The Issue Whether disciplinary action should be taken against Respondent's license to practice as a physician, license number ME 67443, based on a two-count violation, Sections 458.331(1)(m) and (t), Florida Statutes, as alleged in the Administrative Complaint filed against Respondent in this proceeding.
Findings Of Fact Based on the evidence and the testimony of witnesses presented in this proceeding, the following facts are found: Respondent is, and has been at all times material hereto, a licensed physician, having been issued license number ME 67443 by the State of Florida. At all times material hereto, Respondent practiced as an emergency room physician. When treating a patient, an emergency room physician has a duty to rule out the most serious life- threatening conditions. Pulmonary embolism is a blood clot, which forms in or travels to the lungs. It is a life-threatening condition. A thrombus is a blood clot that forms at a particular site, while an embolus is a piece of a thrombus that breaks off and wedges itself in another artery. The most common type of thrombus that causes pulmonary embolism is a deep vein thrombus, which originates in the lower extremities (legs). Once a thrombus forms in the leg, an emboli can break off from the thrombus, travel through the bloodstream and wedge itself in the lungs, creating a pulmonary embolism. On June 13, 1995, Patient R.D. presented to the emergency room of the Daytona Beach Medical Center in Daytona Beach, Florida, at approximately 7:35 p.m. Patient R.D. was a 41 year-old obese male who weighed 305 pounds. Patient R.D. presented to the emergency room complaining of chest pain (rated 3-4 on a scale of 10) and shortness of breath beginning at 8:30 a.m. that day. The patient was seen by a nurse who prepared a "triage nursing assessment." The nurse documented the following about Patient R.D.: Chief complaint of nausea and diaphoresis (cold sweat) earlier in the day; pulse rate of 112, which indicated tachycardia; elevated respiratory rate of 28; labored breathing; clear breath sounds; and trace pedal edema. The "Implementation: Nursing Action" noted that Patient R.D. had marked dyspnea (labored breathing). He was immediately placed on oxygen. At 7:40 p.m., Respondent, the emergency room physician on duty, examined Patient R.D. During Respondent's subjective examination of Patient R.D., Respondent documented: Chest pain all day, heaviness in the center of the chest with some nausea, negative vomiting; negative numbness and sweating; negative history of this [sic]; positive shortness of breath all day with chest pain, but can work; negative history of asthma; negative history of heart disease; family history positive for cardiac disease (mother in her 60's); social history (smoked a joint 24 hours ago). The patient reported that despite his complaints, he was still able to work. Patient R.D. was obese and had recently smoked marijuana, two of the secondary risk factors associated with pulmonary embolism. Patient R.D. did not present to Respondent with the classic signs and symptoms of pulmonary embolism. While taking Patient R.D.'s history, Respondent did not document any history of cholesterol levels, cigarette smoking, recent leg injury, prior blood clots, or sedentary time periods. Respondent failed to document important aspects of Patient R.D.'s family and social history. Respondent failed to adequately document the history taken. Respondent performed a complete physical examination of the patient, including an examination of his legs. During Respondent's objective examination of Patient R.D., Respondent documented: lungs clear to auscultation (no rattles or wheezing) with good alveolar BS bilaterally; cardiac S1S2 and distant; abdomen obese and negative tender; legs with 1+ pedal edema; negative CVA tender (no tenderness over kidneys); no nuchal rigidity (no neck stiffness). The patient had no diaphoresis in the emergency room. Respondent then ordered a chest X-ray, an electrocardiogram (EKG), blood work (CBC), and electrolyte panel and cardiac enzymes. Respondent also had a pulse oximetry performed. Major risk factors of pulmonary embolism include: history of malignancy, recent leg injury, prior blood clots including deep vein thrombosis, and sedentary time periods. Secondary risk factors include: obesity and smoking, including marijuana smoking, and elevated cholesterol levels. The signs and symptoms of pulmonary embolism include, but are not limited to, shortness of breath, chest pain or pressure, diaphoresis (sweating), increased respiratory rate, and tachycardia (abnormal rapid heart rate). Although Respondent testified that he considered pulmonary embolism as one of his top five differential diagnoses, the patient's clinical signs and symptoms were insufficient for Respondent to have to rule out a pulmonary embolism. As the signs and symptoms of a pulmonary embolism can wax and wane, it is not an easy diagnosis to make. When examining the legs of a patient suspected of having a pulmonary embolism, the standard of care requires a physician to look for swelling, edema, tenderness and a cord, which would be a clotted vein. In order to determine tenderness, a physician must palpate the legs of the patient. Also, when examining the legs, a physician should perform an examination by stretching the calf to look for tenderness (called Homan's sign). Respondent performed a palpation of the patient's legs, but did not perform an examination for Homan's sign. Respondent's physical examination of Patient R.D. was adequate under the circumstances. The standard of care requires that a physician document pertinent positives and negatives in the medical records. Swelling, edema, tenderness and results of palpation are pertinent positives and negatives. Although Respondent performed an adequate physical examination of Patient R.D., Respondent failed to adequately document the physical examination. In this case, the pertinent positives or negatives should have included the results of the leg examination including, but not limited to, swelling, tenderness, palpation for cords and tenderness, and motion of the foot. Specifically, Respondent did not document whether he palpated the legs of Patient R.D., or whether the examination revealed any swelling or tenderness in the legs. Moreover, Respondent did not document Patient R.D.'s respiratory status. Also, Respondent did not document any history of deep vein thrombosis (DVT), which is a pertinent positive or negative. An EKG reveals the rhythm of the heart. Respondent ordered an EKG and reviewed the computer printout of the EKG results, which revealed non-specific ST changes. Respondent noted the non-specific ST changes in his notes. The EKG also revealed sinus tachycardia and S1-Q3-T3 changes. Tachycardia on an EKG is abnormal, unless the cause is determined. In order to treat tachycardia, a physician must determine the underlying cause, which directs the physician to the appropriate treatment plan. Respondent did not determine the underlying cause of Patient R.D.'s tachycardiac condition. S1-Q3-T3 reveals a strain on the right side of the heart. Respondent did not document the tachycardia or S1-Q3-T3 changes, or determine their underlying cause. Respondent did not recommend admission for Patient R.D. even though Patient R.D. had an abnormal EKG. Respondent also ordered blood work, a chest X-ray, and a pulse oximeter test. Respondent and the Radiologist interpreted the chest X-ray as negative. The patient's pulse oximeter initially revealed a 91 percent rating, a subsequent pulse oximeter revealed a 92 percent. A 91-92 percent pulse oximeter is low in a 41 year-old male, unless the patient has a long standing history of chronic lung disease. Respondent did not order arterial blood gases or a lung scan for Patient R.D. An arterial blood gas test is more accurate than a pulse oximeter. Respondent should have ordered an arterial blood gas only if the pulse oximeter did not improve. After the breathing treatment, Patient R.D.'s pulse oxmeter was 96 percent, which is a significant improvement. A physician must order a lung scan after looking at a constellation of all factors put together, including increased heart rate, low pulse oximeter, increased respiratory rate, abnormal EKG and symptoms of chest pain and shortness of breath. Respondent did not order a lung scan for Patient R.D., even though it could have been ordered. A lung scan is the standard regimen for diagnosing a pulmonary embolism. At approximately 8:00 p.m., Patient R.D. was nauseated and vomited light green bile. Respondent treated Patient R.D. with Proventil, a nebulizer, which is used to treat and relieve bronchospasms. Patient R.D. felt better after the Proventil treatment. Respondent diagnosed Patient R.D. with Hyperactive Airway Disease and Diabetes. Although an emergency room physician does not admit patients, an emergency room physician can recommend to the private physician that a patient be admitted for further evaluation. A private physician relies heavily on the information presented by the emergency room physician. If the private physician disagrees with the emergency room physician recommendation, then the private physician must come to the hospital to personally examine and discharge the patient. Respondent contacted the patient's family physician, advised him of the patient's condition, but did not recommend Patient R.D. be admitted. In the early morning hours of June 14, 1999, Patient R.D. died as a result of a bilateral pulmonary embolism. Respondent's care and treatment of this patient was supported by the testimony of two experts. They indicated that the major risk factors for pulmonary embolism are malignancy, surgery or any trauma to the long bones; none of which were present in this case. The secondary risk factors are pregnancy, cigarette smoking and obesity. Pulmonary embolism is seen most often in orthopaedic surgery patients and, secondarily, in patients with fractured long bones or multiple trauma including the lower extremities. The only sign and symptom that is seen with any regularity in the presentation of pulmonary embolism patients is shortness of breath. Other signs and symptoms occur with such infrequent regularity as to be non-specific and can occur in a plethora of other illnesses. Patient R.D. did not have any of the primary risk factors for pulmonary embolism and any reasonable physician would not think of pulmonary embolism as a primary diagnosis or even as a conceivable diagnosis in a patient with these present symptoms. The experts agree that Patient R.D.'s relatively minor complaints of shortness of breath would have even given Respondent a clinical suspicion of pulmonary embolism. When examined, Patient R.D. was not diaphoretic or apprehensive, had normal color, with skin warm to the touch. The patient simply did not present as one in acute distress secondary to sudden pulmonary embolism as the Petitioner contends. At discharge the patient had improved so significantly that his oxygen saturation rate was near normal and respiration rate near normal. Dr. R. Latanae Parker had reviewed the autopsy and drew several conclusions from it. He interpreted the medical examiner's microscopic examination of the clot to indicate that they were "fresh" and mobilized within minutes of death. Dr. Parker testified that this patient died of a sudden death by a sudden pulmonary embolism that was massive enough to occlude blood flow such as there was not adequate profusion to the coronary system and to the cerebral system. Based on Patient R.D.'s condition before discharge from the emergency department, Dr. Parker testified it was not necessary for Respondent to have pulmonary embolism as one of his differential diagnoses or to have otherwise ruled out that condition. Petitioner has presented no credible testimony which would establish that the deep vein thrombosis (DVT) seen on autopsy was diagnosable in the emergency room by gross exam, palpation or otherwise. The DVT seen on autopsy was silent and, therefore, undiagnosable in the emergency room as Patient R.D. did not have a history of trauma, swelling, inflammation or discoloration of his lower extremities. The autopsy supports Dr. Parker's testimony because the leg circumferences were found to be equal and there was no indication of swelling, discoloration or evidence of trauma. Petitioner's standard of care expert, Dr. Jay Edelberg, provided testimony which actually refutes several allegations in Petitioner's complaint. Specifically, Dr. Edelberg agreed that Respondent's initial assessment of Patient R.D.'s heart was adequate and that Respondent did not ignore Patient R.D.'s cardiac status. Dr. Edelberg also agreed that it was not inappropriate for Respondent to have provided this patient with the Proventil breathing treatment and that a diagnosis of a chronic airway condition was unnecessary in order to treat with such nebulizer. Dr. Edelberg also agreed that Respondent accurately interpreted the EKG and chest X-ray and his findings were properly recorded in the chart. Respondent appropriately diagnosed Patient R.D.'s condition and pursued the appropriate plan of treatment of the patient's condition. Respondent appropriately evaluated the patient's history and complaints which the patient had provided to the triage nursing staff. Respondent performed an appropriate assessment of the patient in the emergency room including obtaining a history of his subjective complaints; his pertinent medical history; and an objective physical evaluation of the patient while in the emergency room. Respondent appropriately ordered the necessary tests to evaluate the patient's condition, based on his examination including an EKG, portable chest X-ray, blood chemical profile, complete blood count, cardiac enzymes and pulse oximeter test. Respondent appropriately interpreted the aforementioned diagnostic studies and tests in establishing his diagnosis and treatment of the patient. Respondent appropriately diagnosed the patient with hyperactive airway disease (i.e., bronchospasm) and properly treated that condition with Proventil while in the emergency room. Respondent appropriately diagnosed the patient with diabetes based on his elevated blood sugars and appropriately coordinated the treatment of that condition with the patient's family practitioner on the following day. Respondent appropriately assessed the patient's risk factors for pulmonary embolism, including his examination of the patient's legs to determine the presence of any signs of deep vein thrombosis. Respondent did consider the patient's report to the triage nurses that he had been diaphoretic earlier in the day. Respondent did consider the patient's complaints of chest pain and appropriately treated him for that condition. Respondent appropriately considered the patient's cardiac status and fully assessed the possibility that the patient's condition was of cardiac origin. Respondent appropriately interpreted and considered the non-specific changes in the patient's EKG in the course of his diagnosis and treatment of Patient R.D. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by not referring the patient to a cardiology or pulmonary specialist. Respondent appropriately discharged the patient from the emergency room, as admission to the hospital was not indicated under the circumstances based on the patient's significant improvement. Respondent's treatment plan for Patient R.D. was appropriate for his presenting complaints. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by gross or repeated malpractice or the failure to practice medicine with that level of care, skill or treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances in the case of Patient R.D. Respondent did not adequately maintain medical records which justified his plan of treatment for Patient R.D. to include the history; examination results; test results; drug prescribed, dispensed and administered; and documentation of his having conferred with Patient R.D.'s reported primary care physician.
Recommendation Based on the foregoing, it is RECOMMENDED that the Board of Medicine enter a final order, in which: Respondent is found not guilty of violating Section 458.331(1)(t), Florida Statutes. Respondent is found guilty of violating Section 458.331(1)(m), Florida Statutes. Respondent be disciplined, as follows: Administrative Fine of $500.00. Reprimand. DONE AND ENTERED this 27th day of December, 1999, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE 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 27th day of December, 1999. COPIES FURNISHED: Carol A. Lanfri, Esquire Kristy Johnson, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Art C. Young, Esquire Rissman, Wiesberg, Barrett, Hurt, Donahue & McLain, P.A. 201 East Pine Street, 15th Floor Orlando, Florida 32801 Tanya Williams, Executive Director Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750 Pete Peterson, General Counsel Department of Health 2020 Capital Circle, Southeast, Bin A02 Tallahassee, Florida 32399-1701 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast, Bin A02 Tallahassee, Florida 32399-1701
The Issue The issue in this case is whether Respondent committed the allegations in the notice of intent to assign a conditional license and, if so, whether Petitioner should have changed the rating of Respondent's license from standard to conditional for the period March 9 through April 11, 2000.
Findings Of Fact Petitioner is the state agency responsible for licensing and regulating nursing homes inside the state. Respondent operates a licensed nursing home at 3636 10th Avenue North in St. Petersburg, Florida (the "facility"). Petitioner conducted an annual survey of the facility from March 6 through March 9, 2000. Petitioner noted the results of the survey on a Health Care Federal Administration form entitled "Statement of Deficiencies and Plan of Correction." The parties refer to the form as the HCFA 2567-L or the "2567". The 2567 is the document used to charge nursing homes with deficiencies that violate applicable law. The 2567 identifies each alleged deficiency by reference to a tag number (the "tags"). Each tag on the 2567 includes a narrative description of the allegations against Respondent and cites a provision of the relevant rule or rules in the Florida Administrative Code violated by the alleged deficiency. In order to protect the privacy of nursing home residents, the 2567 and this Recommended Order refer to each resident by a number rather than by the name of the resident. There are two tags at issue in this proceeding. Tag F327 generally alleges that Respondent provided inadequate hydration to three residents. Tag F490 generally alleges that Respondent failed to effectively administer the facility for the reasons stated in Tag F327. Tag F327, in relevant part, alleges that the facility: . . . did not identify and appropriately assess residents with risk factors for dehydration; develop appropriate preventive Care Plans for residents with dehydration or identified at risk for dehydration and/or provide sufficient fluids to maintain proper hydration and health for 3 (#3, #11 and #14) of 7 sampled residents reviewed for dehydration of a total sample of 14 active residents and 2 extended sample residents. Tag F490 in the 2567 alleges, in relevant part, that the facility: . . . administration did not ensure that residents with risk factors for dehydration were identified and appropriately assessed. The facility administration did not ensure that appropriate preventive. (sic) Care Plans were developed for residents with dehydration or identified as at risk for dehydration. This deficient practice endangered the physical well being of the residents. Applicable federal and state laws require Petitioner to assign two ratings to the deficiencies alleged in the 2567. One rating is a scope and severity rating required by federal regulations. Petitioner assigned a "G" rating to Tags F327 and F490. A "G" rating means that the alleged deficiency was isolated, caused actual harm to one or more residents, but did not involve substandard quality of care. The other rating that Respondent must assign is a class rating required by state law pursuant to applicable rules in the Florida Administrative Code. Petitioner assigned a Class II rating to the deficiencies alleged in Tags F327 and F490. A Class II rating is authorized in Section 400.23(8)(b), Florida Statutes (1999), for any deficiency that has a "direct or immediate relationship to the health, safety or security of the nursing home facility residents." The Class II rating is the only rating at issue in this proceeding. When Petitioner alleges two Class II deficiencies in the 2567, applicable rules require Petitioner to change the rating of a facility's license. Effective March 9, 2000, Petitioner changed the rating of the facility's license from standard to conditional. In a follow-up survey of the facility on April 11, 2000, Petitioner determined that Respondent had corrected the deficiencies alleged in Tags F327 and F490. Effective April 11, 2000, Petitioner changed the rating of the facility's license from conditional to standard. The Class II rating from Petitioner rests on three allegations in Tag F327. Each allegation pertains to one of three residents who are identified individually as Resident 3, Resident 11, and Resident 14. The first allegation in Tag F327 is that Respondent did not identify and assess the particular resident as having risk factors for dehydration. The second allegation is that Respondent did not develop an appropriate preventive care plan for the resident. The third allegation is that Respondent did not provide sufficient fluids to maintain proper hydration and health for each resident. Proof of the first two allegations concerning each resident is not sufficient to support the Class II rating from Petitioner without proof of the third allegation because the essential statutory requirement for a Class II rating is that the alleged deficiencies have a direct or immediate relationship to the health, safety, or security of the resident. For that reason, the allegation that Respondent did not provide sufficient fluids to maintain proper hydration and health for each resident is the gravamen of the complaint against Respondent. Accordingly, Tag F327 concludes that the alleged deficiencies resulted in harm from dehydration to all three residents and that Resident 3 suffered further harm from complications such as constipation and fecal impaction that required hospitalization on February 26 and 27, 2000, to disimpact Resident 3 for hard stools. Petitioner failed to prove the first two allegations in Tag F327 by a preponderance of the evidence. Rather, the preponderance of the evidence shows that Respondent properly identified and assessed Residents 3, 11, and 14 as having risk factors for dehydration and that Respondent developed an appropriate care plan for each resident. Respondent identified and properly assessed Resident 3 as being at risk for dehydration. The admitting diagnosis for Resident 3 was extensive and included glaucoma, depression, a lack of coordination, and cerebral vascular accident. In relevant part, Resident 3 was incontinent of both bladder and bowel, had a history of constipation and urinary tract infections, suffered from nutritional deficiencies, had hemiplegia, had difficulty swallowing, suffered from reflux esophagitis and heartburn, and had hypertension. Respondent identified and properly assessed Resident 11 as being at risk for dehydration. Respondent admitted Resident 11 with organic brain syndrome, dementia, Alzheimer's disease, protein and calorie malnutrition, congestive heart failure, gout, and renal failure. The facility's records properly assessed Resident 11 as at risk for dehydration from a diuretic for congestive heart failure and in need of assistance with meals. Respondent identified and properly assessed Resident 14 as being at risk for dehydration. Resident 14 was 97 years old. Respondent properly identified and assessed many debilitating medical conditions in Resident 14 including hypothyroidism, hypertension, cancer, dementia, hyponatremia, a hip fracture, and incontinence of bladder and bowel. Respondent developed an appropriate care plan for Resident 3. The care plan prescribed appropriate interventions that included a maintenance program of medication for frequent urinary tract infections, assistance with eating, drinking and personal hygiene, and assistance with mobility and swallowing. The care plan also prescribed Milk of Magnesia for numerous complaints of constipation from Resident 3. The care plan for Resident 3 provided appropriate diuretic therapy. Respondent monitored Blood Urea Nitrogen ("BUN") because BUN levels may indicate dehydration. Respondent also monitored meal intake and body weight. Respondent documented that Resident 3's meal intake was 60, 40, and 30 percent, respectively, at breakfast, lunch, and dinner. The care plan placed Resident 3 on a pureed diet with honey thickened liquids and tube feedings. Respondent developed an appropriate care plan for Resident 11. The care plan prescribed appropriate interventions that included assistance with meals, documentation of intake during meals, and the monitoring of weight levels. Respondent developed an appropriate care plan for Resident 14. The care plan prescribed appropriate interventions that included assistance with meals, documentation of intake during meals, and the monitoring of weight levels. The care plan required facility staff to encourage Resident 14 to consume food and liquid during meals. The care plan for Resident 14 included a high calorie liquid supplement. Petitioner failed to prove the third allegation in Tag F327 by a preponderance of the evidence. Rather, the preponderance of the evidence shows that Respondent provided sufficient fluids to maintain proper hydration and health for Residents 3, 11, and 14. Relevant provisions in 42 CFR Section 483.25(j) require Respondent to "provide each resident with sufficient fluid intake to maintain proper hydration and health." However, federal regulations and state rules do not define "sufficient fluid intake." Petitioner's published guidelines interpret federal regulations and state rules (the "guidelines") to mean that a resident has sufficient fluid if he or she has the amount needed to prevent dehydration. The same guidelines define dehydration to exist when the output of fluids far exceeds fluid intake. Dieticians in nursing homes have the duty of estimating each resident's baseline daily fluid needs. One method of estimation requires the dietician to multiply the resident's body weight in kilograms by a recommended number of cc's of fluid. However, the recommended number of cc's can vary from 25 to 30 cc's. The American Dietetic Association recommends 25 cc's for persons over 75, and Petitioner's guidelines recommend 30 cc's with no variation for age. Other adjustments in the recommended cc's are appropriate for certain medical conditions such as renal failure, cardiac distress, and obesity. The estimate of appropriate hydration for a particular resident is usually expressed as a range of the minimum and maximum amount of fluids appropriate for the resident rather than in terms of a specific number. One method of determining whether a facility is meeting a resident's baseline daily fluid needs is a record of daily fluid intake and output for each resident (the "I and O" records.) However, no requirement mandates the use of I and O records. Moreover, I and O records can be of little utility in evaluating hydration for a resident who is incontinent or for a resident who is fed by family members with food brought from home. A facility that does not utilize I and O records may record fluid and meal consumption of a resident in the resident's Medication Administration Records or in the resident's activities of daily living records. A facility may also measure hydration by monitoring a resident for physical signs of dehydration. Typical symptoms of dehydration include dry skin and mucous membranes, cracked lips, poor skin turgor, thirst, fever, sunken eyes, speech difficulty, low blood pressure, decreased urine output, constipation or fecal impaction, confusion, and sudden weight loss. Laboratory tests such as those that measure BUN level or the ratio of BUN to creatinine may also detect dehydration. An abnormally high level of nitrogen in the bloodstream may indicate that a resident is dehydrated. Symptoms of dehydration measured by physical signs and laboratory tests are not conclusive proof of dehydration because other conditions can manifest the same symptoms. A trained medical professional is best able to determine whether the symptoms manifested by a resident show that the resident is in fact dehydrated. The diagnostic uncertainty inherent in the symptoms of dehydration are illustrated in the allegations pertaining to Resident 3. Petitioner's surveyor considered the fecal impaction suffered by Resident 3 on February 26 and 27, 2000, to be a "sentinel event" that required a determination of whether Respondent was meeting the hydration needs of Resident 3. The surveyor calculated Resident 3's baseline daily fluid needs at 2250 cc's by multiplying Resident 3's actual body weight of 165 pounds, converted to kilograms, by 30 cc's of fluid. The surveyor reviewed Resident 3's records and found that Respondent documented Resident 3's body weight at 165 pounds without noting Resident 3's usual body weight. The surveyor rejected the determination by Respondent that Resident 3 had an adjusted body weight of 116 pounds, based on obesity, and rejected the corresponding baseline daily fluid need of 1581 cc's. The surveyor concluded that the appropriate baseline daily fluid level for Resident 3 was 2250 cc's. Based on the I and O records for Resident 3, the surveyor determined that Respondent provided Resident 3 with inadequate daily average fluid intake over four months, consisting of: 766 cc's in December 1999; 1,489 cc's in January 2000; 1,334 cc's in February 2000; and 874 cc's in March 2000. The records reviewed by the surveyor showed that Respondent did not separately record the intake of fluid and food by Resident 3 during meals. In addition, Respondent failed to document Resident 3's entire fluid intake and output in the I and O records every eight hours in violation of Respondent's policy regarding residents who were at risk for dehydration. As Petitioner correctly stated in its PRO, the documentation missing in the records reviewed by the surveyor made it impossible for the surveyor "to accurately assess the amount of fluid" that Resident 3 consumed each day. The surveyor concluded that Resident 3 was dehydrated and that the dehydration caused the fecal impaction suffered by Resident 3. Based upon the determination that Respondent allowed Resident 3 to become dehydrated and that the dehydration led to fecal impaction that required hospitalization, the surveyor concluded that the alleged deficiency caused harm to Resident 3. Petitioner failed to prove the third allegation concerning Resident 3. Rather, the preponderance of evidence shows that Respondent provided sufficient fluids to maintain proper hydration and health for Resident 3. The surveyor is a nurse and not a licensed physician. The surveyor admitted during her testimony that she is not trained to make a medical determination that the fecal impaction suffered by Resident 3 was caused by inadequate hydration. The surveyor did not discuss the issue with Resident 3's physician. The physician for Resident 3 reached a conclusion different from that of the surveyor. Neither dehydration nor inadequate hydration caused the fecal impaction suffered by Resident 3. Respondent 3 experienced constipation and complained of the condition irrespective of the level of hydration. If Resident 3 were to have experienced dehydration at the levels calculated by the surveyor over a three-month period, Resident 3 would have experienced far more symptoms than constipation and fecal impaction. One of those symptoms would have been low blood pressure, and Resident 3 did not experience low blood pressure during the period at issue. Rather than dehydration, it was the sedentary life style, advanced age, and an old vertebral fracture that caused the fecal impaction suffered by Resident 3. Other expert testimony shows that the calculations utilized by Petitioner were not appropriate for Resident 3. The surveyor did not review all of the consumption records for Resident 3. Respondent did not maintain complete I and O records for Resident 3 because such records were fruitless for a resident who was incontinent of bladder and bowel. In addition, the surveyor incorrectly used 30 cc's rather than 25 cc's which would have been appropriate for Resident 3's age group. Finally, the surveyor did not adjust the weight of Resident 3 for obesity. Based on all the consumption records, Resident 3 received adequate hydration during the contested period. Those amounts were: 1803-2003 cc's in December 1999; 2,170-2,370 cc's in January 2000; and 1,843-2,043 cc's in February. Petitioner failed to show by a preponderance of the evidence that Resident 11 suffered from dehydration. Rather, the preponderance of the evidence shows that Respondent provided sufficient fluids to maintain proper hydration and health for Resident 11. On March 8, 2000, Petitioner's surveyor observed Resident 11 eating her lunch and dinner meals. During the lunch meal, Resident 11's meal tray included both cranberry juice and milk. However, Resident 11 drank none of the milk and only 90 cc's of the cranberry juice. The surveyor observed only two instances when facility staff encouraged Resident 11 to eat. During the dinner meal, Resident 11 consumed no fluids but spilled those fluids offered by staff. The surveyor did not observe any staff member replace the spilled liquids and did not see any staff member encourage Resident 11 to eat or drink. The facility records for Resident 11 showed that Resident 11 had elevated BUN levels in December 1999, and in January 2000. On December 1, 1999, the BUN level was 39. On January 7, 2000, the BUN level was 52. Based upon the surveyor's observations of the lunch and dinner meals on March 8, 2000, and the elevated BUN levels in December 1999, and January 2000, Petitioner cited Respondent for a deficiency in Tag F327. Petitioner does not allege that the meal observations and elevated BUN levels caused actual harm to Resident 11 but only potential harm. Petitioner offered no evidence that the elevated BUN levels in December 1999, and January 2000, reflected inadequate hydration on March 8, 2000, when Petitioner determined the existence of a deficiency. Nor did Petitioner offer any evidence that Resident 11 manifested any sign or symptom of dehydration in March of 2000. The physician for Resident 11 reached a conclusion different from that of Petitioner. It was inappropriate to conclude from the elevated BUN levels that Resident 11 was dehydrated. Resident 11 had renal failure. Renal failure is a medical condition that produces elevated BUN levels regardless of hydration. Petitioner's surveyor did not consult Resident 11's physician. The surveyor agreed in testimony during the hearing that elevated BUN levels are symptoms of renal insufficiency. The surveyor was unaware that Respondent 11 suffered from renal insufficiency when the surveyor determined the deficiency during the survey. Based on other expert testimony, it is clear that Resident 11 consumed sufficient fluids. When all of Resident 11's conditions are considered, the appropriate baseline daily fluid intake for Resident 11 in December 1999, and January 2000 was between 1286 and 1522 cc's a day. Resident 11 consumed approximately 1375 cc's of fluid per day during that period. Petitioner failed to show by a preponderance of the evidence that Resident 14 suffered from dehydration. Rather, the preponderance of the evidence shows that Respondent provided sufficient fluids to maintain proper hydration and health for Resident 14. Resident 14 was 97 years old and had many debilitating medical conditions including hypothyroidism, hypertension, a history of cancer, dementia, hyponatremia, and a hip fracture. During the survey, Petitioner's surveyor observed Resident 14 during one meal. Resident 14 consumed only limited amounts of the fluids available, and staff members offered little encouragement for Resident 14 to consume liquid. The surveyor attempted to calculate the consumption of fluids by Resident 14 but was unable to do so based on the available records. The surveyor observed Resident 14 to be weak and to suffer from dry skin. The surveyor concluded that Resident 14 suffered from dehydration. Resident 14's physician reached a conclusion different from that of the surveyor. The resident's generalized weakness and dry skin were caused by hypothyroidism and age. The records of the facility were adequate to calculate the amounts of fluids that Resident 14 consumed in March 2000. The fluid intake ranged from 1476 to 1678 per day and exceeded Resident 14's needs of 1432 to 1722 cc's per day. Petitioner claims that Respondent violated Tag F490, in relevant part, because Respondent committed the acts or omissions alleged in Tag F327. As previously found, however, Petitioner failed to show that Respondent committed the acts or omissions alleged in Tag F327. Petitioner also alleges that Respondent violated Tag F490 because Respondent failed to provide services to residents in a manner that meets "professional standards of quality." Petitioner argues that Respondent violated the quoted standard because Respondent did not maintain I and O records for Residents 3 and 11 in violation of Respondent's own policy requiring those records. The requirement to maintain I and O records is meaningless for residents who are incontinent. Residents 3 and 11 were both incontinent of bladder and bowel. The maintenance of those records would not have been useful in evaluating the hydration of Residents 3 and 11. In any event, Respondent maintained accurate and complete records of the consumption of fluids by both residents in other areas of the residents' medical charts. The facility administrator did not fail to ensure that staff was following through with dietary recommendations. Petitioner failed to provide evidence of a specific recommendation by the dietician that the staff failed to implement. Petitioner alleged in Tag F490 that Respondent did not have sufficient nursing staff on hand to provide nursing and related services to residents. Petitioner failed to provide any evidence to support this allegation. The facility's staffing summaries met all minimum standards for staffing.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that Petitioner enter a Final order finding Respondent not guilty of the acts and omissions alleged in Tags 327 and 490; and reversing the issuance of a conditional license. DONE AND ENTERED this 7th day of December, 2001, in Tallahassee, Leon County, Florida. DANIEL MANRY 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 7th day of December, 2001. COPIES FURNISHED: Michael P. Sasso, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, Room 3106 St. Petersburg, Florida 33701 R. Davis Thomas, Qualified Representative Broad & Cassel 215 South Monroe Street, Suite 400 Tallahassee, Florida 32307 Diane Grubbs, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308 William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308
The Issue The issue addressed in this proceeding is whether Respondent's license to practice nursing should be suspended, revoked, or otherwise disciplined for alleged violations of Chapter 464, Florida Statutes.
Findings Of Fact Respondent, Nan Lynn Baumgartner, is a licensed practical nurse in the State of Florida, holding license number PN-34192-1. Respondent was licensed in 1972. In 1974, Respondent was employed at Tallahassee Convalescent Home located in Tallahassee, Florida and during the time period relevant to this proceeding, worked the 3-11 p.m. shift. The Home's function is to provide for the care of its geriatric residents. Respondent had responsibility for 72 residents. Respondent was employed at the Center until April 26, 1988, when she was terminated by the facility for incompetent nursing skills, exercising poor judgment, failure to follow-up on orders and inability to pass out medications on time and appropriately. Ms. Baumgartner's employer suspected her performance problems were due to a alcohol or drugs. None of the evidence presented at the hearing clearly or convincingly established that Respondent had an alcoholic or drug abuse problem which impaired her ability to function. The bulk of the evidence which would have indicated such a problem was uncorroborated hearsay some of which was contradicted by other more reliable testimony. The remainder of the evidence which was relied upon by the Department to show impairment due to a drug or alcohol abuse problem was Respondent's demeanor, her lethargy and slowness in handing out medications, and various examples of her using poor judgment in performing her duties. All of these incidents occurred during a 1-1 1/2 month period during which Respondent had suffered four broken ribs in the fall from a horse. In fact, her doctor had advised her not to work for several weeks after her fall from the horse. However, Respondent could not get the time off from work and attempted to work during this period of time. As to Respondent's demeanor and lethargy, there was a great deal of conflict in the evidence depending on how each respective witness thought or assumed Respondent should behave. More importantly, however, is that Respondent's demeanor and lethargy during this time period can be attributed to some medical difficulties she had with her jaw and blood pressure and to the fact that she experienced a great deal of pain form her broken ribs. The examples of Respondent's judgment which Petitioner alleges demonstrate Respondent's poor judgment, frankly do not rise to such a level. The examples were: 1) Respondent called the oncall physician instead of the Director of Nursing when the oxygen concentrator being used by a patient malfunctioned; 2) She allowed a certified nursing aide to give oxygen to a patient; 3) She called the police when it was reported to her that a patient had mysteriously been burned; and 4) There was a patient who was not restrained. The incident involving the oncall physician simply does not demonstrate poor judgment. The fact that Ms. Baumgartner may or may not have followed some unproven chain of command in making her calls does not establish below standard judgment. She quite correctly called the physician who was on-call for that evening when she discovered the oxygen concentrator was not working. She then followed the Doctor's instructions. The alleged contents of a later conversation which occurred between the facility's Director of Nursing and the Doctor was the rankest of hearsay and is simply too unreliable to clearly and convincingly demonstrate poor judgment on Respondent's part. Connected with the oxygen concentrator incident was the incident involving Respondent's allowing a Certified Nursing Assistant to work the oxygen concentrator machine. The more persuasive evidence involving this incident was that it occurred during the oxygen concentrator's malfunction discussed above. A group of people surrounded the machine. One of the persons present around the machine was a CNA and at least two nurses were also present. They were attempting to figure out how to fix the oxygen machine. No one could and the Doctor was called. Given the fact that there were at least two other nurses present along with the CNA attempting to fix the oxygen machine, these facts do not clearly and convincingly demonstrate poor judgment on Respondent's part which would fall below minimum standards and constitute a breach of Chapter 479, Florida Statutes. Similarly, the facts surrounding the mysterious burn incident do not demonstrate that Respondent fell below minimum standards or failed to report the incident. There was no reliable evidence demonstrating Respondent's involvement in or knowledge of a patient being burned on her shift. Respondent was called at home around 3:00 or 3:30 in the morning. She had been asleep. The Respondent was called by Pat Yates, who was the charge nurse on the shift following Respondent. Respondent believed the incident had happened on Ms. Yates' shift. After Respondent spoke with Ms. Yates and because of some similar rumors about Ms. Yates floating around the facility, Respondent decided to call the police. 1/ She believed Ms. Yates was trying to "frame" one of the CNA's on Respondent's shift with whom Ms. Yates had a very heated argument at the shift change. Again this incident in which there was no reliable substantive evidence suggesting Respondent's involvement or responsibility, does not demonstrate poor judgment on Respondent's part or her failure to report the incident's occurrence. The incident involving the unrestrained patient likewise does not demonstrate poor judgment on the part of Respondent. The patient was prescribed by the doctor to be restrained on an as needed basis. The as needed prescription by the physician suggests that such restraints were not necessary all of the time unless the patient was showing some sort of behavior which would require her to be restrained. The evidence did not demonstrate that such restraints were needed on Respondent's shift. The only allegation established by the Department was that for approximately a month to a month and a half Respondent was extremely slow in passing out medications to the patients. The center had established medications at 5:00 p.m. and 9:00 p.m.. The 5:00 p.m. medication pass took approximately an hour and a half to perform. The 9:00 p.m. medication pass took approximately 45 minutes to an hour to perform. Respondent frequently, for at least half of the month to a month and a half time period would be handing out medications three hours late. It was not demonstrated that she was not documenting or charting the lateness of these medications since no medical records were introduced into evidence and the testimony on that point was unclear. The standard practice in Florida is to attempt to pass medicine to nursing home residents within plus or minus one hour of the designated time. The fact that the desired hour leeway is not always obtained does not indicate that a nurse is falling below minimum standards. The number of patients to be served, the difficulty in getting the patient to take his or her medication, and the types of medication being given all enter into the determination of whether a nurse is falling below minimum standards in the length of time it takes her to pass out medications. None of these factors were presented at the hearing. 2/ Without, such specific evidence it is impossible to determine whether Respondent was falling below minimum standards. 3/
Recommendation It is accordingly, RECOMMENDED: That the Division enter a Final Order dismissing the Administrative Complaint against Respondent. DONE and ORDERED this 1st day of October, 1990, in Tallahassee, Florida. DIANE CLEAVINGER 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 1st day of October, 1990.
Findings Of Fact Sobel has applied for a license under the provisions of the Florida Clinical Laboratory Law, Chapter 483, Florida Statutes, as a Laboratory personnel supervisor in the speciality of Chemistry, Respiratory Therapy. On August 23, 1977, Sobel was notified by HRS that his application was denied because he lacked a degree in Respiratory Therapy or in the alternative that he lacked seven years experience in Chemistry (special). On September 2, 1977, Sobel requested an administrative hearing. Sobel has been given credit by HRS for six years experience in Chemistry (special). Long Island University, Sobel's alma mater, conducts a respiratory therapist program of at least two years duration. This program is accredited by the Council on Medical Education of the American Medical Association. In addition to his Bachelor of Science degree in Physical Education and his Master of Science degree in Health, Science and Physical Education, Mr. Sobel successfully completed the requirements of training in Respiratory Therapy given by Long Island University. In addition, Sobel is a registered Respiratory Therapist with the National Board of Respiratory Therapy, Inc., and has successfully completed the written registry examination for self assessment administered by the National Board for Respiratory Therapy. HRS recognizes that fourteen hours of Sobel's curriculum as reflected in his transcript of grades qualifies under the suggested basic units of instruction for a two year respiratory therapist program contained in the Allied Medical Directory. These general areas of study form the basis, in part, of accreditation by the Council on Medical Education of the American Medical Association.
The Issue The issue in this case is whether Respondent committed certain disciplinary violations and, if so, what penalty should be imposed.
Findings Of Fact Respondent is a licensed dentist in the State of Florida, holding license number DN 0008830. He was granted a parenteral conscious sedation permit on February 27, 1988. Respondent has been licensed in the State of Florida since August 3, 1981. There is no evidence that he has been the subject of prior disciplinary proceedings. J. C. was born November 28, 1980. J.C. died August 17, 1989, at 7:10 p.m. due to anoxic encephalopathy, which is brain damage from lack of oxygen. Anoxic encephalopathy was due to complications of preparation for dental extractions. Two years prior to visiting Respondent, J. C. had been seen by another dentist, Alexander S. Nurrell. Complaining of a toothache, J. C., who was six years old, was seeing a dentist for the first time. The medical and dental history, which was provided by J. C.'s mother, revealed nothing material to this case. The mother noted that the child had never experienced an "unhappy" reaction of a dental or medical procedure. Following an examination, Dr. Nurrell determined that J. C. had been "neglected," at least in terms of her dental needs, which were considerable. Due to the scope of the work required by J. C., which involved repairs to 11 teeth, Dr. Nurrell intended to hospitalize J. C. in order to provide the necessary dental treatment. About one week after the visit to Dr. Nurrell, J.C.'s father took her to another dentist, Peter Weisbruch. Again, her complaint involved a toothache, which apparently had not been treated by Dr. Nurrell. Dr. Weisbruch commenced a dental treatment plan that J. C. followed for some time. Dr. Weisbruch administered a local anesthetic to J.C. on three occasions. On the first visit, Dr. Weisbruch administered an anesthetic, but failed to record the type or amount. On April 26, 1988, Dr. Weisbruch, while extracting one of J.C.'s teeth, administered 0.9 cc of 3% Carbocaine, which is a brand name of mepivicaine. On May 14, 1988, Dr. Weisbruch administered 0.9 cc of 2% lidocaine, as well as 0.9 cc of 1:100,000 epinephrine solution. On no occasion did J. C. exhibit an unusual reaction to any local anesthetic. She was, however, an uncooperative patient. On June 1, 1988, J. C.'s father informed Dr. Weisbruch's office that J. C.'s mother would be resuming responsibility for ensuring that J. C. received adequate dental care and that J. C. would not be returning to Dr. Weisbruch's office. Financial constraints limited the ability of J.C.'s parents to obtain dental services for their daughter. By June, 1989, however, her mother was prepared to recommence J.C.'s dental treatment. She looked for a dentist in the yellow pages based on physical proximity to their home. When she found Respondent's advertisement, she was impressed by its emphasis upon patient comfort, including such features as stereo headphones and anaesthesia. Aside from her dental problems, J. C.'s health at the time that she first saw Respondent was good. She had been seen periodically by a pediatrician for a well visit and then for a couple of common viral complaints. When she first contacted Respondent's office, J.C.'s mother told the receptionist that she needed to be able to pay for the dental work by periodic payments. The receptionist advised the mother to bring in J. C. for an initial consultation. J. C. and her mother first visited Respondent on June 29, 1989. The medical and dental history revealed nothing unusual except that J. C. had "extensive" dental complaints. Respondent took x-rays and fitted J. C. for a retainer on her first and second visits, with the latter taking place on July 5, 1989. J. C.'s mother paid $157 on July 10, leaving a balance of $125, which was to be paid over 90 days. As a result of his examination of J. C.'s teeth, Respondent advised J. C. and her mother that J. C. should have eight primary teeth removed. He apparently prescribed an antibiotic to treat a dental infection, but this treatment is irrelevant to the case. In any event, Respondent's office gave J. C. an appointment for August 9, 1989, for the extraction of the eight teeth. On August 8, Respondent's receptionist called J.C.'s mother and told her that Respondent had decided to put J.C. asleep during the extractions. Thus, he wanted an early morning appointment. They agreed to reschedule the appointment for August 16 at 8:30 a.m. J. C. was excited about going to the dentist. She intended to go out for the cheerleading squad once school started. She and her mother arrived at Respondent's office just before 8:30 a.m. J. C. sat on her mother's lap and was a little nervous, but they did not have to wait long. J. C. weighed 50- 55 pounds at this time. No later than 8:30 a.m., dental assistant Terri Neff came out to the waiting room and took J. C. and her mother into Operatory #2. Operatory ##2 and 3 are identical in terms of equipment and size. Respondent, who apparently was the only dentist practicing in his office, also used a third operatory, which is smaller and lacked a dental assistant chair. Ms. Neff was, at the time of the incident, a certified dental assistant. She had been for the preceding five years and had assisted in dental procedures and monitored patients in anaesthesia. She also held current certification in dental radiology, the administration of nitrous oxide, and cardiopulmonary resuscitation (CPR). As was the case with all of Respondent's employees, Ms. Neff had never attended the course entitled "Guidelines for Teaching Comprehensive Control of Pain and Anxiety." Just before J. C. was seated in the examination chair, Ms. Neff gave her a glass of water, which J. C. drank. As Ms. Neff explained to J.C.'s mother, the water contained five ml of Phenergan, which Respondent had prescribed to control the nausea occasionally experienced by patients from nitrous oxide. J. C. drank the Phenergan solution at 8:35 a.m. Phenergan, or promethazine, is an antiemetic used to control nausea in patients about to receive nitrous oxide. A central nervous system depressant, Phenergan is an antihistamine with a minor sedative effect. The drug manufacturer's literature, which is inserted into each box or carton of the drug, warns that the sedative action of Phenergan is "additive to the sedative effects of central nervous system depressants; therefore, agents such as . . . narcotic analgesics . . . should either be eliminated or given in reduced dosage in the presence of [Phenergan]." The drug insert advises that the dose of meperidine or Demerol be reduced by one-quarter to one-half. The drug insert also advises: [Phenergan] may lower seizure threshold. This should be taken into consideration when administering to persons with known seizure disorders or when in combination with narcotics or local anesthetics which may also affect seizure threshold. Five ml of Phenergan contains 6.25 mg of promethazine. Used in isolation, this dosage of Phenergan was appropriate and bordered on the low end of a safe and effective dosage. For preoperative medication, the recommended dose is 0.5 mg per pound in combination with an equal dose of meperidine and an "appropriate dose of an atroprinelike drug," according to the drug insert. In J. C.'s case, the recommended dose is thus 27.5 mg, and she received only about 23% of the recommended maximum dose of Phenergan. The same amount is the recommended dose when Phenergan is used in isolation to control nausea. Ms. Neff next placed a nasal mask over J. C.'s nose preparing to administer nitrous oxide. The mask was supposed to have a bubble gum smell, which is intended to please pediatric patients. When Ms. Neff asked J. C. if she could smell the bubble gum, the girl said she could not, so Ms. Neff replaced the mask with a strawberry-scented one. J. C. said she could smell this one, although her mother thought she might be humoring them. The nasal mask does not cover the mouth. It is made of rubber and is not heavy. The mask, which was a child's size, fit tightly on J. C.'s face. The nitrous oxide machine has settings for nitrous and oxygen. Each unit represents one liter of gas delivered per minute. Pursuant to Respondent's direction as to initial mix and time of commencement, Ms. Neff turned on the nitrous oxide machine shortly after placing the mask on J. C. The initial setting was 1:3 nitrous to oxygen. Nitrous oxide is a central nervous system depressant. J. C. was fidgety in the chair. After the mask was applied, she touched the mask frequently. She said that the mask felt funny and made her nose itch. She remained quite talkative. After the nitrous oxide had been administered to J. C. for about 30 minutes, Respondent entered the operatory to check on the girl. He waited awhile, noting that J. C. was still not calm enough to proceed. He then advised Ms. Neff that they would need to give J. C. an injection of Demerol. At about 9:02 a.m., Respondent gave J. C. an injection of 50 mg Demerol, or meperidine, in her right deltoid muscle. J. C. cried upon receiving the injection. Demerol is a narcotic analgesic similar in effect to morphine. Demerol is a central nervous system depressant. The drug insert warns prominently that "[Demerol] should be used with great caution and in reduced dosage in patients who are concurrently receiving . . . other CNS depressants . . .. Respiratory depression, hypotension, and profound sedation or coma may result." In isolation, the maximum dose is 0.8 mg per pound of body weight when the drug is used as premedication, which is how Respondent used the drug in this case, although the drug insert states that the "usual dosage" is 0.5 mg per pound when Demerol is used for preoperative medication. Using the rate of 0.8 mg per pound, the maximum dosage was 44 mg., if the Demerol had been used in isolation. No expert opined that the amount of Demerol administered to J. C. would have been excessive, if the drug had been used in isolation. However, when used, as here, in connection with one or more other central nervous system depressants, the dosage of Demerol was excessive, especially when combined with the administration of mepivicaine, as discussed below. J. C. cried when she received the injection. Respondent left the room, and J. C., evidently agitated, asked her mother, "is this how Grandma died?" Her mother tried to reassure her that everything was alright. After receiving the injection, J.C. began to rub around her eyes and face. This itchiness was due to a combination of one or more of the following: fidgetiness, continued resistance or possibly minor reaction to the mask, and a short-term release of histamines caused by the administration of the Demerol. However, the itchiness was not evidence of a serious allergic or anaphylactic reaction for reasons discussed below. Respondent's testimony that he noticed itchiness to an extent that he had not previously seen is discredited by, among other things, his failure to chart what would have been an unprecedented observation. At about the time of the Demerol injection, the nitrous oxide mix was changed, by Respondent's instructions, to 3:5. 1/ Ms. Neff remained with the mother and J. C. for about 30 minutes, waiting for J. C. to relax sufficiently so Respondent could proceed to administer the local anesthetic and begin the extractions. J. C. remained talkative during this period. While Ms. Neff was waiting with the mother and J.C. for the Demerol to take effect, someone told Ms. Neff that she was needed by another patient. Another assistant, Sarah Staley, joined J. C. and her mother at this time. At about this time, J. C. began to become more subdued. Aside from the receptionist, Ms. Staley was the least trained of Respondent's employees. First employed by Respondent about one year earlier, Ms. Staley had no prior dental experience. She had not undergone any formal training as a dental assistant or in CPR. Her position was best described as a business assistant/clerk. Ms. Staley was not trained to recognize any symptoms of a patient in sedation. At about 9:35 a.m., Respondent returned to Operatory #2. Finding J. C. sufficiently calm to proceed, Respondent began the process of administering mepivicaine. Mepivicaine, which is also a central nervous system depressant, is a local anesthetic. The drug insert warns: "Great care must be exercised in adhering to safe concentrations and dosages for pedodontic administration." The drug insert adds: If sedatives are employed to reduce patient apprehension, use reduced doses, since local anesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect. Young children should be given minimal doses of each agent. Injection of repeated doses of mepivicaine may cause significant increases in blood levels with each repeated dosage due to slow accumulation of the drug or its metabolites, or due to slower metabolic degradation than normal. Tolerance varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their weight and physical status. As to adverse reactions, the drug insert states: Reactions involving the central nervous system are characterized by excitation and/or depression. Nervousness, dizziness, blurred vision, or tremors may occur followed by drowsiness, convulsions, unconsciousness, and possible respiratory arrest. . . . Reactions involving the cardiovascular system include depression of the myocardium, hypotension, bradycardia, and even cardiac arrest. Allergic reactions are rare and may occur as a result of sensitivity to the local anesthetic. . . . As with other local anesthetics, anaphylactoid reactions to Mepivicaine have occurred rarely. The reaction may be abrupt and severe and is not usually dose related. The drug insert states that the "lowest dosage needed to provide effective anesthesia should be administered." The drug insert specifies the dosage as follows: "A dose of up to 3 mg per pound of body weight may be administered." Respondent injected mepivicaine into the area of the upper and lower jaws. Neither Ms. Staley nor the mother noted the number of cartridges of anesthetic that Respondent used. As the injections started, J. C. began to cry, and her mother held her hand to calm her. A cartridge, or carpule, is a glass tube containing medication in solution form. The cartridge in this case contained a 3% solution of mepivicaine. Each cartridge contained 1.8 cc of the medication or 54 mg. of mepivicaine. The cartridge is placed in the syringe, a negligible amount is expressed to eliminate any air bubbles and to ensure proper operation of the syringe, and then the remainder is available to be injected into the patient. The evidence is contradictory as to the amount of mepivicaine actually injected into J. C. There are two reasons for this. First, there is conflicting evidence as to the number of cartridges. Second, there is some evidence that less than an entire cartridge was injected each time. Although not arriving in the operatory until at least 10 minutes after the completion of the mepivicaine injections, dental assistant Kathleen Lyttle charted the entry, "mepivicaine 3%." Respondent later charted the remaining information concerning the number of cartridges of mepivicaine. Respondent first noted that he had used eight cartridges from 9:30 a.m. to 9:50 a.m. He made entries showing injections into the upper and lower left and right jaws. Although no number was placed next to each location, obviously a pair of injections in each of the four locations would result in eight cartridges. Respondent then made two interlineations. First, he wrote above the notes for the two upper-jaw entries the following notation: "x2," meaning that two cartridges each were injected in the upper left and right jaw for a total of six cartridges. The effect of this addition is to imply that only one was injected lower left and right jaw. Second, Respondent crossed out the number "8" and added, above the crossed-out "8," the notation, "5-6," meaning that a total of five to six cartridges were injected. In a conversation with the Orange County Medical Examiner shortly after the incident, Respondent stated that five to six cartridges were administered. Respondent told the medical examiner that he first completed the injections into the upper and lower left and right jaws, then injected a little more. In a written statement to the medical examiner, Respondent stated that six cartridges were administered. Petitioner has proved by clear and convincing evidence that Respondent administered to J. C. no less than six cartridges of mepivicaine. This number is consistent with the written statement that Respondent provided the medical examiner. This number is also consistent with the detailed itemization Respondent noted on the dental chart where he showed one injection each in the lower left and right jaw and then two injections each in the upper left and right jaw. The second issue is whether Respondent injected the entire contents of each cartridge. In his practice, Respondent often did not empty a cartridge of local anesthetic but instead left up to 20% of the contents uninjected. Petitioner has proved by clear and convincing evidence that Respondent injected the entire contents of the first four cartridges used in the upper right and left jaw, except for the negligible amount expressed for the reasons set forth above. Respondent had concluded that J. C. was an uncooperative patient. He had already chosen what he testified was the "upper limit" for the Demerol, which in fact was excessive in view of the prior administration of Phenergan. Respondent had also increased the nitrous oxide ratio to administer more nitrous. Most important, Respondent testified that, during his eight-year career, he had ignored maximum recommended dosages of local anesthetics. Nothing in the record suggests that, in the use of local anesthetics and central nervous system depressants, Respondent subscribed to the maxim, "Start low, go slow." Also, the consequences of the administration of the mepivicaine, which, as noted below, demonstrate local anesthetic toxicity rather than allergic reaction, are strong proof that Respondent administered a dosage of mepivicaine far in excess of the maximum recommended dosage. As to the final two cartridges, Petitioner has proved by clear and convincing evidence that Respondent did not withhold more than 20% of the contents of each cartridge. There is substantial evidence, as set forth in the preceding paragraph, that Respondent withheld less in this case. However, the results would be the same, based on the following findings. Respondent's testimony that he administered no more than about 200 mg of mepivicaine is discredited. This would represent the contents from 3.75 cartridges. By the time that Respondent spoke with the medical examiner, he had had more than enough time to reflect on the possibility that J. C. may have suffered a toxic reaction to a local anesthetic. Given that possibility, and the obvious ramifications that it held for Respondent, he certainly would have carefully reflected upon the actual amount of mepivicaine administered to J. C. It is inconceivable that if, instead of 5-6 cartridges, he determined that he had injected only 3.75 net cartridges, he would not have so informed the medical examiner at that time. It is more likely that the netting process, in order to reflect the unused contents of a cartridge, resulted in a reduction from eight to six cartridges. Based on the foregoing, the least amount of mepivicaine that Respondent actually injected into J. C. is four full cartridges into the upper and lower jaws followed by not less than four-fifths of a cartridge each injected into the upper right and left jaw. This yields a total of 5.6 cartridges or about 300 mg of mepivicaine. The finding of 5.6 cartridges or 300 mg of mepivicaine corresponds to Respondent's estimate of 5-6 cartridges. Petitioner has proved by clear and convincing evidence that Respondent's estimate is already reduced by at least the amount of medication that Respondent actually withheld. There is significant evidence, although not clear and convincing, that Respondent injected eight cartridges, which, assuming a 20% reduction even in each injection, means that he administered 6.4 cartridges or about 345 mg of mepivicaine. When used in isolation, mepivicaine is administered at the rate of not more than three mg per pound of body weight. 2/ In the case of J. C., the maximum recommended dosage would have been 165 mg of mepivicaine, if the drug had been used without any other medications. When used in connection with other central nervous system depressants or sedatives, like Phenergan, nitrous oxide, and Demerol, mepivicaine's maximum recommended dosage is not more than two mg per pound of body weight. In this case, then, the maximum recommended dosage for J. C. was 110 mg because the drug's effect would be potentiated by the other medications already given J. C. If J. C. had not been given other drugs, the dosage that she received was 1.8 times more than the recommended maximum dosage. Because she had already received other central nervous system depressants, the dosage that she received was 2.7 times the recommended maximum dosage. 3/ Respondent injected the mepivicaine from 9:35 a.m until about 9:52 a.m. He then left the operatory. As the mother and Ms. Staley watched over J. C., she said, "I love you, mommy." She then turned her head to the side and seemed to fall asleep, lying back in the chair. Respondent's testimony that, immediately following the injections, J. C. began to experience extremely bad itching around her eyes and face is discredited. If J. C. had experienced such a remarkable response, Respondent would have at least charted it, if not remained in the operatory until the phenomenon resolved itself. At best, Respondent has confused the onset of the itching, which in fact began with the application of the nitrous oxide mask. After Respondent left the operatory, the mother and Ms. Staley chatted about their preparations for the new schoolyear. Suddenly, at about 9:57 a.m., J. C. sat straight up in the chair with her eyes open unnaturally wide, trying to catch a breath, but unable to do so. After a few seconds, she slumped back into the chair and her arms and legs began shaking violently. After a few more seconds, her posturing and convulsions ended. Ms. Staley immediately summoned Respondent. Ms. Neff had by chance just been entering Operatory #2 at the moment that J. C. had sat upright in the chair. Ms. Neff immediately turned the nitrous oxide machine to 100% oxygen at its maximum setting of 10+ liters per minute. Ms. Neff testified that she was unaware that anything was wrong at this time and only thought that J. C. might need to go to the bathroom. Even after a few moments in the operatory, Ms. Neff continued to think that the they simply had "a nervous little girl in the chair." Another dental assistant, Lisa Ann Barlette, who was in the operatory across the hall, happened to see out of the corner of her eye J. C. when she had sat upright. Ms. Barlette had almost two years' experience as a dental assistant and was currently certified in CPR and dental radiology. Immediately excusing herself from her patient, Ms. Barlette started to walk across the hall into Operatory #2 and saw J. C.'s hands trying unsuccessfully to push the nitrous oxide mask up over her nose. Respondent entered the operatory immediately ahead of Ms. Barlette, who remained in the doorway. Respondent and Ms. Staley were telling J. C. to calm down. Upon entering Operatory #2, Respondent immediately tilted J. C.'s head back and chin up so as to establish an airway and eliminate any upper airway obstructions. He also began to take her pulse. Respondent noted that J. C. was in "severe respiratory distress." At about 10:03 a.m., J.C. had a second seizure in which she stiffened and then shook violently. She had a third seizure at about 10:04 a.m. and a fourth at about 10:05 a.m. She suffered a fifth seizure, of somewhat lesser intensity, at about 10:07 a.m. and a more intense seizure at about 10:09 a.m. During these seizures, J. C. gasped, as though sobbing, and continued to breathe as though she was trying to catch her breath. Between seizures, she responded to her mother with eye movements and by squeezing her hand. When told by her mother or Respondent to relax, J. C. responded by relaxing her grip. These were the limits of J. C.'s responses following the onset of the convulsions. At about 10:04 a.m., Respondent ordered that a rubber bite block be inserted to help control the upper airway during the seizures. After a few minutes following the first seizure, Ms. Staley began to suction mucous secretions from J. C. and continued to do so while J. C. remained in the chair. Entering Operatory #2 shortly after the clinical emergency began, Kathleen Lyttle, who later charted the mepivicaine, asked Respondent if he wanted her to take J.C.'s vital signs. Respondent nodded yes, and, because the blood pressure cuff in Operatory #2 was behind Ms. Staley and difficult to reach, Ms. Lyttle obtained one from another operatory. Ms. Lyttle was currently certified in dental radiology and CPR. She seemed to be the most experienced among Respondent's employees in handling a clinical emergency. Respondent administered at about 10:12 a.m. 4/ one cc of Narcan (0.4 mg/ml) by injection into the jaw. Narcan is a narcotic antagonist capable of counteracting the Demerol within seconds. At this time, J. C.'s respirations were beginning to decrease and she began to become cyanotic from a lack of oxygen. About a minute after injecting the Narcan, Respondent administered one ml of adrenalin chloride 1:1000 in the form of epinephrine solution by injection below the tongue. Attaching the blood pressure cuff on J.C.'s right thigh, Ms. Lyttle took her first reading of J. C.'s vital signs at about 10:13 a.m. J. C.'s blood pressure was 160/90, her pulse was 160, and her respiration was irregular. The vital signs were unchanged one minute later. By 10:15 a.m., the pulse and respiration were unchanged, but the blood pressure had dropped to 115/44. The interval between seizures was increasing, the seizures seemed to be lessening in intensity, and J.C. continued to respond between seizures in the manners described above. At about this point, Ms. Lyttle then turned to the mother and asked if J. C. had epilepsy. When told that she did not, Ms. Lyttle said, "Well, she's having an epileptic seizure." Since the first seizure, the mother had been standing in front of J. C. holding her arms or, as instructed by Ms. Lyttle shortly after she entered the operatory, massaging her daughter's chest. She could see her daughter's eyes moving wildly, then focusing as though on something in the distance that the rest of them could not see. Sometime after Ms. Lyttle had asked about epilepsy, which probably was after 10:15 a.m., the mother told Respondent to call the hospital, but no one responded. Ms. Barlette had earlier expressed the possibility of contacting emergency medical services. At about 10:00 a.m., Ms. Barlette caught Respondent's eyes and mouthed the words, "Do you want me to call?" She did not give voice to the words to avoid further alarming the mother. Staring at him, Ms. Barlette saw no response. It is not clear that Respondent comprehended what Ms. Barlette was trying to communicate. Within 30 seconds after her voiceless request, Ms. Barlette, noting that J. C. was turning red, caught Respondent's attention and asked audibly, "Do you want me to call 911?" About one minute later, or no later than 10:02 a.m., by which time J.C. had turned purple, Ms. Barlette repeated her request. Responding to neither request, Respondent evidently was so preoccupied that he either did not hear the requests or their meaning did not register with him. Despite the clear clinical emergency, the only vital sign taken was J. C.'s pulse until 10:13 a.m., when Ms. Lyttle first read J. C.'s vital signs. Surprisingly, the chronologies prepared by Respondent, the dental chart, and the testimony fail to disclose any meaningful activity during the period from 10:15 a.m. through 10:30 a.m. By the end of this 15-minute period, the seizures, which had evidently decreased in frequency and intensity, reintensified to the degree to which they resembled the early seizures. The next entry on the chart following 10:13 a.m. is 10:30 a.m., at which time J. C.'s vital signs are blood pressure 115/44, pulse 180, and respiration irregular. The notes add, "cardiac irreg[ular with] arrhythmia." Respondent's oral and written statements to the medical examiner add that J. C. was cyanotic or becoming cyanotic at this time. Five minutes later the vitals are 90/54, 200 and climbing, and irregular respiration. In the meantime, at about 10:34 a.m., Ms. Neff took the mother out of the room so she could make any telephone calls that she thought necessary, such as to alert J.C.'s father. The mother went into a nearby conference room for a few minutes, but was unable to make any calls because she could not remember anyone's telephone number. At 10:36 a.m., the chart notes for the first time "bronchial spasms [with] laryngeal spasms." The vitals are 60/44, 200 and climbing, and irregular respiration with tachycardia. The pulse is now thready and shallow. At 10:38 or 10:39 a.m., Ms. Lyttle stated that the blood pressure had "bottomed out." J. C. was in respiratory and cardiac arrest. Ms. Lyttle asked, "Call 911?" Respondent answered, "Go." Ms. Lyttle called 911 at about 10:41 or 10:42 a.m. and summarized the situation. Ms. Barlette later helped with the call. In the meantime, Respondent had taken J. C. from the chair and placed her on the floor where he could begin CPR. She vomited and aspirated the vomit and some mucous before Respondent cleared the vomit from her mouth and upper throat. Respondent began mouth-to-mouth and Ms. Lyttle, who had left Ms. Barlette with the phone, returned and immediately commenced compressing J. C.'s chest. As the mother was returning to Operatory #2, the mother heard Ms. Barlette on the telephone saying something about "Demerol." When she reentered the operatory, she saw that her daughter was now on the floor undergoing CPR. Although still without any pulse, J. C.'s color began to return to normal. The first ambulance arrived at 10:51 a.m. The paramedics found that J. C. was unconscious. Her lung sounds were clear, her pupils dilated, and her skin warm and dry. She still had no pulse, respiration, or blood pressure. Within a couple of minutes, the paramedics, after one failed attempt, successfully intubated J. C. and began ventilating her with an ambu bag that is attached to a portable oxygen cylinder. J. C. tried unsuccessfully to take a couple of breaths. After placing MAST pants on her to force the blood from her lower extremities, the paramedics quickly placed her on a rigid back board and transported her to Florida Hospital-- Altamonte Springs. From Florida Hospital--Altamonte Springs, J. C. was transferred by helicopter to Florida Hospital--South. However, she never regained consciousness and expired the evening of the following day. At 11:09 a.m., Respondent's office informed Florida Hospital-- Altamonte Springs of the medications given. In addition to noting aspects of the emergency treatment that J. C. received from the paramedics while still in Respondent's office, including being placed on oxygen under a positive pressure delivery system, the dental chart notes at the bottom: "1) anaphylactic response . . . to Demerol." Under this entry is "2) mepivicaine." The second entry is then crossed out. The internal examination of the autopsy revealed, as to the lungs, "moderate pulmonary congestion and edema . . .." As to the brain, there was "marked generalized brain swelling and softening." As for the brain-stem, cerebellum, and portion of the cerebrum, there was "severe generalized edema and softening." Upon microscopic examination, the autopsy reveals, as to the central nervous system, no evidence of chronic hypoxia, but "diffuse marked edema and hypoxic injury . . .." The lungs show "much pulmonary edema and congestion . . . with multifocal early bronchopneumonia . . .." The report continues: The changes in the lungs are consistent with acute bronchopneumonia, due to gastric aspiration, or due to reduced pulmonary toilet from being on a respirator with a greatly decreased mental status with or without gastric aspiration. Numerous factors compel the rejection of Respondent's theories that J. C. suffered an allergic, anaphylactic, or anaphylactoid reaction, perhaps in combination with an asthma attack. The evidence is clear and convincing that Respondent administered J. C. mepivicaine in excess of the maximum recommended dosage and, as a result of the overdose, J.C. suffered a toxic reaction to the local anesthetic. In dentistry, the overadministration of a drug, including a local anesthetic, accounts for about 85% of all adverse drug reactions. Drug allergies account for only about 15% of adverse drug reactions. Drug overdoses are even slightly more common in children than in adults. The central fact is that Respondent administered an overdose of mepivicaine to J. C. of 2.7 times the maximum recommended safe dosage. The patient's young age raised the possibility of higher blood levels per unit dose due to the greater likelihood that the functions of absorption, metabolism, and excretion in a child may be imperfectly developed. Another predisposing factor of which Respondent was aware was the stress and anxiety that J.C. has previously displayed. The local- anesthetic seizure threshold is reduced in such patients. The ensuing signs and symptoms are further evidence that J. C. died due to local anesthetic toxicity caused by the administration of an overdose of mepivicaine. The first effect of a toxic reaction to mepivicaine would be to depress the central nervous system. This effect manifested itself in J. C.'s case by the first objective signs: posturing and convulsions. Characteristic of toxic reactions to local anesthetics, such as mepivicaine, is a central nervous system excitatory phase. The reason for an excitatory phase is that the neurons in the central nervous system associated with excitation or stimulation are the last to be depressed by plasma levels of local anesthetics. Once unrestrained by the now-depressed inhibitory neurons, the electrical activity proceeds freely along the stimulatory pathways and stimulates muscle tissue, which may result in convulsions. The patient suffering an allergic reaction would not experience seizures until he had suffered hypoxia, which is an oxygen deficiency. At the time of J. C.'s initial seizures, which were due to the depression of aspects of the central nervous system, her breathing was still sufficient to preclude allergy-induced hypoxia. The depression of the central nervous system also affects respiration and blood pressure, as basic brain activities begin to decrease. During the early stages of the clinical emergency, J. C. continued to try to breathe. Contrary to Respondent's assertions, these efforts coupled with labored breathing were not evidence of an allergic reaction, but were entirely characteristic of central nervous system depression. The course of a toxic reaction to a local anesthetic proceeds to respiratory depression, where, as Respondent acknowledges, the desire to breathe is decreased. Then, the patient proceeds to respiratory arrest, followed by cardiac depression and cardiac arrest. This process is the result of reduced oxygen to the brain. The central nervous system depression initiates the reduction of oxygen to the brain. The seizures themselves exacerbate the problem. The convulsing brain requires increased oxygen to continue functioning. During the seizure, the patient breathes little, if at all. Once the brain activity has been impaired to the extent that respiratory depression begins, obviously the flow of oxygen is impaired even further, which further raises the likelihood of seizures. The flow of oxygen to the brain obviously ends completely with respiratory arrest. Within four to five minutes, the oxygen-deprived brain sustains irreversible damage. The evidence of allergy, including an anaphylactic reaction, is insubstantial. As noted above, Respondent administered an excessive amount of mepivicaine to J. C., and allergic reactions are very rare relative to drug overdoses. In addition, seizures and central nervous system excitement are not typically associated with allergic or anaphylactic reactions. Likewise, high blood pressure readings are uncharacteristic of allergic or anaphylactic reactions. The patient suffering an allergic reaction, such as an anaphylactic reaction, typically suffers only depressed blood pressure. The person suffering a toxic reaction to a local anesthetic experiences, as did J. C., first high blood pressure and then decreased blood pressure. Respondent asserts that several signs suggest the presence of an allergic or anaphylactic reaction. Itching is a classic sign of an allergic reaction. However, the itching in this case has been explained above. At most, J. C. may have experienced a minor reaction to the Demerol or a substance in the mask. The timing of J. C.'s subsequent symptoms is too delayed to be attributed as an allergic or anaphylactic reaction to the Demerol, nitrous oxide, or mask itself. Because the itchiness preexisted the administration of the mepivicaine, the local anesthetic could not have caused the itching. Another classic sign of an allergic reaction is a rash, but no rash was reported in this case. The tenacious mucous that Respondent reports did not appear initially. Such mucous is nonspecific and normally attends dental procedures, especially when the patient is a child under sedation. Moreover, when the body is undergoing a crisis of the type suffered by J.C., such mucosal secretions are normal. There is no reliable evidence of significant pulmonary edema, which is the accumulation of fluids within the air cells of the lungs, until at a stage of the clinical emergency at which the sign becomes quite nonspecific. Although associated with allergic reactions, pulmonary edema and congestion may also accompany local anesthetic toxicity, especially following the onset of respiratory depression. In any event, pulmonary edema and congestion are extremely common when persons die other than suddenly, as edema and congestion are associated with the failure of the respiratory and cardiovascular systems. The evidence of bronchial spasms and wheezing offered by Respondent is unpersuasive. Although normally associated with allergic or anaphylactic reactions, bronchial spasms and wheezing, to whatever extent they existed at all, do not appear to have been defining signs or symptoms of J. C.'s clinical emergency. A case report appearing in the November-December 1991 issue of the Journal of Dentistry for Children describes a case featuring many similarities with that of J. C. In the reported case, a five year old girl was being prepared for multiple extractions. After receiving five minutes of nitrous oxide at an unknown concentration, she then received five cartridges of 3% mepivicaine or 270 mg of the drug. Ten minutes later the girl experienced "'stiffening and shaking' of all extremities that lasted approximately ten seconds." She then underwent another convulsive episode, after which she was placed on 100% oxygen. After a third convulsive episode, the patient was still breathing on her own but was no longer responsive to verbal commands. Ten minutes after the first convulsion, she was transferred to a physician's office where she arrived in cardiac and respiratory arrest. Following CPR, the patient was given sodium bicarbonate, epinephrine, calcium gluconate, and atropine about 55 minutes after being given the local anesthetic. She was then transferred to a hospital where she was intubated due to lack of spontaneous respirations. Four days later, she was declared brain dead due to anoxic brain injury secondary to cardiopulmonary arrest following an overdose of mepivicaine. The article quotes "Malamed," who is the author of Respondent Exhibit 2, as advising that the maximum safe dose of mepivicaine is two mg per pound of body weight. 5/ The case report notes that higher blood levels of mepivicaine, resulting from more high overdoses, may result in convulsions due to an initial blockage of inhibitory neurons in the CNS, thus leaving the excitatory neurons firing unopposed. Still further increases in blood levels lead to unconsciousness and respiratory depression. The cardiovascular effects of a local anesthetic overdose include vasodilation, which in turn can lead to a drop in systemic blood pressure. There is also a direct depressant effect on the myocardial cell membrane, which can cause a progressive bradycardia and full cardiac arrest. Death can occur due to either respiratory depression or cardiac arrest. It is also important to realize the narcotic sedative regimens lower the convulsive threshold of local anesthetic and increase the likelihood of respiratory depression. The case report explains that average peak blood levels of 3% mepivicaine usually appear within 15-30 minutes following injection, and the plasma half-life is 90-120 minutes. The report concludes that, based on injection volumes, the maximum safe dosages are more rapidly reached with 3% mepivicaine than with 2% lidocaine plus epinephrin, which extends the effectiveness of the local anesthetic. In addition to confirming signs and symptoms described above, the article provides evidence that, in terms of the timing of signs and symptoms, J.C. suffered from a toxic reaction to an overdose of a local anesthetic. The first seizure took place 22 minutes after the first injection and five minutes after the last, which corresponds both to the timeframe for average peak blood levels and the 10-minute delay in the reported case. Not only did Respondent clearly fail to attain the minimum standards of performance in diagnosis and treatment when measured against prevailing peer performance (Standard of Care) in administering an overdose of mepivicaine to J. C., he then failed to attain the Standard of Care in equipping himself for detecting and managing such a clinical emergency and in the actual management of the crisis. The preparation of J. C. in this case is an example of the use parenteral conscious sedation. Parenteral conscious sedation, which alters a patient's awareness, does not render the patient unconscious or affect his active reflexes, such as a choking response. This type of sedation is defined further in the Conclusions of Law. First, Respondent's office lacked a pulse oximeter. This noninvasive device constantly measures the subject's pulse and oxygen saturation level in the peripheral blood. The failure to have and use a pulse oximeter while administering parenteral conscious sedation is in itself a failure to attain the Standard of Care. With such a device in J.C.'s case, Respondent probably would have been able to detect reduced oxygen levels, as a result of central nervous system depression, well in advance of the first convulsion. With proper treatment, Respondent possibly could have prevented the convulsions and averted the ensuing clinical emergency. Second, Respondent's office lacked a positive pressure oxygen delivery device. Unlike the pulse oximeter, which is a diagnostic device, the positive pressure oxygen device is used to treat certain patients who are suffering respiratory distress. The importance of this device is underscored by the fact that it is not unusual for a patient under parenteral conscious sedation to stop breathing or require breathing assistance. The dentist must then inflate the patient's lungs, typically using one of two devices: the demand valve mask or the breathing bag. The failure to have a positive pressure oxygen delivery system during the parenteral conscious sedation of a patient is in itself a failure to attain the Standard of Care. A dentist with ready access to a pulse oximeter and positive pressure oxygen delivery device should have been able to manage J. C.'s toxic reaction to the mepivicaine without the loss of life or even serious injury. Even without a pulse oximeter, a dentist should have been able to manage this clinical emergency without the loss of life or even serious injury. The proper management of the clinical emergency requires a thorough understanding of the process by which the body reacts to an overdose of a local anesthetic. Respondent tragically failed to apprehend the significance of the mepivicaine overdose that he had administered, evidently thinking instead that J. C. was exhibiting signs of an allergic or anaphylactic reaction, possibly to the mepivicaine. The Standard of Care requires that a dentist determine in the first five minutes following a convulsion if he is going to require emergency medical services and, if so, to summon such services at that time. The first thing the dentist must do after a patient suffers a convulsion is to establish an airway, which is a direct line from the patient's mouth to his lungs. If all that is required is to tilt the head back and chin up, as Respondent did, then such action is of course is sufficient. If, as here, such action is insufficient, the Standard of Care demands that a dentist using parenteral conscious sedation be prepared and able to insert an endotracheal tube or nasal airway in order to create a path for oxygen to reach the lungs. Responding to a question concerning Respondent's care in diagnosing and treating J. C. after the onset of convulsions, Respondent's expert, Dr. Wecht, conceded that Respondent failed to attain the Standard of Care: I think, with the time sequence here, given the circumstances, the panic, the anxiety, you know, were all understandable. I don't see anything dramatically negligent here in terms of wanton gross neglect, criminal negligence and so on. I just don't see it. Could this case be argued in the context of plain, unadorned negligence, could it be a bona fide malpractice case? Those are reasonable observations and inquiries, and I would be the first one to say that the answer to that could, indeed, be yes . . .. Respondent Exhibit 6, page 43. Respondent failed to manage the clinical emergency in a manner consistent with the Standard of Care. The evidence is overwhelming that he did not in fact maintain an effective airway. He was critically handicapped by the absence of a positive pressure oxygen delivery system. Switching the nitrous oxide machine to 100% oxygen did not help J. C., whose inspirations had become so impaired that she required ventilation. Had Respondent commenced CPR within the first few minutes of the onset of the convulsions, rather than about 45 minutes later, the brain injury might have been minimal. However, by the time Respondent commenced CPR, it was too late. By this time, ventilating the patient with 100% oxygen, as the paramedics did upon their arrival 12 minutes later, could do nothing for the severe brain damage that J. C. had already suffered. Respondent again failed to attain the Standard of Care by not summoning paramedics for about 45 minutes after the initial convulsion. Had he heeded the request of Ms. Barlette to call 911, there is a good chance that J. C. would not have died, notwithstanding Respondent's administration of an overdose of mepivicaine, absence of vital equipment, and evident inability to diagnose and treat the ensuing clinical emergency. Malamed, quoting Goodson and Moore, "Life Threatening Reactions after Pedontic Sedation: an Assessment of Narcotic, Local-Anesthetic, and Antiemetic Drug Interaction," in the Journal of American Dental Association, 107:239, 1983, states that the use of sedative techniques accompanied by the administration of narcotics requires continual monitoring of the cardiovascular and respiratory systems, ability of the practitioner to recognize and control the respiratory arrest and convulsions that are "easily induce[d]" by multiple sedative drug techniques, careful selection of dosages based on the body weight of the patient, and readiness to change the technique of sedation or choice of drugs at a later appointment rather than merely increasing the dosage when the initial dosage proves inadequate. Malamed reports that a recent three-year study attributed most deaths occurring in the dental practice related to the administration of drugs involved three factors: Improper preoperative evaluation of the patient. Lack of knowledge of drug pharmacology by the doctor. Lack of adequate monitoring during the procedure. Id. at p. 299. Malamed concludes: . . . with care on the part of the doctor, the incidence of [an overdose reaction to the administration of CNS-depressant drugs] should be extremely low, and a successful outcome should occur virtually every time. Id. On March 28, 1991, Respondent was indicted for the second degree felony of manslaughter in connection with the death of J. C. In a supplemental statement of particulars, the State of Florida alleged that Respondent administered an inappropriately high dosage of mepivicaine, Respondent's office was not equipped with a pulse oximeter or positive pressure oxygen delivery system, Respondent failed timely to contact emergency medical services, and Respondent thereby displayed a reckless disregard for human life. By plea agreement signed October 31, 1991, Respondent pleaded nolo contendere to the charge of manslaughter and waived his right to appeal any pretrial rulings. He was adjudicated guilty by judgment entered the same day and sentenced, pursuant to the agreement, to six months' community control followed by five years' supervised probation, together with various costs.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that the Board of Dentistry enter a final order revoking the license of Respondent. ENTERED this 24th day of February, 1992, in Tallahassee, Florida. ROBERT E. MEALE 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 24th day of February, 1992.
The Issue The issue posed herein is whether or not the Petitioner's imposition of a civil penalty upon Respondent in the amount of $750.00, based on conduct which is set forth hereinafter in detail, should be upheld.
Findings Of Fact Based on the testimony of the witnesses and their demeanor while testifying, the arguments of counsel and Respondent's representative, the documentary evidence received and the entire record compiled herein, the following relevant facts are found. On October 2 and 3, 1979, Petitioner's inspection team led by Jules M. Gayle, Hospital Consultant, made a routine annual inspection of Hollywood Hills Nursing Home (herein sometimes called Respondent or the Home). Based on this inspection, Respondent was issued a list of deficiencies and allowed thru October 6, 1979 to correct same. The deficiencies cited were: A patient in Room #4 had oxygen in use with an improperly grounded electric lamp in use. A patient in Room #61 had oxygen tank in use not properly secured to a base pedestal and an electric clock located on a table next to tank was improperly grounded. The oxygen storage room on the second floor, opposite the elevator shaft, had one tank of oxygen not firmly secured on chain attachment; a prefilled humidifier attachment was left exposed to air, dust and possible bacteria contamination. A full oxygen tank stored within the first floor storage area exhibited a cannula attachment to a prefilled humidifier bottle not encased in any protective covering with the nasal apertures dangling from the tank and resting upon the dirty floor. Approximately 20-23 patients in wheelchairs were observed obstructing the first floor corridor passageway, and a similar situation existed on the second floor corridor, a hazard in the event of an emergency. Two psychiatric hospital or maximum security seclusion rooms, located within the nursing home proper, pose a potential hazard to nursing home patients and to staff. The toilet room ceiling in patient Room #65 was covered with a green mold fungus growth. A follow-up inspection of the home on November 15, 1979 indicated that, with the exception of the mass assembly of patients in the corridor, the cited deficiencies were not corrected. (Testimony of Jules M. Gayle). Based on the results of the follow-up inspection, Respondent was noticed by Petitioner's Administrative Complaint dated February 21, 1980, that a $750.00 fine would be imposed. The Home is a 200 bed facility which is licensed to care for 100 psychiatric and 100 regular patients in need of nursing care. All of the beds (psychiatric and general) are housed under one roof with a security door divider. RESPONDENT'S DEFENSE Messr. Steve M. Raizin, Administrator for the Home related that the Home has a policy of correcting deficiencies as soon as practicable. As examples of this policy, the Administrator pointed out that a dietician was replaced when criticism arose respecting unsanitary conditions of the kitchen and the improper dispensing of food; a roof replacement at a cost of approximately $40,000 when the Home was cited and the purchase of a dumpster for trash and refuse at a cost to the Home of $10,000. The Home immediately removed the improperly grounded electrical lamp and radio from the patients room. The large congregation of patients in the corridor was a result of patients being transferred from the activity room to the cafeteria. The Administrator has attempted to convert the psychiatric seclusion rooms but has encountered resistence and opposition by the local Health Planning Council and the Courts. Finally Respondent has, according to the Administrator, taken steps (unspecified) to ensure the safety of all patients. Even assuming that Respondent has taken the corrective actions set out above, there remains outstanding deficiencies which, as best as can be determined by the record, remain uncorrected. For example, it appears that the cited problem of an unsecured oxygen tank still exists. No mention was made by Respondent's Administrator as to what, if any, corrective action was taken to cover the exposed prefilled humidifier attachment and the fungus growth in the toilet of Room 65. That being the case, in view of the record evidence that these problems exist, it can only be concluded that the deficiencies remain (Petitioners Composite Exhibit #1 and Testimony of Jules M. Gayle). Any one of the above deficiencies amount to a violation of Section 400.141(4)(h), Florida Statutes, for which Respondent is subject to a civil penalty of not less than $500.00 and not more than $1,000.00 for each deficiency. I shall therefore recommend that Petitioner's imposition of a $750.00 civil penalty be upheld.
Recommendation Based on the Foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED: That the Petitioner's imposition of a civil penalty in the amount of $750.00 be UPHELD. RECOMMENDED this 21st day of July, 1980, in Tallahassee, Florida. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings Room 101 Collins Building Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of July, 1980. COPIES FURNISHED: Harold Braynon, Esquire District X Legal Counsel Department of Health and Rehabilitative Services 201 West Broward Boulevard Fort Lauderdale, Florida 33301 Steve M. Raizin, M.H.A. Administrator Hollywood Hills Nursing Home 1200 North Thirty-fifth Avenue Hollywood, Florida 33021
