The Issue Should Petitioner discipline Respondent's license to practice medicine?
Findings Of Fact At the times relevant to the inquiry Petitioner was the state agency charged with regulating the practice of medicine in Florida, pursuant to Section 20.43, Florida Statutes, and Chapters 456 and 458, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician within the state of Florida, having been issued license No. ME0045474, effective December 28, 1984. Respondent's last known address is 1401 Centerville Road, Suite 202, Tallahassee, Florida 32308. Respondent is board-certified in obstetrics and gynecology. The board certification is by the American Board of Obstetrics and Gynecology. Respondent is a fellow of the American College of Obstetricians and Gynecologists. Respondent received his undergraduate degree from Florida State University and his medical degree from Howard University. His training at Howard University included a four- year residency program from 1982 to 1986. Respondent holds staff privileges at Tallahassee Memorial Hospital (TMH) in Tallahassee, Florida. Patient A.G. Patient A.G. began treatment with Respondent in 1998 and continues as Respondent's patient. A.G. is an Hispanic female who is not proficient in English. When seen by Respondent in his office she has been accompanied by an interpreter that would allow Respondent to discuss details of her health care in English for translation into Spanish for the patient's benefit. Respondent's understanding of Spanish is limited to education in high school and a year at the university. He has the ability to describe some matters that are pertinent to gynecologic practice or obstetric practice and in particular as it relates to telling patients, for example "how to push and when not to push." The record does not reveal that Respondent has the ability to discuss A.G.'s overall health care in Spanish, her language. A.G.'s husband, T.Q., who accompanied her at relevant times principally spoke Spanish and not English. He is somewhat proficient in English. On June 16, 1999, A.G. had an office appointment with Respondent. At that time A.G. had undergone gallbladder surgery but her pelvic pain persisted. In consultation on that day it was decided that A.G. would undergo diagnostic laparoscopy to explore the reason for her chronic pelvic pain. Through the discussion the patient was told that biopsies of the pelvic anatomy might be performed during the procedure and that any problems that could be addressed through laparoscopy would be addressed as Respondent felt comfortable in carrying out that correction. Otherwise, Respondent said that he would "take pictures" and "get out of the case" with the decision to offer further treatment left for another time. Patient A.G. had been referred to Respondent for her persistent pelvic pain following an examination on April 27, 1999, that had been made by Margaret Cantor, a Nurse/Mid-Wife and Registered Nurse. She conducted a pelvic examination of the patient that date. The examination included the use of speculum to examine the cervix and vagina in the interest of looking for abnormalities, lesions, growths, and discolorations. No cervical lesions were found in this examination. A pap smear taken at the time revealed normal results with some inflammation. Diagnostic laparoscopy is a surgical procedure involving an incision in the abdominal wall through which a scope is inserted to visualize the abdominal cavity. Typically the workup for performing a diagnostic laparoscopy would include use of ultrasound, pelvic examination, and a pap smear. Possible complications in this procedure include vascular injury, bowel injury, bladder injury, infection, and bleeding. Preliminary to the diagnostic laparoscopy it is the custom and practice in the medical community to perform a vaginal examination with the use of a speculum. On July 1, 1999, patient A.G. was seen by the Respondent in his office for her pre-operative check. On this occasion A.G. was unaccompanied by a translator. Nonetheless, Respondent was able to perform a brief physical and obtain a history with the assistance of A.G.'s husband. Respondent listened to the patient's heart and lungs and performed a bi- manual examination in which one or two fingers were inserted in the vagina and with a hand on the abdomen compression was performed on the pelvic viscera, uterus, tubes, and ovaries and the lower section of the pelvis. Nothing significant was observed in the patient since last seen. On July 1, 1999, an employee in Respondent's office witnessed patient A.G. sign a consent form allowing the diagnostic laparoscopy. The consent form makes no reference to the agreement for Respondent to perform a loop electrocautery excision procedure, referred to by abbreviations as a "LEEP" conization biopsy procedure or a LEEP cone. No evidence of such consent is contained in patient A.G.'s medical records maintained at Respondent's office. The diagnostic laparoscopy was to be performed at TMH. On July 1, 1999, Patricia Charbonneau, a clinical nurse at the hospital, reviewed a consent form with patient A.G. concerning the diagnostic laparoscopy for the purposes of that facility. Nurse Charbonneau was aware of the scheduling of the diagnostic laparoscopy by reference to the history and physical prepared by the Respondent. This conference involved the discussion of potential risks and complications of the laparoscopy. No discussion was conducted concerning possible risks and complications of a LEEP conization biopsy. The consent form from TMH pertaining to patient A.G. and the diagnostic laparoscopy stated "If any unforeseen condition arises and additional surgery is deemed medically necessary during my procedure, I request and authorize my physician to proceed." Nurse Charbonneau was left with the impression that the patient understood the explanation concerning the upcoming procedure and gave her consent. Ms. Charbonneau was assisted in this communication by A.G.'s husband. No discussion was held concerning the performance of a LEEP cone biopsy, in that the permit from Respondent made no mention of that procedure. Ms. Charbonneau took steps for an interpreter to be available the next morning when the surgery was to be performed given the nature of the surgery, the use of anesthesia and the desire to have "everything" reviewed again. A LEEP conization is a form of biopsy performed either in an office or hospital setting with anesthesia. The cervix is examined with the assistance of a speculum. Lugol solution is placed on the cervix to identify any abnormal cells and an excesion is made by shaving a small piece of the cervix for examination. The workup for LEEP conization includes a pap smear and a colposcopy. The performance of LEEP conization presents potential risks and complications related to infection, endometrious, bleeding, cervical stenosis, and cervical incompetence. On July 2, 1999, patient A.G. came to the TMH outpatient surgery center for her scheduled diagnostic laparoscopy to be performed by Respondent. She was the fourth patient on a schedule of surgeries to be performed by Respondent on that date. Respondent was conversant with the sequence of surgeries to be performed. Patient A.G. was placed in a holding area in the outpatient surgery center to prepare her for her surgery and to await transport to the operating room. Sometime before moving the patient to the operating room Respondent saw the patient in the holding area. Respondent addressed patient A.G. by saying hello and asking her how she was doing. This was not a visit intended to educate the patient and was not involved with any other medical purpose. At the time the patient's husband was with her during this brief encounter which was intended to confirm that the patient was there for the surgery as had been previously arranged. Several hours may have passed between the time Respondent saw patient A.G. in the holding area and when he next encountered the patient in the operating room. Respondent also saw patient N.C. in an adjacent cubicle to where patient A.G. was located while the patients were awaiting their surgery. Patient N.C. was the third patient on the schedule, there for the performance of a LEEP conization biopsy. Respondent followed his surgical schedule for the first two patients in the intended sequence. Some delay was occasioned by a problem experienced in the surgery performed on the second patient. Valerie Anne Lazzell, M.D., is an anesthesiologist licensed to practice in Florida. She is employed by Anesthesiology Associates of Tallahassee, Florida. It was intended that she provide anesthesia during Respondent's performance of the diagnostic laparoscopy for patient A.G. It was anticipated that the patient be subjected to general anesthesia which involves a rapid loss of consciousness and blocks the sensory, mental and motor functions of the patient. A general anesthesia can be provided by using an endotracheal tube, with a mask or with an LMA. This is as distinguished from the use of a neurolept employed in most instances when performing LEEP conization biopsies. In that setting the patient is generally anesic, not really aware, and has analgesia "on board." The use of a neurolept promotes a pain-free state of immobility and an insensitivity to pain and is usually accomplished by use of IV medications. From the record, it appears that Jean Mauch, C.R.N.A., with Anesthesiology Associates was scheduled to provide anesthesia by neurolept for the third patient N.C. who was scheduled for LEEP conization biopsy. Patient A.G. at the time in question was 4'9" tall and weighed 103 pounds. Patient N.C., an African-American woman was 5'2" tall and weighed 242 pounds. Their skin tone was similar in color. Dr. Lazzell saw patient A.G. before the patient was taken for surgery. In this examination the doctor filled out the patient's airway, listened to her heart and lungs, and considered the patient's ASA classification which was one of good health. Dr. Lazzell considered the plan for anesthesia with an endotracheal tube. She gained the assistance of a Dr. Becker who was fluent in Spanish in explaining the use of anesthesia to the patient. Dr. Lazzell sought Dr. Becker's assistance when the hospital did not make an interpreter available. Dr. Lazzell discussed the possible risks and complications of use of this form of anesthesia and a consent form was signed and dated. While this assessment was being made A.G.'s husband was in attendance. It was Dr. Lazzell's expectation that the patient A.G. would next be seen as scheduled when the nurse anesthetist called Dr. Lazzell to the operating room to intubate patient A.G. in association with the provision of anesthesia for the diagnostic laparoscopy. Jean Mauch, C.R.N.A., when performing her duties in the operating room setting at TMH outpatient surgery center was expected to induce anesthesia, maintain the anesthesia, monitor vital signs, treat untoward events during surgery and maintain fluids in the patient while under the supervision of the physician, in this instance, Dr. Lazzell. Nurse Mauch was principally responsible for providing the anesthesia for the third procedure on patient N.C., the LEEP conization biopsy. This included preparation in the operating room of medications and other related tools and supplies. The third procedure, the LEEP conization biopsy for N.C., was referred to on a typed surgical schedule in the preoperative desk in the outpatient surgery center. Having checked the schedule Nurse Mauch obtained the chart for N.C. and went to the cubical, not of N.C. but A.G. When Nurse Mauch arrived at A.G.'s cubical, Jamie Martin, R.N., the pre-op nurse and Dale Dunsmore, R.N., the circulating nurse, were there. Nurse Dunsmore and Nurse Mauch arrived at the cubicle where patient A.G. was located at about the same time. When arriving at the cubicle for patient A.G., Nurse Mauch had in mind that the process was one in which she was getting ready for the surgery to be performed on patient N.C. While in the cubical Nurse Mauch introduced herself to the person she believed to be the patient N.C., at which time Nurse Dunsmore said that the patient only speaks Spanish. Nurse Mauch recalls that a translator was not available for assisting in any communication with patient A.G. Realizing that Nurse Dunsmore was checking the armband for identification, the reference to the fact that the patient only spoke Spanish did not cause Nurse Mauch any concern. Nurse Mauch never heard Nurse Dunsmore orally refer to patient A.G. by name. Nurse Mauch continued with her presentation by commenting that she was the nurse anesthetist who was going to put the patient to sleep. Patient A.G. nodded her head in response to Nurse Mauch's physical gesture that the patient was going to be put to sleep. Beyond that point Nurse Mauch and Nurse Dunsmore took patient A.G. to the operating room ostensibly as the third patient on the schedule for provision of a LEEP conization biopsy wherein Nurse Mauch would provide the necessary anesthesia. The chart for N.C. was brought to the operating room. Before the patient was removed from the cubicle Nurse Martin provided pre-op medication to patient A.G., phenergan robinul. The fact that Nurse Martin was giving preoperative medication and that Nurse Dunsmore was checking the armband on what turned out to be patient A.G. led Nurse Mauch to believe that patient A.G. was patient N.C. the third scheduled patient, according to Nurse Mauch. As Nurse Mauch recalls, when the Respondent entered the operating room where the third scheduled procedure was to be performed he checked the chart for patient N.C. Respondent went out and washed his hands, returned and started the procedure. At the end of the procedure Nurse Mauch recalls Respondent commenting that the next patient speaks only Spanish, to which Nurse Mauch said, "No, this patient," meaning the patient who had been subjected to the procedure is the one who speaks Spanish. Respondent replied "I must be mixed up." Nurse Mauch recalls Dr. Lazzell arriving at the door of the operating room with patient A.G.'s chart. Dr. Lazzell looked surprised to find the circumstances. Nurse Mauch told Dr. Lazzell that this is the neurolept, the case involving the LEEP conization biopsy. Dr. Lazzell commented that "No it isn't." Nurse Mauch heard Dr. Lazzell ask Respondent, "What procedure did you do?" Respondent replied "LEEP conization." Dr. Lazzell said "No, this was supposed to be the diagnostic laparoscopy." Nurse Mauch observed Respondent leave the room and return. Patient A.G. was re-preped and the diagnostic laparoscopy scheduled to be provided was performed with the patient being intubated by the use of an endotracheal tube. Nurse Martin in her capacity as pre-op nurse was responsible for receiving patients and getting the patients ready for administering medications that were prescribed and getting IVs and things started on the patients prior to the patients being sent to the operating room. She recalls performing pre- operative duties on the patient A.G. Nurse Martin was familiar with the schedule of patients, the sequence. She understood that patient A.G. was the fourth patient in the schedule and provided the pre-anesthetic to patient A.G. in preparation for the operation. This involved the use of phenergan. Nurse Martin made no mistake in identifying patient A.G. when providing care. Nurse Martin heard Nurse Dunsmore identify patient A.G. in Nurse Martin's presence and agreed with that identification. Nurse Martin had seen the patient A.G. before the occasion at which Nurse Mauch and Nurse Dunsmore were there with the patient in Nurse Martin's presence and the patient A.G. was taken to the operating room. Nurse Martin had reviewed patient A.G.'s chart earlier in caring forward responsibilities for preparing the patient for the operation. Nurse Dunsmore identified her duties as circulating nurse at TMH outpatient surgery center as being related to setting up rooms for surgeries, transporting patients from pre-op holding areas, identifying patients, verifying surgeries, verifying allergies, and so forth. Ordinarily Nurse Dunsmore in performing her duties would read the chart of the patient scheduled for a procedure to make certain that all permits were signed. She would then go to where the patient was being held, introduce herself to the patient and ask for identification, verifying the surgery that is scheduled for the patient, and perform other related assignments. In performing her duties Nurse Dunsmore would accompany the patient with the anesthesiologist to the operating room. The method of identification in effect at the time in question would be to compare an addressograph card which accompanied the patient's chart with the information on an identification bracelet worn by the patient. Nurse Dunsmore verified that the operating room for the third procedure was set up for a LEEP conization biopsy. After the second procedure on the schedule, Nurse Dunsmore recalls that she went to patient A.G.'s room. However Nurse Dunsmore had handed Nurse Mauch patient N.C.'s chart. Nurse Mauch carried the chart to patient A.G.'s cubicle. The two nurses essentially entered the cubicle together. Nurse Martin and patient A.G.'s husband were already there. Nurse Martin left the cubicle shortly thereafter. Nurse Dunsmore introduced herself to the patient and reached for the patient's identification bracelet and read it out loud. The patient smiled and nodded in response. In turn the patient's husband smiled and nodded in response. Patient A.G. was then taken to the operating room by Nurse Dunsmore and Nurse Mauch. The patient was sedated by Nurse Mauch and positioned for provision of the LEEP conization biopsy. Nurse Dunsmore observed the Respondent enter the operating room and look at the chart which was in relation to patient N.C., not patient A.G. Nurse Dunsmore saw Respondent leave the operating room to scrub. Nurse Dunsmore was in attendance when the procedure was performed. Nurse Dunsmore recalls Dr. Lazzell entering the operating room at the end of the procedure with the chart belonging to patient A.G. and the realization by those in attendance that the chart in the operating room was for N.C., whom they understood to be undergoing the procedure when in fact the patient undergoing the procedure was A.G. Diane Jordan was a surgical technician assigned to assist in the third procedure, the LEEP conization biopsy. She recalls the patient being put to sleep by Nurse Mauch and the patient being prepared for the procedure. The patient was covered by draping towels across the upper portion of the thighs. A blanket was placed over the patient's torso. The patient was placed in the lithotomy position allowing observation of the patient's buttocks, vulva, vagina and external pelvic organs. The patient had a mask on her face and a surgical hat to cover her hair. All of these arrangements had been made before Respondent entered the operating room. Ms. Jordan recalls that the chart in the room was for N.C., the patient anticipated to undergo the LEEP conization biopsy. Ms. Jordan did not realize that the patient in reality was patient A.G. Ms. Jordan recalls that the Respondent when entering the room asked is this "such and such" in relation to a LEEP conization biopsy and that Nurse Dunsmore replied in the affirmative. Ms. Jordan remembers Respondent looking at the chart for N.C. and signing it. Ms. Jordan was in attendance while the procedure was performed. Ms. Jordan heard Respondent mention something about a lesion before he started. Ms. Jordan provided medication to be injected during the LEEP conization. Ms. Jordan identified the fact that a specimen was obtained which was given to her and provided to the nurse to send to pathology for evaluation. When Respondent entered the room for what he anticipated to be the third procedure what he asked specifically was "Is this Ms. C our case for the LEEP?" referring to the LEEP conization to be performed on patient N.C. That is when Nurse Dunsmore responded in the affirmative. After inquiring about the identification of the patient in association with the nature of the procedure Respondent expected to perform and in receiving an affirmative response, Respondent took no further steps to personally confirm the identity of the patient. Respondent opened the chart that was patient N.C.'s chart. Respondent took a drawing from his pocket that a Dr. Thompson had made of patient N.C.'s cervix when he had treated the patient. The drawing was in association with a colposcopy. Respondent intended to compare that drawing with what was observed in the patient during the performance of the LEEP conization biopsy in locating the suspected pathology. In proceeding with what he considered to be the third scheduled procedure for N.C., Respondent placed the speculum, applied the tenaculum and observed what looked to be a lesion that roughly approximated what he anticipated it would be based upon the drawing from Dr. Thompson. Respondent applied Lugol's solution and proceeded with the LEEP conization biopsy. Having applied the solution there was an indication of some pathology in roughly the position as the drawing had depicted. Respondent obtained the sample from the cervix. The size of the specimen was less than the diameter of a dime with a depth or thickness of about two dimes. The performance of the LEEP conization biopsy took less than five minutes. As Respondent finished Dr. Lazzell came to the operating room and informed Respondent that this was not the patient the he thought he was treating. Having been told by Dr. Lazzell that there was a misidentification, Respondent for the first time while engaged with the patient in the operating room proceeded to the front of the table and looked at the patient while the patient was being unmasked. By doing so Respondent discovered that indeed the patient had been misidentified and that he had actually performed surgery on patient A.G., not patient N.C. Respondent left the operating room and informed patient A.G.'s husband of the problem. Respondent returned to the operating room. The patient was provided anesthesia by Dr. Lazzell and the diagnostic laparoscopy that was scheduled was performed. Notwithstanding that it was never intended that Respondent perform a biopsy on patient A.G. from the cervix, Respondent expresses the opinion that if the physician encounters a visible lesion some form of biopsy is in order. Respondent expresses the opinion that in performing procedures such as a diagnostic laparoscopy greater latitude is afforded in terms of what the physician can do when he or she discovers "What's amiss with the patient." This in Respondent's view is because the patient is going into the procedure with the understanding that there may be an unanticipated problem and if the unexpected problem can be addressed, it should be taken care of. Of course this assumes that the biopsy that was performed on patient A.G. was in association with the scheduled diagnostic laparoscopy, when in fact the biopsy was the product of happenstance, in that, Respondent when addressing what he considered to be the condition in the patient N.C., by chance observed a similar condition in the patient A.G. Respondent concedes that prior to patient A.G.'s arrival at the outpatient surgical center that LEEP conization was not an indicated procedure for that patient. The biopsy that was performed was with the misapprehension as to the patient whose needs were being addressed, not merely an unanticipated circumstance in a patient whose identity was established when Respondent performed the biopsy. This was not an additional surgical procedure that came about in connection with the scheduled diagnostic laparoscopy; it was perceived by Respondent as the intended surgery being performed on a different patient when the case began. As a consequence it is the planned- for diagnostic laparoscopy which became the additional procedure. Nonetheless, Respondent tries to explain his result by expressing the opinion that other unexpected and unplanned-for procedures may be undertaken in the instance "Within the realm of the comfort level of the physician and the patient ahead of time; where they know each other, other things can be done as well." Respondent believes that the ability to proceed with the biopsy on patient A.G. while thinking that he was responding to the case involving patient N.C. is implicit and is promoted by "A feeling of trust that we had developed at the point in time." This refers to the point in time at which the other surgery, the diagnostic laparoscopy was being discussed with the patient A.G. The type of pathology that was encountered by Respondent with patient A.G. that led to the biopsy was compatible with condyloma with warty atypia. That is what Respondent observed and collected for evaluation. The laboratory confirmation of the specimen was performed by Dr. Woodard Burgert, a board-certified anatomic and clinical pathologist. In his assessment Dr. Burgert observed that the cone biopsy in question was compatible with condyloma with warty atypia. There was no significant dysplasia. Expert Opinions Dr. Edward Zelnick is a board-certified obstetrician and gynecologist who practices in Florida. He has hospital privileges at Hollywood Medical Center and Memorial Regional Hospital. He is familiar with the procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. In the instance where pathology is found in examining the cervix, Dr. Zelnick believes that action should be taken in addressing that pathology, but only in the instance where the pathology has been discussed with the patient and the appropriate alternative treatment has been discussed. Absent an emergency it is necessary to provide the patient the alternative to surgery and identify the risk of surgery. Absent life-threatening circumstances, a biopsy such as that performed on patient A.G. should not be performed without the patient's consent, which had not been given. Dr. Zelnick further describes the instance in which a biopsy in a case such as this would be in order, would be in relation to an instance in which it appeared that the circumstance was an immediate threat to the health of the patient that needed to be addressed. None of the exigent circumstances existed in this case. Therefore, Dr. Zelnick expresses the opinion that the performance of the biopsy by Respondent did not meet the expected standard of care. Based upon his familiarity with the form of consent in this case which states, "If any unforeseen condition arises and additional surgery is deemed medically necessary during my procedure I request and authorize my physician to proceed," Dr. Zelnick believes that the physician's responsibility there is to respond during the course of the surgery, if medically necessary, to such matters as repairing of a blood vessel that has been cut or damage to an internal organ or bowel. None of those circumstances were associated with the biopsy performed on the patient A.G.. While Dr. Zelnick delegates patient identification to surgical staff or nursing staff, he believes that the ultimate responsibility for patient identification to make certain that the right operation is performed on the proper patient resides with the surgeon. To do less is to practice below the standard of care universally accepted and a matter of common sense. According to Dr. Zelnick, Respondent did not meet that standard when performing the biopsy on patient A.G. who was misidentified. Whatever rules and procedures may be in place setting standards for identification in a hospital, Dr. Zelnick does not believe those standards abrogate the duty of the physician to properly identify the patient. What is expected of a physician is 100 percent certainty as to who the proper patient is and to assure that the proper procedure is carried out on the proper patient. The method of arriving at that determination is not significant, in Dr. Zelnick's view. Dr. Roberto Fojo is a board-certified obstetrician and gynecologist licensed to practice medicine in Florida. He has hospital privileges at Jackson Memorial and North Shore Medical Center in South Florida, and he is affiliated with the University of Miami, Department of Obstetrics and Gynecology, Division of Gynecology. He is familiar with the procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. He does not view a diagnostic laparoscopy as being intended to discover and diagnose cervical lesions, where, as here, the lesion is on the surface of the cervix and vagina. A diagnostic laparoscopy is not intended to promote an examination of the cervix, according to Dr. Fojo. Dr. Fojo is familiar with the consent form executed by patient A.G., the language previously described. He has seen that language before or something similar to it and considers it part of the standard surgical consent in connection with a diagnostic laparoscopy that was intended in this case. The consent is designed to allow the surgeon to address matters such as puncture of the bowel or a problem with a major artery or veins or scar tissue or adhesions. This consent would not include addressing lesions on the cervix. A LEEP conization procedure is not an accepted procedure to perform in the patient undergoing diagnostic laparoscopy unless the LEEP conization had already been discussed and there was a problem with the cervix that the patient knew about. There, in Dr. Fojo's perception, the patient would be undergoing what he refers to as dual procedure. Dr. Fojo does not believe that surgery should be performed on a patient absent the patient's consent as being part of the original procedure or in an emergency. The LEEP conization biopsy by Respondent was not related to the consent that had been provided nor pertaining to an emergency. In this sense, Dr. Fojo expresses the opinion that Respondent failed to meet the standard for medical practice when performing the LEEP conization biopsy on Patient A.G. Dr. Fojo believes that a surgeon should ascertain without any doubt that the patient in the room is a patient that he or she should be performing surgery on, the appropriate surgical procedure. This need for identification is an independent responsibility of the physician and may not be delegated. It requires 100 percent accuracy, according to Dr. Fojo. Dr. Fojo holds to the opinion that the physician is responsible for the identification regardless of his or her efforts that may have been compromised by others in attempting to properly identify the patient and perform the indicated procedure. He believes this to be common medical practice. Respondent was not within the standard of care in performing the LEEP conization procedure on patient A.G. under Dr. Fojo's assessment. Dr. Michelle McCallanahan is a board-certified obstetrician and gynecologist who is licensed in Florida and practices in Jacksonville, Florida. She is familiar with the procedures involved in patient A.G.'s care based upon her own experience. She is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. The consent form executed by patient A.G. is not unfamiliar to Dr. McCallanahan. Her perception of this consent language is that it relates to complications that occur during the course of the diagnostic laparoscopy that were not foreseen and constitute an emergency requiring an immediate procedure to correct the condition. Examples are vascular injuries to vessels, bowel injury, bladder injury, infection and bleeding. By contrast, lesions on the cervix do not constitute an example of an unforeseen circumstance. Dr. McCallanahan expresses the opinion that an appropriate workup for LEEP conization was not done for the patient A.G. Nonetheless, there are some circumstances in which it would not be violative of the standard of care to perform LEEP conization without conducting a workup. That circumstance would be in the instance where the lesion that was observed was highly suggestive of cervical cancer, according to Dr. McCallanahan. The case that Respondent was presented with did not constitute such a condition. Ordinarily, the standard of care contemplates the discussion of possible risks or complications associated with LEEP conization procedures before performing them. According to Dr. McCallanahan it would be appropriate to perform a surgical procedure without discussion of the risks and possible complications in an emergency when the patient was unconscious and could not give consent in advance. Those are not the facts here. While Dr. McCallanahan relies upon the assistance of other persons within the surgical and nursing staff, she expresses the opinion that the ultimate responsibility for patient identification prior to the performance of surgery resides with the physician. She believes that it is below the standard of care to not correctly identify the patient before the procedure is done and perform an improper procedure or non- consenting procedure on that patient, as was the case here. Dr. Jana Bures-Forstheoefel is a board-certified obstetrician and gynecologist who is licensed in Florida. She practices in Tallahassee, Florida, and has privileges at TMH and performs surgeries in the outpatient surgery center. She is familiar with the procedures involved in patient A.G.'s care based upon her own experience. She is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. She believes that Respondent met the standard of care for identifying patient A.G. before performing surgery on the patient. The method used by Respondent to identify the patient was common to the practice of other physicians who performed surgeries in that setting, according to Dr. Forstheoefel. In the event that Dr. Forstheoefel was performing a diagnostic laparoscopy and observed a cervical lesion she would evaluate the condition to include the performance of a biopsy, the most common method for cervical biopsy being a LEEP conization. Notwithstanding the lack of specific consent by the patient for Respondent to perform the LEEP conization, Dr. Forstheoefel holds to the opinion that it was correct to biopsy, given what was observed in the patient. The prospect that a physician would be 100 percent accurate in identifying a patient undergoing surgery is not humanly possible and is a standard that should not be imposed upon a physician in Dr. Forstheoefel's opinion. She considers that the matter of proper identification preoperatively is a team effort. One person should not be solely responsible for all things in making certain of the patient's safety and assuring that the right thing is done. Dr. Kenneth John McAlpine is a board-certified obstetrician and gynecologist. He is licensed in Florida. At times relevant he performed surgeries at the TMH outpatient surgery center. He is familiar with the procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. He believes that Respondent met the standard of care in identifying the patient A.G. before performing the surgery and in performing the LEEP conization on that patient. Although Dr. McAlpine has not experienced a situation in which he observed a reason to do a LEEP conization in a diagnostic laparoscopy case, where consent for LEEP conization had not been given ahead of time, he does not question the decision to address the condition observed, such as in the case at issue. From his point of view, it was acceptable to do a LEEP conization biopsy to address the lesion. Although no prior indication existed before the lesion was observed during the procedure Dr. McAlpine would not want to ignore the lesion. Dr. McAlpine believes that the process that Respondent undertook in identifying the patient A.G. before surgery was consistent with practices in effect at the hospital, this included reliance on staff in the operating room. Dr. McAlpine does not believe that it is necessary for a physician to be 100 percent accurate in the identification as a person ultimately in charge. No matter as to the facts, he sees the issue of the identification being a multi-disciplinary approach among health care providers. Dr. David O'Bryan practices obstetrics and gynecology. He is licensed in Florida. At times relevant he performed surgeries at TMH outpatient surgery center. He is familiar with the type procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for the patient. The method employed by Respondent in identifying the patient was consistent with the practice used in the immediate medical community at the time, according to Dr. O'Bryan. Dr. O'Bryan believes that the Respondent performed the appropriate surgery on Patient A.G. For Dr. O'Bryan, what is more important in addressing the patient's needs is the apparent pathology, not the consent that may have been provided by the patient in advance of the procedure. It would be negligent not to address the lesion on the cervix in his view. The pathology present determines the response even without a consent for the procedure. Dr. O'Bryan did not consider that the pathology constituted an issue of life or death. The fact that the LEEP conization biopsy was not planned was less significant than the need to address the pathology. It does not matter if the patient were A.G. or N.C. or some other patient, Dr. O'Bryan believes that it was appropriate to perform the biopsy. Dr. O'Bryan believes that the surgeon bears a great deal of responsibility in patient identification, but the ultimate responsibility for identification does not reside with the physician or any other operating room staff member in Dr. O'Bryan's assessment. Dr. O'Bryan does not conceive that there can be any greater comfort in the identification than in the instance where the "operating room crew" tells the physician who it is and the physician has a chart in his hands which indicates that it is the same patient as the operating staff has identified and the pathology that was found is consistent with what had been anticipated according to the patient chart and the staff identification. Nothing in medicine involves the imposition of a 100 percent standard of care to include properly identifying the patient preoperatively, according to Dr. O'Bryan. Dr. Roberto Morales is a board-certified obstetrician in gynecology licensed to practice in Florida. At times relevant, he performed surgery at the TMH outpatient surgery center. He is familiar with the type procedures involved in Patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for the patient. Dr. Morales believes that Respondent met the standard of care for identifying the patient A.G. in that hospital and in other places as well. Dr. Morales believes that the patient was correctly identified by Respondent earlier in the day and that the incorrect patient was brought back to the operating room. Under those circumstances, Respondent did what was appropriate to identify the patient in the performance of the LEEP conization on patient A.G. and was within the standard of care, according to Dr. Morales. Assuming the patient was scheduled for a diagnostic laparoscopy, if during the examination, visualization of the cervix, a lesion was observed, a biopsy would be the typical next step, according to Dr. Morales. The caveat to his opinion in the ability to perform that biopsy would depend upon the patient that was being taken care of and the sense that the physician had about the patient's expectations of what should be done and not done. It is assumed that Dr. Morales believed that the level of relationship between Respondent and Patient A.G. would allow the performance of the LEEP conization biopsy. Dr. Morales believes that the attempt to be 100 percent accurate in the identification of patients preoperatively is an aspirational goal, not a requirement. For him all persons concerned have the responsibility for taking care of the patient. Having considered the opinions expressed by the experts, the ultimate facts to be determined must be based upon the realization that Respondent proceeded to perform the LEEP conization biopsy on patient A.G. without advance written consent, that Respondent believed that he was confronting the case of patient N.C., and that the performance of the LEEP conization on Patient A.G. was not in its timing and justification part of the diagnostic laparoscopy scheduled to be performed on Patient A.G. The earlier effort by Respondent to identify his patient in the holding area was sufficient for that stage of the process. Respondent acted in the customary manner in relying upon his knowledge that Patient N.C. was to be the third patient based upon the schedule. It was not unexpected that Respondent would rely upon the surgical staff in orally confirming the patient identity and the procedure to be performed when entering the operating room for the scheduled third procedure. This identification was further confirmed by the presence of the chart for Patient N.C. Respondent's failure to take further steps to physically identify the patient by looking at her arm bracelet, by looking at her face, or in some other manner recognizing the mistake that had been made by others in readying Patient A.G., and not Patient N.C. for surgery could be forgiven if there were no consequences, but there were. Although Respondent should not be the absolute guarantor in the identification of the patient, what he did in the operating room was not enough, when the result is that Respondent performed the LEEP conization that was not consented to in advance, and performed believing that the patient was N.C., the patient for whom the procedure was intended, and was not in response to an emergency regardless of patient identity. As a result, Respondent failed to meet the standard of care for reasonably prudent similar physicians under acceptable similar conditions and circumstances in his actions. In mitigation, the outcome was not harmful to the patient. Moreover, other health care professionals were in great measure responsible for the failure to properly identify the patient.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes, and imposing a $1,000.00 administrative fine and costs of investigation and prosecution. DONE AND ENTERED this 8th day of November, 2002, in Tallahassee, Leon County, Florida. CHARLES C. ADAMS 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 8th day of November, 2002. COPIES FURNISHED: Robert C. Byerts, Esquire Kim Kluck, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 David W. Moye, Esquire Linda Loomis Shelley, Esquire Fowler, White, Boggs and Banker, P.A. Post Office Box 11240 Tallahassee, Florida 32302 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 Tallahassee, Florida 32399-1701
Findings Of Fact Procedural issues. In June 1983, Petitioner filed an application for a certificate of need to operate a cardiac catheterization laboratory at Hollywood Medical Center. Respondent, the Department of Health and Rehabilitative Service (HRS) denied the application, and Petitioner filed this petition for administrative review. Notice of hearing was given by order dated August 6, 1984. Two days before the hearing, SOUTH BROWARD HOSPITAL DISTRICT moved to intervene. The petition was denied because it was filed less than five days before the hearing, and was therefore untimely. Rule 28-5.207, F.A.C. Also shortly before the hearing, HRS filed a motion in limine, seeking to exclude evidence of cardiac catheterization utilization other than a base year of 1981. The motion was denied because the relevant rule, rule 10-5.11(15) allows proof of "not normal" circumstances. Prior to the hearing, the parties filed a joint prehearing stipulation, agreeing to certain issues of law and fact. Pursuant to that stipulation, the following criteria are either not applicable in this case or have been satisfied by the Petitioner: section 381.494(6)(c)(3), (4), (5), (6), (7), (8), (10), (11), and (13), Fla. Stat., section 381.494(6)(d), Fla. Stat., and rule 10-5.11(15)(a) through (f), (g), (h)(1) and (2), (i)(1) through (3) and (5), (j), (m), (n), and (o)(2). It was further stipulated that the Petitioner will not be performing coronary angioplasty in its proposed cardiac catheterization laboratory. HRS further stipulated that if the Petitioner satisfies all other applicable criteria, the project will be financially feasible. Remaining at issue in this case are subparagraphs (6)(c)(1), (2), and (12) of section 381.494, Fla. Stat., and subparagraphs (h)(3), (i)(4), (k)(1), and (o)(1) and (3) of rule 10-5.11(15). F.A.C. The central issue in this case is whether pursuant to the relevant statutory and rule criteria there is a need for a cardiac catheterization laboratory at Hollywood Medical Center. The Hollywood Medical Center is located in the southern portion of Broward County. It is a 334 licensed bed medical/surgical hospital, and its medical staff covers all major medical specialties. The hospital has 24 hour emergency service, 14 intensive care beds, a full service operating room, and does cardiovascular surgery, but does not do open heart or bypass surgery. Hollywood Medical Center, based on zip codes from its own patient records, serves patients primarily from the Dade County line a few miles south to the New River Canal on the north and from the ocean on the east to the Collier County line on the west. In this service area, physicians tend to be located in the eastern section, and do not typically have staff privileges at hospitals in northern Broward County, nor do they tend to refer patients to hospitals in the northern section of Broward County. Patients at Hollywood Medical Center who need cardiac catheterization procedures are now referred to Memorial Hospital, which is approximately 2 miles away. In the south Broward County area, there is no other alternative. There was no evidence of any cardiac catheterization facility in northern Dade County accessible to patients from southern Broward County with the exception of a newly granted certificate of need to Humana Biscayne. There was no evidence as to when Humana Biscayne will be open and providing services. In northern Broward County, there are five operating cardiac catheterization laboratories. The one closest to Hollywood Medical Center, Broward General Medical Center, is approximately 6 miles to the north. Rule 10-5.11(15)(1), F.A.C., establishes a method of projecting the number of cardiac catheterization procedures expected for the year in which the proposed new service would begin. This number is the product of the projected population for the service area and the number of procedures performed in 1981 in the service area for one hundred thousand population. HRS interprets this rule to require analysis based upon HRS district data. The HRS district in this case is district ten, which is Broward County. Once the projected number of procedures is determined, that number is divided by 600 to determine the number of catheterization laboratories needed. This number is derived from rule 10- 5.11(15)(o)3., which forbids approval of a new laboratory if the average volume for all laboratories in the service area drops below 600. HRS now argues that the number 600 is only a floor to protect existing providers, and is not to be used to compute need. In the normal computation of need under the rule, this is not true. Thomas Porter, supervisor of the certificate of need section at HRS calculated his Projections of need using 600 procedures per unit in the district as the means to determine the need for a new laboratory. Mr. Porter testified: "Well, in terms of what I would agree with is in terms of numerically determining the need for the number of labs, we divide by 600 procedures. . . . HRS based its denial of the certificate of need in this case by using a use rate for Broward County in 1981 of 329.5 procedures per one hundred thousand population. This use rate in turn was based upon a 1981 population of 1,046,646 and 3,449 procedures in the county for that year. Since the projected population for Broward County in 1986, two years from the date of the hearing, is 1,179,205, HRS concluded that by 1986 the county will need 6.475 laboratories, which rounds to 6. There are 5 licensed and operating laboratories now in Broward County, and 2 additional laboratories have been approved by HRS in the final order in PLANTATION GENERAL HOSPITAL v. HRS, et al., DOAH case number 84-1838, 6 FALR 6796 (1984). Using the method proposed by HRS to calculate need, there is no need for an additional laboratory as sought by Petitioner in this case. Petitioner's exhibit 4, table 5, computes the same formula set forth above, but uses a 1981 rate of 340 catheterization procedures per one hundred thousand. This rate is incorrect. On table 2 of this exhibit the actual procedures for each Broward County facility is recorded for 1981, and the total number of procedures has been incorrectly added. The correct total is 3,449, not 3,546, and the resultant rate (which is based upon a slightly lower estimate of 1981 population, 1,042,941) is 330.7 procedures per one hundred thousand. Correcting table 5 using the 330.7 rate, the need for cardiac catheterization laboratories is: YEAR DISTRICT 1985 6.3 1986 6.5 Thus, if the rule for determining need in a normal situation is followed, the record in this case shows no need for the catheterization facility proposed by the petitioner. Subpart 15(f) of the rule, however, allows approval of an application if the circumstances are other than normal, in which case approval can occur even though need is not shown by subpart 15(l) and 15(o), above, pertaining to calculation of need using the 1981 use rate, future population projections, and division by 600. Mr. Porter testified for HRS that the 1981 use rate has been a fairly accurate predictor of actual use rates in subsequent years, but that it has not yet been accurate in Broward County. In 1981 the use rate, as corrected above, was 329.5, accepting as true the HRS population estimate for Broward County in 1981. In 1982 the use rate was 393.6. This figure differs from Petitioner's exhibit 4, table 3, because the columns are incorrectly added on table 2. The correct total of procedures for 1982 is 4211. The correct total for 1983 is 5008. In 1983 the use rate was 457.9 using the 5008 figure. Thus, in two years, Broward County has increased its use of cardiac catheterization by 39 percent over the 1981 base rate. HRS argued that the 1981 planning rate should continue to be used because current data may be anomalous, and not reflective of the long range trend. This might be true if the base rate were reflective of a stable prior trend, but it is not. It is only the data from one year, and as such, is less persuasive as a predictor of the future. The trend for at least Broward County in the six years from 1977 is reflected in Petitioner's exhibit 4, table 3. In 1977, the use rate in Broward County was 174 procedures per one hundred thousand. The actual rate has increased steadily each year for six years to the rate indicated above for 1983, 457.9 per one hundred thousand. This is an increase from the 1977 rate of about 263 percent. At least in Broward County, this data indicates that the 1981 rate is probably not static, but is only a point on a trend that shows significant increases annually. There was partial evidence that the trend indicated above may be slowing down. Dr. Silvio Sperber, who is a cardiologist in charge of the cardiac catheterization laboratory at Memorial Hospital, testified that Memorial Hospital had had 673 cardiac catheterization procedures from January 1984 through September 1984. He testified that his laboratory was running about 15 percent fewer procedures than the year before. This was not accurate. From Petitioner's exhibit 4, table 2, Memorial Hospital experienced 942 procedures in 1983. By the end of September 1984, it should have experienced about 75 percent of that number at a zero rate of increase, or 706 procedures. Its actual experience in nine months, 673, is only 4.7 percent less than the 1983 expected number of 706.3. The Memorial Hospital experience in 1984 is some evidence that the rate of increase in Broward County may be less or even stabilize in the future at the 1983 utilization rate, but this is evidence from only one hospital. The other four operating laboratories may have experienced a similar decline, or an increase, but there is no evidence on the point. And in any event, Use small decline at Memorial does not persuasively indicate a return to the significantly lower 1981 Broward County rate. There was additional evidence to support the conclusion that the 1983 rate of use would not decline again to the 1981 rate. Atherosclerotic heart disease is the number one cause of death in the United States today. Cardiac catheterization is the best tool currently available for evaluation of the condition of the heart. From 1978 to 1982, Broward County has experienced a higher death rate for major cardiovascular disease than Florida as a whole. The death rate was 16.6 percent higher in Broward County in 1982 than in Florida generally. Additionally, cardiac catheterization seems to he coming more and more useful in the treatment of heart disease. Three years ago, when HRS established the 1981 base rate, catheterization was not considered a state-of- the-art procedure for treatment of an acute heart attack. Today, catheterization during the first few hours of a heart attack for the point injection of a clot dissolving substance, streptokinase, is proving to be a remarkably effective means of reducing the long-range damage of clot caused heart attacks. Further, use of catheterization during the attack itself has enabled physicians to see for the first time that most heart attacks are caused by clots. As good uses for catheterization increase, it is only reasonable to expect that the utilization rate will increase. While the foregoing is some evidence that application of subpart 15(l) and (o) of the rule in this case in Broward County produces a "not normal" result, justifying consideration of additional evidence of need, it still does not necessarily follow that the application herein should be granted. First, using the 1983 use rate of 457.9 procedures per one hundred thousand population, and the 1986 predicted population of 1,179,205 in Broward County, the number of expected procedures by 1986 is 5400. There will be 7 approved laboratories by 1986, and thus each would be able to perform approximately 771 procedures, if there is an even distribution within the county. This would be considerably less than approximate maximum capacity of a catheterization laboratory, which is somewhat less than 1300. Dr. Sperber testified that his laboratory could perform 5 procedures per day, 5 days a week, or 1300 per year. This, however, fails to account for emergency work and angioplasty, both of which take more than two hours. Angioplasty at Memorial now runs about 15 percent of all procedures. It is urged by petitioner that once the number of procedures is predicted for 1986, then the need for laboratories should be derived by dividing that number by 600, which is in subpart 15(o) of the rule. While this is the procedure for determining need in the normal case, as found above, it does not follow that the standard of 600 continues to apply to determine need in the abnormal case. The "not normal" exception of subpart 15(f) of the rule operates to except analysis of need not only from the 1981 use rate (subpart 15(l)), but also the 600 procedures standard (subpart 15(o)). Since the 600 standard is only about 50 percent of maximum capacity, it constitutes a rather low threshold number for commencement of a new laboratory. In effect, although the 1981 use rate apparently predicts only 72 percent of the need as compared to the 1983 rate, the 600 standard overpredicts need by at least the same amount. As indicated above, even if the 1983 use rate is used, the seven approved laboratories would be easily able to handle this need since the average spread among these laboratories would be about 771 procedures per laboratory. Though petitioner sought to show that there would be unmet need in the area actually served by Hollywood Medical Center, the evidence falls short of demonstrating a "not normal" situation of actual unmet need in that area justifying approval of its application. This evidence will be considered in the following findings. HRS does not consider district lines to be absolute if the facts justify consideration of services available in an adjacent district. In Broward County the local health council has debated the issue of dividing the district service area into subdistricts, but has not chosen to do so. Mr. Porter testified that he could think of as many reasons to divide the county as reasons not to divide the county. Broward County is divided north and south by the legislature into two hospital districts, however. As found above, physicians in the southern portion of Broward County tend to refer patients to hospitals in the same area, and do not use hospitals in northern Broward County. These physicians tend to use hospitals closer to their offices, and consequently do not usually have staff privileges at hospitals in the northern portion of the county. These patterns of use, however, have not been shown to be an immutable condition, but simply reflect current practices. Patients at Hollywood Medical Center who currently need cardiac catheterization are transferred to Memorial Hospital, a few miles away. Memorial Hospital is about a ten minute drive from Hollywood Medical Center. The cost of transfer is about 5300 to 5400. Although Hollywood Medical Center cardiac patients needing diagnostic catheterization at times must wait a day or two before Memorial can provide that service, such delays were not typically of major significance or life-threatening. A more significant problem experienced on occasion by Hollywood Medical Center has been inability to transfer unstable patients to Memorial for diagnostic catheterization. Acutely ill patients at times may need catheterization for diagnostic purposes, but are too ill to be transferred by ambulance to Memorial for the procedure. However, the record does not contain evidence of how frequently this occurs. In any event, these inconveniences are normal and expected where not every hospital has cardiac catheterization facilities. Stated another way, the above would be evidence of a "not normal" condition only if the normal condition was for all acute care hospitals to have catheterization laboratories, which is not the case. As discussed above, cardiac catheterization is also used for emergency treatment of heart attack by the injection of streptokinase directly to the clot causing the attack. Cardiac catheterization facilities must be available at the hospital initially receiving the heart attack patient because these patients are usually too unstable to be transferred from the emergency room of the receiving hospital to Memorial. Treatment by streptokinase injection is therapeutically most beneficial only in the first few hours of the heart attack, or at least within six hours of the emergency, because it is during this period that the permanent damage caused by the clot will occur. Dr. Stephen Roth, a cardiologist on the staff of Hollywood Medical Center, had from 5 to 10 heart attack patients in 1984 who needed streptokinase injection by catheterization, and who suffered a deterioration of their condition due to the unavailability of facilities for catheterization at Hollywood Medical Center. He implied that his two other partners had a similar experience, but the record does not contain competent evidence to support a finding as to the magnitude of the problem for them. Dr. Jeffrey Erlich, also a cardiologist, has had a similar problem of having heart attack patients arrive at Hollywood Medical Center in need of emergency streptokinase injection by catheterization, but did not testify as to the magnitude of the problem. In Dr. Erlich's opinion, every acute care hospital that treats heart attack victims should have a cardiac catheterization laboratory to provide emergency injection of streptokinase. Dr. Silvio Sperber, who is one of the only three physicians who run the cardiac catheterization facility at Memorial Hospital, testified that he had performed about 7 streptokinase injection procedures since the beginning of 1984. The foregoing is insufficient evidence of a "not normal" need for a cardiac catheterization laboratory at Hollywood Memorial Hospital. The number of emergencies are not that great, the problem is not atypical of other hospitals not having cardiac catheterization facilities, and there is no evidence of any failed efforts to have emergency vehicle operators take all heart attack patients directly to the available laboratories in the area. See paragraph 24, ahead. Administratively, the process of transferring a patient from Hollywood Medical Center to Memorial for cardiac catheterization causes the sort of problems normally associated with transfer of ill patients. Though the drive is only ten minutes, the time preparing the patient and actually transferring the patient is much longer, and is a hardship on the patient. However, almost all of the cardiologists at Hollywood Medical Center are on the staff of Memorial, and can follow their patients at that facility without much difficulty, since it is only ten minutes away. In 1983, Memorial Hospital had 942 catheterization procedures. If the 1984 experience continues at 4.7 percent less than 1983, Memorial Hospital will perform about 898 procedures. If thereafter it experiences only a 10 percent growth rate, Memorial Hospital will perform 1086 procedures in 1986, and 1195 procedures in 1987. It is reasonable to conclude that it will reach its maximum capacity in a few years, probably by 1988. However, although not currently used by Hollywood Medical Center, there are or will be two catheterization facilities within less than eight miles. Broward General Hospital is the next closest, apparently about six miles away. In 1983, Broward General performed only 551 procedures, indicating significant future capacity. Additionally, a new laboratory has been approved for Plantation General Hospital, about eight miles away. Since this laboratory will be new, it will have a long way to go before it reaches a 1200 capacity. The driving distance to these two other facilities may be a few miles more than this, but the distance is not significantly greater than Memorial. Although Petitioner's physicians testified that they did not consider the hospitals further north to be acceptable as alternatives to Memorial, the distance alone does not pose a significant problem. The major problem is not in the driving distance, as long as the trip is 10 or 20 minutes driving time, but the administrative preparation time at either end, which would be the same inconvenience for transportation regardless which alternative was used. Typically patients who suffer a heart attack are transported to the emergency rooms of any number of hospitals in Broward County. Dr. Erlich testified that his prior patients do not usually call him before arriving at a hospital, and that he has no ability to direct his patients to a hospital having cardiac catheterization capability. Thus, he felt that all such hospitals should have the capability. There is no evidence that Memorial Hospital could not handle more heart attack patients, or that emergency vehicle operators could not transport more heart attack patients to Memorial. An ambulance carrying a heart attack patient could just as easily arrive at the emergency room of Memorial than it could at Hollywood Medical Center, only ten minutes away. The problem of having heart attack patients arrive in an unstable condition at Hollywood, where there is no catheterization facility, ought to be solved at least in part by greater coordination with emergency vehicle operators in the vicinity of the two hospitals. Dr. Sperber and his two partners apparently have a monopoly over the performance of cardiac catheterization procedures at Memorial Hospital. This factor is somewhat relevant to the issue of need for the proposed new catheterization laboratory, but absent additional evidence that patients will in fact be denied the service, or will receive service of poor quality or at unreasonable expense due to this apparent monopoly, this one factor alone does not show sufficient need to warrant approval of the application. Some patients prefer to go to Hollywood Medical Center, which is a smaller, for-profit hospital, but patient preference of this sort does not show a "not normal" need for the proposed catheterization laboratory. Based upon all of the foregoing, there is not sufficient evidence on this record demonstrating a "not normal" condition of need by 1986 to justify granting this application. However, if there were a need shown by the evidence, the following additional findings are made. Thomas Porter testified for HRS that the requirement that there be adequate care for indigents is satisfied if such care is provided by the District as a whole, and that there was no question that indigents were adequately served in District X. Petitioner will provide cardiac catheterization for indigents only on an emergency basis, and will rely upon Memorial to provide other indigent care. Based upon the testimony of Mr. Porter, the criteria with respect to indigent care, rule 10- 5.11(15)(h)3, F.A.C., has been satisfied. Since nearly all of the cardiologists on the staff of Hollywood Medical Center are also on the staff of Memorial Hospital, it is probable that Hollywood Medical Center would do a substantial number of catheterization procedures in the first year of operation, which is projected to be 1986. By the third year of operation, 1989, the Hollywood Medical Center facility would satisfy the requirement of rule 10-5.11(15)(i)4, F.A.C., that it annually perform at least 300 procedures within three years of initiation of service. For these limited purposes it is appropriate to consider the proximate population served, since this population is the most reliable source of patients and revenue. Most of the patients for the Hollywood Medical Center catheterization laboratory will come from its current actual service area, which was defined by the evidence to be a region in southern Broward County. Given the shared cardiologist staffing at both hospitals, it is not at all unreasonable to project that Hollywood Medical Center will service 30 percent of the need in the southern region of Broward County. Based on the 1983 Broward use rate, Hollywood Medical Center would do 518 catheterizations in 1989 if it handled only 30 percent of the need. Memorial would handle the remaining 70 percent, doing 1207 procedures annually. Even using the lower 1981 use rate provided by HRS, 329.5 per 100,000, Hollywood Medical Center would do 372 procedures in 1989, using the assumed market share of 30 percent. (As noted above, however, these figures do not demonstrate need, however, since existing facilities will be able to serve this same population adequately.) As already found above in calculation of need, rule 10- 5.11(15)(o)1 and 3, F.A.C., is satisfied if the 1983 use rate is used. Beginning with 1986, and in every year thereafter, there will be enough catheterization procedures needed so that the average volume for all facilities in the district will be at least 600 annually. HRS stipulated that if all other criteria were satisfied, the project proposed by Petitioner would be financially feasible. From the foregoing findings, all other criteria in dispute have been satisfied, and the project would be financially feasible. All other findings of fact proposed by the parties which have not been discussed above have been considered and have been deemed to be irrelevant.
The Issue The issues for determination are whether Petitioner should have changed the status of Respondent's license from standard to conditional; and whether Petitioner should impose administrative fines of $7,500 and recover costs for alleged deficiencies in the care of four residents of a nursing home.
Findings Of Fact Petitioner is the state agency responsible for licensing and regulating nursing homes in Florida pursuant to Section 400.23(7), Florida Statutes (2003). Respondent is licensed to operate a 150-bed nursing home located at 2916 Habana Way, Tampa, Florida 33614 (the facility). Respondent admitted Resident 1 to the facility on March 9, 2001. The admitting diagnoses included tracheal bronchitis, diabetes mellitus, morbid obesity, and acute respiratory failure. From the time Resident 1 entered the facility until her death, Resident 1 lived with a tracheal tube in place. Resident 1 died on March 4, 2003, at 10:20 a.m. in the emergency room at St. Joseph's Hospital in Tampa, Florida. The tracheal tube of Resident 1 was completely occluded with hardened secretions when Resident 1 arrived at the hospital. The emergency room (ER) physician that treated Resident 1 testified by deposition. The ER physician diagnosed Resident 1 with respiratory arrest and death. However, the diagnosis is merely a clinical impression and is not a medical determination of the cause of death. No certain cause of death could be determined without an autopsy, and no one performed an autopsy on Resident 1. The diagnosis made by the ER physician is a clinical impression that is an educated guess. The respiratory arrest suffered by Resident 1 could have been precipitated by various causes including an occluded tracheal tube, a heart attack, or acute respiratory failure. The ER physician did not determine that the facility committed any negligence and found no evidence of negligence. The ER nurse who assisted the ER physician believed that the facility had been negligent in clearing the tracheal tube of Resident 1. The ER nurse suspected that secretions had been accumulating in the tracheal tube for several days and that the facility did not monitor or clean the tube because the tube was completely occluded when Resident 1 arrived at the hospital. The ER nurse notified Petitioner of her suspicions. On March 11, 2003, Petitioner conducted a complaint investigation of the facility in connection with the death of Resident 1. Petitioner determined that Respondent either had not assessed whether Resident 1 was capable of performing her own tracheal tube care; or had not monitored the respiratory status of Resident 1 between March 2 and March 4, 2003; or both. Petitioner determined that the alleged failure to assess and monitor Resident 1 violated 42 CFR Section 483.25(k)(4) and (5). Florida Administrative Code Rule 59A- 4.1288 applies the federal standard to nursing homes in Florida. 42 CFR Section 483.25(k)(4) and (5) requires Respondent to "ensure that residents receive proper treatment and care for . . . tracheostomy care (sic) . . . [and] tracheal suctioning." Petitioner assigned the charged deficiency a severity rating of class "II." In relevant part, Section 400.23(8)(b), Florida Statutes (2003), defines a Class II deficiency as one that has: compromised the resident's ability to maintain or reach his or her highest practicable physical, mental and psychosocial well-being, as defined by an accurate and comprehensive assessment, plan of care, and provision of services. Petitioner determined that a Class II rating was appropriate because the facility's alleged failure to provide Resident 1 with appropriate tracheal tube care harmed Resident 1. Petitioner changed the license rating for the facility from Standard to Conditional within the meaning of Section 400.23(7), Florida Statutes (2003). The change in license rating was effective March 11, 2003, when Petitioner completed the complaint survey of the facility. The Conditional rating continued until April 10, 2003, when Petitioner changed the rating to Standard. Petitioner also proposed an administrative fine of $2500 pursuant to Section 400.23(8)(b), Florida Statutes (2003). The preponderance of evidence shows, by various measures, that Respondent provided Resident 1 with proper treatment and care for her tracheotomy tube within the meaning of 42 CFR Section 483.25(k)(4) and (5). First, it is uncommon for a person to cough up material in a tracheal tube and have the material gradually accumulate until the tube closes. It is more likely that secretions coughed up will block the tracheal tube immediately. Second, the emergency medical team (EMT) that treated Resident 1 in the facility did not find it necessary to remove or replace the existing tracheal tube in order to obtain an open airway. Rather, EMT personnel administered oxygen through the existing tube. Third, Resident 1 had normal oxygen saturation levels on March 2, 2003. Finally, Resident 1 was experienced in maintaining her tracheal tube, was capable of clearing her own tube, and asked members of the nursing staff to clear the tube whenever Resident 1 needed assistance. On March 4, 2003, Resident 1 complained of shortness of breath rather than a blocked tracheal tube. The ER physician's testimony shows it is uncommon for a person to cough up material in a tracheal tube and have the material gradually accumulate until the tube closes. The ER nurse that suspected secretions had been accumulating in the tracheal tube of Resident 1 for several days had no experience caring for nursing home residents with tracheal tubes. Gradual accumulations of secretions in a tracheal tube are generally associated with a productive cough from causes such as infiltrated pneumonia. There is no evidence that Resident 1 had such a condition. It is more likely that any material Resident 1 coughed up would have occluded the tracheal tube immediately rather than accumulating over time. EMT personnel that treated Resident 1 in the facility did not find it necessary to remove or replace the existing tracheal tube in order to obtain an open airway. When EMT personnel arrived at the facility, Resident 1 was non- responsive. When confronted with a non-responsive patient, standard protocol requires EMT personnel to ensure an open airway. EMT personnel placed an oxygen "bag" over the existing tube to provide Resident 1 with oxygen. EMT personnel then transported Resident 1 to the hospital emergency room. In the emergency room, the ER physician found the tracheal tube of Resident 1 to be completely blocked with hardened secretions. He removed the tube, replaced it with an open tube, and unsuccessfully attempted to ventilate Resident 1. It is likely the hardened secretions found in the tracheal tube at the emergency room blocked the tube between the time EMT personnel administered oxygen to Resident 1 at the facility and the time the treating physician removed the tracheal tube in the emergency room. A contrary finding would require the trier of fact to speculate that EMT personnel found the tracheal tube to be blocked and administered oxygen to a closed tube; or incorrectly diagnosed Resident 1 with a clear tracheal tube before administering oxygen. There is less than a preponderance of evidence to support either finding. Sudden deposits of hardened secretions in the tracheal tube of Resident 1 are consistent with medical experience. A person with a tracheal tube may develop calcified secretions in their lung known as concretions that can be coughed into the tube and cause it to become instantly blocked. It is unlikely that the hardened secretions found in the tracheal tube at the emergency room were present before Resident 1 collapsed in the facility. Hardened secretions can be cleared with a suctioning device or by coughing them through the tube and out of the opening near the neck if the resident has sufficient muscle strength. Resident 1 was a cognitively alert, 40-year-old, and physically capable of cleaning her own tracheal tube with a suctioning device. Resident 1 also had sufficient muscle strength to cough some secretions through the opening in her tube. Whenever Resident 1 was unable to clear her tube through the suctioning device or by coughing, she became anxious and immediately notified a nurse, who would then suction the tube and clear it for her. On March 2, 2003, Resident 1 complained to a nurse that she was experiencing shortness of breath. Significantly, Resident 1 did not complain that her tracheal tube was blocked. The nurse on duty at the facility notified the treating physician of Resident 1's complaints, and the physician ordered the nurse to measure the oxygen saturation levels of Resident 1. The oxygen saturation levels were within normal range, at 97 percent. The treating physician then ordered bed rest for Resident 1 and ordered the nurse to give Resident 1 a breathing treatment. Resident 1 had no further problems on March 2, 2003. On March 4, 2003, at approximately 9:30 a.m., Resident 1 summoned a nurse to come to her bedside and told the nurse that she did not feel well. Resident 1 did not complain that her tracheal tube was blocked. Her skin color was gray. She then passed out and fell to the floor. Nursing staff immediately called for EMT assistance, and EMT personnel arrived at the facility at approximately 9:32 a.m. EMT personnel transported Resident 1 to the emergency room at approximately 9:52 a.m. Between March 2 and March 4, 2003, the preponderance of evidence shows that the tracheal tube of Resident 1 was clear. Nursing staff at the facility monitored Resident 1 three times on March 3, 2003. Resident 1 had no breathing difficulties and did not express any complaints or discomfort. Resident 1 took her scheduled medications and meals on March 3, 2003. The nurse on duty during the 11 p.m. to 7 a.m. shift for March 4, 2003, provided oxygen and suctioning, "as needed," to Resident 1. This action would have cleared secretions, if any, that would have been "accumulating" in the tracheal tube of Resident 1. Resident 1 placed her finger over the opening to her tracheal tube when she spoke to the nurse about not feeling well on March 4, 2003. Resident 1 covered her tracheal tube to force air around her vocal cords so that the nurse could hear Resident 1. It would not have been necessary for Resident 1 to cover her tracheal tube if the tube were occluded. The findings in paragraphs 25 through 27 are based on notes prepared by the unit manager on March 4, 2003, in response to the directive of the facility's risk manager. The risk manager was responsible for investigating the incident and required all nurses who had contact with Resident 1 on March 3 and 4, 2003, to document their experiences with Resident 1. The unit manager then placed the accounts in the medical record. Petitioner questions the credibility of the unit manager notes because they are late-filed entries in the medical records. The trier of fact finds the unit manager and her notes to be credible and persuasive. The testimony and notes of the unit manager are consistent with the apparent determination by EMT personnel that the tracheal tube was clear. In addition, the Medication Administration Record for March 4, 2003, indicates that Resident 1 received a dose of an ordered medication at 6:00 a.m. and did not complain of not feeling well until some time later. If the notes and testimony of the unit manager were disregarded, the trier of fact cannot ignore the administration of oxygen by EMT personnel. The preponderance of evidence shows that the tracheal tube of Resident 1 was clear when EMT personnel administered oxygen. If it were determined that the tracheal tube of Resident 1 were fully occluded at the facility before Resident 1 collapsed on March 4, 2003, such a finding would alter the outcome of this case. Petitioner failed to show by a preponderance of evidence that an occlusion occurred as a consequence of inadequate assessment or monitoring. Resident 1 had normal oxygen saturation levels on March 2, 2003. The preponderance of evidence does not show that facility staff had reason to believe that the tracheal tube of Resident 1 was occluded after March 2, 2003, and failed to take action to clean the tube prior to the time Resident 1 collapsed on March 4, 2003. There is no preprinted or accepted assessment form for nursing homes to use to assess and monitor the ability of Resident 1 to clean her own tracheal tube. The parties agree that the process involves nothing more than a simple observation of Resident 1 to confirm that she understood and could clean the tracheal tube either by suctioning or coughing. Resident 1 was capable of cleaning her tracheal tube. Relevant orders from the treating physician did not require cleaning to be performed by facility staff. One physician's order indicated that Resident 1 could participate in her own self-care. Another physician's order indicated that Resident 1 was to have "trach care" three times a day, but did not describe the nature and scope of the care or designate who was to provide such care. Another physician's order indicated that Resident 1 was to receive oxygen through her tracheal collar while in bed and "suction trach as needed." However, nothing in the order indicated who was to provide those services. Resident 1 had her tracheal tube for more than a year prior to March 4, 2003. Facility staff routinely observed Resident 1 successfully suctioning and otherwise cleaning her own tracheal tube. Resident 1 also routinely notified staff when she could not remove a blockage in her tube. Facility staff appropriately determined that Resident 1 was capable of performing self-care on her tracheal tube. It was appropriate for facility staff to rely on Resident 1 to inform them if Resident 1 were unable to clean the tube. Her transfer to the hospital on March 4th and her subsequent death were not the product of any inadequate or erroneous assessment or monitoring of Resident 1. On May 12, 2003, Petitioner conducted another complaint investigation of the facility. Petitioner determined that Respondent failed to provide adequate care for pressure sores for three residents identified in the record as Residents 1A, 4, and 5, in violation of 42 CFR Section 483.25(c). Florida Administrative Code Rule 59A-4.1288 applies the federal requirements for pressure sore care to nursing homes in Florida. Petitioner assigned the charged deficiency a class II rating. Petitioner determined that a Class II rating was appropriate because actual harm or a negative outcome allegedly occurred with each of the residents cited in the deficiency. Petitioner changed the license rating for the facility from Standard to Conditional within the meaning of Section 400.23(7), Florida Statutes (2003). The change in license rating was effective May 12, 2003, and continued until June 16, 2003, when Petitioner changed the rating to Standard. Petitioner also proposes a $5,000 fine against Respondent. The fine is calculated by doubling the prescribed fine of $2,500, based on the alleged deficiency in the survey conducted on March 11, 2003, in accordance with Section 400.23(8)(b), Florida Statutes (2003). For reasons stated in previous findings, Respondent committed no violation in connection with the survey conducted on March 11, 2003. The fine for the alleged deficiency found on May 12, 2003, cannot exceed $2,500. Petitioner alleges that the pressure sore care provided by Respondent for Residents 1A, 4, and 5 violated 42 CFR Section 483.25(c). In relevant part, 42 CFR Section 483.25(c) requires a nursing home to ensure that: resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. 42 CFR Section 483.25(c) Petitioner alleges that Respondent failed to provide Resident 1A with necessary treatment and services to promote healing of an existing pressure sore on the coccyx of Resident 1A. Resident 1A acquired the pressure sore before Respondent admitted Resident 1A to the facility. In April 2003, Resident 1A had surgery to cover the pressure sore with a skin graft taken from her thigh. The surgery required approximately sixty staples to secure the graft. The alleged improper care of Resident 1A is based on several observations made by the surveyor on May 12, 2003. The surveyor observed that the staples used in the surgical process had not been removed even though a physician's order dated April 16, 2003, directed staff to set up an appointment with the plastic surgeon within two weeks of the date of the order. The surveyor found no evidence that staff had scheduled an appointment or taken any other steps to remove the staples. The surveyor observed that the skin was reddened and growing over some of the areas around the staples. The surveyor also observed Resident 1A positioned on her back in bed in such a manner that her weight was on her coccyx area. The area in question was not a pressure sore. Petitioner has adopted a written definition of a pressure sore in the guidelines that Petitioner requires its surveyors to use in interpreting the federal regulation at issue. In relevant part, the guidelines define a pressure sore as: . . . ischemic ulceration and/or necrosis of tissues overlying a bony prominence that has been subjected to pressure, friction or sheer. If the area of concern were the area over the coccyx of Resident 1A, that area would have been over a "bony prominence" within the meaning of definition of a pressure sore. However, it is undisputed that the area of concern for Resident 1A was located in the fleshy part of the buttocks where staples were used to secure the skin flap to the skin. The area of concern was a surgical wound site, rather than a pressure sore because of its origin and location. The preponderance of evidence shows that the area of concern failed to satisfy the definition of a pressure sore adopted by Petitioner. Section 120.68(7)(e), Florida Statutes (2003), prohibits Petitioner from deviating from its officially stated policy unless Petitioner explains the deviation. Petitioner failed to provide any evidence to explicate legitimate reasons for deviating from its written definition of a pressure sore in this case. Assuming arguendo the staples around the wound site were a pressure sore, the preponderance of evidence shows that Respondent provided necessary treatment to promote healing. Respondent turned and repositioned Resident 1A every two hours in accordance with standard protocol. That schedule included a period during which Resident 1A was on her back in bed, with the head of her bed elevated. The single observation by the surveyor of Resident 1A on her back in bed did not show that Respondent failed to properly turn and reposition Resident 1A. The failure to timely comply with the physician's order for Resident 1A to consult with a plastic surgeon did not deprive Resident 1A of the care necessary to promote healing of a pressure sore. The removal of staples from a skin flap is not an element of required care for a pressure sore. Rather, removal of staples is part of the established care for a surgical wound site. The failure to timely provide a consult was not a violation of the requirements for care of pressure sores. If the removal of staples were required for treatment of pressure sores, the failure to timely obtain a consult and the failure to timely remove the staples did not cause harm to Resident 1A. The undisputed purpose of the physician's order to see a plastic surgeon was to evaluate whether the staples should be removed from the wound site. Respondent removed the staples from the wound site shortly after the survey with no complications to the resident. The surgical wound site healed in a timely and complete manner. The absence of harm to Resident 1A precludes a rating as a Class II deficiency. Petitioner alleges that Respondent allowed avoidable pressure sores to develop on Resident 4 and failed to provide necessary treatment after the pressure sores developed. During the survey, the surveyor and a nurse, who was a clinical consultant to the facility, twice observed Resident 4 lying on a special air mattress that was not inflated. After the second observation, the surveyor and consultant examined Resident 4 and observed what each determined to be two stage II pressure sores on each of the outer heels of Resident 4, a stage IV pressure sore on the right toe, two stage II areas on her left side above her rib cage, and a stage II area under her left breast. The surveyor and the nurse-consultant found nothing in the medical record to indicate that these areas had been previously identified by facility staff. Nor did they find any treatment orders for the areas of concern. The areas of concern were not pressure sores. It is undisputed that pressure sores involve deep tissue damage, do not heal quickly, and would have been present a few days later during examination. The director of nursing and the wound care nurse for the facility examined Resident 4 on May 13, 2003, and found no evidence of the areas that caused concern to the surveyor and nurse-consultant on May 12, 2003. The director of nursing asked the treating physician to examine Resident 4 to confirm the director's observations. On May 19, 2003, the treating physician examined Resident 4 and found no areas of concern on Resident 4. Resident 4 had no conditions that placed her at risk for developing pressure sores. The failure to inflate the special air mattress under Resident 4 did not create any risk for pressure sores. The mattress had not been ordered for Resident 4 and was not necessary for her care because Resident 4 was not at risk for developing pressure sores. Resident 4 was on the mattress because she had moved into a new room, and facility staff had not yet removed the mattress from the bed in the room that was used by the previous occupant. Petitioner alleges that Respondent failed to provide necessary treatment to promote healing of existing pressure sores on Resident 5. Resident 5 had three open areas on his skin: one on each hip and one over the coccyx. The areas on each hip were surgical wounds from hip surgeries prior to admission to the facility. For reasons stated in previous findings, these areas were surgical wound sites and were not pressure sores. It is undisputed that the remaining area on Resident 5 was a stage II pressure sore over the coccyx that was present upon admission to the facility. During the survey, the surveyor and the nurse-consultant observed Resident 5 on a specialty air mattress that contained a number of air chambers. Two of the chambers were not inflated. The surveyor and nurse-consultant determined that the area over the coccyx had worsened to a stage IV pressure sore. Petitioner alleges that Respondent failed to provide necessary care to Resident 5 by failing to properly inflate his specialty air mattress during the survey. Respondent did not fail to properly inflate the air mattress for Resident 5. The level of inflation of that mattress is not determined or set by the facility. Rather, the manufacturer calculates and sets the level of inflation for the mattress. The alleged failure to properly inflate the air mattress did not cause harm to Resident 5. The director of nursing observed the area of concern the day after the survey and determined it to be a stage II, rather than a stage IV, pressure sore. The clinical records that charted the size and stage of the pressure sore for the month after the survey show that the area was never more than a stage II pressure sore. A stage IV pressure sore would not have improved to a stage II sore within a month. Petitioner failed to show by a preponderance of the evidence that the alleged improper inflation of an air mattress caused the pressure sore on Resident 5 to worsen from a Stage II to a Stage IV pressure sore.
Recommendation Based on the foregoing findings of fact and conclusions of law, It is RECOMMENDED that Petitioner enter a Final Order deleting the disputed deficiencies from the survey reports for March 11 and May 12, 2003; replacing the Conditional ratings with Standard ratings; and dismissing the proposed fines and investigative costs with prejudice. DONE AND ENTERED this 2nd day of March, 2004, in Tallahassee, Leon County, Florida. S DANIEL MANRY 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 2nd day of March, 2004. COPIES FURNISHED: Gerald L. Pickett, Esquire Agency for Health Care Administration Sebring Building, Suite 330K 525 Mirror Lake Drive, North St. Petersburg, Florida 33701 Donna Holshouser Stinson, Esquire Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Drawer 11300 Tallahassee, Florida 32302-1300 R. Davis Thomas, Jr. Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Box 11300 Tallahassee, Florida 32302-1300 Rhonda M. Medows, M.D., Secretary Agency for Health Care Administration Fort Knox Building, Suite 3116 2727 Mahan Drive Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308
The Issue Whether disciplinary action should be taken against the license to practice medicine of Respondent, Howard E. Gross, M.D., based on allegations that he violated Subsection 458.331(1)(t), Florida Statutes, as alleged in the Administrative Complaint in this proceeding.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and the entire record in this proceeding, the following findings of fact are made: Petitioner is the state agency charged with regulating the practice of medicine in the State of Florida pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times material to this proceeding, Respondent was a licensed physician in the State of Florida, having been licensed in 1971 and issued license number ME 0017039. Respondent has never been disciplined previously. Respondent is board-certified in internal medicine (1970) and cardiovascular diseases (1973). He is an interventional cardiologist. He has practiced medicine in Orlando since 1971. For the past 10 years, he has done a high-volume catheterization practice. In the most recent one-year period, he did approximately 500 interventional procedures and 400 diagnostic procedure, and in almost all instances, the catheterization involved a ventriculogram. On or about February 18, 1997, patient L. D. L., an 84-year-old male with a history of coronary artery disease, presented to Orlando Regional Medical Center, for catheterization and possible rescue angioplasty to be performed by Respondent. Respondent performed a cardiac catheterization on the patient. During the catheterization procedure, Respondent advanced a 6-French pigtail catheter into the patient's left ventricle and performed a ventriculogram by injecting what he thought was approximately 20cc of ionic dye, utilizing a MEDRAD injector. During the catheterization procedure, Respondent noted that he did not obtain opacification of the left ventricle and noted that free air was in the left ventricle. In fact, Respondent injected the patient with approximately 15cc to 20cc of free air rather than dye. As a result, the patient suffered cardiac arrest, and his blood pressure fell to zero. Respondent initiated various life-saving measures to counter the effects of the injection of free air, which were unsuccessful, and the patient was pronounced dead at approximately 1:55 p.m., as a result of cardiac arrest brought on by an air embolus. At the time, Orlando Regional Medical Center (hereinafter "ORMC") had a policy/procedure (No. 3233-MEDRAD- 0001) for Cardiac Catheterization Laboratory (hereinafter "Cardiac Cath Lab") personnel (Respondent's Exhibit 1). It delineated specific procedures to ensure "the use and safe applications of the power injector." In particular, it states the procedure to be employed by Cardiac Cath Lab staff in loading the MEDRAD injector. At ORMC and other hospitals, Cardiac Cath Lab personnel load the MEDRAD injectors without physician supervision. As explained by both expert witnesses, loading the syringe with dye is a very simple task for a nurse or scrub tech to perform. In the instant case, the nurse loading the MEDRAD injector interrupted the loading procedure because she was concerned about the patient's lab values (kidney function) and was uncertain about what type of dye Respondent would order. Respondent was not yet in the Cardiac Cath Lab. The nurse anticipated asking Respondent which type of dye he wanted and then loading that type dye into the MEDRAD injector. When she interrupted the loading procedure, the nurse left the plunger positioned in the syringe where it appeared that the syringe had been loaded with 20 to 25cc of dye and the injector arm pointing upward. The nurse then left the Cardiac Cath lab to get her lead apron anticipating only a monetary absence from the lab. Unknown to her, Respondent entered the Cardiac Cath Lab within seconds after her departure. Respondent was not in the Cardiac Cath Lab at any time while the nurse was manipulating the MEDRAD injector. As the nurse secured her lead jacket, she was called to another patient to administer medication which required the presence of a registered nurse per hospital procedures. In the nurse's absence, the catheterization and ventriculogram of the patient proceeded. The Registered Cardiovascular Technician (hereinafter "RCT"), observing the MEDRAD injector in what appeared to be a prepared state, wheeled it to the patient's side and lowered the injector arm into a position to receive the catheter. The RCT testified that a MEDRAD injector would never be left as she found it, plunger at the 20 to 25cc mark and arm elevated, if the machine was not loaded with dye. The ionic dye used in the procedure is clear and, due to the nature of the MEDRAD plunger and casing, it is extremely difficult to tell if dye is in the syringe. Further compounding the difficulty in observing dye in the syringe is the fact that the lights in the Cardiac Cath Lab are lowered during the procedure to allow better visualization of the video monitor. While the RCT positioned the MEDRAD injector at the patient's side, Respondent was in the process of entering the catheter into the patient, manipulating the catheter in the patient, visualizing its position in the patient's heart on the video monitor and monitoring hemodynamics. Petitioner's expert witness testified that Respondent did justifiably rely on the Cardiac Cath Lab personnel to follow the procedure outlined in Respondent's Exhibit 1. The nurse and cardiovascular technician did not follow the policy/procedure and, as a result, allowed the presence of air in the MEDRAD injector. After the catheter is properly located in the patient's heart, the external end of the catheter is attached to the MEDRAD injector. Petitioner's expert witness opined the Respondent should have used extension tubing to effect the connection between the catheter and MEDRAD injector. Testimony revealed that extension tubing is used by many physicians who perform cardiac catheterization. Respondent's practice was not to use extension tubing. Both Petitioner's and Respondent's expert witnesses agreed that Respondent's choice not to use extension tubing was a "technique" choice and did not fall below the "standard of care." Petitioner's expert opined that Respondent should have been present in the Cardiac Cath Lab to observe the loading of the MEDRAD injector. Testimony revealed that at ORMC and other hospitals it was the Cardiac Cath Lab staff's responsibility to load the MEDRAD injector without the direct supervision of physicians and that physicians are rarely in the lab when the MEDRAD injector is loaded. The "standard of care" does not require the physician to watch the loading of dye or the expulsion of air from the syringe in the loading process. Petitioner's expert opined that Respondent should have performed a test injection (a process where a small amount of dye is injected into the heart prior to the main injection). Respondent's expert testified that under certain circumstances (none of which is applicable to the instant case) test injections were appropriate; those circumstances occur less than 5 percent of the time. Electing not to perform a test injection in the instant case does not fall below the "standard of care." Petitioner's expert opined that Respondent should have observed a "wet to wet" connection between the catheter and the MEDRAD injector to ensure that no air is in the system. This is accomplished by withdrawing a small amount of blood from the catheter into the MEDRAD injector. Small air bubbles may appear between the blood and dye and are then "tapped" to rise to the top of the syringe. However, Respondent performed the "wet to wet" connection and did not observe anything unusual. He has historically performed some "wet to wet" connections where no air bubbles were present between the blood and dye as it appeared in this case. The RCT confirmed that Respondent performed the "wet to wet" connection, looked for air in the syringe, and tapped on the syringe to loosen and expel air bubbles. Respondent's expert witness testified that he performed an experiment creating a "wet to wet" connection with air in the MEDRAD injector syringe instead of dye. He found that the miniscus formed by blood and air in the syringe has an identical appearance to blood contacting dye in the syringe. The "wet to wet" connection between blood and air in the syringe has the same appearance as a "perfectly clean", "wet to wet" connection between blood and dye in the syringe. Respondent's expert witness testified that from five to ten percent of the time a "perfectly clean", "wet to wet" connection occurs in which no air bubbles appear between the blood and dye. Petitioner's expert witness testified that the physician must make absolutely certain that no gross amount of air is injected into the patient, and, relying on his view that the Respondent as the physician was the "captain of the ship," he testified that "the injection of this volume of air during the ventriculogram fell below the cardiology "standard of care." Petitioner's expert rendered his opinion based upon his examination of the hospital records. Respondent's expert rendered his opinion based upon his examination of the following: Administrative complaint with supporting documents. Dr. Allen Seals' (Petitioner's expert) report and deposition. Agency for Health Card Administration investigative report. ORMC's Code 15 report. Respondent's February 21, 1997 memo for peer review purposes. Hospital records. Death résumé. ORMC's MEDRAD policy/procedure. Experimentation with a catheter and MEDRAD injector. Respondent's expert testified that Respondent met the standard of care in the instant case because he practiced medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar circumstances. Based on the totality of the evidence presented, the undersigned rejects the expert opinion of Dr. Allen Seals, M.D., Petitioner's expert witness, and accepts as being more credible the testimony of David P. Browne, Jr., M.D., Respondent's expert witness.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order finding that Respondent is not guilty of violating Subsection 458.331(1)(t), Florida Statutes, as alleged in the Administrative Complaint. DONE AND ENTERED this 13th day of February, 2001, in Tallahassee, Leon County, Florida. JEFF B. CLARK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 13th day of February, 2001. COPIES FURNISHED: Ephraim D. Livingston, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Robert D. Henry, Esquire Martin D. Buckley, Esquire Ringer, Henry & Buckley, P.A. Post Office Box 4922 Orlando, Florida 32801-4229 Tanya Williams, Executive Director Department of Health Board of Medicine 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703
The Issue The basic issues in these consolidated cases concern whether Rule 10- 5.032, Florida Administrative Code, is an invalid exercise of delegated legislative authority. The validity of the rule has been challenged on both procedural and substantive grounds.
Findings Of Fact South Miami is an acute care hospital located in Dade County. South Miami has a open cardiac catheterization program which means any physician within the community can apply for privileges, and, if granted, perform cardiac catheterizations at South Miami. Until recently, it was a closed program. Doctors' Hospital is an acute care hospital located in Coral Gables, Florida. Doctors' has had a cardiac catheterization program since December of 1986, and is authorized to perform diagnostic catheterization on both inpatients and outpatients. Baptist is a 500 bed full service hospital located in Dade County. Baptist has a cardiac catheterization program serving both inpatients and outpatients. Approximately 2,000 cardiac catheterizations are performed at Baptist each year. Deering is a 260 bed hospital in Miami, Florida. The agency has noticed its intent to grant Deering a CON to initiate a cardiac catheterization program. The Agency for Health Care Administration ("AHCA") is designated as the single state agency to issue, revoke, or deny certificates of need and to issue, revoke, or deny exemptions from CON review in accordance with the district plans, the statewide health plan, and present and future federal and state statutes. In 1987, the certificate of need statute was amended to deregulate all outpatient services. At the same time, the capital expenditure cap was raised from $500,000 to $1 million, and the meaning of "major medical equipment" was redefined to include only equipment which has been approved by the United States Food and Drug Administration for less than three years for general usage. These changes had a major impact on the ability of health care providers to acquire and replace equipment. They could now acquire equipment virtually at will, with the Legislature only expressing a limited interest in controlling expensive emerging technologies. This legislative expression was a major policy change with respect to planning for the distribution of health care resources. Prior to these statutory changes, all cardiac catheterization services had been treated as inpatient institutional health services requiring a certificate of need. With the deregulation of outpatient services, without exception, outpatient cardiac catheterization laboratories were deregulated by the statutory changes. With cardiac catheterization equipment being totally deregulated, and the capital expenditure threshold raised, inpatient cardiac catheterization providers could now expand their catheterization facilities and completely replace their equipment without a certificate of need. For these reasons, the then existing cardiac catheterization rule could not be applied because the policy constraints articulated in it were no longer recognizable by the underlying statewide policy expressed in the amended CON statute. The rule then in effect controlled the expansion of existing laboratories in many cases because the necessary equipment for expansion exceeded the then existing capital expenditure threshold. Furthermore, that rule simply did not contemplate the development of unregulated outpatient cardiac catheterization services. These facts led AHCA to conclude that they could no longer control the capacity of existing providers to offer cardiac catheterization services. The rule in existence at that time was believed to be inoperable because it was based upon the assumption that an inventory of laboratories could be established and predicted for future horizons. Under the statutory changes, this assumption was believed to be no longer valid because the number of laboratories was subject to change without constraint at any given time. Initially, the rule amendment process began with internal discussions. Next, a work group was convened to discuss these specific issues. Next, various possible need methodologies were modeled using a variety of assumptions. An updated literature search was undertaken and the comments of the work group were considered. Subsequently, a rule was developed and circulated for internal review at AHCA. Finally, in April of 1988, the proposed amendment was published in the Florida Administrative Weekly. Administrative challenges were brought against the rule. Based upon concerns of the challengers, changes were made to the rule. The rule, with the changes, was filed for adoption with the Secretary of State on July 18, 1988. It became effective, according to the certification of the Secretary of State, on August 7, 1988, and remained in effect until November of 1991. On July 29, 1988, The changes were published in the Florida Administrative Weekly. Within 21 days of the Notice of Change publication in the Florida Administrative Weekly on July 29, 1988, but after the rule became effective, several challenges were launched against the Notice of Change. These challenges purported to be Section 120.54 challenges to proposed amendments. A final order was issued on June 30, 1989, on the challenges to the changes in the 1988 rule amendments. See Florida Medical Center, et al. v. Dept. of Health and Rehabilitative Services, 11 FALR 3904 (June 30, 1989). In the closing paragraphs of the Final Order in the FMC case, the Hearing Officer ordered the following: That the amendments to Rule 10- 5.011(1)(e), F.A.C., published by the Department of Health and Rehabilitative Services on July 29, 1988, with the exception of the amendments to paragraph 2(h), paragraph 3(c)III, and paragraph 6(a) and the amendment regarding the definition of "inpatient visit", are an invalid exercise of delegated legislative authority, because they were adopted by the Department without adhering to the proper procedures for adoption delineated in Section 120.54, Florida Statutes. That should the Department seek to proceed with the other revisions to the rule previously published on July 29, 1988, it must afford interested parties an opportunity to comment on the merits of those proposed revisions in the manner provided for in Section 120.54, Florida Statutes, with a new point of entry. An appeal of the Final Order was taken by AHCA. On April 9, 1991, the District Court of Appeals upheld the final order of the Hearing Officer, holding that, as to those changes which AHCA was without authority to make, it must either withdraw the changes or reinstitute the rulemaking process. AHCA worked closely with its attorneys and with the Joint Administrative Procedures Committee to come to agreement on the interpretation of the appellate court decision and on the procedure to follow to comply with the court's decision. On July 5, 1991, AHCA published its interpretation of the rule resulting from the Final Order affirmed by the District Court of Appeals, by withdrawing the portions of the rule which had been invalidated. A Section 120.54 challenge was mounted against this publication by South Miami Hospital and others, but the challenges were later voluntarily dismissed. On August 9, 1991, AHCA published the amendments it proposed to adopt to replace those which had been withdrawn. This publication was not challenged. These amendments were filed for adoption with the Secretary of State on October 22, 1991, and became effective November 11, 1991. The current version of the challenged rule, Rule 10- 5.032, Florida Administrative Code, reads as follows, in pertinent part: 3/ Departmental Intent. This rule amendment implements the provision of section 381.706 (1)(c), F.S., which provides that a certificate of need shall not be required for an expenditure to provide an outpatient service. This rule defines the requirements for the establishment of inpatient cardiac catheterization services, including minimum requirements for staffing, equipment, and a need methodology for cardiac catheterization programs. A certificate of need for the establishment of inpatient cardiac catheterization services shall not normally be approved unless the applicant meets all relevant statutory criteria, including the standards and need determination criteria set forth in this rule. A cardiac catheterization program which is established and utilized for the purpose of serving outpatients exclusively is not regulated under this rule. A cardiac catheterization program which provides services to inpatients, regardless of the reason for their admission, including but not limited to coronary angioplasty, valvuloplasty, or ablation of intracardiac bypass tracts, or pediatric cardiac catheterization, requires a certificate of need. Hospitals operating more than one hospital facility under the same hospital license in the same district, shall obtain a separate certificate of need for the establishment of a cardiac catheterization program in each health care facility. Definitions. Cardiac Catheterization. Cardiac catheterization is defined as a medical procedure requiring the passage of a catheter into one or more cardiac chambers of the left and right heart, with or without coronary arteriograms, for the purpose of diagnosing congenital or acquired cardiovascular diseases, or for determining measurement of blood pressure flow. Cardiac catheterization also includes the selective catheterization of the coronary ostia with injection of contrast medium into the coronary arteries. Coronary Angioplasty. Coronary angioplasty is defined as a hospital inpatient procedure requiring the dilation of narrowed segments of the coronary vessels, via a balloon-tipped catheter. Catheterization Program. A cardiac catheterization program is defined as an institutional health service which is provided by or on behalf of a health care facility and which consists of one or more laboratories which comprise a room or suite of rooms, and has the equipment and staff required to perform cardiac catheterization serving inpatients and outpatients. A cardiac catheterization program approved for angioplasty services, or other types of therapeutic cardiac procedures shall have the additional necessary equipment and staff to perform angioplasty procedures. Approved Program. A proposed cardiac catheterization and angioplasty program, not operational as defined by this rule, for which a certificate of need, a letter of intent to grant a certificate of need, or a final order granting a certificate of need was issued, consistent with the provisions of 10- 5.008 (2)(b), Florida Administrative Code, on or before the most recent published deadline for agency initial decisions prior to publication of the fixed need pool, as specified in 10-5.008 (1)(1), Florida Administrative Code. Cardiac Catheterization Annual Program Volume. The cardiac catheterization annual program volume equals the total number of inpatient and outpatient admissions to the cardiac catheterization program, for the purpose of cardiac catheterization or angioplasty, for the 12-month period specified in paragraph (8)(c). A single admission is equivalent to one patient visit to the cardiac catheterization program. Each patient visit will be counted in determining the actual program volume regardless of whether the patient is an inpatient or outpatient at the facility performing the procedure, or has been admitted as an inpatient or outpatient at another facility. Inpatient. An inpatient is defined as a person who has been admitted to a hospital for bed occupancy for purpose of receiving inpatient hospital services. A person is considered an inpatient if he was formally admitted as an inpatient with the expectation that he would remain at least overnight and occupy a bed, even though it later develops that he can be discharged or that he is transferred to another hospital and does not actually use a hospital bed overnight. An inpatient of a hospital cannot be considered an outpatient of that or any other hospital at the same time. Outpatient. An outpatient is defined as a person who receives cardiac catheterization in a health care facility and does not meet the definition of inpatient in paragraph (e) [sic]. Service Planning Area. The service planning area for a cardiac catheterization program is the applicable HRS district unless cardiac catheterization subdistricts have been defined by the respective local health council and promulgated into rule by the department. . . . Operational Program. A new cardiac catheterization and angioplasty program approved by the department that has performed at least one inpatient or outpatient cardiac catheterization as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool; or, in the case of programs which performed only outpatient cardiac catheterization prior to departmental approval, a program that has performed at least one inpatient cardiac catheterization as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool. Scope of Service. Each cardiac catheterization program shall be capable of providing immediate endocardiac catheter pacemaking in cases of cardiac arrest, and pressure recording for monitoring and to evaluate valvular disease, or heart failure. Applicants for cardiac catheterization programs shall document the manner in which they will meet this requirement. A range of non-invasive cardiac or circulatory diagnostic services must be available within the health care facility itself, including: Hematology studies or coagulation studies; Electrocardiography; Chest x-ray; Blood gas studies; and Clinical pathology studies and blood chemistry analysis. At a minimum a cardiac catheterization program shall include: A special procedure x-ray room; A film storage and darkroom for proper processing of films; X-ray equipment with the capability in cineangiocardiography, or equipment with similar capabilities; An image intensifier; An automatic injector; A diagnostic x-ray examination table for special procedures; An electrocardiograph; A blood gas analyzer; A multichannel polygraph; and Emergency equipment including but not limited to a temporary pacemaker unit with catheters, ventilatory assistance devices, and a DC defibrillator. Service Accessibility. Travel Standard. An adult inpatient cardiac catheterization program shall be available within a maximum automobile travel time of 1 hour, under average travel conditions, for at least 90 percent of a service planning area's population provided that the cardiac catheterization program can meet other applicable statutory and related rule criteria. Hours of Operation. Every cardiac catheterization program shall have the capability of rapid mobilization of the study team within 30 minutes for emergency procedures 24 hours a day, 7 days a week. Applicants for new cardiac catheterization programs shall document the manner in which they will meet this requirement. Underserved Population Groups. Applicants for a cardiac catheterization program shall indicate the projected number of medically indigent and Medicaid patients to be served annually. Applicants shall indicate their past provision of health care services to medically indigent and Medicaid patients. Service Quality. Accreditation. Any health care facility providing inpatient catheterization only, or inpatient and outpatient cardiac catheterization, or angioplasty, must be fully accredited by the Joint Commission on Accreditation of Health Care Organizations (JCAHO) for special care units, or be accredited by the American Osteopathic Association. Availability of Health Personnel. Any applicant proposing to establish a cardiac catheterization program must document that adequate numbers of properly trained personnel will be available. At a minimum, a team involved in cardiac catheterization consists of a physician, one nurse, and one or more technicians. An applicant for a new cardiac catheterization program shall document that the following staff are available: A program director, board-certified or board- eligible in internal medicine, or radiology with subspecialty training in cardiology or cardiovascular, radiology; . . . A physician, board-certified or board- eligible in cardiology, radiology, or with specialized training in cardiac catheterization and angiographic techniques who will perform the examination; Support staff, specially trained in critical care of cardiac patients, with a knowledge of cardiovascular medication and an understanding of catheterization and angiographic equipment; Support staff, highly skilled in conventional radiographic techniques and angiographic principles, knowledgeable in every aspect of catheterization and angiographic instrumentation, with a thorough knowledge of the anatomy and physiology of the circulatory system; Support staff for patient observation, handling blood samples and performing blood gas evaluation calculations; Support staff for monitoring physiologic data and alerting the physician of any changes; Support staff to perform systematic tests and routine maintenance on cardiac catheterization equipment, who must be available immediately in the event of equipment failure during a procedure; Support staff trained in photographic processing and in the operation of automatic processors used for both sheet and cine film; and A Medical Review Committee which reviews medical invasive procedures such as endoscopy and cardiac catheterization. Coordination of Services. Cardiac catheterization programs proposed in a facility not performing open heart surgery must submit a written protocol as part of their certificate of need application for the transfer of emergency patients to a hospital providing open heart surgery, which is within 30 minutes travel time by emergency vehicle under average travel conditions. Cardiac catheterization programs which include the provision of coronary angioplasty, valvuloplasty, or ablation of intracardiac bypass tracts must be located within a hospital which also provides open heart surgery. * * * Service Cost. Cost data for cardiac catheterization programs, among similar institutions, shall be comparable when patient mix, cost accounting methods, labor market differences and other extenuating factors are taken into account. Need Determination. In order to assure patient safety and staff efficiency and to achieve maximum economic use of existing resources, the following criteria shall be considered in the approval of certificate of need applications for new adult cardiac catheterization programs. The minimum annual projected net program volume need for the establishment of a new adult cardiac catheterization program shall be at or exceed an annual program volume of 300 admissions for the service planning area. Applicants shall demonstrate that they will be able to reach an annual program volume of 300 admissions within 2 years after the program becomes operational. Need Determination. A new adult cardiac catheterization program may be approved if the difference between the projected program volume and the number of adult cardiac catheterizations performed in the service planning area during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool, minus the number of approved adult programs times 300, is at or exceeds a program volume of 300 for the applicable service planning area. This need formula is expressed as follows: NN = PCCPV - ACCPV - APP Where: NN is the 12-month net adult program volume need in the service planning area projected 2 years into the future for the respective planning horizon. Net need projections are published by the department as a fixed need pool twice a year. The planning horizon for applications submitted between January 1 and June 30 shall be July of the year 2 years subsequent to the year the application is submitted. The planning horizon for applications submitted between July 1 and December 31 shall be January of the year 2 years subsequent to the year which follows the year the application is submitted. PCCPV is the projected adult cardiac catheterization program volume which equals the actual adult cardiac catheterization program volume (ACCPV) rate per thousand adult population 15 years and over for the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool, multiplied by the projected adult population 15 years of age and over 2 years into the future for the respective planning horizon. The population projections shall be based on the most recent population projections available from the Executive Office of the Governor which are available to the department 3 weeks prior to the fixed need pool publication. ACCPV equals the actual adult cardiac catheterization program volume for the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool. APP is the projected program volume for approved adult programs. The projected program volume for each approved program shall be 300 admissions. Irrespective of the net need calculated under paragraph (c), no additional cardiac catheterization program shall normally be granted unless ACCPV divided by the number of operational programs for the service planning area is at or exceeds a program volume of 300 patient admissions. * * * (g) Actual inpatient and outpatient migration from one service planning area to another shall be considered in the review of Certificate of Need applications. Decisions on certificate of need applications for the expansion of existing programs shall be made on the basis of the applicant's justification for the level of the proposed capital expenditure and the utilization of existing laboratories in the facility. The approval of an additional laboratory(ies) in a facility with an operational or approved inpatient program shall not reduce the net program need as calculated according to the formula contained in paragraph (8)(c). Briefly summarized, the current rule projects a number of anticipated admissions to cardiac catheterization programs in the horizon year by multiplying the current use rate (number of admissions per thousand adult population) times the projected population. If the difference between the current volume and the projected volume is greater than 300, a new program may be awarded, so long as all of the existing programs, plus the proposed program, are projected to perform an average of 300 admissions each. An approved program is assigned a value of 300 for purposes of determining the average. The rule takes into consideration the demographic characteristics of the population by establishing a use rate for cardiac catheterization services in a given service area. The use rate identifies the number of individuals per one hundred thousand who used the service in a defined recent historical period. If the demographics of an area cause the service to be used at a greater or lesser rate than the State as a whole, that fact will be revealed in the use rate. In the same way, the use rate takes into account the health status of the individuals seeking services in the service area because a deviation from normal health status will typically result in a higher or lower use rate than the State as a whole. Since the use rate is based on place of access to the service it is reflective of district-wide gross service use patterns. The rule need methodology does not take into account differences in service use patterns as between numbers of inpatient and numbers of outpatient cardiac catheterization procedures, nor does it take into consideration differences in service use patterns as between number of procedures performed in cardiac catheterization programs in facilities performing open heart surgery and numbers of procedures performed in cardiac catheterization programs in facilities not performing open heart surgery. An example of relevant service use patterns that are not taken into account by the rule methodology is the significantly higher utilization of cardiac catheterization laboratories located in facilities that also offer open heart surgical back-up. Cardiac catheterization laboratories in facilities that do not offer open heart surgical back-up receive only seven percent of the inpatient admissions from the MDC-5 patient pool, compared to thirty-eight percent in cardiac catheterization laboratories with open heart surgery back-up in the same facility. Similar differences in service use patterns are reflected at Tab "D" of SMH Exhibit 10, which shows that there were a total of 9,362 inpatient admissions in the laboratories with open heart surgical back-up, compared with only 553 total inpatient admissions in cardiac catheterization laboratories without open heart surgical back-up. The rule addresses quality of care standards at paragraph (5), headed "Service Quality." Within that section, applicants must document accreditation for special care units, availability of adequate numbers of specified properly trained personnel, and medical review procedures. Paragraph (6) of the rule, entitled "Coordination of Services", also establishes quality standards by requiring a written protocol for the transfer of emergency patients to a hospital providing open heart surgery by providing that only hospitals authorized to perform open heart surgery can perform angioplasty, and providing that pediatric cardiac catheterization can only be performed in hospitals performing pediatric open heart surgery. Paragraph (8) of the rule, which contains the various considerations in determining need, also attempts to address quality of care considerations. The extent to which such considerations are adequately treated is addressed further below. Minimum cost efficiency standards are addressed in the need methodology at subparagraphs (8)(a) and (8)(b) of the rule where it requires that applicants must demonstrate that they will be able to reach an annual program volume of 300 admissions within two years after the program becomes operational and net need must equal a minimum of 300 admissions before a new adult program may be established. The extent to which these standards are adequate is addressed further below. Trends in total usage are taken into account by the rule in that the use rate is updated every six months. If a service area is experiencing a significant increase, that trend will be reflected in the updated use rate which is used to project need. But, as noted above, the rule methodology does not take into account certain usage trends related to type of patient or type of facility. The rule contains a geographic access standard at subparagraph (4)(a) where it provides that adult inpatient cardiac catheterization shall be available within a maximum automobile travel time of 1 hour, under average travel conditions, for at least 90 percent of a service planning area's population. The rule addresses market economics in several ways. First, by utilizing the number of admissions to the service area programs, second by projecting population into a future horizon, third, by subtracting the existing volume of providers and fourth by prohibiting, generally, the addition of a new program unless the average patient volume within the district is at least 300. Through the use of this data, the rule looks at current market conditions, and purports to protect current market share while projecting future need. The extent to which the rule is adequate in this regard is addressed further below. The rule does not take into consideration the number of individual catheterization laboratories, rather it considers the number of cardiac catheterization programs. The difference is that an individual hospital will have only one program, but it may have more than one laboratory in each program. Because of the ability of existing providers to expand to add new laboratories without certificate of need approval in most cases, it has become difficult for AHCA to establish and maintain an inventory of existing laboratories for the purpose of projecting need. This difficulty caused AHCA to reject any methodology based upon the number of existing laboratories because AHCA felt there was no way the number of existing cardiac catheterization laboratories could be predicted in the horizon year. AHCA does have the ability to control the growth of programs, however, and, therefore, can establish a reliable inventory of programs and predict their number in the horizon year. The agency's thinking in this regard overlooks the obvious fact that programs are, by definition, comprised of one or more cardiac catheterization laboratories and that existing programs can in most cases continue to add laboratories to their program without going through certificate of need review. Such being the case, the ability to regulate and reliably predict the number of future programs does not in any way enhance the ability to predict the number of future laboratories. Further, because programs are comprised of one or more laboratories, one can reach useful conclusions regarding such things as the efficiency or capacity of existing programs only by considering the number of existing laboratories within each of the existing programs. The extent of usage of any individual laboratory cannot be predicted in advance with certainty because it depends on many variables. This uncertainty is supported by the Florida data which demonstrates that laboratory admissions vary greatly from a very low volume after several years to volumes of 1800 to 2000. But because programs, by definition, are comprised of one or more laboratories, it is equally difficult, for the very same reasons, to predict the extent of future usage of programs. Difficult and uncertain as it may be to do so, any effort to predict future need for new cardiac catheterization services must take into account the capacity of the existing laboratories that make up the existing programs. The rule takes into account the recent usage volume of existing providers by subtracting existing volume of catheterizations performed from projected volume, and by protecting an average of 300 admissions to all inpatient programs, and a minimum of 300 for all approved programs. The rule does not, however, address the capacity of existing cardiac catheterization programs or the capacity of existing cardiac catheterization laboratories. The pre-1988 cardiac catheterization rule used a different formula entirely to predict need. As a minimum threshold requirement, it utilized an average of 600 procedures per lab. The National Guidelines For Health Planning 4/ upon which the previous standard of 600 procedures was based include the following provisions: Sec. 121.208 Cardiac catheterization. Standard. (1) There should be a minimum of 300 cardiac catheterizations, of which at least 200 should be intracardiac or coronary artery catheterizations, performed annually in any adult cardiac catheterization unit within three years after initiation. * * * There should be no new cardiac catheterization unit opened in any facility not performing open heart surgery. There should be no additional adult cardiac catheterization unit opened unless the number of studies per year in each existing unit in the health service area(s) is greater than 500. . . . Discussion. The modern cardiac catheterization unit requires a highly skilled staff and expensive equipment. Safety and efficacy of laboratory performance requires a case load of adequate size to maintain the skill and efficiency of the staff. In addition, the underutilized unit represents a less efficient use of an expensive resource and frequently reflects unnecessary duplication, Based on recommendations from the Inter-Society Commission on Heart Disease Resources, the Department believes that a minimum level of 300 catheterizations per year is indicated to achieve economic use of resources. Several State health planning agencies, such as New Jersey, suggested a higher minimum level and the Department will be considering whether a higher level should be established in the future. The Department has also determined the existing units should be performing more than 500 cardiac catheterizations or 250 pediatric cardiac catheterizations before a new unit is opened. The 500 level is based on an average of two catheterizations a day, a rate that is in the Department's judgement readily achievable in most institutions providing these services and that will foster more effective uses of current resources prior to the development of additional resources. More than 600 procedures are performed annually in some institutions. Pediatric cardiac catheterizations require special facilities and support services. Lower target numbers are presented in these cases because of the special conditions and needs of children. The established levels are consistent with the recommendations of the Section on Cardiology of the American Academy of Pediatrics and the Inter-Society Commission on Heart Disease Resources. The patient studied in the cardiac catheterization unit is frequently recommended for open heart surgery. While acceptable inter-institutional referral patterns exist in some areas, cardiac catheterization units should optimally be located within a facility in which cardiac surgery is performed. Other guidelines regarding the utilization and establishment of new cardiac catheterization laboratories appear in the 1983 Report of Inter-Society Commission for Heart Disease Resources. Page 898A of the Inter-Society Report includes the following: Although the rate of development of new cardiac catheterization laboratories has declined in recent years, there is concern that the performance of many laboratories is less than optimal. This represents a duplication of resources that may seriously compromise quality and safety of studies and increase cost of care. Study of costs of each laboratory on a per-procedure basis does not adequately characterize the total costs and/or needs of a region. A footnote to the above quoted language notes the following: Results of a recent survey suggest that many available laboratories are underutilized. Data indicate that 40 percent performed fewer than 300 catheterization studies per year in the 350 hospitals surveyed. Fifty-five percent of 310 hospitals performing open heart surgery did fewer than 200 operations per year. Additional relevant comments at pages 898A-899A of the Inter-Society Report include the following: There is also a compelling economic reason for high utilization of facilities (fig. 1). The cost of equipping and supporting laboratories is extraordinarily high. Equipment life is relatively short and must be amortized within 5 - 7 years and be included in the cost of the laboratory. If case loads are low, there will be an inadequate depreciation fund for new and replacement equipment. *** Laboratories performing adult studies should maintain a minimal case load of 300 per year to justify the financial outlay for the laboratory and personnel and to keep the skills of the personnel, both physician and non-physician, up to date. (Emphasis added) *** Laboratories supporting an active coronary surgical program should have a case load of approximately nine procedures a week, or 450 cases per year. In many hospitals, economic operation of the laboratory will require this level of use. (Emphasis in original) Figure 1 at page 898A of the Inter-Society Report illustrates the equipment amortization cost per examination and clearly shows that the cost per examination decreases as the number of examinations per year increases. The illustration shows that this decrease continues at least to the point of 1,000 examinations per year. Examples derived from Figure 1 are as follows: Examinations per year Amortized equipment cost each exam 200 Approximately $575.00 300 Approximately $400.00 400 Approximately $350.00 600 Approximately $275.00 1000 Approximately $250.00 Also, the ACC/AHA Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories published in 1991 by the American College of Cardiology/American Heart Association Ad Hoc Task Force On Cardiac Catheterization include the following at page 1167: For optimum laboratory performance and cost- effectiveness, an adequate caseload is required for the staff to maintain their skills and efficiency. The laboratory should be used only for cardiac catheterization procedures; use as a general or multi-purpose radiology room is no longer acceptable. If catheterizations are not performed on a daily basis, then the laboratory should not continue to exist as a cardiac catheterization laboratory. Laboratories for adult studies should maintain a minimum caseload of 300 per year. AHCA modeled several working drafts of the rule using different minimum standards. The standard of 300 was settled on because, according to the agency's interpretation of the Intersociety Commission guidelines, a cost efficient program can operate at the 300 level. Cost efficiency is a major goal of the certificate of need program. Since the agency believed the goal could be achieved at 300, and given the statutory changes which prompted the rule changes, it was felt by the agency that a higher number would be unduly restrictive. The agency's decision to use 300 as the threshold number of procedures is an unexplained deviation from the earlier 600-procedure standard, an unexplained departure from the National Guidelines For Health Planning, and an unexplained departure from other published guidelines recognized as authoritative. 5/ Unlike open heart, which does contain a provision providing a minimum threshold at which all existing programs must be operating, the agency felt such a provision was not appropriate for cardiac catheterization. Although the literature regarding cardiac catheterization generally supports the notion that a laboratory should perform at least 300 procedures per year to maintain proficiency and enhance quality, and most health planners agree that 300 procedures is aa appropriate minimum level to maintain proficiency and quality, because there did not appear to be any empirical evidence of quality differences above and below the 300 level, the agency felt that requiring all existing laboratories to be operating at the 300 level was not warranted. The literature also contains proficiency and quality guidelines for minimum numbers of procedures to be performed by physicians. The use of the number 300 as the threshold average number of procedures to approve additional programs results in the unnecessary duplication of services when the existing cardiac catheterization laboratories are operating below their capacity or below their practical utilization level. This has an obvious adverse effect on the existing laboratories. An essential ingredient of any functional need determination methodology is a method for identifying unmet need. In order to function rationally, the methodology must not only identify a reasonable estimate of future need, but must also identify a reasonable estimate of the future capacity of existing providers to meet that need. The subject rule fails to address the future capacity of existing providers, because in the normal course of events the capacity of an existing program, even a program comprised of a single laboratory, will be much greater than 300 procedures per year. As a general rule, the practical capacity of a cardiac catheterization laboratory is in the range of 1000 to 1500 procedures per year. 6/ Up to the point of practical capacity, there is a direct, but diminishing, relationship between increased numbers of procedures and increased cost efficiency. 7/ Cardiac catheterization laboratories can be operated very efficiently at a level of 80 or 85 percent of capacity. The failure of the subject rule to consider the future capacity of existing providers in calculating future need has an adverse effect upon the ability to accurately predict future unmet need and also has a potential for adverse effect upon the quality of care offered by the existing providers. The rule authorizes the approval of a new inpatient cardiac catheterization program even though many of the existing programs may be operating substantially below their capacity. The addition of new programs under such circumstances has the adverse effect of tending to reduce utilization of existing facilities that are already functioning well below capacity.
Findings Of Fact The Petitioner is the Department of Professional Regulation, Board of Nursing. The Petitioner regulates the practice of nursing pursuant to section 20.30, and Chapters 455 and 464, Florida Statutes. The Respondent, McDonald Knights, is a registered nurse and holder, at all times pertinent to these proceedings, of license number 1715572. He received his formal training in England and became licensed in the State of Florida by endorsement on or about May 5, 1986. At all times material to these proceedings, the Respondent was employed as a registered nurse assigned to work in the surgical cardiac care unit at Cedars of Lebanon Medical Center in Miami, Florida. Francesco Garofalo was a patient in the coronary care unit of the medical center on March 8, 1987, awaiting cardiac aortic bypass surgery the next morning as a result of acute myocardia infarction. He was being intravenously infused with two medications, lidocaine (for arrhythmia) and nitroglycerin (for pain). The medications were applied through continuous intravenous infusion at separate injection sites and through separate volumetric pumps. At approximately 7:45 p.m., the alarm sounded on the volumetric pump responsible for discharging the nitroglycerin intravenous infusion. The Respondent answered the alarm and noted the container of nitroglycerin was empty. Since the previous shift had not provided a back up container of the medication, it was necessary for Respondent to order a replacement be delivered from the unit's pharmaceutical supply. While awaiting delivery of the medication, the Respondent started a dextrose solution running into the patient to prevent the injection site from closing. At this time, the patient complained of pain at the site of his other intravenous injection for lidocaine. The Respondent determined that this injection site had been infiltrated with the lidocaine solution leaking into the subcutaneous tissue of the patient's arm, resulting in discomfort to the patient. The Respondent decided a new site should be secured. In the process of securing a new site for the lidocaine infusion, the Respondent removed a manual plunger apparatus termed a "cassette" from the volumetric pump. This action effectively discontinued the function of the pump. After inserting the needle in the new venous site, Respondent manually operated the plunger apparatus to insure that the line was open and effectively discharging a smooth flow of lidocaine medication into the patient's body. He did not establish a rate of flow for the medication into the patient's body beyond cutting down the manual flow to an amount equal, in his opinion, to 10 to 20 drops per minute. At this point, the Respondent went to take a telephone call and left the patient's care to another nurse who had entered the room. The time was approximately 7:47 p.m. Cordette Steer is a registered nurse with twenty years experience. When she entered the patient's room to allow the Respondent to take the telephone call, she received no instruction from the Respondent. She did not know the medication being injected was lidocaine. Due to the toxic nature of lidocaine and her observation that the volumetric pump for administering this medication had been effectively bypassed, Steer assumed the Respondent had hung a harmless saline or dextrose solution to keep the vein open for the injection. She proceeded to apply tape to secure the needle at the injection site because, as she testified, "nobody would expect lidocaine to be infusing off of the pump, this is something that is never done." At 7:50 p.m., the patient complained of chest pain. Steer was aware of the exhaustion of the patient's nitroglycerin and that a new bag had not yet arrived from the pharmacy. She stepped from the room and returned almost immediately with nitroglycerin tablets which she gave to the patient to relieve his chest pain. He shortly began to exhibit seizure symptoms commonly associated with lidocaine toxicity. Code Blue was sounded. The Respondent was among those personnel responding. He disconnected the lidocaine infusion, stopping the flow of lidocaine to the patient. The time was 7:55 p.m. Resuscitation attempts failed and the patient subsequently expired at approximately 8:30 p.m. Nancy Cox is a critical care educator employed with the Miami Children's Hospital. She is an expert in the fields of surgical and cardiac critical care. She reviewed the medical records pertinent to this proceeding and her expert testimony establishes that: Lidocaine is an extremely toxic medication which can be fatal if the volume administered to a patient is not closely controlled. The dosage the patient should have been receiving was 15 cubic centimeters per hour or approximately three teaspoons per hour. The volumetric pump sets the rate of delivery of an intravenous drug with a finite, or high, decree of accuracy. When the pump is turned off, with the cassette in place, the flow of medication is stopped. When the cassette is removed from the pump device, an open flow is established and the pump fails to act as a regulator. Finite control of drug administration is not possible manually, as was attempted by the Respondent in this case, without taking considerable time to adjust the rate of flow in concert with timed intervals. Even when this is done, the plunger may spring open and allow a greater than desired drug flow. The Respondent should not have established a smooth flow of lidocaine, but rather a dripping or slow rate of infusion. The Respondent deviated from accepted minimal standards of cardiac or critical care nursing when he used the lidocaine solution to initially infuse at an open, unregulated rate in order to determine if the new injection site was functioning as opposed to establishing a patent intravenous route by either injecting saline via a syringe into the catheter, or connecting a bag of a saline or dextrose solution to the catheter for this purpose and then allowing it to infuse, prior to re-connecting the lidocaine. The Respondent also deviated from accepted minimal standards of acceptable and prevailing nursing practice by not informing Cordette Steer that lidocaine was being administered intravenously to the patient without the use of the volumetric pump.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Nursing enter a final order finding the Respondent guilty of the offense charged in the administrative complaint, suspending his license for a minimum period of one year with probationary reinstatement thereafter conditioned upon 1) a showing by the Respondent that he has enrolled and completed continuing education courses, as deemed appropriate by the Board, in the area of cardiac critical care with an emphasis on intravenous medication applications, and 2) he agrees to comply with reasonable terms and conditions of the Board for a subsequent probationary period of two years. DONE AND RECOMMENDED this 22nd day of April, 1988, in Tallahassee, Leon County, Florida. DON W. DAVIS Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of April, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-5633 The following constitutes my specific rulings, in accordance with requirements of section 120.59 Florida Statutes, on proposed findings of fact submitted by the parties. PETITIONER'S PROPOSED FINDINGS Included in finding number 2. Included in finding number 2 Rejected as unnecessary. Including in finding number 2. Included in finding number 3. Included in finding number 4. Rejected as unnecessary. Included in finding number 4. Included in finding number 7. Rejected as unnecessary. Rejected as unnecessary. Included in finding number 4. Included in finding number 4. Rejected as unnecessary. Rejected as unnecessary. Rejected as unnecessary. Rejected as unnecessary. Included in finding number 6. Included in finding number 6. Included in finding number 5. Included in finding number 6. Included in finding number 6. Included in finding number 6. Included in finding number 6. Included in finding number 6. Patient was pronounced officially dead at 8:52 p.m., but Respondent testified that death occurred earlier. Included in finding number 7. Included in finding number 7. Included in finding number 5. Included in finding number 7. Rejected as unnecessary. Rejected as unnecessary. Rejected as unnecessary. Included in finding number 7. Included in finding number 7. Included in finding number 5. Included in finding number 7. Rejected, not supported by the evidence. Included in finding number 7. Rejected as unnecessary. Included in finding number 7. Included in finding number 6. Rejected as a conclusion of law. COPIES FURNISHED: Lisa M. Bassett, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William E. Hoey, Esquire 2398 South Dixie Highway Miami, Florida 33133-2399 William O'Neill, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Judie Ritter Executive Director Department of Professional Regulation Room 504, East Coastline Drive Jacksonville, Florida 32201
Findings Of Fact Based upon the oral and documentary evidence adduced at the hearing, the following relevant facts are found: The petitioner's facility opened in January of 1976 as the Hubert Rutland Hospital. Its name was subsequently changed to Gateway Community Hospital and, after purchase by petitioner, it became Humana Hospital Northside. Dr. D. K. Mukherjee, Board-certified in internal medicine and cardiology, came to petitioner's facility in 1976 for the prime purpose of developing a cardiac catheterization laboratory, and assisted in preparing a list of equipment necessary to begin operation of such a laboratory. On December 31, 1976, petitioner's predecessor entered into a medical equipment service agreement for cardiac catheterization and monitoring equipment. That equipment, costing less than $100,000.00, was delivered to the hospital on or before June 17, 1977. Since that time, cardiac catheterization procedures, as defined in Rule 10-5.11(15), Florida Administrative Code, have been performed on a continuous and regular basis at petitioner's facility in Special Procedures Room No. 3. Over the past eight to nine years, the longest interval between the performance of such procedures has been approximately one or two weeks. Special Procedures Room No. 3, while also utilized for other purposes, has the equipment, staff and support services necessary for providing the studies and procedures associated with cardiac catheterization. The hospital itself is capable of providing the ancillary diagnostic services, such as hematology studies, electrocardiography, chest x-rays, blood-gas studies, pathology, blood chemistry analysis and nuclear studies pertaining to cardiology. Prior to July 1, 1977, Certificate of Need review was not required for the purchase of cardiac catheterization equipment by a hospital unless it involved a capital expenditure of more than $100,000.00. Commencing on July 1, 1977, Certificate of Need review was required when a health care facility sought to provide a substantial change in service, defined as a service which was not offered on a regular basis within the prior twelve-month period. Section 381.494(1)(c), Florida Statutes, and Rule 10-5.02(19), Florida Administrative Code. Because of technological and scientific advances, petitioner desired to replace and update the equipment purchased in 1976 for the performance of special procedures. Accordingly, in April of 1984, it submitted an application for a Certificate of Need to replace special procedures equipment at a project cost of $1,269,000.00. The application, in Section 3 stating the need and justification for the project, noted that: "Our existing equipment is totally inadequate to perform state-of-the-art cardiac catheter- ization and coronary angioplasty. When we began performing cardiac catheterization in 1977 this equipment was adequate, but today it is totally unacceptable. This proposed equipment will not only provide state-of-the- art equipment for these procedures, but will do so in a cost-effective manner since combined utilization of such high cost equip- ment contributes to the reduction of the cost of medical care." HRS issued petitioner Certificate of Need number 3261 for the replacement of special procedures equipment at a total project cost of $1,269,000.00, as requested. However, in a cover letter transmitting the issued Certificate of Need to the petitioner, HRS noted: "Please be advised that neither this office, the Office of Licensure and Certification nor the Local Health Council has documen- tation to support the performance of cardiac catheterization procedures at this hospital." Local Health Councils are private nonprofit corporations which contract with HRS to conduct local planning activities, including the collection of data, the publication of various utilization reports and the development of Local Health Plans. When HRS reviews proposed health care projects which require a Certificate of Need, it utilizes the data submitted to it by the various Local Health Councils, particularly in those instances where its rules contain a methodology or formula which includes as a factor an accounting of existing facilities or services. Application of the methodology contained in HRS's rule for determining the need for additional cardiac catheterization laboratories requires a knowledge of the number of procedures performed per year by existing and approved laboratories. Rule 10-5.11(15), Florida Administrative Code. The Health Council of Pasco/Pinellas, Inc. collects data from hospitals within Pasco and Pinellas Counties regarding bed utilization and service information. Hospitals in the district are requested to complete and submit certain information on a "Monthly Hospital Utilization Form." Among the items of information requested is the number of cardiac catheterization procedures performed during the reporting period. The Health Council also publishes and distributes annual and semi-annual utilization reports for the district. There is no provision in the statutes or rules which require hospitals to report utilization or service data to the various Local Health Councils, and HRS itself does not require that such information be reported to it. It is not unusual for hospitals to report inaccurate, incomplete or inconsistent data to Local Health Councils. Indeed, it is recognized in the "1984 Annual Hospital Utilization Report for District V Pasco/Pinellas Health Council, Inc." that, while all hospitals in the District submitted monthly hospital utilization information, "One limitation to this report involves those institutions who did not, for various reasons, submit data for beds by service categories and/or data pertaining to specialty services." HRS Exhibit F, p. 1. The form utilized by the Pasco/Pinellas Health Council contains no definition of cardiac catheterization procedures and no directions as to how to complete the form. While it has regularly submitted a monthly utilization form to the Local Health Council, petitioner has never reported the performance of cardiac catheterizations at its facility. The various reports published by the Local Health Council do not list petitioner as performing cardiac catheterization procedures. While a health care facility may obtain a written determination from HRS that a given service is exempt from Certificate of Need review due to its "grandfathered" status, there is no agency rule or policy which requires a facility to obtain such a written exemption. It has generally been the agency policy that equipment and services acquired by a facility prior to the date that such acquisition became reviewable under the Certificate of Need law are not reviewable on a retroactive basis.
Findings Of Fact I. Proposed findings of Medivision and DHRS Included in HO # 1. Accepted insofar as included in HO # 13. Included in HO # 2. Included in HO #6. Included in HO #5. Accepted insofar as included in HO #11. Included in HO 8 and 9. Included in HO 3 and 10 and 12, 13, and 14. Rejected insofar as inconsistent with HO #16. Accepted insofar as included in HO #2. Accepted. Not deemed relevant to results reached. Accepted insofar as included in HO #18. Included in HO #2. Accepted. Not deemed relevant to results reached.- Included in HO #2. Rejected as inconsistent with HO #14 and 15. Rejected as inconsistent with HO #15,16, and 17. Rejected as inconsistent with HO #15,16, and 17. Accepted. Not relevant to results reached. Accepted only insofar as included in HO #19. Included in HO #13, 14. Included in HO #18. Accepted. Not relevant to results reached. Rejected insofar as inconsistent with HO #l3. Included in HO #21. Included in HO #15. Included in HO #15, 16, 19, and 20. PROPOSED FINDINGS WFRMC Included in preliminary portion of RO. Accepted insofar as included in HO 42. Rejected as irrelevant. Rejected as irrelevant. Rejected as irrelevant. Included in preliminary portion of RO. Included in HO #6. Included in HO #6. Accepted insofar as not in conflict with HO #8. Rejected as irrelevant. Rejected as stating a negative. Accepted insofar as in agreement with HO #8. Accepted. Included in HO #20. Included in HO #21. Included in HO $17. Accepted. Included in HO #8. Accepted. Accepted insofar as included in HO #13. Included in Ho #21. Included in HO #16. Included in HO #16. Included in HO #16. APPENDIX JOINT PROPOSED FINDINGS OF BAPTIST HOSPITAL AND SACRED HEART HOSPITAL Accepted. Relevant portions are included in HO #1. Included in HO #4. Included in HO #3. Included in HO #3. Included in HO #3. Included in HO #6. Included in HO #8. Included in HO #7. Included in HO #8. Included in HO #10. Included in HO #10. Accepted insofar as included in HO #15. Accepted insofar as included in HO #12 and 16. Accepted insofar as included in HO #16. Rejected as conclusion of law Included in HO #18. Included in HO #18. Included in HO # 2. Rejected as not relevant. Included in HO #2. Included in HO #18. Accepted insofar as included in HO #8,9, and 15. Accepted insofar as included in HO #17. Included in HO #18. Accepted insofar as included in HO #16. Accepted. Not included because irrelevant and immaterial. Figures rejected as speculative. Accepted insofar as included in HO #17. Accepted insofar as included in HO #17. Rejected as inconsistent with HO #18. Rejected as conclusion of law. Rejected. Non-rule policy not applicable to specialty ambulatory surgery centers. ================================================================= AGENCY FINAL ORDER ================================================================= STATE OF FLORIDA DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES MEDIVISION OF ESCAMBIA COUNTY, INC., Petitioner, vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, CASE NO. 85-2443 Respondent, and WEST FLORIDA REGIONAL MEDICAL CENTER, SACRED HEART HOSPITAL OF PENSACOLA and BAPTIST HOSPITAL, INC. /
