The Issue The issue for determination is whether the Petitioner is liable to the Agency for Health Care Administration ("Agency") for Medicaid reimbursement overpayments and related fines, costs, and interest.
Findings Of Fact The Agency is the single state agency charged with administration of the Medicaid program in Florida under Section 409.907, Florida Statutes. The Petitioner provides physician services to Medicaid beneficiaries pursuant to a contract with the Agency under provider number 037381800. The Agency sent the Petitioner a Preliminary Agency Audit report on June 30, 1998, notifying him of a preliminary determination of Medicaid overpayments in the total amount of $21,156.35. The Agency sent the Petitioner a Final Agency Audit Report on October 28, 1998, confirming the Agency's determination of Medicaid overpayments in the total amount of $21,156.35. The Agency's determination of overpayment was based upon findings that obstetrical echography services "were billed and paid in violation of Medicaid policy governing those services." The Agency performed an audit of the Petitioner for the period January 1, 1993, through October 31, 1996. According to the Agency audit report, the Petitioner's records contained violations of two billing policies outlined in the Medicaid Physician Provider Handbook. The first violation was that the Petitioner billed and received payment for more than one initial ultrasound procedure per pregnancy, and the second was that the Petitioner failed to submit documentation of medical necessity for additional procedures. During the years examined by the audit, Medicaid policy allowed providers to bill for more than one complete initial procedure per patient, so long as providers filed supporting documentation of medical necessity. However, the documentation submitted by the Petitioner indicated that the additional ultrasound procedures he conducted were mere follow-up procedures, instead of medically necessary complete procedures. According to the terms of the Medicaid Physician Provider Handbook, "[i]f more than two (or any combination of two) ultrasounds are performed during a pregnancy, they must be billed with modifier-22 and a report documenting the medical necessity for the procedure." The Petitioner submitted bills for more than two ultrasound treatments per recipient without explaining why the procedures were medically necessary. The Agency audit report established that the Petitioner has been overpaid as a result of the Petitioner's erroneous billings. The total overpayment to the Petitioner was calculated as "the difference between what he got paid for a complete procedure and the amount that he should have gotten paid for the follow-up." The Agency records received in evidence and the testimony of the Agency's witness establish that the amount overpaid to the Petitioner totaled $21,156.35. The Petitioner, as an authorized provider of Medicaid services, had signed a Medicaid Provider Agreement. That agreement states, among other things, that the "provider agrees to submit Medicaid claims in accordance with program policies." When the Petitioner became a certified Medicaid provider, he received a handbook outlining billing procedures for the performance of diagnostic ultrasounds. The Petitioner admitted that he knows "little about billing," that he "didn't involve [himself] in the billing at all," and that he has never read the Physicians' Current Procedural Terminology book, which sets forth the universally used billing codes.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Agency issue a final order requiring the Petitioner to reimburse the Agency for overpayments in the total amount of $21,156.35, plus such interest as may accrue as of the date on which payment is made. DONE AND ENTERED this 3rd day of January, 2001, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of January, 2001.
The Issue The issues in this case are whether Respondent, SA-PG Sun City Center, LLC, d/b/a Palm Garden of Sun City (hereinafter "Palm Garden" or the "Facility") failed to follow established and recognized practice standards regarding care to its residents; and whether Respondent failed to comply with the rules governing skilled nursing facilities adopted by Petitioner, Agency for Health Care Administration (hereinafter "AHCA" or the "Agency"). If the answer to those questions is in the affirmative, then there is an issue as to what penalty should be imposed on Respondent. HOLDING: There is no competent and substantial evidence that Palm Garden failed to follow established practice standards that resulted in harm to its residents and failed to comply with rules governing skilled nursing facilities, or that otherwise warrants a fine or Conditional rating. Palm Garden was marginally deficient in two minor areas concerning their own policies, but neither violation is a Class II deficiency, nor warrants imposition of a sanction.
Findings Of Fact AHCA is the state agency responsible for licensing and monitoring skilled nursing facilities in Florida. Part and parcel of its duties is the inspection of all facilities on an approximately annual basis. Further, AHCA may conduct a survey of a facility upon receipt of a complaint from a third party about operations or conditions at a specific facility. Palm Garden is a 120-bed skilled nursing facility located in Sun City, Florida. The Facility provides services to private pay residents and is also certified to provide services for residents under the Medicaid and Medicare reimbursement programs. At all times relevant hereto, Palm Garden was operating under a Standard nursing home license. On April 26 through 30, 2010, AHCA conducted an annual survey at the Facility. During the course of the survey, AHCA surveyors made findings concerning two allegedly deficient practices by the Facility. The deficiencies are identified as follows: (1) One resident, identified herein as Resident 68, complained of burning on urination and said no treatment was offered to relieve the pain; and (2) One resident, identified herein as Resident 138, had wounds on his skin that his family believes were not properly treated. During the survey, Resident 68 purportedly complained to a surveyor that she was currently having pain when she urinated and was not being treated for the condition. The surveyor reviewed the resident's chart and determined that Resident 68 had previously complained of urination pain on April 10, 2010. In response to her complaint, a Diascreen test was performed on that same date. The test came back negative for urine infection. The test was normal in all regards, except for glucose level. The resident was at 250 mg/dL (milligrams per deciliter) of glucose when the normal range is between 50 and 150 mg/dL. The Agency expert opined that the glucose level discrepancy renders the test result less reliable. In her opinion, the report would be inconclusive as to whether a urinary tract infection ("URI") existed. There are, as the Facility's expert opined, other conditions, including diabetes, which can cause a high glucose rating. Resident 68 suffered from diabetes at the time the test was done. On balance, it appears that the test was viable. On the date the Diascreen test was performed, a checklist for potential URI was placed in the resident's medication administration record. That checklist set forth a protocol to follow over the next 72 hours in order to better assess the resident's condition. There is no evidence the protocol was followed. The Facility's infection control nurse, Sue Fuller, admitted that sometimes it is difficult to get all nurses to strictly follow established procedures. However, Resident 68 was receiving 24-hour care by the Facility and was monitored regularly as part of that care. The resident's chart does not indicate any further problems concerning urination pain until April 27, 2010, i.e., day two of the annual survey. On that date, there is a doctor's note indicating dysuria, i.e., painful urination condition. The doctor prescribed Pyridium, a urinary antiseptic (not an antibiotic) for treatments. The physician did not order any additional tests or other treatment. It is apparent a physician was involved in Resident 68's care, but he did not diagnose a UTI. AHCA concluded from its investigation that Resident 68 suffered actual harm between April 10 and April 27, 2010, because there is no documentation that the resident's pain was being addressed. However, Palm Garden charts by exception, meaning that they only place into the chart events which are abnormal or negative. Ignoring the issue of whether that is the best way to chart a resident's care, the absence of chart notations relating to URI or painful urination means, from the Facility's perspective, that there was no complaint of pain on the days it was not mentioned. The resident was visited by a physician on April 16 and 22, 2010, but the doctor's notes do not indicate a complaint concerning pain when urinating. The resident's chart does indicate that Resident 68's activities of daily living, meal consumption, and therapy records reflect normal activity without any notable exceptions. It is unlikely an elderly person with an untreated UTI would be able to pursue normal activities. AHCA did not independently ascertain whether Resident 68 experienced pain during the period between April 10 and April 27, 2010. The Agency's conclusion in that regard is based on pure speculation by the surveyor. There is no competent evidence that there was harm to the resident.2 The resident purportedly told the surveyor that she (resident) had experienced pain during that time, but the clinical records do not support that claim.3 During the survey, Resident 138 was noted to have two skin wounds on his buttocks. The resident's wife had complained to surveyors about the wounds because she did not believe appropriate treatment was being provided by the Facility. A surveyor contacted the Facility's wound nurse to inquire about the wounds, which the surveyor believed to be pressure sores. No measurements had been taken of the wounds, a deficient practice from the surveyor's perspective. The surveyor stated, "And they were Stage II pressure ulcers. I mean, she was saying they were excoriations, but they were on the bony prominence. It was a Stage II. It wasn't very deep when I saw it. The one on the left buttocks was irregular, and the one on the right buttocks was smaller. I didn't see any drainage and there was no odor and it was actually superficial. It would be a Stage II pressure ulcer." (See Transcript, page 84.) In fact, the wounds were considered excoriations, rather than pressure sores by the Facility. The Facility's director of nursing, who was very familiar with Resident 138 and had examined him prior to and during the survey, described the wounds as excoriations based on the way they were healing. Excoriations are not normally measured because they change rapidly and tend to heal quickly. Conversely, pressure sores must be measured as a part of their on-going treatment because they heal slowly and must be monitored. The surveyors found the wounds to be very small and superficial. If they were pressure sores, they would have been Stage I sores. Stage I pressure sores do not blanch. To blanch means that if pressure is applied to the area, blood would rush back after the pressure is released. The wounds on Resident 138 were personally blanched by the Facility's director of nursing.4 There are other wounds that look like pressure sores, but actually come about due to other causes. For example, a sore may occur when a person lies in urine, thus, agitating the skin. Sores may be caused by frequent contact with liquids and by residents being moved in their beds. There is no mention in Resident 138's medical chart of pressure sores. Rather, the doctor's notes refer to the resident's wounds as open sores or excoriation. At one point the Wound Treatment Evaluation Record for the resident listed a Type I and a Type II for wound type and pressure ulcer stage. However, that notation was later indicated as an error by the wound nurse. There is no competent medical evidence that Resident 138's wounds on his buttocks were pressure sores. Nonetheless, the surveyors observed nursing staff treating Resident 138's wounds and found some deficient practices. A treating nurse put on gloves after setting up her treatment table. The nurse then reached back and closed the curtain around the resident's bed (a proper practice), but did so with her gloved hand. That action would desterilize the glove. She then began treating the resident without re-washing her hands or re-gloving. The nurse then discarded the wound dressing and changed gloves. However, she did not wash her hands before changing gloves. She then poured saline on the wounds as required. The surveyor at this point noted what she believed were two wounds, neither of which was draining or had an odor. The wounds were superficial, not deep, according to the surveyor. At that point, the nurse cleaned both wounds using the same piece of gauze. She then applied dressing to the wounds, completing her treatment. The surveyor found that touching the curtain with a gloved hand was an infection control violation. So too was the cleaning of two wounds using the same piece of gauze. The Facility opines that the treatment process was not a sterile situation, until such time as the wound had been cleaned and dressed. Touching the curtain before that process and changing gloves without washing would not necessarily be deemed infection control issues, although transferring germs from the curtain to the wound area was a possibility. The wound area was not a pressure sore, thus did not contain infection. It was, therefore, proper to wash the wound area with the same gauze without violating infection control procedures. It is the opinion of the AHCA surveyor that Resident 138 had two wounds. She believed one wound was smaller than the other and that neither of them were open or had odor, but that each of them was a Stage II decubitus ulcer. It is the opinion of the Facility that there were no decubitus ulcers on the resident. Rather, the resident had an area of excoriation that was treated pursuant to the doctor's orders. Based on the greater degree of personal involvement with the resident and the confirmation of their opinion by the treating physician, the Facility's perception is given greater weight. A number of treatments were used to address Resident 138's wounds. An order for hydrocolloid was entered, followed by elimination of the hydrocolloid in favor of optase jell, then discontinuance of the optase jell in favor of methylex. The Facility properly followed the physician's prescribed treatment for this resident. No persuasive, non- hearsay evidence was presented as to the status of Resident 138's wounds as of the date of the final hearing, so there can be no finding as to whether the wounds healed (an indication of excoriation, rather than decubitus) or not (a contrary indication).
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, denying the imposition of a fine or a Conditional license against Respondent, SA-PG Sun City Center, LLC, d/b/a Palm Garden of Sun City, and dismissing the Administrative Complaint. DONE AND ENTERED this 21st day of December, 2010, in Tallahassee, Leon County, Florida. S 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 21st day of December, 2010.
The Issue Whether Rules 65E-5.2301(1) and (3) and 65E-5.170, Florida Administrative Code, constitute an invalid exercise of delegated legislative authority.
Findings Of Fact All procedural requirements for promulgation of Rules 65E-5.2301(1) and (3) and 65E-5.170, Florida Administrative Code (the challenged Rules) were properly fulfilled. Lash has standing to litigate the validity of the challenged Rules. On September 20, 2001, Lash was admitted to the Crisis Screening and Stabilization Unit (Unit) located in Fort Lauderdale, Florida. The Unit is authorized to receive patients pursuant to that portion of Chapter 394.453 of the Florida Mental Health Act, more popularly known as the Baker Act. Following Lash’s admission to the Unit, a document entitled Certificate of Patient’s Incapacity to Consent and Notification of Health Care Surrogate/Proxy (Certificate) was executed by two physicians (Two Physicians). Pursuant to the Certificate, the Two Physicians declared Lash incompetent to consent to treatment and appointed a Third Party (Third Party) to make medical decisions on her behalf, including authorizing treatment objected to by Lash. In so doing, the parties are of the opinion that the Two Physicians were acting pursuant to the challenged Rules.
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Agency is a state government licensing and regulatory agency. Respondent is now, and has been since June 16, 1980, a physician licensed to practice medicine in the State of Florida. She holds license number ME 0036758. Since the completion of her residency at Engelwood Hospital in New Jersey in 1974, Respondent has specialized in internal medicine, although she is not board-certified. Until December of 1987, when she relocated to Florida, she had her own practice in New Jersey. Following her arrival in Florida, she initially went into private practice. In June of 1990, Respondent went to work part-time at Humana's Urgent Care Center (hereinafter referred to as the "UCC") in Plantation, Florida, a walk-in clinic servicing Humana members who needed to see a physician but, because of the unexpected nature of their illness, did not have a scheduled appointment with their primary care physician. 7/ In February of 1991, Respondent was hired as the full-time Director of the UCC. She remained in that position until her resignation in February of 1994. She presently has her own practice in Fort Lauderdale, Florida. On or about April 22, 1992, patient L.K., an 80-year old female, slipped and fell. Later that same day, at around noon, L.K., accompanied by two companions, presented to the UCC with complaints of right groin pain and difficulty walking after the fall. L.K. did not have any of her medical records with her, nor did her primary care physician provide the UCC with these records in advance of her visit. L.K. was greeted by the receptionist at the UCC. The receptionist asked L.K. for her name, address, telephone number and social security number. L.K. provided the information requested, which the receptionist recorded on a "priority care record" form (hereinafter referred to as the "PCR Form"). Thereafter, a nurse escorted L.K. from the reception area to an examining room. Once in the examining room, the nurse questioned L.K. as to the reason for L.K.'s visit to the UCC and also inquired about any medications L.K. might be taking and allergies she might have. In response to these inquiries, L.K. told the nurse that: she was 80 years old; she had fallen that morning and, as a result, was experiencing pain in her right groin and had "great difficulty walking;" she was taking insulin 8/ and Ecotrin, among other medications; and she was allergic to sulfur. The nurse documented these responses on the PCR Form. By now, it was approximately 12:30 p.m. The nurse then took and recorded on the PCR Form L.K.'s vital signs, which were within normal limits. L.K.'s temperature was 98.6 degrees Fahrenheit, her pulse rate was 68, her respiratory rate was 20 and her blood pressure was 110 over 60. The nurse and L.K. were soon joined in the examining room by Respondent. Upon entering the examining room, Respondent asked L.K. "what had happened." L.K. told Respondent that she had slipped and fallen and that she had pain in her right groin. Respondent recorded this information on the PCR Form. Respondent also noted on the PCR Form that L.K. was "dragging [her] leg." Although Respondent's records do not so reflect, L.K. also complained to Respondent that she had pain in her lower back and that before falling, she had been feeling fine and had not been experiencing any chest pains or dizziness. It was apparent to Respondent, based upon her conversation with L.K., that L.K. was oriented as to person, place and time. Respondent then conducted a thorough physical examination of L.K., but failed to document that she did so or to note the results of the examination on the PCR Form or elsewhere in her records. In not recording any of the findings of her physical examination of L.K., Respondent was following her practice of "charting by exception," that is noting only positive findings or abnormalities in her records. "Charting by exception" is not uncommon in hospital emergency room and walk-in clinic settings. As part of her examination of L.K., Respondent rechecked L.K.'s blood pressure. It was still 110 over 60. She listened to L.K.'s heart and lungs and discovered no abnormalities. She inspected L.K.'s skin. There were no scratches, bruises or abrasions. L.K.'s skin color was "good." She palpated L.K.'s abdominal, pelvic and groin areas. No masses or hernias were found. The abdomen was soft and not tender. The spleen and liver were normal to the touch. She tested the range of motion of L.K.'s hip. The test revealed that it was unlikely that L.K. had suffered a hip fracture. She performed a rectal examination of L.K., which included a guaiac test of L.K.'s stool. The test did not reveal the presence of any blood in the stool. She observed L.K.'s eye movements and found them to be normal. There was no indication from the physical examination Respondent conducted that L.K. had any respiratory, metabolic, hemodynamic or other problem requiring immediate hospitalization. Respondent did not order or perform any tests be done on L.K.'s blood, such as a complete blood count or prothrombin time. In failing to do so, Respondent did not act in a manner that was inconsistent with what a reasonably prudent internist, in view of L.K.'s clinical presentation, would have recognized as being acceptable and appropriate. Notwithstanding that her physical examination of L.K. revealed no signs of any fracture, Respondent, as she noted on the PCR Form, ordered that x- rays be taken of L.K.'s right hip and pelvic area. Humana's x-ray facilities were in a building adjacent to the UCC. L.K. was brought to the building in a wheelchair and the x-rays Respondent had ordered were taken. The radiologist on contract with Humana to read x-rays taken at this site, David Francis, M.D., was not at his station. L.K. returned to the UCC with the x-rays. She told Respondent that the radiologist was unavailable. Respondent telephoned Dr. Francis' office and was told that he had left for the day. Respondent then looked at the x-rays. The x-rays were difficult to read because of the presence of bowel gasses, feces and a pessary and the osteopenic condition 9/ of the x-rayed bone structures. Respondent had obtained L.K.'s medical records from L.K.'s primary care physician and, upon a review of those records, learned, among other things, that L.K. had a "history of osteoporosis," which made her more susceptible to bone fractures. 10/ Nonetheless, as she noted on the PCR Form, Respondent did not see any fractures when she looked at the x-rays. Respondent so informed L.K. and her companions, but added that she was not a radiologist and therefore was not certain that L.K. had not sustained a fracture. She told them that she would have a radiologist look at the x-rays "first thing in the morning" and that she would make arrangements to have L.K. seen by an orthopedic specialist thereafter. Under the circumstances, it was appropriate for Respondent, who was, and did not hold herself out to be anything other than, an internist without any specialized skills or training in either radiology or orthopedics, to seek the input of a radiologist and an orthopedist. Moreover, there was no reason for Respondent to believe that there was any need to have a radiologist or an orthopedist involved in the matter any sooner than the following day. Based upon her reading of the x-rays and the other information she had gathered, Respondent preliminarily determined that L.K. had a lumbosacral sprain, which she noted on the PCR Form by writing, under "assessment," "L/S Sprain." Respondent reasonably believed that there was no present need to hospitalize L.K., particularly inasmuch as she had been assured by L.K.'s companions that there would be someone available at home to watch L.K. at all times. Respondent therefore instructed L.K. to go home and rest. She ordered a walker or a wheelchair for L.K. to use at home when she needed to get out of bed. Respondent told L.K. and her two companions that if there was any increase in L.K.'s pain or discomfort, or if any new problems developed, L.K. should go directly to the Humana/Bennett Hospital emergency room. 11/ That Respondent sent L.K. home is reflected on the PCR Form, however, the form does not indicate what, if any, instructions Respondent gave L.K. Before L.K. left the UCC, she was given injections of Toradol, an anti-inflammatory drug, and Norflex, a muscle relaxant. The injections appeared to make L.K. feel considerably more comfortable. L.K. was also given prescriptions for Indocin and Soma. Respondent listed these medications (Toradol, Norflex, Indocin and Soma) on the PCR Form under "plan." No other entries were made under this heading on the form. Following L.K.'s departure from the UCC, Respondent took L.K.'s x-rays to Dr. Francis' office and laid them on his desk, along with a note requesting that, upon his return to the office, he read the x-rays and call Respondent to tell her of his findings. Respondent also telephoned an orthopedic specialist to schedule an appointment for L.K. for the next day. On the morning of April 23, 1992, Dr. Francis read the x-rays that Respondent had left on his desk the day before. His reading of the x-rays revealed that L.K. had multiple pelvic fractures. Because the anatomy of the pelvis is atypical, it is not uncommon for internists and other primary care physicians who do not have the specialized skills and training of a radiologist or an orthopedist to miss pelvic fractures on x-rays, as did Respondent in the instant case. Respondent's failure to identify the pelvic fractures on L.K.'s x-rays, however, did not result in Respondent rendering care and treatment to L.K. that was inadequate or otherwise inappropriate. Given L.K.'s clinical presentation, whether she had a fractured pelvis or not, sending her home with instructions to rest (as opposed to hospitalizing her) was not inappropriate. Reasonably prudent physicians do not routinely hospitalize patients simply because they have pelvic fractures. After reading L.K.'s x-rays, Dr. Francis telephoned Respondent and advised her that the x-rays revealed that L.K. had fractured her pelvis. Respondent thereupon placed a telephone call to L.K.'s residence. The person who answered the telephone informed Respondent that L.K. had been taken to the Humana/Bennett Hospital emergency room because she was in a great deal of pain. L.K. arrived at the emergency room at approximately 10:30 a.m. complaining of weakness and dizziness. She had a temperature of 95 degrees Fahrenheit (taken orally). Her blood pressure was 98 over 60 and her pulse was 96. Laboratory testing done at the hospital indicated that L.K.'s blood sugar was very high (750 milligrams, which was twice as high as normal), that her hemoglobin 12/ and blood pH were low, 13/ and that she had an enzyme profile indicative of a myocardial infarction. An electrocardiogram administered at the hospital also lent support to the conclusion that L.K. had a myocardial infarction. It appears likely, particularly in light of L.K.'s very high blood sugar, that the myocardial infarction was the product of a diabetic acidosis. X-rays taken at the hospital revealed that L.K. had sustained multiple fractures of her pelvis, but that there was no significant bone displacement. The fracture sites were not near any major arteries or blood vessels. L.K.'s condition quickly deteriorated after her arrival at the hospital. At 2:15 p.m. she was pronounced dead. Thereafter, an autopsy was performed by Stephen Nelson, M.D., of the Broward County Medical Examiner's Office. The following are the "Autopsy Findings" set forth in in Dr. Nelson's Autopsy Report: Atheroscerotic vascular disease, multifocal 14/ Calcific aortic valve Pulmonary congestion, with calcific vessels Ateriolonephrosclerosis Pelvic fracture Cystic encephalomalacia, left putamen, remote Status post resuscitation Edentulous mouth In his report, Dr. Nelson listed the following as the "CAUSE OF DEATH," "CONTRIBUTORY CAUSE OF DEATH" and "MANNER OF DEATH": CAUSE OF DEATH: Pelvic fracture CONTRIBUTORY CAUSE OF DEATH: Coronary atherosclerosis MANNER OF DEATH: Accident Although Dr. Nelson listed "pelvic fracture" as L.K.'s cause of death, in his Autopsy Report, he did not state that he found evidence of tears or lacerations of any major arteries or blood vessels, nor did he indicate that he discovered the loss of an amount of blood sufficient to have caused or contributed to L.K.'s death. He did note, however, the following: Hemorrhage is noted dissecting within the planes of the rectus abdominis muscle extending from umbilicus to pubic symphysis. Hemorrhage is subsequently traced to a 1 inch wide ragged displaced fracture at the pubic symphysis par- ticularly prominent on the left side. There is tearing of the peritoneum, though, no free or clotted peritoneal fluid is noted. There is hemorrhage along the anterior surfaces of the urinary bladder and the serosa of the urinary bladder.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board of Medicine enter a final order dismissing Count One of the Administrative Complaint, finding Respondent guilty of the violation of subsection (1)(m) of Section 458.331, Florida Statutes, alleged in Count Two of the Administrative Complaint, and disciplining her for having committed this violation by issuing her a reprimand. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 14th day of March, 1995. STUART M. LERNER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 14th day of March, 1995.
The Issue Whether Respondent violated Subsections 458.331(1)(d), 458.331(1)(m), 458.331(1)(t), 458.331(1)(ll), and 458.331(1)(nn), Florida Statutes (2001),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency charged with regulating the practice of licensed physicians pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. Dr. Dangl, whose address of record is 3900 Clark Road, Suite E-1, Sarasota, Florida 34233, was issued Florida license number ME 71286 to practice medicine in Florida. During all relevant periods of time, he was not board-certified by the American Board of Medical Specialties or by any agency recognized by the Board of Medicine. Dr. Dangl is the holder of a D.M.D. degree from the Washington University School of Dental Medicine in St. Louis, Missouri. He is not licensed as a dentist in Florida, but he has previously held dental licenses in Missouri, Pennsylvania, and Virginia. He is specialty certified by the American Board of Oral and Maxillofacial Surgery. This specialty is related to the practice of dentistry. During all relevant periods of time, Dr. Dangl's office was fully and properly registered as an office surgical facility. During all relevant periods of time, Dr. Dangl did not have hospital privileges. On August 17, 2001, C.S., a female who was at that time 63 years old, came to Dr. Dangl's office for a consultation regarding facial rejuvenation and body contouring. Dr. Dangl saw C.S. and recommended "that she consider cervicofacial rhytidectomy with full face carbon dioxide laser resurfacing and autogenous fat transfer to the facial area." He further determined that the "degree of liposity in the abdomen and flanks is minimal and this can also be treated at the same time with low-volume tumescent liposuction." Prior to her consultation with Dr. Dangl, C.S. had seen an advertisement for Dr. Dangl in the "Sarasota Herald-Tribune." The advertisement listed Dr. Dangl as "Kurt Dangl, M.D., FAACS" and underneath his name appeared the words "Board Certified." From reading the advertisement, C.S. assumed that Dr. Dangl was board-certified in cosmetic or plastic surgery. C.S. returned to Dr. Dangl's office on August 21, 2001, for preoperative counseling. She signed consent forms for the procedures to be performed. The consent forms listed potential risks and complications involved with the procedures. Complications included infection, wound breakdown, and skin necrosis. The consent forms stated that Dr. Dangl did not guarantee specific results and that wound healing was outside the control of the patient and Dr. Dangl. On the printed consent forms the abbreviation "D.M.D." followed Dr. Dangl's name. No evidence was presented that the consent forms were being used as advertisements. C.S.'s medical records in Dr. Dangl's files indicate a blood sample was taken from C.S. on August 21, 2001, and sent to AccuLab. An AccuLab report dated August 22, 2001, indicated that C.S. had a slightly lowered hemoglobin level of 35.5. Based on a notation on the report, it appeared that Dr. Dangl reviewed the report on August 23, 2001. There is a handwritten note on the AccuLab report that the hemoglobin count was "ok for planned procedure." Dr. Dangl did not advise C.S. prior to the surgical procedures that her hemoglobin count was low. Dr. Dangl's records indicate that C.S. gave a medical history prior to the surgery and that Dr. Dangl performed a physical examination of C.S. prior to the surgery. C.S. advised Dr. Dangl that she had had her coccyx removed about six weeks before her scheduled cosmetic surgery. On August 28, 2001, C.S. returned to Dr. Dangl's office to have Dr. Dangl perform a face and neck lift, laser resurfacing of the face, removing fat from her abdomen and flanks, and transferring some of the fat from the abdomen and flanks to specific areas in her face. Betsy Shecter, who is licensed as an advance registered nurse practitioner in Florida, was the nurse anesthetist for C.S.'s procedures. Ms. Shecter's first contact with C.S. on August 28, 2001, occurred at 13:05, when she interviewed C.S. and then escorted C.S. to the operating room. At 13:15, C.S. was given valium, and an IV infusion of propofol and Sufenta was placed in C.S.'s arm around 13:20. Propofol is an anesthetic and Sufenta is a synthetic narcotic. C.S. was prepped and draped around 13:30, and a local anesthesia was injected at 13:35. Because the local anesthesia required about 20 to 30 minutes to become active, Dr. Dangl did not make the first incision until 14:05. The liposuction procedure to harvest the fat for a fat transfer occurred between 14:05 and 15:00. After liposuction, a local anesthesia was injected in the areas where the face lift would be performed. At 15:20, a garment was applied to the areas where fat had been harvested to keep the swelling down. Sequential leg compressions were put in place to avoid blood clots. The actual face lift started around 15:30 and ended around 20:20, when Ms. Shecter put Opticane ointment and corneal shields in C.S.'s eyes for the laser procedure. The laser procedure began around 20:25. At around 21:00, Ms. Schecter turned off the propofol drip to which Demerol had been added. The actual laser surgery stopped at approximately 20:55. The eye shields were removed at 21:15. The recovery time in the operating room commenced at 21:00 when the drugs were stopped and ended around 21:45. The recovery time continued until C.S. was discharged at 22:30. At the time of her discharge, C.S.'s vital signs were stable, and she was alert and oriented. C.S. was told prior to the surgery that someone would have to stay with her overnight after the surgery. C.S. made arrangements for her daughter and C.S.'s sister to stay overnight with her. C.S.'s sister had training and experience as a certified nurse assistant. Prior to the surgery, Dr. Dangl told C.S. that she would probably be ready to go home around four or five o'clock (16:00 or 17:00). She made arrangements with her daughter to pick her up around 17:00. When her daughter inquired from Dr. Dangl's office at 17:00 whether her mother was ready to leave, she was advised that surgery had not been completed. C.S. was not discharged until over five hours after her daughter first contacted Dr. Dangl's office. C.S.'s daughter became visibly upset when she saw her mother after the surgery and wanted to have C.S. admitted to a hospital. Because of the daughter's agitation, arrangements were made for a licensed practical nurse, Ruth Schneider, to stay overnight with C.S. C.S.'s daughter and sister had some difficulty in getting C.S. into the car for the trip home because of the sequential leg compressions, which C.S. wore home. Dr. Dangl and Ms. Shecter put C.S. in the car. At the time that C.S. was put in the car, C.S. was able to stand on her own and able to walk with support. When C.S. arrived home, Ms. Schneider assisted C.S. into her home. At that time, C.S. was alert and oriented and could ambulate with assistance. When C.S. got in her home, she was able to drink and take nourishment. Ms. Schneider helped C.S. ambulate to the bathroom. C.S. sat in a recliner and slept some during the night. At the close of Ms. Schneider's eight- hour shift, she left C.S. in the care of C.S.'s sister. C.S. was scheduled for a follow-up visit with Dr. Dangl on August 29, 2001, but C.S.'s sister was unable to arouse C.S. and get C.S. up to go to the doctor's office. Dr. Dangl's office was advised that C.S. could not come to his office. Dr. Dangl came to C.S.'s home around nine or ten o'clock in the evening of August 29, 2001, for a follow-up visit. He removed the dressings from her wounds and applied an antibiotic ointment. Dr. Dangl apparently did not have bandages with him that he could place on the surface of the wounds because he asked the sister for sanitary napkins to use as a dressing. C.S.'s sister retrieved sanitary napkins from the bathroom, and Dr. Dangl, using scissors from a nearby basket, cut the napkins up and used them to dress the wounds. He reused the Ace-type bandages which he had removed and placed them over the sanitary pads. C.S. was instructed to come to Dr. Dangl's office on August 31, 2001, for her 72-hour postoperative evaluation. On August 31, 2001, C.S.'s sister took C.S. to Dr. Dangl's office. C.S.'s sister did not accompany C.S. into the treatment room. Dr. Dangl removed the dressings and inspected the wounds. There was no evidence of hematoma, seroma, or infection. He noted that there was a "small area of devascularization immediately anterior to the left tragus on the left side" and described the areas as "about the size of a quarter." His notes indicate that the area would be "followed expectantly and debrided as necessary." He was to follow up with C.S. in 48 or 72 hours. When Dr. Dangl came out of the treatment room, he saw C.S.'s sister and asked her what was wrong with her. She explained that she was tired from being up all night with C.S. Dr. Dangl asked the sister why she did not take one of the sleeping pills that he had prescribed for C.S. The sister replied, "What? Why would you tell me to do that, take someone else's medicine?" Prior to this conversation, Dr. Dangl had not examined the sister in any way, gotten her medical history, or asked her whether she was taking any other medications. Over the next several days, C.S. complained to her sister that she was burning, hurting all over, and was not able to sleep or rest. On September 3, 2001, C.S.'s daughter called Dr. Dangl's office and advised that C.S. had a foul smelling discharge in front of her left tragus. Dr. Dangl called in a prescription for antibiotics for C.S. and told C.S.'s daughter that he wanted to see C.S. the following day. Dr. Dangl saw C.S. in his office on September 4, 2001. His examination of C.S. revealed that the size of the devascularized area in front of her left tragus had increased four times. There was some foul smelling yellow-brown discharge coming from this area as well as from several areas under the mandible approximately following the locations of the previously placed drains. He debrided the devitalized area and irrigated the discharge areas with an antibiotic solution and hydrogen peroxide. An intravenous antibiotic was administered, and wound cultures were obtained from various sites. Dr. Dangl again saw C.S. in his office on the evening of September 4, 2005. There was a minimal amount of drainage and no foul smelling odor. On September 5, 2001, C.S. again presented to Dr. Dangl's office for postoperative infection evaluation and treatment. There was a mild purulent discharge in the left anterior neck and at the left post auricular area. Dr. Dangl debrided the wound area and irrigated the wound area with sterile saline. C.S.'s pain medication was increased. Dr. Dangl saw C.S. in his office on September 6, 2001, for further wound treatment. The laboratory results of the wound cultures indicated a light growth of E. coli. Dr. Dangl administered an antibiotic intravenously and removed necrotic tissue. C.S. returned to Dr. Dangl's office on September 7, 2001. Her temperature was 100.6 degrees Fahrenheit, and she was complaining of significant discomfort. Dr. Dangl debrided the wound area. He examined the abdomen and flank incisions and found no evidence of infection or other signs of untoward wound healing. C.S.'s daughter accompanied her mother to Dr. Dangl's office on September 7, 2001, and expressed her concerns about her mother's condition. The daughter felt that her mother might benefit from hospitalization. Dr. Dangl referred C.S. to Dr. Manual Gordillo for evaluation and determination of the need for hospitalization. Dr. Gordillo treated infectious diseases. Dr. Gordillo saw C.S. and advised C.S. and her daughter that the treatment for the infection could be done in the hospital or on an outpatient basis, but expressed his opinion that admission to the hospital was borderline. C.S. opted for hospitalization and was admitted to Doctors Hospital of Sarasota on September 7, 2001. After C.S. was admitted to the hospital, additional cultures were taken of the wound sites as well as the sites in the abdomen where fat had been harvested. Based on the laboratory results, C.S. had a scant growth of E. coli from her face wound culture and a moderate growth of staphylococcus aureus from abdominal wound culture. C.S. was placed in isolation because of the staph infection. C.S. was experiencing a great deal of pain from her wounds while she was in the hospital. Because of her difficulty with pain management, she was put on a PCP pump to help control the pain. While she was in the hospital, Dr. Dangl visited her several times to observe. He did not perform any treatment on C.S. while she was hospitalized. C.S. told Dr. Dangl that she wished that he would not visit her while she was in the hospital, but he continued to come. The evidence is not clear and convincing that C.S. conveyed to Dr. Dangl that she did not want his services any longer, particularly in light of C.S.'s paying office visits to Dr. Dangl for treatment after she was discharged from the hospital. However, the evidence is clear and convincing that C.S. did not want Dr. Dangl to visit her in the hospital and that she told him so. Dr. Dangl's medical records do not establish a medical basis for continuing to see C.S. in the hospital after she asked him not to do so. C.S. was discharged from the hospital on September 13, 2001. At that time, she was feeling much better, her wounds were stable, and her wounds were not clinically overtly infected. She was directed to follow up with Dr. Dangl as soon as the following day and to follow up with Dr. Gordillo within a week. After her discharge from the hospital, C.S. continued to see Dr. Dangl on September 15, 17, 19, and 21, 2001. Dr. Dangl changed the dressings and, on two of the visits, did some minimal debridement. C.S. discontinued seeing Dr. Dangl after her office visit on September 21, 2001. On September 24, 2001, C.S. began seeing Dr. John Leikensohn, a plastic and reconstructive surgeon, for wound treatment. He diagnosed C.S. as having massive skin necrosis. When C.S. began seeing Dr. Leikensohn, she was asked to sign a medical release for her medical records from Dr. Dangl, and she did so. Dr. Leikensohn's staff contacted Dr. Dangl's office by telephone to get C.S.'s records. The medical release was sent by facsimile transmission to Dr. Dangl's office with a request for C.S.'s records. By October 2, 2001, Dr. Leikensohn had not received the records from Dr. Dangl. Dr. Leikensohn asked C.S. and C.S.'s daughter to stop by Dr. Dangl's office and get a copy of the records. C.S. went to Dr. Dangl's office and personally asked his staff for her records, but was not given the records. She also submitted a written request for her records, but did not receive them pursuant to the written request. Barbie Beaver, Dr. Dangl's office coordinator, does not recall when or from whom she actually received a request for C.S.'s records, but she does remember sending C.S.'s medical records to Barbara Dame, Dr. Dangl's risk manager, for her review on September 27, 2001. When Dr. Dangl's office received a request for a patient's records, she would advise Dr. Dangl and he would decide what to do. She gave a request for C.S.'s medical records to Dr. Dangl, and he instructed her to send them to Ms. Dame for review prior to releasing the records. Ms. Beaver does not recall when she actually sent C.S.'s records to the person who requested them. During his treatment of C.S., Dr. Dangl wrote several prescriptions for C.S. The prescription scripts contained the abbreviation "D.M.D." after his name. No evidence was presented that the prescriptions were intended to be used for advertising purposes. Dr. John J. Obi, a board-certified plastic surgeon, testified as the Department's expert witness. It is Dr. Obi's opinion that it would have been good medical practice to have advised C.S. of her low hemoglobin prior to surgery, but that because the blood level was not dangerously low, he could not "say that's a complete deviation from the standard of care." Dr. Obi further opined that Dr. Dangl exceeded the eight-hour limitation on elective cosmetic surgery in a physician's office when he performed the procedures on C.S. on August 28, 2001. Dr. Obi's opinion is based on his incorrect understanding that the anesthesia was stopped at 22:00. Thus, even if the time for calculating surgical procedures ran from the time the anesthesia was first administered at 13:15 until it was stopped at 21:00, the length of time for the surgical procedures was seven hours and forty-five minutes. Dr. Obi opined that the recovery time for C.S. was insufficient. Again he based his opinion in part on his incorrect assumption that the anesthesia was discontinued at 22:00. Dr. Obi creditably testified that Dr. Dangl's continuing to see C.S. in the hospital after she told him that she did not want him to visit fell below the prevailing standard of care. Dr. William Frazier, the expert who testified on behalf of Dr. Dangl, gave no opinion on whether Dr. Dangl's continued hospital visits after being told not to visit by C.S. violated the standard of care. Dr. Obi opined that it was a violation of the standard of care for Dr. Dangl to tell C.S.'s sister to take some of C.S.'s prescription sleeping pills without examining or taking a medical history of the sister. Dr. Frazier was of the opinion that the conversation between Dr. Dangl and C.S.'s sister did not fall below the standard of care. Dr. Frazier's opinion was based on his misunderstanding that C.S.'s sister had asked Dr. Dangl if it was appropriate for her to take a sleeping medication that she already had.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Dangl violated Subsections 458.331(1)(m), 458.331(1)(t), 458.331(1)(ll), and 458.331(1)(nn), Florida Statutes; finding that Dr. Dangl did not violate Subsection 458.331(1)(d), Florida Statutes; imposing an administrative fine of $2,000 for the violation of Subsection 458.331(1)(nn), Florida Statutes; imposing an administrative fine of $3,500 for violations of Subsection 458.331(1)(t), Florida Statutes; imposing an administrative fine of $1,000 for the violation of Subsection 458.331(1)(ll), Florida Statutes; imposing an administrative fine of $1,000 for the violation of Subsection 458.331(1)(m), Florida Statutes; suspending his license for two years; and requiring Dr. Dangl to attend continuing medical education classes to be specified by the Board of Medicine. DONE AND ENTERED this 16th day of August, 2005, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL 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 16th day of August, 2005.
The Issue Whether disciplinary action should be taken against Respondent's license as a veterinarian based on alleged violations of Section 474.214, Florida Statutes (1997), as charged in the Administrative Complaints filed against Respondent in this proceeding. Count I of the Administrative Complaint in Case No. 00-2357 charged Respondent with a violation of Section 474.214(1)(r), Florida Statutes (1997): being guilty of incompetence or negligence by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent veterinarian as being acceptable under similar conditions and circumstances. Count II of the Administrative Complaint charged Respondent with a violation of Section 474.214(1)(ee), Florida Statutes (1997): failing to keep contemporaneously written medical records as prescribed by Rule 61G18-18.002(3), Florida Administrative Code. The Administrative Complaint in Case No. 00-2358 charged Respondent with a violation of Section 474.214(1)(r), Florida Statutes (1997): being guilty of incompetence or negligence by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent veterinarian as being acceptable under similar conditions and circumstances.
Findings Of Fact Based on the evidence and testimony of the witnesses presented and the entire record in this proceeding, the following facts are found: At all times material, Respondent was a licensed veterinarian, having been issued license number VM 0003822. Facts relating to Case No. 00-2357 On or about March 5, 1998, Respondent performed a spay on "Midnight," a dog owned by Maryjane Greene and her husband. On or about March 8, 1998, "Midnight" expired at the Greene's home. When Mrs. Greene dropped off "Midnight," she was not sufficiently informed by Respondent about her option to have a pre-anesthesia lab work-up performed. There is no indication of an offer to perform a pre- anesthesia lab work-up, nor an indication that Mr. or Mrs. Greene declined such an offer, nor a consent form declining such a work-up, noted in the medical records kept by Respondent for "Midnight." It is a deviation from the standard of care to fail to offer a pre-anesthesia lab work-up. The anesthetic protocol used by Respondent during the spay of "Midnight" included Xylzine (a.k.a. Rompun) a drug with a profound and potentially deleterious effect on the heart which may cause a first degree or second degree heart block. The anesthetic protocol used by Respondent during the spay of "Midnight" also included Ketamine, which is not approved for use in dogs. When used as an anesthetic protocol, it is considered an extra-label use of the drug. An extra-label use of a drug means that there have been no safety studies completed, and it cannot be adequately predicted what effects the medication will have on an animal on a consistent basis. There is no indication in Respondent's records for "Midnight" that Mrs. Greene was informed regarding the use of Ketamine in her dog's procedure. It is a deviation from the standard of care not to make a client aware of the use of an extra-label drug and not to have the client sign a consent form. Xylazine and Ketamine are both cardiac depressants. When used in combination they each make the other more of a cardiac depressant, thus requiring the administration of another drug, such as Atropine, to minimize the cardiac depressant effect. There is no indication in Respondent's medical records for "Midnight" that Atropine or any other drug was administered, other that the Xylazine and Ketamine. Respondent's failure to administer Atropine or any other drug to minimize the cardiac depressant effects of Xylazine and Ketamine was a deviation from the standard of care. Respondent's failure to administer Atropine or any other drug to minimize the cardiac depressant effects of Xyalzine and Ketamine played a substantial role in "Midnight's" demise. Upon picking up "Midnight," Mrs. Greene was given limited post-operative instructions. She was told not to give "Midnight" water until he could walk a straight line; not to give food until he could hold water down; only leash walks for 10 days; and no baths for 7-10 days. Respondent's post-operative discharge instructions given to Mrs. Greene did not comply with the standard of care in veterinary medicine. Facts relating to Case No. 00-2358 On or about August 25, 1998, Respondent performed surgery to remove a mass from the perineal area of "Snoopy," a nine-year-old obese Beagle belonging to Juan Ferras. There is no indication in Respondent's records for "Snoopy" that the surgery was performed due to an emergency, although the credible testimony indicated that it was an emergency. Given "Snoopy's" age (nine years) and weight (60 lbs.), it would be in the dog's best interest to perform a pre- anesthesia lab work-up, or to at least offer one to the owner. Respondent did not indicate in his medical records that he offered to perform a pre-anesthesia lab work-up on "Snoopy." In view of the emergency nature of the surgery, it was not a deviation from the standard of care to fail to offer a pre-anesthesia lab work-up. The anesthetic protocol used by Respondent during the procedure on "Snoopy" included Ketamine, which is not approved for use in dogs. When used, it is considered an extra-label use of the drug. Ketamine should be used with extreme caution in dogs for which the veterinarian is unaware of the renal function or the liver function of the dog. It is a deviation from the standard of care not to make a client aware of the use of an extra-label drug, and not to have the client sign a consent form. There is no indication in Respondent's records for "Snoopy" that Juan Ferras was informed regarding the use of Ketamine in his dog's procedure. Upon picking up "Snoopy," Mr. Ferras was given limited post-operative instructions. Respondent's failure to give specific post-operative discharge instructions to Mr. Ferras constituted a deviation from the standard of care. After discharge, "Snoopy" began vomiting and was readmitted to Respondent's facility on or about August 27, 1998. On or about August 28, 1998, "Snoopy" expired at Respondent's facility. There is no indication in Respondent's records on "Snoopy" that upon "Snoopy's" readmission to Respondent's facility, on or about August 27, 1998, Juan Ferras refused to pay or was only willing to pay a small portion of any treatment rendered to "Snoopy." Because of this finding it is unnecessary to address whether refusal to pay a fee is an appropriate defense by Respondent. Upon "Snoopy's" readmission to Respondent's facility, on or about August 27, 1998, "Snoopy" was determined to be approximately 11 percent dehydrated and in a state of shock. In order to correct the dehydration and maintain "Snoopy," it would have been required to administer approximately 4300-4400 ccs of fluid. Respondent's records indicate that only 800 ccs of fluids were administered to "Snoopy." This left "Snoopy" with a tremendous deficit of fluids. Respondent's explanation as to the reason for the small amount of fluid shown on "Snoopy's" chart is not credible. Respondent's failure to administer the correct amount of fluids constitutes a deviation from the standard of care. Upon readmission to Respondent's clinic, Respondnet did not draw blood or perform any type of bloodwork on "Snoopy." Respondent's failure to draw blood or perform any type of bloodwork on "Snoopy" after being readmitted for dehydration and vomiting and shock constitutes a deviation from the standard of care. The fluids which were administered to "Snoopy" were administered sub-cutaneously. The failure to insert an IV catheter to administer the fluids, rather than administering them sub-cutaneously, constitutes a deviation from the standard of care. One way of re-hydrating a dehydrated patient is by weighing the dog and then adding enough fluids to get the patient to its normal weight. There is no indication in Respondent's records that "Snoopy" was weighed at the end of the day on or about August 27, 1998, or that "Snoopy" weighed approximately 60 pounds late in the day on or about August 27, 1998. Respondent's records for "Snoopy" contain a notation at 10:00 p.m. August 27, 1998, of "ADR" which means "ain't doing right." A patient whose records indicate "ADR" should be continuously monitored or transferred to an emergency facility. "Snoopy" was not monitored overnight and through the early hours of the next morning. Had Respondent taken appropriate steps with regards to fluid resuscitation upon "Snoopy's" readmission to Respondent's facility, "Snoopy's" chance of survival would have been much higher.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is recommended that a final order be render by the Board of Veterinary Medicine, as follows: Finding Respondent guilty of having violated Section 474.214(1)(r), Florida Statutes (1997), as alleged in Count I of the Administrative Complaint for DOAH Case No. 00-2357 (DBPR Case NO. 98-11323). Finding Respondent guilty of having violated Section 474.214(1)(ee), Florida Statutes (1997), as alleged in Count II of the Administrative Complaint for DOAH Case No. 00-2357 (DBPR Case No. 98-11323). Finding Respondent guilty of having violated Section 474.214(1)(r), Florida Statues (1997), as alleged in the Administrative Complaint for DOAH Case No. 00-2358 (DBPR Case No. 98-21230). In light of these findings of guilt and aggravating circumstances, the following penalties are recommended: A thirty-day suspension of licensure. An administrative fine in the amount of four-thousand dollars ($4000.00). Assessing costs of investigation and prosecution, in the amount of $973.24 for Case No. 00-2357 and $684.29 for Case No. 00-2358. Five years of monitored probation upon such terms and conditions as the Board finds necessary and reasonable. DONE AND ENTERED this 19th day of December, 2000, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE 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 19th day of December, 2000. COPIES FURNISHED: Walter H. Dornbusch, D.V.M. 1117 Malabar Road, Northeast Palm Bay, Florida 32907 Robert H. Hosay, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-2202 Barbara D. Auger, General Counsel Department of Business and Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Sherry Landrum, Director Board of Veterinary Medicine Department of Business and Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The ultimate issue to be resolved in this proceeding is whether the SSDB's proposal to construct a freestanding ambulatory surgery center in Volusia County, Florida, should be approved or denied. SSDB and the Department contend that the proposal meets statutory criteria and comports with the Department's rules. SSDB and the Department contend that there is a need for the facility and that SSDB is fully competent to construct and operate the facility. OBMH and HHMC contend that there is no need for the proposed facility, that the facility is not likely to be an economically viable venture, that the facility would injure existing businesses, and that the application should be denied because SSDB did not file a letter of intent with the local health council in a timely manner.
Findings Of Fact SSDB is a corporation that is a wholly owned subsidiary of Surgical Inc. Eighty percent of the stock of Surgical Services, Inc., is owned by American Medical International, Inc., a large, multinational health care corporation which owns and operates hospitals and other health care services. American Medical International is the third largest health care provider in the United States. The remaining 20 percent of Surgical Services, Inc., stock is owned by Randall L. Phillips, the company's president. SSDB is proposing to construct and operate a freestanding ambulatory surgery center in Daytona Beach, Volusia County, Florida. The service area for the proposed facility would be Volusia County. This facility would house four operating rooms and would be designed to handle all types of surgical procedures that can be performed on an outpatient basis. SSDB has entered into a contract to purchase land that provides a suitable site for the facility. It is located at the intersection of Clyde Morris Boulevard and Mason Avenue in Daytona Beach. The contract price for the property is $270,000. In addition to the cost of land acquisition, the preopening costs of the project would total $2,080,000. That amount would cover legal and accounting fees, architectural and engineering fees, a site survey, consulting fees, construction costs, movable equipment costs, and other engineering expenses. The preopening cost estimates are less than the $2,500,000 estimated in the original Certificate of Need application. The reduction is attributable to cost efficiencies primarily in selection and purchase of equipment. The costs estimated by SSDB are adequate to cover all preopening expenses and to provide an adequate facility. Financial support for the facility will be provided by American Medical International. This will include an equity contribution, a loan, and all necessary working capital. American Medical International has committed to provide financing adequate to construct and operate the facility. American Medical International has the financial resources to fulfill this commitment. The facility proposed by SSDB would be 15,500 square feet in size. The design is adequate for the proposed use and satisfies applicable health care facility standards and state and federal laws. The equipment proposed for the facility is sufficient to allow the handling of anticipated types of procedures. The facility will be open to all physicians qualified to perform the types of surgery that can be tone within an ambulatory setting. The facility will accept Medicare patients. The facility will admit any patient scheduled by surgeons, and ability to pay will not be a criterion for admission. SSDB has developed a marketing program to attract physicians and patients to the facility. SSDB has proposed adequate staffing for its facility and will be able to fulfill its staff requirements. SSDB is fully competent, given its backing by American Medical International, to construct and operate the proposed facility. OBMH is a Florida nonprofit corporation. It operates a 205-bed hospital in Volusia County, Florida, and renders medical services to residents of Volusia County and surrounding areas. OBMH presently renders ambulatory surgical services on an outpatient basis in connection with its surgery department. MEMO is a special taxing district. It operates a 345-bed hospital in Volusia County, Florida, and services residents of Volusia County and surrounding areas. HEM has a same-day surgery program and renders ambulatory surgical services through this procam on an outpatient basis. Ambulatory surgical services can be performed either in a hospital- based setting such as operated by OBMH and HHMC, or in a freestanding facility such as proposed by SSDB. HHMC presently has 12 general-purpose operating rooms. The HHMC same-day surgery program utilizes these rooms, but has a separate admitting area and waiting room that is utilized for inpatient surgery cases. OBMH has four general-purpose operating rooms. Outpatient or ambulatory surgeries are regularly performed in these rooms. There are presently 41 general-purpose operating rooms in Volusia County's eight hospitals. Outpatient or ambulatory surgical procedures are performed in these rooms. The Florida Health Care Plan is a health maintenance organization located in Volusia County. It has three operating rooms here inpatient or ambulatory surgery procedures are performed for members of the organization. The Neuman Dye Institute is a freestanding ambulatory surgical center licensed by the Department. It is located in DeLand, Volusia County, Florida. It has two operating rooms which are used for treatment of eye disorders. Approximately 15 percent of the surgeries performed in hospitals in Volusia County during the year August 1, 1982, through July 31, 1983, were done on an outpatient basis. The total number of surgical procedures performed in Volusia County has increased only slightly during the past three years. The number of impatient procedures has decreased, while the number of outpatient procedures has increased rather dramatically. This increase reflects a national trend which increasingly favors ambulatory or outpatient surgeries. It is likely that the number of outpatient cases as a percentage of total surgeries will continue to increase in Volusia County. The 15 percent figure for outpatient surgeries relates only to those procedures conducted in a hospital setting. It does not include procedures performed at the health maintenance organization, the Neuman Eye Institute, or in physicians offices. One major source of patients for ambulatory surgery programs is elective plastic surgery procedures. Two of the plastic surgeons who practice in Volusia County have their own operating rooms where ambulatory surgical procedures can be conducted. These physicians are not likely to use a separate, freestanding facility. The remaining plastic surgeons in Volusia County have utilized the same-day surgery facility at HHMC and have expressed satisfaction with that program. Existing facilities in Volusia County are adequate to accommodate the anticipated growth and the number of outpatient or ambulatory surgeries that will be performed during the next three years in Volusia County. Hospital surgical facilities in Volusia County are significantly underutilized at present. Existing facilities have the capacity to accommodate a more dramatic increase in total surgical procedures and in outpatient surgical procedures than is anticipated over the next three years. Given the existence of the hospital facilities, the Neuman Eye Institute, the health maintenance organization, and operating rooms located in physicians' offices, adequate facilities exist to accommodate the increased demand for outpatient surgeries that is anticipated in Volusia County. SSDB is proposing to offer its services to the public during the first year of operation for an average charge of $490 per procedure. The cost would increase to $540 for the second year. The average per-case cost for outpatient surgeries at HHMC is $393. The average per-case cost at OBMH is $439. Given the fact that one case can Involve multiple procedures, it is evident that existing facilities in Volusia County are charging less for ambulatory surgical services than SSDB proposes to charge. While some increases in present charges are likely, given general trends, it is not likely that HHMC or OBMH will charge as much for outpatient surgical procedures as SSDB proposes to charge. It has been asserted that HHMC's charges for outpatient surgeries are inadequate to cover HHMC's costs and that the charges are being kept low artificially. The evidence is to the contrary. HHMC's charges for outpatient surgeries are adequate to meet the facility's expenses. The facility proposed by SSDB does not present any cost savings to patients. Services at the proposed facility would be more expensive than the same services at existing facilities in Volusia County. Freestanding surgical centers have generally presented some advantages to physicians no consumers. In many places, outpatient surgeries are difficult to schedule in a hospital setting because they are susceptible of being bumped by surgeries that are considered more urgent. Furthermore, in many locations, physicians have had difficulty scheduling their outpatient surgeries in blocks of cases so that they can perform them more efficiently. Those problems have not occurred in Volusia County. Physicians who regularly perform outpatient surgeries in hospitals in Volusia County have been able to schedule their cases in blocks and have experienced no difficulties with bumping. SSDB has projected that its proposed facility would experience an acceptable loss during its first year of operation, but that it would show a net profit during its second and third years of operation. These estimates are based upon projections that 2,160 procedures would be performed at the facility at an average rate per procedure of $490 during the first year and 2,640 procedures at an average rate of $540 during the second year. These projections are unrealistic. The projections contemplate that approximately one-third of all outpatient surgeries in Volusia County would be performed at the proposed facility. The projections also contemplate a very dramatic increase in the number of outpatient surgeries and that more than 60 percent of the increased outpatient procedures would be done at the proposed facility. While it is likely that the number of outpatient surgeries performed in Volusia County and elsewhere will continue to increase as a percentage of total surgeries and that eventually as much as 30 percent of all surgeries performed in Volusia County will be done on an outpatient basis, the increase is not-likely to occur in a single year. Even if It did, it is unlikely that local physicians and consumers cold so dramatically reject present facilities as SSDB projects. Indeed, there is no evidence from which it could be concluded that there is any dissatisfaction on the part of physicians or consumers in Volusia County with present facilities. The evidence is to the contrary. A second reason why the projections are inaccurate is that in making the projections SSDB ignored the existence of the Neuman Eye Institute, the health maintenance organization, and operating rooms that have been established in physicians' offices. A third reason is that SSDB proposes to provide services at a higher cost than at existing facilities. A fourth reason is that SSDB has underestimated the proportion of Medicaid and Medicare cases that are likely to be performed at the facility at a cost that is less than the average cost per procedure proposed by SSDB. It is unlikely that SSDB could operate at a profit during its first three years of operation. At the time that SSDB filed its letter of intent and application with the Department of Health and Rehabilitative Services, there was no local health council in existence Volusia County, Florida. SSDB did not file a copy of its letter of intent or application with the local health council and would have had no place to file it if it attempted to do so.
Recommendation That a final order be entered by the Department of Health and Rehabilitative Services denying the Application for Certificate of Need filed by Surgical Services of Daytona Beach, Inc. RECOMMENDED this 31st day of October, 1983, in Tallahassee, Florida G. STEVEN PFEIFFER Assistant Director Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of October, 1983. COPIES FURNISHED: Fred Baggett, Esq. Michael J. Cherniga, Esq. Post Office Drawer 1838 Tallahassee, Florida 32302 Jay Adams, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Richard B. Orfinger, Esq. 619 North Grandview Avenue Daytona Beach, Florida 32018 Harold C Hubka, Esq. Post Office Box 5488 Daytona Beach, Florida 32018 Mr. David Pingree, Secretary Department of Health and Rehabilitative Services Winewood Boulevard Tallahassee, Florida 32301