The Issue The Administrative Complaint in DOAH Case No. 99-4377, charged Respondent with violating Section 458.331(1)(t), Florida Statutes (failure to practice medicine with care, skill and treatment); Section 458.331(1)(m), Florida Statutes (failure to keep written records justifying treatment); Section 452.331(1)(x), Florida Statutes (violation of a rule of the Board or Department) by violating Rule 64B8-9.003(2), Florida Administrative Code, relating to legibility of medical records, in connection with Respondent's emergency room treatment of Patient B.W. on July 21, 1995. The Administrative Complaint in DOAH Case No. 99-4378, charges Respondent with violation of Section 458.331(1)(s), Florida Statutes (being unable to practice medicine with reasonable skill and safety to patients by reason of illness, use of any material, or as the result of any mental or physical condition).
Findings Of Fact At all times material to the incidents alleged in the Administrative Complaints, Respondent was a licensed medical physician in the State of Florida, having been issued License No. ME 0016828. Respondent specialized in internal medicine and emergency medicine but has never been board certified in any specialty. Respondent's license has been delinquent since January 31, 2000, but because delinquent licenses may be subject to renewal, the Petitioner has persisted in prosecuting these cases. DOAH Case No. 99-4377 On July 21, 1995, B.W., a 56-year-old female, presented to Respondent in the emergency room of Florida Hospital Waterman, with complaints of chest, epigastric, and left shoulder pain. B.W. had a history of dermatomyositis, for which she had been taking 100 mg of Prednisone for a month, along with other medications. Prednisone in such large doses can cause gastrointestinal irritation, ulceration, and bleeding. The day before, B.W. had been prescribed Imuran by her rheumatologist for immunologic problems. Dermatomyositis is a degenerative disease of skeletal muscle that can lead to a multitude of complications, including rheumatologic problems evidenced by abnormal laboratory results. The standard of care in the examination and treatment of a patient with chest pain requires an emergency physician to obtain a history including a complete medical history, family history, and social history. Additionally, in order to meet the standard of care, the emergency physician must perform a complete physical examination, including a review of systems. The emergency room records for Respondent's treatment of B.W. show the information contained above in Finding of Fact No. 4. The emergency room records do not show that Respondent obtained or documented a complete medical history, family history, or social history of B.W. Respondent violated the standard of care in that he failed to obtain or document a complete medical history, family history, or social history of B.W. Respondent also violated the standard of care in that he failed to perform or document a complete physical examination, including a review of systems. Respondent ordered an electrocardiogram (EKG), a chest X-ray, a complete blood count (CBC), complete cardiac enzymes testing (CPK and CKMB), and a metabolic profile or chemistry panel (MPC). He also did a rectal exam which was negative for blood. He did all appropriate tests. He did not fail to order any appropriate tests. The EKG and the chest X-ray yielded normal results, but B.W.'s blood count revealed several abnormal values, including a decreased platelet of 21,000 and a markedly elevated white count of 24,000. A platelet count of 21,000 is extremely low and grounds for major concern, as is the elevated 24,000 white count. Together, in the presence of the other symptoms and abnormal blood values present, which included low RBC, anemic hemoglobin, and low hemocrit, the standard of care requires that an emergency physician obtain a consultation with a specialist, such as a rheumatologist or a hematologist. In light of all the foregoing results and normal corpuscular volume, which B.W. also had, the emergency physician should have recognized that B.W. did not have simple iron deficiency anemia. Under some circumstances, the emergency room physician's consultation with B.W.'s primary care physician, who in this case was also a rheumatologist, would have been sufficient. Respondent maintained that he had obtained a history from B.W. as set forth in Finding of Fact No. 4, and an oral report from the hospital lab technician to the effect that a blood test ordered by B.W.'s treating rheumatologist the preceding day, July 20, 1995, had shown a platelet count of 18,000, and that because Respondent presumed B.W.'s platelets were increasing with the use of Imuran plus other factors, Respondent did not admit B.W. to the hospital, but, instead, discharged her without even consultation. Despite Respondent's foregoing explanation, it is clear that Respondent did not record or document on B.W.'s chart his oral conversation with the lab technician, if, in fact, such a conversation occurred. This was below the acceptable standard of medical care and record-keeping for an emergency room physician. Respondent stated that he felt that because the treating rheumatologist had not admitted B.W. to the hospital or transfused B.W. the previous day, she should not be admitted or transfused on July 21, 1995. He stated that he also relied on a medical text (Merck's Manual) which allegedly states that platelet transfusions should not be given until the count falls to 10,000. Respondent stated that he ruled out a myocardial infarction on the basis that both the CKMB on B.W. and the CKMB Index were not elevated and B.W.'s EKG was normal. However, Dr. Tober, who is certified in emergency medicine, testified more credibly that he had never seen a CPK test so high; that interpretation of CPK and CKMB in such a patient as B.W. would be confounded by the co-existence of the dermatomyositis, grossly throwing off these tests in an acute cardiac setting, sometimes causing several EKGs to come back normal in the course of a myocardial infarction; that B.W.'s extremely low platelet count should cause great concern about the hemologic system and clotting response if B.W. started to hemorrhage; and that the suspiciously low lymphocytes and all blood parameters should have caused Respondent not to discharge B.W. prior to a consultation with a specialist. Respondent failed to meet the standard of care by the treatment he rendered to B.W., in that he did not obtain a consultation from either the primary care physician, another rheumatologist, or a hematologist, before discharging her. That standard of care requires an emergency physician to determine an appropriate diagnosis and treatment as related to the patient's complaint and results of examinations. Respondent violated the standard of care in that he merely wrote into B.W.'s chart a portion of her medical history, "dermatomyositis," instead of a current diagnosis which addressed her current abnormalities when she presented in the emergency room. Thus, Respondent did not discern an appropriate diagnosis while appropriately treating B.W.6 Respondent's chart on B.W. is illegible to the extent that Dr. Tober was unable to read most of 23 lines of it. Because proper care of patients requires that medical records be sufficiently legible for successive professionals to discern what the writer has done and analyzed, I find that Respondent is guilty of keeping written medical records that are illegible and difficult to decipher. I do not consider Hospital Waterman's failure to provide dictation or transcription equipment and/or personnel to excuse this flaw. DOAH Case No. 99-4378 On or about July 14, 1995, Respondent was convicted of driving under the influence and placed on probation for 12 months, and his driver's license was revoked for 12 months. About two years later, on July 12, 1997, Respondent's vehicle collided with another vehicle. Respondent and the driver of the other car were injured. Blood was drawn from Respondent at the hospital. Laboratory studies performed by the Florida Department of Law Enforcement revealed that Respondent's blood alcohol level was 0.10 grams of ethyl alcohol per 100 ml. Under Florida law, a driver is legally intoxicated when his blood alcohol level is 0.08 grams of ethyl alcohol per 100 ml or higher. On August 12, 1997, Respondent was arrested and charged with one count of serious bodily injury while driving under the influence, and two counts of property damage while driving under the influence. On July 2, 1998, Respondent entered a plea of guilty7 to one count of serious bodily injury while driving under the influence and was sentenced to imprisonment for a period of seven years, one month, and eight days. On or about January 13, 1998, Walter J. Muller, M.D., a board-certified psychiatrist, performed a psychiatric evaluation of Respondent. Dr. Muller diagnosed Respondent with major depression, dysthymic disorder, and alcohol abuse, pursuant to The Diagnostic and Statistical Manual-IV. At that time, these conditions were active and not in remission. The diagnosis of major depression correlates with impaired social and occupational functioning. A diagnosis of dysthymic disorder is an indication of impairment and the inability to practice medicine with skill and safety to patients. A diagnosis of alcohol abuse can be an indication of inability to practice medicine with skill and safety to patients, but would depend upon when the abuse is occurring and how long it has been since the abuse occurred. In the expert opinion of Dr. Raymond Pomm, who is board certified in adult psychiatry and general psychiatry, with added qualifications in addiction psychiatry, and who relied on Dr. Muller's evaluation, the combined three diagnoses of major depression, dysthymic disorder, and alcohol abuse revealed that, to a degree of reasonable medical certainty, Respondent was unable to practice medicine with skill and safety to patients on the date of Dr. Muller's report. Respondent was evaluated at Menninger Clinic in Kansas, on or about May 26, 1998, and diagnosed with alcohol dependence. After six weeks of treatment at the Menninger Clinic, Respondent was released as being "in early remission." The treating physician made a number of recommendations for rehabilitation of Respondent, including treating his alcohol dependence by entering into a monitoring contract with the Physician's Resource Network in Florida and requiring a further evaluation by a neurologist of Respondent's apparently diminished cognitive skills. Dr. Pomm did not have the opportunity to read the entire evaluation by the Menninger Clinic, and did not rely upon it in forming his opinion of Respondent's inability to practice medicine with skill and safety to patients. However, according to Dr. Pomm, there is no cure for alcohol dependence. It is a life-long illness, which is incurable, and which at best, can only be "in remission." In Dr. Pomm's opinion, one who is alcohol-dependent cannot practice with skill and safety to patients without undergoing a monitoring program. While I accept Respondent's testimony that he has remained sober since approximately May 27, 1998, because he has been in prison, I also note that Respondent has not entered into a monitoring contract or been monitored in a recovery program because he has been in prison. Accordingly, there is no evidence that Respondent's circumstances have changed sufficiently since January 13, 1998, so as to demonstrate that he is able to practice medicine with skill and safety to patients in the real world.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of all violations charged, and as a penalty therefore, suspending Respondent's license to practice medicine in Florida until such time as Respondent presents to the Board and proves that he can practice with skill and safety. DONE AND ENTERED this 15th day of June, 2000, in Tallahassee, Leon County, Florida. ELLA JANE P. DAVIS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of June, 2000.
Findings Of Fact During the period August 26-28, 1985, James L. Myrah, a hospital consultant for DHRS, accompanied by Ms. Christine Denson, a registered nurse, and other consultants in various disciplines from the Petitioner's office of licensure and certification, conducted a licensure, medicare, medicaid and civil rights survey at the Respondent's facility in Ft. Walton Beach, Florida. During the course of this survey, Mr. Myrah followed the normal procedure for such inquiries which included an entrance conference with the administrator, and a survey process which includes looking at various items for as many days as is required to do a thorough job.1 As a part of the survey, the team looks at every resident physically but examines patient charts on the basis of a random sample. In the instant case, examination of the patient records kept by the Respondent revealed only one variance. That was brought to the attention of the Petitioner's Office of Licensure and Certification by the Local District I omebudsman who commented about a particular patient, whose name will not be recited to preserve patient confidentiality, but whose initials, M.C., will be used as identification. By the time the survey was conducted, M.C. had already been transferred to another nursing home and was not physically present. Therefore, the inspection team was unable to examine her. However, they did examine her medical records and chart closely. This examination resulted in Petitioner drawing the conclusion that Respondent was in violation of the require ment for notification to the patient's physician whenever there is a substantial significant change in the patient's condition. The patient's chart was not entered into evidence. The report form identifying the deficiency (HRS Form 553E) was prepared by the inspection team based on its evaluation of the patient records. This was not objected to by Respondent, and in the absence of any objection to its entry, it was accepted. The entry for the 11 p.m. to 7 a.m. shift on May 22, 1985, reflects,2 "Total care given, nothing per os (by mouth) past midnight. Dr.'s appointment in am--resident seems very listless not talking as usual. Several small bruises noted on lower extremities (rt.) foot very discolored." This entry is, in the opinion of Ms. Denson, important because it relates to the fact that the patient was to go to the doctor in the morning. The use of the term "listless" might indicate a serious medical condition and a change of condition which should have been reported to the person next in charge. The term, "not talking as usual" shows a change that would require comment. In addition, the comment regarding the discoloration of the foot should have been reported to someone and not allowed to remain uncommented on until the visit with the doctor the next morning. The patient saw her physician, Dr. Wilson, at 8 a.m. on May 22, 1985; and returned to the home at 10 a.m. the same morning. Apparently nothing was considered to be wrong with the patient because no prescription for medicine or other treatment was given by the physician who, three days later, on May 25, 1985; when advised by nurses on the 7 a.m. to 3 p.m. shift of large black and blue areas on the patient's inner groin area, indicated he examined the patient and found nothing new clinically on May 22. There are repeated instances of comments which Petitioner alleges were not properly reported to the physician. For example, on May 23, personnel on the 11 p.m. to 7 a.m. shift reflected that the patient "continues to be listless. Right leg turned at a funny angle. Report to D.O.N. (Director of Nursing)." The 7 a.m. to 3 p.m. shift the following morning reported, "Both legs ecchymosis (discolored), hip moves oddly, color pale." The 3 p.m. to 11 p.m. shift the same day reported, "Color remains pale-- unusual movement and rotation of both legs noted." Additional comments of a similar nature were noted by personnel on the 11 p.m. to 7 a.m. shift on May 24 the 3 p.m. to 11 p.m. shift on May 24; and the 11 p.m. to 7 a.m. shift which discovered the discoloration to the pelvis as reported previously. At 4 p.m. on May 25, 1985, personnel reported their concern in reference to the bruises on the patient's groin and lower extremities to the physician and further entries show that at 5:10 p.m., the patient was subsequently returned to the home at 7:30 p.m. after x-rays were accomplished which failed to reveal any fracture. Nonetheless, because of continued concern by the nursing staff and at the urging of family members, the patient was returned to the hospital at 10 a.m. on May 27, 1985. At this point, she was found to have fractures of both lower extremities and upon release from the hospital was transferred to another convalescent center. Mrs. McCasland contends that all due care and concern was given to the patient, M.C., consistent with the long standing convalescent center policy governing changes in patient status. This policy statement, dated March, 1975, which is still in effect, requires that "in the event of a significant change in the patient's physical, mental, or emotional status, the attending physician is immediately called by the charge nurse." As was stated in paragraph 3, above, on May 22, an 11 p.m. to 7 a.m.'s shift nurse noted a small bruise on the left foot of the patient and that the patient was listless. Small bruises are not necessarily significant in geriatric patients (M.C. was 88 years old). Also, often older people do not talk for several days. In any event, the lack of any significant condition was confirmed by the physician who found nothing unusual in the patient's condition during the examination. The doctor's report reflects, inter alia, "physical examination is remarkable for an elderly white female in an involuted state appearing her stated age." Her extremities "show some area of bruising primarily in the upper thighs presumably related to lifting the patient. She has crepitance in the bilateral knees and is unable to fully extend her lower extremities." Neurologically; she was determined to be alert and the physician recommended continuing general support of care. On May 25, 1985, the charge nurse called Ms. McCasland at home indicating that the patient's legs seemed to be getting bluer. Ms. McCasland, at that moment, told the nurse to call the patient's physician which was done and the doctor indicated at that time that when he had examined the patient several days previously, he found nothing wrong. It apparently was the decision of the doctor to take no further action at that time. However, at approximately 4 p.m.; after the conversation with the physician; the charge nurse contacted the physician again, indicating she thought the patient needed to be x-rayed. At 5:10 p.m.; the patient was taken to the hospital; apparently at the order of the physician; for x-rays which showed no fractures. Nonetheless; this action would not have been taken were it not for the attention of the nurse on duty and actions of the Respondent's administrator. On the following day, May 26, the charge nurse from the 7 a.m. to 3 p.m. shift again called Mrs. McCasland at home and stated that the patient's legs were; "bad." Ms. MeCasland told the nurse to call the patient's physician who directed she be sent to the hospital for x- rays. The hospital would not accept the patient and as a result, the physician came to the convalescent center where he examined her and concluded that there was, in fact, a problem. He directed she be sent to the hospital the following day and when she was x-rayed then; fractures were discovered. It should be noted here that again the contact with the physician which resulted in the ultimate diagnosis of leg fractures, was initiated by the charge nurse at Respondent's center and communicated to the physician and Ms. McCasland by center personnel.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that deficiency number NH77(g); relating to the visit to Respondent's convalescent center on August 28, 1985, be removed. DONE and ORDERED this 7th day of May, 1986, in Tallahassee, Florida. _ ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 7th day of May, 1986.
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Petitioner on the basis of alleged violations of the Medical Practice Act, Chapter 458, Florida Statutes. In an eight-count Amended Administrative Complaint, the Respondent has been charged with four violations of Section 458.331(l)(m), Florida Statutes, and four violations of Section 458.331(l)(t), Florida Statutes.
Findings Of Fact The Respondent is, and has been at all times material to this proceeding, a licensed physician in the State of Florida. His license number is ME0022079. Facts regarding Patient #1 The Respondent provided medical treatment to Patient #1 from April 20, 1987, through April 12, 1988. During the period of that treatment Patient #1 was approximately 92 years old and was diagnosed as having organic brain syndrome. Respondent obtained a brief past medical history of the patient and failed to document the patient's current complaints or review any prior medical records of the patient. On May 26, 1987, Respondent diagnosed the patient with pedal edema and ordered Hygroton 25 mg., but failed to document in the medical records the number of times per day the patient was to take the medication or the dosage for the medication. On June 6, 1987, the patient presented with shortness of breath and a blood pressure of 110/80. Respondent did not perform any tests or examinations to determine the cause of the symptoms. On July 14, 1987, and September 22, 1987, the patient again presented with shortness of breath and pedal edema and Respondent only recorded the lungs as clear and took her blood pressure. Respondent did not perform any other tests or examinations to determine the cause of the symptoms. On October 26, 1987, when the patient presented with shortness of breath, Respondent noted an arrhythmia and blood pressure of 136/82. However, Respondent did not perform any tests or examinations to determine the course of the symptoms. When the patient presented with arrhythmia, the applicable standard of care 5/ required Respondent to perform an EKG, to check her digoxin levels, and monitor her electrolytes and renal functions. Respondent's medical records for the patient did not meet the applicable record-keeping standards 6/ because the records were incomplete, inadequate, and illegible. Specifically, the records did not have diagnoses, did not have a plan of treatment, and did not include thorough examinations or histories, making it impossible to determine the appropriate treatment for the patient. Facts regarding Patient #2 Respondent provided treatment to Patient #2 from July 11, 1978, until September 13, 1988. Patient #2, a male, was seventy-one years old when such treatment began. The patient had a history of gastric ulcers. Nevertheless, Respondent prescribed nonsteroidal anti-inflammatory medications which exacerbate or increase difficulties with gastric ulcers and bleeding without obtaining a complete history or conducting a full examination. Respondent's medical records did not document whether Respondent assessed the risk to the patient, discussed the risk with the patient, or made any determinations that the risks outweighed the benefits for the patient. In 1978, the patient presented with a chronic cough and chronic bronchitis. However, Respondent did not perform any chest x-rays to determine the origin of the cough or to rule out lung carcinoma. Over the years, the cough persisted and in 1982-1983, the patient experienced shortness of breath and increased ankle edema. Respondent prescribed diuretics without determining the etiology of the edema and without conducting renal status or electrolyte monitoring. In 1985, the patient was hospitalized with severe ankle swelling. Respondent did not aggressively treat the possibility of deep vein thrombosis or cellulitis, nor did he treat the patient with anticoagulants to lessen the risk of a blood clot going to the lung. The applicable standard of care required anticoagulant treatment under these circumstances. In 1987, the patient suffered a severe weight loss with the chronic cough. The Respondent's records do not reveal any attempt to make a diagnosis. On December 15, 1987, the patient complained of abdominal problems, which could have related to the steroidal anti-inflammatory medications prescribed. The Respondent's records fail to document any laboratory tests or examinations by Respondent to determine the cause of the complaints. Respondent breached the applicable standard of care by failing to perform an EKG on the patient when he presented with dizziness, light-headedness or syncopal episodes from September 1987, until July 12, 1988. When the patient presented on August 30, 1988, and September 13, 1988, with very serious complaints of precordial chest pain, shortness of breath, and palpitations, a reasonably prudent physician would have suspected that the patient was having a heart attack. Despite the symptoms, Respondent made a psychiatric diagnosis, rather than fully evaluating the heart and cardiac status. Respondent's medical records for the patient did not comply with the applicable record-keeping standards in that they did not contain thorough examinations or histories, and did not have diagnoses or plans of treatment for the patient. Facts regarding Patient #3 Respondent provided care to Patient #3 from November 17, 1987, until May 16, 1989. Patient #3, a female, was eighty-five years old when such treatment began. Respondent should have been aware from the patient's initial presentation, that the patient did not qualify to reside in an adult congregate living facility and should have taken steps to have her admitted to a skilled nursing facility. Respondent's failure to do so is a breach of the applicable standard of care. Respondent's initial examination of the patient was limited and Respondent failed to conduct an EKG to reveal the origin of the patient's pedal edema or irregular heartbeat. Respondent also failed to diagnose, treat, or refer the patient for a consult to evaluate her vision and hearing loss. Even though the diagnosis was not made in the Respondent's records, it is apparent from the medications prescribed by Respondent that the patient was being treated for congestive heart failure. She also had pedal edema, shortness of breath, and cardiac arrhythmia. Respondent failed to perform or conduct the appropriate tests and examinations to make a diagnosis of the patient's condition or to provide effective treatment. The patient had frequent episodes of high blood pressure for which Respondent prescribed diuretics. Respondent's prescribing of Tenormin violated the applicable standard of care and subjected the patient to serious cardiac risks. Respondent's medical records for the patient were illegible for the most part and in many instances omitted information about the diagnosis and course of treatment. For these reasons the records failed to comply with applicable record-keeping standards. Facts regarding Patient #4 Respondent provided treatment to Patient #4 from April 1985 until January 5, 1988. Patient #4, a male, was seventy-four years old when such treatment began. When the patient originally presented to Respondent, he was on cardiac medications, had complaints of possible arrhythmias, and had a history of organic brain syndrome and tardive dyskinesia. Respondent was required by the applicable standard of care to evaluate the patient's cardiac condition, renal status, and potassium level. Respondent breached the standard of care by failing to conduct these evaluations and examinations. On October 1, 1985, the patient presented with back pain. Rather than conducting a physical exam to determine the source of the pain, Respondent violated the standard of care and treated the pain symptomatically. The patient was prescribed an anti-psychotic drug, Mellaril, and throughout Respondent's care exhibited side effects, including falls with resulting abrasions. Respondent failed to discontinue the drug or take appropriate measures to determine the extent of the patient's condition and implement a course of treatment. On July 23, 1987, Respondent prescribed an amount of Dalmane considered excessive for geriatric patients. These inappropriate prescriptions constitute a departure from the applicable standard of care. Respondent's medical records for the patient were replete with omissions of physical exams, diagnoses, and plans of care, and were inadequate as to patient history and justification for course of treatment. For these reasons the records failed to comply with applicable record-keeping standards. Facts regarding prior discipline Respondent has been the subject of prior disciplinary action by the Board of Medicine. The prior disciplinary action was based on deficiencies in Respondent's record-keeping. The prior disciplinary action does not appear to have improved Respondent's record-keeping in any significant way.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine issue a final order in this case to the following effect: Concluding that the Respondent is guilty of four counts of violations of Section 458.331(l)(m), Florida Statutes, and four counts of violations of Section 458.331(l)(t), Florida Statutes, as charged in the Amended Administrative Complaint; and Imposing administrative penalties consisting of all of the following: (a) an administrative fine in the total amount of $4,000.00 (representing a $500.00 fine for each of the eight counts); (b) a one-year period of suspension of the Respondent's license; and (c) a one-year period of probation following the suspension, during which probation period the Respondent shall be required to have his records reviewed by a supervising physician approved by the Board, such supervising physician to provide quarterly reports to the Board regarding the sufficiency of the Respondent's record-keeping. DONE AND ENTERED this 2nd day of February 1995 in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH 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 2nd day of February 1995.
The Issue The issues in this case are whether Respondent violated Section 458.331(1)(m), and/or (1)(t), Florida Statutes (Supp. 1996), and, if so, what discipline should be imposed.
Findings Of Fact Based upon the testimony and evidence received at the hearing and the parties' stipulations, the following findings of fact are made: Findings regarding the parties The Board of Medicine (Board) is the regulatory board within the Department of Health that is responsible for the regulation of the practice of medicine in Florida. Respondent is, and was at all times relevant to this proceeding, a licensed physician, Board-certified in plastic surgery. His license number is ME 0030449. At all times relevant to this proceeding, Respondent practiced at the Florida Center for Cosmetic Surgery (FCCS), which was an office surgery center in Ft. Lauderdale, Florida. Respondent performed cosmetic surgery at FCCS about two to three days a week while still maintaining his own office surgery center in Winter Park, Florida, where Respondent currently practices. From the beginning of the professional relationship between Respondent and FCCS, it was contemplated by all concerned that the relationship would be a part-time, short-term relationship; Respondent was merely providing plastic surgery services and follow-up care on a temporary basis until FCCS could make a more permanent arrangement with a plastic surgeon who wanted to work full-time for FCCS. Respondent never had any role in the business practices of FCCS, never had any managerial role at FCCS, and never had any ownership interest in FCCS. The agreement between Respondent and the principals at FCCS included an understanding that all patients who sought services at FCCS were patients of the clinic; not patients of the individual surgeon who performed the surgery on a patient. Consistent with that understanding, FCCS also insisted that it was entitled to custody and control of all of the medical charts, and Respondent was not allowed to remove any medical charts from the premises of FCCS. Respondent performed surgery at FCCS for approximately six weeks. General findings about the relevant surgical procedures A brow lift is a cosmetic surgery procedure that involves an incision in the patient’s scalp. The incision goes quite deeply into the forehead. After the incision, the scalp is dissected and loosened all the way down to the eyebrows, with the intent of this procedure being to raise up the eyebrows to some degree to give a rejuvenated appearance to the forehead. The incision in the scalp bleeds easily. In order to minimize the scalp bleeding, an electrocautery device is used for cauterization at the site of the bleeding. An electrocautery device may either be monopolar or bipolar. A monopolar cauterization device utilizes a “grounding plate” or a “grounding pad” to ground the electric current. The grounding plate or pad is attached to the patient on a fleshy part, typically along the side of a patient’s thigh or on a patient's buttock, away from any bony prominence. "Bovie" is the trade name of a major brand of monopolar cauterization devices. The grounding plate or grounding pad for a monopolar cauterization device is commonly referred to as a "Bovie pad." In contrast, a bipolar cauterization device does not need and does not have a grounding pad. Liposuction is a medical procedure in which fat is removed from an area of a patient's body by means of a suction device. A cannulus, which is a narrow tube with a sharp tip, is inserted into the desired areas of the body. The cannulus is connected to a vacuum-like device and once the cannulus is inserted into the operative area, it is manually maneuvered by the physician to remove the fat within reach of the cannulus with vacuum suction. General findings about Patient F. V. This case arises from surgical procedures performed by Respondent on February 6, 1997, on a patient identified in the record of this case as Patient F. V. Patient F. V. is a white female, who at the time of the relevant surgery was 43 years old. Patient F. V. wished to improve her facial features and wished to reduce the fat in her thighs. She went to FCCS to seek cosmetic surgery for those purposes. Patient F. V. had previously undergone cosmetic surgery performed by Dr. Myron Persoff, also at FCCS, on August 23, 1995. Pre-operative contact between Patient F. V. and FCCS On January 28, 1997, Patient F. V. contacted FCCS (probably by telephone) and someone at FCSS filled out a consultation form about that contact. The form listed the requested procedures of a facelift/browlift and liposuction. The form also noted a prior facelift by Dr. Persoff, a plastic surgeon also with FCCS. Finally, the form indicated a confirmation note of January 29, 1997, for an appointment date and time of January 30, 1997, at 3:00 p.m. On January 30, 1997, Patient F. V. went to FCCS for consultation regarding cosmetic surgery. On that date, Patient F. V. filled out a “Patient Information” form. The form asked Patient F. V. basic questions relating to her medical history and relating to her social history. Patient F. V.’s next visit to FCCS was on February 3, 1997. February 3, 1997, was the first and only time that Respondent met with Patient F. V. prior to the surgery on February 6, 1997. On February 3, 1997, a presurgical and anesthesia evaluation form was completed by Certified Registered Nurse Anesthetist (CRNA) Charlotte Filip. This form detailed some history of Patient F. V. and listed the prior surgery to the breast, face, and eyes. The Patient and Nurse Filip signed the form. During Patient F. V.’s February 3, 1997, visit to FCCS, Respondent conducted an initial physician/patient consultation. During the course of the consultation on February 3, 1997, Respondent conducted a thorough pre-operative consultation with Patient F. V. His activities during that consultation included taking a history and conducting a physical examination. Respondent discussed with Patient F. V. what she wished to have done, and he also discussed with her the risks and benefits of the proposed procedures. During the course of that consultation Respondent made a plan for the surgical procedures to address Patient F. V.'s concerns and desires. Thereafter, Respondent approved Patient F. V. for a brow lift and thigh liposuction. At the conclusion of the consultation on February 3, 1997, Respondent dictated a pre-operative report. The transcription of that dictation is not in F. V.'s medical chart maintained at FCCS. The fate of that dictated pre- operative consultation report is presently unknown.6 At the time of the Patient F. V.'s 1997 surgery, it was the practice of FCCS to prepare, and to maintain in the patient's medical records, a financial check list. For reasons not explained in the record in this case, the financial check list for Patient F. V.'s 1997 surgical procedures is missing from Patient F. V.'s medical chart at FCCS. At that same time, it was also the practice at FCCS for the physician to either provide the patient with pain medications or with a prescription for pain medications prior to surgery, and to document such delivery of medications or prescription for medications in the patient's medical chart. For reasons not explained in the record in this case, such documentation is missing from Patient F. V.'s medical chart at FCCS. At the time of Patient F. V.'s 1997 surgery, it was also the practice at FCCS to provide each patient with a pre- surgery instruction sheet listing numerous things the patient should do prior to surgery, as well as things the patient should not do prior to surgery. It was also the practice of FCCS to place a copy of the instruction sheet in the patient's medical chart. For reasons not explained in the record in this case, the copy of the instruction sheet given to Patient F. V. is missing from her medical chart at FCCS. At the time of the pre-operative consultation on February 3, 1997, FCCS was experiencing delays with the transcription of dictated reports. Such transcriptions often took as long as one or two weeks. Some of the information generated at the pre-operative conference needed to be promptly communicated to the financial staff at FCCS so that the costs of the procedures to be performed could be determined and so that arrangements for payment could be made with the patient. In some manner not presently remembered, Respondent provided the FCCA financial staff with the information they needed to make the necessary financial arrangements with Patient F. V.7 Patient F. V.’s medical records at FCCS do not contain adequate documentation of Respondent’s pre-operative consultation on February 3, 1997, with Patient F. V. Further, Respondent could not produce any adequate documentation of his February 3, 1997, consultation with Patient F. V. Day of Patient F. V.’s surgery Respondent performed surgery on Patient F. V. on February 6, 1997, which consisted of a brow lift and liposuction of her thighs. Before Respondent began the surgical procedure, CRNA Filip (Nurse Filip) conducted her own physical assessment of Patient F. V. for her purposes as the anesthetist. Nurse Filip also documented the results from the lab tests. Nurse Filip documented her results by hand writing notes on the bottom left portion of the Pre-Operative Checklist. As evidenced by the anesthesia record in Patient F. V.’s records, Nurse Filip also performed her duties as the anesthetist for the surgery and documented her pre-operative care of Patient F. V. In the anesthesia record, Nurse Filip documented information including a cursory patient history (allergies, medication being taken, and blood pressure), date, type of surgery, and surgeon. Respondent had no part in documenting any information on the anesthesia records. The anesthesia records for Patient F. V.'s surgery on February 6, 1997, appear to be complete. The circulator who participates in a surgical procedure has the recordkeeping responsibility of creating an operating room record, which should include a detailed description of the equipment used during the surgical procedure, as well as an itemization of all significant events from the time the patient enters the operating room until the patient goes to the recovery room. During 1997 it was the practice of FCCS to keep the circulator's operating room records in the patient's medical chart. For reasons not explained in the record in this case, the circulator's operating room record is missing from Patient F. V.'s medical chart at FCCS. The progress note for the day of surgery, February 6, 1997, is a de minimus notation that lists little more than the type of surgery performed, the surgeon's name, the weight of the patient, the names of the scrub nurse, the circulating nurse, and the CRNA, and the total amount of fat removed. This de minimus progress note is not in Respondent's handwriting.8 In addition to a progress note summarizing the basic details of a surgical procedure, once the surgery is complete the surgeon should also prepare a detailed operative report which describes in detail the manner in which the surgical procedure was performed, including all significant events that occurred during the surgery. Such an operative report should include a description of the type of liposuction and the type of brow lift performed. Such an operative report should also detail the manner in which the surgery was performed and should note any burns, injuries, or other complications arising from the surgery. A sufficiently detailed operative report is especially important in the event of post-operative complications, because details regarding the methods and techniques employed during the surgery can often facilitate an understanding of, and facilitate treatment of, any post- operative complications. There is no clear and convincing evidence as to whether Respondent did or did not prepare a detailed operative report of the type described in the immediately preceding paragraph. What is clear is that such an operative report is missing from Patient F. V.'s medical chart at FCCS.9 Respondent's recollection of the details of the subject surgery on February 6, 1997, is not very good. Although he seems to have a clear recollection of some details, he does not appear to recall some other equally important details. He does, however, remember that after the surgery he wrapped Patient F. V.'s forehead with Ace wrap and placed a strip of tape along the forehead to immobilize the Ace wrap. He also applied Ace wrap to the patient's thighs at the conclusion of the surgery. The Ace wraps on the thighs were also secured with strips of tape. At the conclusion of the surgical procedures on February 6, 1997, there were no visible blisters at the locations where blisters were visible on February 7, 1997. During the surgical procedures performed on February 6, 1997, on Patient F. V., Respondent did not use a monopolar catherization device. Therefore, no grounding pads were used during that surgery. Findings regarding post-operative care FCCS’s post-operative policy in effect in February of 1997 required the patient to return for post-operative follow up as follows: one day, one week, two weeks, and one month. Patient F. V. returned the next day, February 7, 1997, and was seen by Respondent. On February 7, 1997, the patient’s head dressing was removed, the bandages on the patient's thighs were removed, and the patient was advised to follow up in 5 days to have sutures removed. Respondent’s notes for this visit included a notation that the patient was "doing great," and that the patient should return for staple removal. Respondent's notes also mention a "forehead blister" which is noted to be "clean," and a "tape blister" on the left thigh. On February 7, 1997, Patient F. V. had a blister on her left thigh. This thigh blister was located on the front of the thigh, a few inches above the kneecap. On February 7, 1997, the patient also had a smaller blister on her forehead above her left eye.10 Respondent’s post-operative progress note of the February 7, 1997, visit does not document a treatment plan for the injuries on the forehead or the thigh. However, in this regard it must be noted that there is no evidence that either blister required treatment on February 7, 1997, or that either blister appeared to require any future treatment other than follow-up observation.11 Patient F. V. returned to FCCS on February 13, 1997, and was seen again by Respondent. The written progress note for that day recorded her weight, but no other subjective or objective complaints were noted. The progress note mentions a "possible tape blister" on the patient's upper left thigh. On this occasion the top of the thigh blister had come off and an unprotected layer of skin was at that site. The thigh blister needed treatment to prevent infection. The progress note also mentions that Bacitracin, an antibiotic, was applied to the thigh blister and that the blister site was covered by a 4” x 4” piece of gauze held in place by a small piece of paper tape. There are no notes concerning the lesion on the forehead. In this regard it must again be noted that there is no evidence that the forehead blister required any treatment at the time of this visit.12 Patient F. V. was advised to come back in one week to have the staples removed. The next entry in the progress notes states that Patient F. V. returned three days later, on February 16, 1997. Although the matter is not entirely free from doubt, the visit recorded as having occurred on February 16, 1997, probably actually took place on February 17 or 18, 1997.13 The progress note for that visit first notes that the patient was happy. It also notes that the stitches and the staples were removed. The progress note concludes with the following: "Script given for Silvadene 1% due to burn on leg and forehead." It is not clear from the progress notes who saw the patient at this visit, but it was probably one of the physicians (other than Respondent) who worked at FCCS, inasmuch as a prescription was written during this visit. Both Bacitracin and Silvadene were appropriate antibiotics for the patient's thigh and forehead lesions. Silvadene has a more penetrating quality to it and can penetrate scabs better. On February 24, 1997, Patient F. V. called the FCCS regarding the lesion on her leg. A dermatologist friend of hers had advised her to discontinue the Silvadene cream and to contact her physician about the lesion. Patient F. V. wanted Respondent to see her. She was advised to come in the next day to see one of the other physicians employed at FCCS. The next day (February 25) Patient F. V. returned to FCCS for further follow up treatment. She was seen by Dr. Alexander, one of several physicians employed by FCCS, who advised her to leave the lesion dry and see how it heals. The lesion on the thigh was described as "dry and scabbed." The patient was very unhappy during this visit. On February 26, 1997, Patient F. V. returned to FCCS and was seen by Respondent. Respondent noted that she was doing very well “except for left leg burn.” Respondent also noted as a possible cause of the lesion on the patient's left leg: “probable ground plate sensitivity.” There are no subjective complaints recorded. The record also does not contain any type of plan concerning the left leg burn. In this regard it should be noted that on the previous day Dr. Alexander had advised the patient to leave the burn dry and see how it heals. In all probability, during the following 24-hour period there was no change to the lesion on Patient F. V.'s thigh that required any additional treatment plan other than the "wait and see" plan noted by Dr. Alexander the day before. Photographs were taken on the visit of February 26, 1997. There are several post-operative photographs of the left leg lesion. On March 20, 1997, Patient F. V. returned to FCCS and was seen by Respondent. Respondent noted that she was doing better and that her leg lesion was improving. There are no clearly documented objective or subjective complaints. There is no plan documented other than return ASAP. Respondent’s medical record of March 20, 1997, does not document a plan for the course and scope of treatment for Patient F. V. Although Respondent documents a concern with the forehead, he did not document what concerns he had or how he planned to treat the concerns.14 After the visit of March 20, 1997, Patient F. V. did not return to the FCCS for over a year. On June 4, 1998, Patient F. V. was seen by two physicians at FCCS. Both physicians examined Patient F. V. and then prepared progress notes reporting what they had observed and proposing a plan to address what they had observed. Respondent discontinued his professional relationship with FCCS on or about April 1, 1997. Prior to leaving FCCS, Respondent reviewed all of his charts and had the opportunity to make sure all the histories and physicals were complete. To the best of Respondent's recollection, when he left FCCS there were no charting problems in any of the medical charts of any of the patients who had been treated by Respondent at FCCS. Patient F. V. returned to FCCS on June 4, 1998, and was seen by Dr. Alexander. Dr. Alexander was another plastic surgeon who worked at FCCS. Following his examination of Patient F. V. on June 4, 1998, Dr. Alexander prepared a progress report reading as follows: "6/4/98. Depressed area above the left eye on the forehead, dime size. Second degree burn, one- inch long depigmented burn scar left medial thigh. Also two- inch wide scar, medial forehead lift scar. Plan, revise all scars." On June 4, 1998, patient F. V. was seen by another physician identified in progress notes as "Dr. H."15 Following his examination of Patient F. V. on June 4, 1998, the second physician ("Dr. H") prepared a progress note reading as follows: Dr. H, 6/4/98 1.7 x .8 centimeter hypopigmented scar with surrounding hypopigmentation 2mm. flat non-tender .8 x .6 centimenter thin skin left upper forehead appears like lower dermis mobile to touch but doesn't animate on her own. Can't really see scar - just notice conture deformity. Rec - Excise leg scar vertically. ? Alloderm under depressed scar left forehead. Discuss with patient. G.L.A.D. Patient F. V. has elected not to have scar revision surgery. When Respondent discontinued his professional relationship with FCCS, he left all of the medical records concerning his care and treatment of Patient F. V. in the possession and custody of FCCS. Respondent did not take any copies of any medical records concerning Patient F. V. when he discontinued his relationship with FCCS. It was not until the latter part of 1999 that Respondent first obtained possession of a copy of the FCCS medical records concerning Patient F. V. He obtained those copies by means of a discovery request. As of the time of the final hearing in this case, several documents were missing from the medical records concerning Patient F. V. maintained by FCCS. The missing documents included the following: a detailed pre-operative report; a detailed operative report prepared by Respondent or prepared by someone acting pursuant to Respondent's direction and control; a financial check list; written documentation of medications provided to or prescribed for the patient; and a sheet of pre-surgery instructions regarding what the patient should and should not do. At several times during the period from 1998 through 2002, the medical records at FCCS concerning Patient F. V. were searched in an effort to locate a detailed pre-operative report and/or a detailed operative report. Such documents could not be found in the FCCS records on those occasions. Without an operative note (or some other form of detailed information regarding the manner in which the surgical procedures at issue were performed) it is virtually impossible to reach a reliable determination as to what caused the injuries on the patient's left thigh and forehead. On the basis of the record in this case, the causes of the forehead and thigh lesions observed on Patient F. V. on February 7, 1997, are unknown. Because the causes are unknown, it is also unknown whether such lesions were caused by act or omission by Respondent. And, because no specific act or omission by Respondent has been identified as the cause of either lesion, it is impossible to determine whether any such unidentified act or omission, if any, might or might not have constituted a departure from the applicable standards of care. There is no clear and convincing evidence that Respondent "fail[ed] to properly administer liposuction, causing full-thickness burns to Patient F. V.'s left thigh area." There is no clear and convincing evidence that Respondent "fail[ed] to properly perform the brow lift, causing full-thickness burns to Patient F. V.'s forehead." There is no clear and convincing evidence that Respondent "improperly plac[ed] or fail[ed] to appropriately supervise the placement of the grounding pads of the Bovie unit." There is no clear and convincing evidence that Respondent did "not adequately maintain[ ] his surgical equipment relating to liposuction and brow lift procedures." There is no clear and convincing evidence of Respondent's "failing to properly document Patient F. V.'s preoperative consultation." There is no clear and convincing evidence of Respondent's "failing to properly document a post-operative report of the procedures." There is no clear and convincing evidence of Respondent's "failing to complete or create an appropriate operative report for the procedures."
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine issue a final order in this case dismissing all parts of both counts of the Amended Administrative Complaint because none of the violations alleged in the Amended Administrative Complaint have been proved by clear and convincing evidence. DONE AND ENTERED this 31st day of December, 2003, in Tallahassee, Leon County, Florida. S MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 31st day of December, 2003.
Findings Of Fact At all times pertinent to the allegations contained herein, the Respondent, Dr. Julius A. Okuboye, was a medical doctor licensed by and in the State of Florida. In the first of six cases upon which Petitioner bases its case, the patient was receiving medical treatment for a fracture of the right femur, (thigh bone), at Gateway Community Hospital in St. Petersburg, Florida during the period November 21, 1982 and January 13, 1983. Petitioner contends Respondent failed to properly perform the surgical procedure; failed to properly consider alternative courses of treatment; and failed to keep adequate medical records justifying the course of treatment taken. Respondent reduced the bone fracture here by using a metal plate running lengthwise along the bone in an attempt to brace the fracture by securing it to the bone with, initially, screws. The plate used by the Respondent was too short for the procedure in that it did not extend beyond the upper limits of the fracture by that distance considered by some to be appropriate. Petitioner's first expert felt the use of the plate which was too short and the screws used to affix it, which were too short, was improper practice. In his opinion, the procedure followed by the Respondent herein required the patient to undergo three separate operations rather than one, which unnecessarily exposed this elderly patient to infection and the risk of anesthesia on three separate occasions. Petitioner's other expert believes that because the Respondent used a plate which was too short for the fracture involved, it was necessary for him to go back in and fix the plate with Parham bands considered by many in the field to be an old-fashioned practice. These bands, when used, tend to devitalize the tissue. He believes that once having used them, however, Respondent should have used more screws to affix the plate and the bands. In addition, the plate did not fix the smaller bone fragments at the bottom of the fracture. Both experts state Respondent should have considered reducing the fracture by the use of traction and bed rest as an alternative to surgery. On the other hand, Respondent's experts disagreed with Petitioner's experts. One, Dr. Weiss, indicated that Respondent had two choices: (1) a prolonged traction and immobilization which, itself, poses a great risk for an elderly patient, or (2) the surgical fixation which was chosen. Here, the reduction was good but the plate was too short. Dr. Weiss contends, as was urged by Respondent, that this was beyond his control and while it would have been better to use a longer plate, the Respondent used the correct procedure and the fact that a second and third operation was necessary, was beyond his control. His choice to do them was appropriate. The other expert, Dr. Bodden, pointed out that even though the smaller plate was used, there is no assurance a larger plate would have precluded the second and third operations. He believes that in light of all of the medical problems presented in this case and since the ideal plate was not available, Respondent's choice was prudent. The length of the plate was improper but in the opinion of Dr. Bodden, the patient's bone structure contributed to the breakage after the plate was installed. Further, the use of Parham bands was not inappropriate. They have been used for many years and are still widely accepted and used. In fact, he uses them himself. Prior to the surgery, Respondent contacted the operating room charge nurse to determine if the proper plates were available, and was assured by her that a full set of plates was available for the surgery. It was only after entering the operating arena, opening the incision into the patient's leg, and thereafter opening the sterilized and sealed package containing the plates that it was determined the proper plate was not present. Absent a showing to the contrary, it is found it would have been improper to open the plate package in advance of surgery to check since such a procedure would have destroyed the sterile nature of the package. In light of the above, Respondent's actions were appropriate. As to the issue of the adequacy of Respondent's medical records on other patients, an analysis of the records showed that no discharge summary was prepared by the Respondent nor were progress notes kept by him on December 22, 23, 25, and thereafter for several weeks on an irregular basis. It may be that Respondent was not the primary physician and only the consultant, but the records fail to show who was the responsible physician and who was ultimately responsible for the patient. A consultant should always reflect in the patient records who he is and in what capacity he has seen the patient as well as his area of expertise and the actions he has taken. Here, the Respondent's failure to do so, notwithstanding some expert evidence to the contrary, renders the records kept by him inadequate. In the case of the patient who was treated by the Respondent as a consultant on a fracture of the left hip at Gateway Community Hospital between October 27, and November 10, 1983, Petitioner's experts have no quarrel with the orthopedic treatment rendered the patient by Respondent. However, Respondent failed to make proper entries in the patient's medical records and the notes therein were made by an internist. Respondent saw the patient on only four of the nine days the patient was hospitalized and in the opinion of the expert, proper practice requires a doctor, or his substitute in the absence of the doctor, to see the patient each day. It may be that this practice, which is generally accepted as appropriate throughout the medical community, is somewhat less significant in the field of orthopedic surgery. Respondent's expert indicated he did not feel constrained to see his patients each day subsequent to surgery so long as he was kept aware of the patients' conditions. While he makes progress notes, he does not dictate discharge summaries or any of the other records since these are prepared by residents based on the notes he has put in the file. The medical records for this patient show no progress notes by the Respondent on November 1, 3, 4, and 5, 1983, during which time the patient was in the hospital under the Respondent's care. In one expert's opinion, the missing of three consecutive day's progress notes renders the records below standard. Respondent indicates he saw the patient frequently right after the surgery, but once he was satisfied that her orthopedic problems were progressing satisfactorily, did not see her during the time she was being treated for medical problems unrelated to the orthopedic surgery by an internist. He did write medical notes on the first five postoperative days at the conclusion of which his postoperative care for the orthopedic surgery was completed. Were it not for her unrelated medical problems, the patient would have been released and he did see her once, (Nov.2) prior to her discharge after her medical problem had been resolved. On the basis of all the testimony, it is found that in this case, Dr. Okuboye did not fail to keep proper medical records. Respondent also saw a patient for a fracture of the left lateral malleolus, (the protuberance on both sides of the ankle joint), and is alleged to have failed to timely perform an examination of the patient; failed to have timely provided treatment; and failed to have performed a complete examination. In this case, Petitioner's expert pointed out that the chart kept by the Respondent failed to show any reference to a knee injury which was disclosed on post-treatment X-rays evaluated by him. Respondent is also alleged to have failed to have cleaned and irrigated the wound which was a part of the injury, and that he administered only an intramuscular injection of antibiotics. In the opinion of the witness, it makes no difference if there was an infection or not. It is, in his opinion; a bad practice to not debride and clean the wound. Further, he was concerned that the patient records kept by the Respondent did not reflect whether the Respondent responded to the emergency room at the time he prescribed the treatment or not. From the review of the records, he could not tell. Review of the case records by Respondent's expert showed there was no open fracture which required debridement or specific cleaning. The wound was a small abrasion. As a general rule, an injury should be more than 1/2 inch in size or have some bone showing in order to require debridement, (removal of foreign material and dead or damaged tissue). If those conditions are present, proper procedure is to clean the wound and to provide antibiotics, which the Respondent did, and the treatment recommended by him met appropriate standards. This is the better point of view. As to the records kept by the Respondent, a note regarding the action taken here was dictated by Respondent two days after the patient was discharged. The patient records show a postoperative X-ray was taken by Respondent but there is no indication in the record showing that surgery was done. The patient was admitted through the emergency room and was sent to the floor even before the Respondent was contacted. As a result, Respondent did not see the patient in the emergency room. The ER notes prepared by someone else refer to an abrasion and an approximately 1/4 inch tear in the skin. The injury was cleaned in the ER and the patient was sent to the floor after which the Respondent was advised by telephone there was a "questionable" fracture of the ankle. In response, Respondent gave orders for immobilization of the wound and administration of antibiotics. The following day, when Respondent saw the patient, he could see no open wound nor could he find evidence of a fracture. As a result, he discontinued the prescription for antibiotics and discharged the patient who, it should be noted, did not sustain an infection and who did well in his recuperation. Respondent indicates he had been told by the family physician who admitted the patient and the nurses on the floor, with whom he discussed the patient, that there was no open wound sustained by this patient. On the basis of this information, Respondent prescribed the questioned course of treatment and it would appear it was appropriate and well within standards. Between November 12, and November 22, 1983, Respondent acted as surgical consultant regarding a patient being treated at Gateway Community Hospital for a metatarsal fracture. Respondent performed an open reduction and internal fixation of the fracture and Petitioner now claims that Respondent failed to keep adequate medical records justifying the course of that patient's treatment. In that case, Petitioner does not claim improper treatment by the Respondent. However, one expert for Petitioner could not determine with any degree of certainty whether or not the procedure was required because of the absence of pre- operative X-rays and because of the inadequacy of the records for him to look at. The other Petitioner expert agreed that the Respondent took adequate care of the patient but because of the absence of postoperative film, the taking of which is a general practice within the medical community, he was not able to determine, nor would the Respondent be able to determine, whether the surgeon missed anything in performing the surgery. Respondent's evidence unequivocally contradicted the testimony of both Petitioner's experts. There were X-rays taken prior to the procedure by Respondent which showed a fracture of the outside metatarsus, (long foot bone). He proposed outpatient surgery of one day and reduced the fracture, inserting two pins as security. The postoperative X-rays show proper reduction. In fact, there are several sets of postoperative films and those taken after the holding pins placed in the fracture were removed show good reduction and full healing. Respondent discharged the patient from orthopedic care after surgery for release the next day if approved by the referring, physician, Dr. Lew. However, Dr. Lew kept the patient in the hospital one or two days after that for a reason not related to the orthopedic surgery done by Respondent. This would tend to explain the reason for there being no follow-up progress notes on the two days following the operative report done by Respondent on November 23. The failure to keep adequate notes adversely affects the entire care team not just the attending physician, as without adequate notes, the team cannot tell what is going on with the patient. The entire care is summarized in the progress notes and the failure to make notes on time leaves a hole. That cannot be said to have been the case here, however, since the orthopedic treatment of the patient was completed with the dictation of the operative report and the patient was discharged by Respondent. The patient's retention in the hospital for several days more was by another physician on a matter totally unrelated to the Respondent's treatment and Respondent had no responsibility to keep records on that portion of the patient's hospitalization. It cannot be said, then, that Respondent's records were inappropriate in this case. Respondent is also alleged to have improperly failed to perform a procedure of open reduction and internal fixation of an ankle fracture on a patient treated by him at Gateway Hospital between January 20, and January 25, 1983. In this case, Petitioner's expert questions whether the inner bone was properly reduced. X-rays taken subsequent to the procedure, show the reduction left a big gap and an irregular joint and the doctor feels the procedure, as it was done, was below standards. The other Petitioner expert concurs. There were two fractures. The smaller, did not need to be fixed since it was less than 1/3 of the ankle area and medical opinion indicates that fractures of less than 1/3 of the area should not be fixed. The other was fixed improperly in that Respondent should have used a tension band instead of a screw. If he had done so, there would have been a better fixation. Respondent's expert disagrees, pointing out that the postoperative X- rays show the position of the bones as placed by the Respondent, was quite acceptable. The failure to get an anatomic, (as developed by nature), reduction is not indicative of substandard care. It is sometimes not possible to put bones back the way they were prior to the fracture. In the instant case, when the operation and casting were done, the results were acceptable. The doctor concludes this was a very difficult operation to do and under the circumstances, the Respondent's performance met the standards within the community. Respondent's other expert agrees. This was an extremely difficult fracture of three sections of an ankle. Admittedly, Respondent's work resulted in a slight bone irregularity. A smooth reduction would be ideal, but it is unlikely that an anatomic reduction could be had in this case. No matter how skilled the work, a fracture of this kind is likely to result in some arthritis, and the failure to use a tension band, as suggested by one of Petitioner's experts, as opposed to a screw as chosen by the Respondent is a matter of choice. Neither gives better results and the Respondent's choice here, in these circumstances, was reasonable. Between December 18 and December 27, 1984, Respondent performed an open reduction and internal fixation of a fractured right hip. Petitioner alleges that Respondent performed a surgical procedure which was unnecessary, failed to properly perform the surgical procedure done, and failed to keep adequate medical records justifying the patient's treatment. In this case, Respondent inserted a Jewett nail, a non-collapsing nail, into the bone. The bone collapsed and drove the nail up into the end of the bone in an inappropriate manner. One of Petitioner's experts took issue with Respondent's use of the Jewett nail calling it an outdated device. In his opinion, the Respondent did not plan properly to have the appropriate device on hand when it was needed. His opinion is supported by that of the other Petitioner expert who pointed out that the procedure resulted in an inadequate fixation. He contends the Respondent should have used a collapsible nail and that Respondent's technique of cutting the bone after the collapse was inappropriate and resulted in a shortening of the leg. He believes this procedure was improper and falls below medical standards in the community. He was also of the opinion that Respondent's record keeping in this case was inadequate. Petitioner's expert in medical records found several problems with Respondent's records on this patient. The initial note was dictated after surgery instead of when the consult was first done. No progress notes were in the file for those days when the patient was not seen by the Respondent. There was no showing that the patient was seen by someone left in charge by Respondent in his absence. Since medical records provide a history of the case and allow the follow-on staff to provide continuation of care, the evidence showed Respondent's records in this case were below standard. Respondent's witness, Dr. Weiss, does not believe that the use of the Jewett nail is necessarily inappropriate. The fact that the Jewett nail did not work out for the Respondent in this case and required follow-up surgery, is not necessarily indicative of improper treatment. Studies of similar fractures in elderly patients show that 70% had some deviation and many similar cases show penetration of the head of the bone by the nail such as was the case here. While there are newer nails used by many orthopedic surgeons, the Jewett nail is still appropriate. The physician can avoid penetration at the time of the insertion and Respondent did so, but penetration cannot always be avoided after surgery when weight is placed on the limb. Respondent's other expert who reviewed this case stated that the fixed nail used by Respondent, if properly used, gives equally good results as the newer collapsible nail. Cutting of the bone is a well known and appropriate procedure in cases where necessary, as here. In evaluating the testimony of the experts, it should be noted that neither of the Board's experts interviewed Respondent or in any way discussed with him his professional reasons for doing what he did. Their opinions given here as expert testimony were based on evaluation of records and X-rays only whereas the opinions of Respondent's experts were based on review of the same documentation and also on interviews with Respondent who was questioned and who expounded on his medical rationale. Having analyzed the procedure done by the Respondent here and having evaluated the testimony of all witnesses, it is found that the procedure as followed by Respondent did not fall below the appropriate medical standards within the community. However, the allegation regarding Respondent's failure to keep proper medical records has been established. Respondent is a native of Nigeria, who took his medical training in England, graduating from Kings College Medical school in 1961. He interned in the United States at Bridgeport Hospital, served his residency and as a research fellow in Canada, and returned to the United States for a two year general surgery and three year orthopedic surgery residency at Albert Einstein Medical Center in New York. Respondent came to Florida in 1973 and has been in private practice as a sole practitioner since that time. He is Board eligible in orthopedic surgery and certified in neurological and orthopedic surgery by the American College of Neurological and Orthopedic surgery, not to be confused with the American Board of Orthopedic Surgery. He is also a member of the Royal College of Surgeons. At one time, Respondent practiced at Gateway Hospital in St. Petersburg where all the cases involved in the proceeding came up and where he was involved in legal action involving a matter he had handled. Respondent won that case but nonetheless, had to sue the hospital to recover his expenses. When Gateway Hospital was sold to Humana, he was again involved in litigation with the hospital to retain his privilege to practice there. Thereafter, he was called before the hospital committee regarding the instant cases in a staff privilege matter and as a result, the hospital referred them to the Department of Professional Regulation. Respondent believes two factions in the medical community seek his dismissal and the revocation of his license. He presented a detailed litany of grievances against various members of the hospital staff and others who, he contends, are engaged in a program to destroy him professionally and remove him from the practice of medicine. Since his medical privileges at the hospital have been rescinded, he can no longer accept referrals in orthopedic surgery from other members of the staff at Gateway and as a result, referrals that would ordinarily go to him, are now going to other, more favored members of the staff who retain surgical privileges. He contends his troubles, which culminated in this hearing, are both economically and racially motivated, and also involve an effort to rid the hospital of foreign trained physicians. There is no evidence to corroborate Respondent's charges and , therefore, the decision regarding his standard of practice and his record keeping must be based on the professional evidence presented at this hearing.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Respondent, Julius A. Okuboye, be reprimanded. RECOMMENDED this 23rd day of February, 1988, at Tallahassee, Florida. ARNOLD H. POLLOCK, Hearings Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of February, 1988. Appendix to Recommended Order In Case No. 86-1048 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the proposed Findings of Fact submitted by the parties to this case. For the Petitioner Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. Rejected as contra to the weight of the evidence. Rejected as contra to the weight of the evidence. Accepted to the extent that Respondent's reduction was not anatomic but rejected to the extent "it possibly could have been better treated in a cast." Rejected as contra to the weight of the evidence. Rejected as to all but last sentence which is irrelevant since the latter portion of the hospitalization discussed here was after patient had been discharged by Respondent and did not relate to orthopedic treatment. Accepted and incorporated herein. 14-16. Rejected as contra to the weight of the evidence. 17&18. Accepted and incorporated herein. 19. Rejected as contra to the weight of the evidence. 20-21. Rejected as contra to the weight of the evidence. 22. Accepted as to certain records and rejected as to others as discussed in the body of the Recommended Order. For the Respondent Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. First sentence rejected as a restatement of Petitioner's position. Remainder accepted and incorporated. First sentence rejected as above. Last sentence accepted and incorporated. Remainder rejected as a restatement of the evidence. First sentence rejected as above. Second sentence rejected as a restatement of evidence. Third through Sixth sentences accepted and incorporated. seventh rejected as a restatement of Petitioner's position. Eighth and Ninth sentences accepted and incorporated. First sentence rejected as above. second sentence accepted. Remainder accepted and incorporated. First sentence rejected as above. Remainder accepted and incorporated. First sentence rejected as above. Remainder accepted and incorporated. Accepted and incorporated. Rejected as to some cases, accepted as to others as defined in the Findings of Fact herein. COPIES FURNISHED: David E. Bryant, Esquire Suite 2000, Ashley Tower 100 South Ashley Drive Tampa, Florida 33602 Glenn M. Woodworth, Esquire Woodworth and Dugan, Chartered Wittner Centre West 5999 Central Avenue Suite 103 St. Petersburg, Florida 33710 Dorothy Faircloth Executive Director Department of Professional Regulation Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue Whether proposed rules 59B-15.001 through 59B-15.007 are an invalid exercise of delegated legislative authority.
Findings Of Fact The State Center for Health Statistics (State Center) within the Agency collects and disseminates data from hospitals and ambulatory surgery centers. One of the responsibilities of the State Center is to produce comparable and uniform health information and statistics through a Comprehensive Health Information System. § 408.05(3), Fla. Stat. The State Comprehensive Health Information System Advisory Council (CHIS) is established within the Agency to assist the State Center in reviewing the Comprehensive Health Information System and to recommend improvements for the system. § 408.05(8), Fla. Stat. In conjunction with CHIS, the agency is to develop and implement a long-range plan for making available performance outcome and financial data that will allow consumers to compare health services. § 408.05(3)(l), Fla. Stat. In 2004, Section 408.061, Florida Statutes, was amended to require health care facilities to submit hospital emergency department data, data on hospital-acquired infections as specified by rule, and data on readmissions as specified by rule. On October 20, 2004, a meeting of CHIS was held, and a discussion was held on the collection and dissemination of data relating to infection rates. A motion was approved to consider the adoption of Surgical Infection Prevention (SIP) measures and to form a Technical Workgroup for Hospital Acquired Infections (Technical Workgroup) to make recommendations to the Agency on how to report SIP measures, to review the current systems of reporting infection rates, and to determine the appropriate infection measures to report. On December 1, 2004, CHIS met and heard recommendations from the Technical Workgroup concerning the collection and reporting of SIP measures. The recommendations included developing draft rules. The agency assigned Carolyn Turner, a Government Analyst II with the Agency, to draft rules relating to the collection of SIP Measures. Ms. Turner began drafting the rules in December 2004. Ms. Turner drafted the Proposed Rules. On January 13, 2005, the Agency held a rule development workshop, which had been noticed in the Florida Administrative Weekly on December 30, 2004. During the workshop and subsequent to the workshop, the Agency received comments and suggestions for modifications to the Proposed Rules, and, as a result, the Agency made some changes to the Proposed Rules. The Proposed Rules were published in the Florida Administrative Weekly on March 11, 2005, and a public hearing was held on the Proposed Rules on April 4, 2005. The Proposed Rules provide: 59B-15.001 Purpose The rules in this section describe the requirements for reporting Surgical Infection Prevention (SIP) Measures to the Agency for Health Care Administration (Agency) for the purpose of providing comparative information to consumers. 59B-15.002 Definitions "Hospital" means an entity that is licensed per Section 395.002(13), Florida Statutes. "Reporting period" means a calendar quarter. "Eligible patient" means a selected surgical patient 18 years of age or older with no prior evidence of infection as specified by the Center for Medicare and Medicaid Services (CMS) in the Specifications Manual for National Hospital Quality Measures available on the CMS website at: www.cms.hhs.gov/quality/hospital. 59B-15.003 Exclusions State-operated hospitals. Psychiatric hospitals with no licensed acute care beds other than licensed psychiatric or substance abuse beds. Specialty rehabilitation as defined in subparagraph 59A-3.52(1)(c)2. F.A.C. Intensive Residential Treatment Programs for Children and Adolescents as defined in paragraph 59A-3.252(1)(d), F.A.C. 59B-15.004 Reporting Requirements Hospitals shall report Surgical Infection Prevention (SIP) Measures to the Agency for Health Care Administration (Agency) quarterly due on or before December 1, 2005 for the period April 1, through June 30, 2005. Thereafter, data shall be reported for each calendar quarter due 150 days following the end of the quarter. Hospitals shall report the following measures for all eligible patients regardless of type of payer. Prophylactic antibiotics received within 1 hour prior to surgical incision; Prophylactic antibiotic selection for surgical patients; Prophylactic antibiotics discontinued within 24 hours after surgery end time. The methodology used to prepare the measures shall meet the standards specified by the Centers for Medicare and Medicaid Services (CMS) in the Specifications Manual for National Hospital Quality Measures available on the CMS website at: www.cms.hhs.gov/quality/hospital. CMS standards include submission of SIP data to the Quality Improvement Organization Clinical Warehouse, providing records required for reabstraction activities, and compliance with other data quality standards as specified by CMS. Hospitals shall use the SIP methodology specified by the CMS for the applicable reporting period to determine the SIP measures reported to the Agency. If the hospital uses sampling, the hospital must follow the sampling protocol specified by CMS. Hospitals shall report the population size, rate numerator value, and denominator value as specified by CMS for each type of surgery to include coronary artery bypass surgery (CABG), cardiac surgery, hip arthroplasty, knee arthroplasty, colon surgery, hysterectomy, vascular surgery, and for all of the above surgeries overall. Hospitals shall report data separately for each location consistent with Rule 59E-7.012, F.A.C. unless reporting separately would be contrary to CMS specifications. If a combined report is submitted, report the name of the hospital and AHCA hospital identification number required in subsection 59B-15.005(1), F.A.C. for each of the hospitals included in the report. The data shall be submitted in a text file, using a tab between each data element. Start a new line for each type of surgery and for each measure. Order the rows of data by type of surgery as listed in subsection (5) with three consecutive rows of data for each measure in subsection (2) above reported for each type of surgery. Each line of data shall state the name of the type of surgery or state all of the above surgeries overall as in subsection (5) above and state the name of the type of surgery or state all of the above surgeries overall as in subsection (5) above and state the name of the type of measure as in (2) above. The rate shall be reported as a decimal number greater than or equal to zero (0) and less than or equal to one hundred (100) using the format X.XX, XX.XX, or XXX.XX as required. Report hospital contact information required in Rule 59B-15.005, F.A.C. in the order specified starting a new line beginning with contact name and contact telephone number. Hospital contact information should be reported at the beginning of the document. (8) Hospitals shall send the SIP measures by electronic mail to SIPReport@ahca.myflorida.com or, if requested in writing by the hospital and approved by the Agency to the Agency's mailing address using a 3.5" diskette or CD- ROM. The mailing address of the Agency is: Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #16, Tallahassee, Florida 32308 with the statement, "Attention: State Center for Health Statistics." If the hospital has a vendor send the SIP measures to the Agency, the hospital will direct the vendor to copy (cc) the hospital contact when the report is e- mailed to the Agency. 59B-15.005 Hospital Contact Information. Each hospital shall include the following contact information when submitting a report required in this section to the Agency for Health Care Administration: Name of hospital; AHCA hospital identification number; Reporting year in four digits; Reporting quarter as a 1, 2, 3, or 4 where 1 corresponds to the first quarter of a calendar year; Contact name; Contact title; Contact address; Contact direct telephone number; Hospital telephone number; Contact e-mail address; Contact FAX number. The hospital contact information shall be reported in a text file as described in Rule 59B-15.004, F.A.C., using a tab between each data element. 59B-15.006 Certification Each hospital shall provide certification of the accuracy of the Surgical Infection Prevention Measures including all data required in this section as provided in Section 408.061(1)(a), Florida Statutes. The certification shall be submitted to the Agency for Health Care Administration (Agency) using the Certification of Surgical Infection Prevention Measures from SIP-1, dated 2/01/2005, incorporated by reference. The certification shall be submitted to the Agency for Health Care Administration (Agency) quarterly prior to or concurrent with the submission of the Surgical Infection Prevention Measures as provided in Rule 59B-15.004, F.A.C. The Certification of Surgical Infections Prevention Measures Form will be available from the Agency website at www.ahca.myflorida.com. The signed Certification of Surgical Infections Prevention Measures may be submitted electronically to SIPReport@ahca.myflorida.com. using a pdf file with a scanned signature or mailed to the Agency address provided in Rule 59B- 15.004, F.A.C. If a combined report is submitted per subsection 59B-15.004(6), F.A.C., a separate Certification of Surgical Infection Prevention Measures Form SIP-1 must be submitted for each hospital included in the report. 59B-15.007 Administrative Penalties Failure to report as required in this section in whole or in part is subject to administrative fines as provided in Section 408.08(2) and 408.08(5), Florida Statutes, unless the hospital has been granted an extension of up to 30 days by the Agency for Health Care Administration for reasons of extraordinary or hardship circumstances such as a natural disaster or emergency event impacting the hospital. Hospitals must request the extension, in writing, prior to the due date specified in Rule 59B-15.004, F.A.C. The Proposed Rules provide that the specific authority for the promulgation of the Proposed Rules is Subsection 408.06(1)(a)2., Florida Statutes, and the law implemented by the Proposed Rules is Subsection 408.05(3)(l)1., Florida Statutes. Dr. McKalip is a neurological surgeon practicing in St. Petersburg, Florida. He has hospital privileges at Bayfront Medical Center (Bayfront) and St. Anthony's Health Care (St. Anthony's). Both hospitals would be required by the Proposed Rules to report SIP Measures to the Agency. SIP Measures would be required to be reported only on the following surgical categories: coronary artery bypass surgery, cardiac surgery, hip arthroplasty, knee arthroplasty, colon surgery, hysterectomy, and vascular surgery. Dr. McKalip performs vascular surgery of the brain, vascular bypass surgery in the neck, and, as part of his board certification, is required to be able to perform carotid artery surgery in the neck. These procedures would be included under the category of vascular surgery in the ICD-9 codes as other (peripheral) vascular shunt or bypass VASC SHUNT and BYPASS NEC.2 The Proposed Rules do not require Dr. McKalip to report the use of SIP measures; they require the hospitals in which he performs the procedures to report the SIP measures. The Proposed Rules do not require the hospitals to implement SIP measures, merely to report whether the SIP measures were implemented. Some hospitals, including Bayfront and St. Anthony's, have developed policies which require physicians practicing in those hospitals to implement the SIP measures. Data collection relating to SIP measures is not a new concept. The Centers for Medicare and Medicaid Services (CMS) have developed a methodology to collect data on SIP measures, and some hospitals are currently voluntarily reporting the use of SIP measures for certain surgical procedures. The Proposed Rules adopt the methodology developed by CMS. The Proposed Rules are supported by the Florida Hospital Association; Florida Medical Quality Assurance, Inc.; and CMS. The use of SIP measures is supported by many medical societies and organizations. The Agency views the collection of the SIP measures as the first step in a three-step process for collecting and reporting hospital-acquired infection data. The second step will involve the collection of infection rates that are acquired in the inpatient setting, and the third step will involve reporting the infection rates by physicians.
The Issue The administrative complaint charged Respondent in Count I with violating Section 458.331(1)(t), F.S., failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, and in Count II with violating Section 458.331(1)(m), F.S., failure to keep written medical records justifying the course of treatment of the patient, including but not limited to, patient histories, examination results, and test results.
Findings Of Fact At all times material, Respondent was a licensed medical physician in the State of Florida, having been issued license number ME004552. On October 24, 1988, Patient #1, a 67 year old female, presented by wheelchair at the Physicians Referral Center (PRC) emergency room of the Marion Community Hospital in Ocala, Florida. Respondent was on duty there at that time. Patient #1, arrived at the emergency room at approximately 1:50 a.m. complaining of gas, no bowel movements for three days, feeling weak, and a highly elevated blood sugar of 412 as of 5:00 p.m. the evening before. Patient #1 was accompanied by her husband, who provided some of the foregoing information. Alicia Ables, R.N., attended Patient #1 when she arrived, took her vital signs which appeared to be within normal limits, and noted in the patient medical records, at the bottom of the nurse's notes, that the patient had heart problems, diabetes, kidney problems, and was taking medications. The nurse attached to the patient's medical records a list of the patient's current medications which had been provided by the husband. These medications included Isordil, Trental, Ascriptin, Lasix, Lanoxin, Depyridamole, Capoten, Riopan Plus, Mylicon 800, Pilocarpine eye drops, Tylenol and Humulin N-100, 30 units in the morning and 6 units in the evening. Humulin N-100 is a low level prescription for insulin diabetic maintenance. Mylicon is an anti-gas preparation. The foregoing history was on the patient chart when Respondent saw the patient a few minutes later. Respondent saw the patient at approximately 2:10 a.m. At that time, only the patient, her husband, and Respondent were present in the examining room. No nurse was present in the examining room with them, but Ms. Ables testified that the absence of a nurse during a rectal examination of a female patient occurred occasionally if not regularly at PRC. Nurse Ables was not present in the examination room at the time of the examination and is without knowledge of the extent of Respondent's examination of Patient #1. The patient, who is now deceased, did not testify. The patient's husband did not testify. The only person who was present in the examining room on October 24, 1988 who did testify was Respondent, and his testimony is unrefuted that he performed a routine examination of the patient's chest, abdomen, and skin, that he also performed a rectal examination during which he found the patient's rectal vault "empty," and that he concluded that there was no fecal impaction but some retention of gas. He concluded that a soap suds enema was not warranted, given the patient's condition. He stated that despite believing that the patient had some retention of gas, he considered her to be "fixated" in her mind on the gas problem. When the Respondent examined the patient on October 24, 1988, he contemporaneously noted on her chart that her chief complaint was accumulation of gas, that she wanted a soap suds enema, and that she had spoken earlier with Dr. Sunkavalli, who had referred her to the emergency room. Dr. Sunkavalli was the patient's primary treating physician. Respondent also noted on the chart at 2:25 a.m. on October 24, 1988 that Dr. Sunkavalli would follow the patient as an outpatient. He also wrote down that he diagnosed her as having "gas retention fixation." He ordered Mylicon 80 to be administered to her. She was not given a soap suds enema, was not admitted to the hospital, and was not transferred to another hospital. Respondent did not order any laboratory tests or x-rays. Administration of the Mylicon 80 was noted on the patient's chart by a nurse other than Ms. Ables at 2:40 a.m. That nurse also noted on the patient records that Patient #1 was discharged home at 3:00 a.m., in stable condition. None of the typically observable symptoms of ketoacidosis in the patient were observed or noted by Respondent or by Ms. Ables while the patient was at PRC. Patient #1 was admitted to Citrus Memorial Hospital six and one-half hours after being discharged from Respondent's care. Three hours after her admission to Citrus Memorial, the patient died. After autopsy, the principal pathologic diagnosis and cause of death was listed as "marked three vessel artherosclerosis with large, old myocardial infarction." The gross summary reads, "Death of this 67-year old, white female was due to marked three vessel arteriosclerosis secondary to arteriosclerotic heart disease. A contributing factor was diabetic acidosis." There was also evidence of a gastro-intestinal bleed. When Patient #1's death became an issue the next day, Respondent was unable to recall the patient or his examination and treatment of her. The Respondent reviewed the emergency room records and spoke with Ms. Ables in order to recall the care he had rendered to the patient. Respondent prepared an addendum to the patient's medical records three days after he actually examined Patient #1. Only at that late date, October 27, 1988, did Respondent document a history, document that he had made a physical examination, and document that he had had a telephone consultation with Dr. Sunkavalli on October 24, 1988 while the patient was in the emergency room, and further document that he and Dr. Sunkavalli had concurred at that time in treating the patient with Mylicon. Adding the addendum was deemed appropriate under the circumstances by Marion Community Hospital personnel, and Petitioner's expert did not specifically find that adding it was inappropriate or improper. Respondent had not documented the telephone consultation with Dr. Sunkavalli or a history or physical examination of Patient #1 at the time he examined her on October 24, 1988. Neither on the date of examination/treatment nor in his later addendum did Respondent ever document that he had performed a rectal examination on Patient #1. In his testimony at formal hearing, Respondent explained and supplemented his October 27, 1988 addendum notation of a telephone conversation with Dr. Sunkavalli on October 24, 1988 to add that Dr. Sunkavalli was aware at that time of Patient #1's elevated blood sugar reading the previous evening but, hearing Respondent's examination results, Dr. Sunkavalli had recommended no further tests and had said nothing to disagree with Respondent's assessment and treatment of the patient and that while Respondent had not deferred to Dr. Sunkavalli, he had relied on the consultation. Dr. Sunkavalli was not called to corroborate or refute Respondent's testimony on this score. Jack Kareff, M.D., was accepted as an expert in emergency room medicine. He opined that, under similar circumstances, and particularly with an elderly diabetic patient, the minimal acceptable level of care, skill, and treatment of a reasonably prudent similar physician would have been to examine Patient #1's abdomen, perform a rectal examination, and perform a dipstick of urine for both glucose (sugar) and acetone. Dr. Kareff also expressed the opinion that the rectal examination should have been made to eliminate the chance of fecal impaction and that such rectal examination should have included treating a sample of fecal matter found in the rectal vault with a paper reagent to determine if there were occult blood in the patient's stool so as to rule out gastro-intestinal bleeding. Dr. Kareff testified that there is sufficient fecal matter for such a test in the rectal vault 99% of the time. He conceded that an enema might not be warranted and could be potentially traumatic, given such a patient's condition. Dr. Kareff indicated that the urine dipstick test should be done to ensure that the patient was not headed for diabetic ketoacidosis. The urine dipstick test proposed as a minimal requirement by Dr. Kareff was also described by him as actually "problematic" in that he admitted that such a dipstick test can "fool you" occasionally because not enough aceto acetate is formed to tell the patient's true condition. According to Dr. Kareff, ketoacidosis may take anywhere from 2 hours to several weeks to develop in a diabetic. On the foregoing information, the efficacy of a dipstick test was not established. Because he believed that Respondent had not done the abdominal examination, rectal examination with stool testing, and urine dipstick test, Dr. Kareff further opined that Respondent had fallen below the acceptable level of care, skill and treatment as recognized by a reasonably prudent similar physician under similar conditions and circumstances. In forming his foregoing opinions, Dr. Kareff had not had the benefit of hearing Respondent's unrefuted testimony that Respondent had, in fact, performed a rectal examination, determined that there was no fecal impaction, and found the patient's rectal vault empty. Accordingly, the record is devoid of Dr. Kareff's opinion, if any, as to what should have or could have been done as regards a fecal test when the patient's rectal vault is "empty." Dr. Kareff's opinions assumed and relied on some material contrary to the facts established in this proceeding. Dr. Kareff's opinion also relied upon much uncorroborated hearsay evidence, such as the agency's investigative report. These reliances and assumptions on Dr. Kareff's part detract from the weight and credibility of his opinion on minimal professional treatment, and therefore that opinion is not persuasive. The parties have stipulated that Respondent's medical records were inadequate. This stipulation and Dr. Kareff's opinion that Respondent failed to keep written medical records justifying the course of treatment are accepted.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Medicine enter a final order: Finding that Respondent is not guilty of violating Section 458.33(1)(t), F.S. and dismissing Count I of the Administrative Complaint; Finding that Respondent is guilty under Count II of the Administrative Complaint of violating Section 458.331(1)(m), F.S., failure to keep written medical records justifying the course of treatment of the patient, including but not limited to, patient histories, examination results, and test results; and Reprimanding Respondent for the single violation, fining him $1000.00, and requiring him to complete one basic level continuing medical education course in record keeping responsibilities and techniques within one year of the entry of the final order. DONE and ENTERED this 24th day of April, 1992, at Tallahassee, Florida. ELLA JANE P. DAVIS, 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 24th day of April, 1992. APPENDIX TO RECOMMENDED ORDER CASE NO. 90-5014 The following constitute specific rulings pursuant to Section 120.59(2) F.S. upon the parties' respective proposed findings of fact (PFOF): Petitioner's PFOF: 1-12 Except as to subordinate, unnecessary or cumulative material, accepted. 13-14 Rejected because it is largely subordinate to the facts as found in FOF 18-21. 15 Rejected as a conclusion of law but also for the reasons set forth in FOF 18-19. Respondent's PFOF: 1 Covered in the preliminary statement, the FOF, or the Conclusions of Law. Accepted as covered in the rulings on Petitioner's PFOF. Rejected as legal argument. 4-6, 20-21, 37-38, 44, 46-48 Accepted but subordinate to the facts as found. 7-8 Covered in FOF 3-4. 9 Accepted with time adjustment per greater weight of the evidence. 10-11, 13-18, 22-24, 39-40, 45, 49-63, 66 Except as to subordinate, unnecessary, or cumulative material, accepted. 12 Accepted, except as to characterization "necessary". 19 Covered in FOF 17. 25 Covered in FOF 8. 26-28 Covered in FOF 18-21. 41-42 Covered in FOF 18-21. 29, 31 Rejected as irrelevant. 30 Covered in FOF 15. 32-36, 67 These proposals are irrelevant, out of context, or misleading as stated, since Dr. Kareff did not specifically advocate a soap suds enema and Respondent did not feel it was warranted. To the extent necessary, the subject matter is covered in FOF 7-9, 14-17, and 18-22. 43 Covered in FOF 7. 64-65, 68 Rejected as unnecessary and/or unproven. COPIES FURNIISHED: Louis Kwall, Esquire Gross and Kwall, P.A. 133 North Ft. Harrison Avenue Clearwater, Florida 34615 Susan E. Lindgard, Esquire Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Dorothy Faircloth Executive Director Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792
The Issue The issues in these consolidated cases are whether Respondent committed the violations charged in four Administrative Complaints and, if so, what is the appropriate discipline.
Findings Of Fact The Department has regulatory jurisdiction over licensed chiropractic physicians pursuant to section 20.43 and chapters 456 and 460, Florida Statutes. In particular, the Department is authorized to file and prosecute an administrative complaint against a chiropractic physician after a probable cause panel (PCP) of the Board determines there is probable cause to suspect a licensee has committed a disciplinable offense, and provides direction to the Department on the filing of an administrative complaint. At all times material to the allegations in the Administrative Complaints, Dr. Aderholdt has been licensed to practice chiropractic medicine in Florida, having been issued license number CH 7814. He was first licensed on January 6, 2000. He practices in an office in Bradenton, Florida. Vax-D Therapy Three of the four Administrative Complaints involve patients of Dr. Aderholdt who received Vax-D therapy. The complaints are not directed to the provision of Vax-D therapy itself, or to any other treatments provided by Dr. Aderholdt. In all four cases, the patients generally spoke well of the chiropractic care they received from Dr. Aderholdt and the manner in which they were treated by him and his office staff. Vax-D therapy is a modality using the Vax-D model for decompression of the spinal discs and spinal structure. It is used to treat a range of issues associated with low back pain, including herniated, degenerated, and bulging discs. The Vax-D model is the originator of this technology; it was the first spinal decompression device. It is a large computerized moving table. It can be programmed to provide specific axial or distractive loading. The table moves in and out, pumping nutrients at the discs. Some research shows that it can actually pull discs away from where they are causing irritation on nerves and the spinal cord. The Vax-D model is FDA-cleared for use, and the literature supports its efficacy. The Vax-D model is an expensive piece of equipment. The price range for the initial purchase is between $100,000 and $150,000, with ongoing expense thereafter for maintenance and updates. Vax-D therapy is one of the most expensive forms of therapy, if not the most expensive, in the chiropractic profession. Other models coming out after Vax-D, as well as other tools, arguably can be used for similar purposes. However, as Petitioner’s expert readily acknowledged, Vax-D is the “Rolls Royce. It’s a really nice tool.” Vax-D spinal decompression is not covered by Medicare. In fact, when it comes to chiropractic care, Medicare has never covered anything besides spinal adjustments. Coverage for Vax-D treatment by private insurance companies is rare. In 2012, Dr. Salvatore LaRusso presented a study on spinal decompression to the profession, before the Federation of Chiropractic Licensing Boards, to inform state regulators of issues associated with Vax-D therapy. The one regulatory concern he reported was that some physicians were improperly billing Vax-D as a surgical decompression procedure, when it is plainly not surgery; it is an alternative to surgery, properly billed as a non-surgical decompressive tool or traction device. Dr. LaRusso’s study also made findings on the common methods of packaging and selling the service, and the range of charges observed. He found that most practitioners providing Vax-D therapy were selling the service as a cash item in their practice, with payment up front often required. The common model was to sell a package with a certain number of visits, with or without additional services included. Dr. LaRusso found that the per-visit charges ranged from $150 to $450, depending on the ancillary services added to the decompression. Dr. Shreeve does not have any issue with the use of or charges for Vax-D therapy. Dr. Aderholdt offers Vax-D therapy pursuant to a Vax-D Therapy Payment Plan agreement (Vax-D Agreement), which is comparable to the multi-visit packages that Dr. LaRusso’s study found to be common. After initial consultation, with intake forms, patient history, x-rays, evaluation, and examination, if a patient is determined to be appropriate for Vax-D therapy, Dr. Aderholdt will give his treatment recommendations and then turn the patient over to his office staff to address the financial aspects. If the patient wants to proceed with Vax-D therapy, the Vax-D Agreement will be reviewed and signed. Patients A.M., R.O., and P.D. each received Vax-D therapy, pursuant to signed Vax-D Agreements. The terms of the Vax-D Agreements for the three patients were the same. Patient B.O. wanted Vax-D therapy, but she was determined to not be an appropriate candidate for it. The Vax-D Agreements in evidence for Patients A.M., R.O., and P.D. provided that the named patient committed to 25 to 28 Vax-D therapy sessions, for $250.00 per session. The total amount that the named patient agreed to pay Dr. Aderholdt for 25 to 28 sessions was $5,500.00, which computes to an actual per-session cost of between $196.43 (for 28 sessions) and $220.00 (for 25 sessions). For the agreed price for 25 to 28 sessions, the Vax-D Agreement provided the following treatment package: at each session, the patient would receive 30 minutes of Vax-D therapy, 30 minutes of full range interferential electrical muscle stimulation (EMS), 15 minutes of hydro-massage therapy, and manipulation (adjustments) by the doctor if needed. The first set of x-rays was also included. Dr. Aderholdt requires an up-front payment for the Vax-D therapy package. For patients who want Vax-D therapy but need help coming up with the funds, Respondent’s office staff has put the patients in touch with Care Credit, which is a medical credit program. If a patient applies and is accepted, Care Credit will finance the cost without charging interest to the patient if the loan is repaid within one year. Care Credit apparently charges a fee to Respondent when credit is extended, similar to the fees charged to merchants by credit card companies for credit card purchases. No evidence was presented regarding Care Credit’s approval criteria or how widely this method is used. All that is known about Care Credit from the record evidence is that two patients who received Vax-D therapy applied for Care Credit and were approved. The other Vax-D patient charged half of the agreed price on a Visa credit card the first day of treatment, and charged the other half after 15 treatment sessions. Patient A.M. From the end of July 2013 to early February 2014, Dr. Aderholdt treated Patient A.M., then a 66-year-old female, for lower back pain and hip pain. Patient A.M. had tried other treatments and had seen chiropractors before, but reported that her pain kept getting worse. As shown by A.M.’s medical records, A.M. was first seen by Respondent on July 29, 2013. That day, A.M.’s intake form, patient history, and x-rays were taken and evaluated, and A.M. was examined by Respondent. Respondent then formulated A.M.’s initial treatment plan. Respondent recommended Vax-D therapy, along with chiropractic adjustments, EMS, and hydrotherapy. The initial treatment plan specified a two- session per day protocol for the first two to three weeks. On July 30, 2013, A.M.’s husband, J.M., signed the Vax-D Agreement (in the space for Patient Signature). J.M. did not remember signing the Vax-D Agreement, but both he and A.M. identified his signature on the Vax-D Agreement. A.M. was named in the agreement as the patient who committed to 25 to 28 Vax-D therapy sessions and agreed to pay $5,500.00 for those sessions. Respondent did not require full payment of the agreed price prior to treatment. Instead, he accepted payment of one- half ($2,750.00) of the Vax-D therapy package price, which was charged on A.M.’s or J.M.’s Visa credit card on July 30, 2013. In accordance with the initial treatment plan, Patient A.M. received two treatment sessions per day beginning July 30, 2013, in the morning and afternoon, for nearly three weeks. After 15 treatment sessions--more than half of the 25 to 28 sessions covered for $5,500.00--the balance of $2,750.00 was charged on A.M.’s or J.M’s Visa credit card. Between July 30, 2013, and February 3, 2014, Patient A.M. had more than 60 Vax-D therapy sessions--approximately 64 total sessions. A.M. initially testified with a fair degree of confidence that she thought she had about 30 treatment sessions, until she reviewed her prior statement made to Petitioner. A.M. testified that at every session, she received Vax-D decompression therapy, hydrotherapy, adjustments “up and down” her spine, and ice packs. She left every session feeling better, with relief from her pain. The relief was temporary, however; she said the pain would come back after a few hours. After 29 sessions, having received all of the treatment sessions covered by the Vax-D Agreement, A.M. started paying additional amounts for more Vax-D therapy and the other ancillary services that she continued to receive. For approximately 35 additional treatment sessions beyond those covered by the Vax-D Agreement, A.M. made seven additional payments in the total amount of $2,226.00. In all, A.M. paid $7,726.00 for approximately 64 Vax-D therapy sessions. Rounding down to an even 60 sessions, she paid an average of $128.77 per session. A.M. was covered by Medicare at the time of her treatment. She did not have any private “Medicare supplement” health insurance. At some point, the subject of Medicare coverage came up. The details of what was said, when, and to whom were not clearly established. The only fact clearly established was that Dr. Aderholdt did not bring up the subject. Patient A.M. testified that Dr. Aderholdt did not talk to her about payment when she first visited, but that she and J.M. asked him, “Does Medicare cover this,” and he said, “Yes.” J.M. said that Dr. Aderholdt did talk to them about payment, saying “we need to do so many treatments and we should pay so much money.” J.M. said that they asked, “Will Medicare take care of it?” Dr. Aderholdt answered, “Yes, we will bill Medicare.” J.M could not say whether he asked about billing Medicare before or after he signed the Vax-D Agreement, since J.M. did not remember signing the Vax-D Agreement. When Dr. Aderholdt was asked if he told A.M. her treatments would be covered by Medicare, he answered, “No, I don’t believe I did, no.” As an interesting contrast, Patient R.O. testified that Dr. Aderholdt told him Medicare would not cover treatment under the same Vax-D Agreement; Dr. Aderholdt does not believe he made that statement, either. In the middle of the spectrum, Patient P.D. testified that Respondent never said anything to her about insurance coverage or financial arrangements. He would only talk about treatment, turning P.D. over to the office manager or billing person to address the financial issues. This version is consistent with Respondent’s testimony that he does not address “the money thing” with patients. Instead, he said he assesses x-rays, takes patient histories, performs the evaluation and examination, and ultimately formulates the recommended treatment plans, whether Vax-D or something else. Then he turns the treatment plans over to his staff to address the financial issues with the patients. A.M. and J.M. did not demonstrate a clear and certain recollection of what they asked Dr. Aderholdt or exactly what he answered. Indeed, both J.M. and A.M. could not remember most every other detail about A.M.’s treatments, often confidently stating details that were shown to be wrong by more than a little, including how many treatment sessions, and how much was paid. For example, Patient A.M. initially reported that she had paid $13,179.00 to Dr. Aderholdt, when the total was $7,726.00. The undersigned cannot find--without hesitancy--that Dr. Aderholdt made any representation to J.M. and A.M. regarding Medicare coverage before J.M. signed the Vax-D Agreement by which A.M. committed to the Vax-D therapy package. Dr. Shreeve made the point well that it is difficult to resolve this kind of he said-she said conflict, although he made the point while confusing Patient A.M. (who claimed Respondent said there would be Medicare coverage) with Patient R.O. (who claimed Respondent said there would not be Medicare coverage), in the following exchange: Q: With Patient RO, what’s your understanding of what Dr. Aderholdt told him regarding Medicare reimbursements? A: Counselor, I’m going to tell you that the investigative record shows that the patient stated that Aderholdt told him that they would be paid, is what my recollection is. And, yet, that’s not something that weighs heavily on my mind because I wasn’t there. This becomes a “he said, she said.” He said he didn’t; he said he did. I can’t get into that fight. That’s not an issue for me. (Jt. Ex. 12 at 35). (emphasis added). Respondent (or his staff) may have told A.M. and J.M., when they asked about Medicare, that the office would complete and submit the Medicare claim forms. Respondent (or his staff) may have told A.M. and J.M., when they asked, that Medicare proceeds paid on the Vax-D therapy package would be refunded. But it would be unreasonable, on this record, to find that Respondent misrepresented that Medicare would provide full coverage, or that Respondent schemed to induce A.M. and J.M. to sign up for Vax-D by guaranteeing that Medicare would pay back everything, when Respondent did not even bring up the subject.8/ The Administrative Complaint alleges that on one or more occasions, Respondent did not submit Medicare claims for Patient A.M.’s treatment. Petitioner has apparently abandoned this allegation; its PRO has no proposed finding identifying any dates of service for which claims were not submitted. The Medicare claim forms for Patient A.M. were compiled by Petitioner’s counsel for use in taking Respondent’s deposition, and are attached as deposition exhibit 2. The evidence is difficult to cull through, as there are 84 separate pages of claims and they are not in chronological order; they start out in chronological order, but then jump forward two months, then continue jumping around on dates, back and forth and back again. As best can be determined, all service dates shown in Patient A.M.’s medical records appear to be accounted for by corresponding claim forms. It appears that one claim form may have a clerical mistake, identifying the date of service as August 3, 2013, when there was no treatment session that day; the actual service date may instead be September 4, 2013, which is the date the claim form was submitted. The Medicare claim forms in evidence demonstrate that claim forms for A.M.’s treatments were regularly submitted, either on or very shortly after the dates of service. The evidence is insufficient to prove that Respondent did not submit Medicare claims for Patient A.M.’s treatment.9/ The Administrative Complaint contains no allegations regarding the disposition of the Medicare claims, although it does allege that Patient A.M. received no reimbursement from Respondent for Medicare payments. Petitioner’s expert seemed to be under the impression that Respondent received Medicare payments, because he criticized Respondent for not providing reimbursement to Patient A.M. Respondent testified that he has received no payments from Medicare for A.M.’s treatments, and Petitioner acknowledges in its PRO that Medicare has not made payments to Respondent. Acknowledging that the Administrative Complaint allegation has not been established, Petitioner instead proposed a finding (not alleged in the Administrative Complaint) that all of A.M.’s Medicare claims submitted by Respondent were rejected and payment was denied. No evidence was offered to prove the actual disposition of the 84 pages of Medicare claims submitted for A.M.’s treatments. Instead, the only record evidence of Medicare adjudications on any claims for A.M. is a group of explanation of benefits forms (EOBs) attached to a March 6, 2014, letter from Patient A.M. to Petitioner’s investigator, which is a deposition exhibit. Patient A.M. identified the small handful of EOBs attached to the March 6, 2014, letter as EOBs she had at that time, reporting on the disposition of Medicare claims submitted by other providers during the same time period as her treatments with Respondent. The EOBs reported, as to each claim, whether the claim was covered in whole or in part; and, if covered, what amount was paid, or, if not, why not. There were no EOBs for claims submitted by Respondent’s office. Patient A.M. was not asked for, and did not offer, any additional EOBs at her deposition. If, in fact, all of the Medicare claims submitted by Respondent were rejected and payment denied, then there would be a stack of EOBs explaining why each claim was denied. On this record, the evidence is insufficient to make any finding as to the outcome of the Medicare claims submitted for Patient A.M.’s treatment. There is no evidence proving whether the claims were denied, approved, or simply never acted on by Medicare. A separate allegation in the Administrative Complaint is that Patient A.M. requested copies of the Medicare claim forms submitted by Respondent’s office for her treatment. Patient A.M. said that she made verbal requests to Respondent’s office staff for the Medicare claims on more than one occasion, and the parties stipulated that Patient A.M. made these requests. Respondent’s office should have responded by giving Patient A.M. copies of the Medicare claims. Dr. Aderholdt said that he was not aware that Patient A.M. had requested copies of her Medicare claim. But it is his responsibility to ensure that his staff promptly responds to requests by patients for insurance claim forms. In the course of Petitioner’s investigation, the Medicare claim forms for Patient A.M. were provided to Petitioner (according to the investigator’s report, on May 16, 2014). It is unknown whether a set of the claim forms was provided to A.M. at that time. She is entitled to a copy of the claim forms if she has not already been given a set. Respondent should have verified that Patient A.M. has received the claim forms she requested, or, if not, provided them to her. Finally, the Administrative Complaint alleges that on the Medicare claim forms for A.M.’s treatments on August 6, 2013, and December 11, 2013, Respondent utilized Current Procedural Terminology (CPT) code 98941, which is the code for adjustments to three or four regions of the spine. However, Respondent’s Subjective, Objective, Assessment and Plan notes (referred to as SOAP notes) for those dates identify spinal adjustments to L3, L4, and L5, which are in a single region--the lumbar region. Beyond the SOAP notes, however, Dr. Aderholdt’s notes for Patient A.M.’s morning session on August 6, 2013 (there were two sessions that day), show multiple adjustments, not only to the lumbar region, but also, to the sacrum and ilium. Dr. Aderholdt’s notes for December 11, 2013, show multiple adjustments to the thoracic, lumbar, and sacrum regions. At hearing, Dr. Shreeve identified the five spinal regions as follows: “a region would be considered cervical, thoracic, lumbar, sacrum, ilium.” (Tr. 106, lines 21-22). Based on his testimony, and considering all of Patient A.M.’s medical records, there were multiple adjustments to three spinal regions on both days identified in the Administrative Complaint.10/ The Administrative Complaint has no other factual allegations regarding CPT code issues in connection with Patient A.M.’s treatment. The complaint pointedly identified one specific CPT code that was used on two specific dates, but was allegedly not supported by SOAP notes for either date. At hearing, Dr. Shreeve attempted to expand the factual allegations regarding CPT coding issues by questioning other CPT codes shown on A.M.’s patient ledger. Dr. Shreeve’s criticism was improper, not only because he strayed beyond the allegations in the Administrative Complaint, but also, because the criticism was based on his misunderstanding of what Dr. Aderholdt’s patient ledgers portray. In particular, Dr. Shreeve was critical of CPT code 99212 entries (for focused patient examinations) on A.M.’s patient ledger, without use of modifier code -25. He said that these repeated entries of CPT code 99212 were inappropriate without use of modifier code –25, to indicate they should not be considered for payment, because they are redundant with other CPT treatment codes that include examination. Dr. Shreeve should have reviewed the actual Medicare claim forms to look for the modifier codes, because the CPT code 99212 entries do, in fact, add a modifier of -25. The modifier code conveys information to the third-party payor, as Dr. Shreeve acknowledged, regarding whether or how payment should be made. The modifier codes need to be used, when appropriate, on the Medicare claim forms, and they were used just as Dr. Shreeve said was appropriate. The modifier codes do not appear on Dr. Aderholdt’s patient ledgers because they are not claim forms sent to third- party payors, nor are they bills sent to patients. Instead, a patient ledger, as used in Respondent’s practice, is an internal practice management tool to account for and track everything associated with treating patients: how many examinations, how many adjustments, how many Vax-D treatments, how many ice packs, and so on. Dr. LaRusso explained that this is a perfectly reasonable use of patient ledgers, and is a common practice among physicians. The usage statistics are analyzed for practice management, for such purposes as making changes in the services or treatments and stocking supplies. Dr. Shreeve admitted that he assumed Respondent’s patient ledgers reflected the exact CPT coding used on insurance claims and bills sent to patients. The evidence refuted that assumption. Modifier codes were used on the Medicare claims. And Dr. Shreeve admitted he saw no evidence that Respondent’s patient ledger for A.M. was ever sent to her as a bill, or that any patient ledgers were ever sent to any patients as bills. Dr. Shreeve also admitted that there is no standard for patient ledgers, much less a regulation mandating the contents and use of patient ledgers. As he put it, he could go to 1,000 chiropractic offices and find 1,000 different variations in what is called a patient ledger. Dr. Shreeve would like to see a standard adopted for “patient ledgers,” but his aspiration simply underscores that there is no standard now; Respondent’s practices cannot be judged against or held to conform to a non-standard, non-regulation.11/ In somewhat stream-of-consciousness fashion, untethered from the Administrative Complaint, Dr. Shreeve interjected a number of other comments about Dr. Aderholdt’s practices related to Patient A.M., such as the adequacy and legibility of his medical records and the quality of x-rays. He raised questions about Dr. Aderholdt’s compliance with trust accounting requirements in connection with payments for A.M.’s Vax-D therapy, and Dr. Aderholdt’s compliance with obligations in connection with Petitioner’s investigation. None of these factual matters were alleged in the Administrative Complaint, and none of the corresponding statutory or rule provisions implicated by Dr. Shreeve’s open-ended commentary were charged in the Administrative Complaint. No findings can be made on matters not alleged, and violations not charged, in the Administrative Complaint. Moreover, there is no competent evidence fleshing out any of these matters, because they were not alleged, charged, or identified in the Joint Pre-hearing Stipulation as issues of fact or law to be litigated. Patient B.O. Between April and June 2013, Respondent treated B.O., then a 78-year-old female, for back and neck pain. B.O. is married to R.O. They both went to Respondent’s office on the same day for their initial consultation. B.O. completed intake forms, had x-rays and patient history taken, and was examined by Respondent, similar to R.O. Whereas R.O. was determined to be a candidate for Vax-D therapy, B.O. was not. Unlike for the Vax-D therapy plan, there was no protocol calling for a certain range of sessions needed and no set payment correlated to a planned number of sessions for B.O.’s recommended treatment plan that called for adjustments, hydrotherapy, and ice packs. At the time of her treatment, B.O. had Medicare coverage and a “Medicare supplement” insurance policy through Horizon Blue Cross and Blue Shield of New Jersey (Horizon). As was his practice, Respondent had B.O. address the financial aspects of the treatment he recommended with his office staff. Upon review of B.O.’s insurance coverage, B.O. was informed by Respondent’s staff that Horizon would probably cover the cost of her treatment that exceeded her copay. The staff determined that, although it was possible Horizon would apply its lower in-network copay of $15.00 per visit, there was no guarantee that Horizon would not consider Respondent out-of- network, with a copay of $25.00 per visit. Therefore, B.O. was charged $25.00 per visit. She paid that amount per visit, although sometimes she did not pay at all on one or more visits, and would catch up at a subsequent visit. B.O. received treatments on 23 occasions. B.O. experienced some relief from her pain as a result of those treatments.12/ For those 23 visits, B.O. paid a total of $575.00 in copays. After B.O. had stopped going to Dr. Aderholdt for treatment, Horizon determined that its lower in-network copay of $15.00 per visit applied. The total copay amount should have been $345.00 for 23 visits. The difference is $230.00. The Administrative Complaint alleges that Respondent “overcharged” B.O., misrepresenting that her copay was the out- of-network charge, to exploit her for financial gain. This allegation was not proven. Respondent made no representation. The representations of his staff, as described by B.O., were not shown to be the product of anything other than a good faith attempt to determine the undeterminable details of insurance coverage. There is no evidence to support the allegation that B.O. was intentionally charged more than she should have been charged, based on the information available at the time. On this point, the expert testimony was in lockstep: figuring out insurance coverage details is a “nightmare.” It is virtually impossible, according to both experts, to obtain sufficient information to make a correct determination for a new patient on such issues as in-network versus out-of-network, because, as they agreed, the insurance coverage details keep changing. “Now, you can be in network today and they can decide you’re out of network tomorrow. And then you can be out of network and then they decide you’re in network, and they don’t tell you.” That’s--that makes no sense.” (Dr. Shreeve, Tr. 131). In fact, when asked how he determines if a patient is out-of-network, Dr. Shreeve responded: “Counselor, I don’t. I leave that to the patient. I run a cash practice. I give them a bill. We’ll help them fill out a health insurance claim form, if they need it. But they pay us when they receive the service.” (Tr. 130). The Administrative Complaint also alleges that Respondent billed Horizon for medical visits by Patient B.O. that did not occur. There is no credible evidence of this allegation; the evidence is to the contrary. Petitioner contends in its PRO that Respondent billed B.O. for treatments received on June 3, 7, 11, and 14, 2013, when B.O.’s appointments were cancelled on those days. The record citations offered by Petitioner fail to support this proposed finding. Instead, B.O.’s bank records directly refute the proposed finding, and corroborate Dr. Aderholdt’s treatment notes and the SOAP notes that detail B.O.’s treatment on those four days.13/ In addition to B.O.’s bank records, B.O.’s patient records include the “merchant copy” receipt for a debit card payment on June 14, 2013. The receipt shows that a $50.00 payment was made at Dr. Aderholdt’s office on June 14, 2013, and it bears the clear signature of B.O. B.O.’s accusation that she did not go to Respondent’s office for treatment on these four days is belied by the documentation that she personally went there and paid the copay charges for her treatments on those four days ($50.00 check on June 7 for two copays; $50.00 debit card payment on June 14 for two copays). Petitioner’s own expert, Dr. Shreeve, conceded that this evidence refutes B.O.’s accusation that her insurer was billed for treatment on four days when she did not go to Respondent’s office for treatment. A separate problem proving this allegation (besides B.O.’s false accusation) is that there is no evidence to prove what was billed to Horizon for B.O.’s treatments. There is no evidence in the record of claims submitted by Respondent’s office to bill Horizon for B.O.’s treatment. In pre-hearing discovery proceedings, shortly before hearing, Petitioner sought to compel production of Medicare claim forms or Horizon claim forms submitted by Respondent’s office. However, Petitioner declined an Order compelling production that was offered along with additional time to pursue this evidence. Instead, Petitioner chose to go forward with the hearing on the basis that there were no such records (as Respondent represented). Another allegation in the Administrative Complaint is that B.O. was not given a copy of her medical records upon request. B.O. testified that she made several verbal requests to two staff persons at Respondent’s office, Lisa14/ and Amanda, for her medical records. She said she was given a copy of her patient ledger, but nothing more. B.O. and R.O. then mailed a letter addressed to Respondent that they jointly wrote on December 31, 2013, requesting their medical records and updated patient ledgers. Respondent said that he was never informed of any verbal requests for records, nor did he believe he ever saw the letter that was mailed to him. Indeed, B.O. handwrote on her file copy of the letter, provided to Petitioner’s investigator: “Letter to Dr. who probably didn’t see – no response to date.” The evidence is clear and convincing that Respondent has failed in his obligation to promptly respond to B.O.’s requests for medical records. However, there is no evidence that Respondent was aware of the requests before the investigation and intentionally refused to comply, or that he ever instructed his office staff to ignore such requests. But even though the evidence only establishes that Dr. Aderholdt’s staff failed to promptly respond to requests for medical records, the obligation to ensure these patient requests are promptly addressed remains Dr. Aderholt’s responsibility. It is clear that his office procedures require serious overhauling, as both Dr. Aderholdt and his expert acknowledged. It is unknown if B.O.’s medical records were provided to her when they were produced by Respondent’s counsel during the investigation.15/ In her deposition, when B.O. was asked if she had gotten the records from Respondent’s office yet, she said “not from them.” Among other remedial steps in the aftermath of this proceeding, if B.O. and R.O. do not already have copies of their medical records and updated patient ledgers as they requested long ago, Respondent must provide them. It is concerning that he did not come to this hearing with proof that he had provided B.O. and R.O. with the records they had requested or confirmed that they already had a copy. Lastly, the Administrative Complaint alleges that Respondent received payment from Horizon for B.O.’s treatment, but has not provided a refund. There is insufficient evidence to determine whether B.O. is entitled to a refund. The only information regarding the extent to which Horizon covered B.O.’s treatment is the information in the EOBs issued by Horizon after B.O.’s treatment ended, identifying amounts that would be covered and reporting payments to Respondent. For B.O.’s treatments, Horizon paid $1,770.00 to Respondent. What is unknown is whether B.O. owed more for her treatments than what Horizon paid. Dr. LaRusso reasonably opined that the receipt of an insurance payment would not generate an obligation for a patient refund if the payment is applied to a balance due by the patient. No evidence, methodology, or calculation was offered to prove that after Horizon’s payment was applied, a refund was owed to B.O. As noted previously, Respondent’s “patient ledger” is an internal practice management tool that does not function as an accounting of what a patient or insurance company owes. However, the patient ledger for B.O. reflects a total amount of $5,575.00 in services provided to B.O. Application of the Horizon payments of $1,770.00 and B.O.’s payments of $575.00 would reduce the patient ledger amount by less than half. Again, this is not to say that Patient B.O. owes the remaining patient ledger amount, but it is at least a point of reference suggesting the possibility that the Horizon payment did not cover all of B.O.’s treatment costs. Viewed another way, all B.O. paid for 23 treatment sessions was $25.00 per visit. B.O. was informed at the outset that she would not be charged for the full treatments she would be getting, because Horizon would “probably” cover her treatment except for the copay. Although she paid $230.00 more than the amount Horizon ultimately applied as copays, if B.O. owed $230.00 or more for treatment provided that was not covered by Horizon’s payment, then no refund would be due. Patient R.O. As noted previously, Patient R.O. is Patient B.O.’s husband. Like B.O., R.O. was treated by Respondent from April through June 2013. R.O., then a 64-year-old male, sought treatment for severe back pain. R.O. completed the intake form, had x-rays and patient history taken, provided detailed records of recent treatments and surgeries (including back surgery), and was evaluated and examined by Dr. Aderholdt. Dr. Aderholdt determined that R.O. was a candidate for Vax-D therapy. Respondent’s then-office manager, Lisa, took over to address the financial aspects of the recommended treatment. R.O. informed Respondent’s staff that he could not afford to pay $5,500.00 up front. R.O. was given contact information for Care Credit. He called Care Credit, then submitted an application. R.O.’s application was approved, and Care Credit agreed to finance the cost of Vax-D therapy without charging interest if the amount was paid off within one year. R.O. accepted the loan, and the result was that Care Credit paid Respondent $5,500.00 minus a fee absorbed by Respondent, similar to fees by credit card companies charged to merchants for sales using their credit cards. R.O. testified that he has paid off the Care Credit loan. R.O. signed the Vax-D Agreement, by which he committed to 25 to 28 Vax-D therapy sessions at $250.00 per session, for a total payment amount of $5,500.00. His Vax-D Agreement included the treatment package detailed in paragraph 13 above. R.O. testified that during the time of his treatment by Respondent, he had health insurance coverage with Medicare and Horizon (the private Medicare supplement insurance coverage that B.O. also had). He also had Tricare for Life, but said that that coverage would not have been applicable. R.O. recalled that Respondent told him that none of his insurance plans would cover the Vax-D therapy. As previously noted, Respondent does not believe he discussed insurance coverage with R.O., as that is not his standard practice. Regardless, R.O. had no expectation of insurance coverage. R.O. found the Vax-D therapy helpful in relieving his pain. He felt better after every treatment and wanted to continue. Rather than stopping after the 25 to 28 sessions included in the Vax-D Agreement, R.O. had a total of 40 treatment sessions. However, at some point, Respondent’s office manager informed R.O. that he needed to pay for additional sessions. R.O. said he could not afford to pay more, and discontinued treatment. After R.O. discontinued his treatments, he received an EOB from Horizon, stating that Horizon had paid a total of $5,465.84 in claims for both R.O. and B.O. According to the EOB summary, as noted above, $1,770.00 was paid to Respondent for treatments to B.O. The rest--$3,335.84--was paid to two providers for services to R.O. (A minor discrepancy is noted, in that Petitioner’s PRO stated that $3,335.00 was paid to Respondent for treatments to R.O.; however, the EOB reports that $10.84 was paid to a different provider (“Ga Emergency Phys”) for services provided to R.O. Thus, the actual total payment to Respondent for R.O.’s treatment was $3,325.00). The total amount paid to Dr. Aderholdt for R.O.’s 40 Vax-D therapy sessions, including Horizon’s payments, was $8,825.00, an average of $220.63 per session. R.O. believes the insurance payment should be paid to him as reimbursement for part of the $5,500.00 he paid. But that payment was for 25 to 28 sessions. The insurance payment was reasonably applied to the additional amounts due for R.O.’s sessions that were not covered by the $5,500.00 payment. No reason was offered as to why Dr. Aderholdt should not have applied the insurance payment to charges owed for the 12 sessions that were not covered by the Vax-D Agreement. Chiropractic physicians are not required to provide free care. Dr. Shreeve admitted that he does not provide chiropractic care to patients for free. As found above with respect to Patient B.O., R.O. joined B.O. in submitting a written request to Respondent for their medical records and updated patient ledgers by letter dated December 31, 2013, although Respondent said that he did not see the letter that was mailed to him. The findings above with respect to B.O., as one party to the joint written request, apply with equal force to R.O. as the other party to the joint written request. The Administrative Complaint also included an allegation that Respondent failed to practice chiropractic medicine at an acceptable level of skill, care, and treatment, charged as a violation under section 460.413(1)(r). This was the only charge in any of the Administrative Complaints that was based on the care provided by Dr. Aderholdt. The allegation was that adjustments indicated as having been performed on R.O. were physically impossible. However, at hearing, Petitioner’s expert retreated from the allegation, agreeing that the procedure in question was plausible. As a result of his concession, Petitioner’s PRO abandoned the charge, stating, “Petitioner is no longer pursuing discipline for the alleged violation of section 460.413(1)(r).” Pet. PRO at 4. Patient P.D. In March and April 2013, Respondent treated Patient P.D., then a 62-year-old female, for back pain. After completing intake forms and patient history, Patient P.D. was x-rayed, then examined and evaluated by Dr. Aderholdt, who determined that P.D. was a candidate for Vax-D therapy. Dr. Aderholdt turned P.D. over to his then-office manager, Lisa, to address the financial aspects of his recommended treatment plan. P.D. confirmed that Dr. Aderholdt never discussed financial issues or insurance with her. P.D. signed the Vax-D Agreement on March 8, 2013, the same day that she completed a Care Credit application that was approved for $5,500.00. P.D. paid off the Care Credit loan in 11 months, at $500.00 per month, so the loan was interest-free. At the time of the treatments, P.D. was not yet eligible for Medicare. She had insurance coverage through Blue Cross Blue Shield of Michigan (Blue Cross). P.D. said that Lisa, the office manager, told her that she would file claims with Blue Cross. Thereafter, P.D. had 33 Vax-D therapy sessions. P.D. was pleased with the Vax-D therapy. She found it effective in relieving her pain. P.D. learned at some point from Blue Cross that several months after her treatment ended, Blue Cross paid Respondent for a portion of P.D.’s treatment. No evidence was offered to prove the details of the Blue Cross coverage, such as EOBs explaining what was covered and what was not. P.D. said that she contacted Respondent’s office and spoke with staff multiple times before Respondent provided her reimbursement in the full amount of the Blue Cross payment. Respondent refunded $946.45 on April 8, 2015, and $1,046.45 on April 10, 2015, for a total of $1,992.90. P.D. acknowledged that she has been fully reimbursed and is owed nothing further. The Administrative Complaint includes an allegation that Respondent improperly utilized CPT “billing codes” 99204 and 99212 for P.D.’s first session on March 6, 2013. Dr. Aderholdt admitted that for March 6, 2013, P.D.’s patient ledger incorrectly lists both CPT code 99204 (for a comprehensive examination for a new patient), and CPT code 99212 (for a focused examination for an established patient). The first CPT code should have been the only one entered on this day. The second code was entered by mistake. Although Dr. Aderholdt admitted the error made in the patient ledger, there is no evidence that the erroneous CPT code was “utilized” for billing purposes. No evidence was presented that both CPT codes were submitted by Respondent in a claim for payment to Blue Cross (and Petitioner did not charge Respondent with having submitted a claim to P.D.’s insurer for a service or treatment not provided). No evidence was presented of the actual claims submitted to Blue Cross. No evidence was presented to show that P.D. was ever sent a bill utilizing the referenced CPT codes. The error recording an extra CPT code on P.D.’s patient ledger might throw off Respondent’s internal practice management statistics, but there is no evidence that the admitted CPT coding mistake on the patient ledger was repeated in any claim or bill submitted to anyone. Expert Opinions Considering All Four Cases Both Dr. Shreeve and Dr. LaRusso offered their overall opinions, taking the four cases as a whole. Dr. Shreeve’s Oinions Dr. Shreeve testified that, while he might be more understanding of issues he saw in each individual case, “I’ve got four cases that I reviewed together. I received them all at once. So my view on each individual case might be seen as a little more tolerant of something I saw. But when it becomes repeated, it becomes less understanding [sic].” (Tr. 109). In forming his opinions, Dr. Shreeve relied on allegations that have not been proven, his own extension of the Administrative Complaint allegations to add other concerns about use of CPT codes (which were also shown not to be valid concerns), and his observations about a litany of matters nowhere mentioned or charged in the Administrative Complaints. Dr. Shreeve made clear that he elevated his opinion from concerns about sloppy office practices to fraud, misrepresentation, and patient exploitation, because of matters that were either unproven, not alleged or charged, or both. For example, he injected the concern, shown to be based solely on patient ledgers, that CPT code 99212 appeared many times without the -25 modifier when used in conjunction with an adjustment CPT code. Starting with A.M.’s case, he complained of the repeated use of CPT code 99212 without a -25 modifier, when CPT code 98941 (adjustments) was used for the same office visit. He said, “If we were going to bill 99212, an E/M code with that, we would use a modifier of -25.” (Tr. 110). As previously found, however, Dr. Aderholdt did use the -25 modifier with every entry of CPT code 99212 in the Medicare claim forms. In explaining how his opinion was affected by his misimpression from the patient ledgers that CPT code 99212 was not used with the -25 modifier, he said: This is repeated over and over during the record. If it were one off, it occurred in one place in the ledger or on a form, you know, everybody is human. They can make a mistake. If it is the trend, that becomes not a mistake. That becomes, I’m doing the wrong thing. And if I’m doing it over and over again, and I’m then billing for one service two times, two different ways, and I’m – I hope to get paid for it. Then that’s where I start to see the trend of exploiting the patient for financial gain. (Tr. 111). Dr. Shreeve further elevated the significance of not seeing modifiers with the evaluation codes in the patient ledgers, when he spoke about R.O.’s case: If [Dr. Aderholdt] did both codes [for evaluation and adjustments] every visit, if he did, which is not normal, we would have to have a modifier, the -25, to tell us it’s a reduced service because it’s duplicative. A modifier was never present in any record I saw on this patient or any other patient of the records of Dr. Aderholdt. So misusing the codes. This is not standard of care that we expect, and this appears to me exercising influence on the patient to exploit them for financial gain. That’s what it looks like to me. By the time we’re through with the third case that’s what I see. (Tr. 148). Not only was this CPT coding issue not alleged in any of the four Administrative Complaints, but it is a false accusation. If Dr. Shreeve did not see a single use of CPT code 99212 with the -25 modifier in any record he saw, then he did not look at the records very carefully. As found above, the only evidence of actual claims submitted to any third-party payor--the Medicare claim forms for Patient A.M.--shows that CPT code 99212 was never used without the -25 modifier. But Dr. Shreeve only looked at the patient ledgers for modifiers. As also found above, the only two CPT coding issues that were alleged (improper use on two specified dates of CPT code 98941 for adjusting three or four spinal regions for Patient A.M.; and improper use on Patient P.D.’s first day of service of two patient examination CPT codes for billing purposes) were not proven. Dr. Shreeve also relied on the allegation that Patient B.O.’s insurance carrier was billed for treatment that was not provided. He pointed to “notes” written (by B.O.) on the patient ledger stating that the patient cancelled, but CPT codes were entered for treatments that day. He concluded: That’s blatant. I don’t have a way to explain that away. To me that absolutely says, I billed for something that I didn’t do. That’s fraud. Because that’s with intent. That’s not an accident. (Tr. 137). When Dr. Shreeve was shown the $50.00 debit card receipt signed by Patient B.O. on June 14, 2014, he quickly retreated: “That would indicate that they were there, even though they said they were not. So my apologies for that. It’s good to clear that up.” (Tr. 183). Later, he added that the June 14, 2013, payment of $50.00 was for that visit and the prior visit on June 11, 2013. He explained that this was consistent with Respondent’s daily notes, which identified treatments for each visit and also logged the copay charges by visit and B.O.’s periodic payments. Dr. Shreeve did not explain how he would alter his overall opinion after conceding that what he characterized as blatant fraud by Dr. Aderholdt was actually a false accusation by the patient. In formulating his overall opinion that what otherwise might be viewed as mistakes or sloppy office practice were elevated in his mind to fraud and exploitation, Dr. Shreeve also relied heavily on matters that were neither alleged nor charged in the Administrative Complaints, and, as a result, were not fleshed out with competent evidence in the record. Dr. Shreeve repeatedly alluded to issues regarding trust accounting requirements in statute and rule. The four Administrative Complaints that were issued as directed by the PCP on June 19, 2018 (as noted on the Administrative Complaints), contain no allegations related to trust accounting practices. The PCP-authorized Administrative Complaints do not charge Dr. Aderholdt under the trust accounting statute, section 460.413(1)(y), or the trust accounting rule, Board rule 64B2- 14.001. To the extent Dr. Shreeve’s perception of trust accounting issues contributed to his opinion that these four cases rise to the level of fraud and patient exploitation, that was error, and his opinion must be discounted accordingly. Likewise, Dr. Shreeve gratuitously offered critiques of Dr. Aderholdt’s medical records, including complaints about the handwriting, complaints about x-ray quality, questions about the adequacy of justifications for the course of treatment, and suggestions regarding how he would rewrite SOAP notes. Again, the Administrative Complaints are devoid of allegations directed to the quality or adequacy of Respondent’s medical records, and they are devoid of charges under the medical records provision in section 460.413(1)(m) and the corresponding medical records rule, Board rule 64B2-17.0065. To the extent these critiques contributed to Dr. Shreeve’s opinion that these four cases rise to the level of fraud and patient exploitation, that, too, was error, and his opinion must be discounted accordingly. Dr. Shreeve also relied on what he characterized as Respondent’s failure to respond, or failure to respond quickly enough, to investigative subpoenas. He made it clear that his opinion was greatly influenced by his perception that Respondent intentionally failed to meet his obligations in responding to the investigations: I think this is absolute fraud. The doctor is not wanting to do the right thing, has flagrant disregard for the law, and the statutes and the rules for the profession, for the Department of Health by not responding. (Tr. 153). Despite Dr. Shreeve’s view that he thinks it is “very clear” that Dr. Aderholdt did not respond timely during the investigation, the timeline and details of the investigation were not established by competent evidence; there is only hearsay evidence addressing bits and pieces of that history, with huge gaps and many questions about the reasons for those gaps (if the reasons why investigations were so protracted was relevant). But the details of the investigations are not laid out in the evidentiary record because the Administrative Complaints do not contain factual allegations related to Dr. Aderholdt’s actions or inactions during the investigation process, nor are there any charges predicated on what was or was not done during the investigation process. Either these matters were not presented to the PCP in June 2018 for inclusion in the Administrative Complaints, or they were presented and not included. Either way, Dr. Shreeve’s perception regarding whether Dr. Aderholdt met his legal obligations in responding to the investigations cannot be injected now. It was improper for Dr. Shreeve to consider, and give great weight to, circumstances that were neither alleged nor charged in the PCP-authorized Administrative Complaints. As found above, the proven allegations are that Respondent failed to provide Patient A.M. copies of the claims submitted to Medicare for her treatment (although she may have them now); and Respondent failed to provide copies of the medical records of Patients R.O. and B.O. upon their joint written request (although they may have them now). Only by considering allegations that were not proven and by injecting matters not alleged or charged was Dr. Shreeve able to characterize these four cases as involving the same problems again and again. In terms of the proven allegations, however, the only duplicative finding is with respect to the husband and wife team, in that Respondent did not meet his obligation to promptly respond to their joint request for medical records and updated patient ledgers. The matters considered by Dr. Shreeve beyond the allegations and charges in the Administrative Complaints were also improperly used by Dr. Shreeve to buttress his view that two disciplinary actions against Dr. Aderholdt based on facts arising in 2005 and 2006, raised “the same or similar” issues. Dr. Shreeve’s attempt to draw parallels between the prior actions and these four cases was unpersuasive. Dr. LaRusso disagreed with the characterization of the two prior actions as similar to the issues presented here. Dr. LaRusso’s opinion is credited. A comparison of the allegations, ultimately resolved by stipulated agreement in two 2008 Final Orders, confirms Dr. LaRusso’s view in this regard. The first disciplinary action was based on Respondent’s treatment of one patient in February 2005. An administrative complaint alleged that Respondent failed to complete intake forms, take the patient’s history, and conduct a sufficient examination to support the diagnosis. Respondent was charged with violating section 460.413(1)(m) by not having adequate medical records. The same facts gave rise to a second count of violating section 460.413(1)(ff) (violating any provision of chapters 456 or 460, or any rules adopted pursuant to those chapters), through a violation of rule 64B2-17.0065, which elaborates on the requirements for adequate medical records. There is no repetition of these statutory and rule violations charged in any of the four Administrative Complaints at issue here. The prior administrative complaint also alleged that Respondent billed the patient he saw in 2005 for neuromuscular reeducation and therapeutic exercises, when neither Respondent’s notes nor the SOAP notes reflected those services. In these cases, the only allegation regarding discrepancies between billing records and physician/SOAP notes is the allegation as to Patient A.M. that on two dates, Respondent used the CPT code for adjustments to three or four spinal regions, whereas the SOAP notes reflected adjustments to only one region. The prior disciplinary action supports the findings above that Respondent’s notes must also be considered, in addition to the SOAP notes, to determine what services A.M. received on those two days. A different kind of billing discrepancy allegation in Case No. 18-4485 is the claim that Respondent billed B.O.’s insurer for treatment on days on which services were allegedly never provided. This allegation was not proven, as found above. B.O.’s accusation that Respondent falsely charged for treatment on several days when no treatment was provided was itself proven to be a false charge. Perhaps Dr. Shreeve was thinking of this allegation, based on B.O.’s false charge, when he characterized the 2005 incident as involving the same or similar problems that he saw here. The allegation in the prior complaint was that the patient was actually billed for services not provided, and a refunded was ordered. At first, Dr. Shreeve believed the same was true in B.O.’s case. However, he later retreated and acknowledged that B.O. had not been truthful in her accusation. The only other allegation of a billing discrepancy in any of the four cases at issue was not a billing discrepancy at all, but rather, a CPT coding error on P.D.’s patient ledger that was not billed to anyone. As Dr. Shreeve noted, in the prior disciplinary action, Respondent agreed to be put on probation with a requirement that he practice with a monitor. Dr. Shreeve explained that the monitor would have worked with Respondent “to help this doctor not do the same behaviors that got them into trouble.” In his view, these four cases show that Dr. Aderholdt did not learn his lesson from the monitor “not to do the same problems again.” As he put it, “That really flips me rather quickly to think there’s a question of fraud.” (Tr. 152-153). To the contrary, whereas Respondent was faulted for not having intake records, patient histories, and appropriate examinations to support his diagnosis and recommended treatment plan in February 2005, no such issues were raised in these Administrative Complaints. Dr. Aderholdt did learn his lesson. The medical records for the four patients at issue include patient intake forms, patient histories, evaluations, and examinations that were not alleged to be inadequate. Nor was there any repetition of the problem with billing a patient for treatment or services that were not documented in the medical records taken as a whole, including Dr. Aderholt’s notes. The other disciplinary action resolved by settlement in a 2008 Final Order involved an advertising issue. The Department alleged that Respondent improperly advertised as a specialist in Vax-D disc therapy when the Board does not recognize any such specialty. The Department also found fault in the failure of the advertising to disclose the usual fee. The Department also critiqued an advertisement for identifying a different practice location than Respondent’s practice address of record. The charges were under section 460.413(1)(d), (cc), and (ff); rule 64B2-15.001(2)(e) and (i); and rule 64B2-10.0055. Quite plainly, this prior action bears no similarity to the four Administrative Complaints at issue here. No such allegations or charges were raised here. Dr. Shreeve did not contend that this prior action bears any similarity to the four cases here. Dr. Shreeve was never asked for his opinion as to the type or level of discipline he believes is warranted in these cases. However, his “flip” to “fraud,” due to the perceived repetitive nature of the issues in the four cases (whether charged or not)--which he characterized as the “same problems” in 2005 that resulted in discipline--was the basis for Petitioner proposing the most severe penalty available: license revocation, plus substantial fines and assessments of fees and costs. Dr. LaRusso’s Opinions Dr. LaRusso served as a Board member for multiple terms, and is a past-chair. After leaving the Board, he continued to serve on probable cause panels as recently as 2017. Having reviewed and been involved in thousands of disciplinary matters, he was of the strong opinion that nothing in the four Administrative Complaints warrant discipline at the level being sought here. Imposing a severe penalty in these four cases would be out of line with the Board’s prior practice in disciplinary matters. Dr. LaRusso’s studied review of all of the depositions and records in this case led him to opine that there is no evidence that Dr. Aderholdt deceived his patients, committed fraud, or engaged in double-billing or overbilling. Instead, Dr. LaRusso saw evidence of sloppy office practices, which he attributed to Dr. Aderholdt’s poor management skills. He has seen many doctors like Dr. Aderholdt over the years who just want to deal with taking care of patients. They do not want to have anything to do with administrative and clerical responsibilities. Instead, they leave everything besides patient care to their office manager and staff. In Dr. LaRusso’s view, Dr. Aderholdt’s office protocols and procedures require serious fine-tuning. He believes that Dr. Aderholdt would benefit from re-education in billing and collection practices, as well as laws and rules. He needs to ensure that procedures are in place, and followed, for prompt responses to patient requests for medical records or for claims sent to third-party payors. At the same time, however, Dr. LaRusso reasonably characterized the four cases as involving billing, clerical, communication, and correspondence issues. It bears emphasis that Dr. Aderholdt’s patient care is not in question. There are no issues of endangering the public, where a doctor is doing things that will hurt people, doing something dangerous or sexually inappropriate. Those are the cases where it is appropriate to go after someone’s livelihood, when the person does not belong in the profession. Dr. LaRusso observed that, rather than endangering the public, Dr. Aderholdt was helping his patients by relieving their pain, according to their own testimony. Dr. LaRusso agreed to become involved in this case because he found it so incongruous that the Department would be pursuing this action apparently to try to take Dr. Aderholdt’s license. Dr. LaRusso noted that the four investigations against Dr. Aderholdt were originally being spearheaded by a prior prosecutor for the Department (to whom Respondent’s counsel mailed CDs of patient records in 2014), and that the cases were assigned to Dr. Willis, who was a favored expert witness for the Department. Dr. LaRusso alluded to “inappropriate issues” with the prosecutor and expert that led to the Board having to pay a large award of attorneys’ fees and costs for pursuing discipline against Dr. Christian. According to Dr. LaRusso, those issues ultimately led to the prosecutor and expert being discharged from these cases. There is no evidence as to when or why Dr. Willis was replaced with Dr. Shreeve. Dr. Willis apparently was involved long enough to prepare an expert report. But then, according to Dr. LaRusso, the cases went dormant for a long period of time. The bits and pieces of hearsay evidence in the file comport with this understanding: there were four investigations that began upon complaints in 2014 by the four patients about billing and records issues; documents were collected from Respondent and from the patients; and Investigative Reports were issued, all before 2014 was over. It is unknown when Dr. Willis was involved, when he prepared his expert report, or when he was discharged from the cases. It is unknown when Dr. Shreeve was retained, but there was plainly some duplication of work, in that Dr. Shreeve prepared his own expert report. Neither expert report is in evidence. There is no evidence of any additional investigation or follow-up documentation from the patients or otherwise. There is no evidence of what was presented to the PCP--just that the panel met on June 19, 2018, and authorized the four Administrative Complaints issued on June 20, 2018. While this background is a bit of a curiosity, without impermissible speculation, the most that can be said about this history is that the protracted period of time from investigation to the PCP submission that resulted in issuance of the Administrative Complaints is apparently due, at least in large part, to the turnover in the prosecution-expert witness team assignments. Dr. LaRusso did not persuasively demonstrate grounds to cast nefarious aspersions on the Department for continuing forward with its investigation. One might reasonably question whether the Department dropped the ball, so to speak, in not updating its investigation, given the extended period of dormancy. For example, the Administrative Complaint in Case No. 18-4487 incorrectly alleged that P.D. was not reimbursed, when any cursory check with P.D. would have revealed the “news” that she had been repaid in April 2015, more than three years before the Administrative Complaint was authorized by the PCP. Dr. LaRusso may reasonably debate, as he did, whether the charges lodged against Respondent are inappropriate. And Dr. LaRusso may certainly question, as he did in convincing fashion, whether the discipline apparently being sought is unduly harsh, uncalled for, and way out of line with Board practice. But there is no basis in this record for attributing bad motives to the Department for prosecuting the Administrative Complaints. Dr. LaRusso’s opinions regarding the nature of the violations proven and the appropriate discipline in scale with those violations were more persuasive that Dr. Shreeve’s opinions. Dr. LaRusso’s opinions are credited.
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 Chiropractic Medicine: In Case No. 18-4484PL: Dismissing Counts I, II, and IV; and Finding that Respondent violated section 460.413(1)(aa), as charged in Count III; In Case No. 18-4485PL: Dismissing Counts I, III, and IV; and Finding that Respondent violated section 460.413(1)(i), through a violation of rule 64B2-17.0055(1), as charged in Count II; In Case No. 18-4486PL: Dismissing Counts II, III, and IV; and Finding that Respondent violated section 460.413(1)(i), through a violation of rule 64B2-17.0055(1), as charged in Count II; In Case No. 18-4487PL, dismissing Counts I and II; Placing Respondent on probation for a period of three years, with conditions deemed appropriate by the Board; Imposing a fine of $3,000.00; Requiring continuing education deemed appropriate by the Board; and Requiring payment of the costs of investigation and prosecution of the charges on which violations were found. DONE AND ENTERED this 15th day of February, 2018, in Tallahassee, Leon County, Florida. S ELIZABETH W. MCARTHUR 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 15th day of February, 2018.
The Issue The issues in this case are whether Respondent, a physician specializing in obstetrics and gynecology, committed medical malpractice in delivering a baby and/or failed to maintain medical records justifying the course of the mother's treatment; if so, whether Petitioner should impose discipline on Respondent's medical license within the applicable penalty guidelines or take some other action.
Findings Of Fact At all times relevant to this case, Respondent Mark N. Scheinberg, M.D., was licensed to practice medicine in the state of Florida. He is board-certified in obstetrics and gynecology. Petitioner Department of Health (the "Department") has regulatory jurisdiction over licensed physicians such as Dr. Scheinberg. In particular, the Department is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense. Here, the Department alleges that Dr. Scheinberg committed two such offenses——namely, medical malpractice and failure to keep records justifying the course of treatment——in connection with the vacuum-assisted vaginal delivery of an infant born to Patient L.G. on February 2, 2005, at West Boca Medical Center. The crux of this case (though not the sole issue) is whether, as the Department contends, the standard of care required Dr. Scheinberg to perform a Caesarean section ("C- section") on L.G. due to the passage of time, instead of allowing her to continue to labor for approximately 13 hours and, ultimately, deliver vaginally. The events giving rise to this dispute began on February 1, 2005, at around 11:00 a.m., when L.G., whose pregnancy was at term, checked into the hospital after having experienced ruptured membranes. At 12:30 p.m. that day, L.G. signed a form bearing the title "Authorization for Medical and/or Surgical Treatment," which manifested her consent to a vaginal delivery or C-section together with, among other things, "such additional operations or procedures as [her physicians might] deem necessary." Immediately above L.G.'s signature on the form is an affirmation: "The above procedures, with their attendant risks, benefits and possible complications and alternatives, have been explained to me " The evidence is not clear as to when, exactly, Dr. Scheinberg first saw L.G., but that fact is unimportant. The medical records reflect that at 8:30 p.m. on February 1, 2005, Dr. Scheinberg gave a telephone order to initiate an IV push of the antibiotic Ampicillin; therefore, he had taken charge of L.G.'s care by that time. The nurses' notes indicate that at 10:00 p.m., L.G.'s cervix had dilated to "rim" or approximately nine centimeters—— meaning that the dilation was complete, or nearly so. At this time, and throughout the duration of L.G.'s labor, an external fetal heart monitor was in place to detect and record the baby's heartbeats and the mother's uterine contractions. An intrauterine pressure catheter ("IUPC")——a device that precisely measures the force of uterine contractions——was not inserted into L.G.'s uterus at any time during this event. The Department argues (although it did not allege in the Complaint) that, at some point during L.G.'s labor, the standard of care required Dr. Scheinberg either to place an IUPC or perform a C-section. Pet. Prop. Rec. Order at 10, ¶36. The Department's expert witness, Dr. John Busowski, testified unequivocally and unconditionally, however, that the standard of care does not require the use of an IUPC. T. 36. The undersigned credits this evidence and finds that Dr. Scheinberg's nonuse of an IUPC did not breach the standard of care. Dr. Scheinberg conducted a physical at around 2:00 a.m. on February 2, 2005, which included taking L.G.'s complete history and performing a vaginal examination. L.G.'s cervix remained dilated to approximately nine centimeters, and her labor had not substantially progressed for about four hours. Dr. Scheinberg noted in L.G.'s chart that the baby was in the posterior position at 2:00 a.m. The Department argues, based on Dr. Busowski's testimony, that as of 2:00 a.m., the standard of care required [Dr. Scheinberg to] choose one of the following options: (1) watch the patient for a few more hours to allow for progress; (2) place an IUPC to determine the adequacy of Patient L.G.'s contractions; (3) start Pitocin without the placement of an IUPC; or (4) perform a C- section. Pet. Prop. Rec. Order at 9-10, ¶ 32. The Department contends that Dr. Scheinberg breached the standard of care by choosing "simply to watch the patient for approximately 10 more hours"—— which was tantamount to "choosing to do nothing." Id. at 10, ¶¶ 33-34. In fact, Dr. Scheinberg chose to watch the patient, which was, according to Dr. Busowski, within the standard of care. Obviously, at 2:00 in the morning on February 2, 2005, Dr. Scheinberg did not choose to wait for 10 more hours, because at that point he (unlike the parties to this litigation) did not know what was about to happen. The nurses' notes reflect that L.G. was under close observation throughout the early morning hours, and that Dr. Scheinberg was following the situation. At 4:30 a.m., L.G. was set up to push and at 4:45 a.m. was pushing well. At 6:15 a.m., the notes indicate that Dr. Scheinberg was aware of the mother's attempts to push. At 6:45 a.m., he reviewed the strips from the fetal heart monitor. At 7:45 a.m., he was present and aware of L.G.'s status. From 7:00 a.m. until 8:00 a.m., no contractions were identifiable on the external monitor. At 8:00 a.m., however, L.G. was comfortable and pushing well. She stopped pushing at 8:30 a.m., but remained comfortable. Dr. Scheinberg then ordered the administration of Pitocin, a medicine which is used to strengthen contractions and hasten delivery. Although the Department faults Dr. Scheinberg for giving L.G. Pitocin at this relatively late stage of her labor, Dr. Busowski (the Department's expert witness) admitted being unable to say "that Dr. Scheinberg should have started Pitocin earlier " T. 72. The Department therefore has no clear evidential basis for second-guessing Dr. Scheinberg's professional judgment in this particular, and neither does the undersigned. At 9:10 a.m., L.G. resumed pushing. The baby's fetal heart tones (heartbeats) were stable. L.G. continued pushing, with her family present, until around 11:00 a.m., at which time Dr. Scheinberg discussed the situation with the patient and her family. Dr. Scheinberg explained to L.G. or her husband the risks of, and alternatives to, performing a vacuum-assisted vaginal delivery. Either L.G. or her husband gave verbal consent to the use of a vacuum device to assist in the delivery. Between 11:00 a.m. and 11:10 a.m., the fetal heart monitor detected some variable decelerations, meaning a decrease in heart rate that could be a sign of fetal distress. Dr. Scheinberg delivered the baby at 11:23 a.m., using a vacuum device to help pull the infant out of the birth canal. In his post-operative notes, Dr. Scheinberg wrote that his "pre-operative diagnosis" was "+3 station — prolonged second stage 2½ hrs." As a "post-operative diagnosis," Dr. Scheinberg recorded, "same + tight cord." He reported the following "findings": "tight cord cut on perineum[;] mec[onium] aspirated on perineum."
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 Dr. Scheinberg not guilty of the charges set forth in the Complaint. DONE AND ENTERED this 20th day of June, 2011, in Tallahassee, Leon County, Florida. S JOHN G. VAN LANINGHAM 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 20th day of June, 2011.
The Issue Should discipline be imposed against Respondent's license to practice medicine for violation of Section 458.331(1)(m) and (t), Florida Statutes (2005)?
Findings Of Fact Stipulated Facts: Petitioner is the state department charged with the regulation of the practice of medicine pursuant to Chapter 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. Respondent is John B. Milton, M.D. Respondent is a licensed medical doctor in the State of Florida having been issued license ME 53961. Respondent's mailing address of record is 4702 Van Kleeck Drive, New Smyrna Beach, Florida 32169. Additional Facts: Hospital Records (Petitioner's Exhibit numbered 1) On December 31, 2005, Patient W.C. came to the Bert Fish Medical Center (Bert Fish) in New Smyrna Beach, Florida, at 1:40 a.m. He was 40 years old at the time. He was seen in the Emergency Department at Bert Fish. Triage of the patient took place at 1:43 a.m. The triage record reports that he walked in to the hospital complaining of his throat swelling and difficulty breathing. The record reflects that the patient was experiencing pain of an intensity level seven (7) in his throat. At the time his blood pressure was 153/83. His pulse rate was 88. His respirations were 20. His temperature was 98.2. His 02 sat. was 99. In the heading within the Emergency Department Triage Record, statement of "Previous Surgery/Other Medical Hx (referring to history)" it states "allergic reaction to birds with throat swelling, " According to the Emergency Department triage nursing notes Patient W.C. was first seen by Respondent at 1:55 a.m. on the aforementioned date. Respondent was serving in the capacity of emergency room physician at Bert Fish at the time. Among the nursing note entries in the Emergency Department triage record for Patient W.C. are handwritten nursing notes that state: At 2:05 Rocephin was given; at 2:20 a.m. pt. (patient) states throat closing saO2 98%; at 2:25 a.m. pt. (patient) tubed by Dr. Milton- placement checked tube pulled-(pt.) patient vent 100% O2 via ambu; at 2:31 a.m. crick. (cricothyroidotomy) by Dr. Milton tube inserted 100% 02; at 2:35 a.m. H/R 40's - atropine; at 2:37 a.m. b/p 213/90 P-87 Dr. Milton attempting crick 0249 epi 1 mg IV; at 2:41 a.m. Dr. Schreiber here; at 2:43 pt. (patient) tubed by Dr. Schreiber s/r 0 pulses and at 2:54 a.m. code called by Dr. Milton. The Bert Fish Emergency Physician Record refers to Patient W.C.'s chief complaint as "shortness of breath." It states "pt (patient) seems to have acute severe pharyngitis and difficulty breathing and mild stridor at rest." The degree of the condition is further described in the record as "moderate." An associated symptom is listed under "Pulmonary," as "cough." It is noted in this record that the patient is experiencing a "sore throat." The Emergency Physician Record under the "Social Hx (history)," notes that the Patient W.C. was a "smoker" and occasionally used "alcohol." No reference is made to the use of any other form of drugs. On the patient chart describing a physical exam performed on the patient, the categories of "alert" and "anxious" are checked. The level of distress is described as "NAD." There is a reference to "pharyngeal erythema," associated with that entry a handwritten note states "mild stridor at rest." A reference is made to "lymphadenopathy" both right and left "mild." There was no "respiratory distress" and "breath sounds nml (normal);" Again the condition "stridor" is noted while the patient is "at rest." "CVS" is noted as regular rate rhythm with "no JVD." On the same page as discussed in the preceding paragraph, within the patient record maintained by Bert Fish, under "clinical impression," Respondent notes several things in the overall experience in treating the patient. They are in turn: acute severe pharyngitis/epiglottitis; emergency cricothroidotomy cardio pulmonary arrest and ER death. These entries reflect events at the end of the case. The medication administration record at Bert Fish in relation to Patient W.C. notes administration of Decadron (a steroid) at 2 a.m.; Solu-cortef (a steroid) at 2:02 a.m.; Rocephin (an antibiotic) at 2:05 a.m.; Versed (a sedative) at 2:20 a.m. and Anectine (a paralytic agent) at 2:25 a.m. A separate set of entries is made in the Code Blue Record at Bert Fish, noting the administration of Epinephrine, and Atropine during the Code Blue response prior to Patient W.C.'s death due to his cyanotic condition (lack of oxygen). Nurse's notes on the Code Blue Record for Patient W.C. maintained by Bert Fish state: Upon me entering the room Dr. Milton was doing CPR on pt. Dr. Schreiber, Dr. Milton and the ER staff attending to pt. ER staff busy. I started scribing for them. Note pt. was in PRA throughout the code. Pt. was given 3 ep. & 3 atoprine total = (-)response. Respondent signed the Code Blue Record as physician. The ER Physician's Order Sheet, as signed by Respondent concerning Patient W.C., in a shorthand reference, describes orders for nebulized racemic Epinephrine, which is an aerosol adrenaline agent, together with the Solu-cortef, Decadron and Rocephin. In the records maintained by Bert Fish concerning Patient W.C., there is a handwritten note made by Respondent at 3:35 a.m., on December 31, 2005, following Patient W.C.'s death, which says: S/P IV steroids, Racemic epinephrine PT continued to c/o "getting worse" "can't breath." At times his respirations were gasping. .. I discussed with him fact the he may require intubation & he understood. PT placed in TRI and preparation made for intubation. PT had secure IV site, Respiratory TX in Room to assist. S/P preoxygenation 1HR> 80 PT had IV Versed and Anectine to facilitate intubation. The laryngoscope revealed a massive "beefy" appearance of the epiglottis. Attempted X 2 E 8.0 & 7.5 ET to secure an airway but Ø success. PT had attempts to ventilate E BVM? Ø air movement. PT cyanotic @ this point so a scalpel was used to attempt a crichothyroidotomy. When a ETT was passed thru the incision however attempts to ventilate were again unsuccessful. Dr. Schreiber (gen surgery) had been paged and he responded. He was able to place a ETT in the airway but by now PT had arrested. Monitor-bradycardia at this time ACLS measures were undertaken and PT given repeated doses of atropine/epinephrine/CPR-> ventilated E BVM. PT continued to have Ø response to proper ALS measurers and Resus efforts stopped @ 0254. Patient Care Explained Nurse Haas William Haas, R.N., was working at Bert Fish on the early morning that Patient W.C. was seen. Nurse Haas first saw the patient around 1:55 a.m. He hooked the patient up to a monitor and took his vital signs. None of the readings were considered by the nurse to be abnormal. Those readings were blood pressure 153/83, heart rate 88, respirations 20, temperature 98.2. and O2 sat. 99%. Patient W.C. was taken into treatment room 16 and was seen by Respondent and nurse Haas. Nurse Haas asked Respondent what Respondent thought was wrong with the patient. Orders were given by the Respondent for 8 mg. of Decadron and 100 mg. of Solu-cortef IV. The purpose of these medicines was to reduce inflammation. Both medications were steroids designed for that purpose. At that time Respondent gave an order for the antibiotic Rocephin. Respondent also wanted a racemic Epinephrine treatment. That treatment was to be provided by the respiratory therapist. When nurse Haas first saw the patient, the patient was complaining about difficulty breathing. Nurse Haas did not observe any manifestation of those difficulties. At one point the patient told nurse Haas that he, the patient, was experiencing an allergic reaction to feathers or birds. The patient told nurse Haas by way of history that it happened to him in the past. (None of this was true. He had no allergy to birds. The patient's deception was never discovered by the hospital treatment team, and they all proceeded on the basis that the patient had a bird allergy.) On the evening before arriving at the hospital, the patient explained to nurse Haas that he went to bed about 9:00 or 10:00 p.m. and woke up around 1:00 a.m. with a raspy feeling in his throat and he felt like his throat was closing up. So he came to the emergency room for care. After attending to the patient in treatment room 16, nurse Haas left the presence of the patient. He next saw the patient standing in treatment room 17 talking on the phone. This was around 2:20 a.m. The patient was again placed on a monitor to track his vital signs. Nothing about those vital signs appeared abnormal. At that time Mary Boothe, R.N., told nurse Haas that the patient was going to be intubated. Nurse Haas inquired of Respondent on the subject, and Respondent told nurse Haas that the patient wanted to be intubated and to get ready to perform the intubation. The procedure for intubation that was being utilized by Respondent is referred to as rapid sequence intubation or RSI. Nurse Haas retrieved Anectine and Versed to be administered in the intubation. The patient was told about the procedure for intubation. The patient was laid down. Nurse Haas gave the patient Versed and Anectine. The Versed was designed to, as nurse Haas describes it, "muddle the mind." The Anectine was an agent that would promote paralysis in the area where the intubation would occur. When in treatment room 17, at around 2:20 a.m., the patient said to nurse Haas that the patient felt that his throat was closing. Those remarks were made when the patient was being hooked up to the monitor to measure his vital signs. This was the second time that the patient had mentioned his throat closing. He had made similar remarks when nurse Haas first saw him in treatment room 16. Steve Igrec, R.T., participated in the intubation procedure in addition to nurse Haas, nurse Boothe and Respondent. Prior to the laryngoscope being introduced in the intubation procedure, nurse Haas did not notice any sharp decline in Patient W.C.'s vital signs. When Respondent accessed the airway for Patient W.C., nurse Haas heard Respondent say, "Oh, he's got epiglottitis," while proceeding further with the intubation. Respondent was unable to intubate and removed the ET tube. Another tube was used to try and intubate, again without success. Nurse Boothe Nurse Boothe first encountered Patient W.C. after he had undergone his racemic Epinephrine treatment. He came out of the treatment room and told her that he did not feel that the treatment had worked. Respondent came by and the nurse repeated what the patient had told her. Nurse Boothe did not notice anything about the patient that made her believe that he was having difficulty breathing. He coughed and told her, "Can you hear it?" but he was not gasping for air, nor making gestures about his chest or throat. Respondent then offered the patient the option of being admitted to the hospital and continuing treatments by steroids to address his condition or putting him on a ventilator and letting him have the treatments through the ventilator. The patient elected the latter option. The ventilator option would allow the patient to be released the next day. The patient was told by Respondent that he would "knock him out" and put the tube in and give the patient the medication that way and that the patient's release would come the next day. Nurse Boothe did not hear the Respondent make any mention to the effect of what might happen if there were difficulties in intubating the patient. The attempted intubation was made in the treatment room 17, which is also referred to as CC-1. The patient walked into the room. Once in the room nurse Boothe did not notice anything about the patient that indicated any difficulty breathing. The patient did mention that he was not feeling any better. Nurse Boothe overheard the patient talking on the telephone. On his end of the conversation he told his wife that he did not feel any better and that they were going to "knock him out" and put him on a breathing machine overnight and that he would see her the following day. Nurse Boothe noticed that as the attempted intubation proceeded, the patient began to have trouble with the intubation. The equipment that was in the room for those purposes included the laryngoscope, the intubation tube, and a stylet. Before the tube was introduced the patient was being ventilated with a bag and mask. When difficulties arose concerning the intubation, nurse Boothe left the treatment room to get a scalpel and to get what is referred to as a "cric" kit. That kit is a set-up that has been assembled to aid in providing emergency access to the trachea. The kit is not kept in treatment room 17. It was kept in another room on a respiratory cart. Nurse Boothe observed Respondent utilize the scalpel and the "cric." After the Respondent experienced difficulties in this effort, the on-call surgeon was contacted by a secretary at the hospital. The Surgeon Arrives On December 31, 2005, Dr. Schreiber was the on-call surgeon at Bert Fish. When he was paged by the hospital, he called and was told that he needed to go immediately to the emergency room because of an airway problem. He received the call at approximately 2:30 a.m. He arrived at the hospital at 2:41 a.m. Once at the hospital Dr. Schreiber, took over and performed surgery, insertion of the endotracheal tube, thereby ventilating the patient. That procedure by Dr. Schreiber was quickly performed. Mr. Igrec Mr. Igrec administered the racemic Epinephrine treatment to Patient W.C. Prior to providing the treatment Mr. Igrec visibly examined the patient to see if the patient was using assessory muscles to breathe or if he had any stridor, any wheezing or anything of that nature. He did not observe the patient using any assessory muscles to breathe. He did not notice the patient evidencing stridor, that is to say a high- pitched sound that is made when a person experiences upper airway obstruction. Mr. Igrec provided two of the treatments to Patient W.C. Before the second treatment, he visibly examined Patient W.C. and did not notice the patient having difficulty breathing. Sometime during the course of the treatment, near the end, the patient asked the question, "How long is this going to take to work?" Mr. Igrec told the patient to give it time. The patient appeared anxious. He did not appear short of breath. Mr. Igrec reported to Respondent that he had provided Patient W.C. the second treatment. Following the second treatment, Mr. Igrec suggested to Respondent the use of Decadron to aerosolize Patient W.C. The racemic Epinephrine is a short- acting drug, and Decadron is a steroid that takes longer to work. In response, the Respondent told Mr. Igrec "We may have to intubate." Mr. Igrec was called to treatment room 17 where Respondent told him that they were going to intubate Patient W.C. In preparation, an ambu-bag, mask, intubation tube, pressure cuff, stylet and strap were retrieved. The cuff was used to keep the intubation tube in place during the procedure. The stylet keeps the tube rigid. Once the patient was sedated, Mr. Igrec began to use the ambu-bag with the patient. At that time, there was no difficulty using the bag, squeezing the bag to provide air into the patient's lungs. Mr. Igrec had one hand on the mask over the patient's face and one hand on the ambu-bag. Respondent used the laryngoscope in placing the tube, trying to look while placing the tube. The tube went into the stomach and not the trachea, such that ventilation did not occur. After that, when Mr. Igrec was bagging the patient he had a lot more resistance, to the point where Respondent had to hold the mask while Mr. Igrec bagged the Patient W.C. After a second attempt to intubate the patient, Respondent attempted to establish a surgical airway. Respondent was using a scalpel and palpating the patient to try and find the crichothyroid cartilage to create the necessary incision. An incision was created. There was no success in placing an airway because the tube did not pass through the crichothyroid cartilage. Mr. Igrec understood this because the tube that he had cut down to place and to ventilate the patient could not be used because there was no hole in the trachea. Blood was pooling around the patient. Dr. Schreiber arrived and established the surgical airway. During this time, CPR was provided the patient under Code Blue conditions where the patient's heart had stopped beating. Attempts at reviving the patient were not successful. Respondent and Patient W.C. Prior to the occasion when he intubated Patient W.C., Respondent had vast experience in performing intubations. As he describes it, this is a necessary skill for an emergency room doctor, recognizing that having an unobstructed airway is vital to a patient's survival. When intubating a patient, Respondent believes that you would want to do this before they "crash," before they lose their vital signs and become unconscious. Before his attempt to intubate Patient W.C., Respondent had never had an instance in which he could not intubate the patient, a function that he had performed numerous times without the assistance of a surgeon or an anesthesiologist. By contrast, before the circumstance that was confronted in Patient W.C., Respondent had never performed a crichothyroidotomy. He had been trained to perform that procedure. On December 31, 2005, nurse Haas approached Respondent and told Respondent that he placed Patient W.C. in a treatment room, described as the ortho room, and that the patient was having trouble breathing and that he needed to be seen by Respondent. Respondent inquired of the patient about the duration of his problem. He asked the patient if he had asthma. Had this happened before? The patient told Respondent that he was having an allergic reaction to his wife's bird and that this problem that he was experiencing had occurred once years before. Respondent asked the patient if he was telling Respondent that an hour ago he was fine and that now he was not. Patient W.C. said "absolutely." When listening to the patient's lungs Respondent did not notice any wheezing. There was no fever in the patient and the patient had not been sick. Unlike the other health care providers attending the patient, Respondent observed that Patient W.C. was having trouble getting air in, the patient was having inspriatory stridor. Respondent believed that the presentation by Patient W.C. was that of someone having an allergic reaction, with some airway compromise, he refers to as laryngospasm. Respondent told nurse Haas to start an IV on the patient and get respiratory therapy to provide a racemic Epinephrine treatment. The reasons for this decision was Respondent thought the patient was having an allergic reaction. In particular, Respondent's impression at that moment was that the patient was someone having an allergic reaction to birds. Patient W.C.'s case was comparable to another case that Respondent had with a woman who had experienced an allergic reaction. In the case of the woman, the patient worsened and quickly had to be intubated. The differential diagnosis that Respondent was proceeding with was that of a patient having an allergic reaction. The orders Respondent gave concerning administration of medications were designed to alleviate an airway problem associated with an allergic reaction. Consistent with Respondent's orders, the nurse started the IV and provided medications, and the respiratory therapist came to provide the aerosol treatment. Respondent observed that Patient W.C. was sitting up in bed and did not appear to be doing anything unusual. Respondent received the report on the patient's status. Respondent went to see Patient W.C., who at that time was anxious and restless. He was having trouble getting air in and telling Respondent that he could not breathe and that his airway was closing off. Patient W.C. told Respondent that "you guys ain't helping me at all." Respondent told the patient that the treatment already provided was the normal thing that was done. Respondent got more history from the patient by asking the patient, "You were perfectly fine until an hour ago?" The response was "yes." Respondent asked the patient if he had not been sick at all. Again the response was "no." The Respondent asked the patient if he had a sore throat. The patient said a little bit. Respondent took a tongue depressor and looked in the patient's throat. It looked pretty normal. (The Emergency Physician Record indicated the patient had a sore throat.) The patient had very mild prominent lymph nodes but nothing out of the ordinary. There was still no wheezing. At that juncture, the decision was made to give Patient W.C. another aerosol treatment. In addition, the decision was made to provide antibiotics in case there was some tracheitis, pharyngitis. It was anticipated that the antibiotics would take 24 hours to have any effect. Epiglottitis was a condition at the bottom of the list on the differential diagnosis. Respondent's experience with that condition was that a patient would be sick for a period of time before the condition worsened. Nothing in Patient W.C.'s presentation led Respondent to believe that he had epiglottitis at that point. By way of history, there was no indication from the patient that he had used cocaine within 24 hours of the time of his visit to the emergency room. (Indeed subsequent toxicology studies revealed recent use of cocaine.) Had such use been reported Respondent would have acted differently in treating Patient W.C. In his second encounter with the patient on the night in question, the patient told him several times that his airway was closing off and that he believed that any second he was not going to be able to breathe. In reply, Respondent told Patient W.C. that the normal things to address his condition had been done, but there was one other thing that could be done and that would be to intubate Patient W.C. Respondent explained that it meant that they would lay the patient in a critical care room and render him unconscious and take a breathing tube and put it into his lungs and admit Patient W.C. to the hospital. This would then be followed by 24 to 48 hours of ventilatory support with use of steroids to address swelling. Patient W.C. told Respondent "let's do it quick." Respondent told a nurse to gather the standard rapid sequence medication, which in this instance involved the use of Versed and Anecitine. In the procedure room where the intubation was attempted, the procedure commenced with the patient having a good heart rate. There was a crash cart available in case there were problems. At the moment, Respondent continued to believe that the patient was experiencing an allergic reaction. Although the patient could have been experiencing epiglottitis secondary to infection, the patient did not show any signs or symptoms of that condition, indications of an on-going infection such as a fever. He was not sweating, his heart rate was not rapid. Once in the treatment room where the intubation was attempted, the patient worsened. Patient W.C. was gasping. He closed his eyes a second. The respiratory therapist Mr. Igrec experienced problems bagging the patient. Efforts by Respondent and the respiratory therapist were not succeeding in getting air into the patient. When Respondent looked in, using the laryngoscope, he noticed something that he had not encountered before. Patient W.C.'s epiglottis had the appearance of a "mushroom." It did not appear as normal anatomy. Respondent described it as a "moonscape." When Respondent looked into the patient using the laryngoscope, he describes the "picture" as looking like a scorched airway when viewing the larynx and the epiglottis. Now that he had observed the epiglottitis, Respondent decided to try and "get under it" using the ET tube. He encountered a complete blockage. Respondent then asked for a smaller tube. The smaller tube did not work. Efforts at bagging the patient were not successful. Respondent concluded that he could not intubate the patient and could not ventilate the patient in that manner, leaving him the only choice, in his perception, to deal with the obstruction by establishing a surgical airway. Respondent asked for a scalpel to perform a "cric." Respondent also told someone to call and get the surgeon and indicate that there was an airway emergency and to come immediately, as Dr. Schreiber did. Respondent took the scalpel and located the crichothyroid membrane below the crichothyroid cartilage and made an incision and air bubbled out. Respondent widened the incision, as he had been trained to do in a course dealing with trauma associated with the airway. Respondent took the ET tube that he had been using and inserted it. It went in smoothly and the treatment team was able to bag the patient. Respondent then noticed that the heart rate was dropping and that the "stats" were not coming up. Respondent then observed that the patient's neck was bigger. What had happened was that the tube had slipped out of the incision, tracking anteriorly over the trachea and the air was being introduced into the neck. Once the subcutaneous emphysema was seen in the neck, it occurred to Respondent that the tube was in the wrong place. The patient was bleeding profusely. There was an effort at reintroducing the tube but the neck had become more swollen, and the tube could not be replaced. A nursing supervisor, Tom Frith, went to the next trauma room and took one of the crichothyroidotomy kits and brought it back. Respondent was not trained to use that kit. He had seen the kits used at a demonstration. The kit was opened. Respondent took a needle from the kit and tried to find an airway but was unable to locate the airway that had been created because efforts at aspiration produced more blood. Other equipment in the kit was utilized to try to replace the endotracheal tube back in the patient, but the field would quickly fill with blood and the tube could not be placed into the membrane. When Dr. Schreiber arrived, using the skill of a surgeon, not that of an emergency room doctor, he performed an emergency tracheotomy on Patient W.C. Respondent acknowledges that persons suffering from an allergic reaction have a common presentation where they experience hives and itching. Some people have wheezing. Patient W.C. had none of these symptoms. Nonetheless, the patient appeared to Respondent to be having an allergic reaction involving the airway Respondent describes as laryngospasm. Respondent understood the patient's condition to be one in which he was able to move about and speak but he was unable to get air in. While able to compensate for that condition for awhile, that ability did not last. Respondent had never seen a patient with epiglottitis. Hypothetically, if a patient were perceived as having that condition, Respondent would consult with a surgeon or an anesthesiologist, if he had time. If confronted with classic signs of epiglottitis, Respondent would start an IV, give the patient supplemental oxygen and not attempt intubation unless the case was emergent. Given sufficient time, the patient would be taken to an operating room and an anesthesiologist could attempt intubation, failing which a surgeon would be available to address the obstruction by placing a surgical airway. This case became one of an emergency, and Respondent took the measures he deemed appropriate. Concerning notes made pertaining to treatment provided Patient W.C., that record was provided after Patient W.C. died. Given the volume of patients that were being seen in the emergency room, other patients as well as Patient W.C., five sets of records and tests were being established aside from Patient W.C. As a consequence, Respondent was doing paperwork on those patients and telling nurses what to do for Patient W.C. Only after the attempts at trying to save Patient W.C. were unsuccessful and after talking to Patient W.C.'s family did Respondent turn his attention to the medical records for Patient W.C. Expert Opinion Dr. John Murray is an emergency physician at Central Florida Regional Hospital in Sanford, Florida. He is licensed to practice in Florida and has been since 1983. He is also licensed to practice in Alabama. Dr. Murray attended medical school at the University of South Florida in Tampa, Florida. He did his residency at the University of Alabama in Tuscaloosa, Alabama. His residency was in family practice. Dr. Murray practiced in Tuscaloosa, Alabama, in emergency medicine, until four or five years ago. He then entered family practice for about three years. Following that time, he returned to practice in emergency medicine. Dr. Murray is board-certified in family practice and emergency medicine. Dr. Murray was received as an expert in emergency medicine to allow him to offer his opinion as an expert. Dr. Murray served as Petitioner's consultant in the case and was presented as its witness at hearing. To prepare himself to testify, Dr. Murray reviewed the Bert Fish hospital records relating to Patient W.C., the autopsy report, the Administrative Complaint, correspondence from Respondent's attorney, Respondent's deposition, the deposition of the nurses who treated Patient W.C. at Bert Fish, the deposition of the respiratory therapist involved with Patient W.C.'s patient care, and the toxicology report pertaining to Patient W.C. Having prepared himself Dr. Murray testified concerning Respondent's performance when measured against the expected "standard of care." In offering his opinion, Dr. Murray conformed to the expectation that Respondent's performance meet what was minimally acceptable in the standard of care. Dr. Murray does not believe that Respondent met the standard of care incumbent upon Respondent. In Dr. Murray's opinion, when a patient is seen in an emergency room the development of the differential diagnosis begins with the worse case scenario. In Patient W.C.'s case, the first consideration in the differential diagnosis should have been epiglottitis, recognizing that the main problem in the condition is inspiratory stridor, the closing of the airway or the upper airway which may cause the patient to die. Therefore, the physician should do everything possible to assure that this does not happen. Dr. Murray believes that the patient was presenting with signs and symptoms of epiglottitis when he arrived at the emergency room at Bert Fish. Dr. Murray believes that when Respondent decided to intubate Patient W.C., it should have been anticipated that there was going to be a very difficult procedure if the patient had acute epiglottitis. Sometimes the intubation fails and there is the need to provide a surgical airway. Because Respondent did not anticipate that difficulty, the intubation procedure was not properly "setup," according to Dr. Murray. That setup would envision dealing with intubation to potentially be followed by the need to provide a surgical airway. Given the possibility that the patient had epiglottitis, it was important to have the most experienced person available to perform the intubation. Dr. Murray believes that would be an anesthesiologist. Beyond that point, if the surgical airway is needed, a surgeon should be available to provide a surgical airway. Dr. Murray believes there was time to have a successful intubation, or if not, the provision of a successful airway by surgery and these arrangements were not made. Notwithstanding the patient's reported history, recognizing the symptoms present, Dr. Murray did not believe that the patient was suffering from an allergic reaction. Nothing in the medical records suggested to Dr. Murray that Patient W.C. was under the influence of cocaine when he was seen at Bert Fish. Commenting on the medical record where the term "pharyngeal erythema" was circled, Dr. Murray explained that pharyngitis is a form of infection either viral or bacterial in relation to the red or sore throat seen in the back of the throat of Patient W.C. when examined by Respondent. Respondent also made reference to lymphadenopathy both right and left, swollen lymph nodes. Patient W.C. was experiencing inspiratory stridor, difficulty in getting air in to his lungs. With inspiratory stridor, swollen lymph nodes and a red and painful throat, Dr. Murray said he would be concerned about Patient W.C.'s having an infection. Dr. Murray was concerned that if Patient W.C. had a lot of inspiratory stridor that the condition might be epiglottitis. With infection and stridor, the airway can close quickly. These circumstances could make intubation of the patient difficult, if not impossible. Dr. Murray acknowledges that epiglottitis was on Respondent's differential diagnosis for Patient W.C. Respondent's orders for use of racemic Epinephrine through nebulization and the provision of steroids, Decadron and Solu-cortef were appropriate in Dr. Murray's view. Repeating the nebulization would have been appropriate in dealing with an allergic reaction which was the number one condition treated by Respondent. Dr. Murray speaks of the use of antihistamines as well. Dr. Murray opined that as long as Patient W.C. was perceived as having an allergic airway problem, the patient would be treated with updraft treatments and antihistamines, if the patient remained stable and did not appear to be "going down hill and crashing." If the patient is "crashing," stops breathing, then a response to the condition would be necessary before the patient had respiratory arrest. However, with epiglottitis most patients would have to be intubated to protect the airway. The condition would be treated as an infection with use of an antibiotics and steroids over time while being cautious about the patient having his or her airway close off. Criticism that Dr. Murray has of Respondent's care was not the basic idea that the patient was intubated to address epiglottitis. It was the expectation that intubation need not be done unless it was absolutely an emergent circumstance, i.e., the patient had stopped breathing. If there is suspected epiglottitis, the physician should not use a tongue blade that may cause spasms or a laryngoscope. The physician should not paralyze the patient. The doctor is going to be confronted potentially with the fact that there is "no hole" to put the tube, in an attempt at intubation and it becomes necessary to "do something and get an airway in." Again the arrangement that needs to be made, in Dr. Murray's opinion, is the double setup to address the intubation and possible surgical airway. Dr. Murray does not believe that Respondent had the needed equipment to address the patient's condition when he began the intubation. In particular, the necessary equipment for the second step in the double setup, that of providing a surgical airway had not been sufficiently arranged by Respondent. Only in the instances where the patient had stopped breathing and Respondent had no time to call in other physicians would it be appropriate to paralyze the patient and attempt the intubation. Dr. Murray does not believe that the patient was dying, and there was the opportunity to call in the surgeon who was available in eight minutes, to provide assistance if one anticipates difficulty. Dr. Murray described three methods of addressing the surgical airway. One is crichothyroidotomy, which was attempted here. The second method is jet insufflation used in pediatrics but also taught for use in adults. The third method is the use of a needle with a catheter. Dr. Murray explained that if using the crichothyroidotomy is a procedure that is comfortable to the physician, then there is no necessity for redundancy beyond the use of that method for providing a surgical airway. Redundancy would be the use of the kit known as Seldinger that causes a small puncture wound. This method is a new technique, an alternative to needle crichothyroidotomy and regular crichothyroidotomy. The Seldinger method is the jet insufflation. Jet insufflation is not a common procedure in adults and is used more in pediatric care. In Dr. Murray's opinion, a reasonably prudent emergency room doctor would know of the availability of that option for ventilating a patient whether the patient is an adult or a child. Dr. Murray criticizes Respondent's medical records for Patient W.C. In his review, Dr. Murray did not find an explanation why it was necessary to intubate Patient W.C. at that moment and by the method employed. The record does not justify attempting a paralytic intubation under the existing circumstances, according to Dr. Murray. Dr. Marlon Priest, witness for Respondent, graduated from the University of Alabama with a degree in chemistry. He attended the University of Alabama School of Medicine from 1974 until 1977. He completed an internal medicine residency. From 1981 through November of 2006, Dr. Priest was on the faculty of the University of Alabama, Birmingham, Alabama, and served as a professor of emergency medicine and director of critical care transport. Over the years, Dr. Priest has had extensive experience in emergency medicine in a hospital setting. He is licensed to practice medicine in Alabama. Dr. Priest was accepted as an expert and allowed to testify concerning his opinion of Respondent's care provided Patient W.C., whether Respondent met the standard of care. Dr. Priest reviewed the Administrative Complaint, the medical records from Bert Fish concerning Patient W.C., Respondent's deposition, the deposition of Thomas Beaver, M.D., and the deposition of Michael A. Evans, Ph.D. to prepare himself to testify. He found the information sufficient to prepare to offer his opinion concerning the care provided Patient W.C. When asked whether Respondent violated the standard of care for failing to consult with or gain the assistance from an anesthesiologist or the on-call surgeon prior to inducing paralysis and attempting RSI, referring to rapid sequence intubation on Patient W.C., fell below the standard of care for an emergency room physician, Dr. Priest indicated that he felt that Respondent met the applicable standards. Dr. Priest believes emergency medicine has evolved to the point where emergency room physicians are able to assess and carryout that form of intubation. In Dr. Priest's experience, on numerous occasions, he has intubated patients without consulting a surgeon or an anesthesiologist. Based upon those insights Dr. Priest does not believe that Respondent was obligated to consult a surgeon or an anesthesiologist before attempting the intubation on Patient W.C. Specific to Patient W.C.'s case, the patient presented with shortness of breath and stridor and having failed to improve following treatment to address a possible allergic reaction, the decision was made to oxygenate the patient prior to some event where the patient could not breathe. Based upon the symptoms of the patient and gravity of the situation, Dr. Priest is persuaded that it was appropriate to attempt intubation. Concerning the allegation that Respondent failed to meet the standard of care by inducing paralysis in Patient W.C., Dr. Priest indicated that RSI is the preferred method of gaining access to a patient's airway where the patient is awake and alert and who might struggle if that method was not employed in an effort to intubate the patient. In his opinion, Dr. Priest makes mention of the progression in the case from having stridor, complaining of not being able to breathe and Dr. Priest's expectation that the airway was becoming smaller over time. Dr. Priest believes that the principal diagnosis in the differential pertaining to Patient W.C., possible allergic reaction was a reasonable diagnosis based upon information in the patient records. Concerning the allegation about Respondent's medical records related to alleged failure to document symptoms in Patient W.C. that would justify paralysis and RSI, as opposed to other less risky forms of securing the airway, Dr. Priest believes that there is sufficient evidence in the medical record to justify the intubation. Related to the second allegation dealing with record keeping by Respondent alleging that Respondent failed to document Patient W.C.'s O2 sat. and cardiac activity during the RSI attempt and subsequent procedures, Dr. Priest believes that this information would have been written down by someone else on the treatment team during the course of the treatment, the attempt to intubate. Even beyond that point, Dr. Priest believes that standard protocol would call upon the respiratory therapist or the nurse to create the record or potentially someone else on the hospital staff, not the Respondent. The inaccurate report by Patient W.C. concerning his past history with bird allergies changes the priorities in the differential diagnosis, in Dr. Priest's opinion. That history meant that allergic reaction was placed at the top of the differential diagnosis, in particular with a physical examination that was consistent with the history. Dr. Priest holds this belief even in the absence of fever, sweating, or questionable vital signs in the patient. When Dr. Schreiber entered the treatment room, he noticed a group including a physician and nurses who were attending Patient W.C. They were trying to resuscitate the patient. The patient did not have an airway. The patient was cyanotic. The patient was bloated and did not have a pulse. An attempt was being made to revive the patient from arrest. A valve bag mask was being used and drugs administered that would support the patient's blood pressure. An effort at gaining a surgical airway had not succeeded. There was a surgical incision on the patient's neck. Blood was on the patient and on the floor. At the moment no attempt was being made to establish a surgical airway. Dr. Schreiber observed that the patient had a protruding tongue that was obstructing this mouth and airway. Dr. Schreiber observed that the Petitioner's upper check and abdomen were bloated. Dr. Schreiber noted that the patient evidenced crepitancy, indicating subcutaneous air in the patient's neck and chest. This would be consistent with the placement of an airway tube into the subcutaneous tissue outside the trachea and air blown into the area. Dr. Schreiber made a nick in the trachea and placed a number 8 ET tube into the trachea. Following the placement of the ET tube in the trachea, Dr. Schreiber observed air movement in the lungs. However, the patient did not regain a pulse or adequate saturation of oxygen. On January 3, 2006, Dr. Thomas Beaver, Chief Medical Examiner and pathologist, performed an autopsy on Patient W.C. As part of his Medical Examiner's report on Patient W.C., special studies had been done, and a comprehensive toxicology analysis performed by AIT Laboratories. Dr. Beaver determined the cause of death as complications of acute epiglottitis and that the manner of death was of natural causes. The complications of acute epiglottitis were explained as a status post crichothyroidotomy. Dr. Beaver also noted atherosclerotic cardiovascular disease involving coronary arteries, mild. In particular, Dr. Beaver found that the epiglottis was swollen to an extent that it obstructed the deceased's airway. The condition observed was not the result of an attempted intubation of the patient, in Dr. Beaver's opinion. The condition observed was a disease process that Dr. Beaver felt was on-going for a matter of hours or perhaps a number of days before the attempted intubation. This type of mechanical obstruction in the epiglottitis would obstruct the airway and disable the patient from breathing, according to Dr. Beaver. The condition of the epiglottitis was not perceived by Dr. Beaver to be in association with some form of allergic reaction. The exact cause was not clear. Dr. Beaver does not believe that the ingestion of cocaine, whose metabolites were in the body caused the death. Marie Herrmann, M.D., is the present Medical Examiner and pathologist in the jurisdiction where Dr. Beaver served. Dr. Herrmann had the opportunity to review Dr. Beaver's autopsy report on Patient W.C. and to examine some evidence available to Dr. Beaver in performing his examination. She too was not persuaded that cocaine was a contributing factor to Patient W.C.'s death. In offering this opinion Dr. Herrmann was aware of the toxicology report from AIT Laboratories. Dr. Herrmann agrees with Dr. Beaver's opinion concerning Patient W.C.'s cause of death. Dr. Herrmann was unable to determine within a reasonable degree of medical certainty that the efforts by Respondent to intubate Patient W.C. caused the blockage in the airway. Michael Evans, Ph.D., is the founder, president and CEO of AIT Laboratories. He is an expert in toxicology. He testified concerning the findings in his laboratory related to Patient W.C. using established protocols for examination of the samples provided his facility. Based upon his analysis, Dr. Evans believes that Patient W.C. had ingested cocaine as recent as three hours and no longer than 24 hours before his death based upon values found in the blood and urine samples provided. Bruce Goldberger, Ph.D., is an expert in forensic toxicology. He is a professor and director of toxicology at the University of Florida College of Medicine, Departments of Pathology and Psychiatry. He is familiar with the medical examiner's report prepared by Dr. Weaver and the AIT Laboratories' report on Patient W.C. Dr. Goldberger offered the opinion that Patient W.C. could have been using cocaine a day or two before his death. He defers to the medical examiner as to the cause of the patient's death. It is accepted from the findings made in the autopsy report by Dr. Beaver that Patient W.C. died from complications of acute epiglottitis, from natural causes, not as a result of Respondent's attempt to intubate the patient. Having considered the facts and the opinions of experts, clear and convincing evidence was not presented to establish the violations alleged in Count One (Section 458.331(1)(t), Florida Statutes) paragraph 27. a). and b). related to consultation with or assistance from an anesthesiologist or the on-call surgeon prior to inducing paralysis in the patient as part of RSI. Likewise, the violation alleged in Count Two (Section 458.331(1)(m), Florida Statutes) paragraph 30. a). relating to failure to document symptoms justifying paralysis and RSI was not proven by clear and convincing evidence. Concerning the alleged violation in Count Two (Section 458.331(1)(m), Florida Statutes) paragraph 30. b). involving the documentation of Patient W.C.'s O2 sat. and cardiac activity during the RSI attempt and subsequent procedures, the opinion of Dr. Priest is compelling. Based upon that opinion Respondent would not be expected to provide that documentation and maintain the record beyond that point in time. Respondent's Background Respondent received his undergraduate education from the University of Tennessee, earning a B.S. in biology. He attended medical school in Nashville, Tennessee, at Harry Medical College and worked as an emergency physician in Tennessee. He undertook a flexible internship at the University of Tennessee in Knoxville, Tennessee. In 1987 Respondent went to Jacksonville, Florida, to do a three-year residency in pediatrics, graduating from that program in 1990. During that time he worked in local emergency rooms in St. Augustine, Palatka, and Tallahassee, Florida. He took courses in Advanced Trauma Life Support and Advanced Cardiac Life Support. Since 1990 Respondent has been a full-time emergency room physician living in New Smyrna Beach, Florida. At present, Respondent works for M. Care Emergency Services in Jacksonville, Florida. Mitigation and Aggravation Respondent has no prior violations related to his license to practice medicine in Florida. Patient W.C.'s Family Patient W.C. was married to F.C. and had two young children. At his death his daughter was approximately two-and- a-half years old and his son was 14 months old. Following Patient W.C.'s death, the family has had a difficult time coping with their loss.
Recommendation Based upon the findings of facts found and the conclusions, RECOMMENDED: That a final order be entered, which dismisses the Administrative Complaint, as amended. DONE AND ENTERED this 14th day of April, 2008, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS 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 14th day of April, 2008.
