The Issue Should discipline be imposed against Respondent's license to practice medicine for violation of Section 458.331(1)(t), Florida Statutes (2003)?
Findings Of Fact Stipulated Facts Petitioner is the state department charged with the regulation of the practice of medicine pursuant to Chapter 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. Respondent is Michael D. Fox, M.D. Respondent is board certified in obstetrics and gynecology. Respondent is a licensed medical doctor in the State of Florida having been issued license ME 66312. Respondent's address is 3627 University Boulevard, South, Suite 200, Jacksonville, Florida 32216-4211. At all times material to this complaint, Respondent provided professional services as an employee of North Florida Gynecologic Specialists in Jacksonville, Florida. On or about September 26, 2003, Patient T.D. presented to Respondent with a history of worsening pelvic pain and abnormal menstrual bleeding. On or about October 6, 2003, Respondent and Patient T.D. agreed that Patient T.D. would undergo a hysterectomy. On or about October 22, 2003, during a pre-operative examination, Respondent ordered pre-operative lab studies, including a urine pregnancy test, for Patient T.D. On or about October 27, 2003, Respondent performed a total abdominal hysterectomy on Patient T.D. During Patient T.D.'s hysterectomy, Respondent took a specimen from Patient T.D., which was sent to pathology for evaluation. On or about October 29, 2003, a microscopic examination of the surgical specimen was performed that revealed Patient T.D. was pregnant at the time Respondent performed the hysterectomy on Patient T.D. Respondent did not ascertain the correct results of Patient T.D.'s pre-operative pregnancy test prior to performing the October 27, 2003, hysterectomy on Patient T.D. Respondent's Care of Patient T.D. Respondent attended medical school at the University of Alabama, Birmingham, Alabama. He did a four-year residency in obstetrics and gynecology (ob/gyn) in Jackson, Mississippi, and a two-year sub-specialty fellowship in reproductive endochrinology in Lexington, Kentucky. He is board-certified in reproductive endochrinology and ob/gyn. At present his specialty is reproductive endochrinology. Respondent has experience in performing hysterectomies and the pre-operative evaluations associated with those surgeries. Respondent does 30 to 40 hysterectomies a year. That number represented his experience in 2003. The principal reason for performing hysterectomies in his practice, is associated with sub-specialty interests, surgery for endometriosis and adenomyosis, a co-disease with endometriosis. Respondent has privileges to practice in hospitals in the Jacksonville, Florida area. In particular, he has privileges at St. Vincent's, St. Luke's, Baptist, Baptist Beaches, Memorial and Shands hospitals. He performs surgeries in all those hospitals. The hospitals where Respondent practices have computer systems that allow access to laboratory records and other forms of information associated with patient care. Although he has access to the computer systems in the facilities, his routine is to obtain laboratory information in the hospital setting from other persons involved in the patient care. He asks those persons to find out the information for him and report the finding(s). Respondent would have access to the patient hospital record, as well as a source for obtaining laboratory information. Respondent routinely looks at the patient hospital record in preparing for surgery. Concerning Patient T.D., the subject of this proceeding, when seen by Respondent she was described as a young female, of child-bearing age who presented with chronic pain. She had pain with periods which Respondent found to be characteristic of adenomyosis. She had pre-cycle pain approximately a week prior to her menses, another characteristic of adenomyosis. The patient had irregular bleeding that is an indication of adenomyosis. The patient was found to have an enlarged uterus, the primary source of her pain on the examination. This visit with Respondent, that formed the basis for his impression, took place on September 26, 2003. On the initial visit Respondent also obtained a history consistent with endochrine disorder causing irregular cycles. In the patient's case, the cycles extended as much as 60 days in relation to her periods. Based upon his initial impression, Respondent did not find evidence that Patient T.D. was pregnant. The patient told Respondent that she had no desire for fertility. At that time, she did not report having a partner, nor did she indicate that she was sexually active. To further evaluate the Patient T.D.'s condition and complaints, Respondent ordered an ultrasound test. That study was performed on October 2, 2003, and a gynecological ultrasound report rendered. Based upon the report, Respondent held to the view that the report showed evidence of adenomyosis. There was a mild and moderate enlargement of the uterus, which Respondent found to be consistent with adenomyosis. The patient had had a prior pregnancy and delivery and Respondent found the depiction on the ultrasound of a mild enlargement of the uterus consistent with the prior pregnancy and delivery. On their next visit, Respondent discussed the choice of a hysterectomy or some other form of surgery that did not involve a hysterectomy, to treat the endometriosis and relieve her symptoms. That visit took place on October 6, 2003. On October 22, 2003, Respondent met the patient again. He reviewed the details of what he believed was the underlying disease and potential treatments in discussion with the patient. The patient indicated that she wanted to proceed with the hysterectomy. That choice having been made, the surgery was discussed between the patient and Respondent and the necessary paperwork was started to arrange for the surgery in the hospital. When preparing for surgery Respondent ordered a pregnancy test to verify whether the patient was pregnant or not. The nature of the test was a urine pregnancy test under Respondent's preoperative orders given October 22, 2003. The specimen was collected on October 22, 2003, and received by Memorial Hospital (Memorial), Jacksonville, Florida, where the hysterectomy was to be performed. The test result was positive for pregnancy. The point in time that the result was revealed to Respondent will be discussed beyond this reference to the result. On October 27, 2003, Respondent began his surgery cases at Memorial at 7:30 a.m. On that date there was no indication in the patient record or chart maintained in his office practice that reflected information concerning the pregnancy test result, nor was that information found in the hospital chart related to Patient T.D. Absent the information, Respondent testified that he asked the circulating nurse at Memorial about the result of the pregnancy test. That was Tracy Lloyd, R.N. According to Respondent, the nurse went away to check the result and as Respondent describes "subsequently told me it was negative." No further effort was made by Respondent to confirm the oral report that Respondent says was made by the nurse. Respondent did not document the results of Patient T.D.'s pre-operative pregnancy test in the medical record. It was not his habit to write that type of a pre-operative note. Respondent testified that Ms. Lloyd told him about the pregnancy test results while in the holding area in the presence of the patient. Respondent commented that his question to the nurse would have been "What are the results of the pregnancy test?"1/ Aside from the results of the pregnancy test, nothing in the patient's condition, known to Respondent, led him to believe that the patient was pregnant. When the laparoscopic surgery commenced, Respondent did not perform an examination of the patient under anesthesia, given his recent examination of the patient in his office and the results of the ultrasound. Moreover, Respondent does not believe that such an examination under anesthesia would reveal anything other than the adenomyosis and the endometriosis which conformed to his preoperative diagnosis. On that subject, the later examination of the specimen on October 29, 2003, revealed that Patient T.D. had an early pregnancy, estimated as 4 to 5 weeks. In Respondent's opinion, in a 4-to 5-week pregnancy, the uterus would not normally achieve the size of a uterus that was reported on the ultrasound as mildly enlarged, not pregnant. Mildly enlarged refers to a 6 to 8 weeks' pregnancy. Respondent expected to see an enlarged uterus because of the adenomyosis which could be anticipated to cause an inflammatory response in the wall of the uterus, softening the uterus and giving it an appearance that would be similar to an early pregnancy. The rounded globular description of the findings during surgery were consistent with the expectations in addressing cases involving adenomyosis, according to Respondent. Returning to the surgical specimen obtained in Patient T.D.'s case, it was examined through surgical pathology conducted by Robert E. Barnes, M.D. A report was rendered. The report explains that in the examination of the specimen, the endometrium, "gestational endometrium with products of conception" were present. This was the finding related to Patient T.D.'s pregnancy. Dr. Barnes, is a board-certified pathologist in anatomic and clinical pathology. He describes his findings pertaining to Patient T.D., the gestational endometrium with products of conception, as referring to an early embryo, the endometrium showing changes associated with pregnancy. In his opinion the pregnancy was between 10 and 16 days following conception. When Dr. Barnes contacted Respondent on October 29, 2003, to advise of his findings in the pathology. It was a brief conversation and he does not recall the details. After the revelation concerning the pathology, Respondent's office staff found the information concerning the results of the urine pregnancy test in the hospital chart retained in the computer at Memorial. This finding was made around November 4, 2003. In a section within the report on the pregnancy test it refers to the "Result" and underneath that, the word "POSITIVE" is entered referring to pregnancy. When it was discovered that the hysterectomy had been performed while the Patient T.D. was pregnant, at her post- surgery scheduled office visit, a discussion was held with the patient concerning the "checks and balances" in place to avoid the problem. That refers to the surgery at a time the patient was pregnant. Respondent talked to the patient about counseling, or something similar, given the outcome in the case. As a result of the error, steps were taken within Memorial to address this circumstance. The Respondent and the Memorial Department of OB/GYN made changes, by requiring a pre- operative pregnancy test as protocol, that established a urine pregnancy test within 72 hours of surgery. That test would be performed by the nurses in the holding area. Respondent now orders a blood pregnancy test which is a more sensitive test to determine pregnancy. Expert Opinion Jose Cortes, M.D., is board-certified in ob/gyn, licensed to practice in Florida. He was recognized as a expert in ob/gyn for purposes of expressing his opinion about the care Respondent provided Patient T.D. Dr. Cortes has done hysterectomies in his practice, as recent as June 2006. He was called upon to render an opinion concerning the care Respondent provided Patient T.D. involving her hysterectomy. He had access to material concerning her care involved with this case. Dr. Cortes' impression of Respondent's medical treatment of the patient in the beginning, was that it was adequate and correct, with the proper evaluation performed and an appropriate decision made for surgery. Dr. Cortes expressed the opinion that in performing a hysterectomy on a woman who is of child-bearing age, which Patient T.D. was, a physician should order a pre-operative pregnancy test. In reviewing Patient T.D.'s records Dr. Cortes did not find a record documenting that the pregnancy test was ascertained by Respondent, referring to the test results. In his experience the results of the preoperative tests would be reflected in the patient's medical records as a matter of custom. Respondent, according to Dr. Cortes, could have obtained the results of the pre-operative pregnancy test for Patient T.D. by a fax to his office, a copy obtained through a computer, laboratory printouts sent to Respondent's office, and a copy of the pre-operative laboratory results obtained by the hospital placed in its medical record. Dr. Cortes stated the position that an experienced ob/gyn, and Respondent fits that category, could reasonably be expected to rely upon an oral report from a nurse as to the results of the pregnancy test, before entering the operating room, in the area of the pre-operative alcove as the patient is being interviewed by the physician. Dr. Cortes goes on to explain that if the conversation with the nurse in the presence of the patient was in the operating room holding area, then the pregnancy test results would have to have been documented in the patient chart to find the oral report acceptable. Those test results as reported would have had to be entered by the physician in the patient chart to meet the standard of care upon the oral report.2/ Later on, Dr. Cortes in his testimony seems to subscribe to the view that an oral report by the nurse as to the pregnancy test results would meet the standard of care, assuming that the Respondent in this case was provided an oral report. In the testimony at hearing, Dr. Cortes also said that obtaining an oral report or verbal report on test results, in an emergency situation, would meet the standard of care. By contrast, in elective surgery, such as that being performed on Patient T.D., it would be such that there was ample time to review a chart and laboratory studies before the patient was brought into the surgical suite. Generally stated, Dr. Cortes accepts that physicians frequently rely upon oral information imparted by nurses in performing surgeries, be they elective or emergent, but without an oral report this concession is not important. Regardless of the pre-conditions for Respondent to receive and rely on an oral report of the results of the pregnancy test, without an oral report, there being no other basis for Respondent's knowledge of the pregnancy test results, it was below standards to proceed with the hysterectomy. This view is taken from Dr. Cortes' testimony. Dr. Cortes expressed the opinion that it was below the standard of care to not ascertain the results of the patient's pre-operative pregnancy test prior to performing a non-emergent hysterectomy, that is an elective hysterectomy. Dr. Cortes expressed the opinion that it was below the standard of care for Respondent to perform a hysterectomy on Patient T.D. while she was pregnant in an elective setting. In addition to the results of the pregnancy test, Dr. Cortes believes that Respondent had other opportunities to detect the pregnancy, including an examination of the patient while she was under anesthesia during the surgery, and would have allowed a comparison of the results at the time of surgery against previous examinations that Respondent had performed on the patient. In referring to the previous examinations compared to an examination under anesthesia, this included the results of the ultrasound performed on October 2, 2003. Dr. Cortes does agree that the underlying condition visualized under anesthesia could be associated with prior pregnancy or the pre-operative diagnosis of adenomyosis. Dr. Cortes believes that Respondent's medical records, in the context of what could have been found upon an examination under anesthesia during the surgery, could be consistent with a possible pregnancy. A change seen in the pelvic examination at surgery would create an opportunity to evaluate and raise in the Respondent's mind any doubt concerning pregnancy. A slight increase in the size of the uterus between September 26, 2003, and October 27, 2003, is what is being referred to, promoting clinical judgment about possible pregnancy. Bryan Cowen, M.D. specializes in ob/gyn and reproductive endochrinology. He practices at the University of Mississippi in Jackson, Mississippi. He is a professor and chair in the Department of OB/GYN and has been for five years. He has been affiliated with the University of Mississippi for 24 years. He did his undergraduate work at the University of Colorado in Boulder, Colorado, and attended medical school in Denver, Colorado. Dr. Cowen is licensed to practice medicine in Mississippi and is board-certified. Dr. Cowen has performed a number of hysterectomies during his career. Dr. Cowen is familiar with the standard of care applicable for physicians such as Respondent, in the evaluation of patients suspected of endometriosis and adenomyosis and the considerations for treatment by hysterectomy. He is also familiar with the standard of care in relation to pre-operative testing and the associated duties of physicians when ordering such tests. In preparing to testify in this case, Dr. Cowen examined the Memorial medical records, Respondent's office records, and the depositions of Respondent, Dr. Freeman, Dr. Widrich, Dr. Barnes, and Dr. Cortes. With this information in mind, Dr. Cowen was able to provide an opinion concerning the standard of care in relation to the treatment provided by Respondent to Patient T.D. That opinion was that Respondent did not breach the standard of care in that he met due diligence in the process by the pre-operative laboratory-ordered, and pre- operative evaluation and assessment. Speaking to the September 26, 2003, office visit, Dr. Cowen saw nothing on the physical examination to indicate to him that Patient T.D. was pregnant. Concerning the ultrasound that was conducted on October 2, 2003, Dr. Cowen's opinion is that Respondent's assessment that Patient T.D. had adenomyosis based upon presentation, was confirmed by the ultrasound, the overall impression being that the Patient T.D. was not pregnant at that time. The further visit by the patient prior to the hysterectomy did not reveal anything in the history or physical examination that would suggest that Patient T.D. was pregnant, according to Dr. Cowen. On October 22, 2003, the pregnancy test was ordered by Respondent. The arrangement of ordering the test, sending the patient for pre-operative evaluation and laboratory tests is a common practice in Dr. Cowen's experience. In the instance where Respondent did not get a call from the pre-admission testing as to any abnormal results in the pregnancy test, and no report reflecting in the patient chart that the results were normal, Dr. Cowen commented on the need to check the laboratory results before taking the patient into the operating room. Based on Dr. Cowen's experience, there was no necessity to personally lay eyes on the test results to ascertain those results. He recognizes that his hospital may be different from Memorial in its expectations but he believes that Respondent followed Memorial's policy in accepting the report of a nurse as to the results of the pregnancy test. Dr. Cowen's opinion relies upon the factual predicate that Respondent was told by a nurse that the pregnancy test was negative, to the extent that is not true, and it has not been found as a fact, his opinion is without foundation. Further, Dr. Cowen believes that in the setting where surgery is being performed in other than an emergency, it is a sufficient practice to rely upon an oral report of a nurse concerning laboratory results, such as the outcome in the pregnancy test for Patient T.D. In his experience he has relied upon nurses to report both in an emergent and non-emergent settings. He goes on to describe how those reports come back to the medical records and the physician signs off, which did not occur in this case. Dr. Cowen was asked to express his opinion about the value of an examination under anesthesia as an assist to understanding the underlying condition of the Patient T.D. Dr. Cowen does not believe that this would provide additional information. In his experience most physicians have abandoned examinations under anesthesia. If a better insight is needed an ultrasound is the best choice. To Dr. Cowen, an examination under anesthesia does not relate to standard of care, it is in relation to an individual practitioner's protocol. An ultrasound used in this case, a transvaginal ultrasound, may have shown the gestational sack at the time of the hysterectomy but proceeding on the basis that a negative pregnancy test had been established and other findings during the course of the operation, as well as the preoperative record, would not indicate the necessity for an ultrasound in this case, at that time, the place in time where the hysterectomy was being performed. Dr. Cowen did not find anything in the intra-operative findings that would suggest to Respondent that the Patient T.D. was pregnant. Overall Dr. Cowen believes that Respondent met the standard of care in addressing the case of Patient T.D., who probably had polycystic ovarian disease, irregular cycles, was without a sexual partner by history, used condoms for contraception, had an ultrasound that confirmed a slightly enlarged uterus and had symptoms compatible with adenomyosis or endometriosis. Respondent discussed the treatment options, made an appropriate pre-operative evaluation, learned that the lab results for pregnancy were negative (an erroneous assumption), and therefore, he met the standard of care, according to Dr. Cowen. Ultimately, Dr. Cowen believes that it is essential to determine whether a patient is pregnant prior to performing a non-emergent/elective hysterectomy, which was not done here. Wyatt McNeill, M.D., testified. He is an ob/gyn practicing in Jacksonville, Florida, who in the past has had privileges at Memorial. He has performed hysterectomies at that facility. Dr. McNeill graduated from Florida State University. He graduated from the University of Miami Medical School. He is licensed in the state of Florida and is board-certified in ob/gyn. Dr. McNeill is familiar with the standard of care in relation to preoperative laboratory work done before a hysterectomy. Dr. McNeill is familiar with the standard of care applicable to Respondent in the evaluation of Patient T.D. for hysterectomy, knowing after the fact that the patient was found to be pregnant. To familiarize himself with the facts of this case, Dr. McNeill examined the hospital records of Memorial, Respondent's office records, various depositions, to include that of Dr. Cortes and the anesthesiologist and pathologist, before providing testimony. He also examined the testimony of the nurses involved in the care before offering his opinions. Concerning the patient history, objective and subjective evidence available, Dr. McNeill did not believe that there was anything to suggest that Patient T.D. was pregnant. In particular, Dr. McNeill comments on the history and physical done by Respondent, counseling, laboratory evaluation, and the decision beyond that to proceed with the surgery. Dr. McNeill found the ultrasound results consistent with a patient, who by history had a previous child and had the complaints expressed in the report concerning the September 26, 2003, visit with Respondent. Nothing in the ultrasound results compared to the findings in the operative report indicated to Dr. McNeill that the patient needed to be examined under anesthesia. The use of the examination under anesthesia is a training regimne for residents and students, in his experience. It has no utility beyond that application, in Dr. McNeill's opinion. Dr. McNeill believes that an oral report of the results of the pregnancy test meets the standard of care. As with others, Dr. McNeill assumes that Respondent was told the test results, which is not found. There was no further duty by Respondent to investigate those results having been told. In Dr. McNeill's opinion, the test results are either positive or negative, they are highly accurate. A negative test result means that the patient is not pregnant. No further duty is established beyond that realization, according to Dr. McNeill. In summary, there is no disagreement among the experts that Respondent is expected to ascertain the results of the preoperative pregnancy test before performing the hysterectomy and it would be inappropriate to perform the hysterectomy without those results. Respondent does not disagree with that perception. Conceptually, having considered the testimony of Respondent and the experts, it would be acceptable to proceed on an oral report, if one had been made, a report that the pregnancy test was negative.3/ Otherwise, the physical examination of the patient prior to surgery, the results of the ultrasound, and the observations intra-operatively made by Respondent did not indicate that the patient was pregnant. There was no necessity to make an examination under anesthesia. Even if made, it would not necessarily lead to the conclusion that the patient was pregnant, taking into account other information known by Respondent. Mitigation/Aggravation The outcome here was that the patient underwent a hysterectomy when she was pregnant, an adverse result. There is no indication that Respondent has ever been disciplined in Florida or other jurisdictions while practicing medicine.
Recommendation Based upon the findings of facts found and the conclusions, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes (2003), and imposing an administrative fine of $10,000.00, requiring Respondent to take a course on Risk Management for physicians, and issuing a letter of reprimand. DONE AND ENTERED this 22nd day of June, 2007, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 22nd day of June, 2007.
The Issue Whether the license of Respondent should be suspended, revoked, or whether the Respondent should be otherwise disciplined.
Findings Of Fact Upon consideration of the evidence introduced and the testimony elicited, the following facts are found: Am administrative complaint was filed against Respondent Ponte by the Petitioner, Florida State Board of Nursing, on May 26, 1978 seeking to place on probation, suspend or revoke the LPN License No. 38103-1 held by Respondent Beverly Ceraldi Ponte. The complaint was amended at the public hearing to delete allegation number 5. "Respondent, while being searched at the women's annex of the jail, was found to be in possession of one glass vial of promethazine, a prescription drug." The complaint alleged that the Respondent, on several occasions, signed out for controlled narcotics for patients in her care and failed to properly account for the disposition of said narcotics; that Respondent converted a narcotic controlled substance to her own use and admitted to Dade County Police officers the theft of the drug; and that Respondent had in her possession at the time of her arrest a large quantity of syringes (tubex of from 50-75 milligrams of demerol) consisting of a total of 24, of which 7 were empty. The Respondent Beverly Ponte, a Licensed Practical Nurse, was employed at the Miami Heart Institute on January 16, 1978. On that date she signed out for a controlled narcotic, demerol, the generic term being meperedine, for four patients in her care. The medication sheets for the four patients failed to show that demerol or meperedine had been administered to the patients, and no disposition of the narcotics was shown by Respondent. On or about April 7, 1978 Beverly Ponte, the Respondent, was employed at Palmetto General Hospital in Hialeah, Florida. The evening supervisor, a Registered Nurse, was called at about 10:30 p.m. by one of the staff nurses to examine a narcotic sheet kept for patients under the care of the Respondent Ponte, the medication nurse on the shift that evening. The Vice President and Director of Nursing Service was then called and the police were notified that there was an apparent narcotic problem on the floor of the hospital. The police and the director questioned the Respondent. She was searched and on her person was found 24 syringes (tubexes or pre-loaded syringes) of the type used by the hospital. Respondent admitted that she had taken drugs that evening and could not tell the director which of the patients under her care had had medication. The Respondent was arrested and handcuffed. Thereafter an information was filed in the Eleventh Judicial Circuit Court in and for Dade County, Florida charging Respondent with possession of a controlled substance (meperedine) and charged with a count of petit larceny. The Respondent entered a plea of nolo contendre and was found guilty of possession of controlled substance and petit theft and was placed on probation for a period of eighteen months, beginning May 2, 1978, with a special condition that the Respondent not seek employment where she personally had access to narcotic drugs and to also complete the outreach program which is a drug rehabilitation program. The proposed order of the Respondent has been considered and each proposed fact treated herein. Evidence as to the adherence to the condition of probation, the present employment of Respondent, and whether Respondent should be allowed to sit for nursing license examination is insufficient and no finding is made in regard thereto. No memorandum or proposed order was submitted by the Petitioner.
Recommendation Suspend the license of Respondent Ponte. DONE and ORDERED this 21st day of November, 1978, in Tallahassee, Florida. DELPHENE C. STRICKLAND Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 COPIES FURNISHED: Julius Finegold, Esquire 1107 Blackstone Building Jacksonville, Florida 32202 Carl L. Masztal, Esquire Suite 806 Concord Building 66 W. Flagler Street Miami, Florida Norman Malinski, Esquire 2825 South Miami Avenue Miami, Florida Geraldine B. Johnson, R.N. Investigation and Licensing Coordinator State Board of Nursing 6501 Arlington Expressway, Building B. Jacksonville, Florida 32211 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE FLORIDA STATE BOARD OF NURSING IN THE MATTER OF: Beverly A. Ceraldi Ponte 3500 S. W. 47th Avenue CASE NO. 78-1142 West Hollywood, Florida 33023 As a Licensed Practical Nurse License Number 38103-1 /
Findings Of Fact Respondent, Ann Claycomb (Claycomb), was at all times material hereto a licensed practical nurse in the State of Florida, having been issued license number 39853-1. On December 24, 1987, Claycomb was employed as an agency nurse by Alpha Health Care, Inc., and was on assignment to Health South Rehabilitation, a skilled nursing and rehabilitation facility in Miami, Florida. While at the facility on that date, Claycomb worked the morning shift 7:00 a.m. to 3:30 p.m., and was assigned to the skilled nursing floor. The skilled nursing floor contained 20-25 elderly, though mostly alert patients. At the commencement of Claycomb's shift, it was her responsibility to administer medications to these patients which conformed with that prescribed by their medication administration record (MAR). Shortly after Claycomb began her rounds, Elaine Wood, the Unit Manager at Health South Rehabilitation, began to receive complaints from patients for what they perceived to be errors in the medicinal drugs administered or attempted to be administered to them by Claycomb. Upon investigation, the following medication errors were discovered. Claycomb administered what she believed to be two Tylenol tablets to patient H.B. Following administration, the patient became lethargic and her vital signs deteriorated but later returned to normal. Lethargy is not a side effect of Tylenol. Although the MAR prescribed two Slow K tablets at 9:00 a.m., and Lilbrax as needed, Claycomb recorded having administered one Slow K tablet and Atarax to patient H.R. Claycomb dispensed Atarax to patient A.J. at 9:00 a.m. when the MAR prescribed dose to be given at 1:00 p.m. Patient refused medication because given at the wrong time. In committing the foregoing medication errors Claycomb's practice fell below the minimal standards of acceptable and prevailing nursing practice in the administration of medicinal drugs. Verification of other complaints received by Ms. Wood could not be verified because, contrary to accepted and prevailing nursing practice, Claycomb did not annotate some patients' MAR upon dispensing medications.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a final order be entered suspending the license of respondent, Ann Claycomb, until such time as she submits proof satisfactory to the Board of Nursing that she can practice nursing safely. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 27th day of December, 1988. WILLIAM J. KENDRICK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of December, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 88-3603 Petitioner's proposed findings of fact are addressed as follows: 1. Addressed in paragraph 1. 2-4. Addressed in paragraphs 2 and 3. 5 & 6. Addressed in paragraphs 46. Addressed in paragraph 4c. Subordinate or not necessary to result reached. Not necessary to result reached. Not necessary to result reached. To the extent supported by competent proof addressed in paragraph 4. Proposed findings 11a and 11d are based on hearsay which does not supplement or explain any competent proof. 12-15. Not pertinent nor necessary to result reached. COPIES FURNISHED: Michael A. Mone', Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Ms. Ann Claycomb 4175 South West 98th Avenue Miami, Florida 33165 Lawrence M. Shoot, Esquire 6011 West 16th Avenue Hialeah, Florida 33012 Judie Ritter, Executive Director Board of Nursing 504 Daniel Building 111 East Coastline Drive Jacksonville, Florida 32201 Bruce D. Lamb, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue This is a license discipline case in which a medical doctor is charged by administrative complaint with five counts of violations of paragraphs (h), (k), (m), and (t) of Section 458.331(1), Florida Statutes (1988 Supp.).
Findings Of Fact Findings based on parties' stipulations The Respondent, Vladimir Rosenthal, M.D., (hereinafter "Respondent" or "Dr. Rosenthal") is, and at all material times was, a medical doctor, license number ME 0045574, who practiced at 1320 South Dixie Highway, Coral Gables, Florida. Dr. Rosenthal at all material times owned the business operating as Today's Women Medical Center located at 1320 South Dixie Highway, Suite 1070, Coral Gables, Florida. On or about November 3, 1988, Dr. Rosenthal performed an elective abortion on patient B.F. under general anesthesia. On or about November 3, 1988, Dr. Rosenthal ordered a pathology report of the products of the procedure performed on patient B.F. The pathology report regarding patient B.F. bears the date November 8, 1988. The pathology report revealed no chorionic villi and recommended a "close follow-up" of the patient. Missed abortion and continued pregnancy is a recognized risk of early (first trimester) abortions. Patient B.F. suffered no harm as a result of the November 3, 1988, procedure. On or about December 7, 1988, patient B.F. presented to Dr. Rosenthal. On or about December 7, 1988, patient B.F.'s uterus was examined and found to be enlarged. Subsequently, a repeat pregnancy test was performed on patient B.F., which revealed she was still pregnant. On or about December 10, 1988, Dr. Rosenthal performed a second abortion on patient B.F. with positive results. Patient B.F. suffered no harm as a result of the December 10, 1988, procedure. Findings based on evidence at hearing The Respondent specializes in the area of gynecology, but does not practice obstetrics. In the course of his medical practice he regularly performs first trimester abortions. The Respondent is very experienced in the performance of first trimester abortions. In recent years he has averaged five thousand (5,000) such procedures per year. Patient B.F. normally goes to Dr. Nahid Mansoori for routine treatment of gynecological matters. Patient B.F. was seen by Dr. Mansoori on October 28, 1988, with a history of a missed menstrual period. Dr. Mansoori examined the patient and observed that the patient had an enlarged uterus and appeared to be 5 or 6 weeks pregnant. The patient expressed an interest in having an abortion. Because Dr. Mansoori does not perform abortions, she referred patient B.F. to the Respondent. Dr. Mansoori also referred patient B.F. to Dr. Martin S. Goldstein for an ultrasound examination. Dr. Mansoori referred patients to the Respondent on a regular basis. She did so for several reasons, including the facts that (a) patients she referred to the Respondent uniformly reported back to her that they were pleased or satisfied with the services they received from the Respondent, (b) none of her patients had complained about their treatment by the Respondent, and (c) none of the patients she had referred to the Respondent had experienced any infection or problems. On October 31, 1988, Dr. Martin S. Goldstein performed an ultrasound examination of patient B.F. On the basis of that ultrasound examination, Dr. Goldstein concluded and reported that the "gestational age" of patient B.F.'s pregnancy was 6 weeks, 0 days. Dr. Goldstein also concluded and reported that patient B.F. had an intrauterine pregnancy, thus ruling out an ectopic pregnancy. On November 3, 1988, patient B.F. went to the Respondent's clinic at 1320 South Dixie Highway for the purpose of having an abortion. The Respondent remembers this particular patient because she was a medical professional and her husband was an attorney. Because of their respective professions, the Respondent was extra careful to explain everything involved in the process to both B.F. and her husband. He especially explained to both of them the importance of a post-abortion follow up examination at either the Respondent's clinic or at the office of the patient's regular gynecologist. Patient B.F. said that she would return to Dr. Mansoori, her regular gynecologist, for the follow up examination. When patient B.F. went to the Respondent's clinic on November 3, 1988, she told the Respondent that she had had an ultrasound examination. The Respondent called Dr. Mansoori and Dr. Mansoori told him that the results of the ultrasound examination indicated a "gestational age" 1/ of six weeks and that the ultrasound examination confirmed an intrauterine pregnancy. Dr. Mansoori also mentioned that her clinical examination of patient B.F. indicated a "gestational age" of five or six weeks. Upon manual examination of the patient, the Respondent concluded, and noted in the patient's medical record, that patient B.F.'s uterus was enlarged to a size consistent with a "gestational age" of five weeks. Later that same day, the Respondent performed an abortion procedure on patient B.F. Following the abortion procedure, patient B.F. took antibiotic medication for several days, which medication had been prescribed and/or dispensed by the Respondent. The Respondent ordered a pathology report of the products of the abortion procedure performed on patient B.F. on November 3, 1988. The Respondent does not order pathology reports on all of his patients, but he did so in this case because it was an early pregnancy, and also because he wanted to take extra care in view of the professions of B.F. and her husband. The pathology laboratory is supposed to call Dr. Rosenthal on all "abnormal" reports. Sometimes the laboratory fails to call and sometimes the laboratory fails to send a written report. The Respondent has established office procedures for handling laboratory reports to try to prevent any reports from going astray and to identify those that do go astray so that follow up activity may be taken. Pursuant to the Respondent's established office procedures, all laboratory reports received at the clinic must be seen and signed by the Respondent before being placed in a patient chart. When a patient returns for her follow up visit, the laboratory report is reviewed during the course of that visit. If a laboratory examination has been ordered, but there is no laboratory report in the chart at the time of the follow up visit, the laboratory is called by telephone. The Respondent usually makes these calls himself. Pursuant to the Respondent's established office procedures, missing laboratory reports for patients who do not return for follow up visits or who return to their regular physicians for follow up visits are picked up when monthly reports to the Department of Health and Rehabilitative Services are compiled and submitted. In order to complete these monthly reports, a log is kept of every patient who has an abortion procedure performed at the Respondent's clinic. The information kept in the log and reported to DHRS includes: the date of surgery, the estimated "gestational age" of the patient, whether a pathology report was ordered, the results of the pathology report, and the date the pathology report was received by the clinic. Such forms were in use at the time B.F. was a patient at the Respondent's clinic. If any pathology reports "fell through the cracks," they were picked up each month when the reports were prepared. The reports are usually prepared on the ninth or tenth of each month. The implementation of these office procedures for the purpose of following up on laboratory reports is sufficient to comply with applicable standards of medical care. The pathology laboratory prepared a report regarding the material removed from patient B.F. during the November 3, 1988, abortion procedure. The written laboratory report was dated November 8, 1988. The most significant finding noted on the laboratory report was "no chorionic villi." Because of this finding, the laboratory report also stated: "close follow up of patient is recommended." The significance of the notation of "no chorionic villi" is that it indicates that the pathology laboratory examination did not reveal evidence of any fetal tissue or other "products of conception." The need for close follow up in this instance is because the absence of chorionic villi can be due to a number of different things. 2/ On November 18, 1988, patient B.F. went to Dr. Mansoori's office for a post-abortion follow up visit. At that time the patient was complaining of a vaginal "yeast" infection, a not uncommon occurrence following a course of antibiotic medication. Dr. Mansoori treated the patient's "yeast" infection with a prescription for Monistat Vaginal Cream. Dr. Mansoori's medical records for that day also include the following notations regarding the patient B.F.: "Had abortion by Today's Woman. Post AB check up O.K." 3/ Dr. Mansoori told patient B.F. to get back in touch with her if the patient missed her next menstrual period. On December 6, 1988, patient B.F. called Dr. Mansoori to report that she had missed her menstrual period. Dr. Mansoori advised her to return to the Respondent and patient B.F. agreed to do so. Dr. Mansoori called the Respondent to advise him that patient B.F. would be returning because she had missed her menstrual period. Dr. Mansoori also arranged for another ultrasound examination to be performed on patient B.F. by Dr. Goldstein. On December 7, 1988, patient B.F. returned to the Respondent's clinic where she was seen and examined by the Respondent. Examination revealed that the patient's uterus was mildly enlarged. A pregnancy test administered that day indicated that the patient was still pregnant. On December 7, 1988, the Respondent realized that he did not have a report from the pathology laboratory, so he called the laboratory and was advised that the most significant finding of the pathology report was "no chorionic villi." The substance of the telephone conversation with the pathology laboratory was noted in the patient's medical record. When he made the telephone call to the pathology laboratory on December 7, 1988, the Respondent had not received the laboratory's written report dated November 8, 1988, 4/ nor had he been otherwise advised of the results of the pathology study of the materials removed during the November 3, 1988, abortion procedure. On December 8, 1988, Dr. Martin S. Goldstein performed a second ultrasound examination of patient B.F. On the basis of the second ultrasound examination, Dr. Goldstein concluded and reported that the "gestational age" of patient B.F.'s pregnancy was 11 weeks, 6 days. This second gestational age was three days older than one would have predicted based on the October 31, 1988, ultrasound examination. In both of the ultrasound examinations of patient B.F., Dr. Goldstein relied upon the "crown rump" measurement as the basis for his estimate of "gestational age." On December 10, 1988, when patient B.F. returned to the Respondent's office for the second abortion procedure, the Respondent conducted a clinical examination of the patient before commencing the procedure. On the basis of his own clinical examination of the patient, the Respondent was of the opinion that patient B.F.'s "gestational age" was 8 or 9 weeks. He reported this on the "Physical Exam" portion of the patient's chart by writing "8-9" beside the entry for uterus. After the patient was anesthetized and the Respondent could examine her while she was more relaxed, the Respondent further examined the patient's uterus and was of the opinion that its size corresponded to a "gestational age" of 8 weeks. He noted this opinion in the "Operative Notes" portion of the patient's chart. It was, and continues to be, the Respondent's opinion that his December 10, 1988, estimates of the patient's "gestational age" were correct. Although he was aware of Dr. Goldstein's ultrasound examination which reported a somewhat older "gestational age," the Respondent had confidence in his own clinical findings and relied on his own clinical findings, which he duly recorded in the patient's medical chart. Relying on his own estimate of "gestational age," the Respondent performed the abortion procedure on December 10, 1988, on patient B.F. with a number eight suction tip. The abortion procedure was accomplished successfully and without any difficulty or complication. A report from a pathology laboratory confirmed that the December 10, 1988, abortion procedure was successful. 5/ The prevailing standards of acceptable care do not require a physician to order a pathology examination of the material removed during the course of a routine first trimester abortion procedure. In an abortion procedure involving a very early pregnancy, a physician may wish to order such a pathology examination in order to be more certain as to the results of the procedure, but it is a matter of physician preference, rather than a requirement. A physician who orders a pathology examination of the material removed during a first trimester abortion procedure has an affirmative duty to follow up on the examination and find out the results of the examination within a reasonable period of time. 6/ The Respondent's follow up on December 7, 1988, on the results of the pathology examination of the material removed from patient B.F. during the November 3, 1988, procedure was reasonable under the circumstances. 7/ The Respondent's delay until December 7, 1988, before following up on that pathology examination was not a departure from applicable standards of medical care. 8/ The Respondent's medical records for patient B.F. justify the course of treatment of the patient. The use of ultrasound examination as a method of estimating "gestational age" is not an exact science and cannot be relied upon to determine an exact "gestational age." As a general rule, "gestational age" estimates derived by means of ultrasound examination are accurate within a margin of error of plus or minus two weeks. 9/ Clinical or manual examination of a patient as a method of estimating "gestational age" is also not an exact science and cannot be relied upon to determine an exact "gestational age." As a general rule, "gestational age" estimates derived by means of clinical or manual examination of a patient are accurate within a margin of error of plus or minus two weeks, if done by an experienced physician. It is not a departure from applicable standards of medical care for an estimate of "gestational age" to vary from the actual "gestational age" by as much as plus or minus two weeks when the estimate is based on the physician's clinical or manual examination of the patient. A reasonably prudent physician who is experienced in clinical or manual examination of patients for the purpose of estimating "gestational age" should rely on his own findings, even if those findings appear to conflict with findings based on ultrasound examination. Such a physician should also note his own findings on the patient's medical records, regardless of what is reported by the ultrasound. There is no great discrepancy between the estimate of "gestational age" reported in Dr. Goldstein's ultrasound report of December 8, 1988, and the Respondent's estimate of "gestational age" on December 10, 1988. The Respondent's notations in patient B.F.'s medical records on December 10, 1988, to the effect that her pregnancy was of a "gestational age" of eight weeks was an honest notation of the Respondent's clinical judgment and was not a statement the Respondent knew to be false. 10/ Similarly, those notations were not deceptive, untrue, or fraudulent representations. On or about August 3, 1989, the Respondent's clinic, known as Today's Woman Medical Center, located at Suite 1070, 1320 South Dixie Highway, Coral Gables, Florida, was inspected by an employee of the Office of Licensure and Certification of the Department of Health and Rehabilitative Services. 11/ At the time of that inspection the Respondent was not present at the clinic, there were no procedures being performed at the clinic, and there were no patients at the clinic.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that a Final Order be entered in this case DISMISSING all charges against the Respondent, Vladimir Rosenthal, M.D. DONE AND ENTERED this 2nd day of October, 1992, at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH, 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 2nd day of October, 1992.
Findings Of Fact At all times relevant hereto, Respondent was licensed as a medical doctor by the Florida Board of Medicine. He holds License No. ME 0019700. Respondent received his medical degree overseas and did his residence in obstetrics and gynecology at Bayfront Medical Center in St. Petersburg, Florida. He is neither board certified nor board eligible. For the past eight plus years Respondent's practice has been limited to terminating pregnancies at All Women's Health Clinic at Tampa, Florida. He has performed in excess of 15,000 abortions. One reason given by Respondent for so limiting his practice is the cost of medical malpractice insurance. Since he has no private practice, Respondent gave up admitting privileges at hospitals in the area. Without malpractice insurance, he would not be given staff privileges. On August 23, 1986, A. L., a pregnant 16 year old, entered All Women's Health Center, Tampa, to have her pregnancy terminated. A. L. had noted on her history statement that her last menstrual period started some eight weeks ago. Respondent first saw A. L. when he entered the procedures room at All Women's Health Center and commenced his examination prior to instituting abortion procedures. With respect to the examination the testimony varied widely. Diane Roberts, LPN, who was performing the duties of physician's assistant during the procedure, initially told the investigators that the examination lasted only a couple of seconds and consisted of a vaginal examination with two fingers of the right hand in the vagina while the abdomen was palpated with the left hand. At the hearing, Roberts testified that she wasn't paying much attention to the patient during the examination, didn't recall telling investigator the examination only took a couple of seconds, and recalled Respondent telling A. L. several times to relax. Respondent testified he performed a normal vaginal examination. The examination was longer than usual because A. L. wasn't relaxed and tensed her stomach muscles which made the uterus more difficult to palpate; and that following his examination he determined the gestational age of the fetus to be 12 weeks. Respondent testified he also checked the patient's heart and lungs before commencing the pelvic examination. A. L. testified that Respondent palpated her abdomen with two hands, but did not check heart and lungs or do a pelvic examination. A. L. had an earlier pregnancy terminated the previous year when the doctor did a pelvic examination with two fingers in the vagina while the abdomen was palpated with his other hand. The patient was ultimately determined to be 28 to 30 weeks pregnant. Largely because of the large error in gestational age, it is concluded that Respondent performed only a perfunctory examination on A. L. Had he conducted the proper examination, it is inconceivable that he, an experienced gynecologist, could underestimate the gestational age of the fetus by some four months. The magnitude of this error is illustrated by Respondent's testimony that a 12 week fetus is approximately 3 inches long and weighs 30 grams, while a 28 week fetus is approximately 14 inches long and weighs 1100 grams. Respondent started the procedure thinking he was aborting a 12 week fetus with the patient on the table and feet in the stirrups. After the instruments were inserted and the procedure started, Respondent concluded the fetus was 16 weeks, obtained a larger curette, then determined the fetus was more likely 20 weeks, again changed curette, and after removing fluid and part of an arm Respondent concluded that the gestational age of the fetus was some 28 weeks and required hospitalization to complete the procedure. Mistakes in determining gestational age can be made by a prudent physician if: (1) the patient is obese; (2) if the uterus is very soft and the extremities difficult to locate; (3) if the baby has a low fluid volume; (4) if the patient is very tense; or, (5) if the head of the fetus is felt and not the uterus. Here A. L. was more thin than obese which should have greatly facilitated palpation of the abdomen to determine the size of the uterus. Accepting the testimony that she was tense during the examination, and the earlier pregnancy would cause the uterus to be soft, no experienced gynecologist should conduct an examination of a patient such as A. L. and err on the magnitude here involved. Further, if the examination was difficult, the procedure should not have commenced until Respondent was reasonably positive of the gestational age of the fetus. One indication Respondent received that the fetus was older than 12 weeks was the quantity of fluid drawn. Further, no experienced gynecologist should mistake the head of the fetus as the extremity of the uterus on a patient such as A. L. Once Respondent determined the fetus was more than 16 weeks along, he called Dr. Barile, a gynecologist with admitting privileges at Humana Women's Hospital, Tampa, to request he remain available in case Respondent needed to send A. L. to a hospital. When Respondent determined the gestational age of the fetus' was more than 26 weeks, he again called Barile who suggested it would be better to refer the patient to an obstetrician. Respondent then telephoned his backup obstetrician and found she was on vacation, and a doctor with whom Respondent was not acquainted was taking her calls. Since A. L. was stable and in no apparent distress, Respondent called Dr. Klein, a pediatrician with admitting privileges at Bayfront Memorial Hospital in St. Petersburg. Dr. Klein agreed to take care of the patient by having his associate, who had the duty that day, meet the patient at Bayfront. A. L. had been brought to the clinic by her brother, and Respondent concluded A. L. could be safely transported to Bayfront by automobile and suggested her brother drive her. The brother demurred on the ground that his car overheated and might not make the 40-odd mile trip to Bayfront safely, but another brother had a more reliable car. The other brother was called and agreed to take his sister to Bayfront and stated that he would be at the clinic in about 10 minutes. Approximately 1 hour and 15 minutes later this brother arrived, and A. L. was started to the brother's car. At this time she appeared unsteady, and Respondent concluded she should go to Bayfront by ambulance. When a Hillsborough ambulance service was called, they told Respondent of the policy whereby they could not transport a patient out of Hillsborough County and that he should contact a Pinellas County ambulance service to perform the desired transportation. Respondent then called a Pinellas County ambulance service who arrived about an hour later to take A. L. to Bayfront where she was met by Dr. Yeshnick, the associate of Dr. Klein, who admitted the patient. Between the time Respondent determined the abortion could not be performed at the clinic until A. L.'s arrival at Bayfront Hospital, some 6 hours had elapsed. Of the approximately 15,000 abortions that Respondent has performed, less than 5 became emergencies that required removal from the clinic to a hospital. Respondent's backup procedures for emergencies were adequate. On August 23, 1986, A. L. was in the third trimester of her pregnancy, and the abortion was not necessary to save the life or preserve the health of A. L.
The Issue Whether Respondent, an abortion clinic, failed to maintain emergency medications and related supplies in violation of Florida Administrative Code Rule 59A-9.0225(1) and the penalty, if any, that should be imposed.
Findings Of Fact At all times relevant to this proceeding, Respondent has been licensed as an abortion clinic authorized to perform first and second trimester abortions. The facility at issue in this proceeding is located in North Miami Beach, Florida. Ms. Ody conducted an unannounced inspection of the subject facility on April 21, 2011. Ms. Herne was the only other person at the facility during the inspection. Ms. Ody determined that medications inside an orange box located in the subject facility that served as a crash cart included emergency medications that were out-of-date. Those medications were one 500-ml bag of Lactated Ringer's Intravenous Solution (expired April 2009), a one-mg vial of Atropine (expired November 2010), and one 2 percent Llidocaine Hydrochloride injection (expired November 2010). The crash cart belonged to a certified registered nurse anesthetist, who had worked at the facility at one time. That person had not worked at the facility for several years, and had not returned to claim her property. Dr. Rosenthal's efforts to contact that person were unsuccessful. Dr. Rosenthal and Ms. Herne testified, credibly, that they considered the contents of the crash cart to be that of the former employee and they had never used or attempted to use the contents of the crash cart. On April 21, 2011, the facility had no surgical procedures planned, and no patients were present. On September 12, 2011, Ms. Ody and Ms. Render inspected the subject facility. Ms. Herne was the only other person present during the inspection. During the course of their inspection, they found three bottles of antiseptic located inside of a cabinet in the facility's operating room. Each bottle contained the name Humco Strong Iodine. Two of the bottles of iodine expired in August 1995 and the third bottle expired in May 2005. The three bottles of iodine were not used for surgical procedures. The testimony of Ms. Herne and Dr. Rosenthal established that the iodine was used solely to reduce the odor of infectious waste, which was put in a small container in the operating room until it could be transferred to a larger container in an adjacent room. On September 12, 2011, the facility had no surgical procedures planned, and no patients were present. Petitioner failed to prove that the subject facility did not have appropriate emergency medications or supplies on either of the inspection dates.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Agency for Health Care Administration enter a final order dismissing the charges against A Medical Office for Women, Incorporated, d/b/a Medical Office for Women set forth in its Administrative Complaint. DONE AND ENTERED this 31st day of July, 2012, in Tallahassee, Leon County, Florida. S CLAUDE B. ARRINGTON 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 31st day of July, 2012.
The Issue Whether Respondent is guilty of unprofessional conduct, possessed a controlled substance for other than a legitimate purpose, and/or made a false report, knowing same to be false.
Findings Of Fact Respondent, at all times relevant here to, was a licensed practical nurse in the State of Florida, having been issued license no. PN 0702091, and she was employed at Oak Manor Nursing Center in Largo, Florida. Respondent was assigned to the care of terminally ill patient M. G., whose physician's orders called for administration of Demoral, 50 mg. every four hours as needed for pain. Upon reporting for duty at 3 p.m. on June 17, 1989, Respondent checked the narcotics for which she would be responsible on the 3-11 shift with the nurse being relieved and found all properly accounted for. Respondent had possession of the key to the narcotics locker on her wing. At approximately 4:45 p.m. on June 17, 1989, Respondent took four of five ampules of Demoral in a package that had been crushed to Ray Grondin, R.N., her supervisor. Grondin observed what appeared to be small needle holes in the crushed ampules and made arrangements to have the next shots administered by Respondent monitored and to have urine samples of Respondent and the patient taken for analysis. At 6:40 p.m. on June 17, 1989, Respondent administered what purported to be Demoral to patient M. G. This injection in the buttocks was witnessed by Rosemary Griffin, L.P.N. Griffin testified to no apparent change in M. G. immediately following the injection which would indicate relief from pain. Some four hours later, urine specimens were take from patient M. G. and Respondent, labeled and placed in a refrigerator from which these specimens were subsequently removed for laboratory testing. A lab report on the specimen marked as taken from M. G. was subsequently returned to the nursing center, and this report showed no evidence of Demoral. The specimen placed in the refrigerator labeled to be from Respondent disappeared some time between the time it was placed in the refrigerator and the return of the lab report to the nursing center. No chain of custody was established for these specimens, the refrigerator in which they were stored was apparently unlocked and available to anyone in the vicinity, and no one could testify with certainty that the lab report (Exhibit 4) was on the urine sample taken from patient M. G. Respondent denied any misuse of Demoral by her. In her answers to request for admissions (Exhibit 2), she state that R. N. Grondin was in the medication room when the hypodermic was prepared for the 6:40 p.m. injection, and that the urine specimens remained in the refrigerator several days before being picked up by the lab. At the hearing, L.P.N. Griffin, who witnessed the injection, testified that she did not observe the hypodermic syringe being filled. Grondin's testimony did not address this issue.
Recommendation It is recommended that a Final Order be entered finding Respondent not guilty of all allegations in the Administrative Complaint filed March 9, 1990. DONE and ENTERED this 27th day of November, 1990, in Tallahassee, Florida. COPIES FURNISHED: Michael A. Mone', Esquire Department of Professional Regulation 1940 N. Monroe Street Tallahassee, FL 32399-0752 K. N. AYERS 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 27 day of November, 1990. Sherri Lynne Hartley 5821 90th Avenue North Pinellas Park, FL 34668 Judie Ritter Executive Director Board of Nursing 504 Daniel Building 111 East Coastline Drive Jacksonville, FL 32202 Kenneth E. Easley General Counsel Department of Professional Regulation Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0792
Conclusions Having reviewed the Administrative Complaint, and all other matters of record, the Agency for Health Care Administration finds and concludes as follows: 1. The Agency has jurisdiction over the above-named Respondent pursuant to Chapter 408, Part Il, Florida Statutes, and the applicable authorizing statutes and administrative code provisions. 2. The Agency issued the attached Administrative Complaint and Election of Rights form to the Respondent. (Ex. 1) The Election of Rights form advised of the right to an administrative hearing. 3. The parties have since entered into the attached Settlement Agreement. (Ex. 2) Based upon the foregoing, it is ORDERED: 1. The Settlement Agreement is adopted and incorporated by reference into this Final Order. The parties shall comply with the terms of the Settlement Agreement. 2. The Respondent shall pay the Agency $5,000. If full payment has been made, the cancelled check acts as receipt of payment and no further payment is required. If full payment has not been made, payment is due within 30 days of the Final Order. Overdue amounts are subject to statutory interest and may be referred to collections. A check made payable to the “Agency for Health Care Administration” and containing the AHCA ten-digit case number should be sent to: Office of Finance and Accounting Revenue Management Unit Agency for Health Care Administration 2727 Mahan Drive, MS 14 Tallahassee, Florida 32308 3. Conditional licensure status is imposed on the Respondent beginning on February 15, 2013 and ending on March 15, 2013. 1 Filed August 27, 2013 2:59 PM Division of Administrative Hearings ORDERED at Tallahassee, Florida, on this 28-day of Arpt 2013. wie Elizabg¢th Dudek, Bery etary Agency for Health Care Administration
Other Judicial Opinions A party who is adversely affected by this Final Order is entitled to judicial review, which shall be instituted by filing one copy of a notice of appeal with the Agency Clerk of AHCA, and a second copy, along with filing fee as prescribed by law, with the District Court of Appeal in the appellate district where the Agency maintains its headquarters or where a party resides. Review of proceedings shall be conducted in accordance with the Florida appellate rules. The Notice of Appeal must be filed within 30 days of rendition of the order to be reviewed. CERTIFICATE OF SERVICE I CERTIFY that a true and eos Final Order was served on the below-named persons by the method designated on this7S" ry of Ld / ; , 2013. ane Agency for Health Care Administration 2727 Mahan Drive, Bldg. #3, Mail Stop #3 Tallahassee, Florida 32308-5403 Telephone: (850) 412-3630 [ Jan Mills Finance & Accounting Facilities Intake Unit Revenue Management Unit (Electronic Mail) (Electronic Mail) Andrea M. Lang, Senior Attorney Margaret Chamberlain, Esq. Office of the General Counsel Attorney for Respondent Agency for Health Care Administration Kitch Drutchas Wagner Valitutti & Sherbrook (Electronic Mail) 2379 Woodlake Drive, Suite 400 Okemos, Michigan 48864 (U.S. Mail) | STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. Case Nos. 2013002508 SA-PG - VERO BEACH LLC d/b/a PALM GARDEN OF VERO BEACH Respondent. / ADMINISTRATIVE COMPLAINT COMES NOW the Agency for Health Care Administration (hereinafter “Agency”), by and through the undersigned counsel, and files this Administrative Complaint against SA-PG - VERO BEACH LLC d/b/a PALM GARDEN OF VERO BEACH (hereinafter “Respondent”), pursuant to Sections 120.569 and 120.57 Florida Statutes (2012), and alleges: NATURE OF THE ACTION This is an action against a skilled nursing facility to impose an administrative fine of FIVE THOUSAND DOLLARS ($5,000.00) pursuant to Section 400.23(8)(b), Florida Statutes (2012), based upon two (2) Class II deficiencies and to assign conditional licensure status beginning on February 15, 2013, and ending on March 15, 2013, pursuant to Section 400.23(7)(b), Florida Statutes (2012). The original certificate for the conditional license is attached as Exhibit A and is incorporated by reference. The original certificate for the standard license is attached as Exhibit B and is incorporated by reference. JURISDICTION AND VENUE 1. The Court has jurisdiction over the subject matter pursuant to Sections 120.569 and 120.57, Florida Statutes (2012). EXHIBIT 1 2. The Agency has jurisdiction over the Respondent pursuant to Section 20.42, Chapter 120, and Chapter 400, Part II, Florida Statutes (2012). 3. Venue lies pursuant to Rule 28-106.207, Florida Administrative Code. PARTIES 4. The Agency is the regulatory authority responsible for the licensure of skilled nursing facilities and the enforcement of all applicable federal and state statutes, regulations and rules governing skilled nursing facilities pursuant to Chapter 400, Part II, Florida Statutes (2012) and Chapter 59A-4, Florida Administrative Code. The Agency is authorized to deny, suspend, or revoke a license, and impose administrative fines pursuant to Sections 400.121 and 400.23, Florida Statutes (2012); assign a conditional license pursuant to Section 400.23(2), Florida Statutes (2012); and assess costs related to the investigation and prosecution of this case pursuant to Section 400.121, Florida Statutes (2012). 5. Respondent operates a 180-bed nursing home, located at 1755 37" Street, Vero Beach, Florida 32960, and is licensed as a skilled nursing facility, license number 1415096. Respondent was at all times material hereto, a licensed skilled nursing facility under the licensing authority of the Agency, and was required to comply with all applicable state rules, regulations and statutes. COUNTI The Respondent Failed To Ensure Physician Orders Shall Be Followed As Prescribed in Violation Of Rule 59A-4.107(5), Florida Administrative Code 6. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 7. Pursuant to Florida law, all physician orders shall be followed as prescribed, and if not followed, the reason shall be recorded on the resident’s medical record during that shift. Rule 59A- 4.107(5), Florida Administrative Code. 8. On or about February 11, 2013 through February 15, 2013, the Agency conducted a Licensure Survey of the Respondent’s facility. 9. Based on observation, interview and record review, it was determined the facility failed to follow physician orders for catheter placement, pain medication and skin sweeps for one (1) of twenty eight (28) residents, specifically Resident number ninety six (96), which resulted in significant pain for the resident. 10. Resident number ninety six (96) was admitted on January 7, 2013 with diagnoses to inclide urinary retention and urethral erosion. An observation was made of Resident number ninety six (96) on February 13, 2013 at 8:30 a.m. and Resident number ninety six (96) was holding his/her hands over his/her genital area. 11. A review of the medical record documented a physician order dated January 25, 2013 for Keflex 250mg by mouth four (4) times daily for seven (7) days for urethral erosion and lidocaine jelly 2% to the urethra as needed four (4) times a day. The February Physician Order Sheet documented; keep the catheter up and taped to abdomen and positioned out of top of pants. There is an order on the Physician Order Sheet for weekly skin assessment due Friday on the 3:00 p.m. to 11:00 a.m. shift. 12. Catheter care was observed on February 13, 2013 at 8:33 a.m. As the Certified Nursing Assistant started to perform the catheter care, Resident number ninety six (96) moved into the fetal position and started moaning and grunting. The Certified Nursing Assistant stated this is normal for Resident number ninety six (96). As the Certified Nursing Assistant moved the resident’s scrotum, the left groin area was noted to be bright red and patchy. Resident number ninety six (96) yelled out and tried crossing his/her legs. Resident number ninety six (96) was not asked if he/she was in pain. The Certified Nursing Assistant drew back the foreskin of the penis and it appeared to be bright red and excoriated. The resident was moaning when touched, mumbling “Oh God “. Resident number ninety six (96) kept crossing his/her legs and trying to get back into the fetal position and the Certified Nursing Assistant would reposition the resident onto his/her back to wash the catheter and genital area. At one point, Resident number ninety six (96) lifted his/her head and groaned loudly with a grimace on his/her face and his/her eyes bulging. At this point the Certified Nursing Assistant asked Resident number ninety six (96) if he/she was in pain. The resident stated “a little “. Lidocaine Jelly 2% was not applied to the urethra. The catheter was then brought out the bottom of the adult brief, not anchored to any anatomical site. 13. In. an interview with the Registered Nurse who was providing care for Resident number ninety six (96) on February 13, 2013 at 9:01 a.m., the Registered Nurse stated that she would check the catheter to make sure it is patent and positioned properly. The Registered Nurse checked for exudate on the penis and checked the indwelling catheter to make sure it was draining properly. The Registered Nurse stated that the catheter was positioned properly. The catheter was still threaded through the bottom of the adult brief and not taped to Resident number ninety six’s (96) abdomen. 14. A review of the February Medication Administration Record revealed no lidocaine jelly 2% listed. The Treatment Administration Record documented “keep Foley catheter taped to abdomen and position out of top of pants." The last skin sweep documented is February 1, 2013 and did not document anything about redness to the groin area. 15. In an interview with the Unit Manager at 9:28 a.m. on February 13, 2013, the Unit Manager acknowledged that there is an order written for lidocaine jelly 2% that was not transcribed onto the Medication Administration Record. The Unit Manager also verified that there was nothing in the chart to indicate a rash or redness to the groin of Resident number ninety six (96) nor was the weekly skin sweep done as ordered on February 8, 2013. 16. | The Unit Manager went with the surveyor to assess Resident number ninety six (96) at 9:35 a.m. The Unit Manager acknowledged that the catheter tubing was not taped to Resident number ninety six’s (96) abdomen, nor was it up and over the top of the adult brief. The Unit Manager also acknowledged excoriation in the left groin and penis. Resident number ninety six (96) would still flinch and moan when touched, and the Unit Manager stated he/she was in pain. 17. Resident number ninety six (96) was observed with the Licensed Practical Nurse on February 14, 2013 at 11:03 a.m. Resident number ninety six (96) was fidgeting in the wheelchair. When asked, Resident number ninety six (96) stated the catheter did not feel okay. The catheter was angled downwards through the leg of the brief and not taped to the abdomen as ordered. The Licensed Practical Nurse acknowledged the catheter tubing was incorrectly placed and not taped to the abdomen as ordered. 18. The Agency determined that this deficient practice compromised the resident's ability to maintain or reach his or her highest practicable physical, mental, and psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services. The Agency cited Respondent for a Class II deficiency as set forth in Section 400.23(8)(b), Florida Statutes (2012). 19. A Class II deficiency is subject to a civil penalty of $2,500 for an isolated deficiency, $5,000 for a patterned deficiency, and $7,500 for a widespread deficiency. The fine amount shall be doubled for each deficiency if the facility was previously cited for one or more Class I or Class Il deficiencies during the last licensure inspection or any inspection or complaint investigation since the last licensure inspection. A fine shall be levied notwithstanding the correction of the deficiency. 20. Based upon the above findings, the Respondent’s actions, inactions or conduct constituted an isolated Class II deficiency pursuant to Section 400.23(8)(b), Florida Statutes (2012). WHEREFORE, the Agency intends to impose an administrative fine in the amount of TWO THOUSAND FIVE HUNDRED DOLLARS ($2,500.00) against the Respondent pursuant to Sections 400.23(8)(b), and 400.102, Florida Statutes (2012). COUNT IL The Respondent Failed To Ensure The Right To Receive Adequate And Appropriate Health Care in Violation of Section 400.022(1)(I), Florida Statutes (2012) 21. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 22. Pursuant to Florida law, all licensees of nursing home facilities shall adopt and make public a statement of the rights and responsibilities of the residents of such facilities and shall treat such residents in accordance with the provisions of that statement. The statement shall assure each resident the following: The right to receive adequate and appropriate health care and protective and support services, including social services; mental health services, if available; planned recreational activities; and therapeutic and rehabilitative services consistent with the resident care plan, with established and recognized practice standards within the community, and with rules as adopted by the Agency. Section 400.022(1)(), Florida Statutes (2012). 23. Onor about February 11, 2013 through February 15, 2013, the Agency conducted a Licensure Survey of the Respondent’s facility. 24. Based on observation, interview and record review, it was determined the facility failed to provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being for three (3) of twenty eight (28) residents, specifically Resident number ninety six (96), Resident number three hundred five (305) and Resident number two hundred forty two (242), regarding failure to assess and manage pain for a resident with an urethral erosion and two (2) residents with no medical justification for their catheters respectively. 25. Resident number ninety six (96) was admitted on January 7, 2013 with diagnoses to include urinary retention and urethral erosion. An observation was made of Resident number ninety six (96) on February 13, 2013 at 8:30 a.m. to be holding his/her hands over his/her genital area. 26. Catheter care was observed on February 13, 2013 at 8:33 a.m. As the Certified Nursing Assistant started to perform the catheter care, Resident number ninety six (96) moved into the fetal position and started moaning and grunting. The Certified Nursing Assistant stated this is normal for the resident. As the Certified Nursing Assistant moved Resident number ninety six’s (96) scrotum, the left groin area was noted to be bright red and patchy. Resident number ninety six (96) yelled out and tried crossing his/her legs. Resident number ninety six (96) was not asked if he/she was in pain. The Certified Nursing Assistant drew back the foreskin of the penis and it appeared to be bright red and excoriated. The resident was moaning when touched, mumbling “Oh God “. Resident number ninety six (96) kept crossing his/her legs and trying to get back into the fetal position and the Certified Nursing Assistant would reposition the resident to wash the catheter and genital area. At one point, Resident number ninety six (96) lifted his/her head and groaned loudly, with a grimace on his/her face and the eyes bulging. At this point the Certified Nursing Assistant asked Resident number ninety six (96) if he/she was in pain. The resident stated “a little “The catheter was then brought out the bottom of the adult brief, not anchored to any anatomical site. 27. There is a Pain Evaluation in Advanced Dementia sheet in Resident number ninety six’s (96) chart that has the residents name on it but is not filled out. Based on the criteria listed on the form, the combination of "repeated calling out, loud moaning or groaning, crying", "facial grimacing" and "rigid, fists clenched, knees pulled up, pulling or pushing away" indicates distressing pain. On February 14, 2013 at 1:13 p.m., the Director of Nursing acknowledged the form was in the chart and should have been filled out. 28. ‘In an interview with the Registered Nurse on February 13, 2013 at 9:01 a.m., the Registered Nurse stated that she would first give Resident number ninety six (96) medications, then she would check Resident number ninety six’s (96) catheter to make sure it is patent and positioned properly. The Registered Nurse checked for exudate on the penis and checked the indwelling catheter to make sure it was draining properly. The Registered Nurse stated that the catheter was positioned properly and did not assess the groin or pull back the foreskin to properly assess the penis. Resident number ninety six (96) was still moaning and the nurse asked if he/she was in pain but the resident said no. Resident number ninety six (96) appeared more relaxed in bed, not grimacing. The Registered Nurse stated the Certified Nursing Assistant was supposed to tell the nurse when the resident stated he/she is in pain. 29. A review of the medical record documented a physician order dated January 25, 2013 for Keflex 250mg by mouth four (4) times daily for seven (7) days for urethral erosion and lidocaine jelly 2% to the urethra as needed four (4) times a day. The February Physician Order Sheet documented keep the catheter up and taped to abdomen and positioned out of top of pants. 30. A review of the February Medication Administration Record revealed no lidocaine jelly 2% transcribed. The Treatment Administration Record documented “keep Foley catheter taped to abdomen and position out of top of pants. The last skin sweep found is February 1, 2013 and did not document anything about redness to the groin or penis. 31. Inan interview with the Unit Manager at 9:28 a.m. on February 13, 2013, the Unit Manager acknowledged that there is an order written for lidocaine jelly 2% that is not listed in the Medication Administration Record. The Unit Manager also verified that there was nothing in the chart to indicate a rash or redness to the groin of Resident number ninety six (96). 32. The Unit Manager went with the surveyor to assess the resident at 9:35 a.m. The Unit Manager acknowledged that the catheter tubing was not taped to Resident number ninety six’s (96) abdomen, nor was it up and over the top of the residents’ adult brief. The Unit Manager also acknowledged excoriation in the left groin and penis. The Unit Manager acknowledged Resident number ninety six (96) was acting as if he/she was in pain, groaning and guarding his/her genitals when touched. 33. In an interview with the Director of Nursing on February 13, 2013 at 2:42 p.m., the Director of Nursing stated Resident number ninety six (96) was transferred to the Reflections unit for behaviors of yelling and screaming and was given a care plan to reflect the behaviors. The Director of Nursing stated Resident number ninety six (96) is not necessarily in pain; this is just how the resident acts. In a subsequent interview with the Director of Nursing on February 14, 2013 at 1:13 p.m., she acknowledged the care plan indicates Resident number ninety six (96) had behaviors of resisting care, not yelling and screaming. The Director of Nursing also stated she was unable to find any documentation in the chart that indicates Resident number ninety six (96) had yelling behaviors. 34. — A nurse's note dated January 22, 2013 documented that Resident number ninety six (96) had pain which was manifested by fidgeting and shouting out intermittently. Routine pain medication was given and the effect was good with decreased fidgeting and decreased shouting. 35. The pain assessment dated January 7, 2013 documented under the question “Does the patient/resident exhibit any non-verbal signs that would indicate pain?” Moaning is checked off. Under nursing interventions, no evidence of pain is checked off. The monthly summary dated February 12, 2013 indicated Resident number ninety six (96) is alert and confused, quiet and cooperative with a flat affect. Resident number ninety six’s (96) speech is listed as difficult. 36. A review of the fourteen (14) day Minimum Data Set assessment with an Assessment Reference Date of January 24, 2013 revealed Resident number ninety six (96) was severely impaired with cognition. No behavioral symptoms are exhibited, including screaming and disruptive sounds. The Minimum Data Set identified Resident number ninety six (96) as having pain occasionally in five (5) of the seven (7) previous days with a level of five (5) out of ten (10). 37. In an interview with Resident number ninety six (96), the Licensed Practical Nurse on February 14, 2013 at 11:03 a.m. stated the catheter is to be positioned up over the brief and taped to the abdomen to prevent further irritation to the urethra. Resident number ninety six (96) has had a catheter for a long time. Because Resident number ninety six (96) is confused, the Licensed Practical Nurse stated she would watch for grimacing or fidgeting as signs of pain and that Resident number ninety six (96) tried to stand on his/her own if the catheter is placed incorrectly. The Licensed Practical Nurse stated that the staff does not use yelling as an indicator for pain because Resident number ninety six (96) often yells. Because Resident number ninety six (96) was trying to stand up in the activity room, the Licensed Practical Nurse brought him/her back into the room to check on the catheter. The resident stated to the nurse that the catheter "does not feel ok". Resident number ninety six (96) kept crossing his/her legs and fidgeting in the chair. A Certified Nursing Assistant came into the room to assist the Licensed Practical Nurse stand up Resident number ninety six (96). Resident number ninety six (96) stood to have his/her pants pulled down and his/her brief opened. The catheter was angled down and not taped to the abdomen as ordered. This was acknowledged by the Licensed Practical Nurse. When the nurse touched Resident number ninety six (96) he/she would yell out. There was also tape tangled in the pubic hair and as the nurse tried to remove it, Resident number ninety six (96) yelled out “It hurts a lot “. Resident number ninety six (96) kept trying to grab the nurse to make her stop but the Certified Nursing Assistant held his/her hands still. The catheter was then placed correctly. Resident number ninety six (96) stated he/she felt much better when the catheter was properly positioned. 38. Anobservation on February 12, 2013 at 3:25 p.m. revealed Resident number two hundred forty two (242) lying in bed. A Foley catheter (indwelling urinary drainage devise) was observed at bedside draining. 39. A review of the record revealed Resident number two hundred forty two (242) was admitted to the facility on December 31, 2012 with diagnoses to include urinary tract infection, functional decline, hypertension, deep vein thrombosis, anemia, hyperlipidemia, and renal insufficiency. A review of the Nursing Evaluation dated December 31, 2012 documented the existence of the Foley catheter. A review of the admitting physician's orders documented, "Catheter Orders" and further documented the ordered care and treatment for the catheter. A further review of the physician orders revealed the next order related to the Foley was not until nine (9) days after admission. This order was dated January 8, 2013 for the discontinuing of the catheter. A final review of the record lacked any evidence of a diagnosis or medical justification for the Foley catheter. 40. During a review of the record and interview with the Director of Nursing on February 15, 2013 at 9:30 a.m., the Director of Nursing agreed there was no valid diagnosis or medical justification for the Foley catheter for Resident number two hundred forty two (242) upon admission to the facility. When asked the standard procedure related to catheter use the Director of Nursing stated that they try to have the catheters discontinued within a few days of admission to their facility. 41. A review of the facility policy and procedure titled "Urinary Catheters" documents, “Procedure: 1. Eliminate indwelling urinary catheters when possible. 2. Use catheters only when they must be used, and only with documented medical justification by a physician." 42. During an interview on February 11, 2013 12:37 p.m., the Registered Nurse caring for Resident number three hundred five (305) was asked if the resident had a Foley catheter and the diagnosis or medical justification for the catheter. The Registered Nurse stated, "There is no valid reason for the catheter, Resident number three hundred five (305) came with it from the hospital. I'm going to call! the doctor to see if it can be removed." 43. An observation of Resident number three hundred five (305) on February 12, 2013 at approximately 11:45 a.m. revealed the resident sitting in a wheel chair at the nurse's station. Although the bag that holds and covers the Foley catheter for dignity purposes was noted, the Foley catheter was not present. 44. A review of the record documented Resident number three hundred five (305) was admitted to the facility from an acute care hospital on January 31, 2013 having sustained a cerebral vascular accident/stroke and subdural hematoma. Admitting diagnoses included diabetes, hypertension, left ventricle thrombus, hyperlipidemia, and intermittent atrial fibrillation. The record documented the existence of the Foley catheter upon admission to the facility as per the nursing evaluation dated January 31, 2013, the plan of care and in daily nursing notes from admission through February 11, 2012. A review of the plan of care dated January 31, 2013 for the indwelling catheter specifically documented the intervention "Identify documentation in the medical record which substantiates use of indwelling catheter, if absent confer with MD". An order to discontinue the Foley catheter was obtained on February 11, 2013 after surveyor questioning. A final review of the record lacked any diagnosis or medical justification for the catheter for Resident number three hundred five (305). 45. During an Interview on February 13, 2013 at approximately 4:00 p.m., the Unit Manager for the 300 unit was asked the procedure for residents admitted to the facility with a Foley catheter. The Unit Manger stated that the normal practice is to evaluate the resident and ask the physician for an order to discontinue the catheter within a few days of admission. The Unit Manager agreed that Resident number three hundred five (305) had a Foley catheter thirteen (13) days after admission to the facility with no appropriate diagnosis or medical justification. 46. A review of the facility policy and procedure titled "Urinary Catheters" documents, "Procedure: 1. Eliminate indwelling urinary catheters when possible. 2. Use catheters only when they must be used, and only with documented medical justification by a physician." 47, The Agency determined that this deficient practice compromised the resident's ability to maintain or reach his or her highest practicable physical, mental, and psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services. The Agency cited Respondent for a Class II deficiency as set forth in Section 400.23(8)(b), Florida Statutes (2012). 48. A Class II deficiency is subject to a civil penalty of $2,500 for an isolated deficiency, $5,000 for a patterned deficiency, and $7,500 for a widespread deficiency. The fine amount shall be doubled for each deficiency if the facility was previously cited for one or more Class I or Class II deficiencies during the last licensure inspection or any inspection or complaint investigation since the last licensure inspection. A fine shall be levied notwithstanding the correction of the deficiency. 49. Based upon the above findings, the Respondent’s actions, inactions or conduct constituted an isolated Class II deficiency pursuant to Section 400.23(8)(b), Florida Statutes (2012). WHEREFORE, the Agency intends to impose an administrative fine in the amount of TWO THOUSAND FIVE HUNDRED DOLLARS ($2,500.00) against the Respondent pursuant to Sections 400.23(8)(b), and 400.102, Florida Statutes (2012). COUNT Il Assignment Of Conditional Licensure Status Pursuant To Section 400.23(7)(b), Florida Statutes (2012) 50. The Agency re-alleges and incorporates by reference the allegations in Count I. 51. The Agency is authorized to assign a conditional licensure status to nursing home facilities pursuant to Section 400.23(7), Florida Statutes (2012). 52. Due to the presence of one (1) Class I deficiency, the Respondent was not in substantial compliance at the time of the survey with criteria established under Chapter 400, Part II, Florida Statutes (2012), or the rules adopted by the Agency. 53. The Agency assigned the Respondent conditional licensure status with an action effective date of February 15, 2013. The original certificate for the conditional license is attached as Exhibit A and is incorporated by reference. 54. The Agency assigned the Respondent standard licensure status with an action effective date of March 15, 2013. The original certificate for the standard license is attached as Exhibit B and is incorporated by reference. WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully requests the Court to enter a final order granting the Respondent conditional licensure status for the period beginning February 15, 2013 and ending on March 15, 2013 pursuant to Section 400.23(7)(b), Florida Statutes (2012). CLAIM FOR RELIEF WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully requests the Court to enter a final order granting the following relief against the Respondent as follows: 1. Make findings of fact and conclusions of law in favor of the Agency. 2. Impose an administrative fine against the Respondent in the amount of FIVE THOUSAND DOLLARS ($5,000.00.). 3. Assign conditional licensure status to the Respondent for the period beginning on February 15, 2013, and ending on March 15, 2013. 4. Assess costs related to the investigation and prosecution of this case. 5. Enter any other relief that this Court deems just and appropriate. Respectfully submitted this A¢-u day of ne , 2013. A ee ee cae J ‘Andrea M. Lang, Assistant General Counsel Florida Bar No. 0364568 Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 (239) 335-1253 NOTICE RESPONDENT IS NOTIFIED THAT IT/HE/SHE HAS A RIGHT TO REQUEST AN ADMINISTRATIVE HEARING PURSUANT TO SECTIONS 120.569 AND 120.57, FLORIDA STATUTES. THE RESPONDENT IS FURTHER NOTIFIED THAT IT/HE/SHE HAS THE RIGHT TO RETAIN AND BE REPRESENTED BY AN ATTORNEY IN THIS MATTER. SPECIFIC OPTIONS FOR ADMINISTRATIVE ACTION ARE SET OUT IN THE ATTACHED ELECTION OF RIGHTS. ALL REQUESTS FOR HEARING SHALL BE MADE AND DELIVERED TO THE ATTENTION OF: THE AGENCY CLERK, AGENCY FOR HEALTH CARE ADMINISTRATION, 2727 MAHAN DRIVE, BLDG #3, MS #3, TALLAHASSEE, FLORIDA 32308; TELEPHONE (850) 412-3630. THE RESPONDENT IS FURTHER NOTIFIED THAT IF A REQUEST FOR HEARING IS NOT RECEIVED BY THE AGENCY FOR HEALTH CARE ADMINISTRATION WITHIN TWENTY-ONE (21) DAYS OF THE RECEIPT OF THIS ADMINISTRATIVE COMPLAINT, A FINAL ORDER WILL BE ENTERED BY THE AGENCY. CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the Administrative Complaint and Election of Rights form were served to: Anthony Brunicardi, Administrator, SA-PG - Vero Beach LLC d/b/a Palm Garden of Vero Beach, 1755 37" Street, Vero Beach, Florida 32960, by United States Certified Mail, Return Receipt No. 7011 1570 0002 1695 8511 and to Capitol Corporate Services, Inc., Registered Agent, SA-PG - Vero Beach LLC d/b/a Palm Garden of Vero Beach, 155 Office Plaza Drive, Suite A, Tallahassee, Florida 32301, by United States Certified Mail, Return Receipt No. 7011 1570 0002 1695 8528 on this ‘S &_ day of Wg , 2013. Net FP On od Andrea M. Lang, Assistant General‘Cdunsel Florida Bar No. 0364568 Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 (239) 335-1253 Copies furnished to: Anthony Brunicardi, Administrator SA-PG - Vero Beach LLC d/b/a Palm Garden of Vero Beach 1755 37" Street Vero Beach, Florida 32960 (U.S. Certified Mail) Andrea M. Lang, Assistant General Counsel Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 Capitol Corporate Services, Inc. Registered Agent for SA-PG - Vero Beach LLC d/b/a Palm Garden of Vero Beach 155 Office Plaza Drive, Suite A Tallahassee, Florida 32301 (US. Certified Mail) Bernard Hudson, Health Services and Facilities Consultant Supervisor Bureau of Long Term Care Services Long Term Care Unit Agency for Health Care Administration 2727 Mahan Drive, Building #3, Room 1213B Tallahassee, Florida 32308 (Electronic Mail) Arlene Mayo-Davis Field Office Manager Agency for Health Care Administration 5150 Linton Boulevard, Suite 500 Delray Beach, Florida 33484 (Electronic Mail)
The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint December 19, 2005, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 455.225, Fla. Stat. (2009). The Board is the entity responsible for regulating the practice of medicine in Florida and for imposing penalties on physicians found to have violated the provisions of Section 458.331(1), Florida Statutes. See § 458.331(2), Fla. Stat. (2009). At the times pertinent to this proceeding, Dr. Achong was a physician licensed by the State of Florida, having been issued license number ME38304, and his medical office was located at 690 East 49th Street, Hialeah, Florida. Dr. Achong specialized in obstetrics and gynecology, although he was not board-certified in these areas of practice. Dr. Achong has not previously been the subject of disciplinary action by the Board of Medicine, and he is not currently practicing medicine, having retired with a disability in 2006. At the times pertinent to this proceeding, Dr. Achong had hospital privileges at Hialeah Hospital and at North Shore Medical Center ("Medical Center"). Both facilities had his home telephone number and his beeper number. It was his practice to keep his beeper close to him at all times. When he was in the delivery room, it was his practice to give his beeper to the circulating nurse, who would be responsible for alerting him whenever someone tried to reach him on his beeper. The beeper he used in 2004 gave only the telephone number of the person trying to reach him, but he was able to recognize the number of Hialeah Hospital and the Medical Center. On February 12, 2004, Patient L.H. went to her gynecologist, Ramon Hechavarria, M.D., for a routine examination. Patient L.H. was, at the time, a 27-year-old who was 32 weeks' pregnant, and she had previously had one live birth. Dr. Hechavarria's examination revealed that Patient L.H.'s blood pressure was elevated, and Dr. Hechavarria admitted her to Medical Center for 24 hours for observation. On February 12, 2004, Dr. Hechavarria ordered blood and laboratory tests done in the Medical Center. The blood tests included a Disseminated Intravascular Coagulopathy ("DIC") profile and a Fibrinogen Degradation Profile ("FDP"); the results of these blood tests were normal. Patient L.H.'s hemoglobin and her platelet count were normal, and, although there was a slight trace of protein in her urine, that is considered normal. On February 13, 2004, Dr. Hechavarria discharged Patient L.H. with a diagnosis of chronic hypertension and a prescription for 250 milligram tablets of Aldomet, to be taken three times per day. Aldomet is a medication that treats hypertension by lowering the blood pressure. Patient L.H. was in good, stable condition when she was discharged on February 13, 2004. Readings from a fetal heart monitor taken during the time Patient L.H. was in the Medical Center indicated that the fetus was alive. Dr. Hechavarria considered Patient L.H.'s to be a high risk pregnancy in part because of her hypertension but also because she came in late for prenatal care, missed two appointments, and was overweight. Dr. Hechavarria left town for a vacation on February 13, 2004, and Dr. Achong was to cover his patients during his absence under an arrangement whereby Dr. Hechavarria and Dr. Achong provided coverage for each other when one or the other was out of town or otherwise unavailable to see patients. Under the arrangement, Dr. Achong was expected to go to the hospital if one of Dr. Hechavarria's patients were in labor or if a patient were to go to the emergency room complaining of vaginal bleeding or any other obstetrical or gynecological condition. Whenever coverage of patients was passing from one physician to the other, Dr. Hechavarria and Dr. Achong advised each other of any patient that was in the hospital for gynecological, obstetrical, or any other medical reason. They did not advise each other of patients that had recently been discharged from the hospital, and, therefore, Dr. Hechavarria did not discuss Patient L.H. with Dr. Achong because she had been discharged from the Medical Center before Dr. Achong began covering Dr. Hechavarria's patients. Patient L.H. presented at the Medical Center at approximately 2:00 a.m. on February 15, 2004, complaining of abdominal pains. She was seen by labor and delivery nurse Jennifer Williams, a registered nurse with 20 years' nursing experience, with 13 years' experience in the Medical Center's labor room, and with training as a mid-wife. Nurse Williams had worked with Dr. Achong at the Medical Center since 1991. Subsequent to Patient L.H.'s arrival at the Medical Center, Nurse Williams interviewed her, took her medical history, examined her, and entered the pertinent information on the Medical Center's Admission Assessment. The Admission Assessment form was dated February 15, 2004, and the time was noted as 2:45 a.m. The time written by Nurse Williams' signature on the Admission Assessment form was 3:00 a.m., and it appears that the information was obtained and entered on the form between 2:00 a.m. and 3:00 a.m. Pertinent to this matter, Nurse Williams maintained several other documents recording Patient L.H.'s condition and observations and actions taken by Nurse Williams relating to Patient L.H. Nurse Williams began maintaining a Labor Flow Record at 2:07 a.m. and she made periodic entries on the Labor Flow Record related to, among other things, Patient L.H.'s vital signs, the results of vaginal examinations and fetal monitoring, uterine activity, and pain intensity at different times during the night and morning. In addition, Nurse Williams entered on the Labor Flow Record the time and content of her communications with Dr. Achong; the first recorded contact between Dr. Achong and Nurse Williams was recorded on the Labor Flow Record as 2:30 a.m. Nurse Williams also maintained Progress Notes in which she recorded her observations of Patient L.H. and her conversations with Patient L.H. The first entry in the Progress Notes was at 2:35 a.m.2 Nurse Williams' Progress Notes reflect that, at 2:35 a.m., Patient L.H. advised Nurse Williams that she had contractions and believed she had been in labor since 6:00 p.m. the previous evening but had waited to come to the Medical Center until she was certain she was in labor. Patient L.H. also reported abdominal pain in her upper abdomen that did "not go away," and Nurse Williams observed that Patient L.H. was distressed by the pain in her abdomen. Patient L.H. also told Nurse Williams that she had no ruptured membranes or vaginal bleeding. Nurse Williams noted that she examined Patient L.H. and felt contractions but was unable to detect a fetal heart tone. Nurse Williams reported in the Admission Assessment form that Patient L.H. was having uterine contractions of moderate intensity and 60 seconds' duration, that her cervix was dilated 1-to-2 centimeters, that she had vaginal bleeding that was bright red, that her blood pressure was 159/118, which she described as "elevated," and that Patient L.H.'s abdominal pain was the "worse" pain on a pain scale ranging from 1 to 10; there is, however, no indication on the Admission Assessment form that the pain was constant. Nurse Williams also noted on the Admission Assessment form that she heard no fetal heart rate. Although the time noted on the Admission Assessment form was 2:45 a.m., it is apparent from a review of the relevant records that the information included on the Admission Assessment form was obtained by Nurse Williams over a period of time extending from the time Patient L.H. presented to her until 3:00 a.m., the time on the Admission Assessment form beside Nurse Williams' signature. Nurse Williams reported in the "Physician /CNM in/Called Report" section of the Labor Flow Record that she contacted Dr. Achong at 2:30 a.m. and conveyed to him the following information: "[P]atient arrived in ER c/o contractions since 6 pm last night & observation that no FHT [fetal heart tone] and contractions palpated." Nurse Williams telephoned Dr. Achong using his home telephone, even though his beeper number was also on file at the Medical Center. There is nothing in the report Nurse Williams gave to Dr. Achong at 2:30 a.m. that would require that he proceed to the Medical Center and examine Patient L.H., and he did not violate the standard of care by failing to do so. Because Dr. Achong did not know Patient L.H., Nurse Williams' normal procedure would have been to advise Dr. Achong of Patient L.H.'s history, including the medications she was taking, and her vital signs, including her blood pressure. No notation appears in the Labor Flow Record to confirm that she gave Dr. Achong this information during her conversation with him at 2:30 a.m., nor is there a notation in the 2:30 a.m. entry in the Labor Flow Record that Nurse Williams told Dr. Achong about the results of her examination of Patient L.H.'s cervix, Patient L.H.'s complaint of abdominal pain, or the presence of vaginal bleeding of bright red blood.3 Nurse Williams indicated in her entry in the "Physician/CNM in/Called Report" section of the Labor Flow Record that Dr. Achong ordered a "stat," or expedited, obstetrical sonogram during the 2:30 a.m. contact with Nurse Williams. The purpose of the obstetrical sonogram was to determine if the fetus was alive. Although not noted in the Labor Flow Record, the Labor and Delivery Orders form completed by Nurse Williams indicates that, at 2:30 a.m., Dr. Achong ordered a complete blood count, which is routine with a patient in labor; a DIC profile; and a Comprehensive Metabolic Panel ("CMP"). The Labor and Delivery Orders form contains standard orders for a woman in labor, but the DIC profile and the CMP tests were not included on the form but were ordered specifically by Dr. Achong. A DIC profile is used to determine if a patient has a problem with blood clotting. The DIC includes an assessment of prothrombin time and partial thromboplastin time, both of which indicate different levels at which a patient's blood is able to clot. It is important to know whether a woman in labor and delivery has a clotting problem, or coagulopathy, because of the danger of bleeding, and the classic situation in which DIC profiles are ordered is when there is fetal demise. Because Patient L.H. had the high risk factors of overweight and hypertension and because Nurse Williams could detect no fetal heart tone, Dr. Achong's order for the DIC profile was appropriate and met the standard of care. It is also appropriate to order a DIC profile when there is a concern about placental abruption, which is the separation of the placenta from the walls of the vagina. A placental abruption causes a great deal of bleeding, and can cause death when not treated, because the fetus is still in the womb and the uterus is not able to contract and constrict the large blood vessels that attach to the placenta. Although hypertension is one risk factor for placental abruption, the symptoms of placental abruption also include fetal demise, bleeding, constant pain, a decrease in hematocrit, and a number of other conditions. There is no indication in Patient L.H.'s medical records that Dr. Achong had sufficient information at 2:30 a.m. that would indicate that Patient L.H. had a possible placental abruption, and he ordered the DIC profile because of the lack of fetal heart tones.4 The CMP includes tests for kidney and liver function and for uric acid. It is used to determine if a woman has pre-eclampsia, or pregnancy-induced hypertension. Given Patient L.H.'s history of hypertension and the level of her blood pressure as reflected in the Admission Assessment form, Dr. Achong's order for the CMP was appropriate and met the standard of care in ordering the CMP. All orders for blood tests for women in labor and delivery are treated as "stat" orders and are processed ahead of all other test orders except those from the emergency room. When the situation warrants, a physician may order that the tests be performed more quickly than the usual "stat" order would require, and it would be possible to obtain blood-test results within 45 minutes. There is, however, no indication in Patient L.H.'s medical records that Dr. Achong had any information at 2:30 a.m. that might indicate that he should further expedite Patient L.H.'s blood tests. Nurse Williams reported in her Progress Notes that, at 2:40 a.m., Patient L.H. reported a "gush of something down there," and Nurse Williams noted that she observed a large amount of blood; there is, however, no notation in the Progress Notes regarding the color of the blood. Nurse Williams also included a notation in the Progress Notes that Patient L.H.'s cervix was "3cm dilated, 50% effaced, -3 station" to describe the progress of Patient L.H.'s labor. Nurse Williams reported in the Labor Flow Record that she contacted Dr. Achong at 2:45 a.m. and conveyed to him the following information: "Dr. Achong notified of gush of vaginal bleeding. VE [vaginal examination] 2-3, 50% effaced, -3 station and that we are awaiting sonogram." The results of Nurse Williams' vaginal examination of Patient L.H. showed that Patient L.H. was in active labor. The information that Patient L.H. experienced a "gush of vaginal bleeding" did not indicate to Dr. Achong that there was anything more than one episode of bleeding, which he attributed to an especially heavy "bloody show," which is the bleeding that occurs when the cervix is dilating. The notation indicates that Dr. Achong told Nurse Williams to call him if Patient L.H. went to delivery. The information conveyed to Dr. Achong at 2:45 a.m., as reflected in the notation in the Labor Flow Record, was not sufficient to indicate that Patient L.H. was not proceeding through labor normally to a vaginal delivery of the dead fetus, which is preferred over delivery by a Cesarean Section. Nurse Williams did not include in her records a notation that she advised Dr. Achong that the "gush of vaginal bleeding" consisted of a large amount of bright red blood, which would have been an indication of a possible placental abruption. Some bleeding is normal during labor, but it is usually a dark color from having been in the uterus and in a small amount or tickle, although there could be a "gush of blood" during normal labor. When Dr. Achong was advised by Nurse Williams that Patient L.H. had a "gush of blood," however, it was his responsibility to inquire into the amount of blood, the color of the blood, and the persistency of the bleeding to determine if Patient L.H. was proceeding with normal labor or if she was experiencing a hemorrhage or other abnormal condition. Nurse Williams made no entries in the Progress Notes for Patient L.H. between 2:40 a.m. and 3:40 a.m., when she reported that the ultrasound had been completed. She further noted in her Progress Notes: "Report of no fetal heart tones to Dr. Achong. Orders given." Nurse Williams additionally made a notation in the Labor Flow Record that, at 3:40 a.m., she contacted Dr. Achong and reported to him the following: "Ultrasound report No FHT's given to Dr. Achong. Orders received." Nurse Williams did not, however, indicate in her notations what orders were given. Nurse Williams contacted Dr. Achong through his home telephone number, which was normal procedure during the nighttime hours. When the sonographer, that is, the person performing the sonogram, entered Patient L.H.'s room to perform the sonogram, he noted that Patient L.H. was sitting upright in bed, was combative, and was in a lot of pain. He also noted that there was a fair amount of blood on the bed sheets. The sonographer was able to get Patient L.H. to lie on the bed, and he performed "a very short ultrasound,"5 and pulled the machine out of the room and into the hall. He powered the machine back up and read the numbers off the worksheet on the machine. He confirmed that the fetus was dead and that the placenta appeared to be balled up rather than lying smoothly against the uterine wall, as is normal. While he was writing down the information from the worksheet on the machine, Nurse Williams approached him and told him that she had Dr. Achong on the telephone. He told her that he had "a placental abruption and fetal demise."6 He then wrote up his report, left a copy for Nurse Williams, and went downstairs to process the sonogram images.7 The results of the sonogram were reported on a form headed "Obstetrical Preliminary Report," which was completed by the sonographer. A radiologist is usually present at the Medical Center during daytime hours to read sonograms, but on the off-hours, it is the practice of the sonographer to present a sonographer's impression of what was seen during the sonogram. The sonographer who performed the sonogram on Patient L.H. noted on the report that her history included obesity, hypertension, heavy vaginal bleeding, and contractions. He included the following comments in the report: "Ant/Rt [unintelligible] placenta appears to be 'balled up[.]' Suggestion of placental abruption," and, on a separate line, "NO FETAL HEART MOTION SEEN PT IS COMBATIVE." Finally, at the bottom of the report, the sonographer noted that a copy of the report was given to Nurse Williams. There was no notation as to the time the sonographer gave the report to Nurse Williams, but, even if she had the report, she did not read it to Dr. Achong; rather, she put the copy of the report in Patient L.H.'s chart for Dr. Achong to review when he came to the hospital and gave him only a verbal report. Nurse Williams did not tell Dr. Achong during the 3:40 a.m. telephone conversation that the sonographer had reported a possible placental abruption.8 Dr. Achong was familiar with and had treated placental abruptions prior to February 15, 2004, and he always treated patients with placental abruptions on an emergency basis because both the mother and the baby could die if treatment was not received as soon as possible. Had Nurse Williams advised Dr. Achong that the sonographer had told her that he found a placental abruption or that the sonogram report included a reference to a possible placental abruption, he would have gone to the Medical Center immediately. At 3:45 a.m., Nurse Williams noted in her Progress Notes that she gave Patient L.H. Nubain and Phenergan for her painful contractions. There is no mention of continued vaginal bleeding in this entry in the Progress Notes. At 4:15 a.m., Nurse Williams noted in her progress notes that Patient L.H. was sleeping quietly and was relaxed and that Pitocin had been administered in accordance with Dr. Achong's orders. Pitocin is used to induce labor, augment labor, or to stop bleeding. In this case, Dr. Achong ordered the Pitocin to regulate Patient L.H.'s contractions. There is no mention in the 4:15 a.m. entry in the Progress Notes of continued vaginal bleeding. The next entry in Nurse Williams' Progress Notes was made at 5:15 a.m., when Nurse Williams reported that she had observed vaginal bleeding, that a vaginal examination showed dilation of four centimeters, and that Patient L.H. was very restless and moving around the bed. Nurse Williams received the laboratory report showing the results of the blood tests ordered by Dr. Achong at or around 5:00 a.m. According to the laboratory report, the blood for these tests was drawn at or about 3:20 a.m.; the report did not show any critical values in the blood sample. Nurse Williams attempted to contact Dr. Achong to convey these results to him. She noted on the Labor Flow Record that, at 5:15 a.m. "Dr. Achong beeped re lab results. Phone message left on home phone to call LR [Labor Room]." Nurse Williams made another entry on the Labor Flow Record that, at 6:55 a.m., she left a "message to Dr. Achong answering machine at home re labor progress update and labs." Dr. Achong was not, however, at home to receive the telephone calls or the messages. At or about 5:00 a.m. on February 15, 2004, Dr. Achong received a telephone call on his home telephone from Hialeah Hospital advising him that one of his patients or one of Dr. Hechavarria's patients was in active labor and about to deliver. Shortly after receiving the telephone call, Dr. Achong left his home to travel to Hialeah Hospital. He carried his beeper with him, but he did not receive any calls on the beeper. When he arrived at Hialeah Hospital and prepared to go into the delivery room, he gave it to the circulating nurse in case he should receive a beeper call while he was in the delivery room. Nurse Hayes, who had replaced Nurse Williams when Nurse Williams' shift had ended at 7:00 a.m., made a notation on the Labor Flow Record that, at 7:15 a.m., she called Dr. Achong and left a message. At 7:25 a.m., while he was in the delivery room, Nurse Hayes called his beeper. The circulating nurse had his beeper, and she notified him that he had received a call and told him the number. He recognized the number of the Medical Center, and he told the nurse to call the Medical Center and let them know that he was in the delivery room at Hialeah Hospital. Nurse Hayes asked that he call back as soon as possible. Blood for additional blood tests was drawn at or about 7:30 a.m., and the results, which were available within 15 minutes, showed several critical values that indicated that Patient L.H. was entering coagulopathy. At 7:38 a.m., as soon as he finished the delivery, he called the Medical Center and spoke with Nurse Hayes, who gave him a report on the status of Patient L.H. She told him that Patient L.H. had heavy bleeding and that the vaginal examination showed no change in the cervix. Dr. Achong ordered the Pitocin turned off. When Dr. Achong arrived at the Medical Center at 7:56 a.m., he found Patient L.H. very combative, bleeding, and with very bad vital signs. He ordered a "stat" Cesarean Section and ordered a blood transfusion. Patient L.H. died at 8:38 a.m., before any of the measures ordered by Dr. Achong could be implemented. The cause of death was recorded as placental abruption. Summary In summary, the evidence presented by the Department is not of sufficient weight to establish that Nurse Williams conveyed to Dr. Achong the information necessary for him to conclude that he should personally conduct a clinical evaluation of Patient L.H.; that he should consider the possibility that Patient L.H. had placental abruption; or that he should have provided medical assistance to Patient L.H. prior to his contact with Nurse Hayes at 7:38 a.m. Nurse Williams' Progress Notes report only two remarkable items: There were no fetal heart tones detected by physical examination or by sonogram; and, at 2:40 a.m., Patient L.H. reported a "gush of something" and Nurse Williams observed a large amount of blood. Neither Nurse Williams' entries in the Labor Flow Record regarding her contacts with Dr. Achong nor her testimony, to the extent that it has been found persuasive, is sufficient to establish that she advised Dr. Achong that she had observed a large amount of red blood at 2:40 a.m. or that the sonographer detected a possible placental abruption in the sonogram. Finally, Nurse Williams did not follow the protocol that required her to contact Dr. Achong through his beeper when she did not get an answer on his home telephone; she tried his beeper only once, at 5:15 a.m., and when she failed to reach him, left three messages on his home telephone. The Department presented no evidence to establish that Nurse Williams attempted to reach Dr. Achong by beeper between 5:15 a.m. and 7:55 a.m., the time of her last call to Dr. Achong's home telephone. Furthermore, the Department did not present evidence of sufficient weight to establish that Dr. Achong failed to initiate the appropriate procedures after he arrived at the Medical Center and examined Patient L.H. at or around 8:00 a.m. The evidence presented by the Department is, however, of sufficient weight to establish that Dr. Achong should have questioned Nurse Williams further when she advised him at 2:45 a.m. that she had observed a "gush" of vaginal bleeding. Even though vaginal bleeding may not be not unusual during labor, a report of a "gush" of blood should have alerted Dr. Achong to a potential problem. Although a physician practicing obstetrics is meeting the standard of care when relying on labor room nurses to advise him or her of the clinical status of labor and delivery patients and of any unusual symptoms exhibited by the patients, it is also incumbent on the physician to inquire further if a patient is presenting unusual symptoms. The persuasive evidence establishes that Dr. Achong violated the standard of care when he failed to ask Nurse Williams for additional information on Patient L.H.'s status during their 2:45 a.m. telephone conversation. Had he inquired further, Dr. Achong would have been alerted to the possibility that Patient L.H. had a placental abruption and would have gone to the hospital to provide appropriate care for Patient L.H.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Medicine, enter a final order finding that Dr. Achong violated Section 458.331(1)(t), Florida Statutes, by failing to elicit further information from Nurse Williams regarding the gush of blood she observed in Patient L.H and imposing the following penalties: Issuance of a letter of reprimand; Imposition of administrative fine in the amount of $2,500.00; and Six months' probation under such conditions as the Board of Medicine determines appropriate, should Dr. Achong ever resume the practice of medicine. DONE AND ENTERED this 4th day of January, 2010, in Tallahassee, Leon County, Florida. PATRICIA M. HART 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 4th day of January, 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
