The Issue The issue in this case is whether the Respondent should be disciplined for not meeting the “standard of care” by not responding appropriately to calls to him, as an on-call obstetrician, to come to the hospital and assist with a delivery.
Findings Of Fact The Respondent is licensed to practice medicine in Florida. He holds license ME 100568. He is board-certified in obstetrics and gynecology by the American Board of Obstetrics and Gynecology. In March 2011, the Respondent was one of two obstetrician-gynecologists (ob-gyns) employed by Family Health Centers of Southwest Florida (Family Health). Family Health also employed certified nurse midwives (CNM) and had agreements with two area hospitals owned by Lee Memorial System, Health Park and Gulf Coast. Health Park is a Level 3 hospital and has the means to provide the medical services needed for premature and high-risk deliveries. Gulf Coast is a Level 1 hospital and does not provide those services. On March 21, 2011, the Respondent was the on-call ob-gyn for the Family Health practice from 7:00 p.m. that evening until 7:00 a.m. the next morning. At 7:53 p.m. on March 21, 2011, Family Health obstetrical patient, M.T., was admitted to Gulf Coast’s emergency room, where she reported that she had been having contractions for two hours and was experiencing pain at the level of nine on a scale of ten. M.T. was a high-risk patient. She suffered a stillbirth in 2008 and a miscarriage in 2009. Yet, she had late and minimal prenatal care for being high-risk (having been seen by the Family Health practice only twice, not until the second or third trimester, and not by one of the doctors). The standard for viability at the time was 24 weeks, assuming good prenatal care and delivery in a Level 3 hospital with all needed specialists available, which was not the case at Gulf Coast. After triage in the emergency department of Gulf Coast, M.T. was admitted to the hospital and taken to labor and delivery. Barbara Carroll, a CNM employed by Family Health, was on duty there. Labor and delivery was busy that evening, and CNM Carroll saw M.T. at approximately 8:55 p.m. CNM Carroll took the patient’s history and noted in the patient’s medical record that an ultrasound done on February 24, 2011, indicated that the patient was 20 weeks and five days pregnant at that time, with a margin of error of plus or minus two weeks. Based on that ultrasound, CNM Carroll noted that the gestational age of the fetus on March 21, 2011, was 23 weeks and four days. (There was no evidence addressing the apparent miscalculation--if the gestational age on February 24 was 20 weeks and five days, it would have been 24 weeks and 2 days on March 21.) CNM Carroll then did a speculum examination, which revealed that the patient was in active labor, fully dilated and fully effaced, with a bulging bag of water (i.e., amniotic fluid). The type of examination performed did not allow CNM Carroll to determine the presenting part. CNM Carroll wrote these observations and impressions in the patient’s medical record. At approximately 9:00 p.m., CNM Carroll telephoned the Respondent, who was at Health Park at the time. It was not clear from the evidence what was said during their conversation. CNM Carroll testified that she reported what she had written in the medical record and asked the Respondent to come to the hospital immediately to assist with the delivery because she was not comfortable doing it herself. She testified that she thought the fetus was potentially viable, with a gestational age of 27 or 28 weeks, based on her examination and fetal heart monitor tracings. However, she did not recall telling the Respondent her belief as to the actual gestational age of the fetus. CNM Carroll testified that, in response to her report, the Respondent told her to start Pitocin, which would accelerate the labor and delivery process, and turn off the fetal monitor. She testified that when she balked, he said, “I told you what to do,” and she responded, “and I told you, I need you to come in.” She testified that it was clear to her that the Respondent knew from this curt exchange that she was not going to follow his orders. She testified that she declined to “argue” with the Respondent, which she had done on other occasions in the past. She testified that she thought he would change his mind and call back with new orders, which she claimed was a pattern of his. The Respondent recalled the conversation somewhat differently. He denied telling CNM Carroll to start Pitocin or to turn off the fetal monitor. He testified that he anticipated active labor would proceed and result in an abortion, since the fetus was not viable and would not survive a delivery at Gulf Coast that night. His plan was to give the patient pain medication for comfort and to manage the patient expectantly-- meaning do nothing, and continue to monitor the patient. He testified that he hoped labor might cease and the baby might possibly get to 24 weeks and be viable, if the labor and delivery could be arranged to occur at a Level 3 facility like Health Park. After the conversation, CNM Carroll completed her entries in the patient’s medical record. She wrote her impression that the patient was in active labor and her plan that the patient would be monitored, that the Respondent was aware and anticipated a spontaneous vaginal delivery, and that she expected a normal spontaneous vaginal delivery. She testified that she wrote “normal” unintentionally due to the stress she was feeling about the prospect of doing the delivery herself, without the Respondent being there to assist. Her notations make no reference to an order to start Pitocin or to turn off the fetal monitor. CNM Carroll testified that in the same approximate timeframe that she talked to the Respondent, she had Health Park’s transport team called to arrange for transportation to that facility’s neonatal nursery immediately after childbirth and had Gulf Coast’s high-risk delivery team (consisting of a neonatologist, a respiratory therapist, and an anesthesiologist) called to be ready for the delivery and transport to Health Park. She did not tell the Respondent she was doing this. CNM Carroll’s testimony about her telephone conversation with the Respondent at or about 9:00 p.m. that night is inconsistent with some of her entries in the patient’s medical record. If CNM Carroll’s testimony was not false in those respects, it may be mistaken, and it could be that CNM Carroll was confusing this telephone conversation with one later in the evening. CNM Carroll was very busy that evening, attending to several patients at the same time. Although not reflected in CNM Carroll’s entries in the medical record, and unbeknownst to her, the Respondent initially ordered an ultrasound and comprehensive blood test. The ultrasound results indicated at about 9:40 p.m. that the baby was in a breech position. The blood test results, which were communicated to the Respondent at about 10:00 p.m., indicated that the patient had an active infection (i.e., chorioamnionitis). At that point, the Respondent no longer believed that expectant management was appropriate and, at 10:05 p.m., ordered Pitocin to be administered to speed the delivery of the fetus before the infection spread. He reasonably did not expect the baby to survive. It is not clear from the evidence that the Respondent was told during these communications, at about 10:00 p.m., that the baby was breech. The Respondent claims that he was not told. It also is unclear whether the Respondent ordered the fetal monitoring to cease at that time. The Respondent said he did not. Some of the other witnesses recalled that he did, but there is no indication of such an order in the medical record. In any event, there was no clear and convincing evidence that it would have been inappropriate to turn off the fetal monitor at that point. At about the same time that the Respondent was ordering Pitocin, CNM Teresa Buckley returned to the hospital. CNM Buckley’s shift had started at 7:00 a.m. that morning, but CNM Carroll covered for her in the middle of the shift, so CNM Buckley could attend a child’s basketball game. CNM Buckley took report from CNM Carroll on the patient, M.T., and was told the gestational age of the fetus, the status of labor (active), and the imminence of delivery. She probably was told that CNM Carroll thought the fetus could be viable, despite its gestational age based on the heartbeat and monitor tracings, and that the Respondent had been called earlier and asked to come to the hospital to help with the delivery. After taking report, CNM Buckley examined the patient, reviewed the monitor tracings, talked to the patient, palpated the contractions, and examined the patient to determine the position of the fetus. During, or shortly after, the examination, the patient’s membrane ruptured. The rupture of the membrane may have been caused or hastened by CNM Buckley’s examination. Shortly after the membrane ruptured, at approximately 10:20 p.m., the baby’s foot appeared. CNM Buckley attempted to facilitate the breech delivery by sweeping the baby’s arms down and rotating. Both feet and legs and the torso were delivered, but the baby’s head was stuck and could not be delivered. At that point, at about 10:30 p.m., CNM Buckley asked the charge nurse to telephone the Respondent to say she needed him to come in to help with the delivery. The charge nurse telephoned the Respondent. The evidence is unclear exactly what she told him. The medical record states that she asked him to come in to assist with the delivery. The charge nurse testified that she informed him that the patient’s membrane had ruptured and asked if he was coming in. The Respondent’s best recollection is being told that CNM Buckley, who he did not know was on the case, needed his help with a breech delivery. He denies being told that the patient’s membrane had broken or that it was a footling breech delivery with the head stuck. The Respondent testified that he would have immediately agreed to proceed to the hospital had he been told either of those facts. He testified that he interpreted what he was told to mean he was being asked to help the CNM perform a breech extraction and that he said, “no,” his orders were to start Pitocin. The charge nurse testified that the Respondent asked if Pitocin was running, said to make sure it was running, and hung up. It is unclear from the evidence exactly when Pitocin was started. The medical record indicates that it was not started until 10:30 p.m., some 25 minutes after the Respondent ordered it. This would have been about the time when the Respondent asked the charge nurse about it. When the charge nurse reported to bedside, the CNM asked if the Respondent was coming in and if he was almost there. The charge nurse said she didn’t know, he didn’t say. The CNM had her call back to find out. According to the medical record, the charge nurse’s second call was made at 10:33 p.m., the Respondent was asked to “come in for breech delivery,” and the Respondent said, “no.” According to the testimony of the charge nurse, she told the Respondent that the CNM wanted the Respondent at bedside because she was having difficulty with the breech delivery and the baby’s head was stuck. The Respondent denied being told this in either of the two telephone calls. He testified that, still thinking the membrane was intact and the fetus was in the patient’s pelvis, he repeated his instruction, “no,” to a breech extraction. It was not proven by clear and convincing evidence that the Respondent was not being truthful about what he understood from the communications to him in the 10:30 and 10:33 p.m. telephone calls. When the charge nurse heard what the Respondent had to say, she hung up and reported to the CNM and others that the Respondent was not coming in. They paged Dr. Garner, the other ob-gyn employed by Family Health. Dr. Garner promptly answered the page and was asked to come in to assist with the delivery. He proceeded to the hospital and arrived at bedside at 10:55 p.m. The baby died during the delivery process and was delivered at 11:06 p.m. The Respondent testified that notwithstanding his inaccurate understanding of the status of the patient as a result of the telephone calls at 10:30 and 10:33 p.m., and his negative responses to the charge nurse, he actually proceeded to Gulf Coast. He stated that he telephoned the hospital on the way and was told that Dr. Garner was at bedside. At that point, he decided there was no need for him to go to the hospital and turned around to return to Health Park. During the hearing, DOH did not challenge or refute the Respondent’s testimony regarding his last phone call, but DOH’s proposed recommended order questions the Respondent’s veracity on the ground that the medical record does not mention it, and none of the other witnesses testified to knowing about it. Neither party produced other evidence that might establish whether the telephone call actually occurred. On this record, it was not proven by clear and convincing evidence that the Respondent did not proceed to Gulf Coast in response to the telephone call at 10:33 p.m., only to turn around when told that Dr. Garner was at bedside. DOH called an expert, Dr. Babu Veerendra Chitriki, who is a board-certified ob-gyn, to testify that the standard of care required that the Respondent, as the on-call ob-gyn, respond to each and every request for assistance he received from a CNM or nurse on the evening of March 21, 2011, by agreeing to come to the hospital. Dr. Chitriki’s testimony was refuted persuasively by the Respondent’s two experts, also board-certified ob-gyns, Drs. Mark Spence and Allison Thresher. They opined that it would be within the standard of care for the Respondent to ask questions, get an accurate understanding of the medical situation, and exercise medical judgment based on that understanding. Neither thought it was required by the standard of care for the Respondent to drop everything and come to the hospital as a result of the telephone calls he received on March 21, 2011, no questions asked. As to the telephone call from CNM Carroll at 9:00 p.m., it was not proven by clear and convincing evidence that it resulted in a clear request requiring the Respondent to accede and proceed to the hospital immediately. Rather, at most, it appears to have resulted in an unresolved disagreement between the health care professionals as to the appropriate plan of action. As to the 10:30 and 10:33 p.m. telephone calls, Drs. Spence and Thresher, as well as the Respondent, agreed that the standard of care would have required a positive response from the Respondent, had he been told what was occurring with the patient at the time. Instead, they viewed those telephone calls as evidence of an unfortunate failure of communication between the Respondent and the CNMs and nurses. It was not proven by clear and convincing evidence that the Respondent was lying when he testified that he was not told what was occurring at 10:30 and 10:33 p.m. It also was not proven by clear and convincing evidence that the facts were clearly communicated to the Respondent during those telephone calls. Finally, it was not proven by clear and convincing evidence that despite the failure to communicate, the Respondent did not in fact proceed to the hospital in response to those telephone calls, only to turn around when he learned that Dr. Garner was at beside. The Respondent is not without his share of fault for the miscommunications that occurred on March 21, 2011. Conflicts between him and the Family Health practice may have been a factor. He could have been a better listener, and he could have asked more and better questions to make sure he was getting the full picture of what was going on with the patient, particularly at the time of the 10:30 and 10:33 p.m. telephone calls. However, DOH did not charge him with practicing below the standard of care by not communicating. Rather, DOH charged him with failure to come to the hospital to assist with a difficult delivery after receiving a clear request to do so, a charge that was not proven by clear and convincing evidence.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the charges against the Respondent in this case. DONE AND ENTERED this 18th day of July, 2014, in Tallahassee, Leon County, Florida. S J. LAWRENCE JOHNSTON 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 18th day of July, 2014.
The Issue Whether Respondent committed the violations alleged in the Administrative Complaints and, if so, what penalty should be imposed.
Findings Of Fact AHCA is the agency responsible for the licensing and regulation of skilled nursing facilities in Florida pursuant to Chapter 400, Part II, Florida Statutes, and Chapter 59A-4, Florida Administrative Code. At all times material hereto, Oakwood was licensed by Petitioner as a skilled nursing facility. Oakwood operates a 120-bed nursing home located in Eustis, Florida. From June 19 through July 1, 2002, Dorothy Mueller, who at the time was employed by AHCA as a Registered Nurse Specialist, conducted a complaint investigation at Oakwood. She received the complaint from Florida Protective Services of the Department of Children and Family Services (DCFS). Ms. Mueller is Surveyor Minimum Qualification Test (SMQT) qualified. She is currently licensed as a registered nurse in Florida but retired from AHCA in December 2002. Ms. Mueller began the complaint investigation on June 19, 2002. She announced her visit to the facility's administrator, observed residents, interviewed staff, and reviewed records. She requested a sampling of residents' records. The sample she reviewed included the record of Resident D.R. During the course of the complaint investigation, Ms. Mueller did not interview Resident D.R. as she had already been discharged from the facility. Ms. Mueller examined Resident D.R.'s care plans, assessments, nursing notes, and wound care. Nurse Mueller was specifically looking for whether anyone at Respondent's facility was actually looking at the skin of Resident D.R.'s heels because Resident D.R. was wearing TED hose. Because Resident D.R. was at risk for developing pressure sores, Ms. Mueller was concerned that she found no specific preventative measures taken by the facility to help prevent the development of pressure sores on Resident D.R.'s heels.1/ In determining her findings, Ms. Mueller took into consideration the findings of the person from DCFS who had filed the complaint that caused AHCA to send Ms. Mueller to investigate. Additionally, Ms. Mueller also took into consideration notes from Resident D.R.'s family physician and statements he made to her regarding the condition of Resident D.R.'s heels two days after her discharge from Oakwood.2/ Based on Ms. Mueller's findings during this complaint investigation, federal tag F224 was cited against Oakwood. Resident D.R. was admitted to Oakwood on February 24, 2002, following a four-day hospitalization for hip surgery due to a fall at her home which resulted in a hip fracture. Resident D.R.'s hospital records reveal the development of a skin ulcer in her sacral area the morning of February 23, 2002, and that the ulcer worsened before Resident D.R.'s discharge from the hospital on February 24, 2002. Upon admission to Oakwood, Resident D.R. was assessed by Dorothy Gilbert, a Registered Nurse employed by Oakwood. Nurse Gilbert's full skin assessment of Resident D.R. noted two skin ulcers on Resident D.R.'s sacral area with no other skin breakdown. Nurse Gilbert noted that Resident D.R.'s heels were "soft nonreddened." According to Nurse Gilbert, that notation meant that the skin on Resident D.R.'s heels was normal, intact, nonreddened and showed no deterioration. The nurse's assessment form contains a diagram of a person showing front and back with the following instruction: "Skin: Indicate on diagram below all body marks such as old or recent scar, bruise, discoloration, laceration, amputation, decubitus ulcer, and any other questionable marking(s) considered other than normal." Nurse Gilbert made detailed notations and drawings on the diagram indicating any and all skin breakdown of Resident D.R. The foot area of the diagram contained no notation or drawing indicating any skin breakdown on Resident D.R.'s feet upon admission to Oakwood. Another page of the nurse's assessment form is entitled "Braden Scale-For Predicting Pressure Sore Risk." Nurse Gilbert gave Resident D.R. a score of 14 which identified her to be at moderate risk for pressure sores or ulcers. She was at risk for skin breakdown over her entire body, not just her heels, and her care plan accounted for this. Resident D.R. was wearing TED hose at the time of admission and wore them throughout her stay. TED hose are anti- embolism stockings typically used following surgery to enhance blood flow and prevent clotting. Resident D.R. was a petite, elderly woman weighing 83 pounds. Appropriate assessments and interdisciplinary care plans were developed for Resident D.R., including for her existing skin ulcers also referred to as sores or wounds. During Resident D.R.'s stay at Oakwood, one of her existing sacral skin wounds improved and the other wound healed. She received daily wound treatment by the nurses on duty and the wound care nurse measured her ulcers and assessed her skin each Thursday. Cynthia Burbey is an Licensed Practical Nurse employed by Oakwood. She observed Resident D.R.'s heel condition usually every day when she gave her treatment for wound care on her coccyx, and on her shower days which occurred twice a week. While the Certified Nurses Assistants (CNAs) give showers to the residents, the nurses follow the bathing of the resident with a body check/body assessment. Nurse Burbey never saw any skin deterioration on Resident D.R.'s heels, including the day Resident D.R. was discharged. At the time of the discharge, Nurse Burbey did a body assessment from head to toe of Resident D.R. and did not observe any skin deterioration on Resident D.R.'s heels. The CNAs at Respondent's facility play a significant role in observing skin condition and are to report any change in skin condition to the nurses. In addition to their role in observing skin condition at bath time, the CNAs repositioned Resident D.R. every two hours and assisted her in and out of bed each day. She was completely dressed and undressed each day by her attending CNAs who would remove her TED hose and change them. Pressure on skin over bony areas is a primary cause of pressure ulcers or bed sores. Resident D.R. received a variety of services and devices during her stay at Oakwood aimed at reducing the likelihood of bed sores, including knee wedges for both her bed and wheelchair, calf pads for her wheelchair, a pressure reducing mattress, and physical therapy. Because of her petite size, the knee wedge used for her bed resulted in Resident D.R.'s heels being "floated" off her mattress. Resident D.R., also received physical therapy services including range of motion exercises while at Oakwood. The range of motion exercises for her lower extremities would have provided her therapists and restorative aids an opportunity to detect evidence of skin breakdown on her heels, because her heels were touched by the therapists or aides during these exercises. While Resident D.R. wore socks for these therapies, the therapists and aides saw no evidence of staining on her socks, which often happens from drainage from a heel wound, or any evidence that their touching her heels resulted in any pain to Resident D.R. The restorative aides provided Resident D.R. with range of motion exercises six days a week, including the day before her discharge from Respondent's facility. The initial nursing assessment indicating "heel soft, nonreddened" raised Ms. Mueller's concerns that there was no care specifically directed toward Resident D.R.'s heels. However, there is no competent evidence that Resident D.R. had heel wounds either upon admission or which developed during her stay at Oakwood. Accordingly, there was no reason for Oakwood to have a skin care plan specifically addressing Resident D.R.'s heels, particularly in light of the fact that Oakwood had a skin care plan in place for Resident D.R. which was followed. Further, during cross examination, when asked whether the phrase "heel soft nonreddened," was an indicator that Resident D.R. had a problem with her heel, she acknowledged, "I would have to answer yes and no to that." AHCA 's charge of failure to have due diligence taken to prevent, subsequently detect if the condition could not be prevented, and then provide appropriate care and treatment for avoidable bilateral pressure ulcers is based solely on hearsay evidence. AHCA's sole witness, the surveyor who conducted the complaint investigation, never observed Resident D.R. at any time, either in Respondent's facility or after her discharge. The evidence presented does not establish that Oakwood failed to have due diligence to prevent, subsequently detect if the condition could not be prevented, and then provide appropriate care and treatment for bilateral pressure sores. There is no competent proof that any heel sore developed on Resident D.R.'s heels while a resident at Oakwood. Moreover, the evidence shows that the nursing staff appropriately addressed the skin care needs of Resident D.R.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is RECOMMENDED: That the Agency for Health Care Administration enter a final order dismissing the Administrative Complaints issued against Respondent, Oakwood Center. DONE AND ENTERED this 21st day of March, 2003, in Tallahassee, Leon County, Florida. BARBARA J. STAROS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 21st day of March, 2003.
The Issue The issues are: 1) whether Respondent committed medical malpractice, in violation of section 458.331(1)(t)1.; 2) whether Respondent failed to keep or maintain medical records, in violation of section 458.331(1)(m); 3) whether Respondent performed a wrong procedure or wrong-site procedure, in violation of section 456.072(1)(bb); and 4) if so, the determination of the penalty, pursuant to Florida Administrative Code Rule 64B8-8.001. (All references to statutes and rules are to the Florida Statutes and rules in effect in 2012, as cited in the Amended Administrative Complaint.)
Findings Of Fact Respondent is a medical physician, holding license number ME 0062034. He is certified as a pain management specialist by the American Board of Anaesthesia and American Academy of Pain Management. Licensed for nearly 40 years, Respondent practiced in 2012 in Lake Worth at the Palm Beach Pain Management Center, where he was the chief executive officer. Respondent has performed the specific procedures involved in this case at least 500 times and many thousands of epidural injections. Respondent's expert witness was Dr. Brett Schlifka, who is an osteopathic physician licensed in Florida and practicing in Wellington. Dr. Schlifka is certified by the Board of Neurosurgeons of the American College of Osteopathic Surgeons. As a neurosurgeon, Dr. Schlifka performs epidural injections, but never of hypertonic saline, so he was unable to address in any detail the epidural injection of hypertonic saline, nor does he use a catheter in performing epidural steroid injections (ESIs), so he was unable to address in any detail the specifics of the processes of threading a catheter through epidural space and inadvertently into intrathecal space and administering injectates through a catheter. Dr. Schlifka and Respondent are friends and refer patients to each other. Petitioner's expert witness was Dr. Harold Cordner, who is a medical physician licensed in Florida and practicing in Sebastian. Dr. Corner is certified by the American Board of Anesthesiology with an added qualification in Pain Management. For ten years, he has served as a clinical assistant professor at the Florida State University School of Medicine, where he teaches procedures such as those involved in this case--procedures that he himself has performed many times. This case involves procedures performed by Respondent on M.S.'s back on September 28, 2012. From bottom to top, relevant vertebra are sacral 1 (S1), lumbar 5 (L5), L4, L3, L2, and L1. Above the lumbar vertebra are thoracic vertebra, which are not directly pertinent to this case. The spinal cord extends no lower than L1/L2; the tapered end of the spinal cord is known as the conus. Relevant anatomical features in the area of the lumbar vertebrae, from the exterior to the interior, are ligaments, the epidural space, the dura, the subdural space, the arachnoid, the subarachnoid space, and the spinal cord. The subdural space is potential, presumably responding to changes in posture or movement, or even theoretical, because the epidural and subarachnoid spaces may be separated by less than one mm. Cerebral spinal fluid (CSF) is present in the subarachnoid space, but not the epidural space. The subarachnoid space is also known as the intrathecal space, so an intrathecal injection is an injection into the subarachnoid space. Intrathecal injections may be intentional or inadvertent, although this case does not involve any intentional intrathecal injections. "Bilateral" refers to the left and right sides of the vertebrae on the left and right sides of a patient's body. "Transforaminal" is across the space, within the epidural space, occupied by the foramen, which is a bony structure at each vertebral level through which spinal nerves pass. This case involves epidural injections of various injectates, including steroids--i.e., ESIs--although an ESI routinely includes the epidural injection of contrast and an anaesthetic in addition to a steroid. The ESIs in this case all involve lumbar transforaminal ESIs, so any reference to an "ESI" is to a lumbar transforaminal ESI. The alternative to a transforaminal ESI is an interlaminar ESI, which is an ESI within the space between vertebrae. At the time in question, at least, an interlaminar ESI was a safer procedure than a transforaminal ESI, if, for no other reason, than the proximity of an artery to the nerve passing through a foramen and the possibility of causing an infarction of the spinal cord by an inadvertent injection into the artery. M.S. was a patient of Respondent at the Palm Beach Pain Management Center from 2006 through September 28, 2012. On the latter date, Respondent performed procedures on M.S., immediately after which she has been left paralyzed in her lower extremities and incontinent of bladder and bowel. Born in 1951, M.S. presented to Respondent in 2006 with complaints of low back pain for many years. She had undergone failed back surgeries in 1989, 1993, and 2003. In the course of these surgeries, surgeons had performed spinal fusions of L3/L4 and L4/L5 and implanted hardware at L3/L4. M.S. was five feet, two inches tall and weighed 160 pounds. At the time of M.S.'s initial office visit on February 7, 2006, M.S. described the pain in her low back as ranging from 5 to 10 on a scale of 0-10 and stated that she had not had "injection therapy" recently. Respondent's impressions included lumbar failed back surgery syndrome and lumbar radiculopathy, which is a condition in which a compressed spinal nerve causes pain along the nerve. Respondent recommended a bilateral ESI. Imaging conducted shortly after the initial office visit revealed the above-mentioned hardware, postoperative changes in the disc at L4/L5, a mild disc bulge at L1/L2, a "very minimal" posterior disc bulge at the postoperative site of L3/L4, and a small central protrusion at L2/L3 causing a mild compression along the central aspect of the thecal sac, which is within the subarachnoid space. Besides the initial office visit and some imaging reports from late 2010, the evidentiary record contains Respondent's medical records only from December 2011 through September 28, 2012. In late 2010, imaging disclosed disc degeneration at L1/L2 and L2/L3 with mild thecal sac impingement, the surgical fusion of L3/L4 and L4/L5, and disc desiccation at L5/S1. There was also thickening or clumping of nerve roots through the surgical levels that could be regarded as arachnoiditis, which is inflammation of the arachnoid membrane. However, the evidentiary record contains billing records from late 2006 through September 28, 2012. These records indicate that Respondent performed 21 epidural injection procedures on M.S. from December 6, 2006, through September 28, 2012. The last ten such procedures, from April 19, 2010, were billed as ESIs using Code of Procedural Terminology (CPT) code 64483, although one procedure was billed as CPT code 64473. Respondent also billed ESIs under CPT code 64483 or 62311 on February 6, 2008, May 15, 2009, May 29, 2009, and February 22, 2010. The remaining procedures were billed on December 6, 2006, March 20, 2007, June 13, 2007, November 8, 2007, February 21, 2008, September 5, 2008, January 9, 2009, and October 30, 2009, under CPT code 62264 as "Racz" procedures, which are described below. Among other things, these records establish that Respondent performed ESIs on M.S. on 90-day intervals from late 2010 until September 28, 2012. Obviously, the billing records also establish that the lumbar region of M.S. was the site of numerous procedures over the six years leading up to September 28, 2012. Although the experts agree that M.S.'s lumbar epidural space was challenging due to myriad deformities following years of disease and multiple surgeries, Respondent had navigated this space over 20 times, so Respondent at least knew that he would encounter, if not where he would encounter, lesions, narrowed openings, and other pathological changes. For many years, Respondent had prescribed Percocet to control pain. The medical records for the nine months preceding the September 28 procedures indicate that Respondent consistently administered drug screens, which appropriately revealed only oxycodone. However, on at least a half dozen office visits during 2012, M.S. admitted that she was not abiding by the Narcotic Treatment Agreement, but, each time, Respondent's notes misstate that she was in compliance, so as to indicate no inquiry into the details of the noncompliance or its significance, if any, and recordkeeping by rote. Respondent likewise displayed inattention to detail as to the informed consents that he obtained from M.S. during this nine month timeframe. Each informed consent contains a handwritten description of the procedure to which M.S. was consenting by signing the form. For each procedure, the procedure is "lumbar transforaminal epidural steroid injections with fluoroscopy and catheter"; the June 25 informed consent rephrases the last four words as "with catheter with fluoroscopy," and the September 28 informed consent adds "left" to the typical description of the procedure. Respondent never obtained M.S.'s informed consent for the injection of hypertonic saline, even though Respondent injected hypertonic saline, with the amounts shown parenthetically, during the procedures of December 23 (5 cc), June 25 (5 cc), and September 28 (8 cc). For the December 23 procedures, Respondent took 12 minutes from "start" to "end" for the actual procedures and 18 minutes from "in" to "out" of the operating room. Coincidentally, the December 23 procedures' start and end and in and out times are identical to these times for the September 28 procedures. The start to end times of other two procedures were 11 minutes. This brisk pace betrays Respondent's experience as a pain specialist, but belies M.S.'s challenge as a patient. During each set of procedures from December 2011 through September 28, 2012, Respondent injected the same injectates, except for the March 23 procedure that omits hypertonic saline, but at different dosages, which is discussed below. Respondent used a form that allowed him to document his surgical plan by circling levels--L1/L2, L2/L3, L3/L4, and L5/S1--and sides--left, right, and bilateral. For December 2011, Respondent circled nothing; for March and June 2012, Respondent circled levels L3/L4, L4/L5, and L5/S1 and the right side; and for September 28, 2012, Respondent circled the same levels, but the left side. The efficacy of the epidural procedures is revealed in the notes from postsurgical office visits during which M.S. described her pain. On January 2, 2012, M.S. reported that her pain ranged from 6-10 all day and all night, the pain ranged from her back down her legs, everything made her pain worse, and the injections helped, although, after several injections, she reported that she had experienced "floppiness" in one leg--side unspecified. M.S. concluded that the pain relief from the injections made a difference in her life and restored functionality. On January 10, 2012, M.S. returned to Respondent's office complaining of pain ranging from 8-10 without medications and 6-10 with medications. The pain was radiating from her low back down her legs, mostly her right leg. The pain was continuous and "sharp, burning, shooting, achy, knife-like, stabbing, deep, heavy, and gnawing." On February 7, 2012, M.S. returned to Respondent's office with the same complaints. Interestingly, on March 6, 2012, M.S. returned to Respondent's office describing her pain as improved--5-10 without medications and 3-6 with medications. This time the note specifies that "transforaminal epidurals" gave her the greatest relief. The note for this office visit mentions a treatment plan of another ESI of a steroid and anaesthetic, but does not specify the side. On April 3, 2012, M.S. returned to Respondent's office for her first visit after the March 23 ESI. Again, the pain was worse immediately after the procedure--9-10 without medications and 5-8 with medications, although the note adds, "the transforaminal epidural with catheter has also helped her tremendously." The notes contain no analysis of the worsened pain 11 days after the ESI compared to 17 days before the ESI, but leg floppiness does not recur in this or any subsequent note. On May 5, 2012, M.S. returned to Respondent's office describing her pain as 8-10 without medications and 5-9 with medications. M.S. stated that the medications and "transforaminal epidurals with catheter" were the only treatments that helped with the pain. On May 15, 2012, M.S. returned to Respondent's office describing her pain as 6-10 without medications and 4-6 with medications. On June 22, 2012, M.S. returned to Respondent's office following a trip to North Carolina, where she had been unable to obtain her oxycodone and had been in considerable pain. On the day of the visit, though, M.S. reported her pain to be an 8 without medications and 6 with medications. The treatment plan contained in the note includes a right ESI, which Respondent described to M.S. as the injection of Cortisone and Marcaine or lidocaine with no mention of hypertonic saline. On July 20, 2012, M.S. returned to Respondent's office for her first visit after the June 25 ESI. M.S. described the pain as 8-10 without medications and 5-8 with medications. The recent "right lumbar transforaminal with catheter [helped] about 50% to 60%." On August 17, 2012, M.S. returned to Respondent's office describing her pain as 7-10 without medications and 1-7 with medications. The note adds, "She states no real change in her status, just looking forward to another injection." The treatment plan was for a left ESI with Cortisone and Marcaine or lidocaine, but, again, with no mention of hypertonic saline. On September 28, 2012, Respondent performed three procedures-- first, a caudal lumbar epidurogram with interpretation; second, an ESI; and, third, a distinct procedure involving the injection of hypertonic saline. In all three procedures, Respondent relied on live or real-time fluoroscopy to guide the spinal needle and catheter, which are described below. M.S. was positioned on a table, which, as relevant to these procedures, accommodates the 90-degree rotation of a fluoroscope, which is also called a C-arm due to the ability of the device to project onto a monitor anterior-posterior (AP), lateral, and oblique views of the spine and related structures. The AP view is a head-on (or back-on) view, and the lateral view is a side view at 90 degrees from the AP view. At the direction of Respondent, a technician not only rotated the C-arm, but also captured a still image from the radiographic output, which otherwise ran live or in real time or was switched off entirely when unneeded, to avoid over-exposing the patient to radiation. The caudal lumbar epidurogram is a relatively simple diagnostic procedure. Respondent passed a spinal needle through the sacral hiatus, which is a hole in the bony structure at the base of the spine below S1, and into the caudal epidural space. By lightly pushing the syringe plunger, Respondent employed the loss-of-resistance technique to sense the lack of resistance characteristic of the epidural space; by lightly pulling the syringe plunger, Respondent aspirated the needle and line to rule out the presence of any CSF, which would reveal an intrathecal penetration, or blood, which would reveal a vascular penetration. M.S., who remained conscious during the procedures, also did not indicate any paresthesia, which is numbness or tingling. Respondent withdrew the hollow core of the spinal needle in preparation for threading the catheter through the now-hollow needle and up through the epidural space. Respondent has maintained five AP views and one lateral view from the fluoroscopic imagery that he conducted on September 28. The lone lateral view, which is of the sacrum, was taken and preserved as part of the epidurogram. During the entirety of the September 28 procedures, including the epidurogram, Respondent injected 6 cc of contrast in the form of Omnipaque 300. As with all injectates, Respondent's records refer only to divided doses, so it is impossible to know how much of any injectate, including the contrast, that he administered at what level. The ESIs in March and June 2012 may have involved fewer levels than the ESIs in December 2011 and September 2012, because the former involved 3 cc each of Omnipaque and the latter involved 5 cc each of Omnipaque. Returning to the epidurogram, as the contrast flowed up the epidural space, the radiography revealed lesions at S1 on the right and L5 on the left. The dispersal pattern of the contrast indicated that the contrast was within the epidural space. Without incident, Respondent completed the epidurogram about two minutes after starting the procedure. For the ESI and hypertonic saline procedures, Respondent passed the catheter up through the epidural space to the level or levels that he was targeting for treatment. At each level, Respondent injected, in order, the above-described contrast, an anaesthetic, a steroid known as Depo Medrol, and hypertonic saline solution. For all four procedures from December 2011 through September 28, 2012, Respondent used Marcaine 0.25% and lidocaine 1%, but his records did not indicate the location at which he administered each anaesthetic. It appears that the anaesthetic used in the greater dose was used in the epidural space, and the other anaesthetic was used elsewhere, likely at the site of the initial injection. If so, for the September 28 procedures, Respondent used 5 cc of lidocaine in the epidural space--or what he intended to be the epidural space--and 1 cc of Marcaine elsewhere. In March 2012, Respondent used 3 cc of Marcaine and no lidocaine; in December 2011, Respondent used 5 cc of each anaesthetic; and, in June 2012, Respondent used 2 cc of Marcaine and 3 cc of lidocaine. Respondent's use of Depo Medrol was more consistent. He administered 80 mg during the September 28 ESI, but had used 120 mg during each of the three preceding ESIs. The greatest variability occurred with the hypertonic saline, which, as already noted, was omitted from the March 2012 ESI. Respondent administered 8 cc of hypertonic saline during the September 28 procedures and only 5 cc--nearly 40% less--during the December 11 and June 2012 procedures. The record contains no indication of why he failed to inject hypertonic saline during the March 12 procedure, but the sole reference to leg floppiness, as noted above, was after the preceding procedures in December 2011. There is some dispute in this case as to what may be injected as part of an ESI. Obviously, the ESI contemplates the injection of a steroid, as well as contrast and an anaesthetic, which support the injection of the steroid by heightening the safety of the ESI and the comfort of the patient during the ESI. Also, these injectates are amenable to grouping because this record does not suggest that an inadvertent intrathecal injection of these injectates, even at the doses intended for the epidural space, affects patient safety nearly as much as an inadvertent intrathecal injection of hypertonic saline. An intrathecal injection of a very high dose of anaesthetic could proceed up the spinal canal and cause respiratory and cardiovascular collapse, but the record does not indicate that such dangers exist for the dosages involved in the September 28 procedures. For the same reason, an ESI may include an injection of normal saline, which is harmless in the subarachnoid space. The epidural injection of hypertonic saline is the distinguishing feature of a Racz procedure, which also involves an epidural injection. Named after its physician-developer, Gabor Racz, the Racz procedure is intended to break up, or lyse, epidural lesions or adhesions that may be the source of part or all of a patient's pain when a nerve is trapped by an adhesion. In the Racz procedure, a physician injects hypertonic saline near the lesion. The salinity of hypertonic saline solution is ten times greater than the salinity of ambient conditions in the body, so the hypertonic saline solution, by osmosis, causes the body to compensate for the sudden appearance of hypersaline conditions by delivering fluid that expands the space and may thus lyse any nearby adhesions. Although the catheter is typically not stiff enough to break up lesions mechanically, such mechanical lysis may also occur incidentally while performing a Racz procedure. Other distinguishing features of an ESI and Racz procedure involve the sources of pain and the term of pain relief. The lysis of an adhesion permanently eliminates one potential source of pain--a nerve trapped by an adhesion. An ESI reduces inflammation wherever it may be present, so it treats a wider range of conditions, but offers only temporary relief. The pain relief from the steroid may extend weeks or months. The pain relief from the anesthetics--one hour for lidocaine and four hours for Marcaine--is not intended to persist past the intra-operative and recovery stages of the procedures. There may also be a locational difference between the ESI and Racz procedures. As noted above, in the ESI, the catheter traverses the foramen within the epidural space, and, in the Racz procedure, the catheter is threaded to lesions anywhere within the epidural space. Dr. Cordner opined that Respondent failed to perform an ESI due to the lack of proximity of the injection sites to the various foramina. Labels notwithstanding, the procedures performed by Respondent on September 28 substantially conformed to an ESI and, because an ESI does not include the epidural injection of hypertonic saline, a Racz procedure. Determining that Respondent performed two distinct procedures in addition to the epidurogram does not answer several relevant questions. First, which injectate, once introduced into the subarachnoid space, injured M.S.? If introduced to the subarachnoid space, the hypertonic saline is a known cause of the paralysis and incontinence that M.S. suffered, such as myopathic injury resulting in paralysis. Because safe practices, as described by Dr. Cordner below, include the provisional injections of contrast and anaesthetic to confirm that a catheter tip is safely in the epidural space, the only other injectate that might injure the patient is the steroid, but, again, the record is silent on the consequence of the introduction of the Depo Medrol, at the dosages used by Respondent, into the subarachnoid space. Second, when did Respondent decide to inject the hypertonic saline? The record provides no basis to answer this question. As noted above, Respondent did not administer hypertonic saline in the March 2012 procedure, but administered hypertonic saline in the December 2011 and June 2012 procedures, as well as the September 28 procedure, in which he increased the dose by 60%. For none of the three procedures in which Respondent injected hypertonic saline did his treatment plans or informed consents mention hypertonic saline. Respondent may have decided, prior to the day of surgery, to use hypertonic saline and merely failed to document this decision in advance, or he may have decided, during surgery, to use hypertonic saline and documented the use of hypertonic saline as noted above. Third, why did Respondent inject hypertonic saline and why did he administer the dosages that he used? The record provides no basis to answer these questions, although, as noted above, the omission of hypertonic saline from the March 2012 procedure corresponds to leg floppiness after the December 2011 procedure and the increased dose of hypertonic saline in the September 28 procedures corresponds to a lower dose of the Depo Medrol. The medical records indicate that M.S. believed that the ESIs relieved her pain, but she could not have had a preference about hypertonic saline because she evidently never knew that Respondent was using this injectate. On the other hand, M.S.'s rating of her pain after the March 2012 procedure, without hypertonic saline, was not much different from her rating of her pain after the December 2011 and June 2012 procedures. The likely inference is, if Respondent's use of hypertonic saline were not arbitrary or capricious, he injected hypertonic saline, at least when M.S. had not mentioned leg floppiness after the last injection of hypertonic saline, because he believed it worked and used considerably more of it on September 28 because he believed that more would work better. Returning to the remaining September 28 procedures, Respondent injected the four injectates described above on M.S.'s left side at three levels: S1/L5, L4/L5, and L3/L4. At each level, Respondent waited three or four seconds after injecting the contrast, while he watched the radiographic output, before injecting the anaesthetic, after which he waited 30 to 40 seconds to allow the anaesthetic to numb the area. Then, Respondent injected the steroid, waited five seconds, and lastly he injected the hypertonic saline. Assisted directly by the epidurogram, Respondent properly located the catheter tip in the epidural space at S1/L5. The evidence is mixed as to the location of the catheter tip at L4/L5, but the catheter tip was in the subarachnoid space at L3/L4. As Dr. Cordner testified, an inadvertent penetration of the subarachnoid space by a catheter tip is not evidence of negligence; the negligence arises in what a physician does or fails to do after such an intrathecal penetration. Here, the reasons why Respondent failed to realize that the catheter tip was in the subarachnoid space at L3/L4 relate to the reasonable precautions that Respondent failed to take--and thus establish Respondent's negligence. Respondent failed to realize that the catheter tip had entered the subarachnoid space at L3/L4 because, after injecting the contrast, he misread the AP real time view from the fluoroscope that showed a dispersal pattern suggesting that the contrast was not within the epidural space; because, after injecting the contrast, he did not direct the technician to obtain a lateral real time view, which would have provided another dimension, so as to confirm that the contrast was not in the epidural space; because he did not perform the loss-of-reduction technique, which would have confirmed that the catheter tip was not in the epidural space; because he did not aspirate the catheter and line, which would have revealed CSF; and because, after injecting the anaesthetic, he did not wait at least 15 minutes to rule out a gross motor block of the lower extremities, which would have indicated that the catheter tip was in the subarachnoid space. Unreasonably unaware that the catheter tip was in the subarachnoid space, Respondent injected the steroid and hypertonic saline, withdrew the catheter, and completed the ESI and Racz procedures within ten minutes from the end of the epidurogram procedure and turned over responsibility for M.S. to Respondent's nurse. One minute after the completion of the procedure, at 9:38 a.m., M.S. complained of pain in her hips and legs, and Respondent administered 60 mg of Toradol. Ten minutes later, M.S. stated that both of her legs were numb, although by 10:15 a.m. she was moving both legs. By 11:30 a.m., she could move both legs, but had no feeling from the top of her thighs down. By 1:00 p.m., M.S. reported feeling to her mid-calf, but, three hours later, she could not move her legs. Although Respondent justifiably had not been concerned about transient numbness, the deterioration in the ability to move the legs concerned him, and Respondent insisted that M.S. be admitted to a nearby hospital. Respondent thus discharged M.S. at 5:25 p.m. for transfer by ambulance to Bethesda Memorial Hospital (Bethesda), where other physicians assumed responsibility for her care. Imaging conducted at Bethesda upon the admission of M.S. revealed no epidural hematomas, but evidence of arachnoiditis, which is inflammation of the arachnoid membrane. Most significantly, a lumbar CT scan revealed a small amount of air in the subarachnoid space, which was consistent with Respondent's recent intrathecal injections. Also, M.S.'s thecal sac displayed enhancement of disc disease at S1 through L4 suggestive of a recent subarachnoid injury. About six weeks after the procedures, an MRI at the JFK Medical Center (JFK) revealed conus medullaris syndrome posteriorly within the thecal sac at L1/L2 through L3/L4. This syndrome results from injury to the conus, such as from trauma, and is consistent with Respondent's intrathecal injection of hypertonic saline. This hospitalization followed a finding from an outpatient MRI of a large hematoma in the lumbar spine. Respondent and Dr. Schlifka contend that the Bethesda physicians missed the hematoma, but it is as likely that the hematoma formed after M.S.'s discharge from Bethesda. M.S. underwent a resection of a mass, which was found to be an arachnoid cyst. Post-operatively, M.S. still was unable to move her lower extremities, but started to regain sensation in her great toes. Respondent relies on a succinct affidavit from Dr. Racz himself, which, as noted in the Conclusions of Law, is available only to impeach Dr. Cordner's testimony. Dr. Racz's affidavit states that he has examined Respondent's medical records, including the six fluoroscopic images retained by Respondent; all of the images available in connection with the Bethesda and JFK hospitalizations; and some earlier images. From these materials, without more, Dr. Racz's affidavit concludes that Respondent's care was "appropriate and that he met or exceeded the standard of care throughout the lumbar transforaminal epidural steroid injection with catheter and fluoroscopy on September 28, 2012. Further, the complications suffered by [M.S.] are known risks and complications of the procedure that are not indicative of negligence." The most obvious difference between the opinions of Dr. Cordner and Dr. Racz is not the amount of work; each physician has examined all of the available medical records. But Dr. Cordner has painstakingly analyzed the September 28 procedures and Respondent's negligent actions and omissions, and Dr. Racz has declared by fiat that Respondent was not negligent. Undoubtedly, Dr. Racz learned from his examination of the medical records that Respondent injected hypertonic saline on September 28, yet Dr. Racz describes the procedure as an ESI and makes no mention of hypertonic saline. Perhaps Dr. Racz is sensitive to the greater potential for injury introduced by hypertonic saline, which is the prominent injectate of his procedure. Perhaps, the procedure followed by Respondent on September 28 failed to follow strictly the requirements of the Racz procedure. Dr. Cordner, who co-teaches the Racz procedure with Dr. Racz, testified that the procedure requires a physician to wait 15 to 30 minutes after injecting anaesthetic to confirm the injection is in the epidural space. Regardless, an informed opinion as to Respondent's negligence must take into account the injectate that, on this record, bears the clear potential for patient injury, and Dr. Racz's opinion fails to do so. Perhaps, Dr. Racz's affidavit is an expression of agreement with Dr. Cordner's concession that, in itself, an inadvertent intrathecal penetration is not evidence of negligence. But Dr. Racz's affidavit needs to account for the acts and omissions, set forth above, that simultaneously explain why Respondent failed to realize that the catheter tip was in the subarachnoid space at L3/L4 and constitute his failure to take these simple precautions against patient injury. The last sentence of Dr. Racz's affidavit dismisses M.S.'s "complications"--a veiled reference verging on a euphemism when describing permanent paralysis and incontinence--as known risks of the ESI and not indicative of negligence. Obviously, a bad result does not prove medical malpractice, although, as explained in the Conclusions of Law, the risk of a bad result and the impact on a patient of a bad result drive the precautions that a physician must take to avoid a finding of medical malpractice. On the other hand, the known risk of permanent paralysis and incontinence from a Racz procedure or an ESI with the injection of hypertonic saline does not obviate the necessity of analysis of the adequacy of the precautions taken by Respondent to avoid such a result; to the contrary, these grave consequences underscore the importance of such analysis. Notwithstanding Dr. Racz's status in the field of pain management, his affidavit is entitled to no weight whatsoever and fails to impeach the testimony of Dr. Cordner. Dr. Schlifka's testimony is better than Dr. Racz's affidavit in one respect: he clearly acknowledged that injectate had entered the subarachnoid space. It is impossible to dispute this fact based on M.S.'s dramatic response, the dispersal pattern of contrast depicted in one saved AP view, air found in the subarachnoid space shortly after the September 28 procedures, the injury to the thecal sac, and the conus injury. On the other hand, Dr. Schlifka's testimony shared the failure of Dr. Racz's affidavit in addressing the particulars of the September 28 procedures performed by Respondent. As Dr. Racz failed to focus on anything but a theoretical ESI, Dr. Schlifka failed to focus on anything but the fragile anatomy of the dura--never addressing, for instance, the likelihood that a catheter during an ESI could tear the dura--something that the experienced Dr. Cordner has never encountered; whether a tear would introduce air into the subarachnoid space; or whether the injectate entering through a tear could possibly injure the thecal sac and conus. Obviously, Dr. Schlifka lacks the experience to opine as to whether a catheter may tear the dura and, if so, the probability of this complication. On the other hand, Dr. Schlifka failed to explain why a dural tear would admit injectates into the subarachnoid space, but not allow injectates and CSF to escape from the subarachnoid space into the epidural space. Nor did he address the behavior of injectates--the most important one of which he has never worked with--if injected through the dura and into the subarachnoid space or if entering the subarachnoid space through a tear in the dura. Although qualified to advise that the dura may tear, and, as he testified, the dura may be more prone to tearing after numerous surgeries and procedures in the affected area, Dr. Schlifka clearly lacked the means to address, on these facts, the probability that M. S.'s injuries were caused by a dural tear or an intrathecal injection. Compared to Dr. Cordner's detailed analysis and superior relevant experience, Dr. Schlifka's opinions are speculative and perhaps reflective of an understandable desire to help a beleaguered friend. However, Dr. Schlifka's explanation for the intrathecal penetration of the injectate by a dural tear is rejected as unsupported by the evidence. For Count I, Petitioner proved that, based on the standard of care in effect in 2012, Respondent committed medical malpractice by failing to recognize that he was performing intrathecal injections of steroid and hypertonic saline at L3/L4. Petitioner failed to prove that any injections at L4/L5 and L5/S1 were intrathecal. The evidence of intrathecal injections at L3/L4 is set forth in paragraph 48, and Respondent's negligent acts and omissions are set forth in paragraph 37. The intrathecal injections of the contrast and anaesthetic at L3/L4 were wrongful solely because Respondent failed to use the information obtainable from these injections to discover that the catheter tip was in the subarachnoid space. In other words, Respondent would not have committed medical malpractice (or a wrong-site procedure or wrong procedure) if he had injected intrathecally contrast and an anaesthetic as part of what is intended to be epidural injections, as long as he learned from these injections that the catheter tip was in the subarachnoid space and moved the tip into the epidural space or terminated the procedure: the epidural injection of these injectates performs both a therapeutic and diagnostic function. For Count II, Petitioner failed to prove that, in 2012, Respondent was required to obtain and retain a permanent image of any lateral view of L3/L4 or any other location as part of the procedures after the epidurogram or that Respondent's failure to realize that the catheter tip was in the subarachnoid space violated his recordkeeping obligation. The latter point finds no support in the record. As for the images, Dr. Cordner's testimony on this "requirement" of medical recordkeeping was vague, conditional, and never tethered to the requirements in effect in 2012. Although his practice is different, Dr. Schlifka does not keep permanent views from his epidural steroid injections by needles. Petitioner itself seems to have missed the point that a permanent image of an AP view helped prove that the catheter tip was in the subarachnoid space at L3/L4. It is one thing to hold Respondent responsible for failing to interpret a real time AP view of L3/L4 and failing to obtain a real time lateral view of L3/L4, as discussed in connection with Count I, but it is another thing to hold Respondent responsible for failing to maintain permanent images of any views for the procedures following the epidurogram. Among myriad shortcomings in Petitioner's case for Count II is the failure to address whether, for reasons of cost or radiation exposure, a physician in 2012 could still perform a blind ESI and, if so, the ramifications of more elaborate and expensive recordkeeping requirements imposed on the physician who performed image-guided ESIs--or otherwise would do so, but for this expensive recordkeeping requirement. For Count III, Petitioner proved that Respondent performed a wrong procedure or a wrong-site procedure by injecting "injectate," but not contrast, into the intrathecal space when he intended to inject injectates into the epidural space. As noted above, an inadvertent intrathecal administration is not evidence of carelessness, and the timely detection of such a mishap--before the intrathecal injections of a steroid or hypertonic saline--may involve interpreting the dispersal of contrast or the effect of the anaesthetic and determining that either or both injectates have been accidentally injected into the subarachnoid space. For this reason, the inadvertent intrathecal injections of contrast or anaesthetic into the subarachnoid space is not a wrong procedure or wrong-site procedure because of the secondary diagnostic value of this otherwise-therapeutic procedure. The wrong procedure or wrong-site procedure occurred when Respondent then injected the steroid and hypertonic saline into the subarachnoid space at L3/L4; the intrathecal injections of these injectates lacked any diagnostic purpose and were thus wrong procedures or wrong-site procedures. In its proposed recommended order, Petitioner has proposed a reprimand, probation for two years, and a $30,000 fine. Despite the passage of seven years from the September 28 procedures and the transmittal of the file to DOAH, Petitioner failed to identify important features of this complicated case. Although not charged with these matters, Respondent was guilty of serious failures to obtain informed consent for the use of injectate that caused M.S.'s catastrophic injuries--hypertonic saline--and to keep medical records documenting his plans for an ESI or an ESI with hypertonic saline and the locations and dosages of each injectate during the procedures, as well as analysis of the efficacy of each set of procedures. These aggravating factors necessitate the imposition of a suspension. On the other hand, past discipline is not an aggravating factor. By final order entered April 20, 2006, the Board of Medicine fined Respondent for a failure to keep adequate medical records 20 years ago, but the failure was in performing adequate physical examinations, which is not an issue here. Given the age and nature of the offense, past discipline is irrelevant in this case.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order finding Respondent not guilty of the alleged violation of section 458.331(1)(n) in Count II, but guilty of the alleged violations of sections 458.331(1)(t)1. and 456.072(1)(bb) in Counts I and III, respectively, and imposing a reprimand, six months' suspension, two years' probation following the end of the suspension, and a fine of $20,000. DONE AND ENTERED this 18th day of November, 2020, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE 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 18th day of November, 2020. COPIES FURNISHED: Sharon Bidka Urbanek, Esquire Forman Law Offices, P.A. 238 Northeast 1st Avenue Delray Beach, Florida 33444-3715 (eServed) Michael J. Williams, Esquire Geoffrey M. Christian, Esquire Department of Health Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3565 (eServed) Louise St. Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3565 (eServed) Claudia Kemp, J.D., Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 (eServed)
The Issue Whether Respondent is guilty of violating Sections 458.331(1)(c), (j), (t), and (x), Florida Statutes, and if so, what penalty should be imposed.
Findings Of Fact Respondent, Jeffrey L. Katzell, M.D. (Dr. Katzell), is and has been at all material times to this proceeding a physician, licensed in the State of Florida by the Petitioner, Agency for Health Care Administration (AHCA). Dr. Katzell was issued license number ME 0050379. Dr. Katzell is a board certified orthopedic surgeon. He entered the private practice of orthopedic surgery in Palm Beach County in 1987. Prior to the allegations which are the subject of this proceeding, Dr. Katzell has never been the subject of a medical malpractice complaint or any form of disciplinary action by the Board of Medicine in any state. PATIENT T.B. T.B. is the female patient referred to in Counts 1-3 of DOAH Case No. 93-7122, DPR Case No. 92-3917. From December 12, 1991, through February 6, 1992, Dr. Katzell treated T.B. who was at that time 24 years old. Her chief complaints were of pain in her back, neck, wrist and chest as a result of trying to catch herself from falling while walking down some stairs. She complained of chest pain that felt like a band around her chest. She had pain when breathing. On the December 12, 1991, visit, a female medical assistant asked T.B. to disrobe and put on an examining gown which opened down the back. T.B. wore her panties under the gown and no bra. Dr. Katzell examined T.B. in the presence of a female medical assistant. As part of his examination, he palpated T.B.'s sternum and examined her ribs by placing his left hand through the armhole of the examining gown and his right hand on her back. Dr. Katzell moved the fingers of his left hand in different locations on her chest and asked T.B. if it hurt in those areas. During the examination, the palm of Dr. Katzell's hand touched the nipple of T.B.'s breast. It is possible for a physician to examine a female patient's sternum and ribs without touching her nipples but it is also possible that a physician could accidently touch the nipple of the breast while performing such an examination. It was appropriate for Dr. Katzell to examine T.B.'s sternum and ribs, given the nature of her complaints. It was not below the standard of care nor does it constitute sexual activity or sexual misconduct for an orthopedic surgeon to have physical contact with the breast in the manner described by T.B. during the course of performing an examination of the chest. On January 23, 1992, T.B. returned to Dr. Katzell for a follow-up examination. She was complaining of pain in the area of the left sciatic joint which is located in the buttock. For the examination she was wearing a T-Shirt, panties, and a bra underneath the examining gown. Dr. Katzell asked her to remove her panties so that he could give her a cortisone shot in her buttock. She removed her panties. Dr. Katzell gave her an injection of cortisone in her buttock while she lay face down on the examining table. He left the room for a short period of time. When he returned, he rubbed the medication in to diffuse the medicine. Then he asked her to turn over and he began to manipulate her legs to see if the shot had worked. The examination includes flexing and extending the legs, as well as abduction (spread eagle) and adduction (legs crossed). T.B. did not have any panties on while he was putting her legs in different positions and her genital area was exposed. It was appropriate for Dr. Katzell to check T.B.'s range of motion, but it was inappropriate for him to perform the examination while the lower half of her body, including her genitalia were exposed. To have performed the range of motion test while the patient's genitalia was exposed was below the level of care, skill, and treatment which is recognized by a reasonably prudent physician as being acceptable under similar conditions and circumstances. On February 6, 1992, T.B. returned for a follow up visit, continuing to complain of low back pain related to the sciatic joint. Again T.B. was asked to disrobe and put on an examining gown. She wore two tank tops, a bra, and panties underneath the examining gown. Dr. Katzell asked her to remove her panties so that he could give her another cortisone shot. She removed her panties. Another man was present when Dr. Katzell gave T.B. the injection. The man and Dr. Katzell left the examining room after the injection was administered. Dr. Katzell returned a short time later and told T.B. that he probably needed to manipulate the shot into the buttock. He opened the back of her gown and started to rub her buttock with both hands. Cortisone is a non-absorbable medication. The standard of care for orthopedic surgery recognizes that it is helpful and appropriate to massage the area of the injection to diffuse the medication. After Dr. Katzell massaged T.B.'s buttocks, he took his right hand and pulled her leg open. Dr. Katzell then made a sweeping motion with his hand from her vagina to her rectum. T.B. jumped to the side and pulled the gown closed. She asked him why he was giving her a shot in the buttock when it was her hip that hurt. Dr. Katzell told her that if she did not like it that she could come back for more. T.B. started to cry. The touching of T.B.'s genitalia from her vagina to her rectum was inappropriate and was below the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The touching was sexual misconduct in that the touching was a violation of the patient-physician relationship through which Dr. Katzell intentionally touched the vagina of T.B. and such touching was outside the scope of generally accepted treatment and examination of the patient. T.B. left Dr. Katzell's office and went to her workers' compensation attorney complaining of her treatment from the doctor. T.B. told her husband what had happened and they called the police. As a result of the above-described events T.B. filed a complaint with the State Attorney of Palm Beach County, Florida, upon which a criminal information was filed against Dr. Katzell bearing Case No. 92-28364-MMA02. On January 19, 1993, Dr. Katzell entered a plea of nolo contendere to the charge of battery on the person of T.B. and the Court adjudicated Dr. Katzell guilty. T.B. has filed a civil action for monetary damages against Dr. Katzell. PATIENT A.F. A.F. is the female patient referred to in Counts 4-6 of the Administrative Complaint in DOAH Case No. 93-7122, DPR Case No. 92-3917. A.F. was involved in a head on automobile accident on August 30, 1991. At that time she was 30 years old. After the accident she was treated by Dr. Michael Nathanson, a chiropractor. He referred her to Dr. Katzell for a complete orthopedic examination. Dr. Katzell first saw A.F. on October 9, 1991. She was complaining of pain in her sternum, sciatic pain, neck pain, and pain in the middle and low portion of her back. A.F. told Dr. Katzell that she had severe pain in sternum but that she did not have any bruises on her breasts. Her chiropractor had advised her that she had cracked two ribs. During Dr. Katzell's first examination of A.F. no other persons were present in the room. A.F. was wearing an examining gown, panties, and a bra. While A.F. was standing, Dr. Katzell pulled down her examining gown and removed her bra straps from her shoulder, exposing her sternum and breasts. She tried to pull the gown back up but he pushed it back down. Given the nature of A.F.'s complaints relating to her sternum and ribs, it was appropriate for Dr. Katzell to examine the sternum, to palpate the costochondral junction where the ribs meet the sternum, and to palpate the ribs. Dr. Katzell palpated the ribs and the costochondral junction during his examination. While he was examining her, his fingers did come in contact with A.F.'s breasts. The standard of care is not violated when a physician's hand comes in contact with the breast during an examination of the anterior chest such as was performed by Dr. Katzell. By touching A.F.'s breasts, Dr. Katzell did not engage in sexual activity. After her visit with Dr. Katzell, A.F. told Dr. Nathanson that she did not think that Dr. Katzell's examination had been appropriate. On October 29, 1991, A.F. returned to Dr. Katzell for a follow-up visit. She was complaining of hip pain and sciatic pain, with a pain in the crease of her leg where the elastic of her panties would be. She put on the examining robe and left on her panties and bra. No attendant was present during the examination. A.F. was standing while Dr. Katzell was examining her. He put his thumbs underneath her panties and palpated the inguinal crease (where the elastic of the panties would be located). As he was examining her, he put his right thumb in the crease in the vaginal area across her clitoris and went down underneath in the vaginal area. She told him that it did not hurt there and he went back up across the same area. Dr. Katzell's touching of A.F.'s clitoris and her vaginal area was unjustified and inappropriate. The touching was below the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar circumstances. The touching was also sexual misconduct. On November 11, 1991, A.F. returned to see Dr. Katzell for the results of her MRI test. Dr. Katzell asked her twice to put on the examining robe but she refused to do so. A.F. called Petitioner and filed a complaint against Dr. Katzell. Later A.F. instituted a civil action against Dr. Katzell. Additionally, as a result of the above-described events A.F. filed a complaint with the State Attorney of Palm Beach County, Florida, upon which a criminal information was filed against Dr. Katzell bearing case number 92-28366- MMA02. On January 19, 1993, Dr. Katzell entered a plea of nolo contendere to the charge of battery on the person of A.F. and the Court adjudicated the Respondent guilty. PATIENT BB Patient B.B. is the female patient referred to in Counts 7-9 of the Administrative Complaint in DOAH Case No. 93-7122 and DPR Case No. 92-3917. B.B. was a nurse in a hospital where Dr. Katzell performed surgery. In the summer of 1990, she began experiencing pain in her left hip, radiating to her left knee and foot and causing her to limp. Dr. Katzell noticed her limp and told her that a cortisone shot could help. She agreed to the injection. They went to the cast room in the emergency room of the hospital. Dr. Katzell asked her to put on an examining gown while he stepped out of the room. She complied. Dr. Katzell gave B.B. an injection and told her that it was not necessary for him to see her in his office. He did not charge B.B. for the treatment. It is not unusual for physicians to perform courtesy examinations for the nurses. B.B. experienced some minimal relief, but the pain returned in a couple of weeks. Dr. Katzell suggested another injection. They went to the cast room where the first examination had taken place. On the way to the cast room, B.B. told Dr. Katzell that she was also experiencing pain in her tailbone that resulted from an accident she had while giving childbirth years before. He told her that he would need to do a vaginal examination to determine where to place the shot in her tailbone. He performed a vaginal examination by inserting his fingers into her vagina. He did not perform a rectal examination. No one else was present during Dr. Katzell's examination of B.B. Vaginal examinations are not used in the diagnosis or treatment of back pain, coccydynia (pain in the tailbone) or to locate a favorable injection site for the treatment of these conditions. The giving of the vaginal examination fell below the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The vaginal examination also constituted sexual misconduct. B.B. wrote a letter to Petitioner concerning Dr. Katzell's examination but she was not specific about the nature of the complaint. She was later contacted by one of Petitioner's investigators. As a result of the above-described events B.B. filed a complaint with the State Attorney of Palm Beach County, Florida, upon which a criminal information was filed against Dr. Katzell bearing case number, 92-12233-CF. On January 19, 1993, Dr. Katzell entered a plea of nolo contendere to the charge of battery on the person of B.B. and the Court adjudicated Dr. Katzell guilty. PATIENT D.B. Patient D.B. is the female patient referred to in Counts 1-3 of the Administrative Complaint in DOAH Case No. 93-7123 and DPR Case No. 92-14422. D.B. first saw Dr. Katzell on May 16, 1991. She was complaining of instability with her left knee. At the time she was 24 years old. D.B. had had a patella tendon anterior cruciate ligament reconstruction in 1986. She saw Dr. Katzell again on June 13, 1991 and July 9, 1991. Dr. Katzell recommended arthroscopic anterior cruciate ligament reconstruction on her left knee because of a rupture of the anterior cruciate ligament. On July 15, 1991, D.B. was admitted to J.F.K. Medical Center, where Dr. Katzell performed surgery on her left knee. After the surgery, D.B.'s left leg was bandaged from the groin area to half way down her calf. On one of his hospital post-operative visits, Dr. Katzell came to check D.B.'s dressing. D.B. was wearing a hospital gown and no underpants, her left leg was in the air in a continuous motion machine, and she was on a bedpan when Dr. Katzell came into her room. While Dr. Katzell was checking her dressings, he rubbed his hand down her crotch. There was no medical necessity for rubbing across the crotch area of D.B. when Dr. Katzell changed her dressing while she was in the hospital. D.B., who was accompanied by her mother, saw Dr. Katzell in his office on July 26, 1991. He removed the staples. D.B. next saw Dr. Katzell on August 16, 1991. She put on an examination gown and kept on her T-shirt, bra, and panties underneath the gown. Dr. Katzell performed a range of motion test, which required D.B. to lie on the examining table, bend the leg at the knee while the leg was raised in the air, and gradually lower the leg. During the examination, Dr. Katzell placed his hand between her legs and slid it down the middle of the vaginal area from top to bottom. Dr. Katzell next saw D.B. in his office on September 13, 1991. D.B. was dressed in an examination gown with a shirt, panties and bra underneath the gown. Dr. Katzell performed another range of motion test and again touched her in her vaginal area, down the middle of her crotch from top to bottom. On October 11, 18, November 19, and December 19, 1991, D.B. returned for follow-up visits. On each visit, D.B. removed her shorts and put on an examination gown. During each visit Dr. Katzell measured her leg near the groin area for atrophy as she stood up with her back to him as he was sitting on a stool. While he was measuring during each visit, he briefly rubbed his hand between her legs in her crotch. On January 17, 1992, D.B. went to see Dr. Katzell at his office. She was wearing bike shorts and a sweater. She had intentionally worn bike shorts because she felt that the doctor could measure over the shorts and there would be no necessity for removing her shorts. The bike shorts had a built-in pantie so D.B. did not wear any additional underpants. Dr. Katzell asked her to remove the bike shorts and the sweater and put on a gown, explaining that he could not measure over the spandex of the bike shorts. It would not have been medically appropriate to measure the leg over the spandex because the bike shorts compress the muscles of the upper leg. D.B. removed her shorts and sweater and put on the gown, which left her wearing only the gown and a bra. Dr. Katzell performed a range of motion test and measured her leg for atrophy. When he was measuring her leg, he touched her in her vaginal area as he had done previously. There was no medical necessity that required Dr. Katzell to touch D.B. in her vaginal area while he was performing range of motion tests and measuring her leg for atrophy. The touching of D.B. in her crotch while she was in the hospital and during her subsequent office visits was inappropriate and fell below the level of care, skill, and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances. The touching also constituted sexual misconduct. As a result of the above-described events, D.B. filed a complaint with the State Attorney of Palm Beach County, Florida, upon which a criminal information was filed against Dr. Katzell bearing Case No. 92-28362-MMA02. On January 19, 1993, Dr. Katzell entered a plea of nolo contendere to the charge of battery on the person of D.B. and the Court adjudicated Dr. Katzell guilty. D.B. has made a civil claim against Dr. Katzell related to the above- described incidents. PATIENT T.C. Patient T.C. is the female patient referred to in Counts 4-6 of the Administrative Complaint, DOAH Case No. 93-7123 and DPR Case No. 92-14422. Dr. Katzell treated T.C. for chronic knee derangement from December 4, 1987 to November 18, 1991. During that time, he operated on her knee two times for internal derangement of the knee. On March 12, 1991, T.C. went to Dr. Katzell complaining of pain and swelling in her right knee. She also had right sided low back pain radiating into her right hip. Dr. Katzell examined her right hip and palpated the area in the inguinal crease. He moved her underpants to one side, exposing her vagina while he was palpating the inguinal crease. Dr. Katzell did not touch the vagina during the examination. Depending on the cut of T.C.'s underwear it may have been necessary to move her underwear to one side in order to palpate the inguinal crease. Dr. Katzell's actions on March 12, 1991, did not constitute sexual misconduct nor was it below the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. On November 18, 1991, T.C. went to Dr. Katzell's office for a follow- up visit, complaining of continued pain in her right knee. Dr. Katzell asked her to disrobe and put on an examination gown. She complied, leaving on her underwear. During the examination of her knee, Dr. Katzell began to rub T.C. above her knee and on the inside of her right thigh. He touched her vaginal area over her underwear with his fingers. She moved forward when he touched her and he removed his hand. There was no medical necessity to touch the vaginal area of a patient during the examination of a knee. The touching of T.C.'s genitalia during the knee examination was inappropriate and was below the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The touching also constitutes sexual misconduct. Following the knee examination of November 18, 1991, T.C. immediately left Dr. Katzell's office and never returned. As a result of the above-described incident, T.C. filed a complaint with the State Attorney of Palm Beach County, Florida, upon which a criminal information was filed against Dr. Katzell bearing Case No. 92-28365-MMA02. On January 19, 1993, Dr. Katzell entered a plea of nolo contendere to the charge of battery on the person of T.C. and the Court adjudicated the Respondent guilty. T.C. has filed a lawsuit against Dr. Katzell seeking monetary damages. PATIENT S.M. Patient S.M. is the female patient referred to in Counts 7-9 of the Administrative Complaint, DOAH Case No. 93-7123 and DPR Case No. 92-14422. On July 22, 1991, S.M. went to see Dr. Katzell for an independent medical evaluation relating to a slip and fall at her workplace. S.M. was complaining of upper and lower back pain, bilateral hip pain, mild knee pain and some right shoulder discomfort. S.M. was given an examination gown to wear. She put on the gown, leaving on her slip, bra and g-string panties. Dr. Katzell began to examine her and told her she would have to remove her slip. He left the room while she did so. There was no attendant in the room during the examination. She lay on the examining table and he stretched her legs at 90 degree angles. He had his hand underneath the gown, between her legs and on top of her vagina. He would rub the crease area between S.M.'s thigh and pubic area and move his hand across the vaginal area as he went from one to side to the other. There was no medical purpose for Dr. Katzell to touch S.M.'s vaginal area during his examination. The touching was below the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions. The touching also constituted sexual misconduct. As a result of the above-described incident, S.M. filed a complaint with the State Attorney of Palm Beach County, Florida, upon which a criminal information was filed against Dr. Katzell bearing Case No. 92-28362-MMA02. On January 19, 1993, Dr. Katzell entered a plea of nolo contendere to the charge of battery on the person of S.M. and the Court adjudicated him guilty. S.M. has filed a civil action against Dr. Katzell for monetary damages. MITIGATION In 1992, after the complaints surfaced concerning the above-referenced patients, Dr. Katzell voluntarily stopped his practice and sought help through the Physicians Recovery Network (PRN). He entered into a five-year supervisory contract with PRN and was participating in the contract at the date of the hearing. He agrees to remain under contract with PRN as long as necessary to demonstrate that he is safely practicing medicine. Dr. Katzell was in good standing with his agreement with PRN and had no reported problems as of the date of the final hearing. PRN referred Dr. Katzell to the Behavior Medicine Institute in Atlanta, Georgia, where he underwent an out-patient cognitive behavior type of treatment for sexual problems. The treatment program is headed by Dr. Gene Abel. The recidivism rate for physicians treated in Dr. Abel's program is 0 percent. As a result of the charges made by the six patients, Dr. Katzell has made changes in his orthopedic practice. These changes in methods include always examining a female patient in the presence of a chaperon or attendant and explaining to the patient the need for any examinations which could be perceived as being in close proximity to a private area. When patients are to receive a cortisone injection, his female office staff will drape the area outside the presence of Dr. Katzell and he will return simply to administer the injection in the presence of his attendant. The medication will be massaged into place by a female attendant and not by Dr. Katzell. There have been no complaints in the three years since Dr. Katzell has made these changes in his orthopedic practice. Over twenty witnesses testified at the final hearing concerning Dr. Katzell's practice of medicine since the incidents involving the six female patients. The witnesses found that in their dealings with Dr. Katzell they found him to be a capable, professional and caring physician. Dr. Katzell was interviewed, tested, and evaluated by two forensic psychologists, Theodore Blau, Ph.D. and Florence Kaslow, Ph.D. Based on their evaluations, it is their opinion that Dr. Katzell can safely practice medicine in the future and that Dr. Katzell's fear of loss of the ability to practice medicine in the future is so overwhelming that he will not be expected to exceed the boundaries of acceptable behavior that the law or ethics require of him as a physician. The evidence did not establish that the six patients suffered any physical or severe permanent psychological harm. On the advice of counsel, Dr. Katzell entered pleas of nolo contendere to battery on the six patients. When he did so it was his understanding that would not have any significant impact with regard with his license to practice medicine. In order to get the State Attorney to agree to a plea agreement, Dr. Katzell opted to forego the taking of any depositions in the criminal case.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Jeffrey L. Katzell, M.D., violated Section 458.331(1)(c), Florida Statutes, in Counts 1, 2, 3, 4, 5, and 6 of the Administrative Complaint in DOAH Case No. 93-7124, dismissing Count 7 of the Administrative Complaint in DOAH Case No. 93-7124, finding that Jeffrey L. Katzell, M.D. violated Section 458.331(1)(t), Florida Statutes in Counts 3, 6, and 9 in the Administrative Complaint filed in DOAH Case No. 93- 7122 and in the Administrative Complaint filed in DOAH Case No. 93-7123, finding that Jeffrey L. Katzell, M.D. violated Section 458.331(1)(x) by violating Section 458.329, Florida Statutes, in Counts 2, 5, and 8 of the Administrative Complaint in DOAH Case No. 93-7122 and Counts 1, 4, and 7 of the Administrative Complaint in DOAH Case No. 93-7123, dismissing Counts 1, 4, and 7 of the Administrative Complaint in DOAH Case No. 93-7122 and Counts 2, 5, and 8 of the Administrative Complaint in DOAH Case No. 93-7123 as not providing a separate ground for disciplinary action given the findings that Dr. Katzell violated Section 458.329 and thus, Section 458.331(1)(x), Florida Statutes. It is recommended that the following penalty be imposed: Suspension of the license of Dr. Katzell for six months; Imposition of an administrative fine of $2,000 for each violation for a total of $36,000; Five years probation following the suspension of the license; All examinations of female patients by Dr. Katzell be made in the presence of a female chaperon, and this shall be a permanent requirement of his medical license; and Dr. Katzell is to remain under a supervisory contract with the Physician Recovery Network until the conclusion of his probationary period. DONE AND ENTERED this 19th day of May, 1995, in Tallahassee, Leon County, Florida. SUSAN B. KIRKLAND 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 19th day of May, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NOs. 93-7122, 93-7123, and 93-7124 To comply with the requirements of Section 120.59(2), Florida Statutes (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. Paragraphs 1-10: Accepted in substance. Paragraph 10 (there were two paragraphs numbered 10): Accepted in substance. Paragraphs 11-24: Accepted in substance. Paragraph 25: Rejected as not supported by clear and convincing evidence. Paragraphs 26-27: Rejected as unnecessary because incidents related to the December 30 visit were not alleged in the Administrative Complaint. Paragraph 28: Accepted in substance except that the undergarment that Dr. Katzell asked her to remove was her panties. Paragraphs 29-37: Accepted in substance. Paragraph 38: Accepted in substance except as to the date on which he began treatment for chronic knee derangement. Paragraphs 39-54: Accepted in substance. Paragraph 55: Rejected as irrelevant. Paragraph 56: Rejected as not supported by clear and convincing evidence. Paragraphs 57-65: Accepted in substance. Paragraph 66: Accepted in substance except that in relation to the criminal information pertaining to A.F., Dr. Katzell entered a plea of nolo contendere to battery on the person of A.F. not T.B. Paragraphs 67-70: Accepted in substance. Paragraph 71: Rejected because the allegations were not part of the Administrative Complaint Paragraphs 72-77: Accepted in substance. Paragraphs 78: Rejected because the allegation was not part of the Administrative Complaint. Paragraphs 79-81: Accepted in substance. Respondent's Proposed Findings of Fact Paragraph 1: The first two sentences are accepted in substance. The last sentence is rejected as unnecessary. Paragraph 2: The first sentence and the first half of the second sentence are rejected as unnecessary. The remainder is accepted in substance. Paragraph 3: Accepted in substance. Paragraph 4: Rejected as unnecessary detail. Paragraphs 5-7: Rejected as unnecessary detail. Paragraphs 8-11: Rejected as subordinate to the findings that were actually made. Paragraphs 12-15: Rejected as unnecessary detail. Paragraph 16: Rejected to the extent that it implies that all of Dr. Katzell's actions were in compliance with the orthopedic standard of care. Accepted in substance to the extent that the medical records alone do not show the violations charged in the administrative complaints. Paragraphs 17-18: Accepted in substance. Paragraph 19: The first sentence is rejected to the extent that the patient indicated that she had fallen. She indicated that she caught herself from falling as she was walking down the stairs. The remainder is accepted in substance. Paragraphs 20-24: Accepted in substance. Paragraphs 25-26: Rejected as unnecessary. Paragraphs 27-30: Accepted in substance. Paragraphs 31-37: Rejected as unnecessary because the actions of Dr. Katzell during the December 30 visit were not alleged in the Administrative Complaint. Paragraph 38-39: Accepted in substance. Paragraph 40: Rejected as unnecessary detail. Paragraphs 41-42: Accepted in substance. Paragraphs 43-44: Rejected as unnecessary detail. Paragraph 45: The first two sentences are rejected as unnecessary detail. The last sentence is accepted in substance. Paragraphs 46-48: Accepted in substance. Paragraph 49: The first sentence is rejected as constituting argument. The second sentence is rejected as unnecessary detail. Paragraph 50: The portion of the sentence dealing with sexual activity is accepted in substance as it relates to the January 23 visit but the portion dealing with practice below the standard of care is rejected as not supported by the evidence. Paragraphs 51-53: Accepted in substance. Paragraph 54: Rejected as unnecessary detail. Paragraph 55: The first and third sentences are accepted in substance. The second sentence is rejected as unnecessary detail. Paragraphs 56-58: Accepted in substance. Paragraph 59: Rejected as constituting argument. Paragraph 60: Rejected as irrelevant. The inappropriate touching of the vagina is sexual activity and it is irrelevant whether they talked about sexual topics or whether either person was sexually aroused by it. Paragraph 61: The first sentence is accepted in substance. The second sentence is rejected as constituting argument. Paragraph 62: The first sentence is rejected as unnecessary. The second sentence is accepted in substance. Paragraph 63: The first sentence is rejected as not supported by the evidence. Having judged the credibility of the witnesses, the second sentence is rejected. Paragraphs 64-71: Accepted in substance. Paragraph 72: Rejected as unnecessary. Paragraph 73: The first sentence is accepted in substance. The second sentence is rejected as unnecessary detail. Paragraphs 74-75: Rejected as subordinate to the facts found. Paragraphs 76-78: Accepted in substance. Paragraph 79: The first sentence is rejected as unnecessary. The second sentence is accepted in substance. Paragraphs 80-85: Rejected as unnecessary because the Administrative Complaint does not contain allegations related to this portion of the October 9 visit. Paragraphs 86-87: Accepted in substance. Paragraph 88: Rejected as unnecessary detail. Paragraph 89: Accepted in substance. Paragraph 90: Rejected as unnecessary detail. Paragraph 91: The first half of the sentence is rejected as unnecessary detail. The last half of the sentence is accepted in substance. Paragraph 92: Rejected to the extent that it implies that Dr. Katzell did not touch A.F.'s clitoris and her vaginal area. Paragraphs 93-95: Rejected as irrelevant because it was the touching of the clitoris and the vaginal area which was at issue not the palpating of inguinal crease or the touching of the pubic bone. Paragraph 96: The first sentence is accepted in substance. The second sentence is rejected as irrelevant since the complained touching was not in close proximity but was in the vagina. Paragraph 97: Rejected as irrelevant. Paragraph 98: Rejected as constituting argument. Paragraph 99: Accepted in substance. Paragraph 100: Having judged the credibility of the witnesses, this paragraph is rejected. Paragraph 101: Rejected as not supported by the evidence. If the clitoris is covered by the labia, it is uncovered when a person sticks his thumb in the vaginal crease and runs his thumb down the crease and back up again. Paragraph 102: The first sentence is rejected as not supported by the evidence. The last sentence is rejected as irrelevant. Paragraphs 103: Rejected as irrelevant. Paragraph 104: Accepted in substance. Paragraphs 105-107: Rejected as irrelevant. Paragraph 108: Rejected as constituting argument. Paragraph 109: Accepted in substance. Paragraph 110: Rejected as not supported by the evidence. Paragraphs 111-115: Accepted in substance. Paragraphs 116-122: Rejected as unnecessary because the Administrative Complaint does not contain allegations concerning the touching of B.B.'s breasts. Paragraphs 123-127: Accepted in substance. Paragraphs 128: Rejected as unnecessary detail. Paragraphs 129-131: Rejected as irrelevant since the finding is that a vaginal examination was performed. Paragraph 132: Rejected as constituting argument and subordinate to the finding that Dr. Katzell did perform a vaginal examination. Paragraph 133: Rejected as unnecessary detail. Paragraph 134: Rejected as subordinate to the finding that he did perform a vaginal examination. Paragraph 135: Rejected as irrelevant as to whether she felt that he was engaging in sexual activity. Paragraph 136: Rejected as not supported by the greater weight of the evidence that the pressure that B.B. felt was consistent with a rectal examination. Paragraphs 137-138: Rejected as subordinate to the facts actually found. Dr. Koulisis's statement corroborated B.B.'s testimony that a vaginal examination was performed. Paragraph 139: Rejecting as constituting argument. Paragraph 140: Rejected as irrelevant. Paragraph 141: Rejected as constituting argument. Paragraph 142: Accepted in substance. Paragraphs 143-144: Rejected as irrelevant. There was no showing that Dr. Katzell was prejudiced by the loss of the letter. Paragraph 145: Accepted in substance. Paragraph 146: The first and third sentences are accepted in substance. The remainder is rejected as unnecessary detail. Paragraph 147: The first and last sentences are accepted in substance. The second sentence is rejected as unnecessary detail. Paragraph 148: Rejected as unnecessary detail. Paragraph 149: Accepted in substance. Paragraph 150: The first sentence is accepted in substance. The remainder is rejected as unnecessary detail. Paragraphs 151-153: Rejected as constituting argument and subordinate to the facts actually found. Dr. Katzell did see D.B. in the hospital on at least one occasion and he did touch her in her vaginal area during that examination. Paragraphs 154-155: Accepted in substance. Paragraphs 156-157: Rejected as irrelevant. The inappropriate behavior was not touching near the crotch area but the touching of the crotch. Paragraphs 158-159: Rejected as not supported by the evidence. Paragraph 160: Rejected as irrelevant. Paragraph 161: Rejected as subordinate to the finding that there was a touching. Paragraphs 162-164: Accepted in substance. Paragraphs 165-166: Rejected as irrelevant. Paragraph 167: Rejected as it refers to the last visit, otherwise accepted in substance. Paragraphs 168-172: Rejected as subordinate to the finding that there was a touching in the crotch area. Paragraph 173-175: Accepted in substance. Paragraph 176: Accepted. Paragraphs 177-179: Rejected as subordinate to the facts actually found that there was a touching in the vaginal area. Paragraph 180: Accepted in substance. Paragraphs 181-182: Rejected as subordinate to the finding that there was a touching in the vaginal area. Paragraph 183: Rejected as unnecessary. Paragraph 184: The first sentence is rejected as unnecessary. The sentence is rejected as constituting argument and as not supported by the evidence. Both women indicated that D.B. did not go into specifics and the sister-in-law testified that D.B. did not like the way that he had examined her and touched her legs. Paragraph 185: Rejected as not supported by the evidence. There was testimony that D.B. advised her husband. Paragraph 186: Rejected as irrelevant. Paragraphs 187-188: Rejected as subordinate to the finding that there were inappropriate touchings of the vagina. Paragraph 189: Accepted in substance. Paragraph 190: Having judged the credibility of the witnesses, it is rejected. Paragraph 191: Rejected as not supported by the evidence. Paragraphs 192-195: Accepted in substance. Paragraphs 196-199: Rejected as unnecessary detail. Paragraphs 200-203: Accepted in substance. Paragraphs 204-205: Rejected as irrelevant. Paragraphs 206: Accepted in substance. Paragraph 207: Accepted that Dr. Katzell moved the underwear, but rejected as irrelevant as to whether he remembers exposing the vagina. Paragraph 208: Accepted in substance. Paragraph 209: Rejected as unnecessary detail. Paragraph 210: The first sentence is accepted in substance. The remainder is rejected as unnecessary detail. Paragraphs 211-212: Rejected as unnecessary detail. Paragraphs 213: Rejected as subordinate to the finding that he touched the vagina. Paragraph 214-216: Rejected as subordinate to the fact that he touched the vagina. Paragraph 217: Accepted in substance. Paragraph 218: Rejected as not supported by the evidence. Paragraphs 219-220: Accepted in substance. Paragraphs 221-222: Rejected as unnecessary detail. Paragraph 223: Accepted in substance. Paragraph 224: The first sentence is rejected as unnecessary detail. The last sentence is accepted in substance. Paragraph 225: Accepted in substance. Paragraph 226-228: Rejected as unnecessary detail. Paragraph 229-231: Accepted in substance. Paragraphs 232: Rejected as irrelevant. Paragraph 233: Rejected as subordinate to the finding that there was a touching of the vaginal area. Paragraph 234: The first sentence is accepted in substance. The remainder is rejected as subordinate to the finding that there was a touching of the vaginal area. Paragraphs 235-236: Rejected as subordinate to the finding that there was a touching of the vaginal area. Paragraph 237: Accepted in substance. Paragraph 238: Rejected as irrelevant. Paragraph 239: Rejected to the extent that it implies that Dr. Katzell did not touch the vaginal area, but otherwise accepted in substance. Paragraph 240: Accepted in substance to the extent that it refers to the actions described in Paragraph 239 of Respondent's Findings of Fact. Paragraph 241: Rejected as subordinate to the finding that Dr. Katzell touched S.M.'s vaginal area. Paragraphs 242-245: Rejected as irrelevant. Paragraph 246: Rejected as constituting argument. Paragraphs 247: Accepted in substance. Paragraph 248: Rejected as constituting argument. Paragraph 249: Rejected as not supported by the evidence. Paragraph 250: The first sentence is rejected as unnecessary. The second sentence is accepted in substance. Paragraph 251: Accepted in substance. Paragraph 252-257: Rejected as unnecessary detail. Paragraph 258-261: Rejected to the extent it implies that the tests and evaluations indicate that Dr. Katzell did not commit the violations alleged in the Administrative Complaint. Paragraph 262: The first two sentences are rejected as irrelevant. The third sentence is rejected as not supported by evidence that Dr. Katzell did not engage in sexual activity with the patients. Paragraph 263: The first two sentences are rejected to the extent that it implies that Dr. Katzell did not commit the violations alleged in the administrative complaints. The last sentence is accepted in substance. Paragraph 264: Rejected to the extent that it implies that Dr. Katzell did not commit the violations alleged in the administrative complaints. Paragraph 265: Accepted in substance. Paragraph 266: Rejected as not supported by the evidence. Paragraph 267: Rejected as constituting argument. Paragraph 268: The first sentence is accepted in substance. The remainder is rejected as unnecessary detail. Paragraph 269: Accepted in substance. Paragraphs 270-271: Rejected as irrelevant since there was sufficient evidence to establish that Dr. Katzell did commit a battery on each of the six patients. In the case of D.B., he did commit a battery on her on July 17, 1991 and out of the eleven counts of battery on D.B. for which Dr. Katzell was charged there was sufficient evidence to support a charge of battery on eight of the counts. Paragraph 272-273: Rejected as irrelevant. Paragraph 274-277: Accepted in substance. Paragraph 278: Rejected as unnecessary. Paragraph 279: Accepted in substance. Paragraphs 280-282: Rejected as subordinate to the findings that committed the violations as set forth in the Findings of Fact of this Recommended Order. Paragraphs 283-287: Accepted in substance. Paragraph 288: The first sentence is accepted in substance. The second sentence is rejected as unnecessary. Paragraph 289: The first sentence is rejected as unnecessary. The second sentence is accepted in substance. The third sentence is rejected as irrelevant. Paragraph 290: Accepted to the extent that the evidence presented established that it is not likely that Dr. Katzell is not likely to commit in the future the type of actions alleged in the Administrative Complaint. COPIES FURNISHED: Albert Peacock, Esquire Hugh R. Brown, Qualified Representative Department of Business & Professional Regulation 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Mark A. Dresnick, Esquire Grand Bay Plaza Suite 201 2665 South Bayshore Drive Miami, Florida 33133 Dr. Marm Harris Executive Director Agency For Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0770 Tom Wallace Assistant Director Agency For Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
The Issue Should Petitioner discipline Respondent for violating its order entered May 4, 1995, prohibiting Respondent from performing obstetric or gynecological surgical procedures without appearing before the Board of Medicine (Board) and demonstrating his ability to perform OB/GYN surgery with requisite skill and safety to patients? Section 458.331(1)(x), Florida Statutes.
Findings Of Fact Stipulated Facts Respondent is and has been at all times material hereto a licensed medical physician in the State of Florida, having been issued license number ME 0017399. Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes. On or about May 4, 1995, the Board of Medicine issued a Final Order in Case No. 92-05546 imposing discipline on Respondent's license to practice medicine. This discipline was adopted by the Board of Medicine from a stipulated disposition ("consent agreement") voluntarily accepted by Respondent. Respondent does not now challenge the legality or validity of the May 4, 1995, consent agreement. The disciplinary terms of the May 4, 1995, consent agreement include, but are not limited to, the following restriction on Respondent's practice, in pertinent part: Respondent shall refrain from performing obstetric or gynecological surgical procedures until such time as he appears before the Board and Demonstrates that he may perform OB/GYN surgery with the requisite skill and safety to patients. For purposes of this Consent Agreement, OB/GYN surgery shall include, but not be limited to: abortion of a fetus, amniocentesis, dilation and curettage, delivery of a fetus, hysterectomy, PAP smear, cophorectomy, salpingectomy, tubal ligation, and any and all invasive procedures involving any portion of the reproductive organs of the human female, including the vulva, vagina, cervix, uterus, and adnexa of the uterus. Respondent did not appeal or otherwise legally challenge the May 4, 1995, Final Order of the Board of Medicine. At no time through July 1996 did Respondent physically appear before the Board of Medicine or petition the Board of Medicine with respect to the above stated restriction on his license and/or the demonstration [sic] to the Board that he could perform obstetric or gynecological surgical procedures as specified in the Final Order with the requisite skill and safety to patients. Between approximately January 1996 and July 1996, Respondent was employed as a physician at the Gulf County Health Department in Gulf County, Florida. During the period that Respondent was employed at the Gulf County Health Department, he performed PAP smears and gynecological cryosurgery. Irrespective of whether such violation was premeditated, intentional, or willful, Respondent violated the terms of the May 4, 1995, Final Order of the Board of Medicine by performing the gynecological procedures he performed during his practice at the Gulf County Health Department. At the time it was presented to the Board, Respondent received a copy of the Consent Agreement executed by him which formed the basis for the Board of Medicine Final Order. Respondent did not provide a copy of the Consent Agreement and/or the Board of Medicine Final Order to the Gulf County Health Department prior to or at the initiation of his employment there. Additional Facts At the time Petitioner imposed discipline against Respondent in Case No. 92-05546, Respondent appeared before Petitioner and an explanation was given concerning the circumstances involved with the discipline. Respondent signed the consent agreement leading to the discipline. The consent agreement included the statements of restrictions on Respondent's practice, the subject of the present case. Respondent had discussed entry into the consent agreement with counsel who represented his interests in Case No. 92-05546. While employed with the Gulf County Health Department in Gulf County, Florida, between January 26, 1996 and July 18, 1996, Respondent performed 21 PAP smears and two colposcopies/ biopsies in the Port St. Joe, Florida clinic. Respondent performed 29 PAP smears and one colposocopy/biopsy in the Wewahitchka, Florida clinic. In discussing the possibility that Respondent would be employed by the Gulf County Health Department, Respondent did not discuss with that agency the existence of the consent order which restricted his practice. Respondent mentioned a suit and the fact of his appearance before the Board of Medicine in the previous year, at the Board's behest, but not the consent order. Verna Mathes is the Community Health Nursing Director for the Gulf County Health Department. Ms. Mathes was involved with the efforts that lead to Respondent's employment with the Gulf County Health Department. Ms. Mathes spoke with someone at the State of Florida, Department of Business and Professional Regulation to ascertain whether Respondent's medical license was "in good standing," before Respondent was hired. That unnamed person replied that there were no disciplinary actions against Respondent's medical license. Subsequent to that conversation Respondent was hired. Before Respondent was hired by the Gulf County Health Department he telephoned the Board of Medicine and spoke to a secretary. His stated purpose for the call was to arrange to appear before the Board and "to know what steps I have to take in order to have any license up to date subject to the rules, whatever limitations had been posted." According to Respondent, the response by the secretary he spoke with was that the "register" does not show any limitation imposed upon Respondent's medical license. Assume that the communication from the person at the State of Florida, Department of Business and Professional Regulation was made to Ms. Mathes and that there was a communication from a secretary at the Board of Medicine made to Respondent. Assume the communications reflected the understanding which those persons had concerning Respondent's license status. This did not modify nor relieve Respondent of his obligation in Case No. 92-05546. That obligation was to abide by the restrictions on his practice in relation to the performance of OB/GYN surgery. Respondent could only engage in that surgical practice after appearing before the Board of Medicine and demonstrating the requisite skill and safety to patients in performing OB/GYN surgery. Any inquiry by Respondent and that by Ms. Mathes did not release Respondent from his obligation to appear. Once hired by the Gulf County Health Department, the OB/GYN surgeries that have been described were outside the expectations in the consent order related to Respondent's opportunities to practice medicine.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered which finds Respondent in violation of Section 458.331(1)(x), Florida Statutes, imposes a $5,000.00 fine, and requires twenty (20) hours of Continuing Medical Education in Obstetrics and Gynecology. DONE AND ENTERED this 7th day of April, 2000, in Tallahassee, Leon County, Florida. 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 7th day of April, 2000. COPIES FURNISHED: Eric C. Scott, Esquire Agency for Health Care Administration Office of General Counsel Post Office Box 14229 Tallahassee, Florida 32317-4229 Thomas S. Gibson, Esquire Rish, Gibson and Scholz, P.A. 206 East Fourth Street Port St. Joe, Florida 32457 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast Bin A02 Tallahassee, Florida 32399-1701
The Issue The issues in these cases are whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2002), in DOAH Case No. 09-4678PL; Subsections 456.072(1)(l), 458.331(1)(m), and 458.331(1)(t), Florida Statutes (2003), in DOAH Case No. 09-4679PL; and Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2005), in DOAH Case No. 09-4680PL, and, if so, what discipline should be imposed.
Findings Of Fact At all times relating to the three Administrative Complaints at issue, Dr. Kachinas was a licensed medical doctor within the State of Florida, having been issued license number ME 65595. He is board-certified by the American Board of Obstetrics and Gynecology. DOAH CASE NO. 09-4678PL In 2002, Dr. Kachinas was working at several clinics that were owned by the same individual. He received payment from Sarasota Women’s Health Center and Tampa Women’s Health Center. His primary office was located in Sarasota, but he rotated through the offices located in Clearwater and Tampa. He was advised that he would be attending a patient in the Tampa office. One of the medications that he used in his method of sedating patients, Propofol, was not available in the Tampa office. He took a vial of the Propofol and took it to the Tampa office, holding the vial in his hand. While at the Tampa office, Dr. Kachinas drew the Propofol into a syringe. He did not have to use the Propofol for the patient. He placed the syringe filled with Propofol inside the sock that he was wearing. Dr. Kachinas transported the syringe back to the Tampa office. He used this method of transport so that the office manager in the Tampa office would not know that he was transporting the drug. When he got back to the Tampa office, he placed the filled syringe in a secure place. Propofol must be used within 24 hours after being drawn into a syringe. The next day it was decided that the drug would not be used on another patient, and Dr. Kachinas wasted the syringe filled with Propofol. At the clinics where Dr. Kachinas worked, there were no logs to keep track of the drugs, except for the drug Fentanyl. Dr. Kachinas acknowledged in a letter dated January 30, 2007, to the Department of Health that his method of transporting Propofol was “unorthodox.” In the same letter, Dr. Kachinas acknowledged that “a reasonable and prudent doctor would not generally transport medication in that manner, but foolishness seemed reasonable in that aberrant environment.” DOAH CASE NO. 09-4679PL On March 26, 2004, B.S. presented to Premier Institute for Women’s Health (Premier) for an elective termination of pregnancy. Dr. Kachinas was the physician who handled the procedure. Dr. Kachinas maintained records relating to B.S. at Premier. In 2004, Petitioner subpoenaed B.S.’s records from Dr. Kachinas’ office. Petitioner received a packet of documents, which purported to be B.S.’s medical records. In July 2006, Lori Jacobs, an employee of Premier, sent Petitioner another copy of the documents sent in 2004. Neither the records provided in 2004 nor the records provided in 2006 contain progress notes for B.S.’s treatment on March 26, 2004, and March 27, 2004. For the first time on November 5, 2009, Dr. Kachinas produced a three-page document, which he claimed was part of B.S.’s medical records that had been misplaced in B.S.’s insurance file. Two of the pages purported to be progress notes for March 26 and 27, 2004. The third page, which is also labeled as a progress note, is dated June 29, 2004, and appears to relate to insurance claims. The two pages relating to March 26 and 27 are on paper which is a different color from the progress note relating to insurance claims and the progress notes which were previously furnished in 2004 and 2006.1 Additionally, the progress notes for March 26 and 27, 2004, contain a break in each of the ruled lines on the sheets on both the right and left sides of the sheets. The insurance progress note and the progress notes furnished in 2004 and 2006 do not have such breaks in the ruled lines. Dr. Kachinas completed a Laminaria Insertion report documenting procedures done on March 26, 2004, and March 27, 2004. The March 26, 2004, report documents the insertion of Laminaria and administration of medications. The comment section of the report documents the removal of the Laminaria and administration of medications on March 27, 2004. The comment section continues to document the administration of medications and the taking of vital signs after the removal of the Laminaria and also the transfer of the patient to Doctors Hospital. The detail on the comment sections suggests that Dr. Kachinas was making his progress notes in the Laminaria Insertion report. The failure to produce the purported progress notes for March 26 and 27, 2004, until November 5, 2009; the difference in the color of the paper of the March 26 and 27, 2004, purported progress notes and the other progress notes in Dr. Kachinas’ records; the presence of breaks in the ruled lines on the March 26 and 27, 2004, purported progress reports, which do not appear on the other progress notes; and the detail of the comments on the Laminaria Insertion report support the conclusion that the progress notes submitted as Respondent’s Exhibit 1 were not done contemporaneously with the treatment given to B.S. on March 26 and 27, 2004, but were prepared for this proceeding. Thus, the progress notes for March 26 and 27, 2004, are not credited. Dr. Kachinas determined B.S.’s pregnancy to be at approximately 23½-to-24 weeks’ gestation, the last week of the second trimester. He confirmed by sonogram that the gestation period was 24 weeks. On March 26, 2004, Dr. Kachinas began the induction of labor ordering the insertion of ten Laminaria, which are osomotic cervical dilators which cause the cervix to open and allow easier emptying of the uterus. Dr. Kachinas’ records do not show that B.S.’s medical history was taken prior to the insertion of the Laminaria. However, Dr. Kachinas did take a medical history of B.S. at the time of her admission to Doctors Hospital, and the history is recorded in the medical records. Prior to the insertion of the Laminaria, Dr. Kachinas’ records do show that a limited physical examination of B.S. was done. The Laminaria Insertion report shows that B.S.’s baseline blood pressure, temperature, and pulse were taken and recorded. There was no expert testimony of what other physical examination should have been done. Dr. Kachinas injected the fetus with Digoxin, which is injected directly into the fetus to stop the fetal heartbeat, causing an Intrauterine Fetal Demise (IUFD). The injection of the Digoxin was not documented in B.S.’s medical records. B.S. was then released from Premier. On March 27, 2004, B.S. returned to Premier. Prior to removing the Laminaria, Dr. Kachinas did an ultrasound and determined that there was still fetal heart activity and fetal movements. Dr. Kachinas continued the labor induction procedure by removing the Laminaria and administering Cytotec and high dosages of Pitocin. When the Laminaria were removed, there was a rupture of membranes with a loss of essentially all the amniotic fluid. Sometime during the afternoon of March 27, 2004, Dr. Kachinas did another ultrasound and determined that there was no fetal heart activity. Based on the length of time from the Digoxin injection to the ultrasound showing no fetal heart activity, the loss of amniotic fluid, and the administering of medication to cause contractions, Dr. Kachinas determined that the Digoxin injection was not the cause of death. On March 27, 2004, at approximately 6:30 p.m., Dr. Kachinas transferred B.S. to Doctors Hospital and had her admitted to the hospital for failure to progress with the induction of labor procedure. While at the hospital, B.S. continued to experience pain. On March 28, 2004, Dr. Kachinas performed the following procedures on B.S.: mini-laparotomy, hysterotomy, removal of products of conception, and a modified Pomeroy bilateral tubal ligation. In his description of the procedures, he stated that the fetal demise was at least of 48 hours duration. However, Dr. Kachinas’ records do not reflect the time of the fetal demise. Jorge Gomez, M.D., Petitioner’s expert witness, credibly testified that a physician is required to document the time of the fetal demise. In the hospital records following B.S.’s surgery, Dr. Kachinas listed the post-operative diagnosis as a failure to induce labor, an intrauterine fetal demise, a thin umbilical cord, and asymmetric intrauterine growth retardation, a condition in which the fetus is smaller than expected for the number of weeks of pregnancy. An autopsy was performed on the fetus. A surgical pathology report was also issued. The pathology report showed mild infarcts on the maternal side. On the fetal death certificate, Dr. Kachinas listed the immediate causes for the IUFD as a possible cord incident and multiple placental infarctions. Dr. Kachinas did not document the elective termination or the Digoxin injection on the fetal death certificate. Dr. Gomez disagrees with the reasons for IUFD given on the death certificate. His credible reading of the pathology report does not indicate that the infarcts were severe enough to have contributed to the fetal demise. His credible reading of the pathology report does not indicate that there was any evidence of a cord incident. Dr. Gomez is of the opinion that the cause of death should have been listed as elective termination. Dr. Gomez’ opinion is credited. However, Dr. Gomez did not give an opinion on whether the fetal demise was caused by the injection of Digoxin. DOAH CASE NO. 09-4680PL On December 13, 2005, K.M. was seen by Walter J. Morales, M.D., at Florida Perinatal Associates, which specializes in internal fetal medicine. Dr. Morales performed an ultrasound on K.M., who was pregnant with twins as a result of in vitro fertilization. The ultrasound revealed that the twins were fraternal, meaning that each twin had a separate placenta and a separate sac. One of the twins, Twin A, had an anomaly called a cystic hygroma, which results from an obstruction, causing the lymphatic fluid, which normally drains into the juglar vein, to accumulate in the neck area. Approximately 50 percent of the fetuses which have this anomaly in the first trimester also have a chromosomal anomaly, such as Down syndrome. The decision was made to have K.M. return to Florida Perinatal Associates in three weeks for further evaluation. On January 3, 2006, Edgard Ramos-Santos, M.D., a partner of Dr. Morales, performed another ultrasound on K.M. Dr. Ramos-Santos found that Twin A, a male, had a cystic hydroma, a thickening of the nuchal fold2, and shortened femur and humerus. These findings are soft markers for abnormal chromosomes. The ultrasound also revealed a possible heart defect. At the time of the ultrasound, Twin A was cephalic bottom, meaning that Twin A was positioned lowest in the uterus. Dr. Ramos-Santos also performed an amniocentesis on Twin A on the same date as the ultrasound. The amniocentesis showed that Twin A had an abnormal chromosome pattern compatible with trisomy 21 or Down syndrome. Both ultrasounds showed that Twin B, a female, appeared to be normal. At the request of K.M., no amniocentesis was performed on Twin B on January 3, 2006. At the time of the ultrasound performed on January 3, 2006, the presentation of Twin B was cephalic right. The findings of the January 3, 2006, ultrasound were discussed with K.M. and her husband. On January 9, 2006, Dr. Ramos-Santos discussed the results of the amniocentesis with K.M.’s husband. It was decided that a selective feticide would be performed on Twin A. Selective feticide is a procedure in which a solution of potassium hydroxide is injected into the fetus’ heart to make the heart stop beating. K.M. was referred to Dr. Kachinas at Premier for the selective feticide. On January 10, 2006, Roberta Bruce, a nurse at Florida Perinatal Associates, sent to Premier by facsimile transmission the January 3, 2006, ultrasound report for K.M. and K.M.’s insurance information. The cover page for the facsimile transmission included a note from Ms. Bruce, which stated: “* FYI Fetus have different gender. The male is the affected one.” The standard of care as specified in Section 766.102, Florida Statutes (2005), requires a physician performing a selective feticide to correctly identify the affected fetus. Dr. Kachinas did not correctly identify Twin A prior to performing the selective feticide and performed the procedure on Twin B, the normal fetus. Dr. Kachinas performed an ultrasound on K.M., but failed to identify the correct position of Twin A in relation to K.M. The ultrasound done on January 3, 2006, by Dr. Ramos-Santos showed that Twin A was located at the bottom and Twin B was located to the right of K.M. In his progress notes, Dr. Kachinas placed Twin A on the right and Twin B on the left. Although it is possible for twins to shift positions, it is not probable that the twins shifted from left to right. Dr. Kachinas performed an ultrasound, but failed to identify that Twin A was the fetus with multiple anomalies. Although the standard of care required Dr. Kachinas to do a Level 2 ultrasound evaluation, a Level 1 ultrasound evaluation would have identified the cystic hygroma, the shortened long bones, and the sex of Twin A. Dr. Kachinas failed to perform an adequate ultrasound evaluation by failing to identify the anomalies and the gender of Twin A. Dr. Kachinas’ notes do not show whether Twin A or Twin B had anomalies. His notes did not identify the sex of each of the twins. His notes did not document the attempts that Dr. Kachinas made to identify the anomalies such as a recording of the length of the long bones or any examination made to identify the sex of each of the twins. On January 24, 2006, K.M. returned to Florida Perinatal Associates for another consultation. Dr. Morales performed another ultrasound, which revealed that Twin A, who had the anomalies, was still viable. The ultrasound revealed the continued presence of a cystic hygroma, the thickening of the nuchal fold, shortened extremities, and a congenital heart defect. The ultrasound also showed that the viable twin was male. The presentation of Twin A was shown by the ultrasound as cephalic bottom.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4678PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2002), by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent physician as being acceptable under similar conditions and circumstances; finding that Dr. Kachinas did not violate Subsection 458.331(1)(m), Florida Statutes (2002); imposing an administrative fine of $2,500; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4679PL that a final order be entered finding that Dr. Kachinas did not violate Subsections 456.072(1)(l) and 458.331(1)(t), Florida Statutes (2003); finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2003); imposing an administrative fine of $1,000; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4680PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2005), by committing gross medical malpractice; finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2005); imposing an administrative fine of $2,000 and placing him on probation for one year for the violation of Subsection 458.331(1)(m), Florida Statutes (2005); and revoking his license for the violation of Subsection 458.331(1)(t), Florida Statutes (2005). DONE AND ENTERED this 26th day of January, 2010, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of January, 2010.
