Findings Of Fact During the period August 26-28, 1985, James L. Myrah, a hospital consultant for DHRS, accompanied by Ms. Christine Denson, a registered nurse, and other consultants in various disciplines from the Petitioner's office of licensure and certification, conducted a licensure, medicare, medicaid and civil rights survey at the Respondent's facility in Ft. Walton Beach, Florida. During the course of this survey, Mr. Myrah followed the normal procedure for such inquiries which included an entrance conference with the administrator, and a survey process which includes looking at various items for as many days as is required to do a thorough job.1 As a part of the survey, the team looks at every resident physically but examines patient charts on the basis of a random sample. In the instant case, examination of the patient records kept by the Respondent revealed only one variance. That was brought to the attention of the Petitioner's Office of Licensure and Certification by the Local District I omebudsman who commented about a particular patient, whose name will not be recited to preserve patient confidentiality, but whose initials, M.C., will be used as identification. By the time the survey was conducted, M.C. had already been transferred to another nursing home and was not physically present. Therefore, the inspection team was unable to examine her. However, they did examine her medical records and chart closely. This examination resulted in Petitioner drawing the conclusion that Respondent was in violation of the require ment for notification to the patient's physician whenever there is a substantial significant change in the patient's condition. The patient's chart was not entered into evidence. The report form identifying the deficiency (HRS Form 553E) was prepared by the inspection team based on its evaluation of the patient records. This was not objected to by Respondent, and in the absence of any objection to its entry, it was accepted. The entry for the 11 p.m. to 7 a.m. shift on May 22, 1985, reflects,2 "Total care given, nothing per os (by mouth) past midnight. Dr.'s appointment in am--resident seems very listless not talking as usual. Several small bruises noted on lower extremities (rt.) foot very discolored." This entry is, in the opinion of Ms. Denson, important because it relates to the fact that the patient was to go to the doctor in the morning. The use of the term "listless" might indicate a serious medical condition and a change of condition which should have been reported to the person next in charge. The term, "not talking as usual" shows a change that would require comment. In addition, the comment regarding the discoloration of the foot should have been reported to someone and not allowed to remain uncommented on until the visit with the doctor the next morning. The patient saw her physician, Dr. Wilson, at 8 a.m. on May 22, 1985; and returned to the home at 10 a.m. the same morning. Apparently nothing was considered to be wrong with the patient because no prescription for medicine or other treatment was given by the physician who, three days later, on May 25, 1985; when advised by nurses on the 7 a.m. to 3 p.m. shift of large black and blue areas on the patient's inner groin area, indicated he examined the patient and found nothing new clinically on May 22. There are repeated instances of comments which Petitioner alleges were not properly reported to the physician. For example, on May 23, personnel on the 11 p.m. to 7 a.m. shift reflected that the patient "continues to be listless. Right leg turned at a funny angle. Report to D.O.N. (Director of Nursing)." The 7 a.m. to 3 p.m. shift the following morning reported, "Both legs ecchymosis (discolored), hip moves oddly, color pale." The 3 p.m. to 11 p.m. shift the same day reported, "Color remains pale-- unusual movement and rotation of both legs noted." Additional comments of a similar nature were noted by personnel on the 11 p.m. to 7 a.m. shift on May 24 the 3 p.m. to 11 p.m. shift on May 24; and the 11 p.m. to 7 a.m. shift which discovered the discoloration to the pelvis as reported previously. At 4 p.m. on May 25, 1985, personnel reported their concern in reference to the bruises on the patient's groin and lower extremities to the physician and further entries show that at 5:10 p.m., the patient was subsequently returned to the home at 7:30 p.m. after x-rays were accomplished which failed to reveal any fracture. Nonetheless, because of continued concern by the nursing staff and at the urging of family members, the patient was returned to the hospital at 10 a.m. on May 27, 1985. At this point, she was found to have fractures of both lower extremities and upon release from the hospital was transferred to another convalescent center. Mrs. McCasland contends that all due care and concern was given to the patient, M.C., consistent with the long standing convalescent center policy governing changes in patient status. This policy statement, dated March, 1975, which is still in effect, requires that "in the event of a significant change in the patient's physical, mental, or emotional status, the attending physician is immediately called by the charge nurse." As was stated in paragraph 3, above, on May 22, an 11 p.m. to 7 a.m.'s shift nurse noted a small bruise on the left foot of the patient and that the patient was listless. Small bruises are not necessarily significant in geriatric patients (M.C. was 88 years old). Also, often older people do not talk for several days. In any event, the lack of any significant condition was confirmed by the physician who found nothing unusual in the patient's condition during the examination. The doctor's report reflects, inter alia, "physical examination is remarkable for an elderly white female in an involuted state appearing her stated age." Her extremities "show some area of bruising primarily in the upper thighs presumably related to lifting the patient. She has crepitance in the bilateral knees and is unable to fully extend her lower extremities." Neurologically; she was determined to be alert and the physician recommended continuing general support of care. On May 25, 1985, the charge nurse called Ms. McCasland at home indicating that the patient's legs seemed to be getting bluer. Ms. McCasland, at that moment, told the nurse to call the patient's physician which was done and the doctor indicated at that time that when he had examined the patient several days previously, he found nothing wrong. It apparently was the decision of the doctor to take no further action at that time. However, at approximately 4 p.m.; after the conversation with the physician; the charge nurse contacted the physician again, indicating she thought the patient needed to be x-rayed. At 5:10 p.m.; the patient was taken to the hospital; apparently at the order of the physician; for x-rays which showed no fractures. Nonetheless; this action would not have been taken were it not for the attention of the nurse on duty and actions of the Respondent's administrator. On the following day, May 26, the charge nurse from the 7 a.m. to 3 p.m. shift again called Mrs. McCasland at home and stated that the patient's legs were; "bad." Ms. MeCasland told the nurse to call the patient's physician who directed she be sent to the hospital for x- rays. The hospital would not accept the patient and as a result, the physician came to the convalescent center where he examined her and concluded that there was, in fact, a problem. He directed she be sent to the hospital the following day and when she was x-rayed then; fractures were discovered. It should be noted here that again the contact with the physician which resulted in the ultimate diagnosis of leg fractures, was initiated by the charge nurse at Respondent's center and communicated to the physician and Ms. McCasland by center personnel.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that deficiency number NH77(g); relating to the visit to Respondent's convalescent center on August 28, 1985, be removed. DONE and ORDERED this 7th day of May, 1986, in Tallahassee, Florida. _ ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 7th day of May, 1986.
The Issue The issue in this case is whether Petitioner is entitled to an award of attorney’s fees and costs pursuant to Section 57.111, Florida Statutes (2007).1
Findings Of Fact On November 2, 2006, the Department filed with the Board of Medicine a one-count Administrative Complaint against Dr. Thompson, alleging that Dr. Thompson violated Subsection 458.331(1)(t), Florida Statutes (2003). The Administrative Complaint was based on a probable cause finding by the Probable Cause Panel of the Board of Medicine (Panel) on October 27, 2006. The Panel included two physicians. Prior to the meeting of the Panel on October 27, 2006, the members of the Panel received the following materials on the cases to be considered: “the complete case files, including any patient medical records, expert opinions, if any, any materials supplied by the licensee or their counsel” and a draft of the Administrative Complaint. The file on Dr. Thompson included the investigator’s file; the expert opinions of Thomas F. Blake, M.D., F.A.C.S.; Dr. Blake’s curriculum vitae; medical records for the treatment of T.C.; and letters from Bruce M. Stanley, Sr., counsel for Dr. Thompson, along with a draft of the Administrative Complaint. At the Panel meeting, the members indicated that they had received the materials with sufficient time to review and familiarize themselves with the materials. The Panel members did not find any problems with the materials such as missing pages or illegible copies. Additionally, the panel members indicated that they had no conflict of interest or prior knowledge of the cases before them that would make it inappropriate to deliberate and vote on the issues. In the case of Dr. Thompson, the Panel was supplied with expert opinions from Dr. Blake. Dr. Blake was a diplomat certified by the American Board of Obstetrics and Gynecology, a fellow of the American College of Surgeons, and a fellow of the American College of Obstetricians and Gynecologists. By letter dated December 20, 2004, Dr. Blake rendered the following opinion concerning the care provided by Dr. Thompson: Thompson, M.D. fell below the standard of care by abandoning a patient under general anesthesia and leaving the facility to attend to another patient. However, there were no complications or injury to either patient. The potential problem would be that he would unexpectedly be confronted with complications in the delivery. This could detain him for a prolonged period of time and place the patient under anesthesia in jeopardy of having to have the anesthesia discontinued and subjecting her to further risks. By letter dated December 29, 2004, the Department requested clarification on the issue of whether there were any identifiable deficiencies or problems with the medical records that were maintained by Dr. Thompson. Dr. Blake sent an addendum to his report dated January 11, 2005, in which he gave the following opinion: Medical records utilized in the treatment of the patient are complete and justify the treatment. There are no identifiable deficiencies or problems with the medical records maintained by the subject. At the Panel meeting, an attorney for the Department summarized the case against Dr. Thompson as follows: Patient T.C. presented to the surgery center for several gynecological procedures. While T.C. was under general anesthesia, the Respondent physically left the surgery center to attend to another patient in another building. Respondent delivered a baby of that other patient. T.C. was left under the care of a certified registered nurse anesthetist. After returning from delivering the child, Respondent finished the gynecological procedure. The Department is charging a violation of Section 458.331(1)(t), for violation of the applicable standards of care by leaving T.C. for several minutes in the middle of surgery and in between procedures while she was under a general anesthesia, by failing to notify the patient that Respondent had left and by failing to note in the medical record that Respondent had left the building. The Panel members discussed the case against Dr. Thompson during the meeting and voted on the case, finding there was probable cause to believe a violation had occurred. The findings of the Panel resulted in the issuance of the Administrative Complaint. The case was received by the Division of Administrative Hearings on February 8, 2007, for assignment to an Administrative Law Judge to conduct the final hearing. The Department retained another expert, Jose H. Cortes, M.D., F.A.C.O.G, to provide an opinion concerning Dr. Thompson’s actions relating to the treatment of T.C. By letter dated February 27, 2007, Dr. Cortes opined that Dr. Thompson fell below the standard-of-care while attending T.C. by leaving the operating room and going to another building to attend to another patient. Dr. Cortes was also of the opinion that Dr. Thompson did not adequately maintain the medical records for T.C. by the following actions: The departure from the normal course of surgery such as leaving the operating room was not documented by the attending physician, the outpatient establishment nursing staff, nor the anesthesia attending or nurse anesthetist. A signed consent form not available. * * * As the record documents the evaluation of 07/18/03 and 08/05/03 by the Physician Assistant describes the patient’s complaint and ultrasound study review respectively. The blood count presented from 07/18/03 shows a Hemoglobin of 13.6 gms and Hematocrit of 40.1 percent with normal indices, a pelvic ultrasound which documented fibroids of less than 2.1 cm in size each. With the above findings a conservative management strategy is usually employed initially and the patient is followed prior to recommending any surgical procedure unless declined by the patient. However, all of this has to be documented as recommended by the literature and agencies which review patient care and guidelines such as KePRO. On July 10, 2007, the Department filed a motion to amend the Administrative Complaint, which motion was granted by Order dated July 13, 2007. The Amended Administrative Complaint added a count alleging a violation of Subsection 458.331(1)(m), Florida Statutes (2003), alleging that Dr. Thompson: [F]ailed to keep legible medical records justifying the course of treatment by failing to document in T.C.’s medical records that he left the building during the procedures he performed on T.C. on or about September 11, 2003, and/or by failing to document any discussion with T.C. about alternative treatment options such as discontinuing oral contraceptives, a formal dilation and curettage, and/or the use of a Mirena IUD to address T.C.’s problems or concerns. The final hearing was held on July 27, 2007. A Recommended Order was entered on October 31, 2007, recommending that a final order be entered finding that Dr. Thompson did not violate Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2003), and dismissing the Amended Administrative Complaint. A Final Order was entered on December 18, 2007, adopting the findings of fact and conclusions of law of the Recommended Order and dismissing the Amended Administrative Complaint against Dr. Thompson. The parties have stipulated to the reasonableness of the fees and costs claimed by Dr. Thompson. Dr. Thompson has incurred $34,851.00 in attorney’s fees and costs. The parties have stipulated that Dr. Thompson is a prevailing small business party and that Respondent is not a nominal party to this action.
The Issue The issue in this case is whether notice was accorded the patient, as contemplated by section 766.316, Florida Statutes, or whether the failure to give notice was excused because the patient had an emergency medical condition, as defined in section 395.002(8)(b), Florida Statutes, or the giving of notice was not practicable.
Findings Of Fact Ms. Maradiaga was born in Honduras in 1992, where her primary language was Spanish. She moved to the United States in 2005 and attended school here for part of the eighth grade and the ninth and tenth grades. She was taught in English, but did not do well in school because Spanish was her primary language. While in the tenth grade, Ms. Maradiaga became pregnant with Jean Carlos. Ms. Maradiaga went to the health department for prenatal care except for one visit in October 2008 when she went to Central Florida Health Care, Inc. Because she would be required to make monthly payments to Central Florida Health Care, Inc., she decided to remain with the health department for her prenatal care. During her visit to Central Florida Health Care, Inc., on October 20, 2008, Ms. Maradiaga signed an acknowledgement form stating that she had been given information by Central Florida Health Care, Inc., that Dr. Stanton and Corrine Audette were participants in the Florida Birth-Related Neurological Compensation program and that she had received a copy of the pamphlet prepared by the Association (NICA pamphlet). The acknowledgement form was written in Spanish. Ms. Maradiaga admits that she signed the acknowledgement form, but denies that she received the NICA pamphlet. Medical Records from Central Florida Health Care, Inc. (Joint Exhibit 15, Bates stamp 69), state that Ms. Maradiaga was given a NICA brochure and the form was signed on October 20, 2008, which is the date that Ms. Maradiaga signed the acknowledgment form. The greater weight of the evidence establishes that Dr. Stanton and Ms. Audette provided notice pursuant to section 766.316 on October 20, 2008, via the NICA pamphlet provided by Central Florida Health Care, Inc. Ms. Maradiaga was advised at the health department that she would deliver her baby at Lakeland Regional. During her third month of pregnancy, Ms. Maradiaga was given a form by staff at the health department for pre-registration at the hospital. The form was to be sent to Lakeland Regional. Ms. Maradiaga filled out the form with information such as her name address and telephone number. According to Ms. Maradiaga, she mailed the form to Lakeland Regional during the fourth month of her pregnancy, sometime in August 2008. There is no record that Lakeland Regional received the form. When a patient desires to pre-register for delivery at Lakeland Regional, the patient may receive a form from the patient's doctor or clinic. The form requests basic information such as name, address, and telephone number. The patient sends the form to Lakeland Regional. When the hospital receives the form, the information is entered into the computer and a patient account is created for the patient. The patient is assigned a patient medical record number. Future information concerning the patient will be entered into the patient management computer system using the patient account number. During the pre-registration process, the hospital will contact the patient after the patient account is established and provide information to the patient. Included with the information that is sent to the obstetric patient is the NICA pamphlet and the acknowledgment form. Deborah Newbern is the assistant director of patient access services for Lakeland Regional. She oversees the operations of the patient access areas for all admitting, including pre-registration. Ms. Newbern searched the computer system using Ms. Maradiaga's name and the only account number that appeared for Ms. Maradiaga was the account established when she came to Lakeland Regional on December 27, 2008. If Ms. Maradiaga had been pre-registered, there would be an account number documenting the pre-registration. Ms. Newbern found none. Based on the records of Lakeland Regional, the greater weight of the evidence establishes that the first contact that Lakeland Regional had with Ms. Maradiaga was on December 27, 2008. Petitioners argue that because Ms. Maradiaga's prenatal records from the health department and Central Florida Health Care, Inc., are found in Ms. Maradiaga's hospital records that a professional relationship was formed between Lakeland Regional and Ms. Maradiaga either in August or October 2008 based on a notation in the health department records, which states: Hospital Date Sent Staff Initials LRMC 8/14/08 (illegible) LMRC 10/16/08 (illegible) There was no testimony concerning who made the notation, when the notation was made or when Lakeland Regional received the records. The records from Central Florida Health Care, Inc., contain information dated as late as November 10, 2008. The records from Central Florida Health Care, Inc., state that Ms. Maradiaga had transferred from the health department and that partial records had been received and put in the file to be scanned. At the top of the records from Central Florida Health Care, Inc., is the notation: "PRINTED BY: zLinda LRMC z Hooper on 12/27/2008 at 5:59 PM." The notation leads to the inference that Lakeland Regional received Ms. Maradiaga's prenatal records from Central Florida Health Care, Inc., on December 27, 2008, shortly after Ms. Maradiaga arrived at the hospital. The records from the health department contain entries made after October 16, 2008. For example, entries were made on the prenatal record from October 22, 2008, through December 24, 2008, and a notation was made on the clinical notes dated November 19, 2008. (Joint Exhibit 15, Bate stamp 80-82). Obviously, records made after October 16, 2008, could not have been sent on October 16, 2008. A note in the initial nursing assessment at Lakeland Regional states that the prenatal history has been reviewed and is current. Taking the evidence as a whole, it cannot be concluded that Lakeland Regional had Ms. Maradiaga's prenatal records prior to her visit on December 27, 2008. At approximately 4:40 p.m., on December 27, 2012, Ms. Maradiaga presented to the emergency room at Lakeland Regional complaining of abdominal pains. At the time she came to the emergency room, she had been experiencing contractions since 10:00 a.m. the same day, and the contractions had continued to become stronger and more frequent. She was in early active labor, having good strong contractions every five minutes. She was transferred to the labor and delivery unit, where she was admitted as an inpatient by Angie Rogue, who is a patient access representative for Lakeland Regional. Ms. Rogue does not specifically recall Ms. Maradiaga; however, she follows a set routine for admitting obstetric patients. The routine that she uses to admit in-patients is the same for every patient. The only difference that she would make would depend on the number of forms that she gives the patient depending on whether the patient has private insurance, is on Medicaid or has no insurance. After the patient is transferred to the labor and delivery unit, Ms. Rogue receives an in-patient order form, which lets her know that a patient needs to be admitted to the hospital as an in-patient. She inputs into the computer system that the patient is going to be admitted as an in-patient and prints out a patient summary form. She gathers other forms such as the HIPPA form, the NICA pamphlet, and the NICA acknowledgement form to take to the patient. She also prepares the ID armband, which is placed on the patient. Ms. Rogue goes to see the patient in the labor and delivery unit, introduces herself and explains that she is there to admit them. She asks the patient her name and date of birth to make sure that the information on the armband is correct. She goes through the information on the patient summary form to make sure that it is also correct and gives the patient the HIPPA form to sign, the NICA pamphlet and the acknowledgment form for the patient to sign showing the patient received the NICA pamphlet. If the patient is being transferred from the emergency room, the patient would receive the patient summary, the HIPPA form, and a welcome packet from staff in the emergency room. When a patient is given forms or signs forms, the hospital staff person will note it on the patient notes in the computer system. Each staff member has a badge number, which is entered into the computer when patient notes are entered. In the case of Ms. Maradiaga, the patient notes show that Ms. Maradiaga received a welcome packet, HIPPA information, and the patient summary. The patient notes indicate that Ms. Maradiaga's interaction with a hospital employee for these documents was with a staff member, whose badge number is 15070. The medical records contain a patient summary that is signed by Ms. Maradiaga, witnessed by someone other than Ms. Rogue, and dated December 27, 2008. On December 27, 2008, the emergency room staff did not provide obstetric patients with the NICA pamphlet or have the patients sign the acknowledgement form. The patient notes show that the following entry made on December 27, 2008, by Ms. Rogue, whose badge number is 13763, in Ms. Maradiaga's patient account record: 13763: RCVD ORDER TO ADMIT AS INPT FOR LABOR/SCNND, PT IS FROM ER, PT GIVEN NICA, PT SIGNED NICA, PLACED ARM ON PT, PT IS PENDING BIRTH Ms. Maradiaga signed an acknowledgment form dated December 27, 2008, which stated: I have been furnished information by Lakeland Regional Medical Center prepared by the Florida Birth-Related Neurological Injury Compensation Association, and have been advised that my doctor and all nurse midwives associated with my doctor's practice participate in the Florida Birth Related Neurological Injury Compensation program, wherein, certain limited compensation is available in the event certain neurological injury may occur during labor, delivery or resuscitation. For specifics on the program, I understand I can contact the Florida Birth-Related Neurological Injury Compensation Association (NICA), 1435 East Piedmont Dr., Suite 101, Tallahassee, Florida 32312, (904)488-8191. I further acknowledge that I have received a copy of the brochure prepared by NICA. Ms. Rouge's signature appears at the bottom of the acknowledgement form as a witness with the date of December 27, 2008. Ms. Maradiaga and Mr. Sordia claim that the only time that Ms. Rogue had any interaction with Ms. Maradiaga was on the morning after Jean Carlos was born, December 28, 2008. According to Ms. Maradiaga, the acknowledgment form had the date of December 27, 2008, entered when she signed it, and she advised Ms. Rogue that the date was incorrect, but Ms. Rogue told her that the date was okay. However, in her deposition, Ms. Maradiaga testified that she signed the acknowledgment form in the emergency room and then stated that she did not specifically recall signing the form because she had to sign a lot of forms just to enter the hospital and she was in a lot of pain. Both Ms. Maradiaga and Mr. Sordia deny that Ms. Maradiaga received a NICA pamphlet. The data that is entered into the patient's computer records is dated on the date that the data is entered. If an amendment or change were necessary, the date that the amendment or change was made would also be entered into the computer records. In other words, an employee could not go into the computer system and change the date that the original entry was made. The date that was entered into the computer records as the date that Ms. Maradiaga received the NICA pamphlet and signed the acknowledgment form was December 27, 2008. Based on the computer records, the signed and dated acknowledgment form, and the credibility of the witnesses, the greater weight of the evidence establishes that Lakeland Regional provided the NICA pamphlet to Ms. Maradiaga and Ms. Maradiaga signed the acknowledgment form on December 27, 2008. Petitioners have argued that Ms. Maradiaga did not have sufficient notice because she does not speak English and was not provided an interpreter. Mr. Sordia was with Ms. Maradiaga at the hospital on December 27, 2008, and he did translate for Ms. Maradiaga. The hospital records are replete with information that had to come from Ms. Maradiaga or from someone who was translating.
Findings Of Fact Petitioner, the Department of Business and Professional Regulation (now the Agency for Health Care Administration), is the state agency charged with enforcing the statutes and regulations governing the practice of medicine in Florida pursuant to Chapters 20, 55, and 458, Florida Statutes, and the rules and regulations promulgated pursuant thereto. Respondent, Alexander Sonkin, M.D., is a medical doctor licensed in Florida, having been issued License No. 0044838, and his principle place of practice is 11216 North Dale Mabry Highway in Tampa, Florida. Except for this proceeding, there is no evidence that Respondent has ever been the subject of disciplinary action in connection with his medical license. From approximately December 28, 1988, through June 7, 1989, Respondent treated Patient #1, a 70 year old male as a primary care physician. During Respondent's first encounter with Patient #1, on December 28, 1988, he performed a history and physical examination in preparation of Patient #1's entry into a weight reduction program. Based on Respondent's physical examination and history of Patient #1 on December 28, 1988, Respondent diagnosed Patient #1 as suffering from "degenerative joint disease, emphysema, glaucoma and arteriosclerotic heart disease". During the period in which Respondent was Patient #1's treating physician, there were six office visits for medical care. Patient #1's daughter-in-law, Mary Daly, often accompanied him to Respondent's office for treatment. On January 30, 1989, Respondent diagnosed Patient #1 as suffering from hemoptysis (coughing up blood) and chronic obstructive pulmonary disease (COPD). On the January 30, 1989, office visit, Respondent ordered an x-ray which was completed on that same day. The x-ray that was performed on Patient #1 did not reveal any evidence of pulmonary malignancy (lung cancer). The x-ray did, however, reveal that Patient #1 was suffering from COPD and basilar atelectasis but there was no evidence of a mass or malignancy. The primary diagnosis that family physicians usually consider, based on Patient #1's symptoms, would be chronic bronchitis which is the most common source for hemoptysis in the United States. Patients presenting with hemoptysis are difficult to diagnose as there are many different causes for the differential diagnosis of hemoptysis. Specifically, hemoptysis occurs with approximately equal frequency (30 percent) of patients who present with either lung cancer or those patients who present with pulmonary emboli. Respondent next treated Patient #1 on February 21, 1989, at which time he presented with a swollen left leg. A unilateral swollen leg is significant in that the deep veins of the legs are a possible source of clots causing pulmonary emboli. On that visit, there were no complaints or indication of continued hemoptysis at that time. Patient #1 was next treated by Respondent on April 18, 1989, at which time Respondent continued to treat him for COPD. On or about May 9, 1989, Patient #1 was again treated by Respondent for hemoptysis and COPD. On this second episode of hemoptysis, Respondent ordered a chest x-ray and he was hospitalized from May 9 through May 17, 1989. Respondent's diagnosis of Patient #1, upon admission to the hospital, was bilateral pneumonia but he was later diagnosed and treated as a patient suffering from pulmonary emboli and COPD. On May 24, 1989, Respondent again treated Patient #1 for a follow-up visit wherein he was again diagnosed as a patient suffering from COPD and pulmonary emboli. Patient #1's final visit to Respondent was on June 7, 1989, wherein he returned to Respondent's office to undergo blood work studies. Patient #1 was a 70 year old male during 1988 who had been a former smoker, however, he had not smoked for the preceding 15 years when he was first treated as a patient of Respondent. During one of the visits to Respondent's office, Respondent's daughter, Mary Daly, brought a plastic bag of blood which Patient #1 had coughed up. Patient #1 requested that Respondent's nurse send it to the laboratory for analysis. Respondent did not send the blood to the laboratory for analysis as he considered that to be useless in treating Patient #1. Respondent's nurse had a practice of recording everything that a patient complained of and these were reflected in the medical records for Patient #1. Respondent's records indicate that there were two instances wherein Patient #1 presented with hemoptysis and on those two occasions, January 30, 1989, and May 9, 1989, Respondent's records accurately indicate the episodes of hemoptysis. When Respondent treated Patient #1 during his hospitalization in May, 1989 for the bilateral pneumonia and the ultimate diagnoses of pulmonary embolism and COPD, Respondent administered the medications Heparin and Coumadin. Both Heparin and Coumadin are anticoagulants (blood thinners) and can be used to treat patients suffering from pulmonary emboli. Heparin is a fast acting anticoagulant which is usually used to treat people suffering from blood clots and who need rapid action in thinning their blood. Coumadin is used for patients who have been on anticoagulants for long periods of time. All of the experts agreed that a patient in otherwise good health, but who presents with a suspected pulmonary emboli, should be treated or investigated with an arterial blood gas work-up, a chest x-ray, and a Ventilation/Perfusion Scan (VQ Scan). These tests can assist a physician in determining whether a pulmonary emboli is the cause of a patient coughing up blood. All experts expressed an opinion as to whether Respondent deviated from the standard of care in treating Patient #1. 1/ A VQ Scan takes approximately 3 hours and other treatments, such as administering anticoagulants, cannot be safely done when the VQ Scan is being performed. The VQ Scan is an invasive procedure, and a patient undergoing a scan must be lying down throughout the procedure. Patient #1 was not a proper candidate for a VQ Scan based on his medical condition at the time that he presented as he was "fading fast" in the eyes of his doctor. When Respondent administered Heparin to Patient #1, his condition improved quickly and he was able to be released from the hospital within a week's time. Respondent's administration of anticoagulants was indicated for the treatment of a pulmonary emboli and Respondent adequately treated Patient #1 on May 9, 1989. On June 29, 1989, Patient #1 was treated by John G. Greene for a second opinion concerning hemoptysis which had occurred "off and on for a period of several months." This was of course subsequent to Respondent's last treatment of Patient #1. Dr. Greene retired and sold his practice sometime after he last treated Patient #1. He no longer has all of his patient records concerning Patient #1. At the time of his visit, Patient #1 told Dr. Greene that he had been coughing up blood periodically for several months. His daughter-in-law, Mary Daly, also told Dr. Greene that Patient #1 had been periodically coughing up blood. Dr. Greene performed a physical examination and took a medical history. Dr. Greene also determined that Patient #1 had been a heavy smoker approximately 15 years earlier in his life. Dr. Greene sent Patient #1 for a pulmonary work-up including a CAT Scan on the following day. Dr. Greene also ordered a bronchoscopy and a biopsy and made an immediate referral to a pulmonary specialist. The biopsy confirmed cancer approximately one week after his first visit to Dr. Greene. On or about December 25, 1989, Patient #1 expired due to adenocarcinoma of the lung. All of the experts agree that lung cancer is difficult to detect and diagnose as even the most thorough practitioner who utilizes a battery of tests, including a CAT Scan and an MRI, usually cannot detect lung cancer until the growth has reached approximately one centimeter. The experts also agree that a patient, when properly diagnosed with lung cancer, usually has less than a year to live. The experts also all agree that in medically treating a patient who had been a former smoker but who had not been smoking for a period of 15 years or more, would be treated as a nonsmoker since all of the medical problems related to smoking would no longer be evident. Petitioner subpoenaed copies of Respondent's records of his treatment of Patient #1. Upon obtaining Petitioner's request, Respondent reviewed the records and made certain specific findings and additions to the records relative to his recall of specific symptoms and other treatment modalities that he used for treating Patient #1. Respondent admits that he made these specific changes and additions so that the medical records would be complete. The changes were not made for any improper purpose and his treatment modalities, other than the specifics, remain unchanged.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that: Petitioner enter a final order dismissing the Administrative Complaint filed herein in its entirety. DONE AND ENTERED this 31st day of October, 1994, in Tallahassee, Florida. JAMES E. BRADWELL 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 31st day of October, 1994.
The Issue The issues in this case are set forth in 11 separate counts within the four consolidated cases: Case No. 09-5360 Count I--Whether Respondent failed to properly monitor and care for a patient in restraints. Count II--Whether Respondent failed to ensure the physician's plan of care for patient was implemented. Case No. 09-5363 Count I--Whether Respondent failed to properly implement the physician's plan of care for patient. Case No. 09-5364 Count I--Whether Respondent failed to ensure a patients' right to privacy. Count II--Whether Respondent failed to ensure that food was served in the prescribed safe temperature zone. Count III--Whether Respondent failed to ensure that only authorized personnel had access to locked areas where medications were stored. Count IV--Whether Respondent failed to perform proper nursing assessments of a patient. Count V--Dismissed. Count VI--Whether Respondent failed to maintain patient care equipment in a safe operating condition. Case No. 09-5365 Count I--Whether Respondent failed to triage a patient with stroke-like symptoms in a timely fashion. Count II--Whether Respondent's nursing staff failed to assess and intervene for patients or ensure implementation of the physician's plan of care.
Findings Of Fact Petitioner is the state agency responsible for, inter alia, monitoring health care facilities in the state to ensure compliance with all governing statutes, rules and regulations. It is the responsibility of AHCA to regularly inspect facilities upon unannounced visits. Often AHCA will inspect facilities for the purpose of licensure renewal, certification, or in conjunction with federal surveys. AHCA will also inspect facilities on the basis of complaints filed by members of the general public. Respondent, Gulf Coast Medical Center ("Gulf Coast" or "GCH") is a hospital within the Lee Memorial Health System. South West Florida Regional Medical Center ("SWF") was another hospital within the Lee Memorial Health System. SWF closed in March 2009, when it was consolidated with Gulf Coast. On October 15, 2008, the Agency conducted a complaint investigation at SWF; a follow-up complaint investigation was done on November 13, 2008. SWF filed and implemented a plan of correction for the issues raised in each of the investigations. The November investigation resulted in an Administrative Complaint containing two counts. On December 16, 2008, AHCA performed another complaint investigation at Gulf Coast. Gulf Coast filed and implemented a plan of correction for the issues raised in the investigation. The investigation resulted in an Administrative Complaint containing one count. On January 5 through 9, 2009, AHCA conducted a routine licensure survey at Gulf Coast. The hospital filed and implemented a plan of correction for the issues raised in the survey. The survey resulted in an Administrative Complaint containing six counts (although Count V was dismissed during the course of the final hearing). On February 18, 2009, AHCA did its follow-up survey to the previous licensure survey. Gulf Coast filed and implemented a plan of correction for the issues raised in the survey. The survey resulted in an Administrative Complaint containing two counts. Case 09-5360 The complaint investigation at SWF on November 13, 2008, was conducted under the supervision of Charlene Fisher. Count I in this case addresses findings by the Agency concerning a patient who was placed in restraints at the hospital on August 28, 2008. The patient, A.D., came into the hospital emergency department under the Baker Act seeking medical clearance to a facility. The patient presented at approximately 4:00 p.m., with back pain. He had a history of drug abuse, so there was concern by the hospital regarding the use of narcotics or certain other medications to treat the patient. The patient engaged in some scuffling with police. A physician signed and dated a four-point restraint (one on each limb) order, resulting in the patient being physically restrained. The restraint was deemed a medical/surgical restraint, rather than a behavioral restraint. AHCA had concerns about the restraint, specifically whether there was a notation for Q 15 (or every 15 minutes) monitoring of the restrained patient. However, medical/surgical restraints only require monitoring every two hours. The restraint worksheet for the patient confirms monitoring every two hours. The patient was ultimately admitted to the hospital at 9:37 p.m., and, thereafter, began complaining of left shoulder pain. The hospital responded to the patient's complaints about back pain and began treating the pain with analgesics. However, the patient continued to complain about the pain. An X-ray of the patient's shoulder was finally done the next morning. Shoulder dislocation was confirmed by the X-ray, and the hospital (four hours later) began a more substantive regimen of treatment for pain. Surgery occurred the following morning, and the shoulder problem was resolved. It is clear the patient had a shoulder injury, but it is unclear as to when that injury became more painful than the back injury with which the patient had initially presented. The evidence is unclear whether or when the shoulder injury became obvious to hospital staff. During its course of treating this patient, the hospital provided Motrin, Tylenol, Morphine, Percocet and other medications to treat the patient's pain. Count II in this case also involved a restrained patient, M.D., who had presented to the emergency department under the Baker Act. The patient was released from handcuffs upon arrival at the hospital. After subsequently fighting with a deputy, this patient was also placed in a medical/surgical restraint pursuant to a physician's order. The doctor signed and dated, but did not put a time on, the restraint order. A time is important because there are monitoring requirements for patients in restraints. However, the time of 0050 (12:50 a.m.) appears on the patient's chart and is the approximate time the restraints were initiated. The proper procedure is to monitor a restrained patient every two hours. This patient, however, was removed from his restraints prior to the end of the first two-hour period. Thus, there are no records of monitoring for the patient (nor would any be necessary). The evidence presented by AHCA was insufficient to establish definitively whether the hospital nursing staff failed to properly respond to the aforementioned patients' needs. It is clear the patients could have received more care, but there is not enough evidence to prove the care provided was inadequate. Case No. 09-5363 On December 16, 2008, AHCA conducted a complaint investigation at SWF. The Agency had received a complaint that the hospital did not properly implement a physician's plan of care. Count I in this complaint addresses alleged errors relating to two of four patients reviewed by the surveyors. Both of the patients came to the hospital from a nursing home. One patient, I.A., had presented to the emergency department complaining of chest pains. The medication list sent to the hospital by the nursing home for I.A. actually belonged to someone other than I.A. I.A.'s name was not on the medication list. The drugs listed on the patient chart were different than the drugs I.A. had been taking at the skilled nursing facility from which she came. The skilled nursing facility actually sent I.A.'s roommate's medication list. The erroneous medications were then ordered by the admitting physician and administered to the patient. The hospital is supposed to review the medication list it receives and then enter the medications into the hospital system. The person reviewing the medication list does not necessarily have to be a nurse, and there is no evidence that the person making the error in this case was a nurse or was some other employee. It is clear, however, that the person reviewing the medication list did not properly ascertain that the list belonged to patient I.A. The other patient from the nursing home had been admitted for surgery at SWF. Again, the nursing home from whence she came sent a medication list that was incorrect. The medications on the incorrect list were entered into the system by a SWF employee. The erroneous medications were ultimately ordered by the attending physician for the patient, but there is no evidence the patient was ever administered those medications. Neither of the residents was harmed by the incorrect medications as far as could be determined. Case 09-5364 From January 5 through 8, 2009, AHCA conducted a licensure survey at Gulf Coast and SWF in conjunction with a federal certification survey. Count I of the complaint resulting from this survey addressed the right of privacy for two residents. In one instance, a patient was observed in her bed with her breasts exposed to plain view. In the other instance, a patient's personal records were found in a "public" place, i.e., hanging on the rail of a hallway in the hospital. AHCA's surveyor, Nancy Furdell, saw a female patient who was apparently asleep lying in her bed. The patient's breasts were exposed as she slept. Furdell observed this fact at approximately 1:15 p.m., on January 7, 2009. Furdell did not see a Posey vest on the patient. She did not know if anyone else saw the exposed breasts. Furdell continued with her survey duties, and at approximately 5:00 p.m., notified a staff member as to what she had seen. Furdell did not attempt to cover the patient or wake the patient to tell her to cover up. The female patient with exposed breasts was in the intensive care unit (ICU) of the hospital. Visiting hours in ICU at that time were 10:00 to 10:30 a.m., and again from 2:00 till 2:30 p.m. Thus, at the time Furdell was present, no outside visitors would have been in the ICU. ICU patients are checked on by nursing staff every half-hour to an hour, depending on their needs. This particular patient would be visited more frequently due to her medical condition. On the day in question, the patient was supposed to be wearing a Posey vest in an effort to stop the patient from removing her tubing. The patient had been agitated and very restless earlier, necessitating the Posey vest. Also on January 7, 2009, a surveyor observed some "papers" rolled up and stuffed inside a hand-rail in the hospital corridor. This occurred at 1:15 p.m., on the fourth floor of the south wing of the hospital. A review of the papers revealed them to be patient records for a patient on that floor. The surveyor could not state at final hearing whether there were hospital personnel in the vicinity of the handrail where she found the patient records, nor could she say how long the patient records had been in the handrail. Rather, the evidence is simply that the records were seen in the handrail and were not in anyone's possession at that moment in time. Count II of the complaint was concerned with the temperature of certain foods being prepared for distribution to patients. Foods for patients are supposed to be kept at certain required temperatures. There is a "danger zone" for foods which starts at 40 degrees Fahrenheit and ends at 141 degrees Fahrenheit. Temperature, along with time, food and environment, is an important factor in preventing contamination of food and the development of bacteria. Surveyor Mary Ruth Pinto took part in the survey. As part of her duties, she asked hospital staff to measure the temperature of foods on the serving line. She found some peaches at 44 degrees, yogurt at 50 degrees, and cranberry juice at 66 degrees Fahrenheit. According to Pinto, the hospital's refrigerator temperatures were appropriate, so it was only food out on the line that was at issue. Pinto remembers talking to the hospital dietary manager and remembers the dietary manager agreeing to destroy the aforementioned food items. The hospital policies and procedures in place on the date of the survey were consistent with the U.S. Food and Drug Administration Food Code concerning the storage, handling and serving of food. The policies acknowledge the danger zone for foods, but allow foods to stay within the danger zone for up to four hours. In the case of the peaches and yogurt, neither had been in the danger zone for very long (not more than two hours). The cranberry juice was "shelf stable," meaning that it could be stored at room temperature. The food services director for the hospital remembers the peaches and yogurt being re-chilled in a chill blaster. She does not believe any of the food was destroyed. Count III of the complaint addressed whether an unauthorized person had access to a room where medications were being stored. A state surveyor, Gary Furdell, was part of the survey team on January 5, 2009. Furdell was touring the second floor of the hospital when he noticed a locked door. Furdell asked a hospital medical technician who was standing nearby about the door. The medical technician gave Furdell the code to unlock the door. Furdell peeked inside and noticed bottles that he presumed were medications. It would be a violation for a medical technician to have access to medications, because medical technicians cannot distribute drugs. The room Furdell looked into is a "mixed use" room located behind a nursing station. A mixed use room is used to store medical supplies, including medications, as long as there is a locked cabinet in the room for that purpose. This particular mixed use room had a locked cabinet. The room is used for the preparation of medications and for other purposes. No narcotics were stored in this particular mixed use room. The room contained locked cabinets used to store other medications. The evidence presented was insufficient to determine what "medications" Furdell may have seen in the room. Count IV of the complaint concerned the nursing assessment of a patient, and whether the assessment was properly and timely performed. A patient, M.S., had been admitted to the hospital on June 18, 2008, for lung surgery. Following the surgery, Amiodarone (a very toxic drug which can cause clots and other complications) was administered to treat M.S. for heart arrhythmia. The Amiodarone was administered intravenously and M.S. developed blisters and irritation at the intravenous site. That is not an uncommon complication with Amiodarone. M.S.'s attending physician was notified about the irritation and prescribed a treatment. He also ordered a consult with an infectious disease specialist who ultimately changed M.S.'s antibiotics. Although M.S. was seen daily by her physicians, the nursing notes do not reflect the assessment and treatment of her blisters. It appears that proper care was rendered, but the care was not documented properly. Another patient was admitted to the hospital on December 15, 2008, with End Stage Renal Disease and diabetes mellitus for which she began dialysis treatment. The patient was not weighed before and after a particular dialysis treatment on January 5, 2009. However, the patient had been moved to an air mattress bed on that date for comfort. The air mattress bed did not allow for a weight to be taken as it could be on a regular bed. There is an allegation in the Administrative Complaint concerning the discontinuation of the calorie count for a patient. This issue was not discussed in AHCA's Proposed Recommended Order, nor was sufficient evidence of any wrong- doing concerning this matter presented at final hearing. During the survey, the hospital was found to be storing the medication Mannitol in blanket warmers, rather than in warmers specifically designed for the drug. The blanket warmers maintained the Mannitol at 100-to-110 degrees Fahrenheit. The manufacturer's label on the drug calls for it to be dispensed (injected) at between 86 and 98.5 degrees Fahrenheit. In order to meet this requirement, the hospital takes the drug out of the blanket warmer in time for it to cool sufficiently before it is injected. There is nothing inherently wrong with using a blanket warmer to store Mannitol. On January 5, 2009, a surveyor found two vials of Thrombin, one vial of half-percent Lidocaine and Epi, and one vial of Bacitracin in operating room No. 4. The operating room is within the secured and locked suite of surgical rooms on the second floor. Two of the vials had syringes stuck in them and one of them was spiked. Whoever had mixed the medications was not attending to them at the time the surveyor made her observation. There were two unlicensed technicians in the room preparing for the next surgery. A registered nurse anesthetist was present as well. There was no identifying patient information on the medications. The hospital's policies and procedures do not require the patient's name to be on the label of medications prepared for impending surgery. That is because the procedures for the operating room include a process for ensuring that only the correct patient can be in the designated operating room. There is a fail-safe process for ensuring that only the proper patient can receive the medications that are set out. At around 2:45 p.m. on January 5, 2009, there were patient records in the emergency department showing that several drugs had been administered to a patient. The surveyor did not see a written order signed by a physician authorizing the drugs. When the surveyor returned the next morning, the order had been signed by the physician. The hospital policy is that such orders may be carried out in the emergency department without a doctor's signature, but that a physician must sign the order before the end of their shift. AHCA cannot say whether the physician signed the order at the end of his shift or early the next day. Count V of the complaint was voluntarily dismissed by the Agency. Count VI of the complaint concerned the status of certain patient care equipment, and whether such equipment was being maintained in a safe operating condition. A patient was weighed at the hospital upon admission on December 27, 2008, and found to weigh 130 pounds using a bed scale. Six days later, on January 2, 2009, the patient's weight was recorded as 134 pounds. Two days later, in the same unit, the patient weighed 147 pounds and the next day was recorded as weighing 166 pounds. During the survey process, the patient was weighed and recorded at 123 pounds on a chair scale. The hospital does not dispute the weights which were recorded, but suggests there are many factors other than calibration of the equipment that could explain the discrepant weights. For example, the AHCA surveyor could not say whether the patient sometimes had necessary medical equipment on his bed while being weighed, whether different beds were involved, or whether any other factors existed. AHCA relies solely on the weight records of this single patient to conclude that the hospital scales were inaccurate. Case No. 09-5365 On February 18, 2009, AHCA conducted a licensure survey at Gulf Coast. Count I of the complaint from this survey concerned the timeliness of triage for a patient who presented at the hospital emergency department with stroke-like symptoms. AHCA surveyors witnessed two patients on stretchers in the ambulance entrance hallway leading to the emergency department. Each of the two patients had been brought in by a separate emergency medical service (EMS) team and was awaiting triage. One patient was taken to an emergency department room (ER room) 50 minutes after his/her arrival at the hospital. The other patient waited 45 minutes after arrival before being admitted to an ER room. Meanwhile, a third patient arrived at 2:20 p.m., and was awaiting triage 25 minutes later. During their observation, the surveyors saw several nursing staff in the desk area of the emergency department, i.e., they did not appear to be performing triage duties. The emergency department on that date was quite busy. That is not unusual during February, as census tends to rise during the winter months due to the influx of seasonal residents. A summary of the action within the emergency department from 1:00 p.m. to 3:00 p.m., on the day of the survey shows the following: Patient L.G., 74 years old with stable vital signs, was radioed in by her EMS team at 1:08; L.G. was processed into the ER at 1:21 (which is not an unreasonable time; EMS teams call in when they arrive at or near the hospital. By the time they gain access, wait their turn if multiple ambulances are present, and get the patient inside, several minutes may lapse). L.G. was stabilized and quickly reviewed by ER staff, then officially triaged at 2:04. Patient H.M., an 89-year-old male residing in a nursing home, arrived at 1:20 and was processed in at 1:59. He was triaged at 2:01, but ultimately signed out of the hospital against medical advice. Patient E.M. arrived at 2:18 and was processed at 2:25. Triage occurred one minute later. This patient presented as a stroke alert, and hospital protocol for that type patient was followed. Patient C.J. arrived at 1:08 and was processed at 2:38. Triage occurred immediately after C.J. was processed. This patient was not stroke alert, but had some stroke-like symptoms.1 C.J. had not been transported to the hospital as emergent, because the symptoms had been going on for 24 hours. Patient W.M., an auto accident victim, arrived at 1:40 and was processed at 1:49. Triage occurred within six minutes. Patient M.M., W.M.'s wife (who had been with M.M. in the automobile accident, but was placed in a separate ambulance), arrived at 2:06 and was triaged at 2:34. There is no record of when M.M. was processed. Patient L.M. came to the hospital from a nursing home. She arrived at 1:43 and was processed at 2:35. L.M. was triaged at 2:37. Patient K.M. arrived at 2:45 and was processed within three minutes. Triage occurred at 2:52. Her triage was done very quickly due to the condition in which she arrived, i.e., shortness of breath and low oxygen saturation. Patient R.S. arrived at 1:00 and was triaged at 1:15. The aforementioned patients represent the patients presenting to the emergency department by ambulance during a two-hour period on a very busy day. It is the customary procedure for ER staff to make a quick visual review (rapid triage) of patients as they come into the hospital. Those with obvious distress or life-threatening conditions are officially triaged first. Others, as long as they are stable, are allowed to wait until staff is available for them. As part of their duties, nurses necessarily have to be in the desk area (nursing station) in order to field phone calls from physicians concerning treatment of the patients who present. It is not unusual or improper for nurses to be in the nursing station while residents are waiting in the processing area. It is clear that some patients waited a much longer time for triage than others. However, without a complete record of all patients who presented that day and a complete review of each of their conditions, it is impossible to say whether the hospital was dilatory in triaging any of them. Count II of the complaint addressed the nursing staff and whether it failed to assess and intervene in the care of a patient or failed to implement a physician's plan of care for the patient. Patient D.W. was a 67-year-old female who was morbidly obese, diabetic, debilitated, had end stage renal disease, and was receiving dialysis. Upon admission, D.W. had a Stage 3 pressure ulcer to her sacrum and a Stage 4 ulcer on her left calf. A wound care protocol was initiated immediately, and a Clinitron bed was obtained for her on the day of admission. Due to the seriousness of her condition, the wound care physician declined to accept her case at first. He later ordered Panafil, and it became part of the protocol for treating the patient. The nursing documentation for D.W. was only minimally sufficient, but it does indicate that care was provided. Patient R.H. was an 83-year-old male who presented on February 10, 2009, in critical condition. R.H. was suffering from congestive heart failure, pneumonia, and respiratory failure. Due to the critical nature of his respiratory problems, R.H. was placed on a ventilator. As a ventilator patient, he did not fit the profile for obtaining wound care. Nonetheless, the hospital implemented various other measures to deal with R.H.'s pressure wounds.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by Petitioner, Agency for Health Care Administration, imposing a fine in the amount of $500.00 in DOAH Case No. 09-5363 and a fine in the amount of $500.00 in DOAH Case No. 09-5364, Count VI. DONE AND ENTERED this 30th day of April, 2010, in Tallahassee, Leon County, Florida. R. BRUCE MCKIBBEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of April, 2010.
The Issue At issue is whether the Respondent committed the offenses set forth in the Corrected Administrative Complaint and, if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency responsible for regulating the practice of medicine in Florida. Respondent is, at all times material to this case, a licensed physician in the state of Florida and employed by Bennett Family Practice in Boca Raton, Florida. He has no prior disciplinary history, and had been uneventfully licensed to practice medicine in Florida since 1994. C.R. became a patient of Bennett Family Practice on April 21, 2000. She saw medical professionals other than Respondent for a couple of minor matters prior to the office visit which gives rise to this case. On July 9, 2001, C.R. went to Bennett Family Practice in order to seek an MMR vaccination in furtherance of her application to do graduate work at Florida Atlantic University (FAU). FAU required that prospective students obtain this vaccination, as part of the application process, or obtain documentation of a medical excuse to forego the vaccination. The portion of the application package dealing with medical issues, including vaccinations, contains a warning that pregnant women, or women who are attempting to conceive, should not be vaccinated. On July 9, 2001, C.R. was over 34 years old, and newly pregnant. Pregnancy is one of several contraindications to the administration of an MMR vaccine. Other contraindications include certain allergies, and HIV positive status. Murry made no effort to determine what, if any, of these contraindications might be present. No factual circumstances existed at the time which would have justified the administration of the vaccine to C.R. while she was pregnant. C.R. brought to her appointment an FAU immunization form. The form contained four pages with six parts and directed the student or parent to fill in the first three parts on the first two pages and the health care provider to fill in the remainder. C.R. filled in the parts for the student or parent; however, she had not read nor filled out any other portion of the four page form. Murry testified to his expectation that a well educated patient, which C.R. undisputedly is, “should” have read the form she came in with. However, Murry did not communicate that expectation to C.R. It is the responsibility of the physician to take reasonable measures to ascertain the existence of contraindications to administering a vaccination, including the pregnancy status of a woman of childbearing age who seeks an MMR vaccination, yet Murry failed to take any measure directed at obtaining this basic information. More specifically, the Center for Disease Control (CDC) advises that “. . . women of childbearing age should receive rubella-containing vaccines . . . only if they state that they are not pregnant and only if they are counseled not to become pregnant for 3 months after vaccination.” C.R. made no such statement and did not receive the counseling recommended by the CDC. In some practices, including Murry’s, office protocol requires that patients be provided with an information form concerning the risks, benefits, and contraindications for the vaccination. Where this procedure is employed, it remains the physician’s responsibility to take the steps necessary to assure that the patient has in fact read the form, and understands it. Once the doctor affirmatively determines that a female patient of childbearing age is not pregnant, and has been appropriately counseled not to become pregnant for three months, the standard of care further requires that this information be documented in her medical record. Because neither Murry nor an appropriately trained staff member discussed with C.R. the issue of pregnancy as it relates to a woman of childbearing age seeking the MMR vaccination, it follows that her patient chart does not reflect any information on the date she received the vaccine relating to her pregnancy status. Murry's office protocol does not call for either the doctor or the medical technician who prepares and gives the vaccination to document that the patient read the information sheet and understood it. Thus, there is no way to be sure that, on a busy day, the protocol was followed. In this case, the greater weight of evidence suggests that it was not. The vaccination was given to C.R. by certified medical assistant Josette Lewis-Harris (Lewis-Harris). On an average day, Lewis-Harris sees as many as 40 patients. Lewis-Harris claims to have given C.R. an MMR information form. C.R. denies that. In weighing the conflicting evidence on this point, the undersigned had the opportunity to closely observe the demeanor of C.R. and Lewis- Harris and to consider their demeanor while testifying in light of their opportunity and motivation to fully and completely recall the details of C.R.'s July 9 visit. Also taken into account is the testimony of Murry and one of his partners, whose testimony concerning office protocols for vaccinations left room for doubt that medical technicians at Bennett Family Practice are appropriately trained to be the safety net to ensure that vaccinations are not administered where contraindicated. Lewis-Harris does not recall many details about her brief encounter with C.R., while C.R. states unequivocally that no Bennett employee provided her with a form to read. The form which Murry contends was provided to C.R. in accordance with office protocol does state that pregnant women should not have the vaccination; however, the form is dominated by sketches of a little boy and a baby, and is, by its own title, directed to parents of young children. The form is titled M M AND R Vaccine (MMR) and subtitled, "What you need to know before you or your child gets the vaccine." Nothing about the form would attract the attention of a woman who thought herself to be pregnant, or who was attempting to become pregnant. Because C.R. was one of as many of 40 patients encountered that day by Lewis-Harris, the tribunal credits the memory of C.R. as being more accurate on the matter of whether Lewis-Harris provided C.R. with the form. However, even if C.R. had been furnished the form, it would not absolve Murry of liability for violating the standard of care, where, as here, Lewis-Harris admits that she never asked C.R. if she might be pregnant. C.R. was not counseled not to become pregnant, and no contemporaneous documentation exists to establish that C.R. was given the form which explains the dangers of the MMR vaccine, and that she was cognizant of the section of the form which discussed pregnancy. More fundamentally, the evidence failed to establish that the responsibility for averting a possibly life threatening consequence can be shifted onto a patient in the manner suggested by Respondent, no matter how well educated the patient might be. Lewis-Harris testified somewhat ambiguously about C.R. having expressed reluctance to get the shot. Yet, Lewis-Harris did not alert Murry to that reluctance. If in fact Lewis- Harris’ memory on this point is accurate, it further underscores the inadequacy of Murry’s supervision of the potentially dangerous process of administering vaccinations. A patient who expresses reluctance to receive a vaccine warrants scrutiny and evaluation which is beyond the training of a medical technician. In failing to make any effort to ascertain C.R.’s pregnancy status, and to counsel her that, as a woman of childbearing age, she should take care not to become pregnant for three months following administration of the MMR vaccine, Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. In reaching the factual determination that Murry violated the standard of care under the unique facts of this case, careful consideration was given to the testimony of the expert witnesses for both sides. Dr. Libert, Petitioner's expert witness, testified that Murry's conduct did not meet the required standard of care. His testimony was credible. The testimony of Respondent's expert was discredited by his imprecise grasp of the facts of this case and his unwillingness to render unqualified testimony. For example, Respondent’s expert, under direct examination by Murry’s attorney, was asked if he was “familiar with what the standard of care requires for the administration of MMR vaccine.” He attempted an answer, but qualified it by saying "again this is out of my field of course.” This qualification did nothing to bolster confidence in his opinion that ordering the MMR vaccination for CR was within the standard of care. Murry's expert further discredited himself when he stated that “since the patient had received printed literature for her and her husband to review, that there was no breach of the standard of care.” There is no record evidence that C.R.’s husband was present on July 9, 2001, and, in any event, the evidence established that C.R. is a competent adult, thus, the duty of care was owed to her, and not her husband. On balance, the testimony of Petitioner’s expert is the more credible and persuasive and is given greater weight. That testimony, and the record as a whole, amply supports the conclusion that it is not within the standard of care to rely exclusively upon a form document when the answer to one direct question might avoid possible catastrophic consequences. Additionally, the evidence established that an MMR vaccine is a legend drug, which was inappropriately prescribed under the facts and circumstances of this case. After she received the vaccination, C.R. learned of the contraindication and telephoned Murry’s office. Murry arranged for her to be seen by an obstetrician, but C.R. chose not to continue care with Murry and his partners. Murry argues that C.R.’s fetus likely did not suffer any actual injury by reason of the vaccination. Be that as it may, the standard of care was violated when the vaccination was given. What happened after is irrelevant. Neither can any inference in Murry's favor be drawn from C.R.'s refusal to follow his suggestion as to whom to consult for follow-up care.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law and upon consideration of the Recommended Range of Penalty under Rule 64B8-8.001(2), Florida Administrative Code, and Aggravating and Mitigating Circumstances under Rule 64B8- 8.001(3), Florida Administrative Code, it is RECOMMENDED that the Board enter a final order finding Respondent guilty of the charges outlined in the Administrative Complaint and imposing the following penalties: A reprimand; An administrative fine of $20,000 (consisting of $10,000 for the standard of care (t) violation and $5,000 each for the medical records (m) and legend drug (q) violations); Continuing medical education classes specified by the Board; Corrective action with respect to office protocols for determining if vaccinations are appropriate to the particular patient; A refund of all fees paid by C.R. and/or her insurer for services rendered on July 9, 2001. One year of probation, with terms set by the Board. It is further RECOMMENDED that the Board should also impose costs associated with the investigation and prosecution of this case in compliance with Section 456.072(4), Florida Statutes. DONE AND ENTERED this 10th day of June, 2003, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS 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 10th day of June, 2003. COPIES FURNISHED: Irving Levine, Esquire Department of Health 4052 Bald Cypress Way Bin C-65 Tallahassee, Florida 32399-3265 Jon M. Pellett, Esquire Barr, Murman, Tonelli, Slother and Sleet, P.A. 201 East Kennedy Boulevard Suite 1700 Tampa, Florida 33602 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Dr. John O. Agwunobi, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701
