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
The Issue The issues presented for consideration on this occasion concern an administrative complaint brought by the State of Florida, Department of Professional Regulation, against the Respondent. In particular, it is alleged that on the named dates, January 7 and 8, 1983, Respondent failed to check vital signs for patients in the intensive care unit who were receiving her care. Additionally, it is alleged that Respondent abandoned patients in her care by leaving her assigned floor for long periods of time without notifying her supervisor. These actions purportedly are acts of unprofessional conduct which depart from or fail to conform to minimal standards of acceptable nursing practice per Section 464.018(1)(f), Florida Statutes, and violate Section 464.018(1)(j) , Florida Statutes, by violating Board of Nursing Rule 210- 10.05(2)(d) and (2)(e) 1., Florida Administrative Code, through inaccuracies in record keeping or falsification of patient records or charts.
Findings Of Fact Respondent is a licensed practical nurse, having been issued license No. 0524551 by the Board of Nursing in the State of Florida. At all times relevant to these proceedings, Respondent was employed as a nurse at Ormond Beach Hospital, Ormond Beach, Florida. Beginning at 11:00 p.m. on January 7, 1983, and continuing until January 8, 1983, at 7:00 a.m., Respondent was working in the intensive care unit of Ormond Beach Hospital. During that time, she was primarily responsible for the care of the Patients Eleanor Prentzel and Evelyn Burkman. On that duty shift, at 12:00 midnight and 6:00 a.m., Respondent checked the vital signs of the two patients. In addition, other assessments were made during that duty cycle related to the patients. The recordation of the vital signs and statement of assessments may be found in the 24 hour nurse's notes pertaining to the two patients. These entries are part of Petitioner's exhibits 2 and 3 admitted into evidence which are patient records related to the patients in question for Burkman and Prentzel respectively. During the duty shift, between 1:30 a.m. and 5:00 a.m., Respondent was gone from her duty station for an unacceptable amount of time. While absent, Ms. Burkman, who was a cardiac patient, complained of chest pains and had to be attended by Margaret S. Vogini, R.N., who was working in the ICU on this shift. Vogini had the patient do deep breathing and listened to her lungs and heart, checked her blood pressure and watched the cardiac monitor. The patient was experiencing pain on deep inspiration, which led Vogini to believe that the problem was with the patient's lungs and not related to cardiac difficulty. Respondent worked the duty shift beginning 11:00 p.m., January 8, 1983, and concluding 7:00 a.m., January 9, 1983. Again, she attended patients in the intensive care unit. One of those patients was Prentzel. The patient Burkman was assigned to Vogini on this duty shift. Again there were unacceptably longer periods of time when Respondent was out of the intensive care unit. During that duty shift, an unnamed patient became comatose and suffered cardiac arrest; requiring cardiopulmonary resuscitation. At that time, Respondent was not in the intensive care unit and had to be summoned back to the unit to assist other nurses that were working that shift. On this same shift, at 12:00 midnight, Respondent failed to take the temperature of the patient Prentzel. This should have been done in keeping with physician's orders either 30 minutes before or 30 minutes after midnight. Respondent indicated that the reason for not taking the temperature was because she did not want to wake the patient up. This was an inappropriate decision about a patient in the intensive care unit. Respondent also failed to record the blood pressure reading which she took related to the patient Prentzel at 12:00 midnight on this shift. Again, this was an inappropriate judgement about a patient in the intensive care unit. During the two evenings in question, Respondent was suffering from a bladder infection and reported this problem to Virginia Hilbert, R.N., nurse supervisor of the Respondent. This medical problem required frequent trips to the bathroom on the part of Respondent. On occasion, it was necessary for the Respondent to leave the intensive care unit to accomplish her purposes. At most, those trips would have taken four minutes and did not satisfactorily account for the length of time in which the Respondent was not caring for her patients on the two duty shifts at issue. Because of her conduct on the evenings in question, Respondent was called before the hospital administration for counseling. In the course of this session, Respondent admitted that she did not always take respiration of patients in her charge. She made this comment during the course of a discussion of the events of the two duty shifts in question. Nonetheless, the record does not establish with reasonable certainty that her comments pertained to those patients Burkman and Prentzel who were in her care on January 7-8 and 8-9, 1983. The circumstances described in discussing the absence of Respondent on the two duty shifts in question, leads to the conclusion that the Respondent was absent from her duty station without properly notifying another nurse or supervisor working in the unit. That absence without proper notification, as established through testimony of Nurse Vogini, was a departure from acceptable nursing practice in that it was below the minimal standards of acceptable and prevailing nursing practice in Florida. Charlotte Brooks, R.N., Assistant Administrator at Ormond Beach Hospital and Director of Nursing, set forth the importance of taking vital signs as next described. By taking vital signs, the nurse discovers the patient's reaction to illness, stress, and drugs. In the intensive care unit, the results of these checks demonstrate the need to either start or stop medication and measure the patient's response to the disease process. The taking of vital signs can detect shock and various other kinds of problems that the patient may experience. Generally, temperature and respiration checks help to track the patient's progress. Finally, these notations of vital signs made by the nurses assist subsequent shift nurses in treating the patients, to include initiation or institution of doctor's orders based upon reported vital signs.
Findings Of Fact During the period August 26-28, 1985, James L. Myrah, a hospital consultant for DHRS, accompanied by Ms. Christine Denson, a registered nurse, and other consultants in various disciplines from the Petitioner's office of licensure and certification, conducted a licensure, medicare, medicaid and civil rights survey at the Respondent's facility in Ft. Walton Beach, Florida. During the course of this survey, Mr. Myrah followed the normal procedure for such inquiries which included an entrance conference with the administrator, and a survey process which includes looking at various items for as many days as is required to do a thorough job.1 As a part of the survey, the team looks at every resident physically but examines patient charts on the basis of a random sample. In the instant case, examination of the patient records kept by the Respondent revealed only one variance. That was brought to the attention of the Petitioner's Office of Licensure and Certification by the Local District I omebudsman who commented about a particular patient, whose name will not be recited to preserve patient confidentiality, but whose initials, M.C., will be used as identification. By the time the survey was conducted, M.C. had already been transferred to another nursing home and was not physically present. Therefore, the inspection team was unable to examine her. However, they did examine her medical records and chart closely. This examination resulted in Petitioner drawing the conclusion that Respondent was in violation of the require ment for notification to the patient's physician whenever there is a substantial significant change in the patient's condition. The patient's chart was not entered into evidence. The report form identifying the deficiency (HRS Form 553E) was prepared by the inspection team based on its evaluation of the patient records. This was not objected to by Respondent, and in the absence of any objection to its entry, it was accepted. The entry for the 11 p.m. to 7 a.m. shift on May 22, 1985, reflects,2 "Total care given, nothing per os (by mouth) past midnight. Dr.'s appointment in am--resident seems very listless not talking as usual. Several small bruises noted on lower extremities (rt.) foot very discolored." This entry is, in the opinion of Ms. Denson, important because it relates to the fact that the patient was to go to the doctor in the morning. The use of the term "listless" might indicate a serious medical condition and a change of condition which should have been reported to the person next in charge. The term, "not talking as usual" shows a change that would require comment. In addition, the comment regarding the discoloration of the foot should have been reported to someone and not allowed to remain uncommented on until the visit with the doctor the next morning. The patient saw her physician, Dr. Wilson, at 8 a.m. on May 22, 1985; and returned to the home at 10 a.m. the same morning. Apparently nothing was considered to be wrong with the patient because no prescription for medicine or other treatment was given by the physician who, three days later, on May 25, 1985; when advised by nurses on the 7 a.m. to 3 p.m. shift of large black and blue areas on the patient's inner groin area, indicated he examined the patient and found nothing new clinically on May 22. There are repeated instances of comments which Petitioner alleges were not properly reported to the physician. For example, on May 23, personnel on the 11 p.m. to 7 a.m. shift reflected that the patient "continues to be listless. Right leg turned at a funny angle. Report to D.O.N. (Director of Nursing)." The 7 a.m. to 3 p.m. shift the following morning reported, "Both legs ecchymosis (discolored), hip moves oddly, color pale." The 3 p.m. to 11 p.m. shift the same day reported, "Color remains pale-- unusual movement and rotation of both legs noted." Additional comments of a similar nature were noted by personnel on the 11 p.m. to 7 a.m. shift on May 24 the 3 p.m. to 11 p.m. shift on May 24; and the 11 p.m. to 7 a.m. shift which discovered the discoloration to the pelvis as reported previously. At 4 p.m. on May 25, 1985, personnel reported their concern in reference to the bruises on the patient's groin and lower extremities to the physician and further entries show that at 5:10 p.m., the patient was subsequently returned to the home at 7:30 p.m. after x-rays were accomplished which failed to reveal any fracture. Nonetheless, because of continued concern by the nursing staff and at the urging of family members, the patient was returned to the hospital at 10 a.m. on May 27, 1985. At this point, she was found to have fractures of both lower extremities and upon release from the hospital was transferred to another convalescent center. Mrs. McCasland contends that all due care and concern was given to the patient, M.C., consistent with the long standing convalescent center policy governing changes in patient status. This policy statement, dated March, 1975, which is still in effect, requires that "in the event of a significant change in the patient's physical, mental, or emotional status, the attending physician is immediately called by the charge nurse." As was stated in paragraph 3, above, on May 22, an 11 p.m. to 7 a.m.'s shift nurse noted a small bruise on the left foot of the patient and that the patient was listless. Small bruises are not necessarily significant in geriatric patients (M.C. was 88 years old). Also, often older people do not talk for several days. In any event, the lack of any significant condition was confirmed by the physician who found nothing unusual in the patient's condition during the examination. The doctor's report reflects, inter alia, "physical examination is remarkable for an elderly white female in an involuted state appearing her stated age." Her extremities "show some area of bruising primarily in the upper thighs presumably related to lifting the patient. She has crepitance in the bilateral knees and is unable to fully extend her lower extremities." Neurologically; she was determined to be alert and the physician recommended continuing general support of care. On May 25, 1985, the charge nurse called Ms. McCasland at home indicating that the patient's legs seemed to be getting bluer. Ms. McCasland, at that moment, told the nurse to call the patient's physician which was done and the doctor indicated at that time that when he had examined the patient several days previously, he found nothing wrong. It apparently was the decision of the doctor to take no further action at that time. However, at approximately 4 p.m.; after the conversation with the physician; the charge nurse contacted the physician again, indicating she thought the patient needed to be x-rayed. At 5:10 p.m.; the patient was taken to the hospital; apparently at the order of the physician; for x-rays which showed no fractures. Nonetheless; this action would not have been taken were it not for the attention of the nurse on duty and actions of the Respondent's administrator. On the following day, May 26, the charge nurse from the 7 a.m. to 3 p.m. shift again called Mrs. McCasland at home and stated that the patient's legs were; "bad." Ms. MeCasland told the nurse to call the patient's physician who directed she be sent to the hospital for x- rays. The hospital would not accept the patient and as a result, the physician came to the convalescent center where he examined her and concluded that there was, in fact, a problem. He directed she be sent to the hospital the following day and when she was x-rayed then; fractures were discovered. It should be noted here that again the contact with the physician which resulted in the ultimate diagnosis of leg fractures, was initiated by the charge nurse at Respondent's center and communicated to the physician and Ms. McCasland by center personnel.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that deficiency number NH77(g); relating to the visit to Respondent's convalescent center on August 28, 1985, be removed. DONE and ORDERED this 7th day of May, 1986, in Tallahassee, Florida. _ ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 7th day of May, 1986.
The Issue The issues in this case are set forth in 11 separate counts within the four consolidated cases: Case No. 09-5360 Count I--Whether Respondent failed to properly monitor and care for a patient in restraints. Count II--Whether Respondent failed to ensure the physician's plan of care for patient was implemented. Case No. 09-5363 Count I--Whether Respondent failed to properly implement the physician's plan of care for patient. Case No. 09-5364 Count I--Whether Respondent failed to ensure a patients' right to privacy. Count II--Whether Respondent failed to ensure that food was served in the prescribed safe temperature zone. Count III--Whether Respondent failed to ensure that only authorized personnel had access to locked areas where medications were stored. Count IV--Whether Respondent failed to perform proper nursing assessments of a patient. Count V--Dismissed. Count VI--Whether Respondent failed to maintain patient care equipment in a safe operating condition. Case No. 09-5365 Count I--Whether Respondent failed to triage a patient with stroke-like symptoms in a timely fashion. Count II--Whether Respondent's nursing staff failed to assess and intervene for patients or ensure implementation of the physician's plan of care.
Findings Of Fact Petitioner is the state agency responsible for, inter alia, monitoring health care facilities in the state to ensure compliance with all governing statutes, rules and regulations. It is the responsibility of AHCA to regularly inspect facilities upon unannounced visits. Often AHCA will inspect facilities for the purpose of licensure renewal, certification, or in conjunction with federal surveys. AHCA will also inspect facilities on the basis of complaints filed by members of the general public. Respondent, Gulf Coast Medical Center ("Gulf Coast" or "GCH") is a hospital within the Lee Memorial Health System. South West Florida Regional Medical Center ("SWF") was another hospital within the Lee Memorial Health System. SWF closed in March 2009, when it was consolidated with Gulf Coast. On October 15, 2008, the Agency conducted a complaint investigation at SWF; a follow-up complaint investigation was done on November 13, 2008. SWF filed and implemented a plan of correction for the issues raised in each of the investigations. The November investigation resulted in an Administrative Complaint containing two counts. On December 16, 2008, AHCA performed another complaint investigation at Gulf Coast. Gulf Coast filed and implemented a plan of correction for the issues raised in the investigation. The investigation resulted in an Administrative Complaint containing one count. On January 5 through 9, 2009, AHCA conducted a routine licensure survey at Gulf Coast. The hospital filed and implemented a plan of correction for the issues raised in the survey. The survey resulted in an Administrative Complaint containing six counts (although Count V was dismissed during the course of the final hearing). On February 18, 2009, AHCA did its follow-up survey to the previous licensure survey. Gulf Coast filed and implemented a plan of correction for the issues raised in the survey. The survey resulted in an Administrative Complaint containing two counts. Case 09-5360 The complaint investigation at SWF on November 13, 2008, was conducted under the supervision of Charlene Fisher. Count I in this case addresses findings by the Agency concerning a patient who was placed in restraints at the hospital on August 28, 2008. The patient, A.D., came into the hospital emergency department under the Baker Act seeking medical clearance to a facility. The patient presented at approximately 4:00 p.m., with back pain. He had a history of drug abuse, so there was concern by the hospital regarding the use of narcotics or certain other medications to treat the patient. The patient engaged in some scuffling with police. A physician signed and dated a four-point restraint (one on each limb) order, resulting in the patient being physically restrained. The restraint was deemed a medical/surgical restraint, rather than a behavioral restraint. AHCA had concerns about the restraint, specifically whether there was a notation for Q 15 (or every 15 minutes) monitoring of the restrained patient. However, medical/surgical restraints only require monitoring every two hours. The restraint worksheet for the patient confirms monitoring every two hours. The patient was ultimately admitted to the hospital at 9:37 p.m., and, thereafter, began complaining of left shoulder pain. The hospital responded to the patient's complaints about back pain and began treating the pain with analgesics. However, the patient continued to complain about the pain. An X-ray of the patient's shoulder was finally done the next morning. Shoulder dislocation was confirmed by the X-ray, and the hospital (four hours later) began a more substantive regimen of treatment for pain. Surgery occurred the following morning, and the shoulder problem was resolved. It is clear the patient had a shoulder injury, but it is unclear as to when that injury became more painful than the back injury with which the patient had initially presented. The evidence is unclear whether or when the shoulder injury became obvious to hospital staff. During its course of treating this patient, the hospital provided Motrin, Tylenol, Morphine, Percocet and other medications to treat the patient's pain. Count II in this case also involved a restrained patient, M.D., who had presented to the emergency department under the Baker Act. The patient was released from handcuffs upon arrival at the hospital. After subsequently fighting with a deputy, this patient was also placed in a medical/surgical restraint pursuant to a physician's order. The doctor signed and dated, but did not put a time on, the restraint order. A time is important because there are monitoring requirements for patients in restraints. However, the time of 0050 (12:50 a.m.) appears on the patient's chart and is the approximate time the restraints were initiated. The proper procedure is to monitor a restrained patient every two hours. This patient, however, was removed from his restraints prior to the end of the first two-hour period. Thus, there are no records of monitoring for the patient (nor would any be necessary). The evidence presented by AHCA was insufficient to establish definitively whether the hospital nursing staff failed to properly respond to the aforementioned patients' needs. It is clear the patients could have received more care, but there is not enough evidence to prove the care provided was inadequate. Case No. 09-5363 On December 16, 2008, AHCA conducted a complaint investigation at SWF. The Agency had received a complaint that the hospital did not properly implement a physician's plan of care. Count I in this complaint addresses alleged errors relating to two of four patients reviewed by the surveyors. Both of the patients came to the hospital from a nursing home. One patient, I.A., had presented to the emergency department complaining of chest pains. The medication list sent to the hospital by the nursing home for I.A. actually belonged to someone other than I.A. I.A.'s name was not on the medication list. The drugs listed on the patient chart were different than the drugs I.A. had been taking at the skilled nursing facility from which she came. The skilled nursing facility actually sent I.A.'s roommate's medication list. The erroneous medications were then ordered by the admitting physician and administered to the patient. The hospital is supposed to review the medication list it receives and then enter the medications into the hospital system. The person reviewing the medication list does not necessarily have to be a nurse, and there is no evidence that the person making the error in this case was a nurse or was some other employee. It is clear, however, that the person reviewing the medication list did not properly ascertain that the list belonged to patient I.A. The other patient from the nursing home had been admitted for surgery at SWF. Again, the nursing home from whence she came sent a medication list that was incorrect. The medications on the incorrect list were entered into the system by a SWF employee. The erroneous medications were ultimately ordered by the attending physician for the patient, but there is no evidence the patient was ever administered those medications. Neither of the residents was harmed by the incorrect medications as far as could be determined. Case 09-5364 From January 5 through 8, 2009, AHCA conducted a licensure survey at Gulf Coast and SWF in conjunction with a federal certification survey. Count I of the complaint resulting from this survey addressed the right of privacy for two residents. In one instance, a patient was observed in her bed with her breasts exposed to plain view. In the other instance, a patient's personal records were found in a "public" place, i.e., hanging on the rail of a hallway in the hospital. AHCA's surveyor, Nancy Furdell, saw a female patient who was apparently asleep lying in her bed. The patient's breasts were exposed as she slept. Furdell observed this fact at approximately 1:15 p.m., on January 7, 2009. Furdell did not see a Posey vest on the patient. She did not know if anyone else saw the exposed breasts. Furdell continued with her survey duties, and at approximately 5:00 p.m., notified a staff member as to what she had seen. Furdell did not attempt to cover the patient or wake the patient to tell her to cover up. The female patient with exposed breasts was in the intensive care unit (ICU) of the hospital. Visiting hours in ICU at that time were 10:00 to 10:30 a.m., and again from 2:00 till 2:30 p.m. Thus, at the time Furdell was present, no outside visitors would have been in the ICU. ICU patients are checked on by nursing staff every half-hour to an hour, depending on their needs. This particular patient would be visited more frequently due to her medical condition. On the day in question, the patient was supposed to be wearing a Posey vest in an effort to stop the patient from removing her tubing. The patient had been agitated and very restless earlier, necessitating the Posey vest. Also on January 7, 2009, a surveyor observed some "papers" rolled up and stuffed inside a hand-rail in the hospital corridor. This occurred at 1:15 p.m., on the fourth floor of the south wing of the hospital. A review of the papers revealed them to be patient records for a patient on that floor. The surveyor could not state at final hearing whether there were hospital personnel in the vicinity of the handrail where she found the patient records, nor could she say how long the patient records had been in the handrail. Rather, the evidence is simply that the records were seen in the handrail and were not in anyone's possession at that moment in time. Count II of the complaint was concerned with the temperature of certain foods being prepared for distribution to patients. Foods for patients are supposed to be kept at certain required temperatures. There is a "danger zone" for foods which starts at 40 degrees Fahrenheit and ends at 141 degrees Fahrenheit. Temperature, along with time, food and environment, is an important factor in preventing contamination of food and the development of bacteria. Surveyor Mary Ruth Pinto took part in the survey. As part of her duties, she asked hospital staff to measure the temperature of foods on the serving line. She found some peaches at 44 degrees, yogurt at 50 degrees, and cranberry juice at 66 degrees Fahrenheit. According to Pinto, the hospital's refrigerator temperatures were appropriate, so it was only food out on the line that was at issue. Pinto remembers talking to the hospital dietary manager and remembers the dietary manager agreeing to destroy the aforementioned food items. The hospital policies and procedures in place on the date of the survey were consistent with the U.S. Food and Drug Administration Food Code concerning the storage, handling and serving of food. The policies acknowledge the danger zone for foods, but allow foods to stay within the danger zone for up to four hours. In the case of the peaches and yogurt, neither had been in the danger zone for very long (not more than two hours). The cranberry juice was "shelf stable," meaning that it could be stored at room temperature. The food services director for the hospital remembers the peaches and yogurt being re-chilled in a chill blaster. She does not believe any of the food was destroyed. Count III of the complaint addressed whether an unauthorized person had access to a room where medications were being stored. A state surveyor, Gary Furdell, was part of the survey team on January 5, 2009. Furdell was touring the second floor of the hospital when he noticed a locked door. Furdell asked a hospital medical technician who was standing nearby about the door. The medical technician gave Furdell the code to unlock the door. Furdell peeked inside and noticed bottles that he presumed were medications. It would be a violation for a medical technician to have access to medications, because medical technicians cannot distribute drugs. The room Furdell looked into is a "mixed use" room located behind a nursing station. A mixed use room is used to store medical supplies, including medications, as long as there is a locked cabinet in the room for that purpose. This particular mixed use room had a locked cabinet. The room is used for the preparation of medications and for other purposes. No narcotics were stored in this particular mixed use room. The room contained locked cabinets used to store other medications. The evidence presented was insufficient to determine what "medications" Furdell may have seen in the room. Count IV of the complaint concerned the nursing assessment of a patient, and whether the assessment was properly and timely performed. A patient, M.S., had been admitted to the hospital on June 18, 2008, for lung surgery. Following the surgery, Amiodarone (a very toxic drug which can cause clots and other complications) was administered to treat M.S. for heart arrhythmia. The Amiodarone was administered intravenously and M.S. developed blisters and irritation at the intravenous site. That is not an uncommon complication with Amiodarone. M.S.'s attending physician was notified about the irritation and prescribed a treatment. He also ordered a consult with an infectious disease specialist who ultimately changed M.S.'s antibiotics. Although M.S. was seen daily by her physicians, the nursing notes do not reflect the assessment and treatment of her blisters. It appears that proper care was rendered, but the care was not documented properly. Another patient was admitted to the hospital on December 15, 2008, with End Stage Renal Disease and diabetes mellitus for which she began dialysis treatment. The patient was not weighed before and after a particular dialysis treatment on January 5, 2009. However, the patient had been moved to an air mattress bed on that date for comfort. The air mattress bed did not allow for a weight to be taken as it could be on a regular bed. There is an allegation in the Administrative Complaint concerning the discontinuation of the calorie count for a patient. This issue was not discussed in AHCA's Proposed Recommended Order, nor was sufficient evidence of any wrong- doing concerning this matter presented at final hearing. During the survey, the hospital was found to be storing the medication Mannitol in blanket warmers, rather than in warmers specifically designed for the drug. The blanket warmers maintained the Mannitol at 100-to-110 degrees Fahrenheit. The manufacturer's label on the drug calls for it to be dispensed (injected) at between 86 and 98.5 degrees Fahrenheit. In order to meet this requirement, the hospital takes the drug out of the blanket warmer in time for it to cool sufficiently before it is injected. There is nothing inherently wrong with using a blanket warmer to store Mannitol. On January 5, 2009, a surveyor found two vials of Thrombin, one vial of half-percent Lidocaine and Epi, and one vial of Bacitracin in operating room No. 4. The operating room is within the secured and locked suite of surgical rooms on the second floor. Two of the vials had syringes stuck in them and one of them was spiked. Whoever had mixed the medications was not attending to them at the time the surveyor made her observation. There were two unlicensed technicians in the room preparing for the next surgery. A registered nurse anesthetist was present as well. There was no identifying patient information on the medications. The hospital's policies and procedures do not require the patient's name to be on the label of medications prepared for impending surgery. That is because the procedures for the operating room include a process for ensuring that only the correct patient can be in the designated operating room. There is a fail-safe process for ensuring that only the proper patient can receive the medications that are set out. At around 2:45 p.m. on January 5, 2009, there were patient records in the emergency department showing that several drugs had been administered to a patient. The surveyor did not see a written order signed by a physician authorizing the drugs. When the surveyor returned the next morning, the order had been signed by the physician. The hospital policy is that such orders may be carried out in the emergency department without a doctor's signature, but that a physician must sign the order before the end of their shift. AHCA cannot say whether the physician signed the order at the end of his shift or early the next day. Count V of the complaint was voluntarily dismissed by the Agency. Count VI of the complaint concerned the status of certain patient care equipment, and whether such equipment was being maintained in a safe operating condition. A patient was weighed at the hospital upon admission on December 27, 2008, and found to weigh 130 pounds using a bed scale. Six days later, on January 2, 2009, the patient's weight was recorded as 134 pounds. Two days later, in the same unit, the patient weighed 147 pounds and the next day was recorded as weighing 166 pounds. During the survey process, the patient was weighed and recorded at 123 pounds on a chair scale. The hospital does not dispute the weights which were recorded, but suggests there are many factors other than calibration of the equipment that could explain the discrepant weights. For example, the AHCA surveyor could not say whether the patient sometimes had necessary medical equipment on his bed while being weighed, whether different beds were involved, or whether any other factors existed. AHCA relies solely on the weight records of this single patient to conclude that the hospital scales were inaccurate. Case No. 09-5365 On February 18, 2009, AHCA conducted a licensure survey at Gulf Coast. Count I of the complaint from this survey concerned the timeliness of triage for a patient who presented at the hospital emergency department with stroke-like symptoms. AHCA surveyors witnessed two patients on stretchers in the ambulance entrance hallway leading to the emergency department. Each of the two patients had been brought in by a separate emergency medical service (EMS) team and was awaiting triage. One patient was taken to an emergency department room (ER room) 50 minutes after his/her arrival at the hospital. The other patient waited 45 minutes after arrival before being admitted to an ER room. Meanwhile, a third patient arrived at 2:20 p.m., and was awaiting triage 25 minutes later. During their observation, the surveyors saw several nursing staff in the desk area of the emergency department, i.e., they did not appear to be performing triage duties. The emergency department on that date was quite busy. That is not unusual during February, as census tends to rise during the winter months due to the influx of seasonal residents. A summary of the action within the emergency department from 1:00 p.m. to 3:00 p.m., on the day of the survey shows the following: Patient L.G., 74 years old with stable vital signs, was radioed in by her EMS team at 1:08; L.G. was processed into the ER at 1:21 (which is not an unreasonable time; EMS teams call in when they arrive at or near the hospital. By the time they gain access, wait their turn if multiple ambulances are present, and get the patient inside, several minutes may lapse). L.G. was stabilized and quickly reviewed by ER staff, then officially triaged at 2:04. Patient H.M., an 89-year-old male residing in a nursing home, arrived at 1:20 and was processed in at 1:59. He was triaged at 2:01, but ultimately signed out of the hospital against medical advice. Patient E.M. arrived at 2:18 and was processed at 2:25. Triage occurred one minute later. This patient presented as a stroke alert, and hospital protocol for that type patient was followed. Patient C.J. arrived at 1:08 and was processed at 2:38. Triage occurred immediately after C.J. was processed. This patient was not stroke alert, but had some stroke-like symptoms.1 C.J. had not been transported to the hospital as emergent, because the symptoms had been going on for 24 hours. Patient W.M., an auto accident victim, arrived at 1:40 and was processed at 1:49. Triage occurred within six minutes. Patient M.M., W.M.'s wife (who had been with M.M. in the automobile accident, but was placed in a separate ambulance), arrived at 2:06 and was triaged at 2:34. There is no record of when M.M. was processed. Patient L.M. came to the hospital from a nursing home. She arrived at 1:43 and was processed at 2:35. L.M. was triaged at 2:37. Patient K.M. arrived at 2:45 and was processed within three minutes. Triage occurred at 2:52. Her triage was done very quickly due to the condition in which she arrived, i.e., shortness of breath and low oxygen saturation. Patient R.S. arrived at 1:00 and was triaged at 1:15. The aforementioned patients represent the patients presenting to the emergency department by ambulance during a two-hour period on a very busy day. It is the customary procedure for ER staff to make a quick visual review (rapid triage) of patients as they come into the hospital. Those with obvious distress or life-threatening conditions are officially triaged first. Others, as long as they are stable, are allowed to wait until staff is available for them. As part of their duties, nurses necessarily have to be in the desk area (nursing station) in order to field phone calls from physicians concerning treatment of the patients who present. It is not unusual or improper for nurses to be in the nursing station while residents are waiting in the processing area. It is clear that some patients waited a much longer time for triage than others. However, without a complete record of all patients who presented that day and a complete review of each of their conditions, it is impossible to say whether the hospital was dilatory in triaging any of them. Count II of the complaint addressed the nursing staff and whether it failed to assess and intervene in the care of a patient or failed to implement a physician's plan of care for the patient. Patient D.W. was a 67-year-old female who was morbidly obese, diabetic, debilitated, had end stage renal disease, and was receiving dialysis. Upon admission, D.W. had a Stage 3 pressure ulcer to her sacrum and a Stage 4 ulcer on her left calf. A wound care protocol was initiated immediately, and a Clinitron bed was obtained for her on the day of admission. Due to the seriousness of her condition, the wound care physician declined to accept her case at first. He later ordered Panafil, and it became part of the protocol for treating the patient. The nursing documentation for D.W. was only minimally sufficient, but it does indicate that care was provided. Patient R.H. was an 83-year-old male who presented on February 10, 2009, in critical condition. R.H. was suffering from congestive heart failure, pneumonia, and respiratory failure. Due to the critical nature of his respiratory problems, R.H. was placed on a ventilator. As a ventilator patient, he did not fit the profile for obtaining wound care. Nonetheless, the hospital implemented various other measures to deal with R.H.'s pressure wounds.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by Petitioner, Agency for Health Care Administration, imposing a fine in the amount of $500.00 in DOAH Case No. 09-5363 and a fine in the amount of $500.00 in DOAH Case No. 09-5364, Count VI. DONE AND ENTERED this 30th day of April, 2010, in Tallahassee, Leon County, Florida. R. BRUCE MCKIBBEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of April, 2010.
Findings Of Fact On or about December 13, 1984, Petitioner applied to Respondent for a CON for an ambulatory surgical center (ASC). Respondent assigned CON number 3677 to Petitioner's application. Petitioner seeks to construct a two operating room, free standing ASC at 1710 West Colonial Drive in Orlando, Orange County, Florida. The primary area to be served by this application is Orange County, and the facility as proposed is reasonably accessible to Orange County residents. Orange County is located within Respondent's District VII, which is also comprised of Osceola, Brevard and Seminole Counties. Stuart and Joseph Yachnowitz are owners of Y and S Management and are partners in the application here at issue. Y and S Management will provide medical management services at this facility, as it provides at nine other facilities throughout the country which performed approximately 17,500 outpatient surgical procedures in 1985, primarily gynecological. Two of the facilities managed by Y and S Management are licensed as ASCs under the laws of the states in which they are located. The chief operating officer of Y and S Management, Susan Hill, prepared the CON application which is here at issue. Financing for this project will be provided from the personal funds of Stuart and Joseph Yachnowitz. No funds will be borrowed for this purpose. They have sufficient liquid personal funds to fully finance the project cost of $473,000, as well as operating costs. Petitioner will lease 6,500 square feet on the first floor of a professional building to be constructed at 1710 West Colonial Drive in Orlando from West Colonial Properties, Ltd., at $12 per square foot. This property is owned by Stuart and Joseph Yachnowitz. An abortion clinic known as Orlando Women's Health Center, which they also own, is located next door at 1700 West Colonial Drive. The facility as proposed can reasonably be expected to meet licensure requirements for an ASC. Ambulatory surgical procedures to be performed at Petitioner's facility will include, but not be limited to abortions, tubal ligations, hernia repairs, diagnostic laproscopies, eye surgery for cataracts, hand surgery, plastic surgery, tonsillectomies, and dilatation and curettage. Equipment cost estimates for this project of $161,158 are realistic and complete. Staffing requirement estimates of 11.54 F.T.E., and salary requirements of approximately $182,000 annually are also realistic and complete. Petitioner estimates that for 1987 and 1988, 20% of all cases will be paid by Medicaid, 5% by Medicare, and 75% will be insurance and private pay, with 4% of this figure ultimately being bad debt or indigent care. With total cases estimated for 1987 and 1988 to be 1700 and 2100, respectively, total net revenues for 1987 and 1988 are estimated to be $732,000 and $903,000, respectively. Providing services to Medicaid patients in 20% of its cases would be beneficial to the community since this is a high level of service to patients who are typically underserved. Assuming that 20% of the cases handled at Petitioner's facility have multiple procedures, the projected charge rates for 1987 are $326 per case for Medicare and Medicaid, and $489 per case for private pay and insurance. These are reasonable and competitive charges. The projected charge rate for private pay and insurance is simply 150% of the Medicare and Medicaid rate, which in turn is based on the projected case mix considering the various levels of reimbursement. Petitioner will pay Y and S Management a fee of $50 per case for management services. The financial pro forma prepared for Petitioner demonstrates that using a conservative approach that somewhat overestimates expenses, Petitioner will reach the break-even point at 1400 cases, after allowing for management fees, depreciation and amortization. Using a less conservative, but more typical approach to estimating expenses, Petitioner will break-even at 1100 cases. Need in the service area exceeds the conservative break-even point and Petitioner estimates it will handle 1700 cases in its first year of operation and 2100 in its second. These are reasonable estimates. Respondent has not promulgated a rule setting forth a methodology for determining need for an ASC. However, Respondent has utilized an evolving non-rule policy in evaluating the need for such facilities. Reid Jaffe, Respondent's expert in health care planning, explained the methodology used in this case which resulted in his determining that in July, 1987, there will be a need for additional ambulatory surgical facilities in Orange County sufficient to recommend approval of Petitioner's CON application. Specifically, Jaffe's methodology is as follows: Acquire data from the local health council regarding the number of inpatient and outpatient procedures performed by existing providers, as reported for the current calendar year (1985) by hospitals in the appropriate service district (District VII). Acquire data from the Governor's Office of the population estimate for the appropriate service area (Orange County) for the current and planning horizon years. Using this data, calculate the current overall surgical and outpatient surgical use rates per 1000 population for hospitals in the service area. Using the projected population for the planning horizon year (1987) and the current use rates calculated in (c) above, calculate the projection of overall surgical procedures in the planning horizon year. Multiply projected overall surgeries by 40% to establish total number of out-patient surgeries to be performed in the planning horizon year. Subtract from (e) all outpatient surgical procedures to be performed in hospitals, other ASCs in the service area, as well as the financial break-evens of all CON approved free-standing outpatient surgery centers in the service area. After performing these calculations and subtractions, the number of outpatient surgical procedures remaining are compared to the break-even of the CON applicant at issue. If the remaining number is larger than the applicant's break even, a quantitative need is demonstrated. Applying Jaffe's methodology to this case and applying data he obtained from the Local Health Council of East Central Florida, as reported to it by hospitals in District VII for calendar year 1985, as well as population data for Orange County he obtained from the Governor's Office, it appears that a total of 83,054 surgical procedures were performed in District VII in 1985, with 21,084 of these being outpatient procedures performed in a hospital. Using a July, 1985, population estimate for Orange County of 556,384, the overall surgical use rate for Orange County is 83,054 divided by 556,384 over 1000, or 149.27 surgical procedures per 1000 population; the use rate for outpatient procedures performed in hospitals is 21,084 divided by 556,384 over 1000, or 37.89 outpatient procedures performed in hospitals per 1000 population. Multiplying the overall surgical use rate of 149.27 by 574,599 (projected Orange County population for July 1987) over 1000 and applying a factor of 40% yields a projection of 34,308 outpatient surgical procedures to be performed in 1987. The use rate of 37.89 for outpatient services performed in a hospital is then multiplied by 574,599 over 1000 to obtain 21,722 which is the projected number of outpatient procedures which will be performed in a hospital in 1987. By subtracting this number (21,722) from the projection of total outpatient surgical procedures to be performed in 1987 (34,308) you identify 12,536 procedures which could be performed in ASCs in 1987. The reported number of outpatient procedures being performed in existing ASCs and the break-evens of CON approved facilities are calculated to be 5,488 (Surgical Services 2,693; MediVision 903; AMI Single Day Surgery 1,832; Surgical Associates 60) which is then subtracted from 12,536 to leave a need of 7,048 outpatient procedures which could be performed in ASCs which are not now approved for this service area. Since Petitioner has a conservative break-even point of 1400 cases, and a more typical break-even point of 1100 cases, a quantitative need has been identified which far exceeds Petitioner's break-even point. Jaffe testified that in his experience this is the largest margin between break-even and available procedures he has seen in reviewing CON applications. A need analysis conducted by Howard E. Fagin, Ph.D., who was accepted as an expert in health care planning, facility planning and operations analysis, also confirms that there is a quantitative need for the ASC proposed by Petitioner. The methodology used by Dr. Fagin starts by calculating a target utilization for ambulatory surgical operating rooms. Assuming that a facility operates 250 days/year, 6 hours/day, it takes 1.25 hours/case and that there are 1.2 procedures/case with a utilization rate of 75%, a target utilization of 1,080 procedures/year for an ambulatory surgical room is thereby determined. In 1985 there were 10 approved hospital "dedicated" ambulatory surgical rooms in Orange County, and 9 approved rooms in free-standing ASCs (Surgical Services-5, AMI Single Day Surgery-2, MediVision-2) not counting the 2 rooms approved in CON 3313 for Surgical Associates which are used for no more than 60 cases per year. Multiplying these 19 rooms by the target utilization of 1,080 procedures/year results in a calculation of 20,520 total utilization in available dedicated and free-standing ASC rooms. Data from the Local Health Council of East Central Florida for 1985 indicates that 11,413 outpatient procedures were performed in hospital, non-dedicated, operating rooms. Therefore if we take Jaffe's projection of 34,308 outpatient surgical procedures to be performed in 1987, and subtract 20,520 (total utilization in available dedicated and free-standing ASC rooms) and also subtract 11,413 (outpatient procedures performed in hospital, non-dedicated, rooms), we arrive at a need of 2,375 procedures in 1987 and 3,770 procedures in 1989. Since Petitioner's break-even is conservatively 1400 cases, and again assuming 1.2 procedures per case, Petitioner's conservative break-even is 1680 procedures, which is within the need which will exist in 1987, and well within the need in 1989. The need methodology and opinion of Intervenor's expert, Dr. Deborah Kolb, is rejected because she incorrectly: (a) considered Orange and Seminole Counties as comprising a two county service area; (b) included all existing inpatient hospital based operating rooms, regardless of whether they are dedicated to outpatient surgery, in arriving at her conclusion that there is excess capacity; and (c) assumed all hospital operating rooms are available for outpatient surgery without modification. Ambulatory surgery is typically performed in three types of facilities: hospitals which utilize their operating rooms for both inpatient and outpatient surgery; hospitals which maintain separate "dedicated" outpatient operating rooms, sometimes even in separate facilities adjacent to the main hospital; and free-standing ASCs which are not associated with a hospital. There are definite disadvantages to serving outpatients in hospitals without "dedicated" outpatient operating rooms, including the "bumping" of outpatients in emergencies and increased costs to the patient for services. On the other hand there are advantages and disadvantages to the other two modes of delivering ambulatory surgical services. Hospital based "dedicated" rooms are obviously closer to a hospital in case an emergency develops, and some patients may prefer this proximity to additional equipment and emergency medical staff. On the other hand, costs at a free-standing ASC are generally lower, and some patients prefer to avoid a hospital atmosphere altogether. Surgical procedures performed at ASCs have grown from 10% of all procedures in the early 1970s to 40% currently, and are projected to grow to 50% in the near future. This growth is somewhat the result of a change in Medicaid/Medicare reimbursement policies which now pay 80% for procedures performed in a hospital and require a 20% co-payment by the patient, but which pay 100% for procedures performed in an ASC and require no patient co-payment. The decision to have outpatient surgery performed at one or the other of these types of facilities is primarily the result of patient preference. However, it is clear that the increasing utilization of ASCs is a market force that is driving the cost of hospital outpatient services down. Respondent issued its original notice of intent to deny Petitioner's application on or about May 17, 1985, and on June 14, 1985, Petitioner filed its Petition for Formal Hearing. Thereafter, Respondent reconsidered its position and on March 6, 1986, notified the parties that it intended to grant Petitioner's application. The reason for this reconsideration was that when the initial denial was made, Respondent's projections of procedures were premised on the use of a 30% outpatient surgical factor. Subsequently, the Respondent began using 40% in its projection of the total volume of surgical procedures which might be performed on an outpatient basis. Given the fact that the reason Petitioner was initially denied was due to insufficient procedures, and utilization of the new projection of outpatient volume indicated there would be sufficient volume to support the facility, Respondent determined to support Petitioner's application. The notice of change of position was prepared by Reid Jaffe, who based his testimony at hearing on the 40% factor, and was approved by Robert E. Maryanski, Administrator of Community Medical Facilities, and Marta V. Hardy, Deputy Assistant Secretary for Health Planning and Development. Since Respondent has not adopted a need methodology rule for ambulatory surgical centers, the increase in the factor used to calculate outpatient surgeries from overall surgeries performed was not accomplished through rule-making proceedings. In 1985 Respondent used a factor of 30%, but in early 1986 increased this to the 40% applied in this case.. Intervenor provides services similar to those which Petitioner will perform, and has four free-standing, "dedicated" operating rooms which are used for ambulatory surgery. It also has 17 operating rooms that are used for both in and out-patient surgery. The Intervenor opposes Petitioner's application. In 1985, Intervenor made a profit of $10.9 million on total revenues collected of $184 million; it had an actual total of $37.4 million in uncompensated care which includes partial or no payments, charity, bad debt, and contractual patients. For 1986, it projects an $18.9 million profit on collected revenues of $211 million, with projections of actual uncompensated care of approximately $52 million. In 1985, 2% of Intervenor's costs were for providing indigent care, and this totaled approximately $6 million. Petitioner projects net revenues of approximately $900,000, and it has not been established if this will have any impact on Intervenor's revenues. According to Billie June, Assistant Director of Operating Rooms at Florida Hospital who was accepted as an expert in surgical nursing, and the management and operation of surgical units from a nursing standpoint, Intervenor has had considerable difficulty attracting qualified nursing staff for its operating rooms, and has had to develop its own qualified staff through an internship program. However, Petitioner's facility will not contribute to this difficulty or result in higher salaries. Susan Hill testified based on her experience since 1973 of managing and hiring staff in the Orlando area of the type needed to operate an ASC, that she has had no difficulty obtaining the cooperation of physicians in the area and in attracting fully qualified staff. Based on Hill's experience with other ASCs managed by Y and S Management throughout the country as well as her experience in Orange County, it is found that the staffing needs of Petitioner's proposed facility can be met with nursing and medical staff available in the area. It is found as a matter of fact that there is a need in Orange County for the two operating room ASC proposed by Petitioner, that Petitioner has the ability and will provide quality care, the project is financially feasible, Petitioner will work with and help to meet the needs of health maintenance organizations and will promote cost effectiveness in Orange County. Petitioner's proposal is consistent with the goals, objectives and recommended actions in the 1985-87 Florida State Health Plan and the local health plan. The State Plan encourages the existence of ASCs and the removal of obstacles to the use of outpatient surgery; the local plan provides that applicants for an ASC must demonstrate a willingness to provide services to underserved patient groups and considers the provision of ambulatory surgery to the underserved population to be a desirable objective. In this case Petitioner intends to provide 20% of its cases to Medicaid patients, and another 4% to indigents.
Recommendation Based on the foregoing, it is recommended that the Department of Health and Rehabilitative Services issue a Final Order granting Petitioner's application for CON number 3677. DONE and ENTERED this 23rd day of October, 1986, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of October, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Chris H. Bentley, Esquire Post Office Box 1739 Tallahassee, Florida 32302 Douglas Mannheimer, Esquire Post Office Drawer 11300 Tallahassee, Florida 32302 E. G. Boone, Esquire Jeffrey Boone, Esquire Gregory Roberts, Esquire Post Office Box 1596 Venice, Florida 34284. APPENDIX Rulings on Petitioner's Proposed Findings of Fact: 1. Adopted in Findings of Fact 1, 2. 2,3. Adopted in Finding of Fact 3. Adopted in Finding of Fact 6. Adopted in Finding of Fact 5. Adopted in Finding of Fact 7. Adopted in Finding of Fact 11. Adopted in Findings of Fact 11, 22. Adopted in Finding of Fact 9. Adopted in Finding of Fact 2. Adopted in Findings of Fact 2, 14. 12,13. Adopted in Finding of Fact 20. Adopted in Finding of Fact 7. Adopted in Finding of Fact 20. Adopted in Finding of Fact 8. Adopted in Findings of Fact 3, 8. Adopted in Findings of Fact 4, 7. Adopted in Finding of Fact 4. Adopted in Finding of Fact 2. Adopted in part in Finding of Fact 15 but otherwise rejected as cumulative and unnecessary. Adopted in Finding of Fact 19. 23-25. Rejected in Finding of Fact 18 and otherwise rejected as irrelevant and not based on competent substantial evidence. Rejected as cumulative and unnecessary. Rejected in Finding of Fact 18. Adopted in Findings of Fact 12-14. Adopted in Findings of Fact 12, 13. Adopted in Findings of Fact 13, 14. 31-35. Adopted in Finding of Fact 15. 36,37. Rejected as irrelevant and unnecessary. 38. Adopted in Finding of Fact 22. 39,40. Adopted in Finding of Fact 23. 41. Rejected as a Finding of Fact since this is a request for further ruling on Petitioner's Motion to Limine which was granted at hearing. Petitioner filed a Motion in Limine on June 11, 1986 to exclude depositions taken of John Hutchens on April 23, 1986 and June 5, 1986. This is the motion dealt with at the prehearing conference on June 23, 1986. The only deposition of John Hutchens offered by Intervenor and admitted was one taken on June 20, 1986 (I-2). Therefore, Petitioner's motion and the prior ruling is moot since the depositions to which the motion was directed were not offered at hearing. 42-45. Adopted in Finding of Fact 22. Rulings on Intervenor's Proposed Findings of Fact, as set forth beginning on page 3: 1. Adopted in Finding of Fact 12. 2-16. Rejected in Finding of Fact 15, and otherwise irrelevant and cumulative. 17,18. Rejected in Findings of Fact 12-14, 22. 19-26. Adopted in part in Finding of Fact 14, but otherwise rejected as contrary to competent substantial evidence. 27,28. Adopted in part in Findings of Fact 12, 13, but otherwise rejected as contrary to competent substantial evidence. 29. Rejected in Findings of Fact 12-15 and otherwise as argument rather than proposed findings of fact. 30-34. Adopted and rejected in part in Finding of Fact 16 and otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 19, but otherwise rejected as irrelevant. Adopted in Findings of Fact 13, 14. 37,38. Rejected as irrelevant. 39,40. Adopted in part in Finding of Fact 16. Adopted in part in Findings of Fact 2, 3 but otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 6, but otherwise rejected as irrelevant. 43,44. Rejected in Finding of Fact 22. 45-47. Rejected in Finding of Fact 7. Adopted in Finding of Fact 7. Rejected in Finding of Fact 7. Rejected in Findings of Fact 3, 5, 7 and 22. Adopted in part in Finding of Fact 3. Rejected as contrary to competent substantial evidence. 53,54. Adopted and rejected in part in Finding of Fact 21. Adopted in part in Findings of Fact 11, 22 but otherwise rejected as irrelevant. Rejected as cumulative and unnecessary. 57-59. Rejected as simply a summation of testimony, irrelevant and contrary to competent substantial evidence. Adopted in part in Findings of Fact 13, 14 and 16 but otherwise rejected as contrary to competent substantial evidence. Rejected as irrelevant. 62,63. Rejected in Finding of Fact 21 and otherwise irrelevant and contrary to competent substantial evidence. Rejected in Findings of Fact 4, 7. Adopted and rejected in part in Finding of Fact 8. Rejected in Findings of Fact 11, 22. Rejected in Finding of Fact 22 and otherwise irrelevant and contrary to competent substantial evidence. Adopted in part in Finding of Fact 20, but otherwise rejected as irrelevant. Rejected as irrelevant. Adopted in Finding of Fact 16; rejected in Finding of Fact 21 and otherwise rejected as contrary to competent substantial evidence. Rejected in Findings of Fact 4, 5 and otherwise rejected as irrelevant. 72-75. Adopted in part in Findings of Fact 19-21, but otherwise rejected in Findings of Fact 21, 22 and as irrelevant. 76-79. Rejected as irrelevant, cumulative argument which does not provide citations to the record contrary to Rule 221-6.31(3), Florida Administrative Code.
Findings Of Fact Respondent is a licensed medical doctor holding a license to practice medicine in the State of Florida issued by the Board of Medical Examiners, Department of Professional Regulation. The Petitioner is a governmental agency charged with enforcing the provisions of Chapter 458, Florida Statutes, and related rules which regulate the licensure standards and status pertaining to medical doctors in the State of Florida, and enforcing the practice standards for licensed medical doctors embodied in Chapter 458, Florida Statutes. Steven Jones has been employed as a detective in the Narcotics Department of the City of Miami Beach Police Department for approximately three and one-half years. He is a ten-year veteran of the law enforcement profession. In December 1982, an investigation was initiated to determine whether allegations of misprescribing scheduled controlled substances made by a confidential informant against Dr. Ramos, the Respondent, were true. On December 16, 1982, Detective Jones entered the medical offices of the Respondent and asked to see Dr. Ramos. The Respondent's receptionist asked him to fill out a patient information sheet. On this sheet or form he indicated his name was "Steven James." He was then taken to the Respondent's office and met the Respondent. He told the Respondent that he was a construction worker, had recently experienced turmoil in his domestic life, and also suffered from a lumbo-sacral sprain. The Respondent then asked him if he had back pain and, after asking him general questions about his health and whether he suffered from any major illnesses, took out his prescription pad and wrote prescriptions for three medications. Other than the general questions the doctor asked him about his health, no detailed medical history was taken from Mr. Jones and there was no physical examination performed by Dr. Ramos or anyone else, except that his weight and height were recorded. No blood pressure reading was taken. After Dr. Ramos asked Mr. Jones if he had a backache, to which Mr. Jones responded in the affirmative, Dr. Ramos stated that he would prescribe something for the backache and something for stress that caused the backache, and something to sleep at night. Although no blood pressure was taken, Dr. Ramos did ask the patient how his blood pressure was, and the patient answered that it was "fine." The doctor then prescribed 60 tablets of valium, 60 placidyl tablets and 40 darvocet tablets. The only medical history provided in writing to the doctor concerned the name, address and employment, medical insurance information and answers to questions on the form concerning allergies. Additionally, the patient noted that he had been taking "valium" or "valium." Upon receiving the prescriptions, Steven Jones paid Dr. Ramos $40 and left his office. Detective Jones again visited Dr. Ramos' office on February 2, 1983. Upon arriving at the office he was escorted into an examining room by the Respondent's assistant, who was also his wife. While Mr. Jones was seated in the examining room, an assistant placed a blood pressure tourniquet or cuff on the patient's arm, leaving it there four to five minutes, when she ultimately returned to the room and informed Steven Jones that the doctor was ready to see him. The blood pressure tourniquet or arm band was never actually inflated by the Respondent or assistant, and no blood pressure reading was ever taken on this visit. Upon going into the Respondent's office, Mr. Jones was asked by Dr. Ramos about how he was feeling and the "patient" requested stronger pain medication. The doctor refused to do this, saying in effect that the patient, Mr. Jones, would have to be admitted to a hospital before the Respondent could prescribe stronger pain medication. Again, on this office visit no social or medical history was taken, and no physical examination was conducted at all. The Respondent asked the patient if he wanted the same prescriptions he had obtained at his December visit, and the patient answered in the affirmative. There was no discussion between the patient and the Respondent or anyone else concerning the patient's condition or progress between the December visit and this February visit. There was no discussion concerning the need for future treatment. The Respondent simply, at that point, wrote the same prescriptions given at the December visit. The next visit by Detective Steven Jones, a/k/a Steven James, occurred on May 25, 1983, at the Respondent's medical offices. The same medical assistant recognized Jones immediately when he came into the office and asked him if he was there for the same reason, to which he replied in the affirmative. He was then escorted straight to Dr. Ramos' office, who asked him if he wanted the same medication again, to which he assented. There was no discussion at all about his condition and how it may have progressed since the February visit, nor was there any discussions about future prospects for treatment, what treatment if any, was being considered or what it was designed to accomplish. The Respondent simply wrote three prescriptions once again, for valium, placidyl and darvocet, Schedule IV controlled substances. Except for the first visit, there was never any discussion of back pain nor any discussion concerning symptoms of insomnia and nervousness in this patient. Onelia Padron testified for Respondent. She has known the Respondent for many years and has worked for him as a technician for approximately a year. She was working in his office in December 1982, as an x-ray technician and in the performance of blood tests, blood pressure readings and physical therapy. She remembered Detective Jones coming to the office in December 1982, and testified that she did not take a blood pressure reading at the December visit, but did so at the February visit. Her specific memory of taking the blood pressure reading in February was not clear, however. She remembers specifically that his blood pressure was normal at the February visit and testified that she was sure that Dr. Ramos wrote down the blood pressure of the patient in his medical chart for the February visit. The patient medical record of Detective Jones a/k/a James, however, does not reveal that a blood pressure reading was taken at the February visit. Although the witness claims to have taken a blood pressure reading on the patient on his February 1983 visit, the testimony of Detective Jones reveals that no blood pressure reading was taken; although the blood pressure cuff or tourniquet was applied to his arm, it was simply not used. This may account in part for Ms. Padron's mistaken memory of actually taking the blood pressure reading. Her memory may be less than accurate due to passage of time. The testimony of Detective Jones to the effect that no blood pressure reading was taken, when considered with the Respondent's own medical records which do not reveal a blood pressure reading being taken, renders the finding inescapable that no blood pressure reading was taken at the February, 1983 visit and that Ms. Padron, after the passage of over a year, has a less- than-specific, inaccurate memory about the occasion and thus her testimony with regard to this visit is not credible. Rita Ramos, the Respondent's wife, acts as the office receptionist who makes and maintains the medical records for the Respondent. She performs no medical duties, however, she is well acquainted with her husband's handwriting and, of course, her own handwriting, and established that the word "valium" on Petitioner's Exhibit 2 and the word "valium" on Petitioner's Exhibit 6 were not written by her or her husband. She maintains that she specifically remembers the patient (Detective Jones) coming to visit Dr. Ramos on December 16, 1982, and she specifically remembers the doctor conducting a full physical examination and writing at least four lines of notes in the patient's record. She did not take a blood pressure on this patient in either December or February, however, and could not give an adequate explanation of how she could perform all her administrative record-keeping and maintenance duties and still have time to continually watch through the open door of her husband's office to see the physicals performed on approximately 20 patients a day, including Jones, and especially then to be able to remember the details of that one specific patient's visit in December 1982, over a year prior to the hearing. Although this witness supposedly remembered the doctor "always" conducting physical examinations on the first visit by a patient, and specifically conducting a head, eyes and ears examination on the first visit of Detective Jones, given the inherent interest of the patient in this case, the fact that her memory must be suspect regarding a specific patient's visit on a specific date more than a year prior to the hearing, and her own testimony that no irregularity or memorable occurrence happened during the visit of that patient to stimulate her recall, her memory of that event must be deemed less than accurate and therefore her testimony concerning the physical examination cannot be found credible by this Hearing Officer. Dr. Ramos testified on his own behalf. He stated that his standard practice is to interview and examine each patient and that he was especially suspicious of the subject patient who came in wearing earrings and boots. He interpreted his abbreviated notes on the patient's chart to reveal that the patient was 5'8" tall and weighed 145 pounds, had a blood pressure of 120 over 80 and a pulse of 80, and a normal sinus rhythm with no heart murmur and no abnormal respiratory signs. The doctor additionally interpreted his handwritten notes containing his own abbreviations, to reveal that the patient's eyes were normal, neck supple, with normal ears, nose, throat and a fair complexion. Although the patient asked for a stronger medication on at least one of the visits, including quaaludes, the doctor refused, informing the patient that he could not legally prescribe such for him in Florida. The doctor also testified that he remembered that on the second visit in February 1983, Ms. Padron took the blood pressure of the patient. He contends that he did not record the blood pressure reading because it was the same as the first time, that is, the December 1982 visit. No blood pressure was taken or recorded at the December 1982 visit, however, and none is revealed in the doctor's record for that visit. Although the doctor testified that on the February visit he believed that the patient might be trying to trick him and might be an undercover law enforcement officer, he still prescribed the same controlled substance prescribed earlier, with no additional physical examination made nor physical findings recorded in the patient records. He repeated the same instructions as to use of those drugs and the reasons for taking those drugs, but did not record any physical findings related to that visit. By his own admission, he did not ask the patient what had occurred in his medical history between December and February and did not ask questions concerning the success of his previously prescribed course of treatment. If indeed, the Respondent believed that the patient could be an undercover law enforcement officer and thus attempting to trick the doctor into misprescribing drugs for him, one might think that the doctor would take pains to make a thorough physical examination and to thoroughly record his findings and conclusions in the medical records he maintained, instead of failing to document his physical findings and conclusions and continuing to prescribe those drugs over a period of months. Thus, the testimony of Dr. Ramos is not supportive of a finding that a thorough physical examination, including the taking of blood pressure readings at each patient visit and, (in view of the low back pain complaint) straight leg raise tests, tests for impairment of sensation in extremities and other parameter checks, was actually conducted on the patient. Dr. John Handwerker, M.D., testified as an expert witness for the Petitioner. He has served as first chairman of the Department of Family Practice at the University of Florida Family and Community Medicine programs. He is Chairman of the Family Practice Department of Mercy Hospital in Miami, and is assistant professor of pharmacology at the University of Miami. He is knowledgeable regarding generally prevailing and accepted standards of family practice in Dade County and was accepted, without challenge, as an expert in the field of family practice. The drug Darvocet and Darvocet N-100 is a Schedule IV controlled substance, according to the schedule established in Chapter 893, Florida Statutes. Darvocet is characterized by some habituating influence, together with some problems with withdrawal. Its use is contraindicated with tranquilizers, such as valium, which was also prescribed in conjunction with it by Respondent for the patient involved herein. Valium, which is known generically as diazepam, is also a Schedule IV controlled substance and is a sedative or anti-anxiety drug with a wide variety of potentially adverse drug interactions, including darvocet. It can be mildly addictive, has a depressant effect on the central nervous system and is also a muscle relaxant. Placidyl is a short-term drug used in sleep disorders. It is only indicated for use for a maximum of seven days. It is classed as an oral hypnotic, and is a Schedule IV controlled substance pursuant to Chapter 893, Florida Statutes. Prior to prescribing any of these drugs, a physician should take a full history from a patient, and perform a thorough physical examination. The history should include the patient's chief complaint with questions from the physician to the patient involving areas of past problems with the nervous system, ears, eyes, lungs, chest, respiratory system, GI tract, and urinary tract. The physical examination should involve all body systems, including blood pressure, examination of the head, neck and chest and back regions. Further, if the patient requests these or other drugs specifically, a check should then be made for "track marks" and other evidence of prior drug abuse or usage. If the patient complains of low back pain, there should be a physical examination specifically involving the low back area before prescribing the scheduled controlled substances at issue. The past history is important to determine the duration of the problem, any previous medical treatment, examinations or tests by other physicians regarding the lumbosacral or low back area. A physical examination should be performed designed to elicit indications of neurological involvement, including straight leg raise tests, impairment of sensation tests in the extremities and other neurological inquiries. Such a full history and a physical examination is necessary prior to initiating a course of treatment involving treatment of chronic pain due to the existence of a wide assortment of other treatment modalities which might treat the root of the problem, rather than merely the pain symptoms. Dr. Handwerker, upon being questioned concerning the December 1982 visit of Detective Jones to the Respondent's office, posing as a 29-year-old construction worker complaining of lower back pain and insomnia, established that if a doctor performed no physical examination of such a patient, or only a cursory one, and took a history which in essence elicited only the complaint of injury (aside from the non-medical personal background information) that it would amount to inappropriate prescribing of the subject drugs if the patient was given these drugs in the manner prescribed to Detective Jones. The Respondent simply made insufficient findings upon which to base the decision to prescribe those drugs. Such prescribing without an adequate physical examination or the obtaining of detailed patient medical history would constitute a failure to conform to the level of care, skill and treatment recognized by reasonably prudent similar physicians under these conditions and circumstances. The continued prescribing of these drugs at the February and May visits of this patient, without any discussion or consideration of the effect the previous course of treatment had had on the patient, other than a simple question by the Respondent concerning how the patient was feeling, also constitutes inappropriate prescribing of scheduled controlled substances and demonstrates a failure to conform to the generally accepted and prevailing standards of medical practice in the Dade County community. It was similarly established that the medical records failed to justify the course of treatment afforded this patient. Especially regarding the lack of a physical examination at each visit, and the failure to elicit any further medical history on the latter two visits. Even if a full physical examination and history was conducted on the first visit in December 1982, which was not the case, there would still be required an interim update and recording of physical findings related to the patient's experience since the December visit. Notes should have been made in the patient records regarding how the medications were affecting the patient and his pain problem, including notes reflecting that a physical examination had been performed, involving all vital signs, which was not the case with this patient. Not only does the generally accepted and prevailing standard of medical practice in Dade County require that an initial, thorough physical examination including the blood pressure and pulse and the eliciting of a detailed medical history be performed, as well as update physical examinations at later visits to check the progress of the patient under the treatment program; the failure to note the findings in the patient records constitutes a failure to conform to generally accepted and prevailing standards of medical practice for the Dade County community. Dr. Alfred March testified as an expert witness for Respondent, but agreed that the same detailed medical history and examination described by Dr. Handwerker is required before the practitioner should prescribe scheduled controlled substances in the same manner as done by the Respondent. Dr. March was unable to ascertain from simply reviewing the medical records of the Respondent, the reason or justification for the prescribing of any of the drugs on the three dates in question, and established that the medical records of the doctor should always justify the course of treatment for a patient. Indeed, Dr. March established that if a patient came in complaining of a backache, then such would be inappropriate prescribing without the performance of x-rays of the affected area and a full neurological examination, neither of which was performed by the Respondent in this case. Dr. Ramos has never been subjected to disciplinary proceedings in the past, and his past professional record reveals that his medical practice has been characterized by sincere concern for his patients and the highest respect of his colleagues. The subject drugs involved are Schedule IV controlled substances, which are of the class of drugs characterized by the least serious ramifications for patients, if misused. It is to the doctor's credit that when the undercover detective, Mr. Jones, attempted to persuade him to prescribe more powerful medication such as quaaludes, the doctor vigorously protested such a course of treatment and refused to do so, citing his belief that indeed it was illegal to do so in Florida.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is, therefor
The Issue The issues in these consolidated cases are whether Respondent committed the violations charged in four Administrative Complaints and, if so, what is the appropriate discipline.
Findings Of Fact The Department has regulatory jurisdiction over licensed chiropractic physicians pursuant to section 20.43 and chapters 456 and 460, Florida Statutes. In particular, the Department is authorized to file and prosecute an administrative complaint against a chiropractic physician after a probable cause panel (PCP) of the Board determines there is probable cause to suspect a licensee has committed a disciplinable offense, and provides direction to the Department on the filing of an administrative complaint. At all times material to the allegations in the Administrative Complaints, Dr. Aderholdt has been licensed to practice chiropractic medicine in Florida, having been issued license number CH 7814. He was first licensed on January 6, 2000. He practices in an office in Bradenton, Florida. Vax-D Therapy Three of the four Administrative Complaints involve patients of Dr. Aderholdt who received Vax-D therapy. The complaints are not directed to the provision of Vax-D therapy itself, or to any other treatments provided by Dr. Aderholdt. In all four cases, the patients generally spoke well of the chiropractic care they received from Dr. Aderholdt and the manner in which they were treated by him and his office staff. Vax-D therapy is a modality using the Vax-D model for decompression of the spinal discs and spinal structure. It is used to treat a range of issues associated with low back pain, including herniated, degenerated, and bulging discs. The Vax-D model is the originator of this technology; it was the first spinal decompression device. It is a large computerized moving table. It can be programmed to provide specific axial or distractive loading. The table moves in and out, pumping nutrients at the discs. Some research shows that it can actually pull discs away from where they are causing irritation on nerves and the spinal cord. The Vax-D model is FDA-cleared for use, and the literature supports its efficacy. The Vax-D model is an expensive piece of equipment. The price range for the initial purchase is between $100,000 and $150,000, with ongoing expense thereafter for maintenance and updates. Vax-D therapy is one of the most expensive forms of therapy, if not the most expensive, in the chiropractic profession. Other models coming out after Vax-D, as well as other tools, arguably can be used for similar purposes. However, as Petitioner’s expert readily acknowledged, Vax-D is the “Rolls Royce. It’s a really nice tool.” Vax-D spinal decompression is not covered by Medicare. In fact, when it comes to chiropractic care, Medicare has never covered anything besides spinal adjustments. Coverage for Vax-D treatment by private insurance companies is rare. In 2012, Dr. Salvatore LaRusso presented a study on spinal decompression to the profession, before the Federation of Chiropractic Licensing Boards, to inform state regulators of issues associated with Vax-D therapy. The one regulatory concern he reported was that some physicians were improperly billing Vax-D as a surgical decompression procedure, when it is plainly not surgery; it is an alternative to surgery, properly billed as a non-surgical decompressive tool or traction device. Dr. LaRusso’s study also made findings on the common methods of packaging and selling the service, and the range of charges observed. He found that most practitioners providing Vax-D therapy were selling the service as a cash item in their practice, with payment up front often required. The common model was to sell a package with a certain number of visits, with or without additional services included. Dr. LaRusso found that the per-visit charges ranged from $150 to $450, depending on the ancillary services added to the decompression. Dr. Shreeve does not have any issue with the use of or charges for Vax-D therapy. Dr. Aderholdt offers Vax-D therapy pursuant to a Vax-D Therapy Payment Plan agreement (Vax-D Agreement), which is comparable to the multi-visit packages that Dr. LaRusso’s study found to be common. After initial consultation, with intake forms, patient history, x-rays, evaluation, and examination, if a patient is determined to be appropriate for Vax-D therapy, Dr. Aderholdt will give his treatment recommendations and then turn the patient over to his office staff to address the financial aspects. If the patient wants to proceed with Vax-D therapy, the Vax-D Agreement will be reviewed and signed. Patients A.M., R.O., and P.D. each received Vax-D therapy, pursuant to signed Vax-D Agreements. The terms of the Vax-D Agreements for the three patients were the same. Patient B.O. wanted Vax-D therapy, but she was determined to not be an appropriate candidate for it. The Vax-D Agreements in evidence for Patients A.M., R.O., and P.D. provided that the named patient committed to 25 to 28 Vax-D therapy sessions, for $250.00 per session. The total amount that the named patient agreed to pay Dr. Aderholdt for 25 to 28 sessions was $5,500.00, which computes to an actual per-session cost of between $196.43 (for 28 sessions) and $220.00 (for 25 sessions). For the agreed price for 25 to 28 sessions, the Vax-D Agreement provided the following treatment package: at each session, the patient would receive 30 minutes of Vax-D therapy, 30 minutes of full range interferential electrical muscle stimulation (EMS), 15 minutes of hydro-massage therapy, and manipulation (adjustments) by the doctor if needed. The first set of x-rays was also included. Dr. Aderholdt requires an up-front payment for the Vax-D therapy package. For patients who want Vax-D therapy but need help coming up with the funds, Respondent’s office staff has put the patients in touch with Care Credit, which is a medical credit program. If a patient applies and is accepted, Care Credit will finance the cost without charging interest to the patient if the loan is repaid within one year. Care Credit apparently charges a fee to Respondent when credit is extended, similar to the fees charged to merchants by credit card companies for credit card purchases. No evidence was presented regarding Care Credit’s approval criteria or how widely this method is used. All that is known about Care Credit from the record evidence is that two patients who received Vax-D therapy applied for Care Credit and were approved. The other Vax-D patient charged half of the agreed price on a Visa credit card the first day of treatment, and charged the other half after 15 treatment sessions. Patient A.M. From the end of July 2013 to early February 2014, Dr. Aderholdt treated Patient A.M., then a 66-year-old female, for lower back pain and hip pain. Patient A.M. had tried other treatments and had seen chiropractors before, but reported that her pain kept getting worse. As shown by A.M.’s medical records, A.M. was first seen by Respondent on July 29, 2013. That day, A.M.’s intake form, patient history, and x-rays were taken and evaluated, and A.M. was examined by Respondent. Respondent then formulated A.M.’s initial treatment plan. Respondent recommended Vax-D therapy, along with chiropractic adjustments, EMS, and hydrotherapy. The initial treatment plan specified a two- session per day protocol for the first two to three weeks. On July 30, 2013, A.M.’s husband, J.M., signed the Vax-D Agreement (in the space for Patient Signature). J.M. did not remember signing the Vax-D Agreement, but both he and A.M. identified his signature on the Vax-D Agreement. A.M. was named in the agreement as the patient who committed to 25 to 28 Vax-D therapy sessions and agreed to pay $5,500.00 for those sessions. Respondent did not require full payment of the agreed price prior to treatment. Instead, he accepted payment of one- half ($2,750.00) of the Vax-D therapy package price, which was charged on A.M.’s or J.M.’s Visa credit card on July 30, 2013. In accordance with the initial treatment plan, Patient A.M. received two treatment sessions per day beginning July 30, 2013, in the morning and afternoon, for nearly three weeks. After 15 treatment sessions--more than half of the 25 to 28 sessions covered for $5,500.00--the balance of $2,750.00 was charged on A.M.’s or J.M’s Visa credit card. Between July 30, 2013, and February 3, 2014, Patient A.M. had more than 60 Vax-D therapy sessions--approximately 64 total sessions. A.M. initially testified with a fair degree of confidence that she thought she had about 30 treatment sessions, until she reviewed her prior statement made to Petitioner. A.M. testified that at every session, she received Vax-D decompression therapy, hydrotherapy, adjustments “up and down” her spine, and ice packs. She left every session feeling better, with relief from her pain. The relief was temporary, however; she said the pain would come back after a few hours. After 29 sessions, having received all of the treatment sessions covered by the Vax-D Agreement, A.M. started paying additional amounts for more Vax-D therapy and the other ancillary services that she continued to receive. For approximately 35 additional treatment sessions beyond those covered by the Vax-D Agreement, A.M. made seven additional payments in the total amount of $2,226.00. In all, A.M. paid $7,726.00 for approximately 64 Vax-D therapy sessions. Rounding down to an even 60 sessions, she paid an average of $128.77 per session. A.M. was covered by Medicare at the time of her treatment. She did not have any private “Medicare supplement” health insurance. At some point, the subject of Medicare coverage came up. The details of what was said, when, and to whom were not clearly established. The only fact clearly established was that Dr. Aderholdt did not bring up the subject. Patient A.M. testified that Dr. Aderholdt did not talk to her about payment when she first visited, but that she and J.M. asked him, “Does Medicare cover this,” and he said, “Yes.” J.M. said that Dr. Aderholdt did talk to them about payment, saying “we need to do so many treatments and we should pay so much money.” J.M. said that they asked, “Will Medicare take care of it?” Dr. Aderholdt answered, “Yes, we will bill Medicare.” J.M could not say whether he asked about billing Medicare before or after he signed the Vax-D Agreement, since J.M. did not remember signing the Vax-D Agreement. When Dr. Aderholdt was asked if he told A.M. her treatments would be covered by Medicare, he answered, “No, I don’t believe I did, no.” As an interesting contrast, Patient R.O. testified that Dr. Aderholdt told him Medicare would not cover treatment under the same Vax-D Agreement; Dr. Aderholdt does not believe he made that statement, either. In the middle of the spectrum, Patient P.D. testified that Respondent never said anything to her about insurance coverage or financial arrangements. He would only talk about treatment, turning P.D. over to the office manager or billing person to address the financial issues. This version is consistent with Respondent’s testimony that he does not address “the money thing” with patients. Instead, he said he assesses x-rays, takes patient histories, performs the evaluation and examination, and ultimately formulates the recommended treatment plans, whether Vax-D or something else. Then he turns the treatment plans over to his staff to address the financial issues with the patients. A.M. and J.M. did not demonstrate a clear and certain recollection of what they asked Dr. Aderholdt or exactly what he answered. Indeed, both J.M. and A.M. could not remember most every other detail about A.M.’s treatments, often confidently stating details that were shown to be wrong by more than a little, including how many treatment sessions, and how much was paid. For example, Patient A.M. initially reported that she had paid $13,179.00 to Dr. Aderholdt, when the total was $7,726.00. The undersigned cannot find--without hesitancy--that Dr. Aderholdt made any representation to J.M. and A.M. regarding Medicare coverage before J.M. signed the Vax-D Agreement by which A.M. committed to the Vax-D therapy package. Dr. Shreeve made the point well that it is difficult to resolve this kind of he said-she said conflict, although he made the point while confusing Patient A.M. (who claimed Respondent said there would be Medicare coverage) with Patient R.O. (who claimed Respondent said there would not be Medicare coverage), in the following exchange: Q: With Patient RO, what’s your understanding of what Dr. Aderholdt told him regarding Medicare reimbursements? A: Counselor, I’m going to tell you that the investigative record shows that the patient stated that Aderholdt told him that they would be paid, is what my recollection is. And, yet, that’s not something that weighs heavily on my mind because I wasn’t there. This becomes a “he said, she said.” He said he didn’t; he said he did. I can’t get into that fight. That’s not an issue for me. (Jt. Ex. 12 at 35). (emphasis added). Respondent (or his staff) may have told A.M. and J.M., when they asked about Medicare, that the office would complete and submit the Medicare claim forms. Respondent (or his staff) may have told A.M. and J.M., when they asked, that Medicare proceeds paid on the Vax-D therapy package would be refunded. But it would be unreasonable, on this record, to find that Respondent misrepresented that Medicare would provide full coverage, or that Respondent schemed to induce A.M. and J.M. to sign up for Vax-D by guaranteeing that Medicare would pay back everything, when Respondent did not even bring up the subject.8/ The Administrative Complaint alleges that on one or more occasions, Respondent did not submit Medicare claims for Patient A.M.’s treatment. Petitioner has apparently abandoned this allegation; its PRO has no proposed finding identifying any dates of service for which claims were not submitted. The Medicare claim forms for Patient A.M. were compiled by Petitioner’s counsel for use in taking Respondent’s deposition, and are attached as deposition exhibit 2. The evidence is difficult to cull through, as there are 84 separate pages of claims and they are not in chronological order; they start out in chronological order, but then jump forward two months, then continue jumping around on dates, back and forth and back again. As best can be determined, all service dates shown in Patient A.M.’s medical records appear to be accounted for by corresponding claim forms. It appears that one claim form may have a clerical mistake, identifying the date of service as August 3, 2013, when there was no treatment session that day; the actual service date may instead be September 4, 2013, which is the date the claim form was submitted. The Medicare claim forms in evidence demonstrate that claim forms for A.M.’s treatments were regularly submitted, either on or very shortly after the dates of service. The evidence is insufficient to prove that Respondent did not submit Medicare claims for Patient A.M.’s treatment.9/ The Administrative Complaint contains no allegations regarding the disposition of the Medicare claims, although it does allege that Patient A.M. received no reimbursement from Respondent for Medicare payments. Petitioner’s expert seemed to be under the impression that Respondent received Medicare payments, because he criticized Respondent for not providing reimbursement to Patient A.M. Respondent testified that he has received no payments from Medicare for A.M.’s treatments, and Petitioner acknowledges in its PRO that Medicare has not made payments to Respondent. Acknowledging that the Administrative Complaint allegation has not been established, Petitioner instead proposed a finding (not alleged in the Administrative Complaint) that all of A.M.’s Medicare claims submitted by Respondent were rejected and payment was denied. No evidence was offered to prove the actual disposition of the 84 pages of Medicare claims submitted for A.M.’s treatments. Instead, the only record evidence of Medicare adjudications on any claims for A.M. is a group of explanation of benefits forms (EOBs) attached to a March 6, 2014, letter from Patient A.M. to Petitioner’s investigator, which is a deposition exhibit. Patient A.M. identified the small handful of EOBs attached to the March 6, 2014, letter as EOBs she had at that time, reporting on the disposition of Medicare claims submitted by other providers during the same time period as her treatments with Respondent. The EOBs reported, as to each claim, whether the claim was covered in whole or in part; and, if covered, what amount was paid, or, if not, why not. There were no EOBs for claims submitted by Respondent’s office. Patient A.M. was not asked for, and did not offer, any additional EOBs at her deposition. If, in fact, all of the Medicare claims submitted by Respondent were rejected and payment denied, then there would be a stack of EOBs explaining why each claim was denied. On this record, the evidence is insufficient to make any finding as to the outcome of the Medicare claims submitted for Patient A.M.’s treatment. There is no evidence proving whether the claims were denied, approved, or simply never acted on by Medicare. A separate allegation in the Administrative Complaint is that Patient A.M. requested copies of the Medicare claim forms submitted by Respondent’s office for her treatment. Patient A.M. said that she made verbal requests to Respondent’s office staff for the Medicare claims on more than one occasion, and the parties stipulated that Patient A.M. made these requests. Respondent’s office should have responded by giving Patient A.M. copies of the Medicare claims. Dr. Aderholdt said that he was not aware that Patient A.M. had requested copies of her Medicare claim. But it is his responsibility to ensure that his staff promptly responds to requests by patients for insurance claim forms. In the course of Petitioner’s investigation, the Medicare claim forms for Patient A.M. were provided to Petitioner (according to the investigator’s report, on May 16, 2014). It is unknown whether a set of the claim forms was provided to A.M. at that time. She is entitled to a copy of the claim forms if she has not already been given a set. Respondent should have verified that Patient A.M. has received the claim forms she requested, or, if not, provided them to her. Finally, the Administrative Complaint alleges that on the Medicare claim forms for A.M.’s treatments on August 6, 2013, and December 11, 2013, Respondent utilized Current Procedural Terminology (CPT) code 98941, which is the code for adjustments to three or four regions of the spine. However, Respondent’s Subjective, Objective, Assessment and Plan notes (referred to as SOAP notes) for those dates identify spinal adjustments to L3, L4, and L5, which are in a single region--the lumbar region. Beyond the SOAP notes, however, Dr. Aderholdt’s notes for Patient A.M.’s morning session on August 6, 2013 (there were two sessions that day), show multiple adjustments, not only to the lumbar region, but also, to the sacrum and ilium. Dr. Aderholdt’s notes for December 11, 2013, show multiple adjustments to the thoracic, lumbar, and sacrum regions. At hearing, Dr. Shreeve identified the five spinal regions as follows: “a region would be considered cervical, thoracic, lumbar, sacrum, ilium.” (Tr. 106, lines 21-22). Based on his testimony, and considering all of Patient A.M.’s medical records, there were multiple adjustments to three spinal regions on both days identified in the Administrative Complaint.10/ The Administrative Complaint has no other factual allegations regarding CPT code issues in connection with Patient A.M.’s treatment. The complaint pointedly identified one specific CPT code that was used on two specific dates, but was allegedly not supported by SOAP notes for either date. At hearing, Dr. Shreeve attempted to expand the factual allegations regarding CPT coding issues by questioning other CPT codes shown on A.M.’s patient ledger. Dr. Shreeve’s criticism was improper, not only because he strayed beyond the allegations in the Administrative Complaint, but also, because the criticism was based on his misunderstanding of what Dr. Aderholdt’s patient ledgers portray. In particular, Dr. Shreeve was critical of CPT code 99212 entries (for focused patient examinations) on A.M.’s patient ledger, without use of modifier code -25. He said that these repeated entries of CPT code 99212 were inappropriate without use of modifier code –25, to indicate they should not be considered for payment, because they are redundant with other CPT treatment codes that include examination. Dr. Shreeve should have reviewed the actual Medicare claim forms to look for the modifier codes, because the CPT code 99212 entries do, in fact, add a modifier of -25. The modifier code conveys information to the third-party payor, as Dr. Shreeve acknowledged, regarding whether or how payment should be made. The modifier codes need to be used, when appropriate, on the Medicare claim forms, and they were used just as Dr. Shreeve said was appropriate. The modifier codes do not appear on Dr. Aderholdt’s patient ledgers because they are not claim forms sent to third- party payors, nor are they bills sent to patients. Instead, a patient ledger, as used in Respondent’s practice, is an internal practice management tool to account for and track everything associated with treating patients: how many examinations, how many adjustments, how many Vax-D treatments, how many ice packs, and so on. Dr. LaRusso explained that this is a perfectly reasonable use of patient ledgers, and is a common practice among physicians. The usage statistics are analyzed for practice management, for such purposes as making changes in the services or treatments and stocking supplies. Dr. Shreeve admitted that he assumed Respondent’s patient ledgers reflected the exact CPT coding used on insurance claims and bills sent to patients. The evidence refuted that assumption. Modifier codes were used on the Medicare claims. And Dr. Shreeve admitted he saw no evidence that Respondent’s patient ledger for A.M. was ever sent to her as a bill, or that any patient ledgers were ever sent to any patients as bills. Dr. Shreeve also admitted that there is no standard for patient ledgers, much less a regulation mandating the contents and use of patient ledgers. As he put it, he could go to 1,000 chiropractic offices and find 1,000 different variations in what is called a patient ledger. Dr. Shreeve would like to see a standard adopted for “patient ledgers,” but his aspiration simply underscores that there is no standard now; Respondent’s practices cannot be judged against or held to conform to a non-standard, non-regulation.11/ In somewhat stream-of-consciousness fashion, untethered from the Administrative Complaint, Dr. Shreeve interjected a number of other comments about Dr. Aderholdt’s practices related to Patient A.M., such as the adequacy and legibility of his medical records and the quality of x-rays. He raised questions about Dr. Aderholdt’s compliance with trust accounting requirements in connection with payments for A.M.’s Vax-D therapy, and Dr. Aderholdt’s compliance with obligations in connection with Petitioner’s investigation. None of these factual matters were alleged in the Administrative Complaint, and none of the corresponding statutory or rule provisions implicated by Dr. Shreeve’s open-ended commentary were charged in the Administrative Complaint. No findings can be made on matters not alleged, and violations not charged, in the Administrative Complaint. Moreover, there is no competent evidence fleshing out any of these matters, because they were not alleged, charged, or identified in the Joint Pre-hearing Stipulation as issues of fact or law to be litigated. Patient B.O. Between April and June 2013, Respondent treated B.O., then a 78-year-old female, for back and neck pain. B.O. is married to R.O. They both went to Respondent’s office on the same day for their initial consultation. B.O. completed intake forms, had x-rays and patient history taken, and was examined by Respondent, similar to R.O. Whereas R.O. was determined to be a candidate for Vax-D therapy, B.O. was not. Unlike for the Vax-D therapy plan, there was no protocol calling for a certain range of sessions needed and no set payment correlated to a planned number of sessions for B.O.’s recommended treatment plan that called for adjustments, hydrotherapy, and ice packs. At the time of her treatment, B.O. had Medicare coverage and a “Medicare supplement” insurance policy through Horizon Blue Cross and Blue Shield of New Jersey (Horizon). As was his practice, Respondent had B.O. address the financial aspects of the treatment he recommended with his office staff. Upon review of B.O.’s insurance coverage, B.O. was informed by Respondent’s staff that Horizon would probably cover the cost of her treatment that exceeded her copay. The staff determined that, although it was possible Horizon would apply its lower in-network copay of $15.00 per visit, there was no guarantee that Horizon would not consider Respondent out-of- network, with a copay of $25.00 per visit. Therefore, B.O. was charged $25.00 per visit. She paid that amount per visit, although sometimes she did not pay at all on one or more visits, and would catch up at a subsequent visit. B.O. received treatments on 23 occasions. B.O. experienced some relief from her pain as a result of those treatments.12/ For those 23 visits, B.O. paid a total of $575.00 in copays. After B.O. had stopped going to Dr. Aderholdt for treatment, Horizon determined that its lower in-network copay of $15.00 per visit applied. The total copay amount should have been $345.00 for 23 visits. The difference is $230.00. The Administrative Complaint alleges that Respondent “overcharged” B.O., misrepresenting that her copay was the out- of-network charge, to exploit her for financial gain. This allegation was not proven. Respondent made no representation. The representations of his staff, as described by B.O., were not shown to be the product of anything other than a good faith attempt to determine the undeterminable details of insurance coverage. There is no evidence to support the allegation that B.O. was intentionally charged more than she should have been charged, based on the information available at the time. On this point, the expert testimony was in lockstep: figuring out insurance coverage details is a “nightmare.” It is virtually impossible, according to both experts, to obtain sufficient information to make a correct determination for a new patient on such issues as in-network versus out-of-network, because, as they agreed, the insurance coverage details keep changing. “Now, you can be in network today and they can decide you’re out of network tomorrow. And then you can be out of network and then they decide you’re in network, and they don’t tell you.” That’s--that makes no sense.” (Dr. Shreeve, Tr. 131). In fact, when asked how he determines if a patient is out-of-network, Dr. Shreeve responded: “Counselor, I don’t. I leave that to the patient. I run a cash practice. I give them a bill. We’ll help them fill out a health insurance claim form, if they need it. But they pay us when they receive the service.” (Tr. 130). The Administrative Complaint also alleges that Respondent billed Horizon for medical visits by Patient B.O. that did not occur. There is no credible evidence of this allegation; the evidence is to the contrary. Petitioner contends in its PRO that Respondent billed B.O. for treatments received on June 3, 7, 11, and 14, 2013, when B.O.’s appointments were cancelled on those days. The record citations offered by Petitioner fail to support this proposed finding. Instead, B.O.’s bank records directly refute the proposed finding, and corroborate Dr. Aderholdt’s treatment notes and the SOAP notes that detail B.O.’s treatment on those four days.13/ In addition to B.O.’s bank records, B.O.’s patient records include the “merchant copy” receipt for a debit card payment on June 14, 2013. The receipt shows that a $50.00 payment was made at Dr. Aderholdt’s office on June 14, 2013, and it bears the clear signature of B.O. B.O.’s accusation that she did not go to Respondent’s office for treatment on these four days is belied by the documentation that she personally went there and paid the copay charges for her treatments on those four days ($50.00 check on June 7 for two copays; $50.00 debit card payment on June 14 for two copays). Petitioner’s own expert, Dr. Shreeve, conceded that this evidence refutes B.O.’s accusation that her insurer was billed for treatment on four days when she did not go to Respondent’s office for treatment. A separate problem proving this allegation (besides B.O.’s false accusation) is that there is no evidence to prove what was billed to Horizon for B.O.’s treatments. There is no evidence in the record of claims submitted by Respondent’s office to bill Horizon for B.O.’s treatment. In pre-hearing discovery proceedings, shortly before hearing, Petitioner sought to compel production of Medicare claim forms or Horizon claim forms submitted by Respondent’s office. However, Petitioner declined an Order compelling production that was offered along with additional time to pursue this evidence. Instead, Petitioner chose to go forward with the hearing on the basis that there were no such records (as Respondent represented). Another allegation in the Administrative Complaint is that B.O. was not given a copy of her medical records upon request. B.O. testified that she made several verbal requests to two staff persons at Respondent’s office, Lisa14/ and Amanda, for her medical records. She said she was given a copy of her patient ledger, but nothing more. B.O. and R.O. then mailed a letter addressed to Respondent that they jointly wrote on December 31, 2013, requesting their medical records and updated patient ledgers. Respondent said that he was never informed of any verbal requests for records, nor did he believe he ever saw the letter that was mailed to him. Indeed, B.O. handwrote on her file copy of the letter, provided to Petitioner’s investigator: “Letter to Dr. who probably didn’t see – no response to date.” The evidence is clear and convincing that Respondent has failed in his obligation to promptly respond to B.O.’s requests for medical records. However, there is no evidence that Respondent was aware of the requests before the investigation and intentionally refused to comply, or that he ever instructed his office staff to ignore such requests. But even though the evidence only establishes that Dr. Aderholdt’s staff failed to promptly respond to requests for medical records, the obligation to ensure these patient requests are promptly addressed remains Dr. Aderholt’s responsibility. It is clear that his office procedures require serious overhauling, as both Dr. Aderholdt and his expert acknowledged. It is unknown if B.O.’s medical records were provided to her when they were produced by Respondent’s counsel during the investigation.15/ In her deposition, when B.O. was asked if she had gotten the records from Respondent’s office yet, she said “not from them.” Among other remedial steps in the aftermath of this proceeding, if B.O. and R.O. do not already have copies of their medical records and updated patient ledgers as they requested long ago, Respondent must provide them. It is concerning that he did not come to this hearing with proof that he had provided B.O. and R.O. with the records they had requested or confirmed that they already had a copy. Lastly, the Administrative Complaint alleges that Respondent received payment from Horizon for B.O.’s treatment, but has not provided a refund. There is insufficient evidence to determine whether B.O. is entitled to a refund. The only information regarding the extent to which Horizon covered B.O.’s treatment is the information in the EOBs issued by Horizon after B.O.’s treatment ended, identifying amounts that would be covered and reporting payments to Respondent. For B.O.’s treatments, Horizon paid $1,770.00 to Respondent. What is unknown is whether B.O. owed more for her treatments than what Horizon paid. Dr. LaRusso reasonably opined that the receipt of an insurance payment would not generate an obligation for a patient refund if the payment is applied to a balance due by the patient. No evidence, methodology, or calculation was offered to prove that after Horizon’s payment was applied, a refund was owed to B.O. As noted previously, Respondent’s “patient ledger” is an internal practice management tool that does not function as an accounting of what a patient or insurance company owes. However, the patient ledger for B.O. reflects a total amount of $5,575.00 in services provided to B.O. Application of the Horizon payments of $1,770.00 and B.O.’s payments of $575.00 would reduce the patient ledger amount by less than half. Again, this is not to say that Patient B.O. owes the remaining patient ledger amount, but it is at least a point of reference suggesting the possibility that the Horizon payment did not cover all of B.O.’s treatment costs. Viewed another way, all B.O. paid for 23 treatment sessions was $25.00 per visit. B.O. was informed at the outset that she would not be charged for the full treatments she would be getting, because Horizon would “probably” cover her treatment except for the copay. Although she paid $230.00 more than the amount Horizon ultimately applied as copays, if B.O. owed $230.00 or more for treatment provided that was not covered by Horizon’s payment, then no refund would be due. Patient R.O. As noted previously, Patient R.O. is Patient B.O.’s husband. Like B.O., R.O. was treated by Respondent from April through June 2013. R.O., then a 64-year-old male, sought treatment for severe back pain. R.O. completed the intake form, had x-rays and patient history taken, provided detailed records of recent treatments and surgeries (including back surgery), and was evaluated and examined by Dr. Aderholdt. Dr. Aderholdt determined that R.O. was a candidate for Vax-D therapy. Respondent’s then-office manager, Lisa, took over to address the financial aspects of the recommended treatment. R.O. informed Respondent’s staff that he could not afford to pay $5,500.00 up front. R.O. was given contact information for Care Credit. He called Care Credit, then submitted an application. R.O.’s application was approved, and Care Credit agreed to finance the cost of Vax-D therapy without charging interest if the amount was paid off within one year. R.O. accepted the loan, and the result was that Care Credit paid Respondent $5,500.00 minus a fee absorbed by Respondent, similar to fees by credit card companies charged to merchants for sales using their credit cards. R.O. testified that he has paid off the Care Credit loan. R.O. signed the Vax-D Agreement, by which he committed to 25 to 28 Vax-D therapy sessions at $250.00 per session, for a total payment amount of $5,500.00. His Vax-D Agreement included the treatment package detailed in paragraph 13 above. R.O. testified that during the time of his treatment by Respondent, he had health insurance coverage with Medicare and Horizon (the private Medicare supplement insurance coverage that B.O. also had). He also had Tricare for Life, but said that that coverage would not have been applicable. R.O. recalled that Respondent told him that none of his insurance plans would cover the Vax-D therapy. As previously noted, Respondent does not believe he discussed insurance coverage with R.O., as that is not his standard practice. Regardless, R.O. had no expectation of insurance coverage. R.O. found the Vax-D therapy helpful in relieving his pain. He felt better after every treatment and wanted to continue. Rather than stopping after the 25 to 28 sessions included in the Vax-D Agreement, R.O. had a total of 40 treatment sessions. However, at some point, Respondent’s office manager informed R.O. that he needed to pay for additional sessions. R.O. said he could not afford to pay more, and discontinued treatment. After R.O. discontinued his treatments, he received an EOB from Horizon, stating that Horizon had paid a total of $5,465.84 in claims for both R.O. and B.O. According to the EOB summary, as noted above, $1,770.00 was paid to Respondent for treatments to B.O. The rest--$3,335.84--was paid to two providers for services to R.O. (A minor discrepancy is noted, in that Petitioner’s PRO stated that $3,335.00 was paid to Respondent for treatments to R.O.; however, the EOB reports that $10.84 was paid to a different provider (“Ga Emergency Phys”) for services provided to R.O. Thus, the actual total payment to Respondent for R.O.’s treatment was $3,325.00). The total amount paid to Dr. Aderholdt for R.O.’s 40 Vax-D therapy sessions, including Horizon’s payments, was $8,825.00, an average of $220.63 per session. R.O. believes the insurance payment should be paid to him as reimbursement for part of the $5,500.00 he paid. But that payment was for 25 to 28 sessions. The insurance payment was reasonably applied to the additional amounts due for R.O.’s sessions that were not covered by the $5,500.00 payment. No reason was offered as to why Dr. Aderholdt should not have applied the insurance payment to charges owed for the 12 sessions that were not covered by the Vax-D Agreement. Chiropractic physicians are not required to provide free care. Dr. Shreeve admitted that he does not provide chiropractic care to patients for free. As found above with respect to Patient B.O., R.O. joined B.O. in submitting a written request to Respondent for their medical records and updated patient ledgers by letter dated December 31, 2013, although Respondent said that he did not see the letter that was mailed to him. The findings above with respect to B.O., as one party to the joint written request, apply with equal force to R.O. as the other party to the joint written request. The Administrative Complaint also included an allegation that Respondent failed to practice chiropractic medicine at an acceptable level of skill, care, and treatment, charged as a violation under section 460.413(1)(r). This was the only charge in any of the Administrative Complaints that was based on the care provided by Dr. Aderholdt. The allegation was that adjustments indicated as having been performed on R.O. were physically impossible. However, at hearing, Petitioner’s expert retreated from the allegation, agreeing that the procedure in question was plausible. As a result of his concession, Petitioner’s PRO abandoned the charge, stating, “Petitioner is no longer pursuing discipline for the alleged violation of section 460.413(1)(r).” Pet. PRO at 4. Patient P.D. In March and April 2013, Respondent treated Patient P.D., then a 62-year-old female, for back pain. After completing intake forms and patient history, Patient P.D. was x-rayed, then examined and evaluated by Dr. Aderholdt, who determined that P.D. was a candidate for Vax-D therapy. Dr. Aderholdt turned P.D. over to his then-office manager, Lisa, to address the financial aspects of his recommended treatment plan. P.D. confirmed that Dr. Aderholdt never discussed financial issues or insurance with her. P.D. signed the Vax-D Agreement on March 8, 2013, the same day that she completed a Care Credit application that was approved for $5,500.00. P.D. paid off the Care Credit loan in 11 months, at $500.00 per month, so the loan was interest-free. At the time of the treatments, P.D. was not yet eligible for Medicare. She had insurance coverage through Blue Cross Blue Shield of Michigan (Blue Cross). P.D. said that Lisa, the office manager, told her that she would file claims with Blue Cross. Thereafter, P.D. had 33 Vax-D therapy sessions. P.D. was pleased with the Vax-D therapy. She found it effective in relieving her pain. P.D. learned at some point from Blue Cross that several months after her treatment ended, Blue Cross paid Respondent for a portion of P.D.’s treatment. No evidence was offered to prove the details of the Blue Cross coverage, such as EOBs explaining what was covered and what was not. P.D. said that she contacted Respondent’s office and spoke with staff multiple times before Respondent provided her reimbursement in the full amount of the Blue Cross payment. Respondent refunded $946.45 on April 8, 2015, and $1,046.45 on April 10, 2015, for a total of $1,992.90. P.D. acknowledged that she has been fully reimbursed and is owed nothing further. The Administrative Complaint includes an allegation that Respondent improperly utilized CPT “billing codes” 99204 and 99212 for P.D.’s first session on March 6, 2013. Dr. Aderholdt admitted that for March 6, 2013, P.D.’s patient ledger incorrectly lists both CPT code 99204 (for a comprehensive examination for a new patient), and CPT code 99212 (for a focused examination for an established patient). The first CPT code should have been the only one entered on this day. The second code was entered by mistake. Although Dr. Aderholdt admitted the error made in the patient ledger, there is no evidence that the erroneous CPT code was “utilized” for billing purposes. No evidence was presented that both CPT codes were submitted by Respondent in a claim for payment to Blue Cross (and Petitioner did not charge Respondent with having submitted a claim to P.D.’s insurer for a service or treatment not provided). No evidence was presented of the actual claims submitted to Blue Cross. No evidence was presented to show that P.D. was ever sent a bill utilizing the referenced CPT codes. The error recording an extra CPT code on P.D.’s patient ledger might throw off Respondent’s internal practice management statistics, but there is no evidence that the admitted CPT coding mistake on the patient ledger was repeated in any claim or bill submitted to anyone. Expert Opinions Considering All Four Cases Both Dr. Shreeve and Dr. LaRusso offered their overall opinions, taking the four cases as a whole. Dr. Shreeve’s Oinions Dr. Shreeve testified that, while he might be more understanding of issues he saw in each individual case, “I’ve got four cases that I reviewed together. I received them all at once. So my view on each individual case might be seen as a little more tolerant of something I saw. But when it becomes repeated, it becomes less understanding [sic].” (Tr. 109). In forming his opinions, Dr. Shreeve relied on allegations that have not been proven, his own extension of the Administrative Complaint allegations to add other concerns about use of CPT codes (which were also shown not to be valid concerns), and his observations about a litany of matters nowhere mentioned or charged in the Administrative Complaints. Dr. Shreeve made clear that he elevated his opinion from concerns about sloppy office practices to fraud, misrepresentation, and patient exploitation, because of matters that were either unproven, not alleged or charged, or both. For example, he injected the concern, shown to be based solely on patient ledgers, that CPT code 99212 appeared many times without the -25 modifier when used in conjunction with an adjustment CPT code. Starting with A.M.’s case, he complained of the repeated use of CPT code 99212 without a -25 modifier, when CPT code 98941 (adjustments) was used for the same office visit. He said, “If we were going to bill 99212, an E/M code with that, we would use a modifier of -25.” (Tr. 110). As previously found, however, Dr. Aderholdt did use the -25 modifier with every entry of CPT code 99212 in the Medicare claim forms. In explaining how his opinion was affected by his misimpression from the patient ledgers that CPT code 99212 was not used with the -25 modifier, he said: This is repeated over and over during the record. If it were one off, it occurred in one place in the ledger or on a form, you know, everybody is human. They can make a mistake. If it is the trend, that becomes not a mistake. That becomes, I’m doing the wrong thing. And if I’m doing it over and over again, and I’m then billing for one service two times, two different ways, and I’m – I hope to get paid for it. Then that’s where I start to see the trend of exploiting the patient for financial gain. (Tr. 111). Dr. Shreeve further elevated the significance of not seeing modifiers with the evaluation codes in the patient ledgers, when he spoke about R.O.’s case: If [Dr. Aderholdt] did both codes [for evaluation and adjustments] every visit, if he did, which is not normal, we would have to have a modifier, the -25, to tell us it’s a reduced service because it’s duplicative. A modifier was never present in any record I saw on this patient or any other patient of the records of Dr. Aderholdt. So misusing the codes. This is not standard of care that we expect, and this appears to me exercising influence on the patient to exploit them for financial gain. That’s what it looks like to me. By the time we’re through with the third case that’s what I see. (Tr. 148). Not only was this CPT coding issue not alleged in any of the four Administrative Complaints, but it is a false accusation. If Dr. Shreeve did not see a single use of CPT code 99212 with the -25 modifier in any record he saw, then he did not look at the records very carefully. As found above, the only evidence of actual claims submitted to any third-party payor--the Medicare claim forms for Patient A.M.--shows that CPT code 99212 was never used without the -25 modifier. But Dr. Shreeve only looked at the patient ledgers for modifiers. As also found above, the only two CPT coding issues that were alleged (improper use on two specified dates of CPT code 98941 for adjusting three or four spinal regions for Patient A.M.; and improper use on Patient P.D.’s first day of service of two patient examination CPT codes for billing purposes) were not proven. Dr. Shreeve also relied on the allegation that Patient B.O.’s insurance carrier was billed for treatment that was not provided. He pointed to “notes” written (by B.O.) on the patient ledger stating that the patient cancelled, but CPT codes were entered for treatments that day. He concluded: That’s blatant. I don’t have a way to explain that away. To me that absolutely says, I billed for something that I didn’t do. That’s fraud. Because that’s with intent. That’s not an accident. (Tr. 137). When Dr. Shreeve was shown the $50.00 debit card receipt signed by Patient B.O. on June 14, 2014, he quickly retreated: “That would indicate that they were there, even though they said they were not. So my apologies for that. It’s good to clear that up.” (Tr. 183). Later, he added that the June 14, 2013, payment of $50.00 was for that visit and the prior visit on June 11, 2013. He explained that this was consistent with Respondent’s daily notes, which identified treatments for each visit and also logged the copay charges by visit and B.O.’s periodic payments. Dr. Shreeve did not explain how he would alter his overall opinion after conceding that what he characterized as blatant fraud by Dr. Aderholdt was actually a false accusation by the patient. In formulating his overall opinion that what otherwise might be viewed as mistakes or sloppy office practice were elevated in his mind to fraud and exploitation, Dr. Shreeve also relied heavily on matters that were neither alleged nor charged in the Administrative Complaints, and, as a result, were not fleshed out with competent evidence in the record. Dr. Shreeve repeatedly alluded to issues regarding trust accounting requirements in statute and rule. The four Administrative Complaints that were issued as directed by the PCP on June 19, 2018 (as noted on the Administrative Complaints), contain no allegations related to trust accounting practices. The PCP-authorized Administrative Complaints do not charge Dr. Aderholdt under the trust accounting statute, section 460.413(1)(y), or the trust accounting rule, Board rule 64B2- 14.001. To the extent Dr. Shreeve’s perception of trust accounting issues contributed to his opinion that these four cases rise to the level of fraud and patient exploitation, that was error, and his opinion must be discounted accordingly. Likewise, Dr. Shreeve gratuitously offered critiques of Dr. Aderholdt’s medical records, including complaints about the handwriting, complaints about x-ray quality, questions about the adequacy of justifications for the course of treatment, and suggestions regarding how he would rewrite SOAP notes. Again, the Administrative Complaints are devoid of allegations directed to the quality or adequacy of Respondent’s medical records, and they are devoid of charges under the medical records provision in section 460.413(1)(m) and the corresponding medical records rule, Board rule 64B2-17.0065. To the extent these critiques contributed to Dr. Shreeve’s opinion that these four cases rise to the level of fraud and patient exploitation, that, too, was error, and his opinion must be discounted accordingly. Dr. Shreeve also relied on what he characterized as Respondent’s failure to respond, or failure to respond quickly enough, to investigative subpoenas. He made it clear that his opinion was greatly influenced by his perception that Respondent intentionally failed to meet his obligations in responding to the investigations: I think this is absolute fraud. The doctor is not wanting to do the right thing, has flagrant disregard for the law, and the statutes and the rules for the profession, for the Department of Health by not responding. (Tr. 153). Despite Dr. Shreeve’s view that he thinks it is “very clear” that Dr. Aderholdt did not respond timely during the investigation, the timeline and details of the investigation were not established by competent evidence; there is only hearsay evidence addressing bits and pieces of that history, with huge gaps and many questions about the reasons for those gaps (if the reasons why investigations were so protracted was relevant). But the details of the investigations are not laid out in the evidentiary record because the Administrative Complaints do not contain factual allegations related to Dr. Aderholdt’s actions or inactions during the investigation process, nor are there any charges predicated on what was or was not done during the investigation process. Either these matters were not presented to the PCP in June 2018 for inclusion in the Administrative Complaints, or they were presented and not included. Either way, Dr. Shreeve’s perception regarding whether Dr. Aderholdt met his legal obligations in responding to the investigations cannot be injected now. It was improper for Dr. Shreeve to consider, and give great weight to, circumstances that were neither alleged nor charged in the PCP-authorized Administrative Complaints. As found above, the proven allegations are that Respondent failed to provide Patient A.M. copies of the claims submitted to Medicare for her treatment (although she may have them now); and Respondent failed to provide copies of the medical records of Patients R.O. and B.O. upon their joint written request (although they may have them now). Only by considering allegations that were not proven and by injecting matters not alleged or charged was Dr. Shreeve able to characterize these four cases as involving the same problems again and again. In terms of the proven allegations, however, the only duplicative finding is with respect to the husband and wife team, in that Respondent did not meet his obligation to promptly respond to their joint request for medical records and updated patient ledgers. The matters considered by Dr. Shreeve beyond the allegations and charges in the Administrative Complaints were also improperly used by Dr. Shreeve to buttress his view that two disciplinary actions against Dr. Aderholdt based on facts arising in 2005 and 2006, raised “the same or similar” issues. Dr. Shreeve’s attempt to draw parallels between the prior actions and these four cases was unpersuasive. Dr. LaRusso disagreed with the characterization of the two prior actions as similar to the issues presented here. Dr. LaRusso’s opinion is credited. A comparison of the allegations, ultimately resolved by stipulated agreement in two 2008 Final Orders, confirms Dr. LaRusso’s view in this regard. The first disciplinary action was based on Respondent’s treatment of one patient in February 2005. An administrative complaint alleged that Respondent failed to complete intake forms, take the patient’s history, and conduct a sufficient examination to support the diagnosis. Respondent was charged with violating section 460.413(1)(m) by not having adequate medical records. The same facts gave rise to a second count of violating section 460.413(1)(ff) (violating any provision of chapters 456 or 460, or any rules adopted pursuant to those chapters), through a violation of rule 64B2-17.0065, which elaborates on the requirements for adequate medical records. There is no repetition of these statutory and rule violations charged in any of the four Administrative Complaints at issue here. The prior administrative complaint also alleged that Respondent billed the patient he saw in 2005 for neuromuscular reeducation and therapeutic exercises, when neither Respondent’s notes nor the SOAP notes reflected those services. In these cases, the only allegation regarding discrepancies between billing records and physician/SOAP notes is the allegation as to Patient A.M. that on two dates, Respondent used the CPT code for adjustments to three or four spinal regions, whereas the SOAP notes reflected adjustments to only one region. The prior disciplinary action supports the findings above that Respondent’s notes must also be considered, in addition to the SOAP notes, to determine what services A.M. received on those two days. A different kind of billing discrepancy allegation in Case No. 18-4485 is the claim that Respondent billed B.O.’s insurer for treatment on days on which services were allegedly never provided. This allegation was not proven, as found above. B.O.’s accusation that Respondent falsely charged for treatment on several days when no treatment was provided was itself proven to be a false charge. Perhaps Dr. Shreeve was thinking of this allegation, based on B.O.’s false charge, when he characterized the 2005 incident as involving the same or similar problems that he saw here. The allegation in the prior complaint was that the patient was actually billed for services not provided, and a refunded was ordered. At first, Dr. Shreeve believed the same was true in B.O.’s case. However, he later retreated and acknowledged that B.O. had not been truthful in her accusation. The only other allegation of a billing discrepancy in any of the four cases at issue was not a billing discrepancy at all, but rather, a CPT coding error on P.D.’s patient ledger that was not billed to anyone. As Dr. Shreeve noted, in the prior disciplinary action, Respondent agreed to be put on probation with a requirement that he practice with a monitor. Dr. Shreeve explained that the monitor would have worked with Respondent “to help this doctor not do the same behaviors that got them into trouble.” In his view, these four cases show that Dr. Aderholdt did not learn his lesson from the monitor “not to do the same problems again.” As he put it, “That really flips me rather quickly to think there’s a question of fraud.” (Tr. 152-153). To the contrary, whereas Respondent was faulted for not having intake records, patient histories, and appropriate examinations to support his diagnosis and recommended treatment plan in February 2005, no such issues were raised in these Administrative Complaints. Dr. Aderholdt did learn his lesson. The medical records for the four patients at issue include patient intake forms, patient histories, evaluations, and examinations that were not alleged to be inadequate. Nor was there any repetition of the problem with billing a patient for treatment or services that were not documented in the medical records taken as a whole, including Dr. Aderholt’s notes. The other disciplinary action resolved by settlement in a 2008 Final Order involved an advertising issue. The Department alleged that Respondent improperly advertised as a specialist in Vax-D disc therapy when the Board does not recognize any such specialty. The Department also found fault in the failure of the advertising to disclose the usual fee. The Department also critiqued an advertisement for identifying a different practice location than Respondent’s practice address of record. The charges were under section 460.413(1)(d), (cc), and (ff); rule 64B2-15.001(2)(e) and (i); and rule 64B2-10.0055. Quite plainly, this prior action bears no similarity to the four Administrative Complaints at issue here. No such allegations or charges were raised here. Dr. Shreeve did not contend that this prior action bears any similarity to the four cases here. Dr. Shreeve was never asked for his opinion as to the type or level of discipline he believes is warranted in these cases. However, his “flip” to “fraud,” due to the perceived repetitive nature of the issues in the four cases (whether charged or not)--which he characterized as the “same problems” in 2005 that resulted in discipline--was the basis for Petitioner proposing the most severe penalty available: license revocation, plus substantial fines and assessments of fees and costs. Dr. LaRusso’s Opinions Dr. LaRusso served as a Board member for multiple terms, and is a past-chair. After leaving the Board, he continued to serve on probable cause panels as recently as 2017. Having reviewed and been involved in thousands of disciplinary matters, he was of the strong opinion that nothing in the four Administrative Complaints warrant discipline at the level being sought here. Imposing a severe penalty in these four cases would be out of line with the Board’s prior practice in disciplinary matters. Dr. LaRusso’s studied review of all of the depositions and records in this case led him to opine that there is no evidence that Dr. Aderholdt deceived his patients, committed fraud, or engaged in double-billing or overbilling. Instead, Dr. LaRusso saw evidence of sloppy office practices, which he attributed to Dr. Aderholdt’s poor management skills. He has seen many doctors like Dr. Aderholdt over the years who just want to deal with taking care of patients. They do not want to have anything to do with administrative and clerical responsibilities. Instead, they leave everything besides patient care to their office manager and staff. In Dr. LaRusso’s view, Dr. Aderholdt’s office protocols and procedures require serious fine-tuning. He believes that Dr. Aderholdt would benefit from re-education in billing and collection practices, as well as laws and rules. He needs to ensure that procedures are in place, and followed, for prompt responses to patient requests for medical records or for claims sent to third-party payors. At the same time, however, Dr. LaRusso reasonably characterized the four cases as involving billing, clerical, communication, and correspondence issues. It bears emphasis that Dr. Aderholdt’s patient care is not in question. There are no issues of endangering the public, where a doctor is doing things that will hurt people, doing something dangerous or sexually inappropriate. Those are the cases where it is appropriate to go after someone’s livelihood, when the person does not belong in the profession. Dr. LaRusso observed that, rather than endangering the public, Dr. Aderholdt was helping his patients by relieving their pain, according to their own testimony. Dr. LaRusso agreed to become involved in this case because he found it so incongruous that the Department would be pursuing this action apparently to try to take Dr. Aderholdt’s license. Dr. LaRusso noted that the four investigations against Dr. Aderholdt were originally being spearheaded by a prior prosecutor for the Department (to whom Respondent’s counsel mailed CDs of patient records in 2014), and that the cases were assigned to Dr. Willis, who was a favored expert witness for the Department. Dr. LaRusso alluded to “inappropriate issues” with the prosecutor and expert that led to the Board having to pay a large award of attorneys’ fees and costs for pursuing discipline against Dr. Christian. According to Dr. LaRusso, those issues ultimately led to the prosecutor and expert being discharged from these cases. There is no evidence as to when or why Dr. Willis was replaced with Dr. Shreeve. Dr. Willis apparently was involved long enough to prepare an expert report. But then, according to Dr. LaRusso, the cases went dormant for a long period of time. The bits and pieces of hearsay evidence in the file comport with this understanding: there were four investigations that began upon complaints in 2014 by the four patients about billing and records issues; documents were collected from Respondent and from the patients; and Investigative Reports were issued, all before 2014 was over. It is unknown when Dr. Willis was involved, when he prepared his expert report, or when he was discharged from the cases. It is unknown when Dr. Shreeve was retained, but there was plainly some duplication of work, in that Dr. Shreeve prepared his own expert report. Neither expert report is in evidence. There is no evidence of any additional investigation or follow-up documentation from the patients or otherwise. There is no evidence of what was presented to the PCP--just that the panel met on June 19, 2018, and authorized the four Administrative Complaints issued on June 20, 2018. While this background is a bit of a curiosity, without impermissible speculation, the most that can be said about this history is that the protracted period of time from investigation to the PCP submission that resulted in issuance of the Administrative Complaints is apparently due, at least in large part, to the turnover in the prosecution-expert witness team assignments. Dr. LaRusso did not persuasively demonstrate grounds to cast nefarious aspersions on the Department for continuing forward with its investigation. One might reasonably question whether the Department dropped the ball, so to speak, in not updating its investigation, given the extended period of dormancy. For example, the Administrative Complaint in Case No. 18-4487 incorrectly alleged that P.D. was not reimbursed, when any cursory check with P.D. would have revealed the “news” that she had been repaid in April 2015, more than three years before the Administrative Complaint was authorized by the PCP. Dr. LaRusso may reasonably debate, as he did, whether the charges lodged against Respondent are inappropriate. And Dr. LaRusso may certainly question, as he did in convincing fashion, whether the discipline apparently being sought is unduly harsh, uncalled for, and way out of line with Board practice. But there is no basis in this record for attributing bad motives to the Department for prosecuting the Administrative Complaints. Dr. LaRusso’s opinions regarding the nature of the violations proven and the appropriate discipline in scale with those violations were more persuasive that Dr. Shreeve’s opinions. Dr. LaRusso’s opinions are credited.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Board of Chiropractic Medicine: In Case No. 18-4484PL: Dismissing Counts I, II, and IV; and Finding that Respondent violated section 460.413(1)(aa), as charged in Count III; In Case No. 18-4485PL: Dismissing Counts I, III, and IV; and Finding that Respondent violated section 460.413(1)(i), through a violation of rule 64B2-17.0055(1), as charged in Count II; In Case No. 18-4486PL: Dismissing Counts II, III, and IV; and Finding that Respondent violated section 460.413(1)(i), through a violation of rule 64B2-17.0055(1), as charged in Count II; In Case No. 18-4487PL, dismissing Counts I and II; Placing Respondent on probation for a period of three years, with conditions deemed appropriate by the Board; Imposing a fine of $3,000.00; Requiring continuing education deemed appropriate by the Board; and Requiring payment of the costs of investigation and prosecution of the charges on which violations were found. DONE AND ENTERED this 15th day of February, 2018, in Tallahassee, Leon County, Florida. S ELIZABETH W. MCARTHUR Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of February, 2018.
The Issue Respondent was charged in a five count Administrative Complaint with making or filing a report which the licensee knew to be false in his capacity of a licensed chiropractic physician; failing to keep written chiropractic records justifying the course of treatment of a patient; submitting to a third party payor a claim for services or treatment which was not actually provided to a patient; submitting to a third party payor a claim for a service or treatment without at the same time also providing a copy of the claim to the insured; and making misleading, deceptive, untrue, or fraudulent representations in the practice of chiropractic.
Findings Of Fact Petitioner Department of Professional Regulation is the state agency charged with regulating the practice of chiropractic pursuant to Section 20.30 and Chapters 455 and 460, Florida Statutes. Respondent is, and at all times material hereto has been, a licensed chiropractor in the State of Florida, having been issued license number CH 0003234. His address of record is 3822 W. Broward Boulevard, Plantation, Florida. This discipline case arose out of a complaint from a patient named Dale McCormick when Respondent put Mr. McCormick's unpaid bill into "collection." On March 17, 1986, Respondent had examined Dale McCormick and began treating him for shoulder/lower back pain. Mr. McCormick did not testify at formal hearing. Therefore, the only testimony as to what examinations and treatments were actually performed by Respondent on Mr. McCormick was that of Respondent. Respondent first testified that the examination he performed was "brief" and included a depression test on each shoulder and circular depression test on the skull, with observation and touching of swelling, edema, and muscle spasm. Respondent did not remember whether he did a range of motion examination on Mr. McCormick and could not discern from the Confidential Patient Case History whether or not he had done so because it is his practice only to record positive findings (i.e. loss of range of motion) and he had recorded no loss of motion. Respondent's own conclusion from this record was that either he had done a range of motion test with no positive findings worthy of recording in his records or he had not done a range of motion test at all. The ambiguity of this chiropractic record, the only one which can be clearly demonstrated to relate to Mr. McCormick (see Finding of Fact 17), demonstrates the inadequacy of the record in that the chiropractor who actually performed the examination. (Respondent) could not recall from his review of that record what had been involved in his physical examination. Respondent's testimony also illustrates the probable confusion that would be experienced by a different health care professional reviewing the same record. See Findings of Fact 19 and 20. Although Respondent subsequently testified that he also considered his examination of Mr. McCormick to be a "comprehensive" examination, he indicated that this appellation depended on the intensity of what any given doctor wanted to do. Respondent conceded that normally he would have given a much more intensive examination but on the day he examined Mr. McCormick he was rushed; that he had intended to get more information from the patient and supplement his records on a subsequent or follow-up visit; and that his records could have been more complete. Respondent diagnosed lumbar strain. Respondent testified that he prescribed phenylalamine for pain, and cold pack for edema and muscle spasm; that he performed traction, muscle stin, spinal adjustment and hot packs as therapy for pain and muscle spasm, and provided a lumbar sacral brace. Phenylalamine for edema, therapy for pain, and a lumbar sacal brace are treatments also listed on a bill which bears Mr. McCormick's name and the Respondent's file number for Mr. McCormick. They are also noted beside Mr. McCormick's name on a sign-in sheet used for every patient Respondent saw on the same day but they are not listed on either chiropractic "record" discussed in Findings of Fact 12-18 infra. The bill also reflects the initials "SAMSHPTR" which was not directly explained by any testimony but which the undersigned infers from the testimony to signify spinal adjustment (SA), muscle stin (MS), hot packs (HP) and traction (TR). Respondent consistently attempted to justify his diagnosis by describing the treatment rendered after the diagnosis as opposed to using his examination to reach a diagnosis and then justifying the treatment rendered by naming the diagnosis. The bill and the sign-in sheet are forms commonly in use by chiropractors but are not normally considered professional "chiropractic records." Mr. McCormick paid $35 and received a receipt saying he had reduced his account to a zero balance. Nonetheless, he also signed a lien and insurance authorization form by which Respondent was entitled to seek compensation for the treatment rendered from a third party payor, Mr. McCormick's insurance company. In the absence of testimony by Mr. McCormick as to what the financial arrangement was, and considering the logic that liens are not required of persons who have truly paid in full, Respondent's unrefuted testimony that his secretary/clerk issued the "paid in full receipt" to Mr. McCormick in error is accepted. Thereafter, Respondent billed Mr. McCormick's insurance company for $290, the balance of Mr. McCormick's bill claimed due by Respondent. Respondent billed the insurance company for the following: 90020 Initial Exam $150 97260, 97010, 97012, 97014 65 07040 Lumbar/Sacral Belt 50 Therapy for pain 60 Respondent testified that he did not know precisely what each of the insurance claim codes signified because he let his clerk/secretary fill these in. He understood code 90020 to signify however intense an examination he chose to give; 97260 to mean "spinal adjustment," and 97010, 97012, and 97014 to mean traction, muscle stin, and hot packs in one order or another, which order he was unsure. Dr. Robert Butler, accepted as an expert in chiropractic over objection, testified that 90020 meant "comprehensive examination;" he did not opine on what the other codes might mean. There is no independent documentation concerning the insurance codes which would tend to support either witness' "opinion" of what the codes signify. There is no evidence to show whether Respondent did or did not simultaneously provide a copy of the insurance claim to the insured (McCormick) and the third party payor (insurance company). Respondent's chiropractic records relative to this case include only a Confidential Patient Case History Form (P-3) and an Orthopedic Neurological Exam Form (R-1). Both records fail to include basic vital signs or other examination relative to a comprehensive examination as described by Dr. Butler. Respondent's Confidential Patient History Form has left blank several areas of general and specific conditions that normally should be filled in by the patient prior to treatment. There is, in fact, no information covering the history of the onset of the problem or injury for which Mr. McCormick presented himself to Respondent. It merely recites "rt & lt shoulder pain" and "rt and lt. low back pain." Although Respondent's Orthopedic Neurological Exam Form contains blank areas to fill in the date and time of injury and the location of the present complaint, these were not filled in on this form and no information as to overall medical history is recorded thereon. This form contains space to record examination results but none are recorded, including common observations for height, weight, posture, and vital signs. Dr. Butler conceded that if the Orthopedic Neurological Exam Form could be related to McCormick, it would be sufficient written record of justification of an examination being performed for billing purposes and he expressed no opinion as to the appropriateness of the amount charged therefor. From the Orthopedic Neurological Exam Form, Dr. Butler could only conclude that the patient described was a "healthy individual" without any positive findings upon examination, and that although the form also contains information concerning selective tests performed on the patient, none of the tests recorded revealed positive findings to justify Respondent's diagnosis of Dale McCormick. The Orthopedic Neurological Exam Form was not produced by the Respondent in the course of submitting to informal discovery. It was only located by Respondent among his papers in the course of final formal hearing and subsequent to Dr. Butler's initial testimony and Respondent's testimony. It is machine-copied on the back of a copy of the assignment of lien and insurance authorization signed and dated by Mr. McCormick. From the immediately foregoing facts alone, it may be concluded that this particular record was maintained in a haphazard manner and not in conformity with reasonable chiropractic care and practice. Moreover, this form does not have Mr. McCormick's name on its face and does not reflect any other information identifying who the patient was, the date of examination, or any information which would confirm that the form was made out contemporaneously with Respondent's physical examination of Dale McCormick. There is no suggestion it was ever submitted to the insurance company to verify Respondent's treatment of Mr. McCormick. For the foregoing reasons and even though Respondent was permitted to reopen his case so as to present this "newly discovered evidence", admitted as "R-1", the undersigned is not persuaded that this Orthopedic Neurological Exam Form relates to the patient in question, Dale McCormick. Neither report justified the course of treatment rendered by Respondent. Upon the expert testimony of Dr. Butlers it is found that: The single most important aid for a chiropractic physician in evaluating a patient's condition is a comprehensive history. The minimal standards in the chiropractic profession for a comprehensive patient history are obtaining the primary complaint, secondary complaints (if they exist), duration of the problem, the nature of the problem, what has been done for the problem, if any previous accidents or injuries exist, whether the patient is taking any medication for the problem, and if the patient is receiving any other treatment. Patient histories should be recorded to assist the treating chiropractic physician or successive health care professional in subsequent treatment of the patient. The results of examinations should be recorded by the chiropractic physician to assist the treating chiropractic physician or any successive health care professional in subsequent treatment of the patient. It is standard in the profession for chiropractors to maintain a minimal record of proceedings, communications, and findings and procedures relative to the management and care of each patient. Dr. Butler acknowledged that it is possible to treat a patient without obtaining a patient history but insisted it is risky to treat professionally within the confines of the professional standards without knowing what the underlying condition is. While the exact treatment of a patient with shoulder/low back pain may vary, the physician should record his treatment in the chiropractic records for the patient. This was not done in this case by Respondent. In Dr. Butler's opinion, the examination related in Respondent's testimony was insufficient to treat shoulder/low back pain. Respondent has been previously disciplined for violations of Sections 460.413 (1)(d) and (e) Florida Statutes and Rules 21D-15.01 (2)(g) and (i) with regard to advertising, which offenses are unrelated to the one violation proved herein.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is recommended that the Board of Chiropractic enter a final order dismissing Counts I, III, IV, and V of the Administrative Complaint and finding Respondent guilty of Count II, a violation of Section 460.413 (1)(n) Florida Statutes, imposing a fine of $1,000, suspending Respondent's license as a chiropractic physician for one month, and imposing a one year period of probation to follow directly upon the completion of the one month suspension, with the period of probation to be reduced in the event the Respondent demonstrates to the Board satisfactory completion of courses in chiropractic record-keeping, the courses to be selected and specified by the Board in its final order. DONE and RECOMMENDED this 27th day of October, 1988, at Tallahassee, Florida. ELLA JANE P. 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 27th day of October, 1988. APPENDIX TO RECOMMENDED ORDER The following constitute rulings pursuant to Section 120.59 (2) Florida Statutes, upon the parties' respective Proposed Findings of Fact (PFOF). Petitioner PFOF: 1-20 are accepted either in whole or in part. Where not fully accepted, modifications have been made to conform to the greater weight of the evidence as a whole, to distinguish between expert opinion accepted and expert opinion not accepted due to equivocations on the record, or opinions expressed without sufficient predicate to be accepted, or to assess the weight and credibility of the witnesses. Proposal 5 specifically has been modified to more closely conform to the greater weight of the credible evidence as a whole. Proposal 6 is mere recitation of testimony out of context and to the degree it has not been accepted within other findings, is modified and distinguished within the facts as found in FOF 20. Proposal 20 has been accepted but only those matters material have been adopted in FOF 21. Respondent's PFOF and 3 are accepted and adopted except as subordinate or unnecessary. is accepted but is irrelevant and not a disputed issue of material fact. Respondent waived any necessity for a subpoena by offering the materials to the prosecution. Moreover, he complained at formal hearing that the DPR attorney did not pick them up quickly enough. 4-6 are partly accepted in FOF 10 to the extent that Dr. Butler was tendered and accepted as an expert in chiropractic over objection, but the remaining parts of each of these proposals is rejected as mere argument and as merely a recitation of authority. COPIES FURNISHED: PAT GUILFORD, EXECUTIVE DIRECTOR BOARD OF CHIROPRACTIC DEPARTMENT OF PROFESSIONAL REGULATION 130 NORTH MONROE STREET TALLAHASSEE, FLORIDA 32399-0750 RAY SHOPE, ESQUIRE AND CYNTHIA SHAW, ESQUIRE DEPARTMENT OF PROFESSIONAL REGULATION 130 NORTH MONROE STREET TALLAHASSEE, FLORIDA 32399-0750 JOSEPH SMITH, D.C. 3822 WEST BROWARD BOULEVARD FORT LAUDERDALE, FLORIDA 33312 LAWRENCE A. GONZALEZ, SECRETARY DEPARTMENT OF PROFESSIONAL REGULATION 130 NORTH MONROE STREET TALLAHASSEE, FLORIDA 32399-0750 BRUCE D. LAMB, GENERAL COUNSEL DEPARTMENT OF PROFESSIONAL REGULATION 130 NORTH MONROE STREET TALLAHASSEE, FLORIDA 32399-0750
