The Issue The issues are whether Respondent withdrew controlled substances from the narcotics dispensing system and failed to document the administration or wastage of those substances; if yes, whether this conduct fails to conform to minimum acceptable standards of prevailing nursing practice; and, if yes, what penalty should be imposed on Respondent's license as a registered nurse.
Findings Of Fact The Department is the state agency charged with regulating the practice of nursing in the State of Florida. Respondent Marla Gunderson ("Respondent") is, and has been at all times material hereto, a licensed registered nurse in the State of Florida, having been issued license number 2832622 by the Florida Board of Nursing in 1994. Respondent was employed by Lee Memorial Health Care System Rehabilitation Hospital ("Lee Memorial") as a registered nurse from about January 29, 2001, until about March 22, 2001. During the first three or four weeks of Respondent's employment, she participated in a full-time training program through Lee Memorial's education department. A part of this training included training in the administration of medications to patients. After completing the three or four-week training program, Respondent began working directly with patients. From about mid-February 2001 through early-March 2001, Respondent had no problems with documenting the administration of medications to patients. Some time in or near the middle of March 2001, Melanie Simmons, R.N. ("Simmons"), Lee Memorial's Nursing Supervisor, received a complaint from the night nurse following Respondent's shift. The complaint alleged that a patient's wife reported that the pain medication her husband was given by Respondent was not the Codeine that had been ordered by the physician. Pursuant to Lee Memorial's policies and procedures, Simmons conducted an investigation into the allegations of the above-referenced complaint regarding the Respondent. Lee Memorial's policies and procedures set out a specific method for conducting investigations regarding the administration of medications to patients. First, the physician's orders are checked to see what medications have been ordered for the patient. Next, the Pyxis records are pulled to determine if and when medications were withdrawn for administration to patients. The Pyxis system is a computerized medication delivery system. Each nurse has an assigned user code and a password, which must be entered before medication can be withdrawn from the Pyxis system. Then, medication administration records (MARs), the documents used by nurses to record the administration of medications to patients, are checked to verify whether the nurse documented the administration of the medications to the patients for whom they were withdrawn. Finally, the Patient Focus Notes, the forms used by nurses to document non-routinely administered medications, are also checked to determine if, when, and why a medication was given to a patient. If after comparing the physician's orders, Pyxis records, MARs, and Patient Focus Notes, it is determined that medications were not properly administered or documented, the nurse making the errors is advised of the discrepancy and given an opportunity to review the documentation and explain any inconsistencies. Simmons' investigation, which included comparing the physician's orders, Pyxis records, MARs and Patient Focus Notes, revealed discrepancies in medications withdrawn by Respondent and the MARs of the three patients under her care. The time period covered by the investigation was March 12 through March 17, 2001. Of the six days included in the investigation period, Simmons determined that all the discrepancies had occurred on one day, March 13, 2001. Nurses are required to record the kind and amount of medication that they administer to patients. This information should be recorded at or near the time the medication is administered. It is the policy of Lee Memorial that should a nurse not administer the medication or the entire amount of the medication dispensed under his or her password, that nurse should have another nurse witness the disposal of the medication. The nurse who serves as a witness to the disposal of medication would then enter his or her identification number in the Pyxis. As a result of that entry, the nurse who observed the disposal of the medication would be listed on the Pyxis report as a witness to the disposal of the medication not administered to patients. Such excess medication is termed waste or wastage. The physician's order for Patient F.R. indicated that the patient could have 1 to 2 Percocet tablets, to be administered by mouth, as needed every 3 to 4 hours. On March 13, 2001, at 14:06 Respondent withdrew 2 Percocet tablets for Patient F.R. However, there was no documentation in the patient's MAR, focus notes, and other records which indicated that Respondent administered the Percocet tablets to Patient F.R. The physician's order for Patient G.D. indicated that 1 to 2 Percocet tablets could be administered to the patient by mouth as needed every 4 to 6 hours. On March 13, 2001, at 11:18 Respondent withdrew 2 Percocet tablets and on that same day at 17:16, Respondent withdrew another 2 Percocet tablets for Patient G.D. However, there was no documentation in the patient's MAR, focus notes, or any other records which indicated that Respondent administered the Percocet tablets to Patient G.D. The physician's order for Patient T.G. indicated that 1 to 1.5 Lortab/Vicodin tablets could be administered to the patient by mouth as needed every 4 to 6 hours. On March 13, 2001, Respondent withdrew 2 Lortab/Vicodin tablets for Patient T.G. However, Respondent failed to document on the patient's MAR, focus notes, or other records that the medication had been administered to Patient T.G. With regard to the above-referenced medications withdrawn by Respondent on March 13, 2001, there is no documentation that any of the medications were wasted. All the medications listed in paragraphs 13, 14, and 15 are narcotics or controlled substances. Because Respondent did not document the patients' MARs or focus notes after she withdrew the medications, there was no way to determine whether the medications were actually administered to the patients. Proper documentation is very important because the notations made on patient records inform nurses on subsequent shifts if and when medications have been administered to the patients as well as the kind and amount of medications that have been administered. Without such documentation, the nurses taking over the subsequent shifts have no way of knowing whether medication has been administered, making it possible for affected patients to be overmedicated. Respondent has been a registered nurse since 1994 and knows or should have known the importance of documenting the administration of medications to patients. Respondent does not dispute that she did not document the administration and/or wastage of the narcotics or controlled substance she withdrew from the Pyxis system on March 13, 2001, for the patients identified in paragraphs 13, 14, and 15. Moreover, Respondent provided no definitive explanation as to why she did not properly document the records. According to Respondent, she "could have been busy, called away, [or] got distracted." Following Simmons' investigation of Respondent relating to the withdrawal and/or administration of medications, Respondent agreed to submit to a drug test. The results of the drug test were negative. Prior to being employed by Lee Memorial, all of Respondent's previous experience as an R.N. had been in long- term care. Except for the complaint which is the subject of this proceeding, there have been no complaints against Respondent's registered nurse's license.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a Final Order (1) imposing an administrative fine of $250; (2) requiring Respondent to remit the Agency's costs in prosecuting this case; (3) requiring Respondent to complete a continuing education course, approved by the Board of Nursing, in the area administration and documentation of medications; and (4) suspending Respondent's nursing license for two years. DONE AND ENTERED this 1st day of April, 2002, in Tallahassee, Leon County, Florida. CAROLYN S. HOLIFIELD 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 1st day of April, 2002. COPIES FURNISHED: Reginald D. Dixon, Esquire Agency for Health Care Administration General Counsel's Office-Practitioner Regulation Post Office Box 14229 2727 Mahan Drive Tallahassee, Florida 32317-4229 Marla Gunderson 1807 Northeast 26 Terrace Cape Coral, Florida 33909 Ruth R. Stiehl, Ph.D., R.N. Executive Director Board of Nursing Department of Health 4080 Woodcock Drive, Suite 202 Jacksonville, Florida 32207-2714 Mr. 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
Findings Of Fact At all times here relevant Mario Aviles, Jr., was licensed by the Florida Board of Medical Examiners and held license No. ME 0020482. Clara Julio Yanes was a prenatal patient of Respondent in 1980. In 1979 Respondent had delivered Yanes' first child at Mount Sinai Hospital and Mrs. Yanes expected this second child to be delivered in a hospital. Respondent did not tell the Yaneses that he did not have hospital privileges and until the last minute they expected Respondent to deliver the baby. On 4 October 1980 Yanes called Respondent to advise him that Mrs. Yanes was in labor. Respondent's answering service said Respondent was on vacation and Dr. Pina was taking care of Respondent's patients. Pina called Yanes shortly thereafter and said he would meet them at the hospital. Shortly after the baby was born at Hialeah Hospital, Pina arrived and apologized for being late. Grisel Carbajol was a prenatal patient of Respondent in 1980. Aviles said he would take care of hospital admission at either North Shore, Hialeah, Baptist, or Mercy hospitals and that he was trying to get privileges at all of these hospitals. On October 31, 1980, Mrs. Carbajol visited Respondent's office because she was bleeding and thought she was in labor. He examined her and told her it would be a week before the baby would come. The next day, Sunday, she called his office and Respondent answered the telephone. When she described her symptoms, Respondent told her to take medication and to call him in four hours. When she called back she reached his answering service who told her they had passed her message to him, but she received no call from Respondent. Later that day when her labor pains became more frequent, Mrs. Carbajol went to the emergency room at Hialeah Hospital and her baby was delivered at Hialeah Hospital. She had been given Dr. Pina's telephone number two days before the delivery but did not call Pina. Mrs. Mario Mancebo was a prenatal patient of Respondent between January and August 1981. During her seventh month she started bleeding and attempted to contact Respondent, without success. Respondent had told her the baby could be delivered at Baptist Hospital so the Mancebos vent to Baptist Hospital where they learned Respondent did not have hospital privileges and could not have her admitted. Isabel Sierra was a prenatal patient of Respondent in March 1980. Respondent never told Mrs. Sierra which hospital to go to, nor did he tell her he did not have hospital privileges. When she started labor, the last of October 1980, she called Respondent's office but he never returned her call. After trying several times to contact him, she went to the emergency room at Jackson Memorial Hospital where her baby was born. During the period January 1980 to December 1981, Respondent did not have hospital privileges at any hospital in Miami yet he had numerous pregnant patients to whom he provided prenatal care. The practice of these patients turning up at the emergency rooms of several hospitals in the Miami area in a terminal labor state became so prevalent that Baptist Hospital wrote Respondent at least three letters (Exhibit 2) asking him to stop directing his patients to the emergency room at Baptist Hospital near the termination of their pregnancies, reminding him that he did not have privileges at Baptist Hospital, and requesting that he inform his patients that he could not deliver them at Baptist Hospital. Mercy Hospital wrote Respondent that his application for hospital privileges had been denied (Exhibit 3) and sent a complaint to the Dade County Medical Association about Respondent sending his patients in active labor to the emergency room at Mercy Hospital despite the written and oral requests that he desist from this practice The Chief, Emergency Room Service, at Mercy Hospital lodged an ethical complaint with Petitioner as a result of Respondent sending patients to the emergency room at Mercy Hospital near the termination of their pregnancies (Exhibit 4). Prenatal obstetric patients generally expect their obstetrician to deliver their babies. It is both fraudulent and unethical to take a patient for prenatal care when the obstetrician does not have privileges at a hospital and cannot provide hospital delivery for the baby. Furthermore, it is unethical to provide prenatal care up to termination of pregnancy and then send the patient to the emergency room of the nearest hospital for a strange doctor to deliver the baby. This is especially so when no record accompanies the patient, and any history obtained must come from the woman in labor or her accompanying relative. Most of these prenatal patients of Respondent had paid Respondent in full for his services, including delivery. At the termination of their pregnancies when Respondent could not be reached, their babies were delivered by a doctor strange to them when they went to a hospital emergency room. Several of these witnesses testified they could get no refund from Respondent after this happened, but one witness testified her husband had recovered those payments from Respondent after her baby had been delivered by another doctor.
Findings Of Fact Dr. Cambo is licensed by the Board of Medicine, holding license number 48428, and was licensed at all times pertaining to the events alleged in the Administrative Complaint. L. M., a 67 year old male, arrived at the emergency room of John F. Kennedy Memorial Hospital in Atlantis, Florida, at 12:08 p.m., on April 15, 1987. L. M. had been a resident at the Atlantis Nursing Home. L. M. spoke Finnish; he did not speak English. He had had an amputation of a portion of his right leg two weeks earlier due to gangrene caused by peripheral vascular disease. The staples from this amputation were still visible. He had had a stroke, had irregularities in a prior E.K.G. and generally was in poor health. His current medications included ecotrin, motrin, vasotic, lopressor, halcion and catapress. He had indicated that he had chest pain to the nursing home staff and to the Fire-Rescue technicians by signing. When he arrived at the emergency room L. M. was described as cyanotic, diaphoretic and hypotensive. His breathing was labored. He was examined by the emergency room physician, Randall Wolff. L. M.'s chest pain, labored breathing and cyanotic appearance were consistent with cardiogenic shock. Dr. Wolff ordered certain diagnostic tests which included a complete blood count, a chest x-ray, and arterial blood gases. An E.K.G. was performed at approximately 3:00 p.m. that afternoon. L. M.'s urine color that afternoon was indicative of infection. Test results showed an elevated white blood count, and immature white blood cell forms. These are consistent with an active infection from the recent amputation or a myocardial infarction. Dr. Wolff thought the patient should have been admitted to J.F.K. because of his chest pain and abnormal vital signs. Dr. Cambo was contacted by the emergency room staff because Dr. Cambo was on call for the health maintenance organization which provided L. M.'s medical care. Dr. Cambo came to the hospital at about 2:40 p.m. and saw L. M. and other HMO patients. No treatment for L. M., other than oxygen, had been ordered by Dr. Wolff. Apparently, Dr. Wolff did not regard L. M.'s condition as serious. Dr. Cambo conducted a physical examination of L. M., who by that time denied having chest pain by signing. The examination revealed that the right stump had no femoral pulse, while the left leg had 2+ femoral pulse. His blood pressure was on the low side of the normal range. Dr. Cambo also reviewed L. M.'s test results, including the 3:00 p.m. E.K.G. tracing. Dr. Cambo then telephoned Dr. Jerome Vincente, the primary care physician who had managed the care of patient L. M. while L. M. was being served by the International Medical Center No. 90 in West Palm Beach. During that telephone call Dr. Cambo and Dr. Vincente compared the 3:00 p.m. E.K.G. tracing with a prior E.K.G. tracing from L. M.'s records at International Medical Center. The prior E.K.G. tracing was similar to that taken at 3:00 p.m. Dr. Cambo's reading of the 3:00 p.m. tracing led him to diagnose inferior wall ischemia and marked T anterior wall ischemia. Taken in isolation, the 3:00 p.m. tracing would indicate that L. M. might be having a heart attack. After the comparison Dr. Cambo made of the prior tracing, Dr. Cambo concluded that L. M.'s current cardiac condition was not abnormal for him, and decided to transfer L. M. to Humana Hospital for the purpose of achieving continuity of treatment, i.e., so that he would be seen at Humana by his regular physicians. Dr. Cambo believed L. M. had an infection resulting from the recent amputation and had circulatory problems which had resulted in gangrene that had caused the amputation. Dr. Cambo returned to J.F.K. Hospital at 3:30 p.m. to see HMO patients, including L. M. who had not yet been transferred to Humana Hospital. Dr. Cambo again examined L. M. and after reviewing the progress notes of L. M. maintained by the J.F.K. Hospital nursing staff, he determined that L. M.'s condition had not changed since 3:00 p.m. Dr. Cambo left J.F.K. Hospital between 5:30 p.m. and 6:00 p.m. with the instruction that L. M. be transferred to Humana. Due to the delay encountered in obtaining transportation, Dr. Cambo ordered that the patient continue to receive oxygen and that he receive I.V. fluids. Between 6:30 p.m. and 7:30 p.m. Dr. Cambo contacted the nursing staff at the J.F.K. Hospital emergency room on two occasions. Each time he was told that L. M.'s condition remained the same and had not altered since his arrival at the emergency room shortly after noon. The Atlantis Ambulance Service arrived at J.F.K. Hospital at about 7:45 p.m. to transport L. M. to Humana Hospital. At about 11:00 p.m. on April 15, 1987, patient L. M. died from an anterior wall myocardial infarction at Humana Hospital.
Recommendation It is RECOMMENDED that the charges contained in Count I of the Administrative Complaint be dismissed. Count II of the Administrative Complaint was dismissed by the Department at the final hearing and requires no further action by the hearing officer or the Board of Medicine. DONE and ENTERED this 3rd day of April, 1989, in Tallahassee, Leon County, Florida. WILLIAM R. DORSEY 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 3rd day of April, 1989. APPENDIX Rulings on the proposed findings of fact. Findings proposed by Department of Professional Regulation. Covered in finding of fact 1. Covered in finding of fact 2. Covered in finding of fact 3. Covered in finding of fact 2 and 3. Covered in finding of fact 2. Rejected as unnecessary. Covered in finding of fact 3. Covered in finding of fact 3. Covered in finding of fact 2. To the extent appropriate covered in finding of fact 3 and 4. Covered in finding of fact 3. Covered in finding of fact 3. Rejected because the programming of the data scope to produce the quoted printout was not proven to be accurate. What is most important is the judgment of the physicians who examined the patient and were in a much better position to evaluate the significance of the results, not only of the E.K.G., but of all testing. Covered in finding of fact 4. The proposed finding that L. M. communicated non-verbally due to aphasia is rejected because it is equally likely that he could not communicate because English was not his primary language. Rejected as inconsistent with the Hearing Officer's view of the evidence. Rejected because the testimony of Dr. Cambo and Dr. Vincente indicates that the E.K.G. was not clearly indicative of myocardial infarction in this patient. Covered in finding of fact 4. Rejected as unnecessary and because there is no way to know whether the patient's blood pressure was low due to cardiogenic shock or the medication he was taking. Rejected is inconsistent with the Hearing Officer's view of the evidence. Rejected as inconsistent with the Hearing Officer's view of the evidence. Rejected as inconsistent with the Hearing Officer's view of the evidence. Rejected as unnecessary and irrelevant. There is no indication that the patient suffered from any problem because of the absence of written instructions for care to be given during the transfer. Rejected as inconsistent with the Hearing Officer's view of the evidence. Covered in finding of fact 5. Rejected because there was no argument between Dr. Wolff and Dr. Cambo about admitting the patient to J.F.K. The nursing notes, from which this inference is derived, are unreliable. Dr. Wolff did not testify to any such argument. Rejected as irrelevant. Rejected as unnecessary. Rejected as unnecessary. Rejected, the patient's breathing was not labored at 6:30 p.m. To the extent the nurses notes might indicate otherwise, they are rejected as unreliable. Rejected because the second page of the nurses notes is an after-the-fact creation. Rejected because the second page of the nurses notes is an after-the-fact creation. Rejected because the nurses notes have been found to be unreliable. Covered to the extent necessary in finding of fact 9. Covered to the extent necessary in finding of fact 9. Rejected as unnecessary. Rejected as unnecessary. Rejected as inconsistent with the Hearing Officer's view of the evidence. Rejected as inconsistent with the Hearing Officer's view of the evidence. Findings proposed by Respondent The findings proposed by the Respondent are not submitted in numbered paragraphs. The burden of the proposed findings of Dr. Cambo have been accepted. COPIES FURNISHED: LEE SIMMS, ESQUIRE DEPARTMENT OF PROFESSIONAL REGULATION 130 NORTH MONROE STREET TALLAHASSEE, FLORIDA 32399-0750 ROBERT H. SPRINGER, ESQUIRE 3003 SOUTH CONGRESS AVENUE SUITE 1A PALM SPRINGS, FLORIDA 33461 DOROTHY FAIRCLOTH EXECUTIVE DIRECTOR FLORIDA BOARD OF MEDICAL EXAMINERS 130 NORTH MONROE STREET TALLAHASSEE, FLORIDA 32399-0750
The Issue Whether the Agency for Health Care Administration (AHCA or the Agency) should approve the application for certificate of need (CON) 7700 filed by Miami Beach Healthcare Group, LTD. d/b/a Miami Heart Institute (Miami Heart or MH).
Findings Of Fact The Agency is the state agency charged with the responsibility of reviewing and taking action on CON applications pursuant to Chapter 408, Florida Statutes. The applicant, Miami Heart, operates a hospital facility known as Miami Heart Institute which, at the time of hearing, was comprised of a north campus (consisting of 273 licensed beds) and a south campus (consisting of 258 beds) in Miami, Florida. The two campuses operate under a single license which consolidated the operation of the two facilities. The consolidation of the license was approved by CON 7399 which was issued by the Agency prior to the hearing of this case. The Petitioner, Mount Sinai, is an existing health care facility doing business in the same service district. On February 4, 1994, AHCA published a fixed need pool of zero adult inpatient psychiatric beds for the planning horizon applicable to this batching cycle. The fixed need pool was not challenged. On February 18, 1994, Miami Heart submitted its letter of intent for the first hospital batching cycle of 1994, and sought to add twenty adult general inpatient psychiatric beds at the Miami Heart Institute south campus. Such facility is located in the Agency's district 11 and is approximately two (2) miles from the north campus. Notice of that letter was published in the March 11, 1994, Florida Administrative Weekly. Miami Heart's letter of intent provided, in pertinent part: By this letter, Miami Beach Healthcare Group, Ltd., d/b/a Miami Heart Institute announces its intent to file a Certificate of Need Application on or before March 23, 1994 for approval to establish 20 hospital inpatient general psychiatric beds for adults at Miami Heart Institute. Thus, the applicant seeks approval for this project pursuant to Sections 408.036(1)(h), Florida Statutes. The proposed capital expenditure for this project shall not exceed $1,000,000 and will include new construction and the renovation of existing space. Miami Heart Institute is located in Local Health Council District 11. There are no subsdistricts for Hospital Inpatient General Psychiatric Beds for Adults in District 11. The applicable need formula for Hospital General Psychiatric Beds for Adults is contained within Rule 59C-1.040(4)(c), F.A.C. The Agency published a fixed need of "0" for Hospital General Psychiatric Beds for Adults in District 11 for this batching cycle. However, "not normal" circumstances exist within District which justify approval of this project. These circumstances are that Miami Beach Community Hospital, which is also owned by Miami Beach Healthcare Group, Ltd., and which has an approved Certificate of Need Application to consol- idate its license with that of the Miami Heart Institute, has pending a Certificate of Need Application to delicense up to 20 hospital inpatient general psychiatric beds for adults. The effect of the application, which is the subject of this Letter of Intent, will be to relocate 20 of the delicensed adult psychiatric beds to the Miami Heart Institute. Because of the "not normal" circumstances alleged in the Miami Heart letter of intent, the Agency extended a grace period to allow competing letters of intent to be filed. No additional letters of intent were submitted during the grace period. On March 23, 1994, Miami Heart timely submitted its CON application for the project at issue, CON no. 7700. Notice of the application was published in the April 8, 1994, Florida Administrative Weekly. Such application was deemed complete by the Agency and was considered to be a companion to the delicensure of the north campus beds. On July 22, 1994, the Agency published in the Florida Administrative Weekly its preliminary decision to approve CON no. 7700. In the same batch as the instant case, Cedars Healthcare Group (Cedars), also in district 11, applied to add adult psychiatric beds to Cedars Medical Center through the delicensure of an equal number of adult psychiatric beds at Victoria Pavilion. Cedars holds a single license for the operation of both Cedars Medical Center and Victoria Pavilion. As in this case, the Agency gave notice of its intent to grant the CON application. Although this "transfer" was initially challenged, it was subsequently dismissed. Although filed at the same time (and, therefore, theoretically within the same batch), the Cedars CON application and the Miami Heart CON application were not comparatively reviewed by the Agency. The Agency determined the applicants were merely seeking to relocate their own licensed beds. Based upon that determination, MH's application was evaluated in the context of the statutory criteria, the adult psychiatric beds and services rule (Rule 59C-1.040, Florida Administrative Code), the district 11 local health plan, and the 1993 state health plan. Ms. Dudek also considered the utilization data for district 11 facilities. Mount Sinai timely filed a petition challenging the proposed approval of CON 7700 and, for purposes of this proceeding only, the parties stipulated that MS has standing to raise the issues remaining in this cause. Mount Sinai's existing psychiatric unit utilization is presently at or near full capacity, and MS' existing unit would not provide an adequate, available, or accessible alternative to Miami Heart's proposal, unless additional bed capacity were available to MS in the future through approval of additional beds or changes in existing utilization. Miami Heart's proposal to establish twenty adult general inpatient psychiatric beds at its Miami Heart Institute south campus was made in connection with its application to delicense twenty adult general inpatient psychiatric beds at its north campus. The Agency advised MH to submit two CON applications: one for the delicensure (CON no. 7474) and one for the establishment of the twenty beds at the south campus (CON no. 7700). The application to delicense the north campus beds was expeditiously approved and has not been challenged. As to the application to establish the twenty beds at the south campus, the following statutory criteria are not at issue: Section 408.035(1)(c), (e), (f), (g), (h), (i), (j), (k), (m), (n), (o) and (2)(b) and (e), Florida Statutes. The parties have stipulated that Miami Heart meets, at least minimally, those criteria. During 1993, Miami Heart made the business decision to cease operations at its north campus and to seek the Agency's approval to relocate beds and services from that facility to other facilities owned by MH, including the south campus. Miami Heart does not intend to delicense the twenty beds at the north campus until the twenty beds are licensed at the south campus. The goal is merely to transfer the existing program with its services to the south campus. Miami Heart did not seek beds from a fixed need pool. Since approximately April, 1993, the Miami Heart north campus has operated with the twenty bed adult psychiatric unit and with a limited number of obstetrical beds. The approval of CON no. 7700 will not change the overall total number of adult general inpatient psychiatric beds within the district. The adult psychiatric program at MH experiences the highest utilization of any program in district 11, with an average length of stay that is consistent with other adult programs around the state. Miami Heart's existing psychiatric program was instituted in 1978. Since 1984, there has been little change in nursing and other staff. The program provides a full continuum of care, with outpatient programs, aftercare, and support programs. Nearly ninety-nine percent of the program's inpatient patient days are attributable to patients diagnosed with serious mental disorders. The Miami Heart program specializes in a biological approach to psychiatric cases in the diagnosis and treatment of affective disorders, including a variety of mood disorders and related conditions. The Miami Heart program is distinctive from other psychiatric programs in the district. If the MH program were discontinued, the patients would have limited alternatives for access to the same diagnostic and treatment services in the district. There are no statutes or rules promulgated which specifically address the transfer of psychiatric beds or services from one facility owned by a health care entity to another facility also owned by the same entity. In reviewing the instant CON application, the Agency determined it has the discretion to evaluate each transfer case based upon the review criteria and to consider the appropriate weight factors should be given. Factors which may affect the review include the change of location, the utilization of the existing services, the quality of the existing programs and services, the financial feasibility, architectural issues, and any other factor critical to the review process. In this case, the weight given to the numeric need criteria was not significant. The Agency determined that because the transfer would not result in a change to the overall bed inventory, the calculated fixed need pool did not apply to the instant application. In effect, because the calculation of numeric need was inapplicable, this case must be considered "not normal" pursuant to Rule 59C-1.040(4)(a), Florida Administrative Code. The Agency determined that other criteria were to be given greater consideration. Such factors were the reasonableness of the proposal, the ability to afford access, the applicant's ability to provide a quality program, and the project's financial feasibility. The Agency determined that, on balance, this application should be approved as the statutory and other review criteria were met. Although put on notice of the other CON applications, Mount Sinai did not file an application for psychiatric beds at the same time as Miami Heart or Cedars. Mount Sinai did not claim that the proposed delicensures and transfers made beds available for competitive review. The Agency has interpreted Rule 59C-1.040, Florida Administrative Code, to mean that it will not normally approve an application for beds or services unless the statutory and rule criteria are met, including the need determination criteria. There is no list of circumstances which are routinely considered "not normal" by the Agency. In this case, the proposed transfer of beds was, in itself, considered "not normal." The approval of Miami Heart's application would allow an existing program to continue. As a result, the overhead to maintain two campuses would be reduced. Further, the relocation would allow the program to continue to provide access, both geographically and financially, to the same patient service area. And, since the program has the highest utilization rate of any adult program in the district, its continuation would be beneficial to the area. The program has an established referral base for admissions to the facility. The transfer is reasonable for providing access to the medically under-served. The quality of care, while not in issue, would be expected to continue at its existing level or improve. The transfer would allow better access to ancillary hospital departments and consulting specialists who may be needed even though the primary diagnosis is psychiatric. The cost of the transfer when compared to the costs to be incurred if the transfer is not approved make the approval a benefit to the service area. If the program is not relocated, Medicaid access could change if the hospital is reclassified from a general facility to a specialty facility. The proposed cost for the project does not exceed one million dollars. If the north campus must be renovated, a greater capital expenditure would be expected. The expected impact on competition for other providers is limited due to the high utilization for all programs in the vicinity. The subject proposal is consistent with the district and state health care plans and the need for health care facilities and services. The services being transferred is an existing program which is highly utilized and which is not creating "new beds." As such, the proposal complies with Section 408.035(1)(a), Florida Statutes. The availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing services in the district will not be adversely affected by the approval of the subject application. The proposed transfer is consistent with, and appropriate, in light of these criteria. Therefore, the proposal complies with Section 408.035(1)(b), Florida Statutes. The subject application demonstrates a full continuum of care with safeguards to assure that alternatives to inpatient care are fully utilized when appropriate. Therefore, the availability and adequacy of other services, such as outpatient care, has been demonstrated and would deter unnecessary utilization. Thus, Miami Heart has shown its application complies with Section 408.035(1)(d), Florida Statutes. Miami Heart has also demonstrated that the probable impact of its proposal is in compliance with Section 408.035(1)(l), Florida Statutes. The proposed transfer will not adversely impact the costs of providing services, the competition on the supply of services, or the improvements or innovations in the financing and delivery of services which foster competition, promote quality assurance, and cost-effectiveness. Miami Heart has taken an innovative approach to promote quality assurance and cost effectiveness. Its purpose, to close a facility and relocate beds (removing unnecessary acute care beds in the process), represents a departure from the traditional approach to providing health care services. By approving Miami Heart's application, overhead costs associated with the unnecessary facility will be eliminated. There is no less costly, more efficient alternative which would allow the continuation of the services and program Miami Heart has established at the north campus than the approval of transfer to the south campus. The MH proposal is most practical and readily available solution which will allow the north campus to close and the beds and services to remain available and accessible. The renovation of the medical surgical space at the south campus to afford a location for the psychiatric unit is the most practical and readily available solution which will allow the north campus to close and the beds and services to remain available and accessible. In totality, the circumstances of this case make the approval of Miami Heart's application for CON no. 7700 the most reasonable and practical solution given the "not normal" conditions of this application.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That the Agency for Health Care Administration enter a final order approving CON 7700 as recommended in the SAAR. DONE AND RECOMMENDED this 5th day of April, 1995, in Tallahassee, Leon County, Florida. JOYOUS D. 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 5th day of April, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-4755 Note: Proposed findings of fact are to contain one essential fact per numbered paragraph. Proposed findings of fact paragraphs containing multiple sentences with more than one statement of fact are difficult to review. In reviewing for this case, where all sentences were accurate and supported by the recorded cited, the paragraph has been accepted. If the paragraph contained mixed statements where one sentence was an accurate statement of fact but the others were not, the paragraph has been rejected. Similarly, if one sentence was editorial comment, argument, or an unsupported statement to a statement of fact, the paragraph has been rejected. Proposed findings of fact should not include argument, editorial comments, or statements of fact mixed with such comments. Rulings on the proposed findings of fact submitted by Petitioner, Mount Sinai: Paragraphs 1 through 13 were cited as stipulated facts. Paragraph 14 is rejected as irrelevant. With regard to paragraph 15 it is accepted that Miami Heart made the business decision to move the psychiatric beds beds from the north campus to the south campus. Any inference created by the remainder of the paragraph is rejected as irrelevant. Paragraph 16 is rejected as irrelevant. Paragraph 17 is rejected as irrelevant. Paragraph 18 is accepted. Paragraph 19 is rejected as irrelevant. Paragraph 20 is rejected as contrary to the weight of the credible evidence. Paragraph 21 is rejected as contrary to the weight of the credible evidence. Paragraph 22 is accepted. Paragraph 23 is rejected as irrelevant. Paragraph 24 is accepted. Paragraph 25 is rejected as repetitive, or immaterial, unnecessary to the resolution of the issues. Paragraph 26 is rejected as irrelevant or contrary to the weight of the credible evidence. Paragraph 27 is rejected as comment or conclusion of law, not fact. Paragraph 28 is accepted but not relevant. Paragraphs 29 and 30 are accepted. Paragraphs 31 through 33 are rejected as argument, comment or irrelevant. Paragraph 34 is rejected as comment or conclusion of law, not fact. Paragraph 35 is rejected as comment or conclusion of law, not fact, or irrelevant as the FNP was not in dispute. Paragraph 36 is rejected as irrelevant. Paragraph 37 is rejected as repetitive, or comment. Paragraph 38 is rejected as repetitive, comment or conclusion of law, not fact, or irrelevant. Paragraph 39 is rejected as argument or contrary to the weight of credible evidence. Paragraph 40 is accepted. Paragraph 41, 42, and 43 are rejected as contrary to the weight of the credible evidence and/or argument. Paragraph 44 is rejected as argument and comment on the testimony. Paragraph 45 is rejected as argument, irrelevant, and/or not supported by the weight of the credible evidence. Paragraph 46 is rejected as argument. Paragraph 47 is rejected as comment or conclusion of law, not fact. Paragraph 48 is rejected as comment, argument or irrelevant. Paragraph 49 is rejected as comment on testimony. It is accepted that the proposed relocation or transfer of beds is a "not normal" circumstance. Paragraph 50 is rejected as argument or irrelevant. Paragraph 51 is rejected as argument or contrary to the weight of credible evidence. Paragraph 52 is rejected as argument or contrary to the weight of credible evidence. Paragraph 53 is rejected as argument, comment or recitation of testimony, or contrary to the weight of credible evidence. Paragraph 54 is rejected as irrelevant or contrary to the weight of credible evidence. Paragraph 55 is rejected as irrelevant, comment, or contrary to the weight of credible evidence. Paragraph 56 is rejected as irrelevant or argument. Paragraph 57 is rejected as irrelevant or argument. Paragraph 58 is rejected as contrary to the weight of credible evidence. Paragraph 59 is rejected as irrelevant. Paragraph 60 is rejected as contrary to the weight of credible evidence. Paragraph 61 is rejected as argument or contrary to the weight of credible evidence. Paragraph 62 is rejected as argument or contrary to the weight of credible evidence. Paragraph 63 is accepted. Paragraph 64 is rejected as irrelevant. Mount Sinai could have filed in this batch given the not normal circumstances disclosed in the Miami Heart notice. Paragraph 65 is rejected as irrelevant. Paragraph 66 is rejected as comment or irrelevant. Paragraph 67 is rejected as argument or contrary to the weight of credible evidence. Paragraph 68 is rejected as argument or irrelevant. Paragraph 69 is rejected as argument, comment or irrelevant. Paragraph 70 is rejected as argument or contrary to the weight of credible evidence. Rulings on the proposed findings of fact submitted by the Respondent, Agency: Paragraphs 1 through 6 are accepted. With the deletion of the words "cardiac catheterization" and the inclusion of the word "psychiatric beds" in place, paragraph 7 is accepted. Cardiac catheterization is rejected as irrelevant. Paragraph 8 is accepted. The second sentence of paragraph 9 is rejected as contrary to the weight of credible evidence or an error of law, otherwise, the paragraph is accepted. Paragraph 10 is accepted. Paragraphs 11 through 17 are accepted. Paragraph 18 is rejected as conclusion of law, not fact. Paragraphs 19 and 20 are accepted. The first two sentences of paragraph 21 are accepted; the remainder rejected as conclusion of law, not fact. Paragraph 22 is rejected as comment or argument. Paragraph 23 is accepted. Paragraph 24 is rejected as argument, speculation, or irrelevant. Paragraph 25 is accepted. Rulings on the proposed findings of fact submitted by the Respondent, Miami Heart: Paragraphs 1 through 13 are accepted. The first sentence of paragraph 14 is accepted; the remainder is rejected as contrary to law or irrelevant since MS did not file in the batch when it could have. Paragraph 15 is accepted. Paragraph 16 is accepted as the Agency's statement of its authority or policy in this case, not fact. Paragraphs 17 through 20 are accepted. Paragraph 21 is rejected as irrelevant. Paragraph 22 is rejected as irrelevant. Paragraphs 23 through 35 are accepted. Paragraph 36 is rejected as repetitive. Paragraphs 37 through 40 are accepted. Paragraph 41 is rejected as contrary to the weight of the credible evidence to the extent that it concludes the distance to be one mile; evidence deemed credible placed the distance at two miles. Paragraphs 42 through 47 are accepted. Paragraph 48 is rejected as comment. Paragraphs 49 through 57 are accepted. COPIES FURNISHED: Tom Wallace, Assistant Director Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Sam Power, Agency Clerk Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 R. Terry Rigsby Geoffrey D. Smith Wendy Delvecchio Blank, Rigsby & Meenan, P.A. 204 S. Monroe Street Tallahassee, Florida 32302 Lesley Mendelson Senior Attorney Agency for Health Care Administration 325 John Knox Road, Suite 301 Tallahassee, Florida 32303-4131 Stephen Ecenia Rutledge, Ecenia, Underwood, Purnell & Hoffman, P.A. 215 South Monroe Street Suite 420 Tallahassee, Florida 32302-0551
The Issue The issue to be determined in this proceeding is whether Respondent, Babak Saadatmand, M.D. (Respondent or Dr. Saadatmand), has violated section 458.331(1)(m) and (t), Florida Statutes (2013), as alleged in the Administrative Complaint.
Findings Of Fact Based upon the testimony and documentary evidence presented at hearing, the demeanor and credibility of the witnesses, and the entire record of this proceeding, the following findings of fact are made: The Parties Petitioner, the Department of Health, is the agency charged with the regulation of the practice of medicine pursuant to chapters 20, 456, and 458, Florida Statutes. Respondent, Babak Saadatmand, M.D., is a medical doctor licensed by the Board of Medicine. Dr. Saadatmand holds Florida license number ME 114656. Respondent graduated from the University of Maryland, College of Medicine, in 1988, and completed his residency at Case Western Reserve. He then completed a residency in emergency medicine at Cook County Hospital in Chicago, Illinois. Respondent was board-certified in internal medicine, but no longer holds that certification because at the time it was due for renewal, he was no longer eligible because his practice was devoted to emergency medicine as opposed to internal medicine. He remains board-certified in emergency medicine. Respondent has held positions that required him to supervise residents and give lectures at Yale University, New York College of Medicine, and Indiana University. Dr. Saadatmand chose to practice emergency medicine as a traveling physician for the last three years, because of the financial benefits available by doing so while he gained additional experience in emergency medicine. However, he has since or now accepted a position as the assistant program director of the emergency medicine residency program at Jackson Memorial Hospital in Miami, Florida, where his job responsibilities will include the supervision of residents. Dr. Saadatmand holds a medical license in several other states in addition to Florida, and has not been disciplined in any state where he is licensed. Dr. Saadatmand’s Treatment of R.D. In June and July of 2014, Respondent was working as a traveling physician at Parrish Medical Center in Titusville, Florida. While most of his assignments in various emergency facilities have been six months long, the assignment at Parrish Medical Center was for approximately one month. Respondent treated patient R.D. on June 27, 2014, at Parrish Medical Center emergency room. R.D. was accompanied by his wife, C.D. R.D. was a 52-year-old male when he presented to Parrish Medical Center. He had a history of T-cell lymphoma and had been treated for his cancer through the Space Coast Cancer Center. Just days before his presentation to the emergency room on June 27, 2014, he had been cleared to return to his place of employment. However, on June 27, 2014, R.D.’s supervisor called R.D.’s wife, C.D., and asked her to come get R.D. as he was too ill to be at work. R.D. arrived at Parrish Medical Center in the early afternoon, and was triaged by a nurse at approximately 2:13 p.m. The notes from the triage nurse’s assessment recorded, among other things, R.D.’s vital signs upon arrival; his chief complaint, including its duration and intensity; a brief medical history; a list of his current medications; and a drug/alcohol use history. Registered Nurse Sharon Craddock was the emergency room nurse who completed the initial assessment, or triage assessment, of R.D.’s condition. According to her triage notes in the Parrish Medical Center records, R.D.’s chief complaint upon arrival was constipation, which was described as constipation for three days, with bilateral abdominal pain. The pain was described as aching, pressure, shooting, and throbbing, and R.D.’s pain level was reported in Ms. Craddock’s notes as being an eight on a ten-point scale. Her description of his abdomen was “soft, non-tender, round, and obese.” Nurses are directed to record the pain level reported by the patient, and not to alter the pain level based on the nurse’s observation.1/ R.D.’s vital signs were taken upon his arrival at Parrish Medical Center and were recorded in the electronic medical records as follows: temperature, 98.4F; pulse, 127H; respiration, 20; blood pressure, 120/70; and pulse oximeter, 95. The only abnormal reading reflected in R.D.’s vital signs was his pulse, which was above 100, considered to be the upper limit of normal. R.D. reported that he had a medical history which included T-cell lymphoma and that he did not smoke or drink. His current medications were listed as aspirin, Zyrtec, Amaryl, Metformin, Prilosec, Percocet, Pravastatin, and a multivitamin. The Percocet dosage was listed as one tablet, three times daily, as needed for pain. Ms. Craddock also recorded a nursing note for R.D. at 3:37 p.m., and she was in the room when Respondent first went in to see R.D. Ms. Craddock’s nursing note indicates, “Pt with a hx of stomach CA with a recent ‘clean bill of health’ presents with ABD pain and constipation. Occasionally takes Percocet for pain. Wife at BS. Pt. sleepy, states he normally takes a nap this time of day. Pending MD eval with orders.” The Parrish Medical Center chart documents that R.D. was calm, cooperative, and asleep at 15:37 hours (3:37 p.m.). This presentation is generally inconsistent with a patient who is in severe abdominal pain. Dr. Saadatmand saw R.D. at approximately 3:56 p.m. Consistent with the custom at Parrish Medical Center, he worked with a scribe who took Respondent’s dictation for notes during his visit with the patient, and then loaded those notes into the electronic medical record. Respondent would then have the opportunity to review the notes as transcribed and direct the scribe to make any necessary changes. Dr. Saadatmand’s notes indicate that R.D. presented with abdominal pain, and was experiencing moderate pain that was constant with cramping. The description of R.D.’s pain as moderate was based upon Dr. Saadatmand’s observation of R.D. The chief complaint listed was constipation. Dr. Saadatmand took a history from R.D., who reported that he had been diagnosed with gastric lymphoma in 2013, and was treated with radiation and chemotherapy. R.D. and his wife, C.D., reported to Respondent that they feared his cancer might be returning, as his current symptoms were similar to those he experienced when his cancer was first diagnosed. He had returned to Space Coast Cancer Center for some additional screening two to three weeks before the emergency room visit, which included a CT of the abdomen and an upper and lower endoscopy. R.D. and his wife both believed that the results of the screening were normal. Respondent recorded this conversation in the electronic medical record as “[R.D.] had a recent follow up with Dr. Rylander and had normal EGD and colonoscopy. [R.D.] had recent CT scan with cancer center.” Space Coast Cancer Center does not use Parrish Medical Center to perform its CT scans or other testing, so the results of the recent CT scan were not available for Respondent to view. Respondent believed that R.D. and C.D. had followed the directions of R.D.’s oncologists, and R.D. had been a compliant patient. Respondent asked R.D. about his use of Percocet. He did not ask how much he was taking, but how often and whether the use had changed. He considered the answer to this question to be important, because a change in the use could indicate a change in R.D.’s pain intensity. R.D. did not report any change in the amount that he was taking, which was generally an “every other day thing for him.” Respondent testified that, given that the type of Percocet that R.D. was prescribed was an extra-strength as opposed to a standard version of Percocet, it was highly likely that R.D. would suffer from opioid-induced constipation. R.D. reported to Respondent that he had not attempted any laxatives. R.D. also denied having any nausea or surgical history. The lack of a surgical history is significant because patients with a recent surgical history and abdominal pain may be experiencing complications related to the surgery, which would account for the patient’s pain. There is no reference to R.D.’s diabetes in either the nursing triage notes or Dr. Saadatmand’s notes. The only reference in the past medical history is the report of cancer. The list of medications R.D. was taking at home includes Metformin HCI. No evidence was presented to establish whether Metformin is a drug prescribed only for diabetes or whether it is an accepted treatment for other conditions. Moreover, there is no evidence presented to establish how Respondent was to know that R.D. was diabetic if R.D. did not report the condition. In addition to taking R.D.’s medical history, Respondent performed a review of systems and a physical examination, including palpation of his abdomen. In his chart, the electronic medical record states under “review of systems,” “All systems: Reviewed and negative except as stated.” Under the category “Gastrointestinal,” the record indicates “Reports: Abdominal pain, Constipation. Denies: Nausea, vomiting, Diarrhea.” In the physical examination section of the electronic medical record, it is noted that R.D. was alert and in mild distress. The cardiovascular examination indicates that R.D. had a regular rate, normal rhythm, and normal heart sounds, with no systolic or diastolic murmur. With respect to his abdominal exam, Respondent indicated, “Present: Soft, normal bowel sounds. Absent: Guarding, Rebound, Rigid.” The notation that the abdomen was soft with normal bowel sounds is another way of noting that the abdomen is non-tender. Because R.D. was tachycardic upon presentation to the emergency room, Dr. Saadatmand noted R.D.’s anxiety about the possibility of his cancer returning, and checked his pulse a second time. When Respondent checked R.D.’s pulse, it had slowed to 90, which is within a normal range. In light of R.D.’s normal vital signs, normal abdominal examination, and the length of his pain and constipation, Respondent determined that the most likely cause for Respondent’s pain was constipation, and communicated that determination to R.D. and C.D. He asked whether R.D. had used a laxative and was told he had not. Dr. Saadatmand told R.D. and his wife that the pain medication that he took could be a source for his constipation, and that it would be prudent to try a laxative and see if that produced results before considering any further diagnostic tests. Respondent did not order any lab tests for patient R.D. on June 27, 2014, because his vital signs and abdominal examination were normal. He did not order an EKG for R.D. because there were no symptoms to indicate a cardiac issue. Respondent also did not order a CT scan of the abdomen or pelvis for patient R.D. on June 27, 2014. He felt that, in terms of R.D.’s concern about cancer recurrence, there were tests available to R.D.’s oncologist that would be more useful in detecting any recurrence of R.D.’s cancer that are not available through an emergency room visit. For example, a PET scan would be the most helpful, but is not something that Respondent could order through the emergency room because it is not considered an emergent study. The Department has not alleged, and the evidence did not demonstrate, that R.D. suffered from any emergency condition that additional testing would have revealed and that went undetected by Dr. Saadatmand. Respondent did order a prescription-strength laxative, i.e., Golytely, for R.D., which is a laxative commonly used to treat constipation and to prepare patients for a colonoscopy. Dr. Saadatmand communicated his recommendation to R.D. and C.D., who seemed relieved that the problem might be limited to constipation. He also advised them to return to the emergency room should R.D.’s symptoms get worse or if he developed a fever, because those developments would indicate a change in his condition. R.D. received discharge instructions that are consistent with Dr. Saadatmand’s discussion with R.D. and his wife. The discharge instructions referred R.D. to his primary care physician, noted the prescription for Golytely, and provided information related to the community health navigator. The Patient Visit Information sheet received by R.D. specifically noted that the patient was acknowledging receipt of the instructions provided, and stated, “I understand that I have had EMERGENCY TREATMENT ONLY and that I may be released before all my medical problems are known and treated. Emergency medical care is not intended to be a substitute for complete medical care. My Emergency Department diagnosis is preliminary and may change after complete medical care is received. I will arrange for follow-up care.” R.D. also received printed materials about constipation and how to address the problem. These instructions stated that the patient should contact his or her primary care provider if the constipation gets worse, the patient starts to vomit, or has questions or concerns about his or her condition or care. It also instructed the patient to return to the emergency room if he or she had blood in his or her bowel movements or had a fever and abdominal pain with the constipation. R.D. signed the acknowledgment that he had read and understood the instructions given to him by his caregivers. The acknowledgment specifically referenced the instructions regarding constipation. The written instructions are consistent with the verbal advice provided by Respondent. R.D.’s Subsequent Treatment Unfortunately, R.D.’s symptoms did not improve. He developed a fever and his pain level increased significantly. As stated by his wife, his pain the following day was “way worse” than when he saw Dr. Saadatmand. After a call to her niece, a nurse that worked in the emergency room at Parrish Medical Center, C.D. took R.D. back to the hospital on June 28, 2014, at approximately 6:30 p.m. At that point, he had a heart rate of 125, a temperature of 101.6 degrees, and tenderness in the lower left quadrant of his abdomen. Testing indicated that R.D. had intra-abdominal masses and small collections of extra-luminal gas that suggested the possibility of a contained micro-perforation. There is no allegation in the Administrative Complaint that the micro- perforation existed at the time R.D. saw Respondent. R.D. died on August 23, 2014, as a result of end-stage T-cell lymphoma. The Expert Witnesses The Department presented the expert testimony of Annie Akkara, M.D. Dr. Akkara is board-certified in emergency medicine and has been licensed to practice medicine in Florida for approximately nine years. All of her practice has been in the greater Orlando area in the Florida hospital system. She worked full-time for one year when she first moved to Florida, and since that time approximately 80 percent of her practice has involved reviewing medical charts for Veracode Associates, to determine whether diagnostic codes are fully supported in the medical records. She takes emergency room shifts on an as-needed basis, and has supervisory responsibility over patient extenders, such as nurses and physicians’ assistants, but not over other physicians. Dr. Akkara has never served on any committee for a medical staff at a hospital or helped develop protocols for an emergency room, and has not conducted any type of medical research. Although her position requires her to review electronic medical records, she was not familiar with the program used by Parrish Medical Center. Dr. Akkara reviewed the medical records for the emergency room visits for both June 27 and 28, 2014, as well as the records from the inpatient admission after the June 28 visit. She also reviewed the expert witness reports of Drs. Orban and Smoak. Dr. Saadatmand presented the expert testimony of David Orban, M.D. Dr. Orban practices emergency medicine in the Tampa area. He attended medical school at St. Louis University and completed residencies in orthopedics and emergency medicine. Dr. Orban has been licensed to practice medicine in Florida since 1982 and has been board-certified in emergency medicine since 1981. Before he practiced in Florida, Dr. Orban served as an instructor in surgery at the Washington University School of Medicine, and from 1970 through 1983, was an assistant professor of medicine at the University of California, Los Angeles (UCLA). In that position, he supervised residents in the emergency medicine program and helped to develop the program’s curriculum. Dr. Orban left UCLA in 1983 and moved to Florida, in order to help establish the emergency medicine residency program at the University of Florida. Currently, Dr. Orban is the director of emergency medicine for the University of South Florida (USF), College of Medicine, and the Medical Director Emeritus for the Tampa General Hospital Emergency Room. The USF emergency medicine residency program is a competitive program which receives approximately 1,200 applications each year for ten residency positions. Dr. Orban continues to spend approximately 20-24 hours each week practicing in the emergency room, in addition to his teaching responsibilities. He both sees patients on his own and supervises residents who are seeing patients. He has extensive experience in evaluating non-traumatic abdominal pain in the emergency room.2/ Allegations Related to the Standard of Care Dr. Akkara testified that in her opinion, Dr. Saadatmand’s care and treatment departed from the standard of care in a variety of ways. She agreed that Respondent assessed R.D.’s abdomen, but believed that he erred in not specifically documenting that the abdomen was not tender. In this case, the patient record specifically states, “Abdominal exam: Present: Soft, Normal bowel sounds. Absent: Guarding, Rebound, Rigid.” In Dr. Akkara’s view, the notes should have been more specific, and she found fault with the fact that the notes did not use the words “tender” or “non-tender.” Dr. Orban, on the other hand, noted that Respondent specifically documented the absence of guarding, rigidity and rebound tenderness, and described the abdomen as “soft, with normal bowel sounds.” Dr. Orban testified that assessing an abdomen for guarding, rigidity, and rebound are all forms of checking for abdominal tenderness. He did not hesitate to interpret Respondent’s medical records for R.D. as reflecting a normal exam, meaning no tenderness was discovered. Dr. Orban’s opinion is supported by the differences in the medical records from R.D.’s June 27 and 28 emergency room visits, and what options are provided in the electronic medical record when a positive finding for tenderness is chosen. Dr. Orban’s testimony is credited. The Administrative Complaint alleges and Dr. Akkara opined that Respondent departed from the appropriate standard of care by failing to obtain a complete set of normal vital signs before R.D. was discharged from the hospital. The only vital sign that was ever abnormal during R.D.’s June 27 visit was his heart rate, which upon arrival was 127. Respondent rechecked R.D.’s heart rate when he examined him, and upon re-examination it was 90, well within normal limits. Dr. Orban did not believe that the standard of care required the physician, as opposed to possibly supportive staff, to obtain a complete set of vital signs prior to ordering a patient’s discharge. The evidence established that while there is sometimes a nursing standard in emergency rooms requiring a nurse to obtain a second set of vital signs before a patient is discharged, there is no corresponding standard that requires the physician to repeat all of the vitals as well. Dr. Akkara admitted that while she attempts to get a complete set of vital signs before she discharges a patient, she does not always succeed in doing so. The evidence did not demonstrate a departure from the standard of care for not obtaining a second set of vital signs prior to discharge, especially where, as here, all of R.D.’s vital signs were normal when he arrived at the emergency room, except for his heart rate, and Dr. Saadatmand did, in fact, re-assess R.D.’s heart rate prior to discharge. The Administrative Complaint alleges that Respondent fell below the standard of care by not ordering routine lab work for R.D. The Administrative Complaint does not allege what purpose the routine lab work would serve in the emergency treatment of R.D. Dr. Akkara testified that routine lab work should have been completed before discharge, and that it was a departure from the standard of care not to do so. She stated that the labs were necessary to assess white blood cell count, glucose levels, and kidney function, and in those cases where tenderness was noted in the upper right quadrant of the abdomen, also could indicate issues with the patient’s liver enzymes. Dr. Akkara acknowledged, however, that it is possible for a CBC (complete blood count) to be frequently misleading in patients with abdominal pain, and is often normal with patients with appendicitis. Blood work often cannot distinguish between serious and benign abdominal conditions, and Dr. Akkara admitted that with respect to R.D., given the records from the subsequent admission, any results from a CBC ordered on June 27 would not have altered the treatment of the patient or changed his ultimate outcome. Dr. Orban testified that in the majority of cases where a CBC is ordered in the emergency room, it is not helpful. Ordering a CBC is helpful where a patient has a fever because it would help identify infection, or where a patient appears anemic. Other than those instances, it is not all that useful and is over-utilized. A chemistry panel measures a patient’s serum levels for things like sodium, creatinine, and glucose. Dr. Orban testified that, even with a diabetic patient, unless the patient is experiencing vomiting, mental status changes, blurred vision, frequent urination, or other symptoms associated with diabetes, a blood chemistry panel would not be helpful for assessing a patient with non-traumatic abdominal pain. Records for R.D.’s June 28 visit (the day after Respondent saw R.D.) note that he was diabetic, while the June 27 records do not. However, it was not established that either R.D. or his wife ever told anyone, whether nursing staff or Dr. Saadatmand, that he was diabetic. There is no testimony that his prescription for Metformin was to treat diabetes, as opposed to some other condition, and there was no evidence to indicate that diabetes is the only condition for which Metformin can be prescribed. Dr. Akkara repeatedly referred to R.D.’s diabetes as a basis for her opinions, but never identified the records that formed a basis for her knowledge of R.D.’s diabetic condition. The evidence presented does not establish that ordering a blood chemistry or CBC was required by the appropriate standard of care related to the care and treatment of R.D. in the emergency room on June 27, 2016. Dr. Akkara also testified that Respondent departed from the standard of care by failing to obtain a CT scan of the abdomen and pelvis. Her opinion is based, at least in part, on her belief that Respondent failed to document that R.D.’s abdomen was non-tender. She agreed with Dr. Orban that if a patient has no abdominal tenderness, then a CT scan is probably not warranted. In addition, Dr. Orban testified credibly that over the last ten years, there has been a trend toward over-utilization of CT scans, with the concomitant increased risk of radiation- induced cancer. In this case, R.D. had reported having a CT scan just weeks before this emergency room visit. His abdomen was not tender. In a case such as this one, where the patient presents with non-traumatic abdominal pain and a normal abdominal examination and no fever, a CT scan is not warranted. Dr. Orban’s testimony is credited. There is not clear and convincing evidence to establish that the standard of care required Respondent to order a CT scan under the circumstances presented in this case. Dr. Akkara testified that Respondent also violated the standard of care by not ordering an EKG for R.D. However, she acknowledged that R.D. did not present with any cardiac-related symptoms and denied chest pain. The purpose of an EKG is to explore any cardiac-related symptoms, and R.D. did not present with any. Dr. Akkara did not provide any protocols that dictate when an EKG should be ordered. Dr. Akkara also acknowledged that ordering an EKG would have no impact on the care provided to R.D., and that a patient does not need an EKG just because he or she walks in the emergency room with tachycardia.3/ The Department did not establish that the failure to order an EKG violated the applicable standard of care in this case. The Department also has charged Respondent with failing to arrange for follow-up care and failing to discuss follow-up care, as well as reasons for R.D. to return to the emergency room, if necessary. However, as noted in paragraphs 32-34, Dr. Saadatmand discussed follow-up care with R.D. and told him what circumstances would require a return visit to the emergency room. Dr. Akkara acknowledged that the discharge instructions given to R.D. were adequate. As stated by Dr. Orban, the role of an emergency room physician with regard to the assessment of patients is to identify emergency situations and treat them. Emergency situations are those that are acute, rapidly decompensating, and that require either medical or surgical intervention, with most likely a hospital admission for more definitive care. It is not the emergency physician’s responsibility to manage a patient’s chronic conditions. It is routine to advise patients with non- acute conditions to follow up with their established physicians and to provide written instructions to that effect. Dr. Saadatmand’s actions in providing instructions, both in terms of follow-up and possible return to the emergency room, were consistent with the standard of care. Finally, the Administrative Complaint finds fault with Dr. Saadatmand for not conducting another abdominal examination and not re-assessing R.D.’s vital signs prior to discharge. As noted previously, the only vital sign that was abnormal when R.D. arrived was his heart rate. Respondent did re-assess R.D.’s heart rate prior to discharge, and it was normal. With respect to a second examination of Respondent’s abdomen, the Department did not establish that one was necessary. Here, Respondent’s initial examination was normal, and there was a reasonable explanation for his discomfort that Respondent believed needed to be addressed before going any further. Dr. Akkara offered no protocol or other authority other than her own clinical experience to support the opinion that serial examinations of the abdomen were required. On the other hand, Dr. Orban testified that where, as here, where the first examination was normal and there was no fever or vomiting, no second examination would be required.4/ Dr. Orban’s testimony is credited. In summary, the Department did not establish that Respondent violated the applicable standard of care in his care and treatment of R.D. Further, his medical records, while not perfect, justify the course of treatment provided in this case.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 5th day of December, 2016, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 5th day of December, 2016.
