The Issue The issues are whether, during 2015, Respondent held himself out as a “doctor of medicine,” even though he did not hold a license to practice medicine in Florida, in violation of section 456.072(1)(m), Florida Statutes (2014); whether, during 2015, Respondent exceeded the scope of his advanced practice registered nursing (APRN)1 license modifier by removing adipose tissue from a patient’s abdomen, performing intravitreous injections of the processed tissue into both eyes of a patient, and failing to have a protocol in place for the removal of abdominal adipose tissue and the intravitreous injection of any material into a living person, in violation of section 456.072(1)(o); and, if so, the penalty that should be imposed.
Findings Of Fact The Parties Petitioner is the state agency charged with regulating the practice of nursing pursuant to section 20.43, and chapters 456 and 464, Florida Statutes. Respondent was born and raised in Cuba, where he obtained a licensed practical nurse degree and, in 1995, Respondent earned a Doctor of Medicine degree and moved to Florida. On two occasions, Respondent failed to pass the examinations in Florida for licensure as a medical doctor. Respondent obtained a Florida license as a registered nurse in 2005 and, in March 2015, a license modifier as an APRN. Respondent’s highest relevant education in the United States is a Master of Science degree in nursing awarded in December 2014 from the south Florida campus of the University of Turabo. A couple of months later, the American Academy of Nurse Practitioners certified Respondent as a Family Nurse Practitioner. The transfer of processed fat tissue into the eye is thought, by some, to treat conditions of the eye, such as dry macular degeneration, to be part of regenerative medicine. This so-called “stem cell injection procedure” (“procedure”) comprises three steps: (1) removing the fat tissue, usually from the abdomen; (2) processing the fat tissue to prepare it for injection; and (3) injecting the processed fat tissue into the vitreous cavity at the back of the eye. Following the completion of his medical education in Cuba, Respondent obtained varying degrees of training and experience in the each of the three steps of the procedure. Respondent testified that he trained with a “specialist,” possibly an ophthalmologist, in intravitreal injections. This covered such topics as the choice of syringe, the preparation of the patient, maintaining an open eye, the choice of a substance to stabilize the inside and outside eye, and the angle of the needle to the surface of the eye at the point of injection. Respondent also obtained training in intranasal and intraarterial injections, the latter of which is the more complicated. Respondent obtained a certificate in Mexico for completing the training in the removal of tissue from bone marrow. Respondent did not detail his training or experience in processing removed fat tissue. Through much of Latin America, Respondent has injected processed fat tissue, at the rate of about ten patients over one week, and has trained other healthcare providers to perform these procedures. Respondent also testified that he had performed a dozen intravitreal injections of processed fat tissue in Mexico and Chile prior to the three injections at issue in this case, so it seems that most of his experience did not involve intravitreal injections. Respondent’s only evidence of purported “stem cell” experience was assisting in bone marrow aspiration, not surgical adipose tissue removal or intravitreal injections. Respondent admitted that he had never performed intravitreal injections under the supervision of an ophthalmologist, a medical doctor of any type, or in a supervised training program prior to performing intravitreal injections on Patients E.K., E.N., and P.B. in May and June of 2015. Respondent failed to provide any evidence that he was educated or supervised by a licensed physician in the performance of these procedures prior to performing them on Patients E.K., E.N., and P.B. Performance of the Procedure by Respondent at the Clinic Respondent’s first intravitreal injection of fat tissue at the Clinic took place in April 2015, about one month after he had completed the educational requirement for this APRN license modifier. Having retained Respondent as an independent contractor, the Clinic called him a few days before an upcoming intravitreal stem cell injection to confirm his availability. The Clinic paid Respondent $500 per procedure, for which it charged each patient $5000. Although the Clinic operated this program as an FDA- registered clinical trial, all procedures were “patient funded treatment,” and the Clinic was not affiliated with any educational or research institution investigating stem-cell treatment of eye diseases or disorders. The three patients involved in this case are, or were, E.K., P.B., and E.N. E.K.’s procedure took place on May 15, 2015, and P.B. and E.N.’s procedures took place on June 16, 2015. Each patient suffered from dry macular degeneration. Each patient was sighted at the time of the procedure, at the end of which, each patient was substantially blind. At the time of each patient’s procedure, E.K., who died five years after her procedure, was 89 years old and resided in Oklahoma. P.B. was 77 years old and resided in southwest Florida, and E.N. was 72 years old and resided in Missouri, where she had taught research methods to graduate students at the University of Missouri. At the time of the subject procedures, the Clinic was affiliated with Bioheart, Inc., a publicly traded corporation. Key employees of the Clinic included Kristin Comella, who served as the chief scientist of the Clinic and chief scientific officer of Bioheart and holds bachelor’s and master’s degrees in chemical engineering, and Dr. Antonio Blanco, who is an internist in Hollywood, Florida, with 26 years of practice and the medical director of the Clinic and holds a medical degree from Georgetown University. The Clinic’s website adds that Ms. Comella is in the top 50 of global stem-cell influencers. E.K. and E.N. testified that they learned about or confirmed their interest in the Clinic by an online search of clinical trials of stem-cell treatment for dry macular degeneration. Neither patient differentiated between patient-funded clinical trials, such as these, and clinical trials whose treatment costs were subsidized by research centers, universities, hospitals, and pharmaceutical manufacturers. E.K.’s medical records do not include any representations as to Respondent’s status as a healthcare provider. E.K. and her niece, who accompanied her, arrived in Fort Lauderdale in sufficient time for E.K.’s pre-operative appointment with Dr. Greenbaum, an ophthalmologist employed with the Hollywood Eye Clinic. Until she spoke with Dr. Greenbaum, E.K. believed that Dr. Greenbaum would perform the procedure, based on what she had been told by Clinic staff. At the pre-operative exam conducted by Dr. Greenbaum, E.K. and her niece learned that Dr. Greenbaum would not be performing the procedure on the following day. Dr. Greenbaum mentioned Respondent’s name, so the niece had her husband research Respondent that night, but his research revealed nothing. The next day, E.K. and her niece were introduced to Respondent by a Clinic employee, likely Ms. Comella. The niece does not recall if the employee referred to Respondent as a physician, but she assumed that he was. She recalled only that the clinic employee introduced him by saying that he was very experienced and had performed lots of stem cell injections of this type. The niece recalled distinctly that Respondent introduced himself as a “medical doctor.” Respondent denies doing so. The niece’s testimony is credited based on the totality of the evidence. P.B.’s medical records do not include any representations as to Respondent’s status as a healthcare provider except for the operative report, which bears Respondent’s signature above “Physician Signature.” Well prior to the date of the procedure, P.B. called the Clinic, spoke with Dr. Greenbaum and Ms. Comella, who informed her that Dr. Greenbaum would perform the procedure. P.B. later arrived in Fort Lauderdale in time for her pre-operative exam by Dr. Greenbaum, whose office told P.B. that Dr. Greenbaum was no longer performing the procedure. P.B. assumed that another ophthalmologist would perform the procedure. The next day, P.B. and a friend or family member, who had accompanied her on the trip, met Ms. Comella and Respondent, whom Ms. Comella introduced as “Doctor Perez,” and he did not correct her. P.B. asked him if he was an ophthalmologist, and Respondent replied, “no, but I’m well-trained in this procedure.” He never mentioned that, in terms of Florida licensing, he was only a registered nurse or APRN and was not a physician. E.N.’s medical records include the most references to Respondent’s status as a healthcare provider. These records include a page from the Clinic’s website that was initialed and dated by E.N., and prominently identifies Respondent as a “DM, NP-C,” meaning “doctor of medicine” and “nurse practitioner--certified.” The accompanying text discloses that “Dr. Alejandro Perez” graduated from the University of Havana Medical School in 1993 as a “Doctor in Medicine”; since 2007, he has conducted innovative research on regenerative medicine with a focus on adult stem cells from bone marrow and adipose tissue; “Dr. Perez” has worked on adult stem cells to treat multiple chronic diseases; “Dr. Perez” trains national and foreign “Medical Doctors” on the use of adult stem cells; and that “[h]e currently holds a National Board Certification as a Family Nurse Practitioner.” In three out of five references, the document refers to Respondent as a “doctor,” never disclosing that he was not a licensed physician in Florida. This website page may have come into existence after Respondent’s first patient encounter in this case in May 2015. Ms. Comella introduced Respondent to E.N. and her sister, who had accompanied her on the trip, as “Dr. Alex Perez.” Without stating his specialization, Respondent told E.N. that he was a “medical doctor” and was proud of his “profession,” which, in context, meant the practice of medicine, not nursing. Respondent wore a white jacket with a printed name tag, “Alex Perez, M.D.” At no time did Respondent reveal that his Florida licensure was as a registered nurse or APRN and not a physician. Lack of a Written Protocol As a licensed APRN, Respondent was required by section 464.012 and Florida Administrative Code Rule 64B9-4.002 to practice under an APRN protocol filed with the Board of Nursing. At all times material, the scope of practice of a certified family nurse practitioner licensed in Florida as an APRN did not include performing any invasive procedures, including surgical removal of adipose tissue or intravitreal injections, without an APRN Protocol on file that ensured physician supervision. By letter dated March 12, 2015, the Board of Nursing notified Respondent that he was required to have an approved APRN protocol on file with the Department “within 30 days of employment.” Respondent was employed in March 2015 at the time of receipt of the above-referenced letter. In May and June 2015, Respondent was aware of the protocol requirement and the scope of practice as an APRN. He admitted that he received the March 12, 2015, letter and failed to provide a protocol as instructed. At no time did Respondent ever obtain or file with the Board of Nursing a written protocol between him and a supervising licensed physician authorizing Respondent to perform the subject procedure. Respondent claimed, alternatively, that Drs. Greenbaum and Blanco served as his supervising physicians, but admitted that they served remotely and without a signed written protocol. Harm to the Patients The impact on the three patients of this unauthorized procedure performed by Respondent was blindness and its incumbent, incalculable damages, including, but not limited to, loss of independence, loss of mobility, and loss of enjoyment of life. Respondent admitted that, if not for the procedure, the three patients would likely not have been blind.2
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Nursing enter a final order finding that Respondent has violated sections 456.072(1)(o) and 456.072(1)(m) and revoking Respondent’s license to practice as an advanced practice registered nurse. DONE AND ENTERED this 3rd day of May, 2021, in Tallahassee, Leon County, Florida. S MARY LI CREASY 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 3rd day of May, 2021. COPIES FURNISHED: Dirlie Anna McDonald, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Nicole M. DiBartolomeo, Esquire Department of Health Office of the General Counsel 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Louise St. Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Dwight Oneal Slater, Esquire Cohn Slater, P.A. 3689 Coolidge Court, Unit 3 Tallahassee, Florida 32311 Joe Baker, Jr., Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C-02 Tallahassee, Florida 32399 Deborah McKeen, BS, CD-LPN Board of Nursing Department of Health 4052 Bald Cypress Way, Bin D-02 Tallahassee, Florida 32399
The Issue The basic issue in this case is whether Deering Hospital's application for a certificate of need to operate an inpatient cardiac catheterization program should be granted or denied.
Findings Of Fact Deering Hospital, formerly known as Coral Reef Hospital, is located at 9333 Southwest 152nd Street, Miami, Florida, in HRS District 11, Dade County. Deering Hospital has a total of 260 beds: 170 medical/surgical, 54 adult psychiatric, 16 adolescent and child psychiatric and 20 substance abuse beds. It is an acute care hospital. Deering's primary geographic service area is north to the town of Kendall, west to the Everglades, east to Biscayne Bay and south to 232nd Street. The secondary service area is south to the Florida Keys. Deering's primary service is defined by 62 percent of its admissions, its secondary service area by 17 percent, and all other areas, including North Monroe County, comprise 21 percent of all its admissions. Competitors in Deering's primary and secondary service areas include Kendall Regional Medical Center, Baptist Hospital, South Miami Hospital, and South Miami-Homestead Hospital, which was previously called James Archer Smith Hospital. These hospitals have shared a service area as long as they all have existed. South Miami-Homestead Hospital does not have a cardiac catheterization laboratory. Deering is within 30 minutes travel time of three full service cardiac catheterization programs located in facilities with open heart surgery, including two of the challengers to its application. On June 18, 1990 South Dade Health Care Group, Ltd., was formed in order to acquire Coral Reef Hospital. South Dade Health Care Group, Ltd., at the time of the application was and is currently licensed by HRS to operate Deering Hospital. Columbia Hospital Corporation of South Dade ("Columbia') is the general partner of South Dade Health Care Group, Ltd. Columbia, acting on behalf of South Dade Health Care Group, Ltd., acquired Coral Reef on September 26, 1990. Coral Reef changed its name to Deering Hospital on April 2, 1991. Deering's CON application in this batch cycle was submitted on March 25, 1991. The June 18, 1990, audited balance sheet for South Dade Health Care Group, Inc., was prepared for a development stage enterprise and is an audit of costs to start up the hospital after the acquisition by Columbia. The December 31, 1990, audit covers a 97 day period from September 26, 1990, (date of acquisition) to December 31, 1990, and included development and organizational costs. Since the applicant/entity/licensee did not exist before June 18, 1990, and the hospital was not acquired by that entity before September 26, 1992, there are no other financial statements that could have been prepared before the Deering application was submitted on March 25, 1991. South Dade Health Care, Group, Ltd., submitted a timely and valid letter of intent and a timely application for Certificate of Need ("CON") 6664 to provide in the July 1993 planning horizon inpatient cardiac catheterization services at Deering Hospital. South Dade Health Care Group, Ltd., and Columbia have authorized Deering Hospital's participation in this case. The capital projects list in the application is complete. When Deering was purchased by Columbia in 1990, Deering had a special procedure room that was apparently equipped and had the capacity to provide diagnostic coronary catheterizations as well as peripheral (i.e., the extremities) vascular diagnostic and therapeutic procedures. Although outpatient catheterizations had been performed in the special procedure room in the past, none were being done when Columbia acquired the hospital in September 1990. In late 1990, following evaluation of the equipment, Deering recruited an experienced CCRN cardiac catheterization laboratory nurse, hired a qualified CV tech, and began offering outpatient cardiac catheterization services. The decision to begin outpatient cardiac catheterization services was based in part on the idea that there would be no capital costs since the equipment to perform the procedures already existed. In December of 1990, the existing outpatient cardiac catheterization laboratory did about nine procedures and experienced some equipment failures. As a result of the equipment failures, Deering temporarily stopped doing outpatient cardiac catheterization, but was able to continue doing special procedures (vascular and arterial catheterizations, not coronary) in the room. After exploring various possibilities, Deering entered into a lease to obtain new equipment for its existing outpatient cardiac catheterization laboratory and signed a renewal lease to continue the lease of the equipment that was already in the outpatient laboratory. In January of 1992 the hospital resumed doing outpatient cardiac catheterization procedures and ten outpatient cardiac catheterizations have been performed in the room since January 31, 1992. From 1985 through April of 1991 the Deering outpatient cardiac catheterization program has done a total of twenty-nine outpatient procedures. The lab was closed temporarily to outpatient cardiac catheterization procedures from March 1991 through January 1992 in order to bring in new equipment. The hospital has been diligent and persistent, from the date Deering was acquired by Columbia to the present, in its efforts to maintain and enhance its outpatient cardiac catheterization program. Currently, however, if a Deering inpatient needs a cardiac catheterization, that patient must be taken past an active outpatient catheterization laboratory at Deering, only to be transferred to another hospital with an inpatient cardiac catheterization certificate of need. In health planning, it is generally desirable to use existing facilities and equipment to do additional procedures. By its application in this case, Deering proposes to use its existing outpatient cardiac catheterization laboratory to perform inpatient cardiac catheterization. For calendar year 1991, about 50 cardiac catheterization inpatients were transferred from Deering to other hospitals. Patients requiring inpatient cardiac catheterization or open heart are transferred from Deering to South Miami Hospital, Baptist Hospital, or Kendall Regional Medical Center. At Deering the spatial relationships between the existing outpatient cardiac catheterization laboratory and related services such as telemetry and intensive care appear to be adequate. Deering has 16 telemetry beds and they can be easily increased if needed. An uncomplicated inpatient cardiac catheterization typically results in one day in telemetry. Deering has ample capacity for over 300 additional telemetry patient days. At Deering the intensive care unit and the coronary care unit are collectively referred to as the critical care service (CCS). Deering has 14 CCS beds where a patient can be directly connected to a cardiovascular monitor allowing monitoring of any clinical changes. The current CCS average daily census is ten (10). Deering's application is not by or on behalf of an HMO. No evidence was presented to show that HMO's in District 11 have unmet cardiac catheterization needs or that Deering's application would fulfill any needs of HMO's. To the contrary, HMO's have a tendency to prefer cardiac catheterization services at facilities with open heart surgery. Typically an uncomplicated diagnostic cardiac catheterization does not require a CCS stay. Even if 50 percent of Deering's cardiac catheterization inpatients required CCS during their stay, Deering has the capacity to accommodate the 150 additional CCS patients annually. The physical space which comprises the existing outpatient cardiac catheterization laboratory is clinically adequate in its current configuration to facilitate communication during the procedure and time savings. The dark room, computer room and procedure room are all adjunct. There are no medical or clinical reasons why the space is not adequate. According to the medical director, who has extensive experience at other hospitals and who has performed outpatient cardiac catheterizations in Deering's procedure room, Deering's procedure room is more than adequate for performing inpatient cardiac catheterization. If the inpatient certificate of need is granted, the procedure room where outpatient catheterizations are currently performed will continue to be a mixed used room, i.e., peripheral angioplasties and coronary catheterizations will be scheduled in the same room. Deering Hospital is JCAHO accredited. It received a three year accreditation in 1991. The laboratory currently used for outpatient procedures was surveyed by JCAHO as a special procedure room. Deering has never been cited in any JCAHO or HRS licensure survey for any inadequacy in life, safety, or fire codes in the outpatient cardiac catheterization special procedure room. Deering currently has all of the equipment, staff and ancillary services described in, and required by, the applicable rule. Deering has two physicians on staff that serve and are compensated as co-directors of the existing outpatient cardiac catheterization laboratory. Dr. Palomo is co-medical director of the existing outpatient cardiac catheterization program and will be co-medical director of the inpatient program if the program is approved. Dr. Palomo is Board certified in internal medicine and Board certified in cardiovascular diseases. He was previously an assistant professor of medicine at the University of Miami and ran the cardiac catheterization lab at the Veteran's hospital in Miami. Last year Dr. Palomo performed 300 cardiac catheterizations in the Miami area. Dr. Palomo has cardiology staff privileges at six Miami hospitals, including two of the challengers to this application, Baptist Hospital and South Miami Hospital. He lives ten minutes from Deering Hospital and his office is located eight minutes from Deering. There is no industry standard for credentialing cardiac catheterization laboratory nurses, but it is generally agreed that all cardiac catheterization personnel should be ACLS trained. All Deering nurses who are cross-trained for the cardiac catheterization laboratory are ACLS certified. Deering has also cross-trained an ECHOvascular technician into the scrub roll in the laboratory. All current cardiac catheterization laboratory staff and all cross-trained cardiac catheterization laboratory staff are already full time Deering employees. Current staff can accommodate the projected volume of inpatient cardiac catheterizations and the current rate of peripheral and outpatient catheterizations. If awarded the service, Deering would be able to implement the service the day of the award. The current staff is adequate regardless of whether they are performing an inpatient, outpatient, or peripheral procedure. The staffing of the inpatient lab would be the same as the current outpatient laboratory; i.e., a physician, RN and a CVT. There would not be any need to add staff if the number of procedures increased between 300 and 1,000 annually. Accordingly, Deering does not intend to recruit additional professional personnel from the local market. The capacity of Deering's existing laboratory, when used for inpatient cardiac catheterization procedures, can conservatively be calculated as follows: 1 hour from arrival at the procedure room to departure from the procedure room, times an 8 hour day, times a 5 day week, times 52 weeks a year equals 2,080 case theoretical capacity. One-half that theoretical capacity is four cases a day or 1,040 cases a year. A cardiac catheterization laboratory can typically do between 1,000 and 1,500 cases per year. Four cases per day (1,040 cases per year) is a reasonable number to express the capacity of Deering's existing laboratory to accommodate inpatient procedures with current space, equipment and staff. The existing inpatient cardiac catheterization laboratories in District 11 have similar capacities. With additional staffing, Deering or any of the existing laboratories might have even greater capacities. If granted inpatient cardiac catheterization services, Deering would not do coronary angioplasties because it does not have open heart surgery in the same facility. Deering maintains transfer agreements with other facilities for services that Deering does not provide. Deering has developed an adequate protocol outlining how an open heart or angioplasty backup patient would be transferred. Deering has established medically appropriate criteria for granting and maintaining privileges in its outpatient cardiac catheterization laboratory that would be suitable for the proposed inpatient cardiac catheterization program. Deering has developed adequate and appropriate forms to manage its patient care in the outpatient program which would be suitable for the inpatient program. Deering has developed clinically adequate and appropriate protocols for temporary pacemaking, recording hemodynamic data, and insuring the emergency availability of staff in the cardiac catheterization laboratory. Deering has a policy and procedures statement to orient new employees to the cardiac catheterization laboratory. Generally, there is no alternative to cardiac catheterization when catheterization is medically indicated. However, there are alternatives to Deering's application, such as allowing existing providers to achieve efficient levels of utilization. Deering is not proposing joint, shared, or cooperative health care services. Deering is not proposing to provide services for research or teaching purposes. Deering does not propose to provide a substantial portion of its services to individuals not residing in the service district. Indeed, inpatient cardiac catheterization services are readily available in adjoining service areas. Deering is not proposing any new construction in its application. Deering is not proposing to add nursing home beds. No service reductions will occur as a result of this proposal. Financial feasibility of a project means the project can be accomplished within the financial resources of the overall institution. Short- term financial feasibility means the applicant can cover the start-up project costs. Long-term financial feasibility means the project will generate a surplus of operating revenue over operating expenses within two years. The proposed project would most likely be financially feasible in the short and long-term, even though (for reasons addressed below) it is unlikely to achieve the results projected in the pro formas. This is because Deering is already operating an outpatient cardiac catheterization laboratory and would have very little additional expense if it began performing inpatient cardiac catheterizations using the existing staff and the existing equipment. If the project were to be approved, the hospital as a whole would probably have a positive cash flow in the first and second year, because with a mere four or five inpatient procedures it would recover the additional costs associated with converting the existing outpatient lab to an inpatient lab. A contribution margin is the difference between the variable expenses and variable revenues on a per unit basis or in the aggregate. For additional inpatient cardiac catheterization services on a per case basis, Deering projects a positive contribution margin of $2,500 per procedure. This is similar to the contribution margins of other hospitals performing inpatient cardiac catheterizations in Deering's service area. Break-even analysis determines how many procedures must be done before incremental fixed costs are covered. Since incremental fixed costs are $10,000, after only 4 or 5 inpatient procedures the service would break-even. For a number of reasons mentioned below, it is very unlikely that Deering would be able to achieve its projected utilization levels. Specifically, it is unlikely that Deering would be able to achieve a utilization level of 300 admissions per year by the end of its second year of operation. The analysis on which Deering bases its much higher utilization projections appears to be flawed in several respects and is also contrary to reasonable expectations based on the average historical performance of diagnostic-only cardiac catheterization programs in District 11. In an effort to demonstrate that Deering would perform in excess of 300 procedures per year, Deering's health planning expert, undertook the following analysis: The number of MDC-5 (circulatory diagnoses) at Deering in 1990 was approximately 750. It was assumed, from data in the Winslow report and the Dade County actual data that one third of the MDC-5 admissions would receive a cardiac catheterization. Multiplying 750 times one third results in 250 admissions at Deering who would receive a catheterization, or approximately 20 per month. Because some people would refuse to have a catheterization, or would undergo it at another facility, it was assumed that 17 patients per month, or approximately 195 per year, would be cathed at Deering in the first year of operations. It was assumed that the growth at Deering between year one and year two of operations at Deering would be equal to the projected growth in catheterizations in Dade County between July, 1989 and January, 1994. It was assumed that all of the cases projected above would be inpatients. Based on this analysis, it was projected that Deering would be able to do in excess of 300 cases per year starting in its second year of operations. The greater weight of the evidence indicates that this methodology suffers from a number of flaws. The "one third" factor applied in step 2, above, is erroneous and was incorrectly applied even if correct. The Winslow paper provides no support for the proposition that one third of all MDC-5 admissions will require catheterization. The actual statistic from Dade County is that all inpatient catheterizations, including those done in anticipation of open heart surgery and for angioplasty, constitute 21 percent of the number of MDC-5 admissions. Of the catheterizations done in Dade County, 9 percent (1,382 catheterizations out of a total of 16,155) were performed in conjunction with open heart surgery and 16 percent (2,700 of 16,155) were angioplasties. Because Deering will be unable to do either open heart surgery or angioplasty, a full 25 percent of the catheterization case load is unavailable there. Applying the 21 percent factor (percent of actual inpatient catheterizations to MDC-5 admissions) would result in 158 potential catheterizations. Dropping out 25 percent of those (the percent requiring open heart surgery and angioplasty) results in 118 potential cases. Using then the 85 percent figure (to reflect those who refuse to be catheterized or must go elsewhere because of managed care agreements, etc.) leaves approximately 100 inpatient cases in the first year, or roughly half of what Deering projects. There is no persuasive support for the idea advanced by Deering that its growth between year one and year two of operations would be the same rate of growth that all Dade County providers experienced between 1989 and 1994. To the contrary, such an experience is most unlikely. First, the projected rate of growth assumes that Dade County's use rate will continue at the same rate. This is optimistic. Second, it assumes that Deering will reflect the growth in the number of cardiac catheterizations in Dade County even though it is only providing diagnostic catheterizations (i.e. no angioplasties or catheterizations during open heart surgery). Finally, it assumes that Deering's rate in providing cardiac catheterizations will be the same as four and one half years experience in Dade County. If the actual annual rate of increase in Dade County were applied to Deering's own projected first year utilization, it would still only be likely to do 230 cases in the second year. The actual number of patients transferred from Deering for inpatient catheterizations plus its actual number of outpatient procedures provides a more accurate guide to the number of cases Deering could be expected to do. Based upon these figures, Deering might be expected to do between 70 and 150 cases the first year and less than 200 the second. One assumption made by Deering to support its utilization projections was that there would be a growth in the utilization of cardiovascular services at Deering. The historical use pattern at Deering fails to reveal any trend that would suggest such an increase. According to data reported to the HCCCB, there was an overall decline in the number of intensive care days at Deering between 1985 and 1991. Similarly, emergency room visits have also declined during the same period. Emergency room admissions account for 60 percent of all admissions to Deering. As a result, the total number of patient days at Deering has declined from 47,089 in 1985 to 40,975 in 1991. Thus, although Deering is projecting a large increase in utilization to project satisfactory utilization of its proposed laboratory, the historical record does not support that record. According to Deering, indicators of cardiac volume include the following services: EKGs; echocardiograms; holter monitors; treadmills; pulmonary function tests; thallium exams; and, coagulation studies. According to data presented by Deering, none of those "cardiac volume indicators" showed an increase in utilization between 1988 and 1990. In its financial analysis, Deering assumed that all of the 195 procedures in the first year and all 360 in the second year would be inpatient procedures. In Dade County for the 12 months ending September 30, 1991, 39 percent of all catheterizations were done on an outpatient basis (6,240 outpatient procedures out of 16,165 total cases). That percentage would be even higher at facilities that are unable to provide open heart surgery. (For example, currently 80 percent of the cardiac catheterization procedures at Doctors' Hospital are outpatient procedures.) In all of Florida approximately 50 percent of all cardiac catheterizations are inpatient. The trend in Dade County, in Florida, and nationally is that the number, and percentage, of outpatient procedures is increasing. The significance of this fact as it relates to Deering's financial projections is that Deering did not make any adjustment in its utilization projections to account for outpatient utilization and projected the pro formas by assuming that income associated with each case would be the income associated with a full inpatient admission. Thus, the pro forma projections are overstated to the extent that the projected procedures will actually be performed on an outpatient basis. At least 35 percent of Deering's procedures are likely to be on an outpatient basis with the trend indicating that outpatient utilization will actually be much higher. In projecting the average length of stay to be attributed to each inpatient catheterization at Deering, it was assumed that it would be the same length of stay as the District 11 average. The District 11 average includes the average inpatient stay associated with open heart surgery, which is much longer than for a routine diagnostic catheterization. Thus, Deering has overstated its projected average length of stay. In addition, the average length of stay for inpatient catheterizations has been dropping. This compounds the extent to which the number of inpatient days associated with catheterizations has been overstated in Deering's pro formas. One assumption in Deering's financial analysis is that patient days at Deering would increase at the same rate as the population increase in Dade County. This assumption finds no support in the evidence presented at hearing. In fact, it was demonstrated that the actual number of patient days have been declining at Deering since 1985. In 1985, Deering has 47,089 patient days; in 1991 it had 40,975 patient days, a drop of 13 percent. This drop occurred even though Dade County has had continuous steady growth. The financial assumption that Deering's inpatient days will grow at the same rate as the population as a whole is found to be unsupported. One reality check of Deering's projection that it will perform in excess of 300 procedures in its second year of operations is to measure its proposed "capture rate" against that of the other hospitals it will be competing against. In 1990 there were a total of 491 cardiac catheterizations performed on patients who reside in Deering's primary service area. Of these, Baptist, which is a full service provider, was able to capture only 203 cases, or 41 percent. If Deering, with one catheterization lab which is also used to do peripheral procedures, were to capture 300 procedures from its primary service area, this would represent in excess of 60 percent of the procedures from that area, or one and one half times better than Baptist is able to do with a full service catheterization facility, three dedicated catheterization laboratories, four full catheterization teams, and angioplasty and open heart capabilities. It is most unlikely that Deering can achieve such a projection. Deering proposes to provide a diagnostic-only program. Of the 13 cardiac catheterization programs in Dade County, nine are traditional and four are diagnostic-only. The diagnostic-only laboratories in District 11 have historically operated at significantly lower volumes than the laboratories in facilities with open heart surgery. During calendar year 1991 the four diagnostic-only providers performed the following number of procedures: Doctors' Hospital 301 Humana Hospital-Biscayne 55 Palmetto General Hospital 432 Parkway Regional Med. Center 262 TOTAL 1050 The total of 1050 procedures constitutes an average of 262.5 procedures for each of the four existing providers. If this pool of 1050 procedures were to be divided five ways to accommodate a new provider, there would be an average of 210 procedures per diagnostic-only provider. It would require an increase of almost 50 percent in the number of procedures being done by diagnostic-only laboratories for five such laboratories to be performing an average of 300 procedures per year. This is yet another reason for which it is most unlikely that Deering would achieve the utilization levels it projects. There appears to have been little physician acceptance of the outpatient catheterization laboratory at Deering. From 1985 through the date of hearing, Deering only performed 29 cardiac catheterizations. Dr. Palomo is the medical director of the Deering cardiac catheterization laboratory. One of his duties as medical director is "promoting" the laboratory. In 1992, through June 16, Dr. Palomo performed only two or three cardiac catheterizations at Deering; in calendar year 1991, he did four to six cardiac catheterizations at Deering. Dr. Palomo does approximately 300 catheterizations per year. It is unlikely that Deering will perform over 300 catheterization cases per year when its own medical director is doing less than 2 percent of his cases there. South Miami is an acute care hospital located in Dade County. South Miami has a open cardiac catheterization program which means any physician within the community can apply for privileges, and, if granted, perform cardiac catheterizations at South Miami. Until recently, it was a closed program. Baptist is a large, full service acute care hospital located in South Miami, Dade County, District 11. Baptist provides a full array of cardiac services at its Miami Vascular Institute. These include cardiac catheterization, open heart surgery, and angioplasty. Baptist is within the primary service area of Deering. It is approximately eight minutes drive from Deering. Deering currently transfers its cases needing inpatient catheterizations to other hospitals, including Baptist. If Deering were to be approved, and if it were able to perform 360 cases in its second year of operations as it projects, it would most likely be performing something in the neighborhood of 150 cases that otherwise would have been done at Baptist. 3/ This was calculated as follows: There were a total of 491 catheteriza- tions performed in 1990 on patients residing in Deering's primary service area. Of those 491 cases, Baptist performed the catheterizations for 203 patients. If Deering were to perform 360 inpatient catheterizations in its second year of operations, it is projected that Baptist would lose cases in the same relation as its current market penetration, i.e. 41 percent. This equates to 149 cases. This methodology presents a reasonable projection of the number of cases that Baptist would be likely to lose if Deering's application for inpatient cardiac catheterization were approved and Deering were able to achieve its projected utilization levels. Baptist has a contribution margin of approximately $2,560 per cardiac catheterization. This figure is the average revenue per case less the variable costs per case. Using the methodology described above, it is projected that the net annual loss at Baptist, if Deering were approved, would be in the neighborhood of $380,000.00. If Deering were to achieve its projected utilization levels, it is likely that it would also be performing a substantial number of cases that otherwise would have gone to South Miami Hospital or one of the other nearby existing providers. Doctors' Hospital is a 255-bed acute care hospital located in Coral Gables, Dade County, Florida. Doctors' has had a cardiac catheterization program since December of 1986, and is authorized to perform diagnostic catheterization on both inpatients and outpatients. With its current staffing compliment, the Doctors' cardiac catheterization laboratory could comfortably perform four catheterizations per day or between 800 and 900 per year. Doctors' performs cardiac catheterization on all patients regardless of ability to pay. Since 1988, the Doctors' cardiac catheterization laboratory has experienced declining utilization. The following chart represents the utilization of Doctors' cardiac catheterization laboratory since 1988: TOTAL INPATIENT AND CALENDAR YEAR OUTPATIENT CARDIAC CATHS 1988 484 1989 400 1990 380 1991 295 1992 240 (estimated) The Doctors' inpatient cardiac catheterization program is at a crossroads. The current volume is well below the minimum quality threshold which is acceptable for cardiac catheterization laboratories. In its early years of operation, the Doctors' cardiac catheterization laboratory generated a profit. Such is no longer the case. Several factors have resulted in the declining utilization of Doctors' cardiac catheterization laboratory. One of the factors is that more of the existing laboratories have become open staff versus closed staff. Doctors' laboratory has always had an open staff policy. At the time that Doctors' established its cardiac catheterization laboratory, it was one of only two that had an open staff policy. Another factor in the decline of utilization at Doctors' has been a shift from inpatient to outpatient cardiac catheterization. Therefore, the opening of outpatient-only cardiac catheterization laboratories, including the one at Deering, has resulted in a reduction in the number of outpatient cardiac catheterization procedures done at Doctors'. Doctors' does not offer angioplasty or open heart surgery. Doctors' diagnostic-only cardiac catheterization capability has contributed to its declining utilization since Doctors' is unable to compete with full service hospitals for cardiac catheterization patients that require the services of a full service hospital. Another factor which has resulted in the decline in utilization at the Doctors' cardiac catheterization laboratory is a change in HMO service patterns to facilities that can provide full-service cardiology services, including cardiac catheterization, angioplasty, and open heart surgery. The primary reason Doctors' Hospital catheterization laboratory is now losing money is its decrease in utilization. As utilization of a cardiac catheterization laboratory declines, the per unit cost of providing a catheterization increases. Based upon the current market share of inpatient cardiac catheterization patients in District 11, and assuming Deering would be able to achieve its projected year two utilization of 360 new inpatient cardiac catheterization patients, a small number of those patients probably would have otherwise gone to Doctors' Hospital. Because of the declining utilization at the Doctors' cardiac catheterization laboratory, and the fact that its program is not co-located with open heart surgery, the loss of even a small number of patients may be significant to the future viability of the cardiac catheterization program at Doctors' Hospital. If the Deering inpatient program were to be approved, both the Deering and Doctors' programs would likely be low volume programs operating at utilization levels well below the minimum for maintaining quality standards and well below the minimum for economic efficiency. There are 13 providers of inpatient cardiac catheterization services in Dade County which operate a total of 24 catheterization laboratories. These providers are geographically well dispersed in the population centers of the county. The existing inpatient cardiac catheterization providers in District 11 are available, provide high quality care, are appropriate, and are accessible. In District 11 there is an ample excess capacity to provide additional inpatient cardiac catheterizations at existing facilities. The existing catheterization laboratories are not producing sufficient numbers of cases to be operating efficiently. The practical capacity of a typical catheterization laboratory is somewhere between 1,000 and 1,500 cases per year. Given that there are 24 existing catheterization laboratories and four more expected to come on line soon, the existing providers are operating at approximately half of their capacity. These programs have not reached a level of optimal efficiency in terms of operations. Optimal efficiency for health planning purposes should be measured at a level of approximately 80 or 85 percent of capacity. The economic efficiency of the existing providers of inpatient cardiac catheterization would be enhanced if new entries into the market were precluded until existing providers were operating at approximately 80 or 85 percent of their practical capacity. It is well accepted in health planning that a catheterization laboratory must perform at least 300 cases per year in order to maintain proficiency and quality. There appears to be a relative correlation between the number of cases performed in a laboratory and the skill of the staff. In District 11, HMO's and PPO's have shifted their service patterns to facilities that can provide full cardiac services including angioplasty and open heart surgery. The shift in use patterns has had a significant effect on cardiac catheterization laboratories unable to provide angioplasty and open heart surgery. This effect would likely be felt at Deering Hospital if its inpatient lab were approved and supports the conclusion that Deering, as a provider of diagnostic catheterizations only, would be unlikely to achieve its utilization projections. Cardiac catheterization services are highly competitive in District As such, the approval of Deering's application will have little beneficial improvement by way of increased competition. Additionally, the trend in District 11 is for third party payers to contract for the provision of cardiac services at full service providers. As such, Deering would be unable to effectively compete with the nine full service providers of which three, Baptist, South Miami, and Kendall, are in Deering's primary service area. There is no evidence that any patient has had, or is likely to have, problems accessing inpatient catheterization services if this proposal is not approved. The geographic access standard contained in the applicable rule is met by the existing providers. Additionally, none of the programs or doctors have been unable to schedule catheterizations because of heavy utilization at any District 11 catheterization provider. Accordingly, patients are not likely to experience any difficulty in accessing inpatient cardiac catheterization services if Deering's application is denied. Currently and historically, cardiac catheterization has been regulated by HRS as an inpatient institutional health service, not a tertiary service. On February 8, 1991, HRS published official notice of the need for one more inpatient cardiac catheterization program in District 11 for the 1993 planning horizon, calculated in accordance with the methodology in the applicable rule. The fixed need pool in this case was never challenged by Petitioners. The projected number of procedures by population in the planning horizon using the methodology in Joint Exhibit 1 and actual data collected by HRS show that there are enough procedures in the marketplace for Deering to perform 300 in the second year of operation and for the protestants in this case to maintain their annual current volumes. However, major portions of that rule- based methodology have been found to be invalid in the Final Order issued this same day in the related rule challenge cases.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that a Final Order be issued in this case denying the subject certificate of need application. DONE AND ENTERED this 1st day of April, 1994, at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH, 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 1st day of April, 1994.
Findings Of Fact At all times material, Respondent was licensed as an osteopathic physician in the state of Florida, having been issued license number 050004170. Respondent practices in the field of general surgery, and at all times material to this action, Respondent was on staff as Chief of Surgery at the University Hospital, Holly Hill, Florida. The incident which gave rise to the charges herein arose on August 5, 1987 when Respondent inserted a chest tube into patient W.T.'s right chest wall so as to relieve a pneumothorax which had actually occurred in W.T.'s left lung. A pneumothorax is a pocket of air in the cavity surrounding the lung which causes the lung to contract upon itself. At all times material, Patient W.T. had a subcutaneous pacemaker on the left side of her chest. However, the evidence from all credible witnesses is consistent that pacemakers are routinely placed on either the right or left side and that there is no reasonable medical presumption that pacemakers are always placed in someone's left chest area. The subcutaneous pacemaker did not enter significantly into W.T.'s case management at University Hospital. It operated on "automatic" and since it did its job, none of the University Hospital physicians involved in W.T.'s care paid much attention to it. W.T. was admitted to University Hospital for treatment of a drug overdose on July 9, 1987. As a part of her treatment, an Ewald tube was inserted into her stomach by a physician other than the Respondent. Patient W.T. was discharged from the hospital on July 18, 1987 with a portion of the tube inadvertently left in her stomach and her esophagus. On July 21, 1987, W.T. was readmitted to University Hospital. She was suffering from septicemia and bilateral pneumonia. X-rays revealed that a portion of the tubing had not been removed. This tubing was removed by the Respondent via successful gastroesophagoscopy on July 23, 1987. At Respondent's order, W.T. was placed in the Intensive Care Unit (ICU) following the removal of the tube. Dr. Desai was called in as a pulmonologist. When W.T. had been admitted to University Hospital on July 21, 1987, she already had been in a "guarded" condition. Despite successful removal of the Ewald tube, W.T.'s overall condition continued to deteriorate. Prior to the night of August 4, 1987, W.T. had developed adult respiratory distress syndrome (ARDS) which involves a breakdown in the capillary barriers within the lung itself, resulting in a diffuse leakage of fluid throughout all of the air space of the patient's lung. Because of the patient's serious lung condition, Dr. Desai placed her on a volume respirator, and the respirator pressure (PEEP) was progressively increased during her admission until it was set at 20 PEEP at the time of the incident. Twenty PEEP is an unusually high level of respirator pressure which was necessary in this case because of the patient's severe lung problem. The volume respirator essentially breathed for the patient and involved a tube being secured in her mouth. Often, between her admission to the ICU and the date of the incident, W.T. had torn the respirator tube out of her mouth, so she had been continuously restrained and sedated to keep this from happening again. Each time W.T. had extubated herself she had been "blue coded," meaning she had suffered either cardiac arrest or shock. Whether or not W.T. weighed between 225 and 250 pounds or weighed 350- plus pounds cannot be determined with any reasonable degree of accuracy since there is equally credible evidence over the entire foregoing range of poundage. It is material, however, that by all accounts of all witnesses, W.T. was markedly and grossly obese to the extent that her size, shape, and weight contributed to her several health problems and rendered her a patient more difficult to diagnose, more difficult to x-ray, more difficult to move, and more difficult to nurse and medically attend than she would have been otherwise. The evidence as to whether W.T.'s obesity impeded medical personnel from correctly interpreting her breath sounds on August 5, 1987, the date of the incident, is divided, as is the evidence as to whether or not on that date W.T.'s pacemaker was visible to the naked eye, but upon the greater weight of the credible evidence as a whole, it is found that on August 5, 1987, W.T.'s obesity, generally deteriorated condition, and left pneumothorax rendered the presence, volume, and location of breath in each lung subject to interpretation and "judgment call," and that unless one were specifically looking and feeling for a pacemaker, one would not necessarily have been able to detect the pacemaker in W.T.'s left chest due to the extraordinarily heavy pad of fat and the absence of scarring in that location. The foregoing finding of fact has been reached because with the exception of the complaining witness, Nurse Counihan, all factual witnesses either testified that they did not notice a pacemaker scar or they specifically noticed there was no scarring on W.T.'s chest. Also, with regard to breath sounds, both Mr. Starr and Respondent listened for W.T.'s breath sounds on the morning of the incident and within a very few minutes of each other. Mr. Starr described W.T.'s breath sounds when he entered her room as decreased on the right and absent on the left. His findings were consistent with a left pneumothorax but he never informed Respondent what he had found. Respondent arrived only a few minutes later and could not get any breath sounds from either side. Dr. O'Leary, accepted as an expert in pulmonology and the insertion of chest tubes, opined persuasively that one could not rely on breath sounds to locate which side the pneumothorax was on in the face of a recent x-ray. Also, the use of the respirator could have been misleading to either or both Mr. Starr or Respondent. X-rays taken of W.T.'s chest at least ten times between July 23, 1987 and July 31, 1987 clearly depict that the pacemaker was on the left side of W.T.'s chest. These x-rays were reviewed by Respondent with a radiologist the day before the events which are the focus of these charges took place. The radiology reports of W.T.'s chest x-rays dated July 25, 1987, July 28, 1987, and July 31, 1987 specifically mention the pacemaker but only the report dated July 28, 1987 states that the pacemaker overlies the left thorax. Respondent did not review any narrative reports when he and the radiologist were reviewing the actual x-rays together. There is no evidence that this procedure was outside the appropriate standard of care. Dr. Dworkin, expert in radiology and quality assurance and review, Dr. O'Leary, and Dr. Rosin, Petitioner's internal medicine expert, all testified that it is not below the professional standard of care for a treating physician to forget within a day after such an x-ray review which side a pacemaker is on unless the pacemaker enters significantly into his treatment of the patient, which in this case it did not. By the early morning hours of August 5, 1987, W.T. had become even more critically ill with multiple system failures, including a failure in the cardiopulmonary systems, a neurological deficit, and failure of her renal functions. The mortality rate of a patient suffering from ARDS, without considering the other conditions from which W.T. was suffering, exceeds 50%, and responsible medical retrospective estimates made at formal hearing of W.T.'s specific survival chances in the early morning hours of August 5, 1987 fall in the 10-50% range. During the early morning hours of August 5, 1987, the nurses on duty in ICU were having trouble maintaining W.T.'s blood pressure. They began telephoning Dr. Desai and Respondent at approximately 4:00 a.m. One of those doctors, most probably Dr. Desai, ordered a portable chest x-ray of W.T., which was accomplished at 6:30 a.m. by Josephine Christnagel, R.T., who is a registered x-ray technologist. At the time this x-ray was performed, W.T. was already in critical condition and could not speak or respond. W.T.'s condition was such that she probably was not salvageable when Respondent arrived on the scene at 7:00 a.m. on August 5, 1987. Unbeknownst to anyone at this point in time, the 6:30 a.m. x-ray had been inadvertently mislabeled by Ms. Christnagel so that the left side of the patient's chest appeared on the x-ray with a lead marker, "R" (for "right") , on it. This chest x-ray revealed that W.T. had a pneumothorax, and because it was mislabeled, the pneumothorax appeared to be on the right side. If a chest tube is properly inserted from the outside chest wall on the side of the pneumothorax, into the chest cavity, the air can be released and the lung can re-expand, delivering oxygen to the patient and raising blood pressure to normal. At all times material on August 4-5, 1987, the ranking ICU nurse on W.T.'s case was Carey Beninger ne' Counihan, R.N. The ICU nurses notified Dr. Desai by phone of the pneumothorax and he, in turn, notified Respondent. Because Respondent was more nearly ready to go to the hospital, Respondent rushed to the hospital to insert a chest tube into W.T., treatment which he and Dr. Desai, the attending pulmonologist, had agreed was the appropriate treatment for W.T.'s pneumothorax. For the reasons given infra with regard to the time the nurses' notes were compiled and Nurse Counihan's confusion over the x-ray itself, the evidence is not clear and convincing that Respondent was ever told by Dr. Desai or by the nurses by phone that the pneumothorax was on W.T.'s left side (the correct side). Even if Respondent had been so informed by Dr. Desai, since Dr. Desai had never seen the x-ray, it still would have been appropriate for Respondent to rely on the x-ray itself once he got to the hospital, unless at the hospital, something or someone clearly alerted him to the fact that the pneumothorax was actually on the left side. At approximately 7:00 a.m., just prior to the arrival of Respondent, Dr. Michael Danzig, D.O., who was the day-shift emergency room doctor, and Wesley Starr, R.P.T., a respiratory therapist, arrived at ICU and entered W.T.'s room. At approximately the time they arrived, the night-shift emergency room doctor, Dr. Haas, left the room. By all accounts, there was a continuing "commotion," a "ruckus," or "an emergency situation" in progress with at least two nurses, including Nurse Counihan, and other personnel providing various therapies to W.T. who had no palpable blood pressure and was in shock. This atmosphere continued after Respondent arrived shortly thereafter, with the nurses' and Mr. Starr's attention directed to care of the patient. When Respondent arrived, Dr. Danzig became, essentially, an observer. Upon arrival at W.T.'s room, Respondent examined the 6:30 a.m. x-ray against a window with daylight showing through. The x-ray, as it was mismarked, showed a massive tension pneumothorax on W.T.'s right side and a pacemaker on the same side, the right. After review of the x-ray, Respondent examined W.T., including listening for breath sounds. He heard nothing significant from either lung. Dr. O'Leary's opinion that such a finding was not unusual and that Respondent could not rely on either his own examination of breath sounds or that of Mr. Starr (had he even known of Mr. Starr's hearing breath sounds on the right but not the left) at that point is persuasive. Under these circumstances, breath sounds would not have alerted Respondent to a mislabeled x-ray. Respondent relied on the mislabeled x-ray and began to prep the right side of the patient for the chest tube. As Respondent began to prep W.T.'s right side, a dispute arose between himself and Nurse Counihan. Having weighed and evaluated all the testimony and the documentary evidence and exhibits, having reconciled that evidence which can be reconciled, and having eliminated that evidence which is not credible, it is found that the most credible version of this dispute is that Nurse Counihan asked Respondent why he was prepping the right side if W.T. had a left pneumothorax, and Respondent replied, "No, it isn't. Look at the x-ray." To this, Nurse Counihan said, "Yes, it is. I'm sure of it," and pointed to the lung on the x-ray which did not show a pneumothorax (the side next to the nameplate and the side without either a pacemaker or a pneumothorax). Respondent said, "No, it isn't. Look at the damn x-ray!" Respondent then proceeded to intubate on the right side while referring frequently to the mislabeled x-ray. In making the foregoing finding, it is noted that there were significant differences between the testimony of Nurse Counihan and all other witnesses, both factual and expert. Nurse Counihan deposed/testified that both she and another nurse had pointed out to Respondent that the patient's pacemaker was on the patient's left side and so was the pneumothorax. The other three factual witnesses, Starr, Danzig, and Respondent, all testified that they have no recollection whatsoever of anyone mentioning a pacemaker. Even Wesley Starr, called by the Petitioner, and who was present in W.T.'s room at the head of the patient's bed throughout the time of these discussions, testified that, to the best of his recollection, no one mentioned a pacemaker and that he did not recall anyone except Nurse Counihan challenging the Respondent's prepping W.T.'s right side. Also, Dr. Danzig, who was present in the room during the argument, and who testified that he had placed over 200 chest tubes during the course of his medical residency training, testified that if Nurse Counihan had, indeed, mentioned a pacemaker, he would have intervened in order to assist Respondent in determining the correct side of the pneumothorax. Although Petitioner asserted that Dr. Danzig is not credible due to his friendship with Respondent, that argument is not persuasive both due to the remoteness and degree of the friendship and Dr. Danzig's insistence that if Respondent should say that Nurse Counihan pointed to the side of the x-ray showing the pacemaker, then Respondent would be wrong. Respondent apparently did not review W.T.'s records either before or after the dispute with Nurse Counihan. These records were either in her room or elsewhere in the ICU unit, but since, at that point, the nurses' notes had not been compiled from their scratch pads to the patient's chart since before 4:00 a.m., there was nothing in W.T.'s chart/records to alert Respondent that the x- ray was mislabeled or that the patient had a pneumothorax on the left side even if he had reviewed the record. Also, he would have had to go back to the July 31 x-ray or the July 28 radiology narrative before he could have discovered that the pacemaker was on the left. This would have been very time consuming. Also, Dr. Danzig, who actually had made a cursory review of the patient's records when he first arrived in the room, was not alerted by Nurse Counihan's words or her pointing to the x-ray to any reason to search the records for information about the pacemaker. In further assessing Nurse Counihan's testimony, the undersigned has weighed in her favor the consistency of her recent deposition testimony with her notes and the incident report which she completed within five hours after the intubation incident on August 5, 1987. However, weighing against her credibility with regard to her statements then and now that she told Respondent that the pacemaker was on W.T.'s left side is the fact that even her August 5, 1987 report and notes were prepared in the glow of a hindsight favorable to her position and that her deposition shows that she is confused about how a pneumothorax appears on an x-ray. Reconciling all the testimony one can, it is remotely possible that Nurse Counihan said, "It is a left pneumothorax," while pointing to the lung shown on the x-ray as not having a pneumothorax and which, due to the "R" marker on the other lung could be inferred to be the left lung. It is even remotely possible (although not probable or persuasive given the three other factual witnesses' testimony that she had never mentioned a pacemaker) that Nurse Counihan could have told the Respondent, "The pneumothorax is on the same side as the pacemaker," which also was consistent with the x-ray as mislabeled. However, upon the credible evidence as a whole, the only reasonable conclusion is that if Nurse Counihan did mention a pacemaker at the time of her dispute with Respondent, she was ineffective in clearly conveying to Respondent or to anyone else in the room that the pacemaker and the pneumothorax were on the patient's left side or that there was any reason to further search the records or the patient's body to resolve the dispute. It is uncontroverted that, prior to the insertion of the chest tube in W.T.'s right side, absolutely no one, including Nurse Counihan, was aware that the x-ray was reversed, and that Ms. Counihan never informed the Respondent that the x-ray was reversed. Respondent's testimony is accepted that upon placement of the chest tube in W.T.'s right side (the side without the pneumothorax) he heard an immediate audible gush of air. That others in the room did not hear this rush of air is understandable due to the noise and confusion in the room, particularly the respirator sounds. Also, it is uncontroverted that upon placement of the chest tube in W.T.'s right side, the patient's blood pressure, which had been zero, immediately rose into normal range. A dramatic and rapid reestablishment of the patient's blood pressure is the expected result of a proper placement of a chest tube with a tension pneumothorax. All health care personnel present seem to have regarded the blood pressure stabilization as proof that the Respondent had placed the chest tube on the correct side of the patient, because no one, including Nurse Counihan, thereafter protested that a misplacement had occurred. Release of pressure and a return in blood pressure is not normally associated with placement of a chest tube in the wrong side of a patient and there is no definitive medical explanation of why it occurred in this instance, despite Dr. O'Leary's speculation that the gush of air could have been a leak of air across the Mediastrum. After placement of the chest tube in the patient's right side, Respondent ordered an immediate repeat chest x-ray to be certain the tube was placed in the correct lung and was placed correctly. After the patient's blood pressure had been reestablished, Dr. Danzig left the intensive care unit because he believed that the pneumothorax had been relieved completely and because the patient was now stable. If W.T. had not been stable, Dr. Danzig would have remained in the room since he was the day- shift emergency room doctor and he did not know if any physicians other than Respondent and himself were even in the hospital yet. After securing the chest tube and dressing the chest, Respondent left the floor and went to the operating room (OR) to notify the OR staff that there would be a delay before he could begin previously scheduled surgery. Thereafter, on his way to check the new x-ray he had just ordered, Respondent met Ms. Christnagel, who was bringing it to him. Ms. Christnagel then informed Respondent that she had mislabeled the 6:30 a.m. preintubation x-ray. Respondent simultaneously reviewed the new, postintubation x-ray and discovered that he had placed the chest tube in the wrong side of W.T.'s chest. At approximately the same time, W.T.'s blood pressure again dropped and a "code blue" was called. Dr. Gloria Mikula, M.D., who happened to be in the ICU at the time W.T. coded, "ran the code" to attempt to reestablish the patient's blood pressure. Throughout the time in which Dr. Mikula was running the code on this patient, no one, including Nurse Counihan, said anything to the effect that W.T. may have had a chest tube placed in the wrong side. In fact, the nursing staff did not even inform Dr. Mikula that this patient had had a pneumothorax and chest tube insertion prior to the code being called. Such information would have been important from a medical standpoint because it would have allowed Dr. Mikula to act immediately to relieve the tension in the patient's chest. Immediately upon reviewing the repeat chest x-ray and upon hearing the announcement of the code blue at the same time, Respondent rushed back to W.T.'s room, placed a chest tube in the patient's left side, and the patient's blood pressure was again reestablished. However, some time later in her hospitalization, W.T. expired. Nurse Counihan's failure to say anything to Dr. Mikula about the pneumothorax is further indicative of her immediate satisfaction that Respondent's intubation on the right side had been acceptable and that it was only after he discovered his error through the new x-ray and correctly intubated W.T. on the left side that Nurse Counihan completed her notes and incident report describing his error for the chart. The notes were transposed from her scratch pad and memory at approximately noon, August 5, 1987. Dr. Rosin, Petitioner's expert in internal medicine, criticized Respondent's performance as below the professional standard of care because he felt that once Respondent was made aware in the patient's room by Nurse Counihan that the pneumothorax could be on the patient's left side, Respondent had an obligation to make further inquiry or investigation before inserting the chest tube in the patient's right side. In Dr. Rosin's opinion, Respondent's investigation could have taken several routes: review of earlier x-rays and the patient's record, further conversation with the nurse, further hands-on examination of the patient for signs of the pacemaker, and/or ordering a new x- ray. Although Dr. Rosin testified that Respondent should have ordered a repeat x-ray so as to resolve the dispute with Nurse Counihan before inserting the chest tube on W.T.'s right side, he also conceded that the only possible adverse effect of the decision Respondent made was the delay in relieving W.T.'s condition. The chest intubation involved is not a benign or casual procedure, but no actual harm occasioned by misplacement of the chest tube was demonstrated in this case, and the maximum amount of time which would have been saved, under Dr. Rosin's approach, would have been that short period of time it took for the Respondent to place the chest tube and dress the wound. Under the circumstances, if Respondent had delayed intubation, W.T. would probably have "coded blue" before the correctly labelled chest x-ray could have been performed anyway. In light of the confused state of the patient's breath sounds, obesity, and lack of scarring, the fact that no nurses' notes had been codified since before 4:00 a.m., Nurse Counihan's own confusion about the mismarked x-ray, and how far back in the patient's chart Respondent would have had to look before he would have been able to locate anything useful about the pacemaker, it is found that Respondent behaved reasonably in an emergency situation, and Dr. O'Leary's and Dr. Dworkin's expert opinions that he did not violate the professional standard of care in the first insertion of the chest tube are accepted. It is also found that the Respondent's procedure in ordering the new chest x-ray and leaving the room after the first intubation without further search of the records or further conversation in the room was reasonable and appropriate under the circumstances.
Recommendation Upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Osteopathic Physicians enter a Final Order dismissing all charges against Respondent. DONE and ENTERED this 25th day of July, 1991, at Tallahassee, Florida. ELLA JANE P. DAVIS 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 25th day of July, 1991.
The Issue The issue in this case is whether, under Section 57.111, Florida Statutes, Petitioner is entitled to attorneys' fees and costs incurred in the defense of a disciplinary proceeding.
Findings Of Fact On September 2, 1988, an 83-year-old female was admitted to West Orange Memorial Hospital with recurrent rectal bleeding and complaints of pain in the low back and left hip. The patient also reported pain while sitting or lying due to a subcutaneous nodule in the left buttock. As noted in the patient's history dictated by Petitioner on September 12, 1988, the patient had numerous admissions to the hospital for rectal bleeding and previously had been diagnosed as suffering from angiodysplasia. These notes also reflect that the patient had recently undergone a colonoscopy and upper endoscopy, which were negative. The notes of N. Alar, M.D., which were dictated on September 3, 1988, indicate that he had seen the patient in consultation for evaluation of lower gastrointestinal bleeding. The notes disclose that the patient had complained of bloody bowel movements. The notes record a history of diverticulosis and angiodysplasia of the colon. Following a colonoscopy and polypectomy, Petitioner excised the nodule on September 11. The procedure took place at the hospital bed of the patient where her left buttock was prepped and draped in sterile fashion prior to the making of a two-inch incision. Following the removal of the nodule, the area was cleaned, the wound was closed, and sterile dressing was applied. There was no break in technique during the procedureand sterility was maintained. The nodule was later determined to be an area of fat necrosis that had undergone dystrophic calcification. The following day, the patient developed severe respiratory distress and expired. Her final principal diagnoses were anemia secondary to gastrointestinal bleeding, arteriosclerotic heart disease, hypertension, and clostridium with septicemia. A Serious Incident Report was filed on November 29, 1988, and Respondent commenced an investigation on January 11, 1989, to determine if Petitioner's practice was below applicable standards. The first time that Petitioner's case appeared at a Probable Cause Panel Meeting of the Board of Medicine was on May 11, 1990. The following Panel members were present: Chair Robert Katims, M.D.; Marilyn Wells, M.D., and Gilbert Rodriguez. Also present were Assistant Attorney General M. Catherine Lannon and Respondent's attorneys, Carlos Ramos and Stephanie Daniel. At the commencement of the meeting, Ms. Lannon explained the respective roles of herself and Respondent's attorneys. In general, she was present to advise the Panel as to its legal duties under applicable statutes and rules. Respondent's attorneys were available to respond to questions involving specific investigations. In response to a question posed by Ms. Lannon, each Panel member indicated that he or she had received the written materials concerning matters to be considered at the meeting insufficient time to review them. Mr. Ramos identified the materials that had been provided to each Panel member prior to the meeting. The materials included the entire investigative file and Respondent's recommendation in the form of a draft administrative complaint or closing order, as appropriate. When Petitioner's case was announced, Mr. Ramos stated that Respondent recommended the Panel find probable cause and direct the filing of an Administrative Complaint. Mr. Ramos explained that the proposed Administrative Complaint alleged that Petitioner practiced medicine below the acceptable level of care when he excised a nodule from a patient's left buttock while the patient was lying on a hospital bed. Also, Mr. Ramos stated, medical records failed to reflect a rectal examination upon admission. Terming it a "terrible case," Panel member Wells moved to find probable cause and issue the Administrative Complaint. Mr. Ramos stated that Petitioner "wasn't sterile." Transcript of May 11 meeting, page 5. Chair Katims asked if Petitioner had surgical privileges. Ms. Lannon responded by restating Dr. Katims' question whether Petitioner may have performed the procedure in a hospital bed because he lacked surgical privileges. Dr. Wells expressed interest in this point. The motion was then passed without further discussion. The materials available to the Probable Cause Panel on May 11, 1990, included a letter dated March 15, 1989,from Joseph R. Goggin, M.D., who is a board certified surgeon. Retained by Respondent to opine as to the standard of care, Dr. Goggin reviewed the file materials and stated in part: I find it hard to believe that the patient's hospital bed in a usual hospital room would be considered sterile. [Petitioner's] statements throughout both the Discharge Summary and in the chart itself state that the wound infection clostridium perfringens and staph coagulase negative was self-inflicted by the patient following the surgical procedure. I cannot believe that this is true. Clostridium perfringens is not a normal flora found in the human colon. Neither is staph coagulase negative. I would suspect that if the patient had contaminated the wound with her own stool, we would have seen mixed cultures with numerous other bacteria involved. One must assume that because of the pure cultures of clostridium perfringens and staph coagulase negative that a break in sterile technique occurred. I think this occurred because the patient underwent the procedure in her hospital bed and not in a sterile operating environment. Dr. Goggin's letter concludes that the hospital changed its policy so that all procedures involving excision be performed in a "completely sterile environment." The letter adds: If this policy was not in place prior to the procedure, I don't believe that the licensee violated the standard of care as it applied to this hospital. However, most of us would believe that any invasive procedure of this nature should probably be performed in a sterile environment. The letter from Dr. Goggin also faults Petitioner for his failure to obtain a rectal examination upon admission of the patient, even though she had been complaining of rectalbleeding. In terms of the timeliness of Petitioner's diagnosis of clostridium, Dr. Goggin concedes, "I don't think that an earlier diagnosis would have changed this patient's final outcome." The records available to the Probable Cause Panel on May 11, 1990, also included a letter from Respondent to Petitioner advising him that he is the subject of a complaint and inviting him to provide a written explanation. In response, and included in the records available on May 11, were a letter dated April 25, 1989, from Petitioner; a statement dated April 25, 1989, from the attending nurse corroborating that sterility was maintained during the excision of the nodule; and a letter dated July 3, 1989, from James J. McClelland, M.D., whose letterhead indicates that he is a member of a group of infectious disease control consultants. Petitioner's letter states that invasive procedures, such as subclavian insertions, chest tube placements, and lumbar punctures for spinal taps, are commonly performed in the hospital bed. The letter restates the procedures followed to maintain sterility and asserts that the contamination had to take place subsequent to the dressing of the wound, such as by the patient inadvertently loosening the dressing through normal movement in the bed. Dr. McClelland's letter states that, following review of the medical records, he finds that Petitioner "followed the normal standard of care in performing this procedure . . .." The letter explains: [C]lostridial infections in sepsis are well reported in the literature to have occurred after many sterile procedures, using standard medical care and that the presence of the clostridial infection does not imply substandard care. It should be noted that clostridial organisms can colonize the skin, often times in higher numbers below the waist, and that this organism entered the wound in the postoperative period. The record showed that [Petitioner] followed the standard care to prevent contamination of the wound by his prep and subsequent dressing of the wound. In regard to the question con- cerning a break in sterile technique and the findings of pure cultures of Clostridium perfringens and staph coagulase negative, it could also [be] assumed that a break in sterile technique would result in multiple other organisms being present in the wound. It should also be noted that the Clostridium perfringens organism can colonize the gastrointestinal tract, as well as the skin, and in itself does not exclude this as a potential pathophysiologic mechanism for her subsequent sepsis. The potential for the woman to have developed this overwhelming infection, whether the surgical procedure was performed in the office, a hospital bed, or the operating room, all exist and cases have been reported associated with all settings. There is no evidence I can see that [Petitioner] deviated from what would be considered normal procedure in removing this nodule from the patient's buttocks. As a result of the deliberations of the Probable Cause Panel on May 11, 1990, Chair Katims executed a Memorandum of Finding of Probable Cause. In the memorandum, the Panel finds that probable cause was found of a violation of Section 458.331(1)(t) and (m). By Administrative Complaint filed August 24, 1990, commencing DOAH Case No. 90-5298, Respondent alleged that thesurgical wound on the left buttock developed pure cultures of clostridium perfringens and staph coagulase negative, "indicating a break in sterile technique." The Administrative Complaint alleges that the patient was admitted with rectal bleeding, but the records fail to disclose that a rectal examination was performed upon admission. The Administrative Complaint alleges that the hospital involved has since changed its policy to require all procedures involving excision to be performed in a "completely sterile environment." Based on the foregoing allegations, Count One of the Administrative Complaint alleges that Petitioner violated Section 458.331(1)(t) by failing to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician when Petitioner excised the nodule in the "environment of [the] patient's hospital bed, which is not a sterile operating environment." Count Two alleges that Petitioner violated Section 458.331(1)(m) by failing to keep medical records--namely a rectal examination upon admission-- justifying the course of treatment of the patient. On September 26, 1990, Respondent filed a motion to amend the Administrative Complaint to delete the allegation about the change in the hospital procedure as irrelevant. The motion was granted. On October 9, 1990, Respondent also filed responses to interrogatories. In support of the assertion that the hospital bed is not a sterile operating environment,Respondent stated that it would rely upon the following witnesses: Petitioner, the attending nurse, Dr. Goggin, and the medical records custodian. In their entirety, the responses disclose that Respondent had not obtained expert advice other than that set forth above. In response to a letter dated December 28, 1990, requesting an opinion and providing all file materials, Respondent's attorney Randolph Collette received a seven-page letter dated January 3, 1991, from E. Rawson Griffin, III, M.D. Dr. Griffin is Board-certified in family practice. After an extensive recitation of the patient history taken by Petitioner, Dr. Griffin traces the subsequent actions of Petitioner, noting that pathological examination of the biopsied tissue detected "no particular serious abnormalities." Dr. Griffin opines: . . . my first opinion is that overall I find that [Petitioner] followed the basic standard of care in doing a history and physical examination, writing progress notes which justified the treatment, provided a surgical procedure in which he documented proper sterilization, surgical technique and postoperative wound care and that he obtained proper informed consent and signed this informed consent. Based on this review, I feel that the standard of care which is outlined in DeGowan and DeGowan's as well as what any reasonable physician would follow, was pretty much followed. The only criticism that I can find is again that there are no progress notes which may have been made by the covering physician. I also found that it was interesting that [Petitioner] did do progress notes on days that other physicians did not and I felt that this indicated that he was following the patient properly. It should also be emphasized that he did a three page dictation which was a discharge summary which basically outlined the facts of the case and I found this discharge summary to adequately summarize the events as they had occurred. In answering specific questions posed to him by Respondent, Dr. Griffin responds affirmatively to the question whether Petitioner met the applicable standard of care in his examination, diagnosis, and treatment of the patient. Dr. Griffin opines that the bedside location of the procedure did not violate the applicable standard of care. In this regard, Dr. Griffin notes the cost-effectiveness of method of treatment, as well as the documentation of proper anaesthesia, preparation of tissue, proper technique, and proper sterile dressings. As to Petitioner's failure to perform a rectal examination, Dr. Griffin notes that a colonoscopy polypectomy was performed. Again referring to the DeGowan and DeGowan treatise, Dr. Griffin observes that, in some cases, a routine or basic examination is inappropriate. One of the primary purposes of a rectal examination is to detect rectal bleeding, but the patient presented with obvious signs of rectal bleeding. Dr. Griffin concludes that a rectal examination by Petitioner might not have produced any more information, so the trauma associated with repeated rectal examinations was unnecessary. Under the circumstances, Dr. Griffin opines that the records justify Petitioner's failure to perform a rectal examination upon admission of the patient. Dr. Griffin also discredits the findings of a Dr.Khouzan who, based upon what he described as a "very careful review of the chart," found "very severe purulent material." Dr. Griffin notes that this finding was contradictory to multiple other chart entries and concludes that Dr. Khouzan did not in fact examine the patient. Respondent's attorney Randolph Collette received a four-page letter dated January 8, 1991, from Stephen J. Nelson, M.A., M.D., whom Respondent had also retained for an opinion by letter dated December 28, 1990. Dr. Nelson is an Assistant Clinical Professor of Pathology at the University of Miami. He is also an Associate Medical Examiner for Broward County and Attending Neuropathologist. Acknowledging the receipt of relevant file materials, Dr. Nelson states: [The patient's] terminal hospital course is an example of anaerobic Clostridium perfrin- gens cellulitis, and probable myonecrosis, following surgery. The onset is sudden, dramatic, and often fatal with an incubation period of 6-72 hours. There are five types of Clostridium perfringens, A-E, separated according to their production of four major lethal exotoxins. The most important exotoxin is . . . (alpha) toxin, or lecithinase-C, because of its lethal, dermonecrotic, and hemolytic activity. Such wounds classically display no pus because the enzyme lecithinase attacks cell membranes and literally dissolves any and all cells (including inflammatory cells) that are in its path. Other Clostridial exotoxins include collagenase, protease, deoxyribonuclease, hyaluronidase, and a hemolysin. Bacteremia is present in about 15 percent of cases. [The patient's] wound is described in multiple places throughout her medical recordas having a serosanguinous drainage. A "thin blood-stained exudate" is the usual classic textbook description. I'm not sure what Dr. N. Khouzan was referring to . . . when he says that his "careful review of the chart revealed a very severe purulent material . . .." His review couldn't have been that awfully careful as there is no mention of "a very severe purulent material," and he incorrectly identified the species of Clostridium he was hoping to treat as being Clostridium tetany (sic) which causes tetanus, rather than Clostridium perfringens which was one of the organisms cultured from [the patient's] excisional wound (along with coagulase-negative Staphylococcal spp.). I can only hope that Dr. Khouzan is not an infectious disease specialist. . . . Dr. Nelson opines that the presence of Clostridium perfringens was not necessarily evidence of substandard care. To the contrary, Dr. Nelson finds that Petitioner, trained as an orthopedic surgeon, "adequately assessed and documented [the patient's] signs and symptoms." Additionally, Dr. Nelson states that Petitioner properly performed the excisional biopsy himself; although devoting his practice to family/general medicine, Petitioner was trained as a surgeon in orthopedics. The bedside site of the excisional procedure did not bother Dr. Nelson, who states that the operating room is "justifiably reserved for more complex procedures." Dr. Nelson questions whether the procedure was performed at bedside or in a nearby "procedure room," where it was scheduled to be performed according to one of the records provided to Dr. Nelson. Dr. Nelson explains that the procedure rooms can easily be prepared for sterile procedures like excisional biopsies. Dr. Nelson's letter concludes: Clostridial spp. are ubiquitous to the human body. They most often become disease-producing and self-perpetuating when the oxygen tension in tissues is lowered, as with an abscess, decubital ulcers, or other cause of tissue necrosis and/or devitaliza- tion. Debilitated patients are at a higher risk of developing Clostridial infections. Intestinal disorders, most commonly malig- nancies, permit Clostridium perfringens invasion and replication, resulting in severe local or, rarely, septicemic Clostridial disease. The most likely source of Clostridium perfringens in [the patient's] excisional biopsy wound is local fecal contamination, though systemic invasion cannot be absolutely ruled out. [The patient] could have developed the infection from an iatrogenic injury during the colonoscopy on 9/4/88 . . . from which the adenomatous polyp was snared. Or from [the patient's] long-standing diverticulosis with the infection spreading from the abdomen to the wound. These are unlikely scenario, given her medical history and hospital course, but it would have been an easy task to have ruled these out by the performance of an autopsy. On January 11, 1991, Respondent requested that the final hearing set for January 29, 1991, be cancelled and the case abated to allow Respondent to return the case to the Probable Cause Panel for reconsideration. In the absence of objection from Petitioner, the motion was granted and the case was abated until March 10, 1991. At the Probable Cause Panel Meeting of the Board of Medicine conducted on February 22, 1991, the following members of the Panel were present: Chair George P. Vitale; Fuad Ashkar, M.D.; and Margaret Skinner, M.D. Ms. Lannon was present, aswere Mr. Ramos, and Respondent's attorneys Larry McPherson, and Susan Londgard. In response to a question posed by Ms. Lannon, each Panel member indicated that he or she had received the written materials concerning matters to be considered at the meeting in sufficient time to review them. Ms. Lannon then invited the Panel members to ask questions or request material if they encountered a case for which they had not read the materials or were otherwise unfamiliar with. Mr. Ramos identified the materials that had been provided to each Panel member prior to the meeting. The materials included the entire investigative file. When Petitioner's case was announced, Mr. Ramos stated that the case was before the Panel for reconsideration after a previous Panel finding of probable cause and the subsequent filing of an administrative complaint. Mr. Ramos explained: We have brought this case back for your consideration, because discovery revealed that two expert opinions state that the Respondent's excision of the nodule in the bedside of the patient was not below the acceptable standard of care. Furthermore, the information related by the patients--by our expert as to the source of the patient's infection is contradicted by recognized medical treatises and the opinion of an infections disease control specialist, and that has been included in the packet. That came after discovery. And, therefore, the Department has recommended that we close this case without further prosecu- tion. Transcript of February 22 meeting, page 7. Panel member Skinner then indicated that she had noticed that the two expert opinions were from a Broward County assistant medical examiner and a family practitioner. She said that she would like to see an opinion from someone who is "Board certified in internal medicine with a subspecialty of infectious diseases, and I would like to see that . . . before we move to do away with this case. This case is heinous . . .." Id. at page 8. Panel member Skinner complained that the experts did not have any medical records and that her records were incomplete. For instance, she said that she did not know the size of the incision or if a nurse documented erythema or "crud" in the wound. She thus moved that the case be brought back with the medical records with an opinion specifically from somebody Board-certified in internal medicine with a sub-specialty in infectious diseases and be brought back to the Panel, because one of the things that is not in the [Administrative Complaint] is failure to recognize [Clostridium perfringens]. Id. at pages 8-9. Ms. Lannon responded that the standard of care would be a reasonably prudent similar physician, "so unless [Petitioner] was Board-certified in infectious diseases, he wouldn't be held to that standard of care. He would be held to the standard of care of a similar physician." Id. at page 9. Panel member Skinner answered that Petitioner is an "orthopedist practicing family practice." Id. Dr. Skinner then asked if Petitioner had surgical privileges at the hospital at which the incident took place. She suggested that the status of Petitioner's surgical privileges could be an "attributing cause." Id. Panel member Ashkar stated that he agreed with Dr. Skinner. Dr. Ashkar noted that one of the materials in the file indicated that the hospital had since changed its policies, or possibly had done so, in terms of excision procedures being performed in a completely sterile environment. In response to a question posed by Ms. Lannon, Panel members Skinner and Ashkar stated that they would proceed with an administrative complaint if they find "it's a standard-of-care violation." Id. at page 11. Dr. Ashkar added that a previous probable cause panel had good cause when it caused the filing of the Administrative Complaint, and the new panel should proceed with it. Dr. Skinner requested that the Administrative Complaint be expanded to include an allegation that Petitioner failed to recognize the presence or possible presence of a staph infection. Dr. Skinner conceded that she did not have the medical records, so she did not know if Petitioner did a wound culture. She also did not have the nurses' notes, so she did not know if they made if obvious that something was wrong with the wound. At this point, Mr. McPherson reminded the Panel that the case had been before a probable cause panel previously. He added that three expert opinions determined that there was "no standard-of-care violation." Id. at page 12. Ms. Lannon disagreed with Mr. McPherson, and Panel members Skinner and Ashkar agreed with Ms. Lannon. Dr. Ashkar stated that Dr. Goggin opined that there was a standard-of-care violation and that the incident forced the hospital to change their policies. Ms. Lannon cautioned that a change in policy would not establish a violation in the first place. Dr. Ashkar responded by referring to the standard-of-care issue and quoting Dr. Goggin as follows: ". . . the patient probably should have had the surgical procedure performed in a sterile environment under the usual conditions found in an operating room suite where there are sterile instruments, and that the wound infection here is probably due to doing it outside that kind of a setting." Id. at page 13. Ms. Lannon asked the Panel what they thought about Dr. Nelson's opinion that Petitioner could be regarded as overutilizing the operating room by performing the excision procedure there. Dr. Skinner admitted that the Panel's problem was that they did not know the size of the excision. She added that the experts differed as to the appearance of the wound, which went toward the failure to recognize a serious problem. Mr. Ramos suggested that the Panel table the case so that Respondent could provide the Panel with the medical records, which everyone agreed had not been included in thepackage supplied to the Board members prior to the meeting. Concluding their discussion of the case at the February 22 meeting, Panel member Ashkar rejected Dr. Nelson's opinion because, absent an emergency, Dr. Ashkar had "never heard of [performing the subject excision procedure in a hospital bed] recently ywayay." Id. at page 16. Dr. Skinner restated her concern about Petitioner's failure to recognize the complication. Ms. Lannon suggested that an orthopedic specialist who had examined the specialist possibly could provide needed information as to the size and nature of the nodule on the patient's hip. The motion was clarified to include consideration of amending the Administrative Complaint to include an allegation that Petitioner failed to recognize timely the patient's clostridium infection and to investigate whether Petitioner had surgical privileges. The Panel voted unanimously in favor of the motion and tabled the case. By Status Report filed March 5, 1991, Respondent advised that the Probable Cause Panel had tabled the case at its February, 1991, meeting in order to obtain additional information. At the Probable Cause Panel Meeting of the Board of Medicine conducted on May 4, 1991, Panel members present were Chair Vitale, Dr. Skinner, and Dr. Ashkar. Mr. Ramos and two of Respondent's investigators were present, as was Assistant Attorney General Edwin Bayo substituting for Ms. Lannon. Each of the Panel members indicated that he or she had read the file materials. When Petitioner's case came up, Mr. Ramos noted that the case had been in front of the Panel "a couple of times," most recently February 22, 1991. Transcript of May 4 meeting, page 4. Mr. Ramos added that one of Respondent's attorneys had pursued all the issues identified by the Panel at the last meeting. Mr. Ramos stated: Discovery reveals that the [Respondent's] expert's opinion was incorrect. That was the initial expert on which we depended on to file an Administrative Complaint. Dr. Nelson and Dr. Griffin have opined since then that the procedure performed in this case does not constitute the practice of medicine below the acceptable level of care. And at our last meeting, the Panel was informed on the foregoing, and it requested that an expert on infectious disease be obtained, and to obtain information as to the respondent's hospital privileges. There's two letters that are part of your packet from the hospital that says the subject did have hospital privileges. And as to the infectious disease person, the only person we have is the one on record, which is on the subject side of this case and [Respondent's attorney] tried to find someone. If you guys know someone for future reference, we need to know about it, because . . . Id. at pages 4-5. Panel members Ashkar and Skinner offered to provide Mr. Ramos with some names. Then Dr. Skinner confessed that she was still troubled about several things involving the case. She again raised the question why Petitioner failed to recognize the serious infection, clostridium perfringens. Sherestated the other issue concerning whether Petitioner was wrong to remove the cyst in the hospital bed. Addressing the first issue, Mr. Ramos said that Respondent could not obtain an expert opinion on whether Petitioner was culpable in his failure to recognize the infection. Dr. Skinner again offered to give Respondent the names of possible experts. Mr. Ramos responded that the process would take time, and, in the meantime, "we have this doctor in this position." Id. at page 6. Dr. Ashkar offered to contact the proposed expert and expedite the process, so the Panel could accept the expert's credentials at the next Board meeting at the end of May. Mr. Ramos said they could move fast on the case, so Dr. Skinner moved to table the case again. Dr. Skinner noted that they needed to consider the issue whether Petitioner improperly incised the abscess at the hospital bed. She asked that Respondent's attorneys pose to the expert two questions: was it below the standard of care to incise the abscess in the bed and was there a failure to recognize a potential danger. Dr. Ashkar distinguished between the removal of a nodule that is a simple ganglion, an ingrown hair, or a sebaceous cyst, on the one hand, and the draining of an abscess with a "very deadly bacteria in it in a general ward," on the other hand. Id. at page 8. Mr. Ramos answered that the case would depend entirely on the expert. The first expert was dated andcontradicted by treatises. Dr. Ashkar responded that it would have been more acceptable if a surgeon without access to an operating room performed the excision in a sterile setting other than an operating room. In any event, it was, in Dr. Ashkar's opinion, improper to perform the procedure in a general ward where infectious diseases are a recurring problem. Id. at pages 8-9. Dr. Skinner agreed that the situation was worse because Petitioner had operating privileges. Dr. Skinner then moved to table the case pending acquisition of expert witness, and again, . . . I would ask him all the ques- tions you asked the other expert witness. Noting that he did have operating room privileges. The second corner of the question that wasn't asked, is, is if it was failure to recognize an additional problem with this wound below the standard of care. Id. at page 10. The Panel then voted unanimously to table the case. Respondent filed a second Status Report on May 20, 1991, and advised that the Probable Cause Panel again tabled the case at its April, 1991, meeting in order to obtain an additional expert opinion. Petitioner objected to further abatement and requested that the case be dismissed. At the same time, Petitioner requested attorneys' fees and costs. By Order Setting Case for Hearing entered June 12, 1991, the request to dismiss was denied, the request for attorneys' fees and costs was denied, and the final hearing resetfor July 15, 1991. By Notice of Voluntary Dismissal filed June 18, 1991, Respondent dismissed the DOAH Case No. 90-5298 and the Division closed its file by Order entered the following day. On July 10, 1991, Respondent received the opinion of another expert, Stephen M. Kreitzer, M.D., who had been retained by letter dated June 26, 1991. In relevant part, Dr. Kreitzer's letter states: The bacteria [to which the patient succumbed] are present in the skin and certainly the elderly with diminished circulation to the skin are more prone to these types of infec- tions. These types of infections can certainly occur under the sterile conditions surgery or they can occur with any break of the skin on their own. It certainly is within the standard of care to remove the type of nodule removed by [Petitioner] in an outpatient center, hospital in-patient bedside, or in a physician's office. There is no evidence to suggest [Petitioner] violated Surgical Infectious Disease Guidelines. . . . Sepsis was recognized by the Emergency Room physician and the care of the septic patient was begun by the Emergency Room physician. [Petitioner] continued that care in the Intensive Care Unit. Appropriate cultures and the broadened spectrum antibiotics were prescribed. In my opinion, the patient contracted the Clostridium and Staph bacteria from unfortu- nate skin entry. Skin entry can occur from an intravenous site, or wound such as that involved with the nodule removal, joint injection by an Orthopedist which occurred during this hospitalization and finally, colonoscopy and polypectomy with mucosal contamination and septicemia. Bacteria induced septicemia have been documented in all of the above instances and is well recognized. . . . Because of the timing of this patient's sepsis, it is unlikely that the trigger point injection or colonoscopy had anything to do with the patient's subse- quent septicemia and demise. Regardless, there is no evidence in the chart that the patient contracted the infection because of the procedure or treatment falling below the standard of care. [Emphasis added.] The applicable standard of care comes into question with this case because of both record keeping and the admitting orders. The patient did not have a history and physical dictated at the time of admission, but rather that was delayed until the 12th of September. Although rectal exam was not included, since the admitting orders included the consultation with the Gastroenterologist who obviously would per- form the rectal exam and colonoscopy, the patient need not have undergone a rectal exami- nation necessarily upon admission. . . . Petitioner subsequently commenced the present case by filing a Petition for Costs and Attorneys Fees on July 29, 1991.
The Issue The issue for determination is whether Petitioner should be awarded a certificate of need authorizing the establishment of cardiac catheterization laboratory services at its facility in Port Charlotte, Florida. As a result of stipulations of the parties presented at hearing, matters for consideration were limited to whether Petitioner meets the criteria of availability of funds for capital expenditures for the project in accordance with Section 381.705(1)(h), Florida Statutes; and whether Petitioner has shown the existence of need for additional services by any existing medically underserved groups in the service area.
Findings Of Fact The parties have stipulated that Petitioner does not meet the criteria of Section 381.705(1)(a), Florida Statutes, because there is no numeric need for the program established by any agency rule formula and that no emergency or other not normal circumstances exist, including problems of geographic, financial or programmatic access, justifying the program in the absence of such enumerated need. Petitioner's agreement to this stipulation was conditioned upon an assumption that previous Certificates of Need, formerly granted by final orders of Respondent to other entities in previous batching cycles and now the subject of legal appeals by Petitioner in the appellate court, will eventually be confirmed by that court to have been properly issued. The parties have stipulated that Petitioner, as the result of nonexistence of numeric or nonnumeric need, has not met criteria regarding its ability to provide quality care, a requirement of subparagraph (c) of Section 381.705(1), Florida Statutes; has not met criteria regarding availability and adequacy of other health care facilities in the applicant's service district, a review component set forth in Section 381.705(1)(d), Florida Statutes; has not met criteria regarding immediate and long term financial feasibility of Petitioner's proposal, a requirement of Section 381.705(1)(i), Florida Statutes; has not met criteria regarding the impact of the proposed project on the costs of providing such health services, a requirement of Section 381.705(1)(l), Florida Statutes; and has not met criteria, as required by Section 381.705(2)(a)-(d), Florida Statutes, regarding alternative services, efficiency of existing services, alternatives to new construction or the likelihood of patients obtaining the proposed service in the absence of Petitioner's proposal. The parties have stipulated that review requirements of subparagraphs (e), (f), (g), (j), and (k) of Section 381.705(1), Florida Statutes, are found not to be applicable to this proceeding. Those subparagraphs relate, respectively, to economics of shared services, need for special services, need for research and educational facilities, special needs of health maintenance organizations and needs of entities serving residents outside the service area. The parties have stipulated that the criteria ofSection 381.705(1)(b), Florida Statutes, has not been met because they were not addressed or challenged by Petitioner. However, Petitioner does contest the accessibility by medically underserved groups of existing and approved providers in the service district. With the exception of the availability of funds for capital and operating expenditures related to the project in Petitioner's application and the extent to which the proposed services will be accessible to all residents of the service district, further stipulation between the parties also establishes that the review criteria contained in Section 381.705(1)(h), Florida Statutes, does not apply to this proceeding. Portions of Rule 10-5.011(b), Florida Administrative Code, relating to accessibility of services to residents of the service district are also excepted from consideration in this proceeding by the parties' stipulation. By stipulation of the parties, it is established that the review requirement of Section 381.705(1)(l), Florida Statutes, relating to the probable impact of the proposed project on the cost of providing services proposed by Petitioner, is met. The parties' stipulation further establishes that requirements of Section 381.705(1)(m) and Section 381.705(1)(n), Florida Statutes, have been met. These statutory subparagraphs relate, respectively, to methods and costs of proposed construction, and Petitioner's past and proposed provision of health care services to medicaid and medically indigent patients. Petitioner is a separate, albeit subsidiary,corporation from its parent, Bon Secours Health Systems, Inc., (Bon Secours) a "not for profit" corporation based in Marriottsville, Maryland. Approximately 80 percent of the total project cost of $1,450,000 cost is expected to come from the parent organization and not Petitioner's corporation. The project has been approved by Petitioner's corporation and management approval has been granted by Bon Secours, subject only to final board approval and reevaluation by the parent corporation on an annual basis until the actual capital expenditure is incurred. Petitioner's parent corporation uses either a line of credit or goes to the tax exempt bond market to meet capital expenditure needs. The bond market is utilized when capital needs exceed $15 million for the year. Whether the funding source for Petitioner's project would come from a line of credit or bond financing would not be known until the actual year in which the expenditure is incurred. Bon Secours includes Petitioner in its obligated group which consists of a system-wide master trust indenture established in 1985. The group consists of eight hospitals and three long term care facilities. Weaker entities in the group have the benefit of the credit strength of the group's entire system. In this regard, Bon Secours enjoys a Standard & Poors and Moodys' bond rating of A+ and A-1, respectively. The corporation is a good credit risk with a strong financial position and good earnings record. Over the next five years, Bon Secours has the ability to raise in excess of $100,000,000 in the bond market for funding purposes, inclusive of the project which is the subject of theseproceedings. Although final approval of Petitioner's project by Bon Secours' board of directors is expected shortly, that approval had not occurred at the time of final hearing. As a result, the proof fails to establish that Bon Secours is committed to provide financing for Petitioner's project. Petitioner presented expert testimony regarding accessibility by medically underserved groups to Petitioner's and other cardiac catheterization programs. Petitioner's expert placed the size of the medically indigent population, a subcategory of the medically underserved group, at six to seven percent of the total population of the service area. Due to the lack of specificity of the methodology used in arriving at the cited percentage figure, no credibility can be ascribed to that population percentage. However, both Respondent and Petitioner concede the existence of this group in the district service area sought to be served by Petitioner's project. Petitioner has not established whether the medically indigent population is denied access to cardiac catheterization programs within the district service area. While Petitioner's hospital is a medicaid provider with a proactive policy of aiding the medically indigent, the availability of cardiac catheterization services exist for this group at Intervenor's medical center facilities, located only five miles from Petitioner's hospital. Intervenor is also a medicaid provider. The proof fails to establish that medicaid patients or medically indigentpatients are presently denied or turned away from Intervenor's facility. Further, the duplication of such services at Petitioner's hospital could effectively reduce the number of cardiac catheterization procedures required for the medical staff of Intervenor's laboratory to maintain proficiency. In point of fact, there is unused cardiac catheterization capacity at Intervenor's facility. As established by Intervenor's exhibit number one, there were 562 cardiac catheterization procedures performed at Intervenor's facility in 1988. The State Health Plan recites a minimum goal of 600 such procedures a year as a proficiency measurement; the Local Health Plan maintains that a minimum of 300 procedures should be performed to insure proficiency.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered denying Petitioner's application for approval of a cardiac catheterization Certificate of Need. DONE AND ENTERED this 29th day of June, 1989, in Tallahassee, Leon County, Florida. DON W.DAVIS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Fl 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 29th day of June, 1989. APPENDIX The following constitutes my specific rulings, in accordance with Section 120.59, Florida Statutes, on findings of fact submitted by the parties. Petitioner's Proposed Findings. 1.-3. Adopted in substance, except that part (l) of proposed finding 3 was met by Petitioner. 4.-5. Addressed in part. To the extent that the last sentence of proposed finding 5 suggests the establishment of final approval by the parent corporation, it is rejected. 6. Accepted with the exception of approval by the parent corporation. The record supports a finding of approval by management of that corporation, but not the board of directors. 7.-8. Adopted in substance. Adopted in part, remainder rejected due to witness's inability to support her calculations as to percentages of the population within the service district classified as medically indigent. Addressed in part, remainder unnecessary to conclusion. Addressed in part, remainder rejected on basis of relevancy. Addressed. Rejected on basis of relevancy. Addressed in part, remainder rejected as argumentative and speculative. Respondent's Proposed Findings. 1.-2. Rejected. Treated in preliminary discussion. 3.-21. Adopted in substance. 22.-23. Adopted by reference. 24.-25. Addressed in substance. 26.-30. Adopted by reference. 31.-33. Adopted by reference. Intervenor's Proposed Findings. 1.-3. Adopted in substance. 4. Rejected as unnecessary. 5.-9. Adopted in substance. 10. Adopted by reference. 11.-12. Adopted in substance. COPIES FURNISHED: Joseph R. Buchanan, Esq. Suite 900, Sun Bank Building 777 Brickell Avenue Miami, FL 33131 Edgar Lee Elzie, Jr., Esq. 215 South Monroe Street, Suite 804 Tallahassee, FL 32301 E. G. Boone, Esq. 1001 Avenida del Circo Venice, FL 34284 Gregory L. Coler Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 Sam Power Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 John Miller, Esq. General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700
The Issue The issues are: 1) whether Respondent committed medical malpractice, in violation of section 458.331(1)(t)1.; 2) whether Respondent failed to keep or maintain medical records, in violation of section 458.331(1)(m); 3) whether Respondent performed a wrong procedure or wrong-site procedure, in violation of section 456.072(1)(bb); and 4) if so, the determination of the penalty, pursuant to Florida Administrative Code Rule 64B8-8.001. (All references to statutes and rules are to the Florida Statutes and rules in effect in 2012, as cited in the Amended Administrative Complaint.)
Findings Of Fact Respondent is a medical physician, holding license number ME 0062034. He is certified as a pain management specialist by the American Board of Anaesthesia and American Academy of Pain Management. Licensed for nearly 40 years, Respondent practiced in 2012 in Lake Worth at the Palm Beach Pain Management Center, where he was the chief executive officer. Respondent has performed the specific procedures involved in this case at least 500 times and many thousands of epidural injections. Respondent's expert witness was Dr. Brett Schlifka, who is an osteopathic physician licensed in Florida and practicing in Wellington. Dr. Schlifka is certified by the Board of Neurosurgeons of the American College of Osteopathic Surgeons. As a neurosurgeon, Dr. Schlifka performs epidural injections, but never of hypertonic saline, so he was unable to address in any detail the epidural injection of hypertonic saline, nor does he use a catheter in performing epidural steroid injections (ESIs), so he was unable to address in any detail the specifics of the processes of threading a catheter through epidural space and inadvertently into intrathecal space and administering injectates through a catheter. Dr. Schlifka and Respondent are friends and refer patients to each other. Petitioner's expert witness was Dr. Harold Cordner, who is a medical physician licensed in Florida and practicing in Sebastian. Dr. Corner is certified by the American Board of Anesthesiology with an added qualification in Pain Management. For ten years, he has served as a clinical assistant professor at the Florida State University School of Medicine, where he teaches procedures such as those involved in this case--procedures that he himself has performed many times. This case involves procedures performed by Respondent on M.S.'s back on September 28, 2012. From bottom to top, relevant vertebra are sacral 1 (S1), lumbar 5 (L5), L4, L3, L2, and L1. Above the lumbar vertebra are thoracic vertebra, which are not directly pertinent to this case. The spinal cord extends no lower than L1/L2; the tapered end of the spinal cord is known as the conus. Relevant anatomical features in the area of the lumbar vertebrae, from the exterior to the interior, are ligaments, the epidural space, the dura, the subdural space, the arachnoid, the subarachnoid space, and the spinal cord. The subdural space is potential, presumably responding to changes in posture or movement, or even theoretical, because the epidural and subarachnoid spaces may be separated by less than one mm. Cerebral spinal fluid (CSF) is present in the subarachnoid space, but not the epidural space. The subarachnoid space is also known as the intrathecal space, so an intrathecal injection is an injection into the subarachnoid space. Intrathecal injections may be intentional or inadvertent, although this case does not involve any intentional intrathecal injections. "Bilateral" refers to the left and right sides of the vertebrae on the left and right sides of a patient's body. "Transforaminal" is across the space, within the epidural space, occupied by the foramen, which is a bony structure at each vertebral level through which spinal nerves pass. This case involves epidural injections of various injectates, including steroids--i.e., ESIs--although an ESI routinely includes the epidural injection of contrast and an anaesthetic in addition to a steroid. The ESIs in this case all involve lumbar transforaminal ESIs, so any reference to an "ESI" is to a lumbar transforaminal ESI. The alternative to a transforaminal ESI is an interlaminar ESI, which is an ESI within the space between vertebrae. At the time in question, at least, an interlaminar ESI was a safer procedure than a transforaminal ESI, if, for no other reason, than the proximity of an artery to the nerve passing through a foramen and the possibility of causing an infarction of the spinal cord by an inadvertent injection into the artery. M.S. was a patient of Respondent at the Palm Beach Pain Management Center from 2006 through September 28, 2012. On the latter date, Respondent performed procedures on M.S., immediately after which she has been left paralyzed in her lower extremities and incontinent of bladder and bowel. Born in 1951, M.S. presented to Respondent in 2006 with complaints of low back pain for many years. She had undergone failed back surgeries in 1989, 1993, and 2003. In the course of these surgeries, surgeons had performed spinal fusions of L3/L4 and L4/L5 and implanted hardware at L3/L4. M.S. was five feet, two inches tall and weighed 160 pounds. At the time of M.S.'s initial office visit on February 7, 2006, M.S. described the pain in her low back as ranging from 5 to 10 on a scale of 0-10 and stated that she had not had "injection therapy" recently. Respondent's impressions included lumbar failed back surgery syndrome and lumbar radiculopathy, which is a condition in which a compressed spinal nerve causes pain along the nerve. Respondent recommended a bilateral ESI. Imaging conducted shortly after the initial office visit revealed the above-mentioned hardware, postoperative changes in the disc at L4/L5, a mild disc bulge at L1/L2, a "very minimal" posterior disc bulge at the postoperative site of L3/L4, and a small central protrusion at L2/L3 causing a mild compression along the central aspect of the thecal sac, which is within the subarachnoid space. Besides the initial office visit and some imaging reports from late 2010, the evidentiary record contains Respondent's medical records only from December 2011 through September 28, 2012. In late 2010, imaging disclosed disc degeneration at L1/L2 and L2/L3 with mild thecal sac impingement, the surgical fusion of L3/L4 and L4/L5, and disc desiccation at L5/S1. There was also thickening or clumping of nerve roots through the surgical levels that could be regarded as arachnoiditis, which is inflammation of the arachnoid membrane. However, the evidentiary record contains billing records from late 2006 through September 28, 2012. These records indicate that Respondent performed 21 epidural injection procedures on M.S. from December 6, 2006, through September 28, 2012. The last ten such procedures, from April 19, 2010, were billed as ESIs using Code of Procedural Terminology (CPT) code 64483, although one procedure was billed as CPT code 64473. Respondent also billed ESIs under CPT code 64483 or 62311 on February 6, 2008, May 15, 2009, May 29, 2009, and February 22, 2010. The remaining procedures were billed on December 6, 2006, March 20, 2007, June 13, 2007, November 8, 2007, February 21, 2008, September 5, 2008, January 9, 2009, and October 30, 2009, under CPT code 62264 as "Racz" procedures, which are described below. Among other things, these records establish that Respondent performed ESIs on M.S. on 90-day intervals from late 2010 until September 28, 2012. Obviously, the billing records also establish that the lumbar region of M.S. was the site of numerous procedures over the six years leading up to September 28, 2012. Although the experts agree that M.S.'s lumbar epidural space was challenging due to myriad deformities following years of disease and multiple surgeries, Respondent had navigated this space over 20 times, so Respondent at least knew that he would encounter, if not where he would encounter, lesions, narrowed openings, and other pathological changes. For many years, Respondent had prescribed Percocet to control pain. The medical records for the nine months preceding the September 28 procedures indicate that Respondent consistently administered drug screens, which appropriately revealed only oxycodone. However, on at least a half dozen office visits during 2012, M.S. admitted that she was not abiding by the Narcotic Treatment Agreement, but, each time, Respondent's notes misstate that she was in compliance, so as to indicate no inquiry into the details of the noncompliance or its significance, if any, and recordkeeping by rote. Respondent likewise displayed inattention to detail as to the informed consents that he obtained from M.S. during this nine month timeframe. Each informed consent contains a handwritten description of the procedure to which M.S. was consenting by signing the form. For each procedure, the procedure is "lumbar transforaminal epidural steroid injections with fluoroscopy and catheter"; the June 25 informed consent rephrases the last four words as "with catheter with fluoroscopy," and the September 28 informed consent adds "left" to the typical description of the procedure. Respondent never obtained M.S.'s informed consent for the injection of hypertonic saline, even though Respondent injected hypertonic saline, with the amounts shown parenthetically, during the procedures of December 23 (5 cc), June 25 (5 cc), and September 28 (8 cc). For the December 23 procedures, Respondent took 12 minutes from "start" to "end" for the actual procedures and 18 minutes from "in" to "out" of the operating room. Coincidentally, the December 23 procedures' start and end and in and out times are identical to these times for the September 28 procedures. The start to end times of other two procedures were 11 minutes. This brisk pace betrays Respondent's experience as a pain specialist, but belies M.S.'s challenge as a patient. During each set of procedures from December 2011 through September 28, 2012, Respondent injected the same injectates, except for the March 23 procedure that omits hypertonic saline, but at different dosages, which is discussed below. Respondent used a form that allowed him to document his surgical plan by circling levels--L1/L2, L2/L3, L3/L4, and L5/S1--and sides--left, right, and bilateral. For December 2011, Respondent circled nothing; for March and June 2012, Respondent circled levels L3/L4, L4/L5, and L5/S1 and the right side; and for September 28, 2012, Respondent circled the same levels, but the left side. The efficacy of the epidural procedures is revealed in the notes from postsurgical office visits during which M.S. described her pain. On January 2, 2012, M.S. reported that her pain ranged from 6-10 all day and all night, the pain ranged from her back down her legs, everything made her pain worse, and the injections helped, although, after several injections, she reported that she had experienced "floppiness" in one leg--side unspecified. M.S. concluded that the pain relief from the injections made a difference in her life and restored functionality. On January 10, 2012, M.S. returned to Respondent's office complaining of pain ranging from 8-10 without medications and 6-10 with medications. The pain was radiating from her low back down her legs, mostly her right leg. The pain was continuous and "sharp, burning, shooting, achy, knife-like, stabbing, deep, heavy, and gnawing." On February 7, 2012, M.S. returned to Respondent's office with the same complaints. Interestingly, on March 6, 2012, M.S. returned to Respondent's office describing her pain as improved--5-10 without medications and 3-6 with medications. This time the note specifies that "transforaminal epidurals" gave her the greatest relief. The note for this office visit mentions a treatment plan of another ESI of a steroid and anaesthetic, but does not specify the side. On April 3, 2012, M.S. returned to Respondent's office for her first visit after the March 23 ESI. Again, the pain was worse immediately after the procedure--9-10 without medications and 5-8 with medications, although the note adds, "the transforaminal epidural with catheter has also helped her tremendously." The notes contain no analysis of the worsened pain 11 days after the ESI compared to 17 days before the ESI, but leg floppiness does not recur in this or any subsequent note. On May 5, 2012, M.S. returned to Respondent's office describing her pain as 8-10 without medications and 5-9 with medications. M.S. stated that the medications and "transforaminal epidurals with catheter" were the only treatments that helped with the pain. On May 15, 2012, M.S. returned to Respondent's office describing her pain as 6-10 without medications and 4-6 with medications. On June 22, 2012, M.S. returned to Respondent's office following a trip to North Carolina, where she had been unable to obtain her oxycodone and had been in considerable pain. On the day of the visit, though, M.S. reported her pain to be an 8 without medications and 6 with medications. The treatment plan contained in the note includes a right ESI, which Respondent described to M.S. as the injection of Cortisone and Marcaine or lidocaine with no mention of hypertonic saline. On July 20, 2012, M.S. returned to Respondent's office for her first visit after the June 25 ESI. M.S. described the pain as 8-10 without medications and 5-8 with medications. The recent "right lumbar transforaminal with catheter [helped] about 50% to 60%." On August 17, 2012, M.S. returned to Respondent's office describing her pain as 7-10 without medications and 1-7 with medications. The note adds, "She states no real change in her status, just looking forward to another injection." The treatment plan was for a left ESI with Cortisone and Marcaine or lidocaine, but, again, with no mention of hypertonic saline. On September 28, 2012, Respondent performed three procedures-- first, a caudal lumbar epidurogram with interpretation; second, an ESI; and, third, a distinct procedure involving the injection of hypertonic saline. In all three procedures, Respondent relied on live or real-time fluoroscopy to guide the spinal needle and catheter, which are described below. M.S. was positioned on a table, which, as relevant to these procedures, accommodates the 90-degree rotation of a fluoroscope, which is also called a C-arm due to the ability of the device to project onto a monitor anterior-posterior (AP), lateral, and oblique views of the spine and related structures. The AP view is a head-on (or back-on) view, and the lateral view is a side view at 90 degrees from the AP view. At the direction of Respondent, a technician not only rotated the C-arm, but also captured a still image from the radiographic output, which otherwise ran live or in real time or was switched off entirely when unneeded, to avoid over-exposing the patient to radiation. The caudal lumbar epidurogram is a relatively simple diagnostic procedure. Respondent passed a spinal needle through the sacral hiatus, which is a hole in the bony structure at the base of the spine below S1, and into the caudal epidural space. By lightly pushing the syringe plunger, Respondent employed the loss-of-resistance technique to sense the lack of resistance characteristic of the epidural space; by lightly pulling the syringe plunger, Respondent aspirated the needle and line to rule out the presence of any CSF, which would reveal an intrathecal penetration, or blood, which would reveal a vascular penetration. M.S., who remained conscious during the procedures, also did not indicate any paresthesia, which is numbness or tingling. Respondent withdrew the hollow core of the spinal needle in preparation for threading the catheter through the now-hollow needle and up through the epidural space. Respondent has maintained five AP views and one lateral view from the fluoroscopic imagery that he conducted on September 28. The lone lateral view, which is of the sacrum, was taken and preserved as part of the epidurogram. During the entirety of the September 28 procedures, including the epidurogram, Respondent injected 6 cc of contrast in the form of Omnipaque 300. As with all injectates, Respondent's records refer only to divided doses, so it is impossible to know how much of any injectate, including the contrast, that he administered at what level. The ESIs in March and June 2012 may have involved fewer levels than the ESIs in December 2011 and September 2012, because the former involved 3 cc each of Omnipaque and the latter involved 5 cc each of Omnipaque. Returning to the epidurogram, as the contrast flowed up the epidural space, the radiography revealed lesions at S1 on the right and L5 on the left. The dispersal pattern of the contrast indicated that the contrast was within the epidural space. Without incident, Respondent completed the epidurogram about two minutes after starting the procedure. For the ESI and hypertonic saline procedures, Respondent passed the catheter up through the epidural space to the level or levels that he was targeting for treatment. At each level, Respondent injected, in order, the above-described contrast, an anaesthetic, a steroid known as Depo Medrol, and hypertonic saline solution. For all four procedures from December 2011 through September 28, 2012, Respondent used Marcaine 0.25% and lidocaine 1%, but his records did not indicate the location at which he administered each anaesthetic. It appears that the anaesthetic used in the greater dose was used in the epidural space, and the other anaesthetic was used elsewhere, likely at the site of the initial injection. If so, for the September 28 procedures, Respondent used 5 cc of lidocaine in the epidural space--or what he intended to be the epidural space--and 1 cc of Marcaine elsewhere. In March 2012, Respondent used 3 cc of Marcaine and no lidocaine; in December 2011, Respondent used 5 cc of each anaesthetic; and, in June 2012, Respondent used 2 cc of Marcaine and 3 cc of lidocaine. Respondent's use of Depo Medrol was more consistent. He administered 80 mg during the September 28 ESI, but had used 120 mg during each of the three preceding ESIs. The greatest variability occurred with the hypertonic saline, which, as already noted, was omitted from the March 2012 ESI. Respondent administered 8 cc of hypertonic saline during the September 28 procedures and only 5 cc--nearly 40% less--during the December 11 and June 2012 procedures. The record contains no indication of why he failed to inject hypertonic saline during the March 12 procedure, but the sole reference to leg floppiness, as noted above, was after the preceding procedures in December 2011. There is some dispute in this case as to what may be injected as part of an ESI. Obviously, the ESI contemplates the injection of a steroid, as well as contrast and an anaesthetic, which support the injection of the steroid by heightening the safety of the ESI and the comfort of the patient during the ESI. Also, these injectates are amenable to grouping because this record does not suggest that an inadvertent intrathecal injection of these injectates, even at the doses intended for the epidural space, affects patient safety nearly as much as an inadvertent intrathecal injection of hypertonic saline. An intrathecal injection of a very high dose of anaesthetic could proceed up the spinal canal and cause respiratory and cardiovascular collapse, but the record does not indicate that such dangers exist for the dosages involved in the September 28 procedures. For the same reason, an ESI may include an injection of normal saline, which is harmless in the subarachnoid space. The epidural injection of hypertonic saline is the distinguishing feature of a Racz procedure, which also involves an epidural injection. Named after its physician-developer, Gabor Racz, the Racz procedure is intended to break up, or lyse, epidural lesions or adhesions that may be the source of part or all of a patient's pain when a nerve is trapped by an adhesion. In the Racz procedure, a physician injects hypertonic saline near the lesion. The salinity of hypertonic saline solution is ten times greater than the salinity of ambient conditions in the body, so the hypertonic saline solution, by osmosis, causes the body to compensate for the sudden appearance of hypersaline conditions by delivering fluid that expands the space and may thus lyse any nearby adhesions. Although the catheter is typically not stiff enough to break up lesions mechanically, such mechanical lysis may also occur incidentally while performing a Racz procedure. Other distinguishing features of an ESI and Racz procedure involve the sources of pain and the term of pain relief. The lysis of an adhesion permanently eliminates one potential source of pain--a nerve trapped by an adhesion. An ESI reduces inflammation wherever it may be present, so it treats a wider range of conditions, but offers only temporary relief. The pain relief from the steroid may extend weeks or months. The pain relief from the anesthetics--one hour for lidocaine and four hours for Marcaine--is not intended to persist past the intra-operative and recovery stages of the procedures. There may also be a locational difference between the ESI and Racz procedures. As noted above, in the ESI, the catheter traverses the foramen within the epidural space, and, in the Racz procedure, the catheter is threaded to lesions anywhere within the epidural space. Dr. Cordner opined that Respondent failed to perform an ESI due to the lack of proximity of the injection sites to the various foramina. Labels notwithstanding, the procedures performed by Respondent on September 28 substantially conformed to an ESI and, because an ESI does not include the epidural injection of hypertonic saline, a Racz procedure. Determining that Respondent performed two distinct procedures in addition to the epidurogram does not answer several relevant questions. First, which injectate, once introduced into the subarachnoid space, injured M.S.? If introduced to the subarachnoid space, the hypertonic saline is a known cause of the paralysis and incontinence that M.S. suffered, such as myopathic injury resulting in paralysis. Because safe practices, as described by Dr. Cordner below, include the provisional injections of contrast and anaesthetic to confirm that a catheter tip is safely in the epidural space, the only other injectate that might injure the patient is the steroid, but, again, the record is silent on the consequence of the introduction of the Depo Medrol, at the dosages used by Respondent, into the subarachnoid space. Second, when did Respondent decide to inject the hypertonic saline? The record provides no basis to answer this question. As noted above, Respondent did not administer hypertonic saline in the March 2012 procedure, but administered hypertonic saline in the December 2011 and June 2012 procedures, as well as the September 28 procedure, in which he increased the dose by 60%. For none of the three procedures in which Respondent injected hypertonic saline did his treatment plans or informed consents mention hypertonic saline. Respondent may have decided, prior to the day of surgery, to use hypertonic saline and merely failed to document this decision in advance, or he may have decided, during surgery, to use hypertonic saline and documented the use of hypertonic saline as noted above. Third, why did Respondent inject hypertonic saline and why did he administer the dosages that he used? The record provides no basis to answer these questions, although, as noted above, the omission of hypertonic saline from the March 2012 procedure corresponds to leg floppiness after the December 2011 procedure and the increased dose of hypertonic saline in the September 28 procedures corresponds to a lower dose of the Depo Medrol. The medical records indicate that M.S. believed that the ESIs relieved her pain, but she could not have had a preference about hypertonic saline because she evidently never knew that Respondent was using this injectate. On the other hand, M.S.'s rating of her pain after the March 2012 procedure, without hypertonic saline, was not much different from her rating of her pain after the December 2011 and June 2012 procedures. The likely inference is, if Respondent's use of hypertonic saline were not arbitrary or capricious, he injected hypertonic saline, at least when M.S. had not mentioned leg floppiness after the last injection of hypertonic saline, because he believed it worked and used considerably more of it on September 28 because he believed that more would work better. Returning to the remaining September 28 procedures, Respondent injected the four injectates described above on M.S.'s left side at three levels: S1/L5, L4/L5, and L3/L4. At each level, Respondent waited three or four seconds after injecting the contrast, while he watched the radiographic output, before injecting the anaesthetic, after which he waited 30 to 40 seconds to allow the anaesthetic to numb the area. Then, Respondent injected the steroid, waited five seconds, and lastly he injected the hypertonic saline. Assisted directly by the epidurogram, Respondent properly located the catheter tip in the epidural space at S1/L5. The evidence is mixed as to the location of the catheter tip at L4/L5, but the catheter tip was in the subarachnoid space at L3/L4. As Dr. Cordner testified, an inadvertent penetration of the subarachnoid space by a catheter tip is not evidence of negligence; the negligence arises in what a physician does or fails to do after such an intrathecal penetration. Here, the reasons why Respondent failed to realize that the catheter tip was in the subarachnoid space at L3/L4 relate to the reasonable precautions that Respondent failed to take--and thus establish Respondent's negligence. Respondent failed to realize that the catheter tip had entered the subarachnoid space at L3/L4 because, after injecting the contrast, he misread the AP real time view from the fluoroscope that showed a dispersal pattern suggesting that the contrast was not within the epidural space; because, after injecting the contrast, he did not direct the technician to obtain a lateral real time view, which would have provided another dimension, so as to confirm that the contrast was not in the epidural space; because he did not perform the loss-of-reduction technique, which would have confirmed that the catheter tip was not in the epidural space; because he did not aspirate the catheter and line, which would have revealed CSF; and because, after injecting the anaesthetic, he did not wait at least 15 minutes to rule out a gross motor block of the lower extremities, which would have indicated that the catheter tip was in the subarachnoid space. Unreasonably unaware that the catheter tip was in the subarachnoid space, Respondent injected the steroid and hypertonic saline, withdrew the catheter, and completed the ESI and Racz procedures within ten minutes from the end of the epidurogram procedure and turned over responsibility for M.S. to Respondent's nurse. One minute after the completion of the procedure, at 9:38 a.m., M.S. complained of pain in her hips and legs, and Respondent administered 60 mg of Toradol. Ten minutes later, M.S. stated that both of her legs were numb, although by 10:15 a.m. she was moving both legs. By 11:30 a.m., she could move both legs, but had no feeling from the top of her thighs down. By 1:00 p.m., M.S. reported feeling to her mid-calf, but, three hours later, she could not move her legs. Although Respondent justifiably had not been concerned about transient numbness, the deterioration in the ability to move the legs concerned him, and Respondent insisted that M.S. be admitted to a nearby hospital. Respondent thus discharged M.S. at 5:25 p.m. for transfer by ambulance to Bethesda Memorial Hospital (Bethesda), where other physicians assumed responsibility for her care. Imaging conducted at Bethesda upon the admission of M.S. revealed no epidural hematomas, but evidence of arachnoiditis, which is inflammation of the arachnoid membrane. Most significantly, a lumbar CT scan revealed a small amount of air in the subarachnoid space, which was consistent with Respondent's recent intrathecal injections. Also, M.S.'s thecal sac displayed enhancement of disc disease at S1 through L4 suggestive of a recent subarachnoid injury. About six weeks after the procedures, an MRI at the JFK Medical Center (JFK) revealed conus medullaris syndrome posteriorly within the thecal sac at L1/L2 through L3/L4. This syndrome results from injury to the conus, such as from trauma, and is consistent with Respondent's intrathecal injection of hypertonic saline. This hospitalization followed a finding from an outpatient MRI of a large hematoma in the lumbar spine. Respondent and Dr. Schlifka contend that the Bethesda physicians missed the hematoma, but it is as likely that the hematoma formed after M.S.'s discharge from Bethesda. M.S. underwent a resection of a mass, which was found to be an arachnoid cyst. Post-operatively, M.S. still was unable to move her lower extremities, but started to regain sensation in her great toes. Respondent relies on a succinct affidavit from Dr. Racz himself, which, as noted in the Conclusions of Law, is available only to impeach Dr. Cordner's testimony. Dr. Racz's affidavit states that he has examined Respondent's medical records, including the six fluoroscopic images retained by Respondent; all of the images available in connection with the Bethesda and JFK hospitalizations; and some earlier images. From these materials, without more, Dr. Racz's affidavit concludes that Respondent's care was "appropriate and that he met or exceeded the standard of care throughout the lumbar transforaminal epidural steroid injection with catheter and fluoroscopy on September 28, 2012. Further, the complications suffered by [M.S.] are known risks and complications of the procedure that are not indicative of negligence." The most obvious difference between the opinions of Dr. Cordner and Dr. Racz is not the amount of work; each physician has examined all of the available medical records. But Dr. Cordner has painstakingly analyzed the September 28 procedures and Respondent's negligent actions and omissions, and Dr. Racz has declared by fiat that Respondent was not negligent. Undoubtedly, Dr. Racz learned from his examination of the medical records that Respondent injected hypertonic saline on September 28, yet Dr. Racz describes the procedure as an ESI and makes no mention of hypertonic saline. Perhaps Dr. Racz is sensitive to the greater potential for injury introduced by hypertonic saline, which is the prominent injectate of his procedure. Perhaps, the procedure followed by Respondent on September 28 failed to follow strictly the requirements of the Racz procedure. Dr. Cordner, who co-teaches the Racz procedure with Dr. Racz, testified that the procedure requires a physician to wait 15 to 30 minutes after injecting anaesthetic to confirm the injection is in the epidural space. Regardless, an informed opinion as to Respondent's negligence must take into account the injectate that, on this record, bears the clear potential for patient injury, and Dr. Racz's opinion fails to do so. Perhaps, Dr. Racz's affidavit is an expression of agreement with Dr. Cordner's concession that, in itself, an inadvertent intrathecal penetration is not evidence of negligence. But Dr. Racz's affidavit needs to account for the acts and omissions, set forth above, that simultaneously explain why Respondent failed to realize that the catheter tip was in the subarachnoid space at L3/L4 and constitute his failure to take these simple precautions against patient injury. The last sentence of Dr. Racz's affidavit dismisses M.S.'s "complications"--a veiled reference verging on a euphemism when describing permanent paralysis and incontinence--as known risks of the ESI and not indicative of negligence. Obviously, a bad result does not prove medical malpractice, although, as explained in the Conclusions of Law, the risk of a bad result and the impact on a patient of a bad result drive the precautions that a physician must take to avoid a finding of medical malpractice. On the other hand, the known risk of permanent paralysis and incontinence from a Racz procedure or an ESI with the injection of hypertonic saline does not obviate the necessity of analysis of the adequacy of the precautions taken by Respondent to avoid such a result; to the contrary, these grave consequences underscore the importance of such analysis. Notwithstanding Dr. Racz's status in the field of pain management, his affidavit is entitled to no weight whatsoever and fails to impeach the testimony of Dr. Cordner. Dr. Schlifka's testimony is better than Dr. Racz's affidavit in one respect: he clearly acknowledged that injectate had entered the subarachnoid space. It is impossible to dispute this fact based on M.S.'s dramatic response, the dispersal pattern of contrast depicted in one saved AP view, air found in the subarachnoid space shortly after the September 28 procedures, the injury to the thecal sac, and the conus injury. On the other hand, Dr. Schlifka's testimony shared the failure of Dr. Racz's affidavit in addressing the particulars of the September 28 procedures performed by Respondent. As Dr. Racz failed to focus on anything but a theoretical ESI, Dr. Schlifka failed to focus on anything but the fragile anatomy of the dura--never addressing, for instance, the likelihood that a catheter during an ESI could tear the dura--something that the experienced Dr. Cordner has never encountered; whether a tear would introduce air into the subarachnoid space; or whether the injectate entering through a tear could possibly injure the thecal sac and conus. Obviously, Dr. Schlifka lacks the experience to opine as to whether a catheter may tear the dura and, if so, the probability of this complication. On the other hand, Dr. Schlifka failed to explain why a dural tear would admit injectates into the subarachnoid space, but not allow injectates and CSF to escape from the subarachnoid space into the epidural space. Nor did he address the behavior of injectates--the most important one of which he has never worked with--if injected through the dura and into the subarachnoid space or if entering the subarachnoid space through a tear in the dura. Although qualified to advise that the dura may tear, and, as he testified, the dura may be more prone to tearing after numerous surgeries and procedures in the affected area, Dr. Schlifka clearly lacked the means to address, on these facts, the probability that M. S.'s injuries were caused by a dural tear or an intrathecal injection. Compared to Dr. Cordner's detailed analysis and superior relevant experience, Dr. Schlifka's opinions are speculative and perhaps reflective of an understandable desire to help a beleaguered friend. However, Dr. Schlifka's explanation for the intrathecal penetration of the injectate by a dural tear is rejected as unsupported by the evidence. For Count I, Petitioner proved that, based on the standard of care in effect in 2012, Respondent committed medical malpractice by failing to recognize that he was performing intrathecal injections of steroid and hypertonic saline at L3/L4. Petitioner failed to prove that any injections at L4/L5 and L5/S1 were intrathecal. The evidence of intrathecal injections at L3/L4 is set forth in paragraph 48, and Respondent's negligent acts and omissions are set forth in paragraph 37. The intrathecal injections of the contrast and anaesthetic at L3/L4 were wrongful solely because Respondent failed to use the information obtainable from these injections to discover that the catheter tip was in the subarachnoid space. In other words, Respondent would not have committed medical malpractice (or a wrong-site procedure or wrong procedure) if he had injected intrathecally contrast and an anaesthetic as part of what is intended to be epidural injections, as long as he learned from these injections that the catheter tip was in the subarachnoid space and moved the tip into the epidural space or terminated the procedure: the epidural injection of these injectates performs both a therapeutic and diagnostic function. For Count II, Petitioner failed to prove that, in 2012, Respondent was required to obtain and retain a permanent image of any lateral view of L3/L4 or any other location as part of the procedures after the epidurogram or that Respondent's failure to realize that the catheter tip was in the subarachnoid space violated his recordkeeping obligation. The latter point finds no support in the record. As for the images, Dr. Cordner's testimony on this "requirement" of medical recordkeeping was vague, conditional, and never tethered to the requirements in effect in 2012. Although his practice is different, Dr. Schlifka does not keep permanent views from his epidural steroid injections by needles. Petitioner itself seems to have missed the point that a permanent image of an AP view helped prove that the catheter tip was in the subarachnoid space at L3/L4. It is one thing to hold Respondent responsible for failing to interpret a real time AP view of L3/L4 and failing to obtain a real time lateral view of L3/L4, as discussed in connection with Count I, but it is another thing to hold Respondent responsible for failing to maintain permanent images of any views for the procedures following the epidurogram. Among myriad shortcomings in Petitioner's case for Count II is the failure to address whether, for reasons of cost or radiation exposure, a physician in 2012 could still perform a blind ESI and, if so, the ramifications of more elaborate and expensive recordkeeping requirements imposed on the physician who performed image-guided ESIs--or otherwise would do so, but for this expensive recordkeeping requirement. For Count III, Petitioner proved that Respondent performed a wrong procedure or a wrong-site procedure by injecting "injectate," but not contrast, into the intrathecal space when he intended to inject injectates into the epidural space. As noted above, an inadvertent intrathecal administration is not evidence of carelessness, and the timely detection of such a mishap--before the intrathecal injections of a steroid or hypertonic saline--may involve interpreting the dispersal of contrast or the effect of the anaesthetic and determining that either or both injectates have been accidentally injected into the subarachnoid space. For this reason, the inadvertent intrathecal injections of contrast or anaesthetic into the subarachnoid space is not a wrong procedure or wrong-site procedure because of the secondary diagnostic value of this otherwise-therapeutic procedure. The wrong procedure or wrong-site procedure occurred when Respondent then injected the steroid and hypertonic saline into the subarachnoid space at L3/L4; the intrathecal injections of these injectates lacked any diagnostic purpose and were thus wrong procedures or wrong-site procedures. In its proposed recommended order, Petitioner has proposed a reprimand, probation for two years, and a $30,000 fine. Despite the passage of seven years from the September 28 procedures and the transmittal of the file to DOAH, Petitioner failed to identify important features of this complicated case. Although not charged with these matters, Respondent was guilty of serious failures to obtain informed consent for the use of injectate that caused M.S.'s catastrophic injuries--hypertonic saline--and to keep medical records documenting his plans for an ESI or an ESI with hypertonic saline and the locations and dosages of each injectate during the procedures, as well as analysis of the efficacy of each set of procedures. These aggravating factors necessitate the imposition of a suspension. On the other hand, past discipline is not an aggravating factor. By final order entered April 20, 2006, the Board of Medicine fined Respondent for a failure to keep adequate medical records 20 years ago, but the failure was in performing adequate physical examinations, which is not an issue here. Given the age and nature of the offense, past discipline is irrelevant in this case.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order finding Respondent not guilty of the alleged violation of section 458.331(1)(n) in Count II, but guilty of the alleged violations of sections 458.331(1)(t)1. and 456.072(1)(bb) in Counts I and III, respectively, and imposing a reprimand, six months' suspension, two years' probation following the end of the suspension, and a fine of $20,000. DONE AND ENTERED this 18th day of November, 2020, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 18th day of November, 2020. COPIES FURNISHED: Sharon Bidka Urbanek, Esquire Forman Law Offices, P.A. 238 Northeast 1st Avenue Delray Beach, Florida 33444-3715 (eServed) Michael J. Williams, Esquire Geoffrey M. Christian, Esquire Department of Health Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3565 (eServed) Louise St. Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3565 (eServed) Claudia Kemp, J.D., Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 (eServed)
The Issue The ultimate issue is whether the application of Venice Hospital for a CON should be approved. The factual issue is whether Venice Hospital meets the criteria set forth in the statute and rules.
Findings Of Fact The Department hereby adopts and incorporates by reference the findings of fact set forth in the Recommended Order.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law the Hearing Officer would recommend that this CON be granted with appropriate conditions relating to the maintenance of staff and the level of training of the staff which must be met and maintained in order for Petitioner to continue the operation of the laboratory. DONE and RECOMMENDED this 26th day of October, 1984 in Tallahassee, Florida. STEPHEN F. DEAN, 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 26th day of October, 1984. COPIES FURNISHED: Kenneth F. Hoffman, Esquire David Watkins, Esquire 646 Lewis State Bank Building Tallahassee, Florida 32301 Douglas Mannheimer, Esquire 137 North Calhoun Street Tallahassee, Florida 32302 Robert A. Weiss, Esquire The Perkins House 118 North Gadsden Street Tallahassee, Florida 32301 and Lamar Matthews, Esquire 1550 Ringling Boulevard Sarasota, Florida 33578 Courtesy Copy to: William B. Wiley, Esquire 666 Lewis State Bank Building Tallahassee, Florida 32301 =================================================================
The Issue Should Respondent be disciplined for practicing beyond the scope of his license or by accepting and performing professional responsibilities which he knows or has reason to know that he is not competent to perform? See Section 460.413(1)(t), Florida Statutes, formerly Section 460.413(1)(u), Florida Statutes.
Findings Of Fact Petitioner is charged with regulating the practice of chiropractic pursuant to Sections 20.165, 20.42, Florida Statutes and Chapters 455 and 460, Florida Statutes. Respondent is a Florida licensed chiropratic physician. His license number is No. CH-0001538. He was issued that license on September 21, 1968. Respondent practices chiropratic at the McCall Chiropractic Clinic located at 811 Grace Avenue in Panama City, Florida. Respondent is not licensed as an osteopathic or allopathic physician as recognized by the Florida Board of Osteopathic Physicians or the Board of Medicine respectively. In 1992 Respondent sent Micheal Smith, D.C., a chiropractic physician practicing in Panama City, Florida, information described as an invitation for Dr. Smith to join Respondent in clinical research "designed to test the effectiveness of Scalar E.M. Technology upon AIDS-CANCER opportunistic organisms falling within the meaning of chapter 460.403(3)(a)(b)(c)(e), and Rule 21D-1702, Florida Statutes." The correspondence went on to describe some details about the research. In particular, Respondent stated that "preliminary field data suggest that Scalar E.M. TENS Technology is effective in 47 pathological conditions including AIDS-Cancer disease." The correspondence also set forth information concerning patients who wished to contribute to the research by making financial contributions to the "Allaganey Occupational Development Foundation, 22 Floor Pacific First Center, 1425th Avenue, Seattle, Washington 98101-2333". Respondent provided Dr. Smith a sheet on the McCall Chiropractic Clinic letterhead related to purported medical research at Stanford University in 1988 studying "the Biological Interactions with the Scalar Energy Cellular Mechanisms of Action" in response to weak ELF ectromagnetic (EM) radiation and the claimed results. That sheet describes how the McCall Chiropractic Clinic would be "conducting private research into the effectiveness of Scalar E.M. Technology upon the following conditions, for a two-year period of time." Arthritis Arm Pains Angina Pectoras Arethemia Asthma Allergies Bacterial Infection of the Lung Carple Tunnel Syndrome Cancer of the: Bone, Brain, Bladder, Bowell, Lungs, Liver, AIDS Colon Polyps Cholitis Candidia Albicans Deafness Diabetes Neuropathy Emphysemia Eckcemia Ear Infection Epstine Barr Infection Exothalmic Goider Feavers Fungus of the skin Fibrosis of the Lung Gout High Blood Pressure Herniated disc Herpes B infection Hemrroids Hardening of the arteries Herpes of the Genitals Hypertrophy of the Prostate Inflimation of the joints Nectniuria Kendidia Albicans Leg Pains Multipleschlerosis Musculardistrohy Neuropathy Nose bleads Premenstral Syndrome Paracititis of digestive track Phlebitis Sinus Infection Tumors of the Eye Varicose Veines Warts Leupus Erethematosis Parkinsons Disease Dr. Smith was also provided with a copy of an advertisement which stated: ATTENTION: Aids - Cancer Patients Dr. Curtis J. McCall, Jr. Chiropractor Research program utilizing scalar tens antineoplastic technology is available through the provisions of Chapter 460.403(3)(a)(b)(c)(e) Rule 21D-1702 Florida Statutes. Patients suffering with Aids - Cancer disease who would like to participate in the research program should call 769-1708 for an appointment or come by the office: 811 Grace Ave., P.C., Fla. 32401 In the 1993 yellow pages for the Panama City, Florida, telephone book, Respondent placed an advertisement to this effect: MCCALL CHIROPRACTIC CLINIC PEOPLE HAVE TRUSTED THE HANDS OF DR. McCALL SINCE 1968 -- TENS AIDS -- CANCER THERAPY -- 811 Grace Av Panama Cy 769-1708 In the July 8, 1993 advertising service in the "Thrifty Nickel" circulated in Panama City, Florida, Respondent placed the following advertisement: NOTICE: The McCall Chiropractic Clinic has on display a 1953 classified federal document that discloses successful treatment for cancer. Patient response indicates this technology is effective in the treatment of 47 conditions. This technology is available through the provisions or Chapter 460- 1403(3), (a), (b), (c), (e). Rule 210-1702 Florida Statutes. Phone 769-1708 for appointment, 811 Grace Avenue, Panama City, Florida 32401. F24 On July 19, 1993, Respondent, on stationary from McCall Chiropractic Clinic, wrote to TCRS, Inc., in Tallahassee, Florida, asking that company to place McCall Chiropractic Clinic on its list of AIDS/Cancer Therapeutic Center listings for national referrals. That correspondence gave a brief description of the service that Respondent intended to provide. It indicated that the therapy to be provided would cost the patient $18.00 per 20 minutes. Through Respondent's activities that have been described, Respondent directly held himself out to the public as having the ability to treat persons with AIDS. In furtherance of his intentions, Respondent developed a treatment protocol consisting of approximately 55 weeks of treatment to be monitored initially by Respondent at his chiropractic facility. That protocol required the patient to receive TENS therapy for two hours each day. The TENS device is designed to deliver transcutaneous electrical nerve stimulation. Its principal chiropractic use is for pain control. However, Respondent, in his intended care, contemplated that the device would stimulate "T-Cells" in combatting AIDS. In the protocol, Respondent also required monthly blood tests to monitor the patient's "T-Cell" counts. The protocol required the patient to be free from all other drugs, in particular, the AIDS treatment medication "AZT". Under the protocol, the patient was required to receive a weekly injection of a compound identified as "chondriana", in amounts determined by Respondent. Finally, the patient was to ingest a compound identified by Respondent as "life crystals". On or about February 4, 1994, Respondent began to care for the patient C.L. That care ended on September 29, 1994. In this arrangement Respondent and C.L. had a chiropractic physician-patient relationship. Patient C.L. died on August 18, 1995. Respondent made a diagnosis, proposed a course of treatment and directly treated C.L. for AIDS. In this treatment Respondent maintained a patient record for C.L. In an effort to secure reimbursement for the services provided to C.L., Respondent prepared insurance claim forms, affixing a diagnosis of AIDS to the claim forms and had C.L. assign benefits to the Respondent from the insurance policy. In this connection Respondent had C.L. execute a sworn statement describing the services received from Respondent. It was Respondent's expectation that the claim forms would be honored by the insurance carrier and that Respondent would be paid for the services rendered to C.L. With one exception, Respondent's billings to the insurance carrier for C.L.'s visits to Respondent's office were all for the treatment of AIDS. An investigation was instituted by the State of Florida, Department of Business and Professional Regulation/ Agency for Health Care Administration to ascertain whether Respondent was offering patient treatment for AIDS. James Cooksey, an investigator with the regulator, performed that investigation in conjunction with Tom Willoughby, investigator for the Bay County, Florida, Sheriff's Office. James Cooksey is an insurance fraud/medical malpractice investigator. To conduct the investigation Mr. Cooksey assumed the fictitious name James Stark. The reason for assuming the name was to present James Stark as a patient suffering from AIDS. In furtherance of the investigation Mr. Cooksey went to the Tallahassee Memorial Regional Medical Center and obtained a fictitious positive AIDS test in the name James Stark. On May 16, 1994, Mr. Cooksey initiated contact with Respondent. The investigator traveled from Tallahassee to Panama City. When he reached Panama City he called Respondent and told Respondent that he needed to come and talk to him. Respondent invited Mr. Cooksey to come by that afternoon. On May 16, 1994, Mr. Cooksey met with Respondent at Respondent's office. At that meeting Mr. Cooksey told Respondent that the investigator understood that Respondent could possibly cure AIDS. Mr. Cooksey further stated that he had seen something in a newspaper article that Respondent was treating AIDS patients and explained to Respondent that Mr. Cooksey had contracted AIDS and was interested in being cured. Mr. Cooksey provided Respondent with the results of the fictitious blood test. When Mr. Cooksey presented to Respondent he did not complain of any condition other than AIDS. Respondent did not physically examine Mr. Cooksey. Respondent explained to Mr. Cooksey about the nature of Respondent's treatment in which the TENS unit, also known as a Rife machine, chondriana and life crystals would be used. To demonstrate the treatment Respondent took Mr. Cooksey into a room in the back of his office, a treatment room, and had Mr. Cooksey take his shoes and socks off and place his feet on a metal pad associated with the TENS unit. When the unit as turned on Mr. Cooksey could feel tingling inside his feet. On this occasion Respondent told Mr. Cooksey that, he, Mr. Cooksey could get injections of chondriana and then the machine would be turned on and Cooksey would receive stimulation to fight the infection associated with AIDS. Respondent told Mr. Cooksey that the initial treatments for AIDS would have to be done at his office where Respondent would monitor the investigator. Respondent indicated that a nurse would come to the office and give the injections of chondriana and that Mr. Cooksey would be monitored concerning those injections until Mr. Cooksey's "system built up a little". Mr. Cooksey understood that he was to receive those injections and use the TENS unit and was not to take other forms of medication during the treatment. Respondent gave Mr. Cooksey a card with the name of a blood test that would need to be obtained and the results reported to Respondent. Mr. Cooksey was responsible for paying for the blood test. Respondent told Mr. Cooksey that the life crystals were to be taken in orally as a drink and they were described as being part of the AIDS treatment. On this date Respondent gave the investigator an estimate of the costs of this treatment, constituted of $2,000 for the TENS unit and $2,925 for chondriana and life crystals. Subsequent to that date Respondent called Mr. Cooksey and left a message on Cooksey's telephone. Respondent also wrote the investigator on May 23, 1994, providing the investigator more information concerning Respondent's treatment for AIDS. The investigator then went to the state attorney's office in Panama City and informed the state attorney of the nature of the administrative investigation and the belief that the activities by Respondent might constitute a criminal law violation. The state attorney represented to the investigator that he concurred. The state attorney then had Mr. Cooksey contact the Bay County Sheriff's office. Following that contact Mr. Cooksey took up a joint investigation between Mr. Cooksey and Bay County Sheriff's investigator Tom Willoughby. On October 18, 1994, Mr. Cooksey placed a call to Respondent and told the Respondent that he was in Panama City and would like to come by and meet with the Respondent and that he would be accompanied by a friend who might be able to "come up" with the money that was required to purchase the chondriana and life crystals and TENS unit. The part of the friend was to be played by Officer Willoughby. Mr. Cooksey and Officer Willoughby then went to Respondent's office where Respondent again explained the nature of the AIDS treatment. Officer Willoughby asked the Respondent questions concerning the nature of the treatment and how much the treatment would cost. Respondent explained that the treatment involved injections of the chondriana, drinking the life crystals and using the TENS machine for two hours a day to treat James Stark for AIDS. At the October 18, 1994 meeting between the investigators and Respondent, Respondent stated that a nurse practitioner with whom he was friends would administer the chondriana and that activity would be monitored by Respondent in Respondent's office. Officer Willoughby asked Respondent if there would be side affects to the injections. Respondent indicated that there would be sweating and that Respondent would monitor Mr. Cooksey for whatever period of time would be necessary for the side affects to subside. The investigators watched a video tape explaining the treatment for AIDS which Respondent intended to employ. The injections of chondriana would be given monthly. Respondent indicated to the investigators that he would instruct Mr. Cooksey on how many of the life crystals to take. Respondent told the investigators that the cost of the TENS unit was $2,000.00 and that the unit would be used to spread the impulses through out the body. Respondent indicated to the investigators that the nature of the treatment would form new T-cells to replace T-cells containing the AIDS virus or which were cancerous. Respondent had stated in Officer Willoughby's presence that the TENS unit cost $500.00 to produce. Respondent and the two investigators then went to a local health food store, known as the Olive Leaf, to ascertain the amount of money needed to pay for chondriana which the health food store would provide. There, the attendant at the store indicated that he could arrange to provide the chondriana and life crystals for a price approximating $2,800.00. After leaving the health food store the investigators told the Respondent that they would come back with the necessary money on October 21, 1994. The investigators returned to Respondent's office on October 21, 1994, after obtaining warrants to search the office and arrest the Respondent. Before Respondent was arrested and the search made, the investigators asked Respondent to again explain the nature of the treatment that would be provided to Mr. Cooksey and paid Respondent $1,700.00 for the TENS unit from funds belonging to the Bay County Sheriff's Office. Respondent gave the investigators a receipt for the $1,700.00 payment. Respondent was then arrested for practicing medicine without a license. On one occasion Respondent explained to the investigators that the procedures that were used to treat Mr. Cooksey for AIDS were not condoned by the FDA, but that it was working in other places where it had been tried and that three patients treated in another location had gained remission from the AIDS. Based on the proof, it is found that Respondent diagnosed Mr. Cooksey as having AIDS and developed a course of treatment for that condition. Paul Doering, M.S., is a registered pharmacist in the State of Florida. He is also licensed as a consultant pharmacist in the State of Florida. He is a Distinguished Service Professor of Pharmacy Practice at the University of Florida. He is accepted as an expert pharmacist. Mr. Doering established that the drug AZT is an antiviral drug designed to address the HIV virus associated with AIDS. Mr. Doering established that AIDS is an acronym for acquired immuno- deficiency syndrome, "a disease that affects the immune system caused by a virus or different types of viruses which attack the immune system in the body rendering the body unable to effectively mount an immune response when it comes into contact with certain types of infectious organisms." Mr. Doering established that drugs are divided into two basic groups, one group which is sold without prescription and the other group requiring a doctor's prescription. The latter category of drugs are known as Federal Legend Drugs. Mr. Doering established that there is no reference to a medication known as "chondriana" in any directory of medications which he was familiar with. As he established, chondriana does not constitute a food because foods are not generally injected into the human body. Mr. Doering established that chondriana has not been approved to be used as a drug in the United States, nor is it an experimental drug, based upon his research of sources that list drugs or experimental drugs. Marianne Gengenbach, D.C., is licensed to practice chiropractic in Florida and is an expert in chiropractic practice. She established that chiropractors are limited to using proprietary drugs, and then only where the chiropractor has passed a specific exam and obtains a proprietary drug license. Proprietary drugs are "over the counter drugs" not prescription drugs. Absent such as a license to prescribe proprietary drugs chiropractors may only make recommendations, educate patients and prescribe nutritional supplements. Dr. Gengenbach established that Respondent had diagnosed C.L. for AIDS and had treated C.L. for that condition. The treatment was directly related to the condition AIDS, and Dr. Gengenbach established that the treatment was outside the accepted standard of care for chiropractic and exceeded the scope of authorized practice from the view point of a practitioner. As Dr. Gengenbach established, Respondent also exceeded the proper scope of practice in caring for C.L. by recommending that C.L. discontinue the AZT therapy. Those same perceptions were held for treatment of Mr. Cooksey and are accepted. Dr. Gengenbach established that Respondent proposed a course of treatment for Mr. Cooksey related to the condition AIDS, without reference to any other complaints by the patient. As a consequence the course of treatment which Respondent planned for Mr. Cooksey was directed solely to the HIV infection as established by Dr. Gengenbach. Dr. Gengenbach established that the use of the chondriana and life crystals was intended to treat Mr. Cooksey for AIDS. Dr. Gengenbach established that even should the substances chondriana and life crystals be considered food or nutritional supplements, there proposed use for Mr. Cooksey would not meet the prevailing standard of care for chiropractic, in that they would be employed for the treatment of AIDS. Respondent intended that the chondriana and life crystals be used in the cure, treatment, therapy and prevention of AIDS in C.L. and Mr. Cooksey. Respondent intended that those substances affect the structure and function of the bodies of those patients. In proposing and carrying out the treatment that has been described directed to AIDS, Respondent did so mindful that chiropractic physicians in Florida are prohibited from directly treating the AIDS condition. Respondent's treatment of C.L. and proposed treatment of Mr. Cooksey violated the standards of practice acceptable to a reasonably prudent chiropractic physician under similar conditions and circumstances and exceeded the scope of his chiropractic license. In the past Respondent has been disciplined by the Board of Chiropractic on three separate occasions. Two of those cases involve the receipt of a reprimand and in the third case Respondent's license was suspended and he was required to pay an administrative fine. Respondent was also required to cease and desist the activities described in these facts based upon action taken by the Board of Medicine, which was persuaded that Respondent was engaging in the treatment of AIDS without benefit of a medical license.
Recommendation Based upon the facts found and the conclusions of law reached, given the severity of the offense and the danger posed to the public, it is, RECOMMENDED: That a final order be entered which revokes Respondent's license to practice chiropractic medicine in Florida. DONE and ENTERED this 21st day of November, 1995, in Tallahassee, Florida. CHARLES C. ADAMS, 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 21st day of November, 1995. APPENDIX CASE NO. 95-2881 The following discussion is given concerning the proposed findings of fact of the parties: Petitioner's Facts: Paragraphs 1 through 4 are subordinate to facts found. Paragraphs 5 and 6 constitute conclusions of law. Paragraphs 7 through 13 are subordinate to facts found. Paragraph 14 is not necessary to the resolution of the dispute. Paragraphs 15 through 35 are subordinate to facts found. Paragraphs 36 through 40 are conclusions of law. Paragraph 41 is subordinate to facts found. Paragraphs 42 and 43 are conclusions of law. Paragraphs 44 through 51 are subordinate to facts found. Respondent's Facts: Paragraphs 1 through 5 constitute legal argument as reported at pages 2 through 5. The proposed facts 1-3 found at pages 15 and 16, Paragraph 1 is contrary to facts found. Paragraph 2 is rejected as a discussion of activities of the Probable Cause Panel, not a proper subject for consideration. Paragraph 3 constitutes a conclusion of law. COPIES FURNISHED: Jon M. Pellett, Esquire Medical Quality Assurance-Allied Health Agency For Health Care Administration 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 Curtis J. McCall, D.C. 514 North Bonita Avenue Panama City, FL 32401 Diane Orcutt, Executive Director Agency For Health Care Administration Board of Chiropractors 1940 North Monroe Street Tallahassee, FL 32399-0792 Jerome W. Hoffman, General Counsel Agency For Health Care Administration 2727 Mahan Drive Tallahassee, FL 32308
