--has never practiced medicine in the United States. (Testimony of Smith, Rodriquez). III. Respondent's Treatment of Charles Kirk Charles Kirk became respondent's patient on August 13, 1980, and died shortly thereafter on September 9, 1980. Mr. Kirk, a 77-year-old male, was having great difficulty swallowing food and had a history of recurring choriocarcinoma of the larynx or throat. Surgery had been performed on him several times, and his larynx (voice-box) had been removed. Respondent explained to him the alternative methods of treatment, including surgery, chemotherapy, radiation, and metabolic therapy. Mr. Kirk opposed further surgery and objected to chemotherapy and radiation. He requested Laetrile. After he signed an affidavit provided by respondent (the same form which had been provided Ms. Burroughs), respondent ordered Laetrile. (Testimony of Clark; P-2). Respondent then referred him to a general surgeon for the placing of a gastrostomy feeding tube, a device which would enable him to swallow food and liquids. The tube was successfully placed surgically, after which respondent began administering Laetrile to him as part of metabolic therapy. The treatment was brief, only nine or ten days. On September 26, 1980, Mr. Kirk died. (Testimony of Clark; P-2). Mr. Kirk's condition, when he first became respondent's patient, was essentially irreversible; he was in the final stages of a fatal cancer. (Testimony of Clark, Smith; P-2). Respondent administered Laetrile to Mr. Kirk without first obtaining from him a release of liability and without informing him, in writing, that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services. (Testimony of Clark.)
Recommendation Based on the foregoing, it is RECOMMENDED: That respondent's license to practice medicine be suspended for one year, for violating Section 458.331(1)(h), (1), (t), (u), Florida Statutes (1979). DONE AND RECOMMENDED this 9th day of March, 1983, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of March, 1983.
Findings Of Fact Petitioner South Broward Hospital District operates Memorial Hospital located in Hollywood, Florida. On March 14, 1977, Petitioner's hospital administrator, S. A. Mudano, informed the local Health Systems Agency (HSA), which is the Health Planning and Development Council for Broward County, Inc., of Petitioner's intent to acquire an 18 million electron volt linear accelerator capable of providing radiation therapy by means of both X-ray and high energy electrons for its radiation therapy department. The cost of this acquisition was to be $455,000.00 for the machine and accessories, plus approximately $150,000.00 for construction of an addition to the existing radiation therapy department to house the unit and support facilities. This notice of intent was followed by submission of an application to the HSA and Respondent on June 20, 1977. The application was reviewed by the staff of the HSA and, although it was determined that the project did not conform to certain criteria contained in the "Goals and Standards for Diagnostic Radiology, Therapeutic Radiology, and Nuclear Medicine Services" which had been adopted by the HSA after public hearings on August 18, 1977, the HSA recommended the project for approval on October 20, 1977, and so informed Respondent on October 28, 1977. By letter of November 23, 1977, Respondent informed Petitioner that its proposal was not favorably considered because it was inconsistent with the aforesaid local goals and standards for Broward County in that maximum utilization of existing and available like equipment items had not been achieved nor projected, and that such radiation therapy units were accessible within Broward County in less that sixty minutes automobile travel time. In this letter, Respondent pointed out that existing radiation therapy units in Broward County had been utilized at only some 61 percent of their capacity in 1976 and were projected as having only the utilization rate of 87 percent by 1990, and that such rates clearly indicated a lack of demonstrated need for an additional unit. The letter further stated that although the HSA had recommended approval, it had not provided justification for its deviation from its own goals and standards. Petitioner thereafter appealed Respondent's denial of its application on December 20, 1977. (Exhibits 1 - 5) Petitioner South Broward Hospital District is a special tax district created and incorporated by a legislative act of 1947. Memorial Hospital is its only facility and provides medical care on a non-profit basis to persons in the district requiring such treatment. However, individuals living outside of the tax district who require services of Memorial Hospital may utilize the same based upon medical need and criteria established by the district's Board of Commissioners. The radiation therapy department of Memorial Hospital was constructed several years ago and presently has in use a 4 MEV linear accelerator to serve the needs of South Broward cancer patients, mostly on an outpatient basis. In 1977, this machine was operated at 116 percent capacity computed on a forty-hour week and rendered 9,655 patient treatments during that period. The first quarter of 1978, 3,056 treatments were performed, which was a utilization rate of 147 percent on a forty-hour week and 98 percent on a 60-hour week. At the time the radiation therapy department was planned, it was anticipated that additional equipment would be required in the future and therefore "shell" space was reserved in the original construction plans for ease of future installation of new equipment. Construction for the proposed linear accelerator primarily will consist of construction of a concrete vault within the existing shell, plus facilities for operation of the radiation equipment. It will take approximately 18 months "lead-time" from issuance of a Certificate of Need to acquire the equipment, and complete construction. (Testimony of Mudano, Margulies, Exhibits 1, 16, 19) Radiation therapy in cancer cases is accomplished by both external therapy machines and sealed sources of radioactive material The machines include both conventional X-ray machines and the super voltage or megavoltage units which include linear accelerators, cobalt, and betatron units. The conventional machines are used primarily for superficial treatment, such as skin cancer. The megavoltage units deliver much heavier radiation to deep tumors with greater intensity so that a localized volume of tissue can be treated without the danger of damaging surrounding organs and normal tissue. They also produce less side effects such as nausea, weakness and anemia. However, the cobalt and betatron methods have certain limitations which make them less satisfactory for many patients than the linear accelerators. The linear accelerators most commonly used today are those of 4, 6, and 18 million electron volts (MEV). The 18 MEV accelerator provides deep therapy by utilizing an electron beam that is highly controllable to most effectively treat tumor tissue. Additionally, high-energy X-ray radiation can be delivered from an 18 MEV unit for deeper penetration. The 18 MEV is thus particularly effective for obese cancer patients and for those requiring treatment in the neck and head areas. Although machines of lesser voltage, such as the 4 MEV, are capable of treating all types of cancer patients, they do not protect adjoining organs and non-cancerous tissues to the degree afforded by the 18 MEV, nor can they be utilized for the variety of radiation patterns of the larger machine which has the additional flexibility of using pure electron radiation. (Testimony of Green, Margulies, Munson, Exhibits 1 - 2) At the time the HSA staff evaluated Petitioner's application, it predicated much of its data upon the utilization of existing radiation machines in Broward County at various hospitals and one private clinic. The staff report showed that there were four cobalt units, one betatron unit, and four 4 MEV units in Broward County. In addition, the report took into consideration one 18 MEV unit for which a Certificate of Need had been issued for the North Broward Hospital on March 12, 1977, and which is expected to be operational in January, 1979. At the hearing, however, it was discovered that both the HSA and the Respondent had overlooked the fact that a Certificate of Need for three MEV units had been issued to the Florida Medical Center in Broward County on June 27, 1975. It is expected that one 18 MEV unit and two 6 MEV units will be operational in that facility in July, 1978. In view of this information, the Hearing Officer determined that prior data was incomplete and required the parties to make new projections of need for presentation at a subsequent hearing session. The revised data is shown in composite Exhibit 16 and forms the basis for consideration of the need for Petitioner's requested additional 18 MEV unit. (Testimony of Chamlis, Composite Exhibits 16, 19, 21) Although the Respondent has a state medical facilities plan in existence, it does not address the question of radiation equipment. Consequently, the only general criteria issued by an agency in the state on this subject bearing on Petitioner's application is the document issued by the HSA entitled "Goals and Standards for Diagnostic Radiology, Therapeutic Radiology, and Nuclear Medicine Services." The pertinent provisions of that document which were used by the Respondent as a basis for denial of Petitioner's application read pertinently as follow: Cost -. High quality radiology and nuclear medicine services should be provided in the most efficient and effective manner, minimizing duplication of services and facilities, as well as expenses incurred. The utilization of each piece of equipment, and all services, should be maximized; services should be an effective and economical use of resources. If there are excess providers and excess capacity exists, growth or an increase in capacity should be discouraged. If an adequate number of providers exists, yet there is excess capacity, there should not be an increase in services until demand catches up. This does not exclude an allowance for new developments or techniques. If there is an adequate number of providers and sufficient capacity, providers should be encouraged to expand services only in response to an increase in demand. This does not refer to new modalities and services previously unavailable. If there are too few providers and inadequate capacity, existing providers should be encouraged to expand and/or additional qualified providers should be encouraged to offer services. Accessibility -. Quality radiology and nuclear medicine services should be reasonably accessible to all individuals in need, taking into consideration: transportation, sociological and cultural factors and relationships to all components of the health care system. B. Radiation therapy services and equipment should be accessible to the population within sixty (60) minutes travel time by automobile. D. Regardless of economic status, race and geographic location, all individuals should have access to radiology and nuclear medicine services at the most appropriate setting with the most efficient and effective use of resources. The HSA "goals and standards" are a part of its comprehensive health systems plan promulgated to comply with federal and state law and regulations, and are designed to achieve the optimum or ideal health care situation in the community. Although the governing body of the HSA determined that Petitioner's project would not meet the goals contained in paragraphs III C and IV 18, it recommended approval of the application because of "extenuating circumstances." (Testimony of Margulies, Anderson, Tupler, Marrinson, Composite Exhibit 7) Broward County has six hospitals and one private clinic where radiation therapy units are located. However, the two 18 MEV units which have been approved by Respondent will be located in the North Broward Hospital and Florida Medical Center, both of which are in the northern part of the country. Although from a mileage standpoint, each of these facilities is accessible to the county population within an hour's driving time, the large population in the area and congested highways would make it impossible for residents of the extreme southern part of the county to reach these facilities by bus or automobile in sixty minutes during normal hours. If elderly cancer patients living in South Broward County are required to expend the time necessary to journey to the facilities located in the northern part of the county for outpatient services, it would be deleterious to their mental and physical condition, and would be disruptive to the "team" concept employed at Memorial Hospital for the diagnosis, care, and cure of cancer patients. (Testimony of Margulies, Cohen, Tupler, Rodensky, Hartley, Atkin, Marrinson, Zenkel, Boyd, Nelson, Miller, Bennett, Spiegel, McPherson, Exhibits 10, 13 - 15, 17) The data compiled by the HSA and Respondent to assess the need for an additional 18 MEV linear accelerator was obtained from patient statistics in Broward County for prior years and projections of necessary equipment in the future predicated on on a variety of factors. These include population figures, incidence rate for cancer nationally and in Broward County, numbers of patients previously treated in local hospitals and numbers of treatments, estimated capabilities of existing and approved units based on a forty-hour, forty-eight hour and sixty-hour week basis, projected need in the future for radiation therapy treatments, and the percentage of past and projected therapy equipment utilization in Broward County. In its revised statistical charts, Respondent also applied similar projections solely with respect to the population and equipment located in South Broward County. Additionally, it included projections relative to the need and utilization of high-energy equipment, including the betatron machine at Broward General Hospital and the two 18 MEV's which will become operational in the future. Petitioner presented data based primarily on projected utilization of equipment in the South Broward area, and therein employed certain standards and criteria recently announced by the Department of Health, Education and Welfare as national guidelines which will govern health system plans developed after December 31, 1978, unless modified as authorized therein in certain instances. (42 CFR 121.209) The Hearing Officer took official recognition of these guidelines which provide that each megavoltage radiation therapy unit such as Cobalt 60 and linear accelerators, should serve a population of at least 150,000 persons and treat at least 300 cancer cases annually within three years after initiation, and that no additional units should be opened unless each existing unit in the health service area is performing at least 6,000 treatments per year. However, adjustments downward may be justified when travel time to an alternate unit is a serious hardship due to geographic remoteness based on analysis by the HSA. The guidelines indicate that about half of new cancer patients require megavoltage radiation therapy and that the 6,000 treatment standard reflects an average of about 25 patients or treatments per day as a reasonable standard. However, it is also stated that extra high energy machines which have "limited but important applications" may not reach such numbers of treatments and should be evaluated individually by HSA's in the development of the health systems plans. Also, it is noted that when each existing unit cannot reasonably be expected to reach the target level and a new unit is appropriate, the HSA may call for an adjustment in the standard based on pertinent local conditions. Such local conditions may include the age of the local population, seasonal population fluctuation, and access to needed care. (Exhibits 16, 19 - 20) In consideration of the foregoing facts and supporting exhibits, and in the absence of specific published state criteria, the following findings as to the actual projected need are made: Projected need should be based on the year 1980 because Petitioner will require a "lead time" of approximately 18 months from the time any Certificate of Need is issued in which to obtain equipment, construct a vault and ancillary facilities, and place the unit in operating condition. Although there are two separate hospital taxing districts in North and South Broward County that generally service the population in their respective geographic areas, projected need should be based on Broward County as an entirety because it is the designated "health service area." An 18 MEV linear accelerator can provide better treatment in a variety of types of cancer than other radiation therapy equipment presently in use in Broward County. Therefore, projected need should be based on Broward County requirements for such machines or its closest equivalent, the betatron. In 1980, there will one betatron and two 18 MEV linear accelerators in Broward County. The estimated population of Broward County in 1980 is 1,090,400. The incidence rate of cancer patients in Broward County is estimated at 490 per 100,000, which results in 4,910 projected cancer patients. Sixty percent of cancer patients are deemed to require radiation therapy and 40 percent of this number will benefit significantly from treatment by an 18 MEV linear accelerator or equivalent. Thus, 3,205 patients will require radiation therapy in Broward County and 1,282 will benefit from the specialized treatment of the higher voltage machines. At least 20 treatments will be required for the 1,282 patients. Based upon a predicted utilization rate of 3.5 patients per hour for the betatron and four patients per hour for the two projected 18 MEV's, the machines would be utilized in excess of 100 percent in 1980 for a forty-hour week. This does not make allowance for "down time" of the 18 MEV machines for maintenance or seasonal patient fluctuation. It is found from the foregoing that the extra high-voltage units that will be in operation in Broward County in 1980 will not be adequate to serve the needs of the county population and that therefore an additional 18 MEV linear accelerator to become operational during that year would not unnecessarily duplicate the existing resources. Consequently, a need will exist for an additional unit to be operational at that time.
Recommendation It is recommended that the Petitioner's application for Certificate of Need/Capital Expenditure Proposal be approved. DONE and ENTERED this 7th day of July, 1978, in Tallahassee, Florida. THOMAS C. OLDHAM Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Mr. Art Forehand, Administrator Office of Community Medical Facilities 1323 Winewood Boulevard Tallahassee, Florida 32301 Chester Senf, Esquire Assistant General Counsel Department of HRS 1323 Winewood Boulevard Tallahassee, Florida 32301 R. J. Fegers, Esquire 6011 Rodman Street Hollywood, Florida 33023 Clifford F. Anderson, Jr. Executive Director Health Planning and Development Council for Broward County 416 South West 1st Avenue Ft. Lauderdale, Florida 33301
The Issue The issue in this case is whether the Respondent should be disciplined for allegedly practicing medicine below the generally accepted standard of care when he performed a laminectomy and discectomy at the incorrect level of a patient's lumbar spine.
Findings Of Fact Respondent, William O. DeWeese, is a Florida licensed physician, having been issued license number ME 0025687. Respondent is Board-certified in Neurological Surgery and is a Fellow of the American College of Surgeons. He has practiced medicine since graduating from medical school in 1968. He received his Florida license in 1975 and established his practice in Tampa where he has continuously practiced medicine ever since. In twenty-four years of practice, the Florida Board of Medicine has never disciplined Respondent. Respondent's Standard Practice Respondent conducts his practice primarily through two local hospitals, St. Joseph’s Hospital and University Community Hospital. He has a typical practice common to neurological surgery. On average, Respondent performs three to four laminectomy-discectomy procedures each week. Before performing surgery on the spine, Respondent’s protocol is to review available medical records and films (CT, MRI, X-ray), obtain an EKG, obtain chest X-rays, and blood work. During surgery, he routinely obtains "real time" radiological confirmation of the level of the spine where he intends to operate based on his initial pre-surgical work-up. Respondent does this by marking the level where surgery is to take place with radio-opaque material (usually a cottonoid sponge), and has an X-ray film of the patient's spine and the marker exposed and developed in the operatory (OR). Respondent reviews the X-ray in the OR before having the X-ray technician take it to the radiology department for review by a radiologist. The radiologist on duty reviews the X-ray and usually writes on the X-ray to label the location of the marker and has the technician bring the labeled X-ray back to the OR; he then calls the OR, usually on a speaker telephone, to inform the surgeon as to the radiologist's interpretation of the film. Any question as to the level of surgery is resolved at that time. If Respondent is not at the intended level of the spine, he makes the appropriate adjustment in the surgical procedure and completes the surgery at the correct level. The First Surgery S.D. first presented to Respondent in November 1989 with complaints and symptoms of intractable back and left leg pain. She had been seen previously by other physicians but had not experienced any relief. At the time she presented to Respondent, S.D. was 5 feet 5 inches tall and obese (at 175 pounds). Unbeknownst to Respondent at the time, the patient also had an anatomical anomaly of six lumbar vertebrae instead of the more common five. As a result of the patient's anatomical anomaly, physicians could easily be misled, fooled, or misunderstood in reporting the level of spine being evaluated or treated. Depending upon awareness of the patient's specific anomaly and terminology used, the same location on the spine could be referred to as L4-L5, as L5-S1, or as L5-L6. Usually, neurosurgeons can predict the location of nerve root pathology fairly accurately based solely on a patient's complaints, objective examination, and symptoms. Specific nerves innervate specific areas of the body, and a deficit in one area of the body can reasonably lead a physician to suspect nerve root pathology at a particular level of the spine. Because Respondent was unable to determine from initial review of the patient's prior MRI that she had a sixth vertebra, he expected to find nerve root pathology at the L5-S1 level of the spine based on S.D.'s complaints, objective examination, and symptoms. But on X-ray and re-review of the MRI with benefit of the radiologist’s report, Respondent noted the sixth vertebra. Following a complete examination of S.D., including review of a recent CT scan, her prior MRI study, and X-ray films, Respondent believed that S.D. had a "large disc protrusion" at the L5-L6 level of the spine and a "small disc bulge" at the L4- L5 level. The patient's extra lumbar vertebra helped explain the location of the patient's nerve root pathology in relation to her complaints, objective examination, and symptoms. Respondent recommended that S.D. undergo lumbar surgery to explore the disc spaces, remove extruded disc material, and free any entrapped nerves. He expected to have to remove disc material only at the L5-L6 level. His pre-operative diagnosis was: degenerative lumbar disc with lateral angle stenosis (narrowing) at L5-L6; and possible disc protrusion at the L4-L5 level on the left. Respondent performed surgery on S.D. on December 4, 1989. The operation consisted of: a left laminectomy, exploration and inspection of the L4-L5 disc; and a laminotomy, foraminotomy, and partial discectomy at L5-L6. To accomplish the surgery, Respondent dissected away the soft tissues above L4, L5, L6, and S1. He then followed his protocol by placing radio-opaque cotton underneath the ligament at the level he believed was L4-L5 for radiological confirmation. After "real time" radiological confirmation that he was at L4-L5, Respondent removed enough lamina at L4-L5 to inspect the disc and nerve root. He did not observe any entrapment of the nerve and did nothing further at L4-L5. He next proceeded to L5- L6, where he repeated the same procedure but noted entrapment at the posterior aspect of the nerve root. The majority of the pressure on the nerve came from the neural foramen, and this was removed with osteotomy. Some disc material also was removed to free the nerve root. While inspecting the disc space at L5-L6, Respondent observed that the disc space was so narrow that a spinal needle was the thickest instrument that the disc space would receive; a straight pituitary curet could not be placed into the disc space. Respondent recorded these observations in his surgical notes. Similarly, the radiologist's report noted "considerable narrowing of the interspace at the L5-L6 level." Respondent completed the operation by performing a foraminotomy (removal of bone surrounding the point of exit of the nerve from the vertebras of the spinal column). The operation in December 1989 was uneventful; S.D. did well post-operatively and was discharged from the hospital after a normal stay. The Second Surgery S.D. returned to Respondent in March 1993 because of recurrent severe back pain and left leg pain. Following appropriate diagnostic tests and examination of S.D., which revealed what was thought to be a herniated disc on the left side at L5-L6, Respondent planned to "re-do" a laminectomy and discectomy at L5-L6. By the time of the patient's second surgery on May 10, 1993, she had gained about 40 pounds (up to 215 pounds.) The planned surgery was made more difficult by S.D.'s weight gain, as well as by her previous surgery. Additional fatty tissue decreased the operative field of view, as well as the quality of the intra- operative X-ray. S.D.'s anatomical landmarks had been altered as a result of the December 1989 surgery, and there was considerable scaring in the area to be explored during surgery, which obscured the remaining landmarks. Without the presence of normal landmarks and with heavy scaring and weight gain, Respondent had fewer tools to locate the correct level, making the second surgery more difficult. One landmark still available to Respondent to aid in the second surgery was the very narrow interspace at the L5-L6 level. However, Respondent did not the read surgical notes from the first surgery carefully enough to recall the landmark; or, if he read them and recalled the landmark, he attached little significance to the notes and landmark, as compared with other factors influencing his decisions during surgery. One of the reasons Respondent and his expert gave for not attaching more significance to the December 1989 findings as to the remarkably narrow L5-L6 interspace was that a patient's position on the Wilson laminectomy holder and the operation of the holder can alter the apparent width of lumbar interspaces. The holder is a special, adjustable operating table that can be made to "bridge up" in a continuous arc to force the patient (lying on the stomach) to stretch over the "bridge" and make the vertebral interspaces widen for easier access during surgery. While theoretically position on and operation of the holder can affect the width of the interspaces, in practice the surgeon always positions the patient and operates the holder so as to maximize the interspaces. One would not expect the positioning and operation of the holder in two operations at the same level of the lumbar spine to significantly widen an interspace as narrow as the one described in the December 1989 surgical notes. But it might reduce the relative importance of the landmark, compared to other information available to the surgeon, such as radiological confirmation and visual examination of the site. Through answers to his attorney's questions on direct, Respondent also initially attempted to take the position that the patient's weight gain between the two surgeries was enough to warrant ignoring the December 1989 surgical note as to the narrow L5-L6 interspace. But the Department's expert opined that the added weight would not make a significant difference, and on cross- examination Respondent admitted that he actually did not have the patient's weight gain in mind as a reason to gloss over the December 1989 surgical note as to the narrow L5-L6 interspace. Indeed, consistent with Respondent's admission on cross- examination, both Respondent and his expert, Dr. Maniscalco, opined that, if anything, the added weight probably would tend to reduce the maximum flexion obtainable through use of the Wilson laminectomy holder and make the interspaces at the surgical site appear narrower, not wider. Nonetheless, depending on its distribution on the patient, weight gain could possibly alter the apparent width of the interspace during surgery on a Wilson laminectomy holder, and this could also reduce the relative importance of the landmark, compared to other information available to the surgeon, such as radiological confirmation and visual examination of the site. While conceding that he really did not pay much attention to the December 1989 findings as to the remarkable narrowing of the L5-L6 interspace, Respondent also attempted to take the position in testimony that the L4-L5 interspace was fairly narrow itself, as compared for example to the L3-4 interspace. But the L5-L6 interspace clearly was much narrower than L4-L5 and could have been used as a landmark. See Findings 25 and 29, infra. Nonetheless, as previously mentioned, the relatively narrow interspace at L-5-L6 was just one factor to be considered, along with radiological confirmation and visual examination. As Respondent wrote in his notes on May 10, 1993, he thought: "The previous laminectomy site was easily identified and confirmed with a lateral X-ray." The Department's expert took the use of the singular "previous laminectomy site" as evidence that Respondent was unaware of the previous laminectomy at L4-L5. But Respondent testified convincingly that he had reviewed the patient's medical records and was fully aware of both previous laminectomies--at both L5-L6 and L4-L5. (Respondent also testified that his use of the singular, "previous laminectomy site" was intended to mean the general site of both previous laminectomies. But it was the L5-L6 laminectomy site that he thought was "confirmed with a lateral X-ray," so it seems that the language used probably actually referred to the site of the intended surgery. In that respect, the wording of Respondent's surgical notes was ambiguous, if not erroneous.) As usual, an X-ray technician took the lateral X-ray, developed the film, and showed it to Respondent in the OR. Respondent testified that he then had the X-ray technician take the film to the radiology department, along with the pre-operative MRI, and that a radiologist on duty confirmed for him that he was at the "correct level" before he proceeded with the surgery. When Respondent proceeded with the surgery, he widened the laminectomy site and found a disc fragment (which he presumed to be recurrent) underneath and entrapping the nerve root. The nerve root was retracted medially, and the disc space was entered. A large fragment of disc was found in the subligamentous position. Respondent removed the large fragment; then more disc material was removed from the interspace, freeing the nerve. Respondent then performed a foraminotomy and completed the surgery. The pathology found during the second surgery was not inconsistent with the general kind of pathology Respondent expected to find at the L5-L6 level. Relying on visual examination and radiological confirmation, Respondent believed that he was operating at L5-L6. He did not notice, or attached no significance to, the ease of access to the disc space in May 1993, as compared to the narrow interspace encountered at L5-L6 in the first surgery. The Third Surgery After normal recuperation in the hospital, the patient noticed apparent improvement and began regular walking. However, approximately six to eight weeks after surgery, back and leg pain recurred, and the patient returned to Respondent for consultation. Respondent ordered another MRI and scheduled the patient for an appointment in August 1993. When Respondent reviewed the post- operative MRI with the patient, he realized that he had operated at L4-L5 instead of L5-L6. He asked the patient to go to the hospital and get the intra-operative X-ray to help him understand what had happened. It was his belief that the X-ray would show that he had radiological confirmation. With the patient's help, Respondent obtained the X-ray the same day. See Finding 35, infra. Instead of showing radiological confirmation, the X-ray's labeling showed someone's interpretation that the radio-opaque marker on the X-ray was at L4- L5. (There was no evidence as to who labeled the interpretation. Id.) When Respondent saw the writing on the X-ray, he immediately conceded that he had operated at the wrong level and began the process of scheduling a third surgery (the second at L5-L6). Respondent performed the patient's third surgery free-of- charge on September 17, 1993. He had three X-rays taken during the third surgery. The first one apparently was taken before any incision was made. The second was made to confirm that the Respondent was at L5-L6 this time. Instead, the X-ray showed that he was at L6-S1. Respondent tried again, and a third X-ray confirmed L5-L6. Respondent continued with the operation as planned. Findings during the third surgery supported the reasonableness of using the narrow L5-L6 interspace as a landmark during the second surgery. Once again, Respondent found cause to note significant narrowing at L5-L6, stating: "A needle was placed exactly in the interspace, which was small and tight." (The patient weighed 217 pounds at the time of the third surgery--two pounds more than for the second surgery.) The third surgery was otherwise uneventful and apparently successful. The patient discharged after a short stay. The Questionable X-ray Confirmation Although it appears in hindsight that Respondent should have attached more significance to the notes from the first surgery as to the remarkably narrow disc space at L5-L6, even the Department's expert conceded that Respondent should not be found to have practiced below the generally accepted standard of care if he received "real time" radiological confirmation before proceeding with the second surgery. (The Department's expert assumed from the medical records that there was no radiological confirmation. See Finding 33, infra.) Excepting the possibility of an obvious and clear error by the radiologist, the generally accepted standard of care entitles a surgeon to rely on a radiologist's "real time" reading of an intra-operative X-ray. The radiologist's specialty is interpreting X-rays, and the viewing equipment and lighting in the radiology department is far superior to what is available to the surgeon in OR. The question becomes the truth of Respondent's claim of having had "real time" radiological confirmation in the context of the other evidence presented in the case. The radiologist normally would have conveyed the "real time" confirmation of the correct level to the surgeon over a speaker telephone in the OR. But no one else present at the time of the surgery testified. (The patient testified by deposition, but she was under general anesthesia during surgery and could not testify as to radiological confirmation.) Respondent could not remember the name of the radiologist he says confirmed the correct level, and he was unable to show through any other means who confirmed the correct level for Respondent. Meanwhile, the Department did not present any direct evidence to dispute Respondent's claim of "real time" radiological confirmation in the OR. But there was circumstantial evidence that raised questions as to the veracity of the claim. In a hospital radiology report on the intra-operative X- ray, a radiologist named Robert G. Isbell, M.D., stated: "Film was not available for interpretation in the radiology department. The film will be read upon its return." This report was dated May 17, 1993; it was not clear from the evidence whether the report was dictated on that date, released on that date, or both. This could indicate that the X-ray was not taken to the radiology department during the surgery on May 10, 1993, since standard procedure would be for the radiologist to dictate the report immediately after calling down to the OR to confirm the correct level for the surgeon. (The Department's expert assumed from this report that there was no radiological confirmation.) However, it also is possible that an unknown radiologist confirmed the correct level for Respondent and then failed to follow the normal procedure, and either he forgot to dictate the report, or the dictation got lost or for some other reason did not result in a transcribed report to go in the patient's file "jacket" in the radiology department. If there was radiological confirmation in the OR, the radiologist apparently did not label the film and have it sent back to the OR, as usual, because the X-ray apparently was not labeled until later. See Findings 35-36, infra. When the patient went to St. Joseph’s Hospital in August 1993 at the Respondent's request to ask for her X-ray, she was told that a doctor had just asked for it to be sent over to the hospital (apparently from where it ordinarily would have been kept.) S.D. was surprised and somewhat suspicious that the hospital was familiar with her X-ray by name and that it coincidentally had just been requested by a doctor. There was no evidence as to the identity of the doctor who requested the X-ray. S.D. insisted on receiving her X-ray immediately and waited until it was returned to her. When she got it, there appeared to be fresh "grease pen" writing on it. As previously mentioned, the grease pen writing labeled the X-ray and clearly indicated someone's interpretation that the radio-opaque marker on the X-ray was at L4-L5. Respondent has maintained that he had never seen the grease pen writing before the X-ray was brought to him by the patient in August 1993. This is consistent with the patient's testimony that the grease pen writing appeared to her to be fresh, and it seems clear from the evidence that the writing was placed on the X-ray shortly before S.D. retrieved it, contrary to normal procedures. This evidence also makes it possible that the X-ray never was sent to the radiology department during surgery, again contrary to normal procedures. It is not clear from the evidence where the X-ray had been between the time of the May 1993 surgery and the time S.D. picked it up with the fresh grease pen writing. There was no evidence as to who put the markings on the X-ray, or at whose request. There was no evidence of any hospital radiology report recording the mysterious August 1993 "reading" of the X-ray as reflected by the new grease pen writing. It also is not clear from the evidence exactly what was written on the X-ray in August 1993 when S.D. retrieved the film from the hospital, or what that particular X-ray looked like. While S.D. retained the X-ray until some time during her subsequent civil action against Respondent and the hospital, she then gave it to the hospital's risk manager, who was supposed to make her a copy. When S.D. went to retrieve the X-ray for her deposition in this administrative proceeding, she found several X-rays apparently given to her by her lawyer after disposition of the civil action, including one labeled "original" and bearing writing in addition to, or other than, the writing S.D. recalled from August 1993. The writing on the X-ray used in this administrative proceeding may have been placed on the "original" X- ray by experts in the civil action. The other X-rays in S.D.'s possession were not produced for use in this administrative proceeding, and it is not clear which, if any of them, is the X-ray labeled as when S.D. retrieved it in August 1993. The X-ray used in this administrative was of poor quality and actually did not show what was below the marked interspace. (As the Respondent described the lower part of the film, "It looks like a snowstorm.") As a result, it actually would not have been possible to confirm the correct level using that particular X-ray. But X-rays can deteriorate over time, and there is no way of knowing if the intra-operative X-ray as it existed on May 10, 1993, or when seen again by Respondent in August 1993, also was of such poor quality as to be virtually useless. If an unknown radiologist in fact called the OR to confirm the correct level for Respondent, it also is possible that there was a miscommunication. Respondent in his testimony made a point of explaining that he only used the terminology "correct level" in talking to the radiologist "to avoid confusion." But if Respondent just asked if he was at the "correct" level, and the radiologist just said, "yes, you're at the correct level," the radiologist actually either would be simply assuming that the level marked on the X-ray was the "correct" level, or he would be saying that pathology visible on the MRI matched the marked location on the X-ray. If the latter, the radiologist may have thought there was enough pathology showing on the MRI matching the marked interspace in this case (actually L4-L5) to justify surgery there. Taking all of this evidence into consideration, it cannot be found that the Department proved by clear and convincing evidence that Respondent did not receive "real time" radiological confirmation on which he was entitled to rely in proceeding with the second surgery. Without such proof, it cannot be found that Respondent practiced below the generally accepted standard of care, notwithstanding the little attention he paid to his December 1993 surgical notes as to the remarkably narrow interspace at L5-L6.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint in this case. DONE AND ENTERED this 27th day of September, 1999, in Tallahassee, Leon County, Florida. J. LAWRENCE JOHNSTON 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 27th day of September, 1999. COPIES FURNISHED: Britt Thomas, Esquire Agency for Health Care Administration 1580 Waldo Palmer Lane Tallahassee, Florida 32308 Jon M. Pellett, Esquire Grover C. Freeman, Esquire Freeman, Hunter & Malloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Pete Peterson, General Counsel Department of Health 2020 Capital Circle, Southeast, Bin A02 Tallahassee, Florida 32399-1703 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast, Bin A02 Tallahassee, Florida 32399-1703 Tayna Williams, Executive Director Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750
The Issue Whether the Petitioner committed the violations alleged in the Administrative Complaint, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department of Health is the state agency responsible for certifying and regulating basic X-ray machine operators in Florida. Sections 468.3001-.312, Florida Statutes. On March 30, 1993, Paul Butler was issued Basic X-ray Machine Operator Certificate Number 7729. The certificate expired December 31, 1994, and Mr. Butler requested renewal by submitting a renewal form and the required fee to the Department on December 20, 1996. Mr. Butler admitted that he knew his certificate expired December 31, 1994, but that he nonetheless took numerous X-rays subsequent to that date. On January 4, 1996, Mr. Butler prepared and submitted an application for employment to Kristie Green, office manager for South Dade Orthopedic Associates. In that application, Mr. Butler signed his name and appended to his name the designation "RMA, CRT." Ms. Green interviewed Mr. Butler, and he provided her with a copy of his certificate that showed an expiration date of December 31, 1995. Ms. Green noted that his certificate had expired four days previously, and Mr. Butler told her he was short of funds and would send in his renewal application when he received his first paycheck. Ms. Green hired Mr. Butler as an X- ray technician and medical assistant. After Mr. Butler repeatedly assured her that he had sent his renewal application to the Department, Ms. Green fired Mr. Butler on June 20, 1996, because he had not obtained a current Basic X-ray Machine Operator certificate. The evidence presented by the Department is sufficient to establish that Mr. Butler took X-rays without having an active certificate, and that he identified himself in his employment application to South Dade Orthopedic Associates as a Certified Radiologic Technologist by using the letters "CRT" after his signature. The evidence presented is also sufficient to permit the inference that Mr. Butler altered his basic X-ray Machine Operator certificate by changing the expiration date from December 31, 1994, to December 31, 1995.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health issue a final order finding that Paul Butler violated Section 468.3101(h), Florida Statutes, by violating Section 468.302(1) and (2) and that he violated Section 468.3101(f). Based on the violations, the Department of Health should impose the following penalties: Suspend Mr. Butler's Basic X-ray Machine Operator certificate for a period of six (6) months; Impose an administrative fine in the amount of Six hundred twenty-five dollars ($625.00); and Condition the reinstatement of Mr. Butler's certificate on his having completed thirty (30) hours of continuing education. DONE AND ENTERED this 12th day of January, 1998, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO 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 12th day of January, 1998. COPIES FURNISHED: Morton Laitner, Esquire Department of Health 401 Northwest 2nd Avenue Suite N-1014 Miami, Florida 33128 Paul Butler, pro se 30525 Southwest 149th Court Leisure City, Florida 33033 Angela T. Hall, Agency Clerk Department of Health 1317 Winewood Boulevard Building 6 Tallahassee, Florida 32399-0700 Pete Peterson, General Counsel Department of Health 1317 Winewood Boulevard Building 6, Room 102-E Tallahassee, Florida 32399-0700
The Issue The issue in this case is whether the Petitioner's application for certification by examination as a basic X-ray machine operator should be approved or denied.
Findings Of Fact In February 2009, the Petitioner submitted an application to the Respondent for certification by examination as a basic X-ray machine operator. The application was submitted by “Ultimate Medical Academy” (UMA), where the Petitioner obtained his basic X-ray training, but the Petitioner provided the information contained therein and was responsible for the accuracy of the application. On the Petitioner’s application, he stated that he was employed in “basic x-ray” at Palm Harbor MRI, and indicated that “100%” of his time at Palm Harbor MRI was related to duties other than radiography, nuclear medicine, or radiation therapy. On February 19, 2009, the Respondent notified the Petitioner that the application was incomplete because it lacked a criminal history record from the Florida Department of Law Enforcement. On April 14, 2009, the Respondent received the Petitioner’s criminal history record, which revealed convictions between the years 1993 and 2002, and related periods of incarceration, for retail theft, felony grand theft, felony uttering of forged checks, other forgeries, and failure to appear. The Petitioner was also convicted of federal crimes, including possession of counterfeited checks in 2000 and felony uttering a forged check in 2002. The Petitioner spent three years in federal prison and, in December of 2003, was transferred to a halfway house after his release. His most recent sentence included a probationary period that expired at the end of May of 2007. As part of the application process, the Petitioner advised the Respondent that his civil rights had been restored on January 31, 2008. The Petitioner provided documentation to the Respondent that spelled his first name as “Erin.” For purposes of this Recommended Order, the restoration of civil rights has been deemed applicable to the Petitioner. The Respondent reviewed the Petitioner’s application, including the criminal history and the restoration of civil rights, and denied the application because of the Petitioner’s criminal history. The specific basis for the denial was the Respondent’s concern with the access an X-ray operator has to the personal belongings and medications of a patient while X-ray images are obtained, as well as to the personal and medical information contained within patient records. After receiving the Respondent’s decision, the Petitioner requested an administrative hearing to challenge the denial. After issuing the initial Notice of Intent to Deny, the Respondent became aware of potential issues related to the Petitioner’s employment during and after his training at UMA. As part of his educational training, UMA placed the Petitioner into an externship at Palm Harbor MRI for a six-week period of clinical practice. The externship ended on April 4, 2008, when he graduated from the UMA. The quality of the Petitioner’s job performance at Palm Harbor MRI is not at issue in this proceeding. There is no evidence that he was not competent to perform the tasks assigned to him during the externship. On April 9, 2008, the Petitioner began working as a full-time employee at Palm Harbor MRI. He performed some customer contact duties, greeting patients and gathering information. His duties also included placing and positioning patients on the X-ray table, imputing the machine settings (“technique”) and operating the X-ray machine, including the administration of radiation to obtain the desired images. Positioning patients for X-rays, machine technique, and operating the radiation equipment constitutes the practice of radiologic technology. The Petitioner was supervised by a licensed technician at all times during his positioning of patients and operation of the machine. The Petitioner performed these duties without being properly licensed. After the Respondent learned of the Petitioner’s job responsibilities at Palm Harbor MRI, the Respondent issued an Amended Notice of Intent to Deny that identified the alleged unlicensed activity as an additional basis for denial of the application. The Respondent also initiated a review of the Palm Harbor MRI facility’s operating procedures that was continuing at the time of the hearing. The application information originally disclosed by the Petitioner was inaccurate because it failed to reveal that he was involved in performing radiography at Palm Harbor MRI. In May 2009, the office manager at Palm Harbor MRI requested that the Petitioner provide a copy of his certificate, apparently unaware that the Petitioner had no license at that time. When he was unable to provide the certificate, his employment was terminated on May 18, 2009. The Petitioner has asserted that he was exempt from licensure because he was a student attending St. Petersburg College (SPC) with the intention of being admitted to the SPC radiologic technology program, and ultimately to become licensed as a radiography technologist. Students attending a medical school or “enrolled in and attending” a radiologic technology educational program are statutorily exempt from licensure during their educational period; however, there is no evidence that UMA students are entitled to the exemption. Although SPC has a radiologic technology educational program, the Petitioner has neither been admitted to the program nor attended any classes within the program’s curriculum. Additionally, Palm Harbor MRI is not an approved clinical training site for students enrolled in and attending the SPC radiography program. The Petitioner had not applied to the SPC radiography program prior to termination of his employment from Palm Harbor MRI, and the applications subsequently submitted by the Petitioner for application to the SPC radiography program were denied. There was no credible evidence presented at the hearing that the Petitioner was a medical student or was enrolled in and attending a radiologic technology educational program at any time relevant to this proceeding.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a Final Order denying the Petitioner's application for certification by examination as a basic X-ray machine operator. DONE AND ENTERED this 29th day of December, 2009, in Tallahassee, Leon County, Florida. S WILLIAM F. QUATTLEBAUM 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 29th day of December, 2009. COPIES FURNISHED: Donna Erlich, Esquire Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 C. Erica White, Esquire Quintairos, Prieto, Wood & Boyer, P.A. 215 South Monroe Street, Suite 510 Tallahassee, Florida 32301 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 Dr. Ana M. Viamonte Ros, Secretary State Surgeon General Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701
Findings Of Fact Dr. Gans is a chiropractor licensed in Florida on the basis of examination. Dr. Gans prepared and filed an application for examination and licensure with the Florida State Board of Chiropractic Examiners. Dr. Gans answered the question on the application, "Do you have a chiropractic license in any state?" by stating: "Ohio - Mechanotherapy." The Ohio authorities recognized several professions whose functions would be included under the practice of chiropractic in Florida. Mechanotherapy generally would be limited to the practice of manipulation only. Dr. Gans was licensed in Ohio as a mechanotherapist. Dr. Gans answered the question on the application, "Have you ever been refused licensure in any state?" by stating, "No." Dr. Gans had applied for, taken, and failed the Ohio chiropractic examination whereupon he was not issued a license as a chiropractor by the State of Ohio. Dr. Gans was eligible to reapply to take the Ohio examination. At the time of his application to Florida, Dr. Gans had appealed the determination by the Ohio authorities that he had failed the Ohio examination.
Recommendation Based upon the foregoing findings of fact and conclusions of law, the Hearing Officer recommends that the Florida State Board of Chiropractic Examiners revoke the license of Ray E. Gans. DONE AND ORDERED this 2nd day of October, 1978 in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: John R. Sutton, Esquire 250 Bird Road, Suite 310 Coral Gables, Florida 33146 Paul Lambert, Esquire 1311 Executive Center Drive Tallahassee, Florida 32301 C. A. Hartley, Director Florida State Board of Chiropractic Examiners Suite 202, Building B 6501 Arlington Expressway Jacksonville, Florida 32211
