The Issue The issues to be determined in this proceeding are whether Respondent violated section 458.331(1)(t)1., Florida Statutes (2012), and if so, what penalties should be imposed.
Findings Of Fact Based upon the Stipulation of the parties and the evaluation of the evidence presented at hearing, the following facts are found: At all times material to the allegations in the Administrative Complaint, Respondent was a licensed medical doctor within the State of Florida and held license number ME 109501. Respondent’s address of record is 216 Elm Drive, Chattahoochee, Florida 32324. The Department presented no evidence of prior discipline against his license. In 2013, Respondent was under contract to furnish health care services to inmates at Suwannee Correctional Institution (SCI). This case involves the care and treatment for hypertension that Respondent provided to R.G. while R.G. was an inmate at SCI in June and July 2013. David Libert, M.D., who testified on behalf of the Department, is a Board-certified family practice physician who has been licensed in Florida since 1983. Dr. Libert sees patients in a clinical setting approximately three days a week but has never practiced in a correctional institution setting. Dr. Libert testified that a “perfect” blood pressure reading is 120/80. A reading that is under 140/90 is considered acceptable, but blood pressure that is consistently above 140/90 indicates hypertension. Malignant hypertension, or hypertensive emergency, is an acute elevation of blood pressure that is associated with end organ damage. End organ damage is the affect that the high blood pressure has on certain parts of the body, such as the brain, heart, and kidneys. The traditional benchmark reading that signals malignant hypertension is 180/120, which Dr. Libert testified is an arbitrary number but represents the “old” definition of the condition. According to Dr. Libert, newer studies define malignant hypertension as an acute rise on the height in blood pressure associated with end organ damage, even if the blood pressure reading does not go as high as the 180/120 measure recognized in older literature. The record is not clear when the change in definition took place, and if that change reflects the standard of practice in June 2013. Dr. Libert did not describe what constitutes an acute rise in blood pressure, either in terms of the length of time by which it is measured, or how much of a change in blood pressure constitutes an acute rise. The systolic reading is the top number in a blood pressure reading and represents the maximum pressure that is exerted on the arteries with the contraction of the heart. The diastolic reading represents the pressure after the heart has relaxed from its beat and is the lower number in a blood pressure reading. While 180/140 is the traditional reading identified as a signal for malignant hypertension in “older” literature, there was no testimony as to whether systolic and diastolic readings are equally important, or whether one is more important than the other when determining that a patient’s blood pressure is too high. In other words, no testimony was presented to answer the question of whether, for example a blood pressure reading of 185/96 or 170/133 would be considered a symptom of malignant hypertension. While there is no question both readings would indicate hypertension, the evidence did not indicate whether it is enough to have one of the two pressure readings above the 180/120 level to signal the possibility of malignant hypertension. The Department of Corrections has protocols for treatment of different systems of the body. The form for the Hypertension Protocol, which is included several times within R.G.’s medical records from Suwannee, includes several categories of information to be addressed by treating personnel, such as Subjective (which includes the patient’s chief complaint and current symptoms); Objective (which requires notation of vital signs, such as temperature, pulse, respiration, blood pressure, oxygen saturation and weight); Findings Requiring Immediate Clinician Notification; Plan; and Education. Under the heading “Findings Requiring Immediate Clinician Notification,” there are several factors that a health care provider (typically in this setting, a nurse) would check before the need to contact a physician arises. Those factors are blood pressure greater than 160/100 (see PLAN first); oxygen saturation less than 93 percent; heart rate less than 60 or greater than 110; wheezing (chest congestion); blurred vision; pedal edema extending to above the knees; severe headache OR headache not relieved after two hours of OTC pain med; or other. The PLAN portion of the protocol provides the following treatment alternatives: For mild to moderate headache give: Acetaminophen 325mg two tablets every 4-6 hours as needed for pain, OR Ibuprofen 200mg two tablets every 6 hours as needed for pain Put patient in a quiet environment; recheck blood pressure in 15 minutes x2. Notify clinician if BP remains greater than 160/100. 1st blood pressure recheck: / , at . 2nd blood pressure recheck: / , at . Bed rest lay-in x24 hours Blood pressure recheck in 24 hours Return to clinic for BP check Pass Other Respondent was responsible for patient R.G.’s medical care at SCI and had access to all of R.G.’s medical records from SCI’s medical clinic. R.G. was a 61-year-old male inmate who presented to the clinic at SCI for treatment. On or about June 7, 2013, R.G. presented to SCI’s clinic with a blood pressure reading of 164/96, and complaining of a headache. R.G. was given 10 mg Lisinopril to reduce his blood pressure, a pass for three days of bedrest, and a follow-up appointment for June 10, 2013. The medical record entitled Hypertension Protocol does not contain Respondent’s name and he did not see R.G. that day. However, from the Physician’s Order Sheet, it appears that he was consulted and approved the administration of Lisinopril, and prescribed 10 mg of Lisinopril daily for three months. On June 9, 2013, R.G. presented at the clinic complaining about his blood pressure. The medical record notes that he had a headache. His blood pressure reading was 151/90, and the section entitled Findings Requiring Immediate Clinician Notification did not have any symptoms checked. The medical record does not indicate that Respondent saw R.G. on June 9, 2013, and he was not consulted about his care. The PLAN section of the Hypertension Protocol says “No treatment required.” On June 10, 2013, it appears that R.G. may have been seen at the clinic more than once. The initial entry in his medical records for that date, which does not have a time recorded, indicates that his blood pressure was 158/98. The second entry, recorded at approximately 2:00 p.m., indicates that R.G. presented to the clinic with a blood pressure reading of 173/98. Respondent ordered a one-time dose of .2 mg Clonidine, and 10 mg of Lisinopril and directed that his blood pressure be taken again in an hour. Respondent tried to find the underlying cause for the rise in R.G.’s blood pressure by sending him for blood work, and a thyroid and cardiovascular evaluation by the cardiac clinic. Respondent also directed that his blood pressure be checked twice weekly for an indecipherable number of weeks. When R.G.’s blood pressure was rechecked at approximately 4:00 p.m., it was 158/89. Respondent again ordered administration of 10 mg Lisinopril, increased his prescription for Lisinopril to 20 mg for three months, and ordered 600 mg of Ibuprofen to treat R.G.’s headache. R.G. next presented to the clinic on June 11, 2013, at 10:00 a.m. At that time, his blood pressure was noted as 152/94. There is no indication in the medical record that Respondent saw R.G. during that visit, and there is no documentation in the Physician’s Order Sheet to indicate that Respondent ordered any prescriptions for him. On June 18, 2013, R.G. went to the clinic complaining of a headache and vomiting. He listed his pain level at 6 out of 10. At his initial presentation at noon, his blood pressure was 197/105 in the left arm, and 186/86 in the right. Under the PLAN heading, the medical record indicates R.G. was given 200mg Ibuprofen for his headache, and 0.2 mg of Conidine for blood pressure. His blood pressure was rechecked at 1:00 p.m. and had lowered to 139/84. The medical record for June 18, 2013, does not indicate that Dr. Alaka saw R.G. or that he was consulted about him. The Department of Corrections Physician Order Sheet for R.G. has an entry dated June 18, 2013, but part of the record is indecipherable, and there is no doctor Signature/stamp completed for the entry. In addition, the portion of the entry that is readable refers to a Dr. Gonzalez, as opposed to Dr. Alaka. On June 20, 2013, R.G. returned to the clinic, this time complaining that he was stumbling and had a headache. A protocol sheet for Neurological Changes/Deficits was used in the medical records as opposed to the Hypertension Protocol. At this visit, his blood pressure was 120/62. There is no indication on the medical record for this date that Dr. Alaka saw R.G. R.G. returned to the clinic on June 25, 2013, at 5:39 p.m. The medical record indicates that he had a slight headache, a small amount of pitting/extremity swelling, fatigue, and had vomited that morning. His blood pressure was 165/94 in the left arm and 175/91 in the right. Pedal edema was noted to stop at the mid to upper shins, and the records indicate that R.G. had slept only three hours or less in the previous 24-hour period. R.G. was given acetaminophen for his headache, and his blood pressure was rechecked at 5:59 p.m. and 6:15 p.m.. His blood pressure at the first recheck was 165/94, and at the second recheck was 164/93. The Hypertension Protocol indicates that R.G. was administered 10 mg of Lisinopril, was instructed to comply with all prescribed medications, and not to sit with his legs crossed. The Physician’s Order Sheet indicates that per Respondent’s discussion with the nurse who saw R.G.,1 the prescription for 20 mg of Lisinopril was discontinued and replaced with a prescription for the same drug at 10 mg daily for three months. There was speculation throughout the hearing that R.G. did not always take his medications as prescribed, and there are notations in the medical records that R.G. sometimes refused recommended medical treatments, such as a referral for a urologist and a cardiac workup. There was no clear and convincing evidence that R.G. was also failing to take his blood pressure medications as required, although it is certainly a possibility. There is no indication in the medical records that R.G. went to the clinic for treatment after June 25, 2013.2 On July 2, 2013, R.G. was found unresponsive on the floor. He was transferred to ShandsLiveOak Regional Medical Center, and from there, transferred to Jacksonville Memorial on 1 The Administrative Complaint alleges that R.G. was seen by an ARNP during this visit. The signature of the health care provider indicates that he or she was an SRN, not an ARNP. The ARNP who reviewed the records and made what was referred to as an incidental entry (one where the record is reviewed but the patient is not seen) the following day is a different provider. 2 There is an entry for June 28, 2013, entitled Pre-Special Housing Health Assessment. Dr. Alaka testified he did not know what that meant. It appears from the record that the purpose of the assessment was to extend R.G.’s low bunk pass. At that time, his blood pressure was recorded as 158/92. It is not clear who conducted the assessment. July 3, 2013. R.G. died on July 5, 2013. The Medical Examiner’s Report lists R.G.’s cause of death as hypertension. Dr. Libert reviewed the medical records related to R.G.’s treatment. He opined that Respondent did not meet the applicable standard of care in his care and treatment of R.G. because he did not arrange for transportation to the hospital on June 18, 2013. He also opined that Respondent should have transferred R.G. on later dates prior to the transfer that occurred on July 2, 2013. He further opined that Respondent failed to recognize the signs and symptoms of malignant hypertension and failed to diagnose it. Dr. Libert also testified that Respondent failed to order basic blood tests that should have been ordered for a patient with hypertension. However, as noted above, Respondent did order blood work on June 10, 2013. There is no indication in the medical records that Dr. Alaka saw R.G. on June 18, 2013. With respect to the June 25 visit, Dr. Alaka would have received a phone call from staff, but did not see R.G. in person. Dr. Alaka has no independent recollection of seeing R.G., and had to rely solely on his review of the medical records for his account of what happened. The treatment of this patient occurred over eight years prior to the hearing in this case. Dr. Alaka did not believe that treatment in a prison setting is the same as the treatment rendered in a typical outpatient setting, and testified that in an outpatient setting, physician groups are free to set their own protocols. In a correctional setting, physicians were required to follow the protocols established by the Department of Corrections. Dr. Alaka testified that following the protocols was a condition of employment. Dr. Alaka testified that he did not create or maintain the medical records for patients at the facility, but would have access to the records when treating a patient. It is not clear, however, whether he had access to the records when he was not at the facility but received a telephone call regarding the treatment of a patient. Based upon the medical records in evidence, Dr. Alaka saw R.G. on June 10; was consulted about R.G. on June 7 and June 25; and was neither present nor consulted regarding R.G. on June 9, June 11, June 18, and June 20, 2013. The only time that the medical records indicate R.G.’s blood pressure may have been above the standard of 180/120 for malignant hypertension was June 18, 2013, and when rechecked, the pressure went down to 139/84. As noted above, the medical records do not indicate that Dr. Alaka either saw R.G. or was consulted about his care on that day. On June 25, 2013, R.G.’s blood pressure, while still considered high, was well below the standard identified for consideration of malignant hypertension. Dr. Alaka also testified that one must always consider the possibility of malignant hypertension when taking a patient’s blood pressure, but did not believe R.G.’s blood pressure reached that level. He tried to prevent it through the use of medication but did not believe that you needed to transfer a patient because of swelling, vomiting, or headache combined with high blood pressure, because those symptoms can occur with a variety of conditions. In his view, there should be concrete blood pressure readings, with indications of organ disturbance or stress. Organ damage would be substantiated through blood work and treated with medication while waiting for results. If the blood pressure is sustained, then he would call his supervisor and report the blood pressure; that it is not coming down; what medications were given; and request a transfer. He testified he did not request a transfer in this case because the blood pressure came down with treatment. In addition, Dr. Alaka noted that blood pressure readings can vary within the same hour, depending on who took the reading, the size of the cuff used, operator error, etc. Dr. Alaka also testified, credibly, that transfers to facilities outside the prison setting required approval by the regional medical director, and that was a condition for working at SCI. The Department did not provide any evidence to rebut the statement that Respondent did not have the authority to order transfer out of the facility, or that following the protocols reflected in the medical records was not required for employment at the facility. Dr. Alaka’s view of what blood pressure reading would have triggered a diagnosis of malignant hypertension is higher than Dr. Libert’s. Based on the evidence presented, Dr. Libert’s definition appears to be more reasonable. However, based on the totality of the evidence presented, the Department did not present clear and convincing evidence to show that Respondent’s care and treatment of R.G. violated the prevailing standard of care as alleged in the Administrative Complaint.
Conclusions For Petitioner: Hunter M. Pattison, Esquire Michael Jovane Williams, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 For Respondent: Edmond Olatunde Alaka, M.D., pro se 216 Elm Drive Chattahoochee, Florida 32324
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Administrative Complaint against Respondent be dismissed. DONE AND ENTERED this 20th day of December, 2021, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of December, 2021. COPIES FURNISHED: Hunter M. Pattison, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Edmond Olatunde Alaka, M.D. 216 Elm Drive Chattahoochee, Florida 32324 Paul A. Vazquez, JD, Executive Director Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 Michael Jovane Williams, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Louise St. Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399
The Issue The issues in this case are whether Respondent violated section 458.331(1)(t), Florida Statutes (2008),1/ and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state department charged with regulating the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. Dr. Puig was at all times material to the allegations in the Administrative Complaint a licensed physician in the State of Florida, having been issued license No. 82847. Dr. Puig holds a certificate from the American Board of Anesthesiology. In the early morning of January 2, 2009, T.M. presented to the Central Florida Surgery Center in Lakeland, Florida, for outpatient surgery to be performed by Shreekant Tripathi, M.D. The specific procedures to be performed were bilateral lower eyelid blepharoplasty, mini-face lift, and suspension of the mid-face area with the Endotine Midface implant device. She was accompanied by her husband, R.R. T.M. has been licensed as a physician in Florida for 28 years and has worked as the head of the Tampa General Hospital Adult Emergency Department and as that hospital's chief of staff. T.M. has a prior history of a deep vein thrombosis (DVT), which was treated medically. She experienced a DVT in her leg sitting in an airplane for an extended period of time while traveling from Florida to the Midwest. DVT is a medical condition that occurs when a thrombus (blood clot) forms in one of the large veins, leading to either partial or complete blockage of the vein. After completing the financial paperwork and other forms at the front desk of Central Florida Surgery Center, T.M. was taken to the pre-operative holding area at approximately 7:00 a.m. Once in the pre-operative holding area, the nurse went over the contents of T.M.'s procedures and reviewed T.M.'s medical history and medications taken. The nurse administered medications other than sedation and took T.M.'s vital signs, including her blood pressure. In order to take T.M.'s blood pressure, the nurse in the pre-operative holding area placed a blood pressure cuff on T.M.'s right upper arm. The blood pressure cuff would not have given a reading if it was placed too tightly, and T.M. would have complained of pain. At the time that the blood pressure cuff was placed, T.M. was awake and alert and did not express any discomfort. The nurse was able to get a reading from the blood pressure cuff. While T.M. was in the pre-operative holding area and after the vital signs were taken, T.M.'s temperature was 97.4 degrees. T.M. met with Dr. Tripathi, who went over her surgery with her. Dr. Tripathi marked the areas for her facial cosmetic procedures. Dr. Puig served on the surgical team as anesthesiologist. He conducted a pre-anesthesia evaluation of T.M. Dr. Puig examined T.M. and reviewed the medications that she was taking. He also reviewed T.M.'s medical history, including her history of DVT. As part of his plan for anesthesia, Dr. Puig included the use of sequential compression devices on T.M.'s lower extremities. While in the pre-operative holding area, T.M. was given Versed as a pre-medication for the surgery. T.M. was taken to the operating room, accompanied by Dr. Puig, who remained with T.M. until she was handed to the post-anesthesia care unit (PACU) nurse. T.M. entered the operating room at 8:19 a.m. The blood pressure cuff that was placed by the pre-operative nurse was left in place on the upper right arm. The blood pressure cuff was disconnected from the monitoring device in the pre-operative holding area and accompanied T.M. into the operating room, where it was connected to another monitoring device. After T.M. was taken to the operating room, she moved onto the operating table on her own with some assistance. Monitoring equipment was then connected to T.M. The monitoring equipment included a pulse oximeter on the left hand, sequential compression devices on the lower extremities, and the blood pressure monitoring device. Dr. Puig did not use any device to monitor T.M.'s temperature during the surgery. An IV had been placed in the pre-operative area on T.M.'s left wrist and was running in the operating room. T.M. was positioned flat on her back on the operating table with her shoulders on the operating table using a mattress, a pillow, foam pads, and sheets. On the table, under T.M., was a two-to-three-inch thick mattress. On top of the mattress, under T.M., was a bottom sheet that ran longitudinally the length of the table. On top of the bottom sheet, perpendicular with, or at a 90-degree angle to the table, was a folded sheet from 18-to-30 inches wide. This crossways sheet is called a draw sheet and was under T.M. with the top edge at the armpit and the lower end in line with the waist or buttocks. The draw sheet was pulled up between T.M.'s arm and torso for later tucking. A foam pad, egg-crate device was placed on the right arm between the arm and the table and T.M. The device is not large enough to completely cover the arm. The bottom sheet was tucked around the arm between the egg-crate device and T.M.'s torso. The draw sheet was then tucked around the outside of the arm and under the mattress with a portion left protruding, which could be pulled on later to begin the process of removing the sheets. The purpose of the sheets was to keep T.M.'s arm from falling off the table during surgery. The sheets were supposed to be snug, but not so tight that one could not insert two fingers between the sheets and T.M.'s arm. In addition to the sheets that covered T.M., a Bair Hugger was used. A Bair Hugger is a warming device that uses forced warm air to keep a patient warm during surgery. The blood pressure cuff was under a portion of the egg-crate device, the bottom sheet, the draw sheet, and the Bair Hugger. The top edge of the blood pressure cuff was just under the armpit and the bottom edge was approximately three-to-four inches above the elbow joint. The blood pressure cuff had an inflatable rubber bladder and normally would have an attached inlet tube about six-to-eight inches long that would extend down T.M.'s arm toward her wrist. In order to eliminate sources of infection, a sterile field was created by using sterile towels and sterile drapes. The sterile drape covered T.M. after the other sheets and blankets were in place. The sterile towels were placed around T.M.'s head. At 8:41 a.m., the surgery began. Prior to the commencement of surgery and while in the operating room, Dr. Puig monitored T.M.'s blood pressure using the monitoring device in the operating room and the blood pressure cuff that was placed on T.M.'s right arm. Dr. Puig had blood pressure readings until 8:58 a.m., when Dr. Puig was unable to get blood pressure readings. Dr. Puig asked Dr. Tripathi to step aside and allow him to check the blood pressure cuff. Dr. Puig was on the right side of T.M. and moved to the left side of T.M. He asked the circulating nurse to hold the sterile drape so that he could go under the drape to check the blood pressure cuff. Dr. Puig went under the drape and felt the blood pressure cuff. The blood pressure cuff was deflated. He disconnected the tube from the blood pressure cuff and called for a new blood pressure cuff. He placed the new blood pressure cuff on T.M.'s left arm and connected the new blood pressure cuff to the blood pressure monitoring device. Dr. Puig was able to get accurate blood pressure readings from the new blood pressure cuff and the monitoring device that had been attached to the blood pressure cuff on T.M.'s right arm. Dr. Puig left the deflated blood pressure cuff on T.M.'s right arm during the surgery. After a blood pressure cuff was placed on T.M.'s left arm, Dr. Tripathi continued with the surgery. The surgery ended at 1:48 p.m., at which time the circulating nurse began to remove the sterile drape and sheets from T.M. When the nurse removed the deflated blood pressure cuff on T.M.'s right arm, she noticed that the arm below the blood pressure cuff was mottled, blue, red, dark blue and dark red. There were blisters on T.M.'s right arm where the blood pressure cuff had been. T.M.'s right arm was swollen. The condition of T.M.'s right arm was brought to the attention of Dr. Puig. Dr. Puig examined and evaluated T.M.'s condition. At 2:00 p.m., T.M. was transferred to the PACU. T.M. was alert. Her temperature was 98 degrees. Her husband, R.R., was at bedside when T.M. was taken to PACU and stayed at her bedside until T.M. was discharged. T.M. was experiencing extreme pain in her right arm and felt a tender hard spot on her right bicep. The post- operative nurse noted the condition of T.M's right arm as red and swollen from the biceps to the tips of T.M.'s fingers with blisters on the upper part of the extremity. Dr. Puig noted that T.M. had decreased sensation in her right finger tips and some decrease in motor activity and that T.M's radial and ulnar pulses were intact. He ordered that the right arm be elevated with the use of pillows. At 2:15 p.m., Dr. Puig was at T.M.'s bedside, monitoring T.M.'s condition. Dr. Tripathi was aware of T.M.'s condition and also appeared at her bedside to monitor her condition. Dr. Puig consulted with Dr. Tripathi concerning T.M.'s condition. At 2:30 p.m., T.M. was still being monitored by the PACU nurse. T.M. was moving her arm, fingers, and wrist. At 2:55 p.m., T.M. told the nurse that she was unable to feel her pulse. Two nurses took T.M.'s pulse and verified that T.M. did have a pulse. Dr. Puig and Dr. Tripathi had gone back to the operating room for a procedure on another patient. At 2:55 p.m., a nurse notified Dr. Puig of T.M.'s complaint of feeling no pulse. At 3:08 p.m., T.M. complained of a decrease in sensation from her elbow to her fingers. T.M. suggested to the PACU nurse that measurements should be taken of the circumference of her arms to determine how much swelling had occurred. At 3:10 p.m., the nurse marked the area on the arms to be measured and took measurements of the bicep and forearm in each arm. The right bicep measured 30 centimeters, and the right forearm measured 28 centimeters. The left bicep measured 29 centimeters, and the forearm measured centimeters. T.M. and her husband became concerned about the condition of T.M.'s right arm. The right arm was still elevated by pillows, and T.M. continued to exercise the arm. At 3:14 p.m., T.M. stated that she could feel her right radial pulse. T.M.'s right bicep remained red and swollen. T.M. denied the need for pain medication. At 3:20 p.m., T.M. continued to exercise the right arm, hand, wrist, and fingers. T.M. complained of pain in the right bicep and a knot in the right bicep. At 3:40 p.m., T.M. continued to complain of pain in the right bicep. T.M. was squeezing her right hand and moving her right arm. T.M. was experiencing a prickly sensation to her forearm and hand from the elbow down. The nurse determined that there was a right radial pulse. Dr. Puig was notified of T.M.'s condition. The nurse gave T.M. a bolus of 25 micrograms of Fentanyl; however, the pain medication did not give T.M. any relief. Dr. Puig had given an order for 25 micrograms of Fentanyl to be administered every five-to-15 minutes up to a maximum of 100 micrograms. Fentanyl is a short-acting pain medication. The opiate is more potent that morphine. The effects of Fentanyl will wear off about 20 to 30 minutes after administration. At 3:50 p.m., the nurse administered another bolus of micrograms of Fentanyl to T.M. At 3:54 p.m., T.M was fully flexing and extending her right arm and stated that the second dose of Fentanyl had given her some relief to the pain. At 4:00 p.m., the nurse measured the right arm again. The right bicep was 30 centimeters, and the right forearm was 26.5 centimeters. At 4:07 p.m., T.M. requested more pain medication, and the nurse administered another bolus of 25 micrograms of Fentanyl. T.M. received fair relief from the pain as a result of the pain medication. At 4:25 p.m., T.M. stated that she could feel sensation to her right hand, but was unable to distinguish between sharp and dull pain. She denied the need for further pain medication. At 4:41 p.m., T.M. continued to have pain in her right bicep. She was experiencing numbness and tingling in her right hand and forearm. From the right elbow to her hand, her arm was red, mottled, and petechiae. The right bicep was warm and swollen with thin blisters. The bicep was firm and painful. T.M. requested and was given another 25 micrograms of Fentanyl. At 4:50 p.m., the pain medication had produced only minimal relief from the pain. At 4:53 p.m., T.M. told the PACU nurse that her pain and swelling was not getting any better and that she wanted to be transferred to Tampa General Hospital after she saw Dr. Puig and Dr. Tripathi, who were still in surgery. Dr. Puig and Dr. Tripathi were notified in the operating room. The nurse continued to monitor T.M. T.M. thought that she may have compartment syndrome. Compartment syndrome is a condition that results from increased pressure in the compartment (the muscle surrounded by the fascia), which can lead to lack of perfusion, nerve damage, and eventually to the loss of function of the extremity. It is characterized by pain out of proportion to the nature of the observable injury that will not be alleviated by the administration of narcotic pain medication, swelling, pallor, paraesthesia, lack of pulse, and eventually lack of temperature control. Dr. Puig consulted with Dr. Tripathi throughout the time that T.M. was in PACU concerning T.M.'s right arm. Dr. Tripathi has had training in hand surgery, and, as a surgeon, is familiar with compartment syndrome. Compartment syndrome in the upper arm is a rare event. Neither Dr. Puig, nor Dr. Tripathi, felt that the swelling and pain in T.M.'s arm was due to compartment syndrome. Because of her history with DVT and the similarity of some of the conditions associated with both compartment syndrome and DVT, it was felt that T.M. could have DVT in her upper arm. At 5:00 p.m., Dr. Puig and Dr. Tripathi came to T.M.'s bedside. T.M. was able to flex and extend the right fingers, to perform abduction and adduction of the right fingers, and to extend and flex the right wrist. At 5:30 p.m., Dr. Puig was again at T.M.'s bedside. Ice was applied to the elevated bicep. The circumference of the right bicep was measured and recorded at 33 centimeters. T.M. requested that the PACU nurse call Dr. Kelly O'Keefe at Tampa General Hospital. T.M. spoke to Dr. O'Keefe and advised that she was coming to the emergency room at Tampa General Hospital. Dr. Tripathi and Dr. Puig were aware that T.M. was going to Tampa General Hospital. Dr. Tripathi suggested that an ultrasound be done. At 6:00 p.m., T.M. requested that she been given another dose of Fentanyl to help with the pain while she was traveling to Tampa General Hospital, which was about an hour away from the Central Florida Surgery Center. She was discharged to be transported to Tampa General Hospital by her husband via automobile. At the time of discharge, there was continued swelling and redness of T.M.'s right arm. She was experiencing pain in her right bicep. Her right arm from her elbow to fingers was eccymotic. T.M. presented at the Tampa General Hospital Emergency Department approximately an hour after her discharge from the Central Florida Surgery Center. When she arrived at Tampa General Hospital, her right arm was red and swollen from her elbow to her fingertips. Her motor/sensory function was intact with positive radial and ulnar pulse by Doppler. She was triaged as a semi-urgent patient, Acuity 4. Dr. Kelly O'Keefe examined T.M. and found the following: Extremity/Pain-injury to the RUE, pt underwent surgery today, possible issue with bp cuff right arm during surgery, pt with redness and swelling from elbow joint to finger tips, m/s intact, positive radial pulse and dopplarble [sic] ulnar. Had blepharoplasty and chin tuck done. Pain in left arm is 10/10. Arm is swollen. Forearm with petchia [sic] diffusely, NO SOB, no chest pain. No fever. NO other current complaints. Cuff on about an hour. Prior DVT, off Coumadin now, in leg. NO PE in past. Weakness of hand/wrist associated with pain. Primary symptom. Dr. O'Keefe's differential diagnosis was the following: Evaluate for DVT in upper extremity ?arterial occlusion secondary to cuff without ongoing evidence of arterial blockage, but with likely ischemic neuropathy. Will consult neurology. Doppler scans ordered. Dr. O'Keefe ordered, among other things, a Doppler scan, a complete blood count, a cretatine phosphokinase blood (CPK) study, elevation of the arm, and Fentanyl for pain. He requested consultations with a neurologist and a vascular surgeon. At 7:49 p.m., T.M. was given 100 micrograms of Fentanyl. An ultrasound was performed. After T.M. returned from having an ultrasound done, the nurse noted that T.M. was complaining of pain in her right arm as ten, on a scale of one to ten, with ten being the most painful. There was edema to the right bicep area with stripes of vertical ecchymosis around the entire bicep. The bicep was tender to palpitation and slightly hard to the touch. Petechiae and ecchymosis were noted from elbow to fingertips. The area from the elbow to the fingertips was also edematous, tender to palpitation. Radial and ulnar pulses were detected using a bedside Doppler. There was positive motor/sensory function in the right arm, but slightly weak. T.M.'s right arm was elevated and ice packs were applied. At 9:36 p.m., the neurologist was at bedside with T.M. At 9:42 p.m., Dr. O'Keefe noted that T.M.'s pain and swelling were worsening, which suggested the development of compartment syndrome. At 10:07 p.m., T.M. was given another 100 micrograms of Fentanyl. At 10:45 p.m., T.M. was complaining of pain in her right arm as a ten, on a scale of one to ten. T.M. stated that the Fentanyl was not lasting very long. Dr. O'Keefe was notified, and he ordered one milligram of Dilaudid. At 9:56 p.m., Dr. O'Keefe noted that the Doppler study indicated that there was "[n]o evidence of arterial thrombosis or high grade stenosis," thus, ruling out DVT. The vascular surgeon, Dr. Brad Johnson, saw T.M. at 11:23 p.m. Dr. Johnson was concerned about compartment syndrome. He performed a right upper arm fasciotomy. His discharge diagnosis was right upper-extremity compartment syndrome. As part of his board certification, Dr. Puig is required to comply with the American Society of Anesthesiologists guidelines for anesthesia care. The American Society of Anesthesiologists has developed Standards for Basic Anesthetic Monitoring. The preamble provides: These standards apply to all anesthesia care although, in emergency circumstances, appropriate life support measures take precedence. These standards may be exceeded at any time based on the judgment of the responsible anesthesiologist. They are intended to encourage quality patient care, but observing them cannot guarantee any specific patient outcome. They are subject to revision from time to time, as warranted by the evolution of technology and practice. They apply to all general anesthetics, regional anesthetics and monitored anesthesia care. This set of standards addresses only the issue of basic anesthetic monitoring, which is one component of anesthesia care. In certain rare or unusual circumstances, 1) some of these methods of monitoring may be clinically impractical, and 2) appropriate use of the described monitoring methods may fail to detect untoward clinical developments. Brief interruptions of continual monitoring may be unavoidable. These standards are not intended for application to the care of the obstetrical patient in labor or in the conduct of pain management. Standard II of the Standards for Basic Anesthetic Monitoring provides: During all anesthetics, the patient's oxygenation, ventilation, circulation and temperature shall be continually evaluated. * * * BODY TEMPERATURE OBJECTIVE To aid in the maintenance of appropriate body temperature during all anesthetics. METHODS Every patient receiving anesthesia shall have temperature monitored when clinically significant changes in body temperature are intended, anticipated or suspected. Loss of large amounts of blood or exposure of body surface was not contemplated for T.M.'s cosmetic surgery. Since T.M. was an adult, was almost completely covered by sheets, and was under a Bair Hugger which supplied forced warm air, Dr. Puig did not feel that T.M. would experience clinically significant changes in body temperature. Dr. Puig controlled the amount of fluids used during the surgery and anticipated the blood loss based on the incisions that would be used by Dr. Tripathi. Dr. Sanchez-Salazar testified as an expert for the Department. Dr. Sanchez-Salazar is a board-certified anesthesiologist. He has been licensed to practice medicine in Florida since 1963. He has been working as a solo practitioner in a stand-alone outpatient surgical facility since 1993. Dr. Sanchez-Salazar testified at the final hearing that he interpreted the temperature-monitoring standards of the American Society of Anesthesiologists to mean that the body temperature of a patient had to be monitored at all times during surgery. He also testified at the final hearing that he does not monitor the patient's temperature during surgeries that last a short period of time. During his deposition taken on August 17, 2010, he testified that he did not monitor patients' temperatures on procedures that lasted an hour or less. He also opined that the monitoring standards of the American Society of Anesthesiologists required that temperatures be monitored when the surgery lasted more than an hour. It is clear that Dr. Sanchez-Salazar did not consider that the monitoring of temperatures should be determined based on whether a clinically significant change in temperature would be intended, anticipated, or suspected. Dr. Sanchez-Salazar's testimony is not credible. Dr. Nikolaus Gravenstein testified as an expert for Dr. Puig. Dr. Gravenstein has been licensed to practice in Florida since 1983. He became board-certified in anesthesiology in 1984 and has continued to voluntarily recertify. He is a professor of anesthesiology at the University of Florida. Dr. Raphael Miguel testified by deposition as an expert for Dr. Puig. Dr. Miguel has been licensed to practice in Florida since 1984. He is board-certified in anesthesiology. Both Dr. Miguel and Dr. Gravenstein opined that based on the American Society of Anesthesiologists standards for monitoring that Dr. Puig was not required to monitor the temperature of T.M. during surgery because there was a low expectation that there would be a clinically significant change in T.M.'s temperature. The testimony of Drs. Miguel and Gravenstein is credited. At the final hearing, Dr. Sanchez-Salazar testified that it was a violation of the standard of care to leave a blood pressure cuff on a patient who is having surgery when the blood pressure cuff is not working and that Dr. Puig violated the standard of care when he left the blood pressure cuff on T.M.'s right arm. When questioned by counsel for Dr. Puig at his deposition taken on August 17, 2010, Dr. Sanchez-Salazar testified that it was not a violation of the standard of care to leave the blood pressure cuff on T.M. However, when Dr. Salazar was questioned by the Department's counsel in the same deposition, he opined that it was a violation of the standard of care to leave the blood pressure cuff on T.M. Dr. Sanchez- Salazar's testimony concerning leaving the blood pressure cuff on T.M. lacks credibility. It is Dr. Gravenstein's opinion that Dr. Puig did not violate the standard of care when he disconnected from the monitoring device, but did not remove the blood pressure cuff from T.M.'s right arm. It is his opinion that most people in the same situation would not remove the blood pressure cuff, because it would be difficult to remove the blood pressure cuff without violating the sterile field. A violation of the sterile field would risk infection of the surgical site. In balancing the need to remove a blood pressure cuff that is not inflated against the need to keep a sterile field, the anesthesiologist should leave the deflated blood pressure in place. Dr. Gravenstein's testimony is credited.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Puig did not violate section 458.331(1)(t) and dismissing the Administrative Complaint. DONE AND ENTERED this 25th day of March, 2011, 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 25th day of March, 2011.
The Issue Should discipline be imposed against Respondent based upon the allegation that she failed to meet minimal standards of acceptable and prevailing nursing practice in violation of Section 464.018(1)(n), Florida Statutes (2002)?
Findings Of Fact STIPULATED FACTS: Petitioner is the state department charged with regulating the practice of nursing pursuant to Section 20.43, Florida Statutes, Chapter 456, Florida Statutes, and Chapter 464, Florida Statutes. At all times material to the Complaint, Respondent was licensed to practice as a certified registered nurse anesthetist ("C.R.N.A.") within the State of Florida. Respondent's address of record is 4409 Hoffner Avenue, Suite 328, Orlando, Florida 32812. On or about March 13, 2003, Patient M.M. presented to Endosurg Outpatient Center (Endosurg) for a colonoscopy. The colonoscopy began at or about 7:16 a.m. According to the Respondent's Anesthesia Record, Patient M.M. had a blood pressure of 120/70 at 7:30 a.m., and a blood pressure of 140/84 and an oxygen saturation of 96 percent "at the end of case." Respondent began mouth-to-mouth resuscitation and CPR at or about 7:46 a.m., then provided oxygen via a bag-valve mask at or about 7:48 a.m., and then provided oxygen by intubation at or about 7:50 a.m. Section 464.018(1)(n), Florida Statutes (2002), subjects a licensed nurse anesthetist to discipline for failing to meet minimal standards of acceptable and prevailing nursing practice. ADDITIONAL FACTS: The indications for the endoscopic procedure performed on Patient M.M. were in relation to bright red blood per rectum and anemia. The endoscopic diagnosis confirmed by the procedure was diverticulosis and internal hemorrhoids. According to Patient M.M., this was the first colonoscopy she had ever had. In the history reported by Patient M.M. prior to the procedure, there was no report of chest pain, indigestion, heart burn, or nausea. The patient did report rectal bleeding. Patient M.M. provided a history of bronchitis, but it was noted that there were no recent problems with the bronchitis. In the recount of her past medical history, she made no reference to congestive heart failure, coronary artery disease, diabetes, atrial fibrillation, angina, heart murmur, heart valve problems, or irregular heart. She did have a history in her family of heart disease; the family member was her father. By history, the patient suffered from high blood pressure. At the time the patient was seen at Endosurg she was 67 years old, 5 feet 5 inches tall, and weighed 215 pounds. Respondent has practiced for 30 years in numerous settings. Respondent was an independent contractor recently employed at Endosurg. Over time she has met her obligations in relation to continuing education for her profession. When Respondent first saw Patient M.M. on the date in question, the patient was in the holding area adjacent to the procedure room. Respondent introduced herself to the patient and checked the intravenous access. The line had been placed and Respondent checked to make certain that the line was patent. Respondent explained to the patient that the patient would be given sedation. In particular, Respondent told the patient that she would be placed under conscious-sedation during the procedure. The patient responded that her son had had post- operative nausea and vomiting, having undergone sedation, but that the patient had experienced no problems with anesthesia in the past. Respondent listened to the patient's chest. The heart was regular, in that there were no audible sounds of irregularity or murmur at that time. The patient's chest was clear. No signs of wheezing or bronchi or rales were present that would indicate upper-respiratory difficulties. Respondent was aware that the patient suffered from hypertension. Before the procedure Respondent did not observe anything in the patient's demeanor which suggested that the patient was overly anxious. As the anesthesia record reflects, the administration of anesthesia by Respondent commenced at 7:15 a.m. and ended at 7:26 a.m. The procedure commenced at 7:16 a.m. and concluded at 7:25 a.m. Before providing the anesthesia, Respondent placed a blood pressure cuff on the patient, a pulse oximeter, an EKG monitor, and a pre-cordial stethoscope. The patient was anxious and Respondent administered a total of 2 mg of Versed. The Versed was administered twice. After waiting to see the reaction to the first administration, a second administration was provided. During the administration of this medication, Respondent discussed its subjective influence with the patient. Two other persons were in the procedure room with Respondent. They were the physician gastro-endrologist, who was performing that procedure, and an anesthesia technician. The doctor involved was Dr. Nehme Gebrayel. When the scope used to perform the procedure was inserted the patient winced. In response to those circumstances Respondent provided Fentanyl, an ultra-short acting narcotic in an amount considered appropriate to the circumstances. When the scope reached the area within the colon where the scope needed to be turned, the patient grasped the arm of the technician and dug her nails into his forearm. The physician called upon Respondent to provide other sedation to allow him to continue the procedure while providing some comfort to the patient. In response Respondent gave the patient 30 mg of Propofol, an hypnotic sedative with a short half-life. Later the patient began to dig her nails into the technician's forearm once more, which the technician reported to the physician. The physician told Respondent to provide additional sedation. Respondent gave the patient 30 mg more of Propofol. While the procedure was ongoing Respondent monitored the patient's vital signs. Before the procedure, the blood pressure was 142/100, the heart rate was 72. The second reading on blood pressure taken by Respondent during the procedure occurred between 7:18 a.m. and 7:20 a.m., with a reading of 126/66. Pulse oxygen readings that were recorded at the beginning and during the procedure reflected 98 percent and 95 percent saturation respectively. When the physician began to withdraw the scope at the end of the procedure, Respondent told the patient that the procedure was being finished and that the physician was taking the scope out. The patient responded by giving a "thumbs up" gesture. When the Doctor finished the procedure, Respondent asked the patient if the patient was doing "O.K." Respondent asked the patient if the patient was experiencing discomfort, the patient responded "not really." Respondent told the patient that the patient was being taken back to the holding area where she had been picked up before and brought into the procedure room. While the physician was still in the procedure room, Respondent went to the door and opened it into the holding area, and the nurse from the PACU at Endosurg came into the procedure room. Maureen Mayhew, R.N., was that nurse. When nurse Mayhew entered the procedure room, the vital signs in relation to blood pressure, pulse, and the pulse oximeter reading were still displayed on the monitor in the procedure room. Those readings at the end of the case were blood pressure 140/84, heart rate 74, respiratory rate 16 per minute and the saturated oxygen level 96 percent. At that time the patient responded to queries and stimuli. The reference to responding to queries means that the patient was able to converse with the Respondent. When Respondent turned over the care to nurse Mayhew, she told the other nurse that the patient had high blood pressure and a history of bronchitis but that the chest was clear when listened to prior to the procedure. Respondent explained that the patient had undergone a colonoscopy, in which 2 mg of Versed, 50 mg of Fentanyl, which is the equivalent to 1 cc and a total of 60 mgs of Propofol, divided into two doses had been provided. Respondent told nurse Mayhew that the patient was awake and talking and that her blood pressure had started at 140, had drifted down to 120 and was back at 140, as to systolic readings. After Respondent released the patient to the care of nurse Mayhew, she proceeded to address the next case. The administration of anesthesia to that patient commenced at 7:27 a.m. At about 7:45 a.m. a C.N.A. at Endosurg came into the procedure room where the next case was underway. The C.N.A. stated that there was a problem with Patient M.M., in that the patient was not responding as she had been. The C.N.A. asked that the doctor and Respondent come and see the patient. After arranging for someone to continue to monitor the patient that was being examined at that moment and with the placement of intravenous fluid with that patient to keep him hydrated, Respondent and the doctor left the procedure room and entered the holding area where Patient M.M. was found. When Respondent and the physician approached the patient, the patient was alone, flat on the bed. Respondent checked the patient's pulse at her neck, while the physician checked the patient's pulse at the wrist. Respondent called the patient's name and rubbed on the patient's chest. The patient made no response. The patient had no pulse. Respondent told the doctor "I don't have a pulse here." The doctor responded "Neither do I." When Respondent and the doctor addressed the patient in the holding area, they were uncertain when the patient had stopped breathing. The doctor commenced chest compressions as a form of CPR. Respondent leaned over the patient and breathed two quick breaths into the patient through mouth-to-mouth CPR. Respondent asked someone else employed at Endosurg to bring the CODE cart. Someone asked the Respondent if they needed to call 911. Respondent said, "yes" and the call was placed. Respondent was handed an ambubag with a valve mask to assist the patient in breathing. To check the bag's operation Respondent squeezed twice and found that the bag was not working. This bag belonged to Endosurg, and by inference Endosurg, not the Respondent is found to be responsible for its maintenance. During the inception of the mouth-to-mouth resuscitation provided by her, Respondent noticed that the patient's chest rose which is an indication that the patient was being ventilated. By contrast, the initial ambubag provided no evidence that ventilation was occurring. When the facility ambubag failed, Respondent asked another employee at Endosurg to go and pick up her personal ambubag that was located in another part of the procedure room. While someone went to retrieve Respondent's personal ambubag, the Respondent continued to provide mouth-to-mouth resuscitation while the physician gave closed chest compressions to the patient. During that time the chest was rising, indicating that the patient was making ventilatory efforts. When the second ambubag, belonging to Respondent, was handed to her, it was connected to oxygen and it performed as expected. The patient was given several quick breaths of the oxygen through the ambubag. Respondent then used a laryngoscope and an endotracheal tube to intubate the patient and the patient was intubated. While being ventilated through the endotracheal tube, Respondent used a stethoscope to listen to the breath sounds of the patient and she found evidence that the endotracheal tube was secure. While this was occurring the physician continued chest compressions. The physician also administered certain drugs to the patient to assist the patient. One drug being administered to the patient at the time was Epinephrine. The patient was then defibrillated. The defibrillator did not have a separate monitor. It was one in which the paddles associated with the defibrillator were not hooked to a device that would produce print strips of the results when the paddles were applied. This defibrillator belonged to Endosurg. The Respondent and the physician relied upon the EKG monitor hooked up to the patient to gain information and her status. When the Respondent and the doctor had come into the holding area, the patient was not on the monitor. The physician placed the leads on the chest of the patient to connect the monitor to reflect the pulse rate, if any were present. When the patient was first defibrillated and there was no change in the heart rhythm, another dose of Epinephrine was administered. About that time the fire rescue unit that had been summoned by the 911 call arrived. That was at 7:51 a.m. The fire rescue personnel included an EMT paramedic qualified to maintain the airway for the patient. Those persons took over the patient and prepared the patient for transfer. Respondent asked the doctor if it was acceptable to return to the procedure room and check the status of that patient. The physician gave her permission but Respondent did not return to the procedure room until the EMT paramedic had checked the position of the endotracheal tube in Patient M.M. Through the efforts made by Respondent and the physician the patient regained her pulse. A note in the patient's records refers to the existence of the heart rate and pulse when the patient was turned over for transport to a hospital. That hospital was the Villages Regional Hospital. There the patient was diagnosed with cardiac arrest and anoxic brain damage, encephalopathy. Subsequently the patient was transferred to Leesburg Regional Medical Center. The decision was eventually made to remove the patient from life support, given her condition. In an interview nurse Mayhew gave to an investigator with the Department of Health, relied upon by the parties at hearing, Ms. Mayhew told the investigator that five patients were in the PACU at Endosurg when Patient M.M. was transferred to that unit. At the time there was only one registered nurse and a single C.N.A. in the unit. Liz Singleton was the C.N.A. Ms. Mayhew told the investigator that Ms. Singleton indicated to Ms. Mayhew that the patient was alert and talking when the patient entered the unit. Ms. Mayhew said that she gave Patient M.M. a rapid assessment shortly after the arrival of the patient in the unit. Ms. Mayhew told the investigator that she noted that the Patient M.M. had declined from alert to responsive at that time. When checking the color and vital signs, a decrease in blood pressure was noted and the patient was placed in the Trendelenberg position (head down, feet raised) to try to increase the blood pressure. Ms. Mayhew mentioned giving Patient M.M. a sternal rub. The patient was noticed to blink her eyes and move her shoulder. Fluids were started, and the patient was given Romazicon intended to reverse the effects of anesthesia that had been provided to the patient during the procedure. Ms. Mayhew told the investigator that she gave C.N.A. Singleton instructions not to leave the patient's bedside and to give the patient one-on-one care. Ms. Mayhew then went to arrange for another C.N.A. to assist in the PACU. At some time during the care provided by nurse Mayhew, she indicated that there was a monitor for blood pressure, oxygen saturation, respiration and pulse and that the alert alarms were set. Nurse Mayhew told the investigator that she was starting an IV two beds away and heard the second C.N.A. talking to Patient M.M. just before the alarms went off. She said that Patient M.M. was in respiratory arrest and that she called a CODE, meaning nurse Mayhew called a CODE. Any entries concerning the vital signs in relation to Patient M.M. that were made following the procedure while the patient was in the holding area were made by C.N.A. Singleton, according to nurse Mayhew's statement. The monitor had printout capabilities at the time but was not activated. Notwithstanding these remarks attributed to nurse Mayhew in the interview process, it is found that when Respondent and the doctor addressed the patient in the holding area the monitor was disconnected. Although in her remarks made to the investigator nurse Mayhew said that the vital signs were recorded by the C.N.A., the record of nursing assessments reflecting the recording of the vital signs was signed by nurse Mayhew. They show that at 7:30 a.m. the patient's blood pressure was 78/46, with a pulse rate of 52, and a respiratory rate of 12. At 7:35 a.m. the blood pressure was 74/42, with a pulse rate of 40, and a respiratory rate of 14. The physician gave certain post-op orders concerning Patient M.M. which were noted by nurse Mayhew when she affixed her signature. One of those orders indicated that Ms. Mayhew was obligated to "notify physician for blood pressure less than 90/60, pulse >110." This order was not followed. EXPERT OPINION: Cenon Erwin Velvis, C.R.N.A., has been licensed in Florida for eleven years. He was called as an expert for Petitioner to testify concerning Respondent's care rendered Patient M.M. in this case. The witness was received as an expert. Both the Respondent and Mr. Velvis have provided anesthesia on numerous occasions while patients were undergoing colonoscopies. To prepare himself for the testimony, nurse Velvis reviewed medical records pertaining to Patient M.M. and the investigative report of the Department of Health. His opinion is that Respondent in caring for Patient M.M. fell below the standards expected of a C.R.N.A. when considering acceptable and prevailing nursing practice. Concerning his opinion, nurse Velvis believes that Patient M.M. was transferred to the PACU in an unstable condition, that Respondent did not remain with the patient long enough to ascertain this instability and the need for treatment and to conduct an ongoing evaluation secondary to the side effects of the anesthesia, and that once the patient experienced difficulties, the airway and circulatory system were not secured by Respondent in a timely manner. Nurse Velvis believes that the blood pressure reading at 7:30 a.m. of 78/46 and heart rate and pulse of 52 are low, dangerously so. According to nurse Velvis the normal range is 120/80 for blood pressure. There can be an acceptable 15 to 20 per cent departure from what is considered normal. This takes into account that nature of the procedure that the patient had undergone. The vital signs that were reflected at 7:30 a.m. demonstrate patient instability at 7:30 a.m., in Mr. Velvis' opinion. The Romazicon administered to the patient would not ordinarily be used given the amount of anesthesia provided the patient in the procedure. The patient's responsiveness had progressed to a point from what was initially assessed as responsive or responding to queries, to an unresponsive state. This would account for the administration of Romazicon, a reversal agent to the tranquilizer that had been used during the procedure. Nurse Velvis notes that the patient had gone from responding to inquiries to a state of unresponsiveness where the patient would only move when given painful stimuli. Mr. Velvis was aware that the blood pressure at 7:35 a.m. was 74/42, with a pulse rate of 40, indicating a further decline. The approximate time of arrest for the patient was 7:45 a.m. from records reviewed by Mr. Velvis. Mr. Velvis believes that the Respondent was responsible for verifying the patient's vital signs upon admission to PACU. He also originally expressed the opinion that Respondent failed to utilize the intubation equipment in a timely fashion to restore breathing following the emergency. Mr. Velvis concedes that if the cardiac arrest that occurred with Patient M.M. were related to anesthesia, the respiratory response by the patient would be lowered. But the recording of a respiratory rate of 12 at 7:30 a.m. and 14 at 7:35 a.m. does not satisfy Mr. Velvis concerning the quality of ventilation in the patient, even with the efforts of the patient being recorded. He also makes mention that the level of oxygen saturation at those times was unknown when reviewing the record. He does acknowledge that a respiratory rate of 14 as such is not consistent with respiratory arrest. Mr. Velvis acknowledges that nothing in the record indicates that nurse Mayhew notified the doctor when the low blood pressure readings were taken at 7:30 a.m. and 7:35 a.m., contrary to post-op orders. When provided a hypothetical under interrogation at hearing, that reflects the facts that have been reported here concerning the Respondent and the doctor in their effort to restore Patient M.M.'s breathing, Mr. Velvis retreated from his opinion that the airway and circulatory system of the patient was not secured in a timely manner when confronted with the crisis. While Mr. Velvis changed his opinion during cross- examination at hearing concerning the response by Respondent leading to the defibrillation, he still continued to express the opinion that Respondent fell below the standard of care and was responsible for hypoxia in the patient, the patient not breathing. He also restated his opinion that Respondent was below the standard of care for her release of the patient from the procedure room into the PACU in an untimely manner. Mr. Velvis expresses the opinion that immediate patient care was the Respondent's responsibility but in the atmosphere of team work the physician was the captain of the ship. Although the physician was the captain of the ship, the Respondent was responsible to do what was most important for the patient, according to Mr. Velvis. Mr. Velvis recognizes that nurse Mayhew would have been more helpful if she had notified Respondent and the physician earlier about Patient M.M.'s condition in the holding area, and Ms. Mayhew's error in leaving the patient when the patient was unstable. Mr. Velvis expresses the opinion that the mechanism behind the cardiac arrest in Patient M.M. was a lack of oxygen, in that the airway was not secure. Mr. Velvis in his testimony concedes that the patient could have had cardiac failure not due to a problem with respiration. Michael A. Binford, M.D., was called by Respondent as an expert. He is a practicing anesthesiologist in Florida who completed his anesthesiology residency approximately ten years ago. He works with C.R.N.A.s in his practice and as such is able to offer opinion testimony about the performance of C.R.N.A.s in their practice. He is familiar with the type of procedure which Patient M.M. was undergoing and the drugs administered to provide anesthesia. Having reviewed the patient's records and the investigative report from the Department of Health, his opinion is that Patient M.M. was stable when transferred from Respondent's care to nurse Mayhew's care. That opinion is based upon vital signs recorded at the commencement, during, and at the end of the procedure. From what he saw in the record concerning the medication administered to the patient during the procedure, it was appropriate. Nothing that he saw in the record made Dr. Binford believe that the Respondent should have stayed with the patient for a longer period of time, given the amount of medication provided. By contrast Dr. Binford refers to the vital signs recorded when the patient was under nurse Mayhew's care at 7:30 a.m. and 7:35 a.m. Those are not vital signs of a patient in a stable condition. Dr. Binford believes that the patient was deteriorating at that time and that nurse Mayhew violated the physician's post-op order by not immediately notifying the doctor of the vital signs she found. Dr. Binford in referring to nurse Mayhew's statement given to the investigator, reads the statement to indicate that the patient was stable when entering the PACU but declined from alert to responsive. To Dr. Binford this reflects a change in mental status in the patient. Definitive evidence in the change in status is borne out by the vital signs taken at 7:30 a.m., and 7:35 a.m., in Dr. Binford's opinion. Although the Romazicon given by Nurse Mayhew would not have been a drug of choice for Dr. Binford, he understands that nurse Mayhew may have considered it appropriate to provide an antidote to the Versed by using Romazicon. Dr. Binford did not believe that the Versed would have caused the low vital signs encountered by nurse Mayhew. Having reviewed the autopsy report related to Patient M.M., Dr. Binford believes that a cardiac event was associated with the lower vital signs. He does not believe that the respiratory rate of 12 and 14 found at 7:30 a.m. and 7:35 a.m. respectively are consistent with respiratory arrest. Dr. Binford explains that the process involved with a heart attack, which is also referred to a myocardial infarction, is in relation to the entire heart or some segment within the heart not getting sufficient oxygen. If the patient is not breathing for a period of time, the total level of oxygen in the blood drops significantly. That is a possibility. The second possibility is that if there is plenty of oxygen in the blood, but one of the blood vessels supplying the heart muscle becomes blocked and no blood can get past the obstruction, this can also cause oxygen deprivation. Either explanation can cause damage to the heart and the brain. The first example is one in which problems are experienced in getting air and oxygen into the lungs, that can be picked up and transported around the body and the second explanation involves a problem with getting the blood flow into the area as needed. The first example related to problems of respiration is referred to by Dr. Binford as a primary respiratory event. The second example is referred to as a primary cardiac event, involving restricted blood flow. In Dr. Binford's opinion if the patient has respiratory difficulty, the respiratory rate ranges from 0 to 8, which was not the case here. In Dr. Binford's opinion neither the Versed or Romazicon were responsible for the vital signs shown in the patient while she was in the holding area. In Dr. Binford's opinion the cause of the patient's decline was indicative of a primary cardiac event, as opposed to a primary respiratory event and the anesthesia as a causative agent would not explain it. He expresses this opinion within a reasonable degree of medical certainty. Given his knowledge of the case, Dr. Binford did not find any deficiencies in the way the Respondent treated the patient. Within a reasonable degree of medical certainty Dr. Binford believes that the Respondent met her obligations as to the basic standards for her profession in the pre-operative phase, during the procedure, upon the release of the patient to nurse Mayhew and in response to the emergency in the holding area. Having considered the opinions of both experts, the opinion of Dr. Binford is more persuasive and is accepted as it exonerates Respondent for her conduct.
Recommendation Based upon the facts found and the conclusions of law reached, it is RECOMMENDED: That a final order be entered dismissing the Administrative Complaint. DONE AND ENTERED this 8th day of December, 2005, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of December, 2005. COPIES FURNISHED: Irving Levine Assistant General Counsel Department of Health Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Damon A. Chase, Esquire Chase Law Offices, P.A. Post Office Box 196309 Winter Springs, Florida 32719 Alex Finch, Esquire 2180 Park Avenue, Suite 100 Winter Park, Florida 32789 Dan Coble, Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact At all times material hereto, the Respondent was licensed as a general physician in the State of Florida, having been issued license number ME0031490. At times pertinent hereto, Dr. Elkadi operated the "Akbar Clinic" in Bay County, Florida. His operation of the clinic consisted generally of performing medical practice of a general nature as well as practice as a general surgeon, including outpatient surgery. He also practiced at Bay Medical Center, where he treated patients admitted under the auspices of other physicians. Dr. Elkadi had no admitting privileges at Bay Medical Center. The Petitioner is an agency of the State of Florida charged with regulating and enforcing the medical practice standards and licensure standards embodied in Chapter 458, Florida Statutes, including the standards of practice involved in the dispute in this case. Ms. Eunice Stallings was a patient of the Respondent on March 19, 1985, on which date she came to his clinic. She was 70 years of age. After performing some tests and observing the results, Dr. Elkadi informed her that she suffered from gall stones. She filled out a form in his office indicating that she had previously had a tonsillectomy, an appendectomy, a lobectomy and a hysterectomy. The doctor mentioned that she could be admitted to the hospital for surgery or could use his clinic. She elected to stay at the clinic and have the surgery there on account of the greater expense she believed involved with a hospital admission. She did not have any discussions with Dr. Elkadi concerning possible complications or risks associated with the gall bladder surgery prior to the surgery. Her daughter, Ms. Ted Cowens, went to the clinic with her on the day of the surgery. She arrived shortly after 7:00 a.m. on that day. A clinical employee escorted Ms. Stallings to the room to have her change into a surgical gown. Dr. Elkadi had discussed earlier with Ms. Stallings the possibility of staying in a nursing home or something of that nature after the surgery, for recovery. She assumed that the clinic would make the arrangements for that recovery procedure. She was not informed that she might have to stay beyond 24 hours in the clinic's facility. She was not informed prior to the surgery that Dr. Elkadi had no admitting privileges to the hospital, if complications should arise necessitating hospital admission. Ms. Cowens remained at the waiting room from 7:00 a.m. until 2:00 p.m. of March 19, 1985, while her mother-in-law was undergoing the cholecystectomy (gall bladder removal). She saw her mother-in-law at 2:00 p.m. that afternoon and observed that she was attached to a heart monitor and was breathing oxygen with difficulty. Ms. Cowens inquired about the circumstances and was informed by a person who identified herself as a nurse that Ms. Stallings had run into a problem with her lung. She was having difficulty breathing at the time. Ms. Cowens observed a person who identified herself as "Joyce" acting as a nurse right after the surgery. When she returned at 5:00 a.m. the next morning on March 20 to the clinic to see her mother-in-law, Joyce indicated that she had been the sole person on duty with Ms. Stallings during the entire night. She also indicated she had tried to get another person to be on duty, but was unable to do so. Ms. Stallings at this time was still coughing and spitting blood and continued to do so until her transfer from the Akbar Clinic to Bay Memorial Hospital by the Respondent and Dr. Albibi, based upon the other doctor's admitting privileges, at approximately 5:00, on March 20, 1985. Charles Wheelahan is an investigator for the Department of Professional Regulation and interviewed the Respondent in his Panama City office. The Respondent gave him copies of medical records regarding the Stallings case and informed him that a small respiratory problem, involving slight lung congestion, had occurred shortly after Ms. Stallings' operation, while she was still a patient in the clinic. Dr. Elkadi informed the investigator that he had made application to be licensed as a "hospital," but that license application had been denied by the Department of Health and Rehabilitative Services (HRS) and that he was in the process of applying to be licensed as a "surgical center." He also informed the investigator that the nurse on duty with Ms. Stallings on the night of March 19-20, 1985, was Joyce L. Snow. She was a Licensed Registered Nurse in Great Britain, but was unlicensed in the State of Florida. The doctor, in response to a question from Investigator Wheelahan, informed him that he did not maintain any blood supply on the clinic premises, but could obtain blood from the county hospital if needed. In any event, he informed the investigator that only a minor blood loss was expected and actually experienced during the cholecysteotomy surgery and that it would have been anywhere from 20 to 100 cc's blood loss. The investigator also established that a person known as Olga Sutter, apparently an employee of the clinic, was also present and cared for Ms. Stallings during some of the time she was a patient at the Akbar Clinic. Dr. John L. Williams testified as an expert witness on behalf of the Petitioner. He is a Florida licensed physician and general surgeon and has been in private practice in Tallahassee since 1970. He is Board-certified in surgery and belongs to numerous medical societies. His primary practice emphasis has been in direct patient care. Dr. Williams reviewed the hospital and office notes concerning Ms. Stallings, which comprise Exhibits 5A and 5B in evidence. The medical records reveal that Ms. Stallings went into respiratory distress post-operatively, which ended up as acute congestive heart failure, for which she was treated. The doctor's and nurse's notes reflect that she had become short of breath and that her blood pressure fell and that she ultimately became cyanotic. Blood gas test results proved the fact of her congestive heart failure condition. Dr. Williams felt that, although the treatment was adequate in the end result, there should have been some contingency plans developed in advance for handling any disaster or crisis that arose involving the pulmonary edema or bleeding suffered by the patient. The medical records and notes and evidence of record do not reveal that the Respondent had any such contingency plans for handling crises developing from performing such surgery in an outpatient setting. The operation, as shown by Dr. Williams, would have been more appropriately performed in a hospital setting so that the patient would have the crisis-handling ability of the hospital systems and staff during her overnight stay. It was his opinion that, given the history of lung trouble, wheezing, scarring of the chest, as well as her age, that this type of surgery should not have been done in the outpatient setting. Dr. Williams' expert opinion is accepted. Dr. Paul Lahti is an expert witness for Respondent and a retired general surgeon from Michigan. He reviewed the records of the Stallings case and found nothing inappropriate about Dr. Elkadi's care of Ms. Stallings. He stated that the doctor's actions avoided a catastrophe. He also stated that same-day surgery is recognized in 48 states. He has not practiced medicine in Florida. He also has spent a substantial amount of time writing, lecturing and advocating the cause of same-day outpatient surgery. I find his testimony significantly colored by his somewhat partisan view, advocating that a broad range of surgical procedures be performed as outpatient same-day surgery. His opinion appeared based on that and on the fact that nothing inappropriate was determined by him to have been done by the Respondent in his care of Ms. Stallings in terms of the end result. Dr. Edward Woodward, a professor of surgery, from the University of Florida, was also Respondent's expert witness. He likewise found the care of the patient itself appropriate and did not feel the problems she experienced were clinically important. Dr. Williams, the Petitioner's expert himself, however, did not find the actual techniques of the treatment afforded the patient, including that afforded her after the respiratory and congestive heart failure crisis arose, to be inappropriate. The problem was, that it was substandard medical practice, as related above, to handle such a serious surgical procedure for a patient of her age and with her previous health history as an outpatient surgical case. Appropriate medical practice would have dictated that a patient such as this be hospitalized before such surgical treatment. Dr. Woodward, one of Respondent's experts, also felt that it was the surgeon's duty in a case such as this to anticipate problems that may occur during or after surgery. Thus, in this context, and because of his more thorough review of pertinent records, Dr. Williams' expert opinion is the more valid one and is accepted over the others. Expert Witnesses Four experts were called by the Petitioner and Respondent to testify and give expert opinion testimony concerning the nine patients related to Case No. 86-1327, which will now be addressed. Dr. John L. Williams, general surgeon and expert for Petitioner, testified that he reviewed all the cases, involving hospital charts and office notes and other records, in its entirety, spending more than 30 hours reviewing them. Dr. Millard Roberts, a gastroenterologist and expert for Petitioner, read all of the hospital and office notes, which are exhibits, and spent more than 50 hours reviewing them. Dr. David Skinner is Chairman of the Department of Surgery at the University of Chicago and an expert for the Respondent. He stated in his deposition that he read abstracts of the medical records, contained in Respondent's Exhibit 7 in evidence, sent to him by the Respondent. He did not compare those prepared abstracts with the actual medical records which Dr. Williams and Dr. Roberts had reviewed. See Respondent's Exhibit 6, pages 17-21. Dr. Skinner spent approximately seven hours reviewing abstracts of the records furnished him by the Respondent himself, Dr. Edward Woodward is professor at the University of Florida. He stated that he reviewed the hospital charts, but no office records concerning the patients involved. He also looked at the Respondent's attorney's summary of notes to supplement his factual basis for rendering an opinion. The evidence did not reflect what length of time Dr. Woodward spent reviewing this material.. The Surgical Procedure at Issue Fundoplication is the surgical procedure under question in the nine cases comprising Case No. 86-1327. This procedure is designed to prevent "reflux" or regurgitation of stomach contents from the stomach up into the esophagus. "Reflux esophagitis" is the chronic inflammation of the esophagus due to the reflux of gastric juices into the esophagus for various reasons. Reflux esophagitis, if severe enough, may cause scarring or narrowing in the esophagus. Reflux esophagitis is an indication to perform the surgical procedure called fundoplication in those cases in which reflux is due to an inherent weakness in the junction of the stomach and the esophagus. The most common symptom of reflux esophagitis is a substernal burning or discomfort after eating, which is commonly referred to as heartburn. A further symptom is regurgitation of food when the patient bends over or lies flat after large meals. Other less specific symptoms of the condition involve upper abdominal pain. Ruth Cooey is a 73-year-old female who complained of epigastric pain upon admission by the Respondent. The patient had a history of taking Tagamet and antacids for one year. One year prior to admission, an upper GI examination was done which revealed an esophageal hiatal hernia and a duodenal ulcer. Her past history included arthritis with a left total hip replacement, hypertensive cardiovascular disease and a total abdominal hysterectomy. Following her admission to the hospital, Dr. Elkadi entered the case, treating the patient with Tagamet and Regulon. The patient's history contained notes of recurrent epiastic pain, nausea, choking spells and heartburn radiating behind the sternum for several years. Shortly before hospitalization, peptic ulcer had been demonstrated, as well as a hiatal hernia, which the Respondent confirmed. A "Bernstein test" was then conducted. A Bernstein test is designed to reproduce "heartburn" in most cases. The results are not always accurate. The Bernstein test was done three days after admission, with negative results. The results were not noted by Dr. Elkadi in his summary, however. Dr. Elkadi performed an endoscopy with the distal esophagus being described as compatible with chronic esophagitis. There was a "small sliding hiatal hernia with intermedial reflux." The records also reveal a description of two shallow ulcers of three to four millimeters each, in the prepyloric area and a large pyloric channel ulcer, described as being eight to ten millimeters in diameter. Biopsies taken during endoscopy showed chronic esophagitis and revealed chronic inflammation in the prepyloric mucosa. Dr. Elkadi performed a vagotomy, a pyloroplasty, and a Nissen Fundoplication on or about June 8, 1983. Dr. John Williams, the Petitioner's expert, opined that the reflux this patient had experienced was due to the primary disease of pyloric channel ulcer, which can cause reflux and thus produce symptoms of heartburn. If she had an intrinsic weakness of the esophagastric junction, a primary indication for a fundoplication procedure, then she would have had the symptoms before she was 73 years of age and not just had them occur after she had the ulcer. It was Dr. Williams' opinion that fundoplasty, the surgical procedure at issue, was really not indicated in this case. The symptoms exhibited for reflux esophagitis, which would justify the fundoplication were not present in this case. The symptoms existing were likely due to the ulcer as opposed to esophagitis. The symptoms the Respondent listed which he felt showed reflux esophagitis were pain after meals (thirty minutes to an hour and relieved by antacid), heartburn, and the epigastric pain described by Dr. Zawahry in June 1981. It might be noted that Dr. Zawahry, at that time, did not note any choking, dysphagia (difficulty in swallowing) or substernal pain, which are indications for fundoplication. The documentation of those symptoms came from the Respondent's notes. Dr. Williams felt the written records from the charts at the hospital did not justify the need for the fundoplication which was done. Her primary problem was a peptic ulcer. The esophagasoopy did show some esophagitis, which is evidence that some material was getting into the esophagus from the stomach or digestive tract below, but that was caused by the ulcer disease. Dr. Williams indicated that the treatment noted on those written records was below appropriate performance standards for a reasonable physician under reasonable similar conditions and circumstances, as there was no indication that the symptoms exhibited indicated the need for the fundoplication surgery. Dr. Millard Roberts, a gastroenterologist and licensed physician in the State of Florida, is a private practitioner in Tallahassee. He was qualified as an expert witness for the Petitioner in the field of gasroenterology. He received his undergraduate degree from the University of Florida and his medical degree from the University of Miami Medical School. He has admission privileges at Tallahassee Memorial Regional Medical Center and Tallahassee Community Hospital and presently serves on the Medical Records Review Committee of both those hospitals. He has practiced for sixteen years and attends numerous conferences and training sessions within his field of gastroenterology to keep his knowledge and skills current. He formerly practiced in that field, as well as in internal medicine, in Dothan, Alabama, His primary emphasis has been on the symptomology of the patients, which he obtains by taking a history, a physical examination, performing certain studies and arriving at impressions after completing examinations and observing the results of tests or studies. The standard practice in the medical community for determining whether or not symptoms are properly documented in records is based on rules promulgated by the Joint Commission on Accreditation of Hospitals, which method was employed by most hospitals in the country in 1985. Dr. Roberts discussed the various symptoms of esophageal reflux disease, including heartburn, difficulty in swallowing or painful swallowing (dysphagia), regurgitation or reflux of material as high as the throat or mouth. The symptoms noted in the hospital chart of the Cooey case, in his opinion, were related to ulcer, rather than to esophageal reflux disease. There was an absence of symptoms such as heartburn, dysphagia, choking and substernal pain. These symptoms were not noted in Dr. Zawahry's reports. He only reported epigastric pain. Dr. Roberts stated that it would be expected to see the other symptoms of esophageal reflux disease he noted appear in the patient's previous medical records made by Dr. Zawahry. Dr. Elkadi's consultation report is the first time these symptoms are mentioned. Dr. Roberts also pointed out that the Bernstein test is commonly used to confirm reflux esophagitis, but in Ruth Cooey's case the test was negative. It was negative on June 5, three days prior to the June 8 surgery. Dr. Roberts found nothing in the record occurring between the date of the Bernstein best and the date of the surgery three days later to confirm the necessity for doing a fundoplication. He further established that there was nothing in the radiologist's report to indicate any tertiary contractions of the esophagus, which would indicate a motility disturbance, which would be a justifying symptom. Dr. Elkadi's note is the only record he saw which is in any way supportive of the surgery. Dr. Roberts stated that the lack of symptomology to justify the fundoplication led him to conclude that the level of care and treatment fell below that of similar physicians practicing in similar conditions and circumstances. The other surgical procedure (for ulcers) should have taken care of the symptoms that were exhibited in the record without the necessity of the Respondent doing the fundoplication. The Respondent's expert, Dr. Woodward, agreed that the hospital charts and records did not give a clear history of reflux esophagitis in this patient. He also felt it was inexcusable not to have the information from the office notes on the hospital charts. He himself had reservations about the performance of the Nissen Fundoplication in this case, but would not call it malpractice. Dr, Skinner, the Respondent's other expert witness, testified in his deposition that the operation was appropriate. Based upon their greater familiarity with the circumstances of this case, including their more extensive survey and consideration of the records involved and their more direct experience in gastroenterological practice and surgery, I accept the opinions of Drs. Williams and Roberts over that of Drs. Woodward and Skinner. Debra Crosby is a 28-year-old female with a history of morbid obesity. She was admitted to Bay Memorial under the Respondent's care with a history, over the past few weeks, of nausea and dyspepsia, which is epigastric distress after eating greasy, fried foods. She had a past history of acid indigestion. The Respondent immediately ruled out gall bladder disease, the patient having been admitted for abdominal pain as well. The secondary reason for admission was for "morbid obesity," to conduct a surgery to allow the patient to reduce her obese condition. Such surgery limits the intake of food and the ability of the intestines to absorb food to some extent. The patient had surgery to correct morbid obesity. That surgery is called a "Roux-en-y" gastric bypass. That surgery involves making a small pouch near the upper part of the stomach, bringing the small intestine up and attaching it to that pouch so that the patient is only able to eat a limited amount at a time. Dr. Williams opined that that was an appropriate procedure to use for "bariatric surgery," that is, to relieve obesity, although he himself prefers the "vertical bend gastric partition procedure." No gastroesophageal reflux symptoms were documented in this case. In any event, on the 22nd of July, shortly before surgery, the patient was vomiting and suffering epigastric distress. They performed a "GI series" or barium- assisted X-ray of the upper digestive tract. While the patient was actually in the process of vomiting, a small hiatal hernia was demonstrated. Because of the vomiting, they had to abandon the upper GI series test. It was postponed until the next day, at which time another upper GI series test showed normal with no sign of hiatal hernia. So no esophageal reflux condition was demonstrated, nor was there any significant indication of hiatal hernia, which can cause a reflux condition in the esophagus. An ultrasound test of the gall bladder established that there were no gall stones, and her gall bladder appeared normal. She then had surgery for the gastric bypass procedure and also had a fundoplasty. The fundoplasty or fundoplication involved suturing the anterior wall of the stomach pouch to the anterior wall of the esophagus on one side. Only one side of the stomach was sutured up, and Dr. Williams established that fundoplasties all should be characterized by a "wrap" of some sort of the stomach around the base of the esophagus. The manner in which the surgery was described in the Respondent's operation note does not reveal that he could possibly do the appropriate fundoplication wrap procedure in that manner, with only a partial wrap. Esophageal reflux disease usually disappears with weight loss. With surgery to correct morbid obesity, accepted medical practice dictates that reflux-correcting procedures (fundoplasty) not be done. The reduction of the obesity greatly relieves the problem of reflux, and the gastric bypass surgical procedure is effective in preventing reflux of bile and juices itself. In Dr. Williams' opinion, which is accepted, there were no specific symptoms showing a reflux condition. There were some nonspecific symptoms that could possibly have been attributed to reflux involving epigastric pain or acid indigestion. The nausea and vomiting could have been due to many causes, but Dr. Williams thinks most likely that she suffered from gall bladder disease in spite of the fact that she did not have any stones. So, her symptoms could have been due to gall bladder disease, just acid indigestion, obesity or reflux. There were no clear-cut symptoms to justify the anti-reflux operation, however, because the patient had no symptoms of reflux before she had an acute illness, which caused her hospitalization. She was simply morbidly obese and correction of that problem would solve also any reflux symptoms she may have been-having. In summary, the medical records of this patient, maintained by the Respondent, did not justify an anti-reflux procedure such as fundoplasty. In any event, Dr. Williams opined that the procedure that was done would not prevent reflux anyway, even though it was unnecessary. This is so because an appropriate wrap of the stomach around the esophagus was not done. So, as established by Dr. Williams, the partial wrap, fundoplication procedure was supefuous and should not have been performed. Dr. Roberts also reviewed the Crosby case and opined that the gastroesophageal reflux condition would disappear with weight loss, brought on by the Roux-en-y procedure. When the pressure within the stomach exceeds the pressure of the lower esophagus sphincter muscle designed to prevent the reflux or regurgitation, then reflux can occur. The obesity causes a thickness and weight on the abdominal wall which pressures the stomach. The increase in the intraluminal pressure of the stomach enhances the possibility that reflux will occur. Therefore, prevention of increase of intraluminal pressure of the stomach would decrease the likelihood of reflux occurring. The documented symptoms of esophageal reflux disease, such as heartburn, dysphagia, chest pain, chronic cough and epigastric pain were not present in this patient, with the exception of some heartburn pre-operatively. Dr. Roberts established that the written records for this particular patient do not justify, by symptomology recorded, the necessity of doing a fundoplication procedure. Dr. Roberts thus corroborated the finding by Dr. Williams that the treatment and care of this particular patient fell below accepted standards for reasonable physicians under reasonable similar circumstances and conditions, since the indications for the fundoplication procedure were not present in the patient's records. Dr. Skinner opined once again that he felt the operation was appropriate. Dr. Woodward, however, questioned the necessity of the repair of the hiatus hernia and the anti-reflux operation or fundoplication. He felt that with weight loss the reflux condition would disappear with the lessening of pressure on the stomach and that therefore it was probably unnecessary, although he did not go so far as to call it a situation of malpractice. The opinion of Doctor Williams and the opinions of Drs. Roberts and Woodward, to the extent they are corroborative, are accepted. Patient Dorothy Kay was a 68-year-old female with a history of diabetes, cardiovascular disease and legal blindness. She also had some urinary and renal system dysfunction, with hyperemia. She was admitted by Dr. Kahn in June 1981 for abdominal pain, nausea and vomiting of one day duration. She had had three black bowel movements immediately before admission, but these were not tested for blood. Since her hemoglobin level was normal on admission and remained normal, Dr. Williams, in his testimony, discounted the possibility that she had gastrointestinal bleeding. She was thoroughly evaluated after admission, and her gall bladder proved normal. An upper GI examination showed a small hiatal hernia, but with no reflux, on June 15. Examinations of the kidney and a CAT scan of the abdomen were not remarkable, and a barium enema on the 22nd of June revealed some diverticulosis. She had a problem with constipation at this same time, which could have explained some of her complaints of abdominal pain, especially because the abdominal pain ceased after the barium enema, according to the nurse's notes. An endoscopy was performed on June 18 to examine the esophagus and stomach area. The esophagus showed some chronic inflammation. This can either occur as a normal occurrence or as a result of some disease process. This particular patient's history revealed that she had arthritis and had been taking a substantial dosage of Motrin, at 600 milligrams per day. Motrin is one of the drugs that can cause gastrointestinal and peptic symptoms. It can produce ulcers and bleeding. The patient had been maintained on this dosage of Motrin until two days before surgery, which is quite a significant dose. Dr. Williams also found that the abdominal pain was relieved upon administration of saline injections. H3, therefore, thinks the abdominal pain was most likely due to functional disease associated with diabetes and may well have been caused by the Motrin medication. In any event, there was no evidence in her history which would indicate that reflux esophagitis (the indication for a fundoplication procedure) was the cause of her pain. Even Dr. Elkadi's admission notes noted that her tenderness was more prominent in the lower abdomen than in the upper abdomen. The patient was operated on and had a needled biopsy of the liver and the fundoplication procedure, as well as a "lysis" of adhesions. The operation notes were not written until two months after the surgical procedures were done. Operative notes are customarily done at the time of surgery and on the same day if possible, so that the physician will not be as likely to forget details of the procedure as he would if they were dictated two months later. The operative notes on the fundoplasty procedure were done on August 19. The surgery was performed on June 25. Dr. Williams established that the records on this patient simply did not show symptoms of reflux esophagitis, an indication for the fundoplasty. The esophagoscopy was not valid evidence, standing alone, of reflux esophagitis, and that was the only possible suggestion that a chronic reflux condition existed. Dr. Williams established that the small degree of change observed in that procedure, due to reflux, was due to vomiting of the rather short historical duration occurring immediately prior to her admission. The Motrin medication she was taking could, itself, have caused her symptoms. The minimal chronic inflammation of the esophagus was not shown to be due to any defect in the gastroesophageal joint, but could have been due to any number of conditions in a diabetic, aged and infirmed patient like this and most likely was due to the recent vomiting, which is of undiagnosed etiology. Dr. Roberts referred to Dr. Elkadi's consultation of June 12, 1981, wherein he noted that the woman had been having abdominal pain for seven years, progressively worsening. Dr. Roberts did not feel that indicated reflux esophagitis. The reason he did not think so was because there was no mention made of any heartburn pain or difficulty in swallowing as to the upper abdominal area or chest area. There was also no mention in any of the notes or records that the patient was developing any strangling sensations or symptoms suggestions aspiration of gastric contents, bleeding or hemorrhaging, which would be suggestive of sever ulceration of the esophagus. Dr. Roberts agreed with Dr. Williams that this patient's records do not in any way indicate symptomology, clinical or otherwise, which would confirm a diagnosis of reflux esophagitis, indicative of a fundoplication procedure. Dr. Woodward, the Respondent's expert, also felt that the fundoplication was unnecessary. He found no history suggestive of reflux esophagitis and felt that such elective surgery in a person who was this sick, with diabetes and related problems, was a poor idea. He also found it unforgivable that the history was not more descriptive of the patient's problems and that the history concerning the patient's medication regime was not documented in the hospital chart. The doctor was opposed to the patient having this operation but, because of "mitigating circumstances" which he never fully explained in his testimony, would not call this a situation of malpractice either. In any event, based upon the testimony of Drs. Williams and Roberts and corroborated to some extent by that of Dr. Woodward it is found that Dr. Elkadi's treatment of this patient was inconsistent with quality medical care and fell below appropriate standards of practice for similar physicians practicing under similar conditions and circumstances. Agnes McNeil is a 42-year-old female with a history of depression, nausea, vomiting and abdominal pain. She was admitted to the hospital in October 1981 with approximately a six month history of abdominal distress and vomiting. A GI series was performed showing normal results and an upper gastrointestinal and endoscopy showed some esophagtis. There was also a finding made that she had a duodenal ulcer with some reflux. That finding was made October 31, 1981. She was admitted again on the 8th of March, 1982. On March 11, she had an "upper end endoscopy" and was said to have a hiatal hernia with reflux and duodenal ulcer, on the pylorus. The esophagus, however, was normal, and the GI series was negative once again. It showed no hiatal hernia and no reflux. She had surgery for the duodenal ulcer in the pyloric channel. The procedure done was a "highly selective vagotomy" which is done to inhibit the secretion of acid by the stomach. This is a rather new procedure and is not statistically as effective as some other procedures for the same condition. Additionally, the Respondent did a fundoplasty. The fundoplasty was not properly indicated, as established by Dr. Williams, because the significant changes in the esophagus which would indicate such a procedure were not present. The past reflux condition occurring in October 1981 was due to the acute ulcer condition. There had been no significant history of reflux prior to the onset of the peptic ulcer disease. If reflux was present, then the patient should have experienced some regurgitation upon bending over or waking up at night, as well as burning in the chest upon lying down at night, and none of this appeared in the record. A biopsy was done in this case which indicated acute esophagitis, and the patient had suffered severe weight loss, but this, in Dr. Williams' opinion, is related to the peptic ulcer condition and is justification for a vagotomy procedure, either the normal type or the new and somewhat controversial, highly selective vagotomy which Dr. Williams guardedly agreed with. In any event, however, he established that the fundoplasty was not ordered because the evidence of reflux esophagitis in the patient was directly related to the peptic ulcer disease and the procedure to effect a of that problem could be expected to alleviate the eophagitis. In any event, post-operatively, the patient still continued to have upper abdominal pain, nausea and vomiting. The obstruction in the pyloric area caused the reflux and caused the vomiting. The constant vomiting resulted in the inflammation or esophagitis condition. Pyloric channel ulcers cause obstruction which causes vomiting, and vomiting by definition is "reflux." The removal of the cause of the vomiting will also, over time, heal the esophagitis, without the necessity of a partial fundoplasty, as was done in this case. Dr. Roberts, in reviewing the McNeil patient records and notes, found that the upper GI series and the pathology in this particular case did not show significant evidence of reflux esophagitis. Three different "upper GI series" before and after she surgery, were interpreted as normal. His testimony, in effect directly corroborates that of Dr. Williams in establishing that the performance of the fundoplication as treatment in this case was below accepted standards of practice or a reasonable physician practicing under similar conditions and circumstances. Although he did not testify in his deposition that the Respondent fell below the standard and committed malpractice, Dr. Woodward, the Respondent's expert, also questioned and doubted whether the patient needed the Nissen. Fundoplication in view of the medical records he was given to review. Ms. Nguyen was a 77-year-old Vietnamese female at the time of her admission to the hospital by Dr. Kahn in December 1981. Her complaints were abdominal pain, nausea, vomiting, constipation, dehydration and fainting. She had been unable to urinate for approximately 24 hours prior to admission. These conditions are revealed by the notes, but the failure to urinate for approximately 24 hours is inconsistent with the dehydration symptom noted. In any event, she is a Vietnamese national and did not speak English. Communication with the Respondent, whose service she was admitted on, was difficult. It was thus difficult to get an adequate history from her, which made the history somewhat sparse. During her hospitalization, on December 19, Dr. Elkadi noted some "right upper quadrant tenderness." Dr. Elkadi had been consulted on the 18th of December and had noted at that time nausea, vomiting, right upper quadrant tenderness and constipation. Gall bladder X-rays showed probable gall stones or "sludge" in the gall bladder, and a GI series indicated a small hiatal hernia, without mention of reflux. An abdominal ulcer sound test was performed which showed sludge or small stones in the gall bladder. Gall bladder disease fit the physical findings of right upper quadrant tenderness, acute onset of nausea and vomiting and also the history of the patient not having a good appetite, being nauseated over the course of the year and losing a significant amount of weight. She only weighed 87 pounds upon admission. An endoscopy was performed, as a result of which Dr. Elkadi described the patient as having distal esophagitis, moderate erythema and edema, as well as a small hiatus hernia. A cholecystectomy was performed for removal of the gall bladder. There were no symptoms other than nausea and vomiting which would justify a finding that reflux esophagitis was present and that therefore anti- reflux surgery might be indicated. A small hiatal hernia was not significant, and there was minimal esophagitis shown by the endoscopy done immediately prior to surgery. What esophagitis evidence was present was due to the nausea and vomiting related to the gall bladder disease. Dr. Elkadi performed a fundoplication procedure anyway. Performance of a fundoplication is additionally risky for a person who is frequently vomiting, and the fundoplication was shown by Dr. Williams to be unnecessary in this case. The nausea and vomiting were not symptoms of reflux disease, but rather were symptoms of the gall bladder disease. The small hiatal hernia did not justify anti-reflux surgery in this case because that is frequently seen in older people and is not significant in itself. Additionally, although Dr. Elkadi's records showed that he removed a large gastric tumor, in reality that tumor was only one centimeter in diameter sitting on the surface of the stomach and was of no consequence in the patient's condition or related to any of her symptoms. The symptoms of right upper quadrant pain, nausea and vomiting, and the test results, justified the cholecystectomy (gall bladder) procedure, which is what Dr. Elkadi should have done and then stopped. He should have determined whether that alleviated the patient's symptoms, rather than doing the unnecessary fundoplication when the record did not reveal any significant reflux esophagitis indications, and since that procedure represents an additional risk to the patient. In summary, it was established by Dr. Williams that the records were not adequate to justify the fundoplication performed in this case. The performing of it unnecessarily constituted a failure to practice medicine with that degree of care and treatment required of physicians under similar circumstances. It is especially true in the case of a patient such as this, who is old and feeble at best. Performing an unnecessary operation on such a sick, 77-year-old patient increases the mortality risk somewhat and increases the post-operative morbidity risk significantly because the patient will not be able to "burp" any longer and can become subject to "gas bloat," as well as the risk of having difficulty swallowing because the "fundoplication wrap" might be too tight. The fact that it constituted malpractice to proceed forward with the unnecessary fundoplication is especially pointed up by the fact that Dr. Elkadi's own notes reveal that he was unable to understand the patient, who could not speak English, and thus was unable to get an adequate history. If the history is unclear because of a language problem and the doctor cannot understand the patient to make sure of the extent and nature of the symptoms, it is not reasonable to proceed with the operation, as opposed to trying to find an interpreter who can help the physician ascertain clearly what the symptoms are and what the indications for treatment are. Dr. Roberts, likewise, was unable to find any proof in the hospital records of the presence of any reflux esophagitis and felt that the fundoplication was unjustified. In fact, as he pointed out, Dr. Elkadi himself in his operative notes indicated that the limited history he was able to obtain from the patient was not specific enough to distinguish between gall bladder symptoms and gastroesophageal reflux symptoms. Dr. Roberts thus felt that the treatment of this patient fell below acceptable standards of a similar physician under similar circumstances. Dr. Woodward, the Respondent's expert, was unable to determine what was wrong with the patient and found that the hospital chart did not clarify it for him. The purpose of a patient history, according to Dr. Woodward, is to give a word picture of a patient's problem, and he found that the history, in addition to being inadequate, did not indicate any reflux esophagitis. He agreed with Drs. Williams and Roberts that the cholecystectomy was needed, but it was unlikely that the patient really needed anti- refluxsurgery (fundoplication). The additional operation, in addition to being unnecessary, added to the patient's mortality risk and post-operative morbidity. It has therefore been established that, as to this patient, the practice of the Respondent and his treatment of the patient fell below the acceptable standards for similar physicians practicing under similar conditions and circumstances. Rosey Peel was a 66-year-old lady admitted in May 1982 to Dr. Elkadi's service with a history of gastrojejunostomy, appendectomy, total abdominal hysterectomy, with associated adhesions. In October 1980, she had had a history of duodenal ulcer which was medically treated, as well as a history of stomach erosions and bowel gastritis treated medically in May 1981. In April 1982, she underwent an endoscopy, and the pathology report indicates the presence of chronic esophagitis and inflammation of the gastrojejunostomy. She had a history at this time of epigastric pain, nausea and vomiting. The endoscopy showed ulcers in the jejunum at the site of the gastrojejunostomy or the "rough equivalent to the pyloric channel." Thus, the patient had active peptic ulcer disease with related endoscopic evidence of bile in the stomach and in the esophagus. She underwent a vagotomy as a correction for the ulcer disease and a resection of the distal stomach, which disconnected the stomach from the duodenum in order to get rid of the problem of bile entering the stomach and causing the reflux esophagitis. The reconnection process was done in the form of a Roux-en-y procedure or gastric bypass, which has the effect of preventing the bile from entering the stomach. As opined by Dr. Williams, these procedures would alleviate her problem involving the ulcer disease, the reflux biliary gastritis and esophagitis. Consequently, she did not need the fundoplasty procedure, and it was unnecessary. The anti-reflux procedure did not have to be done, and the primary disease process, peptic ulcer disease, would have been alleviated by the Roux-en-y gastrojejunostomy and the vagotomy. Dr. Williams opined that when an operation like this that is unnecessary is done, then strictly speaking malpractice has been committed. He acknowledged, however, that it was possible to interpret her symptoms and records as indicating reflux biliary gastritis, which could have easily led the Respondent to believe that a fundoplication procedure could cure her problem. In fact, it was not necessary to cure the reflux problem she was having, as delineated above. In this particular case, standing alone, it might be said that, given the presence of reflux biliary gastritis and esophagitis, that a practitioner could make a good faith mistake in performing a fundoplication, rather than limiting the surgery to the Roux-en-y repair and the complete vagotomy. Dr. Roberts, after reviewing this patient's file, was unable to find symptomology in the record which would justify the fundoplication. The abdominal pain, nausea and vomiting, which had worsened over several months, were related, in his opinion as well as Dr. Williams', to bile reflux gastritis. Reflux in and of itself is not justification for surgery, especially when the patient is not complaining of chronic reflux esophagitis symptoms. The reflux can be due to other causes, as mentioned above, including the pyloric ulcer situation this patient suffered. He opined that the esophageal reflux situation and the delayed gastric emptying would have been relieved with just the procedures performed short of the fundoplication, as did Dr. Williams. Inasmuch as Dr. Williams felt that this single instance of performing the fundoplication, albeit necessary, could not by itself be called malpractice, since enough symptomology was present to lead a competent practitioner into performing it as a result of a good faith mistake, and since both Respondent's experts felt that the procedure was documented in this case, it cannot be found that this instance, standing alone, was gross or repeated malpractice. It has, however, been proven that the procedure was medically unnecessary. Considered together with the other unnecessary surgeries discussed in these Findings of Fact, however, the overall pattern is one of medical treatment which does not measure up to the standards of reasonable physicians performing such practice and treatment under similar conditions and circumstances. Ms. Rosey Smith is a 63-year-old female with a history of total abdominal hysterectomy, right nephrectomy and adhesion laparotomy, both of which procedures were performed in 1950; cholecystectomy performed in 1962; and hiatal hernia repair performed in 1980. She was admitted to the Respondent's service in 1981 complaining of epigastric pain. An endoscopy performed revealed moderate, chronic esophagitis, but the pathology report failed to confirm esophagitis and was interpreted as being without evidence of inflammation of either the esophagus or gastric mucosa. She was admitted by Dr. Kahn and subsequently consulted by Dr. Elkadi. She had had a Nissei Fundoplication for reflux esophagitis in November 1980. She was admitted again on this occasion in September 1981 with nausea and epigastric pain. Since her surgery in 1980, she has been unable to eat well because of fullness and pain after eating. She had upper gastrointestinal pain upon admission, and the endoscopy performed showed that she had a slight amount of esophagitis. However, biopsy of the stomach and the esophagus were normal. The upper GI series performed failed to show any reflux. It showed tertiary contractions of the esophagitis (spasms) and some delayed emptying of the stomach, as well as some deformity of the antrum of the stomach. That deformity did not have any significance, especially in view of the fact that the endoscopy failed to show any ulcers in that area. Dr. Williams did not feel that the delayed emptying of the stomach was significant either, and he found no evidence of reflux. The Respondent then performed a vagotomy after taking down the previous fundoplasty in order to get to the vagus nerve to do the vagotomy, which is indicated for peptic ulcer disease. Thereafter, he had to redo the fundoplasty, which had previously been done in 1980. Dr. Williams felt that the lady's problem was probably dysfunctional and probably related to her first surgery. After the first fundoplication, she exhibited the same complaints she had before. She had been treated previously with Tagamet and, if she did have peptic ulcer disease, the endoscopy did not reveal it to be significant. Thus she did not need this further surgery which also left her with the same complaint she had before. A month after this surgery some dysphagia or difficulty in swallowing as well as esophageal dilation was experienced. These are symptoms of the so-called "gas bloat syndrome." This is involved with fullness and pain after eating and is a complication of a fundoplication. Dr. Williams found that she did not have significant esophagitis, and the problem was more likely "gas bloat" or some undiagnosed, dysfunctional gastrointestinal disease. She did not have an active ulcer and had no significant reflux. Additionally, the "3 plus" positive standard reflux test is not in and of itself sufficient evidence to justify a fundoplication. This test can be positive and still not represent any symptomatic condition. Dr. Williams thus opined that the performance of the fundoplication being taken down, a vagotomy performed and the fundoplication being redone (which was necessary once it was "taken down") was below the acceptable standards of a reasonable physician under similar circumstances and conditions in light of the symptoms exhibited. In a like vein, Dr. Roberts found that the patient did not appear to have esophageal strictures before she had the surgery. The hospital nursing notes suggest that constipation may have been a problem because of the laxatives given during the days preceding surgery. No ulcer was found demonstrated by Dr. Roberts, only inflammation of the pyloris as a result of the endoscopy. Dr. Roberts likewise felt no fundoplicatio was justified by the patient records in this case. Dr. Woodward, Respondent's expert, likewise indicated that the history reflected in the hospital chart was characteristic of the "gas bloat syndrome." He strongly suspected that the first anti-refluxoperation (fundoplasty) was satisfactory and that she did not need any further surgery. Like Drs. Williams and Roberts, he did not think that Mrs. Smith had an ulcer either. He felt the ulcer surgery and the concomitant taking down and replacing of the previously done fundoplasty was not necessary, but did not feel he had sufficient information to opine concerning whether malpractice existed. Dr. Skinner believed the operation to be appropriate under the circumstances. The opinion of Doctor Williams and the opinions of Drs. Roberts and Woodward, to the extent they are corroborative, are accepted. Linda Turner is a 32-year-old female with a long history of medical complaints. Seven years prior to the subject admission, she had had an ovarian carcinoma which led to a hysterectomy, bilateral salplngo-oophorectomy and appendectomy. She had multiple abdominal complaints after that and was said to have ulcerative cholitis, which causes cramping and mucous in the stool. In November 1981, she was admitted with abdominal pain and was labeled as having a recurrent ulcer and right hip pain. She was admitted by Dr. Kahn from the emergency room. Her two primary complaints were sharp pain in the right hip and numbness in the leg and increased pain on hip movement, which had nothing to do with abdominal pain. She had three weeks of cramping and abdominal pain, which gradually increased with nausea and anorexia, epigastric burning with indigestion, associated with ingestion of food and liquids. She exhibited dark brown vomit on occasion, with lower abdominal tenderness. Her hemoglobin, chest X-ray, upper GI series and small bowel X-ray series was normal, as were pictures of the stomach. The barium enema she received was normal, as were her gall bladder tests, and CAT scan and PH reflux test. Dr. Elkadi was consulted, and he said that she had upper abdominal pain, nausea and vomiting for two years, which had worsened in the last three weeks. He stated that she had occasional regurgitation and dysphagia at the base of the neck. She was said to have had one tarry black stool before her admission, but Dr. Williams doubted there was any bleeding because her hemoglobin test was normal, and no positive stool was documented for blood. The doctor's notes indicated left lower quadrant pain and some stomach cramps. The pain increased with ingestion of food. She had an endoscopy on the 9th, which resulted in a normal biopsy. On one of the biopsy specimens, there was a small amount of blood under the mucosa, but this might be explained, according to Dr. Williams, by vomiting or trauma caused by the instrumentation itself during the endoscopy procedure. He saw no other evidence to indicate she had any bleeding from the esophagus. The patient had surgery on the 19th, and the operative record indicates that extensive adhesions were found in the lower abdomen. She also had a Nissen fundoplasty and a highly selective vagotomy. The vagotomy and the fundoplasty were unnecessary. The patient's primary problem was likely the abdominal adhesions which could explain the pain and cramps in the area of the lower intestine. The patient did have some symptoms that were suggestive of esophagitis in that, when she vomited, she had epigastric distress, but Dr. Williams could see no evidence of ulcer disease in her records and chart. Dr. Williams also was of the opinion that, although the lady had a record of having three tarry black stools, the fact that her hemoglobin had not changed and that no bleeding had been demonstrated after she was in the hospital, nor was any ulcer found, that the dark stools were evidently due to some other reason than bleeding. Although the endoscopy and related biopsy showed intramucosal bleeding, that was of a very slight nature and was likely due to the trauma of the instrumentation or the trauma of vomiting. There was no ulceration and no acute inflammation of the esophageal area. There was no evidence of significant hemorrhage originating in that area. Dr. Williams then opined that the patient's written records only justified an abdominal exploration. He felt that Dr. Elkadi should have stopped with the lysis of abdominal adhesions as a means of alleviating the patient's abdominal pain and cramps related to the small intestine, rather than proceeding with the fundoplasty and vagotomy in the gastroesophageal area, where there was no concrete evidence of esophagitis, ulceration or other disease. In short, the treatment given the patient was unnecessary and fell below the acceptable standards of similar physicians under similar circumstances. He exposed the patient to additional morbidity and a slight additional risk of mortality. Dr. Roberts essentially agreed with Dr. Williams' findings and stated that, other than Dr. Elkadi's own description about the endoscopy on these written records, no evidence or history suggestive of esophagitis was shown in this patient. He stated that, although the patient complained of chronic abdominal pain for three weeks, with nausea and loss of appetite, as well as epigastric "burning," he felt these were not sufficient enough to suggest chronic esophageal reflux disease indicative of a fundoplication. He opined that, on the basis of the tests done in this case, that a diagnosis of specifically what was causing the cramps, abdominal pain, nausea and loss of appetite and upper gastric burning could not be done and certainly not sufficient to support a decision to perform the surgery that was performed. The record was simply bare of any concrete evidence to suggest esophagitis being present, and he, too, felt that the treatment of this patient by the unnecessary surgery performed, fell below standards generally required of physicians under similar circumstances. Dr. Woodward, the Respondent's expert, was of the opinion that the patient's hospital chart did not support the operation and that the patient's history was not suggestive of the presence of esophagitis. He also found that the endoscopy, while being said to show esophagitis, also resulted in a normal biopsy, thus hemorrhage present was likely induced by the biopsy forceps, since you do not typically see hemorrhage caused by esophagitis, rather you see inflammation. Dr. Woodward did not think the patient had ever had esophagitis and did not think she needed the reflux preventative operation. Thus, he felt the procedures performed were unnecessary, although he would not actually state he had sufficient information to call this type and level of treatment malpractice. Once again, Dr. Skinner believed the treatment and operation to be appropriate. The opinion of Dr. Williams and the opinions of Drs. Roberts and Woodward, to the extent they are corroborative, are accepted. Felix Williams was a 62-year-old black male who was admitted in August 1981 to the service of Dr. Kahn. At that time he had a three-week history of epigastric pain with radiation to the back. Mr. Williams had a long medical history of multiple hospital admissions and surgeries. He had previously had a vagotomy and a pyloroplasty, supposedly for duodenal ulcers, which may have been unnecessary. He also had a "Bilroth II" subtotal gasrectomy, or partial removal of the stomach and reattachment of the lower intestine, designed to better drain bile from the stomach. The patient had been taking Tagamet for two to three years before the August 1981 admission. The past surgeries did not relieve the patient's symptoms. He also had had a long history of pancreatitis, with recurring abdominal pain. He had been operated on many times with no relief and continued to have the chronic pancreatitis, related to a long history of alcoholism. After being admitted on August 1, 1981, with a history of abdominal pain, the patient's serum amylase tested as being elevated. Urine amylase was also elevated. The amylase readings were only a little above normal, however, and it is common in people who have had chronic pancreatitis for years to have only a minimal elevation of their amylase when having an acute flare-up of pancreatitis. This is because the pancreas, over the years, has pretty much destroyed itself, according to Dr. Williams. The patient's upper GI series X-rays showed hiatal hernia with some reflux, but no stricture demonstrated. Ultrasound tests of the gall bladder and pancreas showed them as being essentially normal. CAT scans of the abdomen on August 27, compared to previous CAT scans, showed less enlargement of the pancreas, although it was still enlarged, which was consistent with pancreatitis. On August 31, an endoscopy was performed by Dr. Elkadi which showed a hiatal hernia and some esophagitis, as well as some alkaline gastritis and alkaline esophagitis. The biopsy done by the pathologist showed benign gastric mucosa, and the patient had no strictures of the esophagus. Bile studies showed no calcium bilirubinate crystals. In September 1981, during this same admission, Dr. Elkadi performed a cholecystectomy, or removal of the gall bladder, because of chronic cholecystis. He also performed a Roux-en-y revision of the original surgery. That is, he converted the Bilroth II surgical procedure to a Roux-en-y and also did a fundoplasty. Dr. Williams did not feel the patient needed surgery at all, but rather his symptoms were due to chronic pancreatitis. He felt that if the person was going to be operated on, however, that the removal of the gall bladder was certainly indicated, and that this is one of the causes of pancreatitis. In this case, the man had a long history of alcoholism, which serves to cause pancreatitis which, once it gets started, tends to be self- perpetuating. Dr. Williams felt that any surgery done at this point with the patient would result in the same problem, that is not alleviating the pancreatitis and associated abdominal pain. Dr. Elkadi knew of the pancreatitis or should be presumed to have known because the CAT scan taken on August 27, 1981, as well as the amyfase test results, revealed pancreatitis. He did not strongly consider pancreatitis as the primary problem, however, and, according to his notes, thought that repairing the reflux condition he believed to exist would take care of the problem. The Roux-en-y surgical procedure, as well as the fundoplasty, however, would not address the primary problem of pancreatitis, so the abdominal pain would still continue, which in fact it proved to do after Mr. Williams recovered from surgery. The pancreatitis-induced vomiting will not occur as much after the fundoplasty because that procedure prevents vomiting, but the patient will still have the same morbidity; it will just be manifested in a different way. The opinion of Dr. Williams establishes that the gastroesophageal reflux, which was seen on the endoscopy, in reality was due to the pancreatitis, and that the fundoplasty which was performed would do nothing to alleviate the pancreatitis. It might make it be manifested somewhat differently by reducing vomiting, but the abdominal pain and elevated amylase characteristic of the pancreatitis were still there. In summary, Dr. Williams felt that the removal of the gall bladder was justified and that the Roux-en-y procedure, which is designed to move bile juices from the stomach, would be justified, but for the fact that the primary problem was pancreatitis, which surgery of that type will not correct. Dr. Williams did not feel that the Respondent misdiagnosed pancreatitis, but just that he was "overly optimistic" and should have appreciated the fact that surgical treatment of this type would not have helped the man and that the only surgical treatment for chronic pancreatitis is removal of the pancreas, which causes a severe morbidity problem in and of itself and would probably not be indicated either. Thus, Dr. Williams opined that Dr. Elkadi's treatment of Felix Williams fell below accepted standards of physicians practicing under similar circumstances and conditions. Dr. Roberts also felt that the patient's basic problem was pancreatitis, relying on the same records that Dr. Williams relied on in his testimony. The patient had epigastric pain radiating through to the back, which is a classic indication of pancreatitis, which, when coupled with elevated serum amylase, establishes the presence of acute pancreatitis. Dr. Roberts was unable to find any history of nausea or vomiting, which would suggest gastric esophageal reflux, the admitting diagnosis being simply abdominal pain and pancreatitis. Since the patient had pancreatitis, that condition is consistent with the slowness of the stomach to empty itself, which in itself could have permitted reflux with changes consistent in the esophagus with esophagitis. Dr. Roberts was of the opinion that the records did not show the necessary symptomology to justify the anti-reflux surgery which was done. He thus felt that the standards of care of a reasonable, prudent physician under similar conditions and circumstances had not been met by the Respondent. The Respondent's expert, Dr. Woodward, after reviewing the records of Felix Williams, also felt that the symptoms did not suggest reflux esophagitis, the indication for the fundoplication surgery. Dr. Woodward did not, in his testimony, discuss the fundoplication procedure specifically. Dr. Woodward opined that the symptoms did not suggest reflux esophagitis, although this was diagnosed by the endoscopy, which was performed by the Respondent himself. He also did not feel the biopsy report was very convincing and felt that "the pathologist was trying to help out the surgeon." Nevertheless, Dr. Woodward felt that there was no doubt about his having reflux alkaline gastritis, which Dr. Williams noted as well, and felt that this was due to the unnecessary surgeries already performed by past surgeons. Dr. Woodward noted that this was also associated with marked gastric retention or failure of the stomach to empty rapidly enough. He thus felt that the patient should have another operation, if nothing else, to try to get the stomach to empty better and to divert some of the duodenal fluid away and hopefully give him some degree of pain relief. This surgery was done in the form of the Roux-en-y procedure performed by the Respondent. Neither Dr. Williams nor Dr. Woodward felt that this surgery was improperly performed. Dr. Williams merely felt that it was probably unnecessary, since the root problem was pancreatitis. However, Dr. Woodward established that, at least in an effort to aid stomach emptying and avoid gastric pain associated with bile retention in the stomach, that the Roux-en-y procedure probably was necessary. None of the three doctors opined that the fundoplication was necessary, however, since reflux esophagitis was not present. In summary, it is found that the surgeries performed, consisting of the cholecystectomy and the Roux-en-y procedure were appropriately done under the circumstances, although this is a marginal case for such surgeries being indicated, based upon the totality of the expert testimony, because of the underlying problem of pancreatitis. In any event, however, the fundoplication which was done was shown to be unnecessary and not medically indicated. Thus, as to that procedure, the Respondent's practice with regard to this patient fell below the medical practice standards referenced above.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record and the pleadings and arguments of the parties, it is, therefore RECOMMENDED that a Final Order be entered by the Board of Medical Examiners suspending the Respondent's license for a period of one year, with reinstatement to active status contingent on Respondent making satisfactory showing, by completing continuing education courses, or in such manner as the Board may elect, that he has worked diligently to enhance his knowledge and skill in the area of gastroenterological surgery, including the "indications" for such. It is further recommended that the Respondent's license be placed in probationary status for two years thereafter, with such terms and conditions as the Board deems appropriate, within the guidelines of Rule 2lM-20.001(t), Florida Administrative Code. The failure to comply with any such terms and conditions should result in revocation. DONE and ORDERED this 27th day of December, 1988, In Tallahassee, Florida. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 904/488-9675 FILED with the Clerk of the Division of Administrative Hearings this 28th day of December 1988. APPENDIX TO RECOMMENDED ORDER CASE NOS. 86-1140 & 86-1327 Petitioner's Proposed Findings of Fact: 1. Accepted. 2-3. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 6-17. Accepted. 18-20. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 23-25. Accepted. 26. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 27-29. Accepted. 30. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 31 #1. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 31 #2. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. 36 #1. Accepted. 36 #2. Accepted. 37-40. Accepted. 41. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 42-44. Accepted. 45. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Respondent's Proposed Findings of Fact: 13-20. Accepted, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 21-22. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 23. Rejected as not being of probative material import. 24-25. Rejected as to its purported material import. 26-29. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. Rejected as to its purported material import. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 33-34. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 37-39. Accepted. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 42-43. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted, but not as to its purported material import. 46-47. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 48. Accepted. 49-53. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 54-56. Rejected as to its purported material import. 57. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 58-61. Accented. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. 64-65. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. Rejected as not being of probative material import. 68-69. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. Rejected as not being of probative material import. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. 74-77. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. 83-84. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 85-86. Accepted. 87-89. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 90-91. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted, but not in itself dispositive of any material Issue. 94-95. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. 98-99. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 100. Rejected as to its purported material import. 101-102. Rejected as subordinate to the - Hearing Officer's Findings of Fact on this subject matter. 103-104. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 105-107. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as not in accordance with clear and convincing evidence. Rejected as not being of probative material Import. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted, but not to the extent that the fundoplication was indicated. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter, as not being of probative material import and as constituting argument of counsel. Rejected as not being of probative material import. Rejected as contrary to the greater weight of the evidence, was subordinate to the Hearing Officer's Findings of Fact on this subject matter and as not being of probative material import. 117-119. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 120. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and not of material import in itself. 121-122. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and not in itself dispositive of material issues. 123-127. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 128-130. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 131-132. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 133-142. Really amount to legal argument and recitation of testimony and evidence regarding the Motion to Dismiss, which has been dealt with supra. COPIES FURNISHED: Roosevelt Randolph, Esquire KNOWLES & RANDOLPH 528 East Park Avenue Tallahassee, Florida 32301 Spiro T. Kypreos, Esquire LEVIN, MIDDLEBROOKS, MABIE, THOMAS, MAYES & MITCHELL, P.A. 226 South Palafox Place Post OffIce Box 12308 Pensacola, Florida 32581 Harry Rein, Esquire 3803 Lake Sarah Drive Orlando, Florida 32804 Bruce D. Lamb, Esquire General Counsel Department of Professional Regulation 130 North Nonroe Street Tallahassee, Florida 32399-0750 Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issue for determination is whether Respondent, a licensed physician, committed violations of Chapter 458, Florida Statutes, sufficient to justify the imposition of disciplinarysanctions against her license. The resolution of this issue rests upon a determination of whether Respondent intubated the esophagus of a patient, as opposed to the patient's trachea, in the course of rendering anesthesia care; and whether Respondent then failed to provide a record justifying such a course of medical treatment.
Findings Of Fact Respondent is Saroja L. Ranpura, a licensed physician at all times pertinent to these proceedings, holding medical license number ME 0039872. Respondent was licensed in the State of Florida on April 27, 1982. She currently practices medicine in Ohio. Petitioner is the Department of Professional Regulation, Board of Medicine, the state agency charged with the regulation of physicians in the State of Florida. On August 29, 1985, Frank Snydle, M.D., performed a laparoscopy on patient C.P. at Heart of Florida Hospital in Haines City, Florida. This medical procedure was performed on an outpatient basis. As a result, C.P. came into the hospital on the day the surgery was to be performed. She met Respondent, who later provided anesthesia care to her in the course of the laparoscopy. Respondent examined C.P. at that time, prior to the surgery, and noted that C.P. had a small mouth. Later, C.P. was brought into the operating room on a stretcher and moved herself over onto the operating table. Present in the operating room at that time were Jean Allen, L.P.N., Norma Masters, R.N., and Respondent. Respondent proceeded to do an unusual procedure known as a "blind nasal intubation." The procedure requires the placement of an tube in the patient's throat through the nose, as opposed to the mouth, in order to maintain an open airway during later anesthesia administration in the process of surgery. C.P. was sedated, but awake, during this process and was intubated with a minor degree of difficulty. Prior to placement of the endotracheal tube, Respondent had the patient breath pure oxygen through a mask covering the mouth and nose. The preoxygenation process, according to Respondent, provided extra oxygen "as a reservoir and as astorage" to C.P.'s body tissues. By letting a patient breath 100 percent oxygen for three to four minutes, the resultant saturation permits a margin of four to six minutes for such an intubation to be safely completed without risk of the patient becoming hypoxic. Jean Allen, with almost 25 years of nursing experience in a surgical assistance career where she assists in 400 to 600 operations per year, observed Respondent during the entire intubation process, inclusive of the preoxygenation phase. Accepted medical practice after such an intubation requires that the person placing the tube then listen for breath sounds over each lung and over the area of the stomach. Respondent maintains that she did listen for those breath sounds with the aid of a stethoscope. The anesthesia record completed by Respondent has a notation "BEBS" for bilateral and equal breath sounds which Respondent testified that she heard with the stethoscope prior to administering additional sodium pentothal to the patient and inflating the cuff of the endotracheal tube. This testimony of Respondent is not credited in view of the testimony of Ms. Allen that she observed Respondent during this entire time and that Respondent did not listen for the breath sounds with a stethoscope prior to administering the additional sodium pentothal to the patient. Allen's testimony is also afforded the greater credibility due to her opportunity as a neutral witness to observe the events which transpired and her testimony that although she didn't observe Respondent closely after the additional sodium pentothal was administered, she maintained that she would have recalled Respondent's use of the stethoscope prior to that point. Notably, it is at that point prior to the administration of the additional sodium pentothal and inflation of the cuff of the endotracheal tube where Respondent maintains she listened for the breath sounds. Respondent, after completion of the placement of the endotracheal tube, administered additional sodium pentothal to the patient without listening for breath sounds; connected the tube to the anesthesia machine; and remarked that "it must be in place, the bag is moving" in reference to the bag on the anesthesia machine which generally inflates as the lungs of the patient deflate. While inflation or deflation of a breath bag on an anesthesia machine is one part of the procedure for checking placement of an endotracheal tube, the expert testimony of John Kruse, M.D., and David Alan Cross, M.D., establishes that this procedure alone is not a reliable method of determining proper tube placement. Frank Snydle, M.D., who had entered the operating room by this time in the sequence of events, did a manual vaginal examination of the patient, left the room, scrubbed his hands and returned. He then donned surgical gloves and gown, moved to the left side of the patient and prepared to proceed with the operation. Ms. Allen took her position at the foot of the table, between the patient's legs with an unobstructed view of Respondent. Dr. Snydle proceeded to make a small incision in the patient's abdomen through which he inserted a hollow, "Verres" needle. Carbon dioxide was then introduced to C.P.'s abdominalcavity to push the abdominal wall away from the internal organs. Next, a device known as a "trocar" and a "trocar sleeve" was inserted through the incision into the abdomen. The trocar was then withdrawn and a laparoscope was inserted into the sleeve. Built somewhat like a telescope with a built-in light source, the laparoscope permits the surgeon to look inside the abdomen and visually observe the patient's internal organs. During this procedure, Nurse Allen commented that she heard a sound like a fog horn or frogs croaking when she touched the patient's abdomen. Allen's remark is corroborated by Norma Masters and Dr. Snydle. The proof establishes, as corroborated by expert testimony of Dr. Kruse, that such sounds were associated with air, captured in C.P.'s stomach as the result of esophageal intubation, escaping from the stomach when pressure was applied. When Dr. Snydle made his first incision in the patient's abdomen, Allen observed that the blood was dark and Dr. Snydle agreed. Respondent inquired whether it could be venous blood. Snydle indicated he didn't think this was the case. Notably, the dark blood was observed, according to Respondent's medical records at 10:27 a.m. Further, Petitioner's experts, Dr. Kruse and Dr. Cross, based on their review of C.P.'s medical records, determined that the patient was initially intubated at approximately 10:15 a.m. Thus, approximately 12 minutes transpired from the beginning of the intubation process and conclusion of preoxygenation of the patient until the observation of dark bloodat the time of incision. After her inquiry regarding whether the blood could be venous, Respondent further responded that she was giving the patient 50 percent oxygen. She testified that she then increased the oxygen level to 100 percent. While the anesthesia record indicates administration of 100 percent oxygen, there is no time notation when this occurred. Blood again welled up from the incision and Nurse Allen commented that the blood appeared black. The less oxygenated blood becomes, the darker it appears. By this time, Dr. Snydle had inserted the laparoscope in C.P.'s abdomen. He observed that the internal organs were a "blueish color" ; an observation consistent with a decreasing level of oxygen in the patient's blood and an indication that the patient was hypoxic. When the patient's internal organs were discerned to be blue, Respondent asked Dr. Snydle to wait a moment and requested the assistance of Norma Masters, the circulating nurse. Masters came to the head of the operating table and was handed another endotracheal tube by Respondent. Respondent then began the process of intubating the patient with that tube through the mouth. The original nasal tube was left in place during the insertion of the second tube; an unheard of possibility, according to expert testimony, unless one tube was in the patient's esophagus and the other in the trachea. Nurse Allen's testimony establishes that the second tube, inserted via the patient's mouth, became foggy after insertion. The observation by Allen is consistent with experttestimony and establishes the fog was created by warm moist air from the patient's lungs flowing through the second tube. Respondent's testimony that she placed the second tube at the conclusion of the surgical procedure is not credited in view of the very clear, contradictory testimony of Masters and Allen that the endotracheal tube was replaced contemporaneously with the notation that the blood was dark and the patient's organs "blueish". After removal of the nasal tube and connection of the second tube to the anesthesia machine, Respondent manually squeezed the anesthesia bag to ventilate the patient. Dr. Snydle observed that the organs were turning pink again, and continued the procedure without further incident. After finishing the procedure, Snydle went out of the operating room, sat at a desk across the hall and began to write his orders. Following the procedure, the patient was wheeled to the recovery room, a short distance away. Nurses Allen and Masters did not see C.P. open her eyes during this process. Respondent's assertion that the patient opened her eyes and was responsive to commands is corroborated only by Dr. Snydle. However, while he noted in his operative report and his deposition that C.P. was awake following the operation, Snydle's observation is not credited in view of other proof establishing that his back was to the patient as she was wheeled past and that he assumed an awake state in the patient because Respondent was speaking to C.P. In view of the foregoing, Respondent's testimony that the patient was awake or responsive to commands following the surgery is not credited. After the patient was removed approximately 15 feet away to the recovery room, Respondent maintains that she informed Margaret Bloom, R.N., who was on duty there, that the patient's endotracheal tube was not to be removed, although she omitted telling Bloom about the dark blood incident. Bloom, who is also a certified registered nurse anesthetist, maintains that Respondent told her nothing about C.P.'s condition; instead, she went rapidly to the rest room in the lounge area. Bloom, left in the recovery room with the patient, then proceeded to hook up appropriate monitors and oxygen to the patient's endotracheal tube and began the process of monitoring C.P.'s vital signs. Bloom places the time of C.P.'s arrival time in the recovery room at approximately 11:05 a.m. The patient was not responsive to Bloom's spoken commands when brought to the recovery room. The patient appeared well oxygenated to Bloom; a judgement she made based on her observation of the color of C.P.'s lips and fingernails, since C.P. is a black female. Bloom rated C.P.'s circulation at twenty to fifty percent of preanesthetic pressure and determined the patient to be totally unconscious. Respondent returned to the recovery room at this time, told Bloom that she had done an "awake intubation" on the patient and that the tube should remain in place until Bloom determined that the patient was ready for it to be removed. Respondent then left the recovery room. As the result of blood tinged mucus filling the patient's endotracheal tube, Bloom removed the tube after thepatient registered breathing difficulties and attempts by Bloom to suction the mucus failed. She replaced that tube with a device known as an oral pharyngeal airway which goes in the patient's mouth and curves down the throat, holding the tongue forward. The device does not reach to the lungs. Shortly thereafter the patient began making glutteral noises and Bloom placed a venturi mask on the patient. The mask controlled the percentage of oxygen going to the patient, estimated by Bloom to be sixty to one hundred percent oxygen. The patient's breathing improved. Bloom completed replacement of the endotracheal tube with the airway device and mask shortly before Respondent again returned to the recovery room. Respondent, upset at Bloom's action in removing the endotracheal tube, proceeded to replace the oral airway device with a nasal tube. At 11:20 a.m., Bloom noted in her records that the patient's state of consciousness was unchanged. Later the patient made moaning sounds and was responsive to pain stimulation at approximately 12:20 p.m. Respondent concedes that C.P. suffered an hypoxic event at some point which resulted in damaged brain function. It is Respondent's position that such event occurred in the recovery room as the result of laryngospasm, occasioned by Bloom's removal of the endotracheal tube. Allen and Masters working in the operating room a short distance away testified that the sounds they heard emanating from the area of the recovery room were not the type of noise they associated with laryngospasm. Bloom, trained to recognize laryngospasm, testified that C.P. did not have sucha spasm. The expert testimony of David Cross, M.D., based on a study of arterial blood gases of C.P. following the surgery, establishes that the patient suffered an hypoxic episode too severe and too protracted to have been the result of a possible laryngospasm in the recovery room and that, in his expert opinion, she did not have a recovery room laryngospasm. Respondent's defense that C.P.'s survival of such a lengthy esophageal intubation in the operating room is an impossibility, is not persuasive. The opinion of Respondent's expert, Dr. Gilbert Stone, that no esophageal intubation occurred in the operating room is predicated on his belief that the tube was not changed during the surgery. Dr. Stone conceded that replacement of the tube during surgery at the time the dark blood was noticed with resultant improvement in the patient's condition permits a conclusion that esophageal intubation was the cause of the hypoxia. Testimony of Petitioner's experts, Dr. Cross and Dr. Kruse, are consistent in their conclusions that C.P. was esophageally intubated by Respondent, although they differ in their reasons for C.P.'s survival of the event. The opinion of these experts, coupled with the eye witness testimony of Allen and Masters, further support a finding of Respondent's esophageal intubation of the patient in the operating room and that she failed to recognize such intubation in a timely manner as a reasonable and prudent physician should have. The expert opinion testimony of Dr. Cross establishes that C.P. was intubated in her esophagus and survivedas a result of oxygen, going into her stomach under pressure, being forced back up her esophagus into the pharynx and then drawn by negative pressure into the lungs. This resulted in a effect similar to, but not as efficient as, the technique known as apneic oxygenation. The technique, once used to provide marginally adequate oxygen levels to maintain a patient's neurological and cardiac status, has fell into disfavor since patients suffered from respiratory acidosis due to the buildup of carbon dioxide in the lungs. Cross also pointed out that the heart can function for a much longer period of time without adequate oxygen than is possible for the brain. Cross's testimony provides an explanation for C.P.'s neurological damage without similar cardiac impairment. Cross also noted that the preoxygenation process which C.P. initially underwent after entering the operating room added to the time she was able to undergo oxygen deprivation before the onset of tissue damage. Respondent notes the discovery of a tumor in C.P.'s throat some months later as a possible contributor to the patient's hypoxic event during surgery. Another of Respondent's experts, Dr. Deane Briggs, an otolaryngologist specializing in diseases of the ears, nose and throat, treated C.P. in October of 1985, following the August, 1985 surgery. He discovered the existence of a sub-glottic tumor in the patient's throat. However, the existence of the tumor at the time of the initial surgery is not established. Testimony of anesthesiologist experts, including Respondent's own expert, Dr. Stone, do not support a finding that the tumor, if itexisted, had any effect during the operation. Further, Dr. Briggs' opinion that Respondent probably intubated the patient's right stem bronchus, as opposed to the esophagus, and that neurological damage therefore occurred in the recovery room is not credited in view of the conflict of this testimony with that of other witnesses and expert opinions. A finding that C.P.'s neurological impairment following surgery may have been exacerbated by a possible laryngospasm in the recovery room is relevant only with regard to mitigation of the severity of penalty to be imposed for Respondent's misconduct. Respondent's esophageal intubation of the patient in the operating room, and the resultant hypoxic event are established by clear and convincing evidence. The fact that C.P. suffered brain damage is undisputed by the parties. The proof clearly and convincingly establishes that the severe and protracted hypoxic episode sustained by the patient resulted not from a possible mild recovery room laryngospasm, but from Respondent's esophageal intubation of that patient in the operating room. It is concluded with respect to treatment of C.P., Respondent failed to practice medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Respondent failed to keep medical records which justified her course of treatment of the patient, C.P. This finding is based upon the testimony of Dr. Cross that Respondent'smedical records did not justify her course of treatment, as well as the testimony of Respondent's expert, Dr. Stone. While testifying that he did not believe Respondent had intubated the patient's esophagus, Stone also acknowledged that Respondent's records would be inadequate if such had indeed occurred.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered for Respondent's violation of Section 458.331(1)(t), Florida Statutes, placing Respondent's license on probation for a period of three years upon terms and conditions to be determined by the Board of Medicine, including, but not limited to, a condition requiring Respondent's participation in appropriate continuing medical education courses; and imposing an administrative fine of $2,000. IT IS FURTHER RECOMMENDED that such Final Order impose a penalty for Respondent's violation of Section 458.331(1)(m), Florida Statutes, of an administrative fine of $500 and a letter of reprimand. DONE AND ENTERED this 28th day of August, 1989, in Tallahassee, Leon County, Florida. DON W.DAVIS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Fl 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of August, 1989. APPENDIX The following constitutes my specific rulings, in accordance with Section 120.59, Florida Statutes, on findings of fact submitted by the parties. Petitioner's Proposed Findings. 1.-28. Accepted. 29. Unnecessary to result. 30.-31. Accepted. 32.-34. Adopted by reference. 35.-61. Adopted in substance. 62. Unnecessary to result. 63.-68. Adopted in substance. 69.-87. Adopted by reference. Respondent's Proposed Findings. 1.-3. Rejected, not supported by the evidence. 4.-5. Rejected, not supported by the evidence, Further, proposed findings that records were adequate constitute legal conclusions. 6. Rejected, not supported by the evidence. COPIES FURNISHED: David G. Pius, Esq. Department of Professional Regulation The Northwood Centre, Suite 60 1940 N. Monroe St. Tallahassee, FL 32399-0750 Sidney L. Matthew, Esq. Suite 100 135 South Monroe St. Tallahassee, FL 32302 Kenneth Easley, Esq. General Counsel Department of Professional Regulation The Northwood Centre, Suite 60 1940 N. Monroe St. Tallahassee, FL 32399-0750 Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation The Northwood Centre 1940 N. Monroe St. Tallahassee, FL 32399-0750
Findings Of Fact The Petitioner is the Department of Professional Regulation, Board of Nursing. The Petitioner regulates the practice of nursing pursuant to section 20.30, and Chapters 455 and 464, Florida Statutes. The Respondent, McDonald Knights, is a registered nurse and holder, at all times pertinent to these proceedings, of license number 1715572. He received his formal training in England and became licensed in the State of Florida by endorsement on or about May 5, 1986. At all times material to these proceedings, the Respondent was employed as a registered nurse assigned to work in the surgical cardiac care unit at Cedars of Lebanon Medical Center in Miami, Florida. Francesco Garofalo was a patient in the coronary care unit of the medical center on March 8, 1987, awaiting cardiac aortic bypass surgery the next morning as a result of acute myocardia infarction. He was being intravenously infused with two medications, lidocaine (for arrhythmia) and nitroglycerin (for pain). The medications were applied through continuous intravenous infusion at separate injection sites and through separate volumetric pumps. At approximately 7:45 p.m., the alarm sounded on the volumetric pump responsible for discharging the nitroglycerin intravenous infusion. The Respondent answered the alarm and noted the container of nitroglycerin was empty. Since the previous shift had not provided a back up container of the medication, it was necessary for Respondent to order a replacement be delivered from the unit's pharmaceutical supply. While awaiting delivery of the medication, the Respondent started a dextrose solution running into the patient to prevent the injection site from closing. At this time, the patient complained of pain at the site of his other intravenous injection for lidocaine. The Respondent determined that this injection site had been infiltrated with the lidocaine solution leaking into the subcutaneous tissue of the patient's arm, resulting in discomfort to the patient. The Respondent decided a new site should be secured. In the process of securing a new site for the lidocaine infusion, the Respondent removed a manual plunger apparatus termed a "cassette" from the volumetric pump. This action effectively discontinued the function of the pump. After inserting the needle in the new venous site, Respondent manually operated the plunger apparatus to insure that the line was open and effectively discharging a smooth flow of lidocaine medication into the patient's body. He did not establish a rate of flow for the medication into the patient's body beyond cutting down the manual flow to an amount equal, in his opinion, to 10 to 20 drops per minute. At this point, the Respondent went to take a telephone call and left the patient's care to another nurse who had entered the room. The time was approximately 7:47 p.m. Cordette Steer is a registered nurse with twenty years experience. When she entered the patient's room to allow the Respondent to take the telephone call, she received no instruction from the Respondent. She did not know the medication being injected was lidocaine. Due to the toxic nature of lidocaine and her observation that the volumetric pump for administering this medication had been effectively bypassed, Steer assumed the Respondent had hung a harmless saline or dextrose solution to keep the vein open for the injection. She proceeded to apply tape to secure the needle at the injection site because, as she testified, "nobody would expect lidocaine to be infusing off of the pump, this is something that is never done." At 7:50 p.m., the patient complained of chest pain. Steer was aware of the exhaustion of the patient's nitroglycerin and that a new bag had not yet arrived from the pharmacy. She stepped from the room and returned almost immediately with nitroglycerin tablets which she gave to the patient to relieve his chest pain. He shortly began to exhibit seizure symptoms commonly associated with lidocaine toxicity. Code Blue was sounded. The Respondent was among those personnel responding. He disconnected the lidocaine infusion, stopping the flow of lidocaine to the patient. The time was 7:55 p.m. Resuscitation attempts failed and the patient subsequently expired at approximately 8:30 p.m. Nancy Cox is a critical care educator employed with the Miami Children's Hospital. She is an expert in the fields of surgical and cardiac critical care. She reviewed the medical records pertinent to this proceeding and her expert testimony establishes that: Lidocaine is an extremely toxic medication which can be fatal if the volume administered to a patient is not closely controlled. The dosage the patient should have been receiving was 15 cubic centimeters per hour or approximately three teaspoons per hour. The volumetric pump sets the rate of delivery of an intravenous drug with a finite, or high, decree of accuracy. When the pump is turned off, with the cassette in place, the flow of medication is stopped. When the cassette is removed from the pump device, an open flow is established and the pump fails to act as a regulator. Finite control of drug administration is not possible manually, as was attempted by the Respondent in this case, without taking considerable time to adjust the rate of flow in concert with timed intervals. Even when this is done, the plunger may spring open and allow a greater than desired drug flow. The Respondent should not have established a smooth flow of lidocaine, but rather a dripping or slow rate of infusion. The Respondent deviated from accepted minimal standards of cardiac or critical care nursing when he used the lidocaine solution to initially infuse at an open, unregulated rate in order to determine if the new injection site was functioning as opposed to establishing a patent intravenous route by either injecting saline via a syringe into the catheter, or connecting a bag of a saline or dextrose solution to the catheter for this purpose and then allowing it to infuse, prior to re-connecting the lidocaine. The Respondent also deviated from accepted minimal standards of acceptable and prevailing nursing practice by not informing Cordette Steer that lidocaine was being administered intravenously to the patient without the use of the volumetric pump.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Nursing enter a final order finding the Respondent guilty of the offense charged in the administrative complaint, suspending his license for a minimum period of one year with probationary reinstatement thereafter conditioned upon 1) a showing by the Respondent that he has enrolled and completed continuing education courses, as deemed appropriate by the Board, in the area of cardiac critical care with an emphasis on intravenous medication applications, and 2) he agrees to comply with reasonable terms and conditions of the Board for a subsequent probationary period of two years. DONE AND RECOMMENDED this 22nd day of April, 1988, in Tallahassee, Leon County, Florida. DON W. DAVIS Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of April, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-5633 The following constitutes my specific rulings, in accordance with requirements of section 120.59 Florida Statutes, on proposed findings of fact submitted by the parties. PETITIONER'S PROPOSED FINDINGS Included in finding number 2. Included in finding number 2 Rejected as unnecessary. Including in finding number 2. Included in finding number 3. Included in finding number 4. Rejected as unnecessary. Included in finding number 4. Included in finding number 7. Rejected as unnecessary. Rejected as unnecessary. Included in finding number 4. Included in finding number 4. Rejected as unnecessary. Rejected as unnecessary. Rejected as unnecessary. Rejected as unnecessary. Included in finding number 6. Included in finding number 6. Included in finding number 5. Included in finding number 6. Included in finding number 6. Included in finding number 6. Included in finding number 6. Included in finding number 6. Patient was pronounced officially dead at 8:52 p.m., but Respondent testified that death occurred earlier. Included in finding number 7. Included in finding number 7. Included in finding number 5. Included in finding number 7. Rejected as unnecessary. Rejected as unnecessary. Rejected as unnecessary. Included in finding number 7. Included in finding number 7. Included in finding number 5. Included in finding number 7. Rejected, not supported by the evidence. Included in finding number 7. Rejected as unnecessary. Included in finding number 7. Included in finding number 6. Rejected as a conclusion of law. COPIES FURNISHED: Lisa M. Bassett, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William E. Hoey, Esquire 2398 South Dixie Highway Miami, Florida 33133-2399 William O'Neill, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Judie Ritter Executive Director Department of Professional Regulation Room 504, East Coastline Drive Jacksonville, Florida 32201
The Issue The issue is whether Respondent's license as a medical doctor should be disciplined for the reasons given in the Administrative Complaint filed on October 25, 2000.
Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Background At all times material hereto, Respondent, David Lowell Williams (Respondent or Dr. Williams), was a licensed medical doctor having been issued license number ME 0035686 by Petitioner, Department of Health, Board of Medicine (Board). The Board is charged with the responsibility of regulating the practice of medicine in the State of Florida. Respondent is board-certified in cardiovascular disease and internal medicine and has practiced his specialty in Ormond Beach, Florida, since 1983. In 1990, Respondent accepted a position as a cardiologist with Florida Health Care Plan, Inc. Except for the charges raised in this proceeding, there is no evidence that Respondent has ever been involved in a prior disciplinary action. Based on a complaint filed with the Board by an attorney representing the family of a former patient, S.T., on October 25, 2000, the Department of Health, acting on behalf of the Board, filed an Administrative Complaint against Respondent generally alleging that in April 1995 he had failed to practice medicine with the level of skill and care required of a reasonably prudent physician, and that he failed to keep written medical records justifying the course of treatment of S.T. Respondent has denied the charges and contends that he practiced medicine within the standard of care and that the documentation related to the patient justified the course of treatment. In determining whether a deviation from the appropriate standard has occurred, the undersigned has considered the conflicting testimony presented by the witnesses and has accepted the more credible evidence, as reflected in the findings below. In doing so, the undersigned has discounted Petitioner's contention that Respondent's expert, Dr. Henderson, is a close friend of Respondent and therefore his testimony is clearly biased. Although the two once practiced together for a few years in the 1980's, Dr. Henderson acknowledged that they "don't get along very well right now." The treatment of the patient Over a period of years, S.T. was treated by several doctors, including Respondent, who participated in the Florida Health Care Plan, Inc. network. The medical records for that treatment have been received in evidence as Joint Exhibit No. Because they are not in chronological order, contain matters relating to treatment by physicians other than Respondent, and include some partially illigible pages, the records are somewhat difficult for the reader to navigate. They do show, however, that S.T. occasionally cancelled appointments, would not always accept his doctor's advice, sometimes refused to take prescribed medications, and was perhaps not totally candid at all times with the treating physician regarding his symptoms. The records reflect that Respondent first began treating S.T. on March 29, 1989, on referral from his primary care doctor, Dr. Moussly, due to complaints of "burning in chest with exercise." S.T., then a sixty-year-old male, underwent a stress test on the treadmill which was terminated after three and one-half minutes due to fatigue and shortness of breath. The test revealed "significant ST segment depression" and was consistent with ischemia (inadequate blood flow to the heart). Respondent prescribed Lopressor (a beta- blocking agent used in the treatment of hypertension and angina) and a Nitro-patch (transdermal nitroglycerin delivery system). Dr. Williams also recommended that the patient have a cardiac catherization. Even though the records show that the patient was "reluctant to do this at this point in time," they indicate that a coronary angiogram was performed by Respondent on April 26, 1989, and that "a high-grade stenosis of approximately 90 [percent] . . . with deeply ulcerated plaque" was exhibited in the left anterior descending artery. S.T. was again referred by Dr. Moussly to Respondent on March 7, 1990, "on an urgent basis." However, S.T. cancelled his appointment and accepted another appointment on April 4, 1990. Despite the urgency of the referral, S.T. reported to Dr. Williams that he was doing well with no symptoms since his last visit one year earlier. His records reflect that his blood pressure was 136/86, his weight 258, his pulse was 60 and regular, his lungs were clear, and a cardiovascular examination was unremarkable. Dr. Williams concluded that S.T. was stable at that time with minimal chest discomfort, and he recommended that S.T. undergo a routine treadmill exercise test to further evaluate his coronary heart disease. A stress test was performed on May 11, 1990, but it was terminated after three minutes due to shortness of breath. Another stress test was conducted on July 5, 1990, the results of which were "significant for ischemia." Although a cardiac catherization was recommended, "[t]he patient again refuses at this point in time." On May 1, 1991, S.T. was again seen by Respondent (after cancelling an earlier appointment) at which time he indicated he was feeling well and was essentially asymptomatic. He specifically denied having any shortness of breath, light-headedness, dizziness, or chest pain, and he reported that he had skipped taking his prescribed Cardizem on numerous occasions without undergoing any significant change in his symptoms. On that date, his blood pressure was 150/90, his weight 259, his lungs were clear, and the cardiovascular examination revealed no murmur. Dr. Williams concluded that the patient "seems to be stable at this point in time," and allowed S.T. to discontinue Cardizem as a therapeutic trial, and if he had no further symptoms, he would continue on Lopressor only. Otherwise, he would need to start up on that medication again. Finally, Dr. Williams offered S.T. the opportunity to participate in a beta blocker angina trial for which he would be evaluated the following week. The patient apparently declined this offer. The patient did not return to Respondent's office until December 21, 1994, or more than three years later, after he was given a "[r]outine referral for a stress test" by Dr. Moussly. S.T. had seen Dr. Moussly on a "routine followup" on December 1, 1994, at which time he denied having chest pain or shortness of breath. On his visit with Respondent, S.T. underwent another treadmill test that was terminated after two minutes due to the development of ST- segment depression. S.T. also experienced tightness in his chest. The treadmill tests were positive for ischemia "at low exercise tolerance." Based on the above results, S.T. agreed to undergo cardiac catherization. On December 28, 1994, Respondent performed the cardiac catherization on S.T., which revealed that the main coronary artery was very short, but was essentially normal. The left anterior descending artery (one of the three main arteries to the heart) exhibited a proximal 90 percent stenosis (stricture of a canal or narrowing of a cardiac valve). A second 75 percent stenosis was present in the distal portion of the artery. No other significant lesions were noted. The left circumflex artery was a large and dominant system. A stenosis in the distal portion of the parent circumflex of approximately 30 percent was present with no other significant lesions noted. The right coronary artery was a nondominant artery with no significant lesions noted. Based upon the results of the cardiac catherization, Dr. Williams concluded that P.T. demonstrated mild coronary artery disease in the left circumflex artery and "rather severe disease" in the left anterior descending artery. Respondent advised S.T. that he was a candidate for angioplasty (reconstitution or recanalization of a blood vessel) of the left anterior descending artery. On January 4, 1995, Respondent performed the angioplasty of S.T.'s left anterior descending artery, which contained two lesions. The proximal lesion was reduced from approximately 95 percent stenosis to around 10 percent, and the distal lesion was likewise reduced from approximately 75 percent stenosis to around 10 percent. On February 8, 1995, S.T. made a follow-up visit to Respondent's office. According to the patient notes, S.T.'s vital signs were normal, and he stated that he was "doing very well." Respondent's plan of treatment was to have him follow- up on an as-needed basis. In addition, Respondent discussed the "signs and symptoms of recurrence of chest discomfort" and the importance of stopping smoking as well as having good dietary practice and daily exercise. On March 7, 1995, Dr. Moussly again referred S.T. to Dr. Williams for a stress test due to the patient's "having very non[-]specific chest discomfort; non[-]exertional, non[-] radiating [pain that was] apparently . . . different than the pain he had prior to his angioplasty." Dr. Moussly also noted in his records that even though the patient had elevated cholesterol, he refused to take Pravachol, which had been prescribed by Dr. Moussly on December 1, 1994. Pursuant to the referral, on March 15, 1995, S.T. made a follow-up visit to Respondent complaining of "chest discomfort." He underwent another treadmill test which was terminated after three minutes due to chest discomfort and ST- segment depression. The test was positive for ischemia, which meant that restenosis of an artery had likely occurred. Respondent recommended repeat cardiac catheterization and angioplasty. Given S.T.'s age, progression of disease, and risk factors, which included "virtually every one known to man," restenosis was not particularly surprising since Respondent's expert established that "the restenosis rate for this [type of] patient was probably in excess of 50 percent." On March 17, 1995, Respondent performed a second angioplasty of S.T.'s left anterior descending artery and reduced the stenosis from 75 percent to 10 percent in both the proximal and distal lesions. There were no complications from this procedure, which S.T. tolerated well. On April 3, 1995, S.T. visited Respondent's office for a follow-up at which time he complained of chest discomfort. At that time, S.T. was "very vague about his discomfort" in terms of how often it occurred, how long it lasted, whether there were accompanying symptoms present, and whether the Nitroglycerin provided relief. S.T. did acknowledge, however, that the discomfort was "very infrequent." The records for that visit read as follows: Mr. T. since his last visit is having some chest discomfort, although, it has been better. He has taken some sublingual Nitroglycerin on a number of occasions, but is unable to recall exactly how often. His episodes are not exertionally related, different in type and severity than prior to his angioplasty. I feel he may be having coronary spasm, although, I cannot totally rule out restenosis. In any event, his symptoms are relatively mild. I have asked him to continue as we're doing. He wil [sic] return in two more weeks for follow-up examination. I have asked him to call should he get worse and he has, otherwise, been asked to keep a diary so that we can more objectively quantify his Nitroglycerin usage. Although S.T.'s vital signs are not recorded in the above note, Dr. Williams performed a physical examination of the patient that day, and he recorded the vital signs on a separate office record entitled "Vital Sign Sheet." He also maintained a separate patient medication chart, which reflected the various medications taken by all his patients; however, due to its age, that chart has been purged in the normal course of business. A stress test was not ordered by Respondent since he considered the patient's chest discomfort to be "very mild," and the patient described the pain as "completely different" than his previous angina. Also, the pain was not exertionally related, and restenosis was unlikely "at this early date following an angioplasty." Dr. Williams concluded that more than likely the pain was a coronary spasm (a muscular contraction of the wall of the artery), which typically occurs up to 30 to 60 days after the procedure, and he would wait "to see if [the symptoms are going] to go away . . . [w]hich they frequently do after an angioplasty." Finally, Respondent noted that the cardinal indicators of ischemic heart disease (a blockage) were not present - - exertional pain, relief from Nitroglycerin, and a similarity with pain experienced before the angioplasty was performed. He accordingly advised S.T. to continue his present course of treatment and to follow-up in two weeks, or if his condition worsened, to return sooner or go to an emergency room. On Friday, April 7, 1995, S.T. went to the Halifax Hospital Emergency Room in Daytona Beach, Florida, complaining of chest pressure, accompanied by an episode of dizziness, weakness, diaphoresis, and nausea. He also advised that he had been taking several Nitroglycerines on a regular basis. Respondent was not present at the facility, and was not the on-call cardiologist on this date. S.T. was seen by Dr. David E. Stibbins, who observed that S.T. was bradycardic and had low blood pressure. Like the information given to Dr. Williams on April 3, here the patient gave vague information regarding his chest discomfort. The records suggest that Dr. Stibbins opined that the patient's discomfort was not cardiac related and was probably due to anxiety. A cardiac consultation was requested, but not conducted, and S.T. was kept in the hospital overnight for observation. Around 1:15 a.m., S.T. reported a few "twinges" in his chest to the nurse, but he told her the pain was not serious enough to wake up his doctor. After denying that he had experienced any chest pain other than the few twinges described above, on the afternoon of April 8, 1995, S.T. was discharged from the hospital in stable condition (without ever being seen by a cardiologist) and advised to follow-up with Respondent in two days (the following Monday). On Sunday, April 9, 1995, the patient suffered a cardiac event and expired. The cause of death on his certificate of death is probable sudden death as a result of coronary artery disease, but neither expert in this case could give a precise reason for S.T.'s demise. The standard of care In the aftermath of an angioplasty, a variety of things can occur causing chest discomfort in the patient. While the beneficial effects of an angioplasty "can last . . . [up] to 20 years," three to five percent of patients experience an acute closure within a matter of minutes or hours, which is the sudden and complete obstruction of the artery. Because of this risk, after a procedure is performed, patients are kept in the hospital at least over night for observation. An acute closure often occurs in patients with a 70 to 80 percent narrowing of the artery. During the first few weeks after a procedure, acute thrombosis to the vessel at the site of the injury sometimes occurs, but a patient with that condition would experience "intense discomfort that's exactly the same as the patient's pre-intervention discomfort." Without such symptoms, that diagnosis would be "down [on] the list of considerations" by the treating physician. Between six and eight weeks and four months after the procedure, up to a third of balloon angioplasty patients experience a subacute closure (or restenosis) of the artery. Typically, these patients return to the physician's office with clinical symptoms of angina chest pain (similar to that experienced before the procedure) and require a repeat procedure. If restenosis has occurred, the patient is at risk for additional cardiac complications, such as myocardial infarction (heart attack). In some cases, within 30 to 60 days after a procedure, a patient will experience a "different type of sensation" in the chest due to the mechanical stretching of the vessel wall during the procedure. Other patients experience an artery spasm (cramping of the vessel wall), which occurs when the muscle cells go into spasm and constrict the artery. In both of these situations, the discomfort is dissimilar to that experienced before the procedure. Given the foregoing, if a patient presents himself to the doctor within a matter of weeks after an angioplasty with vague, non-ischemic related chest discomfort, it is not a deviation from the standard of care for the physician to choose a course of treatment consisting of "medical management" of the patient, that is, the close monitoring of the patient in the following days and weeks, and treating the patient with beta blockers, nitrates, and aspirin to ameliorate his symptoms. Conversely, if a patient presents himself to the physician with chest discomfort which is ischemic in nature, the ordering of further tests, including an exercise EKG, would be appropriate, with possible referral to a hospital for another cardiac catherization. Other considerations in determining the appropriate course of treatment of a patient include the cardiologist's familiarity with the patient's prior symptoms and history and the symptoms presented at the current time. In addition, the physician must rely upon his experience, knowledge, and education in the field. Taking into account all of these circumstances and considerations, the more convincing evidence establishes that Respondent did not deviate from the standard of care. c. The adequacy of the patient's records The Board has also alleged that Respondent failed to keep adequate medical records on the April 3, 1995, office visit in that he failed to document a physical examination or the results of any ancillary tests, and that the records as a whole fail to justify the course of treatment of the patient. The criticisms of Dr. Williams are based upon the testimony of the Board's expert, Dr. Dormois, who presented deposition testimony in this matter. In his deposition, however, Dr. Dormois withdrew his earlier criticisms of the records, and he indicated that the records provided by Dr. Williams "are generally adequate." He also concluded that this case "is not an issue of a medical record deficiency," but rather is "a deficiency of [a] failure to make clinical decisions." When these admissions are coupled with the testimony of Dr. Henderson, who concluded that the records were adequate, it is found that the Respondent kept written medical records justifying the course of treatment of the patient.
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, with prejudice, the Administrative Complaint. DONE AND ENTERED this 30th day of August, 2001, in Tallahassee, Leon County, Florida. ___________________________________ DONALD R. ALEXANDER 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 30th day of August, 2001. COPIES FURNISHED: Kim M. Kluck, Esquire Agency for Health Care Administration Post Office Box 4229 Tallahassee, Florida 32317-4229 Michael R. D'Lugo, Esquire Wicker, Smith, Tutan, O'Hara, McCoy, Graham & Ford, P.A. Bank of America Center, Suite 1000 390 North Orange Avenue Orlando, Florida 32802-1646 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701
