Findings Of Fact Petitioner is the governmental agency responsible for issuing licenses to practice veterinary medicine. Petitioner is also responsible for regulating the practice of veterinary medicine. Respondent is licensed as a veterinarian pursuant to license number VM 0002578. Respondent practices veterinarian medicine in Orlando, Florida. Kari On May 5, 1993, Respondent performed an ovariohysterectomy on a feline ("Kari"). An ovariohysterectomy is the surgical removal of the uterus and both ovaries, i.e., a "spay." Respondent failed to remove the left ovary from "Kari." During the surgery, Respondent noted that the ovary was not on the gauze where Respondent had placed the right ovary and other incidental material that Respondent removed surgically. 3/ Respondent searched inside and outside the surgical area for about an hour but could not locate the ovary. Respondent noted in the medical record that an ovarian remnant may have been left in the cat. Respondent advised the owner that if the cat went into heat she should bring the cat back for exploratory surgery to attempt to find and remove the remnant. On July 12, 1993, 4/ the owner observed "Kari" in heat and returned the cat to Respondent. Respondent performed exploratory surgery in an attempt to find an ovarian remnant. Respondent spent approximately one hour searching for microscopic tissue that could be the ovarian remnant. He cleaned the ovarian ligaments in the area of the left and right ovaries, searched the peritoneal area, and searched the adjacent organs. Respondent removed some material but did not locate and remove an ovarian remnant. Respondent advised the owner that he did not find a remnant but that he thought he had removed all of the ovary. Respondent instructed the owner to advise him if the cat came back into heat. Respondent did not charge the owner for the second surgery. In August, 1993, the owner advised Respondent that the cat was in heat. The owner was unwilling to have Respondent perform surgery again. Respondent advised the owner to see a surgical specialist at Respondent's expense. On November 18, 1993, the owner took "Kari" to the Kissimmee Animal Hospital. Medical tests established the cat's estrogen level to be 43.4 pg/ml. The normal estrogen level for a spayed cat is below 25 pg/ml. The treating physician at Kissimmee Animal Hospital referred the owner to a specialist for a third surgery. The owner did not want to subject the cat to a third surgery or incur additional veterinary expenses. On February 16, 1994, "Kari" died. The owner had a necropsy performed. The left ovary was still present in the cat. The pathologist who performed the necropsy retrieved the left ovary from the cat. He initially identified the ovary by visual examination and subsequently confirmed his initial identification on histopathology. The histopathology examination revealed that the ovary and oviduct fimbria were normal. The ovary was the original ovary in its original anatomic position. The ovary was attached to the ligaments that attach the ovary to the dorsal abdominal wall and posterior part. The pathologist found no suture on the ligament that attaches the left ovary to the posterior wall of the abdomen. Respondent's treatment of "Kari," including Respondent's failure to remove the left ovary, did not cause the cat to die. The cat died from a massive infection in the abdominal cavity. The cause of infection could not be determined. Based upon the type and severity of the infection, it could not have begun more than two weeks before the cat's death on February 16, 1994. Respondent last treated "Kari" on July 12, 1993. Neither Respondent nor the treating physicians at Kissimmee Animal Hospital detected any infection in the cat. Dudley On September 7, 1994, Robert and Susan Micalizio took their dog ("Dudley") to a veterinarian who diagnosed the dog as having kidney stones. On September 8, 1994, the owners brought Dudley to Respondent for a separate opinion. Respondent confirmed the original diagnosis. Respondent performed a urinary catheterization. The catheterization failed to unblock the dog's urinary tract. On September 9, 1994, Respondent performed a cystotomy and urethrostomy on "Dudley." Respondent made three separate incisions in the dog's bladder to determine if kidney stones were present. Respondent did not take x-rays before performing surgery on the dog. Respondent's failure to take radiographs prior to surgery in order to properly diagnose the problem departed from the standard of care in the community. Respondent found no kidney stones in the dog's bladder or urethra. Respondent discharged the dog. The dog's urinary symptoms persisted after Respondent released the dog on September 9, 1994. The dog's condition worsened. On September 13, 1994, the owners took "Dudley" to an emergency clinic. X-rays disclosed the presence of kidney stones in the dog's urethra and bladder. The emergency clinic diagnosed the dog with kidney failure. On September 16, 1994, "Dudley" underwent a successful cystotomy and urethrostomy at another animal clinic. It was necessary to perform a cystotomy and urethrostomy to remove the kidney stones and successfully treat the dog. Respondent performed the appropriate procedures but failed to locate the kidney stones, extract them, and otherwise treat the dog appropriately. Respondent reimbursed the owners for the costs of his procedures. Respondent paid for the cost of the subsequent surgical procedures required to treat "Dudley." Penalty Respondent was incompetent and negligent in his care of "Kari." Respondent failed to remove all of the left ovary from "Kari" after two surgical attempts to do so. "Kari" went into heat several more times and endured a second surgery as a result of Respondent's incompetence and negligence. Respondent was incompetent and negligent in his care of "Dudley." Respondent failed to take x-rays prior to performing surgery. Although the surgery Respondent performed ultimately proved to be necessary to treat "Dudley," Respondent failed to detect kidney stones at the time Respondent performed surgery and failed to correct the condition causing "Dudley's" problems. As a result, the dog suffered longer and endured additional surgery. The incompetence and negligence committed by Respondent did not involve deceit, fraud, or misconduct. Respondent did not mislead the owners of either animal. Respondent's incompetence and negligence did not result in the death or serious injury of either animal. Respondent made a reasonable effort to locate the ovary he left in "Kari." Respondent either reimbursed or offered to reimburse the owners of each animal for expenses incurred by them as a result of Respondent's incompetence and negligence. Respondent has no history of prior disciplinary action against him. Respondent has performed over 20,000 spay procedures without incident. Veterinarians leave ovaries, or ovarian remnants, in approximately three percent of spayed animals. Respondent readily admits his lack of care in the treatment of "Dudley." 4 Subject Matter Index Petitioner maintains an index of its agency orders. Petitioner's index is not alphabetical, hierarchical, or numbered sequentially. Petitioner's index does not contain indentations below the subject headings or titles which are more specific than the subject heading or title. The index does not contain cross- referenced common and colloquial words as required by Florida Administrative Code Rule 1S-6.008. 5/ Petitioner's index complies with the requirements of Section 120.53(2)(a)3. In lieu of a hierarchical subject matter index, Petitioner maintains an electronic database that allows users, including Respondent, to research and retrieve the full text of agency orders through an ad hoc indexing system prescribed by statute. Petitioner's electronic database contains complete case files related to any final order issued by Petitioner from July 1, 1992, to the present. The files include administrative complaints, settlement agreements, and orders. Any person may access this information between 8:00 a.m. and 5:00 p.m. Monday through Friday, either in person, by mail, or by telephone. Respondent is able to determine those final orders that involve the statutory or rule violations for which Respondent is charged. Respondent's search of Petitioner's index revealed that Petitioner has never suspended or revoked a license for the same or similar charges as those against Respondent. Petitioner has not revoked the licenses of veterinarians for more serious offenses. Petitioner has imposed a reprimand, required direct supervised probation, or mandatory appearances before Petitioner in only two cases in which the veterinarian's treatment of the animal did not result in the death of the animal treated. Both of those cases involved charges more serious than those against Respondent. Petitioner has imposed the sanctions of suspension, direct supervision, and fines in excess of $500 only where a violation of the law has occurred and the veterinarian's treatment resulted in the death of the animal treated. Respondent's treatment did not result in the death of either animal treated by Respondent.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding Respondent guilty of violating Section 474.214(1)(r), imposing a fine of $499, requiring Respondent to attend 4.9 hours of continuing education courses, and placing Respondent on probation for one year without requiring mandatory appearances in front of Petitioner. The costs of compliance with the final order are the obligation of Respondent. RECOMMENDED this 6th day of August, 1996, in Tallahassee, Florida. DANIEL S. MANRY, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 6th day of August, 1996.
The Issue Whether Respondent committed the violations alleged in the Amended Administrative Complaint? If so, what disciplinary action should be taken against him?
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Parties The Department is a state government licensing and regulatory agency. Respondent is now, and has been at all times material to the instant cases, a family practice physician licensed to practice medicine in the State of Florida. He holds license number ME 0030309. Facts Relating to Patient L.A. On April 29, 1991, L.A., a forty-one year old male, presented to Respondent with complaints of left elbow swelling, chills, and a temperature of 102 degrees Fahrenheit. His wife, R.A., had recommended that he see Respondent about these complaints. This was his first visit as a patient to Respondent. L.A.'s past medical history revealed no illnesses, injuries or surgeries. During the visit, L.A. was given a physical examination, which revealed, among other things, a temperature of 100 degrees Fahrenheit. Respondent diagnosed L.A. as having a fever, polyarthritis and left olecranon bursitis. As part of the course of treatment, Respondent injected L.A.'s left elbow with 1 cc of Decadron, which is a steroid. Respondent also aspirated 10 cc's of fluid from the elbow. The fluid was cloudy and straw-colored. In addition, Respondent prescribed an antibiotic (Keflex), as well as pain medication (Percocet) for L.A. to take. Respondent did not send the aspirated fluid to the laboratory for testing to ascertain if L.A. was suffering from septic arthritis. Nor did he order that any diagnostic x-rays be taken. Respondent did send to the laboratory blood that was drawn from L.A. during the visit. The test results revealed, among other things, a high white blood cell count and an extremely high eosinophil count. Given these test results and the symptoms with which L.A. had presented, there was a substantial likelihood that L.A. had an infection that was spreading throughout his body and that had the potential to become life- threatening if not properly treated. After receiving the results of the laboratory testing, Respondent ordered an arthritis profile. He did not order any additional tests, however, to find out the cause of L.A.'s highly elevated eosinophil count. Nor did he follow-up on the arthritis profile to determine the etiology of L.A.'s polyarthritis. On May 9, 1991, L.A. made his second and final visit to Respondent. He had continued complaints of a swollen left elbow and generalized joint aches and pains. During the visit, L.A. also mentioned that he had an ulcer, but he gave no indication that it was causing him any problems. Respondent examined L.A., after which he diagnosed L.A. as having a fever (99 degrees Fahrenheit) and polyarthritis. For the pain L.A. was experiencing, Respondent prescribed Percocet (quantity of 30). In not doing the following while L.A. was his patient, Respondent failed to practice medicine with that level of care, skill and treatment that, in light of the surrounding circumstances, a reasonably prudent family practice physician would have recognized as being acceptable and appropriate at the time: having the fluid he had aspirated from L.A.'s elbow tested; ordering additional tests to determine the cause of L.A.'s highly elevated eosinophil count; and following-up on L.A.'s arthritis profile to determine the etiology of L.A.'s polyarthritis. Facts Relating to Patient R.A. R.A. first visited Respondent on March 29, 1990. She was 38 years of age at the time. R.A. presented with complaints of migraine headaches, back pain and depression. The primary purpose of her visit was to obtain treatment for her migraine headaches. She had been suffering from migraine headaches since she was 16 years of age. Although she was depressed that she still had these migraine headaches, R.A.'s depression was not severe and, based upon his conversation with her, Respondent reasonably believed that she was not a candidate to commit suicide. Consequently, he did not specifically ask her whether she had any suicidal ideation. During this initial visit, Respondent administered 100 mg. of Vistaril and 1 cc of Nubain to R.A. He also prescribed 30 tablets of Percocet. R.A. visited Respondent again on June 25, 1990, still complaining of severe migraine headaches. Her next visit to Respondent was on October 16, 1990. Her chief complaint was severe abdominal pain in an area where she had accidentally poked herself with a pointed object. Although Respondent believed that there was a possibility that R.A. had a laceration of her liver, he did not have her hospitalized for further evaluation and treatment to make certain that she was not going to bleed to death. Instead, he gave R.A. injections of Nubain (20 mg.) and Vistaril (100 mg.), prescribed Halcion (0.25 mg., quantity of 60), Fioricet (quantity of 40), and Percocet (quantity of 20) for her and sent her home. Blood that was drawn from R.A. during the visit was sent to the laboratory for testing. Blood cell profile testing revealed a low hemoglobin of 11.9 and a low hematocrit of 33.7. On R.A.'s next visit to Respondent, on December 17, 1990, she presented with complaints of abdominal pain and bloating, night sweats, black bowel movements, severe headaches, and the two-month absence of menstrual periods. Notwithstanding that R.A. reported having black bowel movements, Respondent did not perform a stool Hemoccult to check for the presence of blood in R.A.'s stool. Respondent did conduct a pregnancy examination, which revealed that R.A. was pregnant. In addition to concluding that R.A. was pregnant, Respondent diagnosed R.A. as having migraine headaches, fibrocystic breast disease, and intractable nausea. He prescribed Compazine (10 mg., quantity of 30) for her and sent her home. On May 6, 1991, R.A. presented to Respondent with complaints of migraine headaches and depression and she requested that Respondent put her on antidepressant medication. Respondent did not specifically ask R.A. if she was contemplating suicide, however, based upon his conversation with her, he had reason to believe that she had no suicidal ideation. Respondent treated R.A. with injections of Demerol (100 mg.) and Vistaril (100 mg.). He also prescribed Percocet (quantity of 30), Fiorinal and Desyrel for R.A.. Respondent did not record in R.A.'s medical records the amount of Fiorinal and Desyrel he prescribed. On September 29, 1991, R.A. presented to Respondent with complaints of severe abdominal cramps and bloating, back ache, diarrhea, vomiting, rapid heart beats, and chest pain and pressure. After being treated by Respondent with injections of Nubain (20 mg.) and Vistaril (100 mg.), R.A. remained in the office, under observation, for approximately an hour and a half, during which time her anxiety decreased. At the time she left the office, she was virtually pain-free. Respondent did not order an electrocardiogram or other cardiac work-up for R.A. given the improvement in her condition and that she was a pre- menopausal, 38-year old woman with a low risk of having a myocardial infarction. During the period of time that R.A. was his patient (March 29, 1990, to October 27, 1991), Respondent, in toto, saw her 29 times and gave her the following injections, prescriptions and samples: Injections- eight injections of Nubain; 16 injections of Vistaril; seven injections of Tigan; five injections of Demerol; one injection of Buprenex; and one injection of Toradol; Prescriptions and samples: 490 tablets of Percocet; four Tigan suppositories; 40 Tigan tablets; 30 tablets of Reglan; 20 Norflex tablets; three Lortab tablets; Desyrel; and samples of Vicodin. In not doing the following while R.A. was his patient, Respondent failed to practice medicine with that level of care, skill and treatment that, in light of the surrounding circumstances, a reasonably prudent family practice physician would have recognized as being acceptable and appropriate at the time: hospitalizing R.A. on October 16, 1990, for further evaluation and treatment to make certain that she was not going to hemorrhage to death as a result of a liver laceration; and performing a stool Hemoccult on December 17, 1990, to check for the presence of blood in R.A.'s stool. Facts Relating to Patient R.M. R.M. first visited Respondent on April 10, 1990. She was 34 years of age at the time. R.M. presented with complaints of severe migraine headaches, nausea and a history of sinus allergies. Respondent had R.M. fill out a Forest Headache Questionnaire. In response to one of the questions on the questionnaire, R.M. listed the following as "headache medications" she had taken in the past: Fiorinal plain & Fiorinal #3 Fioricet Percocet Lortab Nolamine Rutuss Beconase Nasal Spray After examining R.M., Respondent concluded that she was suffering from sinusitis, anxiety, tension headaches and migraine headaches. Respondent treated R.M. with injections of Phenergan and Toradol, but did not record in R.M.'s medical records the amounts he injected. Respondent next saw R.M. on January 3, 1991, and again on January 14, 1991. R.M.'s following visit was on March 10, 1991. On this occasion, she presented with complaints of nausea, vomiting and a swollen and painful left eye. In addition, she was suffering from photophobia. A physical examination of R.M. revealed, among other things, that she had a temperature of 99 degrees Fahrenheit. Notwithstanding R.M.'s symptoms, which suggested that she might have some type of life-threatening facial or neurological infection, Respondent did not attempt to conduct either a basic eye or neurological examination (which would have included an examination of R.M.'s fundi) to further explore this possibility and find out if referral to a specialist was warranted. Instead, Respondent diagnosed R.M. as having a migraine headache, anxiety and intractable nausea, gave her an ice pack to place over her eye, treated her with injections of Nubain (20 mg.) and Vistaril (100 mg.) and prescribed Vistaril (100 mg., quantity of 50) for her. On March 22, 1991, R.M. presented to Respondent with complaints of depression. She told Respondent, among other things, that she was having marital problems. While R.M. was depressed about her family situation, her depression was not severe and, based upon his conversation with her, Respondent reasonably believed that she was not a candidate to commit suicide. Consequently, he did not specifically ask her whether she had any suicidal ideation. Respondent's record of this March 22, 1991, visit reflects that R.M. had been taking Fioricet, Lortab and Prozac. His records of her prior visits, however, gave no indication that Respondent or another physician had prescribed these medications for her. Fioricet is used to relieve tension headaches. Lortab is a pain medication. Prozac is used to treat depression. On March 25, 1991, R.M. presented to Respondent with a migraine headache and a non-healing abscess on her left hip. Respondent drained the abscess. He also gave R.M. injections of Phenergan and Nubain (10 mg.). Respondent's record of this March 25, 1991, visit reflects that R.M. had been taking, among other medications, Xanax, a medication that is indicated for the management of generalized anxiety disorders. His records of her prior visits, however, gave no indication that Respondent or another physician had ever prescribed Xanax for her. On April 10, 1991, Respondent treated R.M. for severe headaches and nausea. Respondent's record of this April 10, 1991, visit reflects that R.M. had been taking, among other medications, Percocet. His records of her prior visits, however, gave no indication that Respondent or another physician had ever prescribed Percocet for her. On May 2, 1991, R.M. presented to Respondent with a headache, sinus troubles, and an abscess on her buttock. Respondent drained the abscess. He also gave R.M. injections of Vistaril (100 mg.) and Nubain (20 mg.). On November 27, 1991, R.M. presented to Respondent with complaints of a headache and sinus trouble. She had a swollen face and blood coming out of both sides of her nose. Respondent treated R.M. with injections of Nubain (20 mg.) and Vistaril (100 mg.) and referred her to an ear, nose and throat (hereinafter referred to as "ENT") specialist. In addition, he suggested that X-rays be taken and that a CAT scan be done of her sinuses. Respondent did not conduct a funduscopic examination during the visit. R.M.'s last visit to Respondent was on November 28, 1991. It was an unscheduled, emergency visit. During the period of time that R.M. was his patient (April 10, 1990, to November 28, 1991), Respondent, in toto, saw her 28 times. On approximately 15 of these visits, including R.M.'s initial visit on April 10, 1990, Respondent diagnosed R.M. as having either sinusitis, acute sinusitis, or sinus headaches. In treating R.M., Respondent gave her, collectively, the following injections and prescriptions: Injections- 16 injections of Nubain; 25 injections of Vistaril; seven injections of Demerol; two injections of Phenergan; and three injections of Toradol; Prescriptions: 90 tablets of Percocet; 50 Halcion tablets; 140 units of Fiorinal; two prescriptions of Prozac; one prescription of Toradol tablets; two prescriptions of Beconase; and one prescription of Ru-Tuss. In not doing the following while R.A. was his patient, Respondent failed to practice medicine with that level of care, skill and treatment that, in light of the surrounding circumstances, a reasonably prudent family practice physician would have recognized as being acceptable and appropriate at the time: attempting, during R.M.'s March 10, 1991, visit, to conduct either a basic eye or neurological examination (which would have included an examination of R.M.'s fundi); and referring R.M. to an ENT specialist sooner than November 27, 1991. Facts Relating to Counts 10 and 11 On December 16, 1988, the Board of Medicine issued a Final Order in DPR Case Nos. 00-37320 and 00-53427 disposing of disciplinary charges that had been filed against Respondent by, among other things, placing Respondent on probation for a period of five years, with the condition that he "not in the future violate Chapters 455, 458 and 893, Florida Statutes, or the rules promulgated pursuant thereto." On or about May 15, 1991, Respondent's license to practice medicine in the State of Florida was suspended. On that same date, Respondent was presented with, and he signed, a Voluntary Surrender of Controlled Substances Privilege form. By signing the form, he effectively surrendered his federal Drug Enforcement Administration (hereinafter referred to as "DEA") Certificate of Registration and acknowledged that he understood that he would "not be permitted to order, manufacture, distribute, possess, dispense, administer, prescribe, or engage in any other controlled substance activities whatever, until such time as [he was] again properly registered." In conjunction with the surrender of his federal registration, he also surrendered to an agent of the State of Florida Department of Health and Rehabilitative Services (hereinafter referred to as "HRS") the controlled substances in his possession. In or about August of 1991, Respondent's license to practice medicine in the State of Florida was reinstated. Shortly thereafter HRS returned to Respondent the controlled substances he had surrendered. During August and September of 1991, Respondent possessed, stored and dispensed controlled substances without having a DEA registration. Although his attorney at the time told him that, inasmuch as his medical license had been reinstated, there was no legal impediment to his engaging in such controlled substance activities, Janice Barnes, a DEA investigator, advised him to the contrary on several occasions.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board enter a final order finding Respondent guilty of the alleged violations of subsection (1) of Section 458.331, Florida Statutes, noted above, dissmissing the remaining allegations against him and disciplining him for the violations he committed by suspending his license to practice medicine in the State of Florida for a period of five years, placing him on probation for the following five years, and imposing an administrative fine in the amount of $10,000.00. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 15th day of June, 1994. STUART M. LERNER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of June, 1994. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 93-3689 The following are the Hearing Officer's specific rulings on the "facts" proposed by the Department in its proposed recommended order: 1-3. Rejected because of inadequate evidentiary/record support. 4-6. Accepted and incorporated in substance, although not necessarily repeated verbatim, in this Recommended Order. First and third sentences: Accepted and incorporated in substance; Second sentence: To the extent that this proposed finding states that L.A. mentioned, during his May 9, 1991, visit, that he had an ulcer, it has been accepted and incorporated in substance. To the extent that it states that L.A. "complained" about the ulcer, it has been rejected because of inadequate evidentiary/record support. Accepted and incorporated in substance. First sentence: Accepted and incorporated in substance; Second sentence: Rejected because it is more in the nature of a summary of testimony than a finding of fact. Accepted and incorporated in substance. First and second sentences: Accepted and incorporated in substance. Rejected because it is outside the scope of the specific charges set forth in the Amended Administrative Complaint. To the extent that this proposed finding states that Respondent should have "conduct[ed] a physical examination of L.A. on February 25, 1991 and on April 26, 1991," it has been rejected because of inadequate evidentiary/record support. Otherwise, it has been accepted and incorporated in substance. 14-15. Rejected because of inadequate evidentiary/record support. Accepted and incorporated in substance. Rejected because of inadequate evidentiary/record support. First sentence: Rejected because of inadequate evidentiary/record support; Second and third sentences: Accepted and incorporated in substance. 19-20. Accepted and incorporated in substance. 21. Rejected because it is outside the scope of the specific charges set forth in the Amended Administrative Complaint. 22-24. Accepted and incorporated in substance. To the extent that this proposed finding states that the amount of Percocet Respondent prescribed for R.A. was not in any way reflected in Respondent's medical records on R.A. and further states that Respondent had reason to believe that R.A. had "possible suicidal ideation," it has been rejected because of inadequate evidentiary/record support. Otherwise, it has been accepted and incorporated in substance. Accepted and incorporated in substance. Rejected because of inadequate evidentiary/record support. First sentence: Accepted and incorporated in substance; Second sentence: Rejected because of inadequate evidentiary/record support. To the extent that this proposed finding states that Respondent should have "inquire[d] into possible suicidal ideation on March 29, 1990 and through May 6, 1991" and "order[ed] an EKG or further cardiac work-up on September 29, 1991," it has been rejected because of inadequate evidentiary/record support. Otherwise, it has been accepted and incorporated in substance. Rejected because of inadequate evidentiary/record support. To the extent that this proposed finding states that "Respondent failed to record the amount of Percocet . . . prescribed to R.A. on May 6, 1991," it has been rejected because of inadequate evidentiary/record support. Otherwise, it has been accepted and incorporated in substance. First, second and third sentences: Accepted and incorporated in substance; Remaining sentences: To the extent that these proposed findings are intended to refer to R.M.'s visit of April 10, 1991, they are accepted and incorporated in substance. To the extent that they are intended to refer to R.M.'s visit of April 10, 1990, they have been rejected because of inadequate evidentiary/record support. 33-35. Accepted and incorporated in substance. Rejected because it is more in the nature of a summary of testimony than a finding of fact. Accepted and incorporated in substance. First and third sentences: Accepted and incorporated in substance; Second sentence: Rejected because of inadequate evidentiary/record support. To the extent that this proposed finding states that R.M. visited Respondent 27, not 28, times, that on 16, not 15, of these visits Respondent diagnosed R.M. with either sinusitis, acute sinusitis, or sinus headaches, and that Respondent did not refer R.M. to an ENT specialist until November 28, rather than 27, 1991, it has been rejected because of inadequate evidentiary/record support. Otherwise, it has been accepted and incorporated in substance. Accepted and incorporated in substance. 41-43. Rejected because inadequate evidentiary/record support. To the extent that this proposed finding states that Respondent should have "inquire[d] into possible suicidal ideation of R.M. or refer her for psychiatric consultation or counseling," it has been rejected because of inadequate evidentiary/record support. Otherwise, it has been accepted and incorporated in substance. Rejected because of inadequate evidentiary/record support. To the extent that this proposed finding states that Respondent should have "explain[ed] or justif[ied] R.M.'s being on the following drugs on the corresponding dates; Lortab and Prozac on March 22, 1991; Xanax, on March 25, 1991; [and] Percocet, on April 10, 1991," it has been rejected because of inadequate evidentiary/record support. Otherwise, it has been accepted and incorporated in substance. 47-48. Accepted and incorporated in substance. 49. Rejected as a finding of fact because it is more in the nature of legal argument. 50-52. Accepted and incorporated in substance. 53-54. Rejected as findings of fact because they are more in the nature of legal argument. COPIES FURNISHED: Steven A. Rothenburg, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Sheldon R. Zilbert, Esquire 200 South Biscayne Boulevard Suite 3120 Miami, Florida 33131 Dr. Marm Harris, Executive Director Board of Medicine Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, Esquire General Counsel Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issues in this case for determination are whether Respondent Samuel Cox, M.D., committed the violations of Chapter 458, Florida Statutes, as alleged in an Administrative Complaint filed by the Department of Health on November 18, 2006; and, if so, what disciplinary action should be taken against his license to practice medicine in Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Samuel Cox, M.D., is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 77851 on April 22, 1999. Dr. Cox's mailing address of record at all times relevant to this matter is 2438 East Commercial Boulevard, Fort Lauderdale, Florida 33308. Dr. Cox is a board-certified general surgeon who has specialized his practice to bariatric surgery. He has performed bariatric surgery since 1985, performing approximately 3,000 such surgeries since that time. Dr. Cox has performed approximately 214 Roux-en Y procedures in Florida. No evidence that Dr. Cox has previously been the subject of a license disciplinary proceeding was offered. Bariatric Surgery. Bariatric surgery, also known as gastro-bypass surgery, is a type of surgery performed on morbidly obese patients to assist them in losing weight. In order to be found to be morbidly obese and, therefore, to be considered a candidate for the procedure, a patient must be found to have a Body Mass Index greater than 40. Body Mass Index is a measure of body fat based on height and weight (weight in kilograms divided by the square of height in meters). For example, a six-foot-tall individual weighing 296 pounds would have a Body Mass Index of 40.1. See http://www.nhlbisupport.com/bmi/. A patient with a Body Mass Index of 35 may also be considered a candidate for the surgery if they present with certain comorbidities associated with obesity. Comorbidities are physical problems associated with obesity and include diabetes, lung problems, heart problems, and high blood pressure. The more comorbidities a patient has, the higher the risk is to that patient from bariatric surgery. While there is more than one type of bariatric surgery, at issue in this case is a procedure known as Roux-en-Y gastric- bypass surgery (hereinafter referred to as "RNY Surgery"). RNY Surgery is a surgical method of creating a reduced-sized stomach. This reduced-sized stomach is created by removing a small portion of the stomach, where the esophagus (which brings food from the mouth to the stomach) attaches to the stomach, from the larger remaining portion of the stomach. The small portion of the stomach attached to the esophagus is then formed into a pouch, creating a much smaller stomach. The remaining larger portion of the stomach is completely by-passed. Often a device called a silastic ring is used at the bottom of the newly created stomach to help the pouch maintain the desired size and prevent it from stretching into a larger pouch. A portion of the small intestine is attached to the bottom of the newly created stomach. Approximately 150 centimeters down the small intestine, the excluded or removed portion of the stomach, the liver, and the pancreas are connected back to the intestine. This allows digestion of food to continue, but reduces the amount of digestion that previously occurred in the 150 centimeters of the intestine which are bypassed. RNY Surgery allows a patient to lose weight in two ways: first, by limiting the amount of food the patient can eat; and secondly, by reducing the absorption of nutrients by bypassing part of the intestine. The most common and serious complication of RNY Surgery is a leak at the gastrojejunal anastomosis, or the point where the newly created stomach pouch (the gastro) is connected to the intestine (the jejunal)(a gastrojejunal anastomosis leak will hereinafter be referred to simply as a "Leak"). This complication may be evidenced by several symptoms exhibited by a patient. Surgeons performing bariatric surgery must look for these symptoms. The typical symptoms of a Leak include left shoulder pain (caused by pooling of the leakage under the diaphragm which causes irritation which manifests as left shoulder pain), decreased urine output, fever, shortness of breath, and high heart rate. Some manifestations of a Leak, such as atrial fibrillation, are indirect signs of a Leak in that they are associated with the stress on the body caused by the Leak. Dr. Cox's Treatment of Patient W.T. Patient W.T. presented to Dr. Cox for bariatric surgery. W.T., a male, was 47 years of age at the time and was morbidly obese. W.T. weighed 458 pounds and had a Body Mass Index of Because his Body Mass Index exceeded 50, he was considered "super" morbidly obese. He also had the following comorbidities: high blood pressure, sleep apnea, congestive heart failure, thrombophlebitis, pulmonary eboli, diabetes, and gatroesophageal reflux disease. There is no dispute that W.T. was an appropriate candidate for bariatric surgery. W.T. underwent RNY Surgery on August 31, 2005. During the surgery, Dr. Cox experienced difficulty seeing, due to the size of W.T.'s liver, the staples which he used to connect the intestine to the bottom of the newly formed stomach. Instead of confirming the placement of the staples, he was required to assess the staples with his fingers. This should have made him more sensitive to the possibility of a Leak. Before ending the surgery, Dr. Cox performed a test called a methylene blue test. To perform this test, an anesthesiologist puts medicine down a tube which passes through the patient's nose and into the new stomach. The physician then looks for any sign of a leak where the physician has sewn or stapled the small intestine to the stomach. With W.T., the methylene blue test did not disclose any leaks. The day after W.T.'s bariatric surgery, September 1, 2005, W.T. began to complain of pain in his left shoulder which is an important symptom of a Leak. W.T. also experienced decreased urine output during the night (he had, however, "responded well to fluid increases and diuretics"), and a low- grade fever, which are also indicators of a Leak. Although pain is a normal response to any operation, pain in the shoulder for the type of non-laparoscropic bariatric surgery performed by Dr. Cox should have made Dr. Cox more concerned than he apparently was as to the cause. The normal pain response to the type of operation Dr. Cox performed would be expected where the incision was made, but not in the shoulder. Dr. Cox treated W.T.'s shoulder pain with narcotic analgesia by a patient-controlled analgesia pump. He treated the decreased urine output with increased fluids and a diuretic (Mannitol). The fever was treated with Tylenol. Although the left shoulder pain, decrease in urine output, and low-grade fever could have been indicative of a Leak, Dr. Cox made no note in the patient records that he had considered the possibility that W.T. had a Leak, prematurely ruling out the possibility of a Leak. Dr. Cox suggested that the left shoulder pain was related to a diaphragmatic irritation caused by the use of surgical instruments on the diaphragm and that the urine output decline could have been attributable to the impact on W.T.'s kidneys by his diabetes. While these might have been appropriate considerations at the time, Dr. Cox could have not known for sure what was causing W.T.'s symptoms and, therefore, should have considered all the possible causes of these symptoms, especially the possibility of a Leak. On the second post-operative day, September 2, 2005, W.T. exhibited an abnormal heart rhythm, called atrial fibrillation. With a normal heart rhythm, the atrial (the first two of the four heart chambers) contracts, followed by contraction of the ventricles (the other two heart chambers). Atrial fibrillation is an abnormal heart rhythm characterized by a failure of the atria to completely contract. The fact that W.T., who had no prior history of atrial fibrillation, was evidencing atrial fibrillation on post-operative day two should have raised a concern about what was happening to W.T., including, but not limited to, the possibility of a Leak. W.T. was also experiencing an abnormally high heart rate of 148, which could have also been indicative of a Leak. Dr. Cox continued to treat W.T.'s shoulder pain with narcotic analgesia and the decreased urine output with increased fluids and Mannitol. He treated the elevated heart rate with Cardizem, a medicine used to slow the heart. W.T.'s shoulder pain appeared to decrease, which was to be expected given the course of treatment ordered by Dr. Cox. Dr. Cox had not, however, appropriately determined the cause of the pain. Again, nothing in Dr. Cox's medical records indicates that he considered the possibility that W.T.'s various symptoms might be indicative of a Leak. Nor did he take any action, such as an upper gastrointestinal test, to rule out the possibility of a Leak. To perform a gastrointestinal test, a patient drinks a water-soluble contrast called Gastrografin and a radiologists takes serial pictures of the patient, which show the contrast as it moves down the esophagus and then crosses through the anastomosis of the pouch and intestine. From these pictures, it can be determined whether the anastomosis is open and functioning properly and whether any of the contrast leaks outside of the new stomach-intestine path. The test is not fool-proof, but it is an appropriate diagnostic tool for Leaks. Dr. Cox suggests that the atrial fibrillation and high heart rate could have simply been a recognized complication of any stress W.T., with his borderline cardiac status, was experiencing. Again, while these might have been appropriate considerations at the time, Dr. Cox could have not known for sure what was causing W.T.'s symptoms and, therefore, should have considered all the possible causes of these symptoms, especially the possibility of a Leak. On the third post-operative day, September 3, 2005, air and serosanguinous fluid were observed seeping from W.T.'s abdominal incision. The existence of air may be evidence of a Leak. Although some air gets into the abdominal cavity during surgery, it is usually absorbed by the body very, very quickly. Air coming from an incision on post-operative day three suggests a hole in the intestine. Dr. Cox responded to the finding of air coming from the abdominal incision by ordering a methylene blue swallow, where W.T. swallowed a small amount of blue dye. Blue dye was then seen either coming out of the incision or drains placed in W.T.'s abdomen. Either way, the test was "positive" indicating a leak in W.T.'s intestine. Dr. Cox correctly took W.T. back into surgery. He discovered and corrected a Leak which had been caused by failure of the staples used in W.T.'s surgery. Although much was made as to when the staples failed, that evidence was not conclusive nor is it necessary to resolve the dispute. Whether the staples failed immediately after surgery or at some later time does not excuse Dr. Cox's failure to appropriately react to signs exhibited by W.T. which could have indicated that W.T. had a Leak. This case does not turn on whether a Leak actually existed. It turns on whether Dr. Cox appropriately considered the possibility of a Leak and took the steps medically necessary. With W.T., he did not. Dr. Cox's error was not in failing to find the Leak earlier; it was in failing to properly consider the possibility of a Leak when W.T. exhibited signs that should have prevented Dr. Cox from, with reasonable medical certainty, ruling out the possibility that a Leak was present. For this reason, the fact that a Leak was ultimately found is of little importance in deciding whether the charges leveled against him in the Administrative Complaint are accurate. Even if no Leak had ultimately been found, Dr. Cox's failure to properly respond to the potential of a Leak evidenced by W.T.'s symptoms was inconsistent with the standard of care. Dr. Cox's Treatment of Patient J.L. Patient J.L. presented to Dr. Cox for bariatric surgery. J.L., a male, was 35 years of age at the time and was morbidly obese. J.L. weighed 417 pounds and had a Body Mass Index of Because his Body Mass Index exceeded 50, he was considered "super" morbidly obese. He also had the following comorbidities: high cholesterol, stress incontinence, depression, anxiety, high blood pressure, gastroesophageal reflux disease, and shortness of breath on exertion associated with asthma. There is no dispute that J.L. was an appropriate candidate for bariatric surgery. J.L. underwent RNY Surgery on August 4, 2005. Dr. Cox also removed J.L.'s gallbladder. Before ending the surgery, Dr. Cox performed a methylene blue test. The methylene blue test performed on J.L. did not disclose any leaks. On the first post-operative day, August 4, 2005, J.L.'s heart rate was as high as 155 (anything over 120 is problematic), was experiencing decreased oxygen saturation of 89 percent (95 percent to 98 percent are considered normal saturation levels), had increased BUN and creatinine levels, and his urine output was borderline low. The increased BUN and creatinine, indicative of a problem with the kidneys, were are not being perfused well. J.L. was also complaining of right shoulder pain. Dr. Cox's note concerning the right shoulder pain specifically notes that it was not the "left" shoulder, which suggests that Dr. Cox was aware of the significance of left shoulder pain. J.L.'s high heart rate and low oxygen saturation level were considered significant enough to return him to the intensive care unit. On the second post-operative day, August 5, 2005, J.L.'s BUN and creatinine levels rose higher. That evening J.L. had a high heart rate. His urine output level, which Dr. Cox had treated with a diuretic and increased fluids, had improved. J.L. also became agitated and restless. He began to constantly request water. Dr. Cox eventually ordered, however, that J.L. not be given water. Dr. Cox failed to note in his records that he considered the possibility that J.L. had a Leak. Instead, Dr. Cox focused on the possibility that J.L. was suffering from rhabdomyolysis, a malfunction of the kidneys caused by the breakdown, as a result of surgery, of muscle tissue into cells too large in size for the kidneys to process. Dr. Cox ordered a CK test which found elevated creatine phosphor kinase or CPK, a marker of muscle death. Dr. Cox then consulted with a nephrologists. While the symptoms evidenced by J.L. could have very well been a result of rhadbodmyolysis, they also could have been symptomatic of a Leak. Dr. Cox did not have adequate information on August 5, 2005, to conclusively find that J.L. was suffering from rhadbodmyolysis and, more importantly, not from a Leak. As of the second post-operative day, J.L. was exhibiting a high heart rate, low urine output, pain in his right shoulder, a worsening oxygen saturation level and hunger for air, and a changed mental status (anxiety and combativeness). Due to these symptoms, Dr. Cox should have considered the possibility of a Leak, rather than merely concluding that J.L. was suffering from rhabdomyolysis and treating J.L.'s individual symptoms. On the third post-operative day, August 6, 2005, J.L.'s condition worsened. His agitation and combativeness due to his thirst and air hunger worsened. J.L. was treated with Haldol, a psychiatric medication. Dr. Cox continued to suspect rhadbdomyolysis and to ignore the possibility of a Leak. On the fourth post-operative day, August 7, 2005, at approximately 15:30, pink-tinged fluid was seen draining from J.L.'s incision. A pulmonologist consulting on J.L.'s case was the first to suggest the possibility of a Leak, questioning whether the entire clinical picture pointed to intra-abdominal sepsis due to a Leak. It was not until the drainage from J.L.'s incision that Dr. Cox first considered the possibility of a Leak. Even then, Dr. Cox did not return J.L. to surgery until August 7, 2005, where a Leak was found and repaired. Dr. Cox's error in his treatment of J.L., like his error in his treatment of W.T., was not in failing to find the Leak earlier, but in failing to properly consider the possibility of a Leak when J.L. exhibited signs which should have prevented Dr. Cox from, with reasonable medical certainty, ruling out the possibility that a Leak was present. For this reason, the fact that a Leak was ultimately found is of little importance in deciding whether the charges leveled against him in the Administrative Complaint are accurate. Even if no Leak had ultimately been found, Dr. Cox's failure to properly respond to the potential of a Leak, evidenced by J.L.'s symptoms, was inconsistent with the standard of care. Dr. Cox's explanation at hearing as to why he waited from August 5, 2005, when it was apparent that J.L. had a Leak, until August 7, 2005, to repair the Leak, is not contained in Dr. Cox's medical records. The Standard of Care. The Department's expert, Christian Birkedal, M.D., credibly opined that Dr. Cox failed to practice medicine in accordance with the level of care, skill, and treatment recognized in general law related to health care licensure in violation of Section 458.331(1)(t), Florida Statutes (hereinafter referred to as the "Standard of Care"), in his treatment of W.T. and J.L. In particular, it was Dr. Birkedal's opinion that Dr. Cox violated the Standard of Care as to W.T. by failing to recognize W.T.'s signs and symptoms of a Leak and by failing to perform a post-operative upper gastrointestinal test on W.T. once he evidenced those signs. Dr. Birkedal's opinion is credited and accepted. As to J.L., Dr. Birkedal's opinion that Dr. Cox violated the Standard of Care by failing to recognize the signs and symptoms of a Leak for two days post-operatively is credited and accepted. The opinions to the contrary offered by Dr. Cox and his witnesses as to W.T. and J.L. are rejected as not convincing and as not addressing the issue precisely enough. The opinions offered by Dr. Cox and his witnesses with regard to both patients were essentially that the various symptoms pointed to by Dr. Birkedal were not "evidence" of a Leak. Those opinions do not specifically address the issue in this case. Dr. Cox and his witnesses based their opinions on whether Dr. Cox should have "known" there was a Leak at the times in issue. That is not the charge of the Administrative Complaint or the basis for Dr. Birkedal's opinion. The question was, not whether Dr. Cox should have known there was a Leak, but whether he should have considered a Leak as a possible cause for the symptoms exhibited by W.T. and J.L. Additionally, and finally, Dr. Birkedal based his opinions, not by looking at the record as a whole, as did Dr. Cox and his experts, but by looking at only those records in existence at the times relevant to this matter. In this way, Dr. Birkedal limited himself to a consideration of what Dr. Cox knew about his patients at the times relevant in the Administrative Complaint.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that Samuel Cox, M.D., has violated Section 458.331(1)(m) and (t), Florida Statutes, as alleged in Counts I, II, and III of the Administrative Complaint; issuing a reprimand; placing his license on probation for two years, with terms to be established by the Board; and imposing a fine of $15,000. DONE AND ENTERED this 19th day of June, 2007, in Tallahassee, Leon County, Florida. S LARRY J. SARTIN 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 19th day of June, 2007. COPIES FURNISHED: Patricia Nelson, Esquire Assistant General Counsel Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3250 Jonathon P. Lynn, Esquire Marci Strauss, Esquire Stephens, Lynn, Klein 301 East Las Olas Boulevard, Suite 800 Fort Lauderdale, Florida 33301 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701
The Issue Whether Respondent is guilty of the isolated Class III deficiency alleged in Count II of the Administrative Complaint and the penalties, if any, that should be imposed.
Findings Of Fact Respondent is a licensed, skilled nursing home facility located in North Miami, Florida. Respondent was at all times pertinent hereto licensed by Petitioner pursuant to the provisions of Chapter 400 Part II, Florida Statutes. Petitioner is the agency of the State of Florida with the responsibility to regulate skilled nursing homes in Florida. Petitioner surveys nursing home facilities to evaluate their compliance with applicable rules. Petitioner classifies any deficiency noted by a survey according to the nature and scope of the deficiency. The severity of the deficiency determines the amount of any administrative fine and whether the licensure status of the facility should be "standard" or "conditional." A licensee’s failure to comply with an applicable statute or rule is a deficiency. A survey results in a report that lists each deficiency that is found, identifies the applicable regulatory standard that the surveyor believes has been violated, provides a factual basis for the alleged violation, and indicates the scope and severity of the deficiency. A facility is given a deadline to correct each alleged deficiency found during the initial survey. Disciplinary action is typically initiated if a facility has not corrected a deficiency as determined by a follow-up survey. Petitioner conducted a survey of Respondent during the period February 28 - March 3, 2005 (the initial survey). Barbara Catinella, who is a registered nurse and an experienced surveyor, participated in the initial survey on behalf of Petitioner. On March 1, 2005, Ms. Catinella observed perineal care being administered to two female residents (identified as Resident 26 and Resident 27). Each resident was being attended to following an episode of urinary incontinence. The first observation began at approximately 2:00 p.m. and the second began approximately thirty minutes later. Two certified nurses assistants (CNAs) administered the perineal care to Resident 26 and two different CNAs administered the perineal care to Resident 27. In both instances, the CNAs failed to properly perform the perineal care. In each instant, the CNAs performing the perineal care failed to open and clean the labia. At all times pertinent to this proceeding, Respondent had a policy as to perineal care for female residents that conformed to accepted perineal care standards. Paragraph 15 of the policy required Respondent's staff to do the following in sequence for a female resident who had suffered an episode of incontinence, whether the episode was of bowel, bladder, or both: For a female resident: Wet washcloth and apply soap or skin cleansing agent. Wash perineal area, wiping from front to back. Separate labia and was area downward from front to back. Continue to wash the perineum moving outward to and including thighs, alternating from side to side, and using downward strokes. Rinse perineum thoroughly in same direction, using fresh water and a washcloth. Gently dry perineum. Instruct the resident to turn on her side. Rinse wash cloth and apply soap or skin cleansing agent. Wash the rectal area thoroughly, wiping from the base of the labia and extending over the buttocks. Rinse. Dry area. 8. At all times pertinent to this proceeding, Respondent had a policy as to perineal care for male residents that conformed to accepted perineal care standards. Paragraph 16 of the policy required Respondent's staff to do the following in sequence for a male resident who had suffered an episode of incontinence, whether the episode was of bowel, bladder, or both: For a male resident: Wet washcloth and apply soap or skin cleansing agent. Wash perineal area starting with the urethra and working outward. Retract foreskin of the uncircumcised male. Wash and rinse urethral area using a circular motion. Continue to was the perineal area, including the penis, scrotum and inner thighs. Thoroughly rinse perineal area in [the] same order using fresh water and clean washcloth. Gently dry perineum following [the] same sequence. Reposition foreskin of uncircumcised male. Instruct or assist the resident to turn on his side. Rinse washcloth and apply soap or cleansing agent. Wash and rinse the rectal area thoroughly, including the area under the scrotum, the anus, and the buttocks. i. Dry area. The perineal care policy was adopted ". . . to provide cleanliness and comfort to the resident, to prevent infections and skin irritation, and to observe the resident's skin condition." Respondent's staff is trained to adhere to the perineal care policy. The perineal care provided Resident 26 and Resident 27 as observed by Ms. Catinella failed to adhere to Respondent's policy and constituted a failure to provide care and services to prevent potential urinary tract infection as alleged in the Administrative Complaint. Respondent argued that the failure to adhere to its policy by failing to spread and cleanse the labia would not cause a urinary tract infection as alleged in the Administrative Complaint. Respondent correctly argues that urine, in the body, is sterile and would not by itself cause a urinary tract infection. Most, but not all, urinary tract infections are caused by the e-coli bacteria found in feces. Respondent established that incontinent residents typically receive perineal care from Respondent's staff 10 times during a 24-hour period. Respondent also established that the facility uses only anti-bacterial soap for perineal care. Based on those considerations, Respondent argued that the perineal care observed by the surveyors may have led to a skin irritation, but that it would not have resulted in a urinary tract infection as alleged in the Administrative Complaint. The greater weight of the credible evidence established clearly and convincingly that the failure to spread and cleanse the labia has the potential for various adverse consequences for the resident, including urinary tract infection.3 If staff does not spread and cleanse the labia, the fact that anti-bacterial soap is being used is irrelevant. If the soap does not reach the labia, that area will not be cleansed, regardless of the number of times perineal care is administered during a typical day. Petitioner established the Class III violations pertaining to perineal care as to the initial survey by the requisite evidentiary standard. Petitioner also established that the violations should be considered "isolated" since there were some 55 incontinent residents in Respondent's facility at the time of the initial survey and only two episodes of improper perineal care were observed. Respondent was provided with a correction date thirty days from the conclusion of the initial survey to correct the noted deficiencies by coming into substantial compliance with accepted perineal care standards. The first follow-up survey occurred April 19-20, 2005. Eleanor Kennedy participated in that follow-up survey and testified, in her deposition, as to three incidents of perineal care that she observed. During the course of the follow-up survey, Ms. Kennedy observed two CNAs administering inappropriate perineal care to a female resident referred to as Resident 15. Ms. Kennedy observed that this resident had suffered an episode of incontinence involving both bowel and bladder. In the course of administering the perineal care, the CNAs failed to open and clean the labia. In addition to observing perineal care to Resident 15, Ms. Kennedy observed perineal care administered to a female resident referred to as Resident 16 and a male resident referred to as Resident and to a male resident referred to as Resident The perineal care administered to Resident 16 and to Resident 17 were inconsistent with Respondent's perineal care policy. The CNAs performing the perineal care for Resident 16 did not follow the proper sequence for cleaning. They first washed the resident's abdominal folds and thigh creases and then opened and washed the labia with the same disposable cloth. Ms. Kennedy testified that the sequence of the cleaning is significant because it risked the transfer of bacteria from the areas first washed to an area that could result in a urinary tract infection. The CNAs who performed the perineal care for Resident 17 first washed the resident's face, underarms, and back. Then, without changing water, the CNAs took a clean cloth and washed the resident's groin area, his retracted foreskin area, and the urinary urethral meatus. The CNAs then dried the resident, but failed to follow the required sequence. As with Resident 16, Ms. Kennedy testified that the incorrect sequence followed by the CNAs risked the transfer of bacteria to an area that could result in a urinary tract infection. Although this sequence clearly violated Respondent's perineal care policy, Respondent established that the potential for urinary tract infection as a result of the sequence was reduced because anti-bacterial soap was used. Ms. Kennedy was uncertain as to whether the use of anti-bacterial soap would alleviate the concerns she had as to the care given these two residents. Because of that uncertainty, it is found that Petitioner did not prove that the perineal care provided Resident 16 and Resident 17 constituted a failure to provide care and services to prevent potential urinary tract infection as alleged in the Administrative Complaint. The perineal care provided Resident 15 as observed by Ms. Kennedy failed to adhere to Respondent's policy and constituted a failure to provide care and services to prevent potential urinary tract infection as alleged in the Administrative Complaint. On May 26, 2005, Petitioner conducted a second follow- up survey and determined that Respondent was in substantial compliance with applicable regulations.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order adopting the Findings of Facts and Conclusions of Law set forth herein. It is recommended that Count I of the Administrative Complaint be dismissed. It is further RECOMMENDED that Petitioner find Respondent guilty of an isolated, Class III deficiency based on Count II of the Administrative Complaint. It is further RECOMMENDED that Petitioner assess an administrative fine against Respondent in the amount of $1,000.00 for the Class III deficiency found in Count II of the Administrative Complaint and that Petitioner's records reflect that Respondent's licensure was classified "conditional" for the period April 20 - May 19, 2005, and that Respondent's licensure was classified as "standard" before and after those dates. DONE AND ENTERED this 6th day of February, 2006, in Tallahassee, Leon County, Florida. S CLAUDE B. ARRINGTON 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 6th day of February, 2006.
Findings Of Fact The current petition Following the entry of a final order of the Board of Medicine dismissing the administrative action previously filed against her, petitioner filed the pending request for an award of attorney's fees and costs, pursuant to Sections 57.111 and 120.57(1)(b)5, Florida Statutes. Respondent, Department of Business and Professional Regulation, Board of Medicine (Department), has conceded that: the underlying licensure disciplinary "action in Department of Professional Regulation v. Ada Gonzalez, M.D., DBPR Case No. 90-06789, was initiated by the Department of Professional Regulation (now Department of Business and Professional Regulation), a state agency, and, therefore, the Department is not a nominal party only"; the "Petitioner qualifies as a small business party as defined by Section 57.111, Florida Statutes"; the "Petitioner prevailed in the underlying case . . . in that the Board of Medicine dismissed the case with a Final Order filed on October 27, 1993"; and, the "Petitioner's claimed attorney's fees and costs [attorney's fees of $20,189.00 and costs of $3,784.95] seem reasonable; however, Respondent asserts that the statutory cap of $15,000.00 inclusive of fees and costs, is applicable." Under the circumstances, the sole issue with regard to the claim for attorney's fees and costs under Section 57.111, Florida Statutes, is whether the actions of the Department were "substantially justified" when it initiated the underlying disciplinary action and, with regard to the claim for attorney's fees and costs under Section 120.57(1)(b)5, Florida Statutes, apart from the applicability of such section to the instant case, is whether any pleading, motion or other paper was filed in the underlying proceeding for an "improper purpose." The underlying disciplinary action On or about May 22, 1990, the Department received, pursuant to statutory requirement, a closed claim report from the Department of Insurance. The report reflected that an indemnity of $160,000 had been paid to the family of Patient C. D. through a settlement within the presuit period prescribed by Section 768.57, Florida Statutes. The predicate for the claim against petitioner, Ada Gonzalez, M.D., was the apparent assertion that the patient died as a consequence of petitioner's failure to appropriately treat her. By memorandum of May 22, 1990, the Division of Medical Quality Assurance recommended to the Department of Professional Regulation's complaints department that a case be opened. That memorandum provided: DISCUSSION: This review is predicated upon receipt of a closed claim DOI report. The specific allegation is that the doctor treated the patient for PID - rule out urinary tract infection. The patient was reportedly treated with antibiotics on 11/14/88 and on 11/16/88 appeared better. However, the patient reportedly did not improve and died of a ruptured ovarian abscess on 11/18/88. There are no medical records to review and there is no history or explanation given as to what happened in the time period from the onset of the pain to the demise of the patient. * * * COMMENTS AND RECOMMENDATIONS: I recommend a case be opened. There is a question of stan dard of care. Records should be obtained and referred to a similarly placed physician for review. As a consequence of the foregoing referral, the Department opened its Case No. 90-06789, and assigned its investigator Providence Padrick to the case. The investigator obtained a copy of the Palm Avenue Physicians Center and the Fatima HMO medical records, which included the documentation reflecting petitioner's treatment of the patient; the Jackson Memorial Hospital medical records, the facility at which the patient expired; and the autopsy report. Petitioner was duly informed by the Department that the case had been opened against her, and she was offered an interview but declined. The Palm Avenue Physicians Center and Fatima HMO medical records reflect that the patient was first seen by petitioner on November 14, 1988, and presented with a complaint of bilateral flank pain radiating to the lower abdomen, frequency of urination with some tingling on urination, a yellowish vaginal discharge, and a low grade temperature; such symptoms of approximately one day duration. Examination revealed lower abdominal tenderness to palpation, cervical motion tenderness, and a brown cervical discharge. Petitioner diagnosed pelvic inflammatory disease ("PID") and possible urinary tract infection ("UTI"). As a consequence of the history and examination, petitioner ordered x- rays of the abdomen, biochemical profile, pregnancy test, syphilis test and cultures of the vaginal discharge and urine; prescribed antibiotics; made a referral for the patient to see a gynecologist in two weeks; and, advised the patient to return for a follow-up visit in two days. As for the testing results, the urine culture and sensitivity came back positive for a urinary tract infection; however, all of the other laboratory tests came back negative. The patient was next seen by petitioner on November 16, 1988, for her follow-up visit. At the time, the patient reported that she felt better, and petitioner's examination revealed less vaginal discharge and discomfort, although she still suffered a low grade fever. Petitioner confirmed her earlier diagnosis of pelvic inflammatory disease, and prescribed another antibiotic (Septra DS) for urinary tract infection. The following day, November 17, 1988, the patient returned to see petitioner complaining of severe abdominal pain over the whole abdomen, nausea and vomiting. Examination revealed that the patient was in distress, with a distended abdomen, decreased bowel sounds and positive tenderness on palpation over the abdominal area. Petitioner again diagnosed pelvic inflammatory disease and urinary tract infection, and referred the patient to the Fatima HMO for observation, IV fluids and x-rays. The patient refused, however, to go to the Fatima HMO and, in fact, evidenced her intent to cancel her membership in the HMO. At or about 6:34 p.m., November 17, 1988, the patient presented to the Jackson Memorial Hospital Emergency Room complaining of severe abdominal pain, nausea and vomiting, and yellow vaginal discharge. Routine laboratory work was undertaken, but when she was taken to the x-ray department and placed on the table she became unresponsive. Cardiopulmonary resuscitation was immediately commenced without success, and the patient was pronounced dead at 11:25 p.m. that evening. An autopsy performed by the Dade County Medical Examiner revealed the following abnormal findings: Diffuse peritonitis Ruptured left fallopian tubal abscess Crude intrauterine contraceptive device Bilateral ovarian cysts Soft liver, spleen, and kidneys Congested lungs Gallstones Scarred gallbladder The autopsy concluded that the cause of death was acute diffuse peritonitis due to ruptured fallopian tubal abscess. On August 11, 1992, the Department forwarded its investigative report and related exhibits to its expert, Stanley H. Bernstein, M.D., for review and opinion concerning petitioner's adherence to the appropriate standard of care. By letter of August 20, 1992, Dr. Bernstein responded to the Department's request as follows: The subject A. G. [petitioner] was treating this 49 year old female for symptoms related to the genito-urinary tract. The scant information noted in the medical office records suggested that the patient had a urinary tract infection as well as symptoms suggesting pelvic inflammatory disease. How ever no studies were initiated to define the extent of the infection in the pelvis. No consultations from either a urologist of [sic] gynecologist were obtained. Although antibiotic was given, there was no realization that the infection in the pelvis might have needed much more intensive therapy. The subject is unknown to me. There was no adequate assessment of the patient's condition. Since pelvic inflammatory disease was suspected, a consultant gynecologist and/or appropriate x-rays of the pelvis should have been done. Since the subject did not suspect the true diagnosis in this case, inappropriate antibiotics were given. Since appropriate diagnostic tests such as ultrasound and/or cat scan of the pelvis were not done the diagnosis could not be appreciated. The plan of treatment was inadequate. There was no adequate monitor being carried out for this patient in regard to antibiotic therapy. The written medical records were woefully inadequate. The applicable standard of care for this patient was not met since the subject did not appreciate the possibility that the patient had more extensive infection in her pelvis. The subject did note that pelvic infection was probably present but she never used appropriate consultants. This suggests that the subject had a poor understanding of the extent to which such infections can cause major catastrophic events. It seem to be that the subject needs further training-certainly in medical conditions where infection is present. On September 24, 1992, the probable cause panel of the Board of Medicine (Board) met in Tampa, Florida. Those present at the meeting were panel members Louis Murray, M.D., chairman, and Mr. Gilbert Rodriguez; Alan Grossman, Assistant Attorney General; Larry McPherson, Jr., chief medical attorney for the Department; Randolph Collete, senior attorney for the Department; and, James Reese, chief medical investigator for the Department. At the commencement of the meeting, the panel members (Dr. Murray and Mr. Rodriguez) acknowledged that they had received and reviewed the complete investigative file pertaining to, among others, the petitioner. With regard to petitioner's case, the transcript of that meeting reflects the following brief discussion: MR. COLLETTE: Item A-03 is on Ada Gonzalez, M.D., case number 90-06789. The case is before the Panel on a recommendation that probable cause be found and an adminis trative complaint be filed. It's alleged that the respondent practiced medicine below the acceptable level of care by failing to appropriately diagnose and treat the patient C. D.'s condition and mistakenly treating her for a urinary tract infection with antibiotics when, in fact, the patient was suffering from an ovarian abscess; and that the respondent failed to keep written medical records justifying the course of treatment; and that the records are sketchy and inadequate. Based upon these facts, the Department is alleging a violation of 458.331(1)(t) and (m), and recommends that probable cause be found and an administrative complaint be filed. MR. RODRIGUEZ: Move a finding of probable cause and the filing of an administrative complaint. MR. MURRAY: Second. MR. MURRAY: So moved a finding of probable cause and the filing of an administrative complaint, seconded, and passed without objection. On October 8, 1992, an administrative complaint was filed against petitioner alleging that she violated the Medical Practices Act, Section 458.331(1)(m) and (t), Florida Statutes, by failing to practice medicine at the accepted standard of care in that petitioner was guilty of "mistakenly treating [the patient] for a urinary tract infection with antibiotics, when in fact [the patient] was suffering from an ovarian abscess," and that petitioner's "medical records are sketchy and inadequate in that they fail to justify [her] course of treatment." Subsequent to the filing of the administrative complaint, petitioner's counsel employed an expert, Martin Arostegui, M.D., to review the matter and render an opinion regarding the merits of the claim against petitioner. Based on his review of the investigative file and an interview with petitioner, Dr. Arostegui concluded: . . . As a result of my extensive review, I have come to an opinion that is substantially different from that of the other physician who previously reviewed this file. I attribute this difference to the level and intensity of my review and scrutiny of the file records and my interview with Dr. Gonzalez who I found to be very professional, concerned and wholly credible. CONCLUSION: Dr. Ada Gonzalez was faced with a very difficult patient who was obese and, as a result, difficult to examine and who appeared to be clinically less sick than she really was. This patient developed a severe pelvic infection as a result of a home made intrauterine contraceptive device which probably was placed illegally and without regard for patient safety. The device was not disclosed to Dr. Gonzalez by the patient and it is reasonable to expect that Dr. Gonzalez would not uncover the device under the circumstances. Dr. Gonzalez attempted to get proper surgical evaluation and care for this patient but the patient refused, went home and, at least six hours later, appeared at an emergency department where the continuity of communication with Dr. Gonzalez was broken, the diagnosis was completely missed and the patient expired. In my opinion, Dr. Ada Gonzalez' care did not fall below community standards. However, Dr. Gonzalez did a less than satisfactory job of documenting her care of this patient and this probably had a role in the formulation of the different opinion by the other reviewing physician. It is particularly worth noting that the physician reviewer did not mention the existence of the home made intrauterine contraceptive device. On or about February 11, 1993, petitioner's counsel provided the Department a copy of their expert's report with the understanding that the Department would provide the report to its expert and if the expert's opinion was materially changed as a result the Department "would entertain taking this case back to probable cause, perhaps dismissing it or softening at least the consent agreement by eliminating perhaps probation or other items" [TR. pp. 15- 16]. Upon receipt and review of the aforesaid report, the Department amended the administrative complaint to correct certain factual inaccuracies. In this regard, paragraphs three, four and five of the original compliant, which had inaccurately averred that petitioner had treated the patient on October 8 and 31, 1988, were dropped; paragraph 7 of the original complaint, now paragraph 4 of the amended complaint, was amended to reflect that petitioner had "referred her [the patient] to a gynecologist in two weeks, and asked her to return in two days," as opposed to having simply "scheduled her to see a gynecologist" as alleged in the original complaint; and paragraph 10 of the original complaint, now paragraph 7 of the amended complaint, was amended to correctly reflect that petitioner referred the patient to Fatima HMO for observation, as opposed to referring her to Jackson Memorial Hospital as alleged in the original complaint. Other than such factual corrections, the premise for the charges leveled against petitioner remained unchanged. On April 16, 1993, the Department forwarded a copy of the amended complaint, which had been filed that date with its clerk, and a copy of petitioner's expert report to Dr. Bernstein for review. The cover letter that accompanied such materials concluded "Please read over the enclosed materials. If you see anything that you want to bring to my attention, please give me a call . . . ." Here, the proof fails to demonstrate any change in Dr. Bernstein's opinion as a consequence of his review of the materials, but fails to explicate why no change occurred. 2/ By letter of April 19, 1993, the Department advised petitioner's counsel of the amendment of the complaint, consequent to her review of his expert's analysis, and encouraged petitioner's agreement to a proposed stipulation for settlement of the case. Ultimately, in September 1993, the parties entered into a written consent agreement, subject to Board approval, to resolve the subject dispute. On or about October 2, 1993, the consent agreement was presented to the Board of Medicine for consideration. Present were fourteen members of the Board; however, one member, Dr. Louis Murray, was excused from participating since he had served on the probable cause panel. Pertinent to this case, the transcript of the Board meeting reflects the following comments by Board members: CHAIRMAN DAUER: Thank you. I just want to make a few opening comments here. I was a little bit disturbed when I saw the materials here, and let me express my concerns here. I think the doctor in this case probably did everything right. You had a patient that she first saw on November 14th, she ordered a beta HCG, it's clearly on the order here, the pregnancy test came back negative, there's no history of the IUD, she appropriately treated her, I think her medical records are adequate, and what happened, she even referred her to a gynecologist. She got the patient back in 48 hours, and I think it was an incident that could not be expected. There's no way to expect this woman to have a ruptured tubal with the results she had done, the history that was not adequate. I think this doctor did everything right. I looked at this case material and I said why is this even here. I think the case should have been dismissed. * * * DR. ECHEVARRIA: I thoroughly agree with your comments, Mr. Chairman. As I read the original AC, I made a note to take issue with the Administrative Complaint to start with, and I really feel that she did things according to the book and it is an unfortunate final ending in this case, and I'm kind of wondering why peritonitis with a ruptured tubal would kill her this quickly. We see people with ruptured diverticulitis, ruptured appendices that linger on and on and on, and it doesn't kill them. So I don't know why the death occurred so quickly without a lot of other symptoms being associated with it. So I think there may have been something like toxic shock or whatever, as a result of the foreign body. I would agree, I would certainly favor a move to dismiss. Following such dialogue, a motion was made by a member of the Board to reject the consent agreement and dismiss the case. The motion passed unanimously, and by final order dated October 8, 1993, filed with the Department of Professional Regulation October 27, 1993, the consent agreement was formally rejected and the case dismissed. Whether the action of the agency was substantially justified or other special circumstances exist which would make an award of attorney's fees and costs unjust. Here, facially, the probable cause panel had before it evidence in the form of its expert's report that would, if his opinions were credited at final hearing, suggest that petitioner had failed to maintain adequate medical records and had failed to maintain the appropriate standard of care. The reliability or efficacy of that expert's opinions has, however, been rendered suspect by the Board's unanimous conclusion that petitioner's medical records and treatment were appropriate. Under such circumstances, and the Department having failed to demonstrate, at hearing, that the information upon which the Board based its decision differed in some marked degree from that considered by the probable cause panel or to offer proof to explicate the basis or reasonableness of the expert's conclusions, the expert's report cannot be accepted at face value as reasonably indicating that the violations had occurred. Therefore, it must be concluded that the Department has failed to demonstrate that its decision to initiate the underlying action was substantially justified or special circumstances exist which would make an award of attorney's fees and costs unjust. While the Department may have failed in its burden to demonstrate that its action was substantially justified, such does not compel the conclusion that any pleading or paper filed by the Department was interposed for an "improper purpose," such that attorney's fees and costs would be appropriately awarded under Section 120.57(1)(b)5, Florida Statutes. To the contrary, the proof fails to support such conclusion. Moreover, and most importantly, the proof fails to demonstrate that the subject charges ever pended before the Division of Administrative Hearings and, therefore, as discussed in the Conclusions of Law, there is no basis upon which to assess attorney's fees and costs under Section 120.57(1)(b)5, Florida Statutes.
