The Issue The issue is whether respondent's license as a physician should be disciplined for the reasons cited in the administrative complaint filed on December 21, 1992.
Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Background Respondent, Kenneth Aung-Din, is a licensed medical doctor having been issued license number ME 0051923 by petitioner, Agency for Health Care Administration, Board of Medicine (Board). He is board certified in emergency medicine having received his certification in 1994. When the events herein occurred, respondent was an emergency room physician at Memorial Medical Center (MMC) in Jacksonville, Florida. On the evening of February 21, 1991, V. P., a thirty-five year old female who was then eight months pregnant, presented herself to the MMC emergency room complaining of lower abdominal discomfort, difficulty urinating, and a five-hour history of nausea and vomiting. After being examined and treated by respondent, and diagnosed as having a urinary tract infection, the patient was released the same evening. Less than an hour later, however, the patient went into labor and delivered a new born. On December 21, 1992, the Board issued a two-count administrative complaint charging that, while treating V. P., respondent failed to practice medicine with that level of care, skill, and treatment which a reasonably prudent similar physician recognizes as acceptable under similar conditions and circumstances in that he "failed to obtain fetal heart tones, determine fetal position, and ausculatate for fetal heart tones with a doppler that was available to him in the ER when he examined (the) patient, who was a high risk near term obstetrical patient." The complaint further alleges that respondent failed to keep written medical records justifying the course of treatment of V. P., "including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations." Respondent denied all material allegations and requested this hearing to contest these charges. Did respondent deviate from the standard of care? On presentment to the emergency room nurse around 8:53 p.m. on February 21, 1991, V. P. complained of generalized abdominal pain and pressure since around 3:30 p.m. that day, with nausea and two episodes of vomiting. She also complained that she was unable to urinate since approximately 2:30 p.m. An additional complaint was allegedly made by the patient, but it is not a part of the nurse's notes and thus is hearsay in nature. The patient further disclosed that this was her second pregnancy. After recording in her notes the patient's complaints, the nurse, on her own volition, conducted a nitrozine test which was negative. It later came to light that the test was improperly conducted by the nurse, but respondent was never told this fact. Respondent first observed the patient around 9:08 p.m. and recalled that she "was obviously in discomfort." Based on V. P.'s complaints, respondent initially suspected that she might be in preterm labor. After obtaining a patient history, respondent palpitated V. P.'s abdomen for any pain, tenderness, abnormalities or contractions. Although V. P. was eight months pregnant, she was nontender and exhibited no signs of active labor. The patient also denied that she was having contractions. Based on V. P.'s primary complaint of urinary retention, respondent asked the nurse to insert a Foley catheter in V. P.'s bladder. Before the nurse did so, V. P. was able to urinate on her own accord. Even so, respondent ordered a catheter inserted around 9:30 p.m. to empty any residual in the bladder. This procedure yielded approximately 200cc. of urine which was used for a urinalysis test. By now, having urinated at least once, and having her bladder emptied, V. P.'s pain and discomfort had gone away, and she appeared to be "totally comfortable and with no complaints." After seeing the results of the nitrozine test around 9:55 p.m., respondent conducted a pelvic examination. Still considering the possibility of preterm labor, respondent inserted a vaginal speculum into the patient to see if there was any bleeding or fluid. Neither was present, and a manual examination of the patient revealed that the opening to her cervix was thick and closed. A patient in preterm labor would generally present signs of bleeding or fluid, and the cervix would have begun to open and "thin out." Given these findings, and the fact that V. P. was exhibiting no signs of labor or discomfort, it was reasonable for respondent to conclude that V. P. was not in preterm labor. The results of the urinalysis were reviewed by respondent around twenty minutes before the patient's discharge. By that time, she had voluntarily urinated at least three times since first arriving at the emergency room. The test results revealed 1+ protein, trace ketones, and 0-2 white and red blood cells. Also, they indicated that a sterile (uncontaminated) specimen had been taken, and that trace bacteria were present. Because trace bacteria, if not treated, can lead to "a very significant" urinary tract infection, and V. P. had previously experienced abdominal "pressure" and an inability to urinate, both signs of an infection, respondent prescribed Ampicillin, an antibiotic, on the assumption V. P. had a urinary tract infection. This diagnosis is not unusual for pregnant women, and even petitioner's expert agreed that V. P. had presented some of the "classical signs" of a urinary tract infection. After having observed the patient for almost two hours, during which time V. P. exhibited no objective clinical signs of active labor, respondent discharged the patient around 10:50 p.m. In doing so, respondent relied not only on the above observations, but also upon the results of his pelvic and abdominal evaluations, the urinalysis test results, and the fact that all of V. P.'s complaints (pain, nausea and vomiting) had been resolved. It was also reasonable to conclude that had the patient been in preterm labor, her symptoms would have progressed, rather than abated, during the two hours she was in the emergency room. At the time of discharge, respondent gave V. P. instructions to make a follow-up visit that week with her primary physician at University Medical Center (UMC), and if her condition did not improve during the interim, to return to MCC or call the "emergency department right away for further assistance." She was also given a prescription for an antibiotic for the urinary tract infection. Just prior to leaving the hospital, V. P. urinated one last time and allegedly told the nurse that she had started "spotting." Even if V. P. actually reported this critical fact, the nurse failed to disclose this to respondent, and he cannot be faulted for the nurse's omission. Had respondent known, or even suspected, that she had just begun bleeding, he would have sent her upstairs to the obstetrical wing for further observation. The complaint levels a number of criticisms at respondent's conduct which, if true, indicate that he failed to meet the appropriate standard of care. In addressing these criticisms, it should be noted that petitioner's own expert agreed that, at best, this was "a difficult case," and one that all emergency room physicians "hate to see." The complaint characterizes V. P. as a "high risk near term obstetrical patient." The use of the term "high risk" is based principally on the fact that an ultrasound conducted at UMC on February 19, 1991, revealed that the fetus was in a breech position. But respondent was never told this fact, and even petitioner's expert conceded that without this information, it was reasonable for respondent to consider V. P. as a normal risk pregnancy. The complaint first alleges that respondent "failed to assess the status of the fetus by neglecting to auscultate for fetal heart tones with a doppler that was available to him in the Emergency Department." A doppler is a device used to listen for fetal heart tones and, while not as effective as other monitoring devices, is nonetheless useful in detecting fetal distress or preterm labor. Here, respondent did not assess the status of V. P.'s fetus because her pain and discomfort had disappeared after her urinary tension was resolved, and she no longer exhibited any signs, clinical or otherwise, of preterm labor. At the same time, while doppler machines were available in emergency rooms, including MMC, during the early 1990's when this incident occurred, it was not prevailing protocol for emergency room physicians to automatically conduct fetus monitoring for what they perceived to be normal risk pregnancies. While the standard for emergency room physicians has subsequently changed, and fetal heart tones are now routinely monitored on all pregnant women twenty weeks and above, respondent did not deviate from the prevailing standard of care in February 1991 by failing to use a doppler. The complaint next alleges that a prudent physician "would have telephoned (V. P.'s) treating physician from UMC, or the obstetrician- gynecologist on call in order to properly assess (her) condition." As to calling V. P.'s treating physician, however, the more persuasive evidence shows that it would have been imprudent to attempt to contact V. P.'s primary treating physician because she had been treated by an unknown resident at another hospital, and at that hour of the night the chance of speaking with that resident was highly improbable. Then, too, since her complaints had been resolved, there was no need to contact another physician. As to respondent's failure to obtain a specialist consultation, the more persuasive evidence shows that the diagnosis of urinary tract infection was reasonable under the circumstances, and after the patient exhibited no signs of distress for at least an hour and a half, her discharge was appropriate. While it is true, as petitioner suggests, that the initial complaints by V. P. of pressure, nausea, vomiting and abdominal pains can be signs of preterm labor, these complaints were resolved after the catheter was inserted, and there were no corroborating indications of labor. Then, too, based on the information at hand, respondent reasonably concluded that V. P. was a normal risk pregnancy. Finally, later inquiry disclosed that during her first pregnancy, V. P. was in labor for only fifteen minutes, a remarkably short period of time. Respondent was not aware of this fact at the time of treatment. As it turned out, V. P. experienced another remarkably short period of labor on the evening of February 21, 1991. In summary, the more persuasive evidence supports a finding that, while treating V. P. in February 1991, respondent practiced medicine with that level of care, skill and treatment which was recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. C. Adequacy of Medical Records The complaint generally alleges that respondent failed to keep written medical records justifying the course of treatment of the patient. In the history section of his notes for patient V. P., which have been made a part of this record, respondent made the following recordations: 2110 - 35-year old white female, eight months pregnant; complaining of unable to urinate; dysuria; feels like pressure; denies vaginal bleeding; no contractions; Under the physical examination portion of his notes, respondent reported as follows: white female, well developed, awake, alert, times 3. Abdomen, pregnant uterus equals 8 months; nontender. Pelvic - zero blood; oz thick and closed. Late entry - 2/26/91, Nitrozine Test performed, which was negative. Finally, under his diagnostic impressions and discharge instructions, respondent wrote as follows: UTI (urinary tract infection) Ampicillin 250 mg, q.i.d., for 7 times. Tylenol if needed. Follow up, UMC this week. Return if any problems. In responding to the charge that his notes were inadequate or incomplete, respondent agreed that the diagnostic impressions section would have been more accurate and complete if he had written "urinary retention- resolved/UTI" rather than "UTI" alone. This is because urinary retention was a secondary diagnosis which was resolved during the patient's visit. In this respect, the records are not adequate. In addition, because the records fail to note that V. P.'s symptoms of abdominal pain and pressure were resolved, they lack completeness. In all other respects, they are found to be adequate.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Medicine enter a final order finding respondent guilty of violating Section 458.331(1)(m), Florida Statutes, as described above, and that he be given a reprimand. Count I should be dismissed. DONE AND ENTERED this 1st day of October, 1996, in Tallahassee, Florida. DONALD R. ALEXANDER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 1st day of October, 1996. COPIES FURNISHED: Dr. Marm Harris, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0770 Kevin W. Crews, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 W. Jerry Foster, Esquire 1342 Timberlane Road, Suite 101-A Tallahassee, Florida 32312-1775 Jerome W. Hoffman, Esquire Agency for Health Care Administration Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403
The Issue Whether the Agency for Health Care Administration should approve the application of Kindred Hospitals East, LLC, for a Certificate of Need to establish a 60-bed, long- term care hospital ("LTCH") to be located in Brevard County, one of four counties in AHCA District 7.
Findings Of Fact The Parties Kindred Hospitals East, LLC, ("Kindred" or the "Applicant") is a subsidiary of Kindred Healthcare, Inc. ("Kindred Healthcare"). Kindred Healthcare operates 84 LTCHs nationwide, including eight in the State of Florida. Twenty-four of Kindred Healthcare's LTCHs are operated by Kindred Hospitals East, LLC, including the eight in Florida. The Agency is the state agency responsible for the administration of the Certificate of Need program in Florida. See § 408.034(1), Fla. Stat., et seq. Pre-hearing Stipulation The Joint Pre-hearing Stipulation between Kindred Hospitals East, LLC, and Agency for Health Care Administration, filed May 25, 2006, contains the following: E. STATEMENT OF FACTS WHICH AREADMITTED AND WILL REQUIRE NO PROOF The CON application filed by Kindred complies with the application content and review process requirements of Sections 408.037 and 408.039, Florida Statutes (2005), and Rule 59C- 1.008, Florida Administrative Code, and the Agency's review of the application complied with the review process requirements of the above-referenced Statutes and Rule. With respect to compliance with Section 408.035(3), Florida Statutes (2005), it is agreed that Kindred has the ability to provide a quality program based on the descriptions of the program in its CON application and based on the operational facilities of the applicant and/or of the applicant's parent facilities which are JCAHO certified. With respect to compliance with Section 408.035(4), Florida Statutes (2005), it is agreed that Kindred has the ability to provide the necessary resources, including health personnel, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation. With respect to compliance with Section 408.035(6), Florida Statutes (2005)it is agreed that the project is likely to be financially feasible. The parties agree there are no disputed issues with respect to Kindred's compliance with Section 408.035(8), Florida Statutes (2005), which relates to an applicant's proposed costs and methods of proposed construction for the type of project proposed. The parties agree there are no disputed issues with respect to Kindred's compliance with Section 408.035(9), Florida Statutes (2005), which relates to an applicant's proposed provision of health care services to Medicaid patients and the medically indigent. Section 408.035(10), Florida Statutes (2005), relating to nursing home beds, is not at issue with respect to the review of Kindred's CON application. With respect to compliance with Rule 59C-1.008(1)(a)-(c), Florida Administrative Code, it is agreed that Kindred complied with the letter of intent requirements contained therein. 9. Rules 59C-1.008(1)(d), (e), (h), (i), and (j) are not at issue with respect to the review of Kindred's CON applications. With respect to compliance with Rule 59C-1.008(1)(f), Florida Administrative Code, it is agreed that Kindred complied with the applicable certificate of need application submission requirements contained therein. The need assessment methodology is governed by Rule 59C-1.008(2)(e)2.a.- d., Florida Administrative Code. With respect to Rule 59C-1.008(2), Florida Administrative Code, except as to Rule 59C-1.008(2)(e)2.a-d and (2)(e)3, Florida Administrative Code, it is agreed that this provision is not applicable to this proceeding, as the Agency did not at the time of the review cycle at issue, and currently does not, calculate a fixed need pool for LTCH beds. With respect to compliance with Rule 59C-1.008(3), Florida Administrative Code, it is agreed that Kindred submitted the required filing fees. With respect to compliance with Rule 59C-1.008(4)(a)-(e), Florida Administrative Code, it is agreed that Kindred complied with the certificate of need application requirements contained therein. Rule 59C-1.008(5), Florida Administrative Code, relating to identifiable portions of a project, is not at issue with respect to the review of Kindred's CON applications. In light of the stipulation, the issues remaining generally concern: the need for Kindred's proposed facility (including the reasonableness of Kindred's need methodology and whether its need assessment conforms to AHCA rules), the accessibility of existing LTCH facilities, and the extent to which the proposal will foster competition that fosters cost-effectiveness and quality. Long-Term Care Services The length of stay in the typical acute care hospital (a "short-term hospital" or a "STACH") for most patients is four to five days. Some hospital patients, however, are in need of acute care services on a long-term basis, that is, much longer than the average lengths of stay for most patients in an short-term hospital. Patients appropriate for LTCH services represent a small but discrete sub-set of all inpatients. They are differentiated from other hospital patients. Typically, they have multiple co-morbidities that require concurrent treatment. Patients appropriate for LTCH services tend to be elderly and frail, unless they are victims of severe trauma. All LTCH patients are generally medically complex and frequently catastrophically ill. Generally, Medicare patients admitted to LTCHs have been transferred from short-term hospitals. At the LTCH, they receive a range of services, including cardiac monitoring, ventilator support, and wound care. Existing LTCHs in District 7 At the time of the CON application there were 12 LTCHs operating in Florida with a total licensed bed capacity of 805 beds. There is one existing LTCH within District 7. Another is approved and under construction. Select Specialty Hospital-Orlando, Inc. ("Select-Orlando") contains 35 beds; it was licensed in 2003. The occupancy rate for this facility for CY 2005 was 73.57 percent. Select-Orlando's history shows few discharges to Brevard County. The majority of its discharges are to Orange, Seminole, and Osceola Counties. Most of the balance are to Volusia, Lake, and Polk Counties. A second LTCH, Select Specialty-Orange, Inc., has been approved and is under construction. It will contain 40 beds. The total licensed capacity of these two LTCHs will be 75 beds. Both of the facilities are located in Orange County and are located in or near Orlando within a few miles of each other. The acuity levels of the patients in the existing LTCH are not known. There are no LTCHs in Brevard County where Kindred proposes to build and operate a new LTCH should its application be approved. Kindred's Proposal Kindred's proposal in Brevard County, AHCA District 7, is for a freestanding 60-bed LTCH, with all private rooms, including an 8-bed intensive care unit (ICU). The proposed LTCH will follow a care model template that is similar to Kindred's other LTCHs. It will be a freestanding, licensed, certified and accredited acute-care hospital with an independent self-governed medical staff under the same model as a short-term acute hospital. The majority of patients in an LTCH typically arrive after discharge from a short-term acute care hospital, most often ending their STACH stay in an ICU. Not surprisingly, Kindred projects that its proposed LTCH will receive the bulk of its referrals from STACHs in the surrounding area. Kindred's LTCH patients will be discharged to either their homes, home health care, or to another post-acute provider on the basis of patient needs, family preference, and geography. There are several levels of care provided within an LTCH such as Kindred's proposed facility. Typically, LTCHs accept stable medical patients but with catastrophically ill patients some are bound to become medically unstable. There are eight ICU beds for the medically unstable patient. Thus, Kindred's patients who undergo changes of condition (such as becoming medically unstable) can be cared for without a transfer, unlike in skilled nursing facilities or comprehensive medical rehabilitation hospitals facilities not suited for the medically unstable patient. The goal of an LTCH is to take acute care hospital patients and provide them with a higher level of medical rehabilitation than they would receive in an STACH, and rehabilitate them so that they can be transferred home, or to a rehab hospital, or to a nursing facility. The "medical rehabilitation" of an LTCH addresses system failures and dependence on machines. This is different from the rehabilitation that takes place in an inpatient or outpatient rehab center, where patients usually have suffered an injury or trauma to a muscular or bone system, and their care is based on physical medicine rather than internal medicine. The Orlando Metropolitan Area and Brevard County In evaluating markets that may need an LTCH, Kindred looks at established metropolitan areas the boundaries of which are determined on the basis of population concentrations and commuting data. District 7 contains most of the metropolitan area associated with the city of Orlando (the "Orlando Metropolitan Area"). Like District 7, the Orlando Metropolitan Area has a presence in four counties. But the counties are different. The Orlando Metropolitan Area encompasses all or part of Orange, Osceola, Seminole, (shared with AHCA District 7) and a county that is not in District 7: Lake County. In addition to the three counties it shares with the Orlando Metropolitan Area, District 7 includes Brevard County. At hearing, Mr. Wurdock explained the following about the Orlando Metropolitan Area: When we talk about the Orlando area, we are not just talking about Orange County. Orange County, Osceola County, and Seminole County are all part of the Orlando metro area. That means they're an integrated economic unit based on commuting patterns. Lake County is also part of [the Orlando metropolitan area.] . . . [W]hen we looked at . . . Orange, Osceola and Seminole and ran an analysis . . ., we found . . . there was a need for approximately 180 more beds beyond the . . . 35 that currently existed. So even after you take out the 40 under construction, there is still a really huge need [in the Orlando metropolitan area.] Tr. 56-57. That Brevard County is not part of the Orlando Metropolitan Area is a consideration in this case. Kindred's evaluation also showed two other factors about Brevard County that distinguish it from the Orlando Metropolitan Area. First, it does not have adequate access to long-term care hospitals. Second, it's population with a significant number of seniors and a high number of discharges from STACHs makes it one of the few markets of its size that does not have at least one LTCH. As Mr. Wurdock continued at hearing: Brevard County has a population of more than a million people and it's got more than 100,000 seniors and they have six short term hospitals that produce more than 60,000 discharges a year. . . . [T]here are very few markets of that size in this country that do not have at least one long term hospital . . . Tr. 57. These two factors led Kindred to pursue the application that is the subject of this proceeding. Kindred's decision to pursue a CON for an LTCH in District 7 also stemmed from the interest of Brevard County physicians who had referred patients to Kindred facilities in Fort Lauderdale and Green Cove Springs in Duval County, a government unit consolidated with the city of Jacksonville. This interest was also supported by evidence that showed a predominate north/south referral pattern along the I-95 corridor. Patients in Brevard County STACHs appropriate for LTCH services are referred to facilities in Duval County (north) and Fort Lauderdale (south), but generally not to the lone District 7 LTCH in Orlando. The number of short-term acute hospitals in an area affects the decision of whether to locate a facility in a particular market. The presence of STACHs in a market is significant because the vast majority of an LTCH's patients are transfers from STACHs. The growing senior population (persons aged 65 and over) in Brevard County was also a factor; the elderly population is a large constituent of an LTCH's patient base. Dr. Richard Baney, who practices with Melbourne Internal Medicine Associates, the largest physician- practice group in Brevard County, holds privileges at Holmes Regional Medical Center, and is familiar with the various health care facilities of all types in Brevard County, including hospitals, inpatient rehabilitation hospitals, and nursing homes. Dr. Baney anticipates serving as either an attending or consulting physician if the Kindred facility in Brevard is approved, as do several of the other physicians in his group, including some "intensivists" such as pulmonologists, critical-care physicians, and cardiologists. Dr. Baney's physician group consists of 45 primary care physicians, including internists, family practitioners and pediatricians. The group also includes OB/GYNs, neurologists, medical sub-specialists such as cardiologists, pulmonologists, endocrinologists, hematologists, and oncologists. Among the oncologists are radiological oncologists. There are general surgeons in the group, surgery sub-specialists, including vascular surgeons, and ENT (ear, nose, and throat) physicians. Dr. Baney summed up his opinion on the need for an LTCH in Brevard County as follows: In our area we have excellent acute- care hospitals, and we have a good network located throughout the area of subacute rehab facilities, as well as nursing homes, and then home care, and then eventually a patient is home. What we don't have in this area is a long-term acute-care facility that would handle the more significantly ill patients who need more intensive medical and nursing and physical therapy support. Right now those patients that would normally benefit from this type of facility have to dwell in the hospital for . . . weeks and weeks at a time until they achieve a point of stability where they can be moved into a subacute rehab. What this does in turn is clog up the hospital beds, ICU beds in particular, and every year we have at our large acute-care hospitals here at Holmes patients who are being quartered in the . . . auditorium at the hospital, in the hallways of the emergency room, since the hospital gets just overwhelmed with patients and cannot move them out. Certainly I believe a facility in this area would have no trouble being able to fill that need of taking many of these patients who need this kind of care out of the [STACH] into a better, more efficient setting. Also, we don't have any place that's nearby that patients and their families can go for this kind of care. . . . [I]t's really not logistically feasible for patients and their families to go 80, 90 miles away or further to . . . have their care for this type of duration. Kindred No. 7, Deposition of Richard Baney, Jr., M.D., at 10-11. When asked about the difficulty presented by the distance to the LTCHs in Fort Lauderdale and Duval County, Dr. Baney answered with regard to one of his patients that administratively there a few if any problems. The problem is for the family: But the family was very hesitant to allow their father to be transported . . . 150, 180 miles away and be there for weeks or months while they were recovering. They were quite resistant to the idea of him so far away, since the family would have to travel back and forth. Eventually they overcame that and the patient did go . . . to the facility down south. * * * But it was quite a hurdle that we had to get over. Id., p. 16, 17. Aside from the logistical problems faced by the families whose loved one is a potential patient at an LTCH at great distance from home, Dr. Baney's testimony accentuates another factor faced by potential LTCH patient in Brevard County. This is a factor favoring approval of an LTCH application recently recognized by AHCA when it approved Select-Orange, a second LTCH in the Orlando Metropolitan Area dominated by two large hospital organizations. Similar to the Orlando area, Brevard County STACHs, for the most part, belong to one of two hospital organizations predominate in the area. Brevard County's Two Main Hospital Organizations There are two main hospital organizations in Brevard County: the Health First system and the Wuesthoff system. Health First includes Holmes Regional Medical Center; Palm Bay Community Hospital, which is about 90 beds; and Cape Canaveral Hospital, which is also about 90 beds, in the central part of the county. Palm Bay is a large community about 15 miles south of Melbourne. Cape Canaveral is about 20 miles from Melbourne, and Rockledge is about 15 miles from Melbourne. The Wuesthoff system consists of Wuesthoff Rockledge and Wuesthoff Melbourne. Wuesthoff Rockledge is a 267-bed acute care facility with 32 ICU beds, 8 cardiac surgery beds, and an active emergency room that sees about 1,500 visits a month. Wuesthoff Melbourne is a 115-bed facility with a 12-bed ICU and an active ER of around 800 visits a month. Wuesthoff currently refers LTCH patients- primarily long-term ventilator patients-to Kindred's facilities in Fort Lauderdale and near Jacksonville. When Wuesthoff refers a patient to Kindred, it calls Kindred's intake coordinator who journeys to Wuesthoff to review the patient's records, meet with the family, and determine if the patient can be placed. Only if a physician from the LTCH signs an admission order concurring that the patient is clinically appropriate for admission to an LTCH is the patient transferred. Often, however, because the Kindred facilities are so far away, just as Dr. Baney pointed out, the families do not want to move the patient out of Wuesthoff. This resistance continues despite increased education about the benefit of LTCHs to potential LTCH patients. LTCH Education When an LTCH comes into a market, an education process begins. It begins with the physicians, and with the case managers and social workers in the STACH. Kindred educates these professionals about what an LTCH is, what its services are, and where it fits into the continuum of care. Kindred's Admission and Patient Evaluation Processes Kindred does not admit every patient that falls within the diagnoses that might produce LTCH-appropriate patients. Patients are pre-assessed before admission using what is nationally known as Interqual criteria for hospital admissions. That set of criteria is based on severity of the patient's illness and the intensity of services required to treat the patient, and then a review committee at the LTCH makes a clinical determination whether or not the patient is appropriate for LTCH services. The sole way that a patient gets referred to a Kindred Hospital is through a physician order. Before a patient comes to a Kindred Hospital, a physician has determined that to the best of his or her judgment the patient requires continued care at the level of an acute care hospital and that the patient's course of treatment will be prolonged. A physician from a Kindred Hospital must write the admission order, concurring that it is appropriate for that patient to be in an LTCH. Prior to obtaining that physician order, potential candidates for transfer are identified through the STACH case management staff, with the assistance of the LTCH staff. The STACH medical staff, nurses, or other personnel initiate the request for Kindred to visit the patient, interview the family, talk with the STACH attending physician, and make a determination of whether transfer and care at Kindred is clinically appropriate. Kindred gathers information on a potential patient to assist in making the admission determination using individuals in the field known as "clinical liaisons," who are primarily licensed registered nurses. The clinical liaison gathers the information, but does not make the ultimate determination as to whether to admit the patient to a Kindred facility. The ultimate determination for admission is made by the physician who will be seeing the patient at the Kindred facility. In order to comply with Medicare reimbursement requirements, Kindred employs such safeguards to make sure only appropriate patients are admitted. Medicare reviews the patients treated into the hospital, and it can and does reduce payment for "short stay outliers" who do not stay at least five-sixths of the geometric mean of the length of stay (GMLOS) for the patient's diagnosis. Mathematically, however, LTCHs will always have some patients who are short stay outliers. Even if GMLOSs rise as result of the elimination of short stay patients, between 35 and 40 percent of patients will always be "short stay outliers" under CMS's current definition. They will just be hospitalized for a stay that is short relative to a longer length of stay. Kindred LTCHs utilize criteria that assure that patients, once admitted, have sufficient severity of illness and need sufficient intensity of service to continue to warrant acute care. Case managers in LTCHs apply discharge screens to patients as they near completion of their LTCH care plan to help physicians make a judgment of when they are ready to be transferred either home or to a lower level of post-acute care. Kindred's CON application included a utilization review plan, using an example from Kindred Hospital North Florida. Every hospital has a utilization review plan designed to assure that appropriate care is given to patients. It serves an oversight function for medical care, nursing care, medication administration, and any other area where resources are expended on behalf of the patient. A PPS for LTCHs Effective October 1, 2002, the federal Centers for Medicare and Medicaid Services (CMS) established a prospective payment system for LTCHs. Through this system, CMS recognizes the patient population of LTCHs as separate and distinct from the populations treated by providers of short-term acute care or other post short-term acute care providers. Under the system, each patient is assigned an LTCH DRG, indicating that the patient's diagnosis is within a certain Diagnostic Related Group. The LTCH is reimbursed the pre-determined payment rate for that DRG, regardless of the cost of care. The creation of separate DRGs for LTCH patients is the mark of the federal government's recognition of the validity of LTCH services and the distinct place occupied by LTCHs in the continuum of care based on the high level of LTCH patient acuity. Despite this recognition, concerns about the identification of patients that are appropriate for LTCH services have been voiced both at the federal level and at the state level. With the rise in LTCH applications over the last several years, AHCA has been consistent in voicing those concerns, particularly when it comes to LTCH population levels of acuity. Acuity The Agency is not convinced that there is not significant overlap between the LTCH patient population and the population of patients served appropriately in healthcare settings other than LTCHs. The Agency has reached the conclusion that there are options (other than an LTCH in Brevard County) available to patients targeted by Kindred. The options depend on such matters as physician preference and the availability of long-term care hospitals in a given geographic area. Kindred answers the concerns, in part, with evidence that relates to acuity. A "case mix index" for the hospital is a measure of its average resource consumption. Resource consumption can be viewed as a surrogate measure of complexity and severity of illness, so case mix index is often cited as a readily available measure of patient acuity. Using that indicator, the case mix index of Kindred hospitals is high compared to the entire LTCH industry, and is higher than the average case mix index for STACHs. The APR/DRG system is a way to further refine the variation of patients' acuity within a DRG. The system assigns not only a DRG, but a severity of illness on a scale of one (minor severity) to four (extreme severity). Using that tool with the Kindred data base (as well as the federal MedPAR data base) confirms that the distribution of severe and extreme severity of illness is skewed toward LTCH patients, meaning that there are more patients with higher severity of illnesses in LTCHs than in STACHs. As is to be expected, and one would hope if LTCHs are appropriately serving their niche in the continuum of care, this is consistent with the empirical observation that patients in LTCHs, are more sick than those in STACHs. A third measure of patient acuity routinely used in Kindred hospitals is an APACHE score, which is a combination of physiologic derangement and concurrent illnesses. The average Kindred patient has an APACHE score of about 45, whereas the average critical care patient in all STACHs has a score about two-and-a-half points higher. Thus, Kindred's LTCHs treat a severely ill population only a few points, on the APACHE measure, below that of critical care units in STACHs across the country. The Agency does not, by rule or order, define the level of acuity at which LTCH patients should be for admission. Information on acuity level of patients in STACHs is not available through the State's health statistics data base, nor is any information that would allow an LTCH applicant to undertake an acuity analysis of potential patients. AHCA acknowledges that it has no reason to believe that Kindred admits lower-acuity patients with the least need for resources among those in LTCH- appropriate DRGs. Family Hardship In those markets that do not have LTCHs, STACH patients typically have no choice of treatment but to stay in the STACHs, unless they are willing to travel long distances. As Dr. Baney pointed out in his deposition testimony, many patients who could benefit from an LTCH are not inclined to travel long distances. One reason is that the patients' families are not able to commute that distance. If the patient is going to be in an LTCH for weeks or months, it creates a hardship on the family to have their loved one that far away. The family either loses contact with their loved one or they actually have to relocate to where the loved one is and abandon their home temporarily. The need for family presence and involvement is more than just an emotional matter of patient and family preference. Families are involved in the treatment of a patient in a long-term care hospital, not only through their presence in the hospital but also because they will participate in patient care after the patient leaves the LTCH. Families have to learn how to get the patients out of bed, feed them, and possibly suction them. The families would be taught how to care for their family members once they leave the LTCH, by nursing and therapy staff, teaching them exercises for the patient, how to regulate the oxygen, and giving medications. Differences between LTCHs and Other Providers LTCHs and STACHs do not have the same purpose, and the gap is widening between the two. Over the last 20 years, STACHs have evolved into settings that are very good at stabilizing patients, diagnosing their conditions, and developing treatment plans. Most admissions to the medical ward of an STACH come in through the emergency room where patients are so acute, so unstable, that emergency care is required to stabilize the patient. In their role as diagnostic centers, STACHs provide imaging and laboratory services, and then develop a treatment plan based on the diagnostic work-up performed. STACHs have moved away from the function of carrying out a treatment plan. This is borne out by shrinking STACH lengths of stay over the last 20 years, which now average four to six days. As a result, STACHs have limited capability to provide a prolonged treatment plan for patients with multiple co-morbidities. In contrast, LTCHs do not hold themselves out to be diagnostic or stabilization centers. They have developed expertise in caring for the small subset of patients that require a prolonged treatment plan. A multi-disciplinary physician- based care plan is provided in LTCHs that is not provided in STACHs or other post-acute settings. LTCH patients meet hospital level criteria, and if there is no LTCH readily accessible to provide a hospital-level discharge option for these patients, then the STACH has no option but to keep them, and manage their treatment and costs as best they can. LTCHs take care of those patients who need to be in a hospital, but for whom reimbursement is not adequate for STACHs to treat. The reimbursement system is driving this to a great extent, because of the incentives it gives to discharge patients as quickly as possible. Not every STACH patient needs LTCH care; as a rule of thumb, about one percent of all non-obstetric patients are potentially LTCH-appropriate. Ms. Woods, Vice President for Wuesthoff Health System which operates STACHs in Brevard County, testified in deposition that Wuesthoff's ICUs in Wuesthoff hospitals often retain patients who could be placed in an LTCH. As the Wuesthoff ICUs remain full, the ability to move patients through the hospital, from the emergency department through the ICU, is significantly impacted. While long-term care hospitals take a team approach to getting patients weaned from ventilators or getting them to a rehab involvement, an acute care hospital ICU deals more with acute crisis situations, such as an acute MI (myocardial infarction) or an acute blood clot to the lungs, or someone who has acute sepsis or infection. The roles that LTCHs play have a significant impact on acute care hospitals such as Wuesthoff. If an acute care hospital has to maintain a patient for 30 to 60 days on a ventilator in order to get them weaned or to meet their needs, that poses the potential to interfere with the acute care hospital from meeting the needs of the community, such as patients who are coming in the emergency room with acute conditions. Most of the stays in Wuesthoff's ICU beds, for example, are five to seven days; they are trauma patients, surgery patients that need support and critical care, and patients coming in with major infections. When ICU beds are unavailable, these patients are being held in the emergency departments; it stops the patient flow if the beds in a community hospital are taken up from a long-term ventilator patient. SNFs and LTCHs are different both in intent and execution. SNFs are appropriate for patients whose primary needs are nursing, who are stable and unlikely to change, and who do not require very much medical intervention. Conversely, LTCHs, being licensed and accredited as acute care hospitals, are appropriate when daily medical intervention is required. LTCHs are able to respond to changes in conditions and changes in care plans much better than SNFs because LTCHs have access to diagnostics, laboratory, radiology, and pharmacy services. Further, there are no skilled nursing facilities in Brevard County that operate beds for ventilator dependent patients, nor are there hospital-based skilled nursing units ("HBSNUs"). Using Kindred's own nursing data base, which consists of 250 SNFs across the country, and Kindred's LTCH data base, consisting of 75 LTCHs, Kindred has discovered that that overlap in patient condition is very small. Where there is overlap, it tends to be at the ends of care in LTCHs and the beginning of care in SNFs. This progression makes sense, since SNFs are a common discharge destination for LTCH patients. LTCHs and rehab hospitals are also distinctly different. Rehab hospitals are geared for people with primarily neurologic or musculoskeletal orthopedic issues, and are driven with a care model based on physical medicine rather than internal medicine; LTCH care requires the oversight of an internist rather than a physical medicine doctor. While rehab is a concurrent component of LTCH care, the patient in an LTCH cannot tolerate the three hours per day of therapy required for admission to rehab hospitals due to their medical conditions. In fact, a common continuum of care is for an LTCH patient to receive treatment and improve to the point where they can tolerate three hours of rehab and so be transferred to a rehab hospital. There is one acute rehab center in Brevard County, and it does not take ventilator-dependent patients. There are no hospital based skilled nursing units in Brevard County. There are no skilled nursing facilities in Brevard County that can accommodate ventilator-independent patients. Often ventilator-dependent patients also have IV antibiotics and tube feedings, and these are complicated conditions that a nursing home will not treat. LTCH care cannot be provided through home health care, because, by definition, LTCH patients meet criteria for inpatient hospitalization. Home health care is designed for patients who are very stable and have such a limited medical need that it can be administrated by a visiting nurse or by families. This is in sharp contrast to an LTCH patient where many hours a day of nursing, respiratory, and other therapies are required under the direct care of a physician. On the basis of regulation alone, STACHs could provide LTCH care. They generally do not do so because they have evolved into centers of stabilization, diagnosis, and initiating a treatment plan. Case studies bear out that when patients who made very little progress in STACHs are transferred to LTCHs, where the multidisciplinary approach takes over from the diagnostic focus, the patients improve in both medical and physical well-being. Those patients that would normally benefit from an LTCH have to dwell in the hospital for weeks until they achieve a point of stability where they can be moved in to a subacute facility; instead of continuing to move efficiently down the continuum they remain in the "upper end of the stream." This, in turn, may overwhelm the short-term acute care hospital, particularly in its ICU, resulting in patients being quartered in the auditorium at the hospital and in the hallways of the emergency room. The LTCHs available along the east coast of Florida in Fort Lauderdale or Jacksonville are at a distance from Brevard County that is an obstacle to referral of a Brevard County patient. Having a long-term care hospital in Brevard County would enhance the continuum of services available to Brevard County residents. On the other end of the referral process from Dr. Baney is Rita DeArmond, the clinical liaison for Kindred Hospital Fort Lauderdale. Her duties include, "patient evaluations on potential admissions to [Kindred Fort Lauderdale], which also involves meeting with families and educating the families, . . . case managers, . . . physicians and other people in the community about our hospital and long-term acute care hospitals in general." Kindred No. 8, at 5. She serves "Palm Beach County, the area around Lake Okeechobee [Okeechobee and Hendry Counties], Martin County, . . ., St. Lucie County, Indian River County and Brevard County." Id. at 11. In Ms. DeArmond's experience in dealing with potential long-term care hospital patients and their families not in the immediate vicinity of an LTCH, the willingness of those patients to travel great distances is the biggest hurdle for the patients admission to an LTCH. Most of the patients and their spouses are elderly, and they do not tend to travel long distances, or on the interstate. Being faced with traveling hundreds of miles round-trip to visit a loved one is very distressing to most of them. Not only would potential Brevard County LTCH patients be more likely to avail themselves of LTCH services if there were an LTCH in Brevard County but so would patients in other counties. For example, according to Ms. DeArmond, Lawnwood Regional Medical Center in Fort Pierce, a St. Lucie County STACH, and Sebastian River Medical Center, an STACH in Indian River County, would definitely send potential LTCH patients to an LTCH in Brevard County rather than the current closest LTCH, Kindred Fort Lauderdale. Having an LTCH would be a positive impact for other Brevard County STACHs as well. For example, Wuesthoff would not experience the backup in its emergency department and in its ICU beds, especially in the winter time where there is a high census due to more cases of pneumonia in the winter. If a patient who might be clinically appropriate for an LTCH remains in the ICU in an acute care hospital such as Wuesthoff, that patient does not receive the same care that he or she would receive at an LTCH. Acute care hospitals do not provide the medical rehabilitation work that LTCH's do, such as a plan of care just for the rehab of ventilator patients. An acute care hospital can deal with the pneumonia, and can wean the patient, but does not have the same plans or care or the same focus that an LTCH does with those types of patients. If the patient does not go to an LTCH, they will stay in the acute care hospital using the hospital resources. Wuesthoff has had patients there up to 65 days. The hospitals and physicians visited by Kindred- Fort Lauderdale clinical liaison Ms. DeArmond on a regular basis are located in Brevard County in District 7, as well as Indian River and St. Lucie counties. The hospitals within Brevard County that she contacts include Holmes Regional and Wuesthoff Melbourne Hospital; within Indian River County, Indian River Memorial Hospital in Vero Beach and Sebastian River Medical Center, and within St. Lucie County, St. Lucie Medical Center in Port St. Lucie and Lawnwood Hospital in Fort Pierce. In gathering letters of support that were submitted with Kindred's CON application for a long-term care hospital in Brevard County, Ms. DeArmond met with case managers and physicians and informed them of Kindred's intention to apply for a CON to build a hospital in Brevard County. The physicians and case managers who provided letters of support had previously referred patients to Kindred Hospital in Fort Lauderdale, so they were familiar with the services that Kindred can offer in an LTCH. It is reasonable to assume that such physicians and case managers would refer patients to a Kindred LTCH in Brevard County, if approved. MedPAC Concerns In denying Kindred's application, AHCA relied on reports issued to Congress annually by the Medicare Payment Advisory Committee (MedPAC) that discuss the placement of Medicare patients in appropriate post-acute settings. The June 2004 MedPAC report state the following about LTCHs: Using qualitative and quantitative methods, we find that LTCHs' role is to provide post-acute care to a small number of medically complex patients. We also find that the supply of LTCHs is a strong predictor of their use and that acute hospitals and skilled nursing facilities are the principal alternatives to LTCHs. We find that, in general, LTCH patients cost Medicare more than similar patients using alternative settings but that if LTCH care is targeted to patients of the highest severity, the cost is comparable. AHCA Ex. 7, at 121. The June 2004 MedPAC report, therefore, concludes that LTCHs should "be defined by facility and patient criteria that ensure that patients admitted to these facilities are medically complex and have a good chance of improvement." Id. Despite the above language in the June 2004 MedPAC report, discussion in the SAAR of portions of the MedPAC report shows that AHCA may have misread some of the subtleties of the MedPAC findings. The MedPAC report makes statements that LTCHs and SNFs substitute for one another. While there is some gross administrative data to support that hypothesis, that conclusion cannot yet be drawn due to limitations in data and the wide variation of patient conditions that may be represented by a single administrative grouping such as a DRG. An example of patients in different settings who would appear to be similar are those under DRG-475, which means they were on ventilator life support for at least 96 hours. Such patients may be discharged in conditions that vary greatly. These conditions range from an "alert, talking patient, no longer on life support," to a patient who is "not on life support but is making no progress." There is no administrative data that describes patients at the time of their discharge. MedPAC analysis, therefore, lacks the data to determine why some of those patients went to a higher versus a lower level of care. The SAAR also concludes, based on a letter from the MedPAC Chairman, that LTCH patients cost more on average than patients in other settings. This conclusion is based on an analysis that is unable to differentiate patients within a DRG based on their severity at the time of discharge. The limitation in the DRG is that it is designed to describe the patient's need at the time of admission rather than discharge, so the DRG classification alone does not identify whether the patient was healthy or ill at the time of discharge. Furthermore, MedPAC found that patients who tended to be more severe based on DRG assignment tended to be cared for at similar cost between LTCHs and other settings. In fact, for the tracheostomy patient, which is the extreme of severity and complexity, there was evidence of lower cost of care for patients whose case included an LTCH stay. MedPAC Chairman Glenn Hackbaith, in his March 20, 2006 letter, agreed that CMS's proposed change to the short stay outlier policy was "too severe"; that it affects a "substantial percentage of LTCH patients"; and that it would continue to affect a large percentage of admissions "regardless of the admission policies of LTCHs." MedPAC's March 2006 Report to Congress notes that the total Medicare payments to LTCHs nationwide -- $3.3 billion in 2004 -- represented less than one percent of all Medicare spending. Need Analysis in the Absence of an AHCA Need Methodology The Agency does not have a rule that sets out a formula for determining the need for LTCH beds. Accordingly, AHCA does not publish a fixed need pool for LTCH beds. As the parties agree, this case is governed, therefore, by Florida Administrative Code Rule 59C- 1.008(2)(e)2.a-d (the "Needs Assessment Rule"). Application of the Needs Assessment Rule makes Kindred responsible for demonstrating need through a needs assessment methodology that covers specific criteria listed by the rule as detailed below, following the sections of this Order devoted to Kindred's Need Methodology and AHCA's criticisms of it. Kindred's Need Methodology Kindred bases its need methodology (the "Kindred Methodology") in this case on long-stay patients in short- term hospitals. A description of the Kindred Methodology, supported and proved by the testimony of Mr. Wurdock at hearing, appears in Kindred's CON application under a section entitled "Bed Need Analysis," see Exhibit K-1, at 14. It begins with the statement: "Long-term care hospital bed need can be estimated directly based on the acute care discharges and days occurring in the market." Id. There follows a chart that lists the six Brevard County STACHs and shows the number of patient discharges in the six months ending March 2004 and the patient days for the same period. These total 68,710 and 309,704, respectively. To identify the number of patient days appropriate for LTCH care, the Kindred Methodology takes into account patient diagnosis at discharge, patient age and length of stay. Some types of patients (burn patients, obstetric and pediatric patients or behavioral patients) are not appropriate for LTCH admission. Likewise, patients with short-term rehabilitation diagnoses typically are not appropriate for LTCH care. The first step in the Kindred Methodology, therefore, is to identify and omit those diagnoses which represent patients not appropriate for long-term care admission. Those include all DRGs in the Major Diagnostic Categories (MDC) of 13-Female Reproductive System; 14-Pregnancy, Childbirth and Puerperium; 15- Newborns and Other Neonates; 19-Mental Diseases and Disorders; 20-Alcohol and Substance Abuse; 22-Burns; and 23-Factors Influencing Health Status. Two additional groups of DRGs are omitted by the Kindred Methodology: DRGs specific to patients less than 18 years of age and DRGs for organ transplant patients who are usually required to remain in the STACH for specialized care. The end result of the first step in the Kindred Methodology is a list of 387 short-term acute care DRGs ("LTCH Referral DRGs") that represent patients who potentially could be eligible for LTCH admission. The Kindred Methodology's second step is to identify discharges that are assigned to one of the LTCH Referral DRGs and are aged 18 or older and whose length of stay exceeds a threshold number of days. This threshold is described in the application as follows: The length of stay threshold is defined in terms of the national geometric mean length of stay (GeoMean). That statistic is calculated annually by the federal Centers for Medicare and Medicaid Services (CMS) for each DRG. The number of long-term hospital patients and patient days is affected by the timing of the referrals. Referrals usually occur after the patient's length of stay has become longer than average. It is commonly accepted that many patients who stay in the acute care hospital beyond the geometric mean length of stay would be best cared for in a specialized, long- term environment. Therefore, in this analysis it is assumed that referral to Kindred Hospital Brevard will occur five days after a patient has passed their DRG-specific geometric mean length of stay. This allows time for patient assessment and transfer arrangements. Another important factor affecting the potential number of long-term hospital patients and patient days is the length of time a patient stays in the LTCH. In order to qualify for Medicare certification, long-term care hospitals must maintain a minimum average length of stay of twenty-five days or greater among their Medicare patients. Admission criteria, therefore, are used to minimize the number of Medicare patients requiring just a few days of care. To reflect this in the analysis, patients are considered to be LTCH appropriate only if they would have a long-term hospital length of stay of ten days or more. Exhibit K-1, at 16. Discharged patients, therefore are considered appropriate for LTCH care by the Kindred Methodology if they are discharged from a Brevard County STACH, are at least 18 years of age, are assigned to one of the 387 Referral DRGs, and have a hospital length of stay that exceeds the geometric mean by at least 15 days, the sum of a referral period of five days and an LTCH minimum length of stay of ten days. The third step in the Kindred Methodology is to sum the potential LTCH days produced by the appropriate patients. For these patients, potential LTCH days include all days after the "'transfer day' (i.e., all days that exceed the GeoMean + five days)." Id. For the 12-month period ending March 2004, this calculation yielded approximately 18,400 hospital days in the six Brevard County hospitals, for an average daily census (ADC) of 50.4. The fourth step in the Kindred Methodology is to identify the number of patient days that are leaving Brevard County for LTCH care, due to the absence of an LTCH in the county. During the 12-month period ending in March 2004, 41 Brevard County residents were discharged from Kindred Hospital North Florida in Green Cove Springs and Kindred Hospital Fort Lauderdale. Those patients received 2,229 days of LTCH care, equaling an average daily census of 6.1. Adding that to the 50.4 ADC un-served patients in Brevard County, yields a potential LTCH ADC of 56.5. The fifth step is to account for population growth. This is especially important when there is rapid growth in senior population as there is in Brevard County. According to AHCA projections, the population 65 and over will increase 9.2 percent during the next five years, while the total population will increase 10.8 percent. It is appropriate to increase LTCH ADC at least by 9.2 percent during this time period, since the proposed project will not open until 2007 at the earliest, and will not achieve full utilization until at least 2011. This step produces an LTCH ADC of 61.7. The sixth and final step is to calculate LTCH "bed need" by assuming 85 percent occupancy. Dividing the LTCH ADC of 61.7 by 0.85 yields a bed need of 72 LTCH beds. The Kindred Methodology does not account for the five percent or more of referrals that come from sources other than LTCHs such as nursing homes. Nor does it take into account the admissions from Indian River County currently served by Kindred Hospital Fort Lauderdale, some of which are sure to come to the proposed project if approved. AHCA Criticism The methodology is criticized by AHCA on the bases, among others, that it does not account for beds available elsewhere in District 7, and that it determines need solely within Brevard County, a departure from the statutory mandate which requires Agency review of CON applications with regard to "availability, quality of care, accessibility, and extent of utilization of existing health care facilities in the service district of the applicant." § 408.035(2), Fla. Stat. (emphasis supplied). The Agency's argument with regard to the un- utilized beds at the one existing LTCH in District 7, Select-Orlando, is undermined by recent action of the agency in approving a second Select facility in Orange County, a 40-bed freestanding facility: Select Specialty Hospital-Orange, Inc. ("Select-Orange"). The Agency approved the 40-bed Select-Orange facility, not open at the time of hearing, by way of a Settlement Agreement (the "Select-Orange Settlement Agreement") with the applicant. The two parties to the agreement, AHCA and Select-Orange, jointly stated in that document: [T]he Agency, in recognizing that there are two distinct health systems in the Orlando area, believes that this LTCH is needed for the Orlando Regional Healthcare System due to that unique situation . . . Kindred Ex. 4, at 2. The two distinct health systems in the Orlando area are Orlando Regional Healthcare System, Inc., which has a number of STACHs in the Orlando area including Orlando Regional Medical Center (ORMC), a tertiary medical facility with more than 500 beds, and the Adventist Health System, Inc. (Adventist), a hospital organization with a nationwide presence that as of 2002 operated seven acute care campus systems under a single license held by Adventist d/b/a Florida Hospital in the Orlando Metropolitan Area. See Orlando Regional Healthcare System, Inc. vs. AHCA, Case No. 02-0449 (DOAH November 18, 2002), pp. 8-10. The Select-Orange Settlement Agreement was entered in the midst of administrative litigation over AHCA's preliminary agency action with regard to a CON application. The meaning and impact of AHCA's statement quoted above from the Select-Orange Settlement Agreement were not fully elaborated upon at hearing by any direct evidence. Kindred established through the testimony of Mr. Wurdock and through cross-examination of Ms. Rivera that although Select-Orange was originally approved as a "hospital-in- hospital" or "HIH," that Select-Orange obtained a modification of its CON to become a freestanding facility. Had the facility remained an HIH, federal regulations would have limited the percentage of Medicare referrals that could come from its host hospital, ORMC. As a freestanding facility, Select-Orange has no such limitations. It can fill its beds with referrals from ORMC. Whatever the impact of the freestanding nature of Select-Orange, the Agency's recognition of the unique situation in the Orlando area created by two distinct health systems, such that there is support for a new LTCH when the existing LTCH has available beds, gives rise in this case to an inference in Kindred's favor. If two distinct hospital systems in the Orlando area can support the addition of 40 LTCH beds, then it is highly likely that Brevard County can support a 60-bed LTCH. The county is not a part of the Orlando Metropolitan Area. LTCH referral patterns are north-south along the I-95 corridor (not to Select-Orlando). There are geographic and roadway access issues from Brevard County to the Orlando area demonstrated by commuting patterns that exclude Brevard County from the Orlando Metropolitan Area. And most significantly, the methodology reasonably established need for more than 60 beds in Brevard County. The Needs Assessment Rule The need for any health care service or program regulated by CON Law for which AHCA has not provided a specific need methodology by rule is governed by Florida Administrative Code Rule 59C-1.008(2)(e)(the "Need Assessment Rule"), which states in part: . . . If an agency need methodology does not exist for the proposed project: . . . If an agency need methodology does not exist for the proposed project: The Agency will provide to the applicant, if one exists, any policy upon which to determine need for the proposed beds or service. The applicant is not precluded from using other methodologies to compare and contrast with the agency policy. If no agency policy exist, the applicant will be responsible for demonstrating need through a needs assessment methodology which must include, at a minimum, consideration of the following topics, except when they are inconsistent with the applicable statutory and rule criteria: Population demographics and dynamics; Availability, utilization and quality of like services in the district, subdistrict or both; Medical treatment trends; Market conditions; and Competition. The Agency does not publish a fixed need pool for LTCH beds because it does not have a specific need formula or methodology for LTCH beds. The Agency, furthermore, has not provided Kindred with any policy upon which to determine need in this case. Accordingly, Kindred used its own methodology for determining need in Brevard County and elsewhere in the district (the Orlando Metropolitan Area). Finally, since no agency policy exists with regard to an LTCH need methodology, Kindred is required to prove the existence of need for its proposed project on the basis of the five categories of criteria (referred to in the rule as "topics") listed in sub-paragraphs "a. through e.," of paragraph 2., in subsection (2)(e) of the Rule. Population Demographics and Dynamics In assessing an area's population and demographics for the purpose of evaluating LTCH need, special attention is paid to the elderly population because the majority of LTCH patients are Medicare patients. The elderly are also more likely to produce LTCH patients because they are more likely to be medically complex and catastrophically ill with co-morbidities and dependent on medical equipment like ventilators. Brevard County, while home to only an approximate one-quarter of District 7's population, accounts for more than a third of its seniors. While Brevard County's elderly population is experiencing average or slightly below average growth in relation to the rest of the state, there is no question that Brevard County's elderly population is on the increase and reasonably projected to increase in the future. Availability, Utilization, and Quality of Like Services in the District "[B]y definition, putting a long term hospital in Brevard County will increase accessibility [make LTCH services more available] because . . . the people in Brevard County will no longer have to go all the way to Orlando, or Jacksonville, or Ft. Lauderdale for [LTCH] care." Tr. 48. Mr. Wurdock elaborated on the point of district availability at hearing: We did look at the entire district. . . . [T]here [are] only four counties in the district, three of which orbit around the Orlando and then there is the Palm Bay/Melbourne metropolitan area, which is Brevard. And when we looked at the district as a whole, what we discovered was that there is a need really for two new long term hospitals in the district. There is clearly a need for another one in Orlando [beyond the existing Select- Orlando and the approved not yet operating Select-Orange] and there is also a need for one in Brevard County. . . . [You] could build . . . two new long term care hospitals, both of them in Orlando, but that doesn't . . . make . . . sense when you've got a very large concentration of seniors significantly removed from the Orlando area with six short term hospitals in . . . [Brevard C]ounty comprising essentially its own market. So logically, you . . . put one long term hospital in Brevard and then another long term hospital in Orlando. Tr. 48-49. The presence of six STACHs in Brevard County and the large senior population is significant. The closest LTCH is Select-Orlando more than an hour's drive away. The distance to Select-Orlando and Select-Orange's future site from the municipality in which Kindred proposes to site its proposed LTCH, Melbourne, is more than 60 miles, in a direction not favored by Brevard County residents oriented to driving north or south along the I-95 corridor, but not to the west into the Orlando Metropolitan Area. Furthermore, and most significantly, family members rarely fully understand and accept that their catastrophically ill elderly loved one should be shipped 60 miles away when the patient is in a hospital with a good reputation. Their resistance to a referral at such a distance is unlikely to increase utilization at the Orlando area LTCHs no matter how convinced are their physicians and other clinical practitioners that such a move is required for better care. Medical Treatment Trends LTCHs are recognized as a legitimate part of the health care continuum by the federal government and CON approvals of LTCHs in Florida have been on the upswing throughout this decade. At the federal level, in recognition of their treatment of a small but important subset of patients, Medicare has adopted LTCH DRGs, that is, DRGs specific to LTCHs, for reimbursement under Medicare's PPS. At the state level, the Agency recognizes that "[t]he trend is for LTCHs to be increasingly used to meet the needs of patients in other settings who for a variety of reasons are better served in LTCHs." Respondent Agency for Health Care Administration's Proposed Recommended Order, at 15. This recognition is made by AHCA despite MedPAC's concerns, many of which were tempered and adequately addressed by Kindred in this proceeding. Market Conditions At first blush, market conditions might not seem to favor Kindred's application. The occupancy rate in the District indicates that there are available beds. In AHCA's view, the occupancy rate at the one existing LTCH in District 7, the 35-bed Select-Orlando facility, an H-I-H in a converted nursing home at Florida Hospital Orlando, is not optimal. Select-Orlando opened in 2003, only a few years ago, and it is operating at a high occupancy rate that is approaching optimal. Kindred, moreover, did not confine its need case to its Brevard County methodology. It also presented evidence of need in the Orlando Metropolitan Area consisting, in part, of the three other counties in District 7. Competition While the Agency asserts that it did not give competition much weight in this application, AHCA has not taken the position that Kindred's proposed facility would not foster competition. Having an LTCH in Brevard County would foster competition in the traditional sense in that the only LTCHs in the District, one existing and one approved, are those of Select Medical Corporation, Kindred's chief competitor. A Reasonable Methodology for Brevard County In short, Kindred's methodology is reasonable for determining need in Brevard County and it appropriately includes the topics required by the Needs Assessment Rule. The Agency's argument that there is no need for LTCH beds in Brevard County when there are LTCH beds available elsewhere in the district is defeated by its approval of the Select-Orange facility. Whether Kindred's methodology in this case carries the day for Kindred, given the Agency's approach on a district-wide basis to the need for LTCHs, is addressed in the section of this Order devoted to conclusions of law.
Recommendation Based on the foregoing Findings of Facts and Conclusions of Law, it is recommended that the Agency for Health Care Administration issue CON No. 9835 to Kindred Hospitals East, LLC, for a 60-bed, long-term acute care hospital in AHCA Health Planning Service District 7, to be located in Brevard County. DONE AND ENTERED this 29th day of November, 2006, in Tallahassee, Leon County, Florida. S DAVID M. MALONEY 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 29th day of November, 2006. COPIES FURNISHED: Alan Levine, Secretary Agency for Health Care Administration Fort Knox Building III, Mail Stop 3 2727 Mahan Drive, Suite 3116 Tallahassee, Florida 32308 Christa Calamas, General Counsel Agency for Health Care Administration Fort Knox Building III, Mail Stop 3 2727 Mahan Drive, Suite 3116 Tallahassee, Florida 32308 Richard Shoop, Agency Clerk Agency for Health Care Administration Fort Knox Building III, Mail Stop 3 2727 Mahan Drive Tallahassee, Florida 32308 M. Christopher Bryant, Esquire Oertel, Fernandez, Cole & Bryant, P.A. 301 South Bronough Street Tallahassee, Florida 32302 Sandra E. Allen, Esquire Agency for Health Care Administration Fort Knox Building III, Mail Stop 3 2727 Mahan Drive Tallahassee, Florida 32308
The Issue Whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact The Department is the State agency charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. At all times material to this proceeding, Dr. Mationg was a licensed physician in the State of Florida. His license, numbered ME 0028183, was issued on April 13, 1976. Dr. Mationg is the primary care physician of A.A. Dr. Mationg referred A.A. to Dr. Steven Schafer, an orthopedic surgeon, for pain in the right shoulder, which was found to require arthroscopic surgery and repair of a rotator cuff. On January 10, 2000, A.A. was admitted to Regional Medical Center Bayonet Point (Bayonet Point) for surgery. At the time of his admission to the hospital, A.A. was 65 years old and suffered from numerous medical problems. He had cardiomyopathy, meaning his heart was enlarged and not functioning properly. A.A. had high blood pressure and a history of heavy smoking. He had generalized arteriosclerosis and peripheral artery disease. A.A. had previously had surgeries involving the placement of a stint and angioplasty. Based on his medical history, A.A. was subject to a stroke and a heart attack. Prior to his admission to the hospital, A.A. had been taking aspirin daily. Approximately three days prior to surgery, A.A. was directed by Dr. Schafer to discontinue taking aspirin. The aspirin was discontinued to reduce the risk of A.A.'s blood not being able to clot sufficiently. The hospital records of A.A. contain a request for consultation with Dr. Mationg for medical management dated January 10, 2000. The discharge summary shows that the medical evaluation was obtained so that A.A. could be followed by his primary care physician for his hypertension and other medical history. Dr. Schafer performed the surgical procedure on A.A. on January 10, 2000. A.A. had some respiratory problems, and Dr. Mationg ordered a pulmonary consultation with Dr. Patel the afternoon of January 10, 2000. Because of the respiratory problems, A.A. was placed on a ventilator and transferred to the intensive care unit. On January 11, 2000, Dr. Patel extubated A.A., which means that A.A. was taken off the ventilator. On January 11, 2000, Dr. Mationg saw A.A. at 9:00 a.m. and wrote and signed an order for lasix and lanoxin for A.A. Around 3:15 a.m. on January 12, 2000, A.A. was awakened for respiratory therapy and experienced numbness in his left arm and slurring of speech. When A.A. smiled, the left side of his mouth remained flat while the right side turned up. The nurse on duty was called, and he observed A.A.'s symptoms. A.A.'s symptoms indicated that he was having a stroke. Nurse Culligan notified Drs. Schafer and Mationg. Dr. Mationg did not come to the hospital to evaluate A.A. The standard of care would have required him to come to the hospital to evaluate A.A. because A.A. was exhibiting the symptoms of a stroke. Instead of coming to the hospital to do an evaluation, Dr. Mationg gave the following orders telephonically to Nurse Culligan at 4 a.m., on January 12, 2000: T.O. Dr. Mationg/M. Culligan do CT head [without] contrast today a.m. do carotid doppler study today a.m. consult Dr. S. Shah for neuro eval. get speech therapy eval. and video swallow today. Nurse Culligan wrote the orders on A.A.'s chart; Dr. Mationg later countersigned the orders. The term "stat" in medical parlance means immediately or as soon as possible. An order is not presumed to be stat if the order does not specify that it is stat. The tests and consultation which Dr. Mationg ordered at 4 a.m., on January 12, 2000, were not ordered to be implemented stat. The standard of care for treating A.A. required that Dr. Mationg order a stat neurological consultation and a stat head CT scan. Bayonet Point has established policies for its imaging services department, including CT services. The normal hours for CT services are 7 a.m. to 11 p.m., Monday through Sunday. After normal hours, the services are provided on-call. Bayonet Point's call-back procedures include the following: When an emergent radiologic procedure is ordered after hours, the Radiology personnel will contact the appropriate on call technologist via the hospital operator. Once the procedure is complete, the Technologist will call the Radiologist on call and then transmit those images via Teleradiography. Definition of an emergent procedure: In- house STAT, Emergency Department physician requesting radiologist interpretation, any outpatient whose physician requests immediate radiologist interpretation or "wet reading." Prior to A.A.'s experiencing the symptoms of a stroke at 3:15 a.m., no orders had been given for A.A. to resume taking aspirin. At 10 p.m. on January 10, 2000, Dr. Schafer ordered that "till further notified" all medications taken by mouth which could be taken intravenously were to be administered via an IV. Aspirin could not be administered intravenously. Because Dr. Schafer had ordered that aspirin therapy be stopped prior to surgery, it would be the responsibility of Dr. Schafer to order the aspirin to be restarted. Dr. Schafer was at A.A.'s bedside at 8:30 a.m., on January 12, 2000. Dr. Schafer noted that a head CT scan was ordered for that morning and that the patient was on his way down for the test. Dr. Schafer also noted that a neurological evaluation had been ordered for A.A. for that morning. The hospital records show that at 8:50 a.m., on January 12, 2000, a call was made to Dr. Shah's answering service, requesting a neurological consultation. The request for consultation form, which was filled out after Dr. Schafer's visit at 8:30 a.m., indicated that the request was an emergency request. The request for consultation form was filled out by someone other than the nurse who charted Dr. Mationg's verbal order for a neurological consultation. Based on the evidence presented, the request for a neurological consultation was not treated as an emergency request until after Dr. Schafer saw A.A. at 8:30 a.m. Tissue Plaminogen Activators (TPA) are used to dissolve clots which may be causing a stroke. The use of TPA is limited to a three-hour window following the onset of stroke symptoms. Dr. Mationg did consider the use of TPA, but felt that it was contraindicated based on the recent surgery. This opinion was confirmed at final hearing by a neurologist.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Dr. Mationg violated Subsection 458.331(1)(t), Florida Statutes; finding that Dr. Mationg did not violate Subsection 458.331(1)(m), Florida Statutes; placing Dr. Mationg on two years probation; imposing an administrative fine of $5,000; and requiring that Dr. Mationg attend ten hours of continuing medical education courses in the diagnosis and treatment of strokes and four hours of continuing medical education courses in risk management. DONE AND ENTERED this 3rd day of July, 2003, in Tallahassee, Leon County, Florida. S ___________________________________ SUSAN B. KIRKLAND Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of July, 2003. COPIES FURNISHED: James W. Earl, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 A. S. Weekley, Jr., Esquire Holland & Knight, LLP 400 North Ashley Drive, Suite 2300 Tampa, Florida 33602 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, the documentary evidence received and the entire record compiled herein, I hereby make the following Findings of Fact: Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME 0040343. On the morning of October 7, 198A, the Metro-Dade County Rescue Squad called the emergency room at Miami General Hospital and informed the staff that they were enroute to the hospital with a gunshot victim. Dr. Segurola, the emergency room physician, was informed of the victim's condition and immediately ordered a nurse to notify the operating room team and call a surgeon because he knew in advance that "this was going to be a serious surgical case." At approximately 7:42 a.m., the rescue squad arrived at Miami General Hospital with the victim, Samuel Kaplan. Kaplan was taken to the emergency room suffering from a gunshot wound to the abdomen inflicted by a .32 caliber bullet. When Kaplan arrived in the emergency room, his systolic blood pressure was approximately 60, he was wearing a MAST suit, he had an intravenous (IV) line going, and he was receiving oxygen. Although Kaplan was conscious and able to speak, his condition was unstable and very serious. Kaplan was initially treated by Dr. Segurola, the emergency room physician. Three nurses, a respiratory therapist and an x-ray technician were also present in the emergency room. Dr. Segurola conducted a brief physical examination of Kaplan. An entrance wound was found, but there was no exit. After the examination, a second IV line was started in the other arm and a third, central line was started in the subclavin vein. The IV lines were set at maximum or "wide open." The emergency room staff was attempting to rapidly increase Kaplan's blood volume and pressure. Kaplan's hemoglobin level was low (approximately 8 or 9), which is a sign that a patient is anemic due to loss of blood. At approximately 8:00 a.m., Respondent received a message from his telephone answering service to call Dr. Segurola at the hospital's emergency room. At approximately 8:02 a.m., the Respondent returied the telephone call and spoke with Dr. Segurola concerning the patient's condition. During the conversation, the Respondent advised Dr. Segurola to contact the operating room team and anesthesiologist to prepare for surgery. The Respondent arrived at the emergency room of Miami General Hospital in response to the call at approximately 8:12 a.m. Upon the Respondent's arrival at the emergency room, he was informed that Kaplan's blood pressure was 108/50, heart rate 106 and respiration 28. The Respondent spoke to Kaplan and Kaplan stated that he had been shot in the stomach. Respondent then proceeded to conduct a brief, but thorough, physical examination of the patient. When Respondent completed his examination, he was advised that Kaplan's blood pressure was approximately 124/50, heart rate remained at 106 and respiration remained at 28. At this point, the Respondent believed that Kaplan's condition was stabilized. Respondent advised Dr. Segurola that Kaplan should immediately be taken to the operating room for surgery. The Respondent was informed that the operating room was not quite ready and that the anesthesiologist had not arrived. While waiting for the operating room team, Respondent and Dr. Segurola reviewed x-rays of Kaplan. The emergency room nurse continued to take Kaplan's vital signs. Kaplan's blood pressure remained at 124/50. At approximately 8:20 a.m., while Respondent, Dr. Segurola and others in the emergency room were waiting for confirmation that the operating room was ready, a hospital admissions clerk walked in and informed the emergency room staff that Kaplan belonged to the Health Maintenance Organization ("HMO"). An HMO is a plan in which a patient makes pre-payment for services and is then provided medical services from a designated panel of participating physicians. The emergency room maintained two "on-call" lists, one for HMO surgeons and one for non-HMO surgeons. The Respondent was on the non-HMO list. Dr. Segurola and Respondent had a brief discussion wherein both men acknowledged that under existing hospital policy, the HMO surgeon should have been called. Thereafter, Dr. Segurola informed a nurse to telephone the on-call HMO surgeon. The HMO surgeon on call was Dr. Moises Jacobs. A secretary in the emergency room placed a call to Dr. Jacobs at approximately 8:25 a.m. Dr. Jacobs returned the phone call between 8:25 a.m. and 8:30 a.m. Dr. Jacobs spoke with Dr. Segurola. While Dr. Segurola was on the phone, Dr. Jose Selem, the anesthesiologist, arrived in the emergency room. Dr. Jacobs told Dr. Segurola to ask the Respondent to take the patient to surgery immediately and stated that he would arrive at the hospital in about 20- 30 minutes. When the Respondent was told of Dr. Jacobs' request he replied that the patient was stable and could wait for Dr. Jacobs. Dr. Selem, the anesthesiologist, also spoke with Dr. Jacobs on the telephone. Dr. Jacobs told Dr. Selem to advise Respondent that Respondent could take the patient to surgery. When Dr. Selem advised Respondent of what Dr. Jacobs has said, the Respondent replied that since Dr. Jacobs was coming to the hospital and Kaplan was an HMO patient, Respondent preferred to wait for Dr. Jacobs, the HMO surgeon. Dr. Selem then left the emergency room and went to the operating room to prepare the necessary instruments. At approximately 8:30 a.m., the Respondent advised Dr. Segurola that he was going to the hospital cafeteria for a cup of coffee and, if any changes occurred in the patient, he should be contacted. The cafeteria was located across a corridor approximately 20-25 feet from the emergency room. At the time, Kaplan was still alert and his vital signs were being constantly monitored by the nursing staff. Dr. Segurola remained in the emergency room. The operating room and all necessary personnel were ready for surgery at approximately 8:40 a.m. Sometime between 8:40 a.m. and 8:45 a.m., one of the nurses told Dr. Segurola that the Respondent's condition was deteriorating and that his blood pressure was dropping. At approximately 8:45 a.m., Kaplan's blood pressure had dropped to 80/50. Dr. Segurola told the nurse to give more blood to Kaplan (a blood transfusion had already been started). Dr. Segurola then went to the cafeteria to speak with Respondent. Dr. Segurola told Respondent that the patient's condition was deteriorating, a blood transfusion had been started, and he feared that Kaplan might die in the emergency room. The Respondent inquired as to how long it had been since Dr. Jacobs had been called and Dr. Segurola responded twenty (20) minutes. Respondent questioned whether it really had been 20 minutes. Both men looked at their watches and determined that it had been about 15 minutes since Dr. Jacobs had been called. Respondent told Dr. Segurola to call the anesthesiologist. Dr. Segurola went back to the emergency room, believing that Respondent was going to immediately follow him there. When Dr. Segurola arrived back at the emergency room, Kaplan's condition had not improved. Dr. Segurola waited about three (3) more minutes and went back to the cafeteria for the second time. Dr. Segurola again informed the Respondent about Kaplan's deteriorated condition and his fear that Kaplan was going to die in the emergency room. Respondent once more asked Dr. Segurola to call the anesthesiologist. Dr. Segurola told Respondent that the anesthesiologist was there and that "we need you there." Dr. Segurola then went back to the emergency room. The Respondent remained in the cafeteria. Shortly before 9:00 a.m., while Dr. Segurola was away from the emergency room, Dr. Lustgarten, a neurologist, had just finished his rounds and was leaving the hospital through the emergency room to the parking lot. Dr. Lustgarten looked in on Kaplan to determine if there was any neurological damage. Dr. Lustgarten examined Kaplan and concluded that there was no neurological damage and that, in his opinion, Kaplan's condition was stable with a systolic blood pressure of approximately 100. Dr. Lustgarten left the emergency room just as Dr. Jacobs arrived at approximately 9:00 a.m. Dr. Lustgarten told Dr. Jacobs that Kaplan had no neurological damage. Dr. Jacobs conducted a brief examination of Kaplan and determined that Kaplan needed to be taken to the operating room immediately for surgery. The anesthesiologist, Dr. Selem, had by then been summoned to the emergency room and assisted Dr. Jacobs in an unsuccessful attempt to intubate Kaplan prior to taking him to the operating room. Shortly after Dr. Jacobs arrived, the Respondent left the cafeteria and headed towards the emergency room. Before Respondent reached the entrance to the emergency room, he was informed by one of the nurses that Dr. Jacobs had arrived. The Respondent stood at the entrance to the emergency room for a brief period and watched as Dr. Jacobs and others attended to Kaplan. Respondent then left the building, went to his car and drove home. Meanwhile, Dr. Jacobs performed an emergency exploratory laparotomy and left thoracotomy on Kaplan. Between 9:00 am. and 9:15 a.m., after Kaplan was moved from the emergency room to the operating room, his blood pressure went from 90 down to 60, and he went into shock. There are three possible contributing factors for Kaplan's going into shock at this time: (1) moving him may have dislodged ,a blood clot which in all likelihood prevented an earlier complete "bleeding out"; (2) the blood clot may have been diluted by the IV fluid; and (3) the institution of anesthesia. During surgery it was discovered that the bullet had perforated the aorta, a major blood vessel. While still in surgery, Kaplan went into cardiac arrest and was pronounced dead at 10:25 a.m. on October 7, 1984. At the time that Respondent left the emergency room and went to the hospital cafeteria, Kaplan's vital signs were in a relatively stable condition. Kaplan's vital signs de-stabilized while Respondent was in the hospital cafeteria, and his systolic blood pressure dropped from approximately 120 to approximately 80. At all times prior to being taken to the operating room, Kaplan's vital signs were maintained with the assistance of a MAST suit. A MAST suit is an inflatable device used in the treatment of trauma patients which applies pressure to the body and assists in elevating blood pressure. When the MAST suit is removed, the patient's vital signs will deteriorate again. For this reason, many physicians consider vital signs obtained under such conditions to be false readings, and the MAST suit is usually not removed until the patient is in the operating room. Although the Respondent suspected that the bullet might have damaged the small bowels and caused some internal bleeding, the Respondent neglected to ask about the amount of fluids Kaplan had received. Kaplan had received over 4 to 5 liters of fluid prior to arriving at the hospital and received an additional 5 liters of fluid while waiting to be taken to surgery. Although this information would have been useful, it would not necessarily have indicated the extent of Kaplan's massive internal bleeding. The amount of fluids that Kaplan received prior to the Respondent leaving the emergency room was not necessarily a sign that Kaplan's condition was unstable. In the treatment of trauma cases, time is of the essence. A trauma patient with a gunshot-wound to the abdomen should be taken to surgery as soon as possible. In some cases, it may be advantageous to delay surgery in order to stabilize the patient's vital signs or to increase blood volume. Generally, if surgery is performed within the first hour after the injury is sustained (referred to as "the golden hour"), the better the chances of the patient surviving. The golden hour does not apply to injuries of the heart and major blood vessels. In those cases, the patients will "bleed out" in a time much shorter than one hour. Nevertheless, even where the golden hour has passed, the patient should be taken to surgery at the first available opportunity and without delay. While in the emergency room at Miami General Hospital, Kaplan's condition ranged from "serious" to "critical." From the time that Kaplan was initially admitted to Miami General Hospital his condition was such that he required immediate surgical intervention. A reasonably prudent physician in the Respondent's position would have performed surgery at the first available opportunity and would not have waited for the arrival of another surgeon. Although pursuant to hospital and HMO rules, the HMO surgeon should have been called first, where an emergency situation exists the first surgeon available is expected to take the patient to surgery, and that physician will be provided payment by the HMO. The Respondent was aware of the hospital's and HMO's policies regarding HMO and non-HMO patients based on prior experience. The Respondent has never previously been disciplined or investigated by Petitioner or any medical board in any jurisdiction. Respondent maintains an excellent reputation for competence and compassion among his fellow physicians. Respondent is well liked by his patients and has provided medical services in the past to patients with no medical insurance.
The Issue The issue is whether Respondent properly cited Petitioner for violating Section 400.0225(11), Florida Statutes, by taking a resident to the emergency room for a mental health evaluation without complying with the requirements outlined in Section 394.463, Florida Statutes, for an involuntary examination.
Findings Of Fact Respondent is the agency responsible for licensing and regulating nursing home facilities under Chapter 400, Part II, Florida Statutes. Petitioner is a nursing home facility in Baker County, Florida. Petitioner is located in the same building as Ed Fraser Memorial Hospital (Ed Fraser). The distance from Petitioner to Ed Fraser's emergency room is approximately 300 feet. Petitioner and Ed Fraser have separate licenses. However, they are operated by the same parent organization. At all times material here, Resident E. E. was one of Petitioner's residents. Resident E. E. had a history of psychological problems but did not require psychiatric inpatient care. Resident E. E. was well enough to be a resident at the nursing home under the care of her attending physician and Petitioner's Medical Director, Angelito Tecson, M.D. Resident E. E., at 72 years-of-age, suffered from Alzheimer's and chronic schizophrenia, paranoid type. Her medications included Fosamax, eye drops, Seroquel, Zoloft, Risperdal, and Namenda. Resident E. E. received treatment from a consulting psychiatrist for her psychiatric condition. Her psychiatrist usually visited the nursing home once a month. The psychiatrist lived in Jacksonville. Dr. Tecson is a family practitioner who maintains an office in Baker County, Florida. Because he lives in Jacksonville, Florida, Dr. Tecson usually is not at his office after 5:00 p.m. Around the first of August 2006, Resident E. E. began to exhibit troublesome behaviors that did not respond to redirection or a change in medication. On August 14, 2006, after 5:00 p.m., Resident's E. E.'s escalating behaviors included the following: (a) trying to eat food out of the garbage can; (b) taking her clothes off; (c) taking soiled laundry out of the basket; (d) drinking coffee creamer; and (e) hitting Petitioner's Director of Nursing, Phyllis Rhoden, R.N., who was trying to redirect her. Ms. Rhoden knew Resident E. E. was being treated for a urinary tract infection (UTI) and was concerned that the medicine was not controlling the infection. Ms. Rhoden was aware that a UTI can do "really wicked things" to elderly people such as causing mental status changes. Petitioner usually tested for and treated UTIs in the nursing home. However, Ms. Rhoden did not initiate any procedure in the nursing home to determine whether Resident E. E. continued to suffer from a UTI. Instead, Ms. Rhoden directed one her nurses, Samantha Godwin, L.P.N., to call Dr. Tecson on the telephone. Ms. Godwin told Dr. Tecson that Resident E. E. was combative and creating concerns about her own safety and the safety of others. Dr. Tecson gave Ms. Godwin a verbal order to transfer Resident E. E. to Ed Fraser's emergency room for a mental evaluation. On August 14, 2006, at 5:30 p.m., Ms. Godwin wrote and initialed the following physician's order in Resident E. E.'s medical chart: "Send to ER for mental eval., V. O. Dr. Tecson." Dr. Tecson initialed the order on August 30, 2006. Petitioner had a part-time social worker, Rosa Williams, who happened to be at the nursing home. Ms. Williams witnessed Resident E. E.'s behavior. Ms. Rhoden and Ms. Williams walked Resident E. E. down the hall to the emergency room. Ms. Williams stayed with Resident E. E. and Ms. Rhoden returned to the nursing home. Petitioner's staff did not follow the procedure set forth in Section 394.463, Florida Statutes, before involuntarily transferring Resident E. E. to the emergency room for a mental evaluation. Petitioner's staff transferred Resident E. E. without a certificate from a designated professional, without an ex-parte order, and/or without law enforcement involvement. The emergency room medical records indicate that Resident E. E.'s major complaint was an "altered mental status." The diagnosis was "decompensated schizophrenia." The emergency room medical records do not refer to any other medical problem being evaluated and/or ruled out. The emergency room doctor called for an emergency screening assessment by an evaluator from the Northeast Florida State Hospital (NEFSH) Community Behavioral Healthcare Services. The evaluation resulted in a disposition plan that called for stabilization and admittance to the least restrictive facility. A deputy sheriff transported Resident E. E. from the emergency room to the NEFSH Receiving Facility on August 14, 2006, sometime after 8:30 p.m. She was subsequently admitted to that facility. On August 14, 2006, at 8:40 p.m., Dr. Tecson gave Ms. Godwin another verbal order over the telephone. The order was to transfer Resident E. E. to NEFSH. Dr. Tecson initialed the order in Resident E. E.'s medical chart on August 30, 2006. Resident E. E.'s medical record contains two nursing progress notes for August 14, 2006. The first one states that Resident E. E. was sent to the emergency room for a mental evaluation. The second one states that Resident E. E. was sent to NEFSH for treatment of mental status. Ms. Williams, the social worker, also made the following notation in Resident E. E.'s medical record on August 14, 2006: It was reported upon this S.W.'s arrival that resident's behavior is getting progressively worse by the day. On today she attempted to leave the facility and staff tried to re-direct her but she struck the person. She continues to come out of her room nude and when she is not totally nude, she pulls her dress up to show that there is no underwear. She also became aggressive (physically) with the ladies who deliver the [washed] clothes to the nursing home. She wanted to take all of the clothes and began hitting them when they refused to give them to her. She cursed them, which is totally out of character for her. At this point it was felt that resident now needs to be evaluated by the local mental health CSU. The resident has been evaluated by her attending psychiatrist on 8/8/06, but there has been very little improvement. In fact, there has been no improvement and resident's condition continues to get worse. Also, from reviewing her records, the resident appears to have been decompensating since May 2006. In addition to above stated inappropriate behaviors, the resident has been refusing her medication or was observed spitting them out. This S.W. called the local mental health office and requested assistance from the emergency service department by dialing two numbers. A response was not received, but in the message on voice mail it was stated that if someone needed their emergency services they should go to the jail or nearest ER (emergency room of a hospital). This resident was taken to ER at Fraser Hospital, evaluated by doctor on duty, an MH evaluator was called and later responded to the call. It was decided by the MH evaluator that residential treatment was needed. The resident was transported to Northeast Florida State Hospital by the Sheriff Dept. Upon arriving, she was accepted, bathed, and hopefully given something to eat. The resident should remain at NEFSH for at least 3 days for an evaluation. Hopefully, after being evaluated, she may be able to return back to the nursing home. If not stable in three days, NEFSH should consider long term treatment at their facility. It should be noted that this resident has a long psychiatric history. She resided at NEFSH for four years and G. Pierce Woods for almost eight years. Her first hospitalization occurred at the age of 14. This S.W. will continue to check on resident's status. In a memorandum dated August 15, 2006, Kevin D. Harris, Petitioner's Administrator, stated as follows: Approximately @ 1:50 p.m., I refused the readmission of [Resident E. E.]. This refusal was based on the recommendation of the Medical Director, Dr. Angelito Tecson, the Director of Nursing, Phyllis Rhoden, R.N., and Rosa Williams, Social Worker. [Resident E. E.] was transported here via Century ambulance without a 300B transfer sheet. Prior to this onsite refusal of readmission, the readmission was denied by Phyllis Rhoden, R.N., to NEFSH discharge personnel. The readmission was refused due to the fact that [Resident E. E.] had been Baker Acted on the evening of August 14, 2006, by Ed Fraser Memorial Hospital Emergency Room physician. Her ER visit was precipitated by a mental status change whereby [Resident E. E.] was combative and a danger [to] staff, residents and perhaps herself. Readmission would be reconsidered, after appropriate stabilization of [Resident E. E.] on a medication protocol that is appropriate for her needs and can be regulated in a nursing home environment.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Agency for Health Care Administration enter a final order finding that Petitioner violated Section 394.463(2), Florida Statutes, and confirming the imposition of the class- three citation. DONE AND ENTERED this 31st day of August, 2010, in Tallahassee, Leon County, Florida. S SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 31st day of August, 2010. COPIES FURNISHED: Laura Beth Faragasso, Esquire Henry, Buchanan, Hudson, Suber & Carter, P.A. Post Office Box 14079 Tallahassee, Florida 32317 Richard Joseph Saliba, Esquire Agency for Health Care Administration 2727 Mahan Drive, Building 3, Mail Station 3 Tallahassee, Florida 32308 Richard J. Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Justin Senior, General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Thomas W. Arnold, Secretary Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308
The Issue Whether Respondent committed the violations alleged in the Amended Administrative Complaint, and, if so, what disciplinary action should be taken against him.
Findings Of Fact Based upon the evidence adduced at the final hearing and the record as a whole, the following findings of fact are made: Respondent is now, and has been since October 17, 1996, a Florida-licensed registered nurse. He holds license number 3109442. From September 11, 2000, to March 28, 2001, Respondent was employed as a registered nurse by the North Broward Hospital District and assigned to the emergency room at Imperial Point Medical Center (IPMC) in Broward County, Florida. IPMC is a division of the North Broward Hospital District. It serves as a designated Baker Act receiving facility where persons are "brought involuntary[ily] for psychiatric evaluation" and referral. Some of these persons are "dangerous and violent" and have "cause[ed] injuries to the staff of the emergency room." In early 2001, Respondent was involved in two separate incidents in which he mistreated a patient in the emergency room at IPMC. The first incident occurred on or about February 23, 2001. On that day, K. N., a 21-year-old female, was admitted to the emergency room suffering from "acute intoxication." Pursuant to emergency room policy, upon her admittance to the emergency room, K. N. was "completely undressed . . . to make sure that [she was] not hiding any drugs, contraband, weapons, [or other] things of that nature." K. N. was lying, "passed out" and completely naked, on a stretcher in an examining room with Respondent by her side, when one of the hospital's emergency room technicians, Robert Russo, walked into the room to assist Respondent. Respondent greeted Mr. Russo by making the following comments about K. N.: "Look at those tits. Wouldn't you like to get a piece of that?" Mr. Russo left the room to get a hospital gown for Respondent to put on K. N., as Respondent was required to do, in accordance with hospital policy, so as "to preserve [K. N.'s] dignity." Mr. Russo returned with a gown and gave it to Respondent, but Respondent did not put it on K. N. or otherwise use it to try to cover K. N. Respondent, though, did continue making comments about K. N.'s body. Referring to K. N.'s genitals, he remarked to Mr. Russo, "That's sweet," or words to that effect. Feeling "uncomfortable," Mr. Russo left the room. By allowing K. N. to remain completely naked and by making the remarks he did to Mr. Russo about K. N.'s body, Respondent failed to conform to the minimal acceptable standards of prevailing nursing practice. The following month, Respondent was involved in another incident in which he acted inappropriately toward an IPMC emergency room patient. This second incident occurred on March 18, 2001. The patient Respondent mistreated on this day was F. L., a 17-year-old male with a history of drug abuse. F. L. was brought to the IPMC emergency room by the City of Pompano Beach Fire/Rescue at the request of F. L.'s mother, J. L., who accompanied him to the emergency room and remained there for the duration of F. L.'s stay. J. L. had "called 911" after F. L. had come home from a night of drinking and, in her presence, had had a seizure. By the time fire/rescue arrived at their home, F. L. was conscious, and he remained conscious during the ambulance ride to IPMC. J. L. wanted F. L. to be involuntarily committed under the Baker Act. She did not think she would be able to handle his coming back home because he "was on drugs at the time" and she thought that he would "go crazy" if he did not receive treatment. F. L. was aware of his mother's desire. In the past, he had attempted to "fight" (verbally, but not physically) efforts to have him "Baker Acted." F. L. was admitted to the IPMC emergency room at 3:49 a.m. on March 18, 2001. At the time of his admittance, F. L. was conscious, "somewhat calm," and able to stand up and walk "with a wobble" and to speak coherently (although his speech was slurred). He was asked to give a urine sample for a "urine screen," and with the help of his mother, who accompanied him to bathroom "[s]o he wouldn't fall or miss the cup," he complied. F. L. soon became upset and "verbally abusive to the staff" on duty, including Respondent. Respondent decided that F. L. needed to be restrained. With the help of others, including Mr. Russo, Respondent restrained F. L. "with Velcro restraints on the wrists and the ankles." Respondent then requested that F. L. give another urine sample. F. L., in turn, "asked for a urine bottle." Respondent refused F. L.'s request. Instead, he took out a Foley catheter. A Foley catheter is a thin, flexible rubber tube that is threaded through the urethra and into the bladder. It is used to drain urine from the bladder. It should be sterile and lubricated when inserted. F. L. went "totally beserk" when he saw the catheter, letting it be known in no uncertain terms that he did not want to be catherized and again requesting that he be given a "urine bottle." Respondent responded, inappropriately, by "hit[ting] [F. L.] in the face with the catheter numerous times," while telling F. L. two or three times, "I'm going to shove this hose down your dick." This caused F. L., understandably, to become even more loud and boisterous. Respondent enlisted the assistance of three or four others, including Mr. Russo and George Austin, a Wackenhut security officer on patrol at the hospital, to place F. L. in four-point leather restraints (one for each ankle and wrist) on a stretcher in Room 6. 1/ F. L. resisted, but was eventually subdued and restrained on the stretcher. Given F. L.'s out-of-control behavior, placing him in four-point restraints was warranted. After F. L. was restrained on the stretcher, Respondent, against F. L.'s will, inserted the Foley catheter (that he had used to hit F. L. and that was therefore not sterile) in F. L. 2/ Respondent did so in a rough and negligent manner, without using lubricating jelly or any other type of lubrication. Subsequently, while F. L. was still in four-point restraints on the stretcher, he became "more upset, more verbally abusive," and "tried to sit up." Respondent responded, inappropriately, by "grabb[ing] [F. L.] by the neck," "slapp[ing] him back down onto the stretcher," and "choking [F. L.] until [F. L.] was almost blue." Respondent "let go" of F. L. only after an observer intervened. After Respondent stopped choking him, F. L. "asked for his mother." 3/ Respondent responded, again inappropriately, by telling F. L. three times, "I got your mother right here," as he "grabbed his own testicles." 4/ As could be expected, this "further upset" F. L., and he again tried to sit up. Respondent's response was, again, an inappropriate one. He "climbed up on the stretcher," "put his right knee on [F. L.'s] chest," "cover[ed] F. L.'s face" with his left hand, and with his right hand "grabbed" F. L.'s penis and scrotum and "squeeze[d] and twist[ed]." Respondent, without any justification, "squeeze[d] and twist[ed]" F. L.'s penis and scrotum "two or three times" while F. L. was in four-point restraints on the stretcher. On one of these occasions, he told F. L. (as he was "squeeze[ing] and twist[ing]") "something like," "What are you going to do now?" During his encounter with F. L. on March 18, 2001, Respondent used more force against F. L. than was reasonably necessary to properly discharge his nursing duties and to protect himself and those around him. 5/ By physically, and also verbally, abusing F. L., Respondent failed to conform to the minimal acceptable standards of prevailing nursing practice. 6/ When J. L. was finally reunited with her son, she noticed that he had red marks on his face and "bruise[s]" on his extremities. The IPMC emergency room physician who evaluated F. L. determined that there was reason to believe that F. L. was "mentally ill as defined in Section 394.455(18), Florida Statutes" (based upon an "initial diagnosis" of "acute agitation"), and that F. L. otherwise met the "criteria for involuntary examination" under the Baker Act. At approximately 2:45 p.m. on March 18, 2001, F. L. was discharged from IPMC and transferred to Florida Medical Center. Sometime after the March 18, 2001, incident involving F. L., a security officer and nurse working at IPMC expressed to Beverly Gilberti, the nurse/manger of IPMC's emergency room, their "concerns" regarding Respondent's "practice." On March 26, 2001, Ms. Gilberti contacted Gayle Adams, IPMC's human resources specialist, and told her about the security officer's and nurse's "concerns." Ms. Adams began an investigation into the matter. Ms. Gilberti telephoned Respondent and advised him that he was being suspended pending the outcome of an investigation into alleged wrongdoing on his part. Respondent was given "very little information as to what type of complaint[s]" were being investigated. On March 28, 2001, before the investigation had been completed, Respondent telephoned Ms. Adams and "verbally resigned over the phone."
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Board issue a final order in which it dismisses Count Three of the Amended Administrative Complaint, finds Respondent guilty of the violations alleged in Counts One and Two of the Amended Administrative Complaint, and, as punishment for having committed these violations, permanently revokes Respondent's license and requires him to pay a fine in the amount of $1,000.00, as well as the "costs related to the investigation and prosecution of the case." 16/ DONE AND ENTERED this 4th day of November, 2002, in Tallahassee, Leon County, Florida. STUART M. LERNER 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 4th day of November, 2002.
The Issue An administrative complaint dated November 9, 1990 alleges that Respondent violated Chapter 458, F.S., governing the practice of medicine, by failing to conduct a complete history and medical examination, failing to order an EKG, failing to admit for cardiac observation and failing to keep adequate written medical records of a patient which he treated in a hospital emergency room in Kissimmee, Florida. The issue is whether those violations occurred and if so, what discipline is appropriate.
Findings Of Fact Respondent, Benjamin P. Delgado, M.D., is now and at all times relevant has been a licensed physician in the State of Florida, having been issued license number ME 0029222. Dr. Delgado has been licensed in Florida since 1982, and for the last nine years has maintained a private practice of internal medicine in Kissimmee, Osceola County. Dr. Delgado has also provided emergency room services, under contract, at Humana Hospital in Kissimmee. He came on duty at the emergency room on February 23, 1989, at 8:00 p.m. The patient, identified as "Patient #1" in the administrative complaint, checked into the emergency room on February 23, 1989 at approximately 8:19 p.m., accompanied by his wife. Patient #1 was a 56-year old male, approximately 6'1", weighing 181 lbs. He complained of severe upper abdominal pain. After the emergency room clerk recorded the patient's name, address, relevant insurance information and chief complaint, the patient was seen by the emergency room staff nurse, Janet Kusser, R.N. The nurse noted on her chart that the patient had complained of severe pain in his upper abdomen on and off since 3:00 a.m. She recorded his temperature, pulse, respiration rate and blood pressure; she inquired about allergies and any medications he might be on. She also completed an emergency room assessment sheet, which involved circling relevant answers on a questionnaire form addressing a brief medical history, and current physical condition. The patient was ambulatory, had normal respiration, was alert and cooperative, had warm skin with pink extremities. He exhibited tenderness in his upper abdomen, and that is where he said the pain was -- centered beneath his chest. Two attempts to notify the patient's family physician, at 8:25 and 8:55 p.m., were unsuccessful. When the nurse completed her assessment, she introduced Dr. Delgado and gave him the chart. The emergency room was not crowded, although staff was busy. A patient vocally complaining of chest pains was being seen around the same time that patient #1 checked in. Still, Dr. Delgado was able to devote full attention to Patient #1 in his examination. He went through the same questions as the nurse did on the emergency room assessment form and substantially agreed with her findings. He also found the upper abdomen to be tender. The patient clutched his stomach and was doubled over. He was not grasping his arm and he denied having pain in any extremities. The patient denied having prior medical conditions as heart disease, asthma, hypertension or diabetes. Negative findings were not recorded by Dr. Delgado on the chart. For example, he noted tenderness in the epigastrium, but did not note the lack of pain in the extremities. Dr. Delgado considered the complaints to be related to gastritis and ordered a complete blood count, urinalysis, SMA-7 and X-rays of the abdomen. The results of those tests are attached to the emergency room chart for the patient. The total time Dr. Delgado spent with the patient was approximately 30 minutes. Dr. Delgado also inquired of the patient from time to time as to how he felt, as the other emergency room patients being attended were on stretchers nearby. The patient's wife remained in the waiting room and was not interviewed by the nurse or physician. After reviewing the laboratory reports and X-rays, Dr. Delgado diagnosed the problem as gastritis and released the patient with Donnatol for his stomach and suggested he contact his family physician in the morning. The patient checked out around 10:10 p.m. The patient returned home with his wife. He died in bed early in the morning at approximately 2:30 a.m., on February 24, 1989. After an autopsy, the medical examiner, G.V. Ruiz, M.D., determined the immediate cause of death was cardiac arrhythmia due to arteriosclerotic cardiovascular disease. This is also referred to as sudden death due to clogging or hardening of the arteries. In this case the patient had severe occlusion, up to 75% in some areas, in all three main coronary arteries. Based on a reading of the medical record, the pathologist's report and deposition of the pathologist, Petitioner's expert witness, Jay W. Edelberg, a Board-certified emergency room physician, opined that the patient's chart was not adequately documented and that the patient should have been worked up for the possibility of cardiac problems. From ten to twenty percent of people with cardiac problems present symptoms that mimic gastrointestinal complaints. A variety of risk factors needs to be documented to rule out or minimize the risk of a complaint being cardiac- related. Those risk factors include smoking, family history, history of hypertension, blood sugar problems, sedentary lifestyle, overweight, and high cholesterol. Dr. Edelberg was unaware that Dr. Delgado did pursue questions with regard to those risk factors and simply did not note the negative findings. Dr. Delgado did observe that the patient was a smoker -- he had his cigarettes with him -- and did not note that on the record. The other risk factors identified by Dr. Edelberg were essentially negative. Moreover, Dr. Delgado had no substantial clue from his examination that cardiac problems should be suspected: there was no prior history of heart disease, no reported pains in the neck or arms, no observed sweating or shortness of breath. For that reason, the EKG or other cardiac work-up was not ordered. David John Orban, M.D., Medical Director at Shands Teaching Hospital at the University of Florida, Board certified in emergency medicine, testified as an expert witness on behalf of Dr. Delgado. Dr. Orban agreed that the complaints and symptoms of the patient pointed to gastritis rather than heart disease, and that the medical record adequately reflected the basis for the diagnosis. Although brief, the notes focus on the problem at hand. The patient's vital signs were normal. An EKG is not generally indicated for patients who present abdominal pain. The chart is typical of charts found in busy community emergency departments. Reasonable, competent, expert physicians simply disagree on whether Dr. Delgado's treatment and his medical records violate a standard of care. Dr. Edelberg stops short of saying that any 56 year old male who appears in an emergency room with upper abdominal pain should receive a cardiac work-up. On the other hand, Dr. Orban concedes that a reasonable prudent physician does not simply rely on what a patient tells him without further inquiry and observation. Dr. Delgado's conduct falls between those two extremes. He conducted a physical examination and an inquiry into the patient's history and symptoms. He made cursory notes without duplicating the information already obtained by the emergency room staff nurse. He failed to document that the patient was a cigarette smoker, but in other respects documented relevant positive findings, such as tenderness in the epigastrium. The patient's external physical signs, his history, and the complaints he articulated reasonably led Dr. Delgado to conclude that the patient was suffering from gastritis. The patient's age and his smoking habit did not, given his other signs and symptoms, require a cardiac work-up, and Dr. Delgado reasonably did not suspect nor pursue possible cardiac complications. Dr. Delgado's failure to record the fact of cigarette smoking does not alone make his medical records of the patient inadequate. Essential information was noted, albeit briefly, and was consistent with standards for community emergency facilities.
Recommendation Based on the foregoing, it is hereby, RECOMMENDED: That a Final Order be entered dismissing the Administrative Complaint against Respondent, Benjamin P. Delgado, M.D. DONE AND RECOMMENDED this 16th day of October, 1991, in Tallahassee, Leon County, Florida. MARY CLARK 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 16th day of October, 1991. APPENDIX The following constitute specific rulings on the findings of fact proposed by the parties: Petitioner's Proposed Findings Rejected as unnecessary. Adopted in paragraph 1. Adopted in paragraph 3. Rejected as contrary to the evidence or immaterial. Rejected as immaterial or contrary to the evidence. The questions were asked or the conditions were observed and primarily positive findings were recorded. Rejected as contrary to the evidence. 7.-8. Rejected as immaterial. Evidence indicates the examination and tests were sufficient for the symptoms presented. Rejected as contrary to the evidence. See Joint Exhibit #1, where the test results are found attached. Adopted in paragraph 9. Adopted by implication in paragraph 9. Adopted in paragraph 10. 13.-14. Rejected as contrary to the weight of evidence. Adopted in paragraph 12. Adopted in paragraphs 3 and 9. Adopted in paragraph 9. Rejected as immaterial. Rejected as contrary to the evidence. Rejected as immaterial. Adopted in paragraph 12. Adopted in paragraph 7. 23.-24. Rejected as contrary to the weight of evidence. Respondent's Proposed Findings Adopted in paragraph 1. Rejected as unnecessary. Adopted in paragraph 3. 4.-5. Adopted in substance in paragraph 15. Adopted in paragraph 12. Adopted in paragraph 15. Adopted in paragraph 12. 9.-10. Adopted in substance in paragraph 12. Adopted in substance in paragraph 15. Adopted in paragraph 10. Adopted by implication in paragraph 12. COPIES FURNISHED: William B. Nickell, Sr. Atty. Dept. of Professional Regulation 1940 N. Monroe Street Tallahassee, FL 32399-0792 Robert Rao, Esquire 20 S. Rose Avenue Kissimmee, FL 34741 Mark Dabold, Esquire Suite 1550, Firstate Tower 255 South Orange Avenue Orlando, FL 32801 Dorothy Faircloth, Exec. Director DPR-Board of Medicine 1940 N. Monroe Street Tallahassee, FL 32399-0792 Jack McRay, General Counsel Dept. of Professional Regulation 1940 N. Monroe Street Tallahassee, FL 32399-0792
