Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: The petitioner Brookwood Medical Center of Lake City, Inc., d/b/a Lake City Medical Center (hereinafter referred to as LCMC) is a 75-bed acute care hospital, which presently has 65 medical/surgical beds and 10 alcohol treatment beds. Plans are under way to convert 10 of the medical/surgical beds to a psychiatric unit with 10 beds. LCMC primarily serves Columbia County, a primarily rural community with a population of 34,625, and derives 74 percent of its patients therefrom. The remaining 261 of its admissions come from the surrounding counties of Hamilton, Lafayette and Suwannee. Approximately 60 percent of its patients are sixty years of age or older. The source of reimbursement for the year 1980 was 40 percent Medicare, 8 percent Medicaid, 8 percent indigent or bad debt, and the remaining portion from other third-party payors. The current occupancy rate at LCMC is approximately 502 or 37.5 patients per day. Seasonal trends cause this figure to vary between 32 and 37.5. The daily census is expected to increase over the next year due to the planned addition of four new programs. These include the ten-bed psychiatric unit for which a Certificate of Need application is pending, an industrial medical and occupational health program which would provide on-site care to employees and their family members, the recruitment of an internist/cardiologist and the recruitment of an ophthalmologist. It is projected that the proposed new psychiatric unit will add eight patients to LCMC's daily census, the industrial health program will add 2.5 patients per day as well as outpatients, and that the internist/cardiologist will generate five patients per day. Psychiatric beds are less likely to generate intensive care patients than medical/surgical beds. It is expected that LCMC's program of expansion will change the mix of the primary and secondary service areas and will increase the average daily census to 42.5 by the end of 1981. Petitioner presently has a nursing staff of 48 and a medical staff of Of its medical staff, 13 are listed as active, 4 as courtesy, 4 as consulting and one with temporary privileges. LCMC has one operating room, no emergency room, and no intensive care/cardiac care unit (also referred to as IC/CCU). On an average basis, it is estimated that from ten to twelve surgical procedures per week are performed at LCMC. In 1980, 468 surgical procedures were performed. For the first quarter of 1981, the busiest time of the year, 156 surgical procedures were performed. Petitioner does have a step-down unit or a progressive care unit (also referred to as PCU) with four beds. The current utilization of the PCU is 2.7 patients per day, with a 50 percent medical component and a 50 percent surgical component. If petitioner's application for a Certificate of Need were granted, LCMC's PCU would be converted to an IC/CCU with invasive monitoring capabilities and patients who currently receive treatment in the PCU would be treated in the new IC/CCU. The current patient charge for the PCU is $111.00 per day. LCMC proposes an IC/CCU charge of $250.00 per day. Petitioner estimates that 8 percent of its patients would need and use an IC/CCU, and that, for the first year of operation, the IC/CCU would have a daily census of 3.5 patients. For the second year of operation, a daily patient census of 4.5 is projected. The projected daily utilization of over 50 percent is not consistent with actual utilization achieved in the IC/CCUs of other hospitals in the area. The prime concept of an IC/CCU is to provide more intensive nursing care and monitoring capabilities for unstable medical and surgical patients. The majority of admissions to an IC/CCU come from the emergency room and the second largest source is from the operating room after surgery. While some physicians feel that no physician or acute care facility should be without an IC/CCU, that all post-operative patients should be monitored in an ICU and that it is not good practice to transport an unstable patient under any circumstances, others disagree. These physicians, while agreeing that all hospitals need some form of life support capability, feel that for general routine surgery, only a very small percentage of patients are in need of an intensive care unit. It is possible to reduce the need for an intensive care unit by screening patients prior to surgery. A recovery room and/or a progressive care unit can provide the routine noninvasive monitoring and more intensive nursing care and observation needed by many medical and surgical patients. The use of a recovery room for critical care patients does pose serious problems due to the exposure to additional commotion and the potential mixing of well surgical patients with septic unstable patients. It is better medical practice to have separate personnel for infectious and noninfectious patients. The transfer of an unstable patient to another facility can pose serious risk to the patient. The intervenor Lake Shore Hospital (also referred to as LSH) is located approximately 1.5 miles from the petitioner. Lake Shore Hospital is a full- service, acute care, public hospital with 128 beds, an emergency room and a 9- bed IC/CCU. LSH has had an IC/CCU since 1970 or 1971. More than 50 percent of its intensive care patients come from its emergency room. Approximately 1600 surgical operations per year are performed at LSH. The IC/CCU at LSH provides basic noninvasive monitoring equipment connected to the patient's bedside and the nurses' stations. It does not presently have Swans-Ganz monitoring equipment, an invasive device which measures a patient's hemodynamics. The wiring and other equipment for two such monitoring capabilities are in place and, with the addition of a module and transducer for each unit, two units can be installed for a cost of approximately $4,400.00. At the present time, no one in Lake City has the extensive training required to utilize the Swans-Ganz monitoring equipment. LSH is in the recruitment process and plans to purchase and install this equipment when a cardiologist or other trained specialist is recruited. The IC/CCU at LSH experiences an occupancy rate of 3.5 patients per day, or 35 percent of its capacity. It has only achieved full capacity on two occasions in the ten years of its existence. Lake Shore Hospital presently charges $275.00 per day for the use of its IC/CCU. If it were to lose one patient per day, LSH would lose approximately $100,000.00 per year in revenue. Such a loss could result in either increased taxes or increased patient charges. In spite of the fact that several major admittors to LCMC and LSH have their offices at LCMC, It was their testimony that were a Certificate of Need granted to LCMC for an IC/CCU, they would continue to admit and refer patients to both facilities. Lake Shore Hospital has a medical staff of 22 or 23 specialists and nonspecialists. Of this number, all but one are also on the staff of Lake City Medical Center. The PCU at LCMC and the IC/CCU at LSH are presently comparable. While the nursing staff at Lake Shore's IC/CCU is better trained, at least one physician who practices at both hospitals felt that the same level of care could presently be obtained at LCMC's PCU as at LSH's IC/CCU. This is due to the fact that LSH does not now have the invasive monitoring capabilities felt to be essential to an IC/CCU. The traditional difference between a PCU and an IC/CCU is the degree of training of the nursing staff and the sophistication of the equipment. Underutilization of an IC/CCU can have an adverse effect upon the quality of care provided. One of the most important aspects of an intensive care unit is superior trained personnel. A reduction in patient use obviously reduces the personnel's exposure to complications and skills become dull. Thus, a reduction in patients reduces the quality of care. There is presently a shortage of nurses in the Lake City area. Lake Shore Hospital presently has 8 nursing vacancies and has been actively recruiting to fill those vacancies. In order to operate its proposed IC/CCU, LCMC would have to employ two full-time equivalent nurses with training in that area. The petitioner projects the cost of its requested IC/CCU to be $240,000.00. In 1979, LCMC ran a deficit of $1 million, the sixth largest loss in the State. In 1980, the deficit was $390,000.00. LCMC is presently experiencing a positive cash flow for 1981. It appears that LCMC anticipates the proposed IC/CCU to be a profit-making venture and projects that, if its presumptions are true with respect to patient use, the project will be financially feasible. At the time of the hearing, negotiations were under way for the sale of petitioner to another entity. The reviewing Health Systems Agency, the North Central Florida Health Planning Council, Inc. (NCFHPC), unanimously denied the petitioner's request for an IC/CCU at every level of the review process. The 1981-1985 Health Systems Plan for the NCFHPC contains certain criteria and standards for intensive and coronary care units which should he met within five years of operation. Two of the criteria are that an IC/CCU should have an average annual occupancy rate of 80 percent and that an IC/CCU should be available within one hour's (one-way) travel time of 95 percent of the region's residents. As noted above, LSH is approximately 1.5 miles away from LCMC. Lake City is 45 miles from Gainesville and 65 miles from Jacksonville with interstate highways connecting these cities. With an optimal utilization rate of 80 percent, it is projected that 8.5 IC/CCU beds are needed in the planning area in 1980, and, by 1985, there will be a need for 9 beds. There are presently 15 IC/CCU beds in the Level 2 planning area, which includes Lafayette, Suwannee, Hamilton and Columbia Counties. Of the licensed 212 acute care medical/surgical hospitals in Florida, 22 or 10 percent do not have intensive or coronary care units. The approximate bed size of most of these facilities is 50.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that petitioner's application for a Certificate of Need to construct and operate an intensive care/coronary care unit at Lake City Medical Center be DENIED. Respectfully submitted and entered this 7th day of August, 1981, in Tallahassee, Florida. DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 7th day of August, 1981. COPIES FURNISHED: John H. French, Jr. Messer, Rhodes and Vickers Post Office Box 1876 Tallahassee, Florida 32301 Donna H. Stinson General Counsel Department of HRS 1323 Winewood Boulevard Tallahassee, Florida 32301 Jon Moyle and Thomas Sheehan, III Moyle, Jones and Flannagan, P.A. 707 North Flagler Drive Post Office Box 3888 West Palm Beach, Florida 33402 Honorable Alvin J. Taylor Secretary, Department of HRS 1323 Winewood Boulevard Tallahassee, Florida 32301
The Issue Whether Respondent should recoup Medicaid payments made to Petitioner for health care services provided to eight patients.
Findings Of Fact Petitioner, Indian River Memorial Hospital, Inc., (Hospital), has contracted with Respondent, Agency for Health Care Administration (AHCA), to provide services to Medicaid patients. The parties have agreed that there is a dispute for Medicaid reimbursement for goods and services provided to eight patients: S.G., J.D., R.J., C.A., G.M., S.S., M.P., and C.T. The Agency has paid the Hospital for the services rendered to these eight patients and seeks to recoup the payment based on a retrospective review by a peer review organization, Keystone Peer Review Organization (KePro). The Agency claims that either the admission or a portion of the length-of-stay for the eight patients was medically unnecessary. Services were provided to C.T. in 1994 and to the remainder of the patients at issue in 1995. Payment for Medicaid services is on a per diem basis. The rate for 1994 is $473.22 per day, and the rate for 1995 is $752.14. The Agency contracted with KePro to do a review of the Medicaid payments to the Hospital. KePro employs nurses to review the patient files based on criteria on discharge screens. If the services meet the criteria, there is no further review and the payment is approved. If the nurse determines that the services do not meet the criteria on the discharge screens, the patient's files are reviewed by a board certified physician, who in this case would be a psychiatrist. If the physician determines that the services are not medically necessary, a letter is sent to the Medicaid provider, giving the provider an opportunity to submit additional information. Additional information submitted by the provider is reviewed by a board certified physician. If the doctor concludes that the services are still medically unnecessary, the provider is notified that that services do not qualify for reimbursement and the provider may ask for a reconsideration of the denial. If the provider seeks reconsideration, the file is reviewed by a physician, and the provider has an opportunity to be present during the review. If the physician determines that the services are medically unnecessary, KePro sends a letter to the Agency stating the reasons for denial. The denial letters that KePro sends to the Agency are reviewed by the Medical Director of KePro, who is not a psychiatrist. Dr. John Sullenberger, the Agency's Medicaid physician, reviews the KePro denial letters sent to the Agency, and 99.9 percent of the time he agrees with the findings of KePro regarding whether the services were medically necessary. Dr. Sullenberger does not review the patient's charts when he does this review. The Agency sends a recoupment letter to the Medicaid provider requesting repayment for services provided. Patient S.G., a 12 year-old boy, was being treated pursuant to the Baker Act. He was admitted to the Hospital on March 8, 1995, and discharged on March 25, 1995. The Agency denied Medicaid reimbursement for the admission and the entire length-of-stay for S.G. based on KePro's determination that it was not medically necessary for the services to S.G. to be rendered in an acute care setting because the patient was neither suicidal nor homicidal. Three to five days prior to his admission to the Hospital, S.G. had attempted to stab his father. He also had further violent episodes, including jumping his father from behind and choking him and pulling knives on his parents. S.G. had a history of attention deficit and hyperactive disorder. He had been using multiple substances, such as alcohol, LSD, cocaine, and marijuana, prior to his admission. His behavior was a clear reference that he was suffering from a psychosis. A psychosis is a significant inability to understand what is reality, including delusions of false beliefs, hallucinations, hearing and seeing things which do not exist, and ways of thinking that are bizarre. Psychosis is a reason to admit a patient, particularly combined with substance abuse. S.G.'s treating psychiatrist noted that S.G. had tangentiality, which means that his thoughts did not stay together. He did not have a connection between thoughts, which is a sign of a psychosis. The chart demonstrated that S.G. had disorder thinking, which includes the possibility of a psychosis. There was also a reference in the charts to organic mental disturbance which could infer brain damage as the cause for the mental disturbance. Two days after admission, there was an issue of possible drug withdrawal because S.G. was agitated and anxious and showed other symptoms. Drug withdrawal, psychosis, and a demonstration of overt violence require a stay in an acute care facility. There was some indication that S.G. was suicidal. While in the Hospital he was placed under close observation, which is a schedule of 15-minute checks to determine if the patient was physically out of harm's way. S.G. was started on an antidepressant, Wellbutrin, because the treating physician thought S.G. was becoming increasingly depressed and was having trouble organizing his thoughts. Antidepressants, as contrasted to a medication such as an antibiotic, may take a minimum of two to three weeks before the patient will benefit from the full effect of the drug. It is difficult to stabilize the dosage for an antidepressant on an outpatient basis. S.G. was taking Ritalin, which is commonly used for children with attention deficit, hyperactivity disorders. During his stay at the Hospital, S.G. was engaging in strange behavior, including absence seizures. On March 16, 1995, he was still lunging and threatening harm. On March 20, 1995, he was still unstable and at risk. The dosage of Wellbutrin was increased. On March 21 and 22, 1995, S.G. was still threatening and confused. S.G. was discharged on March 25, 1995. The admission and length-of-stay for S.G. were medically necessary. Patient J.D. was a 16 year-old boy who was admitted to the Hospital on March 7, 1995, and discharged on March 14, 1995. The Agency denied the admission and entire length-of-stay based on KePro's determination that the patient was not actively suicidal or psychotic and services could have been rendered in a less acute setting. J.D. was admitted from a partial hospitalization program pursuant to the Baker Act because he was observed by a health care professional banging his head against the wall and throwing himself on the floor. He had a history of depression and out-of-control behavior, including being a danger to himself and running away. At the time of his admission, he was taking Prozac. Banging his head against the wall can mean that the patient is psychotic, can cause brain damage, and can be dangerous if the cause of the behavior is unknown. Admission to the Hospital was justified because the patient was extremely agitated and self abusive, requiring restraints and medication to decrease his agitation and self abusiveness. One of the tests administered during his hospital stay indicated that J.D. was a moderate risk for suicidal behavior. During his hospital stay, it was discovered that J.D. had threatened to kill himself while at school. He had been in a partial treatment program during the day, but that environment was not working. There was violence in the home, and J.D. was becoming overtly depressed. During his stay at the Hospital, J.D. was placed on close observation with 15-minute checks. His dosage of Prozac was increased. The admission and length-of-stay for J.D. were medically necessary. R.J., a 10 year-old male, was admitted to the Hospital on January 1, 1995, and discharged on February 9, 1995. The Agency denied Medicaid reimbursement based on a determination by KePro that the treatment in an acute care facility was not medically necessary because R.J. was not psychotic, not suicidal, and not a threat to others; thus treatment could have been provided in an alternate setting. R.J. had been referred by a health care professional at Horizon Center, an outpatient center, because of progressive deterioration over the previous fourteen months despite outpatient treatment. His deterioration included anger with temper outbursts, uncontrollable behavior at school, failing grades, sadness, depressed mood, extreme anxiety, extensive worrying and a fear of his grandmother. R.J. also suffered from encopresis, a bowel incontinence. He was agitated, lacked energy, neglected his hygiene, experienced crying spells, and had difficulty concentrating. R.J. needed to be admitted for an evaluation to rule out a paranoid psychosis. It was necessary to do a 24-hour EEG as opposed to a 45-minute EEG. In order to do a 24-hour EEG, the patient is typically placed in an acute care facility. The EEG showed abnormal discharge in the brain, which could be contributing to a psychiatric illness. At school R.J. had smeared feces on the walls, behavior that could be seen in psychotic persons. There was evidence that he had been hitting and throwing his stepbrother and 3 year-old brother. He was fearful of his grandmother and, based on his family history, there was reason to fear her. R.J. was placed on Buspar, a medication which generally takes two weeks to take effect. Contrary to the Agency's determination, R.J. was disorganized. He was also violent in terms of threatening danger and extreme anger. The admission and length-of-stay for R.J. at the Hospital were medically necessary. Patient C.A., a 9 year-old male, was admitted to the Hospital on June 1, 1995, and discharged on June 12, 1995. The Agency disallowed one day of the length-of-stay based on a determination by KePro that the services provided on June 11, 1995, could have been provided in a less restrictive setting. C.A. was admitted for violent and disruptive behavior. He also had an attention deficit, hyperactivity disorder and was taking Lithium and Depakote. These medications are used for patients who experience serious mood swings and abrupt changes in mood, going from depression to anger to euphoria. To be effective, medicating with Lithium and Depakote requires that the blood levels of the patient be monitored and the dosage titrated according to blood level. C.A. also was given Wellbutrin during his hospital stay. On June 11, 1995, C.A. was given an eight-hour pass to leave the hospital in the care of his mother. The physician's orders indicated that the pass was to determine how well C.A. did in a less restrictive setting. He returned to the Hospital without incident. He was discharged the next day to his mother. The treatment on June 11, 1995, could have been provided in an environment other than an acute facility; thus the stay on June 11, 1995, was not medically necessary for Medicaid reimbursement purposes. Patient G.M., an 11 year-old male with a history of being physically and sexually abused by his parents, was admitted to the Hospital on March 21, 1995, and was discharged on April 3, 1995. The Agency denied Medicaid reimbursement for inpatient hospital treatment from March 28 to April 3, 1995, based on KePro's determination that the length of hospital stay exceeded health care needs at an inpatient level and could have been provided in a less acute setting. At the time of admission, G.M. had suicidal ideation. His school had reported that G.M. had mutilated himself with a pencil, banged himself on the knuckles, and told the school nurse that he wanted to die. Prior to admission, G.M. had been taking Ritalin. His treating physician took G.M. off the Ritalin so that she could assess his condition and start another medication after a base-line period. The doctor prescribed Clonidine for G.M. Clonidine is a drug used in children to control reckless, agressive and angry behavior. Clonidine must be titrated in order to establish the correct dosage for the patient. During his hospital stay, G.M. was yelling and threatening staff. He was placed in locked seclusion, where he began hitting the wall. G.M. was put in a papoose, which is similar to a straitjacket. The papoose is used when there is no other way to control the patient. The patient cannot use his arms or legs while in a papoose. This type of behavior and confinement was occurring as late as March 31, 1995. G.M. was given a pass to go to his grandparents on April 2, 1995. He did well during his pass, and was discharged on April 3, 1995. Treatment in an acute facility was medically necessary through April 1, 1995. Treatment on April 2, 1995, could have been provided in a less acute setting. Patient S.S., a 5 year-old male, was admitted to the Hospital on March 9, 1995, and was discharged on April 3, 1995. The Agency denied Medicaid reimbursement for the admission and entire length of his hospital stay based on a determination by KePro that S.S. was not psychotic or an immediate danger to himself or others and the evaluation and treatment could have been rendered in a less acute setting. Prior to admission to the Hospital, S.S. was threatening suicide, ran into a chalk board at school, scratched his arms until they bled, and showed aggressive intent toward his sister, saying that he would kill her with a saw. S.S.'s condition had been deteriorating for approximately three months before his admission. At the time of admission, he had been suicidal, hyperactive, restless, and experiencing hallucinations. The hallucinations imply a psychosis. S.S. was put on Trofanil, an antidepressant which needs to be titrated. The patient's blood level had to be monitored while taking this drug. During his hospital stay, S.S. was on close observation. All objects which he could use to harm himself were removed from his possession. After he ate his meals, the hospital staff would immediately remove all eating utensils. On March 28, 1995, S.S. threatened to kill himself and became self-abusive. His blood level on March 31, 1995, was sub-therapeutic, and his medication dosage was increased. On April 1, 1995, S.S. had a temper tantrum. The admission and length-of-stay for the treatment of S.S. were medically necessary. Patient M.P., a 10 year-old male, was admitted to the Hospital on April 27, 1995, and was discharged on May 6, 1995. The Agency denied Medicaid reimbursement for the admission and entire length-of-stay based on a determination by KePro that the patient functions on an eighteen to twenty-four month level but is not psychotic and the treatment could have been provided in a less acute setting. M.P.'s IQ is between 44 and 51. He was diagnosed with a pervasive development disorder, which is a serious lack of development attributed to significant brain damage. His condition had deteriorated in the six months prior to his admission. He had episodes of inappropriate laughter, fits of anger, hit his head, hit windows, and put his arm in contact with the broken glass through the window. At the time of his admission, he had a seizure disorder. An EEG and an MRI needed to be performed on M.P. in order to evaluate his condition. M.P. had to have a regular EEG, a 24-hour EEG, and a neurological examination. The patient was aggressive, restless, and uncooperative. In order for the MRI to be performed, M.P. had to be anesthetized. The admission and length-of-stay for M.P. were medically necessary. Patient C.T., a 34 year-old female, was admitted to the Hospital on November 11, 1994, and was discharged on November 26, 1994. The Agency denied the treatment from November 17, 1994, to November 26, 1994, based on a determination by a peer review organization that the patient was stable by November 17, 1994, and psychiatric follow-up could have been performed in an outpatient setting. C.T. was admitted for kidney stones. She did pass the kidney stones but continued to have severe pain. Her doctor asked for a psychiatric consult. The psychiatrist diagnosed C.T. as having a personality disorder, chronic psychogenic pain disorder, and an eating disorder. Her depressive disorder exacerbated pain. C.T. had been given narcotics for the pain associated with the kidney stones. In order to assess her mental status, the physicians needed to taper the dosage of Demerol which she had been receiving. She was started on Sinequan, which is an anti-depressant given to alleviate the psychological condition and to help with the physical complaints. C.T. was later put on Vicodin, an oral narcotic, which seemed to bring the pain under control. The drugs used could cause a drop in blood pressure; therefore, they had to be titrated slowly. Her treating physician was trying to find an appropriate anti-depressant, while weaning the patient from intramuscular narcotics. On November 17, 1994, C.T. left her room and went to the hospital lobby, where she was found by nursing staff. C.T. was crying and saying that she was in pain and wanted to die. During her hospital stay, C.T. was in much distress; she would scream out that she was in pain. On November 18, 1994, she was found crying on the floor of the hospital chapel and had to be returned to her room. It was the opinion of Dr. Bernard Frankel, an expert retained by the Hospital, that C.T. probably could have been discharged a day earlier. The hospital stay for C.T. from November 17, 1994, to November 25, 1994, was medically necessary. The last day of her stay was not medically necessary.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered requiring Indian River Memorial Hospital, Inc., to pay to the Agency $752.14 for one day of service provided to G.M., $752.14 for one day of service provided to C.A., and $473.22 for one day of service provided to C.T. and finding that the Hospital is not liable for payment for any of the other services at issue in this proceeding. DONE AND ENTERED this 2nd day of November, 1998, in Tallahassee, Leon County, Florida. SUSAN B. KIRKLAND 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 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of November, 1998. COPIES FURNISHED: Thomas Falkinburg, Esquire Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308 John D. Buchanan, Jr., Esquire Henry, Buchanan, Hudson, Suber & Williams, P.A. 117 South Gadsden Street Tallahassee, Florida 32302 Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308 Paul J. Martin, General Counsel Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308
The Issue The ultimate issue to be resolved in this proceeding is whether the SSDB's proposal to construct a freestanding ambulatory surgery center in Volusia County, Florida, should be approved or denied. SSDB and the Department contend that the proposal meets statutory criteria and comports with the Department's rules. SSDB and the Department contend that there is a need for the facility and that SSDB is fully competent to construct and operate the facility. OBMH and HHMC contend that there is no need for the proposed facility, that the facility is not likely to be an economically viable venture, that the facility would injure existing businesses, and that the application should be denied because SSDB did not file a letter of intent with the local health council in a timely manner.
Findings Of Fact SSDB is a corporation that is a wholly owned subsidiary of Surgical Inc. Eighty percent of the stock of Surgical Services, Inc., is owned by American Medical International, Inc., a large, multinational health care corporation which owns and operates hospitals and other health care services. American Medical International is the third largest health care provider in the United States. The remaining 20 percent of Surgical Services, Inc., stock is owned by Randall L. Phillips, the company's president. SSDB is proposing to construct and operate a freestanding ambulatory surgery center in Daytona Beach, Volusia County, Florida. The service area for the proposed facility would be Volusia County. This facility would house four operating rooms and would be designed to handle all types of surgical procedures that can be performed on an outpatient basis. SSDB has entered into a contract to purchase land that provides a suitable site for the facility. It is located at the intersection of Clyde Morris Boulevard and Mason Avenue in Daytona Beach. The contract price for the property is $270,000. In addition to the cost of land acquisition, the preopening costs of the project would total $2,080,000. That amount would cover legal and accounting fees, architectural and engineering fees, a site survey, consulting fees, construction costs, movable equipment costs, and other engineering expenses. The preopening cost estimates are less than the $2,500,000 estimated in the original Certificate of Need application. The reduction is attributable to cost efficiencies primarily in selection and purchase of equipment. The costs estimated by SSDB are adequate to cover all preopening expenses and to provide an adequate facility. Financial support for the facility will be provided by American Medical International. This will include an equity contribution, a loan, and all necessary working capital. American Medical International has committed to provide financing adequate to construct and operate the facility. American Medical International has the financial resources to fulfill this commitment. The facility proposed by SSDB would be 15,500 square feet in size. The design is adequate for the proposed use and satisfies applicable health care facility standards and state and federal laws. The equipment proposed for the facility is sufficient to allow the handling of anticipated types of procedures. The facility will be open to all physicians qualified to perform the types of surgery that can be tone within an ambulatory setting. The facility will accept Medicare patients. The facility will admit any patient scheduled by surgeons, and ability to pay will not be a criterion for admission. SSDB has developed a marketing program to attract physicians and patients to the facility. SSDB has proposed adequate staffing for its facility and will be able to fulfill its staff requirements. SSDB is fully competent, given its backing by American Medical International, to construct and operate the proposed facility. OBMH is a Florida nonprofit corporation. It operates a 205-bed hospital in Volusia County, Florida, and renders medical services to residents of Volusia County and surrounding areas. OBMH presently renders ambulatory surgical services on an outpatient basis in connection with its surgery department. MEMO is a special taxing district. It operates a 345-bed hospital in Volusia County, Florida, and services residents of Volusia County and surrounding areas. HEM has a same-day surgery program and renders ambulatory surgical services through this procam on an outpatient basis. Ambulatory surgical services can be performed either in a hospital- based setting such as operated by OBMH and HHMC, or in a freestanding facility such as proposed by SSDB. HHMC presently has 12 general-purpose operating rooms. The HHMC same-day surgery program utilizes these rooms, but has a separate admitting area and waiting room that is utilized for inpatient surgery cases. OBMH has four general-purpose operating rooms. Outpatient or ambulatory surgeries are regularly performed in these rooms. There are presently 41 general-purpose operating rooms in Volusia County's eight hospitals. Outpatient or ambulatory surgical procedures are performed in these rooms. The Florida Health Care Plan is a health maintenance organization located in Volusia County. It has three operating rooms here inpatient or ambulatory surgery procedures are performed for members of the organization. The Neuman Dye Institute is a freestanding ambulatory surgical center licensed by the Department. It is located in DeLand, Volusia County, Florida. It has two operating rooms which are used for treatment of eye disorders. Approximately 15 percent of the surgeries performed in hospitals in Volusia County during the year August 1, 1982, through July 31, 1983, were done on an outpatient basis. The total number of surgical procedures performed in Volusia County has increased only slightly during the past three years. The number of impatient procedures has decreased, while the number of outpatient procedures has increased rather dramatically. This increase reflects a national trend which increasingly favors ambulatory or outpatient surgeries. It is likely that the number of outpatient cases as a percentage of total surgeries will continue to increase in Volusia County. The 15 percent figure for outpatient surgeries relates only to those procedures conducted in a hospital setting. It does not include procedures performed at the health maintenance organization, the Neuman Eye Institute, or in physicians offices. One major source of patients for ambulatory surgery programs is elective plastic surgery procedures. Two of the plastic surgeons who practice in Volusia County have their own operating rooms where ambulatory surgical procedures can be conducted. These physicians are not likely to use a separate, freestanding facility. The remaining plastic surgeons in Volusia County have utilized the same-day surgery facility at HHMC and have expressed satisfaction with that program. Existing facilities in Volusia County are adequate to accommodate the anticipated growth and the number of outpatient or ambulatory surgeries that will be performed during the next three years in Volusia County. Hospital surgical facilities in Volusia County are significantly underutilized at present. Existing facilities have the capacity to accommodate a more dramatic increase in total surgical procedures and in outpatient surgical procedures than is anticipated over the next three years. Given the existence of the hospital facilities, the Neuman Eye Institute, the health maintenance organization, and operating rooms located in physicians' offices, adequate facilities exist to accommodate the increased demand for outpatient surgeries that is anticipated in Volusia County. SSDB is proposing to offer its services to the public during the first year of operation for an average charge of $490 per procedure. The cost would increase to $540 for the second year. The average per-case cost for outpatient surgeries at HHMC is $393. The average per-case cost at OBMH is $439. Given the fact that one case can Involve multiple procedures, it is evident that existing facilities in Volusia County are charging less for ambulatory surgical services than SSDB proposes to charge. While some increases in present charges are likely, given general trends, it is not likely that HHMC or OBMH will charge as much for outpatient surgical procedures as SSDB proposes to charge. It has been asserted that HHMC's charges for outpatient surgeries are inadequate to cover HHMC's costs and that the charges are being kept low artificially. The evidence is to the contrary. HHMC's charges for outpatient surgeries are adequate to meet the facility's expenses. The facility proposed by SSDB does not present any cost savings to patients. Services at the proposed facility would be more expensive than the same services at existing facilities in Volusia County. Freestanding surgical centers have generally presented some advantages to physicians no consumers. In many places, outpatient surgeries are difficult to schedule in a hospital setting because they are susceptible of being bumped by surgeries that are considered more urgent. Furthermore, in many locations, physicians have had difficulty scheduling their outpatient surgeries in blocks of cases so that they can perform them more efficiently. Those problems have not occurred in Volusia County. Physicians who regularly perform outpatient surgeries in hospitals in Volusia County have been able to schedule their cases in blocks and have experienced no difficulties with bumping. SSDB has projected that its proposed facility would experience an acceptable loss during its first year of operation, but that it would show a net profit during its second and third years of operation. These estimates are based upon projections that 2,160 procedures would be performed at the facility at an average rate per procedure of $490 during the first year and 2,640 procedures at an average rate of $540 during the second year. These projections are unrealistic. The projections contemplate that approximately one-third of all outpatient surgeries in Volusia County would be performed at the proposed facility. The projections also contemplate a very dramatic increase in the number of outpatient surgeries and that more than 60 percent of the increased outpatient procedures would be done at the proposed facility. While it is likely that the number of outpatient surgeries performed in Volusia County and elsewhere will continue to increase as a percentage of total surgeries and that eventually as much as 30 percent of all surgeries performed in Volusia County will be done on an outpatient basis, the increase is not-likely to occur in a single year. Even if It did, it is unlikely that local physicians and consumers cold so dramatically reject present facilities as SSDB projects. Indeed, there is no evidence from which it could be concluded that there is any dissatisfaction on the part of physicians or consumers in Volusia County with present facilities. The evidence is to the contrary. A second reason why the projections are inaccurate is that in making the projections SSDB ignored the existence of the Neuman Eye Institute, the health maintenance organization, and operating rooms that have been established in physicians' offices. A third reason is that SSDB proposes to provide services at a higher cost than at existing facilities. A fourth reason is that SSDB has underestimated the proportion of Medicaid and Medicare cases that are likely to be performed at the facility at a cost that is less than the average cost per procedure proposed by SSDB. It is unlikely that SSDB could operate at a profit during its first three years of operation. At the time that SSDB filed its letter of intent and application with the Department of Health and Rehabilitative Services, there was no local health council in existence Volusia County, Florida. SSDB did not file a copy of its letter of intent or application with the local health council and would have had no place to file it if it attempted to do so.
Recommendation That a final order be entered by the Department of Health and Rehabilitative Services denying the Application for Certificate of Need filed by Surgical Services of Daytona Beach, Inc. RECOMMENDED this 31st day of October, 1983, in Tallahassee, Florida G. STEVEN PFEIFFER Assistant Director Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of October, 1983. COPIES FURNISHED: Fred Baggett, Esq. Michael J. Cherniga, Esq. Post Office Drawer 1838 Tallahassee, Florida 32302 Jay Adams, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Richard B. Orfinger, Esq. 619 North Grandview Avenue Daytona Beach, Florida 32018 Harold C Hubka, Esq. Post Office Box 5488 Daytona Beach, Florida 32018 Mr. David Pingree, Secretary Department of Health and Rehabilitative Services Winewood Boulevard Tallahassee, Florida 32301
Findings Of Fact At all times relevant hereto Daniel Francis Sanchez was licensed as a physician by the Florida Board of Medical Examiners having been issued license number ME0038795. At all times relevant hereto Respondent was Regional Medical Director of IMC which operated HMO offices in Hillsborough and Pinellas Counties. On October 17, 1985, Alexander Stroganow, an 84 year old Russian immigrant and former cossack, who spoke and understood only what English he wanted to, suffered a fall and was taken to the emergency room at Metropolitan General Hospital. He was checked and released without being admitted for inpatient treatment. Later that evening his landlady thought Stroganow needed medical attention and again called the Emergency Medical Service. The ambulance with EMS personnel arrived and concluded Stroganow was no worse than earlier when taken to the emergency room and they refused to transport him again to the hospital. The landlady then called the HRS hotline to report abuse of the elderly. The following morning, October 18, 1985, an HRS case worker was dispatched to the place where Stroganow lived. She was let in by the landlady and found an 84 year old man who was incontinent, incoherent, apparently paralyzed from the waist down, with whom she could not carry on a conversation to find out what condition he was in. She called for a Cares Unit to come and evaluate the client. An HRS Cares Unit is a two person team consisting of a social worker and nurse whose primary function is to screen clients for admission to nursing homes and adult congregate living facilities (ACLF). The nurse on the team carries no medical equipment such as a stethoscope, blood pressure cuff, or thermometer, but makes her determination on visual examination only. Upon arrival of the Cares Unit both members felt Stroganow needed to be placed where he could be attended. A review of his personal effects produced by his landlady showed his income to be over the maximum for which he could qualify for medicaid placement in a nursing home; that he was a member of IMC's Gold- Plus HMO; his social security card; and several medications, some of which had been prescribed by Dr. Dayton, a physician employed by IMC at the South Pasadena Clinic. The Cares team ruled out ACLF placement for Stroganow at the time because he was not ambulatory but felt he needed to be placed where he could be attended to and not left alone over the coming weekend. To accomplish this, they proceeded to the South Pasadena HMO clinic of IMC to lay the problem on Dr. Dayton, the Assistant Medical Director for IMC in charge of the South Pasadena Clinic. Stroganow had been a client of the South Pasadena HMO for some time and was well known at the clinic and by EMS personnel. There were two and sometimes three doctors who treated patients at this clinic and, unless the patient requested a specific doctor, he was treated by the first doctor available. Stroganow had not specifically requested he be treated by Dr. Dayton. When the Cares team met with Dr. Dayton they advised him that Stroganow had been taken to Metropolitan General Hospital Emergency Room the night before but did not advise Dayton that the EMS team had refused to transport Stroganow to the hospital emergency room a second time the previous evening. Dayton telephoned the emergency room at Metropolitan General to ascertain the medical condition of Stroganow when brought in the evening before. With the information provided by the Cares team and the hospital, Dayton concluded that Stroganow should be given a medical evaluation and the quickest way for that to occur was to call the EMS and have Stroganow taken to an emergency room for evaluation. When the Cares team arrived, Dayton was treating patients at the clinic. A doctor's office, or clinic, is not a desirable place to have an incontinent, incoherent, non- ambulatory patient brought to wait with other patients until a doctor is free to see him. Nor is the clinic equipped to do certain procedures frequently needed in diagnosing the illness and determining treatment needed for an acutely ill patient. EMS squads usually arrive within minutes of a call to 911 for emergency medical assistance and it was necessary for someone to be with Stroganow with the EMS squad arrived. Accordingly, Dayton suggested that the Cares team return to Stroganow and call 911 for assistance in obtaining a medical evaluation of Stroganow. If called from the HMO office, the EMS squad would have arrived long before the Cares team could have gotten back to Stroganow. Dr. Dayton did not have admitting privileges at any hospital in Pinellas County at this time. Upon leaving the South Pasadena HMO clinic, the Cares team returned to Stroganow. Enroute, they stopped to call a supervisor at HRS to report that the HMO had not solved their problem. The supervisor then called the Administrator at IMC to tell them that one of their Gold-Plus patients had an emergency situation. Respondent, Dr. Sanchez, called and advised that Dr. Dayton would take care of the problem. Later, around 2:00 p.m. when no ambulance had arrived, the Cares team called 911 from a telephone a block away from Stroganow's residence and arrived back just before the emergency squad. The EMS squad again refused to transport Stroganow to an emergency room and this information was passed back to Sanchez who directed that Stroganow be taken to Lake Seminole Hospital. This was the first time either Dayton or Sanchez was aware that the EMS squad had refused to transport Stroganow to an emergency room. Although Sanchez did not have admitting privileges at Lake Seminole Hospital, IMC had a contractual agreement with Lake Seminole which provided that certain staff doctors at Lake Seminole would admit patients referred to Lake Seminole by IMC. Pursuant to this contractual arrangement, Stroganow was admitted to Lake Seminole Hospital where he was treated for his injuries and evaluated for his future medical needs.
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, the documentary evidence received and the entire record compiled herein, I hereby make the following Findings of Fact: Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME 0040343. On the morning of October 7, 198A, the Metro-Dade County Rescue Squad called the emergency room at Miami General Hospital and informed the staff that they were enroute to the hospital with a gunshot victim. Dr. Segurola, the emergency room physician, was informed of the victim's condition and immediately ordered a nurse to notify the operating room team and call a surgeon because he knew in advance that "this was going to be a serious surgical case." At approximately 7:42 a.m., the rescue squad arrived at Miami General Hospital with the victim, Samuel Kaplan. Kaplan was taken to the emergency room suffering from a gunshot wound to the abdomen inflicted by a .32 caliber bullet. When Kaplan arrived in the emergency room, his systolic blood pressure was approximately 60, he was wearing a MAST suit, he had an intravenous (IV) line going, and he was receiving oxygen. Although Kaplan was conscious and able to speak, his condition was unstable and very serious. Kaplan was initially treated by Dr. Segurola, the emergency room physician. Three nurses, a respiratory therapist and an x-ray technician were also present in the emergency room. Dr. Segurola conducted a brief physical examination of Kaplan. An entrance wound was found, but there was no exit. After the examination, a second IV line was started in the other arm and a third, central line was started in the subclavin vein. The IV lines were set at maximum or "wide open." The emergency room staff was attempting to rapidly increase Kaplan's blood volume and pressure. Kaplan's hemoglobin level was low (approximately 8 or 9), which is a sign that a patient is anemic due to loss of blood. At approximately 8:00 a.m., Respondent received a message from his telephone answering service to call Dr. Segurola at the hospital's emergency room. At approximately 8:02 a.m., the Respondent returied the telephone call and spoke with Dr. Segurola concerning the patient's condition. During the conversation, the Respondent advised Dr. Segurola to contact the operating room team and anesthesiologist to prepare for surgery. The Respondent arrived at the emergency room of Miami General Hospital in response to the call at approximately 8:12 a.m. Upon the Respondent's arrival at the emergency room, he was informed that Kaplan's blood pressure was 108/50, heart rate 106 and respiration 28. The Respondent spoke to Kaplan and Kaplan stated that he had been shot in the stomach. Respondent then proceeded to conduct a brief, but thorough, physical examination of the patient. When Respondent completed his examination, he was advised that Kaplan's blood pressure was approximately 124/50, heart rate remained at 106 and respiration remained at 28. At this point, the Respondent believed that Kaplan's condition was stabilized. Respondent advised Dr. Segurola that Kaplan should immediately be taken to the operating room for surgery. The Respondent was informed that the operating room was not quite ready and that the anesthesiologist had not arrived. While waiting for the operating room team, Respondent and Dr. Segurola reviewed x-rays of Kaplan. The emergency room nurse continued to take Kaplan's vital signs. Kaplan's blood pressure remained at 124/50. At approximately 8:20 a.m., while Respondent, Dr. Segurola and others in the emergency room were waiting for confirmation that the operating room was ready, a hospital admissions clerk walked in and informed the emergency room staff that Kaplan belonged to the Health Maintenance Organization ("HMO"). An HMO is a plan in which a patient makes pre-payment for services and is then provided medical services from a designated panel of participating physicians. The emergency room maintained two "on-call" lists, one for HMO surgeons and one for non-HMO surgeons. The Respondent was on the non-HMO list. Dr. Segurola and Respondent had a brief discussion wherein both men acknowledged that under existing hospital policy, the HMO surgeon should have been called. Thereafter, Dr. Segurola informed a nurse to telephone the on-call HMO surgeon. The HMO surgeon on call was Dr. Moises Jacobs. A secretary in the emergency room placed a call to Dr. Jacobs at approximately 8:25 a.m. Dr. Jacobs returned the phone call between 8:25 a.m. and 8:30 a.m. Dr. Jacobs spoke with Dr. Segurola. While Dr. Segurola was on the phone, Dr. Jose Selem, the anesthesiologist, arrived in the emergency room. Dr. Jacobs told Dr. Segurola to ask the Respondent to take the patient to surgery immediately and stated that he would arrive at the hospital in about 20- 30 minutes. When the Respondent was told of Dr. Jacobs' request he replied that the patient was stable and could wait for Dr. Jacobs. Dr. Selem, the anesthesiologist, also spoke with Dr. Jacobs on the telephone. Dr. Jacobs told Dr. Selem to advise Respondent that Respondent could take the patient to surgery. When Dr. Selem advised Respondent of what Dr. Jacobs has said, the Respondent replied that since Dr. Jacobs was coming to the hospital and Kaplan was an HMO patient, Respondent preferred to wait for Dr. Jacobs, the HMO surgeon. Dr. Selem then left the emergency room and went to the operating room to prepare the necessary instruments. At approximately 8:30 a.m., the Respondent advised Dr. Segurola that he was going to the hospital cafeteria for a cup of coffee and, if any changes occurred in the patient, he should be contacted. The cafeteria was located across a corridor approximately 20-25 feet from the emergency room. At the time, Kaplan was still alert and his vital signs were being constantly monitored by the nursing staff. Dr. Segurola remained in the emergency room. The operating room and all necessary personnel were ready for surgery at approximately 8:40 a.m. Sometime between 8:40 a.m. and 8:45 a.m., one of the nurses told Dr. Segurola that the Respondent's condition was deteriorating and that his blood pressure was dropping. At approximately 8:45 a.m., Kaplan's blood pressure had dropped to 80/50. Dr. Segurola told the nurse to give more blood to Kaplan (a blood transfusion had already been started). Dr. Segurola then went to the cafeteria to speak with Respondent. Dr. Segurola told Respondent that the patient's condition was deteriorating, a blood transfusion had been started, and he feared that Kaplan might die in the emergency room. The Respondent inquired as to how long it had been since Dr. Jacobs had been called and Dr. Segurola responded twenty (20) minutes. Respondent questioned whether it really had been 20 minutes. Both men looked at their watches and determined that it had been about 15 minutes since Dr. Jacobs had been called. Respondent told Dr. Segurola to call the anesthesiologist. Dr. Segurola went back to the emergency room, believing that Respondent was going to immediately follow him there. When Dr. Segurola arrived back at the emergency room, Kaplan's condition had not improved. Dr. Segurola waited about three (3) more minutes and went back to the cafeteria for the second time. Dr. Segurola again informed the Respondent about Kaplan's deteriorated condition and his fear that Kaplan was going to die in the emergency room. Respondent once more asked Dr. Segurola to call the anesthesiologist. Dr. Segurola told Respondent that the anesthesiologist was there and that "we need you there." Dr. Segurola then went back to the emergency room. The Respondent remained in the cafeteria. Shortly before 9:00 a.m., while Dr. Segurola was away from the emergency room, Dr. Lustgarten, a neurologist, had just finished his rounds and was leaving the hospital through the emergency room to the parking lot. Dr. Lustgarten looked in on Kaplan to determine if there was any neurological damage. Dr. Lustgarten examined Kaplan and concluded that there was no neurological damage and that, in his opinion, Kaplan's condition was stable with a systolic blood pressure of approximately 100. Dr. Lustgarten left the emergency room just as Dr. Jacobs arrived at approximately 9:00 a.m. Dr. Lustgarten told Dr. Jacobs that Kaplan had no neurological damage. Dr. Jacobs conducted a brief examination of Kaplan and determined that Kaplan needed to be taken to the operating room immediately for surgery. The anesthesiologist, Dr. Selem, had by then been summoned to the emergency room and assisted Dr. Jacobs in an unsuccessful attempt to intubate Kaplan prior to taking him to the operating room. Shortly after Dr. Jacobs arrived, the Respondent left the cafeteria and headed towards the emergency room. Before Respondent reached the entrance to the emergency room, he was informed by one of the nurses that Dr. Jacobs had arrived. The Respondent stood at the entrance to the emergency room for a brief period and watched as Dr. Jacobs and others attended to Kaplan. Respondent then left the building, went to his car and drove home. Meanwhile, Dr. Jacobs performed an emergency exploratory laparotomy and left thoracotomy on Kaplan. Between 9:00 am. and 9:15 a.m., after Kaplan was moved from the emergency room to the operating room, his blood pressure went from 90 down to 60, and he went into shock. There are three possible contributing factors for Kaplan's going into shock at this time: (1) moving him may have dislodged ,a blood clot which in all likelihood prevented an earlier complete "bleeding out"; (2) the blood clot may have been diluted by the IV fluid; and (3) the institution of anesthesia. During surgery it was discovered that the bullet had perforated the aorta, a major blood vessel. While still in surgery, Kaplan went into cardiac arrest and was pronounced dead at 10:25 a.m. on October 7, 1984. At the time that Respondent left the emergency room and went to the hospital cafeteria, Kaplan's vital signs were in a relatively stable condition. Kaplan's vital signs de-stabilized while Respondent was in the hospital cafeteria, and his systolic blood pressure dropped from approximately 120 to approximately 80. At all times prior to being taken to the operating room, Kaplan's vital signs were maintained with the assistance of a MAST suit. A MAST suit is an inflatable device used in the treatment of trauma patients which applies pressure to the body and assists in elevating blood pressure. When the MAST suit is removed, the patient's vital signs will deteriorate again. For this reason, many physicians consider vital signs obtained under such conditions to be false readings, and the MAST suit is usually not removed until the patient is in the operating room. Although the Respondent suspected that the bullet might have damaged the small bowels and caused some internal bleeding, the Respondent neglected to ask about the amount of fluids Kaplan had received. Kaplan had received over 4 to 5 liters of fluid prior to arriving at the hospital and received an additional 5 liters of fluid while waiting to be taken to surgery. Although this information would have been useful, it would not necessarily have indicated the extent of Kaplan's massive internal bleeding. The amount of fluids that Kaplan received prior to the Respondent leaving the emergency room was not necessarily a sign that Kaplan's condition was unstable. In the treatment of trauma cases, time is of the essence. A trauma patient with a gunshot-wound to the abdomen should be taken to surgery as soon as possible. In some cases, it may be advantageous to delay surgery in order to stabilize the patient's vital signs or to increase blood volume. Generally, if surgery is performed within the first hour after the injury is sustained (referred to as "the golden hour"), the better the chances of the patient surviving. The golden hour does not apply to injuries of the heart and major blood vessels. In those cases, the patients will "bleed out" in a time much shorter than one hour. Nevertheless, even where the golden hour has passed, the patient should be taken to surgery at the first available opportunity and without delay. While in the emergency room at Miami General Hospital, Kaplan's condition ranged from "serious" to "critical." From the time that Kaplan was initially admitted to Miami General Hospital his condition was such that he required immediate surgical intervention. A reasonably prudent physician in the Respondent's position would have performed surgery at the first available opportunity and would not have waited for the arrival of another surgeon. Although pursuant to hospital and HMO rules, the HMO surgeon should have been called first, where an emergency situation exists the first surgeon available is expected to take the patient to surgery, and that physician will be provided payment by the HMO. The Respondent was aware of the hospital's and HMO's policies regarding HMO and non-HMO patients based on prior experience. The Respondent has never previously been disciplined or investigated by Petitioner or any medical board in any jurisdiction. Respondent maintains an excellent reputation for competence and compassion among his fellow physicians. Respondent is well liked by his patients and has provided medical services in the past to patients with no medical insurance.
The Issue The issue in this case is whether Respondent, Arnaldo Carmouze, P.A., committed violations of Chapter 458, Florida Statutes (2001), alleged in an Administrative Complaint filed with Petitioner on February 25, 2004, in DOH Case Number 2002- 16502, as amended; and, if so, what disciplinary action should be taken against his license to practice as a physician assistant in Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians and physician’s assistants licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Arnaldo Carmouze, P.A., is, and was at the times material to this matter, a physician's assistant licensed to practice in Florida, having been issued license number PA 9100713. Mr. Carmouze's address of record at all times relevant to this matter is 6545 Southwest 95th Avenue, Miami, Florida 33173. No evidence that Mr. Carmouze has previously been the subject of a license disciplinary proceeding was offered. Mr. Carmouze's Supervising Physician. At the times relevant Mr. Carmouze worked under the supervision of Dr. Manuel Fernandez-Gonzalez, a physician licensed to practice medicine in Florida. Dr. Fernandez-Gonzalez, who has practiced emergency medicine, holds Florida medical license number ME 17907. Dr. Fernandez-Gonzalez currently practices family medicine at 9600 Southwest 8th Street, Miami, Florida. Prior to April 2002, Dr. Fernandez-Gonzalez and Mr. Carmouze worked together in Miami, providing emergency room care and seeing patients at a nursing home. The emergency room services were provided pursuant to employment contracts that both had entered into with a company providing emergency room services at the hospital in south Florida where Dr. Fernandez- Gonzalez and Mr. Carmouze provided services. Mr. Carmouze's Assignment to Weems Memorial Hospital. The company for which Mr. Carmouze was employed also provided emergency room services for Weems Memorial Hospital (hereinafter referred to as "Weems"). Weems is located in Apalachicola, Florida, located in the Florida Panhandle, approximately 520 miles from Miami. Weems is a rural hospital, licensed under Chapter 395, Florida Statutes. It does not have 24-hour, on-site ancillary services such as X-ray, laboratory, and respiratory therapy. These services are available to the emergency room on an on-call basis after business hours. At the times relevant, Malvinder Ajit, M.D., a Florida licensed physician, was the Director of the Emergency Department at Weems. Dr. Ajit has not provided any documentation to the Department indicating that he has ever acted as supervising physician of record for Mr. Carmouze. Mr. Carmouze was assigned by the company by which he was employed to work in the emergency room at Weems in April 2002 and again in June 2002. He worked in the emergency room at Weems as a physician's assistant for part of April 2002, and part of June 2002. While at Weems, Mr. Carmouze provided emergency room medical services to more than 100 patients. While working at Weems, Dr. Fernandez-Gonzalez, who remained in Miami, continued to act as Mr. Carmouze's supervising physician. Mr. Carmouze did not notify the Department that he was practicing as a physician's assistant at Weems in April or June 2002. The evidence, however, failed to prove that Mr. Carmouze was working for, and thus "employed," by anyone different from the employer that he worked for in Miami. The only evidence on this issue proved that Mr. Carmouze continued throughout the relevant period to work for Dr. Fernandez-Gonzalez and the company that provided emergency room services at Weems. Dr. Carmouze's Treatment of Patient A.M. On June 7, 2002, Patient A.M., an 84-year-old female, was brought to the emergency room (hereinafter referred to as the "ER"), at Weems by ambulance. She arrived at approximately 23:24 hours (11:24 p.m.). A.M.'s medical history included congestive heart failure, coronary artery disease, and atrial fibrillation. She presented to Mr. Carmouze in apparent respiratory distress (respiratory rate of 36 to 40), had no measurable blood pressure, and a pulse rate of 100 to 108. While being transported to the ER from her home, A.M. was given oxygen by rebreather mask. During her transport, her oxygen saturation level improved from 68% to 91%. Mr. Carmouze assessed A.M.'s condition, obtained her medical history, ordered lab work and other tests, and ordered and initiated nebulizer treatments for her. She was alert, oriented and had a Glasgow score of 15/15, indicating she was responding to verbal and pain stimuli. Mr. Carmouze ordered nebulizer treatments with albuterol and atrovent to assist her breathing. Additionally, A.M. received 100% oxygen through a nonrebreather mask. Mr. Carmouze also determined that A.M. was "dry," meaning that her fluid volume was depleted and, therefore, she was dehydrated. As a result, her blood pressure was low. In an effort to treat this condition, Mr. Carmouze ordered an I.V. with 0.9 normal saline. He also ordered a Dopamine drip to increase A.M.'s heart rate in an effort to increase her blood pressure. Mr. Carmouze appropriately denied a request from a nurse to administer Lasix to A.M., because A.M. was "dry." Lasix is a diuretic used to decrease fluid volume. It opens the arteries and reduces fluids, thereby lowering blood pressure. Lasix was contraindicated for A.M. and contrary to the appropriate efforts initiated by Mr. Carmouze to treat A.M.'s low blood pressure. Despite Mr. Carmouze's treatment of A.M., her condition continued to deteriorate. At or near 23:50 hours (11:50 p.m.), approximately 25 minutes after A.M. had arrived at the ER, an ER nurse contacted A.M.'s primary physician by telephone and obtained an order to administer Lasix to A.M. The Lasix was administered immediately. A.M.'s oxygen saturation level was 81%, down 10 points since her arrival, when the Lasix was administered. Within half an hour, at 0:18 hours (18 minutes after midnight) on June 8, 2002, A.M.'s oxygen saturation level had dropped another 10 points, to 71%. A.M. then "crashed and coded." Mr. Carmouze initiated appropriate emergency measures when A.M. coded, including initiating Cardio Pulmonary Recitation and endotracheal intubation. A.M. was given epinephrine, atropine, and a CVP line was placed. These actions by Mr. Carmouze were appropriate. Mr. Carmouze did not attempt or order that A.M. be intubated prior to 0:18 hours when she coded. A.M.'s primary physician, Dr. Sanaullah, arrived at the ER. Shortly after she coded, Dr. Sanaullah continued the same efforts initiated by Mr. Carmouze. A.M., however, did not recover, expiring at 01:00. The "Standard of Care" for Treating A.M. Four expert witnesses testified in this matter, rendering opinions as to whether Mr. Carmouze's treatment of A.M. was consistent with "that level of care, skill, and treatment which is recognized by a reasonably prudent similar [physician assistant] as being acceptable under similar conditions and circumstances. . . " (hereinafter referred to as the "Standard of Care"). The expert witnesses who testified were Dr. Fernandez-Gonzalez, Dr. Julio Lora, Dr. Harry W. Lee, and James L. Cary, P.A. Dr. Fernandez-Gonzalez's testimony as to whether Mr. Carmouze treated A.M. within the Standard of Care is rejected for lack of credibility. Dr. Fernandez-Gonzalez's testimony has been found to lack credibility for the reasons explained by Petitioner in paragraph 25 of Petitioner's Proposed Recommended Order. That paragraph, except for the last two sentences, is hereby adopted. Additionally, Dr. Fernandez- Gonzalez's testimony is rejected because, in the undersigned's judgment, he made too much of an effort to give the answers that he appeared to conclude that Mr. Carmouze wanted him to give. The testimony of Dr. Lora on the other hand is found to be credible. Dr. Lora, testifying as an expert in cardiology and internal medicine, offered convincing explanations as to why Mr. Carmouze did not violate the Standard of Care in his overall treatment of A.M. and, in particular, in not attempting to intubate A.M. earlier than he did. Dr. Lee's testimony, while corroborating Dr. Lora's testimony, was cumulative and of little weight. A.M. was reported to be awake, alert, and oriented. She was breathing, albeit with difficulty, on her own. Therefore, it was appropriate for Mr. Carmouze to attempt the other measures to assist her breathing he instituted. Mr. Cary's testimony, while credible, was not convincing, especially given Dr. Lora's expert opinions. Mr. Cary's testimony was taken during a discovery deposition by Respondent and, as a result, the benefit of his testimony to Petitioner's case was limited. The evidence failed to prove that Mr. Carmouze violated the standard of care: In his treatment of A.M.; By failing "to contact his supervising physician, the ED director, and/or Patient A.M.'s primary physician for assistance in treating Patient A.M."; By failing "to identify a treatment plan for Patient A.M."; and By failing "to consult his supervising physician prior to ordering Demerol, a controlled substance, for Patients C.M., J.S., B.M., R.M., M.F., G.C., G.B., K.S., C.W., M.A.C., R.S., and K.M." Mr. Carmouze's Treatment Plan and Medical Records for Patient A.M. Mr. Carmouze, as the Department has conceded in Petitioner's Proposed Recommended Order, paragraph 13, page 20, did identify a treatment plan for Patient A.M. Having found that Mr. Carmouze did not err when he did not initiate intubation of A.M. earlier than he did, the evidence failed to prove that "he failed to maintain medical records that justified the course of treatment in that he failed to record a reason for not intubating sooner in an attempt to address Patient A.M.'s respiratory distress." There is no indication in Mr. Carmouze's medical records for A.M. that Mr. Carmouze attempted to contact Dr. Ajit or Dr. Fernandez-Gonzalez. The medical records do indicate, however, that A.M.'s primary physician, Dr. Sanaullah, was "notified and arrived for code." While the evidence did not prove who notified Dr. Sanaullah, Petitioner failed to prove that Mr. Carmouze was not responsible for Dr. Sanaullah's notification. Mr. Carmouze failed to identify himself by name or professional title in A.M.'s medical records. He also failed to include Dr. Fernandez-Gonzalez's name and title in A.M.'s medical records. Mr. Carmouze did not ensure that either the signature of his supervising physician or Dr. Ajit was included on A.M.'s medical records. While the quality of Mr. Carmouze's medical records for A.M. was correctly characterized as "minimally acceptable" by Mr. Cary, the evidence failed to prove clearly and convincingly that those medical records were not adequate. This finding is based upon the lack of an unequivocal opinion from Mr. Cary concerning the adequacy of the medical records and a comparison of Mr. Cary's opinions with those of Dr. Lee in support of Mr. Carmouze's medical records for Patient A.M. Mr. Cary, on the one hand, made the following negative comments about Mr. Carmouze's medical records for A.M: "[T]he record isn't really clear on what did happen because he did not write down any times on intervention of what he did." Petitioner's Exhibit numbered 1, page 14; "[W]hen you look at this face sheet here you don't get a picture of what happened and at what time, there's no real times there, no progression of the treatment." Petitioner's Exhibit numbered 1, page 67. Mr. Cary stated that there was no time noted in Patient A.M.'s history/physical section, and that a portion of that section was illegible. Petitioner's Exhibit numbered 1, page 21 and 25. On the other hand, Mr. Cary stated that "[the medical record for A.M.] is minimally acceptable, it just doesn't give a good clear picture of the sequence of events." Petitioner's Exhibit numbered 1, page 68. Mr. Cary also stated the following when asked if he thought Mr. Carmouze maintained medical records that justified the course of his treatment regarding Patient A.M.: "There were medical records that were there, I think they could have been more complete and more detailed . . . ." These statements, taking into account the fact that Mr. Cary was able to read almost all of Mr. Carmouze's medical record pertaining to A.M. on direct examination by counsel for Mr. Carmouze, reduces the effectiveness of his other opinions. Finally, it is noted that all of Mr. Carmouze's experts, along with Mr. Cary, were able to read Mr. Carmouze's notes, other than a word or two. Patients C.M., J.S., B.M., R.M., M.F., G.C., G.B., K.S., C.W., M.A.C., R.S., and K.M. Patient C.M. On April 23, 2002, Patient C.M., a 20-year-old male presented to Mr. Carmouze at Weems' ER. C.M. complained of a server headache. In pertinent part, Mr. Carmouze ordered 50 milligrams of Demerol and 50 milligrams of Vistaril. Patient J.S. On April 24, 2002, Patient J.S., a 37-year-old female presented to Mr. Carmouze at Weems' ER. J.S. complained of a burn. In pertinent part, Mr. Carmouze ordered 50 milligrams of Demerol and 50 milligrams of Vistaril. Patient B.M. On April 24, 2002, Patient B.M., a 46-year-old female, presented to Mr. Carmouze at Weems' ER. B.M. complained of a headache of two-days' duration. In pertinent part, Mr. Carmouze ordered 25 milligrams of Demerol administered to B.M. at the ER. Mr. Carmouze noted in the medical record for B.M. a diagnosis of scabies/headache cluster, severe. This is the only diagnosis made at Weems' ER for B.M. Patient R.M. On April 24, 2002, Patient R.M., a 73-year-old male, presented to Mr. Carmouze at Weems' ER. R.M. complained of abdominal pain and constipation of several days’ duration. In patient part, Mr. Carmouze ordered 50 milligrams of Demerol and 50 milligrams of Vistaril administered to R.M. at the ER. Mr. Carmouze noted in the medical record for R.M. a diagnosis of abdominal pain, impaction. This is the only diagnosis made at Weems' ER for R.M. Patient M.F. On April 25, 2002, Patient M.F., a 34-year-old female, presented to Mr. Carmouze at Weems' ER. M.F. complained of left-flank pain. In relevant part, Mr. Carmouze ordered 50 milligrams of Demerol and 50 milligrams of Vistaril administered to M.F. at the ER. Mr. Carmouze noted in the medical record for M.F. a diagnosis of left-flank pain, left nephrolithiasis. Patient G.C. On June 7, 2002, Patient G.C., a 20-year-old male, presented to Mr. Carmouze at Weems' ER. G.C. complained of right-flank pain. In relevant part, Mr. Carmouze ordered two separate doses of Demerol, 50 milligrams each, and Vistaril, 50 milligrams each. Patient G.B. On June 7, 2002, Patient G.B., an 83-year-old female, presented to Mr. Carmouze at Weems' ER. G.B. complained of wrist, knee, and leg pain, secondary to a fall. In relevant part, Mr. Carmouze ordered two separate doses of Demerol, 50 milligrams each, and Vistaril, 50 milligrams each. Mr. Carmouze noted in the medical record for G.B. a diagnosis of chest contusion, leg edema, and right Colles' fracture. This is the only diagnosis made at Weems' ER for G.B. Patient K.S. On June 8, 2002, Patient K.S., an 18-year-old female, presented to Mr. Carmouze at Weems' ER. K.S. complained of lower back pain secondary to a fall. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for K.S. a diagnosis of intractable back pain, trauma to spine. This is the only diagnosis made at Weems' ER for K.S. Patient C.W. On June 8, 2002, Patient C.W., a 46-year-old female, presented to Mr. Carmouze at Weems' ER. C.W. complained of headache and dizziness. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for C.W. a diagnosis of headache and anemia. This is the only diagnosis made at Weems' ER for C.W. Patient M.A.C. On June 9, 2002, Patient M.A.C., a 49-year-old female, presented to Mr. Carmouze at Weems' ER. M.A.C. complained of pain in the lower right abdomen and back. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for M.A.C. a diagnosis of diabetes mellitus and abdominal pain. This is the only diagnosis made at Weems' ER for M.A.C. Patient R.S. On June 9, 2002, Patient R.S., a 34-year-old male, presented to Mr. Carmouze at Weems' ER. R.S. complained of shoulder pain. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for R.S. a diagnosis of right shoulder tendon tear. This is the only diagnosis made at Weems' ER for R.S. Patient K.M. On June 11, 2002, Patient K.M., a 52-year-old male, presented to Mr. Carmouze at Weems' ER. R.S. complained of wrist pain secondary to a fall. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for K.M. a diagnosis of a Colles' fracture. This is the only diagnosis made at Weems' ER for K.S. Facts Common to Patients C.M., J.S., B.M., R.M., M.F., G.C., G.B., K.S., C.W., M.A.C., R.S., and K.M. Mr. Carmouze did not note in his medical records for Patients C.M., J.S., B.M., R.M., M.F., G.C., G.B., K.S., C.W., M.A.C., R.S., and K.M. (hereinafter referred to jointly as the "Pain Patients "), that he had consulted with Dr. Fernandez- Gonzalez or Dr. Ajit prior to ordering Demerol for the Pain Patients. Demerol is a controlled substance. Dr. Fernandez-Gonzalez' testimony regarding alleged consultations he had with Mr. Carmouze concerning the Pain Patients and other patients seen by Mr. Carmouze while at Weems is rejected as lacking credibility for the reasons explained, supra. Mr. Carmouze also failed to note in the medical records for the Pain Patients his name and professional title. His name was stamped on the Emergency Room Record he completed for Patients M.A.C., G.M., and R.S. His name was also written into the space under "Time/Initials" on the Emergency Room Record for Patients M.A.C., C.W., R.M., and J.S. None of these records, however, included his title of "physician assistant." Mr. Carmouze failed to identify Dr. Fernandez-Gonzalez or Dr. Ajit by name and professional title in the medical records of the Pain Patients. Mr. Carmouze failed to ensure that the signature of Dr. Fernandez-Gonzalez or Dr. Ajit was included in the medical records of the Pain Patients. The Other "106 Patients". While at Weems ER, Mr. Carmouze provided medical services, in addition to A.M. and Pain Patients, to 106 other patients at issue in this case (hereinafter referred to as the "106 Patients"). Petitioner's Exhibit numbered 4 is a composite exhibit of medical records for the 106 Patients. There are approximately two patients for whom more than one medical record has been included in Petitioner's Exhibit numbered 4. The foregoing findings relate to the 108 medical records for the 106 Patients. Mr. Carmouze failed to note in most of the medical records for the 106 Patients his name and professional title. Of the approximately 108 records, Mr. Carmouze's name does not appear in any fashion on 48 of them. The rest either include his name (but not title) either stamped on the record or written into the box titled "Time/Initials." On two of the medical records both Mr. Carmouze's name and "P.A." have been written into the box titled "Time/Initials." Mr. Carmouze failed to identify Dr. Fernandez-Gonzalez or Dr. Ajit by name and professional title in the medical records of the 106 Patients. Mr. Carmouze did not ensure that either the signature of his supervising physician or Dr. Ajit was included on the medical records of the 106 Patients.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that, Arnaldo Carmouze, P.A., has violated Subsections 458.331(1)(m) and (v), Florida Statutes, as described in this Recommended Order; issuing a reprimand; placing Mr. Carmouze's license on probation for one year; requiring that he pay an administrative fine of $5,000.00; requiring that he perform five hours of CME in a subject(s) determined appropriate by the Board; and suspending his license for six months (with the suspension stayed provided he complies with probation). DONE AND ENTERED this 13th day of December, 2006, in Tallahassee, Leon County, Florida. S LARRY J. SARTIN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 13th day of December, 2006. COPIES FURNISHED: Irving Levine Matthew Casey Assistants General Counsel Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Julie Gallagher, Esquire Greenberg Taurig, P.A. 101 East College Avenue Tallahassee, Florida 32301 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Timothy M. Cerio, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Dr. M. Rony François, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701
Findings Of Fact The parties further stipulated at the hearing that the billing for which Shands seeks payment does not include charges for services rendered during the months Linda Sue Austin was being treated as an out-patient at Shands. All other facts, as stipulated to by the parties and as set forth above, are hereby adopted.
