The Issue Whether Petitioner's request for authorization for the autologous chondrocyte implantation (ACI) procedure should be approved pursuant to worker's compensation laws and rules.
Findings Of Fact Witherspoon is a 41-year-old police officer. He has worked in law enforcement for 20 years and is currently employed as a police officer for the City of Fort Lauderdale. Witherspoon was injured in an employment-related accident on September 14, 1999. The accident significantly aggravated a pre-existing injury to his left knee. At the time of the accident, Witherspoon had already had two arthroscopic surgical procedures to treat his pre- existing knee injury. He underwent a third arthroscopic surgery following the accident, and returned to work in the Spring of 2000. In addition to surgery and physical therapy, Witherspoon has been treated continuously with injections and medications in an effort to alleviate his symptoms, to no avail. At all times relevant to this case, Witherspoon has two separate injuries to the articular cartilage of his knee: one in the trochlea and one in the medial femoral condyle. Because of these injuries, Witherspoon's articular cartilage, which is necessary for proper functioning of the knee joint, has been degrading and flaking off and will continue to do so. The injuries cause him to walk with a significant limp. He is in constant pain and constant danger of his knee buckling. Witherspoon's situation is complicated by a defect in the articular cartilage of his patella. ACI was not recommended for this defect, and it is unknown how debilitating the patella injury would continue to be, if and when ACI treatment is successfully completed. Because of his injuries, Witherspoon is unable to perform the duties of a uniformed police officer. He is presently assigned to desk work, at a significantly reduced salary. Witherspoon is on an accelerated course to advanced degenerative arthritis, for which a complete knee replacement is the standard recommended treatment. Because Witherspoon is relatively young and knee replacements do not last indefinitely, the unanimous weight of medical opinion is that knee replacement should be postponed as long as possible. Witherspoon's treating physician, having exhausted all viable treatment options, referred Witherspoon to Dr. Douglas Stringham (Stringham), a Board-certified orthopedic surgeon. After reviewing Witherspoon's arthroscopic photographs and medical records, Stringham recommended that he undergo ACI. Witherspoon requested authorization for the ACI procedure, which was denied by his Employer/Carrier City of Fort Lauderdale (Employer). The dispute was referred to AHCA for review in accordance with Subsection 440.13(1)(m), Florida Statutes. AHCA consulted with Dr. Peter Indelicato (Indelicato), a Board-certified orthopedic surgeon. Indelicato rendered an opinion that the procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. He further opined that there was not reliable evidence that ACI would provide significant benefit to Witherspoon's recovery and well being within the meaning of Rule 59B- 11.004(3), Florida Administrative Code. Relying exclusively upon Indelicato’s opinion, AHCA declined to order the Employer to provide ACI to the Petitioner. Upon the filing of this petition, Witherspoon was advised by the Employer that neither ACI nor any other form of intervention would be offered to him. AHCA has not promulgated, endorsed, or approved any particular treatment for injuries to the articular cartilage of the knee in accordance with Subsection 440.13, Florida Statutes. The ACI procedure which has been recommended to Witherspoon was initially developed in Sweden. Over the course of two separate surgical procedures, a sample of cartilage is first harvested arthroscopically from another area of the patient's knee joint. The sample is sent to the Boston Laboratory of Genzyme Tissue Repair, Inc. (“Genzyme”), which owns the rights to the process. Genzyme uses its proprietary process to culture the cells into an estimated five million chondrocytes over a period of approximately five weeks. Genzyme returns the cultured chondrocytes to the surgeon. The surgeon then performs an open surgical operation. The surgeon creates a periosteal flap. In addition, the injury is debrided and the chondrocytes are implanted in the wounded cartilage and covered with the periosteal flap. The claimed benefit of ACI is that the cartilage that is generated and implanted into the knee will approximate natural human cartilage to an extent significant enough to provide substantial benefit to the patient. Because ACI is in its infancy, questions remain about the long-term efficacy of the procedure. Other available treatments for a defect in articular cartilage of the knee include, abrasion chondroplasty, arthroscopic microfracture or drilling, osteochondral autograft surgery or “plugs”, and an osteochondral allograft using transplanted tissue from a cadaver (collectively, "conventional interventions"). Each of these procedures is, standing alone, less expensive than ACI. Each of these procedures, whether used singly or in combination, is not appropriate for Witherspoon at this time. Individually and collectively, conventional interventions afford no realistic hope of providing any noticeable relief for his symptoms, nor will they forestall the deterioration of his knee. The evidence establishes that there are no viable alternatives to ACI in the facts and circumstances of this case. Witherspoon is either not a candidate for conventional interventions, or has had such treatments and they have failed. Of the three Board-certified orthopedic surgeons who testified, AHCA's expert, who has never performed ACI, opined that Witherspoon could be treated by conventional interventions and Witherspoon's experts, who do perform ACI, testified that conventional interventions have failed and will continue to fail. There is no evidence to suggest that the testimony of any of the doctors was tainted by personal financial considerations of any kind. The ACI procedure, if successful, would be less expensive than a continuing course of short-term "housekeeping" treatments. Conventional interventions would, at most, stave off the inevitable knee replacement. They would not alleviate Witherspoon's disability in any way. Reliable evidence establishes that the ACI procedure presents the only possibility of providing Witherspoon with significant benefits toward recovery and well being. AHCA stipulates and the evidence establishes that ACI has been established to be safe. Under the facts and circumstances of this case, the benefits of the ACI procedure outweigh the risks to Witherspoon.
Recommendation Based upon the foregoing, it is RECOMMENDED that the Agency for Health Care Administration enter a Final Order approving the proposed ACI for the Petitioner. DONE AND ENTERED this 24th day of April, 2001, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS 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 24th day of April, 2001. COPIES FURNISHED: Barry A. Pemsler, Esquire 307 Ros Centre 770 Ponce de Leon Boulevard Coral Gables, Florida 33134 Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Mail Stop 3 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308
Findings Of Fact § 57.111(3)(f) Fla. Stat. (2005) "state agency" The Department of Health meets the definition found within Section 120.52(1)(b)1, Florida Statutes (2005), as an "agency." § 57.111(3)(b)2. and 3., Fla. Stat. (2005) "initiated by a state agency." On June 21, 2005, an Administrative Complaint in Department of Health, Petitioner, v. Donna M. Cameron Connolly, R.N., C.R.N.A, Respondent, DOH Case No. 2004-34970 was signed and served on Nurse Connolly. It accused the Respondent of violating Section 464.018(1)(n), Florida Statutes (2002), in the treatment and care of Patient M.M. Nurse Connolly elected to contest material facts within the Administrative Complaint. On September 9, 2005, the case was referred to the Division of Administrative Hearings (DOAH) to conduct a hearing pursuant to Section 120.57(1), Florida Statutes (2005). It became DOAH Case No. 05-3268PL. The hearing was held, and, on December 8, 2005, a Recommended Order was entered with a recommendation that the case be dismissed. § 57.111(3)(c)1., Fla. Stat. (2005) "prevailing small business party" On February 27, 2006, the Department of Health entered a Final Order dismissing the Administrative Complaint against Nurse Connolly. § 57.111(3)(d)1a., Fla. Stat. (2005) "small business party" The incident involving Patient M.M. that related to the Administrative Complaint took place on March 13, 2003. On the date Nurse Connolly cared for Patient M.M. She did so at Endosurg Outpatient Center (Endosurg) in Lady Lake, Florida, a gastroenterologist practice. She was providing anesthesia to the patient during a colonoscopy. She was acting as an independent contractor for a limited period of time in her engagement with Endosurg. It is her routine to take temporary positions in providing her services. Nurse Connolly works through placement agencies who serve clients who have the need for anesthesia coverage by a C.R.N.A. The placement agency, Nature Coast Anesthesia Providers (Nature Coast), had contacted Respondent to determine her interest in working for two weeks at Endosurg. For the services provided at Endosurg, Nurse Connolly had a verbal agreement with Nature Coast that formed the basis for her pay. The equipment and materials necessary to perform her duties at Endosurg were to be provided by that entity. In addition to the equipment provided by Endosurg, Petitioner Connolly had certain equipment of her own, including a stethoscope and an ambu-bag. At the time that the incident involving Patient M.M. occurred, Nurse Connolly had worked for Endosurg in two separate facilities for seven days. After the incident involving Patient M.M., Petitioner worked for Endosurg for an additional three days. For the year 2003, Petitioner Connolly and Joseph F. Connolly filed a Joint Form 1040 U.S. Individual Income Tax Return, with a Schedule C, representing profit or loss from a business naming Donna C. Connolly as a proprietor, "anesthesia provider," reflecting income and expenses with a net profit of $34,506.00. In 2003, Nurse Connolly's proprietorship carried business insurance through Bloom Insurance Services with a policy written by Evanston Insurance Company. Nature Coast paid Nurse Connolly for services provided at Endosurg. No insurance coverage was provided to Nurse Connolly from Nature Coast for the work done at Endosurg, nor was she entitled to any form of benefits from Nature Coast for that work. Nurse Connolly gave Nature Coast an invoice reflecting the services provided at Endosurg for which she requested payment and was paid. Nurse Connolly had other arrangements with agencies in 2003 to place her. Those agencies were Nation Wide Anesthesia Services and MDA Associates. Arrangements with the latter two agencies were under terms set forth in written contacts. At all times relevant Nurse Connolly did not advertise her services as a sole proprietor. She did provide business cards that set forth her address, telephone number, and e-mail. When performing her duties as an anesthesia provider in outlying locations, Nurse Connolly deducts meals, hotel expenses and her malpractice insurance for purposes of her income tax return. During the relevant period in time, Nurse Connolly had no other employees working for her. Her net worth was not more than two million dollars. § 57.111(4)(b)1., Fla. Stat. 2005 "itemized affidavit" To support Nurse Connolly's application for attorney's fees and costs, an affidavit has been provided by her counsel setting forth a claim for 105.1 hours of work performed by the law firm at a charge of $350.00 per hour for legal services, with an additional $45.08 in costs for federal express expenses in relation to her defense against the Administrative Complaint in DOAH Case No. 05-3268PL/DOH Case No. 2004-34970. The affidavit was prepared on May 23, 2006. Counsel for Petitioner Connolly also provided an itemized statement of work done between June 7, 2005, and February 5, 2006, as to the dates and nature of the services and time necessary to perform the incremental services totaling 105.2 hours, a discrepancy compared to the affidavit of .1 hours. In further support of the request for attorney's fees and costs, the application is accompanied by an affidavit provided by Paul C. Perkins, Jr., Esquire, as to the reasonableness of the fees requested for 105.1 hours of time expended. He comments, that recognizing the complexity and novelty of the issues in the case, an hourly rate for attorney work performed would range from $250 to $400 an hour. Attorney Perkins, like Petitioner Connolly's counsel, practices law in Florida. The affidavit by attorney Perkins refers to his admission to the Florida Bar and license to practice in the State of Florida for a period of 14 years. The affidavit was executed before a notary in Seminole County, Florida. In particular, he speaks to the complexity of the underlying case involving the administrative prosecution of Nurse Connolly, as a matter where expert testimony in the areas of pharmacology, anesthesiology, and cardio-pulmonary health were considered. In addition, the underlying case involved medical ethics and extensive research, according to attorney Perkins. On September 20, 2006, Nurse Connolly's attorney in this case, Damon A. Chase, Esquire, filed a supplemental affidavit as to attorney's fees and costs in the matter, asking that he be reimbursed for his fees at a rate of $350.00 per hour. Attached to the affidavit was a rendition of the services provided in the present case from July 12, 2006, through September 5, 2006, totaling 24.4 hours. A second affidavit by attorney Perkins has not been filed to support the additional 24.4 hours. § 57.111(4)(c), Fla. Stat. (2005) "opposition affidavit" Respondent in this cause filed a counter-affidavit in opposition to Petitioner's attorney's affidavit for fees and costs. The counter-affidavit was provided by Edwin A. Bayo, Esquire, who practices in Leon County, Florida, where he has practiced for the last 22 years. The majority of his practice was in the Office of the Attorney General, State of Florida. Attorney Bayo served as Board counsel for professional regulatory boards to include the Boards of Pharmacy, Dentistry, Osteopathic medicine, Chiropractic medicine, Veterinary medicine and Professional Engineers. His law practice has involved significant administrative law litigation. In response to the original request for reimbursement of attorney's fees in relation to the 105.1 hours, his opinion is that the appropriate hourly rate for the type of work performed in the case, as reviewed by Attorney Bayo, would be from $200 to $325 an hour, with the higher rate of charge being associated with counsel who has had more experience in administrative litigation, that is to say in excess of 15 years. Attorney Bayo contrasts that number of years with the amount of time that counsel for Nurse Connolly has been in practice in Florida, which attorney Bayo represents as being three years. Ultimately attorney Bayo offers the opinion that the rate of reimbursement for Attorney Chase should not exceed $225 per hour. § 57.111(4)(d)1., Fla. Stat. (2005) "nominal party" When the Department of Health undertook its prosecution directed to Donna M. Cameron Connolly, R.N., C.R.N.A., it was not acting as a nominal party. § 57.11(3)(e), Fla. Stat. (2005) "substantially justified" Exhibit "B" to Respondent's Notice of Filing of Additional Documents in the present case, as filed August 25, 2006, is constituted of the investigative report by the Department of Health, with exhibits. It includes patient records and expert opinions in DOH Case No. 2004-34970, all the material being mailed to the Probable Cause Panel which decided in favor of Probable Cause to bring the Administrative Complaint in the case. Exhibit "B" also contains the written response to the investigation provided by Nurse Connolly. The information available to the Probable Cause Panel continues in this discussion. On April 8, 2003, a confidential code 15 report was received by the Health Facility Regulation Hospital and Outpatient Services, within the State of Florida, Agency for Health Care Administration. In content, it pertained to Patient M.M. The report was made in compliance with Section 395.0197(8), Florida Statutes (2002). The report concerned the incident on March 13, 2003, which forms the basis of the administrative prosecution that underlies the present case. The Code 15 report was acknowledged by an Investigation Specialist with the Department of Health in a letter to the reporter dated July 1, 2003. Beyond that date, the Department of Health undertook its investigation into the matter concerning Patient M.M. and her treatment on March 13, 2003. After the investigation commenced, a Uniform Complaint Form was executed by the Investigation Specialist for the Department of Health, in a setting were Donna Connolly was named as the Respondent in relation to the March 13, 2003, incident. Generally, it summarized the events of that day and the withdrawal of life support from Patient M.M. on March 16, 2003, followed by the patient's death on March 17, 2003. The focus of the investigation was on a possible violation of Section 464.018(1)(h), Florida Statutes (2002), and Florida Administrative Code Rule 64B9-8.005(2)(i). In pursuing the investigation, the Department of Health made contact through its investigator with an official at Endosurg in Lady Lake, Florida. The investigation was facilitated by a subpoena issued October 8, 2003, calling for the release from Endosurg of medical information about Patient M.M. and the care received at Endosurg. The subpoena duces tecum that was sent to Endosurg on October 8, 2003, asked for the outpatient center to provide a copy of the medical records for the March 13, 2003, admission in relation to Patient M.M. Among the items that Endosurg gave the Department of Health concerning the care received by Patient M.M. on March 13, 2003, were the nursing assessments, pre-op and post-op information, the endoscopy report for the procedure being performed on the patient, the anesthesia record, the endoscopy procedure record, the past medical history of the patient, information concerning the provision of anesthesia in advance of its provision, a pre-operative evaluation questionnaire including the history of present illnesses, physical examination and a cardio-pulmonary resuscitation report form in relation to the CPR team who responded to the patient's arrest, which the report form refers to as occurring around 7:45 a.m. on March 13, 2003. It describes the CPR team responding to the incident as Nurse Connolly; Nurse Mayhew, who was a registered nurse; and the attending physician, who performed the colonoscopy. The Department of Health also issued a subpoena duces tecum to Lake Sumter Emergency Medical Services of Mt. Dora, Florida, who responded to the incident, providing care and transport for Patient M.M. on March 13, 2003. In response the Medical Services Agency provided transport information in relation to Patient M.M., who had suffered the cardiac arrest and was taken to the Villages Regional Hospital (Villages Hospital). A copy of a report reflecting the intubation and treatment provided by the agency to the patient was also given to the Department of Health, with a code summary critical event record. The patient was taken to the Villages Hospital for emergency treatment. The Department of Health issued a subpoena duces tecum to the hospital. The response to the subpoena included a written record of the diagnosis, including cardiac arrest, anoxic brain damage. Information from the Villages Hospital included physicians' orders, history and physical, laboratory studies, diagnostic studies, etc. The clinical indication at the time the patient was cared for in the Villages Regional Hospital was that the status was post-cardiac arrest, altered mental status. On that same date, March 13, 2003, the patient was transferred from the Villages Hospital to Lake Regional Medical Center (LRMC) in Leesburg, Florida. LRMC also provided records related to Patient M.M. The information received from LRMC was pursuant to a subpoena duces tecum. The death summary provided by LRMC, where Patient M.M. expired on March 17, 2003, referred to a discharge diagnosis as, severe anoxic encephalopathy following cardio- respiratory seizure, and cardiac arrest secondary to ventricular fibrillation. The patient expired when life support was withdrawn. LRMC patient information included physician's orders, patient progress notes, medication administration record, etc. On March 21, 2003, an associate medical examiner for the District Five Medical Examiner's office located in Leesburg, Florida, determined that the cause of Patient M.M.'s death was hypertensive and arteriosclerotic heart disease. On October 20, 2004, a medical malpractice investigator for the Department of Health wrote to Donna Connolly, A.R.N.P., advising her of Complaint No. 2004-3490. That correspondence referred to an enclosed document that had been determined sufficient for investigation pursuant to Section 456.073, Florida Statutes (2004), and extended an invitation to Nurse Connolly to file a written response or to call in and schedule an interview within 20 days of receiving the letter. Nurse Connolly was reminded that any response "will be made a part of the file and will be considered by the Department and the Probable Cause Panel in determining whether a formal Administrative Complaint should be filed in the matter." Nurse Connolly was also advised that she was not required to answer any questions or give statements and that she could be represented by counsel. On November 12, 2004, as received by the Department of Health on November 15, 2004, Nurse Connolly responded in writing to the ongoing investigation addressing the documents involved in the investigation. She provided an explanation of her recollection of the events on March 13, 2003, related to the care she provided Patient M.M., disavowing any unprofessional conduct on her part. On June 1, 2005, an Order of Emergency Restriction of the license of Donna M. Cameron Connolly, A.R.N.P., C.R.N.A, was entered by the Secretary of the Department of Health. The significance here, is that C. Erwin Velbis, C.R.N.A., A.R.N.P., performed a review of what was referred to at that time as Case No. 2004-3490. On February 4, 2005, utilizing an outline provided by the Department of Health, he performed the medical review related to the overview of the March 13, 2003, case involving Patient M.M., the colonoscopy and the eventual death of the patient on March 17, 2003. In response to the question in the form, Question 3, which says: The applicable standard of care, step by step in this case is He replied: Preanesthesia Care, Basic Standards for Basic Anesthetic Monitoring, Standards for Safe use of Propofol Appropriate level of sedation (Monitored Anesthesia Care vs. Conscious Sedation vs. Deep Sedation/Analgesia vs. General Anesthesia Postanesthesia Care, Basic Standards for Documentation of Anesthesia Care Nurse Velbis indicated that Nurse Connolly, in providing care to Patient M.M. on March 13, 2003, failed to meet the standard of care set out in the questionnaire by: Subject's PACU arrival vital signs do not reflect what was first documented by nursing staff which revealed hypotension and bradycardia that was treated with romazicon and trendelenburg positioning. Subject left an unstable patient upon arrival to PACU no documented ECG rhythm strips support what dysrhythmia patient was having that required ACLS. Under the response to question number 6 in the form, Nurse Velbis opines that Nurse Connolly should have done the following: Stayed with patient upon arrival in the PACU after a bp 74/42 and p40 was assessed Initiated defibrillation more quickly once the airway was secured (10 minutes had expired before the Fire and Rescue Paramedics defibrillated the patient). Provided clear ECG documentation. In this review, Nurse Velbis indicated items that might increase or lessen Nurse Connolly's culpability to the effect: gastroenterologist assumed "captain of the ship" regarding responsibility and accountability in the anesthesia care team model no supplemental oxygen was applied to the patient at PACU nor were [sic] there documentation of the SpO2 dose of Romazicon given by PACU nursing staff is unknown from the records. Was the dosage appropriate for the level of sedation? Nursing staff should have called the subject if Ramazicon was necessary to awaken a previously conversant patient What is the patient to staff ratio in the combined holding area in PACU? Depositions illustrate providers physically too far away from the patient in this case (this is an obese patient with a BMI of 35, no supplemental oxygen, and in trendelenburg position). Patients can resedate and become apneic without continual stimulation. Nurse Velbis was also asked to comment on the Emergency Restriction Order in draft form, which took into account his expert opinion that had been rendered in his written review as a means to make certain that the Emergency Restriction Order accurately reflected his expert opinion. There was also a reference in April 4, 2005, correspondence to Nurse Velbis concerning the addition of a paragraph 19 to the Emergency Restriction Order describing Nurse Connolly's failure to utilize the bag-valve mask immediately as a failure to meet applicable standards of care. This correspondence also describes some discrepancy between the author and Nurse Velbis concerning information that he had reflected in his written review about vital signs associated with Patient M.M. when the patient first arrived at the PACU at Endosurg. On April 21, 2005, Nurse Velbis responded in writing to the April 4, 2005, correspondence, giving advice to omit paragraph 19c to the Emergency Restriction Order for reasons stated in the written response noting in the end that Nurse Connolly "remains justfully [sic] culpable for the underlying cause, primarily hypoxia, of M.M.'s PEA rhythm." Nurse Velbis, who had been called upon to review materials associated with the investigation into Nurse Connolly's conduct on March 13, 2003, in treating Patient M.M., had access to the Department of Health's investigative report that included medical records. Nurse Velbis' assessment of the circumstances in relation to care of Patient M.M. received on March 13, 2003, at Endosurg, contrasts with the January 11, 2005, memorandum from Kay Frank, R.N., B.S.N., a nurse consultant whose recommendation was "close complaint against D.C. (Donna Connolly) no violation. Consider further investigation of recovery and resuscitation of this client." The investigative report form by the Department of Health that addressed the complaint that was made October 15, 2004, was completed when approved on December 30, 2004. By its table of contents, it refers to written records received from the various sources under subpoena duces tecum to Endosurg, Lake Sumter Emergency Medical Services, Villages Hospital, and LRMC, with a summary of the impression gained from a review of these materials. The investigative report also includes summaries of interviews conducted with the Endosurg Risk Manager Consultant; the Nurse Administrator at Endosurg; the Risk Manager of the Villages Hospital; Maureen Mayhew, R.N. at Endosurg, who was in the PACU when Patient M.M. was transferred to that unit from the procedure room; and the Risk Manager for LRMC, as well as a summary of Nurse Connolly's response to the investigation. On June 20, 2005, a Probable Cause meeting was convened in which panel members Maria Seitz and Jeanne Stark participated. As the transcript of that meeting establishes, the panel members confirmed that they had had sufficient time to review the materials that have been described in aid of their deliberations. Among the cases on the agenda was the subject case involving Donna Connelly. Attorney Judy Law from the Department of Health, who participated in the panel discussion, noted that the panel members had been provided with complete case files including the investigative reports, attached exhibits, all patient medical records, and any expert opinion, as well as any material provided by a licensee to respond to the Department investigation. It was indicated that the panel members had been provided a draft of the Recommended Administrative Complaint in the Connolly case. Attorney LeeAnn Gustafson for the Board of Nursing, who participated in the meeting for probable cause, explained to the Probable Cause Panel members, that if they had questions concerning interpretation or the application of any provision within Chapters 456 and 464, Florida Statutes, they should direct them to her, as well as any of the specifics concerning the cases that were on the agenda at that time, to include the case involving Nurse Connolly. There is a reference in the probable cause transcript to a scrivener's error that needed clarification in the Administrative Complaint related to Nurse Connolly and a need to correct numbers in the paragraphs to the Administrative Complaint without changing the underlying facts. The panel members agreed to these corrections. During the Probable Cause Panel meeting, a Mr. Monte gave a case overview involving the March 13, 2003, incident related to Patient M.M. and commented that the basis for the case was a failure to meet minimum standards of acceptable and prevailing nursing practice: by leaving an unstable patient; by failing to verify the patient's vital signs upon admission; by failing to stay with the patient long enough to ensure that the patient was stable; by disregarding the patient's unstable vital signs; by failing to provide oxygen via bag, valve or mask, or through incubation (intubation) immediately; by failing to ensure the proper equipment for incubation (intubation) was readily available; by failing to utilize incubation (intubation) equipment in a timely fashion, as necessary to restore breathing in an emergency; and by choosing to use mouth to mouth resuscitation as a first intervention. With this explanation, Ms. Sietz moved to find probable cause, which was seconded by Ms. Starke. There ensued subsequent discussion about the case between the panel members and a possible disposition of the case by way of discipline imposed on Nurse Connolly. § 57.111(4)(a), Fla. Stat. (2005) "special circumstances" No evidence was presented by Respondent in this case to show that special circumstances exist which would make the award of attorney's fees and costs unjust.
Findings Of Fact Upon consideration of the oral and documented evidence adduced at the hearing, the following relevant facts are found: In General Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes; Chapter 455, Florida Statutes; Chapter 458, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician in the state of Florida, having been issued license number ME 0016786. On February 27, 1984, Florida Medical license of the Respondent was suspended for a period of one year in Department of Professional Regulation vs. Teotimo D. Bonzon, M.D., Case Number 82-799. At all times material to this proceeding, Respondent was the primary care physician for Mary T. Upton, a patient with a history of bronchial asthma. Valium On January 11, 1985 the patient, Mary T. Upton, developed onset of acute respiratory distress and was seen by the Respondent, first in his office and then as an outpatient. On the second occasion, Respondent gave the patient valium, a Schedule IV Controlled Substance. On January 12, 1985, Upton was admitted to Methodist Hospital of Jacksonville, Florida, with a complaint of Acute Asthmatic Bronchitis. Bronchial Asthma is a condition that affects the respiratory drive. Valium relaxes the muscles and sedates the central nervous system and respiratory drive of a person and, as such, is not a drug to be administered in an outpatient setting under the circumstances that Respondent administered valium to Upton. Theo-Dur After admission and initial treatment, the patient continued to experience respiratory distress, and the Respondent was notified. Respondent ordered the drug Theo-Dur to be given orally. This was after Upton was given Theophylline, but before she was stabilized on Theophylline. Theo-Dur is a long sustained action form of Theophylline, which takes twelve hours to have an appreciable affect and, as such, is used primarily for maintenance and should not be used in acute situations such as Upton's until the patient is stabilized. Theophylline At the time Upton was admitted to the hospital on January 12, 1985 and Respondent started her on Aminophylline (also called Theophylline I.V.), Respondent was aware of Upton's previous use of medication containing Theophylline for her asthma condition and that she had a prescription to obtain such medication. Although Respondent was aware of Upton's previous use of medication containing Theophylline, Respondent did not inquire of Upton, or in any other manner determine, if she had ingested any form of Theophylline before administering the Aminophylline I.V. upon admission to the hospital on January 12, 1985. Upton had taken Theophylline before the Theophylline I.V. was administered. It is the recognized standard of care for a physician to obtain the level of Theophylline in the patient's body before administering Theophylline and, to periodically check the level of Theophylline to assure the best therapeutic level is achieved. Upton was on the hospital floor at approximately 11:20 a.m. on January 12, 1985 and the first time a physician ordered the Theophylline level checked was between 4:00 p.m. and 5:00 p.m. on January 12, 1985 after Respondent consulted with Dr. Libao. Before the Theophylline level was checked, Respondent had already administered Theo-Dur. Toxicity of Theophylline occurs when the content of the blood exceeds 20 milligrams per 100cc and any level over the 20 milligrams per 100cc may cause the patient to have gastrointestinal side affects such as nausea, vomiting and nervousness which may be life threatening. Respondent's failure to monitor the Theophylline level resulted in the patient receiving a toxic level of 24 milligrams per 100cc of Theophylline; however, there was no evidence that Upton suffered any side affects. D. Thoracostomy On January 17, 1985, routine chest x-rays confirmed a pneumothorax in Upton's left lung which was reported to the Respondent by the radiologist, Dr. Victor Saenz, by telephone between 10:00 a.m. and 11:00 a.m. on January 17, 1985. Without reviewing the x-rays, Respondent proceeded to treat the left pneumothorax with a chest tub (or Thoracostomy) in Upton's right lung. There was sufficient time to review the x-rays since the Thoracostomy was not performed until between 2:00 p.m. and 3:00 p.m. on January 17, 1985. Respondent did not order follow-up x-rays the day of the surgery to determine the effectiveness of the surgery. It is accepted medical practice for the physician, particularly a surgeon who performs an invasive procedure such as a thoracostomy, to order x- rays immediately following the surgery to make sure the procedure is working By placing the chest tub in the wrong side of the lung, Respondent created a situation wherein another pneumothorax might occur; however, by removing the chest tub from the right lung and placing it in the left lung alleviated this possibility. Respondent failed to realize that the chest tub had been placed in the wrong side of the lung (the right side) until the morning of January 18, 1985 when he was advised by the nurse that Upton had a pneumothorax on the left side rather than the right side where the chest tub had been placed by Respondent. Respondent's error was discovered as a result of routine x-rays performed by Dr. Walkett at 7:45 a.m. on January 18, 1985, the day following surgery. These follow-up x-rays also revealed Subcutaneous Emphysema throughout Upton's chest. Placing the chest tub in the right lung will not re-expand the left lung. Upon being informed of his error, Respondent proceeded to the hospital and removed the chest tub from Upton's right lung and placed it in her left lung. As a result of Respondent's error, Upton's heart beat increased around 3:00 a.m. on January 18, 1985 causing cardiac distress. Allergies At the time of the patient's admission it was noted that she was allergic to iodine. However, Respondent having treated Upton for some time prior to this admission, had knowledge that she was not allergic to iodine. Prior to the Thoracostomy and Tracheostomy, Respondent used Betadine scrub on Upton. Betadine contains iodine. Other solutions are readily available at Methodist Hospital that are not iodine-based. Tracheostomy On January 17, 1985 at or about the same time he performed the Thoracostomy, the Respondent performed a surgical procedure known as a Tracheostomy on Upton. Following the Tracheostomy, performed by the Respondent, the patient's condition did not improve and she continued to experience complications, including Subcutaneous Emphysema. Subcutaneous Emphysema occurs when air pockets form under the patient's fat tissue layer which cause swelling and can compromise the patient. On January 18, 1985, the Respondent's temporary admitting and consultation privileges at Methodist Hospital were suspended in a letter from Dr. Wallace Walkett, the president of the Medical and Dental Staff. The treatment of Upton was turned over to other physicians. Dr. Frederick Vontz, a Board Certified Cardiovascular and Thoracic Surgeon was called in by Dr. Walklett to repair the problems with Upton's trachea. When Dr. Vontz first saw Upton she was in moderate to severe distress and her body was swollen from the Subcutaneous Emphysema. On January 26, 1985, Dr. Vontz performed a Bronchoscopy on Upton that showed granulation tissue, which is scar tissue that may be an obstacle to breathing. The cause of this granulation tissue was the tracheostomy procedure performed by Respondent. Due to Upton's difficulty in breathing and the continuing Subcutaneous Emphysema, she was taken to the operating room on January 31, 1985. In the operating room, Dr. Vontz discovered a tear in the trachea that extended to six and one-half centimeters above the carina. Dr. Vontz also discovered that the air causing the Subcutaneous Emphysema was escaping from a false channel in the trachea. The damage to the posterior wall of the patient's trachea was caused by the improper tracheostomy procedure performed by Respondent on January 17, 1985. Upton died at 12:00 noon on March 6, 1985 and, although there is evidence that the tear in Upton's trachea may have contributed to Upton's death, there is insufficient evidence to show that it was clearly the sole cause of Upton's death. The record is clear that the level of care, skill and treatment provided Upton by the Respondent, fell below that which would be recognized as being acceptable under similar conditions and circumstances by a prudent similar physician.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, evidence of record, the candor and demeanor of the witnesses, and Rule 21M- 20.001(2), Florida Administrative Code, it is, therefore RECOMMENDED that the Board enter a Final Order suspending the Respondent, Teotimo D. Bonzon's license to practice medicine in the state of Florida for a period of two (2) years with condition for reinstatement determined by the Board as it deems appropriate. RESPECTFULLY SUBMITTED and ENTERED this 24th day of February, 1989, in Tallahassee, Leon County, Florida. WILLIAM R. CAVE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of February, 1989. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 87-3022 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties in this case. Specific Rulings on Proposed Findings of Fact Submitted by Petitioner In General 1.-4. Adopted in Findings of Fact 1-4. Valium 1.-4. Adopted in Findings of Fact 5, 8, 7 and 6, respectively. Theo-Dur 1.-2. Adopted in Findings of Fact 9 and 10. Theophylline 1.-2. Adopted in Findings of Fact 11 and 13, respectively. 3.-4. Adopted in Finding of Fact 14. Adopted in Finding of Fact 15. Adopted in Findings of Fact 12 and 16. 7.-8. Adopted in Findings of Fact 12 and 17, respectively. Thoracostomy 1.-4. Adopted in Finding of Fact 18. Adopted in Finding of Fact 19. Adopted in Finding of Fact 20. 7.-8. Adopted in Finding of Fact 19. Adopted in Finding of Fact 21. Adopted in Finding of Fact 20. Adopted in Finding of Fact 22. Adopted in Finding of Fact 23. Adopted in Finding of Fact 24. Adopted in Finding of Fact 26. 15.-l6. Adopted in Finding of Fact 27. 17. Adopted in Finding of Fact 25. Allergies 1.-2. Adopted in Findings of Fact 28 and 29. 3. Rejected as not being material or relevant. Tracheostomy 1.-9. Adopted in Findings of Fact 31-39 Unnecessary in reaching a conclusion in this case. Adopted in Finding of Fact 40. 12.-13. Subordinate to facts actually found in the Recommended Order. Specific Rulings on Proposed Findings of Fact Submitted by Respondent A. General 1.-3. Adopted in Findings of Fact 2, 1 and 4, respectively. B. The Use of Betadine 1. Adopted in Finding of Fact 28, but clarified. Theophylline Adopted in Finding of Fact 9, but clarified. Adopted in Finding of Fact 13 that Respondent had ordered Theophylline intravenously before checking the Theophylline level in the patient. Theo-Dur Rejected as not supported by substantial competent evidence in the record. Valium Rejected as not supported by substantial competent evidence in the record. Thoracostomy Adopted in part in Findings of Fact 18-27, otherwise rejected. Tracheostomy Adopted in Finding of Fact 31, but modified. Adopted in Finding of Fact 34. Adopted in Findings of Fact 24, 32 and 33, but modified. Adopted in Finding of Fact 36. The first sentence and the first phrase of the second sentence are adopted in Findings of Fact 38 and 39. The balance is rejected as being a restatement of testimony rather than a finding of fact. However, even if the last sentence was stated as a finding of fact, it would be rejected as not being supported by substantial competent evidence in the record. Rejected as not supported by substantial competent evidence in the record. COPIES FURNISHED: MARK A. SIERON, ESQUIRE POST OFFICE BOX 855 ORANGE PARK, FLORIDA 32067 JOHN R. WEED, ESQUIRE 605 SOUTH JEFFERSON STREET PERRY, FLORIDA 32347 STEPHANIE A. DANIEL, ESQUIRE CHIEF ATTORNEY DEPARTMENT OF PROFESSIONAL REGULATION 130 NORTH MONROE STREET TALLAHASSEE, FLORIDA 32399-0750 KENNETH D. EASLEY, ESQUIRE GENERAL COUNSEL DEPARTMENT OF PROFESSIONAL REGULATION 130 NORTH MONROE STREET TALLAHASSEE, FLORIDA 32399-0750 DOROTHY FAIRCLOTH, EXECUTIVE DIRECTOR BOARD OF MEDICINE 130 NORTH MONROE STREET TALLAHASSEE, FLORIDA 32399-0750 =================================================================
The Issue Whether Petitioner should be given a passing grade for the pharmacology portion of the Optometry Licensure Examination given on August 1999.
Findings Of Fact Jackson took the optometry licensure examination given on August 5-8, 1999. The examination consisted of three parts: clinical, laws and rules, and pharmacology. Jackson failed the pharmacology portion of the examination with a score of 65.70. The minimum passing score for the pharmacology portion is 70. The pharmacology portion is a practical examination that tests the candidate's competency in diagnosing and treating ocular diseases. The pharmacology examination consists of a series of case studies followed by questions of varying point values. Each case study is worth seven points. The questions for each case study require the candidate to correctly identify a differential diagnosis, a second differential diagnosis, and a final diagnosis and to answer two follow-up questions, giving the best answer. Jackson challenged the scores that she received for the answers to questions 86, 31, 33, 85, 7, 9, 80, 111, 113, 66, and 69. Question 86 dealt with a differential diagnosis for a patient who was complaining of tenderness in one eye. An initial scraping and cytology showed some organisms but no hyphae or gram negative cocci. Jackson listed a homograft rejection as the first differential diagnosis. Her answer was incorrect because the case study did not present the characteristics of a homograft rejection and did give indicators of a bacterial infection. The correct answer was "F," and Jackson gave "C" as the answer. Questions 31 and 33 dealt with a case study of a patient who was complaining of some tearing, feeling like something was in her eye when nothing was there, light sensitivity, and redness in her right eye. For question 31, Jackson answered that a differential diagnosis was gonococcal conjunctivitis, which is incorrect because the patient did not have a severe purulent discharge, which is characteristic of gonococcal conjunctivitis. The correct answer for question 31 was "G," and Jackson gave "L" as the answer. Question 33 was for the final diagnosis, and Jackson again answered gonococcal conjunctivitis. The answer was incorrect because of the absence of a severe purulent discharge. The correct answer to question 33 was "A," and Jackson answered "L." Question 85 dealt with a patient who was complaining of decreased vision in one eye. The applicant was asked to pick the next step in the management of care to be taken if the appropriate medical care had been unsuccessful. Jackson incorrectly indicated that the answer was retinal focal laser therapy. Such treatment would be appropriate for a patient who had diabetic macular edema but not for the diagnosis of the patient in question. The correct answer to question 85 was "A," and Jackson answered "H." Questions 7 and 9 dealt with a patient complaining of floaters and decreased vision. Question 7 called for a second differential diagnosis. Jackson answered rheumatoid arthritis, which is incorrect because the patient was experiencing chronic granulomatous uveitis. The correct answer to question 7 is "I," and Jackson answered "E." Question 9 asked the candidate to identify the testing which would be appropriate for the correct final diagnosis. Jackson correctly identified the final diagnosis, but did not correctly identify the appropriate treatment. Jackson's answer gave the appropriate test for rheumatoid arthritis, which was not the final diagnosis. The correct answer was "B," and Jackson answered "G." For question 80, Jackson stated that she bubbled in the wrong answer. She bubbled in "F," and the correct answer was "E." The responsibility for bubbling in the correct answer rests with the candidate; thus, "F" is considered an incorrect answer even if it was bubbled in by mistake. Questions 111 and 113 dealt with a patient complaining of intermittent haloes and blurred vision. Question 111 asked for a differential diagnosis. Jackson answered acute angle closure glaucoma, which is incorrect because the patient did not present the characteristics of acute angle disclosure glaucoma, particularly with an intraocular pressure of 27. The correct answer was "C," and Jackson answered "A." Question 113 asked for the final diagnosis. Again Jackson answered acute angle closure glaucoma, which is incorrect. Questions 66 and 69 dealt with a patient who had a dark shadow which obscured the vision in his right eye six hours before his visit to the doctor. Question 66 asked for a differential diagnosis. Jackson answered traumatic vitreous hemorrhage, which is incorrect because there was no evidence of trauma given in the case study. The correct answer was "F," and Jackson answered "K." Question 69 asked for the immediate treatment or management which would be indicated for the right eye. Jackson answered vitrectomy, which is incorrect because a vitrectomy would not be performed on a hemorrhage which had been present for only six hours. The correct answer is "D," and Jackson answered "F."
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Karen Jackson failed to earn a passing score of 70 on the pharmacology portion of the optometrist licensure examination given in August 1999. DONE AND ENTERED this 31st day of July, 2000, 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 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 31st day of July, 2000. COPIES FURNISHED: Karen Jackson Post Office Box 7157 West Palm Beach, Florida 33405 Cherry A. Shaw, Esquire Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 Angela T. Hall, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 Joe Baker, Jr., Executive Director Board of Optometry Department of Health 4052 Bald Cypress Way, Bin C07 Tallahassee, Florida 32399-1703 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703
