The Issue The issues to be determined in this proceeding are whether Respondent, John L. Lentz, Jr., M.D., committed the disciplinary violations charged with respect to seven patients in three Administrative Complaints that have been consolidated for the purpose of hearing. If the facts demonstrate that any of the charged violations have been committed, then the appropriate penalty to be imposed for such violations must be recommended.
Findings Of Fact Based upon the testimony and documentary evidence presented at hearing, the demeanor and credibility of the witnesses, and on the entire record of this proceeding, the following findings of fact are made: Petitioner is the state agency charged with the licensing and regulation of the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to these proceedings, Respondent was a licensed physician in the State of Florida, having been issued license number ME 82437. Respondent’s address of record is 15200 Emerald Coast Parkway, St. Marten Unit 506, Destin, Florida 32541. Respondent was board-certified by the Academy of Family Physicians until 2009. He currently holds no board certification in any specialty area, and did not complete any residency other than his residency in family medicine. Respondent went to medical school at the University of South Carolina and initially practiced in that state. He moved to Florida in 2001 and since that time, has worked in a variety of practice settings, including working as an emergency room physician in several hospitals in areas such as Phenix City, Alabama; Panama City, Florida; and Defuniak Springs, Florida. At some point, Respondent became interested in the diagnosis and treatment of Lyme disease, and in approximately 2007, he opened a clinic in Destin named the Lentz Lyme Clinic. Respondent attended four continuing medical education courses that focused on the diagnosis and treatment of Lyme disease. Each of the courses he attended was three to four days long. Diagnosis and Treatment of Lyme Disease Lyme disease is an infectious disease caused by the bacteria Borrelia burgdorferi. Lyme disease is typically transmitted by a tick bite from what is often referred to as a deer tick, more formally known as the Ixodes scapularis tick. The tick is usually very small, and must remain on the person’s skin for approximately 36 hours or more in order for the disease to be transmitted. Lyme disease is generally considered to be endemic to the Northeastern United States, in states such as the New England states, Pennsylvania, upstate New York, Delaware, and northern Virginia. While it is not impossible to contract Lyme disease in Florida, the more persuasive evidence established that it is not prevalent in this state. The most credible, compelling evidence presented established that most people who are diagnosed in Florida with Lyme disease were most likely infected while traveling in a part of the country that is endemic for the disease, and that states in the Southeastern United States are in a low-risk area for Lyme disease. There was some conflict in the testimony concerning the stages and symptoms of Lyme disease, and what factors should be considered in diagnosing the disease at the various stages. The more credible and persuasive descriptions of Lyme disease and its stages describe the disease as having three stages: early localized Lyme disease; early disseminated Lyme disease; and late Lyme disease. The probable stage of the disease at the time a patient presents for diagnosis and treatment determines what is necessary for a diagnosis. Early localized Lyme disease is the disease as it typically presents within the first four weeks of the tick bite. The patient often, but not always, presents with a rash called an erythema migrans, which is generally over five centimeters wide (and can be as large as 19 centimeters) and is sometimes clear in the center, leading to the term “bull’s-eye rash” to describe it. In addition to the erythema migrans, a patient may present with virus-like symptoms, such as fatigue, malaise, fever, chills, myalgia (muscle aches), and/or headache. Often the symptoms at this stage, or any stage, for that matter, are non-specific symptoms that are common to a variety of conditions, including ALS and MS. According to Respondent’s expert, Dr. Cichon, these are conditions that a physician should also consider when diagnosing Lyme disease, Babesiosis, or Bartonellosis. In other words, when a patient presents with symptoms that do not include the erythema migrans, but are vague and non-specific, Lyme disease and co-infections related to Lyme disease should not be the only diagnoses considered. In order to diagnose Lyme disease a thorough history is required, including information on a patient’s travel locations, whether travel included states that are typically endemic for Lyme disease; the time of year the travel occurred; whether the patient engaged in the type of activity (such as hunting, fishing, hiking, or other outdoor activities) that would expose him or her to the possibility of a tick bite; any history of rashes; and whether the patient remembers a tick bite. The history should also include any symptoms the patient is experiencing and when the symptoms began. If the patient reports travel to an endemic area, and presents with an erythema migrans that the physician can examine, a diagnosis of early Lyme disease can be made without confirmatory laboratory tests. At that early stage, laboratory tests would not be particularly useful because they detect antibodies to the Borrelia burgdorferi, as opposed to detecting the bacteria itself. At that early stage of the disease, there is not sufficient time for the body to develop the antibodies necessary for detection through laboratory testing. The second stage of Lyme disease is called early disseminated Lyme disease, which may be characterized by multiple erythema migrans lesions; cardiac symptoms, such as atrioventricular block; arthralgia (joint pain); myalgia; or neurologic involvement, such as lymphocytic meningitis, facial nerve Palsy (Bell’s palsy), or encephalitis. If a patient presents with some combination of these symptoms, along with a history indicating travel to an endemic area and activities in that area consistent with tick exposure, a reasonable prudent physician would seek confirmatory laboratory tests to reach a diagnosis of Lyme disease, assuming the patient presents four weeks or more after possible exposure to a tick bite. The type of test to use is discussed below. Late Lyme disease is characterized by neurological symptoms, such as encephalomyelitis, peripheral neuropathy; and arthritis and arthralgia, usually in a single joint, such as a knee. As with early disseminated Lyme disease, a thorough history and physical is required for a diagnosis, as well as a confirmatory laboratory test. There was a great deal of testimony presented regarding the type of testing that is appropriate for the diagnosis of Lyme disease. Petitioner advocated the use of the ELISA test, followed by the Western blot test, commonly referred to as the two-tiered approach. ELISA and Western blot will be discussed in more detail below. Respondent contends that this two-tiered approach is inaccurate and that other tests are more definitive. His argument regarding the testing to use is consistent with his claim that there are two “standards of care,” one recognized by the Infectious Disease Society of America (IDSA), and one recognized by the International Lyme and Associated Diseases Society (ILADS). The tests recognized as standard for diagnosis of Lyme disease by Drs. Robbins, Anastasio, Robertson, Rosenstock, and Powers, are the two-tiered approach ELISA and Western blot tests. The ELISA is an enzyme-linked immunosorbent assay screening test. If the screening test is positive or equivocal for enzymes indicative of Lyme disease, a Lyme Western blot test is performed to confirm the presence of antibodies to Borrelia burgdorferi. For patients with early Lyme disease, the two-tier testing process may produce false negatives because the patient has not had sufficient time to develop antibodies in response to the bacteria. For those with late Lyme disease, the test is highly sensitive and specific because late Lyme disease patients have ample time to develop antibodies. The two-step approach is recommended by the Centers for Disease Control (CDC) because it provides for both sensitivity and specificity. Usually lab tests are either sensitive or specific, but not both. For a test to be considered “sensitive,” there are no false negatives. ELISA is considered a sensitive test. Specificity refers to the specific antibody bands being evaluated. With Western blot, there is an examination of different specific antibody bands. A Western blot IgM test looks for antibodies that are created initially from white blood cells that specifically attach to the infectious organism. A Western blot IgG looks for a different set of antibodies that continue to persist long after the infection is gone. A Western blot IgG is considered positive if five of the ten antibody bands are positive, while an IgM is considered positive if two of three bands are positive. The ILADS guidelines criticize use of the ELISA and Western blot tests because in the organization’s view, the two- tiered testing lacks sensitivity. The guidelines state that several studies “showed that sensitivity and specificity for both the IgM and IgG western blot range from 92 to 96% when only two [as opposed to five] specific bands are positive.”2/ While the ILADS guidelines criticize the two-tiered approach represented by ELISA and Western blot and indicate that other testing has been evaluated, “each has advantages and disadvantages in terms of convenience, cost, assay standardization, availability and reliability.” The ILADS guidelines do not expressly advocate not using the ELISA and Western blot, and note that while other tests remain an option to identify people “at high risk for persistent, recurrent, and refractory Lyme disease,” the tests have not been standardized. Dr. Michael Cichon, testifying for Respondent, opined that the ELISA and Western blot tests had little value and that Respondent’s failure to use them was not a departure from the standard of care. However, while at hearing he denied that he would order either test, in his deposition he indicated that he would order both tests, as a guide to diagnosis. His testimony that the ELISA and Western blot tests are not useful in the diagnosis of Lyme disease is rejected as not credible. Clear and convincing evidence at hearing established that a reasonable, prudent physician who is presented with a patient having possible exposure to Lyme disease occurring four weeks or more before seeing the physician would order the two- tier testing of ELISA and Western blot if it was appropriate to test for Lyme disease. While performing other tests in conjunction with the two-tier tests is not per se a departure, the standard of care requires either ordering the ELISA and where necessary, the Western blot, or reviewing any test results for these tests previously obtained by the patient. Treatment of Lyme disease also depends on the stage at which the condition is diagnosed. If a patient is diagnosed with early localized Lyme disease, a single course of doxycycline for 14 to 28 days is generally appropriate. Early disseminated Lyme disease and late Lyme disease may be treated with IV antibiotics, for a similar period of time. In summary, the standard of care in the diagnosis and treatment of Lyme disease requires a physician to take an appropriate medical history, perform a physical examination, obtain objective laboratory test results in the absence of an erythema migrans rash, and refer patients who do not improve after an initial course of antibiotic treatment to an infectious disease specialist for further evaluation. An appropriate history must include the information described in paragraph nine, and the testing to be ordered should include an ELISA and, where positive or equivocal, a Western blot test. Diagnosis and Treatment of Babesiosis Babesiosis is a parasitic disease of the blood caused by infection with Babesia. Babesiosis, like Lyme disease, is typically transmitted by a tick bite, and can be transmitted by the same tick that carries Lyme disease. There are occasions when a patient properly diagnosed with Lyme disease also will have Babesiosis as a co-infection. It is, however, not a common diagnosis, and even infectious disease specialists may go an entire career without diagnosing it. If a family practice physician suspects Babesiosis, the better approach would be to refer the patient to an infectious disease specialist. However, failure to refer a patient to a specialist, assuming that the family physician performs the appropriate testing and treatment, is not necessarily a departure from the standard of care. At all times material to the allegations in the Administrative Complaints, the standard of care for the diagnosis and treatment of Babesiosis included the physician taking an appropriate medical history, performing a physical examination of the patient, and obtaining objective laboratory test results in order to make an evidence-based diagnosis. As with Lyme disease, the patient’s medical history should contain information regarding the patient’s travel; whether they had exposure to a tick bite; whether they recall being bitten by a tick; as well as what symptoms the patient is experiencing. Babesiosis typically presents with virus-like symptoms, fever, sweats, and the identification of Babesia parasites in the patient’s blood. The tests that a reasonably prudent similar physician would order to determine whether a patient had Babesiosis are either a blood smear to identify Babesial parasites or a polymerase chain reaction (PCR) amplification of Babesial DNA. Should a patient be diagnosed with Babesiosis, the normal and customary treatment is a ten-day course of clindamycin and atovaquone. Diagnosis and Treatment of Bartonellosis Bartonellosis is an infectious disease caused by bacteria of the genus Bartonella. It is generally transmitted by lice or fleas on a person’s body, coming off of other animals, such as rats. It also can be transmitted through a cat scratch, as the cat gets fleas under its claws by scratching itself. As is the case with Babesiosis, a family practice physician is unlikely to diagnose Bartonellosis. It is not a common diagnosis, and even infectious disease specialists may go an entire career without diagnosing it. If a family practice physician suspects Bartonellosis, the better approach would be to refer the patient to an infectious disease specialist. However, failure to refer a patient to a specialist, assuming that the family physician performs the appropriate testing and treatment, is not necessarily a departure from the standard of care. In order to make a diagnosis, a thorough history and physical is required, along with objective laboratory test results. A physician should inquire about exposure to animals that could carry fleas, ticks, or lice, and whether there had been any recent instances where the patient has been scratched by a cat. The symptoms of Bartonellosis are nonspecific and include fever, headaches, myalgia, and arthralgia. The generally accepted test used to confirm a diagnosis of Bartonellosis would be a PCR amplification of Bartonella DNA, or paired blood serologies. DOAH Case No. 15-2888PL; DOH Case No. 2011-15106 (Patient C.C.) From approximately September 28, 2010, through approximately February 28, 2012, Respondent provided medical care and treatment to patient C.C. At the time of her original presentation to Respondent, C.C. was 27 years old. Prior to seeing Dr. Lentz, C.C. had a series of orthopedic injuries. For example, in 1998, C.C. was involved in a serious car accident, resulting in multiple broken bones and internal injuries requiring a two-week stay in the hospital. C.C. joined the Air Force in 2006, where she served as an aircraft mechanic. During basic training she suffered an injury to her shoulder, which caused problems with her neck, back, and shoulder. While in the military, C.C. was involved in two additional accidents: she broke her wrist in a motorcycle accident at some point, and on March 31, 2009, she had a second accident where the car she was driving was struck by another vehicle. While C.C. denied any injuries as a result of this second accident, shortly thereafter in July 2009, she had neck surgery because of discs impinging on the nerves in her neck. C.C.’s work as an aircraft mechanic required her to work in the fuel tanks of an airplane, which is a very confined space. C.C. is approximately 5’10” tall, and the work she performed required her to become contorted in a very small space for approximately 13 hours at a time. After her neck surgery, she started having increasing amounts of pain in her back and hips, to the point where she could no longer perform her job duties and in August of 2010, resorted to a wheelchair because of her inability to walk. Although she consulted multiple doctors both in the military and through referrals to outside physicians, she did not discover the cause of her pain. On or about September 28, 2010, Respondent evaluated C.C. for complaints of severe back, buttock, and right leg pain. When she presented for her first office visit, Dr. Lentz’s review of symptoms indicated that C.C. had a frontal headache with pain at a level of 10 out of 10; sensitivity to light and sound; loss of hearing and buzzing; nausea but no vomiting; withdrawal symptoms described as sweats when she did not take Ultram or Lortab; and feelings of hopelessness and emotional lability. His physical examination reported that C.C. was in a wheelchair, and documented “soles of feet painful, SKIN: rashes, soles of feet red, NEURO: paresthesia, pain, tender extremity.” At that time, Respondent diagnosed C.C. as having chronic fatigue syndrome and chronic pain syndrome. In C.C.’s history, Respondent noted that she “grew up in Texas/Arkansas-hunting, forests, etc. There is no notation of recent travel on this first visit. Dr. Lentz asked her about any flu-like symptoms, which she denied having. Many of the symptoms listed by C.C. are general symptoms that are common to a variety of ailments. Respondent, however, focused only on chronic fatigue, chronic pain, Lyme disease, Babesiosis, and lupus. On this first office visit, Respondent prescribed CD57, C3a, C4a, and eosinophilic cationic protein (ECP) laboratory tests of C.C.’s blood. With respect to the order for CD57, Respondent listed Lyme disease as a diagnosis. For the C4a and C3a, he listed Lyme disease and Lupus as the diagnoses, and for the ECP he listed a diagnosis of Babesia infection. Respondent did not prescribe an immunoassay (ELISA) test or Western blot test for Borrelia burgdorferi for C.C. The ECP test result for C.C. collected on October 6, 2010, was 20.8. The reference range for a normal test result is 1-10. The notation for the test on the lab result states: This test uses a kit/reagent designated by the manufacturer as for research use, not for clinical use. The performance characteristics of this test have been validated by Advanced Diagnostic Laboratories at National Jewish Health. It has not been cleared or approved by the US Food and Drug Administration. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. On or about October 15, 2010, Respondent diagnosed C.C. with Lyme disease. He based his diagnosis of Lyme disease on the results of the CD57 blood test. The CD57 test is a cluster designation test that measures a marker found on lymphocytes, which are a type of white blood cell that are sometimes referred to as natural killer cells. Although Respondent claimed at hearing that he did not consider the test to be definitive, in his deposition he indicated that he believed that it was in fact definitive. Dr. Cichon, on the other hand, testified that the CD57 test used by Dr. Lentz is not a definitive test for Lyme disease, but is useful for measuring the progress of treatment. At least one test result for C.C. reflecting the results for a CD57 panel has the following notation from the laboratory: This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Results of this test are for investigational purposes only. The result should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure. On or about October 15, 2010, Respondent also diagnosed C.C. with Babesiosis. Respondent did not prescribe a blood smear examination for Babesial parasites or PCR amplification for Babesial DNA for C.C. He based his diagnosis on the ECP test. On October 15, 2010, Dr. Lentz received an e-mail from C.C.’s roommate, M.B., informing him that C.C. had visited the emergency room over the weekend because of the level of her pain. The e-mail asked whether C.C. could begin with her treatment before her next appointment. In response, Dr. Lentz called in prescriptions for doxycycline and Cleocin, both of which are oral antibiotics. On or about October 18, 2010, Respondent described C.C. as being in no acute distress, with a gait that is within normal limits. He also noted some wheezing, pain all over, tears, and cramps in her muscles. Respondent prescribed long-term IV antibiotic therapy and referred C.C. to a specialist for venous port placement for the administration of intravenous (IV) antibiotic therapy. The specific medications prescribed at this visit are acetaminophen-oxycodone 300 mg - 7.5 mg oral tablets to be taken three times daily; Cymbalta 30 mg oral, once a day; Flagyl 500 mg oral tablets, to be taken three weeks on, one week off; heparin 5000 units/ml injectable solution, once a day; Omnicef 300 mg oral capsules, once a day; Interfase Plus Prothera, a supplement; and boluoke lumbrokinase, also a supplement. At the October 18, 2010, visit, he also ordered a Fry test for Bartonellosis and prescribed intravenous vancomycin, with weekly vancomycin trough levels. Dr. Lentz testified at hearing that the prescription for vancomycin was to treat Bartonellosis.3/ However, at this juncture, no diagnosis for Bartonellosis had been made. Heparin is an anticoagulant that is used for a variety of issues, such as blood clots, pulmonary emboli, and Berko emboli. It is also used in coronary heart disease if a patient has a myocardial infarction. The more persuasive and credible testimony established that it was below the standard of care to use heparin in the treatment of Lyme disease, Babesiosis, or Bartonellosis. Not only did heparin have no efficacy, it had the potential to be very dangerous for C.C., or any other patient. On October 28, 2010, Respondent noted that the vancomycin was at 1.5 grams and still not therapeutic, and ordered that the medication be changed to Primaxin and that the Omnicef and vancomycin troughs be stopped. On November 10, 2010, Respondent noted that C.C. was experiencing flu-like symptoms, but was now resting fewer hours each day. For the first time, he noted “past 4 years in military=Virginia, Canada, Honduras, as sites for exposure to Lyme.” He also noted “no wheelchair, but slow to move, pain to rt LS-hip-leg.” He continued to list her diagnoses as Lyme disease, Babesiosis, chronic pain syndrome, and chronic fatigue syndrome. Respondent also saw C.C. in the office on December 8, 2010, and January 10, 2011. At the December 8, 2010, visit, he discontinued the use of Flagyl because of her nausea and switched to Tindamax (one tablet daily for three weeks, then off one week) instead. On January 19, 2011, Dr. Lentz received an e-mail from C.C.’s roommate regarding a fall C.C. had over the weekend. As a result, he wrote an e-mail to C.C. and told her to stop the Tindamax and “add the neurotoxins to remove the neurologic toxins that are being created by the antibiotics.” He also directed her to stop the heparin injections, as she needed to be off of heparin before having some hand surgery to remove a cyst. C.C. returned for an office visit on February 9, 2011. At that time, Respondent’s notes indicate that she was ambulatory but still significantly fatigued and still falling. He noted, “rt hip. sciatic nerve still #1 symptom, can not stand or walk for long periods of time, not sure if neurologic/Lyme or degenerative nerve dis.” In his assessment, he stated she “needs CT lumbar sacrum to r/o orthopedic issue with back pain.” During the course of treatment, Respondent was consistently prescribing OxyContin at 10 mg, three times daily. On March 16, 2011, he referred C.C. to Dr. Beach at Andrews Institute to detox off the OxyContin. He also noted that she had been given 100 percent disability through the military, and would take approximately four months to process out of the military. He also noted “electrical ablation at T9, T10 for chronic back pain per Dr. Nyguen.” Dr. Lentz continued to see C.C. on April 12, 2011; May 4, 2011; and May 13, 2011. Throughout her treatment with IV antibiotics, C.C. experienced problems with nausea, rashes, and diarrhea, but claims that over time, her symptoms began to improve so that she could walk and eventually was able to hold down part-time employment. Toward the end of her military tenure, C.C. needed a referral in order to continue to see Dr. Lentz. To that end, on June 8, 2011, she saw Dr. Janelle Robertson, M.D., a board certified infectious disease specialist at Eglin Air Force Base. Dr. Robertson evaluated C.C. for Lyme disease, and documented her history, including travel history and history of tick bites. She reviewed prior records from Eglin Air Force base that indicated C.C. had an ELISA screening on June 10, 2010 (approximately two and a half months before seeing Dr. Lentz), that was negative. The ELISA test was not only performed before C.C. saw Dr. Lentz, but well after C.C. began suffering the symptoms that led her to seek out Dr. Lentz. Accordingly, the ELISA test was administered at a time at which C.C. would have developed sufficient antibodies for the test to be useful. Dr. Robertson also noted that while C.C. had a history of tick bites in Florida, Texas, and Alabama, she did not report any rashes or illness at or near the time of the tick bites. She also had no history of migratory arthralgia or Bell’s palsy. Dr. Robertson testified credibly that C.C. was having no night sweats, weight loss, changes in vision, palpitations, difficulty breathing, or gastrointestinal problems, and that her primary complaint was back and hip pain. C.C.’s pain remained in the same locations and persisted without resolution since 2009. Dr. Robertson concluded that C.C. did not have Lyme disease, and that her prior negative ELISA test conclusively established that she did not have the disease. She opined that, given that C.C.’s symptoms had persisted since 2009, if she had actually had Lyme disease, she would have developed antibodies that would have been detected with the ELISA test. She also determined that Respondent did not have Babesiosis and recommended to C.C. that she immediately stop the therapy prescribed by Dr. Lentz, because in Dr. Robertson’s view, the therapy was unsafe. C.C. has since transitioned out of the military into civilian life. Although she believes that the treatment by Dr. Lentz was effective in treating her condition, the events since she stopped treatment for Lyme disease suggest otherwise. For example, C.C. testified in her deposition that her treatment ended in mid-May 2011 because Dr. Lentz determined that she did not need more treatment, yet it appears that the military would no longer authorize treatment by Dr. Lentz once C.C. saw Dr. Robertson. Moreover, she continues to have some of the same pain that led her to treatment with Dr. Lentz. In approximately October 2014, she had hip surgery because her “hips are pretty much shot.” She has had three surgeries for kidney stones, steroid injections for temporary relief from her back pain, and acupuncture treatments for her back pain. At least one physician attributed her problem to the kind of work she performed as an aircraft mechanic, and at deposition she indicated that a recent MRI indicated that she has some lumbar narrowing. In short, it appears that the months-long IV antibiotic therapy she endured has provided no lasting solution to her pain. Respondent’s care and treatment of C.C. was a departure from the standard of care in that he diagnosed Lyme disease based upon an inadequate history and no objective laboratory test results from an ELISA test and Western blot. Specifically, Respondent failed to obtain C.C.’s travel history or any history of rashes, possible tick bites, including the size of the tick, and in fact obtained a history devoid of any flu-like symptoms characteristic of Lyme disease. C.C.’s primary symptoms were related to her back pain. Respondent’s own expert, Dr. Cichon, testified that the key to a diagnosis of Lyme disease is the patient’s history.4/ With this inadequate history in mind, Respondent did not obtain an ELISA test or Western blot, but instead relied on a test that, on its face, indicates that it is for investigational use only and should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically-established diagnostic product or procedure. The more persuasive and compelling testimony established that the failure to obtain objective laboratory confirmation of Lyme disease through the use of the ELISA and Western blot tests is a departure from the standard of care recognized by a reasonably prudent similar physician. The more persuasive and compelling evidence also established that C.C. did not actually have Lyme disease, despite Respondent’s diagnosis of the disease. Respondent also departed from the appropriate standard of care by his failure to use the appropriate tests for the diagnoses of Babesiosis and Bartonellosis. His test of preference, the ECP test, is by its own terms, not intended to be used as the sole means for clinical diagnosis or patient management decisions. As stated by Dr. Robbins, it has no clinical relevance and is diagnostic of nothing. Likewise, his credible testimony indicated that use of the Fry test was not appropriate, as it is a proprietary test of the laboratory and not FDA approved.5/ Respondent’s care and treatment of C.C. also departed from the applicable standard of care by prescribing surgery for placement of a venous port for administration of intravenous medication, and by prescribing both intravenous and oral antibiotic therapy in inappropriate and excessive amounts. The more credible and persuasive testimony demonstrated that C.C. did not have Lyme disease, Babesiosis, or Bartonellosis, and therefore did not need any of the antibiotic therapy prescribed. Even had C.C. received a correct diagnosis, the more persuasive evidence demonstrated that the amounts and duration of the antibiotics prescribed were not only unwarranted, but potentially dangerous for the patient. C.C. had the possibility of negative reactions from the many antibiotics prescribed, but also the very real possibility that she has built up a resistance to the antibiotics such that they will be ineffective should she actually need them in the future. Finally, Respondent’s care and treatment of C.C. departed from the applicable standard of care by the prescription of heparin. There was no medical justification for the prescription of an anticoagulant for the treatment of Lyme disease, even if appropriately diagnosed (which did not happen here), and as with the prescription of multiple long-term antibiotics, was potentially dangerous and harmful to the patient. DOAH Case No. 15-2889PL; DOH Case No. 2011-18613 (Patients D.H., S.L., J.L., W.L., and D.D.) Patient D.H. Respondent provided care and treatment to patient D.H. from approximately November 24, 2010, to approximately October 14, 2011. D.H. was previously seen by a physician’s assistant, Thomas Gregory Roberts, who at various times worked under Respondent’s supervision, including the period from April 29, 2009, to May 26, 2010, and again from September 21, 2010, through December 18, 2010.6/ Mr. Roberts had ordered a previous CD57 test for D.H., and had prescribed doxycycline for him on a long-term basis. Mr. Roberts’ office was closing and his records were no longer available, so on November 24, 2010, D.H.’s wife, J.H., e-mailed Dr. Lentz to request laboratory tests and to schedule an appointment for D.H. She stated in part: Dear Dr. Lentz: Both my husband and I have been to you before, but not at your current office. [D.H.] went to Tom Roberts at Village Health Assoc. and was sent for blood work. His CD57 counts were off, so he put him on Doxycycline [sic] and was on it for several months. His last blood work was done in July and by the sound of it showed some improvement, but he told him to stay on the antibiotics. Tom Roberts gave him an order for follow up bloodwork which reads CD57 + NK Cells Dx2793. Since he is currently not practicing that we know of, we are requesting that you please write an order so that [D.H.] can have blood work done and come to you for the results. Based upon this e-mail, Respondent ordered a CD57 test, using the diagnostic code for and reference to Lyme infection, and an ECP test using the diagnostic code for and reference to Babesia infection. He did so without actually seeing D.H., taking a history, or performing a physical examination. Respondent diagnosed D.H. as having Lyme disease and Babesiosis. He communicated the diagnoses to D.H. on December 25, 2010, via e-mail, stating, “CD57 is positive for Lyme and ECP positive for Babesia. Call Amy at 424-6841 for an appointment. Dr. Lentz.” It does not appear from the record that he considered or ruled out any other condition for D.H.’s complaints. Respondent did not prescribe or order for D.H. an ELISA or Western blot test, PCR amplification of Bartonella or Babesial DNA, or blood smear tests at any time during D.H.’s care and treatment. Respondent did not refer D.H. to a specialist in the diagnosis and treatment of infectious diseases, such as Lyme disease, Bartonellosis, and Babesiosis at any time during Respondent’s treatment and care of D.H. D.H.’s first office visit was January 17, 2011. At that time, J.H., D.H.’s wife, who attended the majority of his doctor’s visits with him, testified that his only complaint at that point was fatigue, and ongoing diarrhea she attributed to the lengthy time he had already been on antibiotics. She acknowledged that he checked off those items on a form at the doctor’s office, but was not going to see Dr. Lentz complaining about those: he went simply because of his fatigue. He had no rash at that point, and never complained of a tick bite. Dr. Lentz’s records, however, indicate that he complained about exhaustion; face-neck, jaw, and orbital pain; diarrhea; cramping; stiff and painful joints; mood swings; irritability; explosive [sic]; and poor concentration. From what J.H. could remember, the physical examination Respondent performed on D.H. was very brief. Respondent took D.H.’s blood pressure, possibly looked in his mouth, palpated his abdomen, and did a knee reflex test. She did not remember him doing anything else, except having D.H. fill out a long form. Dr. Lentz’s medical records for this visit contain no prior medical history, no pulse, and no respiration rate. Respondent diagnosed D.H. with Lyme disease. When J.H. asked him if he was sure, Respondent said, absolutely. J.H. had done some research and knew that Respondent had only ordered a CD57 for D.H. She asked him about ordering the Western blot, but he did not order it. She could not remember Respondent’s exact response, but was led to believe that he did not think that the Western blot test was as accurate in diagnosing Lyme disease. At this first visit, Respondent also ordered the Fry test. Results from the Fry test are dated January 25, 2011, and indicate: Based on the accompanying test results for the sample for listed patient and accession number is suggested for follow up confirmation of the putative organism(s). Protozoan: The Special Stains (100x magnification) or the Advanced Stains (magnification listed) for this sample is suggestive of a protozoan. PCR testing for putative FL1953 is suggested for follow-up confirmation. EPierythrozoan/Hemorbartonella: The Special Stains (100x magnification) or the Advanced Stains (magnification listed) for this sample is suggestive of epierythrozoan/ hemobartonella. PCR or serology testing for the putative epierythrozoan/hemobartonella (Bartonella spp.) is suggested for follow up confirmation and speciation. (emphasis added). The records do not indicate that Respondent ordered any of the follow-up testing recommended by the Fry laboratory which, ironically, is the very testing for Bartonellosis that a reasonably prudent similar physician should order for this condition. His records also do not indicate that he ever added Bartonellosis as a diagnosis for D.H. During the course of his treatment, Respondent prescribed for D.H. the antibiotics Omnicef, azithromycin, and Cleocin, as well as Interface Plus Prothera (an enzyme supplement formulation), boluoke lumbrokinase (a fibrinolytic supplement), atenolol (a beta blocker used primarily in cardiovascular disease, added March 7, 2011), heparin injections (an anticoagulant, also added March 7), artemisinin (an antimalarial, added June 14), Mepron (an antiparasitic, added June 14), Tindamax (added June 14), Plaquenil (an antimalarial), and Vermox (an anthelmintic)(both added August 21). J.H. understood that, based upon Respondent’s explanations, the heparin was prescribed to help other medicines be absorbed into the cells, or something along those lines. She was concerned about D.H. being on the heparin, in part because as a result of him injecting the heparin in his abdomen, D.H. had a lot of bruising and knots all over his belly. She was also concerned because D.H. worked as a boat captain on the Mississippi River, which required him to be away from home for weeks at a time. She was concerned about the ramifications should he have an accident at work when he had no access to medical care. Her concerns were warranted. The couple also had concerns about the number of medications D.H. was taking while under Respondent’s care. He developed blurred vision, did not sleep well, and had chronic diarrhea. When D.H. came home from his last visit, which J.H. apparently did not attend, he reported that Dr. Lentz had said something about having a port placed for the administration of more antibiotics. That shocked her, so before he would go through with port placement, they sought a second opinion. Dr. Patrick Anastasio is an osteopathic physician who is a board-certified infectious disease specialist. During all times relevant to these proceedings, he was a solo practitioner in private practice at Emerald Coast Infectious Diseases in Fort Walton Beach, Florida. He has worked in the area for approximately 12 years. D.H. sought a second opinion from Dr. Anastasio regarding his Lyme disease and Babesiosis diagnoses. To that end, he saw Dr. Anastasio for the first time on September 29, 2011. Dr. Anastasio did not believe that D.H. had the symptoms initially to place him in a high risk group for Lyme disease. During his examination, he looked for signs that would be consistent with Lyme disease, such as arthritis, cognitive problems, or neurological problems, but did not discover any. Dr. Anastasio did not believe that D.H. had either Lyme disease or Babesiosis, but ordered a blood smear, and a Western blot and a Babesia PCR test to rule out the conditions. All tests came back negative.7/ Dr. Anastasio recommended to D.H. that he stop taking all of the medications prescribed by Dr. Lentz, and D.H. did so. It still took months for the diarrhea, most likely caused by the long-term antibiotic therapy, to subside. However, D.H. began to feel better once he stopped taking the antibiotics. Dr. Charles Powers, M.D., testified that Dr. Lentz’s medical records for D.H. were not adequate for the evaluation of whether D.H. had Lyme disease. He also believed that it was below the standard of care to use the CD57 for the diagnosis of Lyme disease as opposed to the ELISA and Western blot tests, and that it was below the standard of care not to order the ELISA and Western blot tests in the absence of an erythema migrans rash that Dr. Lentz could physically observe. Dr. Powers believed that there was no basis upon which to diagnose D.H. with Lyme disease, and therefore any treatment based on this faulty diagnosis would be below the standard of care. Even assuming the diagnosis was correct, Dr. Powers opined that the treatment ordered also was below the standard of care. According to Dr. Powers, a reasonably prudent family practitioner would usually prescribe doxycycline for the majority of cases, as opposed to the regimen of medications used by Dr. Lentz. Prescribing antibiotics the way they were prescribed would include adverse side effects, such as nausea and/or diarrhea with resistance to bacteria; development of C. difficile infection, which can be difficult to treat; and potential for allergic reactions, which can be fatal. Dr. Powers testified that when a combination of antibiotics is being used, with each additional antibiotic prescribed, the risk for complications increases exponentially. His testimony is credited. Dr. Powers also opined that the use of heparin in the treatment of Lyme disease, Babesiosis, or Bartonellosis was a departure from the standard of care, and was a dangerous choice for this or any other patient who did not have a need for a blood thinner. Dr. Robbins also believed that Respondent’s care and treatment of D.H. was below the standard of care. He testified that Respondent breached the standard of care by diagnosing D.H. with Babesiosis using the ECP test and the Fry testing for the purpose of diagnosing Bartonellosis. He also testified, consistent with Dr. Powers, that using heparin in the treatment of any of these three diseases was an egregious departure from the standard of care. The testimony of Drs. Robbins and Powers is credited. Dr. Cichon expressed concerns about the amount of medications prescribed by Dr. Lentz to D.H., specifically singling out the prescriptions for Plaquenil and Vermox. While his testimony fell far short of declaring that prescribing these medications represented a departure from the standard of care, his testimony was certainly not a ringing endorsement. It seemed as if he was trying to convince himself that Respondent’s care and treatment of this patient fell within the standard of care. His testimony to that effect is rejected as not credible. D.H. did not have a medical condition that justified the prescription of any of the medications and supplements that Dr. Lentz prescribed, much less for the duration taken. The prescription of any of these medications without a valid diagnosis was a departure from the standard of care attributed to a reasonably prudent similar physician. Patient S.L. Respondent provided care and treatment to patient S.L. from on or about August 17, 2010, to on or about January 7, 2011. On or about August 17, 2010, at her first office visit with Dr. Lentz, S.L. presented with and reported to Respondent a history of heavy rectal bleeding, which occurred every four to five days. At that visit, S.L. informed Respondent that in June, she had been advised to get a colonoscopy. Because of economic constraints, S.L. did not obtain the requested colonoscopy. There is no indication in the patient records for S.L.’s first office visit (or any later visit) that the reason for S.L.’s bleeding prior to his treatment of her had been determined or that it had resolved. S.L. first went to see Dr. Lentz at Hope Medical Clinic8/ because she believed that she had a urinary tract infection. She also had severe back pain, with pins and needles down both legs. Her back pain had started in 2005, following a car accident. S.L. does not recall Respondent ever performing a physical examination, although the patient records indicate that at least a minimal examination was performed. She does recall him talking to her about being from Pennsylvania, but does not recall him asking her about any travel history, whether she had been exposed to ticks, or had ever been bitten by a tick. Dr. Lentz’s medical records for this first visit make no mention of a travel history; no mention of tick exposure; and no mention of any type of rash. Much of the history related to other issues, such as S.L.’s history of bleeding, as opposed to any symptoms that could be said to be indicative of Lyme disease. The symptoms documented are “paresthesis to both legs due to lumbar path. Recent hematochezia. No melena. No upper abd. Pain. No diarrhea. Mostly awake sxs, not hs.” Yet in his assessment/plan notes, he lists diagnoses of lumbago, displacement of lumbar intervertebral disc without myelopathy, and chronic pain syndrome. He prescribed Lyrica, Elavil, Lortab, and ordered a CD57, listing the Lyme disease diagnostic code. There was no medical basis, based on the history presented, to suspect or test for Lyme disease. On September 21, 2010, S.L. presented to Dr. Lentz for a follow-up appointment. At this appointment, Respondent diagnosed S.L. as having Lyme disease. He ordered a Fry Bartonella test as well as an ECP test, and prescribed doxycycline, Omnicef, and Flagyl. On September 30, 2010, S.L. called Respondent and reported throwing up all of her antibiotics, and asked about medication for her nausea. Dr. Lentz added the diagnosis of Bartonellosis without seeing S.L. or performing any further physical examination. The results of the Fry test in the patient records state: “rare (1-4 organisms per total fields observed) coccobacilli adherent to erythrocytes – indicated by yellow arrow(s). This is suggestive of Hemobartonella(1) or Hemoplasma(2).” The notes also state, “[t]his stain is not FDA approved and is for research only.” At S.L.’s next appointment on October 5, 2010, Dr. Lentz prescribed rifampin and Cleocin, as well as Lovenox injections. Lovenox is a low molecular weight heparin that can be given subcutaneously. At the time Dr. Lentz prescribed it, there was no determination regarding the cause of her heavy rectal bleeding just a few months before. On October 19, 2010, just two weeks after starting the Lovenox injections, S.L. presented to the emergency room at Sacred Heart Hospital with complaints of blood in her urine.9/ Physicians in the emergency room attributed the blood in her urine to the Lovenox injections, and discharged her with a diagnosis of hematuria. That same day, she presented to Dr. Lentz and told him about her emergency room visit. Dr. Lentz lowered the dose for Lovenox, but did not discontinue its use. His notes for this visit indicate that she had left flank pain, slight liver tenderness, no masses, and a “light liver test elevated, <2X normal.”10/ He added a diagnosis for Babesiosis, but did not appear to explore what was causing the liver tenderness and elevated tests. Under his assessment and plan, it states: “1. Cut Lovenox BID to QAM. 2. Add Culturelle/probiotics to GI tract due to antibiotics being used, if urine lightens up and less blood on dipstick, then improvement.” Respondent did not prescribe S.L. a PCR amplification or Bartonella or Babesial DNA, or Western blot immunoassay tests at any time during Respondent’s care and treatment of S.L. Respondent did not refer patient S.L. to a specialist in the diagnosis and treatment of infectious diseases, such as Lyme disease, Bartonellosis, and Babesiosis, at any time during Respondent’s care and treatment of S.L. S.L. testified that the physicians at Sacred Heart Hospital informed her that there was no reason for her to be on the antibiotics or blood thinner prescribed by Dr. Lentz, and based upon their advice, she stopped the medication regimen he prescribed. The medical records from Sacred Heart do not mention this advice, and she saw Dr. Lentz at least twice after her emergency room visit: October 19 and November 2, 2010. After that, the only communications in Dr. Lentz’s medical records for S.L. appear to be requests for medication related to urinary tract infections as opposed to treatment for Lyme disease, Babesiosis, or Bartonellosis. In any event, she quit seeing Dr. Lentz for Lyme disease, Babesiosis, and Bartonellosis at least as of November 2, and testified credibly that she feels fine. Based on the credible testimony of Drs. Powers and Robbins, Dr. Lentz’s diagnosis and treatment of S.L. violated the applicable standard of care in that he failed to obtain an appropriate history to diagnose Lyme disease, Babesiosis or Bartonellosis in the first place. He failed to obtain a travel history, any information regarding possible tick bites, and if there was such a bite, the size of the tick and duration of the bite. He also failed to document symptoms that would suggest the possibility of Lyme disease to justify any objective laboratory testing. S.L.’s symptoms were related to back pain and a history of heavy bleeding. Her symptoms simply did not justify testing for Lyme disease. The evidence was not clear and convincing that Respondent failed to perform an adequate examination. As noted above, while S.L. does not remember one, the medical records reflect notations indicating that one was in fact performed. The problem is that the history and physical examination do not support further investigation for Lyme disease. Respondent also departed from the applicable standard of care by relying on tests that were not appropriate for the diagnosis of Lyme disease, Babesiosis, or Bartonellosis. As stated above, there was no basis to test for these conditions at all, but if testing was going to be performed, then the appropriate tests were not the CD57, ECP, and Fry tests, but rather the ELISA, Western blot, PCR, and serologies discussed above. Respondent’s prescription of multiple antibiotics of lengthy duration also violated the standard of care, for reasons discussed above at paragraphs 60 and 79. Likewise, Respondent’s prescription of Lovenox fell below the standard of care. The use of Lovenox for Lyme disease, Babesiosis, and Bartonellosis is not warranted at all, but is especially egregious here, where S.L. had excessive bleeding problems of which Respondent was aware just months before Lovenox was prescribed, with no documentation that the cause of the bleeding had been identified and addressed, and no indication that Respondent did anything to investigate the cause of the bleeding. That he continued to prescribe the Lovenox, albeit at a lower dose, after her visit to the emergency room with hematuria, just compounds the problem. Dr. Cichon testified that Respondent met the standard of care in diagnosing and treating S.L., saying that she had unexplained pain that could be due to Lyme disease. He struggled to identify any symptoms that are commonly associated with Lyme disease. His testimony seemed to indicate anytime there is unexplained pain, Lyme disease is a possibility. His testimony on this issue is not credible. The same can be said for his support of the diagnosis of Babesiosis. Dr. Cichon identified the primary symptoms of Babesiosis as headaches, sweating, and air hunger. S.L. did not have these symptoms, leaving only the ECP test as a basis for diagnosis. Relying on the ECP (which is only slightly elevated) is contrary to Dr. Cichon’s own testimony regarding the primary importance of a thorough history to support such a diagnosis. Similarly, Dr. Cichon acknowledged in his testimony that he could not tell from Respondent’s medical records whether S.L. had any symptoms to support a diagnosis for Bartonellosis, and stated that her symptoms could be due to her lumbar pathology. Given these inconsistencies, his opinion that Dr. Lentz did not depart from the applicable standard of care in the diagnosis of each of these diseases is not credible and is rejected. Medical records must justify the course of treatment for a patient. Dr. Lentz’s medical records for S.L. do not justify the diagnosis or treatment of Lyme disease, Babesiosis, or Bartonellosis. The medical records do not document symptoms that are consistent with the diagnoses of any of these diseases, and fail to provide a complete medical history. Patients J.L., W.L., and D.D. J.L. is the mother of S.L. W.L. is J.L.’s husband and S.L.’s father, and D.D. is S.L.’s son and J.L. and W.L.’s grandson. On September 22, 2010, approximately one month after S.L. began treatment with Dr. Lentz, J.L. wrote him the following e-mail: Dr. Lentz: Thank you for talking with me on the phone today. We are really concerned about S.L. and we can not [sic] express to you how much you are appreciated for all you have done for her. You are a true blessing to our family. My husband was bitten by a tick over the July 4th weekend in MO. He developed the bulleye [sic] rash and went to our family doctor. Dr. Calvin Blount. He was give [sic] 10 days of antibiotics, but no follow up or blood test were ever ordered. We would like to be tested for Lyme. We believe that S.L. might have contracted Lyme before she became pregnant with D.D. and would like him tested also. Here is our information. Please let me know if you need any additional information. Thank you again for all you have done. As noted above, there was an insufficient basis to justify the ordering of any tests related to Lyme disease for S.L. The only basis for ordering tests for D.D. is the suspicion that S.L. may have been infected prior to giving birth to D.D. If there is no basis for suspecting S.L. has Lyme disease, there is no basis for suspecting D.D. has Lyme disease. Respondent did not make an appointment for, take a history from, or perform a physical examination of J.L., W.L., or D.D. Based upon this e-mail alone, he ordered CD57 and ECP tests for all three of them, as well as C4a and C3a tests for J.L. and W.L. To justify ordering the tests, he listed “Lyme Disease (088.81)” under his assessment/plan for each patient. Although he never saw any of these patients, he coded each encounter as “high complexity.” On October 14, 2010, Dr. Lentz sent an e-mail to J.L. stating that “D.D. is positive for Lyme and negative for Babesia.” On October 24, 2010, Dr. Lentz sent an e-mail to J.L. stating, “W.L. C4A is back=20,000+ indicative of active Lyme.” On October 25, 2010, Dr. Lentz sent an e-mail to J.L. which stated, “[t]he CD57 is 50=positive, and the ECP is 11.5=positive for Babesia. My initial charge is $400 and $200 for return visits. Since I will be seeing both you and [W.L.], I will drop that to $300 initial visits. Call Amy for the schedule.” Dr. Lentz testified that he did not diagnose J.L., W.L., or D.D. with any condition, and did not really consider them to be patients. In his view, he was simply doing a favor for the family members of a patient. However, he created records that referred to each patient as being new patients needing tests for Lyme disease, and included diagnostic codes for the lab tests. With respect to each of them, he made an interpretation of the tests that he ordered. At least with respect to D.D., he admitted in his deposition that he diagnosed D.D. with Lyme disease based on the laboratory tests. Both S.L. and W.L. testified credibly that, based on the communications received from Dr. Lentz, they each believed that he had diagnosed them with Lyme disease, and that he had diagnosed J.L. with Babesia. It is found that he did, in fact, provide diagnoses to J.L., W.L., and D.D., without the benefit of a personal history, or a physical examination. Respondent did not refer J.L., W.L., or D.D. to a specialist in the diagnosis and treatment of infectious diseases such as Lyme disease, Bartonellosis, or Babesiosis. Respondent did not order for J.L., W.L., or D.D. an ELISA or Western blot test, PCR amplification of Bartonella or Babesial DNA, or blood smear tests. J.L. and W.L. decided to get a second opinion regarding the Lyme disease and Babesiosis diagnoses, and went to see Dr. Anastasio. Dr. Anastasio testified that J.L. did not have the required exposure to or symptoms for Lyme disease. Because she came to him with a Lyme disease diagnosis, he ordered a Lyme Western blot, a PCR for Babesiosis, and a PCR for Bartonellosis. J.L.’s Western blot IgM was negative, with two of the three antibody bands tested returning as absent. The Western blot IgG was negative, with all ten antibody bands returning as absent. J.L.’s PCRs for both Babesiosis and Bartonellosis were negative. Dr. Anastasio testified that he did not believe that J.L. had either Lyme disease or Babesia. His testimony was persuasive, and is credited. Dr. Anastasio testified that, given W.L.’s history of a tick bite followed by a rash, there was at least a basis to believe his symptoms could be an indication of Lyme disease. The tick bite and rash were approximately six months prior to W.L. presenting to Dr. Anastasio, and almost three months prior to Dr. Lentz ordering tests for him. Given these time frames, there was plenty of time for W.L. to develop antibodies to Lyme disease if he was in fact infected with the disease. Dr. Anastasio testified that at the time he saw W.L., W.L.’s symptoms were not consistent with late Lyme disease. Dr. Anastasio ordered several tests for W.L., including a Lyme Western blot, a PCR for Babesiosis, a blood smear for Babesiosis, and a PCR for Bartonellosis. The Western blot test was negative, with zero out of ten antibodies present. Both PCR tests and the blood smear were also negative. Dr. Anastasio concluded that W.L. did not have Lyme disease, Babesiosis, or Bartonellosis, and his testimony to that effect is credited.11/ Respondent failed to meet the applicable standard of care with respect to the care and treatment of patients W.L., J.L., and D.D. Based on the credible testimony of Drs. Powers and Robbins, Dr. Lentz departed from the standard of care in ordering tests for all three patients when he did so without seeing them, taking a history with respect to any of them, or conducting a physical examination of any of them to determine whether any of the requested tests were warranted or even justified. Respondent also departed from the applicable standard of care when he ordered tests that would not even assist in diagnosing Lyme disease, Babesiosis, or Bartonellosis had testing for those conditions been appropriate. Moreover, Dr. Powers testified credibly that the appropriate way to order tests for a suspected condition is to use the symptoms that are being investigated by the physician ordering the test, as opposed to the suspected disease being considered. For example, one ordering a mammogram would list “screening” or “diagnostic,” not “breast cancer,” because at that point, breast cancer has not been, and might never be, diagnosed. Documenting the symptom as opposed to the disease is important in terms of continuing care, so that there is no confusion by a subsequent health care provider reading the records about a premature diagnosis. Dr. Powers’ testimony is credited. Dr. Lentz also claimed that because J.L., W.L., and D.D. were not his patients, he did not need to have medical records for them that complied with section 458.331(1)(n). However, Dr. Lentz created patient records for all three in order to order the laboratory tests for them. He coded the action taken as having high complexity. The definition of medicine includes “diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition.” § 458.305(3), Fla. Stat. Respondent clearly engaged in the practice of medicine when he wrote prescriptions for tests for the purpose of diagnosing disease. By ordering these tests, creating medical charts for them (however limited they may be), interpreting the test results and communicating those results, he established a physician-patient relationship with J.L., W.L., and D.D. Accordingly, he was required to have patient records that justified the course of treatment (here, the diagnosis of Lyme disease, Babesiosis, and Bartonella). The records presented do not meet that requirement. DOAH Case No. 15-2890PL; DOH Case No. 2012-01987 (Patient C.H.) At the time of the events giving rise to this case, C.H. was a 23-year-old woman. She was married and attending her final year of chiropractic school in Kennesaw, Georgia. C.H. testified that in December 2010, she had experienced a bout with the flu, including an episode where she passed out in the shower, for which she was prescribed a Z-pack, and recovered. She then had gum surgery during the Christmas break, requiring anesthesia, after which she visited her husband’s family in Missouri over the Christmas holiday. After C.H. returned to Georgia, she returned to class for the spring semester. In early February of 2011, she had an episode in class where her heart started beating very rapidly, and upon a physician’s advice, went to the emergency room. Tests given there were normal. Follow-up tests also did not reveal the basis for her symptoms, and in March 2011, her mother contacted Dr. Lentz based upon the suggestion of a family friend who had treated with him. On or about March 20, S.H. contacted Respondent by e-mail regarding her 23-year-old daughter, C.H. S.H. had been referred to Respondent by a family friend. S.H. reported that she had found a checklist for Lyme disease symptoms online, which included some of the symptoms her daughter was experiencing, such as fatigue, rapid heartbeat, chest pain, headaches, blurry vision, and difficulty concentrating. She also related that C.H. was in her final year of chiropractic school and had recently completed her national boards, and thought that some of the symptoms might be related to stress and anxiety from her studies. In that e-mail, S.H. reported to Respondent that C.H. had tested negative for Lyme disease the previous week. Respondent received a copy of C.H.’s negative Lyme disease test report from blood collected on or about March 16, 2011. On or about March 22, 2011, Respondent documented his assessment of C.H. as Lyme disease and chronic fatigue syndrome. He ordered CD57, C3a, C4a, and ECP laboratory tests of C.H.’s blood. At the time these tests were ordered, Respondent had not seen or talked to C.H., taken her history, or performed a physical examination. Respondent did not at any time prescribe an ELISA test or Western blot test for C.H. On April 14, 2011, S.H. e-mailed Dr. Lentz to see if any test results had been received for C.H. Dr. Lentz replied, “CD57 51+ positive for Lyme. Babesia is negative at this time.” When asked how to proceed, he told her she needed to start treatment until the CD57 is over 120.12/ S.H. asked via e-mail whether C.H. should get treatment from Dr. Lentz or her family doctor, saying they would prefer to work through him, as this is his specialty. Dr. Lentz responded, “This is more than a good family physician can handle. I have 35 years of family practice and know first hand. Lyme is a multi-faceted problem and requires extra time and effort to educate and direct this complex problem.” On or about April 18, 2011, Respondent prescribed the antibiotics Omnicef (cefdinir) and azithromycin to C.H. At the time he prescribed these medications, Respondent had not seen C.H., and there is no documentation in the patient records that Respondent made any inquiry regarding potential allergies before prescribing these antibiotics. On or about April 25, 2011, C.H. presented to Respondent for the first, and only, office visit. The medical records for that date contain symptoms that C.H. credibly denies having reported to him, such as double vision, twitching, tremors and shakes, explosive (behavior), and shortness of breath. C.H. does not recall being weighed at that visit, although the record contains a weight for her. It does not however, indicate her temperature, pulse, or respiration rate. She recalls a minimum examination for which she remained clothed in shorts and a t- shirt. During the examination, Respondent asked if she had ever been bitten by a tick or had a rash, and checked some areas of her body for a tick bite/rash, which she denied ever having. Dr. Lentz did not inquire about her travel history. Despite the fact that one of her symptoms was the inability to take a deep breath and had suffered from heart palpitations, his patients do not reflect a temperature, pulse, or respiration rate. At that visit, Respondent added the antibiotic Flagyl (metronidazole) and Interfase Plus Prothera, an enzyme formulation, to C.H.’s medications. C.H. testified that at that visit, Dr. Lentz told her that he was a specialist with numerous years of experience, and that he was the only one certified to be able to treat this, and she would have to be under his constant care. C.H. also testified that he told her she would need to be medicated for the rest of her life, because Lyme disease lives forever in your body, and that she would probably never be able to get pregnant or have children. C.H. was devastated by this information. The entire visit with Dr. Lentz, including both the taking of her history and the physical examination, lasted approximately ten minutes. C.H.’s testimony is credited. On or about June 10, 2011, Respondent prescribed CD57, C3a, C4a, and ECP tests for C.H. On or about July 2, 2011, Respondent prescribed C.H. with Babesiosis. He made this diagnosis completely on the basis of test results, as C.H. had not returned to his office after her first and only visit. On or about July 9, 2011, Respondent added artemisinin (an antimalarial), Hepapro (a nutritional supplement); Mepron (atovaquone, an antiparasitic), heparin injections (an anticoagulant), magnesium oxide (antacid, laxative, dietary supplement), and omega-3 fatty acids to C.H.’s treatment. Respondent did not prescribe a blood smear examination for Babesial parasites or PCR amplification for Babesial DNA for C.H. At no time during her treatment did Dr. Lentz refer C.H. to a specialist. Indeed, he represented to her and to her mother that he was a specialist in Lyme disease and that he was better equipped to treat these conditions than a normal family practitioner would be. C.H.’s condition worsened rather than improved under the medication regimen Dr. Lentz prescribed. She suffered diarrhea and blurred vision and her other symptoms did not improve. Dr. Joel Rosenstock is a medical doctor licensed to practice medicine in the State of Georgia. He is board certified in internal medicine with a subspecialty in infectious disease, and has practiced infectious disease medicine for over 30 years. During the time related to this proceeding, Dr. Rosenstock was practicing in Atlanta, Georgia, at the AbsoluteCARE Medical Center and Pharmacy. C.H. first presented to Dr. Rosenstock on July 12, 2011, at which time she reported Dr. Lentz’s diagnoses of Lyme disease and Babesiosis. In contrast to her brief visit with Dr. Lentz, her consultation with Dr. Rosenstock lasted two to three hours. Dr. Rosenstock immediately ordered a Western blot test for C.H., which was negative. He conducted a thorough history and physical for her, and asked C.H. questions about her travel history, her dogs and where they slept, her hobbies, etc. He advised her that he did not believe that she had Lyme disease or Babesiosis, and recommended that she stop all of the antibiotics and other medications that Dr. Lentz had prescribed. He warned her that it could take several months before the drugs were out of her system, so relief from the side effects would not be immediate. Within a few weeks of stopping the medications, C.H. was feeling much better and was on her way to feeling back to her old self. Dr. Rosenstock did not believe that any of the tests that Dr. Lentz ordered for C.H. were useful in diagnosing Lyme disease or Babesiosis, and did not believe that heparin served any purpose in treating C.H. Based on the credible opinions of Drs. Powers and Robbins, and the testimony of Dr. Rosenstock as a subsequent treating provider, it is found that Dr. Lentz departed from the applicable standard of care in the care and treatment of C.H. in several respects. First, Respondent departed from the applicable standard of care by ordering blood tests and prescribing antibiotic treatment for C.H. (as well as other medications) when he had never actually seen her. At the time he ordered the blood tests, and at the time he first ordered medications for C.H., he had not obtained a history for her, much less a history that was suggestive of Lyme disease, and had not conducted a physical examination of any kind. All he had as a basis for ordering tests was the e-mail from her mother. This e-mail was an insufficient basis upon which to determine that testing for Lyme disease was warranted. When he did actually see C.H., he failed to perform an adequate physical examination and failed to take an adequate history that included travel history, possible exposure to ticks, how long any tick bite may have lasted, and the size and appearance of the tick. Respondent failed to use the generally accepted tests for the diagnosis of Lyme disease and Babesiosis, instead relying on tests that are meant for investigational purposes and indicate on their face that they are not meant for diagnostic purposes. Moreover, as noted above, at the time he ordered the tests, he had no basis upon which to believe C.H. had Lyme disease. Although even his own expert witness consistently stated that a diagnosis of Lyme disease is based in large part upon a thorough history, here, Dr. Lentz had no history. Dr. Cichon’s testimony that it was appropriate to rely on the information in S.H.’s e-mail about her daughter’s symptoms (keeping in mind that her daughter is an adult, not a child) is rejected as not credible. Respondent also departed from the applicable standard of care by prescribing Omnicef, azithromycin, artemisinin, Hepapro, Mepron, heparin injections, magnesium oxide, and omega-3 fatty acids for a condition that she did not have. Given that C.H. had no condition justifying the prescription of these drugs, the prescriptions were both inappropriate and excessive. They also were prescribed for a duration that was not justified, and exposed C.H. to complications that were unnecessary. Respondent was required to keep medical records that justified the course of treatment. His medical records for C.H. fell well short of this requirement. He failed to document a complete history, an adequate physical examination, or why he did not refer her case to a specialist. He also departed from the applicable standards when he used a diagnosis of Lyme disease as the basis for blood tests at a time when he had never seen the patient. Failure to Timely Report Diagnoses or Suspicion of Lyme Disease to the Department of Health (DOAH Case Nos. 15-2889 and 15-2890) Finally, in DOAH Case Nos. 15-2889 and 15-2890, the Department alleged that Respondent failed to report his diagnoses of Lyme disease or suspicions of Lyme disease for patients D.H., J.L., W.L., S.L., D.D., and C.H. to the Department of Health. Section 381.0031, Florida Statutes (2010-2011), requires certain licensed health care practitioners and facilities in Florida to report the diagnosis or suspicion of the existence of diseases of public health significance to the Department of Health. Lyme disease is one of the diseases identified by rule that meets the definition of a disease that is “a threat of public health and therefore of significance to public health.” § 381.0031(2), Fla. Stat.; Fla. Admin. Code R. 64D-3.029. There are forms that are identified by rule for use in reporting these cases. Fla. Admin. Code R. 64D-3.030(3). Ashley Rendon is a biological scientist for the Department of Health in Okaloosa County. Ms. Rendon is an epidemiologist whose duties include investigating reportable disease conditions and outbreaks of public health significance in Okaloosa County. According to Ms. Rendon, whose testimony is consistent with the Department’s rules on this subject, all diagnosed or suspected cases of Lyme disease must be reported to the Department. Once reported, the county health office will conduct an analysis of the reported diagnosis or suspicion, based on a “guidance to surveillance” document, to determine whether the reported case meets the definition for Lyme disease such that the case needs to be reported to the statewide system and to the CDC. Ms. Rendon testified that whether a suspected case or a diagnosis meets the case definition is not for the practitioner to decide. Ms. Rendon’s testimony is credited. According to Ms. Rendon, the Department maintains records both for those reported cases that met the case definition and those reported cases that did not. For 2010, there was one case of Lyme disease that was confirmed, probable, or suspect. None were reported for 2011. There were seven to eight additional cases that were reviewed, but not reported as probable, confirmed, or suspect. Not all reported results are confirmed by ELISA or Western blot. Ms. Rendon reviewed the records of the Department to determine whether Dr. Lentz had reported any cases of Lyme disease, whether suspected or diagnosed, to the Department. There was one instance where a patient of Dr. Lentz’s apparently called in and asked questions, but there was no record of Dr. Lentz or anyone in his office reporting Lyme disease. Dr. Lentz claimed that he had at least on one occasion attempted to report in the past, but that he could not say if he had reported any of the patients named in the Administrative Complaints. He claimed that the Department would not accept reports that are not supported by two-tier testing results, so he stopped trying to report. His claim is rejected as not credible. There is clear and convincing evidence to establish that Respondent failed to report his diagnoses of Lyme disease for patients D.H., J.L., W.L., D.D., S.L., and C.H. General Observations Of the seven patients presented in this proceeding, Dr. Lentz saw only two before ordering tests for Lyme disease and in some cases, Babesiosis or Bartonellosis. With respect to C.H., not only did he fail to see her before ordering testing, but he ordered medications for her without ever obtaining a medical history or performing a physical examination. Some of the patients specifically requested testing for Lyme disease. However, it is the physician’s responsibility to determine whether there is any realistic reason to believe that a patient has a need for such tests. Moreover, in several instances, the general, non-specific symptoms related by the patients suggest several other alternative conditions that could cause the patients’ problems. Even Respondent’s expert opined that Lyme disease, Bartonellosis and Babesiosis share a lot of general, non-specific symptoms with other illnesses, including serious diagnoses such as ALS, MS, and rheumatoid diseases. These are all, according to Dr. Cichon, differential diagnoses that a physician should sometimes consider when trying to find a diagnosis. Yet with all of these patients, Dr. Lentz went straight to Lyme disease every time. He did not consider much of anything else when even to a lay person, the records cry out for a more thoughtful and measured approach. In short, it seems that Dr. Lentz wanted to find Lyme disease regardless of the symptoms presented, and so he did. By doing so, he cost these patients not only the money used for testing and, with respect to C.C., W.L., S.L., and C.H., subjecting them to treatments they did not need and, in at least with respect to S.L., could not afford, but he subjected them to a treatment regimen that made them miserable, was of questionable benefit, and exposed them to unnecessary risks. Petitioner presented the expert testimony of Dr. Charles Powers, a general family practitioner, and Dr. William Robbins, an infectious disease specialist. It also presented the testimony of subsequent treating physicians: Dr. Janelle Robertson, Dr. Patrick Anastasio, and Dr. Joel Rosenstock. Each subsequent treating physician testified credibly that the symptoms presented simply did not justify a diagnosis of Lyme disease, and the testing they either conducted or reviewed did not indicate a basis for such a diagnosis. Their testimony was consistent with that of both expert witnesses presented by the Department, and the testimony of these subsequent treating physicians and expert witnesses have been accorded great weight. Respondent presented the testimony of Dr. Michael Cichon, a retired infectious disease specialist. Dr. Cichon’s testimony was in many respects inconsistent, and at times he seemed to be struggling to actually support the care and treatment that Respondent performed in these cases. While he championed Respondent’s use of the CD57, the ECP, and the Fry test, he also admitted that he seldom, if ever, used some of these tests, and that there were problems with standardization of the tests. Moreover, the tests themselves indicated on their face that they were for investigational, as opposed to diagnostic, use, and should not be used as the sole basis for diagnosis of patients. Because of the significant inconsistencies with his testimony and the contrasts between what he advocated and what Dr. Lentz sometimes did, his testimony is given little weight.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Respondent has violated section 458.331(1)(g), (m), and (t), as alleged in the three Administrative Complaints at issue in this proceeding; and by the findings that Respondent violated section 458.331(1)(t) with respect to all seven patients, Respondent is guilty of repeated malpractice. It is further recommended that the Board of Medicine revoke his license to practice medicine in the State of Florida, impose an administrative fine in the amount of $30,000, and impose costs pursuant to section 456.072. DONE AND ENTERED this 8th day of July, 2016, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON 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 8th day of July, 2016.
Findings Of Fact The following findings of fact, stipulated to by the parties, are hereby accepted: NHL is a Delaware corporation headquartered in La Jolla, California and is registered to do business in Florida. It provides clinical laboratory services to physicians and their patients. Examples of Florida public entities for whom NHL has rendered services, include the Florida Department of Health and Rehabilitative Services, the University of Florida and health services units in various Florida counties, such as Dade and Broward. On or about December 18, 1992, NHL was convicted of a public entity crime as described within paragraph 287.133(1)(g), Florida Statutes. This conviction occurred in the United States District Court, Southern District of California. (See Exhibits "A", "B", "C", "D", "E", "F", and "FF") The NHL conviction arose out of investigations initiated by the United States Justice Department in conjunction with the Inspector General and the U.S. Attorney's Office for the Southern District of California. On February 8, 1993, the Department, by letter, informed NHL of the Department's duty to conduct an investigation pursuant to paragraph 287.133(3)(c), Florida Statutes, into the circumstances involving NHL's conviction. (See Exhibit "G") Pursuant to subparagraph 287.133(3)(e)1., Florida Statutes, the Department shall investigate and determine whether good cause exists to place NHL on the Convicted Vendor List. Subparagraph 287.133(3)(e)3., Florida Statutes, establishes factors which, if applicable to a convicted vendor, will mitigate against placement of that vendor on the Convicted Vendor List. (See Exhibit "H") Subsubparagraph 287.133(3)(e)3.b., Florida Statutes, establishes "[t]he nature and details of the public entity crime" as a factor mitigating against placement on the Convicted Vendor List. The Plea Agreement entered into between the United States and NHL contains a Stipulated Statement of Facts between the parties. (See Exhibit "A") Subsubparagraph 287.133(3)(e)3.c., Florida Statutes, establishes "[t]he degree of culpability of the person or affiliate proposed to be placed on the Convicted Vendor List" as a factor mitigating against placement on the Convicted Vendor List. NHL began investigating the medical efficacy of a test for high- density lipoprotein cholesterol (HDL) in September, 1978. NHL continued its study and in 1987 placed the HDL on NHL test requisition forms. A copy of the HDL NHL Information Pamphlet, the HDL chronology, and the synopsis of selected HDL cholesterol scientific papers are hereto attached as Exhibits "I", "J", and "K". NHL began investigating the medical efficacy of a serum ferritin test in place of serum iron when a number of NHL clients had inquired in June of 1988 as to whether NHL could offer the test on chemistry profiles. NHL immediately began investigation and study of serum ferritin. NHL continued its study and concluded that the serum ferritin test was a more valuable test and in June 1989 placed the test on NHL test requisition forms. A copy of the Serum Ferritin NHL Information Pamphlet, the serum Ferritin Chronology, the selected Serum Ferritin Scientific Papers, the Serum Ferritin Medical Perspective, and the US News article titled "Iron and Your Heart" are hereto attached as Exhibits "L", "M", "N", "O", "P", and "Q". NHL did send in April 1987 over 30,000 medical information packets with an accompanying letter to all physician clients announcing the addition of the HDL test to the SMAC chemistry profile. The accompanying letter clearly explained that the HDL would be automatically performed in conjunction with all SMAC chemistry profiles. It disclosed that physician and patient charges would be adjusted to reflect the addition of the HDL test. (See Exhibit "R") NHL did send in June 1989 over 40,000 medical information packets with an accompanying letter to all physician clients announcing the addition of the serum ferritin test to the SMAC chemistry profile. The accompanying letter clearly explained that NHL would now automatically perform the serum ferritin test as part of the basic chemistry profile. It disclosed that physician and patient charges would be adjusted to reflect the addition of the serum ferritin test. (See Exhibit "S") Subsubparagraph 287.133(3)(e)3.d., Florida Statutes, establishes "[p]rompt or voluntary payment of any damages or penalty as a result of the conviction" as a factor mitigating against placement on the Convicted Vendor List. As a result of its conviction, NHL has been directed and has agreed to pay $100,000,000 as recoupment to the Federal Government, $65,000,000 paid with balance paid in quarterly installments of $4,000,000 each plus interest through the third quarter of 1995. A $1,000,000 fine and approximately $10,000,000 has been paid to various state Medicaid agencies. (See Exhibits "A", "D", "E" and "F") NHL has timely paid all civil and criminal damages owed to the Federal Government as they have become due. (See Exhibits "E" and "F") NHL entered into an Agreement Not to Terminate with Department of Health and Rehabilitative Services. NHL paid to the Florida Medicaid Program the sum of $1,470,917.00, representing all ferritin payments made to NHL by the Florida State Medicaid Program. NHL timely paid said amount. (See Exhibit "T") NHL was not required to post any bond in relation to any charges herein mentioned due to the good faith effort exhibited by NHL. (See Exhibit "A") Subsubparaghraph 287.133(3)(e)3.e., Florida Statutes, establishes "[c]ooperation with state or federal investigation or prosecution of any public entity crime" as a mitigating factor. NHL cooperated with the federal authorities in connection with the investigation as described in the Plea Agreement. (See Exhibit "A") NHL produced documents requested from the Federal Government during the investigation, further, made employees available for interview, provided analyses of various charges, and voluminous scientific documentation to prove the efficacy of the tests involved. NHL negotiated in good faith with the Federal Government and with the various state Medicaid programs to reach a resolution with all parties concerned. NHL fully cooperated with the Department in connection with its investigation initiated pursuant to Section 287.133, Florida Statutes. Subsubparagraph 287.133(3)(e)3.f., Florida Statutes, establishes "[d]isassociation from any other persons or affiliates convicted of the public entity crime" as a mitigating factor. Individuals convicted of wrongdoing which gave rise to the pleas in question are no longer employed by NHL. As described in paragraph 5 of the Plea Agreement: NHL agrees that Robert E. Draper (former President) and Vance Randy White (former Vice President) will not be considered for reemployment or consulting purposes by NHL. (See Exhibit "A") On December 16, 1992, both Robert E. Draper and Randy White resigned from NHL. NHL accepted the resignations. (See Exhibits "U" and "V") Subsubparagraph 287.133(3)(e)3.g., Florida Statutes, establishes "[p]rior or future self-policing by the person or affiliate to prevent public entity crimes" as a mitigating factor. NHL has created a position of Director of Corporate Compliance. The position is held by Executive Vice President and General Counsel, James G. Richmond, who reports directly to the CEO and the Board of Directors. NHL's Board of Directors has adopted a Corporate-wide Compliance Program. Included within this program are training programs for all NHL employees. (See Exhibit "W") NHL has an active Ethics Compliance and Training Program. NHL has made both past and present efforts to ensure the highest standard of business conduct by NHL and its employees, as shown within NHL Code of Business Conduct. (See Exhibit "X") NHL distributed to all Regional Directors, Controllers, Sales Managers, Sales Representatives, Client Service Managers and Client Service Coordinators, a memorandum regarding prohibited client incentives in an effort to further police any improper activities. (See Exhibit "Y") Each physician/client was sent a letter along with a new test requisition form which clearly informed the physician of his ability to order stand-alone Automated Chemistry Panels. (See Exhibits "R", "S", "Z", and "AA") Each physician was sent information which clearly explained the billing practices to Medicare and Medicaid. (See Exhibits "R", "S", "Z", and "AA") Subsubparagraph 287.133(3)(e)3.h., Florida Statutes, establishes "[r]einstatement or clemency in any jurisdiction in relation to the public entity crime at issue in the proceeding" as a mitigating factor. NHL has not received pardon or clemency in any jurisdiction as it relates to its guilty plea. However, due to NHL's cooperation in the Plea Agreement and Settlement, including all the states concerned, NHL has not been nor will be suspended or debarred from Medicare or any Federal program or any state Medicaid program. (See Exhibit "T") Subsubparagraph 287.133(3)(e)3.k., Florida Statutes, establishes "[a]ny demonstration of good citizenship" as a mitigating factor. NHL has in the past and continues to provide gratuitous laboratory testing services to indigent patients in Florida. A contract exists between NHL and HRS wherein NHL provides approximately $3,000 per month gratuitous lab work for indigent patients. (See Exhibit "BB") NHL has in the past and continues to disseminate gratuitous medical literature on the efficacy of NHL testing. (See Exhibit "CC") After Hurricane Andrew destroyed much of South Florida, NHL provided six to seven weeks of gratuitous laboratory service, supplies and a computer printer so that doctors could receive laboratory results as quickly as possible. (See Exhibit "DD") This Joint Stipulation provides a full and complete factual basis for determining whether NHL should be placed on a Convicted Vendor List. In light of the facts of the criteria set forth in subparagraph 287.133(3)(e)3.a-k., Florida Statutes, there are no disputed issues of material fact between Department and NHL which would require a formal hearing.
The Issue The issues in this case are whether Respondent committed the allegations contained in the Amended Administrative Complaint, and if so, the penalty that should be imposed.
Findings Of Fact The Parties Petitioner Department of Health has regulatory jurisdiction over licensed physicians such as Respondent. In particular, Petitioner is authorized to file and prosecute an administrative complaint, as it has done in this instance, when a panel of the Board of Medicine has found probable cause exists to suspect that the physician has committed one or more disciplinable offenses. At all times relevant to this proceeding, Respondent was a physician licensed in the State of Florida, having been issued license number ME 36889, and his medical office was located at 7200 West Commercial Boulevard, Suite 210, Fort Lauderdale, Florida. As mentioned previously, Petitioner alleges in this cause that Respondent's treatment of patient L.V. fell below the minimum standard of care in that: thyroid medication was prescribed in the absence of medical necessity; or, even assuming that some amount of thyroid medication was indicated, L.V. was prescribed excessive doses of the drug. To facilitate the reader's understanding of these issues, the factual recitation will be preceded by a brief description of the thyroid gland and anterior pituitary, as well as the hormones secreted by these glands. Relevant Glands and Hormones The thyroid gland (or simply, "the thyroid") is one of the human body's primary endocrine glands. The thyroid secretes several thyroid hormones——Triiodothyronine ("T3"), the active form of thyroid hormone; and Thyroxine ("T4"), which is inactive——that control and regulate the body's metabolism, development, growth, and temperature. The production of T3 and T4 is regulated by thyroid- stimulating hormone ("TSH"), which is produced by the anterior pituitary gland. Generally speaking, when thyroid hormone levels are low, the production of TSH increases; conversely, TSH production decreases when thyroid hormones concentrations are high. Accordingly, a high TSH level is suggestive of an underactive thyroid or hypothyroidism, while a depressed level of TSH indicates an overactive thyroid or hyperthyroidism. Treatment of L.V. On October 7, 2008, patient L.V., a 57-year-old female, presented to Respondent's medical office to address, in the patient's words, "hormonal problems." As it was her first visit to Respondent's office, L.V. was asked to complete a new patient intake form that solicited, among other information, her current symptoms and previous medical conditions. In the form, L.V. disclosed a variety of complaints: dizziness, fatigue, insomnia, forgetfulness, a rapid heartbeat,2/ and post-menopausal symptoms. After completing the paperwork referenced above, L.V. was seen by Shirley Jimenez, Respondent's physician assistant, who conducted a physical examination3/ and gathered a complete history. During her visit with Ms. Jimenez, L.V. revealed, as an additional complaint, that she occasionally experienced intolerance to cold. At the conclusion of the October 7, 2008, appointment, Ms. Jimenez recommended, with Respondent's approval, that blood work be conducted——to determine, among other things, the levels of T3, T4, and TSH——and that L.V. return for a follow-up appointment in several weeks. On or about October 21, 2008, the results of L.V.'s blood work were forwarded to Respondent for his review. With respect to L.V.'s levels of T3, T4, and TSH, the laboratory report indicated the following values and reference ranges (i.e., the levels deemed "normal" by the laboratory): Hormone Result Reference Ranges T3, Free: 264 pg/dL 230-420 pg/dL T4, Free: 1.1 ng/dL 0.8-1.8 ng/dL TSH: 2.94 mIU/L 0.40-4.50 mIU/L L.V.'s next office appointment was on October 23, 2008, during which she met Respondent for the first time. On that date, Respondent determined, based upon a review of L.V.'s complaints and symptoms (fatigue, dizziness, cold intolerance, forgetfulness, and low basal body temperature) and an examination of the laboratory results——as enumerated above, a T3 level at the low end of the reference range and a TSH value greater than 2.50 mIU/L, considered by Respondent to be high in light of L.V.'s symptoms——that the patient suffered from thyroid dysfunction. Notably, and contrary to Petitioner's allegations, Respondent did not diagnose L.V. with hypothyroidism.4/ Believing that L.V.'s symptoms could be alleviated by increasing her T3 level into the upper half of the typical range (i.e., 350 pg/dL), Respondent prescribed a low dosage of desiccated thyroid——a medication prepared from pig thyroids, which contains both T3 and T4——in the amount of .25 grain, which L.V. was instructed to take twice daily.5/ By all accounts, L.V. began taking the desiccated thyroid medication on or about October 23, 2008, and continued to do so until April 19, 2009. L.V. appeared for her third appointment on November 12, 2008, during which the patient made no indication of adverse side effects from the desiccated thyroid. At the conclusion of the office visit, Respondent refilled L.V.'s prescription at the same dosage. One month later, on December 12, 2008, a second blood sample was collected from L.V. The results, which were reported to Respondent on December 22, 2008,6/ indicated little to no change in L.V.'s levels of T3, T4, and TSH: Hormone Result Reference Ranges T3, Free: 255 pg/dL 230-420 pg/dL T4, Free: 1.0 ng/dL 0.8-1.8 ng/dL TSH: 3.00 mIU/L 0.40-4.50 mIU/L During her next office appointment, which occurred on December 29, 2008, L.V. once again reported no adverse side effects from the medication. L.V. did, however, state that she continued to suffer from vertigo, fatigue, and forgetfulness. In light of these persistent symptoms, as well as the laboratory results that revealed no meaningful change in the levels of T3, T4, and TSH (indeed, the T3 value had decreased slightly), Respondent increased the dosage of desiccated thyroid to .5 grain twice daily. L.V. appeared for her fifth office visit on January 13, 2009, at which time she reported, once again, that she continued to experience vertigo and fatigue. Respondent concluded, reasonably, that L.V. should be continued on desiccated thyroid at the current dosage due to the relatively short amount of time that had elapsed (15 days) since the medication's increase to .5 grain twice daily; in other words, Respondent believed that the additional time was needed for the higher dosage to produce results. On February 10, 2009, L.V. provided a third blood sample, the results of which were reported to Respondent 14 days later. In contrast to the previous sample, which demonstrated little or no change in L.V.'s hormone levels, the February 10 laboratory report showed that the medication was beginning to achieve the desired effect——i.e., increases in the T3 and T4 hormones, as well as a corresponding decrease in TSH: Hormone Result Previous Result Reference Ranges T3, Free: 293 pg/dL 255 pg/dL 230-420 pg/dL T4, Free: 1.1 ng/dL 1.0 ng/dL 0.8-1.8 ng/dL TSH: 1.78 mIU/L 3.00 mIU/L 0.40-4.50 mIU/L L.V.'s final office appointment, at least as an active patient of Respondent's, was on February 24, 2009. During the visit, L.V. reported some improvement with her vertigo and fatigue, and, as was the case during each of the prior appointments, L.V. neither disclosed, nor did Respondent or his staff detect, any adverse side effects from the thyroid medication. In light of L.V.'s continued symptoms; her T3 level, which was still significantly below Respondent's target of 350 pg/dL; and demonstrated ability to tolerate the medication, Respondent determined that an increase of the desiccated thyroid to .5 grain three times daily would prove helpful. L.V.'s Hospitalization Nearly two months later, on April 19, 2009, L.V. presented to the emergency room at Coral Springs Medical Center ("Coral Springs") and reported that she was experiencing "chest pains"; she also informed the medical staff that she had been suffering, for approximately three weeks, from persistent diarrhea——a condition that L.V. had experienced on multiple occasions over the years, long before she began taking the desiccated thyroid medication prescribed by Respondent. Based upon the nature of the complaints, L.V. was promptly admitted to the hospital for evaluation and treatment. L.V. remained hospitalized at Coral Springs for the next several days, during which time no evidence of a cardiac event was discovered. Indeed, the treating cardiologist summed up L.V.'s symptoms as follows: "Non-cardiac chest pain. The less said about this the better. No further investigation needed." With respect to L.V.'s diarrhea, the treating endocrinologist, Dr. Vanessa Rodriguez, attributed the symptom to iatrogenic hyperthyroidism (i.e., physician-induced overactive thyroid). Dr. Rodriguez reached this conclusion based upon L.V.'s low TSH level (.02 and .03 mIU/L on April 19 and 21, respectively), notwithstanding L.V.'s normal thyroid values7/ and the absence of symptoms frequently associated with hyperthyroidism, such as rapid heartbeat,8/ tremors, and hyperreflexia. Based upon her diagnosis——which, as discussed later in this Recommended Order, is rebutted by the credible testimony of Respondent's expert——Dr. Rodriguez instructed L.V. to discontinue the desiccated thyroid medication. Expert Testimony During the final hearing in this cause, Petitioner presented the testimony of Dr. Elton Shapiro, a board-certified endocrinologist, in support of its contention that Respondent's treatment of L.V. departed from the standard of care. During his direct examination, Dr. Shapiro opined, first, that Respondent violated the standard of care by initiating treatment with desiccated thyroid medication where the patient's TSH did not fall outside the testing laboratory's reference range. In Dr. Shapiro's view, once it is determined that a patient's TSH level is within the upper limit of the reference range established by the laboratory (typically 4.5 mIU/L),9/ it is improper for a physician to begin thyroid supplementation——irrespective of the patient's symptoms,10/ thyroid hormone levels (i.e., T3 and T4), or the proximity of the TSH value to the upper end of the range. Thus, per Dr. Shapiro's conception of the standard of care, a physician would commit misconduct by prescribing, ab initio, thyroid medication to a patient with a TSH of 4.4 mIU/L (a value barely within the upper limit), even if the levels of T3 and T4 are low and the patient exhibits symptoms consistent with thyroid dysfunction. Dr. Shapiro further opined that once thyroid medication is prescribed——which, per the witness, may only occur if the TSH is greater than 4.5 mIU/L——a physician should endeavor to decrease the patient's TSH to a range of .3-3.0 mIU/L, with an optimum level of 2.0 mIU/L. Thus, Dr. Shapiro accepts as "normal," for initial diagnostic purposes, a TSH level that does not exceed the upper reference range of 4.5 mIU/L; upon the initiation of therapy, however, a TSH level previously regarded during the diagnostic phase as acceptable (e.g., 4.0 mIU/L) is less than ideal and worthy of downward movement. In other words, what is considered "normal" or optimal depends, in Dr. Shapiro's view, on whether the patient has already been placed on thyroid medication or has yet to begin such therapy.11/ With respect to Respondent's treatment of L.V. during the period of November 2008 through February 2009 (i.e., after the patient began taking thyroid medication), Dr. Shapiro testified that Respondent deviated from the standard of care by: ordering a refill of the thyroid medication in November 2008; increasing the dosage of thyroid medication in December 2008; continuing L.V. on the medication in January 2009; and increasing the dosage a second time in February 2009. As the sole basis for his opinion that continued treatment was not warranted, Dr. Shapiro noted that L.V.'s TSH levels in December 2008 and February 2009 (3.00 mIU/L and 1.78 mIU/L, respectively) did not exceed the upper end of the laboratory reference range (4.5 mIU/L) and were therefore "normal." This testimony appears, however, to be inconsistent with the witness' own standard, as described in the previous paragraph of this Recommend Order: i.e., once thyroid supplementation has begun, the laboratory reference ranges are supplanted by a permissible range of .3-3.0 mIU/L and a target of 2.0 mIU/L.12/ Finally, Dr. Shapiro opined, based solely upon L.V.'s extremely low TSH levels upon her admission to the hospital, that Respondent's treatment resulted in the patient's development of iatrogenic hyperthyroidism. On cross-examination, Dr. Shapiro was asked, on a number of occasions, to enumerate the sources upon which he relied in his articulation of the standard of care. In response, Dr. Shapiro repeatedly testified that his opinions were derived from guidelines promulgated by the American College of Endocrinology ("ACE guidelines"),13/ which contemplate that thyroid supplementation is properly initiated only where a patient's TSH level is greater than the testing laboratory's reference range14/; once treatment is initiated, the guidelines call for a TSH range of .3-3.0 mIU/L and a target of 2.0 mIU/L.15/ Critically, however, Dr. Shapiro never testified that the ACE guidelines were intended by its drafters to establish a standard of care, nor, more importantly, did he testify that Florida physicians adhere to these guidelines with such uniformity that they mark the standard of a minimally competent practitioner. Instead, Dr. Shapiro's testimony simply reflects that he regards the ACE guidelines as absolute and binding, which, as discussed later in this Recommended Order, is insufficient to establish the standard of care by clear and convincing evidence. Even assuming that Dr. Shapiro' exclusive reliance on the ACE guidelines is a deficiency that can be brushed aside, the undersigned would nevertheless reject his opinions in favor of those articulated by Respondent's expert witness, Dr. Edwin Lee.16/ Dr. Lee, a board-certified endocrinologist, credibly opined, first, that Respondent's initiation of treatment was consistent with the standard of care in light of L.V.'s symptoms, initial TSH value (which exceeded 2.5 mIU/L), as well as L.V.'s level of T3, Free, which was measured at the low end of the reference range. (Dr. Lee explained that 95% of normal patients have a TSH level of 2.5 mIU/L or less, and that a value in excess of 2.5 mIU/L is an indication of mild underactive thyroid.) Further, Dr. Lee testified, again credibly, that Respondent's continued treatment of L.V. with increasing levels17/ of desiccated thyroid supplementation comported with the standard of care where the patient, who had demonstrated no adverse reactions to the medication, continued to present with symptoms and sub-optimal laboratory values (i.e., levels of T3 below an ideal range of 300-350 pg/dL, and TSH values outside a target range of .3-1.0 mIU/L). Finally, Dr. Lee credibly opined that that Respondent's treatment of L.V. with desiccated thyroid medication did not result in iatrogenic hyperthyroidism. In support of this opinion, Dr. Lee emphasized, among other factors, that L.V.'s T3 and T4 levels, as well as heart rate, were entirely normal upon the patient's admission to the hospital.18/ Dr. Lee further observed, correctly in the undersigned's view, that L.V.'s persistent diarrhea——a condition from which the patient had suffered on multiple occasions over the years, long before she began treatment with Respondent——was more likely caused by medications (Flagyl and Levaquin) prescribed by another physician.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Board of Medicine dismissing Counts I and II of the Amended Administrative Complaint. DONE AND ENTERED this 7th day of January, 2013, in Tallahassee, Leon County, Florida. S EDWARD T. BAUER 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 7th day of January, 2013.
The Issue The issues in these cases are whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2002), in DOAH Case No. 09-4678PL; Subsections 456.072(1)(l), 458.331(1)(m), and 458.331(1)(t), Florida Statutes (2003), in DOAH Case No. 09-4679PL; and Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2005), in DOAH Case No. 09-4680PL, and, if so, what discipline should be imposed.
Findings Of Fact At all times relating to the three Administrative Complaints at issue, Dr. Kachinas was a licensed medical doctor within the State of Florida, having been issued license number ME 65595. He is board-certified by the American Board of Obstetrics and Gynecology. DOAH CASE NO. 09-4678PL In 2002, Dr. Kachinas was working at several clinics that were owned by the same individual. He received payment from Sarasota Women’s Health Center and Tampa Women’s Health Center. His primary office was located in Sarasota, but he rotated through the offices located in Clearwater and Tampa. He was advised that he would be attending a patient in the Tampa office. One of the medications that he used in his method of sedating patients, Propofol, was not available in the Tampa office. He took a vial of the Propofol and took it to the Tampa office, holding the vial in his hand. While at the Tampa office, Dr. Kachinas drew the Propofol into a syringe. He did not have to use the Propofol for the patient. He placed the syringe filled with Propofol inside the sock that he was wearing. Dr. Kachinas transported the syringe back to the Tampa office. He used this method of transport so that the office manager in the Tampa office would not know that he was transporting the drug. When he got back to the Tampa office, he placed the filled syringe in a secure place. Propofol must be used within 24 hours after being drawn into a syringe. The next day it was decided that the drug would not be used on another patient, and Dr. Kachinas wasted the syringe filled with Propofol. At the clinics where Dr. Kachinas worked, there were no logs to keep track of the drugs, except for the drug Fentanyl. Dr. Kachinas acknowledged in a letter dated January 30, 2007, to the Department of Health that his method of transporting Propofol was “unorthodox.” In the same letter, Dr. Kachinas acknowledged that “a reasonable and prudent doctor would not generally transport medication in that manner, but foolishness seemed reasonable in that aberrant environment.” DOAH CASE NO. 09-4679PL On March 26, 2004, B.S. presented to Premier Institute for Women’s Health (Premier) for an elective termination of pregnancy. Dr. Kachinas was the physician who handled the procedure. Dr. Kachinas maintained records relating to B.S. at Premier. In 2004, Petitioner subpoenaed B.S.’s records from Dr. Kachinas’ office. Petitioner received a packet of documents, which purported to be B.S.’s medical records. In July 2006, Lori Jacobs, an employee of Premier, sent Petitioner another copy of the documents sent in 2004. Neither the records provided in 2004 nor the records provided in 2006 contain progress notes for B.S.’s treatment on March 26, 2004, and March 27, 2004. For the first time on November 5, 2009, Dr. Kachinas produced a three-page document, which he claimed was part of B.S.’s medical records that had been misplaced in B.S.’s insurance file. Two of the pages purported to be progress notes for March 26 and 27, 2004. The third page, which is also labeled as a progress note, is dated June 29, 2004, and appears to relate to insurance claims. The two pages relating to March 26 and 27 are on paper which is a different color from the progress note relating to insurance claims and the progress notes which were previously furnished in 2004 and 2006.1 Additionally, the progress notes for March 26 and 27, 2004, contain a break in each of the ruled lines on the sheets on both the right and left sides of the sheets. The insurance progress note and the progress notes furnished in 2004 and 2006 do not have such breaks in the ruled lines. Dr. Kachinas completed a Laminaria Insertion report documenting procedures done on March 26, 2004, and March 27, 2004. The March 26, 2004, report documents the insertion of Laminaria and administration of medications. The comment section of the report documents the removal of the Laminaria and administration of medications on March 27, 2004. The comment section continues to document the administration of medications and the taking of vital signs after the removal of the Laminaria and also the transfer of the patient to Doctors Hospital. The detail on the comment sections suggests that Dr. Kachinas was making his progress notes in the Laminaria Insertion report. The failure to produce the purported progress notes for March 26 and 27, 2004, until November 5, 2009; the difference in the color of the paper of the March 26 and 27, 2004, purported progress notes and the other progress notes in Dr. Kachinas’ records; the presence of breaks in the ruled lines on the March 26 and 27, 2004, purported progress reports, which do not appear on the other progress notes; and the detail of the comments on the Laminaria Insertion report support the conclusion that the progress notes submitted as Respondent’s Exhibit 1 were not done contemporaneously with the treatment given to B.S. on March 26 and 27, 2004, but were prepared for this proceeding. Thus, the progress notes for March 26 and 27, 2004, are not credited. Dr. Kachinas determined B.S.’s pregnancy to be at approximately 23½-to-24 weeks’ gestation, the last week of the second trimester. He confirmed by sonogram that the gestation period was 24 weeks. On March 26, 2004, Dr. Kachinas began the induction of labor ordering the insertion of ten Laminaria, which are osomotic cervical dilators which cause the cervix to open and allow easier emptying of the uterus. Dr. Kachinas’ records do not show that B.S.’s medical history was taken prior to the insertion of the Laminaria. However, Dr. Kachinas did take a medical history of B.S. at the time of her admission to Doctors Hospital, and the history is recorded in the medical records. Prior to the insertion of the Laminaria, Dr. Kachinas’ records do show that a limited physical examination of B.S. was done. The Laminaria Insertion report shows that B.S.’s baseline blood pressure, temperature, and pulse were taken and recorded. There was no expert testimony of what other physical examination should have been done. Dr. Kachinas injected the fetus with Digoxin, which is injected directly into the fetus to stop the fetal heartbeat, causing an Intrauterine Fetal Demise (IUFD). The injection of the Digoxin was not documented in B.S.’s medical records. B.S. was then released from Premier. On March 27, 2004, B.S. returned to Premier. Prior to removing the Laminaria, Dr. Kachinas did an ultrasound and determined that there was still fetal heart activity and fetal movements. Dr. Kachinas continued the labor induction procedure by removing the Laminaria and administering Cytotec and high dosages of Pitocin. When the Laminaria were removed, there was a rupture of membranes with a loss of essentially all the amniotic fluid. Sometime during the afternoon of March 27, 2004, Dr. Kachinas did another ultrasound and determined that there was no fetal heart activity. Based on the length of time from the Digoxin injection to the ultrasound showing no fetal heart activity, the loss of amniotic fluid, and the administering of medication to cause contractions, Dr. Kachinas determined that the Digoxin injection was not the cause of death. On March 27, 2004, at approximately 6:30 p.m., Dr. Kachinas transferred B.S. to Doctors Hospital and had her admitted to the hospital for failure to progress with the induction of labor procedure. While at the hospital, B.S. continued to experience pain. On March 28, 2004, Dr. Kachinas performed the following procedures on B.S.: mini-laparotomy, hysterotomy, removal of products of conception, and a modified Pomeroy bilateral tubal ligation. In his description of the procedures, he stated that the fetal demise was at least of 48 hours duration. However, Dr. Kachinas’ records do not reflect the time of the fetal demise. Jorge Gomez, M.D., Petitioner’s expert witness, credibly testified that a physician is required to document the time of the fetal demise. In the hospital records following B.S.’s surgery, Dr. Kachinas listed the post-operative diagnosis as a failure to induce labor, an intrauterine fetal demise, a thin umbilical cord, and asymmetric intrauterine growth retardation, a condition in which the fetus is smaller than expected for the number of weeks of pregnancy. An autopsy was performed on the fetus. A surgical pathology report was also issued. The pathology report showed mild infarcts on the maternal side. On the fetal death certificate, Dr. Kachinas listed the immediate causes for the IUFD as a possible cord incident and multiple placental infarctions. Dr. Kachinas did not document the elective termination or the Digoxin injection on the fetal death certificate. Dr. Gomez disagrees with the reasons for IUFD given on the death certificate. His credible reading of the pathology report does not indicate that the infarcts were severe enough to have contributed to the fetal demise. His credible reading of the pathology report does not indicate that there was any evidence of a cord incident. Dr. Gomez is of the opinion that the cause of death should have been listed as elective termination. Dr. Gomez’ opinion is credited. However, Dr. Gomez did not give an opinion on whether the fetal demise was caused by the injection of Digoxin. DOAH CASE NO. 09-4680PL On December 13, 2005, K.M. was seen by Walter J. Morales, M.D., at Florida Perinatal Associates, which specializes in internal fetal medicine. Dr. Morales performed an ultrasound on K.M., who was pregnant with twins as a result of in vitro fertilization. The ultrasound revealed that the twins were fraternal, meaning that each twin had a separate placenta and a separate sac. One of the twins, Twin A, had an anomaly called a cystic hygroma, which results from an obstruction, causing the lymphatic fluid, which normally drains into the juglar vein, to accumulate in the neck area. Approximately 50 percent of the fetuses which have this anomaly in the first trimester also have a chromosomal anomaly, such as Down syndrome. The decision was made to have K.M. return to Florida Perinatal Associates in three weeks for further evaluation. On January 3, 2006, Edgard Ramos-Santos, M.D., a partner of Dr. Morales, performed another ultrasound on K.M. Dr. Ramos-Santos found that Twin A, a male, had a cystic hydroma, a thickening of the nuchal fold2, and shortened femur and humerus. These findings are soft markers for abnormal chromosomes. The ultrasound also revealed a possible heart defect. At the time of the ultrasound, Twin A was cephalic bottom, meaning that Twin A was positioned lowest in the uterus. Dr. Ramos-Santos also performed an amniocentesis on Twin A on the same date as the ultrasound. The amniocentesis showed that Twin A had an abnormal chromosome pattern compatible with trisomy 21 or Down syndrome. Both ultrasounds showed that Twin B, a female, appeared to be normal. At the request of K.M., no amniocentesis was performed on Twin B on January 3, 2006. At the time of the ultrasound performed on January 3, 2006, the presentation of Twin B was cephalic right. The findings of the January 3, 2006, ultrasound were discussed with K.M. and her husband. On January 9, 2006, Dr. Ramos-Santos discussed the results of the amniocentesis with K.M.’s husband. It was decided that a selective feticide would be performed on Twin A. Selective feticide is a procedure in which a solution of potassium hydroxide is injected into the fetus’ heart to make the heart stop beating. K.M. was referred to Dr. Kachinas at Premier for the selective feticide. On January 10, 2006, Roberta Bruce, a nurse at Florida Perinatal Associates, sent to Premier by facsimile transmission the January 3, 2006, ultrasound report for K.M. and K.M.’s insurance information. The cover page for the facsimile transmission included a note from Ms. Bruce, which stated: “* FYI Fetus have different gender. The male is the affected one.” The standard of care as specified in Section 766.102, Florida Statutes (2005), requires a physician performing a selective feticide to correctly identify the affected fetus. Dr. Kachinas did not correctly identify Twin A prior to performing the selective feticide and performed the procedure on Twin B, the normal fetus. Dr. Kachinas performed an ultrasound on K.M., but failed to identify the correct position of Twin A in relation to K.M. The ultrasound done on January 3, 2006, by Dr. Ramos-Santos showed that Twin A was located at the bottom and Twin B was located to the right of K.M. In his progress notes, Dr. Kachinas placed Twin A on the right and Twin B on the left. Although it is possible for twins to shift positions, it is not probable that the twins shifted from left to right. Dr. Kachinas performed an ultrasound, but failed to identify that Twin A was the fetus with multiple anomalies. Although the standard of care required Dr. Kachinas to do a Level 2 ultrasound evaluation, a Level 1 ultrasound evaluation would have identified the cystic hygroma, the shortened long bones, and the sex of Twin A. Dr. Kachinas failed to perform an adequate ultrasound evaluation by failing to identify the anomalies and the gender of Twin A. Dr. Kachinas’ notes do not show whether Twin A or Twin B had anomalies. His notes did not identify the sex of each of the twins. His notes did not document the attempts that Dr. Kachinas made to identify the anomalies such as a recording of the length of the long bones or any examination made to identify the sex of each of the twins. On January 24, 2006, K.M. returned to Florida Perinatal Associates for another consultation. Dr. Morales performed another ultrasound, which revealed that Twin A, who had the anomalies, was still viable. The ultrasound revealed the continued presence of a cystic hygroma, the thickening of the nuchal fold, shortened extremities, and a congenital heart defect. The ultrasound also showed that the viable twin was male. The presentation of Twin A was shown by the ultrasound as cephalic bottom.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4678PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2002), by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent physician as being acceptable under similar conditions and circumstances; finding that Dr. Kachinas did not violate Subsection 458.331(1)(m), Florida Statutes (2002); imposing an administrative fine of $2,500; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4679PL that a final order be entered finding that Dr. Kachinas did not violate Subsections 456.072(1)(l) and 458.331(1)(t), Florida Statutes (2003); finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2003); imposing an administrative fine of $1,000; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4680PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2005), by committing gross medical malpractice; finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2005); imposing an administrative fine of $2,000 and placing him on probation for one year for the violation of Subsection 458.331(1)(m), Florida Statutes (2005); and revoking his license for the violation of Subsection 458.331(1)(t), Florida Statutes (2005). DONE AND ENTERED this 26th day of January, 2010, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL 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 26th day of January, 2010.
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 disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been licensed as a physician in the State of Florida, having been issued license number ME 0017602. He graduated from St. Louis University School of Medicine in 1966. He taught obstetrics and gynecology at the Portsmouth Naval Hospital in 1970-1972. He was board-certified in obstetrics and gynecology in 1972 and retired from the active practice of medicine in 1996. Licensed in Missouri, Virginia, and Florida, Respondent has never been disciplined by Petitioner or any other licensing authority. During his active practice of obstetrics and gynecology, Respondent specialized in high-risk obstetrics, i.e., the treatment of patients whose lives and pregnancies are at risk during the course of their pregnancy. He treated patients with diabetes, with heart disease, with blood disease, and with abnormal pregnancies such as ectopic pregnancies. He is well respected in the medical community, including by others who practice high-risk obstetrics. He enjoys a reputation for being a caring, concerned, intelligent, and capable physician. On November 30, 1993, R. C. was a 35-year-old patient who had been seen previously by Respondent's associate but not by Respondent. She had a long history of infertility and had been treated with fertility drugs. She had had one ruptured ectopic pregnancy that resulted in the removal of her right ovary. She had three failed attempts at in vitro fertilization. She reported to Respondent that she felt pregnant. She had taken three home pregnancy tests, which were positive. Her HMO primary care physician, following laboratory confirmation of her pregnancy, had referred her to Respondent. She advised Respondent that her last menstrual period was October 16, 1993. Respondent conducted a physical examination and agreed that she was pregnant. Her breasts were tender, and her uterus may have been a little soft but it was not enlarged. The presence of a normal-sized uterus at six weeks gestation, while not unusual, is one possible indication that a woman might have an abnormal pregnancy or be in the process of having a miscarriage. It raised the suspicion that the nature of her pregnancy, intra-uterine versus abnormal, must be considered by Respondent. However, enlargement of the uterus during pregnancy is different for each patient. Significantly, R. C. did not have any bleeding. She had no abdominal pain, and no adnexal masses were palpated. Essentially, she was asymptomatic for an abnormal pregnancy. Because of her history, Respondent considered R. C. to be at a higher risk for an abnormal or ectopic pregnancy than that expected for a normal female from the general population. It is generally understood that the risk of a repeat ectopic pregnancy is between 10 and 15 percent. Respondent was aware that even with an ectopic pregnancy, the uterus undergoes many of the changes associated with an early normal intra-uterine pregnancy, including an increase in uterine size and softening of the cervix. These changes occur as a result of the hormones circulating through the body during the early stages of pregnancy. Concerned since R. C. was at risk although asymptomatic, Respondent decided that the prudent course would be to evaluate R. C.'s pregnancy to rule out an ectopic or other abnormal pregnancy. Consequently, he took steps different from those that would be taken during a normal routine pregnancy. Respondent obtained an immediate quantitative human chorionic gonadotropin (hCG) value that day. The quantitative hCG is a diagnostic test available to physicians to evaluate the progress of a pregnancy when there is concern as to its nature. It is not a test that is ordered when there is no concern as to the nature of the pregnancy. The test measures the secretions of the placenta. It confirmed R. C.'s pregnant state and was an indicator of the presence of a placenta somewhere in her body. The hCG value was reported as 7,371. By itself, the hCG value told Respondent little about R. C.'s pregnancy. It did, however, provide some comfort that R. C. might have an intra-uterine pregnancy, particularly given her lack of symptoms for an ectopic pregnancy. It is generally understood that less than 25 percent of ectopic pregnancies have hCG values greater than 6,000. With an hCG value greater than 7,000, R. C. was in the group more likely to have an intra-uterine pregnancy. Her lack of symptoms also indicated that she had an intra-uterine pregnancy. It is generally understood that bleeding is present in over 85 percent of cases where there is an ectopic pregnancy. Pain is present in over 90 percent of the cases where there is an ectopic pregnancy, and over half of such women have palpable adnexal masses or lumps. R. C. was not experiencing any of what are known as the classic triad of symptoms for an ectopic pregnancy. Respondent obtained the hCG to be used as a baseline. The quantitative hCG is best used serially, and a single value has no real meaning in evaluating the nature of a pregnancy. By repeating the test at certain intervals, a physician can observe where the pregnancy might be going from a hormonal point of view. The initial value is a starting point from which other tests can be used to determine if the pregnancy is likely normal or abnormal. In an early normal intra-uterine pregnancy, the hCG values generally double approximately every 48 hours. Then, the rise begins to plateau, and the doubling time lengthens. To determine the course of a pregnancy, repeat tests of the hCG at set intervals can be an aid in the diagnosis of ectopic pregnancies. The possibility of an ectopic or other pathologic pregnancy exists when the hCG value fails to rise in accordance with the expectations of a normal intra-uterine pregnancy or does not rise at all. Although R. C. was asymptomatic, given her history, Respondent determined that he should obtain a repeat hCG and an ultrasound examination to confirm the presence of an intra- uterine pregnancy. He scheduled the repeat hCG and the ultrasound to be performed 7 to 10 days from that visit, or December 9, 1993. Respondent's plan of treatment was reasonable under the circumstances. If R. C. had had any of the classic symptoms consistent with an ectopic pregnancy, the standard of care would have required an immediate ultrasound. However, R. C. did not have any symptoms. It is a matter of physician judgment as to when an ultrasound examination and repeat hCG should be obtained for an asymptomatic patient. When there is no urgent need for the tests, the standard of care does not define the time frame in which the tests should be performed. Respondent wanted to wait another 7 to 10 days to allow for better visualization of the fetus on the ultrasound and to avoid a misinterpretation of the result of the repeat hCG test. By waiting, Respondent would likely obtain more useful information from the ultrasound than if the ultrasound were performed that day or during the next few days. He wanted to combine the findings of the ultrasound with the results of the repeat hCG test. Reasonably-prudent, similarly-trained physicians support Respondent's conclusions. The possibility of a misinterpretation of the hCG results is lessened by the passage of a reasonable period of time between tests. Before she left the office on November 30, 1993, R. C. was asked to contact Respondent in two days to obtain the results of her initial hCG test and to follow-up on her condition. On December 2, 1993, R. C. contacted Respondent. During their telephone conversation, R. C. expressed concern that her pregnancy might be in the fallopian tube rather than the uterus. Respondent wanted to calm her fears. He inquired as to how she was doing, and she reported that she was doing fine, no bleeding or pain. Generally, an ultrasound is not performed until at least the fifteenth or sixteenth week. After speaking with R. C. on December 2, 1993, Respondent continued with his plan to obtain an ultrasound evaluation of R. C. in her 7th or 8th week of gestation. Her history indicated that Respondent should confirm the nature of her pregnancy, and Respondent took those steps necessary to monitor and confirm R. C.'s condition. At approximately 6:00 p.m. on December 6, 1993, R. C. contacted Respondent's office and spoke with his midwife. R. C. complained that she was having some cramping that began after she had eaten a very heavy meal. This is not an unusual complaint during a pregnancy. R. C. reported that the cramping was resolving, but she just wanted to touch base with someone. The midwife advised her to go to the emergency room if the cramping worsened during that evening or if she was concerned. The midwife also advised R. C. that if she felt better by morning but not completely better, she should come in to the office. If she felt fine, she should keep her scheduled appointment for the ultrasound. The advice given to R. C. by the midwife was appropriate and consistent with the standard of care. R. C. began to experience severe lower abdominal pain on the morning of December 7, 1993, and was taken to the emergency room of Bethesda Memorial Hospital. She did not have any vaginal bleeding. Respondent was present in the hospital when R. C. arrived at the emergency room, and he came immediately upon being called. An ultrasound was performed and confirmed that the uterus was empty except for a pseudo-gestational sac. A viable ectopic pregnancy was seen in the left adnexal area with an estimated gestational age of 6 weeks. Respondent assessed R. C. as having a leaking tubal pregnancy, and he had her taken to surgery immediately following the ultrasound. Respondent removed her left tube and ovary and provided blood transfusions due to free blood found in the abdomen. R. C. experienced a fever following the surgery, but she recovered and was discharged from the hospital. Respondent's plan and action in evaluating R. C. on her November 30, 1993, visit to his office were in accordance with the standard of care, and were reasonable and appropriate. The patient's telephone report of doing well on December 2, 1993, strengthened Respondent's judgment that there was no immediate need to obtain an ultrasound and repeat hCG and that he could wait until those tests were likely to be reliable.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding Respondent not guilty and dismissing the Administrative Complaint filed against him in this cause. DONE AND ENTERED this 23rd day of February, 2000, in Tallahassee, Leon County, Florida. LINDA M. RIGOT 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 23rd day of February, 2000. COPIES FURNISHED: Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast Bin A02 Tallahassee, Florida 32399-1703 Britt Thomas, Esquire M. Rosena Hitson, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Grover C. Freeman, Esquire Jon M. Pellett, Esquire Freeman, Hunter & Malloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602
