The Issue The issues for determination in this case are whether the following statement was made by Respondent, AGENCY FOR HEALTH CARE ADMINISTRATION; whether the statement violates the provisions of Section 120.535, Florida Statutes; whether the statement constitutes a declaratory statement under Section 120.565, Florida Statutes; whether Petitioner, ALL CHILDREN'S HOSPITAL, INC., has standing to maintain this action; and whether Petitioner is entitled to attorney's fees and costs. The alleged agency statement which is at issue in this case is: The Agency for Health Care Administration takes the position that a shared service agreement may be modified, without prior approval of the Agency, as long as each party continues to contribute something to the program, and the shared service contract remains consistent with the provisions of Rule 59C-1.0085(4), Florida Administrative Code. In addition, the Agency takes the position that modifications to a shared service agreement do not require prior review and approval by the Agency.
Findings Of Fact Petitioner, ALL CHILDREN'S HOSPITAL, INC. (hereinafter ALL CHILDREN'S), is a medical facility located in St. Petersburg, Florida, which provides pediatric hospital care. Respondent, AGENCY FOR HEALTH CARE ADMINISTRATION (AHCA), is the agency of the State of Florida vested with statutory authority to issue, revoke or deny certificates of need in accordance with the statewide and district health plans. Intervenor, BAYFRONT MEDICAL CENTER (BAYFRONT), is an acute care hospital located in St. Petersburg, Florida. ALL CHILDREN'S and BAYFRONT are located adjacent to each other and are connected by a thirty-yard tunnel. In 1969, ALL CHILDREN'S began operation of a pediatric cardiac catheterization program. ALL CHILDREN'S pediatric cardiac catheterization program existed prior to the statutory requirement for a certificate of need to provide such service. Neither AHCA, nor its predecessor agency, Florida Department of Health and Rehabilitative Services, issued a certificate of need for ALL CHILDREN'S cardiac catheterization program. Since 1969, ALL CHILDREN'S has expended at least $500,000 on upgrading the cardiac catheterization program. Since 1970, ALL CHILDREN'S has operated a pediatric open heart surgery program. ALL CHILDREN'S open heart surgery program existed prior to the statutory requirement for issuance of a certificate of need to perform such service. Neither AHCA, nor its predecessor agency, Florida Department of Health and Rehabilitative Services (HRS), issued a certificate of need for ALL CHILDREN'S open heart surgery program. By letter dated May 13, 1974, HRS specifically advised ALL CHILDREN'S that modifications to the ALL CHILDREN'S open heart surgery program were not subject to agency approval. In May of 1973, ALL CHILDREN'S and BAYFRONT entered into a shared service agreement to provide adult cardiac catheterization services. In accordance with the shared service agreement, the actual catheterizations are performed in the physical plant of ALL CHILDREN'S and with equipment located on the ALL CHILDREN'S campus. BAYFRONT contributed to the adult cardiac catheterization shared service program by providing, inter alia, patients, management, medical personnel, and pre- and postoperative care. Beginning in 1975, BAYFRONT has also provided adult open heart surgery services through a joint program with ALL CHILDREN'S with the actual surgeries being performed at the physical plant on ALL CHILDREN'S campus. BAYFRONT contributed to the adult open heart surgery shared service by providing, inter alia, patients, management, medical personnel, and pre- and postoperative care. The shared service agreement between ALL CHILDREN'S and BAYFRONT to provide adult cardiac catheterization and open heart surgical services was in existence prior to the statutory requirement for a certificate of need to perform such services. Neither AHCA, nor its predecessor agency, Florida Department of health and Rehabilitative Services, issued a certificate of need to provide such services. The cardiac catheterization and open heart surgery program operated by ALL CHILDREN'S and BAYFRONT was "grandfathered" in because the program existed prior to the certificate of need requirement. Because no certificate of need was issued to ALL CHILDREN'S and BAYFRONT for its shared adult cardiac service program, no conditions have been imposed by AHCA on the operation of the program. "Conditions" placed on certificates of need are important predicates to agency approval and typically regulate specific issues relating to the operation of the program and the provision of the service such as access, location, and provision of the service to Medicaid recipients. The ALL CHILDREN'S and BAYFRONT cardiac shared services program is the only "grandfathered in" shared service arrangement in Florida, and is the only shared service arrangement operating without a certificate of need in Florida. An open heart surgery program is shared by Marion Community Hospital and Munroe Regional Medical Center in Ocala, Florida. The Marion/Munroe program operates pursuant to a certificate of need issued by AHCA. On December 22, 1995, AHCA published a notice of its intent to approve a certificate of need for a shared pediatric cardiac catheterization program between Baptist Hospital and University Medical Center in Duval County, Florida. BAYFRONT has applied for, but has not yet been issued, a certificate of need to perform cardiac catheterization services independent of the shared services arrangement with ALL CHILDREN'S. The agency receives hundreds of inquiries each year requesting information and guidance from health care providers regarding the certificate of need application process and other requirements of the certificate of need program. On more than one occasion ALL CHILDREN'S and BAYFRONT have inquired either orally or in letters to the agency regarding whether certain changes in their adult cardiac shared services program would require agency approval through a certificate of need application. In response to a 1990 written inquiry from ALL CHILDREN'S and BAYFRONT regarding modifications to the shared services agreement, the agency (then HRS) by letter dated September 18, 1990, stated in pertinent part that "the alterations you propose still constitute shared services." The agency response went on to state that it is therefore "...determined that they (the proposed changes) have not altered the original intent." On January 31, 1991, Rule 59C-1.0085(4), Florida Administrative Code, governing shared service arrangements in project-specific certificate of need applications was promulgated. The rule provides: Shared service arrangement: Any application for a project involving a shared service arrangement is subject to a batched review where the health service being proposed is not currently provided by any of the applicants or an expedited review where the health service being proposed is currently provided by one of the applicants. The following factors are considered when reviewing applications for shared services where none of the applicants are currently authorized to provide the service: Each applicant jointly applying for a new health service must be a party to a formal written legal agreement. Certificate of Need approval for the shared service will authorize the applicants to provide the new health service as specified in the original application. Certificate of Need approval for the shared service shall not be construed as entitling each applicant to independently offer the new health service. Authority for any party to offer the service exists only as long as the parties participate in the provision of the shared service. Any of the parties providing a shared service may seek to dissolve the arrangement. This action is subject to review as a termina- tion of service. If termination is approved by the agency, all parties to the original shared service give up their rights to provide the service. Parties seeking to provide the service independently in the future must submit applications in the next applicable review cycle and compete for the service with all other applicants. All applicable statutory and rule criteria are met. The following factors are considered when reviewing applications for shared services when one of the applicants has the service: A shared services contract occurs when two or more providers enter into a contractual arrangement to jointly offer an existing or approved health care service. A shared services contract must be written and legal in nature. These include legal partnerships, contractual agreements, recognition of the provision of a shared service by a governmental payor, or a similar documented arrangement. Each of the parties to the shared services contract must contribute something to the agreement including but not limited to facilities, equipment, patients, management or funding. For the duration of a shared services contract, none of the entities involved has the right or authority to offer the service in the absence of the contractual arrangement except the entity which originally was authorized to provide the service. A shared services contract is not transferable. New parties to the original agreement constitute a new contract and require a new Certificate of Need. A shared services contract may encom- pass any existing or approved health care service. The following items will be evaluated in reviewing shared services contracts: The demonstrated savings in capital equipment and related expenditures; The health system impact of sharing services, including effects on access and availability, continuity and quality of care; and, Other applicable statutory review criteria. Dissolution of a shared services contract is subject to review as a termination of service. If termination is approved, the entity(ies) authorized to provide the service prior to the contract retains the right to continue the service. All other parties to the contract who seek to provide the service in their own right must request the service as a new health service and are subject to full Certificate of Need review as a new health service. All statutory and rule criteria are met. By letter dated October 22, 1993, ALL CHILDREN'S and BAYFRONT inquired again of the agency regarding modifications of the adult inpatient cardiac shared service program. AHCA did not respond to the 1993 inquiry, and AHCA ultimately considered the inquiry withdrawn. By letter dated February 24, 1995, BAYFRONT made further inquiry of the agency, and requested agency confirmation of the following statement: The purpose of this letter is to confirm our understanding that the Agency for Health Care Administration ("Agency") takes the position that the shared services agreement between Bayfront and All Children's may be modified, without prior approval of the Agency, as long as each party continues to contribute something to the program, and that the shared services contract remains consistent with the provisions of Rule 59C-1.0085(4) F.A.C. By letter dated March 16, 1995, the agency made the following reply to BAYFRONT from which this proceeding arose: The purpose of this letter is to confirm your understanding of this agency's position with reference to the reviewability of a modifica- tion of the shared services agreement between Bayfront Medical Center and All Children's Hospital set forth in your February 24, 1995 letter.
The Issue The issues to be determined in this proceeding are whether Respondent violated section 458.331(1)(t)1., Florida Statutes (2012), and if so, what penalties should be imposed.
Findings Of Fact Based upon the Stipulation of the parties and the evaluation of the evidence presented at hearing, the following facts are found: At all times material to the allegations in the Administrative Complaint, Respondent was a licensed medical doctor within the State of Florida and held license number ME 109501. Respondent’s address of record is 216 Elm Drive, Chattahoochee, Florida 32324. The Department presented no evidence of prior discipline against his license. In 2013, Respondent was under contract to furnish health care services to inmates at Suwannee Correctional Institution (SCI). This case involves the care and treatment for hypertension that Respondent provided to R.G. while R.G. was an inmate at SCI in June and July 2013. David Libert, M.D., who testified on behalf of the Department, is a Board-certified family practice physician who has been licensed in Florida since 1983. Dr. Libert sees patients in a clinical setting approximately three days a week but has never practiced in a correctional institution setting. Dr. Libert testified that a “perfect” blood pressure reading is 120/80. A reading that is under 140/90 is considered acceptable, but blood pressure that is consistently above 140/90 indicates hypertension. Malignant hypertension, or hypertensive emergency, is an acute elevation of blood pressure that is associated with end organ damage. End organ damage is the affect that the high blood pressure has on certain parts of the body, such as the brain, heart, and kidneys. The traditional benchmark reading that signals malignant hypertension is 180/120, which Dr. Libert testified is an arbitrary number but represents the “old” definition of the condition. According to Dr. Libert, newer studies define malignant hypertension as an acute rise on the height in blood pressure associated with end organ damage, even if the blood pressure reading does not go as high as the 180/120 measure recognized in older literature. The record is not clear when the change in definition took place, and if that change reflects the standard of practice in June 2013. Dr. Libert did not describe what constitutes an acute rise in blood pressure, either in terms of the length of time by which it is measured, or how much of a change in blood pressure constitutes an acute rise. The systolic reading is the top number in a blood pressure reading and represents the maximum pressure that is exerted on the arteries with the contraction of the heart. The diastolic reading represents the pressure after the heart has relaxed from its beat and is the lower number in a blood pressure reading. While 180/140 is the traditional reading identified as a signal for malignant hypertension in “older” literature, there was no testimony as to whether systolic and diastolic readings are equally important, or whether one is more important than the other when determining that a patient’s blood pressure is too high. In other words, no testimony was presented to answer the question of whether, for example a blood pressure reading of 185/96 or 170/133 would be considered a symptom of malignant hypertension. While there is no question both readings would indicate hypertension, the evidence did not indicate whether it is enough to have one of the two pressure readings above the 180/120 level to signal the possibility of malignant hypertension. The Department of Corrections has protocols for treatment of different systems of the body. The form for the Hypertension Protocol, which is included several times within R.G.’s medical records from Suwannee, includes several categories of information to be addressed by treating personnel, such as Subjective (which includes the patient’s chief complaint and current symptoms); Objective (which requires notation of vital signs, such as temperature, pulse, respiration, blood pressure, oxygen saturation and weight); Findings Requiring Immediate Clinician Notification; Plan; and Education. Under the heading “Findings Requiring Immediate Clinician Notification,” there are several factors that a health care provider (typically in this setting, a nurse) would check before the need to contact a physician arises. Those factors are blood pressure greater than 160/100 (see PLAN first); oxygen saturation less than 93 percent; heart rate less than 60 or greater than 110; wheezing (chest congestion); blurred vision; pedal edema extending to above the knees; severe headache OR headache not relieved after two hours of OTC pain med; or other. The PLAN portion of the protocol provides the following treatment alternatives: For mild to moderate headache give: Acetaminophen 325mg two tablets every 4-6 hours as needed for pain, OR Ibuprofen 200mg two tablets every 6 hours as needed for pain Put patient in a quiet environment; recheck blood pressure in 15 minutes x2. Notify clinician if BP remains greater than 160/100. 1st blood pressure recheck: / , at . 2nd blood pressure recheck: / , at . Bed rest lay-in x24 hours Blood pressure recheck in 24 hours Return to clinic for BP check Pass Other Respondent was responsible for patient R.G.’s medical care at SCI and had access to all of R.G.’s medical records from SCI’s medical clinic. R.G. was a 61-year-old male inmate who presented to the clinic at SCI for treatment. On or about June 7, 2013, R.G. presented to SCI’s clinic with a blood pressure reading of 164/96, and complaining of a headache. R.G. was given 10 mg Lisinopril to reduce his blood pressure, a pass for three days of bedrest, and a follow-up appointment for June 10, 2013. The medical record entitled Hypertension Protocol does not contain Respondent’s name and he did not see R.G. that day. However, from the Physician’s Order Sheet, it appears that he was consulted and approved the administration of Lisinopril, and prescribed 10 mg of Lisinopril daily for three months. On June 9, 2013, R.G. presented at the clinic complaining about his blood pressure. The medical record notes that he had a headache. His blood pressure reading was 151/90, and the section entitled Findings Requiring Immediate Clinician Notification did not have any symptoms checked. The medical record does not indicate that Respondent saw R.G. on June 9, 2013, and he was not consulted about his care. The PLAN section of the Hypertension Protocol says “No treatment required.” On June 10, 2013, it appears that R.G. may have been seen at the clinic more than once. The initial entry in his medical records for that date, which does not have a time recorded, indicates that his blood pressure was 158/98. The second entry, recorded at approximately 2:00 p.m., indicates that R.G. presented to the clinic with a blood pressure reading of 173/98. Respondent ordered a one-time dose of .2 mg Clonidine, and 10 mg of Lisinopril and directed that his blood pressure be taken again in an hour. Respondent tried to find the underlying cause for the rise in R.G.’s blood pressure by sending him for blood work, and a thyroid and cardiovascular evaluation by the cardiac clinic. Respondent also directed that his blood pressure be checked twice weekly for an indecipherable number of weeks. When R.G.’s blood pressure was rechecked at approximately 4:00 p.m., it was 158/89. Respondent again ordered administration of 10 mg Lisinopril, increased his prescription for Lisinopril to 20 mg for three months, and ordered 600 mg of Ibuprofen to treat R.G.’s headache. R.G. next presented to the clinic on June 11, 2013, at 10:00 a.m. At that time, his blood pressure was noted as 152/94. There is no indication in the medical record that Respondent saw R.G. during that visit, and there is no documentation in the Physician’s Order Sheet to indicate that Respondent ordered any prescriptions for him. On June 18, 2013, R.G. went to the clinic complaining of a headache and vomiting. He listed his pain level at 6 out of 10. At his initial presentation at noon, his blood pressure was 197/105 in the left arm, and 186/86 in the right. Under the PLAN heading, the medical record indicates R.G. was given 200mg Ibuprofen for his headache, and 0.2 mg of Conidine for blood pressure. His blood pressure was rechecked at 1:00 p.m. and had lowered to 139/84. The medical record for June 18, 2013, does not indicate that Dr. Alaka saw R.G. or that he was consulted about him. The Department of Corrections Physician Order Sheet for R.G. has an entry dated June 18, 2013, but part of the record is indecipherable, and there is no doctor Signature/stamp completed for the entry. In addition, the portion of the entry that is readable refers to a Dr. Gonzalez, as opposed to Dr. Alaka. On June 20, 2013, R.G. returned to the clinic, this time complaining that he was stumbling and had a headache. A protocol sheet for Neurological Changes/Deficits was used in the medical records as opposed to the Hypertension Protocol. At this visit, his blood pressure was 120/62. There is no indication on the medical record for this date that Dr. Alaka saw R.G. R.G. returned to the clinic on June 25, 2013, at 5:39 p.m. The medical record indicates that he had a slight headache, a small amount of pitting/extremity swelling, fatigue, and had vomited that morning. His blood pressure was 165/94 in the left arm and 175/91 in the right. Pedal edema was noted to stop at the mid to upper shins, and the records indicate that R.G. had slept only three hours or less in the previous 24-hour period. R.G. was given acetaminophen for his headache, and his blood pressure was rechecked at 5:59 p.m. and 6:15 p.m.. His blood pressure at the first recheck was 165/94, and at the second recheck was 164/93. The Hypertension Protocol indicates that R.G. was administered 10 mg of Lisinopril, was instructed to comply with all prescribed medications, and not to sit with his legs crossed. The Physician’s Order Sheet indicates that per Respondent’s discussion with the nurse who saw R.G.,1 the prescription for 20 mg of Lisinopril was discontinued and replaced with a prescription for the same drug at 10 mg daily for three months. There was speculation throughout the hearing that R.G. did not always take his medications as prescribed, and there are notations in the medical records that R.G. sometimes refused recommended medical treatments, such as a referral for a urologist and a cardiac workup. There was no clear and convincing evidence that R.G. was also failing to take his blood pressure medications as required, although it is certainly a possibility. There is no indication in the medical records that R.G. went to the clinic for treatment after June 25, 2013.2 On July 2, 2013, R.G. was found unresponsive on the floor. He was transferred to ShandsLiveOak Regional Medical Center, and from there, transferred to Jacksonville Memorial on 1 The Administrative Complaint alleges that R.G. was seen by an ARNP during this visit. The signature of the health care provider indicates that he or she was an SRN, not an ARNP. The ARNP who reviewed the records and made what was referred to as an incidental entry (one where the record is reviewed but the patient is not seen) the following day is a different provider. 2 There is an entry for June 28, 2013, entitled Pre-Special Housing Health Assessment. Dr. Alaka testified he did not know what that meant. It appears from the record that the purpose of the assessment was to extend R.G.’s low bunk pass. At that time, his blood pressure was recorded as 158/92. It is not clear who conducted the assessment. July 3, 2013. R.G. died on July 5, 2013. The Medical Examiner’s Report lists R.G.’s cause of death as hypertension. Dr. Libert reviewed the medical records related to R.G.’s treatment. He opined that Respondent did not meet the applicable standard of care in his care and treatment of R.G. because he did not arrange for transportation to the hospital on June 18, 2013. He also opined that Respondent should have transferred R.G. on later dates prior to the transfer that occurred on July 2, 2013. He further opined that Respondent failed to recognize the signs and symptoms of malignant hypertension and failed to diagnose it. Dr. Libert also testified that Respondent failed to order basic blood tests that should have been ordered for a patient with hypertension. However, as noted above, Respondent did order blood work on June 10, 2013. There is no indication in the medical records that Dr. Alaka saw R.G. on June 18, 2013. With respect to the June 25 visit, Dr. Alaka would have received a phone call from staff, but did not see R.G. in person. Dr. Alaka has no independent recollection of seeing R.G., and had to rely solely on his review of the medical records for his account of what happened. The treatment of this patient occurred over eight years prior to the hearing in this case. Dr. Alaka did not believe that treatment in a prison setting is the same as the treatment rendered in a typical outpatient setting, and testified that in an outpatient setting, physician groups are free to set their own protocols. In a correctional setting, physicians were required to follow the protocols established by the Department of Corrections. Dr. Alaka testified that following the protocols was a condition of employment. Dr. Alaka testified that he did not create or maintain the medical records for patients at the facility, but would have access to the records when treating a patient. It is not clear, however, whether he had access to the records when he was not at the facility but received a telephone call regarding the treatment of a patient. Based upon the medical records in evidence, Dr. Alaka saw R.G. on June 10; was consulted about R.G. on June 7 and June 25; and was neither present nor consulted regarding R.G. on June 9, June 11, June 18, and June 20, 2013. The only time that the medical records indicate R.G.’s blood pressure may have been above the standard of 180/120 for malignant hypertension was June 18, 2013, and when rechecked, the pressure went down to 139/84. As noted above, the medical records do not indicate that Dr. Alaka either saw R.G. or was consulted about his care on that day. On June 25, 2013, R.G.’s blood pressure, while still considered high, was well below the standard identified for consideration of malignant hypertension. Dr. Alaka also testified that one must always consider the possibility of malignant hypertension when taking a patient’s blood pressure, but did not believe R.G.’s blood pressure reached that level. He tried to prevent it through the use of medication but did not believe that you needed to transfer a patient because of swelling, vomiting, or headache combined with high blood pressure, because those symptoms can occur with a variety of conditions. In his view, there should be concrete blood pressure readings, with indications of organ disturbance or stress. Organ damage would be substantiated through blood work and treated with medication while waiting for results. If the blood pressure is sustained, then he would call his supervisor and report the blood pressure; that it is not coming down; what medications were given; and request a transfer. He testified he did not request a transfer in this case because the blood pressure came down with treatment. In addition, Dr. Alaka noted that blood pressure readings can vary within the same hour, depending on who took the reading, the size of the cuff used, operator error, etc. Dr. Alaka also testified, credibly, that transfers to facilities outside the prison setting required approval by the regional medical director, and that was a condition for working at SCI. The Department did not provide any evidence to rebut the statement that Respondent did not have the authority to order transfer out of the facility, or that following the protocols reflected in the medical records was not required for employment at the facility. Dr. Alaka’s view of what blood pressure reading would have triggered a diagnosis of malignant hypertension is higher than Dr. Libert’s. Based on the evidence presented, Dr. Libert’s definition appears to be more reasonable. However, based on the totality of the evidence presented, the Department did not present clear and convincing evidence to show that Respondent’s care and treatment of R.G. violated the prevailing standard of care as alleged in the Administrative Complaint.
Conclusions For Petitioner: Hunter M. Pattison, Esquire Michael Jovane Williams, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 For Respondent: Edmond Olatunde Alaka, M.D., pro se 216 Elm Drive Chattahoochee, Florida 32324
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Administrative Complaint against Respondent be dismissed. DONE AND ENTERED this 20th day of December, 2021, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of December, 2021. COPIES FURNISHED: Hunter M. Pattison, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Edmond Olatunde Alaka, M.D. 216 Elm Drive Chattahoochee, Florida 32324 Paul A. Vazquez, JD, Executive Director Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 Michael Jovane Williams, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Louise St. Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399
Findings Of Fact St. Mary's Hospital, Inc. ("St. Mary's"), is a certificate of need ("CON") applicant for an adult open heart surgery program in Department of Health and Rehabilitative Services ("HRS"), District IX. The Agency for Health Care Administration ("AHCA") is the state agency responsible for the administration of CON laws. Intervenor, Martin Memorial Hospital Association, Inc., d/b/a Martin Memorial Medical Center ("Martin Memorial") has standing to intervene as a CON applicant for an open heart surgery program in HRS District IX. Intervenors, JFK Medical Center, Inc., ("JFK") and Palm Beach Gardens Community Hospital, Inc., d/b/a Palm Beach Gardens Medical Center ("Palm Beach Gardens") have standing to intervene as existing providers of open heart surgery services in HRS District IX. AHCA published a net need projection for zero additional adult open heart surgery programs in HRS District IX, with the following notice: Any person who identifies any error in the fixed need pool numbers must advise the agency of the error within ten (10) days of publication of the number. If the agency concurs in the error, the fixed need pool number will be adjusted prior to or during the grace period for this cycle. Failure to notify the agency of the error during this ten day time period will result in no adjustment to the fixed need pool number for this cycle and a waiver of the person's right to raise the error at subsequent proceedings. See, Volume 18, Number 32, Florida Admiministrative Weekly, at page 4501 (August 7, 1992). By letter dated August 14, 1992, St. Mary's notified AHCA that it believed an error had been made in the fixed need pool projection for adult open heart surgery programs in HRS District IX. This letter was hand delivered to AHCA on August 14, 1992, within the ten days required by the fixed need pool publication. All of the parties to this proceeding agree with St. Mary's that the numeric need formula in Rule 10-5.033(7), Florida Administrative Code (subsequently, renumbered as Rule 59C-1.033(7), showed a need for one additional adult open heart surgery program in District IX, except that AHCA determined that the provisions of subsection 7(a)2. were not met. St. Mary's letter also asserted that there was evidence that all existing adult open heart surgery providers performed in excess of 350 adult open heart surgery operations during the applicable base period calendar year 1991. The minimum of 350 operations in each existing program is an additional prerequisite to the publication of need for a new open heart surgery program in subsection 7(a)2. of Rule 59C-1.033, which the parties refer to as a "default" provision. The default provision is invoked in this case because JFK reported fewer than 350 operations. The subsection provides that a new adult open heart surgery program will not normally be approved if: One or more of the operational adult open heart surgery programs in the district that were operational for at least 12 months as of 6 months prior to the beginning date of the quarter of the publication of the fixed need pool performed less than 350 adult open heart surgery operations during the 12 months ending 6 months prior to the beginning date of the quarter of the publication of the fixed need pool. (Emphasis added). In its letter of August 14, 1992, St. Mary's stated that: According to the information provided by JFK to the local health council JFK performed 347 adult open heart surgery operations during the applicable base period (calendar year 1991). Notwithstanding the data reported by JFK to the local health council, data obtained from the Health Care Cost Containment Board for the same 12 month period reflects a total of 356 adult open heart surgery discharges from JFK. All parties agree that for calendar year 1991, JFK Medical Center, Inc. ("JFK"), reported a total of 356 discharges within DRG's 104 through 108 to Florida's Health Care Cost Containment Board and, for the same period of time, JFK reported 347 adult open heart surgery operations to the Treasure Coast Health Council, Inc. Based on the data provided by JFK to the HCCB, St. Mary's requests that AHCA enter a final order finding that there is a need for one additional open heart surgery program in District IX in the September, 1992 review cycle. The determinative factual issue, in this proceeding, is whether the term "discharge" is equivalent to the term "operation" and, if it is, should the HCCB data be accepted as more reliable than the Health Council data. The term "open heart surgery operation" is defined by Rule 59C- 1.033(2)(g), Florida Administrative Code, to mean: Surgery assisted by a heart-lung by-pass machine that is used to treat conditions such as congenital heart defects, heart and coronary artery diseases, including replacement of heart valves, cardiac vascularization, and cardiac trauma. One open heart surgery operation equals one patient admission to the operating room. Open heart surgery operations are classified under the following diagnostic related groups (DRGs): DRGs 104, 105, 106, 107, 108, and 110. (Emphasis added). The definition of "open heart surgery operation" was also considered in Humhosco, Inc. v. Department of Health and Rehabilitative Services, 14 FALR 245 (DOAH 1991). The hearing officer found that: [D]iagnostic related groups, or "DRGs," are a health service classification system used by the Medicare System. The existing rule does not include the reference to DRG classifications. Some confusion had been expressed by applicants as to whether certain organ transplant operations which utilized a bypass machine during the operation should be reported as open heart operations or as organ transplantation operations. The amendment was intended to clarify that only when the operation utilizes the bypass machine and falls within one of the enumerated categories should it be considered an open heart surgery operation. The inclusion of the listed DRGs was meant to clarify the existing definition by limiting the DRG categories within which open heart surgery services may be classified. There is no dispute that the primary factor in defining an open heart surgery procedure is the use of a heart-lung machine. Florida Hospital argued that the proposed definition is ambiguous and vague because not all procedures which fit into the listed DRG categories necessarily involve open heart surgery. Florida Hospital's fear that the new language would seem to indicate that each procedure falling into the listed DRGs qualifies as an open heart surgery operation is unfounded. While the provision could have been written in a simpler and clearer manner, the definition adequately conveys the intent that the use of a heart-lung bypass machine is an essential element to classify an operation as open-heart surgery. Humhosco, supra, at 255. (Emphasis added).
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order determining that the fixed need pool publication, dated August 7, 1992, for Department of Health and Rehabilitative Services District IX for the July 1994 planning horizon is accurate. DONE and ENTERED this 22nd day of December, 1992, at Tallahassee, Florida. ELEANOR M. HUNTER 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 22nd day of December, 1992. APPENDIX Both parties have submitted Proposed Recommended Orders. The following constitutes my rulings on the proposed findings of fact submitted by the parties. The Petitioner's Proposed Findings of Fact Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or Reason for Rejection. Accepted in Findings of Fact 5 and 6. Subordinate to Findings of Fact 13. Accepted in Findings of Fact 11, conclusion rejected in Findings of Fact 13-15. Accepted in Findings of Fact 15, conclusion rejected in Conclusions of Law 18-19. Rejected in Conclusions of Law 17-19. Rejected in Findings of Fact 13-15. Accepted in Conclusions of Law 1. Accepted in Findings of Fact 7 and 9. Accepted in Findings of Fact 7 and 9. Accepted, in part, and rejected, in part in Findings of Fact 10 and 11. Rejected in Findings of Fact 11 and 13-15. The Respondent's Proposed Findings of Fact Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or Reason for Rejection. Accepted in Findings of Fact 5. Accepted in Findings of Fact 5. Accepted in Findings of Fact 6. Preliminary Statement Accepted in Preliminary Statement. Accepted in Preliminary Statement. Accepted in Preliminary Statement. Accepted in Preliminary Statement. Accepted in Preliminary Statement. Accepted in Findings of Fact 7 and 9. Accepted in Findings of Fact 10 and 11. Accepted in relevant part in Findings of Fact 4. Subordinate to Findings of Fact 9 and 11. Subordinate to Findings of Fact 7. Subordinate to Findings of Fact 12. Subordinate to Findings of Fact 12. Subordinate to Findings of Fact 12. Subordinate to Finding of Fact 11. Accepted in Conclusions of Law 17. Accepted in Findings of Fact 13-15. Accepted in Findings of Fact 13-15. COPIES FURNISHED: W. David Watkins, Esquire Oertel, Hoffman, Fernandez & Cole, P.A. 2700 Blair Stone Road Tallahassee, Florida 32301 Lesley Mendelson, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Byron B. Mathews, Jr., Esquire 201 S. Biscayne Boulevard Suite 2200 Miami, Florida 33131 Gerald M. Cohen, P.A. Steel Hector & Davis 4000 Southeast Financial Center Miami, Florida 33131-2398 Robert A. Weiss, Esquire John M. Knight, Esquire Parker, Hudson, Rainer & Dobbs The Perkins House 118 N. Gadsden Street Tallahassee, Florida 32301 Sam Power, Agency Clerk Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Harold D. Lewis, General Counsel Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
The Issue Whether Respondent, a physician, committed the offenses alleged in the Administrative Complaint and the penalties, if any, that should be imposed.
Findings Of Fact At all times pertinent to this proceeding, Respondent was a licensed physician in the State of Florida (license number ME 0031217) who practiced in the specialty of orthopedic surgery. Respondent was not board certified. At all times pertinent to this proceeding, Respondent had hospital privileges at Palm Springs General Hospital (Palm Springs) in Hialeah, Florida. On Saturday, February 26, 1994, T. P., a 29 year-old male, suffered a badly fractured leg while playing soccer. T. P. was taken to the emergency room at Palm Springs where the emergency room physician partially reduced the angulation of the fracture and placed the patient's leg in a splint cast. The patient was thereafter admitted to Palm Springs on February 26, 1994, under the care of Dr. Stephen Ticktin, an orthopedic surgeon. X-rays revealed that the patient had sustained a jagged fracture of both the tibia and the fibula. The fractures were similar to sharp-edged spears. There was a laceration and significant bruising at the fracture sight. Dr. Ticktin examined the patient's leg on February 26, 1994, but did not reduce the fracture (set the leg) on that date. Instead, Dr. Ticktin kept the leg in the splint cast to immobilize it, and planned to perform surgery on the following Monday morning. The patient and his girlfriend told Dr. Ticktin that they did not want to have surgery at Palm Springs. They wanted the patient transferred to a Broward County hospital so that he could be closer to his residence. On Monday, February 28, 1994, Dr. Ticktin did not perform surgery on T. P. On Monday, February 28, 1994, T. P. changed his mind and agreed to have surgery at Palm Springs. (Dr. Ticktin's notes reflect that the patient changed his mind after talking to a representative of his insurance company.) Surgery was planned for Wednesday, March 2, 1994. On that Wednesday, the patient ran a fever. Because of that fever, the anesthesiologist cancelled the surgery that had been scheduled for March 2, 1994. The patient terminated the services of Dr. Ticktin on March 2, 1994, and refused to be treated by him. Late in the day of Wednesday, March 2, 1994, the hospital administrator asked Respondent to assume the care of the patient. Respondent first saw the patient between 10:00 p.m. and 11:00 p.m. on Wednesday, March 2, 1994. At the time Respondent first saw him, T. P. had been immobile with the cast that Dr. Ticktin had placed on his leg on February 26, 1994. His fractured leg had not been set. The patient was very upset. On the evening of March 2, 1994, Respondent determined that the fracture would have to be reduced with the patient being under general anesthesia. Respondent observed that the leg did not appear to be excessively swollen and that the circulation in the leg was appropriate. Respondent noted that there was numbness in the foot, which indicated that a peritoneal nerve had been injured. Respondent had no reason to believe that that the patient was suffering from a compartment syndrome on March 2, 1994. Compartment syndrome is a relatively rare occurrence that results in restricted or total loss of blood flow due to swelling within a compartment, which is an enclosed facia. The tibia and fibula are encased in a compartment from the knee to the ankle. Swelling within that compartment produces pressure on the arteries and smaller blood vessels that can restrict or completely block the flow of blood below the area of the swelling. It typically takes several hours or days for a compartment syndrome to manifest itself. On the morning of March 3, 1994, Respondent aligned T. P.'s leg, thereby reducing the fractures, and stabilized it by inserting pins in the leg and applying an external fixater attached above and below the fracture sites. At approximately 10:00 a.m. on March 3, 1994, the patient was moved from the operating room to the recovery room. At the time the patient left the operating room, there were no signs that anything untoward had happened. The recovery room records reflect that at approximately 10:05 a.m., there was no pulse below the fracture site. Respondent observed in the recovery room that the leg below the fracture was ischemic (receiving little or no oxygen). Respondent testified, credibly, that he considered whether the patient was suffering a compartment syndrome, but that he concluded that he probably was not because of the rapid onset of the problem following the reduction and the placing of the fixater, and because the leg remained supple and had not changed from the earlier examination. Respondent immediately ordered an angiogram, the appropriate diagnostic examination, and contacted Dr. Marcos Zequeira, a vascular surgeon on the staff of Palm Springs. Both Respondent and Dr. Zequeira were of the opinion that the patient had suffered a vascular accident and neither one formed the opinion that they were dealing with a compartment syndrome. Dr. Zequeira and Respondent agreed that an angiogram should be performed to diagnose the cause of the loss of blood flow in the leg. Dr. Zequeira advised Respondent that there were no facilities to perform an angiogram at Palm Springs. 1 Dr. Zequeira and Respondent decided to transfer the patient to Dr. Felix Freshwater, a micro-surgeon at Deering Hospital, to perform an angiogram and perform the procedure that would be necessary to resolve the problem. As soon as could be done, Dr. Zequeira contacted Dr. Freshwater, who agreed to accept the patient. Respondent thereafter immediately made the arrangements for an ambulance, which transported the patient to Deering Hospital. Respondent followed the ambulance in his own car and remained with the patient until after Dr. Freshwater performed surgery on the patient. The patient arrived at Deering Hospital at 2:00 p.m. and the angiogram was completed at 3:40 p.m. Anesthesia was started on the patient at 4:37 p.m. and surgery began at 5:30 p.m. The angiogram performed at Deering Hospital revealed that the patient had suffered a type of a compartment syndrome. It was not a typical compartment syndrome and it could not have been accurately diagnosed without the angiogram. Dr. Freshwater testified that his and Dr. Zequeira's presumptive diagnosis prior to the angiogram was that of a direct arterial injury as opposed to a compartment syndrome. Appropriate surgical intervention required an angiogram. The surgical procedure performed by Dr. Freshwater (fibulectomy-fasciotomy) restored the circulation in the patient's leg. Loss of blood flow presents a serious threat to a patient's leg and can result of the loss of the limb. The longer the blood flow is cut off, the more damage to the leg occurs. Damage can begin to occur in as little as two hours after the flow is cut off. Damage to the leg is certain if blood flow is cut off for twelve hours or longer. Here, the patient's circulation in his leg had been significantly restricted or blocked from approximately 10:05 a.m. until the surgical intervention by Dr. Freshwater. Petitioner did not establish that the patient's subsequent problems with his leg were attributable to that fact.2 Petitioner's experts opined that when he first detected that the blood flow in the leg had been compromised, Respondent should have immediately removed the fixater from the patient and, if necessary, displaced the fracture, thereby restoring the flow of blood. These witnesses, both of whom are highly qualified in their fields of practice, testified that Respondent's failure to take prompt action to restore the flow of blood was below the acceptable standard of care. Dr. Freshwater and Dr. Shall were of the opinion that Respondent did not practice below the standard of care. All experts agree that it was appropriate for Respondent to consult with Dr. Zequeira, a vascular surgeon, and to order an angiogram. All experts agree that the restricted or blocked blood flow presented a danger to the patient's leg, and all agreed that the leg would suffer more damage the longer it took to restore appropriate blood flow. Dr. Freshwater and Dr. Shall were of the opinion that removing the fixater and displacing the fractures as suggested by Petitioner's experts without an angiogram would have presented an unwarranted risk to the patient because an appropriate diagnosis had not been made (and could not have been made without an angiogram) and because moving these spear-like fractures could easily have resulted in more damage to the leg, such as cutting or puncturing an artery. The more persuasive evidence established that it was appropriate for the Respondent to transfer the patient to the care of Dr. Freshwater because Dr. Freshwater was imminently qualified to perform the delicate surgery that was thought necessary to restore the blood flow and because Deering Hospital had the facilities to perform the requisite angiogram. All of the treating physicians were aware that time was of the essence and they moved as expeditiously as circumstances and prudence permitted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Administrative Complaint against the Respondent be dismissed. DONE AND ENTERED this 11th day of February, 1999, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON 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 11th day of February, 1999.
Findings Of Fact Southwest Florida Blood Bank, Inc., is a nonprofit community blood bank operating principally in the Tampa Bay Area. It operates a number of facilities known as "transfusion services" in hospitals in the Tampa Bay Area. It has paid separate licensure fees for three of these facilities. Leon County Blood Bank, Inc., is a nonprofit community blood bank operating in Leon County, Florida. It operates several facilities known as "transfusion services" within the County. It has been required to pay separate licensure fees for one of these facilities. No evidence was presented as to Petitioner Jacksonville Blood Bank, Inc. No evidence was presented as to Petitioner Florida Association of Blood Banks, Inc., although the parties did stipulate that it is a trade group which develops professional standards. "Blood banking" is an activity which involves administrative and medical functions in making available for transfusion to patients human blood and blood components. The operational procedures of a blood bank typically involve recruiting activities to attract volunteer donors. These donors are screened, questioned, and evaluated for suitability. If suitable, a blood donation is voluntarily obtained. Screening and collection procedures involve performance of a hematocrit, hemoglobin and blood typing. These procedures are clinical laboratory procedures subject to regulation under Chapter 483, Florida Statutes. They provide information about the health of the prospective donor and the suitability of blood for ultimate transfusion. Blood is typically collected at either the principal blood bank facility or at remote collection stations sometimes referred to as branch offices or mobile donor units. Blood is infrequently collected at facilities known as transfusion services. Once the blood is collected, it is processed using a variety of test procedures including antibody screens, serologic tests, and other procedures to determine the suitability of blood for storage prior to a need for ultimate transfusion. Human blood can be and is frequently separated into various blood components. Separation into components can occur before or after various test procedures are performed. Once the blood or components have been completely processed, the label is identified as to blood type and immunohematologic properties. The blood is then stored until it is needed for transfusion. All of these procedures typically occur in the principal blood bank facilities and are referred to as processing. Before blood can be transfused to a patient, further procedures must be performed. When a physician orders blood or a blood component for transfusion to a patient, a sample must first be obtained from the intended patient/recipient. The patient's sample is then mixed with a sample of blood or blood component obtained by donation in order to test compatibility. This procedure is known as a crossmatch. If the blood is determined to be compatible, then it is provided to the hospital for transfusion to the patient/recipient. The hospital will then either transfuse the blood or store it awaiting transfusion. Crossmatch procedures are often performed in the principal blood bank facility. However, they are also performed in facilities known as "transfusion services" located in hospitals. These facilities are operated both by hospitals and blood banks. Blood collection is usually performed in the principal blood bank, a collection station branch office or a mobile donor unit. Processing is typically done at a central location. Blood banks frequently rent or lease space in hospitals in which they operate facilities referred to as "transfusion services." These facilities have the capacity to store limited amounts of blood and to perform crossmatch procedures when blood or a blood component is requested for transfusion to a patient/recipient. A "collection station" is a remote location in which the only activity is the collection of blood from donors. The Southwest Florida Blood Bank (hereinafter "SWFBB") operates multiple locations in which it collects blood. It also operates four mobile donor units. The SWFBB performs the majority of its procedures at its principal location near the University of South Florida. This facility is licensed by the Department and a licensure fee is paid. SWFBB leases or rents space in hospitals at Tampa General Hospital, St. Joseph's Hospital, Humana-Brandon Hospital and a new facility known as Women's Hospital. It performs crossmatch procedures at each of these locations. The Department has required separate licensure and payment of a separate fee for each facility. SWFBB also provides blood and blood components to a number of hospitals in which the hospital performs the crossmatching. The Leon County Blood Bank (hereinafter "LCBB") performs crossmatch and compatibility testing at its principal location for blood supplied to hospitals. LCBB also leases or rents space at Tallahassee Memorial Hospital and Tallahassee Community Hospital where it provides personnel to perform crossmatch and compatibility testing procedures within the hospital. The Department requires separate licenses and payment of separate fees for facilities located at Leon County Blood Bank and Tallahassee Community Hospital. (It does not charge a separate fee for the facility located within Tallahassee Memorial Hospital because LCBB is located on property adjacent to the hospital, but it does require separate licensure.) The LCBB also provides blood to hospitals in nearby counties where the hospital operates a transfusion service to perform the crossmatch. The Department has defined the activities which it considers to be a "transfusion service." They include the performance of therapeutic pheresis; preparation of red blood cells; recovery of human plasma; and collection of blood. According to the Department, these activities do not require licensure. However, activities involving crossmatching, prenatal immunohematology procedures or other procedures for therapeutic administration of blood or blood components are considered to be clinical laboratory procedures and require a separate license. Hence, they are not activities of a "transfusion service" according to the Department. The separation of activity the Department has established fails to comport with any breakdown recognized or applied in the medical, blood bank or hospital industry. All witnesses who testified indicated that a "transfusion service" has always included the activity of crossmatching or compatibility testing of blood. Dr. Paul Schmidt, a preeminent national authority in blood banking with over thirty years experience, testified "transfusion service" has always included the activity of crossmatching. This was confirmed by Dr. Malloy who has been involved in both national and state blood banking for over twenty years. Their understanding is further confirmed by the Department's own witness, Laura Phillips, who was responsible for promulgation of the challenged rule. No witness who testified could identify a single instance in which a "transfusion service" operates in the manner of the activities broken down by the Department in its rule under challenge in this cause. The Department's exclusion of crossmatching procedures from the definition of "transfusion service" contradicts the historical meaning of the term and the functional breakdown of activities which exist and have always existed in the industry. Dr. Schmidt and Dr. Malloy testified without contradiction that a transfusion service does not collect blood. Furthermore, neither is aware of any transfusion service which has ever been involved in continuous blood collection. The Department offered no evidence of a facility which engages in such activity. Both Dr. Schmidt and Dr. Malloy admitted that preparation of red blood cells and recovery of human plasma could be done in a transfusion service, but that these activities as a matter of practice were generally done in a blood collection and processing facility. Neither is aware of any entity or facility which has performed the various functions which the Department attributes to a transfusion service in their rule. The Department has never attempted to ascertain whether facilities exist which meet the definition contained within their rule. The only facilities which the Department could identify as meeting their definition were "collection stations or mobile units." Finally, the testimony is uncontradicted that crossmatching is inherently a function of a "transfusion service." Authoritative medical and industry standards as well as state and federal regulations uniformly include the function of crossmatching within the activities performed by a "transfusion service." The American Association of Blood Banks Standards, which are the most comprehensive recognized standards existing within the United States and perhaps the world, define and refer to a transfusion service as including the functions of "storing, crossmatching and issuing blood for transfusion." These standards are applied by organizations such as the Joint Commission on Accreditation of Hospitals and the College of American Pathologists in defining hospital practice and inspection procedures. The Department itself uses these standards. It has entered into an agreement for alternate-year inspections of blood banks and transfusion services with the AABB which adopts the AABB standards and guidelines, including the definition of a "transfusion service." The federal Health Care Financing Administration has adopted a definition for "transfusion services" which includes the crossmatching and compatibility testing of blood. The federal Food and Drug Administration also defines transfusion service as involving compatibility testing. More importantly, the Department has been delegated inspection responsibilities under federal regulations and pursuant to federal regulations in determining qualifications for Medicare reimbursement certification. Finally, the Department's own survey reports contain reference to "transfusion service" in the context of procedures which include activities involving crossmatching and compatibility testing. The Department acknowledges that its rule definition of "transfusion service" is inconsistent with federal regulations as well as their own practices and procedures. The Department justifies its rule distinction between those activities which are referred to as a "transfusion service" and those activities which are not and require licensure and payment of a separate fee, by claiming that certain activities performed by "transfusion services" are not "clinical laboratory procedures". However, even this explanation is contradicted by the evidence. The testimony is uncontradicted that collection of blood involves performance of procedures known as hemotocrit, hemoglobin and blood typing. These procedures are acknowledged to be clinical laboratory procedures. Hence, under the Department's own analysis, a "transfusion service" performing collection of blood would be a clinical laboratory and thus fail the Department's rule definition. The Department has required payment by SWFBB and LCBB of licensure fees for facilities which each leases or rents at hospitals where the principal activity is the crossmatching and storing of blood of transfusion. The most recent separate fee charge for each of these facilities is $750.00 per year per facility. The Department is not able to cite any authority, standard or state or federal regulation consistent with its definition of transfusion service. It is unable to identify any facility which has met, or in the future would meet, its definition. Petitioners have stipulated that transfusion services are a kind of clinical laboratory and are thus subject to separate licensure as a clinical laboratory.
Findings Of Fact The Respondent, Charles P. Shook, M.D., is a medical doctor having been issued license number 0020414, pursuant to Chapter 458, Florida Statutes. He is board certified in the areas of general and peripheral vascular surgery and practices in those specialty areas in Fort Myers, Lee County, Florida. He has been practicing in Lee County since 1973. The Petitioner is an agency of the State of Florida, charged with enforcing the licensure and practice standards embodied in Chapter 458, Florida Statutes and related statutes and rules and imposing disciplinary measures for departure from those standards by physicians licensed in Florida when such are proven. Mrs. Betty A. Fiore, at times pertinent hereto, was an obese, 47-year old female, with a history of thrombo-phlebitis and progressively enlarging and painful bilaterial varicosities of the veins in her right and left legs. She was admitted to Fort Myers Community Hospital on January 28, 1979, by the Respondent, for performance of a bilateral "vein-stripping" surgical procedure. Her medical history reflected that she had had a similar vein-stripping procedure performed over 20 years previously. The patient was operated on by the Respondent on January 29, 1979, beginning at approximately 9:25 a.m. The procedure was quite lengthy due to certain complications and lasted until 1:25 p.m. that day. After normal preparations, under general anesthesia, the Respondent began the operation by performing an oblique groin incision on the left leg just below the inquinal liagment, approximately ten centimeters in length. The incision penetrated the subcutaneous tissue and, as the "fossa-ovalis" was approached, the Respondent noted a significant amount of scar tissue, apparently related to the earlier surgical procedure, which obliterated and concealed much of the normal anatomy and structure in the area of surgery. It was of such a dense nature that only a faintly palpable pulse could be felt in the vessel. The Respondent dissected out the various venous branches in the area and individually ligated them. During his dissection process, the distal common femoral artery was injured by being slightly nicked with the surgical instrument. Repair procedures for the injury to the artery were carried out as will be described below. In any event, the "codman stripper" was employed in carrying out the stripping operation on the vein in question and additionally, several incisions were made around the calf of the leg to alleviate smaller varicosities. One large perforating vein in the malleolar area had to be ligated after the superficial portion had been stripped away. The Respondent then began to perform a similar procedure on the right leg, in spite of the initial difficulties he had had on the left leg, because he did not expect such severe scar tissue involvement with the anatomical structures in the area of incision on both legs. When he carried out the incision on the right leg however, he found that the anatomy of the right leg was essentially the same as that of the left and that substantial scar tissue reaction had occurred, related to prior surgery, with obliteration of much of the normal anatomy, including concealment of the femoral artery. Due in large part to these anatomical changes and complications involved in dissecting out the various venous branches involved in the stripping procedure, the right femoral artery was also slightly nicked by the scalpel. The Respondent attempted to suture the femoral arteries nicked in both legs at the time these injuries occurred, but the sutures would not hold in the arteries due to some then unknown, medical condition. After the same failure to hold sutures was encountered with regard to both femoral arteries, the Respondent sent samples of the arteries to the pathologist for evaluation. The pathologist report indicated that the arteries were "normal." Parenthetically it should he noted that the "complaining witness," Mrs. Fiore, has been found to exhibit symptoms of diabetes mellitus. Her testimony was somewhat evasive concerning the degree to which she may suffer from this malady, which can have a detrimental effect on the vascular system. In any event, when working first on the left leg, the Respondent elected to resect back along the artery for approximately a half-inch on each side of the wound and after that resection, to repair the femoral artery with the insertion of a 6 millimeter gortex graft. Likewise, with regard to the right leg, the Respondent found the sutures would not hold in the damaged artery (which was of a "cheese-like" consistency). He therefore performed a similar resection and insertion of a 6 millimeter gortex graft to repair the injury. The surgical procedure was then successfully concluded. Post-operatively the patient encountered some complications involving infection in the groin area, requiring two additional admissions to Fort Myers Community Hospital. Subsequently, she was transferred to Methodist Hospital in Houston, Texas, where she underwent two additional surgical procedures. The Petitioner presented the opinions of two expert witnesses, Dr. Alexander Braze and Dr. E. William Reiber. Dr. Braze's expert opinion is predicated on the review of Mrs. Fiore's office records from the Respondent's office, the hospital charts for her three admissions to Fort Myers Community Hospital, and summaries of her two admissions to the Methodist Hospital in Houston, Texas. His opinion is not based on any examination of the patient involved. Dr. Braze thus opined that because of the previous surgery on the greater saphenous vein, bilaterally, there would be obvious and considerable scarring and scar tissue in the subcutaneous area which would distort and conceal the individual anatomical structures. He himself has never nicked a femoral artery while doing a vein-stripping operation but, although he acknowledges it is an "uncommon complication, he has heard of it occurring. He was unable to render an opinion concerning whether or not the operation was performed properly because this was not a typical vein ligation and stripping procedure, due to the presence of extensive scar tissue, and resulting difficulty involved. The dense scar tissue precluded identification of the structures in the area of the surgical incision and meant that the Respondent had to proceed slowly and very meticulously with a careful dissection, deviation from which careful procedure could cause difficulty. The doctor's procedure was slow and meticulous. The procedure (for both legs) took approximately four hours. Although the Respondent proceeded with care, he nicked the arteries anyway. Dr. Braze could not state that such a complication, albeit uncommon, constituted a departure from standards normally recognized in the medical community. With regard to the doctor's judgmental decision to proceed to the right leg after nicking and repairing the artery in the left leg and completing the vein stripping procedure in the left leg. Dr. Braze opined that he was acting as a reasonable physician in proceeding to the other leg since he had already corrected the initial injury, especially since it was the leg in which she was having her chief complaints. In any event, Dr. Braze was unable to render an opinion as to whether or not the procedure up to the point of nicking the artery was properly or improperly done, although he acknowledged that the lengthy time taken to perform the total procedure indicates that the doctor was proceeding slowly and with greater than normal difficulties. In any event, after the arteries were nicked, the procedure followed by the Respondent was excellent and the repair work was competently and efficiently performed. Dr. Reiber, Petitioner's other expert witness, testified by deposition, which was stipulated into evidence. His expert opinion was based on a review of the deposition of the Respondent, the Fort Myers Community Hospital records of the patient, and the depositions of the patient, Betty Fiore, Arnold Flare and Quillen Jones. Additionally, he reviewed the records dealing with Mrs. Flare's treatment in Houston, Texas. He thus opined that the Respondent made two technical errors when he injured the arteries in each leg and he felt that it was an error in judgment to have performed the procedure on the right leg after having encountered difficulty in the initial procedure on the left leg. He was unable to opine however, that the treatment rendered the patient by Respondent fell below the appropriate standard of care accepted by similar physicians in the community. Moreover, he also opined that the Respondent's treatment after nicking the arteries affirmatively met the standard of care for reasonably prudent physicians in such circumstances. The expert witnesses presented on behalf of the Respondent were Drs. Peter M. Sidell and Luis A. Ruilova. Both witnesses opined, in effect, that, given the obesity of the patient and the difficult surgical process that alone entailed, coupled with the significant involvement of scar tissue in the area of the incision, that the complications associated with this procedure could occur in the hands of even the most renowned surgeon. The fact that the Respondent experienced these complications does not render his practice in this regard to be below the standard of care for vascular surgeons in that community or area of practice. They further opined that it is a matter of personal judgment on whether to proceed to the other leg after encountering these difficulties. A reasonable judgment would have been to explore the groin area on the other side, after accomplishing repair of the first injured artery, which was done. The initial arterial injury having been repaired in a successful manner, both of the Respondent's experts opined that, the patient then being stabilized, the Respondent was justified in proceeding to the other leg and performing the procedure on that side. The main purpose of the operation was to remove the veins of the patient since the patient was symptomatic with varicosities. It therefore would be poor judgment to simply repair the nicked artery and proceed no further, since the symptomatic vein would remain uncorrected. In short, both experts for Respondent opined that neither the vein-stripping procedure, the repair of the damaged arteries nor post-operative management for which Respondent was responsible were performed in a manner below the appropriate standard of care of reasonably prudent physicians in the community. Thus, although the patient unfortunately experienced difficulties during a procedure involving the accidental nicking of her femoral arteries and, after the grafts repairing those injured arteries were performed, later suffered an infection at the operative site necessitating further hospitalization, no expert witness could describe the treatment and care afforded this patient as being below the appropriate standard of care exercised by a reasonably prudent physician performing such vascular surgical practice in the Fort Myers community or area. The Respondent has never encountered this difficulty either before or since this occasion in his practice, which is characterized by frequent vascular surgical procedures. Additionally, Dr. Ruilova established that the nicking of the femoral arteries during such a procedure, although not a common occurrence, is well documented in the literature and not at all unheard of. Indeed, Dr. Ruilova, when assisting a distinguished surgeon who was chief of surgery at the Mayo Clinic at the time, observed that expert surgeon nick a femoral artery in a vein- stripping procedure on two occasions. Finally, it is noted that the Respondent's practice has been characterized by a high level of professional expertise, competence and compassion in caring for his patients, both before and since the occasion in question. He has never before been subjected to disciplinary action.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is, therefore RECOMMENDED that a Final Order be entered by the Board of Medical Examiners dismissing the complaint in its entirety. DONE and ENTERED this 11th day of October, 1984, in Tallahassee, Florida. P. MICHAEL RUFF 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 11th day of October, 1984. COPIES FURNISHED: Barbara K. Hobbs, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Patrick Geraghty, Esquire HENDERSON, FRANKLIN, STARNES & HOLT Post Office Box 280 Fort Myers, Florida 33902 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
