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 issue for determination is whether the Petitioner is liable to the Agency for Health Care Administration ("Agency") for Medicaid reimbursement overpayments and related fines, costs, and interest.
Findings Of Fact The Agency is the single state agency charged with administration of the Medicaid program in Florida under Section 409.907, Florida Statutes. The Petitioner provides physician services to Medicaid beneficiaries pursuant to a contract with the Agency under provider number 037381800. The Agency sent the Petitioner a Preliminary Agency Audit report on June 30, 1998, notifying him of a preliminary determination of Medicaid overpayments in the total amount of $21,156.35. The Agency sent the Petitioner a Final Agency Audit Report on October 28, 1998, confirming the Agency's determination of Medicaid overpayments in the total amount of $21,156.35. The Agency's determination of overpayment was based upon findings that obstetrical echography services "were billed and paid in violation of Medicaid policy governing those services." The Agency performed an audit of the Petitioner for the period January 1, 1993, through October 31, 1996. According to the Agency audit report, the Petitioner's records contained violations of two billing policies outlined in the Medicaid Physician Provider Handbook. The first violation was that the Petitioner billed and received payment for more than one initial ultrasound procedure per pregnancy, and the second was that the Petitioner failed to submit documentation of medical necessity for additional procedures. During the years examined by the audit, Medicaid policy allowed providers to bill for more than one complete initial procedure per patient, so long as providers filed supporting documentation of medical necessity. However, the documentation submitted by the Petitioner indicated that the additional ultrasound procedures he conducted were mere follow-up procedures, instead of medically necessary complete procedures. According to the terms of the Medicaid Physician Provider Handbook, "[i]f more than two (or any combination of two) ultrasounds are performed during a pregnancy, they must be billed with modifier-22 and a report documenting the medical necessity for the procedure." The Petitioner submitted bills for more than two ultrasound treatments per recipient without explaining why the procedures were medically necessary. The Agency audit report established that the Petitioner has been overpaid as a result of the Petitioner's erroneous billings. The total overpayment to the Petitioner was calculated as "the difference between what he got paid for a complete procedure and the amount that he should have gotten paid for the follow-up." The Agency records received in evidence and the testimony of the Agency's witness establish that the amount overpaid to the Petitioner totaled $21,156.35. The Petitioner, as an authorized provider of Medicaid services, had signed a Medicaid Provider Agreement. That agreement states, among other things, that the "provider agrees to submit Medicaid claims in accordance with program policies." When the Petitioner became a certified Medicaid provider, he received a handbook outlining billing procedures for the performance of diagnostic ultrasounds. The Petitioner admitted that he knows "little about billing," that he "didn't involve [himself] in the billing at all," and that he has never read the Physicians' Current Procedural Terminology book, which sets forth the universally used billing codes.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Agency issue a final order requiring the Petitioner to reimburse the Agency for overpayments in the total amount of $21,156.35, plus such interest as may accrue as of the date on which payment is made. DONE AND ENTERED this 3rd day of January, 2001, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of January, 2001.
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 for consideration in this hearing is whether the Intervenor, St. Joseph Hospital of Port Charlotte, should be issued Certificate of Need #6202 for the establishment of a cardiac catheterization laboratory at its facility in Port Charlotte, Florida.
Findings Of Fact At all times pertinent to the issues herein, the Department was the state agency responsible for the regulation and certification of health care facilities in this state and charged with the responsibility of issuing Certificates of Need, (CON), under the criteria set forth in Section 381.705 Florida Statutes and the Department's Rules. St. Joseph Hospital is a 212 bed general acute care hospital located in Port Charlotte, Florida, within the jurisdiction of the Department's District VIII. It is a not for profit, tax exempt corporation owned by Bon Secours Health Systems, a multi-hospital system. It offers varied medical and surgical services, including obstetrics and pediatrics, and operates a 24 hour emergency room. The facility is accredited by the Joint Commission on Accreditation and Health care Organization, and its laboratory is accredited by the American College of Pathology. Because St. Joseph opened a nursing home in Port Charlotte in 1975, Chapel Manor Nursing Home, Fawcett's predecessor, and at that time, the only nursing home in Port Charlotte, applied for and was issued a CON to convert from a nursing home to an acute care hospital and began operation as Fawcett Memorial Hospital that year. Fawcett is now a 254 bed general medical surgical acute care hospital providing a broad range of services with the exception of obstetrics and pediatrics, and is located directly across the street from St. Joseph. It offers diagnostic cardiac catheterization service only, implementing that service in August, 1989. Both Fawcett and St. Joseph have the same service area and utilize the same physicians on their medical staffs, which are practically identical. St. Joseph offers a full array of cardiology services with the exception of cardiac catheterization. As a result, any St. Joseph patient requiring cardiac catheterization must be discharged from St. Joseph and transferred to another hospital in the area which provides that service. Between January 1989 and February, 1990, approximately 97 St. Joseph patients required transfer because of the fact that St. Joseph had no pertinent program. Because of this fact, and recognizing that the Department had determined there was a numeric need for an additional cardiac catheterization lab within the district, specifically based on the under-served indigent and Medicaid patients, in February, 1990, St. Joseph submitted a letter of intent to file a CON application for the establishment of an adult inpatient cardiac catheterization laboratory at its facility in District VIII. This letter of intent was based on proper Board Resolution, and was filed not only with the District but also with the local Health Council, and the required notice was published in a local paper. Thereafter, in March, 1990, St. Joseph filed its CON application for the facility, along with the appropriate fee, with the Department, at the same time filing a copy with the local Health Council. The Department responded with an omissions letter, the requirements of which were met by St. Joseph in a timely manner, and the Department thereafter deemed the application complete. Notwithstanding Fawcett's allegations in the post hearing submission that St. Joseph's application was not complete, there was no evidence presented at hearing to so establish, and the Department deemed it both timely and ultimately complete. On on about July 17, 1990, the Department issued its State Agency Action Report and notified St. Joseph of its decision to approve the application. Approximately one month later, in a timely fashion, Fawcett filed its Petition challenging the Department's approval of St. Joseph's application. St. Joseph projects implementation of service by the unit in December, 1992. The unit will encompass approximately 3,800 square feet and will be part of and companion to a larger construction project designed to expand St. Joseph's surgical capacity. It will be located in a proposed two-story addition to the south side of the existing hospital. Total cost of the project, including construction of the building and equipment, is estimated to be approximately $2.6 million, one hundred percent of which will be financed by debt. It is estimated that interest costs over the term of the financing will be an additional $2.25 million. St. Joseph anticipates the charge for a cardiac catheterization will be $6,657.48 in 1993, and $7,123.50 in 1994. This is the same as the average charge for the procedure by existing providers in the district, adjusted for inflation in later years. The facility will be open routinely from 7:00 AM to 2:30 PM, Monday through Friday. An on-call team will, however, be available 24 hours a day although cardiac catheterization, usually an elective procedure, should not require much in the way of emergency services. Dr. Victor Howard, a Board certified internist and cardiologist, who is already on staff at St. Joseph, is projected to be the medical program director for the new facility without additional compensation. Cardiac catheterization is a relatively new diagnostic and therapeutic invasive procedure which involves the insertion of an extremely fine hollow tube through a blood vessel in the groin, up into the patient's heart. Because the patient faces danger from collateral problems such as bleeding, stroke, congestive heart failure and medication reactions, at least three staff members are required to assist the physician performing the catheterization. As with most procedures, the more it is done, the more proficient the individuals doing it become. By the same token, the medical staff assistants to the physician in charge must have specialized skills and training, and the Department rules require that in order to properly provide for therapeutic catheterization patients, an open heart surgery facility must be available within thirty minutes of the facility where the catheterization is being carried out. St. Joseph intends to rely on Medical Center Hospital in Punta Gorda, approximately ten miles away, as the required backup open heart facility. Medical Center is within the maximum thirty minute drive time criteria. It provides not only an open heart surgery program but also both diagnostic and therapeutic cardiac catheterizations. Diagnostic catheterizations, as opposed to therapeutic catheterizations, can be done on an outpatient basis. Experience has indicated that staff assistant technicians, nurses and others, are frequently not reasonably available. As a result, there is continuing competition between hospitals providing the services requiring these individuals, and this competition is often severe. Nonetheless, Fawcett has, up to the present, been able to recruit and retain adequate numbers of experienced personnel without the necessity for paying a bonus over and above normal salary. By the same token, St. Joseph believes it, too, will be able to attract and retain sufficient numbers of qualified personnel to successfully operate its laboratory as approved. At the present time, St. Joseph has ten registered nurses on staff who have cardiac catheterization laboratory experience. The laboratory, if approved, will not open at St. Joseph until the second half of 1992. At that time, manpower requirements for the project call for 3.36 full time employees, (FTE's), and that number appears capable of being satisfied by the current staff, though a cardiovascular technician, (CVT), has not yet been hired for the lab. In addition, St. Joseph appears to have on hand adequate management and supervisory personnel. It projects salary and benefits expense of almost $140,000.00 in 1993 and almost $150,000.00 in 1994. Maintenance expense is expected to approximately $65,000.00 the second year of operation. The proposed project has been enthusiastically received by the medical community in the service area. Because, in that area, the treating physician determines where the patient will be treated, support for the project by the area cardiologists is important as a positive factor for consideration. Because it has both the financial and personnel resources to provide the service, access to the service will be improved for the medically indigent and the facility's current cardiology program will be enhanced. The Florida legislature has, by its passage of Section 381.705, Florida Statutes, laid the basic analytical framework to be used in determining whether the facility here in question is needed. Consistent with the terms of the enabling statute, the Department has promulgated Rule 10-5.011, F.A.C., to implement the provisions of the statute. The rule formula provides a showing of "need" if at least 300 procedures could be performed by the new program, based on the total number of catheterizations, diagnostic and therapeutic, projected for the District. Projections for Charlotte County alone indicate 180 additional catheterizations between 1989 and 1994. Consistent therewith, the Department has determined that within DHRS District VIII, the pertinent service district, there is a numeric need for one additional cardiac catheterization laboratory. Need, however, goes beyond the question of numeric need. It is also a factual issue that requires an analysis of health planning principles and standards used within the ultimate goal of providing the best quality medical care for the citizens of this state in a sound, economically justified manner. In that regard, it is appropriate to evaluate need with an eye that looks toward avoiding unnecessary and costly duplication of services that are unnecessary. Fawcett contends there is no need for an additional lab in District VIII, based on the underutilization of existing programs. The Department's rule, the use of which resulted in a determination of need for one additional unit, does not regulate capacity. District VIII consists of Sarasota, DeSoto, Glades, Hendry, Charlotte, Lee, and Collier Counties. Sarasota and Lee Counties each have three cardiac catheterization programs while Collier has one in its only hospital. Charlotte County has two, Fawcett and Medical Center. It has already been noted that Fawcett and St. Joseph are located across the street from one another. Medical Center, which is used for therapeutic catheterizations, is located not far from the other two, and all three are Medicaid providers. All three also serve generally the same service area and use, essentially, the same medical staff. Moreover, the three facilities' cardiology staffs are essentially identical. When evaluating the service availability, however, it must be noted that Charlotte County experienced the highest relative increase in population among all the District VIII counties during the decade of the 1980's, and projections are that it will continue to lead up through 1995. At the present time, Charlotte County has the highest percentage of residents over age 65, (34%), of any of the District VIII counties. Looking at the proposed service in light of the pertinent State Health Plan, that for 1989, four preferences should be considered when evaluating the need for the proposed service. One deals with giving preference to those who propose to establish both cardiac catheterization and open heart surgical services. Since there is no established need for an open heart surgery service in the District, St. Joseph could not and does not plan to provide for one. Consequently, this preference is not pertinent here. The second preference is for those applicants who propose to establish a cardiac catheterization program in a county without any existing program. Again, this is not pertinent to the current situation. The third preference is toward applicants with a history of providing a disproportionate share of Medicaid and charity care. Here, St. Joseph is not a disproportionate Medicaid share provider, a point made by Fawcett. By the same token, however, neither is Fawcett. Fawcett did not, over the years, keep an accurate record of the number of patients to whom it provided free medical services, or of the value of those services. It claims it did not realize the importance of those numbers, concerning itself more with the provision of the service rather than with the recording of it. It was not, for most of its existence, however, a Medicaid provider, applying for and gaining that certification as of September l, 1989. Yet, during those non-certified, unrecorded years, it claims to have provided care to patients regardless of their ability to pay. While this claim is accepted as true, it is impossible to quantify it. The fourth preference is given to applicants who agree to provide services to all patients regardless of ability to pay. St. Joseph has agreed to do so and has a history of providing care to the medically indigent. So does Fawcett, but Fawcett is not an applicant, so the preference issue does not, necessarily, apply. It is clear, however, that neither the existing providers nor the applicant are precluded or disqualified as a result of the application of these preferences. Turning to the local, (District) Health Plan, which is also to be considered in the evaluation of the projects, the 1989 update of the District VIII Plan, that pertinent here, also provides for applicants to be evaluated in light of several preferences. One calls for an applicant to provide certain services, all of which are provided currently by St. Joseph. The second preference calls for the laboratory to be open no less than 40 hours a week and to provide a maximum waiting time of one month for simple, elective cases. The evidence presented indicates that the currently operating facilities meet this criteria, but also that St. Joseph will likely do the same if approved. Another preference relates to the proposed program's impact on existing providers in the area. It is here that the parties disagree radically on whether or not such an impact exists. St. Joseph has taken the position that its program will have only minimal impact on the ability of Fawcett and other existing providers to continue to provide quality economic service. On the other hand, Fawcett projects a major negative impact on its services, and claims the Department apparently failed to consider, at the time it did its initial evaluation, whether or not St. Joseph's program would adversely impact on it's existing service. Fawcett contends that its presently improving financial posture will be definitely impacted adversely by St. Joseph's implementation of the new service, if approved, in that its anticipated positive financial improvement will be reduced, if not destroyed, by the opening of St. Joseph's proposed program. Evidence produced by Fawcett tends to indicate that by 1994, if current projections hold true, Charlotte County will experience an increase of only 180 diagnostic catheterizations per year. St. Joseph's projections indicate that in that timeframe it expects to perform 509 diagnostic catheterizations per year. Simple arithmetic, then, would reveal that if those figures are correct, 329 of the 509 projected diagnostic procedures would have to come from the number of procedures performed by both Fawcett and Medical Center. Since approximately 75% of the current cardiac catheterizations performed in Charlotte County are performed at Fawcett, by far the greatest impact would be on that institution. The figures projected indicate a loss by Fawcett, then, of 232 procedures in 1993 and 318 in 1994. Medical Center's projected losses would be somewhat less, but nonetheless, such a reduction, if realized, would result in a loss of revenue to each of the existing providers from current income levels. Fawcett experienced severe financial problems during the past several years prior to the incumbency of the present CEO. In 1987 and 1988, it had financial losses which were improved in 1989 to a result showing a marginal excess of revenue over expenses. For 1990, Fawcett expects to show a profit for the first time in several years. Its prior negative operating result, however, has had a negative impact on its debt to equity ratio which, itself, is significant in that it is used by lenders as an index or flag regarding the financial health of an institution which seeks to borrow money. Because of its poor financial condition in the past, Fawcett was unable recently to borrow money needed for 1990 capital projects, and it is the increasing profit margin, which Fawcett hopes will make it more competitive in the borrowing market, that is most threatened by the proposed initiation of St. Joseph's project. The improved financial picture which Fawcett experienced in the most recent financial years has been directly attributed to the revenue earned by its cardiac catheterization program. In 1989, Fawcett determined that each cardiac catheterization patient contributed $1,927.00 to the hospital's financial health, and Fawcett contends that each patient taken from it by the opening of St. Joseph's proposed program will result in a financial loss to it. Utilizing the 1989 contribution margin projected to 1993 and 1994 reflects that if St. Joseph's program is approved, and if the anticipated numerical patient load is lost, the net financial loss to Fawcett would be in excess of $446,000.00 in 1993 and in excess of $612,000.00 in 1994. If these figures are inflated to 1993 and 1994 dollars, the loss could well be greater. Fawcett contends that it is currently experiencing a healthy improvement in its financial position which it anticipates would be substantially and adversely affected by the loss of cardiac catheterization patients to St. Joseph if that facility's project were approved as proposed. No doubt there would be a negative impact, but the degree thereof is speculative. Both the statute and the rule mentioned previously set forth criteria for the evaluation of these projects. One is the existence of an alternative to the service provided. Whereas St. Joseph contends there is no alternative diagnostic procedure preferable to cardiac catheterization, Fawcett contends there are several alternatives to St. Joseph's proposed project. Nonetheless, prior to its application, St. Joseph considered some alternatives. One was the setting up of a mobile laboratory on an interim basis. Since this could be used only by outpatients, it was determined not to meet the need of those patients requiring an inpatient procedure or of the physicians who would perform in it, and the anticipated $1.3 million cost was considered excessive for a short term fix. It is so found. Another was the possibility of establishing the lab somewhere within the hospital's existing space, but a survey of the facility quickly revealed there is no available existing space. However, since a part of the service proposed by St. Joseph would include outpatient catheterization, this part of the need could be met by the laboratory established in Charlotte County by several cardiologists who practice on the staff of St. Joseph, and who recently established a facility in the county. By the same token, if a need for outpatient procedures is demonstrated, the existing inpatient program could, Fawcett contends, provide it. Finally, is the existence of under-utilized programs at Fawcett and the Medical Center which have existing excess capability which could be considered an adequate and available alternate to the St. Joseph program. Turning to the question of financial feasibility, another evaluation criteria, there is no doubt that St. Joseph has the ability to borrow the capital to make the project financially feasible in the immediate future. St. Joseph's financial condition is sound. As might be expected, there is substantial difference in opinion as to the reasonableness of the pro forma projections submitted by St. Joseph's as evaluated by the Department. In fact, the parties agree to very little. St. Joseph contends that the patient mix estimated in the application is reasonable and based on its experience and that of Lee Memorial Hospital, and that the staffing level is appropriate and reasonable, and there is little to contest. The major difference in positions is in the area of supply costs and the percentage of patients accounted for by Medicare. St. Joseph estimated a supply cost of $248.00 per admission in 1989 dollars, inflated by 7% per year up to 1993 and 1994, but Fawcett contends the actual supply cost in 1989 dollars is $492.00 per admission. Assuming, arguendo, that Fawcett is correct, the projected supply costs would then be increased by in excess of $85,000.00 in 1993 and almost $126,000.00 in 1994, and this would result in a reduction of projected income for the service in both years. Fawcett's evidence and argument here are not persuasive, however. Fawcett also contends that St. Joseph's assumption that 58.9% of the cardiac catheterization patients would be Medicare, a figure which assumes that the Medicare patient utilization for catheterization would be the same as the facility as a whole, is not reasonable. Fawcett relies on the fact that St. Joseph is the sole obstetrics provider in Charlotte County and the majority of these obstetric patients are not Medicare patients. Considering that along with the fact that cardiac catheterization is a service which has a higher level of Medicaid utilization than St. Joseph presently provides, a more likely and reasonable predictor of the Medicare utilization of St. Joseph's program would be the Medicare utilization for the two existing catheterization programs. Fawcett's utilization in that regard is 64.6% and Medical Center's is 70.5%. Extrapolating from those figures, Fawcett contends a reasonable financial projection for St. Joseph's program would be 65% Medicare utilization. Since that type of service is reimbursed on the basis of DRG, the amount of income to the hospital is less, and the resultant contractual allowances, deductions from revenue, would be in excess of $61,000.00 in 1993 and more than $87,000.00 in 1994. Therefore, combining both the increase in projected supply costs and the decrease in projected income from Medicare, Fawcett contends that the projected number of catheterizations in 1994 and 1994, as modified using Fawcett's figures would result in a net reduction of approximately $210,000.00 in the former year and in excess of $126,000.00 in the latter. If those figures prove correct, St. Joseph's proposed program , it is suggested, would apparently not be feasible in the long term. On the other hand, St. Joseph contends its utilization figures for 1993 and 1994 are reasonable in that it projects a volume slightly greater than one-half of the number of procedures accomplished by Fawcett in its first year of operation. St. Joseph's expert evaluated the use projections for the first two complete years of operation and the costs assumptions and found both to be reasonable. Nonetheless, he also accomplished calculations of profitability utilizing Fawcett's suggested increased costs figures, and utilizing three different approaches, ultimately concluded that even looking at the worst case scenario, St. Joseph's proposal would be financially feasible both in the short and the long term. Independent analysis of the evidence leads to the conclusion that the projected staffing level and the salaries and benefits for that staff are reasonable. The anticipated reimbursements on the basis of the DRG's are reasonable. The projected utilization in the first and second years of operation are reasonable, and taken together, the evidence supports the conclusions drawn by St. Joseph's expert. It is so found. Another area for consideration is the impact St. Joseph's program would have on Fawcett's existing program. Fawcett's program has now been in operation for several years and even with approval of St. Joseph's, will continue to operate without competition until the second half of 1992, after which St. Joseph's program would be in a start-up configuration for at least a year. As such, it will be well into 1993 and possibly into 1994 before St. Joseph's program can be considered to have its full impact vis-a-vis the Fawcett program. Fawcett's expert, who concluded that St. Joseph's program would have a serious adverse effect on Fawcett's ability to contribute to its improving financial picture did not consider the fact that Fawcett does not currently perform outpatient cardiac catheterization procedures, and any of that nature done by St. Joseph should have no impact on Fawcett. The expert also did not consider in his analysis of impact any population growth beyond 1990 or growth in the demand for diagnostic catheterization procedures. Fawcett listed approximately $13.7 million in proposed capital expenses over the next five years which, it claims, will be adversely impacted by the effect of St. Joseph's proposed program on its cash picture. Many of the line items within this figure are much the same as normal routine replacement items, and only $3.5 million represent the cost of items specifically identified as needed to meet existing life safety code violations or for accreditation purposes. No doubt there will be some impact on Fawcett's operation by the opening of St. Joseph's program, yet Fawcett has not demonstrated clearly that the impact will result in a return to the pre-1990 negative cash position which was shown to now be reversing. Even accepting Fawcett's expert's assumptions, the likelihood is great that Fawcett's equity balance would increase by over $900,000.00 from 1992 to 1993 and by over $800,000.00 from 1993 to 1994. So long as Fawcett's cardiac catheterization program performs more than 182 procedures per year, its current break-even point, no negative impact to the hospital's overall financial picture is likely to occur. Assuming that Fawcett's procedures were no more than one-half its 1990 admissions, at current rates, its program would render a positive contribution of more than $650,000.00 to the hospital's financial picture. This figure could not be considered as other than a viable financial contribution. What is more, the implementation of the program at St. Joseph should not exert any upward pressure on the cost of other services rendered by St. Joseph, and should, by competition, moderate future price increases for this procedure at the two competing facilities. As regards Medicaid and indigent care, St. Joseph has been a Medicaid provider since 1965 and has a history of providing service to indigent patients and under-served groups. In fact, the value of care rendered without cost to patients by St. Joseph has climbed from $418,000.00 in 1988 to a projected $1.5 million in 1991. By the same token, its commitment to Medicaid has increased to almost 4% in 1990, in addition to approximately 2% of uncompensated care that same year. The obstetric unit has been shown to operate $500,000.00 a year in the red because of the volume of indigent care provided. Nonetheless, St. Joseph agrees to accept a condition to its CON requiring it to provide 1.5% Medicaid and 2% charity care. In comparison, Fawcett was not certified for Medicaid until late 1989 and its experience since that time has not been substantiated. This tends to underscore the Department's contention that Medicaid and charity patients are under-served within the Charlotte County area. Other criteria outlined within the statute have not been shown by evidence presented, as being significantly affected one way or the other by the implementation of St. Joseph's proposed program. Several of the statutory criteria are, in fact, not applicable to the proposed project in this case. Much the same can be said for the criteria outlined in Rule 10-5.011(1), F.A.C., which tend to overlap to a substantial degree with the statutory review criteria. Fawcett claims that the application filed with the Department by St. Joseph is "very incomplete" in that it omits significant information regarding project costs, capital expenses, source of funds, and a litany of other required information. It claims, therefore, that the Department could not have conducted any meaningful review of the application based upon the information provided. The Department's representative, Ms. Dudek, admits that most, if not all applications omit some information. That is the purpose of the omissions letter which is sent to an applicant after initial review. Not all information called for by the statute is deemed essential however. If an omission is considered immaterial, it will not cause the application to be denied, all other essential material being provided. There are primarily two criteria called for by the statute which are essential to Departmental approval. The first deals with the applicant's access to resources to develop and operate the project, and the second is that the applicant offer quality care. In this case, both were deemed to have been met as was stipulated to by Fawcett. In the instant case, the Department's representative concluded that St. Joseph's application was one of the most thorough and comprehensive, in terms of presentation and backup, to have been filed within the past few years.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be entered by the Department approving St. Joseph's application for an inpatient cardiac catheterization laboratory, (CON #6202) for District VIII. RECOMMENDED in Tallahassee, Florida this 4th day of April, 1991. ARNOLD H. POLLOCK, 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 4th day of April, 1991. APPENDIX TO RECOMMENDED ORDER CASE NO. 90-5815 The following constitutes my specific rulings pursuant to Sec 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. & 2. Accepted and incorporated herein. 3. & 4. Accepted. 5. & 6. Accepted. 7. - 10. Accepted and incorporated herein. 11. & 12. Accepted. 13. & 14. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Accepted. & 19. Accepted and incorporated herein. 20. & 21. Accepted and incorporated herein. 22. - 26. Accepted and incorporated herein. 27. - 34. Accepted. Rejected. - 39. Accepted. 40. - 42. Accepted and incorporated herein, except for the first sentence of Finding 41. Rejected. Accepted and incorporated herein. & 46. Accepted. Rejected. Rejected. - 51. Accepted and incorporated herein. Accepted. Accepted. Not proven. - 59. Accepted and incorporated herein. Accepted that the loss of revenue will have an impact but the loss has not been shown to be substantial. - 65. Accepted and incorporated herein. 66. & 67. Accepted. 68. - 76. Accepted incorporated herein in substance. Rejected that the loss of revenue would "cripple" the health trend. It would adversely affect it but not cripple it. - 83. Accepted and incorporated herein. 84. - 90. Accepted. Accepted. Accepted and incorporated herein. - 97. Accepted that there are alternatives, but rejected that they are acceptable or adequate. Rejected as too broad a statement. Rejected as to the conclusion of waste. & 101. Accepted. Ultimate conclusion rejected. Need for level of education and experience accepted. Accepted. Underlying fact accepted. Balance is editorialization. - 108. Accepted. Accepted. Not an appropriate Finding of Fact. Accepted. & 113. Accepted and incorporated herein. 114. - 116. Rejected. Accepted. & 119. Rejected. 120. & 121. Accepted and incorporated herein. Rejected. - 126. Accepted. 127. & 128. Accepted. 129. & 130. Rejected. 131. & 132. Accepted. 133. & 134. Rejected. Not a Finding of Fact but a comment of the state of the evidence. Accepted. & 138. Accepted. Accepted. Rejected. & 142. Accepted. Rejected. St. Joseph was a Hill-Burton hospital. Accepted. Accepted that St. Joseph receives funds from taxes and other sources, but the conclusions that aid to Medicaid an the indigent "is to be expected" is an unjustified conclusion. 146. Accepted. 147. Accepted but probative value questionable. 148. Accepted that it is less costly. 149. First two sentences accepted. Remainder not proven. 150. Rejected. 151. & 152. Accepted in the short term. 153. Accepted. 154. Not proven. 155. Rejected. 156. - 158. Rejected. 159. & 160. Accepted. FOR THE RESPONDENT AND INTERVENOR: 1. - 3. Accepted and incorporated herein. Accepted. - 8. Accepted and incorporated herein. Accepted. - 13. Accepted. 14. - 16. Accepted and incorporated herein. Accepted. & 19. Accepted and incorporated herein. 20. & 21. Accepted. 22. - 24. Accepted and incorporated herein. Accepted and incorporated herein. - 28. Accepted and incorporated herein. Accepted and Incorporated herein. - 35. Accepted and incorporated herein. 36. - 41. Accepted and incorporated herein. Accepted. - 45. Accepted and incorporated herein. 46. & 47. Accepted. 48. & 49. Accepted and incorporated herein. 50. & 51. Accepted. 52. - 54. Accepted and incorporated herein. 55. - 58. Accepted. 59. & 60. Accepted and incorporated herein. Accepted. Accepted. & 64. Not Findings of Fact but a comment on the state of the evidence. 65. & 66. Accepted and incorporated herein. Not a Finding of Fact but a statement of party position. Not a Finding of Fact but a comment on the evidence. & 70. Accepted and incorporated herein. 71. & 72. Accepted and incorporated herein. Accepted. Accepted. Not a Finding of Fact but a comment on the evidence. Accepted. - 80. Accepted and incorporated herein. Accepted but irrelevant to the issues here. Accepted but considered more a statement of party position and a comment on the evidence. & 84. Accepted and incorporated herein. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted and noted in the Conclusions of Law portion of the Recommended Order. - 100. More proper as Conclusions of Law than as Findings of Fact, but accepted where pertinent. COPIES FURNISHED: John D. C. Newton, II, Esquire Aurell, Radey, Hinkle & Thomas Suite 1000, Monroe-Park Tower P.O. Drawer 11307 Tallahassee, Florida 32302 Richard Patterson, Esquire DHRS 2727 Mahan Drive Tallahassee, Florida 32308 R. Terry Rigsby, Esquire Philip Blank, P.A. P.O. Box 11068 Tallahassee, Florida 32302 Linda K. Harris Acting General Counsel Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32399-0700 Sam Power Agency Clerk DHRS 1323 Winewood Blvd. Tallahassee, Florida 32399-0700
The Issue Whether the Respondent committed the acts alleged in the administrative complaint contrary to Section 458.331(1)(t), Florida Statutes.
Findings Of Fact (Stipulated) The Respondent is and was at all times material to the allegations a licensed physician in Florida, holding license number ME 0050839 issued by the state. The Respondent was a board certified internist and board certified cardiologist practicing with Diagnostic Cardiology Associates at St. Vincent's Medical Center (St. Vincent's) at the time of the events which gave rise to these allegations. On or about June 25, 1988, W.V., referred to in the complaint as Patient #1, was admitted to St. Augustine General Hospital in St. Augustine, Florida. W.V. was a 68 year old male with a history of heart problems including four bypasses performed in 1977, a pacemaker implantation in 1979, chronic obstructive pulmonary disease, and prior prostate surgery. W.V. was determined to have had an acute myocardial infarction for which he was treated at St. Augustine General Hospital for five days. As W.V.'s condition improved, he was encouraged to walk at St. Augustine where he complained of chest pain and weakness. A echocardiogram showed segmental wall motion disturbance involving the posterior wall of the heart. A second electrocardiogram was performed which showed ventricular pacemaker rhythm and ST-T wave changes. On this basis, given his history and myocardial infarction, he was referred for a cardiac catheterization to St. Vincent's where his earlier heart surgeries had been performed. The patient was monitored during his hospitalization in St. Augustine, and did not show any signs of arrhythmias. On June 30, 1988, W.V. was transferred to St. Vincent's and received through the Emergency Room, where he was interviewed by the Respondent. After giving the Respondent a brief outline of his problems, W.V. was placed on a general medical floor for the evening, and scheduled for cardiac catheterization the following day. Cardiac catheterization and its risks were explained to W.V., who signed the patient consent forms authorizing the procedure. On the morning of July 1, 1988, after examining the patient and finding no changes, the Respondent performed on W.V. a cardiac catheterization, which verified the recent acute myocardial infarction, the blockage of two of the bypasses, damage to the heart muscle serving the lungs, and high vascular resistance with severe pulmonary hypertension. The patient tolerated the procedure well and showed no signs of arrhythmias during or after the procedure. The test results indicated that he could not benefit from surgery or angioplasty. W.V.'s primary health threat was from congestive heart failure, a condition likened to drowning in one's own fluids. (Tx-129, line 1.) A patient suffering from congestive heart failure will call for assistance from the nursing staff, as one of the expert's phrased it, "he would have been crawling out the door on his hands and knees calling for the nurse." (See Dr. Gilmore, Tx-130, line 8.) Conversely, heart failure alone would not have caused the patient to have chest pains, unless the patient developed elevated pressures to the point where pulmonary hypotension caused chest pain. However, the chest pain in such a case is not caused by clogged arteries or an impending heart attack, but by build up of fluid in the lungs which causes the heart to work harder to pump the blood through the lungs. (Dr. Campbell, Tx- 107, line 16.) The Respondent's post-catheterization order initially directed that W.V. be moved to a monitored bed following the procedure. The purpose of monitoring a patient is to observe, document and ultimately treat cardiac rhythm disturbances. (Dr. Gilmore, Tx-117,line 6.) Approximately 75 percent of post- catheterization patients were placed on telemetric monitoring (monitoring or telemetry hereafter). Monitored beds existed on 3 East (eight monitored beds), 5 East (eight monitored beds), Coronary Care Unit (eight monitored beds), Intensive Care Unit (12 monitored beds), and open heart unit which, although monitored, would not take catheterization patients. Notwithstanding the number of monitored beds, the critical piece of equipment is the monitor because each room on a monitoring unit was set up to receive telemetry. The monitor is a small radio transmitter that relays information from leads attached to the patient to receivers in each room. The monitors are removed by patients upon discharge, thrown into the laundry, and into the trash. They also require repair. As a result, the actual number of monitors varied from the planned number of monitored beds. Upon completion of the catheterization, the catheterization nurse would advise the nurse in charge of placing patients that the cardiac catheterization patient was ready for admission to the hospital, and whether the doctor had ordered a monitored or unmonitored bed. If the doctor had ordered a monitored bed and one was not available, the placement nurse would ask the admitting physician whether the patient being admitted really needed monitoring given the critical number of monitored beds available and the necessity to poll the treating physicians of all the monitored patients to see if any could be taken off monitoring. Inferentially, the Respondent considered the status of his other patients who were being monitored. If the physician deemed the patient's need for monitoring critical, then the placement nurse would poll the physicians of all other monitored patients, and request that they reassess the needs of their patients on monitoring. (See Lipsky Deposition, Page 26) The unit which normally received post-catheterization patients, 5 East, had eight monitored beds and eight unmonitored beds which were used as "stepdown" beds for patients taken off monitoring so that the monitors could be changed, but the patient retained in the same bed. Not only were all the monitored beds occupied on 5 East, the post-catheterization unit, but that unit had almost a full census. (See Lipsky Deposition, Page 20 - Page 26) The hospital's procedures required cardiac catheterization patients to remain in the catheterization laboratory until a monitored bed was available if the doctor stated that the patient was to go to a monitored bed. The catheterization patient would be held in the catheterization laboratory where there was a shortage of nursing care until a bed was found. Contrary to the experts' testimony which presumed the authority of the Respondent to place the patient in a monitored bed, it was the placement nurse who placed the patient once the doctor ordered a monitored bed post-catheterization. No evidence was received regarding her authority to place patients requiring monitoring in the ICU or CICU. Typically, doctors reassessed their patients' need for monitoring during morning rounds, and those that were stable were removed from monitoring so the monitor became available for a more critical patient. (See Libsky deposition, Page 24, line 20) W.V. catheterization was completed at approximately 11:00 a.m., following morning rounds when a maximum number of monitors should have been available; however, no evidence was received when a monitor would have been available. Testimony revealed that the wait could be as long as two hours for a monitored bed. During that time, under hospital protocols, W.V. would have remained in the catheterization lab. Contrary to facts assumed by the Petitioner's experts, the Respondent's options for placing the patient were: to place the patient in an unmonitored bed on the cardiac floor, or to retain the patient in a monitored bed in the holding area where he would be monitored by the cardiac catheterization nurse until the patient placement nurse found a monitored bed. The Respondent did not retain the patient in the cardiac catheterization area because the nurses could not adequately monitor W.V. and perform their other duties. The Respondent did not place W.V. in the Cardiac Care Unit or the regular Intensive Care Unit to obtain monitoring because it was not his function to place the patient. The only way he could have placed W.V. in CICU or ICU would have been to change W.V.'s status to justify the overall intensive care of the patient. However, this would have been unsupportable if questioned given the patient's condition which was stable upon admission six days after the myocardial infarction, and remained stable after the procedure. See Dr. Edwards Depostion, Page 41, line 19 et seq. Staffing levels on 5 East at the time of W.V.'s hospitalization were one nurse to four or five patients. There were five nurses, a charge nurse, and nursing assistant, and 22 beds on the unit. (See Lipsky Deposition, Page 72, line 15.) The Hospital's Standing Order 01-009 provided that "The critical care nurse, in consultation with the charge nurse, may initiate the following (list of nursing interventions) and notify the physician as soon as possible in the event of an acute deterioration [of] patient status and in the absence of a physician." (See Burnsed Deposition, Page 112, line 4) The Hospital Standing Order 01-017 provided "Any changes in the patient's condition will be called to the attention of the attending physician and appropriate consulting physicians. The emergency standing orders may be initiated by the nursing staff, but the physician must be informed of their use." (See Burnsed Deposition, Page 113, line 10) The Respondent placed the patient on 5 East, the cardiac care floor, in an unmonitored bed at approximately 11:50 a.m., as indicated by the notation on the patient's chart "nonmonitored," which indicated a change from the initial orders. (See Cavin Deposition, Page 34, line 7 and Page 35, line 7 et seq.) There was no order that W.V. should not be resuscitated. The Respondent's standing orders called for the patient's vital signs, together with shortness of breath and chest pain, to be monitored every 15 minutes for four hours. This was done until 3:15 p.m., when the monitoring was reduced to every 30 minutes. The Respondent advised the cardiac catheterization nurse, Mary Cavin, who accompanied the patient to the floor, of his findings, to include evidence of a recent myocardial infarction, and the patient's response to the procedure. (See Cavin Deposition, Page 19-20) Ms. Cavin identified her handwriting on the charts describing the Respondent's findings. However, these notes do not mention the recent myocardial infarction. The referenced notes were not sufficiently identified to check in the patient's charts. W.V. was taken to 5 East by Mary Cavin. Ms. Cavin had worked in this area at St. Vincent's for three years. Cardiac catheterization nurses were described by one of the experts as being among the best trained nurses in the profession, who because they work with the medical staff continuously during the procedures, are aware of the physician's findings and the patient's status. They pass this information along to the floor nurses when they transport the patients back to the floor. Ms. Cavin did not remember specifically W.V., but testified in her deposition regarding her normal practice when delivering a patient. She advised the staff on 5 East how the patient did during the catheterization, and what the findings had been. However, as stated above, in Cavin's notes she did not mention the recent myocardial infarction, and it is unclear whether she mentioned this to the staff of 5 East. The record is unclear to whom Ms. Cavin reported W.V.'s condition; however, Ms. Burnsed received a report on W.V. when she came on duty from Carolyn Johnson, the nurse who had cared for W.V. on the preceding shift. Ms. Burnsed was advised by Ms. Johnson that W.V. was stable post-catheterization, that he had previous open heart surgery, and that one of his grafts was blocked, but "had good collateral circulation to that." Further, Johnson advised Burnsed that W.V.'s vital signs were good, and he had no problems. Johnson did not mention the recent myocardial infarction suffered by W.V. Although Ms. Burnsed could not specifically remember her actions, her general course of action was to do a complete assessment upon starting the shift, make sure her patients were all right and having no problems, and orient them about the call light and calling her. Her physical assessment of W.V. revealed an apical heart rate of 72, respiration 18, and blood pressure of 100/70. W.V.'s vital signs were monitored by the staff of 5 East every 15 minutes as ordered by the Respondent until 3:15 p.m., when this was reduced to every 30 minutes. At 5:00 p.m., the Respondent saw W.V., who had no complaints and was stable. Ms. Burnsed found W.V. up going to the bathroom at 5:30 p.m., and got him back into bed explaining that it was important that he stay in bed because of his incision for at least 24 hours. Ms. Burnsed checked W.V.'s incision, and found that it was not bleeding at that time. At 7:00 p.m., Ms. Burnsed administered Lasix to W.V., and W.V. asked for and was provided sleeping medication at 9:00 p.m., at which time, Ms. Burnsed took W.V.'s vital signs which were essentially unchanged and stable. At 9:20 p.m. the patient's charts reflect that he was complaining of mild shortness of breath (SOB), and pains in his chest. Pursuant to the Respondent's orders, Ms. Burnsed administered nitroglycerin, 150 grains times one, after checking his blood pressure to insure it was within limits for the administration of nitroglycerine, and oxygen via nasal cannula, two liters, pursuant to emergency orders. This relieved the patient's symptoms. Ms. Burnsed did not report to the Respondent that W.V. had suffered mild shortness of breath and chest pain because the nitroglycerin and oxygen relieved his symptoms. The decision to notify or not to notify the treating physician was described as a nursing judgment based upon the nurse's assessment of the patient's condition after being medicated and placed upon oxygen. (See Lipsky Deposition, Page 56, line 8 et seq.) Ms. Burnsed did not consider the patient's condition to have deteriorated given his response to the medication, and did not notify the Respondent. Subsequent to administering the nitroglycerin and oxygen, Ms. Burnsed spoke with W.V.'s wife on the telephone. It is intimated in the depositions that Mrs. W.V. called to advise that her husband had called complaining of shortness of breath and chest pains and an inability to get anyone to assist him; however, no evidence was submitted regarding the content of the conversation between Ms. Burnsed and Mrs. W.V. Five to ten minutes after speaking with W.V.'s wife, Ms. Burnsed returned to W.V.'s room, where she found him resting in bed without complaint. W.V. stated that he wanted to go to sleep. Ms. Burnsed did not remember checking his vital signs on this second visit, and it is most probable that she did not because he was trying to go to sleep. Ms. Burnsed checked W.V. at 10:10 p.m., and found he was not breathing, had no pulse, and was unresponsive. The Cardiac Resuscitation Team was called, and responded. Despite their efforts, W.V. was pronounced dead at 10:50 p.m. Although a partial autopsy was performed which confirmed the findings of the catheterization and the diagnosis of a recent myocardial infarction, the cause of death was not precisely determined. It was assumed by the experts that W.V. did not die of congestive heart failure because he would have complained more. Therefore, the experts concluded that his death was relatively sudden, most probably brought on by an arrhythmia or perhaps a stroke. There was a suggestion that the Respondent did not put W.V. on a monitor because he had a pacemaker. While patients with pacemakers are at no less risk of developing arrhythmias than patients without pacemakers, there was no evidence that this was a consideration of Respondent in placing the patient on a cardiac floor following cardiac catheterization. It was general practice to place cardiac catheterization patients who exhibited signs of cardiac pathology on telemetry for 24 hours following the procedure. The initial orders of the Respondent were consistent with this practice. Testimony was received from the Petitioner's experts was that the Respondent's care was substandard because he did not place the patient on monitoring as they would have done by placing the patient in the emergency room, or the intensive care unit, or the cardiac intensive care unit to obtain telemetry monitoring, or retain the patient in the cardiac catheterization area pending the availability of a monitored bed. Their assumptions regarding the doctor's authority were inconsistent with the procedure for placing patients at St. Vincent's which was the function of the placement nurse. The Petitioner's experts also testified that placing a patient on telemetry notified the nursing staff that the patient required special attention. The Respondent's witnesses were more credible in stating that placing a patient on telemetry was not the way to indicate to nursing staff that the patient required special attention. The testimony of Respondent's witnesses that intensive care personnel were not as well trained as personnel on the cardiac floor to deal with cardiac emergencies is not credible. Both groups of personnel, if not equally versed in cardiac care, are sufficiently skilled in steps to be taken in the event of a cardiac emergency that there would be no appreciable difference in the care provided. Placing the patient in the regular intensive care unit or the cardiac intensive care unit would have required changing the patient's medical status be changed, and there was no change in the patient's condition which would have warranted the change. The patient was extremely ill upon admission, and his prognosis was very poor. W.V. was going to die because of his cardiac condition and chronic pulmonary congestion unless he had a stroke. His condition was irreversible in the opinions of the various experts; however, he would have been released the day following the catherization and treated medically for his problems. The Petitioner's experts opined that the Respondent's decision not to place W.V. in a monitored bed was substandard care because they felt that there was an ethical duty to monitor the patient in the absence of orders directing that efforts not be made to resuscitate notwithstanding the dismal chances for success. Their opinion assumed the Respondent could direct the placement of the patient in a monitored bed on a specific unit within a relatively short period of time because of all the monitored beds in the hospital. The Respondent's experts opined that the decision not to monitor W.V. was within the acceptable standards of medical care by physicians under similar circumstances, i.e., retain the patient in the catherization laboratory where nursing care would have been inadequate pending availability of a monitored bed for up to two hours. Their opinion considered the circumstances at St. Vincent's, and is deemed more credible.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is, RECOMMENDED: That the charges against the Respondent be dismissed. DONE and ENTERED this 2nd day of June, 1995, in Tallahassee, Florida. STEPHEN F. DEAN, 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 2nd day of June, 1995. APPENDIX The parties filed proposed findings of fact which were read and considered. The following states which of those findings were adopted, and which were rejected and why: Petitioner's Recommended Order Findings Paragraph 1-3 Paragraph 1-3. Paragraph 4 Paragraph 5. Paragraph 5 Paragraph 3. Paragraph 6 Paragraph 6. Paragraph 7 While true, this finding is unnecessary to a consideration of the issues. Paragraph 8 Paragraph 7. Paragraph 9 Paragraph 9. Paragraph 10 Paragraph 32. Paragraph 11 Subsumed in Paragraph 37. Paragraph 12 Subsumed in Paragraph 38,39. Paragraph 13 Rejected as contrary to more credible evidence. Paragraph 14 If arrythmias were undetected, they would have been irrelevant to consideration of the patient's condition. Paragraph 15 Subsumed in Paragraph 9. Paragraph 16 Paragraph 46. Paragraph 17 Subsumed in Paragraph 9. Paragraph 18 Contrary to more credible evidence; See Parag 48. Paragraph 19 Rejected at Paragraph 43. Paragraph 20 Rejected at Paragraph 40. Paragraph 21 Rejected as contrary to more credible evidence; See Paragraph 12. Paragraph 22 Accurately states the expert's credentials, but is not relevant to consideration of the issues. Paragraph 23 Rejected as contrary to more credible evidence; See Paragraphs 42 and 47. Paragraph 24 Subsumed in Paragraphs 9,12,47-49. Paragraph 25 Rejected at Paragraph 16. Paragraph 26 See comments to Paragraph 22. Paragraph 27 See comments to Paragraph 23. Paragraph 28 While the may have been a national standard of care, there was not a national set of circumstances which impact the issue of whether the Respondent adhered to the appropriate standard of care. Paragraph 29 Subsumed in Paragraph 47. Paragraph 30 Subsumed in Paragraph 24. Paragraph 31 Subsumed in Paragraph 9. Respondent's Recommended Order Findings Paragraph 1 Paragraph 4,5. Paragraph 2,3 Paragraph 6. Paragraph 4 Paragraph 6,4. Paragraph 5 Paragraph 9. Paragraph 6 Rejected as contrary to most credible evidence; See Paragraphs 12-14. Paragraph 7-10 Subsumed in Paragraphs 17-19. Paragraph 11 Accurate; however, the patient was stable upon admission. Paragraph 12 Subsumed in Paragraph 46. Paragraph 13 Paragraph 46. Paragraph 14 Paragraph 24. Paragraph 15 Subsumed in Paragraph 25-28. Paragraph 16 Paragraph 24. Paragraph 17 Paragraph 31. Paragraph 18 Subsumed in Paragraph 33. Paragraph 19 Paragraph 37. Paragraph 20 Subsumed in Paragraph 46. Paragraph 21 Paragraph 38,48. COPIES FURNISHED: Hugh R. Brown, Esq. Agency for Health Care Administration 1940 N. Monroe St. Tallahassee, FL 32399-0792 Michael J. Obringer, Esq. Osborne, McNatt, Shaw, et al One Enterprise Center 225 Water St., Ste. 400 Jacksonville, FL 32202-5147 Marm Harris, M.D. Executive Director Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, Esq. Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue The issue for determination at formal hearing was whether Respondent committed the offenses set forth in the administrative complaint, and, if so, what action should be taken.
Findings Of Fact The Department of Professional Regulation (now, the Agency for Health Care Administration), Board of Medicine (Petitioner), is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times material hereto, Arthur J. Schatz, M.D. (Respondent), has been a licensed physician in the State of Florida, having been issued license number ME 0024745. On or about September 7, 1988, Patient A. H., a 61-year-old female, presented to her internist with complaints of left pelvic pain. The internist ordered a pelvic sonogram and an MRI. Both procedures revealed a five centimeter mass on the left side of Patient A. H.'s pelvis. The internist referred Patient A. H. to Respondent. On or about September 16, 1988, she presented to Respondent who performed an examination by palpation, which revealed a mass on the left side of her pelvis. Respondent diagnosed Patient A. H. as having a left ovarian tumor. Respondent scheduled Patient A. H. for exploratory laparotomy and probable total abdominal hysterectomy and bilateral salpingo-oophorectomy. Exploratory laparotomy is a surgical procedure in which a patient's abdomen is opened to explore the abdominal cavity in order to determine whether there is any pathology present. Exploratory laparotomy was indicated, and Respondent was qualified and credentialed to perform the surgical procedure. Because of the location of the mass and because of Patient A. H.'s history, especially her age, pre-operatively, Respondent believed that the mass was highly suggestive of a malignancy. Respondent did not perform or order any other diagnostic test or seek any consultation with any other physician or any specialist. Such conduct by Respondent was within the acceptable standard of care, skill, and treatment in the practice of medicine. On or about September 25, 1988, Respondent admitted Patient A. H. to Parkway Regional Medical Center for the surgical procedure to be performed. On or about September 26, 1988, Respondent performed the exploratory laparotomy. Upon entering Patient A. H.'s abdomen, Respondent took washings. Respondent then proceeded to examine her female organs and discovered that they were normal. Continuing, Respondent palpated the mass on the left side of Patient A. H.'s pelvis in the retroperitoneal area, behind a very thin layer of tissue called the peritoneum. Pre-operatively, Respondent could not have known that the mass was retroperitoneal. The overwhelming majority, ninety-eight percent, of gynecologic surgery is performed on the intra-peritoneal structures, while only two percent is performed retroperitoneally. General gynecologists are trained to and do perform surgical procedures retroperitoneally. Respondent appropriately elected to open the peritoneum and entered the retroperitoneal space to identify and surgically address the area of suspected pathology. He found a somewhat soft mass, approximately five centimeters in diameter, on the pelvic side wall with a white structure running through the middle of the mass. The mass, a tumor, which was encapsulated was round in shape and yellowish in color. Encapsulation is more commonly associated with benign tumors than malignant tumors. Unsuccessfully, Respondent attempted several times to dissect the mass off the white structure. Respondent recognized the white structure as the obturator nerve which was later identified as such. Respondent observed that the mass had the general appearance of a lymphoma which is a benign, fatty, slow-growing tumor. However, he was unable to precisely identify the nature of the mass which could also have been lymphosarcoma, malignant, since no analysis had been performed on the mass. Respondent believed that the tumor was more likely benign than malignant. Confronted with a most unusual situation in that the tumor was in a very unusual location and the obturator nerve was within the mass itself, Respondent requested that the entire hospital be paged for a gynecologic oncologist. He was informed that neither of the two gynecologic oncologists on the hospital staff were in the hospital or scheduled to be in the hospital. Respondent's act of not having a gynecologic oncologist present or on call during the scheduled surgery was not practicing medicine below the acceptable standard of care, skill, and treatment. Respondent then requested the paging of a general surgeon. A board certified general surgeon responded and entered the operating suite where Respondent was operating on Patient A. H. The general surgeon did not scrub to assist Respondent but came into Respondent's operating suite and viewed the operating field. He advised Respondent that he had never seen a condition like that of Patient A. H. and could offer no suggestions. Getting no assistance from the general surgeon, Respondent requested that a neurosurgeon or orthopedist be called. A board certified orthopedist was in surgery in an adjacent operating suite. Respondent broke scrub, left his operating suite and entered the orthopedist's operating suite. He questioned the orthopedist regarding the function of the obturator nerve and the anticipated effect of sacrificing the nerve, if that were necessary, in order to remove the tumor in its entirety. The orthopedist advised Respondent that the obturator nerve was a major nerve which governs the muscles involved in the adduction of the thigh and affects the ability to walk. He further advised Respondent that sacrificing the nerve should result in only a minimal disability which could be adequately addressed with physical therapy. Generally, a general gynecologist, including Respondent, has a cursory understanding of the function of the obturator nerve. Arising from the lumbar section of the spinal column, the obturator nerve is a major nerve and is extremely important in allowing a person's legs to move to the midline for the purpose of walking. After being advised by the orthopedist, Respondent re-scrubbed and returned to his operating suite. He again attempted, without success, to dissect the tumor from the obturator nerve. Thereupon, Respondent decided that Patient A. H. would benefit from a complete resection of the tumor even though it would mean sacrificing the obturator nerve in order to remove the tumor in its entirety. He had no experience in the removal of lymphomas from nerves. Respondent appropriately decided against performing a frozen section on the tumor, prior to removal, because such a procedure might expose Patient A. H. to the risk of cancer cells being spread through the retroperitoneal space if the tumor was malignant. His action was within the acceptable standard of care, skill, and treatment in the practice of medicine. A frozen section is a procedure in the intraoperative period 2/ in which a surgeon attempts to remove a piece of a tumor or mass to send to a pathologist to determine whether the mass is malignant or benign. The procedure is important because it provides the surgeon with direction as to how to proceed in terms of treatment and care of a patient while the patient is under anesthesia and in the operating room. Furthermore, Respondent appropriately decided against removing only portions of the tumor, thereby leaving some of it behind, because such a procedure could result in the tumor re-growing, and possibly as a malignancy. His action was within the acceptable standard of care, skill, and treatment in the practice of medicine. Respondent removed the tumor in its entirety which included removing the portion of the obturator nerve to which the tumor was attached to and incorporated within the tumor. Respondent sent the specimen to the pathology lab for analysis which revealed that the tumor was a fatty, benign lymphoma and that the white structure incorporated within the tumor was nerve tissue. Prior to removing the tumor in its entirety, there was no acceptable method available to Respondent for him to definitively know that the tumor was benign. Respondent failed to record his contacts with the general surgeon and the orthopedic surgeon in his operative notes for the surgery but recorded the contacts in his discharge summary. It is customary and appropriate to record intra-operative consultations in an operative report. Neither the general surgeon nor the orthopedist considered their contact with Respondent as a consultation. Patient A. H.'s postoperative recovery was not as anticipated in that she suffered severe, instead of minimal, disability which has affected her ability to walk. She is unable to walk without the assistance of either a cane or a leg brace. No literature or authority exists which supports the sacrifice of the obturator nerve for a benign tumor or a tumor which appears to be benign. Patient A. H.'s condition was a rare case because of the location of the tumor and because the tumor was attached to the obturator nerve which was incorporated within the tumor. Neither the expert for Petitioner nor for Respondent had ever experienced, or heard or read of such a situation. Furthermore, because of Respondent's experience with Patient A. H. and her resulting condition, both experts have greater knowledge of the obturator nerve. Respondent's removal of the tumor in its entirety, including removing a portion of the obturator nerve, was within the acceptable standard of care, skill, and treatment in the practice of medicine.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency For Health Care Administration, Board of Medicine, enter a final order dismissing the administrative complaint. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 2nd day of December 1994. ERROL H. POWELL 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 2nd day of December 1994.
The Issue An Administrative Complaint dated February 2, 1998, alleges that Respondent, Dennis Gross, M.D., violated Section 458.331(1)(t), Florida Statutes, by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. More specifically the Administrative Complaint alleges that Dr. Gross failed to properly diagnose and treat a 20-month old patient on August 8, 1994, which patient expired that same day.
Findings Of Fact Dennis Gross, M.D., is now and since December 31, 1973, has been licensed as a medical doctor in the state of Florida with license no. ME0021286. Dr. Gross is board-certified in pediatrics. He has had an active, private general pediatric practice in central Florida for the last 22 years, seeing an average of 30-35 patients a day. His practice consists of well child care, routine visits, physicals, and immunizations, but also includes acute care, illnesses, and injuries. His office hours are Monday through Friday and a half-day on Saturday; he routinely takes calls from his patients' parents and does not rely on his nurses to handle those calls. He also sees patients at night or on weekends at the hospital, but generally if a patient is critically ill and requires in-hospital care, he calls for a consult from a pediatric intensivist, a sub-specialty of pediatric care for critically ill children. Dr. Gross was the pediatrician for the M. family for about 12 years. R.M., a male child was born on November 18, 1992, and Dr. Gross began treating him from birth. During the course of his treatment of R.M., Dr. Gross learned that the child had a rare immunodeficiency syndrome, cyclic neutropenia, characterized by cyclical (generally 14-45 days) reduction in the patient's neutrophils (the most prevelant type of white blood cells.) R.M.'s father and older half-sibling also had this condition. When the patient's neutrophils are low, bacterial infections occur. In the infant R.M. such infections occured frequently. Between his birth and August 1994, Dr. Gross treated R.M. for various infections on approximately 24 occasions. These included boils and abcesses, infected rashes and other infections primarily localized on the skin. R.M. was also treated for normal childhood illnesses such as coughs, colds, and ear infections. On each occasion Dr. Gross was able to quickly identify the problem and treated it appropriately. For approximately 22 months R.M. thrived and achieved age-appropriate growth and developmental levels. On August 8, 1994, between 9:00 a.m. and 9:30 a.m., R.M.'s mother called Dr. Gross at his office and told him that R.M. had a low-grade fever and had vomited through the night. She said he had not vomited, however, within the 4 to 5 hours. Dr. Gross told the parent to put R.M. on clear liquids, to call back if the vomiting persisted, and to check back the following day anyway because of the child's history. Although the mother was aware of Dr. Gross' practice of seeing patients the same day on request she did not make such a request at that time. Instead, R.M.'s father, a school principal, stayed home with him in the morning and brought him to school to the mother, a teacher, in the later morning. R.M.'s mother took him home and apparently called Dr. Gross' office for a same-day appointment because she appeared with R.M. at the pediatrician's office around 3:30-4:00 p.m. When Dr. Gross entered the examining room, R.M. was walking around the room. Dr. Gross placed him on the examining table and observed an "alert and active child." His mouth appeared slightly dry and with the exception of increased bowel sounds and a rectal temperature of 104.1?, all other signs were normal. Dr. Gross told the mother that he felt R.M. had gastroenteritis, a viral infection, and told her he didn't want the child to dehydrate. He administered a shot of antiemetic and R.M. howled, a thoroughly normal reaction. Dr. Gross also prescribed Phenergan suppositories and told the mother to keep him on clear liquids slowly and call back if necessary. The child walked out of the office with his mother. Approximately 45 minutes later at home R.M. stopped breathing and was taken to the hospital. Dr. Gross was called to the hospital where CPR, epinephrine and other emergency measures were employed to attempt to revive the child. He was pronounced dead at 6:25 p.m. The autopsy determined that the cause of death was "septicemia, due to complications of cyclic neutropenia." More specifically, bacteriology studies revealed three species of clostridium, including clostridium septicum identified in the blood culture. (Petitioner's Exhibit No. 4, p. 5/83) The Standard Of Care The foregoing facts are substantially uncontroverted. The parties' dispute is whether Dr. Gross' diagnosis of R.M. on August 8, 1994, constituted failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. On this issue, the experts are at odds. Petitioner's sole witness was Dr. Lucian DeNicola, a professor of pediatrics in pediatric critical care medicine at the University of Florida Health Science Center in Jacksonville, Florida. Dr. DeNicola's opinion formed the basis for the Administrative Complaint in this case. Dr. DeNicola is board-certified in pediatrics and in pediatric critical care. With outstanding education and experience Dr. DeNicola has, nonetheless, very limited experience in an active outpatient general pediatrics practice such as Dr. Gross' practice. That practice was for 6 years at an outpatient clinic operated by the University of Massachusetts and that experience ceased approximately 16 years ago. Dr. DeNicola is an intensivist, specializing in the care of critically ill children. Based on R.M.'s history and the elevated temperature, Dr. DeNicola's opinion is that Dr. Gross should have suspected something serious, should have taken or ordered a blood culture, and should have immediately administered a broad spectrum antibiotic. Clostridia infections are virulent and highly toxic, but they are killed with antibiotics, usually a penicillin. Dr. DeNicola's opinion was considered and weighed in this proceeding but has been rejected in favor of the more relevant and, under the circumstances of this case, more credible, opinions of Respondent's witnesses. Dr. Raymond Caron is board-certified in pediatrics and has practiced in Orlando, Florida, for approximately ten years. A sole-practitioner like Dr. Gross, he sees children from birth through adolescence, providing a mix of routine well-child care and acute care. Dr. Cody Meissner's training and experience is closely analogous to that of Dr. DeNicola. That is, he practices medicine in a teaching hospital setting, through the Tuft's University School of Medicine in Boston, Massachusetts. Dr. Meissner is head of the Pediatric Infectious Disease Division at the New England Medical Center. He teaches, directs research, consults with pediatricians throughout New England, and spends several hours a day with patients in the hospital or emergency room. Dr. Meissner is board-certified in pediatrics and in pediatric infectious diseases. There are viral infections and bacterial infections. Viral infections do not respond to antibiotics and administering antibiotics indiscriminately is contraindicated and can be very detrimental. The indiscriminate use of antibiotics can create drug-resistent strains of infections and the antibiotics may ruin an outcome of subsequent blood cultures which are supposed to identify the potential bacteria. Dr. Gross did not have an in-office capacity to perform a blood culture nor did most his colleagues in private pediatric practice have that capacity. The standard of care did not require that capacity. Even a culture taken in an emergency room setting would have meant a several-hour delay between the time R.M. was seen by Dr. Gross and the results of the culture. In the meantime, the injection of an antibiotic by Dr. Gross would likely have masked the result of the culture and would have produced a false negative. More significantly, and even with Dr. Gross' foreknowledge of R.M.'s propensity for infections, nothing specifically in the child's condition on the afternoon of August 8, 1994, clued the pediatrician to the fact that the child was already full of deadly toxins. Bacterial infections, in contrast with viral infections, are generally identified with a focus of the infection: lesions, draining, inflammation, tenderness or localized pain or swelling. Impending septicemia typically is manifested by lethargy, limpness, cyanosis (paleness), low blood pressure, an inability to make eye contact, and severe irritability. R.M. presented none of these signs to Dr. Gross. R.M.'s very normal reaction to the injection would not be typically found in a child as sick as he truly was. Young children with temperatures of 104? are not extraordinary. Pediatricians in an active practice like Dr. Gross' may see several such patients daily, or weekly, depending on the season. Dr. Gross' diagnosis of gastroenteritis was consistent with his observations, examination and knowledge of the child's history. According to Dr. DeNicola, R.M. could have had an interferring viral infection that caused the earlier vomiting that set up the bacteremia. (deposition, p. no. 66) In summary, the standard of care as more credibly described by Respondent's witnesses did not require that Dr. Gross perform or order a blood culture or administer an antibiotic to R.M. on the afternoon of August 8, 1994.
Recommendation Based on the foregoing, it is hereby RECOMMENDED: that the Board of Medicine issue a Final Order dismissing the Administrative Complaint at issue. DONE AND ENTERED this 8th day of December, 1998, in Tallahassee, Leon County, Florida. MARY CLARK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 8th day of December, 1998. COPIES FURNISHED: Carol A. Lanfri, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Martin B. Unger, Esquire Unger, Swartwood, Latham & Indest, P.A. Post Office Box 4909 Orlando, Florida 32802-4909 Tanya Williams, Executive Director Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750 Angela Hall, Agency Clerk Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750
