Findings Of Fact At all times pertinent to this hearing, Respondent, M. J. Warhola, was a doctor of osteopathic medicine and properly licensed as such by the State of Florida by license number OS 0001256, issued in 1957. He has been practicing osteopathic medicine at his present location in Tampa, Florida, for the past 17 or 18 years. Respondent first started treating Pearl O. Knowles in 1965. Generally, she was suffering from severe diabetes and was overweight. He also, over the years, treated her for arteriosclerosis. Among the drugs he was prescribing for her during the 1979-1989 time period were Placidyl (sleeping pill), Verstran (tranquilizer), Triavil (antidepressant), Dilantin (anticonvulsant) Teldrin (antiallergenic), Donnatal (sedative), Synalgos (painkiller), Talwin (painkiller), various antibiotics, and such other substances as insulin, stool hardeners, vitamins, diuretics, antihistamines, and antiemetics. During the period from January, 1979, through December, 1981, prescriptions written by Respondent for these varying medications for Mrs. Knowles or her husband were filled by area pharmacies in accordance with the following chart: MONTH/YR TOTAL MRS. K MONTH/YR TOTAL MRS. K Jan. 79 11 4 July 80 22 15 Feb. 79 15 7 Aug. 80 15 10 Mar. 79 10 5 Sept.80 26 19 Apr. 79 14 11 Oct. 80 20 10 May 79 13 10 Nov. 80 21 16 June 79 10 8 Dec. 80 22 17 July 79 11 6 Jan. 81 16 11 Aug. 79 15 10 Feb. 81 15 12 Sept.79 13 10 Mar. 81 25 17 Oct. 79 15 6 Apr. 81 26 17 Nov. 79 7 5 May 81 21 10 Dec. 79 17 12 June 81 11 4 Jan. 80 12 8 July 81 23 8 Feb. 80 17 12 Aug. 81 25 23 Mar. 80 21 17 Sept.81 5 5 Apr. 80 17 14 Oct. 81 20 14 May 80 24 22 Nov. 81 4 2 June 80 27 21 Dec. 81 2 2 TOTAL: 588 400 Many of the above instances are refills of the same prescription. According to Respondent, some prescriptions were authorized five refills without contact with him. Some, such as Prescription #27162 for 100 Triavil, initially filled on December 1, 1979, was subsequently refilled at least 11 times, and three other separate prescriptions for the same drug were filled multiple times. From January, 1979, through September, 1980, a period of 20 months, 30 tablets each prescriptions for Placidyl tablets, written by Respondent for Mrs. Knowles, were filled 46 times for a total of 1,380 tablets. During the same period, Triavil prescriptions for 100 capsules each written by Respondent for Mrs. Knowles were filled 22 times for 3,200 tablets, Talwin at 100 tablets 13 times for 1,300 tablets, at least 10 prescriptions for either Tylenol #3 or Fiorinol #3, both with codeine, at 50 tablets each for the Fiorinol at least totalling more than 509 tablets, as well as all the others stated in paragraph 2 above. Mrs. Knowles admits taking too much medication, but claims it is not the fault of Respondent. Whenever Respondent saw her and gave her a prescription for any medicine, he would tell her what dosage to take. She would see the Respondent every two or three weeks and get a new prescription each time and would also give her prescriptions at her request without her going to the office personally. Regardless of what instructions Respondent would give her concerning the dosage of the various painkillers and "nerve medicines" he would give her, she often exceeded the directed dose either by accident or in an effort to relieve the extreme pain she was experiencing in her hands and feet. Not only did she get drug prescriptions from Respondent, but by her own admission, she also saw other doctors during the period from whom she got "pain pills," as well as taking those given to her on her release from the hospitals to which she was admitted. She recognized that she was taking too many drugs at the time, but the pain was severe and she felt it was required. During this same period of time, from mid-1979 on through early 1982, while Mrs. Knowles was seeing Respondent for her diabetes and other chronic ailments, she was admitted to several hospitals in the area. On June 11, 1979, she was admitted to the Brandon Community Hospital (BCH) in Brandon, Florida (Brandon is a small community east of Tampa), in a confused and disoriented state. The admission diagnosis was diabetes with electrolyte imbalance. The attending physician noted at the time that the patient "is somewhat dependent on drugs." Approximately two months later, on August 15, 1979, Mrs. Knowles was again admitted to BCH, this time for uncontrolled diabetes and overdosing her drugs including Placidyl and Fiorinol. Again, the attending physician noted the failure of the patient to take care of her diabetes, her drinking, and her drug dependency. Mrs. Knowles thereafter stayed out of the hospital for about a year until, on September 1, 1981, she was again admitted to BCH, again for her diabetes. Secondary diagnoses on this occasion were hypertension and taxciencephalopathy, a disorder of brain function. At this time, she was seen in the hospital by Dr. Mark Stern. Based on the lab work performed and examination by Dr. Stern and other specialists to whom she was referred, it was concluded that her condition, aside from the diabetes and hypertension, was related to her overuse of drugs such as Talwin, Valium, Triavil, and the like. She was again seen by Dr. Stern at BCH on October 24, 1981, when she was admitted for an unintentional drug overdose. A drug screen done at the time of admission revealed a Placidyl level of 69.4 (normal level is 0.5 to 10, with toxic levels being greater than 20). A repeat test six and a half hours later showed the level of Placidyl at 62.4. Other lab tests showed opiates, benzodiazepan (tranquilizers such as Valium and Librium), and salecylates. When she was admitted on this occasion, she had with her a box containing several medicine bottles. Notwithstanding Petitioner's allegation that "Said labels were not labeled by Respondent," the testimony of Deborah Ann Brown, Director of Pharmacy at BCH, to whom the box of bottles was given for identification, shows that only one of all the bottles did not have the appropriate markings on it. It also appears that some of the medicines in the box had been prescribed for Mrs. Knowles' husband, Ira. Dr. Stern again saw Mrs. Knowles when she was brought to BCH on January 6, 1982, complaining of weakness and difficulty in walking. Again, her history showed she was taking antidepressants and Placidyl for chronic insomnia. Dr. Stern recalls that Mrs. Knowles telephoned him on October 9, 1981, and requested prescriptions for Placidyl, Triavil, and Talwin, but he refused to prescribe them for her. He terminated his relationship with her in August, 1982. During the period she was his patient, however, he did prescribe for her such substances as painkillers, sleeping pills, and antianxiety drugs, the same generic types of drugs as prescribed by Respondent, by written prescriptions, some of which called for multiple refills. Though Mrs. Knowles advised Dr. Stern that she was being treated by Dr. Warhola, Dr. Stern did not discuss her with Dr. Warhola or even contact him. Even when Mrs. Knowles threatened to get drugs from Respondent when Dr. Stern refused to give her prescription over the phone in October, 1981, Dr. Stern still did not contact Dr. Warhola. Between the fourth and fifth BCH hospitalizations, on December 21, 1981, Mrs. Knowles was admitted to Tampa General Hospital (TGH) and was examined by Dr. Jeffrey L. Miller, a rheumatologist internist, at the request of her regular physician, Dr. Sugarman. When Dr. Miller first saw her, Mrs. Knowles was overmedicated. She was confused, and her speech was slurred. She indicated to Dr. Miller that she was taking Triavil and other drugs as well, such as Zomax and Placidyl, but refused to tell him all the drugs she was taking. Those she mentioned are addictive, and it appeared that she was addicted because she had been hospitalized for nonaccidental overmedication and because her condition was consistent with addiction. Mrs. Knowles denied having a drug problem. In Dr. Miller's opinion, however, Mrs. Knowles was not receiving the proper therapy. Her diabetes did not require the drugs she was getting. Her other symptoms, in his opinion, did not justify the apparent liberal prescriptions she was getting and should have been treated with psychotherapy rather than drugs. In his opinion, therapy should be tailored for an individual like Mrs. Knowles so that the medication is limited and regulated to prevent addiction and the buildup of tolerance to a drug, which results in larger and larger doses. The evidence also shows, however, that Mrs. Knowles was a difficult patient. Dr. Sugarman was having difficulty with her and requested the consult by Miller. What must also be considered is that Mrs. Knowles' leg, about which she constantly complained of the pain, was subsequently surgically removed in 1982 as a result of her diabetes. The pain associated with this condition leading up to the amputation was real and required relief to some degree. In any case, Dr. Miller did not ever discuss Mrs. Knowles with Respondent or advise him of her addiction. Mrs. Knowles still receives painkillers and "nerve medicine" from her current physician, Dr. Sugarman, whom she sees every two weeks. She stopped seeing Dr. Warhola when she started seeing Dr. Sugarman, who, she felt, was more current in some of her problem areas than Respondent. She did not leave Respondent because she was dissatisfied with him. In fact, he was the only one who helped her blood clots. According to Respondent, he gave Mrs. Knowles the Placidyl for sleep because she had a lot of pain as a result of her diabetes and needed it to help her sleep. At this same time, Mrs. Knowles' husband was a severe alcoholic and, since she was under a lot of strain because of that, he gave her the drug to help her sleep. The call he got from Dr. Stern on October 26, 1981, when she was in BCH, indicating she was mixing drugs, was the first indication he had that she was abusing drugs. He told Stern she was not to get any more, and he, Respondent, has not prescribed any for her or seen her since. In fact, he was not informed of her hospitalizations in June or August, 1979, or in September, 1981. It is, even by the testimony of Petitioner's expert, Dr. Gladding, not uncommon in Florida for M.D.s to admit a D.O.'s patient to a hospital and not ever notify the D.O. of that fact. Mrs. Clifton M. Wood of Winter Haven, Florida, was first taken to see Respondent for a diet regimen in 1980. On the first visit on February 7, 1980, he gave her a physical examination which included a complete laboratory workup, cardiogram, and weight and pressure check. He gave her some pills which had instructions for use on the bottle, but did not tell her what they were. Each time she came to his office for a visit thereafter, on a monthly basis, either Respondent or his nurse would weigh her and take her blood pressure and adjust her medication as required. During the course of treating Mrs. Wood, Respondent gave her phedymetrazine, an appetite suppressant, methahydrine for high blood pressure, Donnatal, and vitamins and minerals. He gave Mrs. Wood only the drugs he felt she needed in the amount she needed. Mrs. Wood was admitted to Winter Haven Hospital on October 26, 1980, because a neighbor who was concerned about her brought her in. At the time, Mrs. Wood had trouble with dizziness, her balance, and falling. Before this incident, however, Respondent on one or more of his visits, had given her pills for her blood pressure and potassium pills for her to take in water. According to Dr. Gordon Rafool, who had also treated Mrs. Wood since 1979 and who admitted her to the hospital in October, 1989, at the time of admission, she was, among other things, dehydrated and had an electrolyte imbalance (lack of body salt, specifically potassium), the latter possibly being caused by the intemperate use of a diuretic. A diuretic is often used in cases of heart failure, high blood pressure, and, though not recommended, weight reduction, to get rid of body water. Since it was important to know what medicines Mrs. Wood was taking to help determine the reason for her condition, Dr. Rafool and other hospital personnel tried to get an identification of the drugs in Mrs. Wood's possession when she was brought in. The hospital pharmacy could not identify them, and no drug screen was done, but Dr. Rafool obtained a written authorization of Respondent to permit Respondent to release any information regarding drugs dispensed or prescribed to the patient by him. This authorization was forwarded to Respondent's office with a request for Mrs. Wood's medical records, but they were never released. Dr. Warhola's office manager, Mrs. Zacchini, states the request and authorization on Mrs. Wood were received, but were apparently inadvertently filed in the office record without the requested records being sent out. Though Dr. Rafool says that numerous follow-up calls were made to Respondent's office, Mrs. Zacchini denies any were received from either the hospital or Dr. Rafool. In any case, there is no evidence to indicate any calls were made to or received by Respondent directly, and he denies every having received any. Mrs. Wood still considers Respondent to be a good doctor, but she has not gone back to see him since her release from the hospital because Dr. Rafool told her to stay away from him. She has been seeing Dr. Rafool, who has been treating her with pills for her arthritis and high blood pressure. Petitioner presented the deposition of Dr. Lloyd D. Gladding, D.O., over the partial objection of Respondent, whose objection was not to the use of the deposition, but to specific parts thereof based on particular grounds. For example, Respondent objected to Dr. Gladding's testifying as an expert because, he contended, there had been no showing by Petitioner that the witness's experience compares to that of Dr. Warhola. He contends the witness does not practice in the same geographical area nor is there a showing he is a similar health care provider with a similar specialty or a similar type practice. However, Dr. Gladding's curriculum vitae, admitted without objection, shows he is currently co-chairman of a family practice seminar in his area and a clinical preceptor (teacher) at an osteopathic medical school and has been engaged in a family practice in the Fort Myers area since 1978. This area is geographically not far removed from the Tampa Bay area (the distance is not significant) and there is no showing that the patient conditions involved in the two cases at issue would or could be affected significantly by the geographical location of the patient or that treatment of these conditions varies greatly from location to location. In fact, according to this witness, he finds patients from widely differing areas (Pennsylvania, where he was trained, as opposed to Florida, where he practices) to be the same. Accepting the witness as an expert, then, with reference to Mrs. Knowles and her condition, he has had patients with a similar series of health problems where the patient was placed on multiple drug regimens. Sometimes, these patients developed drug dependencies for the different medications he prescribed. In the case of Mrs. Knowles, based on the number of Placidyl prescribed by the Respondent over about a year, she received enough to take two per day, which would constitute 1,500 mg. of the drug per day (two tablets of 759 mg. each). The drug company's recommended daily dose is between 590 and 750 mg. given at bedtime, with an additional 109 to 200 mg. later on, if needed. The fact that Mrs. Knowles was also getting other drugs, including a different type of sleeping pill, makes Dr. Gladding feel the prescriptions by Respondent were excessive. He admits, however, he does not know how much pain the patient was in and this makes it difficult to render an opinion. Because of this, he cannot unequivocally say that the dosage prescribed was excessive. Good practice is to prescribe as few Schedule II drugs as is possible. However, without knowing the patient, her attitude, and her actual condition, an opinion as to the appropriateness of the drugs prescribed, unless clearly inappropriate, would be merely guesswork. As to the patient Mrs. Wood, Dr. Gladding could not read Dr. Warhola's notes of what drugs he gave her. Therefore, in analyzing Respondent's prescriptions, he relied on and referred to a federal drug analysis of the unmarked drugs she got from Respondent as including barbiturates or their derivatives. This analysis was not introduced into evidence, and Dr. Gladding's reference to it is hearsay which cannot, by itself and without other independent evidence of the identity of the drugs, support a finding of fact even though it would appear some were drugs that would not be used in weight control. However, there were drugs identified independently, such as the potassium replacement and the weight reduction drug, which were appropriate and, in addition, the tranquilizer could also be appropriate. In any case, Dr. Gladding does not know what Mrs. Wood told Respondent about the problems she was having sleeping. If she did tell him this, even the barbiturates could be appropriate. Dr. Gladding has also been confronted with a situation where a patient of his has been hospitalized and the hospital calls him for information on the patient on an emergency basis. He knows, he says, everyone in the local hospitals and generally provides the requested information on the spot without a formal release. He is more concerned with the patient's welfare than with technicalities. However, in the case of Mrs. Wood, there was not an emergency situation and there was no showing Respondent was ever personally contacted. In addition, there was evidence of only one written release, not three, as reflected by the witness.
Recommendation Based on the foregoing, it is, therefore, RECOMMENDED: That the Administrative Complaint filed herein against Dr. Warhola be dismissed, but that he be officially reminded of the necessity to conservatively prescribe controlled substances in the course of his practice. RECOMMENDED this 6th day of March, 1984, in Tallahassee, Florida. ARNOLD H. POLLOCK Hearing Officer 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 6th day of March, 1984. COPIES FURNISHED: James H. Gillis, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32391 Gerald Nelson, Esquire 4950 West Kennedy Boulevard Suite 693 Tampa, Florida 33609 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee. Florida 32301 Ms. Dorothy Faircloth Executive Director Board of Osteopathic Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issues to be resolved in this proceeding concern whether disciplinary action should be taken against the Respondent's license to practice medicine based on allegations that the Respondent violated the standard of care, specifically Subsection 458.331(1)(q) and (t), Florida Statutes, by allegedly inappropriately or excessively prescribing legend drugs and by failing to practice medicine with that level of care, skill and treatment recognized as acceptable by reasonably prudent physicians under similar conditions and circumstances. It must also be determined, if any of the alleged violations are proven, what, if any, penalty is warranted.
Findings Of Fact The Petitioner is an agency of the State of Florida charged, in pertinent part, with regulating the entry into practice and the regulation of practice of licensed physicians in the State of Florida. That statutory authority includes ascertaining whether physicians practice in accordance with the appropriate standard of care, including determinations of whether and to what degree disciplinary sanctions should be imposed, by standard set forth in Subsection 458.331, Florida Statutes. The Respondent at all times material hereto has been a licensed physician in the State of Florida. He holds license No. ME0010390. The Respondent is board-certified in surgery and thoracic surgery and has been most recently employed by the Department of Corrections (DOC) as a physician and Assistant Medical Director at the NFRC. This is a DOC facility in Lake Butler, Florida, which medically screens and processes prison inmates before they are transferred to a permanent prison location. It also provides, through a 130-bed hospital, care and treatment for inmates around the state for non-emergency conditions. The NFRC hospital does not have an intensive care unit but the DOC has a contract to provide care for emergency or complicated medical cases with the Memorial Medical Center in Jacksonville for the performance of any complex or emergency surgeries. The DOC contracted with a private company to provide surgical facilities at the NFRC for minor surgery. This includes hernia repairs and liver biopsies. The private facility maintains a "mobile surgical unit" located a few hundred yards from the NFRC hospital. This unit is not designed for serious post-surgical complications. In order to perform any surgery at this mobile surgical unit an independently-contracted surgical consultant must request the DOC to approve the surgery. Then the requested surgery must be reviewed and approved through a utilization management process. Finally, the recommended surgery is reviewed by Dr. Azcuy, the Medical Director of NFRC. Dr. Azcuy has veto power on any surgery performed at the mobile surgical unit. Once he approves a surgery, an independently contracted surgeon performs the surgery at the mobile surgical unit. After surgery is completed at the unit the patient is then taken back to the NFRC hospital where DOC employees provide follow-up care and treatment. The Respondent, as Assistant Medical Director of the NFRC hospital, is such a DOC medical employee. The Respondent, Dr. Vontz, was born May 31, 1930, in Germany. He grew up and was educated in pre-war, war-time and post-war, occupied Germany. He received his medical education at Universities in Hamburg and Freiburg, Germany, as well as at the University of Florida and the University of Michigan in the United States. He has been an Assistant Medical Professor at the University of Florida/Shands Medical Center and is board- certified in surgery and in thoracic surgery. He became a United States citizen in 1961 and located his practice primarily in Jacksonville, Florida. He practiced thoracic surgery in Jacksonville, Florida, from the early 1960's until his initial retirement on December 31, 1993. He was primarily responsible for organizing and initiating the first cardiac surgery unit and surgical team in Jacksonville, Florida. His practice involved any type of surgical intervention in the chest cavity including heart, lungs, major vessels, diaphragm, as well as open-heart surgery. He performed open-heart surgery in Jacksonville from 1965 to 1993. After initially retiring from the performance of heart surgery in 1993, Dr. Vontz was unsatisfied with retirement and returned to work as the medical director of Methodist Medical Center in Jacksonville. As Medical Director he supervised physicians and observed and monitored their manner and means of practice. He also became medical director of Champion Health Care, a Health Maintenance Organization (HMO). When Champion Health Care closed its operations in Jacksonville due to financial circumstances in 1996, Dr. Vontz went to work as an employed physician at NFRC as Senior Physician and Assistant Medical Director. He was thus an employee of the Department of Corrections at that point. Dr. Vontz stays current in knowledge of medicine and proper medical practice by participating in continuing medical education. He has never before been the object of a complaint concerning his medical practice and his rendition of medical care for patients. The Surgical Procedures A liver biopsy is a sampling of the tissue of the liver. A percutaneous liver biopsy can be performed with a closed abdomen, involving no incision. It can be done "blindly" meaning without a CT scan or laproscopic instrument for guidance of the insertion and placement of the biopsy needle device. The standard of care requires a surgeon to continue making passes or inserting a needle until an appropriate sample in obtained. The requirement of making three passes of the needle to obtain an adequate sample is probably within the standard of care. The making of four passes, as was the case with this patient, T.C., may or may not be within the standard of care. The standard of care does not specifically determine the number of passes permitted or required. The procedure for a percutaneous liver biopsy involves the use of a "trecut needle." That is a needle with a hollow metal sheath designed to allow the insertion of the needle device into the liver with the hollow sheath taking a core sample of the liver tissue, which is then withdrawn for laboratory analysis. The appropriate standard of care for such a liver biopsy, done blindly, is for the patient to be in a sitting position. This allows gravity to force the organs, including the colon and intestine in the area of the liver, to fall away from the vicinity of the liver somewhat so as to avoid some of the risk of puncturing a hollow intestine or "hollow viscous" organ with the needle. The standard of care would also require that the procedure be done under a local anesthetic so that the patient remains conscious and can demonstrate to the surgeon performing the procedure through reaction to excessive pain, etc., when the procedure may have gone awry through improper placement of the needle device. The two surgical procedures performed on patient T.C. were the percutaneous liver biopsy, with a trecut needle, and a left, inguinal hernia repair. These procedures were performed on the same surgical occasion and were performed under a general, endotracheal anesthesia with the patient on the operating table in a supine position for both procedures. Patient T.C. was a 33-year-old male. He had a left, inguinal hernia which required repair and the attendant liver biopsy procedure was performed on him because he suffered from "Hepititis C." The procedures were performed on April 14, 1998, at 8:30 a.m. by Dr. Zomorodian, a board-certified surgeon and independent contractor for the DOC. The liver biopsy in the upper quadrant required four "runs" or "passes" in order to obtain a specimen. A "gooey substance" was obtained in the trecut biopsy needle. On April 14, 1998, at approximately 9:30 a.m., right after the surgical procedures were performed, Dr. Zomorodian wrote a hand-written operative note reading in pertinent part as follows: "percutaneous biopsy of liver done first the patient tolerated the procedures well- to recovery room in stable condition." This hand-written operative note was the only report of any kind available to the Respondent from Dr. Zomorodian, the operating surgeon, concerning patient T.C. On that same day however, Dr. Zomorodian also a dictated a more detailed operative report. The operative report indicated that a "gooey substance" was obtained during the liver biopsy. Operative reports, in the normal course of business, have to be typed and filed by the administrative staff and are not generally available for approximately three days. That was the case in the instant situation and the operative report was not available at any pertinent time to the case at hand for Dr. Vontz's benefit. Although the extraction of a "gooey substance" does not automatically mean that a bowel or hollow viscous organ has been perforated by the biopsy needle, for instance it could possibly have been a substance obtained from the diseased portion of a patient's liver, it is a strong indication that a hollow viscous organ, for instance the colon, has been penetrated by the needle. The presence of the gooey substance in the biopsy needle specimen should have placed T.C.'s surgeon, Dr. Zomorodian, on notice that a complication had occurred during the liver biopsy, including the likelihood of perforation of a hollow viscous organ such as the colon or other intestinal portion. It is significant that Dr. Zomorodian, after patient T.C.'s death, asked the hospital staff to change his dictated and typed operative note to remove reference to the "gooey substance". The DOC's hospital staff refused to do so. The operative procedures were finished by 9:23 a.m. on April 14, 1998. The patient was removed to the recovery room of the mobile surgical unit and at 9:43 a.m. was given 50 milligrams of Demerol intravenously for pain. At 10:30 a.m. he was moved from the surgical unit to the second floor of the NFRC hospital. Dr. Zomorodian expected him to have pain subsequent to the liver biopsy and hernia repair. At 9:30 a.m. that morning he ordered Demerol in the amount of 75 milligrams with Phenergan intramuscularly on an as-needed basis for pain and also ordered Tylenol No. 3, one or two tablets every three hours for pain. Tylenol No. 3 contains codeine. This analgesic pain medication order by Dr. Zomorodian, according to normal written protocol for the hospital, was to be in effect for three days. Post-Operative Care On April 14, 1998, during the course of the day after surgery, T.C. complained of pain. He was given Demerol and Phenergan (25 milligrams) at 11:00 a.m., 2:30 p.m., and 10:00 p.m., in accordance with Dr. Zomorodian's standard medication order and protocol. Phenergan is a drug used to accentuate the effect of Demerol. T.C. at age 14 began to use marijuana and to drink alcoholic beverages at the age of 16. By age 20 he had started cocaine use. As shown by Dr. Lynn's testimony a patient with a drug history such as this is more resistant to pain medications and requires more of them to alleviate pain than someone who has not used such drugs on a frequent and recurring basis. T.C., in the recovery room, was given 50 milligrams of Demerol intravenously. Dr. Lynn established that this medication approximately an hour after surgery would be abnormal for a hernia repair and an uneventful liver biopsy, if such were the case, especially after receiving 20 cc's of 0.5% marcaine containing epinephrine at the end of the operation in addition to the general anesthetic which has it own pain reliever in it. The installation of the marcaine with the epinephrine should have alleviated any immediate wound pain associated with the surgical procedures. During the afternoon of April 14, 1998, the Respondent was asked by the charge nurse to examine T.C. because of her suspicion that T.C. was complaining of pain merely as a ruse to obtain drugs. The Respondent assessed the patient and determined that his complaints of pain were genuine and so he continued the medication order according to Dr. Zomorodian's standing order. Dr. Vontz had no reason to believe that the patient was having any complication or acute distress at that point and therefore went home at his usual time of approximately 4:00 p.m. His normal working hours were 7:00 a.m. to 4:00 p.m. Other senior physicians and emergency room physicians were present or on-call during evening and early morning hours under the standard operating procedure of the hospital. Dr. Vontz returned to the hospital at approximately 6:30 to 7:00 a.m. on the morning of April 15, 1998, and saw the patient at 7:15 a.m. The pain medication had been continued according to Dr. Zomorodian's order with the last Demerol injection, with Phenergan, occurring at approximately 4:05 a.m. that morning. The patient had not urinated during the day on April 14 until approximately 5:00 p.m. when he voided 300 cc's of urine with pain. When the Respondent examined the patient at 7:15 a.m. on April 15 he found and noted in his record: "abdomen tightly distended ?? rebound. Will treat as acute abdomen and follow closely." An abdomen described as "tightly distended" means that the abdomen is tense, firm and swollen. "Rebound" means that the physician has placed pressure on the abdomen with his fingers and upon release of the pressure the patient has pain. "Acute abdomen" is severe abdominal pain that could occur for a number of reasons. It could be a potentially catastrophic event needing immediate surgical intervention (abdominal exploratory surgery). It may be caused by a disease process secondary to a perforated bowel or ruptured appendix for which immediate surgery is indicated, or it may result from conditions such as a subscapsular hematoma (blood under the membrane capsule enclosing the liver), an ileous or blockage of an intestine, or may be pain resulting from a "shutdown" or failure of bowel function. It is not uncommon when abdominal surgery, even a hernia repair, has occurred that for a certain period of time, due to possible contact with the bowel during surgery, that the bowel will simply cease to function temporarily or have a halt to the peristalic movement of the bowel. Dr. Vontz thus made a decision to treat T.C. condition as an acute abdomen and then follow the patient closely to try and diagnose whether the abdominal distress was caused by a catastrophic event such as a perforated bowel requiring surgical intervention (surgically acute abdomen) or whether some other non-infectious disease process or condition was occurring causing the abdominal pain in which case it would be termed and diagnosed as a "medically acute abdomen," not necessarily requiring surgical intervention. Thus the standard of care required that the Respondent attempt to determine the underlying cause of the acute abdomen which he did by ordering a number of diagnostic tests or procedures. He also placed the patient at "NPO," meaning no nourishment or liquids by mouth. He ordered fluids administered intravenously at the rate of 150 cc's per hour, ordered an upright and "flat plate" X-ray of the abdomen and chest and additionally ordered a "stat CBC" meaning an immediate complete blood count. The stat blood count was designed to show whether white blood cell counts were elevated, which would indicate that an infectious process was going on which would require surgical exploration to determine if the colon and/or another organ had been penetrated, required repair and emergency treatment for infection. At 11:10 a.m. on the morning of April 15, Dr. Vontz also ordered a catheterization for T.C. because of the previously noted problem of low urine output. At 12:15 p.m. Dr. Vontz met with the radiologist, Dr. V. M. Saenz, and evaluated the chest and abdominal X-rays. It was their joint opinion that the chest X-ray was not remarkable. The abdominal X-ray did not show any air or fluid levels which the Respondent would expect if a perforated bowel had occurred. The presence of air (gas) or fluid would indicate the perforation of a hollow viscous organ, such as the colon. The X-ray did show a large amount of feces in the colon however. Because of the history of the recent liver biopsy the possibility of a subcapsular hematoma of the liver was considered. A subcapsular hematoma is the accumulation of blood and fluid within the membrane capsule surrounding the liver and could occur due to bleeding from the penetration of the liver by the biopsy needle. In order to investigate that possibility a CT scan of the abdomen was ordered by the Respondent and performed. The CT scan was requested on an emergency basis and performed at 1:47 p.m. on April 15. A CT scan images a patient in "slices" giving a three dimensional picture of the area in question so that the patient can be observed for any abnormalities. Drs. Vontz and Saenz interpreted the CT scan of the abdomen as follows: . . . a crescent-shaped, hypodense collection of fluid is demonstrated along the supra lateral portion of the liver. Although this could correspond to a liquefied subcapsular hematoma taking into consideration that the liver biopsy was performed yesterday . . . would expect this to be of higher density . . . there are also several fluid filled distended loops of small bowel in the left upper quadrant which most probably correspond to jejunum. Because, in effect, the collection of fluid referenced in this quoted note is not of sufficient density to be recognized as a collection of blood along the supra lateral portion of the liver, it was determined that this was serum or other fluid. Thus on April 15th at 4:00 p.m. Dr. Vontz ruled out a subcapsular hemorrhage, thus ruling out both blood and "free air" in the abdomen. In cases where the colon or other hollow viscous organ is penetrated the presence of "free air" or gas is noted in approximately 75% of the cases. Thus the lack of it is indicative, although not conclusive, of the lack of a perforation of a hollow viscous organ. When the Respondent saw the patient at 7:15 on the morning of April 15th and ordered the stat CBC the blood count was then made, some 22 to 24 hours post-surgery. The blood count showed a white blood cell count of 4.6 with the upper end of the normal range being 12.3. Thus the white blood cell count, a marker for infection, appeared entirely normal. The neutrophil portion of the blood count revealed a slightly elevated reading or a slight abnormality. Neutrophils are immature white blood cells which, if abnormally high, can indicate the presence of infection. Because they were only slightly elevated that did not really indicate infection to the Respondent since they can normally occur after surgery. A slight elevation can normally be attributed to atelectasis, a condition associated with the fact that the patient had had a general anesthesia and therefore somewhat decreased lung function as well as an abdominal operation which subsequently resulted in severe pain in the abdomen, which can cause a slight elevation in the neutrophil count. The normal white blood cell count, with only a slight increase in neutrophil reading and the absence of any significant elevated temperature on April 15th understandably resulted in the Respondent's not concluding that any infectious process was going on at that point. This is certainly an abnormal presentation of symptoms by a patient, who upon autopsy, was proven to have had a large, two centimeter perforation of the colon, with a massive peritonitis infection. In such a patient it is highly unusual for more blatant signs of an infectious process, including a significantly elevated, white blood cell count, not to have occurred 24 hours after the surgical procedure which resulted in the perforation. On April 15th at 4:00 p.m., Dr. Vontz ruled out a subcapsular hematoma or hemorrhage and ruled out blood and free air being present in the abdomen. The CT scan however, did show the presence of a fluid collection in the vicinity of the liver, as found above. Also on April 15th at 5:00 p.m., Dr. Vontz ordered the placement of nasogastric tube in the patient in order to prevent his swallowing air and causing further distention of the alimentary tract. At 7:00 p.m. that evening the patient removed the nasogastric tube on his own and refused to have it replaced. He was uncooperative with care throughout that shift even when the nurse explained the necessity of his treatment. On the morning of April 15th at 6:30 a.m., just before the Respondent saw him, T.C.'s vital signs were within normal limits. At 1:25 p.m. that day, some 29 hours after the liver biopsy, his vital signs were still within normal limits. His blood pressure was 134/88, his temperature was 97.4, his heart rate was 110, and his respiratory rate was 20 at 1:25 on April 15th. Thus he was still not demonstrating an infectious process some 29 hours after the surgical procedure involved. On April 15, 1998, at approximately 5:00 p.m. the patient's abdomen remained distended, without audible bowel sounds and he continued to complain of pain. His urine was dark and concentrated. Once again, in accordance with Dr. Zomorodian's orders, was given Demerol at approximately 5:00 p.m. on April 15th. On April 16, at approximately 6:25 a.m., T.C. was restless and continued to complain of severe pain, he was again given Demerol. At 6:22 a.m. on the morning of April 16th approximately 46 hours subsequent to the liver biopsy, his vital signs were still within normal limits. At 8:00 a.m. that morning Dr. Vontz ordered that he be maintained on NPO status; that intravenous fluids be decreased to 100 cc's per hours and that he be given a dulcolax suppository because of his bowel status. T.C., as a result, had a large emptying of the bowel, which made him feel grossly better. During his interview with Dr. Vontz at approximately noon that day he was able to stand at his bedside and sit by his bedside and converse with Dr. Vontz. At 8:45 that morning of April 16th, Dr. Vontz had ordered a "stat Chem 20 test." The "Chem 20" revealed hemoconcentration or concentration of the blood, which indicated dehydration. At 12:40 p.m. on April 16th, Dr. Vontz ordered a foley catheter inserted in the patient's bladder and ordered another Chem 20 test of his blood for April 17th. He also ordered clear liquids for T.C. since he seemed to be feeling better after the bowel movement and the Respondent felt he could take clear liquids by mouth. His urine output remained low and at 1:00 p.m. on April 16th, Dr. Vontz ordered a urine culture and sensitivity study. The urine culture was ordered by the respondent by telephone upon a nurse contacting him because he was at an in-service training seminar some half-mile away from the patients hospital floor at that time. By 1:00 p.m. the patient was very restless, becoming somewhat confused and was tachycardic, which means increased heart rate. His heart rate was as high as 159 beats per minute. He had a respiratory rate of 28 and a blood pressure of 94/64 in the afternoon of the 16th. In addition to ordering the urine culture, an electrocardiogram was performed on the patient, ordered approximately at 1:00 p.m., which revealed abnormal tachycardia. Dr. Vontz listened to T.C.'s bowel sounds on both the morning of the 15th and the morning of the 16th. His bowel sounds were returning to normal on the morning of the 16th and after receiving the suppository T.C. had a bowel movement, which gave the Respondent the impression that the patient was improving. Clinically, he exhibited no nausea, vomiting, or any sign of bowel obstruction. The low urine output and the tachycardic condition along with the elevated respiratory rate and depressed blood pressure after 1:00 p.m. on the 16th showed that the patient, however was becoming more critically ill. In retrospect it is apparent that he was in septic shock. Dr. Vontz last visited the patient at 4:30 p.m. on the 16th. He determined that he should be transported to Memorial Hospital for more aggressive care, including surgical exploration of the abdomen to attempt to determine the cause of his condition. The Respondent elected however, because of the lateness in the day to avoid confusion and discontinuity in his care and treatment by having him transported early the following morning. Dr. Vontz felt there would be less likelihood of delay or interruption in the level of care for the patient than if he arrived at the critical care hospital in the middle of the evening. After seeing the patient at approximately 4:30 p.m., Dr. Vontz went home but remained in telephone communication with the hospital, medical staff and the registered nurse on duty. At approximately 8:15 p.m. on the 16th Katherine Kravitz, R.N., called Dr. Vontz informing him that T.C. had "spiked a fever," measured at the axcilla (armpit) at 103 degrees. She also advised the Respondent that the Chem 20 test had been returned and demonstrated a BUN of 55. Dr. Vontz determined that this demonstrated hemoconcentration, indicating dehydration. Dr. Vontz therefore increased his fluids intravenously to 150 cc's per hour. He also ordered Lasix to be provided, as a "one-shot" medication, because he was concerned about T.C.'s kidney function being substandard, in view of the rising BUN reading and because the fluid was being increased to 150 cc's per hour. He wanted to be sure that T.C. was able to void sufficient urine to accommodate the increase in intravenous fluid. He learned that T.C. had adequate kidney function to accommodate the increase in IV fluid administration. He also ordered at this time that T.C. be given Fortaz at 1 gram every 8 hours intravenously. Fortaz is an antibiotic specifically designed to attack abdominal infectious processes especially attributable to escherichia coli (e-coli) contamination in the abdomen. Dr. Vontz was of the belief that the sudden temperature elevation indicated that there had been a sudden burst of infection. Up to the point of the telephone call at 8:15 the evening of the 16th T.C.'s temperatures had not been significantly elevated, although other of his vital signs on the afternoon of the 16th had indicated abnormality, involving low blood pressure, elevated respiratory rate and tachycardia, as found above. Dr. Vontz called nurse Kravitz at 11:00 p.m. on April 16th and learned that T.C.'s temperature was down from 103 to 100.6 degrees. This led him to believe that the antibiotic administration and the IV fluid therapy was improving the patient. Earlier on April 16th at approximately 4:30 p.m. in response to the patient's restlessness and continued severe pain the Respondent had ordered Ativan and Morphine, as well as placing him in restraints and a posey vest. The Ativan and restraints were ordered because of his restlessness and anxiety. The Morphine is a narcotic stronger than Demerol in its analgesic properties. Patient T.C. at 6:00 p.m. that day was still confused and his urine was dark amber in color, indicating dehydration. Throughout the late night of April 16, 1998, the nursing notes indicated that the patient was moaning and groaning without verbal response and was no longer fighting against his restraints. In retrospect it is clear that he was dying. The information given Dr. Vontz when he called the nurse to check on the patient at approximately 11:00 p.m. on April 16th, and learned that the patient's temperature was down to 100.6 and that his other vital signs were returning to normal levels, indicated to him that the antibiotic and intravenous fluid therapy was helping the patient to improve. Curiously, the hospital records indicate that on the early morning of April 17th at 1:15 a.m., the patient's temperature was 100.6, his pulse rate was down to 80, and his respiratory rate was 24 with blood pressure at 100/60, indicating vital signs returning to normal levels. At 3:45 a.m. on April 17th however, T.C. was found to be without vital signs and was shortly thereafter pronounced dead. Thus, within 55 hours of the attempted liver biopsy by Dr. Zomorodian, T.C. was dead. Upon autopsy, it was found that he had a two centimeter diameter hole in his colon which caused significant release of e-coli bacteria into T.C.'s abdominal cavity, resulting in massive, acute bacterial peritonitis. Dr. Vontz arose at his home at approximately 4:00 a.m. on the morning of April 17th to go to the hospital to arrange for the patient's transfer to the acute facility at Memorial Medical Center. He was shocked to arrive and find that the patient had died. The patient had been seen on the night of the 16th and early morning of the 17th by the emergency room physician on duty, Dr. Edwards. Emergency room physicians are involved in continuing the treatment of in-house patients at NFRC when attending physicians are off-duty. Analysis of Responsibility The medical examiner, Dr. Hamilton, who performed the autopsy on T.C. found the two centimeter hole in the proximal transverse colon. The proximal transverse colon is on the right side of T.C.'s body adjacent to the liver. This clearly demonstrated that the attempted liver biopsy by Dr. Zomorodian caused the perforation of the colon in the vicinity of the liver. The patient had been given 50 milligrams of intravenous Demerol at 9:43 a.m. by Dr. Zomorodian's order. This need for medication only approximately an hour after surgery would be abnormal for a hernia repair and an uneventful liver biopsy. Less than an hour after receiving this Demerol T.C. was moved out of the surgical unit recovery room and taken to "two West" in the NFRC hospital. When transferred to the NFRC hospital it would have been certainly appropriate for Dr. Zomorodian to admonish, in his post-operative note, as testified to by Dr. Lynn, that "we may have caused this patient some problems, we did four sticks, we came back with a gooey substance, watch this patient carefully." Instead Dr. Zomorodian only made a cryptic post- operative note to the effect that the liver biopsy was done, with no more description than the fact that it was done. Although he dictated and had typed a more elaborate post-operative note that mentioned the gooey substance, this was not available at any time to Dr. Vontz during his care of the patient. Moreover, Dr. Zomorodian attempted to have the reference to the gooey substance edited out of his post-operative note, which the hospital staff quite correctly refused to do. The surgeon performing the surgical procedures, under the protocol of the American College of Surgeons and the NFRC protocol should not delegate post- operative care to someone else, under normal circumstances. If that surgeon cannot be involved in the post-operative care, he must communicate in a very clear and unequivocal fashion, to one who has been delegated the post-operative care, all information concerning the surgical procedure and the care of the patient while the patient was under his care and treatment, which Dr. Zomorodian did not do. It was thus incumbent upon Dr. Zomorodian to make certain that there was effective follow-up care for his patient but there is nothing in the record to indicate that Dr. Zomorodian ever called anyone associated with the NFRC hospital, post-operatively, to check on his patient or to provide them information concerning the patient. Be that as it may, the Respondent, in the absence of any information from Dr. Zomorodian, in following the appropriate standard of care, should have contacted Dr. Zomorodian as the surgeon of record during the course of the care of T.C., and he failed to do so. Dr. Vontz also departed from the appropriate standard of care in several other particulars. First, he failed to adequately recognize and act on the knowledge produced by the CT scan that there was a fluid collection, which did not appear to be blood, in the vicinity of the liver. This clue, learned by the Respondent and the radiologist at approximately 4:00 p.m. on April 15th would seem to indicate that aggressive, surgical intervention early in this patient's course of care was in order. Moreover, in the face of the patient's continuing symptoms, and even though the initial complete blood count did not show an elevated white cell count, and thus did not seem to indicate infection, a later CBC should have been ordered on April 15th or even April 16th; particularly on the morning of April 16th in a continuing effort to rule out an infectious process beginning in the patient. This was not done after the initial CBC was obtained on the morning of April 15th. Additionally, compliance with an appropriate standard of care would dictate that by the early afternoon of April 16th, with the presence of tachycardia, depressed blood pressure, elevated respiratory rate, and the continuing severe abdominal pain, that the Respondent should have transferred the patient to Memorial Medical Center that afternoon for more aggressive treatment. The decision to transfer him did not occur until early in the evening of the 16th and then the Respondent, for the reasons found above, decided not to effect the actual transfer until early the following morning, by which time it was, of course, too late. Although the Respondent was not clearly alerted to an infectious process until the high temperature which occurred after 8:00 p.m. on the night of the 16th, the other critical symptoms earlier in that afternoon should have compelled him to have the patient transferred to the acute care facility. Indeed, if a CBC had been ordered to look at white blood cell count earlier on the 16th or even on the afternoon of the 15th the progress of the infection might have been detected even though it was not resulting in any significant increase in body temperature. Thus, in these particulars, the Respondent must be found to have violated the appropriate standard of care as well as in the fact that during the day on April 16th he did not make progress notes outlining his treatment plan. That is not a finding that he had no treatment plan, however. Taking a more prophylactic, cautious view of the results of the CT scan and the ordering of an additional CBC on late April 15th or early on April 16th might have pointed him toward a finding of the existence of a surgical problem rather than a medically acute abdomen problem. This would have impelled him to effect aggressive surgical intervention earlier, with the possibility of saving the patient. In fairness to Dr. Vontz it should be pointed out that infectious peritonitis is a rapid and devastating illness, but death within the third day of contamination is a bit rapid and unusual. Moreover, traditionally a patient experiencing one or more perforations of the colon usually evolves a clearly discernable infectious process around the 24th hour after the perforation occurs. The medications ordered and administered by the surgeon, Dr. Zomorodian, could have masked some symptoms and led the later care-giver astray as to the evolving signs and symptoms of a perforated viscous for a time. T.C.'s infectious process presented in an unusual manner. A typical patient would demonstrate severe illness, with nausea, vomiting, and severe pain. In the vast majority of cases he would exhibit free air or gas under the diaphragm and would have an elevated white blood cell count fairly early, with associated elevated body temperature or fever and chills. Dr. Vontz indeed considered the issue of a perforated bowel and performed the above-found tests in an effort to find evidence of it. He believed the test results, including the complete blood cell count did not produce evidence to support the existence of a perforated bowel. In fact, however, the abnormality on the CT scan involving hypodense fluid in the vicinity of the liver should have alerted him to that potential and he should have ordered an updated complete blood cell count which might have told him of the advancing infectious process at an early enough time to have saved the patient. In fact, the evidence demonstrates that the time period between 12 hours and 48 hours after such a perforation and inoculation with e-coli bacteria occurs is critical and that after 48 hours without aggressive, surgical intervention it is improbable that such a patient can be saved. A more aggressive approach to the result of the CT scan abnormality, an updated complete blood cell count and contact with the surgeon involved would have been a more appropriate standard of care and might have compelled Dr. Vontz to have acted more quickly in having the patient transported for more critical intensive care.
Recommendation Accordingly, having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties it is, therefore, RECOMMENDED: That a final order be entered by the Board of Medicine finding the Respondent guilty of violating Subsection 458.331(1)(t), Florida Statutes, in the above-found and concluded manner, and not guilty of violating Subsection 458.331(1)(q), Florida Statutes, and that, as a penalty therefor the Respondent shall: Complete 50 hours of continuing medical education in surgery; Complete the Florida Medical Association Quality Medical Records Course; Remain on a probationary status for a period of one year with the probationary term to require a review of 25% of the Respondent's medical records by a supervising physician approved by the Board of Medicine. DONE AND ENTERED this 19th day of July, 2000, in Tallahassee, Leon County, Florida. P. MICHAEL RUFF 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 July, 2000. COPIES FURNISHED: Kristy Johnson, Esquire Department of Health Post Office Box 14229 Tallahassee, Florida 32317-4229 Thomas R. Brown, Esquire Brown, Terrell, Hogan, Ellis, McClamma and Yegelwel, P.A. Blackstone Building, Eighth Floor 233 East Bay Street Jacksonville, Florida 32202 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Angela T. Hall, Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue The issues for determination in this case are whether Respondent committed the acts alleged in four separate administrative complaints and, if so, what penalties, if any, should be imposed.
Findings Of Fact 1. Petitioner is the governmental agency responsible for inspecting assisted living facilities ("ALFs") and for enforcing applicable licensing requirements in accordance with Chapter 400, Florida Statutes, 1/ and Florida Administrative Code Rule 58A-5. 2/ Respondent is licensed to operate an ALF for eight residents and operates such a facility at 2580 First Street, Fort Myers, Florida 33901 (the "facility"). Ms. Mary Elliott is the ALF administrator and owns the real and personal property used by the ALF (the "administrator"). Overview The Initial Survey On April 5, 1994, Petitioner conducted an initial survey of the facility (the "initial survey"). During the initial survey, several deficiencies existed in the minimum licensing requirements ("deficiencies"). Petitioner provided Respondent with timely and adequate notice of the deficiencies and the need to correct them or to provide a plan of correction. Respondent neither corrected the deficiencies nor provided a plan of correction. All of the uncorrected deficiencies are Class III violations within the meaning of Section 400.419(3)(c) ("Class III violations"). The First Complaint Investigation On February 15-17, 1995, Petitioner conducted a complaint investigation of the facility (the "first complaint investigation"). Petitioner found several deficiencies. Some of the deficiencies were uncorrected deficiencies from the initial survey and others were found to exist for the first time. Petitioner provided Respondent with timely and adequate notice of the deficiencies and the need to correct the deficiencies or to provide a plan of correction. Respondent neither corrected the deficiencies nor provided a plan of correction. Some of the uncorrected deficiencies were Class III violations and others were Class II violations within the meaning of Section 400.419(3)(c) ("Class II violations"). The Moratorium During the first complaint investigation, the facility exceeded its licensed capacity. The facility was licensed for eight residents. However, Petitioner's census correctly disclosed that the facility actually housed 10 residents. Petitioner imposed a moratorium effective February 20, 1995. The moratorium precluded Respondent from admitting any new residents to the facility. Petitioner provided Respondent with adequate and timely notice of Respondent's right to request a formal hearing in which Respondent could challenge the moratorium. Respondent did not request a formal hearing. On December 26, 1995, Petitioner issued a final order making the moratorium permanent. The Follow-Up Visits On April 10, 1995, Petitioner conducted the first of four follow-up visits to the facility. Petitioner conducted the first follow-up visit to determine whether Respondent had corrected the deficiencies found in the initial survey and in the first complaint investigation. Petitioner correctly determined that several uncorrected deficiencies existed. Petitioner provided Respondent with adequate and timely notice of the uncorrected deficiencies and the need to correct them or to propose a plan of correction. On September 12, 1995, Petitioner conducted a second follow-up visit to the facility to determine whether Respondent had corrected the deficiencies found in the initial survey, the first complaint investigation, and the first follow-up survey. Uncorrected deficiencies persisted and new deficiencies existed. Petitioner provided Respondent with adequate and timely notice of the need to correct the uncorrected and new deficiencies or to submit a plan of correction. Respondent neither corrected the deficiencies nor proposed a plan of correction. On October 20, 1995, Petitioner filed two administrative complaints against Respondent. The two complaints seek to fine Respondent $2,750 and $3,350, respectively, for uncorrected deficiencies. Petitioner referred the matters to DOAH, and they became respective Case Numbers 95-5680 and 95-5681. The Unlicensed Facility On July 11, 1995, Petitioner conducted a second complaint investigation of the facility (the "second complaint investigation"). Petitioner correctly determined that Respondent was operating an unlicensed facility at a separate address. Petitioner instructed Respondent to apply for a license or to close the separate facility. Respondent did neither. On September 14, 1995, Petitioner conducted a third follow-up visit to determine if Respondent had closed the unlicensed facility. Respondent had not. On October 24, 1995, Petitioner filed a third administrative complaint against Respondent. In the third complaint, Petitioner seeks to fine Respondent $500 for operating an unlicensed facility. Petitioner referred the matter to DOAH, and it became Case Number 95-5682. Revocation On November 30, 1995, Petitioner conducted a fourth follow-up visit to the facility. Uncorrected deficiencies persisted and new deficiencies existed. Petitioner provided Respondent with adequate and timely notice of the uncorrected and new deficiencies and the need to correct them or to submit a plan of correction. Respondent neither corrected the deficiencies nor proposed a plan of correction. On January 4, 1996, Petitioner filed an administrative complaint against Respondent seeking to revoke Respondent's license. Petitioner referred the matter to DOAH, and it became Case Number 96-9712. Case Number 95-5680 Current Work Schedule Respondent does not maintain a current work schedule. This uncorrected deficiency is a Class III violation. Capacity The facility is licensed for eight residents. On February 15, 1995, there were 10 residents in the facility. The facility exceeded its licensed capacity. Respondent had 30 days to bring its facility into compliance with its licensed capacity. On April 10, 1995, all 10 residents remained and an eleventh had been admitted. Admission And Discharge Log Respondent does not maintain an accurate admission and discharge log. The log is not current. Respondent does not enter required information such as dates and resident identity. The log omitted five admissions and two discharges. This uncorrected deficiency is a Class IV violation within the meaning of Section 400.419(3)(d) ("Class IV violation"). Financial Ability Respondent does not maintain required income and expense records. Petitioner can not determine Respondent's financial ability to operate the facility. This uncorrected deficiency is a Class III violation. Accident And Incident Reports Respondent does not maintain required accident and incident reports accurately. The reports maintained by Respondent do not include essential information such as: a description of what happened; names of those who witnessed the incident or found the resident involved; the health care given; the names of those contacted by staff members; and the steps taken to prevent recurrence. Entries that are made in the reports are not made by individuals with first-hand knowledge of an accident or incident. The administrator makes the entries after-the-fact. One report, for example, merely states that the resident's ankle was swollen. Another report merely states that a resident had choked and was given a squeeze. Petitioner correctly classified uncorrected deficiencies in accident and incident reports as Class III violations. Staff Training Staff members are not adequately trained in First Aid and CPR. Respondent does not provide adequate job descriptions for staff. This uncorrected deficiency is a Class III violation. Staff members are not trained in CORE regulations for their job description after they attend initial CORE training. This uncorrected deficiency is a Class III violation. Medical Screening For Staff And Residents Respondent failed to document that all staff members are free from communicable disease within 30 days of hire. This uncorrected deficiency is a Class III violation. Respondent failed to document that residents are examined by a health care provider within 60 days prior to admission or within 30 days after admission. This uncorrected deficiency is a Class III violation. Dispensing Medication Respondent does not dispense prescribed medication according to the prescription. Staff members do not dispense medications to residents properly and do not assure that self- administered medication is taken properly. Pain medication is prescribed for one resident, as needed, up to four times a day. Staff members dispense the medication to the patient four times a day, every day, routinely, without regard to whether the resident requests the medication or complains of pain. One Propoxy pill is prescribed for another resident, as needed, up to two times a day. The resident takes one pill three times a day routinely. Another resident is supposed to take 500 milligrams of Relafan two times a day after meals. The resident is given 500 milligrams of Relafan once a day at 8:00 a.m. One, two milligram dose of Prosom is prescribed for another resident, as needed, at hours of sleep. The resident receives one, two milligram dose at 5:00 p.m. routinely. One ten milligram tablet of Chlordiazepoxine is prescribed for another resident, as needed, at hours of sleep. The required medication is dispensed at 5:00 p.m. daily. Another resident is supposed to receive two sprays of Nasacort at 8:00 p.m. each day. The medication is dispensed at 5:00 p.m. each day. Petitioner correctly classified some of the uncorrected deficiencies in medications as Class III violations. Petitioner properly classified others as Class II violations. Medication Labels And Records Respondent does not label resident medications properly. Paxil prescribed for one resident has no label. An inhaler prescribed for another resident is not labeled. Nor is a dermotropic cream prescribed for another resident. Petitioner properly classified uncorrected deficiencies in medication labeling as Class II violations. Respondent does not maintain required medication records accurately. Respondent's records show that insulin prescribed for one patient was dispensed on January 11, 1994. However, that date was the date the insulin was ordered. The insulin was actually dispensed on February 10, 1994. Petitioner properly classified uncorrected deficiencies in medication records as Class III violations. Storage Of Medication Respondent does not store resident medications in a secure, central location. The lock on the cabinet used to store medication is broken. Medication in the cabinet is accessible by any member of the staff and by any resident. Insulin is not stored in a locked area. Insulin vials are stored in a Tupperware container in the refrigerator of the facility. Petitioner properly classified some of the uncorrected deficiencies in storing resident medication as Class III violations. Petitioner properly classified others as Class II violations. Transfer Of Medications Individuals other than a pharmacist transfer medications from one container to another. One resident had a bottle labeled Lanoxin. The bottle contained six Lanoxin pills with 14 unidentified white pills. The administrator routinely transfers prescription medications from their labeled container to an unlabeled one and retains the labeled container in the facility. She usually does this when residents are discharged from the facility. Petitioner properly classified some of the uncorrected deficiencies in medication transfers as Class III violations. Petitioner properly classified others as Class II violations. Case Number 95-5681 Petitioner conducted a second follow-up survey on September 12, 1995. 3/ Several uncorrected deficiencies persisted and new deficiencies existed. Staff Training Staff members are not trained in CORE regulations after attending initial CORE training classes. Staff members are not adequately trained in First Aid and CPR. Staff members are not trained in a manner that is consistent with their assigned job duties and responsibilities. Staff members are not trained adequately to implement Fire Safety and Disaster Plans. Staff members who provide personal hygiene care are not trained by a nurse prior to providing such care. Petitioner properly classified some of the uncorrected deficiencies in staff training as Class III violations. Petitioner properly classified others as Class II violations. Medical Screening Staff members are not documented as free from communicable disease within 30 days of the date of their hire. Petitioner properly classified this uncorrected deficiency as a Class III violation. Resident Medications Respondent does not document medications dispensed to residents. Respondent failed to document 16 medications that were dispensed to residents at 5:00 p.m. each day. Respondent failed to document any daily medications dispensed to residents at 8:00 a.m. Respondent commits significant errors in dispensing medications to residents. In one day, Respondent committed nine errors in dispensing 20 doses of prescription medication. In addition, Respondent consistently fails to verify the dosage taken by residents who self-administer their medication. Respondent had no doctor orders changing written prescriptions. Respondent's records did not disclose that a doctor had verbally authorized a change in the written prescription for any medication. Staff members incorrectly identify medication to residents. Staff members incorrectly identified antihistamine prescribed for one resident as the resident's "water pill." Staff members do not wash their hands before dispensing medications. Staff members do not wash their hands after dispensing medication to one resident or before dispensing medication to the next resident. Staff members do not provide residents with needed assistance. Staff members often place medication in front of a resident but give the resident no spoon or water. Staff members do not verify that a resident takes his or her medication. Petitioner properly classified some of the uncorrected deficiencies in resident medication as Class III violations. Petitioner properly classified others as Class II violations. Consultant Pharmacist After the initial survey, first complaint investigation, and first follow-up visit, Petitioner imposed a plan of correction. The plan required Respondent to retain a consulting pharmacist until no longer required by Petitioner. Respondent did not continue the services of the consulting pharmacist until no longer required by Petitioner. Respondent did not ensure that the pharmacist made quarterly visits to the facility. Respondent did not file the required quarterly reports with Petitioner. Respondent failed to comply with the requirements of the plan of correction. Petitioner properly classified this uncorrected deficiency as a Class II violation. Nutritional Needs Food substitutions for planned menus do not have comparable nutritional value. A breakfast in one planned menu required each resident to receive two ounces of protein. The substituted breakfast provided no protein. Respondent failed to provide residents with the basic nutritional requirements set forth in four other planned menus. Respondent failed to plan menus and post them at least one week in advance. Respondent does not record substitutions before or when they are served. Respondent does not provide therapeutic menus prescribed for residents. Respondent does not retain therapeutic menus in the files of the facility for at least six months. Petitioner properly classified the uncorrected deficiencies in nutritional needs as Class II violations. Case Number 95-5682 On July 11 and on September 12 and 14, 1995, Respondent operated an unlicensed facility as an ALF. Respondent operated the unlicensed facility at 1604 Evans Avenue, Fort Myers, Florida 33901. Five residents lived at the unlicensed facility. Each resident suffered from dementia and required personal care. The residents were supervised by one caretaker. The caretaker provided the residents with food, lodging, assistance with personal care, and supervision of medication. Case Number 96-0712 Petitioner conducted a fourth follow-up visit to the facility on November 30, 1995. Uncorrected and repeat deficiencies in staff training, resident medication, and resident nutrition persisted at the facility. New deficiencies existed in good business practice, residents' rights, and emergency food supplies. Repeat Uncorrected Deficiencies Respondent repeatedly fails to adequately document personnel records. Personnel records do not document that staff members are adequately trained or that they are free of communicable disease. Respondent does not maintain an accurate work schedule. Respondent fails to document that staff members are properly trained in providing personal hygiene care for residents. Untrained staff members actually provide such care. Respondent fails to document that staff members are properly trained in infection control and in Fire Safety and Disaster Plans. Respondent fails to document that staff members are properly trained in CORE regulations. Respondent assigns staff members to job duties for which they are not trained. Staff members without proper training are assigned to provide personal hygiene, to assist in case of disasters or fires, and to dispense medication. Respondent dispenses medication improperly. Staff members do not properly supervise self-medicating residents. Staff members who dispense medication are not properly trained for that duty. Respondent stores medication unsafely. Medication labels lack required information. Respondent fails to provide residents with basic nutritional needs. Substitutions to planned menus are not of equal nutritional value. Respondent does not serve therapeutic diets prescribed for residents. Menu substitutions are not recorded when served. New Deficiencies Respondent does not maintain adequate staff to meet the needs of residents. Respondent maintains three staff members to assist eight residents who need assistance with daily living. Respondent does not provide adequate activities and socialization for residents. Respondent does not allow residents to present grievances to staff members or to governing officials without interference, coercion, or reprisal. Respondent does not maintain the emergency food supplies needed for an ALF with eight residents. The facility needs and maintains the following emergency foods: Food Needed Maintained Protein 336 ounces 94 ounces Milk 896 ounces 96 ounces Water 112 gallons 0 gallons Respondent does not maintain the financial records needed to determine the financial ability to operate the facility. On February 17, 1995, Respondent had a $10,000 outstanding debt and two checks returned for insufficient funds. On September 12, 1995, Respondent had $11,000 in outstanding bills and a negative bank balance. Recreated profit and loss statements for July, 1995, through October, 1995, revealed a net loss of $104,458.79. Bank statements show 26 checks returned for insufficient funds. Records of local water and electric companies from December 2, 1993, through December 4, 1995, show that water for the facility was turned off five times for nonpayment. The water was scheduled to be turned off three more times for nonpayment. A final notice was sent by the electric company to the facility almost every month. Two employees twice had payroll checks returned for insufficient funds. A writ of possession was entered in circuit court on June 21, 1996. The writ precludes the administrator from possession of the facility due a default in a debt she owes.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding Respondent guilty of the violations at issue in this proceeding, imposing fines of $6,800, and revoking Respondent's ALF license. RECOMMENDED this 10th day of December, 1996, in Tallahassee, Florida. DANIEL S. MANRY, Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 10th day of December, 1996.
